<ichicsr lang="en">
  <ichicsrmessageheader>
    <messagetype>ICSR</messagetype>
    <messageformatversion>2.1</messageformatversion>
    <messageformatrelease>1.0</messageformatrelease>
    <messagenumb>2006-07</messagenumb>
    <messagesenderidentifier>FDA CDER ODS</messagesenderidentifier>
    <messagereceiveridentifier>Public Use</messagereceiveridentifier>
    <messagedateformat>204</messagedateformat>
    <messagedate>2006120811:10:02</messagedate>
  </ichicsrmessageheader>
  <safetyreport>
    <safetyreportid>4963115-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060405</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060327</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ES-GLAXOSMITHKLINE-B0419016A</companynumb>
    <primarysource>
      <reportercountry>SPAIN</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>85</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HEPATITIS CHOLESTATIC</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMOXICILLIN + CLAVULANATE POTASSIUM</medicinalproduct>
        <drugauthorizationnumb>50564</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>UPPER RESPIRATORY TRACT INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060212</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADIRO</medicinalproduct>
        <drugdosagetext>100MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ESSENTIAL HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugdosagetext>20MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060214</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ESSENTIAL HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060214</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4967094-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060403</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060321</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006039135</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>58</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>62.1428</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRONCHITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EFFECT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLATULENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RETCHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUTENT</medicinalproduct>
        <drugauthorizationnumb>21938</drugauthorizationnumb>
        <drugdosagetext>37.5 MG (37.5 MG, 1 IN 1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060313</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN CAP</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VICODIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MONTELUKAST SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEXAPRO</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADVAIR DISKUS 100/50</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROTONIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVAQUIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASCORBIC ACID</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4967123-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060403</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060321</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2005158897</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>74</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>73.7</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL ABSCESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUTENT</medicinalproduct>
        <drugauthorizationnumb>21938</drugauthorizationnumb>
        <drugdosagetext>50 MG (25 MG, 2 IN 1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTROINTESTINAL STROMAL TUMOUR</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050714</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYANOCOBALAMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLYBURIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PSYLLIUM HYDROPHILIC MUCILLOID (PSYLLIUM HYDROPHILIC MUCILLOID]</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN CAP</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4968821-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060411</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060330</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AT-GLAXOSMITHKLINE-B0419637A</companynumb>
    <primarysource>
      <reportercountry>AUSTRIA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>81</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>54</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD CREATININE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD UREA INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRESCRIBED OVERDOSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMOXICILLIN + CLAVULANATE POTASSIUM</medicinalproduct>
        <drugauthorizationnumb>50564</drugauthorizationnumb>
        <drugdosagetext>2.2G THREE TIMES PER DAY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>FURUNCLE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051213</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051216</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4970386-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060412</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060410</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0601153A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>54</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EMOTIONAL DISTRESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOOD ALTERED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMICTAL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>20241</drugauthorizationnumb>
        <drugdosagetext>200MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BIPOLAR DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
        <drugtreatmentduration>14</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMOXICILLIN + CLAVULANATE POTASSIUM</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>050564</drugauthorizationnumb>
        <drugdosagetext>875MG UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BRONCHITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060408</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMOXICILLIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>050542</drugauthorizationnumb>
        <drugdosagetext>500MG UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BRONCHITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4975380-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060411</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060329</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>RS005896-F</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>69</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>60</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HEPATITIS FULMINANT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RABEPRAZOLE SODIUM</medicinalproduct>
        <drugauthorizationnumb>20973</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEPAKENE</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMITRIPTYLINE HCL</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>CORDARONE</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IDARAC</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONAZEPAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLPIDEM TARTRATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NITRIDERM (GLYCERYL TRINITRATE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATARAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SMECTA (SMECTITE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZAMADOL (TRAMADOL)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4975966-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060412</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060331</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006RR-01906</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>91</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>JAUNDICE CHOLESTATIC</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUCLOXACILLIN</medicinalproduct>
        <drugauthorizationnumb>65102</drugauthorizationnumb>
        <drugdosagetext>500 MG, QID, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CELLULITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060309</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060313</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMOXICILLIN + CLAVULANATE POTASSIUM</medicinalproduct>
        <drugdosagetext>375 MG, TID, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CELLULITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060305</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060313</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIGOXIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENDROFLUAZIDE (BENDROFLUMETHIAZIDE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4977461-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060413</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060406</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006014535</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANAPHYLACTIC REACTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMLODIPINE</medicinalproduct>
        <drugauthorizationnumb>19787</drugauthorizationnumb>
        <drugdosagetext>5 MG, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PERINDOPRIL ERBUMINE</medicinalproduct>
        <drugdosagetext>2 MG, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CO-CODAMOL (CODEINE PHOSPHATE, PARACETAMOL)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4978823-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060417</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060404</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200603626</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>84</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ERYTHEMA MULTIFORME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC FUNCTION ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALESION (EPINASTINE)</medicinalproduct>
        <drugauthorizationnumb>21565</drugauthorizationnumb>
        <drugdosagetext>20 MG QD PO</drugdosagetext>
        <drugindication>HYPERSENSITIVITY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060225</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060302</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOXONIN</medicinalproduct>
        <drugdosagetext>240 MG QD PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060225</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060302</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLARITHROMYCIN</medicinalproduct>
        <drugdosagetext>800 MG QD PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060225</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060302</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PL (GR)</medicinalproduct>
        <drugdosagetext>4 G QD PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NASOPHARYNGITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060225</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060302</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CALONAL</medicinalproduct>
        <drugdosagetext>200 MG QD PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060225</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060302</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4979707-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060418</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060405</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>6021794</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>39</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EPISTAXIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIC PURPURA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENTRICULAR FIBRILLATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BISOPROLOL FUMARATE</medicinalproduct>
        <drugauthorizationnumb>19982</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060207</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REOPRO</medicinalproduct>
        <drugdosagetext>INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MYOCARDIAL INFARCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060131</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060131</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METALYSE</medicinalproduct>
        <drugdosagetext>INTRAVENOUS (NOT OTHERWISE SPECIFIED)</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MYOCARDIAL INFARCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050131</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060131</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPEGIC 1000</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATORVASTATIN CALCIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RAMIPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NICOPATCH  (NICOTINE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVENOX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4981621-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060425</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060328</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ABBOTT-06P-087-0329482-00</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>28</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>48</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EOSINOPHIL COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLARITHROMYCIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>50662</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>COUGH</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050708</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050714</drugenddate>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENOXACIN TABLETS</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ENTEROCOLITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050719</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050725</drugenddate>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CIPROFLOXACIN HCL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ENTEROCOLITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050725</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050728</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CEFIXIME CHEWABLE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050804</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050804</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BROMELAIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>COUGH</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050708</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050711</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIMEMORFAN PHOSPHATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>COUGH</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050708</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050714</drugenddate>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARBOCISTEINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>COUGH</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050708</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050714</drugenddate>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOXOPROFEN SODIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>COUGH</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050708</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050714</drugenddate>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUMIN TANNATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ENTEROCOLITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050719</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050728</drugenddate>
        <drugtreatmentduration>9</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTIBIOTICS-RESISTANT LACTIC ACID BACTERIAE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ENTEROCOLITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050719</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050728</drugenddate>
        <drugtreatmentduration>9</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4987999-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060426</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060403</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006009954</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>37</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DISEASE RECURRENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT AND COLD</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN EXFOLIATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWELLING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CETIRIZINE HCL</medicinalproduct>
        <drugauthorizationnumb>19835</drugauthorizationnumb>
        <drugdosagetext>1 DF (1 IN 1 D)</drugdosagetext>
        <drugindication>SWELLING</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050901</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ERYTHROMYCIN</medicinalproduct>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PENICILLIN V</medicinalproduct>
        <drugindication>RASH</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19920101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19920101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUCLOXACILLIN</medicinalproduct>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CEFIXIME CHEWABLE</medicinalproduct>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4989879-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060428</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060425</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>HQWYE481223MAR06</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>59</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANGIONEUROTIC OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CLOSTRIDIUM COLITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORTHOSTATIC HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUFFOCATION FEELING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CEFIXIME CHEWABLE</medicinalproduct>
        <drugauthorizationnumb>50621</drugauthorizationnumb>
        <drugdosagetext>400 MG DAILY ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>URINARY TRACT INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050503</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050509</drugenddate>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4997894-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060508</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060425</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2005161855</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>55</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>69.4003</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>APPENDICITIS PERFORATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACTEROIDES INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BILE DUCT STONE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CLOSTRIDIAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ESCHERICHIA INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERBILIRUBINAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERITONITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POST PROCEDURAL COMPLICATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUTENT</medicinalproduct>
        <drugauthorizationnumb>21968</drugauthorizationnumb>
        <drugdosagetext>50 MG, DAILY FOR 28 DAYS EVERY 6 WEEKS, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RENAL CELL CARCINOMA STAGE UNSPECIFIED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051108</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOSYN</medicinalproduct>
        <drugindication>PERITONITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCONTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PERCOCET</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COLACE (DOCUSATE SODIUM)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROTONIX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5000049-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060509</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060426</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006052904</companynumb>
    <primarysource>
      <reportercountry>KOREA, REPUBLIC OF</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>70</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>63</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CULTURE WOUND POSITIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PHLEBITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEPHROPATHY TOXIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STAPHYLOCOCCAL INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUTENT</medicinalproduct>
        <drugauthorizationnumb>21968</drugauthorizationnumb>
        <drugdosagetext>50 MG (50 MG, 1 IN 1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>METASTATIC RENAL CELL CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060406</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATORVASTATIN CALCIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RAMIPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOLAZONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUMIN (HUMAN)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARVEDILOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALSARTAN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5000116-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060509</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060426</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006011109</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>32</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FACE OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOCALISED OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NECK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARYNGOLARYNGEAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROCEDURAL COMPLICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UNEVALUABLE EVENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUTENT</medicinalproduct>
        <drugauthorizationnumb>21968</drugauthorizationnumb>
        <drugdosagetext>50 MG (50 MG, DAILY INTERVAL: EVERY DAY), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>METASTATIC RENAL CELL CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051230</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060117</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCONTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYNORM (OXYCODONE HYDROCHLORIDE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DICLOFENAC SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CO-DANTHRAMER (DANTRON, POLOXAMER)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BISACODYL (BISACODYL)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANSOPRAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NOZINAN (LEVOMEPROMAZINE)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5000123-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060509</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060426</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006038620</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>43</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERAL PHYSICAL HEALTH DETERIORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUTENT</medicinalproduct>
        <drugauthorizationnumb>21968</drugauthorizationnumb>
        <drugdosagetext>50 MG (50 MG, 1 IN 1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>METASTATIC RENAL CELL CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060213</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060309</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SENOKOT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COLACE (DOCUSATE SODIUM)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MORPHINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCODONE HYDROCHLORIDE AND ACETAMINOPHEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOFRAN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5000221-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060509</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060426</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006051538</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>46</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>82.4</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUTENT</medicinalproduct>
        <drugauthorizationnumb>21938</drugauthorizationnumb>
        <drugdosagetext>50 MG (50 MG, DAILY-INTERVAL:  CYCLIC), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>COLON CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060225</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IRINOTECAN HCL</medicinalproduct>
        <drugdosagetext>(360 MG, 2 WKLY - INTERVAL: EVERY 2 WEEKS), INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLON CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060223</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUOROURACIL</medicinalproduct>
        <drugdosagetext>(800 MG, 2 WKLY - INTERVAL: EVERY 2 WEEKS), INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLON CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060223</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEUCOVORIN CALCIUM</medicinalproduct>
        <drugdosagetext>(400 MG, 2 WKLY - INTERVAL: EVERY 2 WEEKS), INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLON CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060223</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5001659-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060511</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060511</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>50</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BACTERIAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CULTURE POSITIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CSF PROTEIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CSF WHITE BLOOD CELL COUNT POSITIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENTAL STATUS CHANGES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPHIL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GLEEVEC</medicinalproduct>
        <drugdosagetext>500 MG  PO  BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GLIOBLASTOMA MULTIFORME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060105</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HYDROXYUREA</medicinalproduct>
        <drugdosagetext>500 MG  PO  BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GLIOBLASTOMA MULTIFORME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060105</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PTK/ZK</medicinalproduct>
        <drugdosagetext>750 MG  PO  BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GLIOBLASTOMA MULTIFORME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060105</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TEGRETOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DECADRON</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZANTAC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENALOPRIL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5001663-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060511</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060511</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>111.2</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ATRIAL FIBRILLATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMATINIB MESYLATE</medicinalproduct>
        <drugdosagetext>400 MG  PO QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GLIOBLASTOMA MULTIFORME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051025</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060315</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HYDREA</medicinalproduct>
        <drugdosagetext>500 MG PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GLIOBLASTOMA MULTIFORME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051025</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060315</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PTK</medicinalproduct>
        <drugdosagetext>500 MG  PO  BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051025</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060315</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SCH66366</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TEMOZOLOMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KEPPRA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREVACID</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5001839-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060512</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060512</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>30.2</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>RASH PRURITIC</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ADVATE</medicinalproduct>
        <drugbatchnumb>LE01E107AD</drugbatchnumb>
        <drugdosagetext>1201 UNITS THREE TIMES A WEEK IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>FACTOR VIII DEFICIENCY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060315</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060508</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ADVATE</medicinalproduct>
        <drugbatchnumb>LE01E101AD</drugbatchnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5002948-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060516</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060509</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-GLAXOSMITHKLINE-B0423048A</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>25</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>116</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ALANINE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASPARTATE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CELL DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CYTOLYTIC HEPATITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ABACAVIR</medicinalproduct>
        <drugauthorizationnumb>21652</drugauthorizationnumb>
        <drugdosagetext>1TAB PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051121</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051230</drugenddate>
        <drugtreatmentduration>40</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TELZIR</medicinalproduct>
        <drugauthorizationnumb>021548</drugauthorizationnumb>
        <drugdosagetext>700MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051121</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051230</drugenddate>
        <drugtreatmentduration>40</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </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>20051121</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051230</drugenddate>
        <drugtreatmentduration>40</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVONORGESTREL AND ETHINYL ESTRADIOL</medicinalproduct>
        <drugdosagetext>30MCG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ORAL CONTRACEPTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5005616-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060515</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060502</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006059828</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>58</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>APHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOUTH ULCERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL CANDIDIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUTENT</medicinalproduct>
        <drugauthorizationnumb>21968</drugauthorizationnumb>
        <drugdosagetext>50 MG (50 MG, CYCLIC), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RENAL CELL CARCINOMA STAGE UNSPECIFIED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060322</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CO-CODAMOL (CODEINE PHOSPHATE, PARACETAMOL)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAMADOL HCL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5005629-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060515</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060502</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006059807</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>47</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>75</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>OESOPHAGITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUTENT</medicinalproduct>
        <drugauthorizationnumb>21968</drugauthorizationnumb>
        <drugdosagetext>50 MG (50 MG, CYCLIC), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RENAL CELL CARCINOMA STAGE UNSPECIFIED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060424</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5006894-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060517</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060504</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006056147</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>51</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>61.1</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ASPARTATE AMINOTRANSFERASE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD ALBUMIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD ALKALINE PHOSPHATASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>C-REACTIVE PROTEIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FIBRIN D DIMER INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROTEIN TOTAL DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RED BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUTENT</medicinalproduct>
        <drugauthorizationnumb>21938</drugauthorizationnumb>
        <drugdosagetext>50 MG (50 MG, DAILY), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTROINTESTINAL STROMAL TUMOUR</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060420</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MORPHINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOCLOPRAMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VENLAFAXIINE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIAZEPAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TEMAZEPAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMOXICILLIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MOVICOL (MACROGOL, POTASSIUM CHLORIDE, SODIUM BICARBONATE, SODIUM CHLO</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ORAMORPH SR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DICLOFENAC SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MICONAZOLE NITRATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANSOPRAZOLE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5006943-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060516</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060504</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>6022400</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>81</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ATROPHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLINDNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CATARACT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISEASE RECURRENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EOSINOPHILIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERAL PHYSICAL HEALTH DETERIORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OPTIC NEURITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RETINITIS PIGMENTOSA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TUBERCULOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
        <drugdosagetext>75 UG + 25 UG (100 MCG, 1 IN 1 D) ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CORTANCYL  (PREDNISONE)</medicinalproduct>
        <drugdosagetext>60 MG (60 MG, 1 D) ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051027</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RIFAMPIN AND ISONIAZID</medicinalproduct>
        <drugdosagetext>2 DOSAGE FORMS (2 DOSAGE FORMS, 1 D) ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051027</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREVISCAN  (FLUINDIONE)</medicinalproduct>
        <drugdosagetext>15,000 MG (15 MG, 1 IN 1 D) ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051227</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MYAMBUTOL</medicinalproduct>
        <drugdosagetext>4 DOSAGE FORMS (4 DOSAGE FORMS, 1 D) ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051027</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060126</drugenddate>
        <drugtreatmentduration>91</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CORDARONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MODOPAR  (LEVODOPA, BENSERAZIDE HYDROCHLORIDE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CACIT D3 (COLECALCIFEROL, CALCIUM CARBONATE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FORADIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PULMICORT</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5008996-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060519</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060515</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>HQWYE481223MAR06</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>59</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANGIONEUROTIC OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORTHOSTATIC HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSEUDOMEMBRANOUS COLITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUFFOCATION FEELING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CEFIXIME CHEWABLE</medicinalproduct>
        <drugauthorizationnumb>50621</drugauthorizationnumb>
        <drugdosagetext>400  MG DAILY ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050101</drugenddate>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5009624-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060524</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060111</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-US164399</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NON-CARDIAC CHEST PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PANITUMUMAB - OBSERVATION/NO DRUG</medicinalproduct>
        <drugindication>COLORECTAL CANCER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEULASTA</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>CHEMOTHERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVASTIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXALIPLATIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUOROURACIL</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLINIC ACID</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5010626-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060525</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060516</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHNU2006DE02022</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>CARDIAC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIABETIC NEPHROPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYSIPELAS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GOITRE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC CONGESTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SANDIMMUNE</medicinalproduct>
        <drugauthorizationnumb>50715</drugauthorizationnumb>
        <drugdosagetext>150/0/175MG/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEART TRANSPLANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19930101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMOXICILLIN + CLAVULANATE POTASSIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5014078-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060525</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060503</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>MX200605001001</companynumb>
    <primarysource>
      <reportercountry>MEXICO</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>78</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>68</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FEMORAL NECK FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE MYELOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugauthorizationnumb>21318</drugauthorizationnumb>
        <drugdosagetext>20 UG DAILY (1/D) SUBCUTANEOUS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050801</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POSTURE D (CALCIUM PHOSPHATE, COLECALCIFEROL, ERGOCALCIFEROL)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALFA D (ALFACALCIDOL)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CENTRUM SILVER (ASCORBIC ACID, CALCIUM, MINERALS NOS, RETINOL, TOCOPHE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EUTIROX (LEVOTHYROXINE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACTONEL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RAMIPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALZAM (ALPRAZOLAM)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5016585-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060414</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050504</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20050404983</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>53</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG ABUSER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ULTRAM</medicinalproduct>
        <drugauthorizationnumb>20281</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5016705-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060602</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041004</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0528405A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>7</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSGEUSIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMOXICILLIN + CLAVULANATE POTASSIUM</medicinalproduct>
        <drugbatchnumb>AD0679</drugbatchnumb>
        <drugauthorizationnumb>50575</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>URINARY TRACT INFECTION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5016713-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060602</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050126</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0542462A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>15</patientonsetage>
      <patientonsetageunit>802</patientonsetageunit>
      <patientweight>10.9</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>GINGIVAL BLEEDING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GINGIVAL SWELLING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMOXICILLIN + CLAVULANATE POTASSIUM</medicinalproduct>
        <drugauthorizationnumb>50575</drugauthorizationnumb>
        <drugdosagetext>1TSP TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>LOWER RESPIRATORY TRACT INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050121</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050125</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NO CONCURRENT MEDICATION</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5016743-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060602</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060329</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0599512A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>2</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMOXICILLIN + CLAVULANATE POTASSIUM</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>50575</drugauthorizationnumb>
        <drugdosagetext>4ML SINGLE DOSE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>EAR INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060327</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060327</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NO CONCURRENT MEDICATION</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5016815-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060602</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060221</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0594616A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>52</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HAEMATURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGE URINARY TRACT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMOXICILLIN + CLAVULANATE POTASSIUM</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>50564</drugauthorizationnumb>
        <drugdosagetext>875MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>URINARY TRACT INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051001</drugstartdate>
        <drugtreatmentduration>10</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5018421-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060530</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060515</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006RR-02156</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABNORMAL FAECES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CANDIDIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EPISTAXIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMPAIRED HEALING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LACTOSE INTOLERANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALNUTRITION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARYNGEAL OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH GENERALISED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UPPER LIMB FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UPPER RESPIRATORY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY RETENTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING PROJECTILE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMOXICILLIN + CLAVULANATE POTASSIUM</medicinalproduct>
        <drugauthorizationnumb>65102</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19960101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19960101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMOTRIGINE</medicinalproduct>
        <drugdosagetext>75 MG, BID, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONVULSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PHENYTOIN</medicinalproduct>
        <drugdosagetext>9 MG</drugdosagetext>
        <drugindication>CONVULSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PHENOXYMETHYLPENICILLIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5018651-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060414</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20051230</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>2006SP000031</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LUNESTA</medicinalproduct>
        <drugauthorizationnumb>21476</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SLEEP DISORDER DUE TO GENERAL MEDICAL CONDITION, INSOMNIA TYPE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5019320-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060606</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060525</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-ROCHE-449639</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>38</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>SPERMATOZOA PROGRESSIVE MOTILITY ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELLCEPT</medicinalproduct>
        <drugauthorizationnumb>50723</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RENAL TRANSPLANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020615</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060315</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOXAZOSIN MESYLATE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOSPORINE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ISONIAZID</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PYRIDOXINE HCL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMIVUDINE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HEPATITIS B</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PERINDOPRIL ERBUMINE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ATORVASTATIN CALCIUM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HYPERLIPIDAEMIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5019620-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060601</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060519</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006BH010242</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>43</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIDAZOLAM HCL</medicinalproduct>
        <drugbatchnumb>016096</drugbatchnumb>
        <drugauthorizationnumb>75243</drugauthorizationnumb>
        <drugdosagetext>2 MG; ONCE; IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>SEDATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060519</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060519</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5019958-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060601</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060529</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>HQWYE481223MAR06</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>57</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANGIONEUROTIC OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORTHOSTATIC HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSEUDOMEMBRANOUS COLITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUFFOCATION FEELING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CEFIXIME CHEWABLE</medicinalproduct>
        <drugauthorizationnumb>50621</drugauthorizationnumb>
        <drugdosagetext>400 MG DAILY ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>URINARY TRACT INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050101</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5022108-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060605</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060518</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>S06-FRA-02007-01</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>49</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHLEBITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RECTAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ESCITALOPRAM OXALATE</medicinalproduct>
        <drugauthorizationnumb>21323</drugauthorizationnumb>
        <drugdosagetext>5 MG QD PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060408</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ESCITALOPRAM OXALATE</medicinalproduct>
        <drugdosagetext>10 MG QD PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060321</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060407</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREVISCAN (FLUINDIONE)</medicinalproduct>
        <drugdosagetext>20 MG QD PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PHLEBITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060324</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060407</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRAZEPAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INNOHEP</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5029342-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060614</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060526</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US200603005178</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>74</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>57.1</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BONE DENSITY DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUMBAR VERTEBRAL FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EVISTA</medicinalproduct>
        <drugauthorizationnumb>20815</drugauthorizationnumb>
        <drugdosagetext>60 MG, UNK, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5030201-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060614</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060523</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA200605005251</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>59</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CLOSTRIDIUM DIFFICILE COLITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIMB INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugauthorizationnumb>21318</drugauthorizationnumb>
        <drugdosagetext>20 UG, DAILY (1/D)</drugdosagetext>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050427</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5030585-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060614</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060609</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>S06-FRA-02007-01</companynumb>
    <primarysource>
      <reportercountry>DENMARK</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>49</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHLEBITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RECTAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ESCITALOPRAM OXALATE</medicinalproduct>
        <drugauthorizationnumb>21323</drugauthorizationnumb>
        <drugdosagetext>5 MG QD PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060408</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ESCITALOPRAM OXALATE</medicinalproduct>
        <drugdosagetext>10 MG QD PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060321</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060407</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREVISCAN (FLUINDIONE)</medicinalproduct>
        <drugdosagetext>20 MG QD PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PHLEBITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060324</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060407</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRAZEPAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INNOHEP</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5033686-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060623</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060619</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B06000089</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>46</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>113</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PURPURA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMOXICILLIN + CLAVULANATE POTASSIUM</medicinalproduct>
        <drugauthorizationnumb>50564</drugauthorizationnumb>
        <drugdosagetext>1G THREE TIMES PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>LOCALISED INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060520</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060525</drugenddate>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5033773-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060623</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060610</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IE-SOLVAY-00206002038</companynumb>
    <primarysource>
      <reportercountry>IRELAND</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>70</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>85</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEGENER'S GRANULOMATOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE</medicinalproduct>
        <drugdosagetext>DAILY DOSE:  UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COVERSYL</medicinalproduct>
        <drugauthorizationnumb>020184</drugauthorizationnumb>
        <drugdosagetext>DAILY DOSE: 4 MILLIGRAM(S)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COVERSYL</medicinalproduct>
        <drugauthorizationnumb>020184</drugauthorizationnumb>
        <drugdosagetext>DAILY DOSE: 4 MILLIGRAM(S)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021009</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060609</drugenddate>
        <drugtreatmentduration>1339</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALSARTAN</medicinalproduct>
        <drugdosagetext>DAILY DOSE:  UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020514</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060609</drugenddate>
        <drugtreatmentduration>1488</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PERINDOPRIL ERBUMINE</medicinalproduct>
        <drugdosagetext>DAILY DOSE: 2 DOSAGE FORM</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021127</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATORVASTATIN CALCIUM</medicinalproduct>
        <drugdosagetext>DAILY DOSE:  UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990105</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METORMIN W/ROSIGILITAZONE</medicinalproduct>
        <drugdosagetext>DAILY DOSE:  UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021009</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060609</drugenddate>
        <drugtreatmentduration>1339</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>19990101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ELTROXIN</medicinalproduct>
        <drugdosagetext>DAILY DOSE:  UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INDAPAMIDE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5036208-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060531</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20051111</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>200513964GDS</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>55</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIAC ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FIBRILLATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEASONAL ALLERGY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRACHEITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIFEDIPINE</medicinalproduct>
        <drugauthorizationnumb>20198</drugauthorizationnumb>
        <drugdosagetext>30 MG, TOTAL DAILY, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
        <drugdosagetext>150 MG, TOTAL DAILY, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugdosagetext>75 MG, TOTAL DAILY, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EZETROL (EZETIMIBE)</medicinalproduct>
        <drugdosagetext>10 MG, TOTAL DAILY, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PERINDOPRIL ERBUMINE</medicinalproduct>
        <drugdosagetext>2 MG, TOTAL DAILY,ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugdosagetext>10 MG, TOTAL DAILY, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VASTEN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5037574-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060628</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060606</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>NL-GLAXOSMITHKLINE-B0427266A</companynumb>
    <primarysource>
      <reportercountry>NETHERLANDS</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>74</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>86</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>LEUKOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POST PROCEDURAL HAEMATOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMOXICILLIN + CLAVULANATE POTASSIUM</medicinalproduct>
        <drugauthorizationnumb>50564</drugauthorizationnumb>
        <drugdosagetext>1200MG PER DAY</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060511</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADALAT</medicinalproduct>
        <drugdosagetext>30MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANTOZOL</medicinalproduct>
        <drugdosagetext>40MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RENITEC</medicinalproduct>
        <drugdosagetext>20MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugdosagetext>40MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MONOCEDOCARD RETARD</medicinalproduct>
        <drugdosagetext>50MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BISOPROLOL</medicinalproduct>
        <drugdosagetext>2.5MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5040711-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060702</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060524</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-ABBOTT-06P-020-0334296-00</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>40</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>40</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INFLUENZA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INVESTIGATION ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG NEOPLASM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLEURAL EFFUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY OEDEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>292269A</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060501</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NSAID'S</medicinalproduct>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5040712-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060702</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060623</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-ABBOTT-06P-167-0336961-00</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>62</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>THROMBOANGIITIS OBLITERANS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040215</drugstartdate>
      </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>ARTHROTEC</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN W/ PROPOXYPHENE HCL</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREMPAK /OLD FORM/</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5040713-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesscongenitalanomali>1</seriousnesscongenitalanomali>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060702</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20020326</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-ABBOTT-02P-056-0190302-00</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>2.1</patientweight>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRADYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC MURMUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIOMYOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONGENITAL TRICUSPID VALVE ATRESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CYANOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART DISEASE CONGENITAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METABOLIC ACIDOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OXYGEN SATURATION DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALLOR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENTRICULAR FIBRILLATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FENOFIBRATE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>19304</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG EXPOSURE DURING PREGNANCY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ISOPTIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG EXPOSURE DURING PREGNANCY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PENTOXIFYLLINE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG EXPOSURE DURING PREGNANCY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUOXETINE HYDROCHLORIDE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG EXPOSURE DURING PREGNANCY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PERINDOPRIL ERBUMINE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG EXPOSURE DURING PREGNANCY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALPRAZOLAM</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG EXPOSURE DURING PREGNANCY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DINOPROSTONE</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CEFOTAXIME</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMPICILLIN</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMIKACIN</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN INITARD NORDISK</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG EXPOSURE DURING PREGNANCY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACTRAPID</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG EXPOSURE DURING PREGNANCY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ISOPHANE INSULIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG EXPOSURE DURING PREGNANCY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SOTALOL HCL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG EXPOSURE DURING PREGNANCY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONIDINE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG EXPOSURE DURING PREGNANCY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG EXPOSURE DURING PREGNANCY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DL-LYSINE  ACETYSALICYLATE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG EXPOSURE DURING PREGNANCY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5040714-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060702</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060623</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>MX-ABBOTT-06P-107-0336929-00</companynumb>
    <primarysource>
      <reportercountry>MEXICO</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>37.3</patientweight>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ASCITES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHOLECYSTECTOMY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATITIS C</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KALETRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>21906</drugauthorizationnumb>
        <drugdosagetext>400/100 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050922</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060501</drugenddate>
        <drugtreatmentduration>221</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CEFATOXIME</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KETOROLAC TROMETHAMINE</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5040715-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060623</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHO2006JP10399</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>75</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>GASTRIC CANCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SURGERY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
        <drugauthorizationnumb>021283</drugauthorizationnumb>
        <drugdosagetext>UNK, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030203</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040531</drugenddate>
        <drugtreatmentduration>484</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEVALOTIN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030203</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040531</drugenddate>
        <drugtreatmentduration>484</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5040716-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060317</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2006US03629</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>73</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>83.446</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE FLUCTUATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIPLOPIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EPISTAXIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRANSIENT ISCHAEMIC ATTACK</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
        <drugauthorizationnumb>20665</drugauthorizationnumb>
        <drugdosagetext>160 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010614</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020611</drugenddate>
        <drugtreatmentduration>363</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
        <drugauthorizationnumb>020665</drugauthorizationnumb>
        <drugdosagetext>320 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030624</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050119</drugenddate>
        <drugtreatmentduration>576</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
        <drugauthorizationnumb>020665</drugauthorizationnumb>
        <drugdosagetext>80 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990127</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010613</drugenddate>
        <drugtreatmentduration>869</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIOVAN HCT</medicinalproduct>
        <drugdosagetext>160MG VAL/12.5MG HCT, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020612</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030923</drugenddate>
        <drugtreatmentduration>469</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIOVAN HCT</medicinalproduct>
        <drugdosagetext>160MG VAL/12.5MG HCT, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050120</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060518</drugenddate>
        <drugtreatmentduration>484</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5040717-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060529</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2006JP08195</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>78</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>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>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
        <drugauthorizationnumb>21283</drugauthorizationnumb>
        <drugdosagetext>80 MG/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060112</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060126</drugenddate>
        <drugtreatmentduration>21600</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
        <drugauthorizationnumb>021283</drugauthorizationnumb>
        <drugdosagetext>160 MG/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060126</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060315</drugenddate>
        <drugtreatmentduration>70560</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
        <drugdosagetext>5 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050203</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARDENALIN</medicinalproduct>
        <drugdosagetext>2 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060207</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5040718-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060622</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHFR2006GB02072</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>50</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ELECTROCARDIOGRAM ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ELECTROCARDIOGRAM QT CORRECTED INTERVAL PROLONGED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE IRREGULAR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZARIL</medicinalproduct>
        <drugauthorizationnumb>019758</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060323</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060622</drugenddate>
        <drugtreatmentduration>92</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5040719-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060619</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2006US08180</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRY EYE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRY MOUTH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRY SKIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAIR TEXTURE ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTESTINAL OBSTRUCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAIL DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENABLEX</medicinalproduct>
        <drugauthorizationnumb>021513</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5040720-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060621</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHNU2006DE02343</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MEGACOLON</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZAPINE</medicinalproduct>
        <drugauthorizationnumb>019758</drugauthorizationnumb>
        <drugdosagetext>UP TO 600 MG/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19830101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5040721-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060424</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHFR2006GB01535</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUROPATHY PERIPHERAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SALAGEN</medicinalproduct>
        <drugdosagetext>UNK, UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5040722-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060623</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2006US08360</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>69</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>66.666</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD CREATININE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXJADE</medicinalproduct>
        <drugbatchnumb>F001</drugbatchnumb>
        <drugauthorizationnumb>021882</drugauthorizationnumb>
        <drugdosagetext>1250 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD IRON INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060424</drugenddate>
        <drugtreatmentduration>83</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXJADE</medicinalproduct>
        <drugauthorizationnumb>021882</drugauthorizationnumb>
        <drugdosagetext>750 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060425</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5040723-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060622</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHO2006FR10211</companynumb>
    <primarysource>
      <reportercountry>DENMARK</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>90</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD CREATININE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEMENTIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EXTRAPYRAMIDAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FACIAL PALSY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEAD INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOTOR DYSFUNCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORTHOSTATIC HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALLOR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARALYSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ESIDRIX</medicinalproduct>
        <drugauthorizationnumb>11793</drugauthorizationnumb>
        <drugdosagetext>12.5 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RAMIPRIL</medicinalproduct>
        <drugdosagetext>2.5 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MEPRONIZINE</medicinalproduct>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TERCIAN</medicinalproduct>
        <drugdosagetext>16 DRP, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HEPARIN</medicinalproduct>
        <drugdosagetext>1.4 ML (0.7)</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>DEEP VEIN THROMBOSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060208</drugenddate>
        <drugtreatmentduration>11520</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EFFEXOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANAFRANIL</medicinalproduct>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRANXENE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
        <drugindication>DEEP VEIN THROMBOSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIGOXIN</medicinalproduct>
        <drugdosagetext>124 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugdosagetext>20 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5040724-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060623</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2006JP09593</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>COMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDE ATTEMPT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TEGRETOL</medicinalproduct>
        <drugauthorizationnumb>016608</drugauthorizationnumb>
        <drugdosagetext>49 TABLETS, ONCE/SINGLE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5040725-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060622</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2006CO09430</companynumb>
    <primarysource>
      <reportercountry>COLOMBIA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>48</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>82</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ACTIVITIES OF DAILY LIVING IMPAIRED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOUTH ULCERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS GENERALISED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TEGRETOL</medicinalproduct>
        <drugauthorizationnumb>020234</drugauthorizationnumb>
        <drugdosagetext>200 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>EPILEPSY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060614</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060618</drugenddate>
        <drugtreatmentduration>7200</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOSARTAN</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5040726-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060620</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHFR2006GB02037</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>3</patientonsetage>
      <patientonsetageunit>803</patientonsetageunit>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE VIA BREAST MILK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POOR WEIGHT GAIN NEONATAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TEGRETOL</medicinalproduct>
        <drugauthorizationnumb>016608</drugauthorizationnumb>
        <drugdosagetext>UNK, UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5040727-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060504</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2006US05900</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>32</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENOPIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EAR DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NASAL DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NUCLEAR MAGNETIC RESONANCE IMAGING BRAIN ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OCULAR HYPERAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OCULAR ICTERUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANIC ATTACK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENOUS ANGIOMA OF BRAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISION BLURRED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL DISTURBANCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMISIL</medicinalproduct>
        <drugauthorizationnumb>20539</drugauthorizationnumb>
        <drugdosagetext>250 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NAIL TINEA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060424</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060503</drugenddate>
        <drugtreatmentduration>14400</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5040728-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060518</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2006JP07419</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>64</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>52</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <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 ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD BILIRUBIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CREATININE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD POTASSIUM INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD SODIUM DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD UREA INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSED LEVEL OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISSEMINATED INTRAVASCULAR COAGULATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ECHOCARDIOGRAM ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAMMA-GLUTAMYLTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATOCRIT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATITIS FULMINANT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JAUNDICE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LARGE INTESTINE PERFORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTI-ORGAN FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RED BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY RATE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SHOCK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRIMPERAN TAB</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>VOMITING</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060306</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060306</drugenddate>
        <drugtreatmentduration>1440</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VOLTAREN</medicinalproduct>
        <drugauthorizationnumb>019201</drugauthorizationnumb>
        <drugdosagetext>25 MG, TID</drugdosagetext>
        <drugadministrationroute>054</drugadministrationroute>
        <drugindication>POSTOPERATIVE ANALGESIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060306</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060307</drugenddate>
        <drugtreatmentduration>2880</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEVOFLURANE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SEDAPAIN</medicinalproduct>
        <drugdosagetext>15 MG/DAY</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>POSTOPERATIVE ANALGESIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060306</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060306</drugenddate>
        <drugtreatmentduration>1440</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5040729-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060608</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2006US07520</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>20</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ACUTE CHEST SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SICKLE CELL ANAEMIA WITH CRISIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXJADE</medicinalproduct>
        <drugauthorizationnumb>21882</drugauthorizationnumb>
        <drugdosagetext>1000 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD IRON INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060508</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5040730-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060620</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2006FR09246</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>61</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ALANINE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAEMIA</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>ECCHYMOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EPISTAXIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH MACULAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VITAMIN C DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VITAMIN C DEFICIENCY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEORAL</medicinalproduct>
        <drugauthorizationnumb>50715</drugauthorizationnumb>
        <drugdosagetext>50 MG, BID</drugdosagetext>
        <drugindication>LIVER TRANSPLANT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISONE (NGX)</medicinalproduct>
        <drugdosagetext>2 MG PER DAY</drugdosagetext>
        <drugindication>LIVER TRANSPLANT</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5040731-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060620</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2006US09336</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>69</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BONE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE LESION EXCISION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DENTAL CARIES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERBARIC OXYGEN THERAPY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL SURGERY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLASTIC SURGERY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SENSITIVITY OF TEETH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STOMATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTH DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTH EXTRACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTH LOSS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOLEDRONIC ACID</medicinalproduct>
        <drugauthorizationnumb>21223</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>METASTASES TO BONE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020501</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5040732-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060529</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2006JP08192</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>72</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>45</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>BLOOD LACTATE DEHYDROGENASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD UREA INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>C-REACTIVE PROTEIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHILLS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GASTER D</medicinalproduct>
        <drugdosagetext>10 MG/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060521</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060522</drugenddate>
        <drugtreatmentduration>2880</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CEFAMEZIN</medicinalproduct>
        <drugdosagetext>2 G/DAY</drugdosagetext>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060522</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060523</drugenddate>
        <drugtreatmentduration>2880</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METILON</medicinalproduct>
        <drugdosagetext>250 MG/DAY</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>PYREXIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060522</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060522</drugenddate>
        <drugtreatmentduration>1440</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SOLDEM 3A</medicinalproduct>
        <drugdosagetext>2000 ML/DAY</drugdosagetext>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>PROPHYLAXIS AGAINST DEHYDRATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060519</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060528</drugenddate>
        <drugtreatmentduration>14400</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VOLTAREN</medicinalproduct>
        <drugdosagetext>100 MG/DAY</drugdosagetext>
        <drugadministrationroute>054</drugadministrationroute>
        <drugindication>PYREXIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060522</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060522</drugenddate>
        <drugtreatmentduration>1440</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BIOGAMMA</medicinalproduct>
        <drugdosagetext>2 MIU/DAY</drugdosagetext>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>MYCOSIS FUNGOIDES</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060515</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060515</drugenddate>
        <drugtreatmentduration>1440</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BIOGAMMA</medicinalproduct>
        <drugdosagetext>2 MIU/DAY</drugdosagetext>
        <drugadministrationroute>041</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060519</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060519</drugenddate>
        <drugtreatmentduration>1440</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BIOGAMMA</medicinalproduct>
        <drugdosagetext>2 MIU/DAY</drugdosagetext>
        <drugadministrationroute>041</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060522</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060522</drugenddate>
        <drugtreatmentduration>1440</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VOLTAREN</medicinalproduct>
        <drugdosagetext>25 MG/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060521</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060522</drugenddate>
        <drugtreatmentduration>2880</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5040733-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060602</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2006BR08530</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>75</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE DISCOLOURATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE NECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VOLTAREN</medicinalproduct>
        <drugauthorizationnumb>019201</drugauthorizationnumb>
        <drugdosagetext>75 MG, UNK</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>POSTOPERATIVE ANALGESIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060107</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060107</drugenddate>
        <drugtreatmentduration>1440</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5040734-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060530</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHO2006JP08771</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>68</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METASTASES TO BONE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOMYELITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DECADRON</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROSTATE CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYPEN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugauthorizationnumb>021223</drugauthorizationnumb>
        <drugdosagetext>4 MG MONTHLY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>METASTASES TO BONE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051227</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5040735-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050812</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHNR2005AU01761</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MOUTH ULCERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARYNGEAL ULCERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TONGUE ULCERATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOSAMINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VOLTAREN</medicinalproduct>
        <drugbatchnumb>T4025</drugbatchnumb>
        <drugauthorizationnumb>020142</drugauthorizationnumb>
        <drugdosagetext>2-3 X 25 MG/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRALGIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5040736-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060605</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHRM2006FR01734</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>COLITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>STALEVO 100</medicinalproduct>
        <drugauthorizationnumb>021485</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5040737-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060516</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHNU2006DE02022</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>61</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>133</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ARRHYTHMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIABETIC NEPHROPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYSIPELAS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAMMA-GLUTAMYLTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GOITRE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC CONGESTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XANEF</medicinalproduct>
        <drugdosagetext>20 MG DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CARDIAC FAILURE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060321</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CONCOR COR</medicinalproduct>
        <drugdosagetext>2.5 MG DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CARDIAC FAILURE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>L-THYROXINE</medicinalproduct>
        <drugdosagetext>100 MICROGR DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPOTHYROIDISM</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METAMIZOLE</medicinalproduct>
        <drugdosagetext>30 DROPS DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GOITRE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SANDIMMUNE</medicinalproduct>
        <drugauthorizationnumb>050715</drugauthorizationnumb>
        <drugdosagetext>150/0/175MG/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEART TRANSPLANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19930101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMOXICILLIN + CLAVULANATE POTASSIUM</medicinalproduct>
        <drugdosagetext>500 MG, TID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ERYSIPELAS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060309</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5040738-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060621</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2006US08086</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>JAW DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugauthorizationnumb>021223</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5040739-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060621</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2006US08087</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANHEDONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DECREASED INTEREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERAL PHYSICAL HEALTH DETERIORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AREDIA</medicinalproduct>
        <drugauthorizationnumb>020036</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5040740-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060621</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2006ES09232</companynumb>
    <primarysource>
      <reportercountry>SPAIN</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>67</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BONE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE FORMATION INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CELLULITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTH EXTRACTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugauthorizationnumb>021223</drugauthorizationnumb>
        <drugdosagetext>4 MG, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PROSTATE CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030724</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DECAPEPTYL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MITOXANTRONE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051201</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5040741-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060607</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHNR2006AU00806</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>63</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ARRHYTHMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUPRAVENTRICULAR TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RANITIDINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SEPTRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MYCOPHENOLATE MOFETIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEORAL</medicinalproduct>
        <drugauthorizationnumb>050715</drugauthorizationnumb>
        <drugdosagetext>100 MG, BID</drugdosagetext>
        <drugindication>RENAL TRANSPLANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060420</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEORAL</medicinalproduct>
        <drugauthorizationnumb>050715</drugauthorizationnumb>
        <drugdosagetext>50 MG, BID</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DILTIAZEM HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CERTICAN</medicinalproduct>
        <drugdosagetext>0.7 MG, BID</drugdosagetext>
        <drugindication>RENAL TRANSPLANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060602</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5040742-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060224</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHNU2006DE01108</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>53</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>111.2</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SURGERY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WOUND DEBRIDEMENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HUMALOG</medicinalproduct>
        <drugdosagetext>14 - 16 - 12 - 0 /DAY</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>DIABETES MELLITUS INSULIN-DEPENDENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19950101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROTAPHAN</medicinalproduct>
        <drugdosagetext>0 - 0 - 0 - 12/DAY</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>DIABETES MELLITUS INSULIN-DEPENDENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19950101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VOLTAREN</medicinalproduct>
        <drugdosagetext>75 MG, TID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRALGIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041103</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AREDIA</medicinalproduct>
        <drugdosagetext>90 MG, QMO</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000322</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030429</drugenddate>
        <drugtreatmentduration>1134</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugauthorizationnumb>021223</drugauthorizationnumb>
        <drugdosagetext>4 MG, QMO</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030603</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050627</drugenddate>
        <drugtreatmentduration>756</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5040743-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060621</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHRM2006FR01885</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>57</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BREAST CANCER RECURRENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MASTECTOMY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METASTASES TO BONE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GLEEVEC</medicinalproduct>
        <drugauthorizationnumb>021588</drugauthorizationnumb>
        <drugdosagetext>400 MG DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CHRONIC MYELOID LEUKAEMIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5040744-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060621</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHNU2006DE02338</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ORAL SURGERY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugauthorizationnumb>021223</drugauthorizationnumb>
        <drugdosagetext>4 MG, UNK</drugdosagetext>
        <drugindication>PROSTATE CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020919</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5040745-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060621</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2006US08085</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DECREASED INTEREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERAL PHYSICAL HEALTH DETERIORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AREDIA</medicinalproduct>
        <drugauthorizationnumb>020036</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5040746-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060608</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHO2006FR09362</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>21</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>42</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ALANINE AMINOTRANSFERASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASPARTATE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIOMYOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FACE OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STRABISMUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VERTIGO</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EFFERALGAN</medicinalproduct>
        <drugindication>HEADACHE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060604</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060605</drugenddate>
        <drugtreatmentduration>2880</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ICL670A</medicinalproduct>
        <drugauthorizationnumb>021882</drugauthorizationnumb>
        <drugdosagetext>875 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD IRON INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060524</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060605</drugenddate>
        <drugtreatmentduration>18720</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ICL670A</medicinalproduct>
        <drugauthorizationnumb>021882</drugauthorizationnumb>
        <drugdosagetext>NO TREATMENT</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060606</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060609</drugenddate>
        <drugtreatmentduration>5760</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ICL670A</medicinalproduct>
        <drugauthorizationnumb>021882</drugauthorizationnumb>
        <drugdosagetext>875 MG, QD</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060610</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060622</drugenddate>
        <drugtreatmentduration>18720</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5040747-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHO2006US01900</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>43</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>81.1</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>AMNESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROENTERITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUMBAR PUNCTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RAD001A</medicinalproduct>
        <drugdosagetext>1.5 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RENAL TRANSPLANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060131</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RAD001A</medicinalproduct>
        <drugdosagetext>1.5 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19981206</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEORAL</medicinalproduct>
        <drugauthorizationnumb>050715</drugauthorizationnumb>
        <drugdosagetext>100 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RENAL TRANSPLANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050602</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEORAL</medicinalproduct>
        <drugauthorizationnumb>050715</drugauthorizationnumb>
        <drugdosagetext>100 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060129</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugdosagetext>10MG/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RENAL TRANSPLANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050603</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONIDINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MINOXIDIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VASOTEC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BACTRIM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COLACE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM CHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYLENOL (CAPLET)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CADUET</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5040748-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060620</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHO2006HU09963</companynumb>
    <primarysource>
      <reportercountry>HUNGARY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>23</patientonsetage>
      <patientonsetageunit>802</patientonsetageunit>
      <patientweight>12.8</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BENIGN NEOPLASM OF SKIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EPITHELIOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SURGERY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ELIDEL</medicinalproduct>
        <drugauthorizationnumb>21302</drugauthorizationnumb>
        <drugdosagetext>APPLIED TWICE DAILY</drugdosagetext>
        <drugadministrationroute>061</drugadministrationroute>
        <drugindication>DERMATITIS ATOPIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050321</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5040749-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060612</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHO2006JP09485</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>58</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>46</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ANOREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DECREASED APPETITE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCYTOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY ARREST</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GLEEVEC</medicinalproduct>
        <drugauthorizationnumb>21588</drugauthorizationnumb>
        <drugdosagetext>400 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTROINTESTINAL STROMAL TUMOUR</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031120</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060320</drugenddate>
        <drugtreatmentduration>852</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5040750-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050114</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHO2005JP01075</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>81</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>71</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANOREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ELECTROCARDIOGRAM T WAVE AMPLITUDE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGE SUBCUTANEOUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLAMMATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NECK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEPHROLITHIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARYNGITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARYNGOLARYNGEAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRODUCTIVE COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
        <drugauthorizationnumb>021283</drugauthorizationnumb>
        <drugdosagetext>80 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030901</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIGMART</medicinalproduct>
        <drugdosagetext>20 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANGINA PECTORIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990520</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ISOSORBIDE MONONITRATE</medicinalproduct>
        <drugdosagetext>40 MG, UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990520</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
        <drugdosagetext>200 MG, UNK</drugdosagetext>
        <drugindication>HYPERURICAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990520</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HERBESSER</medicinalproduct>
        <drugdosagetext>200 MG, UNK</drugdosagetext>
        <drugindication>ANGINA PECTORIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990520</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
        <drugdosagetext>2 MG, UNK</drugdosagetext>
        <drugindication>ANGINA PECTORIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990520</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MARZULENE</medicinalproduct>
        <drugdosagetext>1 G, UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020508</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BUFFERIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5040751-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060213</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHO2006DE02573</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </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>ADENOVIRUS INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRAIN OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTRACRANIAL PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENINGOENCEPHALITIS ADENOVIRAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL STIFFNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SIMULECT</medicinalproduct>
        <drugdosagetext>10 MG, DAY 0</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RENAL TRANSPLANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050104</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050104</drugenddate>
        <drugtreatmentduration>1440</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SIMULECT</medicinalproduct>
        <drugdosagetext>10 MG, DAY 4</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050108</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050108</drugenddate>
        <drugtreatmentduration>1440</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEORAL</medicinalproduct>
        <drugauthorizationnumb>050715</drugauthorizationnumb>
        <drugdosagetext>100 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RENAL TRANSPLANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050721</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELLCEPT</medicinalproduct>
        <drugdosagetext>250 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RENAL TRANSPLANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050926</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DECORTIN-H</medicinalproduct>
        <drugdosagetext>5 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RENAL TRANSPLANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050604</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5040752-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060308</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHO2006DE04144</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>26</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>HAEMATOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER TRANSPLANT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POST PROCEDURAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYSTEMIC INFLAMMATORY RESPONSE SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SANDIMMUNE</medicinalproduct>
        <drugdosagetext>NOT REPORTED</drugdosagetext>
        <drugindication>RENAL TRANSPLANT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugdosagetext>NOT REPORTED</drugdosagetext>
        <drugindication>RENAL TRANSPLANT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MYFORTIC</medicinalproduct>
        <drugauthorizationnumb>050791</drugauthorizationnumb>
        <drugindication>RENAL TRANSPLANT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CERTICAN</medicinalproduct>
        <drugdosagetext>NO TREATMENT</drugdosagetext>
        <drugindication>RENAL TRANSPLANT</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5040753-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060308</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHO2006IT04170</companynumb>
    <primarysource>
      <reportercountry>ITALY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>56</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>86</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY DISEASE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIOVAN OR COTAREG AND/OR LESCOL</medicinalproduct>
        <drugauthorizationnumb>20665</drugauthorizationnumb>
        <drugdosagetext>160 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5040754-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060623</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2006JP09584</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>BLOOD URINE PRESENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPHADENOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPECIFIC GRAVITY URINE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UROBILIN URINE PRESENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TEGRETOL</medicinalproduct>
        <drugauthorizationnumb>016608</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060609</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5040755-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060621</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-RB-3464-2006</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>63.56</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>APRAXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COORDINATION ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSARTHRIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ENCEPHALOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCOHERENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LETHARGY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUBOXONE</medicinalproduct>
        <drugauthorizationnumb>20733</drugauthorizationnumb>
        <drugadministrationroute>060</drugadministrationroute>
        <drugindication>DRUG DEPENDENCE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060615</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060616</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUBOXONE</medicinalproduct>
        <drugauthorizationnumb>020733</drugauthorizationnumb>
        <drugadministrationroute>060</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060617</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060617</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUBOXONE</medicinalproduct>
        <drugauthorizationnumb>020733</drugauthorizationnumb>
        <drugadministrationroute>060</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060618</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060618</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5040840-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060525</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-13390422</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>59</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANAPHYLACTIC REACTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ERBITUX</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>SQUAMOUS CELL CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060505</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060505</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENADRYL</medicinalproduct>
        <drugindication>PREMEDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060505</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060505</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DURAGESIC-100</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORTAB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOFRAN</medicinalproduct>
        <drugindication>PREMEDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060505</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060505</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RADIATION THERAPY</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COMPAZINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5040841-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060410</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PT-BRISTOL-MYERS SQUIBB COMPANY-13342522</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>76</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PANCYTOPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MITOMYCIN</medicinalproduct>
        <drugauthorizationnumb>62336</drugauthorizationnumb>
        <drugadministrationroute>043</drugadministrationroute>
        <drugindication>BLADDER CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051215</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051215</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CIPROFLOXACIN</medicinalproduct>
        <drugindication>PROPHYLAXIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5040842-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060627</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-13426671</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>50</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>74</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>APLASIA PURE RED CELL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG SPECIFIC ANTIBODY ABSENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYTOXAN</medicinalproduct>
        <drugauthorizationnumb>012141</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>AUTOIMMUNE DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>ANAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARANESP</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>ANAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060502</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCODONE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5040843-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060526</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-13392758</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>56</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>51</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>BLOOD CREATININE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOCALCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPHIL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ERBITUX</medicinalproduct>
        <drugdosagetext>INITIATED ON 04-APR-2006 AT 400 MG/M2 F/B 250 MG/M2 WEEKLY X 9 WEEKS/TOTL DOSE THIS COURSE = 400 MG.</drugdosagetext>
        <drugindication>SQUAMOUS CELL CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060516</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060516</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CISPLATIN</medicinalproduct>
        <drugauthorizationnumb>018057</drugauthorizationnumb>
        <drugdosagetext>ADMINISTERED ON WEEKS 3, 6, 9. TOTAL DOSE THIS COURSE = 0 MG.</drugdosagetext>
        <drugindication>SQUAMOUS CELL CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060509</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060509</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RADIATION THERAPY</medicinalproduct>
        <drugdosagetext>VIA EXTERNAL BEAM, 3D STARTING ON WEEK 3/TOTAL DOSE TO DATE = 3800 CGY/19 FRACTIONS/0 ELAPSED DAYS.</drugdosagetext>
        <drugindication>SQUAMOUS CELL CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060522</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060522</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5040844-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060428</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-BRISTOL-MYERS SQUIBB COMPANY-13370234</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</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>GRAFT VERSUS HOST DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENOOCCLUSIVE LIVER DISEASE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENDOXAN</medicinalproduct>
        <drugauthorizationnumb>12142</drugauthorizationnumb>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>BONE MARROW CONDITIONING REGIMEN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050205</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050208</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MABLIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BONE MARROW CONDITIONING REGIMEN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050131</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050203</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUDARA</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>BONE MARROW CONDITIONING REGIMEN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050131</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050203</drugenddate>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>URSODEOXYCHOLIC ACID</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050207</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050217</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SALOBEL</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050129</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050130</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RIVOTRIL</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050130</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050205</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROGRAF</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19950209</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050307</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugauthorizationnumb>086358</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050211</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050216</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEU-UP</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050211</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050317</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOVIRAX</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050211</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050317</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FIRSTCIN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050212</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050228</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMIKACIN SULFATE</medicinalproduct>
        <drugauthorizationnumb>062311</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050212</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050221</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARBENIN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050223</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050307</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARBENIN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050314</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050317</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEUART</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050224</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050309</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROGRAF</medicinalproduct>
      </drug>
    </patient>
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  <safetyreport>
    <safetyreportid>5040846-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050221</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-BRISTOL-MYERS SQUIBB COMPANY-12870960</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>65</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>115</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOALBUMINAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOCALCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOMAGNESAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALIGNANT NEOPLASM PROGRESSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ERBITUX</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLORECTAL CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050126</drugstartdate>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALTACE</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOPICLONE</medicinalproduct>
        <drugindication>SEDATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POLYSPORIN</medicinalproduct>
        <drugadministrationroute>061</drugadministrationroute>
        <drugindication>RASH</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050201</drugstartdate>
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    </patient>
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  <safetyreport>
    <safetyreportid>5040854-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
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    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060626</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
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    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <patientonsetage>53</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>70</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>COMA</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ERBITUX</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>TONSIL CANCER</drugindication>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DECADRON</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PREMEDICATION</drugindication>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DECADRON</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060625</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060626</drugenddate>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENADRYL</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PREMEDICATION</drugindication>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYLENOL (CAPLET)</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PREMEDICATION</drugindication>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PAIN MEDICATIONS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INHALERS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPROL-XL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRONOLACTONE</medicinalproduct>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMITRIPTYLINE HCL</medicinalproduct>
      </drug>
    </patient>
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  <safetyreport>
    <safetyreportid>5040855-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
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    <receiptdate>20060627</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-13426861</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
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    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <patientonsetage>74</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>52</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DYSPHAGIA</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>MUCOSAL INFLAMMATION</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ERBITUX</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NEOPLASM MALIGNANT</drugindication>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARBOPLATIN</medicinalproduct>
        <drugauthorizationnumb>019880</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NEOPLASM MALIGNANT</drugindication>
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    </patient>
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  <safetyreport>
    <safetyreportid>5040856-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
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    <receiptdate>20060622</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
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    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
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    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
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      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
        <drugauthorizationnumb>009218</drugauthorizationnumb>
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  <safetyreport>
    <safetyreportid>5040857-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
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    <receivedate>20060703</receivedate>
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    <receiptdate>20060608</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PL-BRISTOL-MYERS SQUIBB COMPANY-13412168</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>3</qualification>
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    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <patientonsetage>61</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
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        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
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      <reaction>
        <reactionmeddrapt>HEPATORENAL SYNDROME</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ERBITUX</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>COLORECTAL CANCER METASTATIC</drugindication>
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        <drugstartdate>20060110</drugstartdate>
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        <drugtreatmentduration>140</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXALIPLATIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLORECTAL CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060110</drugstartdate>
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        <drugenddate>20060528</drugenddate>
        <drugtreatmentduration>138</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUOROURACIL</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLORECTAL CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
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        <drugtreatmentduration>139</drugtreatmentduration>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEUCOVORIN CALCIUM</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLORECTAL CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060110</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060523</drugenddate>
        <drugtreatmentduration>133</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
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  <safetyreport>
    <safetyreportid>5040858-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
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    <receiptdate>20060622</receiptdate>
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    <companynumb>JP-BRISTOL-MYERS SQUIBB COMPANY-13421136</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <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>1</patientsex>
      <reaction>
        <reactionmeddrapt>PULMONARY ALVEOLAR HAEMORRHAGE</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PARAPLATIN</medicinalproduct>
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        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GEMZAR</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
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    </patient>
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  <safetyreport>
    <safetyreportid>5040887-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
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    <primarysource>
      <reportercountry>GERMANY</reportercountry>
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    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <patient>
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      <patientsex>2</patientsex>
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        <reactionmeddrapt>REVERSIBLE POSTERIOR LEUKOENCEPHALOPATHY SYNDROME</reactionmeddrapt>
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        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ERBITUX</medicinalproduct>
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        <drugindication>COLORECTAL CANCER METASTATIC</drugindication>
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        <drugstartdate>20060308</drugstartdate>
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        <drugcharacterization>1</drugcharacterization>
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        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MIRTAZAPINE</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
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        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VENLAFAXINE HCL</medicinalproduct>
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        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BROMAZEPAM</medicinalproduct>
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    <safetyreportid>5040962-5</safetyreportid>
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      <reportercountry>FRANCE</reportercountry>
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      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>BOVINE TUBERCULOSIS</reactionmeddrapt>
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        <reactionmeddrapt>UNEVALUABLE EVENT</reactionmeddrapt>
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        <drugcharacterization>1</drugcharacterization>
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        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
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    <safetyreportid>5040974-1</safetyreportid>
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      <reportercountry>UNITED STATES</reportercountry>
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      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
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        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
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        <reactionmeddrapt>STILLBIRTH</reactionmeddrapt>
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        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KALETRA</medicinalproduct>
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      <reportercountry>UNITED STATES</reportercountry>
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      <senderorganization>FDA-Public Use</senderorganization>
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    <patient>
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        <reactionmeddrapt>ANGINA PECTORIS</reactionmeddrapt>
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        <reactionmeddrapt>CORONARY ARTERY STENOSIS</reactionmeddrapt>
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      <reportercountry>UNITED STATES</reportercountry>
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      <senderorganization>FDA-Public Use</senderorganization>
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    <patient>
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      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ENERGY INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MANIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PARNATE</medicinalproduct>
        <drugauthorizationnumb>012342</drugauthorizationnumb>
        <drugdosagetext>10MG SEE DOSAGE TEXT</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMINS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HERBAL SUPPLEMENTS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KLONOPIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5040991-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050214</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0545456A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>50</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ALOPECIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PARNATE</medicinalproduct>
        <drugauthorizationnumb>12342</drugauthorizationnumb>
        <drugdosagetext>60MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041201</drugstartdate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARICEPT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5040992-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050418</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0554500A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>61</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG ADMINISTRATION ERROR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANIC REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PARNATE</medicinalproduct>
        <drugbatchnumb>20537AF21</drugbatchnumb>
        <drugauthorizationnumb>12342</drugauthorizationnumb>
        <drugdosagetext>10MG EIGHT TIMES PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugtreatmentduration>26</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORAZEPAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IRON</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5040993-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050519</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0559365A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>28</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PARNATE</medicinalproduct>
        <drugauthorizationnumb>012342</drugauthorizationnumb>
        <drugdosagetext>40MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAZODONE HCL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5040994-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050610</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0562140A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>35</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>EUPHORIC MOOD</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FREQUENT BOWEL MOVEMENTS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PARNATE</medicinalproduct>
        <drugauthorizationnumb>012342</drugauthorizationnumb>
        <drugdosagetext>60MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugtreatmentduration>10</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NO CONCURRENT MEDICATION</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5040995-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050620</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0563390A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>50</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SLUGGISHNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PARNATE</medicinalproduct>
        <drugauthorizationnumb>012342</drugauthorizationnumb>
        <drugdosagetext>10MG UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MECLIZINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5040996-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050622</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0563833A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ALOPECIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAIR TEXTURE ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PARNATE</medicinalproduct>
        <drugauthorizationnumb>012342</drugauthorizationnumb>
        <drugdosagetext>20MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19850101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030901</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN MEDICATION</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIGOXIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MOBIC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATIVAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5040997-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050727</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0567920A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE IRREGULAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PARNATE</medicinalproduct>
        <drugauthorizationnumb>12342</drugauthorizationnumb>
        <drugdosagetext>10MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050501</drugstartdate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREPARATION H</medicinalproduct>
        <drugadministrationroute>061</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SLEEP AID</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5040998-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050729</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0568272A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>65</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>88.6</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DERMATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DERMATITIS ACNEIFORM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FOLLICULITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH PAPULAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SECRETION DISCHARGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PARNATE</medicinalproduct>
        <drugauthorizationnumb>012342</drugauthorizationnumb>
        <drugdosagetext>30MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041101</drugstartdate>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
        <drugdosagetext>100MG PER DAY</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19860101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>325MG PER DAY</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19800101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5040999-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050801</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0568465A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>62</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PARNATE</medicinalproduct>
        <drugauthorizationnumb>012342</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugtreatmentduration>20</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NO CONCURRENT MEDICATION</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5041000-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050808</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0569269A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PARNATE</medicinalproduct>
        <drugauthorizationnumb>012342</drugauthorizationnumb>
        <drugdosagetext>100MG UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5041001-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050829</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0572191A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PARNATE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>012342</drugauthorizationnumb>
        <drugdosagetext>50MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050829</drugstartdate>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RISPERDAL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5041002-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050908</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0573490A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>59</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PARNATE</medicinalproduct>
        <drugauthorizationnumb>012342</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EVISTA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GEODON</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SONATA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATIVAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MOBIC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYOSCINE HBR HYT</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5041003-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050919</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0574819A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>53</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PARADOXICAL DRUG REACTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PARNATE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>012342</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugtreatmentduration>20</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONIDINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5041004-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20051017</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0578471A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>60</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>65.9</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PARNATE</medicinalproduct>
        <drugauthorizationnumb>012342</drugauthorizationnumb>
        <drugdosagetext>10MG THREE TIMES PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050901</drugstartdate>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KLONOPIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORAZEPAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RISPERDAL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORTRIPTYLINE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NARDIL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5041005-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20051031</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0580303A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>59</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PARNATE</medicinalproduct>
        <drugbatchnumb>NOT AVAILBLE</drugbatchnumb>
        <drugauthorizationnumb>012342</drugauthorizationnumb>
        <drugdosagetext>40MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051011</drugstartdate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KLONOPIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAZODONE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VICODIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5041006-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20051108</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0581429A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>40</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NERVOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PARNATE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>012342</drugauthorizationnumb>
        <drugdosagetext>60MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GEODON</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5041007-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20051114</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0582175A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>20</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>50</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PARNATE</medicinalproduct>
        <drugauthorizationnumb>012342</drugauthorizationnumb>
        <drugdosagetext>40MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050801</drugstartdate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMBIEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TEMAZEPAM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5041008-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20051123</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0583412A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>58</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PARNATE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>012342</drugauthorizationnumb>
        <drugdosagetext>20MG THREE TIMES PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONAZEPAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOPID</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5041009-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20051223</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0586925A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>48</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BREATH ODOUR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PARNATE</medicinalproduct>
        <drugauthorizationnumb>012342</drugauthorizationnumb>
        <drugdosagetext>60MG UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050815</drugstartdate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GABAPENTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRIAZOLAM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5041010-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060112</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0589042A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>62</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NECK PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PARNATE</medicinalproduct>
        <drugauthorizationnumb>012342</drugauthorizationnumb>
        <drugdosagetext>10MG THREE TIMES PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugtreatmentduration>20</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5041011-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060112</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0589510A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>55</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>90.9</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THINKING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREATMENT NONCOMPLIANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PARNATE</medicinalproduct>
        <drugauthorizationnumb>012342</drugauthorizationnumb>
        <drugdosagetext>6TAB PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BIPOLAR DISORDER</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060113</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>WELLBUTRIN</medicinalproduct>
        <drugauthorizationnumb>018644</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060113</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAZODONE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LITHIUM CARBONATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACIPHEX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5041012-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060224</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0595592A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>56</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRY MOUTH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRESCRIBED OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PARNATE</medicinalproduct>
        <drugauthorizationnumb>012342</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5041013-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060309</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0596931A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>50</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ILL-DEFINED DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PARNATE</medicinalproduct>
        <drugbatchnumb>27771AF22</drugbatchnumb>
        <drugauthorizationnumb>012342</drugauthorizationnumb>
        <drugdosagetext>120MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TEMAZEPAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARICEPT</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5041014-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060404</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0600324A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>70</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PARNATE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>012342</drugauthorizationnumb>
        <drugdosagetext>15MG THREE TIMES PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KLONOPIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>QUININE SULFATE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5041015-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060419</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0602498A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CHILLS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PARNATE</medicinalproduct>
        <drugauthorizationnumb>012342</drugauthorizationnumb>
        <drugdosagetext>30MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MAJOR DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RISPERDAL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LITHIUM CARBONATE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5041066-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060621</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ES-GILEAD-2006-0009790</companynumb>
    <primarysource>
      <reportercountry>SPAIN</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>51</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>AGRANULOCYTOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRUVADA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050830</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060428</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KALETRA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041013</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060428</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5041079-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050309</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-398241</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>16</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>90</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AFFECT LABILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AGGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AGITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANGER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANKLE FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BIPOLAR DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BIPOLAR I DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD TRIGLYCERIDES INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRONCHITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CELLULITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CRYING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DELIRIUM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DELUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FIBULA FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMPULSE-CONTROL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMPULSIVE BEHAVIOUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLUENZA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JOINT DISLOCATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MAJOR DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERITONSILLAR ABSCESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERSONALITY DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARYNGITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POLLAKIURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESTLESSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SLEEP DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDE ATTEMPT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VIRAL INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>18662</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19970120</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>018662</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980723</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19980819</drugenddate>
        <drugtreatmentduration>28</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>018662</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980819</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5041080-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050406</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-401271</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>29</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>68</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>APHTHOUS STOMATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLITIS ULCERATIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CROHN'S DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRY EYE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLATULENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROOESOPHAGEAL REFLUX DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHOIDS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLAMMATORY BOWEL DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERNAL INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IRRITABLE BOWEL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTI-ORGAN DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NASAL DRYNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NIGHT BLINDNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OESOPHAGITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RECTAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ROSACEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>18662</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19961002</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19970601</drugenddate>
        <drugtreatmentduration>243</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METRONIDAZOLE CREAM</medicinalproduct>
        <drugadministrationroute>061</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19961213</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NOVACET LOTION</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19970215</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SUMYCIN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19970227</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ORTHO TRI-CYCLEN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19970328</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5041081-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041007</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-382882</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>36</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ADHESION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ALOPECIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AMNESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAPHYLACTIC SHOCK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANEURYSM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHILLS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONTUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ECZEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FIBROMYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FULL BLOOD COUNT ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GRAND MAL CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTRACRANIAL ANEURYSM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE STRAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NERVOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVARIAN CYST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPEECH DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL ACUITY REDUCED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL DISTURBANCE</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>050</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050114</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEGASYS</medicinalproduct>
        <drugdosagetext>ROUTE: INJ.</drugdosagetext>
        <drugadministrationroute>050</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040730</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEGASYS</medicinalproduct>
        <drugadministrationroute>050</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041108</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEGASYS</medicinalproduct>
        <drugadministrationroute>050</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COPEGUS</medicinalproduct>
        <drugauthorizationnumb>021511</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041108</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050114</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COPEGUS</medicinalproduct>
        <drugauthorizationnumb>021511</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040730</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NUBAIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HEADACHE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060319</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060319</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5041083-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050609</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-407485</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>21</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>65.8</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ADJUSTMENT DISORDER WITH DEPRESSED MOOD</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AFFECT LABILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AGGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AGITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANGER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLITIS ULCERATIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DELIRIUM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRY SKIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FACIAL BONES FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FOOT FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROENTERITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROOESOPHAGEAL REFLUX DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMPULSIVE BEHAVIOUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MORBID THOUGHTS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANIC ATTACK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDE ATTEMPT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL ACUITY REDUCED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>18662</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ACNE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021215</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030315</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>018662</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030315</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030615</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SULFASALAZINE</medicinalproduct>
        <drugindication>COLITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugindication>ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRILOSEC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADVIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MOTRIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5041084-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060427</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-ROCHE-446828</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>33</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>109</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISION BLURRED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XENICAL</medicinalproduct>
        <drugauthorizationnumb>20766</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XENICAL</medicinalproduct>
        <drugauthorizationnumb>020766</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5041085-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20051103</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-423646</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>29</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>54.9</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANHEDONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BUNDLE BRANCH BLOCK RIGHT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLITIS ULCERATIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CROHN'S DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATOCHEZIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC ENZYME INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLAMMATORY BOWEL DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IRRITABLE BOWEL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL ISCHAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>18662</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ACNE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19840115</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19840615</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5041086-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060601</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>NL-ROCHE-451297</companynumb>
    <primarysource>
      <reportercountry>NETHERLANDS</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>73</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DUODENAL ULCER HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATEMESIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUCOSAL INFLAMMATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STOMATITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CAPECITABINE</medicinalproduct>
        <drugauthorizationnumb>20896</drugauthorizationnumb>
        <drugdosagetext>ON DAYS 1-14 DOSING AND FREQUENCY AS PER PROTOCOL REPORTED DOSE  =  2 X 2000MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060309</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVASTIN</medicinalproduct>
        <drugauthorizationnumb>020896</drugauthorizationnumb>
        <drugdosagetext>ON DAY 1 DOSE AND FREQUENCY AS PER PROTOCOL REPORTED  =  700MG</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060310</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXALIPLATIN</medicinalproduct>
        <drugdosagetext>ON DAY 1 DOSE AND FREQUENCY AS PER PROTOCOL REPORTED  =  250MG</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060309</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ERBITUX</medicinalproduct>
        <drugdosagetext>ON DAY 1 CYCLE 1 ONLY DOSE AND FREQUENCY AS PER PROTOCOL</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060309</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ERBITUX</medicinalproduct>
        <drugdosagetext>ON DAY 1 DOSE AND FREQUENCY AS PER PROTOCOL REPORTED  =  500MG</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060413</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NSAID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASCAL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5041087-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060113</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-432356</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>14</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>79.4</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABSCESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ACROCHORDON</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHROPOD BITE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLISTER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CELLULITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLITIS ULCERATIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COXSACKIE VIRAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CROHN'S DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRY SKIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSGEUSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EPSTEIN-BARR VIRUS INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROOESOPHAGEAL REFLUX DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GROIN PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOSMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLAMMATORY BOWEL DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTESTINAL OBSTRUCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IRRITABLE BOWEL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIP DRY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MELANOCYTIC NAEVUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NECK INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NECK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARYNGITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARYNGOLARYNGEAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POLLAKIURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POLYP</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROSTATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ROAD TRAFFIC ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SCAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN LESION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN PAPILLOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TESTICULAR PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>XEROSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>18662</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ACNE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19960106</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19970625</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYLENOL (CAPLET)</medicinalproduct>
        <drugindication>HEADACHE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GENERIC DRUGS</medicinalproduct>
        <drugdosagetext>UNSPECIFIED OVER-THE-COUNTER MEDICATION TAKEN FOR COLDS AND/OR FLU.</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTIBIOTIC NOS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5041088-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060616</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-452104</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>59</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>49.9</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MYCOPHENOLATE MOFETIL</medicinalproduct>
        <drugauthorizationnumb>50723</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051231</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MYCOPHENOLATE MOFETIL</medicinalproduct>
        <drugauthorizationnumb>050723</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TACROLIMUS</medicinalproduct>
        <drugauthorizationnumb>050723</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051231</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TACROLIMUS</medicinalproduct>
        <drugauthorizationnumb>050723</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060612</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugdosagetext>DOSE FORM REPORTED AS PILL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060104</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060613</drugenddate>
        <drugtreatmentduration>161</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BACTRIM</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051231</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROTONIX</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060106</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVENOX</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060202</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIFLUCAN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060106</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGNESIUM OXIDE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060320</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FERROUS SULFATE TAB</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060209</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLORINEF</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060320</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
        <drugdosagetext>DRUG NAME REPORTED AS LANTUS INSULIN</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060202</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5041089-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060410</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-ROCHE-444186</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>20</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>18662</drugauthorizationnumb>
        <drugdosagetext>AVERAGE DAILY DOSE OF 50 MG.</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ORAL CONTRACEPTION</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5041090-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050914</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-417937</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>15</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>54.4</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>AFFECT LABILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AGGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AGITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANGER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ATTENTION DEFICIT/HYPERACTIVITY DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DELIRIUM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISTURBANCE IN ATTENTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSTHYMIC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HIGH DENSITY LIPOPROTEIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMPULSE-CONTROL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLAMMATORY BOWEL DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IRRITABILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IRRITABLE BOWEL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MELANOCYTIC NAEVUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANIC ATTACK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSYCHOTIC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RECTAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESTLESSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPORTS INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDE ATTEMPT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VIRAL PHARYNGITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>18662</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010308</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010523</drugenddate>
        <drugtreatmentduration>77</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>018662</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010523</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010625</drugenddate>
        <drugtreatmentduration>34</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>018662</drugauthorizationnumb>
        <drugdosagetext>DOSAGE REPORTED AS 40MG EVERY MORNING (QAM) AND 60 MG EVERY NIGHT (QHS).</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010625</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20011015</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5041092-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060215</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-436812</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>21</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>APPENDICITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD ALBUMIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CALCIUM DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CHOLESTEROL INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD LACTATE DEHYDROGENASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD TRIGLYCERIDES INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CROHN'S DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRY SKIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERALBUMINAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOKALAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ILEUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLAMMATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEUKOCYTOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIP DRY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALNUTRITION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUROPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SMALL INTESTINAL OBSTRUCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>18662</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040106</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040309</drugenddate>
        <drugtreatmentduration>64</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>018662</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040310</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040515</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5041093-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-433851</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>16</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>77.1</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD TRIGLYCERIDES INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EPISTAXIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLAMMATORY BOWEL DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IRRITABLE BOWEL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>18662</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ACNE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19960615</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19990615</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>018662</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020307</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020608</drugenddate>
        <drugtreatmentduration>94</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYLENOL (CAPLET)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TUMS</medicinalproduct>
        <drugindication>ABDOMINAL PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19970615</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5041094-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060615</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>SE-ROCHE-451924</companynumb>
    <primarysource>
      <reportercountry>SWEDEN</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>50</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING COLD</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTHERMIA</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>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041015</drugenddate>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COPEGUS</medicinalproduct>
        <drugauthorizationnumb>021511</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040415</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041015</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>UNSPECIFIED DRUG</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040415</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041015</drugenddate>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5041095-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060621</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ROCHE-452876</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>66</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANTI-INSULIN ANTIBODY POSITIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIABETIC KETOACIDOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INTERFERON ALFA</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19940516</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19940614</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INTERFERON ALFA</medicinalproduct>
        <drugdosagetext>DISCONTINUED DUE TO BONE MARROW SUPPRESSION.</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19930727</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19940502</drugenddate>
        <drugtreatmentduration>280</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5041096-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060622</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-ROCHE-452964</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>71</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <reaction>
        <reactionmeddrapt>THROMBOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KEVATRIL</medicinalproduct>
        <drugauthorizationnumb>20239</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051128</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060313</drugenddate>
        <drugtreatmentduration>106</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5041097-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060623</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-453029</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>32</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE BEFORE PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NO ADVERSE EFFECT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PREGNANCY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>018662</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19881115</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19890515</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5041098-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060621</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-ROCHE-452852</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>25</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>91</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EATING DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EPISTAXIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LETHARGY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SLEEP DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>018662</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ACNE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010615</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020105</drugenddate>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5041101-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060622</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-ROCHE-453054</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>55</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE NECROSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ROCEPHIN</medicinalproduct>
        <drugauthorizationnumb>050585</drugauthorizationnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>LUNG ABSCESS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLAGYL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HEPARIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5041102-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060623</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-453112</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>42</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSARTHRIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEGASYS</medicinalproduct>
        <drugdosagetext>ROUTE REPORTED AS INJ.</drugdosagetext>
        <drugadministrationroute>050</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060613</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060615</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEGASYS</medicinalproduct>
        <drugadministrationroute>050</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060615</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060623</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COPEGUS</medicinalproduct>
        <drugauthorizationnumb>021511</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060613</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060623</drugenddate>
        <drugtreatmentduration>11</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
        <drugdosagetext>DOSAGE REGIMEN REPORTED: DAILY.</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KLONOPIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LAMICTAL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5041109-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060404</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GILEAD-2006-0009415</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>32</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABORTION SPONTANEOUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRUVADA</medicinalproduct>
        <drugauthorizationnumb>21752</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050228</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FUZEON</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TIPRANAVIR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NORVIR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugindication>ANAEMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AZITHROMYCIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEPRON</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5041110-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060602</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>NL-ROCHE-451346</companynumb>
    <primarysource>
      <reportercountry>NETHERLANDS</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>70</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PANCREATITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CAPECITABINE</medicinalproduct>
        <drugauthorizationnumb>20896</drugauthorizationnumb>
        <drugdosagetext>DAYS 1-14 OF A 3 WEEK CYCLE DOSE AND FREQUENCY AS PER PROTCOL REPORTED  =  2000MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVASTIN</medicinalproduct>
        <drugauthorizationnumb>020896</drugauthorizationnumb>
        <drugdosagetext>ON DAY 1 DOSE AND FREQUENCY AS PER PROTOCOL REPORTED  =  450MG</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXALIPLATIN</medicinalproduct>
        <drugdosagetext>ON DAY 1 DOSE AND FREQUENCY AS PER PROTOCOL NO DOSE OR FREQUENCY REPORTED</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOCLOPRAMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SLOW-K</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOPERAMIDE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5041111-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050819</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-415262</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>3.7</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABORTION SPONTANEOUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONTUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE BEFORE PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NORMAL NEWBORN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>018662</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19920708</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19921115</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GENERIC UNKNOWN</medicinalproduct>
        <drugdosagetext>TRADE NAME: KENALOG.</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19920814</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRENATAL VITAMINS</medicinalproduct>
        <drugindication>VITAMIN SUPPLEMENTATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYLENOL (CAPLET)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5041116-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041206</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CH-ROCHE-388224</companynumb>
    <primarysource>
      <reportercountry>SWITZERLAND</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>56</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BONIVA</medicinalproduct>
        <drugauthorizationnumb>21858</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040512</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FEMARA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>STILNOX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040505</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PONSTAN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040615</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN DRUG</medicinalproduct>
        <drugdosagetext>DRUG REPORTED AS DEROXADE.</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040505</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN DRUG</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040609</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOLEDRONIC ACID</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030615</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAMIDRONIC ACID</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030515</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5041117-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060608</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ZA-ROCHE-451621</companynumb>
    <primarysource>
      <reportercountry>SOUTH AFRICA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>69</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>96</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CEREBRAL ATROPHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUBDURAL HAEMATOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEGASYS</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060320</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060520</drugenddate>
        <drugtreatmentduration>62</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COZAAR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5041118-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20051221</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-439612</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>16</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>59</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABORTION THREATENED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ALANINE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ALOPECIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASPARTATE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AUTOIMMUNE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD ALKALINE PHOSPHATASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BULIMIA NERVOSA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHRONIC FATIGUE SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLITIS ULCERATIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CYSTITIS INTERSTITIAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEVICE RELATED INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE BEFORE PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ELECTROCARDIOGRAM T WAVE ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EXPOSURE TO TOXIC AGENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EXTRASYSTOLES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FIBROMYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FOETAL MOVEMENTS DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FUNGAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHOIDS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLAMMATORY BOWEL DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTESTINAL OBSTRUCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IRON DEFICIENCY ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIMB CRUSHING INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LONG QT SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MELANOCYTIC NAEVUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NECK INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUROPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHOTOPHOBIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POLYCYSTIC OVARIES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POSTNASAL DRIP</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POSTPARTUM DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PREGNANCY TEST URINE POSITIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROCTITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSEUDOPOLYPOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESTLESSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEASONAL ALLERGY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUS HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUS TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN PAPILLOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUPRAVENTRICULAR EXTRASYSTOLES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYSTEMIC LUPUS ERYTHEMATOSUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THERAPY NON-RESPONDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UPPER RESPIRATORY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VAGINAL CANDIDIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VAGINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VAGINITIS BACTERIAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VIRAL PHARYNGITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VULVOVAGINAL MYCOTIC INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>18662</drugauthorizationnumb>
        <drugdosagetext>ALTERNATING 40/80MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ACNE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19941216</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19950502</drugenddate>
        <drugtreatmentduration>138</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>018662</drugauthorizationnumb>
        <drugdosagetext>ALTERNATING 40/80MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19960726</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19961127</drugenddate>
        <drugtreatmentduration>125</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>018662</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19971129</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19980215</drugenddate>
        <drugtreatmentduration>79</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ORTHO TRI-CYCLEN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5041120-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060623</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-453027</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>30</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABORTION COMPLETE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE BEFORE PREGNANCY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>018662</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19881115</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19890515</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5041121-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060622</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-452915</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>29</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>OVERDOSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEGASYS</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060314</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COPEGUS</medicinalproduct>
        <drugauthorizationnumb>021511</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060314</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHADONE HCL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5041122-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060301</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-438847</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>17</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>93</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEILITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CROHN'S DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG ERUPTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRY MOUTH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRY SKIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEAD INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLAMMATORY BOWEL DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JOINT SPRAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NECK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERIRECTAL ABSCESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARYNGITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ROAD TRAFFIC ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPINAL X-RAY ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDE ATTEMPT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUNBURN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TELANGIECTASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TENDONITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THERAPY NON-RESPONDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL DISTURBANCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>18662</drugauthorizationnumb>
        <drugdosagetext>PT WAS STARTED ON ACCUTANE 40MG 1 TAB PO DAILY FOR NODULAR AND CYSTIC SCARRING ACNE.</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19880608</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>018662</drugauthorizationnumb>
        <drugdosagetext>ALTERNATING DOSE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19880706</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>018662</drugauthorizationnumb>
        <drugdosagetext>PT WAS GIVEN REFILL OF ACCUTANE 40MG ONE TAB DAILY ALTERNATING WITH TWO TABS DAILY.</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19880928</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>018662</drugauthorizationnumb>
        <drugdosagetext>PT WAS ALSO GIVEN A REFILL OF ACCUTANE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19881025</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19881117</drugenddate>
        <drugtreatmentduration>24</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>018662</drugauthorizationnumb>
        <drugdosagetext>PT WAS ON ACCUTANE 40MG 1 TAB QOD AND 2 TABS QOD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19900808</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19900908</drugenddate>
        <drugtreatmentduration>32</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYLENOL (CAPLET)</medicinalproduct>
        <drugdosagetext>TAKEN 5 YEARS BEFORE TAKING ACCUTANE</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19830615</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5041129-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060403</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-GILEAD-2006-0009417</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>61</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ASCITES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIABETES MELLITUS NON-INSULIN-DEPENDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC CIRRHOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METABOLIC ACIDOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POLYNEUROPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIREAD</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050801</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VIDEX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REYATAZ</medicinalproduct>
        <drugindication>HIV INFECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVIR</medicinalproduct>
        <drugindication>HIV INFECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COTRIM DS</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANTIBIOTIC PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CEDUR RETARD</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERLIPIDAEMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ISMO RETARD</medicinalproduct>
        <drugindication>CORONARY ARTERY DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CARDIAC FAILURE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CORONARY ARTERY DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KALINOR SPARKLING TABLETS</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TEGRETOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALNA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BENIGN PROSTATIC HYPERPLASIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROSCAR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BENIGN PROSTATIC HYPERPLASIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARTHROTEC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTERIOSCLEROSIS CORONARY ARTERY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5041134-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060625</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-GLAXOSMITHKLINE-A0610830A</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DEPENDENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NICORETTE</medicinalproduct>
        <drugauthorizationnumb>018612</drugauthorizationnumb>
        <drugdosagetext>2MG SEE DOSAGE TEXT</drugdosagetext>
        <drugadministrationroute>002</drugadministrationroute>
        <drugindication>SMOKING CESSATION THERAPY</drugindication>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5041135-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060630</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0610869A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>HALLUCINATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NICODERM CQ</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>020165</drugauthorizationnumb>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5041154-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060412</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-13344502</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>54</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>141</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PANCREAS INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ORENCIA</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060123</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020416</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060105</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRILOSEC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060309</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACTONEL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060116</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHROID</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060105</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5041155-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060626</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-13423934</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>70</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>89</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>ASPIRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD ALBUMIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD POTASSIUM DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STOMATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CISPLATIN</medicinalproduct>
        <drugauthorizationnumb>18057</drugauthorizationnumb>
        <drugdosagetext>COURSE 2. GIVEN DAY 1 + 22 OF TREATMENT COURSE. START DATE COURSE 1: 27-FEB-06.</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NEOPLASM MALIGNANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060320</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060320</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RADIATION THERAPY</medicinalproduct>
        <drugdosagetext>MOST RECENT DOSE 07-APR-06. GIVEN 1 DAY/WK(BID TREATMENT) OVER 6 WEEKS. TOTAL DOSE TO DATE: 70GY.</drugdosagetext>
        <drugindication>NEOPLASM MALIGNANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5041156-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20051117</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-13187505</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BREAST CANCER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ESTRACE</medicinalproduct>
        <drugauthorizationnumb>84499</drugauthorizationnumb>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ESTRADIOL</medicinalproduct>
        <drugauthorizationnumb>084499</drugauthorizationnumb>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROVERA</medicinalproduct>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MEDROXYPROGESTERONE ACETATE</medicinalproduct>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5041158-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PL-BRISTOL-MYERS SQUIBB COMPANY-13427505</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>54</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>102</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTI-ORGAN FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CISPLATIN</medicinalproduct>
        <drugauthorizationnumb>018057</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060613</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060613</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GEMCITABINE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060613</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060613</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BISOPROLOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRANDOLAPRIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000406</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MONONIT</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000406</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETYLSALICYLIC ACID SRT</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000406</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5041159-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060613</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-13410899</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>8</patientonsetage>
      <patientonsetageunit>800</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MENINGIOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ORENCIA</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5041169-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060619</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BE-GILEAD-2006-0009789</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
    </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>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN LOWER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANOREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACTERAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIOMEGALY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIABETES MELLITUS INADEQUATE CONTROL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIABETIC NEUROPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ENCEPHALOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERAL PHYSICAL HEALTH DETERIORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERCALCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOVOLAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCORRECT DOSE ADMINISTERED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER FUNCTION TEST ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METABOLIC ACIDOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEPHRITIS INTERSTITIAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL CANDIDIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL TUBULAR NECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY TRACT INFECTION BACTERIAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINE FLOW DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TENOFOVIR DISOPROXIL FUMARATE</medicinalproduct>
        <drugauthorizationnumb>21356</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060404</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060511</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TMC114</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060404</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060511</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RITONAVIR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060404</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060511</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EUSAPRIM FORTE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENFUVIRTIDE</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060404</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060511</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COMBIVIR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060404</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060511</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATAZANAVIR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060404</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060511</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DAKTARIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULACTRAPID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULATARD NPH HUMAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CORUNO RETARD</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COVERSYL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DUOVENT</medicinalproduct>
        <drugadministrationroute>055</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SERETIDE</medicinalproduct>
        <drugadministrationroute>055</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TEARS NATURALE</medicinalproduct>
        <drugadministrationroute>047</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5041179-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0535167A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>70</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRODUCTIVE COUGH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ADVAIR DISKUS 100/50</medicinalproduct>
        <drugauthorizationnumb>21077</drugauthorizationnumb>
        <drugdosagetext>1PUFF TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021101</drugstartdate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NIFEDIPINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLOMAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVODART</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLONASE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VIAGRA</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5041180-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060322</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0598605A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>57</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLINDNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLINDNESS TRANSIENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONTUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRIC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRIC HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATOCHEZIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RETINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL ACUITY REDUCED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>21071</drugauthorizationnumb>
        <drugdosagetext>8MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060318</drugenddate>
        <drugtreatmentduration>263</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLYBURIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALIUM</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN</medicinalproduct>
        <drugdosagetext>8UNIT PER DAY</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIBRIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTI-ANXIETY MED- NAME UNKNOWN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5041181-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060614</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006-06-0161</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>33</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ACCIDENTAL OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOKALAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTHYROIDISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MANIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THERAPEUTIC AGENT TOXICITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ESKALITH</medicinalproduct>
        <drugauthorizationnumb>16860</drugauthorizationnumb>
        <drugdosagetext>300MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BIPOLAR DISORDER</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060525</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INTRON A</medicinalproduct>
        <drugdosagetext>10MU PER DAY</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060109</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060525</drugenddate>
        <drugtreatmentduration>137</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBETOL</medicinalproduct>
        <drugdosagetext>1000MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060109</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060525</drugenddate>
        <drugtreatmentduration>137</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMBIEN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MOTRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LAMICTAL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5041182-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060614</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0609198A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>24</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>68.2</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD UREA INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG LEVEL BELOW THERAPEUTIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FAECAL INCONTINENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERKALAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPONATRAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCONTINENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY INCONTINENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMICTAL</medicinalproduct>
        <drugauthorizationnumb>20241</drugauthorizationnumb>
        <drugdosagetext>100MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>EPILEPSY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NO CONCURRENT MEDICATION</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5041183-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060623</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0610165A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>52</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EPZICOM</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021652</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REYATAZ</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5041184-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060626</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0610319A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC ENZYME INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>WELLBUTRIN SR</medicinalproduct>
        <drugauthorizationnumb>020358</drugauthorizationnumb>
        <drugdosagetext>150MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADDERALL 10</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAZODONE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTIBIOTICS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5041185-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060626</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0610331A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>58</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEAD INJURY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>WELLBUTRIN</medicinalproduct>
        <drugauthorizationnumb>021515</drugauthorizationnumb>
        <drugdosagetext>150MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5041186-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060626</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0610335A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>47</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MANIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BUPROPION HYDROCHLORIDE</medicinalproduct>
        <drugauthorizationnumb>020358</drugauthorizationnumb>
        <drugdosagetext>75MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051201</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5041187-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0610776A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>ANGIONEUROTIC OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWOLLEN TONGUE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EPZICOM</medicinalproduct>
        <drugauthorizationnumb>021652</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KALETRA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SULFA</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5041188-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0610781A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>15</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMICTAL</medicinalproduct>
        <drugauthorizationnumb>020241</drugauthorizationnumb>
        <drugdosagetext>200MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>EPILEPSY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5041189-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060627</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0610818A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>4.3</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEONATAL ASPIRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OXYGEN SATURATION DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUMATRIPTAN SUCCINATE</medicinalproduct>
        <drugauthorizationnumb>020132</drugauthorizationnumb>
        <drugdosagetext>100MG PER DAY</drugdosagetext>
        <drugindication>MIGRAINE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051001</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5041190-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0610826A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>34</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABORTION SPONTANEOUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANTEPARTUM HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TWIN PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VAGINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMICTAL</medicinalproduct>
        <drugauthorizationnumb>020241</drugauthorizationnumb>
        <drugdosagetext>200MG PER DAY</drugdosagetext>
        <drugindication>EPILEPSY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5041191-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesscongenitalanomali>1</seriousnesscongenitalanomali>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0610828A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>0.9</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CONGENITAL ANOMALY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYDROPS FOETALIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZIDOVUDINE</medicinalproduct>
        <drugauthorizationnumb>019655</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRUVADA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VIRAMUNE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5041192-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0610836A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE CONGESTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>12.5MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CARDIAC DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POLYPHARMACY</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEFIBRILLATION</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5041193-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>8017476</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>62</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMICTAL</medicinalproduct>
        <drugauthorizationnumb>020241</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KEPPRA</medicinalproduct>
        <drugdosagetext>500MG TWICE PER DAY</drugdosagetext>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEPAKOTE</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5041194-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0610839A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>57</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COORDINATION ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTHYROIDISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>WELLBUTRIN XL</medicinalproduct>
        <drugauthorizationnumb>021515</drugauthorizationnumb>
        <drugdosagetext>150MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060618</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060625</drugenddate>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRAVACHOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5041195-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060630</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0610893A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOFRAN</medicinalproduct>
        <drugauthorizationnumb>020781</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5041196-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060630</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0610897A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MACULAR DEGENERATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5041197-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060630</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0610900A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLINDNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLINDNESS UNILATERAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5041199-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060630</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0610907A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>EXTRAPYRAMIDAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TARDIVE DYSKINESIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMICTAL</medicinalproduct>
        <drugauthorizationnumb>020241</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>EPILEPSY</drugindication>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5041200-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-GLAXOSMITHKLINE-A0610922A</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMOTRIGINE</medicinalproduct>
        <drugauthorizationnumb>020241</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5041201-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060623</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-GLAXOSMITHKLINE-B0379351C</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>32</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CREPITATIONS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NASOPHARYNGITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA VIRAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EPIVIR</medicinalproduct>
        <drugauthorizationnumb>020564</drugauthorizationnumb>
        <drugdosagetext>300MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030104</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>20030104</drugstartdate>
      </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>20030104</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5041202-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050915</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-GLAXOSMITHKLINE-B0395986A</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>8</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CAPILLARY DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CUSHING'S SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CUSHINGOID</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SERETIDE</medicinalproduct>
        <drugauthorizationnumb>21077</drugauthorizationnumb>
        <drugdosagetext>2PUFF TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050501</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5041203-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
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    <receiptdate>20050930</receiptdate>
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    <companynumb>FR-GLAXOSMITHKLINE-B0396112A</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <patientonsetage>12</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CAPILLARY DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CUSHING'S SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CUSHINGOID</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SERETIDE</medicinalproduct>
        <drugauthorizationnumb>21077</drugauthorizationnumb>
        <drugdosagetext>2PUFF TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050501</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5041204-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
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    <companynumb>FR-GLAXOSMITHKLINE-B0396113A</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <patientonsetage>16</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CAPILLARY DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CUSHING'S SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CUSHINGOID</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FAT TISSUE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIPOHYPERTROPHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SERETIDE</medicinalproduct>
        <drugauthorizationnumb>21077</drugauthorizationnumb>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050701</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CORTICOID</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041201</drugenddate>
        <drugtreatmentduration>10</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SINGULAIR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030901</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NASACORT</medicinalproduct>
        <drugadministrationroute>045</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030901</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLARYTINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030901</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5041205-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050930</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-GLAXOSMITHKLINE-B0396114A</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>12</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CAPILLARY DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CUSHING'S SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CUSHINGOID</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SERETIDE</medicinalproduct>
        <drugauthorizationnumb>21077</drugauthorizationnumb>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050701</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5041206-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060116</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-GLAXOSMITHKLINE-B0407524A</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>2</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>ALANINE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASPARTATE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHILLS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPHOCYTE COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARYNGEAL ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRANSAMINASES INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMICTAL</medicinalproduct>
        <drugauthorizationnumb>20764</drugauthorizationnumb>
        <drugdosagetext>100MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GRAND MAL CONVULSION</drugindication>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5041207-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060325</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>109382ISR</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>57</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CYANOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERSTITIAL LUNG DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMOTRIGINE</medicinalproduct>
        <drugauthorizationnumb>20241</drugauthorizationnumb>
        <drugdosagetext>75MG PER DAY</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>CONVULSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VALPROIC ACID</medicinalproduct>
        <drugdosagetext>700MG PER DAY</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>CONVULSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5041208-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesscongenitalanomali>1</seriousnesscongenitalanomali>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060323</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DK-GLAXOSMITHKLINE-B0417434A</companynumb>
    <primarysource>
      <reportercountry>DENMARK</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENTRICULAR SEPTAL DEFECT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMICTAL</medicinalproduct>
        <drugauthorizationnumb>20241</drugauthorizationnumb>
        <drugindication>EPILEPSY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5041209-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesscongenitalanomali>1</seriousnesscongenitalanomali>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060405</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ZA-GLAXOSMITHKLINE-B0420137A</companynumb>
    <primarysource>
      <reportercountry>SOUTH AFRICA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>18</patientonsetage>
      <patientonsetageunit>802</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DEVELOPMENTAL DELAY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MICROCEPHALY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMICTAL</medicinalproduct>
        <drugauthorizationnumb>20241</drugauthorizationnumb>
        <drugindication>EPILEPSY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARBAMAZEPINE</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
        <drugdosagetext>4MG UNKNOWN</drugdosagetext>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTIVITAMIN</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5041210-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060622</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ZA-GLAXOSMITHKLINE-B0420137B</companynumb>
    <primarysource>
      <reportercountry>SOUTH AFRICA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EPILEPSY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMOTRIGINE</medicinalproduct>
        <drugauthorizationnumb>020241</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TEGRETOL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
        <drugdosagetext>4MG UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTIVITAMIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5041211-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060414</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>NL-GLAXOSMITHKLINE-B0421238A</companynumb>
    <primarysource>
      <reportercountry>NETHERLANDS</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>69</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>91</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>VISUAL ACUITY REDUCED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUTICASONE PROPIONATE</medicinalproduct>
        <drugauthorizationnumb>20548</drugauthorizationnumb>
        <drugdosagetext>1U PER DAY</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>BRONCHITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20011113</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUTICASONE PROPIONATE</medicinalproduct>
        <drugauthorizationnumb>020833</drugauthorizationnumb>
        <drugdosagetext>250MCG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020219</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FORADIL</medicinalproduct>
        <drugdosagetext>1TAB TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020114</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5041212-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060427</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>100#08#2006-00719</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>57</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CYANOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERSTITIAL LUNG DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMOTRIGINE</medicinalproduct>
        <drugauthorizationnumb>20241</drugauthorizationnumb>
        <drugdosagetext>75MG PER DAY</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>CONVULSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VALPROIC ACID</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>CONVULSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5041213-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060508</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-GLAXOSMITHKLINE-B0422919A</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>60</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METHAEMOGLOBINAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMBIVIR</medicinalproduct>
        <drugauthorizationnumb>20857</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KALETRA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRUVADA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOSULEPIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAMSULOSIN HCL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYBUTYNIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OLANZAPINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COTRIMOXAZOLE ORAL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5041214-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060511</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-JPN-A200601529</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>84</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>53</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DELIRIUM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VALTREX</medicinalproduct>
        <drugauthorizationnumb>20487</drugauthorizationnumb>
        <drugdosagetext>1000MG THREE TIMES PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HERPES ZOSTER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060502</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060504</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HYPEN</medicinalproduct>
        <drugdosagetext>200MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>FEMUR FRACTURE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060430</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060504</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5041215-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060515</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-GLAXOSMITHKLINE-B0423824A</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>20</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>INTENTIONAL SELF-INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDE ATTEMPT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROXAT</medicinalproduct>
        <drugauthorizationnumb>20031</drugauthorizationnumb>
        <drugdosagetext>20MG UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIAZEPAM</medicinalproduct>
        <drugdosagetext>8MG AT NIGHT</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OLANZAPINE</medicinalproduct>
        <drugdosagetext>7.5MG AT NIGHT</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5041216-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060515</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>NL-GLAXOSMITHKLINE-B0424696A</companynumb>
    <primarysource>
      <reportercountry>NETHERLANDS</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>40</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>61</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FOREIGN BODY TRAUMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SALBUTAMOL SULPHATE</medicinalproduct>
        <drugauthorizationnumb>18473</drugauthorizationnumb>
        <drugadministrationroute>055</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5041217-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060522</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-GLAXOSMITHKLINE-B0424879A</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>76</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>86</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DEPRESSED LEVEL OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISTURBANCE IN ATTENTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESTLESS LEGS SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ADARTREL</medicinalproduct>
        <drugbatchnumb>X6755</drugbatchnumb>
        <drugauthorizationnumb>20658</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RESTLESS LEGS SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEXAQUINE</medicinalproduct>
        <drugdosagetext>3TAB PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIANTALVIC</medicinalproduct>
        <drugdosagetext>2CAP PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADANCOR</medicinalproduct>
        <drugdosagetext>10MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5041218-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060601</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>J200601489</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>53</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>LARYNGOTRACHEO BRONCHITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SAWACILLIN</medicinalproduct>
        <drugauthorizationnumb>62216</drugauthorizationnumb>
        <drugdosagetext>250MG THREE TIMES PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>TONSILLITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060417</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060420</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AZELASTINE HCL</medicinalproduct>
        <drugdosagetext>1MG THREE TIMES PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060308</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060415</drugenddate>
        <drugtreatmentduration>39</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HISPORAN</medicinalproduct>
        <drugdosagetext>3MG THREE TIMES PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060308</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060415</drugenddate>
        <drugtreatmentduration>39</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLARITHROMYCIN</medicinalproduct>
        <drugdosagetext>200MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>LARYNGOTRACHEO BRONCHITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060420</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060424</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PONTAL</medicinalproduct>
        <drugdosagetext>750MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>TONSILLITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060417</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060420</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LYSOZYME HYDROCHLORIDE</medicinalproduct>
        <drugdosagetext>90MG THREE TIMES PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>TONSILLITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060417</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060420</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALESION</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NIPOLAZIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
        <drugdosagetext>.625MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060524</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MUCODYNE</medicinalproduct>
        <drugdosagetext>500MG THREE TIMES PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>LARYNGOTRACHEO BRONCHITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060420</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060424</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASVERIN</medicinalproduct>
        <drugdosagetext>20MG THREE TIMES PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>LARYNGOTRACHEO BRONCHITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060420</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060424</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLORIAMIN</medicinalproduct>
        <drugdosagetext>.5G THREE TIMES PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>LARYNGOTRACHEO BRONCHITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060420</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060424</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5041219-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050620</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-JPN-A20051278</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>28</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY HYPERTENSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLOLAN</medicinalproduct>
        <drugauthorizationnumb>20444</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PULMONARY HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030520</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5041220-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060607</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FRPFM-E-20060065</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>51</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>CEREBRAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG RASH WITH EOSINOPHILIA AND SYSTEMIC SYMPTOMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROTHROMBIN LEVEL DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PURPURA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH MACULO-PAPULAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SHOCK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOXIC SKIN ERUPTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CIBLOR</medicinalproduct>
        <drugauthorizationnumb>50564</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ORCHITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060321</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMICTAL</medicinalproduct>
        <drugauthorizationnumb>020241</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060209</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060328</drugenddate>
        <drugtreatmentduration>48</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CIFLOX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ORCHITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060321</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREVISCAN</medicinalproduct>
        <drugdosagetext>10MG AT NIGHT</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PHLEBITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060328</drugenddate>
        <drugtreatmentduration>87</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5041221-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060607</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>EG-GLAXOSMITHKLINE-B0427628A</companynumb>
    <primarysource>
      <reportercountry>EGYPT</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>35</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>100</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANAPHYLACTIC SHOCK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRADYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRAIN OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBRAL ATROPHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CYANOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEMENTIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLEURAL EFFUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY DISTRESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTUM</medicinalproduct>
        <drugauthorizationnumb>50578</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>SKIN GRAFT</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5041222-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060615</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-GLAXOSMITHKLINE-B0427837A</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>88</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>CEREBRAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROTHROMBIN LEVEL DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARIXTRA</medicinalproduct>
        <drugauthorizationnumb>021345</drugauthorizationnumb>
        <drugdosagetext>7.5MG PER DAY</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>DEEP VEIN THROMBOSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060515</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060501</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEEP VEIN THROMBOSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060515</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COMPRESSION STOCKINGS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5041223-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060616</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BE-GLAXOSMITHKLINE-B0428178A</companynumb>
    <primarysource>
      <reportercountry>BELGIUM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>40</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PSYCHOTIC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STATUS EPILEPTICUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KIVEXA</medicinalproduct>
        <drugauthorizationnumb>21652</drugauthorizationnumb>
        <drugdosagetext>1TAB PER DAY</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZIAGEN</medicinalproduct>
        <drugauthorizationnumb>020977</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>STOCRIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EPIVIR</medicinalproduct>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5041225-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060622</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-GLAXOSMITHKLINE-B0428838A</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>32</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>GLAUCOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRIZIVIR</medicinalproduct>
        <drugauthorizationnumb>21205</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CIALIS</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5041226-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060620</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>20060065-V001</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>51</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>CEREBRAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG ERUPTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG RASH WITH EOSINOPHILIA AND SYSTEMIC SYMPTOMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EOSINOPHILIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NONSPECIFIC REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL SOFT TISSUE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROTHROMBIN LEVEL DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PURPURA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH MACULO-PAPULAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SHOCK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOXIC SKIN ERUPTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CIBLOR</medicinalproduct>
        <drugauthorizationnumb>50564</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ORCHITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060301</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMICTAL</medicinalproduct>
        <drugauthorizationnumb>020241</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060209</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060328</drugenddate>
        <drugtreatmentduration>48</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CIFLOX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ORCHITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060301</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREVISCAN</medicinalproduct>
        <drugdosagetext>10MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PHLEBITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060328</drugenddate>
        <drugtreatmentduration>87</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5041227-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-GLAXOSMITHKLINE-B0429094A</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>2</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>15</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANALGESIC DRUG LEVEL INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CALCIUM DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COAGULATION FACTOR DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSED LEVEL OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ELECTROENCEPHALOGRAM ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ENCEPHALITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATEMESIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC ENCEPHALOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATITIS FULMINANT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATOCELLULAR DAMAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MELAENA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROTHROMBIN LEVEL DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLAMOXYL IV</medicinalproduct>
        <drugdosagetext>150MG PER DAY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>GASTROENTERITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060503</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060503</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOLIPRANE</medicinalproduct>
        <drugdosagetext>150MG FOUR TIMES PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTROENTERITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060503</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060503</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRIMPERAN TAB</medicinalproduct>
        <drugdosagetext>1UNIT PER DAY</drugdosagetext>
        <drugadministrationroute>054</drugadministrationroute>
        <drugindication>GASTROENTERITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060503</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060503</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5041228-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-GLAXOSMITHKLINE-B0429132A</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>43</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD PHOSPHORUS INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CYTOMEGALOVIRUS INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAMMA-GLUTAMYLTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATITIS CHOLESTATIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATITIS TOXIC</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AUGMENTIN '125'</medicinalproduct>
        <drugauthorizationnumb>50564</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>FEBRILE INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060507</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060515</drugenddate>
        <drugtreatmentduration>9</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLINOMEL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DYSPHAGIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060502</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060515</drugenddate>
        <drugtreatmentduration>14</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYMEVAN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>CYTOMEGALOVIRUS INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060504</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060509</drugenddate>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOSPHENYTOIN SODIUM</medicinalproduct>
        <drugdosagetext>3UNIT PER DAY</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>CONVULSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060430</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060501</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
        <drugdosagetext>1G THREE TIMES PER DAY</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>BACTERIAL INFECTION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060504</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KEPPRA</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>EPILEPSY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CORTICOIDS</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>EPILEPSY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BACTRIM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PNEUMOCYSTIS JIROVECI PNEUMONIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060401</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5041229-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060627</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-JPN-A200602321</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>84</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FACE OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUTIDE</medicinalproduct>
        <drugauthorizationnumb>20548</drugauthorizationnumb>
        <drugadministrationroute>055</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ERYTHROMYCIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNICON</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MUCOSAL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDERGINE</medicinalproduct>
        <drugadministrationroute>060</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CHINESE HERBAL MEDICINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HOKUNALIN</medicinalproduct>
        <drugadministrationroute>062</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEO UMOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGNESIUM OXIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5041230-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060627</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-B0429286A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>HAEMOLYTIC URAEMIC SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOTIC THROMBOCYTOPENIC PURPURA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MELPHALAN</medicinalproduct>
        <drugauthorizationnumb>14691</drugauthorizationnumb>
        <drugdosagetext>140MGM2 SINGLE DOSE</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>STEM CELL TRANSPLANT</drugindication>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GEMTUZUMAB OZOGAMICIN</medicinalproduct>
        <drugdosagetext>2MGM2 SINGLE DOSE</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>STEM CELL TRANSPLANT</drugindication>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUDARABINE</medicinalproduct>
        <drugdosagetext>30MGM2 UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>STEM CELL TRANSPLANT</drugindication>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TACROLIMUS</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PROPHYLAXIS AGAINST TRANSPLANT REJECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PROPHYLAXIS AGAINST TRANSPLANT REJECTION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5041231-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060627</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ES-GLAXOSMITHKLINE-B0429321A</companynumb>
    <primarysource>
      <reportercountry>SPAIN</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>CYSTITIS HAEMORRHAGIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ENTEROCOLITIS HAEMORRHAGIC</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MELPHALAN</medicinalproduct>
        <drugauthorizationnumb>14691</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BUSULFAN</medicinalproduct>
        <drugauthorizationnumb>009386</drugauthorizationnumb>
        <drugdosagetext>16MGK UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CHEMOTHERAPY</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5041232-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060623</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>13020763</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>45</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>LIVER DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RETROVIR</medicinalproduct>
        <drugauthorizationnumb>19655</drugauthorizationnumb>
        <drugdosagetext>400MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050527</drugenddate>
        <drugtreatmentduration>666</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EPIVIR</medicinalproduct>
        <drugauthorizationnumb>020564</drugauthorizationnumb>
        <drugdosagetext>150MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050527</drugenddate>
        <drugtreatmentduration>666</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>STOCRIN</medicinalproduct>
        <drugdosagetext>600MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050527</drugenddate>
        <drugtreatmentduration>666</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>20050528</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RITONAVIR</medicinalproduct>
        <drugdosagetext>100MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050528</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRUVADA</medicinalproduct>
        <drugdosagetext>1TAB PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050528</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5041233-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060627</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ES-GLAXOSMITHKLINE-B0429339A</companynumb>
    <primarysource>
      <reportercountry>SPAIN</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>CYSTITIS HAEMORRHAGIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ENTEROCOLITIS HAEMORRHAGIC</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MELPHALAN</medicinalproduct>
        <drugauthorizationnumb>14691</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BUSULFAN</medicinalproduct>
        <drugauthorizationnumb>009386</drugauthorizationnumb>
        <drugdosagetext>16MGK UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CHEMOTHERAPY</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5041234-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060627</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ES-GLAXOSMITHKLINE-B0429340A</companynumb>
    <primarysource>
      <reportercountry>SPAIN</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>SYSTEMIC CANDIDA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MELPHALAN</medicinalproduct>
        <drugauthorizationnumb>14691</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>STEM CELL TRANSPLANT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BUSULFAN</medicinalproduct>
        <drugauthorizationnumb>009386</drugauthorizationnumb>
        <drugdosagetext>16MGK UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>STEM CELL TRANSPLANT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CHEMOTHERAPY</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>STEM CELL TRANSPLANT</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5041235-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060627</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>NO-GLAXOSMITHKLINE-B0429356A</companynumb>
    <primarysource>
      <reportercountry>NORWAY</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>75</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BALANCE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSSTASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MONOPARESIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOVEMENT DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NERVOUS SYSTEM DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYBAN</medicinalproduct>
        <drugauthorizationnumb>18644</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SMOKING CESSATION THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>APODORM</medicinalproduct>
        <drugdosagetext>5MG AT NIGHT</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INSOMNIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060518</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SURMONTIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060522</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ORFIRIL LONG</medicinalproduct>
        <drugdosagetext>300MG SEE DOSAGE TEXT</drugdosagetext>
        <drugindication>EPILEPSY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PARALGIN FORTE</medicinalproduct>
        <drugdosagetext>1TAB AS REQUIRED</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LESCOL</medicinalproduct>
        <drugdosagetext>80MG AT NIGHT</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5041236-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060627</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-JPN-A200602312</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>94</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANOREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY RETENTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VALTREX</medicinalproduct>
        <drugauthorizationnumb>020487</drugauthorizationnumb>
        <drugdosagetext>2TAB THREE TIMES PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HERPES ZOSTER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060624</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060625</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5041237-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060630</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-GLAXOSMITHKLINE-B0429415A</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>17</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CREATININE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>C-REACTIVE PROTEIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROTEINURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TUBULOINTERSTITIAL NEPHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLAMOXYL</medicinalproduct>
        <drugauthorizationnumb>50754</drugauthorizationnumb>
        <drugdosagetext>1.5G PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NASOPHARYNGITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060415</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060422</drugenddate>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ANTADYS</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DYSMENORRHOEA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060516</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5041238-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FI-GLAXOSMITHKLINE-B0429499A</companynumb>
    <primarysource>
      <reportercountry>FINLAND</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>PNEUMONIA FUNGAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MELPHALAN</medicinalproduct>
        <drugauthorizationnumb>20207</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYCLOPHOSPHAMIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEUPOGEN</medicinalproduct>
        <drugdosagetext>5MCK PER DAY</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COTRIMOXAZOLE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>INFECTION PROPHYLAXIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5041239-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060627</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>452851</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EUCARDIC</medicinalproduct>
        <drugauthorizationnumb>20297</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5041240-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060627</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>452540</companynumb>
    <primarysource>
      <reportercountry>CHINA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>60</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HEPATIC FUNCTION ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DILATREND</medicinalproduct>
        <drugauthorizationnumb>20297</drugauthorizationnumb>
        <drugdosagetext>6.25MG PER DAY</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>CARDIAC FAILURE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060519</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060607</drugenddate>
        <drugtreatmentduration>20</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPANTHYL</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060518</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060602</drugenddate>
        <drugtreatmentduration>16</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUTATHIONE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5041241-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060627</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>452247</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG ERUPTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARTIST</medicinalproduct>
        <drugauthorizationnumb>20297</drugauthorizationnumb>
        <drugdosagetext>1.25MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CARDIAC FAILURE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060420</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060504</drugenddate>
        <drugtreatmentduration>15</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HERBESSER</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NU-LOTAN</medicinalproduct>
        <drugdosagetext>25MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5041242-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060301</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-GLAXOSMITHKLINE-D0048884A</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>7</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>22</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DISTURBANCE IN ATTENTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NERVOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALBUTEROL</medicinalproduct>
        <drugauthorizationnumb>018473</drugauthorizationnumb>
        <drugdosagetext>8DROP PER DAY</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060220</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATROVENT</medicinalproduct>
        <drugdosagetext>20CAP PER DAY</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060220</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5041243-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060627</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-GLAXOSMITHKLINE-D0050146A</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ILEUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SELECTIVE IGA IMMUNODEFICIENCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYSTEMIC LUPUS ERYTHEMATOSUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RETROVIR</medicinalproduct>
        <drugauthorizationnumb>019655</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19950101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BROMOCRIPTIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>MASTITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>L-THYROXIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIVIELLA</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5041265-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060630</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BW-BRISTOL-MYERS SQUIBB COMPANY-13430053</companynumb>
    <primarysource>
      <reportercountry>SOUTH AFRICA</reportercountry>
      <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>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATOTOXICITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>STAVUDINE</medicinalproduct>
        <drugauthorizationnumb>020412</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050929</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060220</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EFAVIRENZ</medicinalproduct>
        <drugauthorizationnumb>020972</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050516</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060220</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMIVUDINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050516</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060220</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RIFAMPICIN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051005</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060323</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ISONIAZID</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051005</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060323</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5041287-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060623</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-ROCHE-453199</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MUCOSAL DRYNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAPILLOMA VIRAL INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ROACCUTANE</medicinalproduct>
        <drugauthorizationnumb>18662</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5041288-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060428</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BE-ROCHE-446044</companynumb>
    <primarysource>
      <reportercountry>BELGIUM</reportercountry>
      <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>ANOREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEBRILE NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HERPES ZOSTER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STOMATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CAPECITABINE</medicinalproduct>
        <drugauthorizationnumb>20896</drugauthorizationnumb>
        <drugdosagetext>ON DAYS ONE TO FOURTEEN EVERY THREE WEEKS</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060414</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CAPECITABINE</medicinalproduct>
        <drugauthorizationnumb>020896</drugauthorizationnumb>
        <drugdosagetext>DOSE REDUCED FOR CYCLE II</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060602</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAXOTERE</medicinalproduct>
        <drugdosagetext>ON DAYS ONE AND EIGHT EVERY THREE WEEKS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060414</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAXOTERE</medicinalproduct>
        <drugdosagetext>DAYS 1 AND 8 EVERY 3 WEEKS. DOSE REDUCED FOR CYCLE II</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060602</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAZOLAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BETASERC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SERENASE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>1 CONCOMITANT DRUG</medicinalproduct>
        <drugdosagetext>REPORTED AS FLUNITROPAN</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM</medicinalproduct>
        <drugdosagetext>TDD = 2 * 15CC</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060415</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5041290-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060623</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-ROCHE-452996</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>20</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>90</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRY MOUTH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ROACUTAN</medicinalproduct>
        <drugauthorizationnumb>18662</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ACNE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060515</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060618</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5041304-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060627</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-KINGPHARMUSA00001-K200600851</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>73</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>70</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HEART RATE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE IRREGULAR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALTACE</medicinalproduct>
        <drugauthorizationnumb>019901</drugauthorizationnumb>
        <drugdosagetext>10 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060622</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REQUIP</medicinalproduct>
        <drugdosagetext>UNK, TID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PARKINSON'S DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>^STILEU^</medicinalproduct>
        <drugdosagetext>UNK, QID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PARKINSON'S DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRAVACHOL</medicinalproduct>
        <drugdosagetext>UNK, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5041305-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060622</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-BRISTOL-MYERS SQUIBB COMPANY-13422522</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>39</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>51</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>SKIN DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VERTIGO</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REYATAZ</medicinalproduct>
        <drugauthorizationnumb>021567</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041230</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EPIVIR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041230</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZIAGEN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041230</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NORVIR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041230</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COMBIVIR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KALETRA</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5041396-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-BRISTOL-MYERS SQUIBB COMPANY-13428636</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>68</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HYPERKALAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LACTIC ACIDOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METFORMIN HYDROCHLORIDE</medicinalproduct>
        <drugauthorizationnumb>21202</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>APROVEL TABS 300 MG</medicinalproduct>
        <drugauthorizationnumb>020757</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050125</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5041397-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060623</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-BRISTOL-MYERS SQUIBB COMPANY-13424296</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>GALACTORRHOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ELISOR TABS 20 MG</medicinalproduct>
        <drugauthorizationnumb>19898</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERCHOLESTEROLAEMIA</drugindication>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5041408-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060516</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-BRISTOL-MYERS SQUIBB COMPANY-13379490</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOLYTIC URAEMIC SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALIGNANT NEOPLASM PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAXOL</medicinalproduct>
        <drugauthorizationnumb>20262</drugauthorizationnumb>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>LUNG NEOPLASM MALIGNANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060331</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060331</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PARAPLATIN</medicinalproduct>
        <drugauthorizationnumb>019880</drugauthorizationnumb>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>LUNG NEOPLASM MALIGNANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060331</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060331</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GASTER</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060405</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060406</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GASTER</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060311</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060404</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ORGARAN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060318</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060325</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ORGARAN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060328</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060406</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDONINE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060313</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060406</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMINOFLUID</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060311</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060325</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5041409-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060608</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-BRISTOL-MYERS SQUIBB COMPANY-13407291</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>83</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BRADYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS POSTURAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CORGARD</medicinalproduct>
        <drugauthorizationnumb>18063</drugauthorizationnumb>
        <drugdosagetext>DURATION: 10 YEARS</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19960101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASILIX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19960101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RENITEC</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060408</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METEOSPASMYL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTROINTESTINAL DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060408</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EVISTA</medicinalproduct>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060401</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5041458-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-BRISTOL-MYERS SQUIBB COMPANY-13431143</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>68</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE MARROW FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ERBITUX</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060517</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARBOPLATIN</medicinalproduct>
        <drugauthorizationnumb>019880</drugauthorizationnumb>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060517</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GEMCITABINE</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5041466-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20000921</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2000COU1165</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>79</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERNATIONAL NORMALISED RATIO INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROTHROMBIN TIME PROLONGED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUSITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
        <drugauthorizationnumb>009218</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>AORTIC VALVE REPLACEMENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19930101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20000822</drugenddate>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>AVELOX</medicinalproduct>
        <drugdosagetext>400 MG FROM 27-JUL-2000 TO 05-AUG-2000 AND FROM 15-AUG-2000 TO 24-AUG-2000</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ACUTE SINUSITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000727</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20000824</drugenddate>
        <drugtreatmentduration>29</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugindication>HYPERLIPIDAEMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5041467-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050311</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-12894002</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>79</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERNATIONAL NORMALISED RATIO INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROTHROMBIN TIME PROLONGED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
        <drugauthorizationnumb>9218</drugauthorizationnumb>
        <drugdosagetext>WARFARIN HELD FOR 3 DAYS</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>AORTIC VALVE REPLACEMENT</drugindication>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>AVELOX</medicinalproduct>
        <drugdosagetext>400MG QD 27-JUL-2000 TO 05-AUG-00 X 10 DAYS;THEN FROM 15-AUG-00 TO 24-AUG-00 X 10DAYS;STOPPED.</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SINUSITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000727</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20000824</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5041485-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-BRISTOL-MYERS SQUIBB COMPANY-13429394</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>82</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ADENOMA BENIGN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CATECHOLAMINES URINE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SINEMET</medicinalproduct>
        <drugauthorizationnumb>017555</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
        <drugauthorizationnumb>073318</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BEZAFIBRATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRAMIPEXOLE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIAZEPAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THYROXINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BETAXOLOL</medicinalproduct>
        <drugadministrationroute>047</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5041676-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060704</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060630</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-RB-3518-2006</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>2.51</patientweight>
      <reaction>
        <reactionmeddrapt>AORTA HYPOPLASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONGENITAL AORTIC ANOMALY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART DISEASE CONGENITAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTONIA NEONATAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IRRITABILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEONATAL TACHYPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POOR SUCKING REFLEX</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PREMATURE BABY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SHOCK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENTRICULAR SEPTAL DEFECT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BUPRENORPHINE HCL</medicinalproduct>
        <drugauthorizationnumb>020732</drugauthorizationnumb>
        <drugadministrationroute>064</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060426</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5041677-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060704</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-RB-3516-2006</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPEECH DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUBOXONE</medicinalproduct>
        <drugauthorizationnumb>020733</drugauthorizationnumb>
        <drugadministrationroute>060</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060607</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060620</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
        <drugadministrationroute>059</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORAZEPAM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANXIETY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANXIETY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5041680-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060704</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060630</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-RB-3517-2006</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>33</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UNEVALUABLE EVENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UNWANTED PREGNANCY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BUPRENORPHINE HCL</medicinalproduct>
        <drugauthorizationnumb>020732</drugauthorizationnumb>
        <drugdosagetext>6 - 8 MG QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG DEPENDENCE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BUPRENORPHINE HCL</medicinalproduct>
        <drugauthorizationnumb>020732</drugauthorizationnumb>
        <drugdosagetext>2 - 3 INJECTIONS  QD</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5041681-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060704</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060630</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-RB-3519-2006</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>35</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DYSPHONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FACIAL PALSY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARESIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BUPRENORPHINE HCL</medicinalproduct>
        <drugauthorizationnumb>020732</drugauthorizationnumb>
        <drugdosagetext>THERAPY DISCONTINUED</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060522</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DISULFIRAM</medicinalproduct>
        <drugdosagetext>DOSAGE UNKNOWN; THERAPY DISCONTINUED.</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060521</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OLANZAPINE</medicinalproduct>
        <drugdosagetext>THERAPY DISCONTINUED.</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060521</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5041741-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060704</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060703</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-RB-3520-2006</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>58</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG DEPENDENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BUPRENORPHINE HCL</medicinalproduct>
        <drugauthorizationnumb>018401</drugauthorizationnumb>
        <drugdosagetext>4 - 6 AMPULES/DAY</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMINOPHYLLINE</medicinalproduct>
        <drugdosagetext>DOSAGE UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CANDESARTAN CILEXETIL</medicinalproduct>
        <drugdosagetext>DOSAGE UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CODEINE PHOSPHATE</medicinalproduct>
        <drugdosagetext>DOSAGE UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOFLOXACIN</medicinalproduct>
        <drugdosagetext>DOSAGE UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5041820-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060704</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060627</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-SP-2006-01627</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>82</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CYSTITIS NONINFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMMUCYST</medicinalproduct>
        <drugbatchnumb>LOT NOT REP</drugbatchnumb>
        <drugadministrationroute>043</drugadministrationroute>
        <drugindication>BLADDER CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051202</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051202</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMMUCYST</medicinalproduct>
        <drugbatchnumb>LOT NOT REP</drugbatchnumb>
        <drugadministrationroute>043</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060323</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060323</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5041821-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060704</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-SP-2006-01601</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>77</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CONTRACTED BLADDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTONIC BLADDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMMUCYST</medicinalproduct>
        <drugbatchnumb>LOT NOT REP</drugbatchnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>BLADDER CANCER RECURRENT</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5041822-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060704</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-SP-2006-01612</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>72</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD CREATININE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FIBROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLANK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GRANULOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEPHRITIS INTERSTITIAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TENDERNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BCG  THERAPEUTICS</medicinalproduct>
        <drugbatchnumb>LOT NOT REP</drugbatchnumb>
        <drugadministrationroute>043</drugadministrationroute>
        <drugindication>CARCINOMA IN SITU OF BLADDER</drugindication>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5041823-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060704</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-SP-2006-01615</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>56</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CONTRACTED BLADDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POLLAKIURIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMMUCYST</medicinalproduct>
        <drugbatchnumb>LOT NOT REP</drugbatchnumb>
        <drugadministrationroute>043</drugadministrationroute>
        <drugindication>BLADDER CANCER</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060331</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5041824-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060704</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050801</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-SP-2005-01445</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>70</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DYSURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POLLAKIURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TUBERCULOSIS BLADDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMMUCYST</medicinalproduct>
        <drugbatchnumb>LOT NOT REP</drugbatchnumb>
        <drugadministrationroute>043</drugadministrationroute>
        <drugindication>BLADDER CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041221</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050315</drugenddate>
        <drugtreatmentduration>84</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CEFDINIR</medicinalproduct>
        <drugindication>CYSTITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050111</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050208</drugenddate>
        <drugtreatmentduration>28</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRANEXAMIC ACID</medicinalproduct>
        <drugindication>HAEMATURIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050111</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOXOPROFEN SODIUM</medicinalproduct>
        <drugindication>ABDOMINAL PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050125</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROPIVERINE HYDROCHLORIDE</medicinalproduct>
        <drugindication>POLLAKIURIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050204</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050412</drugenddate>
        <drugtreatmentduration>66</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CEFCAPENE PIVOXIL HYDROCHLORIDE</medicinalproduct>
        <drugindication>CYSTITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050208</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050516</drugenddate>
        <drugtreatmentduration>96</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5041825-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060704</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060630</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-SP-2006-01629</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>SUBARACHNOID HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMMUCYST</medicinalproduct>
        <drugbatchnumb>LOT NOT REP</drugbatchnumb>
        <drugadministrationroute>043</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5041826-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060704</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060630</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-SP-2006-01630</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>64</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLADDER TAMPONADE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATURIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMMUCYST</medicinalproduct>
        <drugbatchnumb>LOT NOT REP</drugbatchnumb>
        <drugadministrationroute>043</drugadministrationroute>
        <drugindication>BLADDER CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060613</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMMUCYST</medicinalproduct>
        <drugbatchnumb>LOT NOT REP</drugbatchnumb>
        <drugadministrationroute>043</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060613</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5041841-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060704</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050810</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2005US08899</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>46</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ACUTE PULMONARY OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CREATININE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD UREA INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE CONGESTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA PAROXYSMAL NOCTURNAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATOMA EVACUATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE IRREGULAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG INFILTRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORTHOPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENTRICULAR HYPERTROPHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOSPORINE</medicinalproduct>
        <drugauthorizationnumb>50715</drugauthorizationnumb>
        <drugdosagetext>500 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RENAL TRANSPLANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050705</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELLCEPT</medicinalproduct>
        <drugdosagetext>2000 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050706</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugdosagetext>15 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050710</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5041998-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060627</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060609</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US200606002531</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugauthorizationnumb>21318</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5042233-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060622</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20060605243</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>62</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>APNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBRAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REOPRO</medicinalproduct>
        <drugdosagetext>10 MG/MIN INFUSION FOR 12 HOURS</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REOPRO</medicinalproduct>
        <drugindication>ACUTE MYOCARDIAL INFARCTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HEPARIN</medicinalproduct>
        <drugindication>ACUTE MYOCARDIAL INFARCTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHYLPREDNISOLONE</medicinalproduct>
        <drugindication>PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIPHENHYDRAMINE HCL</medicinalproduct>
        <drugindication>PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CAPTOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CAPTOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5042241-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060623</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-KINGPHARMUSA00001-K200600814</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>97</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CREATINE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD UREA ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CREATININE RENAL CLEARANCE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FOLATE DEFICIENCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERAL PHYSICAL HEALTH DETERIORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERKALAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCOHERENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLAMMATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERNATIONAL NORMALISED RATIO INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEMORY IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALLOR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPEECH DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALTACE</medicinalproduct>
        <drugauthorizationnumb>019901</drugauthorizationnumb>
        <drugdosagetext>5 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060130</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SEROPRAM</medicinalproduct>
        <drugdosagetext>1 U, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROX</medicinalproduct>
        <drugdosagetext>25 UG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIAMICRON</medicinalproduct>
        <drugdosagetext>2 U, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SINTROM</medicinalproduct>
        <drugdosagetext>2 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060130</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5042330-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060622</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2006KR09400</companynumb>
    <primarysource>
      <reportercountry>KOREA, REPUBLIC OF</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>39</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ALANINE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASPARTATE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLISTER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD LACTATE DEHYDROGENASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHILLS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DERMATITIS BULLOUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG RASH WITH EOSINOPHILIA AND SYSTEMIC SYMPTOMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EOSINOPHILIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FACE OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEUKOCYTOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPHADENOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPHOCYTE MORPHOLOGY ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPHOCYTIC INFILTRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH ERYTHEMATOUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN EXFOLIATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARBAMAZEPINE</medicinalproduct>
        <drugauthorizationnumb>016608</drugauthorizationnumb>
        <drugindication>EPILEPSY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VALPROATE SODIUM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>EPILEPSY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19990401</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VALPROATE SODIUM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5042331-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060623</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CH-JNJFOC-20060605194</companynumb>
    <primarysource>
      <reportercountry>SWITZERLAND</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>RENAL IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYLENOL (CAPLET)</medicinalproduct>
        <drugauthorizationnumb>19872</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYLENOL (CAPLET)</medicinalproduct>
        <drugauthorizationnumb>019872</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEADACHE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HERCEPTIN</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMILORID</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ESSENTIAL HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PARACETAMOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEADACHE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEADACHE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRETUVAL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEADACHE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARIMIDEX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NAVOBAN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PASPERTIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARVEDILOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALPEROS D3</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACTONEL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5042336-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060602</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHNU2006DE02204</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>47</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>AGGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTOLERANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EPILEPSY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TEGRETOL</medicinalproduct>
        <drugdosagetext>400 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19910101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOGMATIL FORTE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19910101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TEGRETOL</medicinalproduct>
        <drugauthorizationnumb>016608</drugauthorizationnumb>
        <drugdosagetext>900 MG/DAY</drugdosagetext>
        <drugindication>CONVULSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19870114</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19870203</drugenddate>
        <drugtreatmentduration>30240</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TEGRETOL</medicinalproduct>
        <drugauthorizationnumb>016608</drugauthorizationnumb>
        <drugdosagetext>1800 MG/DAY</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19870204</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19870206</drugenddate>
        <drugtreatmentduration>4320</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TEGRETOL</medicinalproduct>
        <drugauthorizationnumb>016608</drugauthorizationnumb>
        <drugdosagetext>1200 MG/DAY</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19900701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19901006</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5042337-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060315</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHRM2006FR01050</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>75</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERMITTENT CLAUDICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MOPRAL</medicinalproduct>
        <drugdosagetext>20 MG/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051207</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060213</drugenddate>
        <drugtreatmentduration>99360</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAHOR</medicinalproduct>
        <drugdosagetext>10 MG/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051207</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060213</drugenddate>
        <drugtreatmentduration>99360</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060213</drugenddate>
        <drugtreatmentduration>378</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COTAREG</medicinalproduct>
        <drugauthorizationnumb>020818</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060213</drugenddate>
        <drugtreatmentduration>440</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5042338-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060626</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2006NL09619</companynumb>
    <primarysource>
      <reportercountry>NETHERLANDS</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLISTER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NASAL MUCOSAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN OF SKIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN DISCOLOURATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN EXFOLIATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TEGRETOL</medicinalproduct>
        <drugauthorizationnumb>016608</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KEPPRA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASASATIN RETARD</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5042339-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060504</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHNU2006DE01854</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DERMATITIS ALLERGIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH PUSTULAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TESTICULAR NEOPLASM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TESTICULAR OPERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TESTICULAR PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TEGRETOL</medicinalproduct>
        <drugbatchnumb>W0027</drugbatchnumb>
        <drugauthorizationnumb>20234</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TEGRETOL</medicinalproduct>
        <drugbatchnumb>W0035</drugbatchnumb>
        <drugauthorizationnumb>020234</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PERENTEROL</medicinalproduct>
        <drugdosagetext>UNK, UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugtreatmentduration>4320</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5042340-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2006JP09731</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MULTI-ORGAN FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TEGRETOL</medicinalproduct>
        <drugauthorizationnumb>016608</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>METASTATIC PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VOLTAREN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>METASTATIC PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCONTIN</medicinalproduct>
        <drugindication>METASTATIC PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DUROTEP</medicinalproduct>
        <drugindication>METASTATIC PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MORPHINE</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>METASTATIC PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FENTANEST</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>METASTATIC PAIN</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5042341-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060626</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHNU2006DE02392</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INTRAOCULAR PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OPTIC ATROPHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL FIELD DEFECT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TEGRETOL</medicinalproduct>
        <drugauthorizationnumb>016608</drugauthorizationnumb>
        <drugdosagetext>400 MG/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SIMPLE PARTIAL SEIZURES</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19880101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TEGRETOL</medicinalproduct>
        <drugauthorizationnumb>016608</drugauthorizationnumb>
        <drugdosagetext>350 MG/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BISOPROLOL FUMARATE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19960101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>L-THYROXIN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEXOTANIL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5042342-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060627</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ES-JNJFOC-20060600720</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>84</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>HEPATITIS FULMINANT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAVANIC</medicinalproduct>
        <drugauthorizationnumb>20635</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>GASTROINTESTINAL DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060218</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060227</drugenddate>
        <drugtreatmentduration>10</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LACIMEN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SEROXAT</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADIRO</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIANBEN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIAMICRON</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5042343-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060627</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-JNJFOC-20060605511</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>63</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYME DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MICTURITION DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULAR WEAKNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TENDON DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TENDONITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAVANIC</medicinalproduct>
        <drugauthorizationnumb>20634</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SINUSITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060203</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SOLUPRED</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SINUSITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060204</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5042344-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2006JP09837</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>53</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CEREBRAL ATROPHY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TEGRETOL</medicinalproduct>
        <drugauthorizationnumb>016608</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5042345-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060616</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20060604546</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>85</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FENTANYL TRANSDERMAL SYSTEM</medicinalproduct>
        <drugauthorizationnumb>019813</drugauthorizationnumb>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>PAIN</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5042346-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060621</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20060605650</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>APPLICATION SITE DERMATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>APPLICATION SITE PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PELVIC FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THERAPEUTIC RESPONSE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DURAGESIC-100</medicinalproduct>
        <drugdosagetext>100 UG AND 25 UG PATCHES TAKEN TOGETHER.</drugdosagetext>
        <drugadministrationroute>062</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DURAGESIC-100</medicinalproduct>
        <drugadministrationroute>062</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DURAGESIC-100</medicinalproduct>
        <drugauthorizationnumb>019813</drugauthorizationnumb>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORCO</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BREAKTHROUGH PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIAZEPAM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MUSCLE SPASMS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLEXERIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MUSCLE SPASMS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPOTHYROIDISM</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5042347-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060626</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-JNJFOC-20060405690</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ACCIDENTAL OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEDICATION ERROR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY RATE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DURAGESIC-100</medicinalproduct>
        <drugadministrationroute>062</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DURAGESIC-100</medicinalproduct>
        <drugadministrationroute>062</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DURAGESIC-100</medicinalproduct>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>SPONDYLITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DURAGESIC-100</medicinalproduct>
        <drugauthorizationnumb>019813</drugauthorizationnumb>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>PAIN</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5042348-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060518</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2006IE07485</companynumb>
    <primarysource>
      <reportercountry>IRELAND</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>78</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CIRCULATORY COLLAPSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NUCLEAR MAGNETIC RESONANCE IMAGING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VERTIGO POSITIONAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ELTROXIN</medicinalproduct>
        <drugdosagetext>100 MG, QD</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NSA</medicinalproduct>
        <drugdosagetext>75 MG, QD</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ESOMEPRAZOLE</medicinalproduct>
        <drugdosagetext>40 MG, QD</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SERC</medicinalproduct>
        <drugdosagetext>8 MG, TID</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CENTYL K</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CO-DIOVAN</medicinalproduct>
        <drugauthorizationnumb>020818</drugauthorizationnumb>
        <drugdosagetext>VALS 80 / HCT 12.5 MG/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060207</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5042349-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060626</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHRM2006FR01900</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>84</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PSORIASIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COTAREG</medicinalproduct>
        <drugauthorizationnumb>20818</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ESSENTIAL HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050915</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SOTALOL HCL</medicinalproduct>
        <drugdosagetext>80 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ESSENTIAL HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050915</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MIANSERIN</medicinalproduct>
        <drugdosagetext>60 MG/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AERIUS</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NOCTRAN 10</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SLEEP DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LAROXYL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANXIETY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5042350-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060622</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-JNJFOC-20060301365</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG ERUPTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEUKOCYTOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ITRIZOLE</medicinalproduct>
        <drugauthorizationnumb>20083</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NAIL TINEA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060220</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060226</drugenddate>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOXOPROFEN SODIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>JOINT DISLOCATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>EMBOLISM</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENEXATE HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>JOINT DISLOCATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FAMOTIDINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTRIC ULCER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5042352-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060607</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHMT2006CA01335</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>60</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANIC ATTACK</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIOVAN HCT</medicinalproduct>
        <drugdosagetext>160VALS-12.5HCT MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060509</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060519</drugenddate>
        <drugtreatmentduration>15840</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugdosagetext>100 MG, BID</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040619</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040620</drugenddate>
        <drugtreatmentduration>2880</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugdosagetext>100 MG, BID</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLEXERIL</medicinalproduct>
        <drugdosagetext>10 MG Q 6 HOURS PRN</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060419</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SINGULAIR</medicinalproduct>
        <drugdosagetext>10 MG QHS</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYMBICORT TURBUHALER ^DRACO^</medicinalproduct>
        <drugdosagetext>6/200 MG QHS</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR ^MERCK FROSST^</medicinalproduct>
        <drugdosagetext>10 MG</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
        <drugdosagetext>0.025 QD</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041124</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5042353-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060626</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IE-JNJFOC-20060201129</companynumb>
    <primarysource>
      <reportercountry>IRELAND</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>65</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABORTION SPONTANEOUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UNINTENDED PREGNANCY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ORTHO EVRA</medicinalproduct>
        <drugauthorizationnumb>21180</drugauthorizationnumb>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>CONTRACEPTION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5042354-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060626</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-JNJFOC-20060200310</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BREAST CANCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METASTASES TO BONE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERDAL CONSTA</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERDAL CONSTA</medicinalproduct>
        <drugauthorizationnumb>021346</drugauthorizationnumb>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA, PARANOID TYPE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERIDONE</medicinalproduct>
        <drugauthorizationnumb>020272</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA, PARANOID TYPE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5042355-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060623</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-JNJFOC-20060605450</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGIC DIATHESIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MICONAZOLE</medicinalproduct>
        <drugauthorizationnumb>017450</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ORAL CANDIDIASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060620</drugenddate>
        <drugtreatmentduration>20</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SODIUM AZULENE SULFONATE</medicinalproduct>
        <drugadministrationroute>002</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060620</drugenddate>
        <drugtreatmentduration>20</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5042362-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060627</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2006US08358</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>48</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>87.074</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WALKING AID USER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZELNORM</medicinalproduct>
        <drugauthorizationnumb>021200</drugauthorizationnumb>
        <drugindication>CONSTIPATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5042372-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060620</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-US183615</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>75</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CALCIUM DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHILLS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSKINESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HALLUCINATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISION BLURRED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SENSIPAR</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>HYPERPARATHYROIDISM SECONDARY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060614</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZEMPLAR</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5042373-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060627</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2006BR09617</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>49</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>82</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MOUTH HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORASEQ</medicinalproduct>
        <drugauthorizationnumb>20831</drugauthorizationnumb>
        <drugdosagetext>UNK, BID</drugdosagetext>
        <drugindication>PNEUMONIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060301</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5042374-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060623</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHO2006US10317</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORADIL</medicinalproduct>
        <drugauthorizationnumb>020831</drugauthorizationnumb>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5042380-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060622</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ITWYE771123JUN06</companynumb>
    <primarysource>
      <reportercountry>ITALY</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>70</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CYSTITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GUILLAIN-BARRE SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugdosagetext>3 VIALS WITHDRAWN 15 DAYS BEFORE SAE OCCURRENCE</drugdosagetext>
        <drugindication>PSORIASIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5042385-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060623</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BRACCO-BDI-008370</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>83</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>45.45</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BRAIN OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSED LEVEL OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ISOVUE-M 300</medicinalproduct>
        <drugbatchnumb>5J82578</drugbatchnumb>
        <drugauthorizationnumb>018735</drugauthorizationnumb>
        <drugadministrationroute>037</drugadministrationroute>
        <drugindication>BACK PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060621</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060621</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ISOVUE-M 300</medicinalproduct>
        <drugbatchnumb>5J82578</drugbatchnumb>
        <drugauthorizationnumb>018735</drugauthorizationnumb>
        <drugadministrationroute>037</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060621</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060621</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ISOVUE-M 300</medicinalproduct>
        <drugbatchnumb>5J82578</drugbatchnumb>
        <drugauthorizationnumb>018735</drugauthorizationnumb>
        <drugadministrationroute>037</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060621</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060621</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5042393-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060601</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-BRISTOL-MYERS SQUIBB COMPANY-13400122</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>69</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>115</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN UPPER</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>PALLOR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COAPROVEL TABS 150MG/12.5MG</medicinalproduct>
        <drugauthorizationnumb>20758</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050329</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COAPROVEL TABS 150MG/12.5MG</medicinalproduct>
        <drugauthorizationnumb>020758</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060415</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRAVASTATIN</medicinalproduct>
        <drugauthorizationnumb>019898</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5042394-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060424</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-BRISTOL-MYERS SQUIBB COMPANY-13355367</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>93</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPEECH DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>APROVEL TABS 75 MG</medicinalproduct>
        <drugauthorizationnumb>20757</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>APROVEL TABS 75 MG</medicinalproduct>
        <drugauthorizationnumb>020757</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060615</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>STILNOX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5042395-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060623</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-13422316</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>62</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>84</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>EYE HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERNATIONAL NORMALISED RATIO FLUCTUATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MELAENA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA VIRAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUSITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL DISTURBANCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
        <drugauthorizationnumb>009218</drugauthorizationnumb>
        <drugdosagetext>7.5 MG ON MONDAY, WEDNESDAY, AND FRIDAY AND 5 MG ^THE REST OF THE DAYS^</drugdosagetext>
        <drugindication>THROMBOSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
        <drugauthorizationnumb>009218</drugauthorizationnumb>
        <drugdosagetext>5 MG DAILY ON TUESDAY, THURSDAY, SATURDAY AND SUNDAY</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN B-12</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5042396-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-13427315</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>25</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUSTIVA</medicinalproduct>
        <drugauthorizationnumb>021360</drugauthorizationnumb>
        <drugindication>ACQUIRED IMMUNODEFICIENCY SYNDROME</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRUVADA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KEPPRA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DARAPRIM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5042397-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060220</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-BRISTOL-MYERS SQUIBB COMPANY-13290481</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>30</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABORTION SPONTANEOUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PREGNANCY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REYATAZ</medicinalproduct>
        <drugauthorizationnumb>21567</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050315</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RITONAVIR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050315</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KIVEXA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050315</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LAMIVUDINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050315</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5042398-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20051021</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-GILEAD-2005-0008844</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HEPATIC NEOPLASM MALIGNANT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPSERA</medicinalproduct>
        <drugauthorizationnumb>21449</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS B</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031113</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZEFFIX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS B</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20011023</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZEFFIX</medicinalproduct>
        <drugindication>HEPATIC CIRRHOSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANPLAG</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SELBEX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIART</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIGOSIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GASTER D</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALDACTONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SLOW-K</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5042407-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060622</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-RB-3495-2006</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BREECH DELIVERY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MICROCEPHALY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PREMATURE LABOUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PREMATURE RUPTURE OF MEMBRANES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STRABISMUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BUPRENORPHINE HCL</medicinalproduct>
        <drugauthorizationnumb>20732</drugauthorizationnumb>
        <drugdosagetext>EVERY 2 TO 3 HOURS (5 TIMES A DAY)</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>DRUG THERAPY</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010821</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BUPRENORPHINE HCL</medicinalproduct>
        <drugauthorizationnumb>020732</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010821</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010823</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOSULEPIN HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010823</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5042425-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060210</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHFR2006GB00819</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>45</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG TOXICITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EPILEPSY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL ISCHAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZARIL</medicinalproduct>
        <drugauthorizationnumb>019758</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000131</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5042426-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050927</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2005CA14309</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>49</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>78.911</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BALANCE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BITE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COORDINATION ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ECCHYMOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWELLING FACE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZARIL</medicinalproduct>
        <drugauthorizationnumb>19758</drugauthorizationnumb>
        <drugdosagetext>UNK, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19921201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZARIL</medicinalproduct>
        <drugauthorizationnumb>019758</drugauthorizationnumb>
        <drugdosagetext>600 MG/D</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZARIL</medicinalproduct>
        <drugauthorizationnumb>019758</drugauthorizationnumb>
        <drugdosagetext>100 MG BID AND 200 MG QHS</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALPROIC ACID</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FRISIUM</medicinalproduct>
        <drugdosagetext>10 MG, QHS</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DILANTIN</medicinalproduct>
        <drugdosagetext>1 DF, QID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALPROIC ACID</medicinalproduct>
        <drugdosagetext>3500 MG/D</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROCYCLIDINE HYDROCHLORIDE 2MG TAB</medicinalproduct>
        <drugdosagetext>5 MG, BID</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5042437-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20020530</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHFR2002GB01847</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>45</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD CREATININE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD UREA INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIALYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZARIL</medicinalproduct>
        <drugauthorizationnumb>19758</drugauthorizationnumb>
        <drugdosagetext>600 MG/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980501</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZARIL</medicinalproduct>
        <drugauthorizationnumb>019758</drugauthorizationnumb>
        <drugdosagetext>275 MG/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALPROATE SODIUM</medicinalproduct>
        <drugdosagetext>2G/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980901</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATORVASTATIN CALCIUM</medicinalproduct>
        <drugdosagetext>10 MG/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LACTULOSE</medicinalproduct>
        <drugdosagetext>90 ML/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugdosagetext>10 MG/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FRUSEMIDE</medicinalproduct>
        <drugdosagetext>40 MG/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCICHEW</medicinalproduct>
        <drugdosagetext>1500 MG/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROXOCOBALAMIN</medicinalproduct>
        <drugdosagetext>1 MG EVERY 3 MONTHS</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EPOGEN</medicinalproduct>
        <drugdosagetext>2000 WEEKLY</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5042439-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060623</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHFR2006GB02099</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>45</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>104.8</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HEPATOCELLULAR DAMAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER FUNCTION TEST ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VENLAFAXINE HCL</medicinalproduct>
        <drugdosagetext>75 MG/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19991101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZARIL</medicinalproduct>
        <drugauthorizationnumb>019758</drugauthorizationnumb>
        <drugdosagetext>100 MG, TID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19911001</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5042440-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060620</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>SEWYE754520JUN06</companynumb>
    <primarysource>
      <reportercountry>NORWAY</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BREAST CANCER STAGE II</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC ENZYME ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC ENZYME INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugadministrationroute>051</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060401</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COAPROVEL</medicinalproduct>
        <drugdosagetext>ONE TABLET (300/ 12,5) PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5042441-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060622</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2006BE09329</companynumb>
    <primarysource>
      <reportercountry>BELGIUM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>51</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ADRENAL CARCINOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCREATIC FISTULA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCREATIC LESION EXCISION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCREATIC PSEUDOCYST</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SANDOSTATIN</medicinalproduct>
        <drugauthorizationnumb>019667</drugauthorizationnumb>
        <drugdosagetext>0.5 MG, TID</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PANCREATITIS NECROTISING</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SANDOSTATIN LAR</medicinalproduct>
        <drugdosagetext>20 MG, QMO</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>PANCREATITIS NECROTISING</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060501</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DILTIAZEM HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SLEEPING PILL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5042442-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060622</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2006US08142</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>62</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL DISTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD UREA INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLONOSCOPY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ENDOSCOPY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATOCHEZIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMPAIRED GASTRIC EMPTYING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SANDOSTATIN LAR</medicinalproduct>
        <drugauthorizationnumb>21008</drugauthorizationnumb>
        <drugdosagetext>UNK, QMO</drugdosagetext>
        <drugindication>CARCINOID TUMOUR</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALTACE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5042443-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2006JP09730</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>20</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MALIGNANT NEOPLASM PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THIRST</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SANDOSTATIN</medicinalproduct>
        <drugauthorizationnumb>019667</drugauthorizationnumb>
        <drugdosagetext>120 UG/D</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>INTESTINAL OBSTRUCTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOCLOPRAMIDE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5042449-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060419</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2006US05196</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>71</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ORAL SURGERY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AREDIA</medicinalproduct>
        <drugauthorizationnumb>20036</drugauthorizationnumb>
        <drugdosagetext>90 MG, UNK</drugdosagetext>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRICOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VASOTEC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FORTAMET</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VICODIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TESTOSTERONE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5042450-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060626</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHRM2006FR01913</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>42</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIAC ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIORESAL</medicinalproduct>
        <drugauthorizationnumb>017851</drugauthorizationnumb>
        <drugdosagetext>5 MG, TID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060421</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060509</drugenddate>
        <drugtreatmentduration>27360</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIORESAL</medicinalproduct>
        <drugauthorizationnumb>017851</drugauthorizationnumb>
        <drugdosagetext>10 MG, TID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060510</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060512</drugenddate>
        <drugtreatmentduration>4320</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5042451-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060623</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2006JP09581</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AREDIA</medicinalproduct>
        <drugauthorizationnumb>020036</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5042452-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060206</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2006IT02202</companynumb>
    <primarysource>
      <reportercountry>ITALY</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>71</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BONE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMPAIRED HEALING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTH ABSCESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTH EXTRACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WOUND TREATMENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugdosagetext>4 MG, QMO</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040401</drugenddate>
        <drugtreatmentduration>306</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugdosagetext>2 MG, QMO</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050901</drugenddate>
        <drugtreatmentduration>305</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AREDIA</medicinalproduct>
        <drugauthorizationnumb>020036</drugauthorizationnumb>
        <drugdosagetext>60 MG, QMO</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060101</drugenddate>
        <drugtreatmentduration>93</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MELPHALAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EPOGEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MORPHINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5042453-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060623</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2006IN09367</companynumb>
    <primarysource>
      <reportercountry>INDIA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>60</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING COLD</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VERTIGO</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VOVERAN</medicinalproduct>
        <drugauthorizationnumb>19201</drugauthorizationnumb>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXONA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADRENALINE</medicinalproduct>
        <drugdosagetext>0.5 ML, UNK</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5042466-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060531</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2006US07089</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CALCITRIOL</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AREDIA</medicinalproduct>
        <drugauthorizationnumb>020036</drugauthorizationnumb>
        <drugdosagetext>30MG Q3MOS</drugdosagetext>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060531</drugenddate>
        <drugtreatmentduration>730</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5042467-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060622</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2006US08219</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>76</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>80.725</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>OSTEOMYELITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AREDIA</medicinalproduct>
        <drugauthorizationnumb>020036</drugauthorizationnumb>
        <drugdosagetext>UNK, UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5042468-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060623</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2006IT09578</companynumb>
    <primarysource>
      <reportercountry>ITALY</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>66</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ACTINOMYCOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE DEBRIDEMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMPAIRED HEALING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOMYELITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PURULENT DISCHARGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTH ABSCESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTH EXTRACTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAMIDRONATE DISODIUM</medicinalproduct>
        <drugauthorizationnumb>020036</drugauthorizationnumb>
        <drugdosagetext>90 MG, QMO</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>PREDNISONE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5042469-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060623</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2006IT09577</companynumb>
    <primarysource>
      <reportercountry>ITALY</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>80</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ACTINOMYCOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE DEBRIDEMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FISTULA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMPAIRED HEALING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOMYELITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PURULENT DISCHARGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTH ABSCESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTH EXTRACTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAMIDRONATE DISODIUM</medicinalproduct>
        <drugauthorizationnumb>020036</drugauthorizationnumb>
        <drugdosagetext>90 MG, QMO</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ORAL ANTIDIABETICS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MELPHALAN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYCLOPHOSPHAMIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE TAB</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5042470-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060623</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2006IT09586</companynumb>
    <primarysource>
      <reportercountry>ITALY</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>58</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BONE DEBRIDEMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FISTULA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMPAIRED HEALING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PURULENT DISCHARGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTH ABSCESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTH EXTRACTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAMIDRONATE DISODIUM</medicinalproduct>
        <drugauthorizationnumb>20036</drugauthorizationnumb>
        <drugdosagetext>90 MG, QMO</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOLEDRONATE</medicinalproduct>
        <drugdosagetext>4 MG, QMO</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>PREDNISONE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CHLORHEXIDINE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5042471-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060623</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2006IT09588</companynumb>
    <primarysource>
      <reportercountry>ITALY</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>44</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BONE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMPAIRED HEALING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTH ABSCESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTH EXTRACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WOUND TREATMENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAMIDRONATE DISODIUM</medicinalproduct>
        <drugauthorizationnumb>20036</drugauthorizationnumb>
        <drugdosagetext>90 MG, QMO</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOLEDRONATE</medicinalproduct>
        <drugdosagetext>4 MG, QMO</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VINCRISTINE + ADRIAMYCIN + DEXAMETHASONE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MELPHALAN</medicinalproduct>
        <drugdosagetext>HIGH-DOSE</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HEMATOPOETIC PROGENITOR CELLS HUMAN</medicinalproduct>
        <drugdosagetext>PERIPHERAL BLOOD STEM CELL TRANSPLANTATION</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THALIDOMIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5042499-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060524</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-KINGPHARMUSA00001-K200600676</companynumb>
    <primarysource>
      <reportercountry>INDIA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>35</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANAPHYLACTIC SHOCK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISSEMINATED INTRAVASCULAR COAGULATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BICILLIN L-A</medicinalproduct>
        <drugbatchnumb>LA 12/198</drugbatchnumb>
        <drugauthorizationnumb>50141</drugauthorizationnumb>
        <drugdosagetext>12 LAC, I.U.</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>RHEUMATIC HEART DISEASE</drugindication>
        <drugtreatmentduration>1095</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5042500-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2006NL09725</companynumb>
    <primarysource>
      <reportercountry>NETHERLANDS</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE RIGIDITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXELON</medicinalproduct>
        <drugauthorizationnumb>020823</drugauthorizationnumb>
        <drugdosagetext>1.5 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEMENTIA ALZHEIMER'S TYPE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXELON</medicinalproduct>
        <drugauthorizationnumb>020823</drugauthorizationnumb>
        <drugdosagetext>3 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5042529-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060601</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006UW11489</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>21540</patientonsetage>
      <patientonsetageunit>804</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ALANINE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASPARTATE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BILIARY TRACT DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DECREASED APPETITE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugauthorizationnumb>21366</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DYSLIPIDAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060213</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060422</drugenddate>
        <drugtreatmentduration>69</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ROSIGLITAZONE MALEATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS NON-INSULIN-DEPENDENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060308</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060422</drugenddate>
        <drugtreatmentduration>46</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GLIMEPIRIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS NON-INSULIN-DEPENDENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060308</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060422</drugenddate>
        <drugtreatmentduration>46</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5042530-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060627</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006UW13583</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>16</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MYDRIASIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugauthorizationnumb>020639</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADDERALL XR 10</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5042534-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060626</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006UW13385</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>35</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRANSPLANT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOPROL-XL</medicinalproduct>
        <drugauthorizationnumb>019962</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5042537-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060615</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2006TR08948</companynumb>
    <primarysource>
      <reportercountry>TURKEY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>50</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>BLOOD CALCIUM DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD POTASSIUM DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD SODIUM DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>C-REACTIVE PROTEIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERAL PHYSICAL HEALTH DETERIORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATOCRIT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RED BLOOD CELL SEDIMENTATION RATE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MYFORTIC</medicinalproduct>
        <drugauthorizationnumb>50791</drugauthorizationnumb>
        <drugindication>PEMPHIGUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUCONAZOLE</medicinalproduct>
        <drugindication>CANDIDIASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060316</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5042545-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060131</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-BRISTOL-MYERS SQUIBB COMPANY-13264619</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>22</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD CREATINE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CREATINE PHOSPHOKINASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FIBRIN D DIMER INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHABDOMYOLYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TENDERNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRAVASTATIN SODIUM</medicinalproduct>
        <drugauthorizationnumb>19898</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERCHOLESTEROLAEMIA</drugindication>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>CYCLOSPORINE</medicinalproduct>
        <drugindication>HEART TRANSPLANT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AZATHIOPRINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>IMMUNOSUPPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugindication>IMMUNOSUPPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RAMIPRIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>LOWER RESPIRATORY TRACT INFECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5042546-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060525</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-13390703</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>66</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>105</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE CONGESTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUS TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUPRAVENTRICULAR TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYTOXAN</medicinalproduct>
        <drugauthorizationnumb>12142</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BREAST CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060405</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060522</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ADRIAMYCIN PFS</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060405</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060522</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ABRAXANE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060407</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060525</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>ANAEMIA OF MALIGNANT DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060417</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060528</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5042547-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060623</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ES-BRISTOL-MYERS SQUIBB COMPANY-13421508</companynumb>
    <primarysource>
      <reportercountry>SPAIN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>74</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HAEMOLYTIC ANAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SINEMET CR</medicinalproduct>
        <drugauthorizationnumb>19856</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5042548-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060213</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006AP00694</companynumb>
    <primarysource>
      <reportercountry>AUSTRIA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>18391</patientonsetage>
      <patientonsetageunit>804</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BODY TEMPERATURE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAMOXIFEN</medicinalproduct>
        <drugauthorizationnumb>17970</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BREAST CANCER IN SITU</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060118</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5042549-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060622</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006GB01078</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>64</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PANCREATITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOLADEX</medicinalproduct>
        <drugauthorizationnumb>020578</drugauthorizationnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060313</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5042550-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060103</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-BRISTOL-MYERS SQUIBB COMPANY-13235551</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>38</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>67</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ALOPECIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPEPSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPHADENOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POLLAKIURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REYATAZ</medicinalproduct>
        <drugauthorizationnumb>021567</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050617</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051215</drugenddate>
        <drugtreatmentduration>182</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMBIVIR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050617</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVIR</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050617</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051215</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SEROPRAM</medicinalproduct>
        <drugindication>DEPRESSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5042551-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050314</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2005GB00544</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>30583</patientonsetage>
      <patientonsetageunit>804</patientonsetageunit>
      <patientweight>87.5</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GROIN PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THORACIC VERTEBRAL FRACTURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NOLVADEX</medicinalproduct>
        <drugauthorizationnumb>017970</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19971112</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20021001</drugenddate>
        <drugtreatmentduration>1785</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CO-PROXAMOL</medicinalproduct>
        <drugindication>SKIN LESION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20011127</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FRUSEMIDE</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020211</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CHLORPHENIRAMINE MALEATE</medicinalproduct>
        <drugindication>RASH PRURITIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990524</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AQUEOUS CREAM</medicinalproduct>
        <drugindication>RASH</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990524</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>QUININE SULFATE</medicinalproduct>
        <drugindication>MUSCLE SPASMS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010421</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010517</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PIRITON</medicinalproduct>
        <drugindication>RASH</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19991115</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM PERMANGANATE</medicinalproduct>
        <drugindication>CELLULITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020215</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PARAFIN</medicinalproduct>
        <drugindication>ECZEMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020215</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PARACETAMOL</medicinalproduct>
        <drugindication>SKIN LESION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020211</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAMADOL HCL</medicinalproduct>
        <drugindication>CELLULITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020312</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CEPHALEXIN</medicinalproduct>
        <drugindication>INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20011210</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GABAPENTIN</medicinalproduct>
        <drugindication>PAIN IN EXTREMITY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020312</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BETNOVATE</medicinalproduct>
        <drugindication>STASIS DERMATITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020322</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KALTOSTAT</medicinalproduct>
        <drugindication>SKIN MACERATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020322</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLOTRIMAZOLE</medicinalproduct>
        <drugindication>FUNGAL RASH</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020404</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCICHEW D3 FORTE</medicinalproduct>
        <drugindication>OSTEOPOROSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5042557-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060621</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006GB01067</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD CREATINE PHOSPHOKINASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CYANOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULAR WEAKNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POOR PERIPHERAL CIRCULATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARIMIDEX</medicinalproduct>
        <drugauthorizationnumb>020541</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060201</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5042558-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060621</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-13419916</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>12</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>42</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FANCONI SYNDROME ACQUIRED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEPHROGENIC DIABETES INSIPIDUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIDEX</medicinalproduct>
        <drugauthorizationnumb>020154</drugauthorizationnumb>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KALETRA</medicinalproduct>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIREAD</medicinalproduct>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5042559-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060627</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2006ES09805</companynumb>
    <primarysource>
      <reportercountry>SPAIN</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>52</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ALANINE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANTIMITOCHONDRIAL ANTIBODY POSITIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANTINUCLEAR ANTIBODY POSITIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASPARTATE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AUTOIMMUNE HEPATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BILIARY TRACT DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD ALKALINE PHOSPHATASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD IMMUNOGLOBULIN M INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAMMA-GLUTAMYLTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GRAFT DYSFUNCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC FUNCTION ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATOCELLULAR DAMAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugindication>LIVER TRANSPLANT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AZATHIOPRINE</medicinalproduct>
        <drugindication>LIVER TRANSPLANT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOSPORINE</medicinalproduct>
        <drugauthorizationnumb>050574</drugauthorizationnumb>
        <drugindication>LIVER TRANSPLANT</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5042560-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2006US08446</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BREAST CANCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BREAST OPERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RADIATION SKIN INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STAPHYLOCOCCAL INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMPRO</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROMETRIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ORTHO-PREFEST</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMBIPATCH</medicinalproduct>
        <drugauthorizationnumb>020870</drugauthorizationnumb>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5042561-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060324</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHNU2006DE01470</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>62</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>APHASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHROPATHY</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>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG LEVEL FLUCTUATING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FIBULA FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPORTS INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTHACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SANDIMMUNE</medicinalproduct>
        <drugauthorizationnumb>50715</drugauthorizationnumb>
        <drugdosagetext>200 MG DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RENAL TRANSPLANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19970101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DECORTIN-H</medicinalproduct>
        <drugdosagetext>2.5 MG DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BISOPROLOL FUMARATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRANOC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGNESIUM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5042567-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060627</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2006IT09742</companynumb>
    <primarysource>
      <reportercountry>ITALY</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>57</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DIFFUSE LARGE B-CELL LYMPHOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EPSTEIN-BARR VIRUS INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPHOPROLIFERATIVE DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOSPORINE</medicinalproduct>
        <drugauthorizationnumb>050574</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>LIVER TRANSPLANT</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5042568-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060627</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2006IT09743</companynumb>
    <primarysource>
      <reportercountry>ITALY</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>68</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>B-CELL LYMPHOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EPSTEIN-BARR VIRUS INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPHOPROLIFERATIVE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPLENECTOMY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOSPORINE</medicinalproduct>
        <drugauthorizationnumb>050574</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>LIVER TRANSPLANT</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5042569-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060426</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AVENTIS-200616576GDDC</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>50</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BACTERIAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CULTURE POSITIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EMPYEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LARYNGEAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LARYNGEAL OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLEURITIC PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STRIDOR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAXOTERE</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>020449</drugauthorizationnumb>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>SQUAMOUS CELL CARCINOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUOROURACIL</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
        <drugindication>SQUAMOUS CELL CARCINOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CISPLATIN</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
        <drugindication>SQUAMOUS CELL CARCINOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLEGRA</medicinalproduct>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATIVAN</medicinalproduct>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EVOXAC</medicinalproduct>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEFAZODONE HCL</medicinalproduct>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ROBITUSSIN</medicinalproduct>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ROXICET</medicinalproduct>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5042570-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060529</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-AVENTIS-200615663GDDC</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>50</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>63.1</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>COLITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROOESOPHAGEAL REFLUX DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPENIC SEPSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOCETAXEL</medicinalproduct>
        <drugbatchnumb>D5F923</drugbatchnumb>
        <drugauthorizationnumb>20449</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060519</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060519</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ADRIAMYCIN PFS</medicinalproduct>
        <drugbatchnumb>S022345</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060519</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060519</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOPHOSPHAMIDE</medicinalproduct>
        <drugbatchnumb>06E24PMM0020</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060519</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060519</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLEXANE</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>ANTICOAGULANT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060530</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060530</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOPERAMIDE</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIARRHOEA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060528</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060528</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CHLORVESCENT</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugdosagetext>DOSE: 2 P</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060529</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060531</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ESOMEPRAZOLE</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060528</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060531</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PARACETAMOL</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANALGESIC EFFECT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060527</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060530</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROMORPHONE HCL</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugdosagetext>DOSE: 2-4 MG</drugdosagetext>
        <drugindication>ANALGESIC EFFECT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060528</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060530</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAXOLON</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>VOMITING</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060527</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060527</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FENTANYL TRANSDERMAL SYSTEM</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugdosagetext>DOSE: 12 MCG PATCH</drugdosagetext>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>ANALGESIC EFFECT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060527</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060527</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5042571-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060511</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-AVENTIS-200611473JP</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>64</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>65</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HEARING IMPAIRED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERICARDITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAXOTERE</medicinalproduct>
        <drugauthorizationnumb>20449</drugauthorizationnumb>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>OESOPHAGEAL SQUAMOUS CELL CARCINOMA STAGE III</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060501</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugauthorizationnumb>016273</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PERICARDITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060504</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DECADRON</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>PREMEDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060501</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NASEA</medicinalproduct>
        <drugdosagetext>DOSE: 1 AMPULE</drugdosagetext>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>PREMEDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060501</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALTAT</medicinalproduct>
        <drugdosagetext>DOSE: 1 AMPULE</drugdosagetext>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>PREMEDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060501</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEPAKENE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAKEPRON</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LAC B</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGNESIUM OXIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PERICARDITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALDACTONE</medicinalproduct>
        <drugindication>PERICARDITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5042572-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060313</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AVENTIS-200612343US</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>APPLICATION SITE BLEEDING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>APPLICATION SITE DISCOLOURATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>APPLICATION SITE ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>APPLICATION SITE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>APPLICATION SITE REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARAC</medicinalproduct>
        <drugbatchnumb>B04225A</drugbatchnumb>
        <drugauthorizationnumb>20985</drugauthorizationnumb>
        <drugdosagetext>DOSE: UNKNOWN</drugdosagetext>
        <drugadministrationroute>061</drugadministrationroute>
        <drugindication>ACTINIC KERATOSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060217</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060307</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
        <drugdosagetext>DOSE: UNKNOWN</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPICORT</medicinalproduct>
        <drugdosagetext>DOSE: UNKNOWN</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOSAMINE W/CHONDROITIN SULFATES</medicinalproduct>
        <drugdosagetext>DOSE: UNKNOWN</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5042573-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060601</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AVENTIS-200615779GDDC</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>58</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>80.74</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PSYCHOMOTOR HYPERACTIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSYCHOTIC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>REFUSAL OF TREATMENT BY PATIENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAXOTERE</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>20449</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060509</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060509</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARBOPLATIN</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugdosagetext>DOSE: AUC 6</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060509</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060509</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE TAB</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060508</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060510</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugindication>INSOMNIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060504</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIGOXIN</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugdosagetext>DOSE: .25 MG</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARDIZEM</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugdosagetext>DOSE: 300 MG</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NICODERM</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRILOSEC</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugindication>ABDOMINAL DISCOMFORT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DARVOCET</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5042574-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060620</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHNU2006DE02313</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>COMPLETED SUICIDE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVERDOSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LOCOL</medicinalproduct>
        <drugauthorizationnumb>021192</drugauthorizationnumb>
        <drugdosagetext>200 DF, ONCE/SINGLE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETYLSALICYLIC ACID SRT</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5042586-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060622</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHFR2006GB02064</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>50</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANAPHYLACTIC REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TEMPERATURE INTOLERANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URTICARIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LUDIOMIL</medicinalproduct>
        <drugauthorizationnumb>017543</drugauthorizationnumb>
        <drugdosagetext>50 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugtreatmentduration>8395</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5042588-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060623</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2006IT09589</companynumb>
    <primarysource>
      <reportercountry>ITALY</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>80</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BONE DEBRIDEMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMPAIRED HEALING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PURULENT DISCHARGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTH ABSCESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTH EXTRACTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOLEDRONATE</medicinalproduct>
        <drugauthorizationnumb>21223</drugauthorizationnumb>
        <drugdosagetext>4 MG, QMO</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RADIATION THERAPY</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MELPHALAN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ORAL ANTIDIABETICS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5042589-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060623</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2006IT09590</companynumb>
    <primarysource>
      <reportercountry>ITALY</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>58</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BONE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMPAIRED HEALING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTH ABSCESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTH EXTRACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WOUND TREATMENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOLEDRONATE</medicinalproduct>
        <drugauthorizationnumb>21223</drugauthorizationnumb>
        <drugdosagetext>4 MG, QMO</drugdosagetext>
        <drugindication>MULTIPLE MYELOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VINCRISTINE + ADRIAMYCIN + DEXAMETHASONE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MELPHALAN</medicinalproduct>
        <drugdosagetext>HIGH-DOSE</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HEMATOPOETIC PROGENITOR CELLS HUMAN</medicinalproduct>
        <drugdosagetext>PERIPHERAL BLOOD STEM CELL TRANSPLANTATION</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5042596-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060623</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2006ES09378</companynumb>
    <primarysource>
      <reportercountry>SPAIN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>69</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BONE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN JAW</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTH EXTRACTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugauthorizationnumb>021223</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>METASTASES TO BONE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RADIOTHERAPY</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CORTICOSTEROIDS</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEFLAZACORT</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FULVESTRANT</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM CARBONATE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5042597-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060622</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2006DK09495</companynumb>
    <primarysource>
      <reportercountry>DENMARK</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>78</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DENTURE WEARER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugauthorizationnumb>021223</drugauthorizationnumb>
        <drugdosagetext>4 MG, EVERY 4 WEEKS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030120</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5042598-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060623</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2006IT09591</companynumb>
    <primarysource>
      <reportercountry>ITALY</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>65</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BONE DEBRIDEMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMPAIRED HEALING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PURULENT DISCHARGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTH ABSCESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTH EXTRACTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOLEDRONATE</medicinalproduct>
        <drugauthorizationnumb>21223</drugauthorizationnumb>
        <drugdosagetext>4 MG, QMO</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VINCRISTINE + ADRIAMYCIN + DEXAMETHASONE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MELPHALAN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5042599-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060612</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2006NO09614</companynumb>
    <primarysource>
      <reportercountry>NORWAY</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>AGRANULOCYTOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugauthorizationnumb>021223</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5042600-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060622</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2006SE09468</companynumb>
    <primarysource>
      <reportercountry>SWEDEN</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTH EXTRACTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugauthorizationnumb>021223</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>METASTASES TO BONE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19970101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5042601-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060623</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2006ES09380</companynumb>
    <primarysource>
      <reportercountry>SPAIN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>55</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugauthorizationnumb>021223</drugauthorizationnumb>
        <drugdosagetext>WEEKLY FOR 3 MONTHS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PROSTATE CANCER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RADIOTHERAPY</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CHEMOTHERAPEUTICS,OTHER</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5042602-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060313</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHO2006AU04210</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>92</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMPAIRED HEALING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTH DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTH EXTRACTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugdosagetext>50 MG, Q48H</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050603</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050701</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugdosagetext>NO TREATMENT</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THALIDOMIDE</medicinalproduct>
        <drugdosagetext>100 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050529</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050701</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THALIDOMIDE</medicinalproduct>
        <drugdosagetext>NO TREATMENT</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALTRATE</medicinalproduct>
        <drugdosagetext>600 MG, TID</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SERTRALINE</medicinalproduct>
        <drugdosagetext>UNK, UNK</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOLEDRONIC ACID</medicinalproduct>
        <drugauthorizationnumb>021223</drugauthorizationnumb>
        <drugdosagetext>4 MG, QMO</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5042603-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060623</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2006IT09592</companynumb>
    <primarysource>
      <reportercountry>ITALY</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>52</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BONE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMPAIRED HEALING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PURULENT DISCHARGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWELLING</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>ZOLEDRONATE</medicinalproduct>
        <drugauthorizationnumb>21223</drugauthorizationnumb>
        <drugdosagetext>4 MG, QMO</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VINCRISTINE + ADRIAMYCIN + DEXAMETHASONE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MELPHALAN</medicinalproduct>
        <drugdosagetext>HIGH-DOSE</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HEMATOPOETIC PROGENITOR CELLS HUMAN</medicinalproduct>
        <drugdosagetext>PERIPHERAL BLOOD STEM CELL TRANSPLANTATION</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5042612-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060622</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2006US08242</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>63</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWELLING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugauthorizationnumb>021223</drugauthorizationnumb>
        <drugdosagetext>4 MG EVERY MONTH</drugdosagetext>
        <drugindication>METASTASES TO BONE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020531</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060331</drugenddate>
        <drugtreatmentduration>1401</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XELODA</medicinalproduct>
        <drugdosagetext>100 MG BID FOR 14 DAYS</drugdosagetext>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060331</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FEMARA</medicinalproduct>
        <drugdosagetext>2.5 MG, QD</drugdosagetext>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060331</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORTAB</medicinalproduct>
        <drugdosagetext>UNK, PRN</drugdosagetext>
        <drugindication>BACK PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20011001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALDACTONE</medicinalproduct>
        <drugdosagetext>UNK, QD</drugdosagetext>
        <drugindication>CARDIAC FAILURE CONGESTIVE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20011001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>UNK, QD</drugdosagetext>
        <drugindication>CORONARY ARTERY DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EFFEXOR</medicinalproduct>
        <drugdosagetext>75 MG, QD</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050701</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5042613-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060622</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2006US08231</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>70</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugauthorizationnumb>021223</drugauthorizationnumb>
        <drugdosagetext>4 MG MONTHLY</drugdosagetext>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060601</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5042615-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060622</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2006US08251</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>82</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ORAL SOFT TISSUE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN JAW</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTH ABSCESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTH EXTRACTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugauthorizationnumb>021223</drugauthorizationnumb>
        <drugdosagetext>4 MG EVERY MONTH</drugdosagetext>
        <drugindication>METASTASES TO BONE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FEMARA</medicinalproduct>
        <drugdosagetext>UNK, QD</drugdosagetext>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050301</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5042616-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060614</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2006US07771</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>69</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BONE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMPAIRED HEALING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUCOSAL INFLAMMATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOMYELITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRIMARY SEQUESTRUM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTH EXTRACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTH INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WOUND DEBRIDEMENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugauthorizationnumb>021223</drugauthorizationnumb>
        <drugdosagetext>MONTHLY</drugdosagetext>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060301</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DECADRON</medicinalproduct>
        <drugdosagetext>200 MG X 4 DAYS EVERY MONTH</drugdosagetext>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040801</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5042617-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060623</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2006US08195</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>62</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SUNITINIB MALATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugauthorizationnumb>021223</drugauthorizationnumb>
        <drugdosagetext>UNK Q3WKS</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050401</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5042618-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060623</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2006US08173</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>OSTEOMYELITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugauthorizationnumb>021223</drugauthorizationnumb>
        <drugdosagetext>UNK MONTHLY</drugdosagetext>
        <drugindication>PROSTATE CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060201</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5042619-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060622</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2006US08130</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BONE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEFORMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MASTICATION DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STOMATITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugauthorizationnumb>021223</drugauthorizationnumb>
        <drugindication>MULTIPLE MYELOMA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5042620-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060622</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2006US08238</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>68</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ORAL SOFT TISSUE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN JAW</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWELLING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugauthorizationnumb>021223</drugauthorizationnumb>
        <drugdosagetext>4 MG EVERY MONTH</drugdosagetext>
        <drugindication>METASTASES TO BONE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060301</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FEMARA</medicinalproduct>
        <drugdosagetext>2.5 MG, QD</drugdosagetext>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030114</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5042621-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060622</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHNR2006AU00835</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BONE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ISCHAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JAW DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugauthorizationnumb>021223</drugauthorizationnumb>
        <drugindication>MULTIPLE MYELOMA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5042624-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060622</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHNU2006DE02344</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugauthorizationnumb>021223</drugauthorizationnumb>
        <drugdosagetext>4 MG, UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020326</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051206</drugenddate>
        <drugtreatmentduration>1352</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5042625-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20051102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHNU2005DE03633</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>53</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>78</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DENTAL TREATMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTH EXTRACTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugauthorizationnumb>21223</drugauthorizationnumb>
        <drugdosagetext>4 MG, QMO</drugdosagetext>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031029</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050725</drugenddate>
        <drugtreatmentduration>636</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5042626-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060623</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHRM2006FR01905</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>37</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugauthorizationnumb>021223</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>METASTASES TO BONE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5042631-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060509</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2006ES07052</companynumb>
    <primarysource>
      <reportercountry>SPAIN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>56</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MENISCUS LESION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TENDONITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRIGGER FINGER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FEMARA</medicinalproduct>
        <drugauthorizationnumb>20726</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050601</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5042632-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHNU2005DE02712</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>66</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DENTAL TREATMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMPAIRED HEALING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTH EXTRACTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugauthorizationnumb>21223</drugauthorizationnumb>
        <drugdosagetext>4 MG, QMO</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>METASTASES TO BONE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050509</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AREDIA</medicinalproduct>
        <drugdosagetext>60 MG, QMO</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>METASTASES TO BONE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FEMARA</medicinalproduct>
        <drugdosagetext>2.5 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAMOXIFEN</medicinalproduct>
        <drugdosagetext>20 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19970101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D3</medicinalproduct>
        <drugdosagetext>1000 IU, QW2</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN K1</medicinalproduct>
        <drugdosagetext>3 UNK, QD</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5042641-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060626</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2006BR09675</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>19</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>47</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RITALIN</medicinalproduct>
        <drugauthorizationnumb>010187</drugauthorizationnumb>
        <drugdosagetext>10 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATTENTION DEFICIT/HYPERACTIVITY DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060622</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5042642-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20051115</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-SANOFI-SYNTHELABO-A01200508036</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>CARDIO-RESPIRATORY ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISSEMINATED INTRAVASCULAR COAGULATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERSTITIAL LUNG DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPHANGIOSIS CARCINOMATOSA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALIGNANT PLEURAL EFFUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DECADRON</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050422</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051102</drugenddate>
        <drugtreatmentduration>195</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEPAS</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050422</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051102</drugenddate>
        <drugtreatmentduration>195</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NAUZELIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050422</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051102</drugenddate>
        <drugtreatmentduration>195</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MUCOSOLVAN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050422</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051102</drugenddate>
        <drugtreatmentduration>195</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>URSO</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050422</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051102</drugenddate>
        <drugtreatmentduration>195</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLARITHROMYCIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050422</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051102</drugenddate>
        <drugtreatmentduration>195</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GEMCITABINE</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051102</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051102</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GASTER D</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050422</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051102</drugenddate>
        <drugtreatmentduration>195</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXALIPLATIN</medicinalproduct>
        <drugauthorizationnumb>021492</drugauthorizationnumb>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>GASTRIC CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051102</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051102</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5042643-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060623</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-SANOFI-SYNTHELABO-A04200600648</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>46</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>RETINAL DETACHMENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>QUENSYL</medicinalproduct>
        <drugauthorizationnumb>9768</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5042644-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060622</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-SANOFI-SYNTHELABO-A01200604954</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>77</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>53</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>INTERSTITIAL LUNG DISEASE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SOLU-MEDROL</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060526</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUOROURACIL</medicinalproduct>
        <drugdosagetext>500 MG/BODY=337.8 MG/M2 IN BOLUS THEN 3000 MG/BODY=2027 MG/M2 AS INFUSION</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060522</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060523</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ISOVORIN</medicinalproduct>
        <drugdosagetext>250 MG/BODY=168.9 MG/M2</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060522</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060523</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXALIPLATIN</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021492</drugauthorizationnumb>
        <drugdosagetext>100 MG/BODY=67.6 MG/M2</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RECTAL CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060522</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060522</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5042648-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20051216</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IT-SANOFI-SYNTHELABO-F01200502807</companynumb>
    <primarysource>
      <reportercountry>ITALY</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>54</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISEASE PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STOMATITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051117</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BUSCOPAN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051104</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE TAB</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051013</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051116</drugenddate>
        <drugtreatmentduration>35</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOBETIN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051004</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEUCOVORIN CALCIUM</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051004</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051128</drugenddate>
        <drugtreatmentduration>56</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEMETREXED</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>GASTRIC CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051014</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXALIPLATIN</medicinalproduct>
        <drugauthorizationnumb>021492</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>GASTRIC CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051014</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5042649-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060515</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-SANOFI-SYNTHELABO-A01200603693</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE SYSTOLIC INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG ADMINISTRATION ERROR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FOAMING AT MOUTH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENTAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREATMENT NONCOMPLIANCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIVALO</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060510</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugauthorizationnumb>020839</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ISCHAEMIC STROKE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060510</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060515</drugenddate>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADALAT</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060510</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060501</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5042650-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060602</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-SANOFI-SYNTHELABO-A02200601471</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>64</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>CARDIAC ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUDDEN DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ELOXATIN</medicinalproduct>
        <drugauthorizationnumb>021759</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RECTAL CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060530</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060530</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM LEVOFOLINATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUOROURACIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DETENTIEL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATRIAL FLUTTER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLECAINIDE ACETATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATRIAL FLUTTER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5042651-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060621</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-SANOFI-SYNTHELABO-A02200601623</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>59</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIPLOPIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EPILEPSY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CAMPTOSAR</medicinalproduct>
        <drugdosagetext>305 MG</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLON CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051206</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVASTIN</medicinalproduct>
        <drugdosagetext>300 MG</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLON CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051206</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060418</drugenddate>
        <drugtreatmentduration>134</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SOPHIDONE</medicinalproduct>
        <drugdosagetext>1 DF</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUOROURACIL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>STILNOX</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM FOLINATE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLON CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051201</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5042652-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050127</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-SANOFI-SYNTHELABO-F01200500167</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DYSAESTHESIA PHARYNX</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PERCOCET</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041206</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCONTIN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041206</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOSS</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041206</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PEPCID</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041206</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEVACIZUMAB OR PLACEBO</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050110</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050110</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CAPECITABINE</medicinalproduct>
        <drugdosagetext>2300 MG (1000 MG/M2 TWICE A DAY FOR 2 WEEKS, Q3W)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050110</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050110</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXALIPLATIN</medicinalproduct>
        <drugauthorizationnumb>021492</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLORECTAL CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050110</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050110</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>805</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5042653-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050822</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-SANOFI-SYNTHELABO-F01200501625</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DYSAESTHESIA PHARYNX</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CAPECITABINE</medicinalproduct>
        <drugdosagetext>2000 MG TWICE DAILY FOR TWO WEEKS OF EACH THREE WEEK CYCLE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXALIPLATIN</medicinalproduct>
        <drugauthorizationnumb>021492</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLORECTAL CANCER METASTATIC</drugindication>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>805</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050322</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE TAB</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041229</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CODEINE PHOSPHATE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041229</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEVACIZUMAB OR PLACEBO</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050302</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050302</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5042656-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060503</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-SANOFI-SYNTHELABO-F03200600093</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>76.7</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AORTIC DISSECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AORTIC THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATEMESIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXALIPLATIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>21492</drugauthorizationnumb>
        <drugdosagetext>125 MG, 65 MG/M2 EVERY TWO WEEKS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NEUROENDOCRINE TUMOUR</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060428</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060428</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALOXI</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060102</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060428</drugenddate>
        <drugtreatmentduration>117</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE TAB</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060102</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060428</drugenddate>
        <drugtreatmentduration>117</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVASTIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>375 MG, 5 MG/KG EVERY TWO WEEKS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NEUROENDOCRINE TUMOUR</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060428</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060428</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEUCOVORIN CALCIUM</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>390 MG, 200 MG/M2 EVERY TWO WEEKS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NEUROENDOCRINE TUMOUR</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060428</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060428</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUOROURACIL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>620 MG + 1870 MG, 320 MG/M2 + 960 MG/M2 EVERY TWO WEEKS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NEUROENDOCRINE TUMOUR</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060426</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060428</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARAFATE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROTONIX</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCONTIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COLACE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KYTRIL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATIVAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COMPAZINE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELEXA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANCREASE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VICODIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5042657-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-SANOFI-SYNTHELABO-F03200600149</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>80</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESUSCITATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GEMCITABINE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ADENOCARCINOMA PANCREAS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051012</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051012</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVASTIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ADENOCARCINOMA PANCREAS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051012</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051012</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXALIPLATIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021492</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ADENOCARCINOMA PANCREAS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051013</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051013</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5042658-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060328</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-SANOFI-SYNTHELABO-A03200601850</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AMNESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONTUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EFFECT INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ROAD TRAFFIC ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SLEEP WALKING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMBIEN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>19908</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040629</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040702</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCODONE BITARTRATE + ACETAMINOPHEN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>5/500 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PAXIL CR</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5042659-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060627</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-SANOFI-SYNTHELABO-A03200604141</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABNORMAL BEHAVIOUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AMNESIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMBIEN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5042660-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041027</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GILEAD-2004-0007666</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>3.133</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ALANINE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAEMIA MACROCYTIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASPARTATE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD AMYLASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CREATINE PHOSPHOKINASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD POTASSIUM INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD URIC ACID INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEONATAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUROMYOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPHIL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TENOFOVIR DISOPROXIL FUMARATE</medicinalproduct>
        <drugauthorizationnumb>21356</drugauthorizationnumb>
        <drugadministrationroute>064</drugadministrationroute>
        <drugindication>PROPHYLAXIS AGAINST HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040924</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040924</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AZT</medicinalproduct>
        <drugadministrationroute>064</drugadministrationroute>
        <drugindication>PROPHYLAXIS AGAINST HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040924</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040924</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AZT</medicinalproduct>
        <drugadministrationroute>064</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040924</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040924</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZIAGEN</medicinalproduct>
        <drugadministrationroute>064</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040602</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040923</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VIRAMUNE</medicinalproduct>
        <drugadministrationroute>064</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040602</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040923</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COMBIVIR</medicinalproduct>
        <drugadministrationroute>064</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040602</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040923</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5042661-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060623</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>KR-SANOFI-SYNTHELABO-A01200604801</companynumb>
    <primarysource>
      <reportercountry>KOREA, REPUBLIC OF</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENISCUS LESION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIGMART</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANGINA PECTORIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050111</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ISOKET</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>ANGINA PECTORIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050225</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATACAND</medicinalproduct>
        <drugdosagetext>8 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050128</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMPUR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANGINA PECTORIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050225</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ISOSORBIDE DINITRATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANGINA PECTORIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050113</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROPRANOLOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050111</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugdosagetext>20 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERLIPIDAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050111</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOPIDOGREL</medicinalproduct>
        <drugauthorizationnumb>020839</drugauthorizationnumb>
        <drugdosagetext>75 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>THROMBOSIS PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050111</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>100 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>THROMBOSIS PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050111</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5042668-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060623</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>KR-SANOFI-SYNTHELABO-A01200604797</companynumb>
    <primarysource>
      <reportercountry>KOREA, REPUBLIC OF</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>GANGRENE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIGMART</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANGINA PECTORIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041116</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALDACTONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIURETIC THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050107</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIURETIC THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050107</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CANDESARTAN</medicinalproduct>
        <drugdosagetext>8 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050107</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>S-CARBOXYMETHYLCYSTEIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>COUGH</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041210</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugdosagetext>10 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERLIPIDAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041116</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugauthorizationnumb>020839</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>THROMBOSIS PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041020</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>100 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>THROMBOSIS PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041116</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5042669-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060616</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CN-SANOFI-SYNTHELABO-A01200604630</companynumb>
    <primarysource>
      <reportercountry>CHINA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>50</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>72</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DELIRIUM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESTLESSNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>STILNOX</medicinalproduct>
        <drugauthorizationnumb>19908</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INSOMNIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060525</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060525</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5042670-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041110</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004AP05755</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>63</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DYSPEPSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEPHRITIS INTERSTITIAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NORMOCHROMIC NORMOCYTIC ANAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugauthorizationnumb>21153</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTROOESOPHAGEAL REFLUX DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031130</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PARIET</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NAUSEA</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031130</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PARIET</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DYSPEPSIA</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031130</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVAPRO</medicinalproduct>
        <drugdosagetext>300/12.5 MG</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ROFECOXIB</medicinalproduct>
        <drugdosagetext>INFREQUENT USE</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5042671-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060508</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006AC00877</companynumb>
    <primarysource>
      <reportercountry>BELGIUM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>23550</patientonsetage>
      <patientonsetageunit>804</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD POTASSIUM DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GLUCOSE TOLERANCE IMPAIRED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVEDO RETICULARIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROTEIN TOTAL DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IRESSA</medicinalproduct>
        <drugauthorizationnumb>21399</drugauthorizationnumb>
        <drugdosagetext>CONCOMITANT PHASE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OROPHARYNGEAL CANCER STAGE UNSPECIFIED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060404</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060504</drugenddate>
        <drugtreatmentduration>31</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CISPLATIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>OROPHARYNGEAL CANCER STAGE UNSPECIFIED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060418</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060418</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CISPLATIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060510</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060510</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RADIOTHERAPY</medicinalproduct>
        <drugdosagetext>2 GRAYS PER DAY</drugdosagetext>
        <drugindication>OROPHARYNGEAL CANCER STAGE UNSPECIFIED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060418</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060420</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RADIOTHERAPY</medicinalproduct>
        <drugdosagetext>4 GRAYS PER DAY TO CATCH UP ON MISSED DOSE</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060421</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060421</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RADIOTHERAPY</medicinalproduct>
        <drugdosagetext>2 GRAYS PER DAY</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060424</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060428</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RADIOTHERAPY</medicinalproduct>
        <drugdosagetext>4 GRAYS PER DAY TO CATCH UP ON MISSED DOSE</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060502</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060502</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RADIOTHERAPY</medicinalproduct>
        <drugdosagetext>2 GRAYS PER DAY</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060503</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060505</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RADIOTHERAPY</medicinalproduct>
        <drugdosagetext>2 GRAYS PER DAY</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060508</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060512</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RADIOTHERAPY</medicinalproduct>
        <drugdosagetext>2 GRAYS PER DAY</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060515</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060519</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RADIOTHERAPY</medicinalproduct>
        <drugdosagetext>2 GRAYS PER DAY</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060522</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060526</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CONTRAMAL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050301</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MS CONTIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060418</drugenddate>
        <drugtreatmentduration>13</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DAFALGAN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060418</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KONAKION</medicinalproduct>
        <drugindication>MINERAL SUPPLEMENTATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DURAGESIC-100</medicinalproduct>
        <drugadministrationroute>003</drugadministrationroute>
        <drugindication>ODYNOPHAGIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WASHMOUTH</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MOTILIUM INSTANT</medicinalproduct>
        <drugindication>DIARRHOEA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MS CONTIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060418</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANXIETY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060418</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5042673-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006CG01122</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>62</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>EOSINOPHILIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERICARDIAL EFFUSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugauthorizationnumb>021153</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OESOPHAGITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050515</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060501</drugenddate>
        <drugtreatmentduration>12</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugauthorizationnumb>021153</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTROOESOPHAGEAL REFLUX DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050515</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060501</drugenddate>
        <drugtreatmentduration>12</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IVERMECTINE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060201</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5042674-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060601</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-SANOFI-SYNTHELABO-F01200601353</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>74</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>EOSINOPHILIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060214</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOPIDOGREL</medicinalproduct>
        <drugauthorizationnumb>020839</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>ACUTE CORONARY SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060215</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugindication>HYPERCHOLESTEROLAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060216</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060519</drugenddate>
        <drugtreatmentduration>93</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5042675-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050614</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-SANOFI-SYNTHELABO-F01200501059</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>67</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGIC DIATHESIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTESTINAL ISCHAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MELAENA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOPIDOGREL BISULFATE</medicinalproduct>
        <drugauthorizationnumb>020839</drugauthorizationnumb>
        <drugdosagetext>300 MG LOADING DOSE FOLLOWED BY 75 MG/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANGINA UNSTABLE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050217</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050615</drugenddate>
        <drugtreatmentduration>17</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRAVIT</medicinalproduct>
        <drugdosagetext>300 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CYSTITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050308</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050312</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRAVIT</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050322</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050331</drugenddate>
        <drugtreatmentduration>10</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRAVIT</medicinalproduct>
        <drugdosagetext>100 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050512</drugenddate>
        <drugtreatmentduration>42</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEUZYM</medicinalproduct>
        <drugdosagetext>90 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CYSTITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050308</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050312</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEUZYM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050322</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050331</drugenddate>
        <drugtreatmentduration>10</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEUZYM</medicinalproduct>
        <drugdosagetext>30 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050512</drugenddate>
        <drugtreatmentduration>42</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SAWACILLIN</medicinalproduct>
        <drugdosagetext>250 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CYSTITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050301</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SAWACILLIN</medicinalproduct>
        <drugdosagetext>750 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050302</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050304</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SAWACILLIN</medicinalproduct>
        <drugdosagetext>500 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050305</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050305</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEPAS</medicinalproduct>
        <drugdosagetext>0.5 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INSOMNIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEVALOTIN</medicinalproduct>
        <drugdosagetext>10 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERLIPIDAEMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIN</medicinalproduct>
        <drugdosagetext>5 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIGMART</medicinalproduct>
        <drugdosagetext>15 MG</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>ANGINA PECTORIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BUFFERIN</medicinalproduct>
        <drugdosagetext>81 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5042676-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060414</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-SANOFI-SYNTHELABO-A03200602366</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>130.6</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COORDINATION ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPENDENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISORIENTATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EATING DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMBIEN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>19908</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INSOMNIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5042681-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060627</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-JNJFOC-20060605879</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HEART RATE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY DEPRESSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMODIUM AD</medicinalproduct>
        <drugauthorizationnumb>017694</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5042691-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060531</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006AP02534</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>22</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD CALCIUM INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CREATINE PHOSPHOKINASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC FUNCTION ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTHERMIA MALIGNANT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METABOLIC ACIDOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROPOFOL</medicinalproduct>
        <drugauthorizationnumb>19627</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>INDUCTION OF ANAESTHESIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SUXAMETHONIUM CHLORIDE</medicinalproduct>
        <drugindication>INDUCTION OF ANAESTHESIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYGEN</medicinalproduct>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>MAINTENANCE OF ANAESTHESIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SEVOFLURANE</medicinalproduct>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>MAINTENANCE OF ANAESTHESIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FENTANYL CITRATE</medicinalproduct>
        <drugindication>MAINTENANCE OF ANAESTHESIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5042692-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060621</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006AP02912</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>57</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>82</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PNEUMOTHORAX</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIPRIVAN</medicinalproduct>
        <drugauthorizationnumb>019627</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>INDUCTION OF ANAESTHESIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VECURONIUM BROMIDE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>INDUCTION OF ANAESTHESIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYGEN</medicinalproduct>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>MAINTENANCE OF ANAESTHESIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NITROUS OXIDE W/ OXYGEN</medicinalproduct>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>MAINTENANCE OF ANAESTHESIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ISOFLURANE</medicinalproduct>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>MAINTENANCE OF ANAESTHESIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PENTOBARBITAL SODIUM</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ANAESTHETIC PREMEDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIAZEPAM</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ANAESTHETIC PREMEDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5042693-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060605</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006AP02551</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>73</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>50</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>AFFECT LABILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD BETA-D-GLUCAN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIVERTICULUM INTESTINAL HAEMORRHAGIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EATING DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERAL PHYSICAL HEALTH DETERIORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSYCHIATRIC SYMPTOM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>REFUSAL OF TREATMENT BY PATIENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MEROPEN</medicinalproduct>
        <drugauthorizationnumb>50706</drugauthorizationnumb>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>EXTRADURAL ABSCESS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060126</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060216</drugenddate>
        <drugtreatmentduration>22</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MEROPEN</medicinalproduct>
        <drugauthorizationnumb>050706</drugauthorizationnumb>
        <drugdosagetext>ONLY ON HAEMODIALYSIS DAYS THREE TIMES A WEEK</drugdosagetext>
        <drugadministrationroute>041</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060224</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060228</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MEROPEN</medicinalproduct>
        <drugauthorizationnumb>050706</drugauthorizationnumb>
        <drugadministrationroute>041</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060309</drugenddate>
        <drugtreatmentduration>9</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MEROPEN</medicinalproduct>
        <drugauthorizationnumb>050706</drugauthorizationnumb>
        <drugadministrationroute>041</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060310</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060316</drugenddate>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MEROPEN</medicinalproduct>
        <drugauthorizationnumb>050706</drugauthorizationnumb>
        <drugdosagetext>FOUR TIMES A WEEK ON NON-HAEMODIALYSIS DAYS</drugdosagetext>
        <drugadministrationroute>041</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060317</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060327</drugenddate>
        <drugtreatmentduration>11</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MEROPEN</medicinalproduct>
        <drugauthorizationnumb>050706</drugauthorizationnumb>
        <drugdosagetext>HAEMODIALYSIS DAYS</drugdosagetext>
        <drugadministrationroute>041</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060317</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060327</drugenddate>
        <drugtreatmentduration>11</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MEROPEN</medicinalproduct>
        <drugauthorizationnumb>050706</drugauthorizationnumb>
        <drugadministrationroute>041</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060328</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060416</drugenddate>
        <drugtreatmentduration>20</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MEROPEN</medicinalproduct>
        <drugauthorizationnumb>050706</drugauthorizationnumb>
        <drugadministrationroute>041</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060417</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060515</drugenddate>
        <drugtreatmentduration>29</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TIENAM</medicinalproduct>
        <drugindication>EXTRADURAL ABSCESS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060124</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060125</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUNGARD</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>CANDIDIASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060410</drugenddate>
        <drugtreatmentduration>41</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NOVOLIN R INJECTION</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>HYPERGLYCAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060124</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060508</drugenddate>
        <drugtreatmentduration>105</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGLAX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONSTIPATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060124</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060308</drugenddate>
        <drugtreatmentduration>44</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MUCOSTA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060124</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060410</drugenddate>
        <drugtreatmentduration>77</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALTAN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERPHOSPHATAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060124</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060410</drugenddate>
        <drugtreatmentduration>77</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERLIPIDAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060124</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060410</drugenddate>
        <drugtreatmentduration>77</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NU-LOTAN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060124</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060410</drugenddate>
        <drugtreatmentduration>77</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RENIVACE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060124</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060410</drugenddate>
        <drugtreatmentduration>77</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HALCION</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INSOMNIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060124</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060410</drugenddate>
        <drugtreatmentduration>77</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SEVOFRANE</medicinalproduct>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>ANAESTHESIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THIOPENTAL SODIUM</medicinalproduct>
        <drugindication>ANAESTHESIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FENTANEST</medicinalproduct>
        <drugindication>ANAESTHESIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MUSCULAX</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ANAESTHESIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5042721-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060620</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ZA-AVENTIS-200613577EU</companynumb>
    <primarysource>
      <reportercountry>SOUTH AFRICA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>83</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>HEPATIC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JAUNDICE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JAUNDICE CHOLESTATIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JAUNDICE HEPATOCELLULAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POST PROCEDURAL COMPLICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugauthorizationnumb>16273</drugauthorizationnumb>
        <drugdosagetext>DOSE: DOSAGE UNKNOWN</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CORONARY ARTERIAL STENT INSERTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060505</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060527</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CIPROBAY</medicinalproduct>
        <drugdosagetext>DOSE: DOSAGE UNKNOWN</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARDURA</medicinalproduct>
        <drugdosagetext>DOSE: DOSAGE UNKNOWN</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZIAK</medicinalproduct>
        <drugdosagetext>DOSE: DOSAGE UNKNOWN</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugdosagetext>DOSE: DOSAGE UNKNOWN</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ECOTRIN</medicinalproduct>
        <drugdosagetext>DOSE: DOSAGE UNKNOWN</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ULSANIC</medicinalproduct>
        <drugdosagetext>DOSE: DOSAGE UNKNOWN</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugdosagetext>DOSE: DOSAGE UNKNOWN</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5042722-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060623</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AVENTIS-200615455US</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIABETES MELLITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIABETES MELLITUS NON-INSULIN-DEPENDENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>016273</drugauthorizationnumb>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5042723-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060626</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ES-AVENTIS-200613555EU</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>69</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPONATRAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TERTENSIF</medicinalproduct>
        <drugauthorizationnumb>18538</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060516</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060520</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRILEPTAL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>EPILEPSY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060520</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5042724-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060630</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-AVENTIS-200611920DE</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>87</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>95</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SHOCK HAEMORRHAGIC</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLEXANE</medicinalproduct>
        <drugauthorizationnumb>20164</drugauthorizationnumb>
        <drugadministrationroute>058</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MARCUMAR</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5042725-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060418</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-AVENTIS-200611280JP</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>93</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>35</patientweight>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERAL PHYSICAL CONDITION ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOGLYCAEMIC COMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOVOLAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA ASPIRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RYTHMODAN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTROPHIC CARDIOMYOPATHY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060316</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060324</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugauthorizationnumb>016273</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OEDEMA PERIPHERAL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060313</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060324</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALDACTONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OEDEMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060313</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060318</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FRANDOL</medicinalproduct>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>ANGINA PECTORIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060316</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060324</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SODIUM BICARBONATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RENAL IMPAIRMENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060316</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060324</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GASTER</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060316</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060324</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SOLANAX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INSOMNIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060316</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060324</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGNESIUM OXIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONSTIPATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060316</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060324</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5042727-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060601</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-AVENTIS-200611626DE</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>74</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>75</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>AGRANULOCYTOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>APHTHOUS STOMATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CELLULITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEUKOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NOVALGIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060522</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060529</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NOVALGIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060401</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLEXANE</medicinalproduct>
        <drugauthorizationnumb>020164</drugauthorizationnumb>
        <drugdosagetext>DOSE: NOT REPORTED</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>DEEP VEIN THROMBOSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DELIX PLUS</medicinalproduct>
        <drugdosagetext>DOSE: COMBINATION 5MG/25MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VIGANTOLETTEN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060522</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM GLUCONATE</medicinalproduct>
        <drugdosagetext>DOSE: NOT REPORTED</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060522</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYGESIC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANALGESIC THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060522</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5042729-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060605</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-AVENTIS-200616075GDDC</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>HYPOCALCAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARAVA</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>20905</drugauthorizationnumb>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5042730-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-AVENTIS-200610039FR</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>64</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>50</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CREATININE RENAL CLEARANCE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTOLERANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHOIDS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARAVA</medicinalproduct>
        <drugauthorizationnumb>020905</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060119</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARAVA</medicinalproduct>
        <drugauthorizationnumb>020905</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>QUESTRAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NSAID'S</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5042731-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050504</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200514051GDDC</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>MESOTHELIOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FRUMIL</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>16273</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>016273</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMBIVENT</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030617</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040513</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030617</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040719</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SALBUTAMOL</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugdosagetext>DOSE: 100 MCG, BID</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ATORVASTATIN CALCIUM</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BECLOMETHASONE DIPROPIONATE</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugdosagetext>DOSE: 50 MCG, 2 BID</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE TAB</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DILTIAZEM HCL</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOSULEPIN</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GAVISCON</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LACTULOSE</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugdosagetext>DOSE: 3.35 G/ 5 ML</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LANSOPRAZOLE</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METOCLOPRAMIDE</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NITROLINGUAL</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NOZINAN</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXYCODONE HCL</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXYGEN</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugadministrationroute>055</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SPIRONOLACTONE</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SYMBICORT</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugdosagetext>DOSE: 200/6 UG, 1-2 PUFFS</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TEMAZEPAM</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugdosagetext>DOSE: 10 MG, 1-2</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5042732-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesscongenitalanomali>1</seriousnesscongenitalanomali>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20020418</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-AVENTIS-200211607FR</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>2.1</patientweight>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>CAESAREAN SECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONGENITAL TRICUSPID VALVE ATRESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CYANOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMODYNAMIC INSTABILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART DISEASE CONGENITAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METABOLIC ACIDOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEONATAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEONATAL HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PREMATURE BABY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENTRICULAR FIBRILLATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TORENTAL</medicinalproduct>
        <drugauthorizationnumb>18631</drugauthorizationnumb>
        <drugadministrationroute>064</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19960223</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ASPEGIC 1000</medicinalproduct>
        <drugadministrationroute>064</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19960403</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ISOPTIN SR</medicinalproduct>
        <drugadministrationroute>064</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROZAC</medicinalproduct>
        <drugadministrationroute>064</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19960131</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COVERSYL</medicinalproduct>
        <drugadministrationroute>064</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19940630</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19960227</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
        <drugadministrationroute>064</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19940630</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19960131</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIXTARD HUMAN 70/30</medicinalproduct>
        <drugadministrationroute>064</drugadministrationroute>
        <drugindication>DIABETES MELLITUS INSULIN-DEPENDENT</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19960227</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPANTHYL</medicinalproduct>
        <drugadministrationroute>064</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19940101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19960227</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INSULATARD NPH HUMAN</medicinalproduct>
        <drugadministrationroute>064</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19960227</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACTRAPID</medicinalproduct>
        <drugadministrationroute>064</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19960227</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SOTALOL HCL</medicinalproduct>
        <drugadministrationroute>064</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ISOPTIN</medicinalproduct>
        <drugadministrationroute>064</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CATAPRES</medicinalproduct>
        <drugadministrationroute>064</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19960701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LASILIX</medicinalproduct>
        <drugadministrationroute>064</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19960101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5042742-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060620</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0606USA03750</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>NEPHRITIS INTERSTITIAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL TUBULAR NECROSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COZAAR</medicinalproduct>
        <drugauthorizationnumb>020386</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5042743-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0606USA05362</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>59</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MUSCLE ATROPHY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VYTORIN</medicinalproduct>
        <drugauthorizationnumb>021687</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060616</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5042751-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060621</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-MERCK-0606USA05034</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>83</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANOREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSED LEVEL OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEPCID RPD</medicinalproduct>
        <drugauthorizationnumb>020752</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060526</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060601</drugenddate>
        <drugtreatmentduration>11</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>[THERAPY UNSPECIFIED]</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FERROMIA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CINAL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALDACTONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LACTULOSE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGNESIUM OXIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5042752-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060623</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0606USA04781</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>77</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ATRIAL FIBRILLATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COGNITIVE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSARTHRIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE IRREGULAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HIP FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEMORY IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULAR WEAKNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RIB FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UPPER LIMB FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WALKING DISABILITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZETIA</medicinalproduct>
        <drugauthorizationnumb>021445</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NAMENDA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>COGNITIVE DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NAMENDA</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NAMENDA</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NAMENDA</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060413</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NAMENDA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONFUSIONAL STATE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NAMENDA</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NAMENDA</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NAMENDA</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060413</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLYBURIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LUPRON</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HERBS (UNSPECIFIED)</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMINS (UNSPECIFIED)</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOCUSATE SODIUM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5042753-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-MERCK-0606GBR00115</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>71</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HYPOKALAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COZAAR</medicinalproduct>
        <drugauthorizationnumb>020386</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051114</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060524</drugenddate>
        <drugtreatmentduration>192</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PERIPHERAL VASCULAR DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN ASPART</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050901</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RAMIPRIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060502</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERCHOLESTEROLAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030501</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5042754-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060626</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-MERCK-0606USA05212</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>69</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEEP VEIN THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EFFECT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUROPATHY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DECADRON</medicinalproduct>
        <drugauthorizationnumb>011664</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>THALOMID</medicinalproduct>
        <drugbatchnumb>0009A</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>THALOMID</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>THALOMID</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060401</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>THALOMID</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>THALOMID</medicinalproduct>
        <drugbatchnumb>0009A</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANTOPRAZOLE SODIUM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AREDIA</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EPREX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5042764-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060523</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-KINGPHARMUSA00001-K200600674</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>74</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>AMYOTROPHIC LATERAL SCLEROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CREATINE PHOSPHOKINASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEURODEGENERATIVE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POLYMYOSITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALTACE</medicinalproduct>
        <drugauthorizationnumb>19901</drugauthorizationnumb>
        <drugdosagetext>5 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060517</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FELODIPINE</medicinalproduct>
        <drugdosagetext>5 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060517</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALNA</medicinalproduct>
        <drugdosagetext>1 TABLET, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MICTURITION DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050301</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BELOC ZOK</medicinalproduct>
        <drugdosagetext>2 TABLETS, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
        <drugdosagetext>80 TO 160 MG, DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050301</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5042765-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060627</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-KINGPHARMUSA00001-K200600835</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ACCIDENTAL NEEDLE STICK</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EPIPEN</medicinalproduct>
        <drugauthorizationnumb>019430</drugauthorizationnumb>
        <drugindication>DRUG ADMINISTRATION ERROR</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060607</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060607</drugenddate>
        <drugtreatmentduration>1440</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5042766-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060623</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-KINGPHARMUSA00001-K200600815</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>96</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHONDROCALCINOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JOINT EFFUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYELODYSPLASTIC SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALTACE</medicinalproduct>
        <drugauthorizationnumb>19901</drugauthorizationnumb>
        <drugdosagetext>1.25 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060224</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COLCHICINE</medicinalproduct>
        <drugdosagetext>.5 MG, QD</drugdosagetext>
        <drugindication>CHONDROCALCINOSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060309</drugenddate>
        <drugtreatmentduration>12960</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MOPRAL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOLIPRANE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MOTILIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FORLAX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TEMESTA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATHYMIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREVISCAN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASILIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OROCAL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5042790-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060512</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006UW09397</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>87</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>29.5</patientweight>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOWER LIMB FRACTURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugauthorizationnumb>20639</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEMENTIA ALZHEIMER'S TYPE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5042796-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050704</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-409563</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>53</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>86.5</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PERITONITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEG-INTERFERON ALFA 2A (RO 25-8310)</medicinalproduct>
        <drugbatchnumb>C21088404</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050427</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050525</drugenddate>
        <drugtreatmentduration>29</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEG-INTERFERON ALFA 2A (RO 25-8310)</medicinalproduct>
        <drugbatchnumb>C21088404</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RIBAVIRIN</medicinalproduct>
        <drugbatchnumb>C20829309</drugbatchnumb>
        <drugauthorizationnumb>021511</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050427</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020615</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREVACID</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040615</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PHOSLO</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040615</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DARVOCET</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030615</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALPRAZOLAM</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020615</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EPOGEN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040615</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TUMS</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040615</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HEPARIN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040615</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050504</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMODIUM</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050504</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZANTAC</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050509</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYLENOL (CAPLET)</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050505</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5042798-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20010206</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-ROCHE-254233</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>44</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD ALBUMIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE MARROW FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG TOXICITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMMUNOSUPPRESSANT DRUG LEVEL INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPHIL MORPHOLOGY ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MYCOPHENOLATE MOFETIL</medicinalproduct>
        <drugauthorizationnumb>050723</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MYCOPHENOLATE MOFETIL</medicinalproduct>
        <drugauthorizationnumb>050723</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RABBIT ANTITHYMOCYTE GLOBULIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYCLOSPORINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CO-TRIMOXAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACYCLOVIR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NYSTATIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHYLPREDNISOLONE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5042800-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060627</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20060606658</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>87</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DURAGESIC-100</medicinalproduct>
        <drugadministrationroute>062</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DURAGESIC-100</medicinalproduct>
        <drugauthorizationnumb>019813</drugauthorizationnumb>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>PAIN</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5042801-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060624</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0610870A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>50</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPENDENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG ADMINISTRATION ERROR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IRRITABILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREATMENT NONCOMPLIANCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NICORETTE (MINT)</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>018612</drugauthorizationnumb>
        <drugdosagetext>2MG SEE DOSAGE TEXT</drugdosagetext>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZETIA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVALIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLOMAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVODART</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5042802-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040713</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>NO-ROCHE-374241</companynumb>
    <primarysource>
      <reportercountry>NORWAY</reportercountry>
      <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>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>BLOOD POTASSIUM DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>C-REACTIVE PROTEIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOKALAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEUKOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CAPECITABINE</medicinalproduct>
        <drugauthorizationnumb>20896</drugauthorizationnumb>
        <drugdosagetext>TWO WEEK TREATMENT AND ONE WEEK REST.</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040628</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040711</drugenddate>
        <drugtreatmentduration>14</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BLINDED BEVACIZUMAB</medicinalproduct>
        <drugauthorizationnumb>020896</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040628</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040711</drugenddate>
        <drugtreatmentduration>14</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXALIPLATIN</medicinalproduct>
        <drugauthorizationnumb>020896</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040628</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040711</drugenddate>
        <drugtreatmentduration>14</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5042811-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060331</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-442933</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>49</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HELICOBACTER PYLORI IDENTIFICATION TEST POSITIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEGASYS</medicinalproduct>
        <drugdosagetext>- ROUTE REPORTED AS INK.</drugdosagetext>
        <drugadministrationroute>050</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051127</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COPEGUS</medicinalproduct>
        <drugauthorizationnumb>021511</drugauthorizationnumb>
        <drugdosagetext>- THREE IN THE MORNING. - THREE IN THE EVENING.</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051127</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEUPOGEN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060315</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORAZEPAM</medicinalproduct>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAZODONE HCL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DURICEF</medicinalproduct>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORTRIPTYLINE HCL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5042812-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060530</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ROCHE-450187</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>59</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>47</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANTINUCLEAR ANTIBODY POSITIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AUTOIMMUNE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIABETES MELLITUS INADEQUATE CONTROL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISSEMINATED INTRAVASCULAR COAGULATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC FUNCTION ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLAMMATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPHOCYTE STIMULATION TEST POSITIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCYTOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ROCEPHIN</medicinalproduct>
        <drugauthorizationnumb>050585</drugauthorizationnumb>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>MENINGITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060508</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060508</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ROCEPHIN</medicinalproduct>
        <drugauthorizationnumb>050585</drugauthorizationnumb>
        <drugadministrationroute>041</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060509</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060509</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FAMOTIDINE</medicinalproduct>
        <drugdosagetext>ROUTE: INJECTABLE (NOT OTHERWISE SPECIFIED).</drugdosagetext>
        <drugadministrationroute>050</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060508</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060508</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FAMOTIDINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060509</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLYCEROL 2.6%</medicinalproduct>
        <drugdosagetext>GENERIC REPORTED AS CONCENTRATED GLYCERINE, FRUCTOSE.</drugdosagetext>
        <drugadministrationroute>041</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060508</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060509</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HUMULIN 70/30</medicinalproduct>
        <drugdosagetext>GENERIC REPORTED AS INSULIN HUMAN (GENETICAL RECOMBINATION). ROUTE: INJECTABLE (NOT OTHERWISE SPECI+</drugdosagetext>
        <drugadministrationroute>050</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060508</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060509</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NOVORAPID</medicinalproduct>
        <drugdosagetext>REPORTED DOSING: 8-6-6 BEFORE EACH MEAL.</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060509</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060523</drugenddate>
        <drugtreatmentduration>15</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5042813-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060320</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>NZ-ROCHE-440921</companynumb>
    <primarysource>
      <reportercountry>NEW ZEALAND</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>32</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>59</patientweight>
      <patientsex>2</patientsex>
      <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>20051003</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060202</drugenddate>
        <drugtreatmentduration>123</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RIBAVIRIN</medicinalproduct>
        <drugauthorizationnumb>021511</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051003</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060202</drugenddate>
        <drugtreatmentduration>123</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYCLOSPORINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOSEC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INHIBACE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHADONE HCL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5042814-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060531</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-450339</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>52</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>74.8</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>AMNESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATOCELLULAR DAMAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLUENZA LIKE ILLNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</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>PEGASYS</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060404</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060523</drugenddate>
        <drugtreatmentduration>50</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEGASYS</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060612</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COPEGUS</medicinalproduct>
        <drugauthorizationnumb>021511</drugauthorizationnumb>
        <drugdosagetext>DOSAGE REGIMEN 3 AM/ 2PM</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060404</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060523</drugenddate>
        <drugtreatmentduration>50</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COPEGUS</medicinalproduct>
        <drugauthorizationnumb>021511</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060612</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COPEGUS</medicinalproduct>
        <drugauthorizationnumb>021511</drugauthorizationnumb>
        <drugdosagetext>DOSAGE REGIMEN 3 AM/ 2PM</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060612</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BACK PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010615</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5042816-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060607</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ROCHE-451183</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>60</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>45</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>APLASIA PURE RED CELL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELLCEPT</medicinalproduct>
        <drugauthorizationnumb>50722</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050615</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060607</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELLCEPT</medicinalproduct>
        <drugauthorizationnumb>050722</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060608</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EPOGEN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060317</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060602</drugenddate>
        <drugtreatmentduration>78</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ESPO</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050916</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060303</drugenddate>
        <drugtreatmentduration>169</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDONINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060608</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060608</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060608</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PERSANTIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040615</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KREMEZIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040615</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMIYU</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060608</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5042817-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-ROCHE-384310</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>47</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>AUTONOMIC NEUROPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CAPECITABINE</medicinalproduct>
        <drugauthorizationnumb>20896</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040917</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CAPECITABINE</medicinalproduct>
        <drugauthorizationnumb>020896</drugauthorizationnumb>
        <drugdosagetext>ADMINISTERED DAILY FOR FOURTEEN DAYS, EVERY THREE WEEKS. PATIENT RECEIVED FOUR CYCLES PRIOR TO EVENT</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041013</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CAPECITABINE</medicinalproduct>
        <drugauthorizationnumb>020896</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041104</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041107</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CAPECITABINE</medicinalproduct>
        <drugauthorizationnumb>020896</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041109</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IXABEPILONE</medicinalproduct>
        <drugdosagetext>INFUSED OVER 3 HOURS ON DAY 1 EVERY 21 DAYS. (1/1 CYCLE)</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FENTANYL TRANSDERMAL SYSTEM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROMORPHONE HCL</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040714</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYCLIZINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5042818-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060516</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-ROCHE-448010</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>73</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>90</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELLCEPT</medicinalproduct>
        <drugauthorizationnumb>050722</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CORNEAL TRANSPLANT</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5042819-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060623</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-ROCHE-452858</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>OPTIC ATROPHY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEGASYS</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COPEGUS</medicinalproduct>
        <drugauthorizationnumb>021511</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5042825-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050114</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-392707</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>55</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>91.6</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LETHARGY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENTAL STATUS CHANGES</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>PEG-INTERFERON ALFA 2A (RO 25-8310)</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050107</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050112</drugenddate>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RIBAVIRIN</medicinalproduct>
        <drugauthorizationnumb>021511</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050107</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050112</drugenddate>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATACAND HCT</medicinalproduct>
        <drugdosagetext>TOTAL DAILY DOSE REPORTED AS 16/125 MG.</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONIDINE</medicinalproduct>
        <drugdosagetext>REPORTED AS CLONIDINE HCL.</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050115</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYTRIN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050107</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MONOPRIL</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPROL-XL</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NOVOLOG</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROCARDIA XL</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041001</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5042826-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-ROCHE-453548</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>57</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIOMYOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY OEDEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RIVOTRIL</medicinalproduct>
        <drugauthorizationnumb>17533</drugauthorizationnumb>
        <drugdosagetext>5 DOSES EVERY DAY.</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050615</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAROXYL</medicinalproduct>
        <drugauthorizationnumb>017533</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050615</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIORESAL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19960615</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COPAXONE</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040615</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VASOBRAL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040615</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5042827-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040706</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0521360A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</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>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOVEMENT DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREATMENT NONCOMPLIANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
        <drugauthorizationnumb>20031</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000818</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20000926</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELEXA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000912</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RITALIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATTENTION DEFICIT/HYPERACTIVITY DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000922</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5042828-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050328</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0553285A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>19</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>60.9</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>COMPLETED SUICIDE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CRYING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EMOTIONAL DISTRESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOOD ALTERED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAXIL CR</medicinalproduct>
        <drugauthorizationnumb>20936</drugauthorizationnumb>
        <drugdosagetext>12.5MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANXIETY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040914</drugstartdate>
        <drugtreatmentduration>12</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5042829-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050503</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0558207A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>53</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>124.5</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>AMNESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CRYING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG WITHDRAWAL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
        <drugauthorizationnumb>20031</drugauthorizationnumb>
        <drugdosagetext>20MG THREE TIMES PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANXIETY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19991201</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5042830-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050509</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0558615A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>40</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>60.5</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>AGGRESSION</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>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VERTIGO</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
        <drugauthorizationnumb>20031</drugauthorizationnumb>
        <drugdosagetext>20MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANXIETY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19991221</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEXAPRO</medicinalproduct>
        <drugdosagetext>10MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANXIETY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELEXA</medicinalproduct>
        <drugdosagetext>20MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANXIETY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5042831-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060420</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0602646A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>36</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>89.1</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC ENZYME INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMICTAL</medicinalproduct>
        <drugauthorizationnumb>20241</drugauthorizationnumb>
        <drugdosagetext>200MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BIPOLAR DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050509</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EFFEXOR</medicinalproduct>
        <drugdosagetext>75MG THREE TIMES PER DAY</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050523</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5042832-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060424</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0603006A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NASOPHARYNGITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUSITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugauthorizationnumb>20297</drugauthorizationnumb>
        <drugdosagetext>25MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CENTRUM SILVER</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5042833-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060503</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0604899A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>ALCOHOL USE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INCREASED</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>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERFORMANCE STATUS DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
        <drugauthorizationnumb>020031</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5042834-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060606</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0608086A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>61</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>115.9</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>APNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CYANOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GRAND MAL CONVULSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REQUIP</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>20658</drugauthorizationnumb>
        <drugdosagetext>1MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RESTLESS LEGS SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060125</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060515</drugenddate>
        <drugtreatmentduration>111</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>WELLBUTRIN XL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021515</drugauthorizationnumb>
        <drugdosagetext>300MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050520</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060515</drugenddate>
        <drugtreatmentduration>361</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TORSEMIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COZAAR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLOMAX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROTONIX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORCO</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5042835-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060623</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-GLAXOSMITHKLINE-A0610405A</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>67</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANGIONEUROTIC OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHILLS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EPIDEMIC PLEURODYNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARYNGOLARYNGEAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARIXTRA</medicinalproduct>
        <drugauthorizationnumb>21345</drugauthorizationnumb>
        <drugdosagetext>2.5MG PER DAY</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>ANTICOAGULANT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060607</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060620</drugenddate>
        <drugtreatmentduration>14</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FRAXIPARINE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060621</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARTHROTEC</medicinalproduct>
        <drugdosagetext>75MG TWICE PER DAY</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5042836-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0610773A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>34</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISORIENTATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE VIA BREAST MILK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG WITHDRAWAL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERAL PHYSICAL HEALTH DETERIORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IRRITABILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NORMAL NEWBORN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TINNITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>20031</drugauthorizationnumb>
        <drugdosagetext>10MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NO CONCURRENT MEDICATION</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5042837-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060630</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0610908A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>24</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>COMPLETED SUICIDE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>WELLBUTRIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>21515</drugauthorizationnumb>
        <drugdosagetext>300MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5042838-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060630</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-GLAXOSMITHKLINE-A0610944A</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HYPOTHERMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERICARDIAL EFFUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLEURAL EFFUSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMOTRIGINE</medicinalproduct>
        <drugauthorizationnumb>020241</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VALPROIC ACID</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5042839-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060630</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-GLAXOSMITHKLINE-A0610953A</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ADVERSE EVENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPENDENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG WITHDRAWAL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEGAL PROBLEM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDE ATTEMPT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
        <drugauthorizationnumb>020031</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5042840-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060630</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>1-14334415</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>33</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>AMNESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISSOCIATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATEMESIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MIGRAINE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMICTAL</medicinalproduct>
        <drugauthorizationnumb>020241</drugauthorizationnumb>
        <drugdosagetext>25MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BIPOLAR DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060602</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EFFEXOR XR</medicinalproduct>
        <drugdosagetext>187.5MG UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BIPOLAR DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5042841-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060630</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0611013A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>13</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ATRIOVENTRICULAR BLOCK FIRST DEGREE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMICTAL</medicinalproduct>
        <drugauthorizationnumb>020241</drugauthorizationnumb>
        <drugdosagetext>450MG PER DAY</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5042842-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0611020A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>MACULAR OEDEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5042843-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20031212</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-GLAXOSMITHKLINE-B0317728A</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>70</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DEPRESSED LEVEL OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESTLESSNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VALACYCLOVIR HCL</medicinalproduct>
        <drugauthorizationnumb>20487</drugauthorizationnumb>
        <drugdosagetext>1000MG THREE TIMES PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>FACIAL NERVE DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031208</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031209</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDONINE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VASOLAN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BUSCOPAN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOUGHMAC E</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYANOCOBALAMIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CIRCULETIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PENTAZOCINE LACTATE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRINOSIN S</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RHYTHMY</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADETPHOS</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GASTER D</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GASCON</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIGITOXIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FRANDOL S</medicinalproduct>
        <drugadministrationroute>062</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5042844-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060623</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-GLAXOSMITHKLINE-B0379351C</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>32</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD CREATININE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD UREA INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>C-REACTIVE PROTEIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHILLS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONJUNCTIVITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAMMA-GLUTAMYLTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NASOPHARYNGITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RALES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHINORRHOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EPIVIR</medicinalproduct>
        <drugauthorizationnumb>20564</drugauthorizationnumb>
        <drugdosagetext>300MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030104</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>20030104</drugstartdate>
      </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>20030104</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5042845-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-GLAXOSMITHKLINE-B0389128A</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>56</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>50</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DYSARTHRIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENINGITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOXIC INDUCED ENCEPHALOPATHY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VALTREX</medicinalproduct>
        <drugauthorizationnumb>20487</drugauthorizationnumb>
        <drugdosagetext>1000MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HERPES ZOSTER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050721</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050724</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOVIRAX</medicinalproduct>
        <drugauthorizationnumb>020089</drugauthorizationnumb>
        <drugdosagetext>200MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HERPES ZOSTER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050719</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050719</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOVIRAX</medicinalproduct>
        <drugauthorizationnumb>018603</drugauthorizationnumb>
        <drugdosagetext>125MG PER DAY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050720</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050722</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5042847-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20051216</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-JPN-A20053113</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>24</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CERVIX DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
        <drugauthorizationnumb>020031</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PANIC DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050520</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060308</drugenddate>
        <drugtreatmentduration>293</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORAZEPAM</medicinalproduct>
        <drugdosagetext>1.5MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PANIC ATTACK</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050204</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050901</drugenddate>
        <drugtreatmentduration>210</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIHYDROERGOTAMINE MESYLATE</medicinalproduct>
        <drugdosagetext>3MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ORTHOSTATIC HYPOTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050901</drugenddate>
        <drugtreatmentduration>154</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GASMOTIN</medicinalproduct>
        <drugdosagetext>2.5MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NAUSEA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050526</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050901</drugenddate>
        <drugtreatmentduration>99</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALPRAZOLAM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050106</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050714</drugenddate>
        <drugtreatmentduration>190</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5042848-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-GLAXOSMITHKLINE-B0408627A</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>45</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ADRENAL CORTICAL INSUFFICIENCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CORTICOTROPHIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CORTISOL DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLIXOTIDE</medicinalproduct>
        <drugauthorizationnumb>20548</drugauthorizationnumb>
        <drugdosagetext>2PUFF THREE TIMES PER DAY</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NOLVADEX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5042849-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-GLAXOSMITHKLINE-B0409066A</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>68</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ADRENAL CORTICAL INSUFFICIENCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CORTICOTROPHIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CORTISOL DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SERETIDE DISKUS</medicinalproduct>
        <drugauthorizationnumb>021077</drugauthorizationnumb>
        <drugdosagetext>1PUFF TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050601</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5042850-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060306</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>438258</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>61</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIOPULMONARY FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL STIFFNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARVEDILOL</medicinalproduct>
        <drugauthorizationnumb>20297</drugauthorizationnumb>
        <drugdosagetext>6.25MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050115</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051215</drugenddate>
        <drugtreatmentduration>335</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENALAPRIL</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030115</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5042852-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060323</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-JPN-A200601023</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>58</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ACCIDENTAL OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>KIDNEY FIBROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL ARTERIOSCLEROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL TUBULAR NECROSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EPIVIR</medicinalproduct>
        <drugauthorizationnumb>20564</drugauthorizationnumb>
        <drugdosagetext>150MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060316</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060320</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TENOFOVIR DISOPROXIL FUMARATE</medicinalproduct>
        <drugdosagetext>300MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060316</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060320</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KALETRA</medicinalproduct>
        <drugdosagetext>6U PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060316</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060320</drugenddate>
        <drugtreatmentduration>5</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>20060318</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060320</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LOXONIN</medicinalproduct>
        <drugdosagetext>60MG AS REQUIRED</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NASOPHARYNGITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060318</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060320</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ISALON</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NASOPHARYNGITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060318</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060320</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5042853-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060425</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-JPN-A200601371</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>83</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>31</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AFFECT LABILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AGITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMMUNICATION DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSED LEVEL OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSARTHRIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSLALIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULAR WEAKNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NERVOUS SYSTEM DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESTLESSNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VALTREX</medicinalproduct>
        <drugauthorizationnumb>20487</drugauthorizationnumb>
        <drugdosagetext>1000MG THREE TIMES PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HERPES ZOSTER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060421</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060421</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOVIRAX</medicinalproduct>
        <drugauthorizationnumb>018603</drugauthorizationnumb>
        <drugdosagetext>200MG PER DAY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ENCEPHALITIS HERPES</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060422</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060424</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SENNOSIDE</medicinalproduct>
        <drugdosagetext>1U PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONSTIPATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALTAN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BIOFERMIN</medicinalproduct>
        <drugdosagetext>3TABS PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ENTEROCOLITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALFAROL</medicinalproduct>
        <drugdosagetext>1CAP PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RENAL OSTEODYSTROPHY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FERRO</medicinalproduct>
        <drugdosagetext>1U PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </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>ZOVIRAX</medicinalproduct>
        <drugadministrationroute>061</drugadministrationroute>
        <drugindication>HERPES ZOSTER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060417</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5042854-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060510</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-JPN-A200601518</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>40</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLAMMATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRODUCTIVE COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UPPER GASTROINTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UPPER RESPIRATORY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINE OUTPUT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLOLAN</medicinalproduct>
        <drugauthorizationnumb>20444</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PULMONARY HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19991025</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040303</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRONOLACTONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIART</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUITRAN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BIOFERMIN R</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMIODARONE HCL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GOODMIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040210</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040227</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HALCION</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040209</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FESIN</medicinalproduct>
        <drugdosagetext>40MG PER DAY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040204</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040227</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAKEPRON</medicinalproduct>
        <drugdosagetext>30MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040228</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040302</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5042855-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060510</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-GLAXOSMITHKLINE-B0424354A</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>36</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ACID FAST STAIN POSITIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD LACTATE DEHYDROGENASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GRANULOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HILAR LYMPHADENOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMMUNE RECONSTITUTION SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPHADENOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MARROW HYPERPLASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MITOCHONDRIAL CYTOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYCOBACTERIAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL CANDIDIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL HAIRY LEUKOPLAKIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH ERYTHEMATOUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN PAPILLOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TUBERCULOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMBIVIR</medicinalproduct>
        <drugauthorizationnumb>020857</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EFAVIRENZ</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COTRIMOXAZOLE</medicinalproduct>
        <drugdosagetext>960MG PER DAY</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>ANTIBIOTIC PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TENOFOVIR</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIDANOSINE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PYRAZINAMIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DAPSONE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>ANTIBIOTIC PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OFLOXACIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROTHIONAMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>STREPTOMYCIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYCLOSERINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5042856-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060523</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-JPN-A200601675</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>3</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>12</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ANURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD AMYLASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CREATINE PHOSPHOKINASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CREATININE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD TRIGLYCERIDES INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD UREA INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUCOUS MEMBRANE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINE OUTPUT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALKERAN</medicinalproduct>
        <drugauthorizationnumb>14691</drugauthorizationnumb>
        <drugdosagetext>58MGM2 PER DAY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>STEM CELL TRANSPLANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060225</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060226</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PARAPLATIN</medicinalproduct>
        <drugdosagetext>175MGM2 PER DAY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>STEM CELL TRANSPLANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060223</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060226</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ETOPOSIDE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>STEM CELL TRANSPLANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060223</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060226</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARBOPLATIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEUTROGIN</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060303</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GASTER</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060223</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEO-MINOPHAGEN-C</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060223</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KYTRIL</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060223</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MIRACLID</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060228</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUTHAN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060227</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARBENIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060227</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUNGUARD</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060228</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HAPTOGLOBIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060301</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SAXIZON</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060228</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060301</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUMIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060302</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060302</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INOVAN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060303</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060303</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOBUTREX</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060303</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060303</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCICOL</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060303</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060303</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEYLON</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060303</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060303</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATROPINE SULFATE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060303</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060303</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BOSMIN</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060303</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060303</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATARAX</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060228</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060301</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUID</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5042857-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060524</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-B0425208A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>34</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>78</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHILLS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALATAL OEDEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOFRAN</medicinalproduct>
        <drugauthorizationnumb>20007</drugauthorizationnumb>
        <drugdosagetext>4MG SINGLE DOSE</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060523</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060523</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PLACEBO</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060523</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060523</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5042858-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060525</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-JPN-A200601724</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>78</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>40</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>NASAL NECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NASAL SEPTUM PERFORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHINALGIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUTICASONE PROPIONATE</medicinalproduct>
        <drugauthorizationnumb>020121</drugauthorizationnumb>
        <drugdosagetext>100MCG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>045</drugadministrationroute>
        <drugindication>RHINITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050604</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051210</drugenddate>
        <drugtreatmentduration>190</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARNACULIN</medicinalproduct>
        <drugdosagetext>3U PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYANOCOBALAMIN</medicinalproduct>
        <drugdosagetext>3U PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KINEDAK</medicinalproduct>
        <drugdosagetext>3U PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RISUMIC</medicinalproduct>
        <drugdosagetext>2U PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
        <drugdosagetext>10MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEPAS</medicinalproduct>
        <drugdosagetext>3U PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MYONAL</medicinalproduct>
        <drugdosagetext>3U PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOIPAN</medicinalproduct>
        <drugdosagetext>3U PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BERIZYM</medicinalproduct>
        <drugdosagetext>3G PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PEON</medicinalproduct>
        <drugdosagetext>1U PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVISHOT</medicinalproduct>
        <drugdosagetext>1U PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LENDORMIN</medicinalproduct>
        <drugdosagetext>1U PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LAXOBERON</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5042859-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060526</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-JPN-A200601736</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>56</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>92</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIAC ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS GENERALISED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SHOCK</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZANTAC</medicinalproduct>
        <drugauthorizationnumb>018703</drugauthorizationnumb>
        <drugdosagetext>50MG PER DAY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PREMEDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060108</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROTONE</medicinalproduct>
        <drugdosagetext>10MG PER DAY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NAUSEA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060511</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060525</drugenddate>
        <drugtreatmentduration>15</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RENIVACE</medicinalproduct>
        <drugdosagetext>5MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060207</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARTIST</medicinalproduct>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>10MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051011</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CIBENOL</medicinalproduct>
        <drugdosagetext>50MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CARDIOMYOPATHY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051011</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SEISHOKU</medicinalproduct>
        <drugdosagetext>100ML PER DAY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060108</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DECADRON</medicinalproduct>
        <drugdosagetext>16MG PER DAY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060108</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060528</drugenddate>
        <drugtreatmentduration>141</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RESTAMIN</medicinalproduct>
        <drugdosagetext>5U PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060108</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060525</drugenddate>
        <drugtreatmentduration>138</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
        <drugdosagetext>2.5MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>THROMBOSIS PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031218</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAXOL</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>OVARIAN CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060420</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060420</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5042860-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060530</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-JPN-A200601774</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>37</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>60</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ELECTROCARDIOGRAM QT PROLONGED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LONG QT SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
        <drugauthorizationnumb>20031</drugauthorizationnumb>
        <drugdosagetext>40MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060525</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEPAS</medicinalproduct>
        <drugdosagetext>1MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5042861-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060529</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-JPN-A200601761</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>46</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>65</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABULIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANOREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BODY TEMPERATURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRADYKINESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CREATINE PHOSPHOKINASE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DECREASED ACTIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DECREASED APPETITE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSED LEVEL OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSIVE SYMPTOM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IRRITABILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL STIFFNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUROLEPTIC MALIGNANT SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINE OUTPUT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
        <drugauthorizationnumb>20031</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060207</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060513</drugenddate>
        <drugtreatmentduration>96</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MEDEPOLIN</medicinalproduct>
        <drugdosagetext>.4MG SEE DOSAGE TEXT</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060207</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ELIETEN</medicinalproduct>
        <drugdosagetext>5MG THREE TIMES PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060207</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060513</drugenddate>
        <drugtreatmentduration>96</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HIZULEN S</medicinalproduct>
        <drugdosagetext>1.5G PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060207</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060513</drugenddate>
        <drugtreatmentduration>96</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
        <drugadministrationroute>045</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060524</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDEPOLIN</medicinalproduct>
        <drugadministrationroute>045</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HORIZON</medicinalproduct>
        <drugdosagetext>10ML PER DAY</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060522</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060522</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SERENACE</medicinalproduct>
        <drugadministrationroute>050</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060522</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060524</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AKINETON</medicinalproduct>
        <drugdosagetext>5MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060522</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060523</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DANTRIUM</medicinalproduct>
        <drugadministrationroute>050</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060523</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PERORIC</medicinalproduct>
        <drugadministrationroute>045</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060523</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN</medicinalproduct>
        <drugdosagetext>2G TWICE PER DAY</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060523</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUID</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060523</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADEFURONIC</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060523</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SALINE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060603</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HORIZON</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060522</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXTROSE 5%</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060523</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060523</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THIAMINE HCL</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060523</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5042862-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060531</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-JPN-A200601617</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>51</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DYSPEPSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OESOPHAGEAL ULCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARYNGOLARYNGEAL DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUTIDE DISKUS</medicinalproduct>
        <drugauthorizationnumb>20833</drugauthorizationnumb>
        <drugdosagetext>200MCG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNIPHYL</medicinalproduct>
        <drugdosagetext>200MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020824</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050218</drugenddate>
        <drugtreatmentduration>130</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ONON</medicinalproduct>
        <drugdosagetext>225MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020829</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20021220</drugenddate>
        <drugtreatmentduration>16</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HOKUNALIN</medicinalproduct>
        <drugdosagetext>2MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020419</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5042863-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060530</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-GLAXOSMITHKLINE-B0426360A</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>71</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>85</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERICARDIAL EFFUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>8MG PER DAY</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060601</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DILTIAZEM HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLICLAZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IRBESARTAN - HYDROCHLOROTHIAZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ESOMEPRAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLOPIDOGREL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMIPRAMINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRAVASTATIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5042864-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060605</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-JPN-A200601874</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>46</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>55</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANTITHROMBIN III DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OXYGEN SATURATION DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROTHROMBIN LEVEL DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZEFIX</medicinalproduct>
        <drugauthorizationnumb>20564</drugauthorizationnumb>
        <drugdosagetext>100MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS B</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060427</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACINON</medicinalproduct>
        <drugdosagetext>300MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060428</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BIOFERMIN</medicinalproduct>
        <drugdosagetext>3G PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060426</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROMAC</medicinalproduct>
        <drugdosagetext>1G PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060429</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGLAX</medicinalproduct>
        <drugdosagetext>1320MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060520</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLASMA</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060427</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTITHROMBIN III</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060427</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIAZEPAM</medicinalproduct>
        <drugadministrationroute>050</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060518</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PHENOBARBITAL TAB</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060518</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALPROATE SODIUM</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060520</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYGEN</medicinalproduct>
        <drugindication>OXYGEN SATURATION DECREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LACTULOSE</medicinalproduct>
        <drugdosagetext>45MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060425</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060517</drugenddate>
        <drugtreatmentduration>23</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KANAMYCIN</medicinalproduct>
        <drugdosagetext>1000MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060428</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060502</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5042865-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060614</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-JPN-A200602054</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>64</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>COMPLETED SUICIDE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
        <drugauthorizationnumb>20031</drugauthorizationnumb>
        <drugdosagetext>10MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION POSTMENOPAUSAL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030205</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060527</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEPROMEL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION POSTMENOPAUSAL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030205</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060527</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIMAS</medicinalproduct>
        <drugdosagetext>400MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION POSTMENOPAUSAL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030122</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030205</drugenddate>
        <drugtreatmentduration>15</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METLIGINE</medicinalproduct>
        <drugdosagetext>4MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030205</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060527</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GRAMALIL</medicinalproduct>
        <drugdosagetext>50MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION POSTMENOPAUSAL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030205</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060527</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORAZEPAM</medicinalproduct>
        <drugdosagetext>2MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION POSTMENOPAUSAL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030205</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060527</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEPAS</medicinalproduct>
        <drugdosagetext>1MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION POSTMENOPAUSAL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030205</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060527</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FORSENID</medicinalproduct>
        <drugdosagetext>2U PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONSTIPATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030205</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060527</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LENDORMIN</medicinalproduct>
        <drugdosagetext>.25MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030122</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030205</drugenddate>
        <drugtreatmentduration>15</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5042866-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060621</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-JPN-A200602177</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>78</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>58</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DECREASED APPETITE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPONATRAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESTLESSNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
        <drugauthorizationnumb>020031</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060522</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060605</drugenddate>
        <drugtreatmentduration>15</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEUCOVORIN CALCIUM</medicinalproduct>
        <drugdosagetext>75MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>LARGE INTESTINE CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060508</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UFT</medicinalproduct>
        <drugdosagetext>450MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>LARGE INTESTINE CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060508</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>URSO</medicinalproduct>
        <drugdosagetext>600MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>LIVER DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEVALOTIN</medicinalproduct>
        <drugdosagetext>10MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERLIPIDAEMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEPAS</medicinalproduct>
        <drugdosagetext>.5MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANXIETY DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADALAT</medicinalproduct>
        <drugdosagetext>10MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060322</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5042867-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060626</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-GLAXOSMITHKLINE-B0428763A</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>63</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>70</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>RETINAL DETACHMENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SERETIDE</medicinalproduct>
        <drugauthorizationnumb>21077</drugauthorizationnumb>
        <drugdosagetext>1PUFF TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>BRONCHIECTASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RABEPRAZOLE SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTIBIOTIC (UNSPECIFIED)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PARIET</medicinalproduct>
        <drugdosagetext>20MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5042868-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-GLAXOSMITHKLINE-B0429126A</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>49</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CONSCIOUSNESS FLUCTUATING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DELIRIUM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYDRIASIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROXAT</medicinalproduct>
        <drugauthorizationnumb>20031</drugauthorizationnumb>
        <drugdosagetext>20MG AT NIGHT</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060627</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TEMAZEPAM</medicinalproduct>
        <drugdosagetext>10MG AT NIGHT</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060620</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5042869-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-GLAXOSMITHKLINE-B0429152A</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>37</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ACID BASE BALANCE ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ALPHA 1 GLOBULIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASCITES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD BICARBONATE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CALCIUM 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>BLOOD URIC ACID DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CANDIDA SEROLOGY POSITIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CREATININE URINE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIABETES MELLITUS INSULIN-DEPENDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRODUODENAL ULCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERAL PHYSICAL HEALTH DETERIORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC CIRRHOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERGAMMAGLOBULINAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOALBUMINAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOCALCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOCAPNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEUKOCYTOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METABOLIC ACIDOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPHILIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCREATITIS CHRONIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RALES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STAPHYLOCOCCAL SEPSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EPIVIR</medicinalproduct>
        <drugauthorizationnumb>020564</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060214</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CRIXIVAN</medicinalproduct>
        <drugdosagetext>800MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041015</drugstartdate>
      </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>250MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050131</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060214</drugenddate>
        <drugtreatmentduration>12</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZERIT</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VIRACEPT</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050614</drugenddate>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SUBUTEX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NOVOMIX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVLOCARDYL LP 160</medicinalproduct>
        <drugdosagetext>160MG PER DAY</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AERIUS</medicinalproduct>
        <drugdosagetext>1TAB PER DAY</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MIANSERINE</medicinalproduct>
        <drugdosagetext>10MG PER DAY</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FORTIMEL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5042870-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-JPN-A200602354</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>64</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>COMPLETED SUICIDE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
        <drugauthorizationnumb>020031</drugauthorizationnumb>
        <drugdosagetext>10MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060605</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060619</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5042872-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060630</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-GLAXOSMITHKLINE-B0429515A</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>71</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANAPHYLACTIC SHOCK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS GENERALISED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TINNITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL DISTURBANCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLAMOXYL</medicinalproduct>
        <drugauthorizationnumb>50754</drugauthorizationnumb>
        <drugdosagetext>1G SINGLE DOSE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060617</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060617</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RHINOCORT</medicinalproduct>
        <drugdosagetext>1PUFF SINGLE DOSE</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060617</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060617</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVLOCARDYL</medicinalproduct>
        <drugdosagetext>160MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLOR</medicinalproduct>
        <drugdosagetext>5MG PER DAY</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PAROXETINE HCL</medicinalproduct>
        <drugdosagetext>20MG PER DAY</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRANXENE 10</medicinalproduct>
        <drugdosagetext>10MG PER DAY</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5042873-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060626</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-JPN-A200602284</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>45</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SHOCK</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZANTAC</medicinalproduct>
        <drugauthorizationnumb>018703</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5042874-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BE-GLAXOSMITHKLINE-B0429591A</companynumb>
    <primarysource>
      <reportercountry>BELGIUM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>PSORIASIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMOTRIGINE</medicinalproduct>
        <drugauthorizationnumb>020241</drugauthorizationnumb>
        <drugindication>BIPOLAR DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5042875-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IT-GLAXOSMITHKLINE-B0429595A</companynumb>
    <primarysource>
      <reportercountry>ITALY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>74</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CIRCULATORY COLLAPSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FACE OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS GENERALISED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMOXYCILLIN + CLAVULANIC ACID</medicinalproduct>
        <drugauthorizationnumb>50564</drugauthorizationnumb>
        <drugdosagetext>1MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>TOOTH ABSCESS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060626</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060626</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE BESYLATE</medicinalproduct>
        <drugdosagetext>10MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLIMEPIRIDE</medicinalproduct>
        <drugdosagetext>2MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5042876-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060627</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ES-GLAXOSMITHKLINE-B0429600A</companynumb>
    <primarysource>
      <reportercountry>SPAIN</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>29</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>56</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>APLASTIC ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BIOPSY BONE MARROW ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMMUNE SYSTEM DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AUGMENTIN '125'</medicinalproduct>
        <drugauthorizationnumb>050564</drugauthorizationnumb>
        <drugdosagetext>1.5MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ORAL SOFT TISSUE DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050115</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050122</drugenddate>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5042877-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060630</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-GLAXOSMITHKLINE-B0429623A</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>44</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DERMATITIS BULLOUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH MACULO-PAPULAR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYBAN</medicinalproduct>
        <drugauthorizationnumb>020711</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060524</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060606</drugenddate>
        <drugtreatmentduration>14</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5042878-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DK-GLAXOSMITHKLINE-B0429647A</companynumb>
    <primarysource>
      <reportercountry>DENMARK</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>63</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>84</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEMIPLEGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SENSORY DISTURBANCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYBAN</medicinalproduct>
        <drugauthorizationnumb>020711</drugauthorizationnumb>
        <drugdosagetext>150MG UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060410</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060502</drugenddate>
        <drugtreatmentduration>23</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5042879-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CH-GLAXOSMITHKLINE-B0429689A</companynumb>
    <primarysource>
      <reportercountry>SWITZERLAND</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>36</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ACNE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ACNE CYSTIC</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMICTAL</medicinalproduct>
        <drugauthorizationnumb>20241</drugauthorizationnumb>
        <drugdosagetext>250MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050501</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LITHIUM SULPHATE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>BIPOLAR I DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TEGRETOL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>BIPOLAR I DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5042880-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>SE-GLAXOSMITHKLINE-B0429694A</companynumb>
    <primarysource>
      <reportercountry>SWEDEN</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>55</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VERTIGO</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MALARONE</medicinalproduct>
        <drugauthorizationnumb>021078</drugauthorizationnumb>
        <drugdosagetext>1TAB PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MALARIA PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060519</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060519</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5042881-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>SE-GLAXOSMITHKLINE-B0429701A</companynumb>
    <primarysource>
      <reportercountry>SWEDEN</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>85</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HYPONATRAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMICTAL</medicinalproduct>
        <drugauthorizationnumb>20241</drugauthorizationnumb>
        <drugdosagetext>75MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ERGENYL</medicinalproduct>
        <drugdosagetext>450MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SALURES-K</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060603</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRONOLAKTON</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TROMBYL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5042882-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060627</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ES-GLAXOSMITHKLINE-B0429704A</companynumb>
    <primarysource>
      <reportercountry>SPAIN</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>87</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AUGMENTIN '125'</medicinalproduct>
        <drugauthorizationnumb>50564</drugauthorizationnumb>
        <drugdosagetext>.86G THREE TIMES PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050816</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050928</drugenddate>
        <drugtreatmentduration>44</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAZOCEL</medicinalproduct>
        <drugdosagetext>4G THREE TIMES PER DAY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050831</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050902</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COLCHICINE</medicinalproduct>
        <drugdosagetext>1MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050816</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RENITEC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5042883-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ZA-GLAXOSMITHKLINE-B0429715A</companynumb>
    <primarysource>
      <reportercountry>SOUTH AFRICA</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISION BLURRED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL ACUITY REDUCED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>4MG PER DAY</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060601</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLIMEPIRIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5042884-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-GLAXOSMITHKLINE-B0429756A</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INAPPROPRIATE SCHEDULE OF DRUG ADMINISTRATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARIXTRA</medicinalproduct>
        <drugauthorizationnumb>021345</drugauthorizationnumb>
        <drugdosagetext>2.5MG PER DAY</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>THROMBOSIS PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTIVITAMINS K</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5042885-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-GLAXOSMITHKLINE-B0429759A</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>75</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INAPPROPRIATE SCHEDULE OF DRUG ADMINISTRATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARIXTRA</medicinalproduct>
        <drugauthorizationnumb>021345</drugauthorizationnumb>
        <drugdosagetext>2.5MG PER DAY</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>THROMBOSIS PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5042886-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>NL-GLAXOSMITHKLINE-B0429848A</companynumb>
    <primarysource>
      <reportercountry>NETHERLANDS</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>BALANCE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COORDINATION ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMOTRIGINE</medicinalproduct>
        <drugauthorizationnumb>020764</drugauthorizationnumb>
        <drugdosagetext>150MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5042887-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20020128</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-GLAXOSMITHKLINE-D0025264A</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>42</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>75.7</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FAT REDISTRIBUTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC STEATOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIPODYSTROPHY ACQUIRED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIPOHYPERTROPHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URTICARIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZIAGEN</medicinalproduct>
        <drugauthorizationnumb>20977</drugauthorizationnumb>
        <drugdosagetext>300MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990715</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051024</drugenddate>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMBIVIR</medicinalproduct>
        <drugauthorizationnumb>020857</drugauthorizationnumb>
        <drugdosagetext>450MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19970411</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051024</drugenddate>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTIPLE MEDICATION</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INDINIVIR SULFATE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19970411</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19990824</drugenddate>
        <drugtreatmentduration>866</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EFAVIRENZ</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990824</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20001221</drugenddate>
        <drugtreatmentduration>486</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TENOFOVIR</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030617</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PEGASYS</medicinalproduct>
        <drugdosagetext>180MCG WEEKLY</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RIBAVIRIN</medicinalproduct>
        <drugdosagetext>800MG UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5042888-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060322</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-GLAXOSMITHKLINE-D0049157A</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>73</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>68</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABNORMAL DREAMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABNORMAL FAECES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISTURBANCE IN ATTENTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ILLUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NASAL DRYNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUDDEN ONSET OF SLEEP</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>YAWNING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REQUIP</medicinalproduct>
        <drugauthorizationnumb>20658</drugauthorizationnumb>
        <drugdosagetext>2MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PARKINSON'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050901</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HEADACHE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5042889-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060508</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-GLAXOSMITHKLINE-D0049652A</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>75</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ALOPECIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANOREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EXCESSIVE EYE BLINKING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE DISCHARGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HALLUCINATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOGORRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOVEMENT DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOTONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NIGHTMARE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMICTAL</medicinalproduct>
        <drugauthorizationnumb>20241</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>EPILEPSY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACIMETHIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANGOCIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BOTOX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DICLOFENAC</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5042890-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060524</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-GLAXOSMITHKLINE-D0049846A</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>7</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>21.4</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULAR WEAKNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIANI</medicinalproduct>
        <drugauthorizationnumb>21254</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060124</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060523</drugenddate>
        <drugtreatmentduration>120</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5042891-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060620</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-GLAXOSMITHKLINE-D0050165A</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>CONDUCTION DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAGONIS</medicinalproduct>
        <drugauthorizationnumb>20031</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5042892-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-GLAXOSMITHKLINE-D0050171A</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>55</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BURNING SENSATION MUCOSAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC ENZYME INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AUGMENTIN '125'</medicinalproduct>
        <drugauthorizationnumb>50564</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060511</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060515</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5042893-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060630</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-GLAXOSMITHKLINE-D0050183A</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>73</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>77</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINOATRIAL BLOCK</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>QUILONUM RETARD</medicinalproduct>
        <drugauthorizationnumb>18152</drugauthorizationnumb>
        <drugdosagetext>450MG UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>APONAL</medicinalproduct>
        <drugdosagetext>100MG PER DAY</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugdosagetext>10MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EUTHYROX</medicinalproduct>
        <drugdosagetext>75UG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OSSOFORTIN FORTE</medicinalproduct>
        <drugdosagetext>1TAB UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIET PROGRAM</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5042894-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060701</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006012023</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>17</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INTENTIONAL OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NO ADVERSE EFFECT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDE ATTEMPT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAGONIS</medicinalproduct>
        <drugauthorizationnumb>20031</drugauthorizationnumb>
        <drugdosagetext>5TAB SINGLE DOSE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5042895-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-ROCHE-453551</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>56</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>LEUKOCYTOCLASTIC VASCULITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VASCULAR PURPURA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VALIUM</medicinalproduct>
        <drugauthorizationnumb>13263</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060516</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERDAL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060503</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TERCIAN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060503</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>THERALENE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060516</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ANAFRANIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060516</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5042896-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060626</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-KINGPHARMUSA00001-K200600833</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>39</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ALANINE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASPARTATE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</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>BODY TEMPERATURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CATHETER RELATED INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAMMA-GLUTAMYLTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMODIALYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HERPES VIRUS INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIPASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METABOLIC ACIDOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHABDOMYOLYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUS TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEPTRA</medicinalproduct>
        <drugauthorizationnumb>017376</drugauthorizationnumb>
        <drugdosagetext>2 TABLETS, QID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PNEUMOCYSTIS JIROVECI PNEUMONIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5042897-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060623</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-453095</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSYCHOTIC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SCHIZOPHRENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THINKING ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEGASYS</medicinalproduct>
        <drugdosagetext>REPORTED AS INJECTABLE POWDER</drugdosagetext>
        <drugadministrationroute>050</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060115</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060115</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RIBAVIRIN</medicinalproduct>
        <drugauthorizationnumb>021511</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060115</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5042898-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060626</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-ROCHE-453045</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>59</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>120</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ACUTE CORONARY SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LOXEN LP</medicinalproduct>
        <drugauthorizationnumb>19488</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CORTANCYL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OLMESARTAN MEDOXOMIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARANESP</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060218</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEULASTA</medicinalproduct>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060218</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYCLOPHOSPHAMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ONCOVIN</medicinalproduct>
        <drugdosagetext>DRUG REPORTED AS ^ONCOVIN (VINCRISTINE SULPHATE)^</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5042899-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060622</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AVENTIS-200615425US</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER FUNCTION TEST ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCREATIC ENZYMES INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KETEK</medicinalproduct>
        <drugauthorizationnumb>021144</drugauthorizationnumb>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
        <drugindication>PHARYNGITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5042900-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060623</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AVENTIS-200615453US</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ALANINE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASPARTATE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD ALKALINE PHOSPHATASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER FUNCTION TEST ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA ASPIRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UNEVALUABLE EVENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KETEK</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021144</drugauthorizationnumb>
        <drugindication>PNEUMONIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060611</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060601</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMBIEN</medicinalproduct>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KLONOPIN</medicinalproduct>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5042901-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060623</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-AVENTIS-200616773GDDC</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>43</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METRONIDAZOLE</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>20743</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LANSOPRAZOLE</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HELICOBACTER INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060520</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060522</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLARITHROMYCIN</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RANITIDINE</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DYSPEPSIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5042902-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-AVENTIS-200612333FR</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>ANOREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD ALKALINE PHOSPHATASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERAL PHYSICAL HEALTH DETERIORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATOCELLULAR DAMAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JAUNDICE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RIFADIN</medicinalproduct>
        <drugauthorizationnumb>50420</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY TUBERCULOSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060403</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PIRILENE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY TUBERCULOSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060403</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060414</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RIMIFON</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY TUBERCULOSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060403</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060414</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RIMIFON</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060415</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MYAMBUTOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY TUBERCULOSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060403</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5042903-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060530</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-AVENTIS-200611944FR</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>55</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ASPARTATE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST X-RAY ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHLAMYDIAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CYTOLYTIC HEPATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATOCELLULAR DAMAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALLOR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLEUROPERICARDITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KETEK</medicinalproduct>
        <drugauthorizationnumb>21144</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BRONCHITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060315</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060320</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMOXICILLIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BRONCHITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060320</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060327</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PYOSTACINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060329</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060409</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CIFLOX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060329</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060403</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5042904-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AVENTIS-200610036US</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BRUXISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOKINESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULAR WEAKNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KETEK</medicinalproduct>
        <drugbatchnumb>1087177</drugbatchnumb>
        <drugauthorizationnumb>21144</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SINUSITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051229</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051229</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KETEK</medicinalproduct>
        <drugbatchnumb>1087177</drugbatchnumb>
        <drugauthorizationnumb>021144</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BRONCHITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051229</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051229</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GUAIFENEX</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051229</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEPO-MEDROL</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051229</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5042905-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060519</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-AVENTIS-200611567JP</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>71</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>34.1</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>DELIRIUM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSED LEVEL OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KETEK</medicinalproduct>
        <drugauthorizationnumb>21144</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NOCARDIOSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060407</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060408</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KLARICID</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PNEUMONIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060409</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060413</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MENESIT</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PARKINSON'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19750101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060524</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GASTER</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>REFLUX OESOPHAGITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040426</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060409</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOWARAT</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060409</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MUCOSTA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>REFLUX OESOPHAGITIS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060409</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GANATON</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PARKINSON'S DISEASE</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060409</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CABASER</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PARKINSON'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040607</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060524</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SELEGILINE HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PARKINSON'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031110</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060524</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FERROMIA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>REFLUX OESOPHAGITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040224</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060409</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FERROMIA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040224</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060409</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SHAKUYAKUKANZOUTOU</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PARKINSON'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060405</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060409</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PENTCILLIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NOCARDIOSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060317</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060320</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FIRSTCIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NOCARDIOSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060320</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060407</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMIKACIN SULFATE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NOCARDIOSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060413</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060417</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ROCEPHIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NOCARDIOSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060413</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060426</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HABEKACIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NOCARDIOSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060417</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060426</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VANCOMYCIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NOCARDIOSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060426</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060507</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MINOCYCLINE HCL</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NOCARDIOSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060507</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060516</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TARGOCID</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NOCARDIOSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060516</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060522</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5042907-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060623</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ROCHE-452978</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>64</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>GAMMA-GLUTAMYLTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATOCELLULAR DAMAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PANALDINE</medicinalproduct>
        <drugauthorizationnumb>19979</drugauthorizationnumb>
        <drugdosagetext>ADDITIONAL INDICATION: DILATED CARDIOMYOPATHY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANGINA PECTORIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060515</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060525</drugenddate>
        <drugtreatmentduration>11</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060410</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MICARDIS</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060410</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060416</drugenddate>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060410</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACINON</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060412</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALDACTONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060424</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5042908-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-ROCHE-453549</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>20</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD CREATINE PHOSPHOKINASE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VALIUM</medicinalproduct>
        <drugauthorizationnumb>13263</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RIVOTRIL</medicinalproduct>
        <drugauthorizationnumb>017533</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060528</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRIENTINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051115</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PARKINANE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVLOCARDYL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5042909-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20020215</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-ROCHE-307176</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>63</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>117</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANAPHYLACTIC SHOCK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CAPILLARY LEAK SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISSEMINATED INTRAVASCULAR COAGULATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EXTRAVASATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HYPNOVEL</medicinalproduct>
        <drugauthorizationnumb>18654</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ANAESTHESIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010608</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010610</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AUGMENTIN '125'</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010608</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010608</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AUGMENTIN '125'</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010609</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010609</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AUGMENTIN '125'</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010610</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010610</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORCURON</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010608</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010608</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FENTANYL CITRATE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010608</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010608</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5042925-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060612</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-BRACCO-BEI-006334</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>31</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>58</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANAPHYLACTIC SHOCK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ELECTROCARDIOGRAM QT CORRECTED INTERVAL PROLONGED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROHANCE</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>20131</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>INDURATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060609</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060609</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROHANCE</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>020131</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060609</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060609</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5042935-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060626</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-BRISTOL-MYERS SQUIBB COMPANY-13427455</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>63</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CONJUNCTIVAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VASTEN TABS</medicinalproduct>
        <drugauthorizationnumb>19898</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5042936-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060607</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-13404330</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>90</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLINDNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GLAUCOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLAMMATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KENALOG</medicinalproduct>
        <drugauthorizationnumb>12041</drugauthorizationnumb>
        <drugadministrationroute>031</drugadministrationroute>
        <drugindication>MACULAR DEGENERATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060519</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060519</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPROL-XL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMDUR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARDIZEM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACIPHEX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5042937-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060623</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-13421599</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>58</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ABILIFY</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEXAPRO</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5042938-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060621</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AT-JNJFOC-20060306864</companynumb>
    <primarysource>
      <reportercountry>AUSTRIA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>62.7</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ALANINE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANTINUCLEAR ANTIBODY POSITIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASPARTATE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD ALKALINE PHOSPHATASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHILLS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FIBROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAMMA-GLUTAMYLTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERAL PHYSICAL HEALTH DETERIORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC ENZYME INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMPAIRED WORK ABILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUPUS-LIKE SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL STIFFNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARYNGOESOPHAGEAL DIVERTICULUM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARYNGOLARYNGEAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RED BLOOD CELL SEDIMENTATION RATE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SENSATION OF FOREIGN BODY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPINAL OSTEOARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STIFF-MAN SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugbatchnumb>5RMKA703</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PSORIATIC ARTHROPATHY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugbatchnumb>5RMKA703</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PSORIASIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEODOLPASSE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ARTHRALGIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5042939-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060626</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-JNJFOC-20060204307</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>52</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>99</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HEPATIC ENZYME INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC STEATOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPLENOMEGALY</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>PSORIASIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOPHAG</medicinalproduct>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLIBENCLAMID</medicinalproduct>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BLOPRESS</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5042940-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060626</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ZA-BRISTOL-MYERS SQUIBB COMPANY-13425269</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>2</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>11</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REYATAZ</medicinalproduct>
        <drugauthorizationnumb>21567</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050811</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>STAVUDINE</medicinalproduct>
        <drugauthorizationnumb>020412</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050811</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMIVUDINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050811</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RITONAVIR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050811</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BACTRIM</medicinalproduct>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMIN</medicinalproduct>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5042958-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060627</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-JNJFOC-20060606056</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>PUSTULAR 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>5042959-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060627</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ES-JNJFOC-20060606471</companynumb>
    <primarysource>
      <reportercountry>SPAIN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HALLUCINATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARANOIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSYCHOTIC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SCHIZOPHRENIA</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>5042976-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060627</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-ABBOTT-06P-062-0337152-00</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>CEREBRAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ERGENYL SOLUTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>18081</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PHENPROCOUMON</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HEPARIN</medicinalproduct>
        <drugadministrationroute>051</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5042977-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060616</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-ABBOTT-06P-056-0336392-00</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>60</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>LEUKOERYTHROBLASTIC ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEUKOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NORVIR</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>20945</drugauthorizationnumb>
        <drugindication>ACQUIRED IMMUNODEFICIENCY SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060301</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SULFADIAZINE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>TOXOPLASMOSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BACTRIM</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>TOXOPLASMOSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PYRIMETHAMINE TAB</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>TOXOPLASMOSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AZITHROMYCIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>TOXOPLASMOSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMIVUDINE AND ZIDOVUDINE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060515</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMPRENAVIR</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060301</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5042992-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20051123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-426618</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>16</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>68</patientweight>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AFFECTIVE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANOGENITAL WARTS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>APPENDICECTOMY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASCITES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AUTOIMMUNE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AUTOIMMUNE HEPATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BUNDLE BRANCH BLOCK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CELLULITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHILLS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHOLECYSTITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLITIS ULCERATIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMPLEMENT FACTOR C3 DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMPLEMENT FACTOR C4 DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CROHN'S DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEEP VEIN THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIABETES MELLITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG DEPENDENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ENDOMETRIOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLANK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FUNGAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRIC VARICES HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHOIDS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC CIRRHOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMPAIRED HEALING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLAMMATORY BOWEL DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IRRITABLE BOWEL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEUKOCYTOCLASTIC VASCULITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOWER EXTREMITY MASS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENSTRUATION IRREGULAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METRORRHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTI-ORGAN DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEPHROLITHIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OBSESSIVE-COMPULSIVE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVARIAN CYST RUPTURED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCYTOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PELVIC INFLAMMATORY DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERIRECTAL ABSCESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PORTAL HYPERTENSIVE GASTROPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRECANCEROUS CELLS PRESENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROTHROMBIN TIME PROLONGED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYELONEPHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RAYNAUD'S PHENOMENON</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SJOGREN'S SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN ULCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPLENOMEGALY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STAPHYLOCOCCAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYSTEMIC LUPUS ERYTHEMATOSUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TIBIA FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UMBILICAL HERNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VARICES OESOPHAGEAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>18662</drugauthorizationnumb>
        <drugdosagetext>ACCUTANE 40 - 80 ALTERNATING.</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ACNE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19930716</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>018662</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19930815</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19931130</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASACOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMURAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugindication>AUTOIMMUNE HEPATITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PHENERGAN HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CIPRO</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TEGRETOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEMEROL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHADONE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CORTISOL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5042996-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060614</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHFR2006GB01983</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>39</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZARIL</medicinalproduct>
        <drugauthorizationnumb>019758</drugauthorizationnumb>
        <drugdosagetext>UNK, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060524</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060615</drugenddate>
        <drugtreatmentduration>33120</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5042997-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060512</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHNU2006AU02030</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>35</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ECHOCARDIOGRAM ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY VALVE INCOMPETENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRICUSPID VALVE INCOMPETENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENTRICULAR DYSFUNCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENTRICULAR DYSKINESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENTRICULAR HYPOKINESIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZARIL</medicinalproduct>
        <drugauthorizationnumb>019758</drugauthorizationnumb>
        <drugdosagetext>200 MG/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000207</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060530</drugenddate>
        <drugtreatmentduration>2305</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5042998-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060627</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2006CL09616</companynumb>
    <primarysource>
      <reportercountry>CHILE</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG DISPENSING ERROR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG TOXICITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZAPINE</medicinalproduct>
        <drugauthorizationnumb>019758</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5042999-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060626</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHNU2006DE02358</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BRONCHOPNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERICARDITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLEURAL EFFUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZAPINE</medicinalproduct>
        <drugauthorizationnumb>019758</drugauthorizationnumb>
        <drugdosagetext>12.5 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050901</drugenddate>
        <drugtreatmentduration>1440</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZAPINE</medicinalproduct>
        <drugauthorizationnumb>019758</drugauthorizationnumb>
        <drugdosagetext>37.5 MG/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050902</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050902</drugenddate>
        <drugtreatmentduration>1440</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZAPINE</medicinalproduct>
        <drugauthorizationnumb>019758</drugauthorizationnumb>
        <drugdosagetext>75 MG/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050903</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050903</drugenddate>
        <drugtreatmentduration>1440</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZAPINE</medicinalproduct>
        <drugauthorizationnumb>019758</drugauthorizationnumb>
        <drugdosagetext>100 MG/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050904</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050905</drugenddate>
        <drugtreatmentduration>2880</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZAPINE</medicinalproduct>
        <drugauthorizationnumb>019758</drugauthorizationnumb>
        <drugdosagetext>125 MG/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050906</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050906</drugenddate>
        <drugtreatmentduration>1440</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZAPINE</medicinalproduct>
        <drugauthorizationnumb>019758</drugauthorizationnumb>
        <drugdosagetext>150 MG/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050907</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050907</drugenddate>
        <drugtreatmentduration>1440</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZAPINE</medicinalproduct>
        <drugauthorizationnumb>019758</drugauthorizationnumb>
        <drugdosagetext>175 MG/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050908</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050908</drugenddate>
        <drugtreatmentduration>1440</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZAPINE</medicinalproduct>
        <drugauthorizationnumb>019758</drugauthorizationnumb>
        <drugdosagetext>200 MG/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050908</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050914</drugenddate>
        <drugtreatmentduration>10080</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAVOR</medicinalproduct>
        <drugdosagetext>4.5 MG/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050901</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NOCTAMID</medicinalproduct>
        <drugdosagetext>2 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050901</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5043013-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060419</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2006NZ05597</companynumb>
    <primarysource>
      <reportercountry>NEW ZEALAND</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>39</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>AGRANULOCYTOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPHIL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NON-HODGKIN'S LYMPHOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZARIL</medicinalproduct>
        <drugauthorizationnumb>19758</drugauthorizationnumb>
        <drugdosagetext>UNK, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19940314</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060429</drugenddate>
        <drugtreatmentduration>4430</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZARIL</medicinalproduct>
        <drugauthorizationnumb>019758</drugauthorizationnumb>
        <drugdosagetext>RED. BY 50 MG EVERY 4 WEEKS</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060430</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060519</drugenddate>
        <drugtreatmentduration>28800</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OLANZAPINE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENZTROPINE MESYLATE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5043014-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060626</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHNR2006AU00847</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HEPATOMEGALY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EPILIM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NEUROSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZARIL</medicinalproduct>
        <drugauthorizationnumb>019758</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NEUROSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5043015-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060626</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHNU2006DE02359</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>C-REACTIVE PROTEIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG LEVEL INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEUKOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UPPER RESPIRATORY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZAPINE</medicinalproduct>
        <drugauthorizationnumb>19758</drugauthorizationnumb>
        <drugdosagetext>150 MG/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19950101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060126</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZAPINE</medicinalproduct>
        <drugauthorizationnumb>019758</drugauthorizationnumb>
        <drugdosagetext>50 TO 150 MG/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060127</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060213</drugenddate>
        <drugtreatmentduration>25920</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZAPINE</medicinalproduct>
        <drugauthorizationnumb>019758</drugauthorizationnumb>
        <drugdosagetext>200 MG/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060214</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060218</drugenddate>
        <drugtreatmentduration>7200</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZAPINE</medicinalproduct>
        <drugauthorizationnumb>019758</drugauthorizationnumb>
        <drugdosagetext>250 MG/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060219</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060223</drugenddate>
        <drugtreatmentduration>7200</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZAPINE</medicinalproduct>
        <drugauthorizationnumb>019758</drugauthorizationnumb>
        <drugdosagetext>300 MG/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060224</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060312</drugenddate>
        <drugtreatmentduration>24480</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZAPINE</medicinalproduct>
        <drugauthorizationnumb>019758</drugauthorizationnumb>
        <drugdosagetext>400 MG/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060313</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060328</drugenddate>
        <drugtreatmentduration>23040</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZAPINE</medicinalproduct>
        <drugauthorizationnumb>019758</drugauthorizationnumb>
        <drugdosagetext>425 MG/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060329</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060329</drugenddate>
        <drugtreatmentduration>1440</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZAPINE</medicinalproduct>
        <drugauthorizationnumb>019758</drugauthorizationnumb>
        <drugdosagetext>450 MG/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060330</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060405</drugenddate>
        <drugtreatmentduration>10080</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZAPINE</medicinalproduct>
        <drugauthorizationnumb>019758</drugauthorizationnumb>
        <drugdosagetext>500 MG/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060406</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060507</drugenddate>
        <drugtreatmentduration>46080</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZAPINE</medicinalproduct>
        <drugauthorizationnumb>019758</drugauthorizationnumb>
        <drugdosagetext>550 MG/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060508</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060517</drugenddate>
        <drugtreatmentduration>14400</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EUNERPAN</medicinalproduct>
        <drugdosagetext>100 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060403</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060518</drugenddate>
        <drugtreatmentduration>66240</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RISPERDAL</medicinalproduct>
        <drugdosagetext>1 TO 2 MG/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060420</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060425</drugenddate>
        <drugtreatmentduration>8640</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RISPERDAL</medicinalproduct>
        <drugdosagetext>3 MG/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060426</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060427</drugenddate>
        <drugtreatmentduration>2880</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RISPERDAL</medicinalproduct>
        <drugdosagetext>4 MG/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060428</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060501</drugenddate>
        <drugtreatmentduration>5760</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RISPERDAL</medicinalproduct>
        <drugdosagetext>6 MG/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060502</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060522</drugenddate>
        <drugtreatmentduration>30240</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RISPERDAL</medicinalproduct>
        <drugdosagetext>8 MG/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060523</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060523</drugenddate>
        <drugtreatmentduration>1440</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RISPERDAL</medicinalproduct>
        <drugdosagetext>4 MG/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060524</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANTOZOL</medicinalproduct>
        <drugdosagetext>40 MG/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060125</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYREA</medicinalproduct>
        <drugdosagetext>1000 MG/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060125</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060412</drugenddate>
        <drugtreatmentduration>78</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYREA</medicinalproduct>
        <drugdosagetext>1500 MG/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060413</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GASTROZEPIN</medicinalproduct>
        <drugdosagetext>50 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060313</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BISOHEXAL</medicinalproduct>
        <drugdosagetext>2.5 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060125</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5043033-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060613</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-NOVOPROD-254058</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>61</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>74</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>INFLUENZA LIKE ILLNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NOVOMIX 30</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugdosagetext>46 IU, QD</drugdosagetext>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060617</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060618</drugenddate>
        <drugtreatmentduration>1440</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVEMIR</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021536</drugauthorizationnumb>
        <drugdosagetext>20 IU, QD</drugdosagetext>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060520</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060522</drugenddate>
        <drugtreatmentduration>2880</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVEMIR</medicinalproduct>
        <drugauthorizationnumb>021536</drugauthorizationnumb>
        <drugdosagetext>206 IU, QD</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060527</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060529</drugenddate>
        <drugtreatmentduration>2880</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NOVORAPID PENFILL</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugdosagetext>26 IU, QD</drugdosagetext>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060520</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060522</drugenddate>
        <drugtreatmentduration>2880</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NOVORAPID PENFILL</medicinalproduct>
        <drugdosagetext>26 IU, QD</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060527</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060529</drugenddate>
        <drugtreatmentduration>2880</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5043045-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060622</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DK-NOVOPROD-254353</companynumb>
    <primarysource>
      <reportercountry>DENMARK</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>57</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>116</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>LEFT VENTRICULAR FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
        <drugdosagetext>500 MG, PRN</drugdosagetext>
        <drugindication>HEADACHE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19950101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
        <drugdosagetext>120 MG, QD</drugdosagetext>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051117</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
        <drugdosagetext>80 MG, QD</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040202</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041108</drugenddate>
        <drugtreatmentduration>280</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
        <drugdosagetext>160 MG, QD</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041108</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051117</drugenddate>
        <drugtreatmentduration>374</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KALEORID</medicinalproduct>
        <drugdosagetext>750 MG, QD</drugdosagetext>
        <drugindication>MINERAL SUPPLEMENTATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041104</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050307</drugenddate>
        <drugtreatmentduration>123</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COZAAR</medicinalproduct>
        <drugdosagetext>100 MG, QD</drugdosagetext>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050519</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050818</drugenddate>
        <drugtreatmentduration>91</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COZAAR</medicinalproduct>
        <drugdosagetext>50 MG, QD</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041104</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050216</drugenddate>
        <drugtreatmentduration>104</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRIX</medicinalproduct>
        <drugdosagetext>50 MG, QD</drugdosagetext>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050307</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugdosagetext>20 MG, QD</drugdosagetext>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050818</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NOVORAPID FLEXPEN</medicinalproduct>
        <drugauthorizationnumb>020986</drugauthorizationnumb>
        <drugdosagetext>52 U, QD</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>INSULIN-REQUIRING TYPE II DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031120</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BLINDED</medicinalproduct>
        <drugdosagetext>1 TAB, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INSULIN-REQUIRING TYPE II DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031120</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BLINDED</medicinalproduct>
        <drugdosagetext>2 TAB, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031120</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OCULAC</medicinalproduct>
        <drugdosagetext>UNK, PRN</drugdosagetext>
        <drugadministrationroute>031</drugadministrationroute>
        <drugindication>DRY EYE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031010</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SELOZOK</medicinalproduct>
        <drugdosagetext>200 MG, QD</drugdosagetext>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19981130</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZARATOR                            /01326101/</medicinalproduct>
        <drugdosagetext>20 MG, QD</drugdosagetext>
        <drugindication>HYPERLIPIDAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20001122</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041108</drugenddate>
        <drugtreatmentduration>1447</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COVERSYL                           /00790701/</medicinalproduct>
        <drugdosagetext>8 MG, QD</drugdosagetext>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020227</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050307</drugenddate>
        <drugtreatmentduration>1104</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COVERSYL                           /00790701/</medicinalproduct>
        <drugdosagetext>4 MG, QD</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050307</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050828</drugenddate>
        <drugtreatmentduration>174</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COVERSYL                           /00790701/</medicinalproduct>
        <drugdosagetext>2 MG, QD</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050828</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETYLSALICYLIC ACID SRT</medicinalproduct>
        <drugdosagetext>150 MG, QD</drugdosagetext>
        <drugindication>ANTICOAGULANT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19981129</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5043046-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>HK-GILEAD-2006-0009805</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ALANINE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPSERA</medicinalproduct>
        <drugbatchnumb>TEP022</drugbatchnumb>
        <drugauthorizationnumb>021449</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS B</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060301</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5043047-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060622</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DK-NOVOPROD-254363</companynumb>
    <primarysource>
      <reportercountry>DENMARK</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>59</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>138</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BRADYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INSULATARD FLEXPEN HM(GE)</medicinalproduct>
        <drugauthorizationnumb>19959</drugauthorizationnumb>
        <drugdosagetext>80 IU, QD</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>INSULIN-REQUIRING TYPE II DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030616</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BLINDED</medicinalproduct>
        <drugdosagetext>1 TAB, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INSULIN-REQUIRING TYPE II DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030618</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BLINDED</medicinalproduct>
        <drugdosagetext>2 TAB, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030618</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC                            /00972401/</medicinalproduct>
        <drugdosagetext>10 MG, QD</drugdosagetext>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040610</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC                            /00972401/</medicinalproduct>
        <drugdosagetext>20 MG, QD</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040610</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BURINEX</medicinalproduct>
        <drugdosagetext>UNK, BID</drugdosagetext>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040610</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BURINEX</medicinalproduct>
        <drugdosagetext>UNK, QID</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040610</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZARATOR                            /01326101/</medicinalproduct>
        <drugdosagetext>80 MG, QD</drugdosagetext>
        <drugindication>HYPERCHOLESTEROLAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COVERSYL                           /00790701/</medicinalproduct>
        <drugdosagetext>4 MG, QD</drugdosagetext>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040829</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COVERSYL                           /00790701/</medicinalproduct>
        <drugdosagetext>8 MG, QD</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040829</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SELOZOK</medicinalproduct>
        <drugdosagetext>50 MG, QD</drugdosagetext>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040610</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5043052-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060703</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>58.9676</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ADVERSE EVENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>REACTION TO AZO-DYES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THERAPEUTIC RESPONSE UNEXPECTED WITH DRUG SUBSTITUTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URTICARIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMITRIPTYLINE HCL</medicinalproduct>
        <drugbatchnumb>T07IJ05B</drugbatchnumb>
        <drugdosagetext>10 MG QHS PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060624</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMITRIPTYLINE HCL</medicinalproduct>
        <drugbatchnumb>T07IJ05B</drugbatchnumb>
        <drugdosagetext>10 MG QHS PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SLEEP DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060624</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5043053-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060622</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006178</companynumb>
    <primarysource>
      <reportercountry>SPAIN</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>63</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ENDOMETRIAL CANCER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VAGIFEM</medicinalproduct>
        <drugauthorizationnumb>020908</drugauthorizationnumb>
        <drugdosagetext>2 TABL./ WEEK</drugdosagetext>
        <drugadministrationroute>067</drugadministrationroute>
        <drugindication>ATROPHIC VULVOVAGINITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5043058-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060703</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>71.6683</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MIGRAINE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THERAPEUTIC RESPONSE UNEXPECTED WITH DRUG SUBSTITUTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FIORICET W/ CODEINE</medicinalproduct>
        <drugdosagetext>1 T.I.D. W/ MIGRAINE</drugdosagetext>
        <drugindication>MIGRAINE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5043061-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060703</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>71.6683</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MIGRAINE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STOMACH DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THERAPEUTIC RESPONSE UNEXPECTED WITH DRUG SUBSTITUTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ATIVAN</medicinalproduct>
        <drugdosagetext>1 MG 1 QHS</drugdosagetext>
        <drugindication>PARKINSON'S DISEASE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5043066-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060531</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-NOVOPROD-254465</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>74</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>70</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NODULE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVEMIR</medicinalproduct>
        <drugauthorizationnumb>021536</drugauthorizationnumb>
        <drugdosagetext>26 IU, QD</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>INSULIN-REQUIRING TYPE II DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051103</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060302</drugenddate>
        <drugtreatmentduration>119</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASILIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOPHAGE                         /00082701/</medicinalproduct>
        <drugdosagetext>3 G, QD</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMARYL</medicinalproduct>
        <drugdosagetext>6 MG, QD</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREVISCAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIGITALINE NATIVELLE</medicinalproduct>
        <drugdosagetext>2 G, QD</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SELECTOL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5043073-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060614</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-AVENTIS-200611859JP</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>67</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE DIASTOLIC INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GLYCOSYLATED HAEMOGLOBIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOGLYCAEMIC COMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LACTIC ACIDOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY RATE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EUGLUCON</medicinalproduct>
        <drugauthorizationnumb>17532</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS NON-INSULIN-DEPENDENT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METFORMIN HCL</medicinalproduct>
        <drugindication>DIABETES MELLITUS NON-INSULIN-DEPENDENT</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5043074-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnesscongenitalanomali>1</seriousnesscongenitalanomali>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060529</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-AVENTIS-200611960FR</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>30</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABORTION INDUCED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAL ATRESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASCITES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIABETES MELLITUS INADEQUATE CONTROL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FOETAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FOETAL MALFORMATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL MALFORMATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PREGNANCY ON ORAL CONTRACEPTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREATMENT NONCOMPLIANCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
        <drugauthorizationnumb>21081</drugauthorizationnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>DIABETES MELLITUS INSULIN-DEPENDENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040622</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ORAL CONTRACEPTIVE PILLS</medicinalproduct>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HUMALOG</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5043075-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20051005</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200517102US</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>70.5</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANIC REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WRONG TECHNIQUE IN DRUG USAGE PROCESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021081</drugauthorizationnumb>
        <drugdosagetext>DOSE UNIT: UNITS</drugdosagetext>
        <drugadministrationroute>051</drugadministrationroute>
        <drugindication>DIABETES MELLITUS NON-INSULIN-DEPENDENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050930</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OPTICLIK (INSULIN INJECTION PEN)</medicinalproduct>
        <drugbatchnumb>D086</drugbatchnumb>
        <drugauthorizationnumb>021081</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050930</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MICRONASE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>DOSE: UNKNOWN</drugdosagetext>
        <drugindication>DIABETES MELLITUS NON-INSULIN-DEPENDENT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPROL-XL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>DOSE: UNKNOWN</drugdosagetext>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRICOR</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>DOSE: UNKNOWN</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5043076-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060405</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-AVENTIS-200616794GDDC</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABORTION SPONTANEOUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CAESAREAN SECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PREGNANCY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021081</drugauthorizationnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>DIABETES MELLITUS INSULIN-DEPENDENT</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5043077-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060405</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-AVENTIS-200616797GDDC</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABORTION SPONTANEOUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CAESAREAN SECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIMB REDUCTION DEFECT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021081</drugauthorizationnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>DIABETES MELLITUS INSULIN-DEPENDENT</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5043079-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060405</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-AVENTIS-200616799GDDC</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABORTION SPONTANEOUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CAESAREAN SECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIMB REDUCTION DEFECT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021081</drugauthorizationnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>DIABETES MELLITUS INSULIN-DEPENDENT</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5043080-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesscongenitalanomali>1</seriousnesscongenitalanomali>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060405</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-AVENTIS-200616802GDDC</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>0</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <reaction>
        <reactionmeddrapt>ABORTION SPONTANEOUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CAESAREAN SECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIMB REDUCTION DEFECT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021081</drugauthorizationnumb>
        <drugadministrationroute>064</drugadministrationroute>
        <drugindication>DIABETES MELLITUS INSULIN-DEPENDENT</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5043081-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060622</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AVENTIS-200615401US</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>APHASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLINDNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLINDNESS UNILATERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRONCHOSCOPY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COGNITIVE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEMIPLEGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LETHARGY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THINKING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021081</drugauthorizationnumb>
        <drugdosagetext>DOSE UNIT: UNITS</drugdosagetext>
        <drugindication>DIABETES MELLITUS NON-INSULIN-DEPENDENT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021081</drugauthorizationnumb>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021081</drugauthorizationnumb>
        <drugdosagetext>DOSE UNIT: UNITS</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021081</drugauthorizationnumb>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060613</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060616</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMBIVENT</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HUMULIN N</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HUMALOG</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIGITEK</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5043082-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-AVENTIS-200611987JP</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>26</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CAESAREAN SECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FOETAL GROWTH RETARDATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLACENTAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SMALL FOR DATES BABY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
        <drugauthorizationnumb>021081</drugauthorizationnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>DIABETES MELLITUS INSULIN-DEPENDENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040720</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NOVORAPID</medicinalproduct>
        <drugdosagetext>DOSE: 58-64 UNITS/DAY</drugdosagetext>
        <drugindication>DIABETES MELLITUS INSULIN-DEPENDENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040517</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5043083-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060626</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PL-AVENTIS-200616740GDDC</companynumb>
    <primarysource>
      <reportercountry>POLAND</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>83</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSGEUSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
        <drugbatchnumb>E162</drugbatchnumb>
        <drugauthorizationnumb>021081</drugauthorizationnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060621</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060626</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5043084-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060626</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AVENTIS-200615527US</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>73.6</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE FLUCTUATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERKALAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISION BLURRED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
        <drugbatchnumb>N298</drugbatchnumb>
        <drugauthorizationnumb>021081</drugauthorizationnumb>
        <drugdosagetext>DOSE UNIT: UNITS</drugdosagetext>
        <drugindication>DIABETES MELLITUS INSULIN-DEPENDENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060501</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROCARDIA</medicinalproduct>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRICOR</medicinalproduct>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDREA</medicinalproduct>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HUMALOG</medicinalproduct>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HUMALIN</medicinalproduct>
        <drugdosagetext>DOSE: 3 INJECTIONS DAILY</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5043085-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060317</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AVENTIS-200612927US</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARPAL TUNNEL DECOMPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIABETIC RETINOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GLYCOSYLATED HAEMOGLOBIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE BRUISING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>KNEE ARTHROPLASTY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
        <drugbatchnumb>E051</drugbatchnumb>
        <drugauthorizationnumb>021081</drugauthorizationnumb>
        <drugdosagetext>DOSE UNIT: UNITS</drugdosagetext>
        <drugindication>DIABETES MELLITUS NON-INSULIN-DEPENDENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OPTICLIK (INSULIN INJECTION PEN)</medicinalproduct>
        <drugbatchnumb>E035</drugbatchnumb>
        <drugauthorizationnumb>021081</drugauthorizationnumb>
        <drugindication>DIABETES MELLITUS NON-INSULIN-DEPENDENT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZETIA                                   /USA/</medicinalproduct>
        <drugdosagetext>DOSE: UNKNOWN</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NOVOLOG</medicinalproduct>
        <drugdosagetext>DOSE: UNKNOWN</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PHENTERMINE</medicinalproduct>
        <drugdosagetext>DOSE: UNKNOWN</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
        <drugdosagetext>DOSE: UNKNOWN</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENICAR                                 /USA/</medicinalproduct>
        <drugdosagetext>DOSE: UNKNOWN</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LUMIGAN</medicinalproduct>
        <drugdosagetext>DOSE: UNKNOWN</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALPHAGAN</medicinalproduct>
        <drugdosagetext>DOSE: UNKNOWN</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGNESIUM</medicinalproduct>
        <drugdosagetext>DOSE: UNKNOWN</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>DOSE: UNKNOWN</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN E</medicinalproduct>
        <drugdosagetext>DOSE: UNKNOWN</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASCORBIC ACID</medicinalproduct>
        <drugdosagetext>DOSE: UNKNOWN</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOSAMINE</medicinalproduct>
        <drugdosagetext>DOSE: UNKNOWN</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CENTRUM</medicinalproduct>
        <drugdosagetext>DOSE: UNKNOWN</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FISH OIL</medicinalproduct>
        <drugdosagetext>DOSE: UNKNOWN</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMIPRAMINE</medicinalproduct>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SERUMLIPIDREDUCING AGENTS</medicinalproduct>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5043086-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060526</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AVENTIS-200614736US</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HYPERGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
        <drugbatchnumb>40N010</drugbatchnumb>
        <drugauthorizationnumb>021081</drugauthorizationnumb>
        <drugdosagetext>DOSE UNIT: UNITS</drugdosagetext>
        <drugindication>DIABETES MELLITUS NON-INSULIN-DEPENDENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060525</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OPTICLIK (INSULIN INJECTION PEN)</medicinalproduct>
        <drugbatchnumb>E018</drugbatchnumb>
        <drugauthorizationnumb>021081</drugauthorizationnumb>
        <drugindication>DIABETES MELLITUS NON-INSULIN-DEPENDENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060525</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060528</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>APIDRA</medicinalproduct>
        <drugbatchnumb>40N010</drugbatchnumb>
        <drugauthorizationnumb>021629</drugauthorizationnumb>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
        <drugindication>DIABETES MELLITUS NON-INSULIN-DEPENDENT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONIDINE</medicinalproduct>
        <drugdosagetext>DOSE: UNKNOWN</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
        <drugdosagetext>DOSE: UNKNOWN</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugdosagetext>DOSE: UNKNOWN</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
        <drugdosagetext>DOSE: UNKNOWN</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PERCOCET</medicinalproduct>
        <drugdosagetext>DOSE: UNKNOWN</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SOMA</medicinalproduct>
        <drugdosagetext>DOSE: UNKNOWN</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
        <drugdosagetext>DOSE: UNKNOWN</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5043087-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060623</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-NOVOPROD-254358</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>2</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>DYSPHONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEMIPARESIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEMIPLEGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOGLYCAEMIC SEIZURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARESIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPEECH DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY INCONTINENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVEMIR</medicinalproduct>
        <drugauthorizationnumb>021536</drugauthorizationnumb>
        <drugdosagetext>39 U, QD (16+23)</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>DIABETES MELLITUS INSULIN-DEPENDENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050801</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRAMADOL HCL</medicinalproduct>
        <drugdosagetext>100 MG, PRN</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DELIX</medicinalproduct>
        <drugdosagetext>.5 TAB, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HUMALOG                            /00030501/</medicinalproduct>
        <drugdosagetext>8-12+6+6-10</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SALOFALK                           /00000301/</medicinalproduct>
        <drugdosagetext>1 TAB, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PIROXICAM</medicinalproduct>
        <drugdosagetext>20 MG, PRN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5043094-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060622</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2006IT09558</companynumb>
    <primarysource>
      <reportercountry>ITALY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>39</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DIABETIC RETINOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEUKAEMIC RETINOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MACULAR OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RETINAL ISCHAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RETINAL NEOVASCULARISATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VITREOUS HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GLEEVEC</medicinalproduct>
        <drugauthorizationnumb>021588</drugauthorizationnumb>
        <drugdosagetext>400 MG/D</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CHRONIC MYELOID LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060504</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060518</drugenddate>
        <drugtreatmentduration>21600</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5043095-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060331</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2006JP05013</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>50</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>79</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD CREATINE PHOSPHOKINASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHABDOMYOLYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STOMATITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GLEEVEC</medicinalproduct>
        <drugauthorizationnumb>21588</drugauthorizationnumb>
        <drugdosagetext>100 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CHRONIC MYELOID LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060405</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060412</drugenddate>
        <drugtreatmentduration>11520</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GLEEVEC</medicinalproduct>
        <drugauthorizationnumb>021588</drugauthorizationnumb>
        <drugdosagetext>400 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060413</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GLEEVEC</medicinalproduct>
        <drugauthorizationnumb>021588</drugauthorizationnumb>
        <drugdosagetext>400 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060330</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARDENALIN</medicinalproduct>
        <drugdosagetext>1 MG/D</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050901</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NU LOTAN</medicinalproduct>
        <drugdosagetext>50 MG/D</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050901</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5043096-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHNU2006DE02406</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>36</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>90</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>AMNESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRAIN OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISTURBANCE IN ATTENTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG WITHDRAWAL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA EXERTIONAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE CONTRACTIONS INVOLUNTARY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEGLECT OF PERSONAL APPEARANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEOPLASM PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SIMPLE PARTIAL SEIZURES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISION BLURRED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GLEEVEC</medicinalproduct>
        <drugauthorizationnumb>21588</drugauthorizationnumb>
        <drugdosagetext>600 MG/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ASTROCYTOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060501</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LITALIR</medicinalproduct>
        <drugdosagetext>500 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ASTROCYTOMA</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060501</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANTOPRAZOLE</medicinalproduct>
        <drugdosagetext>1 DF, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LAMOTRIGINE</medicinalproduct>
        <drugdosagetext>2 DF, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LAMOTRIGINE</medicinalproduct>
        <drugdosagetext>425 MG/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KEPPRA</medicinalproduct>
        <drugdosagetext>2 DF, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KALINOR-BRAUSETABLETTEN</medicinalproduct>
        <drugdosagetext>1 DF, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5043097-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060627</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHFR2006GB02088</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>89</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GLEEVEC</medicinalproduct>
        <drugauthorizationnumb>021588</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5043107-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060531</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHRM2006FR01679</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>75</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DYSURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POLLAKIURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROSTATE CANCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROSTATIC SPECIFIC ANTIGEN INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GLEEVEC</medicinalproduct>
        <drugauthorizationnumb>21588</drugauthorizationnumb>
        <drugdosagetext>400 MG DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CHRONIC MYELOID LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030813</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5043108-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2006PL09660</companynumb>
    <primarysource>
      <reportercountry>POLAND</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>64</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BONE MARROW FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUCOSAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPTIC SHOCK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMATINIB</medicinalproduct>
        <drugauthorizationnumb>21588</drugauthorizationnumb>
        <drugdosagetext>600 MG/D</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CHRONIC MYELOID LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040315</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMATINIB</medicinalproduct>
        <drugauthorizationnumb>021588</drugauthorizationnumb>
        <drugdosagetext>300 MG/D</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
        <drugdosagetext>100 MG/D</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
        <drugdosagetext>40 MG EVERY OTHER DAY</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5043109-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060623</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2006JP09612</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>47</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DIABETES MELLITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GLYCOSYLATED HAEMOGLOBIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GLEEVEC</medicinalproduct>
        <drugauthorizationnumb>021588</drugauthorizationnumb>
        <drugdosagetext>400 MG/D</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CHRONIC MYELOID LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041106</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GLEEVEC</medicinalproduct>
        <drugauthorizationnumb>021588</drugauthorizationnumb>
        <drugdosagetext>300 MG/D</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5043120-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHO2006VE10639</companynumb>
    <primarysource>
      <reportercountry>VENEZUELA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>33</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>GASTRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MELAENA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GLEEVEC</medicinalproduct>
        <drugauthorizationnumb>021588</drugauthorizationnumb>
        <drugdosagetext>400 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CHRONIC MYELOID LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060524</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060628</drugenddate>
        <drugtreatmentduration>51840</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5043121-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060622</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHRM2006FR01909</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>RENAL AMYLOIDOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GLEEVEC</medicinalproduct>
        <drugauthorizationnumb>021588</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CHRONIC MYELOID LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5043134-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060623</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006CG01105</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>21624</patientonsetage>
      <patientonsetageunit>804</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CARPAL TUNNEL SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARIMIDEX</medicinalproduct>
        <drugauthorizationnumb>020541</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BREAST CANCER FEMALE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050706</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5043135-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060113</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006CG00114</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>887</patientonsetage>
      <patientonsetageunit>802</patientonsetageunit>
      <patientweight>80</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHOLESTASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CYTOLYTIC HEPATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EOSINOPHILIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAMMA-GLUTAMYLTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CASODEX</medicinalproduct>
        <drugauthorizationnumb>20498</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROSTATE CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051223</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAHOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051213</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENANTONE</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PROSTATE CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SINTROM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060401</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SINTROM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060401</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASILIX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060301</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASILIX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060301</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLECAINIDE ACETATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALPRAZOLAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BECOTIDE</medicinalproduct>
        <drugadministrationroute>055</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>STILNOX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PARACETAMOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MUCOMYST</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DUPHALAC</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5043136-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060517</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006AP02290</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>13575</patientonsetage>
      <patientonsetageunit>804</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERVENTILATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STRESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOLADEX</medicinalproduct>
        <drugauthorizationnumb>019726</drugauthorizationnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>ENDOMETRIOSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060304</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060401</drugenddate>
        <drugtreatmentduration>29</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5043137-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060630</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006SE03668</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>77</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HYPOGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BLOPRESS</medicinalproduct>
        <drugauthorizationnumb>20838</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NOVOLIN 30</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZONISAMIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5043138-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060621</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2006JP09373</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>42</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANAPLASTIC LARGE CELL LYMPHOMA T- AND NULL-CELL TYPES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE MARROW DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIFFUSE LARGE B-CELL LYMPHOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EPSTEIN-BARR VIRUS INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPHADENOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SANDIMMUNE</medicinalproduct>
        <drugauthorizationnumb>50625</drugauthorizationnumb>
        <drugdosagetext>50 MG/D</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RENAL TRANSPLANT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugindication>RENAL TRANSPLANT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AZATHIOPRINE</medicinalproduct>
        <drugindication>RENAL TRANSPLANT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYCLOPHOSPHAMIDE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5043150-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060703</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>80</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>94.7</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BACTERIAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATITIS FULMINANT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CIPROFLOXACIN</medicinalproduct>
        <drugdosagetext>500 MG PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIVERTICULITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060530</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5043155-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060703</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>95.2554</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD CREATININE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD UREA INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MAXIPIME</medicinalproduct>
        <drugbatchnumb>6C21660</drugbatchnumb>
        <drugdosagetext>2GM EVERY 24 HOURS IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PNEUMONIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060603</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060613</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GENTAMICIN</medicinalproduct>
        <drugbatchnumb>200518</drugbatchnumb>
        <drugdosagetext>210 MG EVERY 24 HOURS IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PNEUMONIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060603</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060612</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BUPROPION HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REQUIP</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VIT A AND D</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MOBIC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROVIGIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OCUVITE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEXAPRO</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COMBIVENT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DYAZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SINGULAIR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRILOSEC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADVAIR DISKUS 100/50</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCODONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORAZEPAM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5043160-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060703</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>47</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>82</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANAPHYLACTIC REACTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
        <drugdosagetext>1600 MG QID PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANKLE FRACTURE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060301</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5043163-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060703</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>42</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>74.1</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PERIORBITAL CELLULITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUSITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RIBAVIRIN</medicinalproduct>
        <drugdosagetext>1200 MG DAILY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INTERFERON</medicinalproduct>
        <drugdosagetext>SQ</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5043165-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060703</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>44</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>66.7</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG LEVEL INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OESOPHAGEAL CANDIDIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUCONAZOLE</medicinalproduct>
        <drugdosagetext>100 MG DAILY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OESOPHAGEAL CANDIDIASIS</drugindication>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TACROLIMUS</medicinalproduct>
        <drugdosagetext>5 MG BID PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>TRANSPLANT REJECTION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5043166-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060703</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>73</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>58.9</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPONATRAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THERAPEUTIC RESPONSE UNEXPECTED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMANTADINE HCL</medicinalproduct>
        <drugdosagetext>100 MG TID PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5043167-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060703</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>189.8</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HOT FLUSH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENOPAUSAL SYMPTOMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWELLING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FENOFIBRATE</medicinalproduct>
        <drugdosagetext>48 MG Q DAY PO BUCCAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTRIGLYCERIDAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060207</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060424</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYANOCOBALAMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LABETALOL HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HYDROCHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5043170-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060703</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>87</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>65.7716</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANGIONEUROTIC OEDEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugdosagetext>20 MG TWICE DAILY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060601</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CAMPHOR/MENTHOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONIDINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOCHSATE/SENNOSIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUNISOLIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FORMOTEROL FUMARATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRIAMTERENE AND HYDROCHLOROTHIAZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MOMETASONE FUROATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THEOPHYLLINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TIOTROPIUM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5043176-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060703</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>85</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>61.8</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VANCOMYCIN</medicinalproduct>
        <drugdosagetext>1 GRAM ONCE IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PREOPERATIVE CARE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060417</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5043179-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060703</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>59</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>98.4306</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABNORMAL BEHAVIOUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ACCIDENTAL OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASPARTATE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CREATINE PHOSPHOKINASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOOD ALTERED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERSONALITY CHANGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugdosagetext>40 MG DAILY</drugdosagetext>
        <drugindication>HYPERCHOLESTEROLAEMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GEMFIBROZIL</medicinalproduct>
        <drugdosagetext>600 MG BID</drugdosagetext>
        <drugindication>HYPERCHOLESTEROLAEMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LITHIUM CARBONATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROPRANOLOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BUPROPION HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BUSPAR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RISPERIDONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GABAPENTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GEMFIBROZIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RANITIDINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GABAPENTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GEMFRIBROZIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RANITIDONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENZOTROPINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5043181-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060703</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>27</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>GRAND MAL CONVULSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZONEGRAN</medicinalproduct>
        <drugdosagetext>100 MG AM 300 MG PM</drugdosagetext>
        <drugindication>CONVULSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060502</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5043183-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060703</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>61.2356</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABNORMAL BEHAVIOUR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMBIEN</medicinalproduct>
        <drugbatchnumb>XD/ 6T</drugbatchnumb>
        <drugdosagetext>10 MG HS PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>FATIGUE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060405</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060626</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMBIEN</medicinalproduct>
        <drugbatchnumb>XD/ 6T</drugbatchnumb>
        <drugdosagetext>10 MG HS PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INSOMNIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060405</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060626</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5043187-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060703</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>62</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>105</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ENCEPHALOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERIPHERAL MOTOR NEUROPATHY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VELCADE</medicinalproduct>
        <drugdosagetext>2.8 MG DAYS 1,4 IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060616</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VELCADE</medicinalproduct>
        <drugdosagetext>2.8 MG DAYS 1,4 IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060619</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5043194-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060703</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>30</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOVEMENT DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCLONUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUROLEPTIC MALIGNANT SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TARDIVE DYSKINESIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DILANTIN</medicinalproduct>
        <drugdosagetext>300 MG DAILY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONVULSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRILEPTAL</medicinalproduct>
        <drugdosagetext>300 MG BID PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONVULSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060612</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM CARBONATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MECLIZINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5043199-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060703</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>89.3586</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>GASTROOESOPHAGEAL REFLUX DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THERAPY NON-RESPONDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREVACID</medicinalproduct>
        <drugdosagetext>15 MG QD</drugdosagetext>
        <drugindication>GASTROOESOPHAGEAL REFLUX DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050113</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050217</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5043204-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060703</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>77</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLADDER DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROSTATIC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROSTATIC HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TARCEVA</medicinalproduct>
        <drugdosagetext>150 MG QD</drugdosagetext>
        <drugindication>PROSTATE CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060426</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060614</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5043209-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060703</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>64</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCREATIC ENZYMES INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAXOTERE</medicinalproduct>
        <drugdosagetext>60MG/M2  EVERY 3 WEEKS</drugdosagetext>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060228</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HERCEPTIN</medicinalproduct>
        <drugdosagetext>6MG/KG EVERY 3 WEEKS</drugdosagetext>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060228</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IRESSA</medicinalproduct>
        <drugdosagetext>250MG  DAILY  (PO) ON DAYS 2-15</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060301</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5043210-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060703</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>64</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>115</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORATADINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TERAZOSIN HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOSARTAN POTASSIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OLANZAPINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VARDENAFIL HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUNISOLIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAZODONE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM CITRATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CITALOPRAM HYDROBROMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MENTHOL / METHYL SALICYLATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ETODOLAC</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5043211-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060703</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>90.2658</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG EFFECT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUROPATHY PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVOFLOXACIN</medicinalproduct>
        <drugdosagetext>500MG  DAILY  PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ACUTE SINUSITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060515</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060615</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5043213-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060703</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>79.8331</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ENTERITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEBRILE NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SMALL INTESTINAL OBSTRUCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEVACIZUMAB   5MG/KG,   GENENTECH</medicinalproduct>
        <drugbatchnumb>M87720</drugbatchnumb>
        <drugdosagetext>400 MG QS   Q2WEEKS   IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PANCREATIC NEOPLASM</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060502</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060530</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
        <drugdosagetext>20MG    Q2WEEKS  IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PANCREATIC NEOPLASM</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060502</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060530</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LORAZEPAM</medicinalproduct>
        <drugdosagetext>1MG   Q2WEEKS   PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PANCREATIC NEOPLASM</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060502</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060530</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GRANISETRON,  10 MCG/KG</medicinalproduct>
        <drugdosagetext>800 MCG   Q2WEEKS   IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PANCREATIC NEOPLASM</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060502</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060530</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXALIPLATIN,  85 MG/M2,  SANOFI-SYNTHELABO</medicinalproduct>
        <drugdosagetext>170 MG   Q2WEEKS  IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PANCREATIC NEOPLASM</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060502</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060530</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEUCOVORIN CALCIUM</medicinalproduct>
        <drugdosagetext>400 MG   Q2WEEKS  IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PANCREATIC NEOPLASM</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060502</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060530</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUOROURACIL</medicinalproduct>
        <drugdosagetext>800 MG  + 2400 MG   Q2WEEKS   IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PANCREATIC NEOPLASM</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060502</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060530</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VICODIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATIVAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLEGRA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRILOSEC</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5043216-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060703</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>50</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>70.3075</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>COGNITIVE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISSOCIATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISTURBANCE IN ATTENTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERFORMANCE STATUS DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugdosagetext>1 TABLET  TWICE DAILY  PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN MANAGEMENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060510</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060510</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5043218-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060703</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>79.3795</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABNORMAL BEHAVIOUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DELIRIUM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EMOTIONAL DISTRESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING GUILTY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING OF DESPAIR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE DRUG OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugdosagetext>30 MG   1/DAY   PO     (SINGLE DOSE)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BIPOLAR DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugdosagetext>30 MG   1/DAY   PO     (SINGLE DOSE)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEPAKOTE ER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PAXIL CR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORAZEPAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMBIEN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5043219-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060703</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>19</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>36.2878</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>LIVER FUNCTION TEST ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZELNORM</medicinalproduct>
        <drugdosagetext>2MG   BID   PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONSTIPATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060610</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060620</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5043220-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20051212</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-BRISTOL-MYERS SQUIBB COMPANY-13221395</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>67</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ARRHYTHMIA SUPRAVENTRICULAR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ERBITUX</medicinalproduct>
        <drugdosagetext>FIRST INFUSION.</drugdosagetext>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051212</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051212</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VINORELBINE</medicinalproduct>
        <drugdosagetext>FIRST INFUSION.</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051212</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051212</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TIOTROPIUM BROMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANTOPRAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NOREPINEPHRINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5043221-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060627</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-BRISTOL-MYERS SQUIBB COMPANY-13427406</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>NEPHROLITHIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL COLIC</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REYATAZ</medicinalproduct>
        <drugauthorizationnumb>021567</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5043222-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060623</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-BRISTOL-MYERS SQUIBB COMPANY-13428081</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>55</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ERBITUX</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PANCREATIC CARCINOMA METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050823</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050823</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GEMCITABINE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PANCREATIC CARCINOMA METASTATIC</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXALIPLATIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PANCREATIC CARCINOMA METASTATIC</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FENISTIL</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PREMEDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5043223-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060627</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-BRISTOL-MYERS SQUIBB COMPANY-13427331</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>NEPHROLITHIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL COLIC</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REYATAZ</medicinalproduct>
        <drugauthorizationnumb>021567</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5043224-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060622</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PL-BRISTOL-MYERS SQUIBB COMPANY-13427042</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>68</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE REACTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ERBITUX</medicinalproduct>
        <drugdosagetext>1ST DOSE: 02MAR06</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLORECTAL CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060525</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060525</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXALIPLATIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLORECTAL CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060525</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060525</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUOROURACIL</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLORECTAL CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060525</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060525</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOLINIC ACID</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLORECTAL CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060525</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060525</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5043225-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060623</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-BRISTOL-MYERS SQUIBB COMPANY-13431481</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>66</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HYPERTENSIVE CRISIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ERBITUX</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PANCREATIC CARCINOMA METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050727</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXALIPLATIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PANCREATIC CARCINOMA METASTATIC</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GEMCITABINE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PANCREATIC CARCINOMA METASTATIC</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE TAB</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050727</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
        <drugauthorizationnumb>073318</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DELIX PLUS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANTOZOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NOVALGIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PASPERTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DURAGESIC-100</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5043226-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>19981011</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-BRISTOL-MYERS SQUIBB COMPANY-13427901</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>63</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>62</patientweight>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>GENERAL PHYSICAL HEALTH DETERIORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMPAIRED HEALING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALIGNANT NEOPLASM PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPINAL LAMINECTOMY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAXOL</medicinalproduct>
        <drugauthorizationnumb>020262</drugauthorizationnumb>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980619</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19980724</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5043227-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060703</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>66.6788</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>RASH ERYTHEMATOUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH PRURITIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URTICARIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugdosagetext>1 TAB   BID   PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060524</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060609</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugdosagetext>1 TAB   BID   PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060524</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060609</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5043255-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060703</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>48</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>81.6475</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERIDONE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5043257-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060703</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>14</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>61.2356</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ELECTROCARDIOGRAM QT PROLONGED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYRTEC</medicinalproduct>
        <drugdosagetext>ONE TABLET EVERY DAY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE ALLERGIES</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060518</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060618</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MINICYCLINE  50 MG</medicinalproduct>
        <drugdosagetext>ONE CAPSULE 2-3 TIMES A DAY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ACNE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041115</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060618</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5043261-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060703</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>85.7298</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD POTASSIUM DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHOIDAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE TWITCHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RECTAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WOUND HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHYLPRES 4 MG VINTAGE</medicinalproduct>
        <drugdosagetext>4 MG DEC. DAILY 6-1 PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG HYPERSENSITIVITY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060621</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060626</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5043264-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060703</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOPENTOLATE HYDROCHLORIDE</medicinalproduct>
        <drugbatchnumb>90414F</drugbatchnumb>
        <drugdosagetext>OPHTHALMIC</drugdosagetext>
        <drugadministrationroute>047</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TROPICAMIDE</medicinalproduct>
        <drugbatchnumb>56696F</drugbatchnumb>
        <drugdosagetext>OPHTHALMIC</drugdosagetext>
        <drugadministrationroute>047</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5043267-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060703</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>63</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>59.8748</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYELITIS TRANSVERSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NERVOUS SYSTEM DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SENSORY LOSS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THERAPY NON-RESPONDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WALKING AID USER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugdosagetext>500 MG Q6WEEKS IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050922</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060502</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACTONEL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAQUENIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCONTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAZODONE HCL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5043270-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060703</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>53</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>105.2345</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHABDOMYOLYSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVATIO</medicinalproduct>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060607</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVATIO</medicinalproduct>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060608</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060613</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLOVENT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SEREVENT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL INHALER PRN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SINGULAIR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALDACTONE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5043274-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060703</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>64</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>90.3</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>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5043278-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060703</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>66.2252</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>AKATHISIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FORMICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAROXETINE</medicinalproduct>
        <drugdosagetext>20MG  Q DAY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MAJOR DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060106</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060309</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIPHENHYDRAMINE HCL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5043280-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060703</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>98.0677</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EFFECT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARANOIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAROXETINE HCL</medicinalproduct>
        <drugdosagetext>40MG  Q DAY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BIPOLAR I DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060207</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060309</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIAZEPAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRAZOSIN HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>QUETIAPINE FUMARATE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5043284-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060703</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>34</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>128.8216</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG EFFECT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COUNTERFEIT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POOR QUALITY DRUG ADMINISTERED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PHENTERMINE</medicinalproduct>
        <drugdosagetext>1 PILL ONE HOUR BEFORE BREAKFAST  ONCE DAILY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>WEIGHT DECREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060623</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060630</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5043286-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060703</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>50</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>68.9467</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EFFECT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ADDERALL XR 20</medicinalproduct>
        <drugbatchnumb>3956</drugbatchnumb>
        <drugdosagetext>20MG  2 PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATTENTION DEFICIT/HYPERACTIVITY DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060702</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5043289-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060703</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>55</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>74</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>NEUTROPHIL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUTENT</medicinalproduct>
        <drugdosagetext>37.5 MG QD ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATIC NEOPLASM MALIGNANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060531</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060620</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5043293-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnesscongenitalanomali>1</seriousnesscongenitalanomali>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060703</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>31</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>65.318</patientweight>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ABORTION SPONTANEOUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE BEFORE PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FOETAL CARDIAC DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRILEPTAL</medicinalproduct>
        <drugdosagetext>300 MG 2 TIMES A DAY</drugdosagetext>
        <drugindication>CONVULSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5043297-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060703</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>22</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>59.8748</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ALCOHOL USE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG DEPENDENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSTONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL STIFFNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESTLESSNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GEODON</medicinalproduct>
        <drugdosagetext>40 MG BID PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>AFFECTIVE DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060628</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060701</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GEODON</medicinalproduct>
        <drugdosagetext>40 MG BID PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060628</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060701</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5043299-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060703</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>88</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>54.4316</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISORIENTATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATEMESIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ULCER HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALEVE</medicinalproduct>
        <drugdosagetext>1 TABLET EVERY 24 HOUS PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANALGESIC EFFECT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060617</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060620</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALEVE</medicinalproduct>
        <drugdosagetext>1 TABLET EVERY 24 HOUS PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SPINAL COMPRESSION FRACTURE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060617</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060620</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5043302-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060703</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>90.7194</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEMIPARESIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARALYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHABDOMYOLYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHEELCHAIR USER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRAVACHOL</medicinalproduct>
        <drugdosagetext>40 MG ONE A DAY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADVACOR</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5043307-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060703</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>31</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>77.1115</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HEPATITIS VIRAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMPAIRED WORK ABILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENINGITIS VIRAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KETEK</medicinalproduct>
        <drugdosagetext>PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ACUTE SINUSITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051007</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051012</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5043309-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060626</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GR-ABBOTT-06P-066-0336975-00</companynumb>
    <primarysource>
      <reportercountry>GREECE</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>63</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CHRONIC LYMPHOCYTIC LEUKAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041102</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060616</drugenddate>
        <drugtreatmentduration>590</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEFLUNOMIDE</medicinalproduct>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060616</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NAPROXEN</medicinalproduct>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CETIRIZINE HCL</medicinalproduct>
        <drugindication>HYPERSENSITIVITY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COMMERCIAL HUMIRA</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040211</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5043310-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060703</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>70</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>56.6996</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CONTUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TENDON DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TENDON RUPTURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVAQUIN</medicinalproduct>
        <drugdosagetext>ONE TABLET EACH DAY</drugdosagetext>
        <drugindication>SINUSITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060620</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060624</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5043312-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060703</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>72.5755</patientweight>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VENTAVIS</medicinalproduct>
        <drugdosagetext>5 MCG 6-9 TIMES A DAY INHAL</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>PULMONARY HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060609</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060628</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5043321-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060703</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>64</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>55.1</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANGIONEUROTIC OEDEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORATADINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIPHENHYDRAMINE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RANITIDINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHYLPREDNISOLONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORATADINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THIAMINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLYBURIDE AND METFORMIN HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUNISOLIDE IHN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5043324-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060703</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>56</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>125.6</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRY MOUTH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIRTAZAPINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CHLORTHALIDONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VARDENAFIL HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCODONE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RANITIDINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GABAPENTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MIRTAZAPINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALPRAZOLAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BUSPIRONE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UREA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MORPHINE SULFATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAMADOL HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CITALOPRAM HYDROBROMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TERBINAFINE HYDROCHLORIDE CREAM 1%</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CAPBAICIN CREAM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5043328-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060703</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>77.1115</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSSTASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JOINT SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENISCUS LESION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LISINOPRIL AND HYDROCHLOROTHIAZIDE</medicinalproduct>
        <drugdosagetext>1 DAILY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051214</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060120</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5043330-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060626</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ES-JNJFOC-20060602231</companynumb>
    <primarysource>
      <reportercountry>SPAIN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>51</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSIVE CRISIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFUSION RELATED REACTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugdosagetext>4 INFUSIONS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5043332-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060703</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>87.0906</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HALLUCINATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VARDENAFIL 20 MG</medicinalproduct>
        <drugdosagetext>10 MG PRN PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ERECTILE DYSFUNCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060227</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060419</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATORVASTATIN CALCIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HCTZ 50/TRIAMTERENE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NATEGLINIDE 120 MG/D</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PIOGLITAZONE HCL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5043334-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060703</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>19</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>54.4316</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>HEPATIC FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KETEK</medicinalproduct>
        <drugdosagetext>2 TABLETS ONCE A DAY</drugdosagetext>
        <drugindication>PNEUMONIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060314</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060320</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5043336-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060703</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>12</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>42.6381</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HODGKIN'S DISEASE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ELIDEL</medicinalproduct>
        <drugdosagetext>AS REQUIRED PER</drugdosagetext>
        <drugindication>ECZEMA</drugindication>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5043337-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060703</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>42</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>83.9154</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABNORMAL DREAMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AGITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSED MOOD</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CIPRO</medicinalproduct>
        <drugdosagetext>2X/DAY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>EPIDIDYMITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060524</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060614</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5043346-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060703</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>45</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>60</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ACUTE MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARRHYTHMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EXTRASYSTOLES</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAXOTERE</medicinalproduct>
        <drugdosagetext>100 MG /M2 1 IV DRIP</drugdosagetext>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>GASTRIC CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060303</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060303</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>805</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5043370-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060502</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-AMGEN-UK178351</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONTUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARANESP</medicinalproduct>
        <drugbatchnumb>N1159AD</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>ANAEMIA OF MALIGNANT DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060331</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060522</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEULASTA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>CHEMOTHERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060515</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOCETAXEL</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060421</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOXORUBICIN HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060421</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYCLOPHOSPHAMIDE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060421</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5043389-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-MERCK-0606GBR00118</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>65</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>TACHYARRHYTHMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENTRICULAR EXTRASYSTOLES</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugauthorizationnumb>019766</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060505</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060517</drugenddate>
        <drugtreatmentduration>13</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMOXICILLIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>EAR INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060426</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060507</drugenddate>
        <drugtreatmentduration>12</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5043390-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060518</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-MERCK-0605USA04287</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>50</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ALANINE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAMMA-GLUTAMYLTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>20560</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060517</drugenddate>
        <drugtreatmentduration>16</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BLOPRESS</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060415</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PENTASA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>COLITIS ULCERATIVE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BECLOMETHASONE DIPROPIONATE</medicinalproduct>
        <drugadministrationroute>054</drugadministrationroute>
        <drugindication>COLITIS ULCERATIVE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5043391-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060619</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-MERCK-0606FRA00047</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>75</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PLEURAL EFFUSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugauthorizationnumb>19766</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060410</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE AND VALSARTAN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RILMENIDINE PHOSPHATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RABEPRAZOLE SODIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5043392-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0606USA05345</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>87</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SLEEP DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VYTORIN</medicinalproduct>
        <drugauthorizationnumb>021687</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERLIPIDAEMIA</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060601</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SINEMET</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPROL-XL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5043393-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060627</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0606USA05093</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>80</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD CREATINE PHOSPHOKINASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VYTORIN</medicinalproduct>
        <drugauthorizationnumb>021687</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060601</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VYTORIN</medicinalproduct>
        <drugauthorizationnumb>021687</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060623</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060601</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5043394-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060606</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CH-MERCK-0606CHE00002</companynumb>
    <primarysource>
      <reportercountry>SWITZERLAND</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>60</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>50</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CROSS SENSITIVITY REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERUCTATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLATULENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OESOPHAGITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>20560</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050814</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050918</drugenddate>
        <drugtreatmentduration>36</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISEDRONATE SODIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051023</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051120</drugenddate>
        <drugtreatmentduration>29</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM GLUBIONATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5043398-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060626</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0606USA05084</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>INTERNATIONAL NORMALISED RATIO INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VYTORIN</medicinalproduct>
        <drugauthorizationnumb>021687</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NIACIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5043400-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060525</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0605USA04770</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>72</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>COLON ADENOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLATULENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOPOROSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>20560</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031019</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOSAMAX PLUS D</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPENIA</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060604</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOSAMAX PLUS D</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060625</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TUMS</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5043401-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060511</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-MERCK-0605DEU00108</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>37</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABORTION INDUCED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG ADMINISTRATION ERROR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROPECIA</medicinalproduct>
        <drugauthorizationnumb>020788</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ALOPECIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROPECIA</medicinalproduct>
        <drugauthorizationnumb>020788</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060308</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060509</drugenddate>
        <drugtreatmentduration>63</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5043456-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060518</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2006-BP-05560AU</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</reportercountry>
      <qualification>1</qualification>
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    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ACUTE PULMONARY OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MOBIC</medicinalproduct>
        <drugbatchnumb>NR</drugbatchnumb>
        <drugauthorizationnumb>20938</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051017</drugstartdate>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PARACETAMOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOSAMINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMDUR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADEFIN (NIFEDIPINE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EYE DROPS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5043457-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2006-BP-07433BP</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
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    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>STEVENS-JOHNSON SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CATAPRES-TTS-1</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>018891</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5043458-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2006-DE-03291DE</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>73</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ACUTE MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERCHOLESTEROLAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MOBIC</medicinalproduct>
        <drugauthorizationnumb>020938</drugauthorizationnumb>
        <drugindication>PSORIASIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugindication>PSORIASIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugindication>PSORIASIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugindication>PSORIASIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5043459-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2006-UK-03008UK</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>PHOTOPSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL DISTURBANCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRAMIPEXOLE</medicinalproduct>
        <drugauthorizationnumb>20667</drugauthorizationnumb>
        <drugdosagetext>1MG 3 TIMES A DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050622</drugstartdate>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROPRANOLOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050310</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050513</drugenddate>
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    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5043460-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2006-BP-07416NB</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIRAMUNE</medicinalproduct>
        <drugauthorizationnumb>020636</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050929</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EPIVIR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020708</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZIAGEN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031006</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KALETRA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020708</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050928</drugenddate>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BEZATOL SR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERLIPIDAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050401</drugstartdate>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALESION</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SEASONAL ALLERGY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050619</drugenddate>
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    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5043461-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060327</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2006-BP-03426BP</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
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    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <patientonsetage>79</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BRONCHITIS ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLEURISY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMBIVENT</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>20291</drugauthorizationnumb>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
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    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5043462-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060214</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2006-BP-01670BR</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <patientweight>75</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>NEPHROTIC SYNDROME</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TIPRANAVIR / RITONAVIR CAPSULES</medicinalproduct>
        <drugdosagetext>TIPRANAVIR/RITONAVIR: 1000/400MG AS DAILY DOSE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051122</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060203</drugenddate>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ABACAVIR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051122</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060203</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZIDOVUDINE</medicinalproduct>
        <drugauthorizationnumb>076844</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051122</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060203</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMIVUDINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051122</drugstartdate>
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    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5043463-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
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    <receiptdate>20060628</receiptdate>
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    <companynumb>US-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2006-BP-07435BP</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
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    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>60</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANOREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASCITES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRONCHITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMBIVENT</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>020291</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XOPENEX</medicinalproduct>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XOPENEX</medicinalproduct>
        <drugindication>ASTHMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLOVENT</medicinalproduct>
        <drugadministrationroute>055</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACTONEL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IPRATROPIUM BROMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYGEN</medicinalproduct>
      </drug>
    </patient>
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  <safetyreport>
    <safetyreportid>5043464-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
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    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060512</receiptdate>
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    <companynumb>JP-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2006-DE-02468GD</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DISEASE RECURRENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MEXILETINE HYDROCHLORIDE</medicinalproduct>
        <drugauthorizationnumb>18873</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>VENTRICULAR EXTRASYSTOLES</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010505</drugstartdate>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MEXILETINE HYDROCHLORIDE</medicinalproduct>
        <drugauthorizationnumb>018873</drugauthorizationnumb>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BETA-BLOCKER</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>LONG QT SYNDROME CONGENITAL</drugindication>
      </drug>
    </patient>
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  <safetyreport>
    <safetyreportid>5043465-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
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    <receiptdate>20060328</receiptdate>
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    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
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    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
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        <reactionmeddrapt>AMNESIA</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
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        <drugauthorizationnumb>21395</drugauthorizationnumb>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>021395</drugauthorizationnumb>
        <drugindication>EMPHYSEMA</drugindication>
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    </patient>
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  <safetyreport>
    <safetyreportid>5043466-9</safetyreportid>
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      <reportercountry>UNITED STATES</reportercountry>
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    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
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        <reactionmeddrapt>GASTRIC BYPASS</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIRAPEX</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>020667</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
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  <safetyreport>
    <safetyreportid>5043467-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
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    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060620</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>NL-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2006-NL-00166NL</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>16</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>74</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>APPENDICITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRY EYE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EPIGASTRIC DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRESCRIBED OVERDOSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIXARIT</medicinalproduct>
        <drugauthorizationnumb>17407</drugauthorizationnumb>
        <drugdosagetext>4-3-4 (TOTAL 11) TABLETS PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATTENTION DEFICIT/HYPERACTIVITY DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIXARIT</medicinalproduct>
        <drugauthorizationnumb>017407</drugauthorizationnumb>
        <drugindication>TOURETTE'S DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DUSPATAL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>IRRITABLE BOWEL SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060228</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060308</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5043468-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060512</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2006-DE-02463GD</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DISEASE RECURRENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MEXILETINE HYDROCHLORIDE</medicinalproduct>
        <drugauthorizationnumb>18873</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>VENTRICULAR EXTRASYSTOLES</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19890822</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19901112</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MEXILETINE HYDROCHLORIDE</medicinalproduct>
        <drugauthorizationnumb>018873</drugauthorizationnumb>
        <drugindication>PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ISOPRENALINE HCL</medicinalproduct>
        <drugdosagetext>CONTINUOUS INFUSION (0.02 MCG/KG PER MIN)</drugdosagetext>
        <drugindication>TORSADE DE POINTES</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ISOPRENALINE HCL</medicinalproduct>
        <drugindication>DISEASE RECURRENCE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIDOCAINE</medicinalproduct>
        <drugdosagetext>BOLUS INJECTION (1 MG/KG) AND CONTINUOUS INFUSION (2 MG/KG PER H)</drugdosagetext>
        <drugindication>TORSADE DE POINTES</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIDOCAINE</medicinalproduct>
        <drugindication>DISEASE RECURRENCE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BETA-BLOCKER</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>LONG QT SYNDROME CONGENITAL</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PHENYTOIN</medicinalproduct>
        <drugindication>TORSADE DE POINTES</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PHENYTOIN</medicinalproduct>
        <drugindication>DISEASE RECURRENCE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ATROPINE SULFATE</medicinalproduct>
        <drugindication>TORSADE DE POINTES</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ATROPINE SULFATE</medicinalproduct>
        <drugindication>DISEASE RECURRENCE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NADIC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19890208</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19901111</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGNESIUM OXIDE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19901112</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5043469-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20020322</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2002-FF-00206FF</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>BRONCHOSPASM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFUSION RELATED REACTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PERSANTINE</medicinalproduct>
        <drugauthorizationnumb>12836</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>SCINTIGRAPHY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020227</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAXAIR</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VENTOLIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROLAIR</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THERALAIR</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRAZEPAM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5043470-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060623</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ES-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2006-DE-03248GD</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL ULCER HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UPPER GASTROINTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>} 1 G</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DICLOFENAC SODIUM</medicinalproduct>
        <drugauthorizationnumb>074391</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NAPROXEN</medicinalproduct>
        <drugauthorizationnumb>074190</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PIROXICAM THOMAE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MELOXICAM</medicinalproduct>
        <drugauthorizationnumb>020938</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NSAID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COXIB</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5043471-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2006-FF-00555PF</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>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
        <drugauthorizationnumb>021395</drugauthorizationnumb>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060607</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SINGULAIR</medicinalproduct>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SERETIDE</medicinalproduct>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5043472-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>19991203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-1999-FF-S1752</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>84</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ALPHA 1 FOETOPROTEIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD AMYLASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CHLORIDE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CULTURE POSITIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PHOSPHORUS DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD POTASSIUM DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONJUNCTIVITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATOCRIT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATITIS CHOLESTATIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIPASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOUTH ULCERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OXYGEN SATURATION DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STEVENS-JOHNSON SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIRAMUNE</medicinalproduct>
        <drugauthorizationnumb>020636</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990927</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19991010</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIRAMUNE</medicinalproduct>
        <drugauthorizationnumb>020636</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19991011</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19991017</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COMBIVIR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19981207</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COMBIVIR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020927</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5043473-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060606</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2006-BP-06516BP</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>45.45</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>BLINDNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEAFNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENINGITIS CRYPTOCOCCAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>APTIVUS/RITONAVIR CAPSULES</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>21814</drugauthorizationnumb>
        <drugdosagetext>TPV 1000MG/RTV ?</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050701</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUZEON</medicinalproduct>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050701</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COMBIVIR</medicinalproduct>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050701</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5043474-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060630</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2006-BP-07533BP</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>FOOD ALLERGY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ATROVENT</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugadministrationroute>055</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5043475-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060626</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2006-FF-00537FF</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>EPILEPSY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
        <drugauthorizationnumb>021395</drugauthorizationnumb>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYMBICORT</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5043576-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060626</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20060605602</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>VAGINAL DISCHARGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VESICAL FISTULA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CROHN'S DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALPRAZOLAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAZODONE HCL</medicinalproduct>
        <drugindication>SLEEP DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5043577-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060626</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20060605632</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>57</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>101.15</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>RIB FRACTURE</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>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5043578-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060627</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-JNJFOC-20060602659</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>AUTOIMMUNE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DUPUYTREN'S CONTRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FASCIITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUPUS-LIKE SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugdosagetext>10TH INFUSION</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BEHCET'S SYNDROME</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugdosagetext>7TH INFUSION</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>INFLAMMATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARCOXIA</medicinalproduct>
        <drugdosagetext>90</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>BEHCET'S SYNDROME</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SAROTEN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>ANTIDEPRESSANT THERAPY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5043579-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060627</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-JNJFOC-20060605755</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>109</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BASAL CELL CARCINOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugdosagetext>WITHDRAWN EIGHTEEN MONTHS PRIOR TO EVENT</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMITRIPTYLINE HCL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FENTANYL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANSOPRAZOLE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PIROXICAM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5043580-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060626</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>EC-JNJFOC-20060605797</companynumb>
    <primarysource>
      <reportercountry>ECUADOR</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>16</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>LUPUS-LIKE SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ANKYLOSING SPONDYLITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5043581-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060626</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20060600266</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>58.51</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLITIS ULCERATIVE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>6-MP</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5043582-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060627</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-JNJFOC-20060606050</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>INFUSION RELATED REACTION</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>5043583-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060626</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-JNJFOC-20060606280</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>35</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ILEUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTESTINAL ULCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MELAENA</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>5-ASA</medicinalproduct>
        <drugindication>CROHN'S DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDONINE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CROHN'S DISEASE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5043584-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060626</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20060504577</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANTINUCLEAR ANTIBODY POSITIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATITIS B</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER FUNCTION TEST ABNORMAL</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>
        <drugindication>CROHN'S DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PENTASA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATARAX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5043585-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060627</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PT-JNJFOC-20060605282</companynumb>
    <primarysource>
      <reportercountry>PORTUGAL</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>45</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANAL CANCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAL FISTULA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMPAIRED HEALING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SQUAMOUS CELL CARCINOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugdosagetext>4 INFUSIONS IN TOTAL</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CROHN'S DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AZATHIOPRINE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5043586-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060626</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20060504843</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>84.37</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>TUBERCULOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugdosagetext>18 INFUSIONS TO DATE</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>AVANDIA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOXAZOSIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5043587-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-JNJFOC-20060605505</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>86</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>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CO-PROXAMOL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FORTEPINE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HRT</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INDOCID-R</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5043588-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060627</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ES-JNJFOC-20060605786</companynumb>
    <primarysource>
      <reportercountry>SPAIN</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>55</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PARAPSORIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSORIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VITILIGO</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARAVA</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5043612-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-JNJFOC-20060606128</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>74</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DISSEMINATED TUBERCULOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERITONITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugdosagetext>12 DOSES</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CORTANCYL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCORTISONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5043616-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060425</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHRM2006FR01447</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>65</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE MARROW MYELOGRAM ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYELOID LEUKAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EFFERALGAN</medicinalproduct>
        <drugdosagetext>UNK, PRN</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVOTHYROX</medicinalproduct>
        <drugdosagetext>100 UG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPOTHYROIDISM</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000912</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OGAST</medicinalproduct>
        <drugdosagetext>15 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050729</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060405</drugenddate>
        <drugtreatmentduration>251</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COTAREG</medicinalproduct>
        <drugauthorizationnumb>020818</drugauthorizationnumb>
        <drugdosagetext>1 DF, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031104</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060424</drugenddate>
        <drugtreatmentduration>903</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5043621-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060626</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHMT2006CA01462</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>66</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>COORDINATION ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETYLSALICYLIC ACID SRT</medicinalproduct>
        <drugdosagetext>81MG QD</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PMS-CARBAMAZEPINE</medicinalproduct>
        <drugauthorizationnumb>016608</drugauthorizationnumb>
        <drugdosagetext>1200MG QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>EPILEPSY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050301</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5043622-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2006US08376</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>22</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>82.494</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABORTION SPONTANEOUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINE ANALYSIS ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TEGRETOL-XR</medicinalproduct>
        <drugauthorizationnumb>020234</drugauthorizationnumb>
        <drugdosagetext>400 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONVULSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMICTAL</medicinalproduct>
        <drugdosagetext>100 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONVULSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060428</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZINC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SELENIUM SULFIDE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5043623-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060621</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2006VE09431</companynumb>
    <primarysource>
      <reportercountry>VENEZUELA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>7</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>30</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLISTER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EPSTEIN-BARR VIRUS ANTIBODY POSITIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EPSTEIN-BARR VIRUS INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUCOSAL EROSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH ERYTHEMATOUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN HYPERPIGMENTATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STEVENS-JOHNSON SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIVALENT</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060606</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060606</drugenddate>
        <drugtreatmentduration>1440</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TEGRETOL</medicinalproduct>
        <drugbatchnumb>Z0019</drugbatchnumb>
        <drugauthorizationnumb>020234</drugauthorizationnumb>
        <drugdosagetext>UNK, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ABNORMAL BEHAVIOUR</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060605</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060615</drugenddate>
        <drugtreatmentduration>15840</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CATAFLAM</medicinalproduct>
        <drugindication>PYREXIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5043624-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060627</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2006US08334</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>55</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLISTER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CELLULITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH MACULAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIOVAN HCT</medicinalproduct>
        <drugauthorizationnumb>020818</drugauthorizationnumb>
        <drugdosagetext>80MG VAL/12.5MG HCT, QD</drugdosagetext>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060531</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060601</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIOVAN HCT</medicinalproduct>
        <drugauthorizationnumb>020818</drugauthorizationnumb>
        <drugdosagetext>80MG VAL/12.5MG HCT, QD</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060626</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5043625-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2006JP09836</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>68</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DEPRESSED LEVEL OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG TOXICITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TEGRETOL</medicinalproduct>
        <drugauthorizationnumb>016608</drugauthorizationnumb>
        <drugdosagetext>1400 MG/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>TRIGEMINAL NEURALGIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5043626-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060626</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHRM2006FR01914</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
    </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>TRISOMY 21</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENTRICULAR HYPOPLASIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TEGRETOL</medicinalproduct>
        <drugauthorizationnumb>016608</drugauthorizationnumb>
        <drugdosagetext>200 MG/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>EPILEPSY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEPAKENE</medicinalproduct>
        <drugdosagetext>750 MG/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>EPILEPSY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RIVOTRIL</medicinalproduct>
        <drugdosagetext>2 MG/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>EPILEPSY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5043627-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060703</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2006PT09881</companynumb>
    <primarysource>
      <reportercountry>PORTUGAL</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>5</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>30</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HYPOALBUMINAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STAPHYLOCOCCAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOXIC EPIDERMAL NECROLYSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIAZEPAM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060326</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENZYLPENICILLIN SODIUM</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060320</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060326</drugenddate>
        <drugtreatmentduration>10080</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RISPERIDONE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060405</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SODIUM DOCUSATE + SORBITOL ENEMA</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060424</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060424</drugenddate>
        <drugtreatmentduration>1440</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BACLOFEN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060327</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGNESIUM HYDROXIDE TAB</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060424</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060424</drugenddate>
        <drugtreatmentduration>1440</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONAZEPAM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060507</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060609</drugenddate>
        <drugtreatmentduration>48960</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMOXICILLIN + CLAVULANIC ACID</medicinalproduct>
        <drugdosagetext>2250 MG/DAY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060319</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060321</drugenddate>
        <drugtreatmentduration>4320</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACYCLOVIR</medicinalproduct>
        <drugdosagetext>450 MG/DAY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>VARICELLA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060320</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060326</drugenddate>
        <drugtreatmentduration>10080</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TEGRETOL</medicinalproduct>
        <drugauthorizationnumb>018927</drugauthorizationnumb>
        <drugdosagetext>200 MG/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONVULSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060413</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060426</drugenddate>
        <drugtreatmentduration>20160</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5043655-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050706</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ABBOTT-05P-087-0304928-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>41</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HEPATIC FUNCTION ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERLIPIDAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCYTOPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NORVIR</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>20945</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990123</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20011207</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIDANOSINE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19920904</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010416</drugenddate>
        <drugtreatmentduration>9</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIDEX EC</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010417</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20011207</drugenddate>
        <drugtreatmentduration>234</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>20011208</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>STAVUDINE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20011208</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040702</drugenddate>
        <drugtreatmentduration>936</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>20011208</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040703</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMIVUDINE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040703</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEG-INTRON</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050119</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RIBAVIRIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>200 MG IN THE MORNING AND 400 MG AT NIGHT</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050119</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VIREAD</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040703</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FACTOR VIII, RECOMBINANT</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5043656-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060324</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ABBOTT-06P-087-0329198-00</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DIALYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCORRECT DOSE ADMINISTERED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL TUBULAR NECROSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KALETRA</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>21226</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060316</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060320</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TENOFOVIR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060316</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060320</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NASOPHARYNGITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060318</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060320</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LOXOPROFEN SODIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NASOPHARYNGITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060318</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060320</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LAMIVUDINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060316</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060320</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALDIOXA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060318</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060320</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5043657-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-ABBOTT-06P-056-0337083-00</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>77</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MYELOFIBROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCYTOPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VERCYTE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>016245</drugauthorizationnumb>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060115</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060515</drugenddate>
        <drugtreatmentduration>119</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5043658-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060627</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-06P-163-0336927-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>56.296</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIAC ANEURYSM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL ANEURYSM</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>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GABAPENTIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NEUROPATHY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060605</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD PRESSURE INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE TAB</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5043659-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060404</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-06P-163-0330286-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>32</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABORTION SPONTANEOUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE BEFORE PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NORVIR</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>20945</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TENOFOVIR</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050228</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENFUVIRTIDE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>APTIVUS</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EPOGEN</medicinalproduct>
        <drugindication>ANAEMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATOVAQUONE</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AZITHROMYCIN</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EMTRICITABINE</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5043687-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ES-JNJFOC-20060602226</companynumb>
    <primarysource>
      <reportercountry>SPAIN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>19</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DISORIENTATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENINGITIS LISTERIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THERAPY NON-RESPONDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugdosagetext>5 INFUSIONS OF 400MG</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CROHN'S DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugdosagetext>200MG</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AZATHIOPRINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5043701-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060609</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>HQWYE199813JUN06</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ALANINE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASPARTATE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD LACTATE DEHYDROGENASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060309</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060525</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>UNSPECIFIED MEDICATION</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAKEPRON</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTRIC ULCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060218</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060327</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5043702-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060626</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ESWYE853728JUN06</companynumb>
    <primarysource>
      <reportercountry>SPAIN</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>49</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>RESPIRATORY FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050309</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050317</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050513</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEFLAZACORT</medicinalproduct>
        <drugdosagetext>UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050513</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5043703-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060504</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-STX178557</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPHOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLEURAL EFFUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPLENOMEGALY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>PSORIASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050803</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050813</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVAQUIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HEPARIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROTONIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOFRAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DARVOCET</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MORPHINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYGEN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5043704-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060607</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-STX182315</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ESCHERICHIA URINARY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMMOBILE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHEUMATOID ARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>D066256</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5043705-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2006TR09674</companynumb>
    <primarysource>
      <reportercountry>TURKEY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>POISONING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TEGASEROD</medicinalproduct>
        <drugauthorizationnumb>21200</drugauthorizationnumb>
        <drugdosagetext>24 MG/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>IRRITABLE BOWEL SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060627</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5043706-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060627</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2006BR09745</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROENTERITIS ROTAVIRUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>REFLUX OESOPHAGITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZELMAC</medicinalproduct>
        <drugauthorizationnumb>021200</drugauthorizationnumb>
        <drugdosagetext>6 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONSTIPATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5043709-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060703</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>11</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>27.8</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DECREASED APPETITE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ADDERALL XR 10</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5043716-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060623</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-STX184182</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OXYGEN SATURATION DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY CONGESTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUSITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SLEEP APNOEA SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>D058807</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5043717-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060627</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-JNJFOC-20060606117</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>82</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPEPSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL ACUITY REDUCED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DURAGESIC-100</medicinalproduct>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>OFF LABEL USE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DURAGESIC-100</medicinalproduct>
        <drugauthorizationnumb>019813</drugauthorizationnumb>
        <drugdosagetext>EXPIRY DATE: MAY-2005.</drugdosagetext>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>PROCEDURAL PAIN</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5043718-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060626</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20060606393</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>55.79</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>THYMUS DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DURAGESIC-100</medicinalproduct>
        <drugauthorizationnumb>019813</drugauthorizationnumb>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROTONIX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTROOESOPHAGEAL REFLUX DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EFFEXOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5043719-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20060307212</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>89.36</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WRONG TECHNIQUE IN DRUG USAGE PROCESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DURAGESIC-100</medicinalproduct>
        <drugbatchnumb>0536487</drugbatchnumb>
        <drugadministrationroute>062</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DURAGESIC-100</medicinalproduct>
        <drugbatchnumb>0536487</drugbatchnumb>
        <drugauthorizationnumb>019813</drugauthorizationnumb>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ELAVIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SLEEP DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BUSPAR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SLEEP DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KETEK</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>LUNG INFECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE TAB</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SEREVENT</medicinalproduct>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NOVOLIN N</medicinalproduct>
        <drugdosagetext>60 UNITS A.M., 40 UNITS P.M., SUBCUTANEOUS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROTONIX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTROINTESTINAL DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORFLEX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BACK PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ULTRACET</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5043720-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-JNJFOC-20060606472</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>80</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>AGITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARANOIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DURAGESIC-50</medicinalproduct>
        <drugadministrationroute>062</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DURAGESIC-50</medicinalproduct>
        <drugauthorizationnumb>019813</drugauthorizationnumb>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>GASTROINTESTINAL CARCINOMA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5043727-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2006US08367</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMPAIRED GASTRIC EMPTYING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZELNORM</medicinalproduct>
        <drugauthorizationnumb>021200</drugauthorizationnumb>
        <drugindication>IMPAIRED GASTRIC EMPTYING</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5043728-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060612</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHNU2006DE02244</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PARESIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DESFERAL</medicinalproduct>
        <drugauthorizationnumb>16267</drugauthorizationnumb>
        <drugdosagetext>UNK, UNK</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>THALASSAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19810101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5043737-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060626</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-JNJFOC-20060606115</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>74</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>AORTIC ARTERIOSCLEROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD LACTATE DEHYDROGENASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHOLELITHIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAMMA-GLUTAMYLTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC ENZYME INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMINYL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMINYL</medicinalproduct>
        <drugauthorizationnumb>021169</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NORTRILEN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NORTRILEN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NORTRILEN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NORTRILEN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NORTRILEN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NORTRILEN</medicinalproduct>
        <drugdosagetext>20-100MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLEXANE</medicinalproduct>
        <drugdosagetext>1X0.6</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLEXANE</medicinalproduct>
        <drugdosagetext>2X 0.6</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BLOPRESS</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>L-THYROXIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DISALUNIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5043741-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060626</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-JNJFOC-20060606243</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOFT TISSUE HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ITRIZOLE</medicinalproduct>
        <drugauthorizationnumb>20083</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NAIL TINEA</drugindication>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5043742-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060626</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-JNJFOC-20060601251</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>75</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CIRCULATORY COLLAPSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDE ATTEMPT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOPAMAX</medicinalproduct>
        <drugauthorizationnumb>20505</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5043743-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060626</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-JNJFOC-20060605732</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>35</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG TOXICITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GRAND MAL CONVULSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HALDOL</medicinalproduct>
        <drugauthorizationnumb>015923</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>CLOZAPINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>CLOZAPINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>CLOZAPINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>CLOZAPINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAVOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAVOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAVOR</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5043744-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060626</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-JNJFOC-20060502333</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>APLASTIC ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCYTOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSYCHIATRIC SYMPTOM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERDAL</medicinalproduct>
        <drugauthorizationnumb>20272</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PSYCHOTIC DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARBAMAZEPINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PSYCHOTIC DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VALPROATE SODIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PSYCHOTIC DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRIHEXYPHENIDYL HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PARKINSONISM</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MOSAPRIDE CITRATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTRITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5043745-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060609</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>SE-NOVOPROD-254012</companynumb>
    <primarysource>
      <reportercountry>SWEDEN</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>71</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD CREATININE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHABDOMYOLYSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NOVOLOG MIX 70/30</medicinalproduct>
        <drugauthorizationnumb>021172</drugauthorizationnumb>
        <drugindication>DIABETES MELLITUS INSULIN-DEPENDENT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCONTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOL                          /00661201/</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXAT                        /00113801/</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLACIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALVEDON</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TIBINIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TROMBYL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5043761-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-AVENTIS-200612336FR</companynumb>
    <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>BODY TEMPERATURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA HAEMORRHAGIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BIRODOGYL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060207</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060212</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NASACORT</medicinalproduct>
        <drugauthorizationnumb>019798</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060224</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060225</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EFFERALGAN CODEINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PYREXIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060224</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060225</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOPREC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PYREXIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060224</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060225</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VOGALENE LYOC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NAUSEA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060224</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060225</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VOGALENE LYOC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>VOMITING</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060224</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060225</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5043810-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060626</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-JNJFOC-20060605721</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>60</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ACCIDENTAL OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD BICARBONATE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PH DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERCAPNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCORRECT DOSE ADMINISTERED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OXYGEN SATURATION DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PCO2 INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PURULENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY ACIDOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY RATE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HALDOL</medicinalproduct>
        <drugdosagetext>PATIENT TOOK 3 TIMES DOSE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HALDOL</medicinalproduct>
        <drugauthorizationnumb>015923</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NOZINAN</medicinalproduct>
        <drugdosagetext>PATIENT TOOK 3 TIMES DOSE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NOZINAN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HEPTAMYL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AKINETON</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5043811-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060626</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-JNJFOC-20060506233</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>LARGE INTESTINE PERFORATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>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>METASTASES TO BONE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DUROTEP</medicinalproduct>
        <drugauthorizationnumb>019813</drugauthorizationnumb>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>PROSTATE CANCER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MORPHINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BICALUTAMIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ETODOLAC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROCHLORPERAZINE MALEATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FAMOTIDINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOPICLONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SODIUM BICARBONATE - ANHYDROUS MONOBASIC SODIUM PHOSPHATE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5043825-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060324</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2006US03904</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>75</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD CREATININE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD UREA INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXJADE</medicinalproduct>
        <drugauthorizationnumb>021882</drugauthorizationnumb>
        <drugdosagetext>1250 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD IRON INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000316</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060323</drugenddate>
        <drugtreatmentduration>2199</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE TAB</medicinalproduct>
        <drugdosagetext>5 MG, QD</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugdosagetext>40MG QAM, 60MG QPM</drugdosagetext>
        <drugindication>ASCITES</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRONOLACTONE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5043831-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060622</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHO2006DE10204</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>44</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>66</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANGINA PECTORIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ELECTROCARDIOGRAM ST SEGMENT DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERICARDIAL EFFUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERICARDITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VAL +/- HCTZ VS AMLODIPINE +/- HCTZ</medicinalproduct>
        <drugauthorizationnumb>20818</drugauthorizationnumb>
        <drugdosagetext>LEVEL 1</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060524</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CONTRACEPTIVES UNS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5043832-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060522</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHO2006AT08264</companynumb>
    <primarysource>
      <reportercountry>AUSTRIA</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>AGITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DELIRIUM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISORIENTATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZAPINE</medicinalproduct>
        <drugauthorizationnumb>019758</drugauthorizationnumb>
        <drugdosagetext>300 MG, UNK</drugdosagetext>
        <drugindication>BIPOLAR DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060212</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060216</drugenddate>
        <drugtreatmentduration>7200</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZAPINE</medicinalproduct>
        <drugauthorizationnumb>019758</drugauthorizationnumb>
        <drugdosagetext>400 MG, UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060217</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060225</drugenddate>
        <drugtreatmentduration>12960</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZAPINE</medicinalproduct>
        <drugauthorizationnumb>019758</drugauthorizationnumb>
        <drugdosagetext>450 MG, UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060226</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060307</drugenddate>
        <drugtreatmentduration>14400</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZAPINE</medicinalproduct>
        <drugauthorizationnumb>019758</drugauthorizationnumb>
        <drugdosagetext>150 MG, UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060308</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060309</drugenddate>
        <drugtreatmentduration>2880</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZAPINE</medicinalproduct>
        <drugauthorizationnumb>019758</drugauthorizationnumb>
        <drugdosagetext>UNK, UNK</drugdosagetext>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060211</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZAPINE</medicinalproduct>
        <drugauthorizationnumb>019758</drugauthorizationnumb>
        <drugdosagetext>100MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060314</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060407</drugenddate>
        <drugtreatmentduration>36000</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMICTAL</medicinalproduct>
        <drugdosagetext>25 MG, UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060221</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060302</drugenddate>
        <drugtreatmentduration>14400</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMICTAL</medicinalproduct>
        <drugdosagetext>50 MG, UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060303</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060307</drugenddate>
        <drugtreatmentduration>7200</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TEMESTA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALNA</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5043833-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060501</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2006US05682</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>42</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>LIVER TRANSPLANT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXJADE</medicinalproduct>
        <drugauthorizationnumb>21882</drugauthorizationnumb>
        <drugdosagetext>1000 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060220</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060401</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5043834-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060614</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2006US07826</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>50</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>65.759</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 AMYLASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD POTASSIUM DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLATULENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIPASE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXJADE</medicinalproduct>
        <drugauthorizationnumb>21882</drugauthorizationnumb>
        <drugdosagetext>1250 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD IRON INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060506</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060601</drugenddate>
        <drugtreatmentduration>38880</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
        <drugdosagetext>0.25 - 0.5 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SLEEP DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLEGRA</medicinalproduct>
        <drugdosagetext>180 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SEASONAL ALLERGY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLONASE</medicinalproduct>
        <drugdosagetext>1 UNK, QD</drugdosagetext>
        <drugindication>SEASONAL ALLERGY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5043835-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-AVENTIS-200616824GDDC</companynumb>
    <primarysource>
      <reportercountry>IRELAND</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>74</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ADENOCARCINOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INSULIN GLARGINE</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugdosagetext>DOSE UNIT: UNITS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050222</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OPTIPEN (INSULIN PUMP)</medicinalproduct>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CODE UNBROKEN</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugdosagetext>DOSE: UNKNOWN</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050222</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRAVASTATIN</medicinalproduct>
        <drugindication>DYSLIPIDAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RAMIPRIL</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BISOPROLOL FUMARATE</medicinalproduct>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040601</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5043843-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060509</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2006US06199</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>64</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL DISTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASCITES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEMOTHERAPY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EATING DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLATULENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROOESOPHAGEAL REFLUX DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HUNGER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYSTERECTOMY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL INTAKE REDUCED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVARIAN CANCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVARIAN EPITHELIAL CANCER STAGE III</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SENSATION OF PRESSURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SURGICAL PROCEDURE REPEATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HORMONAL CONTRACEPTIVES</medicinalproduct>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZELNORM</medicinalproduct>
        <drugauthorizationnumb>021200</drugauthorizationnumb>
        <drugindication>IRRITABLE BOWEL SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5043852-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060627</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-JNJFOC-20060603647</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>80</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BRADYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG PRESCRIBING ERROR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRANSIENT ISCHAEMIC ATTACK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREATMENT NONCOMPLIANCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMINYL ER</medicinalproduct>
        <drugauthorizationnumb>21615</drugauthorizationnumb>
        <drugindication>DEMENTIA ALZHEIMER'S TYPE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EBIXA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5043853-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060626</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-JNJFOC-20060606501</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>38</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>127.8</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HALDOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HALDOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HALDOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HALDOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HALDOL</medicinalproduct>
        <drugauthorizationnumb>015923</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIRTAZAPINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIRTAZAPINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENAHEXAL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HCT HEXAL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>JODID</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5043858-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-JNJFOC-20060606476</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>91</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTESTINAL OBSTRUCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OBSTRUCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DURAGESIC-100</medicinalproduct>
        <drugauthorizationnumb>19813</drugauthorizationnumb>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>BACK PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CONTRAMAL</medicinalproduct>
        <drugauthorizationnumb>020281</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BACK PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EFFERALGAN CODEINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BACK PAIN</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5043864-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060420</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2006JP05966</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAMMA-GLUTAMYLTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
        <drugauthorizationnumb>020665</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5043865-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060625</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-STX184314</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>GASTROOESOPHAGEAL REFLUX DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>P059028</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PSORIASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040526</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5043866-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20051128</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2005JP17862</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>84</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>INTERSTITIAL LUNG DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
        <drugauthorizationnumb>21283</drugauthorizationnumb>
        <drugdosagetext>20 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030801</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
        <drugauthorizationnumb>021283</drugauthorizationnumb>
        <drugdosagetext>40 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030801</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5043867-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060511</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-BRISTOL-MYERS SQUIBB COMPANY-13432216</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>67</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>THROMBOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ERBITUX</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLORECTAL CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040715</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IRINOTECAN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLORECTAL CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040715</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5043868-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060601</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AVENTIS-200614880US</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>89.81</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ALANINE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASPARTATE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BAND NEUTROPHIL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BILIRUBIN CONJUGATED INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD ALKALINE PHOSPHATASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD BILIRUBIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CHOLESTEROL INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHROMATURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA PAROXYSMAL NOCTURNAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EOSINOPHIL COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOW DENSITY LIPOPROTEIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEAN CELL HAEMOGLOBIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUS CONGESTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KETEK</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>21144</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>UPPER RESPIRATORY TRACT INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050714</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KETEK</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021144</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060105</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOXYCYCLINE</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050619</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADVIL</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTITUSSIVES AND EXPECTORANTS, COMBINATIONS</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5043869-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060518</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-AVENTIS-200611826FR</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>43</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CEREBELLAR SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VERTIGO</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VESTIBULAR DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KETEK</medicinalproduct>
        <drugauthorizationnumb>21144</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SINUSITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060329</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060401</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SOLUPRED</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SINUSITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060329</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060401</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SOLUPRED</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060406</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROPOFAN                           /00765201/</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SINUSITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060329</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060401</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DERINOX</medicinalproduct>
        <drugindication>SINUSITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXXAIR</medicinalproduct>
        <drugindication>SINUSITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5043870-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060630</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-AVENTIS-200612040JP</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>52</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ALANINE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASPARTATE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC FUNCTION ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALLEGRA</medicinalproduct>
        <drugauthorizationnumb>020872</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHINITIS ALLERGIC</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5043871-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20051018</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AVENTIS-200520456US</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>45</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>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>DEPRESSED LEVEL OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERNATIONAL NORMALISED RATIO INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER FUNCTION TEST ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KETEK</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>21144</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PNEUMONIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051014</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051016</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5043872-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060602</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-AVENTIS-200611712JP</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>82</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>65</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD ALKALINE PHOSPHATASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CREATININE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD LACTATE DEHYDROGENASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD POTASSIUM INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD SODIUM INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EOSINOPHIL PERCENTAGE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATOCRIT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MONOCYTE PERCENTAGE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH GENERALISED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RED BLOOD CELL COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALLEGRA</medicinalproduct>
        <drugauthorizationnumb>20872</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RASH</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060525</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060602</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MINOCYCLINE HCL</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>PYREXIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060522</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060524</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MYOCARDIAL INFARCTION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060602</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIGMART</medicinalproduct>
        <drugindication>MYOCARDIAL INFARCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050809</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATELEC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KREMEZIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RENAL FAILURE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5043873-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-13427315</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>25</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUSTIVA</medicinalproduct>
        <drugauthorizationnumb>21360</drugauthorizationnumb>
        <drugindication>ACQUIRED IMMUNODEFICIENCY SYNDROME</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRUVADA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KEPPRA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DARAPRIM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5043874-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060321</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>TR-BRISTOL-MYERS SQUIBB COMPANY-13324231</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>59</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ABDOMINAL TENDERNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIO-RESPIRATORY ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISORIENTATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOCALCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOMAGNESAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPENIC SEPSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERFORMANCE STATUS DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RALES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ERBITUX</medicinalproduct>
        <drugbatchnumb>CT 1639/2436</drugbatchnumb>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050929</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CISPLATIN</medicinalproduct>
        <drugauthorizationnumb>018057</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050929</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VINORELBINE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050929</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOLEDRONIC ACID</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>METASTASES TO BONE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051010</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051010</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEGESTROL ACETATE</medicinalproduct>
        <drugauthorizationnumb>016979</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050928</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051103</drugenddate>
        <drugtreatmentduration>36</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FENTANYL TRANSDERMAL SYSTEM</medicinalproduct>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050908</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051103</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NYSTATIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE TAB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GRANISETRON  HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RANITIDINE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050929</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051027</drugenddate>
        <drugtreatmentduration>28</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LACTULOSE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RADIATION THERAPY</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051013</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051016</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5043878-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060627</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-13425392</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>67</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG LEVEL INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JOINT INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN GRAFT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
        <drugauthorizationnumb>009218</drugauthorizationnumb>
        <drugdosagetext>DURATION: 2.5 YEARS, CURRENTLY WAS TAKING 1/2 TAB DAILY</drugdosagetext>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BLOOD PRESSURE PILL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIURETIC</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5043879-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060630</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BW-BRISTOL-MYERS SQUIBB COMPANY-13430012</companynumb>
    <primarysource>
      <reportercountry>SOUTH AFRICA</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>53</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EFAVIRENZ</medicinalproduct>
        <drugauthorizationnumb>020972</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060308</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMBIVIR</medicinalproduct>
        <drugdosagetext>LAMIVUDINE 100 MG / ZIDOVUDINE 180 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060308</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060608</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5043880-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060630</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-BRISTOL-MYERS SQUIBB COMPANY-13430210</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>4</patientonsetage>
      <patientonsetageunit>800</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OXYGEN SATURATION DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUSTIVA</medicinalproduct>
        <drugauthorizationnumb>020972</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KIVEXA</medicinalproduct>
        <drugdosagetext>ABACAVIR 600MG / LAMIVUDINE 300 MG</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SEPTRIN</medicinalproduct>
        <drugindication>INFECTION PROPHYLAXIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5043881-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050531</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2005US06164</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>4</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL DISTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATOBLASTOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NIGHT SWEATS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RADIATION EXPOSURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SURGERY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ELIDEL</medicinalproduct>
        <drugauthorizationnumb>21302</drugauthorizationnumb>
        <drugdosagetext>TWICE DAILY</drugdosagetext>
        <drugadministrationroute>061</drugadministrationroute>
        <drugindication>ECZEMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041001</drugenddate>
        <drugtreatmentduration>730</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5043882-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060620</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2006US08109</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>LEUKAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ELIDEL</medicinalproduct>
        <drugauthorizationnumb>21302</drugauthorizationnumb>
        <drugadministrationroute>061</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5043883-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060502</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-13372057</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>67</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>57</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARBOPLATIN</medicinalproduct>
        <drugauthorizationnumb>19880</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>OVARIAN CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060414</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALOXI</medicinalproduct>
        <drugindication>PREMEDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DECADRON</medicinalproduct>
        <drugindication>PREMEDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENADRYL</medicinalproduct>
        <drugindication>PREMEDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZANTAC</medicinalproduct>
        <drugindication>PREMEDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
        <drugauthorizationnumb>009218</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FIBERCON</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALTRATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATIVAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TESSALON</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5043885-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060626</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-13424569</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>44</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>46</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>LACTIC ACIDOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEPHROLITHIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REYATAZ</medicinalproduct>
        <drugauthorizationnumb>021567</drugauthorizationnumb>
        <drugindication>ACQUIRED IMMUNODEFICIENCY SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060523</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVIR</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRUVADA</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BACTRIM DS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MARINOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TESTOSTERONE</medicinalproduct>
        <drugdosagetext>ROUTE OF ADMINISTRATION: INJECTIONS</drugdosagetext>
        <drugadministrationroute>051</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ORAMORPH SR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VIREAD</medicinalproduct>
        <drugdosagetext>DOSE REDUCED TO QOD, DUE TO AN INCREASE IN CREATININE. ON MAY-2006 RETURNED TO FULL DOSE.</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCORTISONE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5043886-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040714</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2004US07674</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>2</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>13.6</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>AGRANULOCYTOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DECREASED APPETITE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPHONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EPSTEIN-BARR VIRUS INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GINGIVAL BLEEDING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPONATRAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEDIASTINAL MASS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUROPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NON-HODGKIN'S LYMPHOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL CANDIDIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL INTAKE REDUCED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHONOLOGICAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLEURAL EFFUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY DISTRESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STAPHYLOCOCCAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STOMATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOCAL CORD DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WOUND INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ELIDEL</medicinalproduct>
        <drugauthorizationnumb>21302</drugauthorizationnumb>
        <drugdosagetext>1 G, BID</drugdosagetext>
        <drugadministrationroute>061</drugadministrationroute>
        <drugindication>DERMATITIS ATOPIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030410</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030401</drugenddate>
        <drugtreatmentduration>20160</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ELIDEL</medicinalproduct>
        <drugauthorizationnumb>021302</drugauthorizationnumb>
        <drugdosagetext>UNK, PRN</drugdosagetext>
        <drugadministrationroute>061</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031013</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZITHROMAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BIAXIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMNICEF</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EUCERIN CREME</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5043887-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060518</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2006BE07642</companynumb>
    <primarysource>
      <reportercountry>BELGIUM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>10</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>25.1</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HODGKIN'S DISEASE MIXED CELLULARITY STAGE I SUPRADIAPHRAGMATIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFECTIOUS MONONUCLEOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPHADENOPATHY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DESONIDE</medicinalproduct>
        <drugdosagetext>UNK, QD</drugdosagetext>
        <drugadministrationroute>061</drugadministrationroute>
        <drugindication>DERMATITIS ATOPIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ELIDEL</medicinalproduct>
        <drugauthorizationnumb>021302</drugauthorizationnumb>
        <drugdosagetext>30 G</drugdosagetext>
        <drugadministrationroute>061</drugadministrationroute>
        <drugindication>DERMATITIS ATOPIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ELIDEL</medicinalproduct>
        <drugauthorizationnumb>021302</drugauthorizationnumb>
        <drugdosagetext>30 G</drugdosagetext>
        <drugadministrationroute>061</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040601</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5043888-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060627</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-13425376</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>ENDOPHTHALMITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KENALOG-40</medicinalproduct>
        <drugbatchnumb>6B21109, 6B19016,5M01513</drugbatchnumb>
        <drugauthorizationnumb>014901</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5043889-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060502</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-13363684</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>75</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>152</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CHEST DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARBOPLATIN</medicinalproduct>
        <drugauthorizationnumb>19880</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>SMALL CELL LUNG CANCER STAGE UNSPECIFIED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060306</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060306</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOFRAN</medicinalproduct>
        <drugindication>PREMEDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DECADRON</medicinalproduct>
        <drugindication>PREMEDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>QUININE SULFATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACTOS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HYDROCHLORIDE</medicinalproduct>
        <drugauthorizationnumb>021202</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DUONEB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BUDESONIDE</medicinalproduct>
        <drugadministrationroute>055</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACIPHEX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYLENOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENEFIBER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGNESIUM OXIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NOVOLOG</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COMPAZINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LUNESTA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALTREX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5043890-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060626</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-13428891</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>9</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>RENAL CELL CARCINOMA STAGE UNSPECIFIED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREATMENT RELATED SECONDARY MALIGNANCY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ETOPOSIDE</medicinalproduct>
        <drugauthorizationnumb>18768</drugauthorizationnumb>
        <drugindication>NEPHROBLASTOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOPHOSPHAMIDE</medicinalproduct>
        <drugauthorizationnumb>012142</drugauthorizationnumb>
        <drugindication>NEPHROBLASTOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOXORUBICIN</medicinalproduct>
        <drugauthorizationnumb>062926</drugauthorizationnumb>
        <drugindication>NEPHROBLASTOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARBOPLATIN</medicinalproduct>
        <drugauthorizationnumb>019880</drugauthorizationnumb>
        <drugindication>NEPHROBLASTOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VINCRISTINE</medicinalproduct>
        <drugindication>NEPHROBLASTOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DACTINOMYCIN</medicinalproduct>
        <drugindication>NEPHROBLASTOMA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5043891-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20051229</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-13232186</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>71</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>85</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARBOPLATIN</medicinalproduct>
        <drugauthorizationnumb>19880</drugauthorizationnumb>
        <drugdosagetext>GIVEN DAY 1 + DAY 8 EVERY 3 WEEKS. THERAPY START DATE 03-NOV-2005. INTERRUPTED/DOSE REDUCED.</drugdosagetext>
        <drugindication>BREAST CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051220</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051220</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IRINOTECAN</medicinalproduct>
        <drugdosagetext>GIVEN DAYS 1 AND DAY 8 EVERY 3 WEEKS. THERAPY START DATE 03-NOV-2005. INTERRUPTED/DOSE REDUCED.</drugdosagetext>
        <drugindication>BREAST CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051220</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051220</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMIN</medicinalproduct>
        <drugdosagetext>DOSAGE FORM = 1 TABLET</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030122</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYLENOL (CAPLET)</medicinalproduct>
        <drugdosagetext>250 MG, 1-2 TABLETS AS NEEDED</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050505</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DARVOCET</medicinalproduct>
        <drugdosagetext>1-2 TABLETS AS NEEDED</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050606</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
        <drugauthorizationnumb>009218</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INTRAVENOUS CATHETER MANAGEMENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050720</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOFRAN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NAUSEA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051220</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENEFIBER</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONSTIPATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051213</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5043893-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060208</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PT-BRISTOL-MYERS SQUIBB COMPANY-13276423</companynumb>
    <primarysource>
      <reportercountry>PORTUGAL</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>37</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ALANINE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASPARTATE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD BILIRUBIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC STEATOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPLENOMEGALY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ATAZANAVIR</medicinalproduct>
        <drugauthorizationnumb>21567</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050818</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060421</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RITONAVIR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050818</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRUVADA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050818</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5043894-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060607</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-BRISTOL-MYERS SQUIBB COMPANY-13410592</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>45</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>88</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MIGRAINE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOPHOSPHAMIDE</medicinalproduct>
        <drugauthorizationnumb>12142</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CHRONIC LYMPHOCYTIC LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060518</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060518</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUDARABINE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CHRONIC LYMPHOCYTIC LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060518</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060518</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5043897-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060614</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AT-AVENTIS-200616389GDDC</companynumb>
    <primarysource>
      <reportercountry>AUSTRIA</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>54</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>46.5</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>COMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSED LEVEL OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOGLYCAEMIC COMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDE ATTEMPT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>APIDRA</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>21629</drugauthorizationnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OPTIPEN (INSULIN PUMP)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5043898-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060522</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2006JP07649</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>66</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ASPIRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ATRIOVENTRICULAR BLOCK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRADYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMPLETED SUICIDE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDUCTION DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DROWNING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
        <drugauthorizationnumb>21283</drugauthorizationnumb>
        <drugdosagetext>1200 MG, ONCE/SINGLE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>COMPLETED SUICIDE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060521</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060521</drugenddate>
        <drugtreatmentduration>1440</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
        <drugauthorizationnumb>021283</drugauthorizationnumb>
        <drugdosagetext>160 MG/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CALBLOCK</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>COMPLETED SUICIDE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060521</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060521</drugenddate>
        <drugtreatmentduration>1440</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CALBLOCK</medicinalproduct>
        <drugdosagetext>16 MG/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TENORMIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>COMPLETED SUICIDE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060521</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060521</drugenddate>
        <drugtreatmentduration>1440</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5043899-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060428</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2006JP06384</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>67</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CHEST X-RAY ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA EXERTIONAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERSTITIAL LUNG DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRODUCTIVE COUGH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
        <drugauthorizationnumb>21283</drugauthorizationnumb>
        <drugdosagetext>40 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030526</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060424</drugenddate>
        <drugtreatmentduration>1065</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEUFAN</medicinalproduct>
        <drugdosagetext>100 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19970519</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HACHIMIGAN</medicinalproduct>
        <drugdosagetext>7.5 G, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000519</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BUP-4</medicinalproduct>
        <drugdosagetext>20 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030621</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALOSENN</medicinalproduct>
        <drugdosagetext>0.5 G, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021115</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5043906-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060614</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2006JP09074</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>80</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MYELOFIBROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
        <drugauthorizationnumb>021283</drugauthorizationnumb>
        <drugdosagetext>40 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020122</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CONIEL</medicinalproduct>
        <drugdosagetext>4 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020122</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CONIEL</medicinalproduct>
        <drugdosagetext>18 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020122</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5043909-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060627</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHMT2006CA01422</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>TRANSAMINASES INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZELNORM</medicinalproduct>
        <drugauthorizationnumb>021200</drugauthorizationnumb>
        <drugdosagetext>36 MG QD</drugdosagetext>
        <drugindication>INTESTINAL OBSTRUCTION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5043910-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060627</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHMT2006CA01421</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>TRANSAMINASES INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZELNORM</medicinalproduct>
        <drugauthorizationnumb>021200</drugauthorizationnumb>
        <drugdosagetext>24 MG QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5043911-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060626</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2006ES09552</companynumb>
    <primarysource>
      <reportercountry>SPAIN</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>67</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BONE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTH EXTRACTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAMIDRONATE DISODIUM</medicinalproduct>
        <drugauthorizationnumb>020036</drugauthorizationnumb>
        <drugdosagetext>90 MG, 20 CYCLES</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>METASTASES TO BONE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5043912-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2006JP09831</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>41</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD CREATININE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENOVASCULAR HYPERTENSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
        <drugauthorizationnumb>020665</drugauthorizationnumb>
        <drugdosagetext>40 MG/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060610</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060620</drugenddate>
        <drugtreatmentduration>15840</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5043913-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060613</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2006JP09087</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>11</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRONCHITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KLARICID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOFRANIL</medicinalproduct>
        <drugauthorizationnumb>011838</drugauthorizationnumb>
        <drugdosagetext>25 MG/D</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOFRANIL</medicinalproduct>
        <drugauthorizationnumb>011838</drugauthorizationnumb>
        <drugdosagetext>30 MG, QHS</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060508</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MACROLIDES</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5043918-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060703</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-SP-2006-01633</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>17</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE SYSTOLIC DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALLOR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TUBERSOL</medicinalproduct>
        <drugbatchnumb>C2369A</drugbatchnumb>
        <drugadministrationroute>023</drugadministrationroute>
        <drugindication>TUBERCULIN TEST</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060703</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MENACTRA</medicinalproduct>
        <drugbatchnumb>U2107A</drugbatchnumb>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>IMMUNISATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060703</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BIRTH CONTROL PILLS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5043919-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-SP-2006-01612</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>72</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD CREATININE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>C-REACTIVE PROTEIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FIBROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLANK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GRANULOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>KIDNEY FIBROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEPHRITIS INTERSTITIAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RED BLOOD CELL SEDIMENTATION RATE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL TUBULAR ATROPHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TENDERNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TUBULOINTERSTITIAL NEPHRITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BCG - IT (CONNAUGHT)</medicinalproduct>
        <drugbatchnumb>LOT NOT REP</drugbatchnumb>
        <drugadministrationroute>043</drugadministrationroute>
        <drugindication>CARCINOMA IN SITU OF BLADDER</drugindication>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5043949-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2006JP09850</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DELIRIUM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RITALIN</medicinalproduct>
        <drugauthorizationnumb>010187</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MALAISE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5043950-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2006JP09852</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DELIRIUM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RITALIN</medicinalproduct>
        <drugauthorizationnumb>010187</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MALAISE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5043951-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2006JP09853</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DELIRIUM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RITALIN</medicinalproduct>
        <drugauthorizationnumb>010187</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MALAISE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5043952-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2006JP09851</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DELIRIUM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RITALIN</medicinalproduct>
        <drugauthorizationnumb>010187</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MALAISE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5043953-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060626</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-06P-163-0337060-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>12</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD OSMOLARITY INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FANCONI SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOPHOSPHATAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEPHROGENIC DIABETES INSIPIDUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL TUBULAR ACIDOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY RATE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KALETRA</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>21226</drugauthorizationnumb>
        <drugindication>ANTIVIRAL PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TENOFOVIR</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugindication>ANTIVIRAL PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIDANOSINE</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugindication>ANTIVIRAL PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5043966-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060626</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2006US08337</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>21</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CATHETER PLACEMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY RETENTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RITALIN</medicinalproduct>
        <drugauthorizationnumb>010187</drugauthorizationnumb>
        <drugdosagetext>10 MG, BID</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060525</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060604</drugenddate>
        <drugtreatmentduration>15840</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEXAPRO</medicinalproduct>
        <drugdosagetext>20 MG, QD</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060201</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5043967-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060329</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2006US04241</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>76</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>61.678</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD CHLORIDE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CREATININE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD UREA INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOKALAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPONATRAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULAR WEAKNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NUCLEAR MAGNETIC RESONANCE IMAGING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SANDOSTATIN LAR</medicinalproduct>
        <drugauthorizationnumb>21008</drugauthorizationnumb>
        <drugdosagetext>60 MG, QMO</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>CARCINOID SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041124</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SANDOSTATIN LAR</medicinalproduct>
        <drugauthorizationnumb>021008</drugauthorizationnumb>
        <drugdosagetext>40 MG, QMO</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SANDOSTATIN LAR</medicinalproduct>
        <drugauthorizationnumb>021008</drugauthorizationnumb>
        <drugdosagetext>40 MG, QMO</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020305</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041124</drugenddate>
        <drugtreatmentduration>996</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
        <drugdosagetext>0.075 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPOTHYROIDISM</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREVACID</medicinalproduct>
        <drugdosagetext>30 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPROL-XL</medicinalproduct>
        <drugdosagetext>25 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VICOPROFEN</medicinalproduct>
        <drugdosagetext>Q6HRS PRN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugdosagetext>4 MG, QMO</drugdosagetext>
        <drugindication>METASTASES TO BONE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INTERFERON</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050711</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5043969-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006AP02996</companynumb>
    <primarysource>
      <reportercountry>TAIWAN, PROVINCE OF CHINA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>21956</patientonsetage>
      <patientonsetageunit>804</patientonsetageunit>
      <patientweight>86</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>LACTIC ACIDOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPTIC SHOCK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SHOCK</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugauthorizationnumb>020639</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MENTAL DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060621</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060628</drugenddate>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5043970-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060511</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006UW09363</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>9</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>31.8</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ABNORMAL BEHAVIOUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AGGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD POTASSIUM DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE SYSTOLIC INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BODY TEMPERATURE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRAIN DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRAIN STEM SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBELLAR INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSED LEVEL OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIABETES INSIPIDUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSARTHRIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROENTERITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPONATRAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTRACRANIAL PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEMORY IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYDRIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMOTHORAX</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WATER INTOXICATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugauthorizationnumb>20639</drugauthorizationnumb>
        <drugdosagetext>1/2-1</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>AFFECTIVE DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060117</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060401</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugauthorizationnumb>020639</drugauthorizationnumb>
        <drugdosagetext>1/2-1</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SLEEP DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060117</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060401</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADDERALL XL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATTENTION DEFICIT/HYPERACTIVITY DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021231</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060401</drugenddate>
        <drugtreatmentduration>40</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GUAIFENESIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TENEX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>TIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021221</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060401</drugenddate>
        <drugtreatmentduration>40</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5043971-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesscongenitalanomali>1</seriousnesscongenitalanomali>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060626</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006UW13512</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FOETAL DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TENORMIN</medicinalproduct>
        <drugauthorizationnumb>018240</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5043972-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060624</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006UW13660</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>VISION BLURRED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL DISTURBANCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RHINOCORT AQUA</medicinalproduct>
        <drugauthorizationnumb>020746</drugauthorizationnumb>
        <drugadministrationroute>055</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060622</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060624</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5043973-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060615</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006AP02811</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>27509</patientonsetage>
      <patientonsetageunit>804</patientonsetageunit>
      <patientweight>43.5</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>RHABDOMYOLYSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OMEPRAL</medicinalproduct>
        <drugauthorizationnumb>19810</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DUODENAL ULCER HAEMORRHAGE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060517</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060614</drugenddate>
        <drugtreatmentduration>29</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEZATOR SR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERLIPIDAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19991208</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060614</drugenddate>
        <drugtreatmentduration>2381</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FERO-GRADUMET</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>IRON DEFICIENCY ANAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060517</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060614</drugenddate>
        <drugtreatmentduration>29</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEPAS</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INSOMNIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19960701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>URSOSAN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATIC FUNCTION ABNORMAL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19991208</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BASEN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20011114</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MELBIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050720</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5043974-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060209</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006UW02254</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>56</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>88.5</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CHOLESTEROL INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD TRIGLYCERIDES INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENISCUS LESION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH MACULO-PAPULAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TENDON INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARIMIDEX</medicinalproduct>
        <drugauthorizationnumb>20541</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BREAST CANCER FEMALE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5043975-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006UW13773</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>60</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugauthorizationnumb>020639</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5043976-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060626</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006UW13376</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </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>CORONARY ARTERY DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIABETES MELLITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ILL-DEFINED DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
        <drugauthorizationnumb>018240</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMDUR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5043977-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060626</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006UW13516</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </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>HALLUCINATION, AUDITORY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERPHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENTAL IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NASAL CONGESTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NECK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHINORRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SNEEZING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugauthorizationnumb>020639</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SLEEP DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040101</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ABILIFY</medicinalproduct>
        <drugindication>SLEEP DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040701</drugenddate>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030901</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RISPERIDONE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030701</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5043978-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2006JP09828</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>7</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <reaction>
        <reactionmeddrapt>ALANINE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASPARTATE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC FUNCTION ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NASOPHARYNGITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZADITEN</medicinalproduct>
        <drugauthorizationnumb>021066</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5043979-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2006BE09744</companynumb>
    <primarysource>
      <reportercountry>BELGIUM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HEPATIC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZADITEN</medicinalproduct>
        <drugauthorizationnumb>021066</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5043990-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060630</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006AP03024</companynumb>
    <primarysource>
      <reportercountry>CHINA</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>56</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>RED BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IRESSA</medicinalproduct>
        <drugauthorizationnumb>021399</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060620</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN DRUG</medicinalproduct>
        <drugindication>WHITE BLOOD CELL COUNT INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN DRUG</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CHEMOTHERAPY</medicinalproduct>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060601</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5044019-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-AVENTIS-200612003JP</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>MESENTERIC ARTERY THROMBOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAXOTERE</medicinalproduct>
        <drugauthorizationnumb>020449</drugauthorizationnumb>
        <drugadministrationroute>041</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CISPLATIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5044020-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060621</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-AVENTIS-200611919JP</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>BONE MARROW FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISEASE PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUCOSAL INFLAMMATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TUMOUR NECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAXOTERE</medicinalproduct>
        <drugauthorizationnumb>020449</drugauthorizationnumb>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>PHARYNGEAL CANCER STAGE UNSPECIFIED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAXOTERE</medicinalproduct>
        <drugauthorizationnumb>020449</drugauthorizationnumb>
        <drugadministrationroute>041</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CISPLATIN</medicinalproduct>
        <drugindication>PHARYNGEAL CANCER STAGE UNSPECIFIED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUOROURACIL</medicinalproduct>
        <drugindication>PHARYNGEAL CANCER STAGE UNSPECIFIED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RADIOTHERAPY</medicinalproduct>
        <drugindication>PHARYNGEAL CANCER STAGE UNSPECIFIED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CBDCA</medicinalproduct>
        <drugindication>PHARYNGEAL CANCER STAGE UNSPECIFIED</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5044046-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060627</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>NO-JNJFOC-20060606090</companynumb>
    <primarysource>
      <reportercountry>NORWAY</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLADDER 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>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5044047-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060627</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20060606693</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>64.41</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ALCOHOLISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugbatchnumb>5KM40011P1</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugbatchnumb>5KM40011P1</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugbatchnumb>5KM40011P1</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugbatchnumb>5KM40011P1</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugbatchnumb>5KM40011P1</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugbatchnumb>5KM40011P1</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugbatchnumb>5KM40011P1</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugbatchnumb>5KM40011P1</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugbatchnumb>5KM40011P1</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugbatchnumb>5KM40011P1</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugbatchnumb>5KM40011P1</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugbatchnumb>5KM40011P1</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugbatchnumb>5KM40011P1</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugbatchnumb>5KM40011P1</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugbatchnumb>5KM40011P1</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugbatchnumb>5KM40011P1</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugbatchnumb>5KM40011P1</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugbatchnumb>5KM40011P1</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugbatchnumb>5KM40011P1</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugbatchnumb>5KM40011P1</drugbatchnumb>
        <drugdosagetext>8 INFUSIONS PRIOR TO BASELINE</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CROHN'S DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MESALAMINE</medicinalproduct>
        <drugindication>CROHN'S DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ANTISPASMODIC</medicinalproduct>
        <drugindication>CROHN'S DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISONE TAB</medicinalproduct>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
        <drugindication>CROHN'S DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>B-12</medicinalproduct>
        <drugadministrationroute>050</drugadministrationroute>
        <drugindication>CROHN'S DISEASE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5044060-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060626</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20060605618</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFUSION RELATED REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5044061-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060626</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20060503959</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFUSION RELATED REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROAT TIGHTNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugbatchnumb>05LO35P1</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugbatchnumb>05LO35P1</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CROHN'S DISEASE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5044062-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060622</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2006PL09404</companynumb>
    <primarysource>
      <reportercountry>POLAND</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>35</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>GINGIVAL HYPERPLASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMANGIOMA OF SKIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMANGIOMA REMOVAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN DEPIGMENTATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN NODULE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THERAPEUTIC RESPONSE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VASCULAR SKIN DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOSPORINE</medicinalproduct>
        <drugauthorizationnumb>50574</drugauthorizationnumb>
        <drugdosagetext>2.5 MG/KG/D</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PSORIATIC ARTHROPATHY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOSPORINE</medicinalproduct>
        <drugauthorizationnumb>050574</drugauthorizationnumb>
        <drugdosagetext>4 MG/KG/D</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOSPORINE</medicinalproduct>
        <drugauthorizationnumb>050574</drugauthorizationnumb>
        <drugdosagetext>3 MG/KG/D</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugdosagetext>17.5 MG, QW</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PSORIATIC ARTHROPATHY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugdosagetext>15 MG, QW</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHYLPREDNISOLONE</medicinalproduct>
        <drugdosagetext>5 MG/D</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PSORIATIC ARTHROPATHY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHYLPREDNISOLONE</medicinalproduct>
        <drugdosagetext>4 MG/D</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5044063-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060627</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2006TR09735</companynumb>
    <primarysource>
      <reportercountry>TURKEY</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>52</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BILE DUCT CANCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHOLECYSTECTOMY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHOLECYSTITIS CHRONIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHOLELITHIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MASS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MASS EXCISION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METASTATIC NEOPLASM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TENDERNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AZATHIOPRINE</medicinalproduct>
        <drugdosagetext>100 MG/D</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>RENAL TRANSPLANT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugdosagetext>5 MG/D</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>RENAL TRANSPLANT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOSPORINE</medicinalproduct>
        <drugauthorizationnumb>050574</drugauthorizationnumb>
        <drugdosagetext>100 MG, BID</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>RENAL TRANSPLANT</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5044071-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050809</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-AVENTIS-200611995JP</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>74</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ALANINE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASPARTATE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC FUNCTION ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARAVA</medicinalproduct>
        <drugauthorizationnumb>20905</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050228</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060627</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LOXONIN</medicinalproduct>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060627</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYTOTEC</medicinalproduct>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060627</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LENDORMIN</medicinalproduct>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060627</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEPAS</medicinalproduct>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060627</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BONALON</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050726</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060627</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FERROMIA</medicinalproduct>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060627</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENET</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIN</medicinalproduct>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060627</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5044072-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060518</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-AVENTIS-200611569JP</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>73</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>65</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DISEASE PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRIC ULCER HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SHOCK HAEMORRHAGIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RILUTEK</medicinalproduct>
        <drugauthorizationnumb>20599</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>AMYOTROPHIC LATERAL SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030325</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RILUTEK</medicinalproduct>
        <drugauthorizationnumb>020599</drugauthorizationnumb>
        <drugdosagetext>ROUTE: GASTROSTOMY TUBE</drugdosagetext>
        <drugadministrationroute>050</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050718</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MYONAL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MUSCLE SPASTICITY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MYONAL</medicinalproduct>
        <drugdosagetext>ROUTE: GASTROSTOMY TUBE</drugdosagetext>
        <drugadministrationroute>050</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050716</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5044073-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040305</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200410760JP</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>70</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>65.5</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 ALBUMIN DECREASED</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>GAMMA-GLUTAMYLTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERSTITIAL LUNG DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLEURAL EFFUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA STAPHYLOCOCCAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROTEIN TOTAL DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRACHEAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARAVA</medicinalproduct>
        <drugauthorizationnumb>20905</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040109</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040111</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARAVA</medicinalproduct>
        <drugauthorizationnumb>020905</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040112</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040127</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INFREE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040219</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDONINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040128</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYTOTEC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS AGAINST GASTROINTESTINAL ULCER</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040305</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTACID TAB</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTRITIS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040305</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYANOCOBALAMIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NEURALGIA</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040305</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERLIPIDAEMIA</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040304</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ONE-ALPHA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040305</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACTONEL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040305</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010629</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030421</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030422</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031219</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIAMIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>FOLATE DEFICIENCY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010713</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031219</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INTEBAN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040219</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040305</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PARIET</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>REFLUX OESOPHAGITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040123</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040305</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENAMBAX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5044074-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060613</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-AVENTIS-200616368GDDC</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>70</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>GASTRIC HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARAVA</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>20905</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020619</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARAVA</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>020905</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KETOPROFEN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5044075-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060626</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AVENTIS-200615473US</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PITUITARY-DEPENDENT CUSHING'S SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NASACORT AQ</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>020468</drugauthorizationnumb>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5044095-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060626</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20060502173</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFUSION RELATED REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TONGUE DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugbatchnumb>06A123P1</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugbatchnumb>06A123P1</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugbatchnumb>06A123P1</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugbatchnumb>06A123P1</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CROHN'S DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYLENOL (CAPLET)</medicinalproduct>
        <drugindication>PREMEDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLEGRA</medicinalproduct>
        <drugindication>PREMEDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE TAB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SOLU-CORTEF</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENADRYL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5044096-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060626</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20060300076</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>92.99</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>COLON CANCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RECTAL CANCER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAZODONE HCL</medicinalproduct>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACTOSE</medicinalproduct>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLIPIZIDE</medicinalproduct>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAQUINEL</medicinalproduct>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE TAB</medicinalproduct>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHATREXATE</medicinalproduct>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5044097-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060626</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHRM2006FR01940</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>15</patientonsetage>
      <patientonsetageunit>804</patientonsetageunit>
      <patientweight>3.5</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CONVULSION NEONATAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEEDING DISORDER NEONATAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WRONG DRUG ADMINISTERED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHERGINE</medicinalproduct>
        <drugauthorizationnumb>006035</drugauthorizationnumb>
        <drugdosagetext>0.125 MG, TID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060517</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060517</drugenddate>
        <drugtreatmentduration>1440</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5044109-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060627</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2006JP09712</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ACUTE GENERALISED EXANTHEMATOUS PUSTULOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG ERUPTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRIC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TONSILLAR DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TONSILLITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMISIL</medicinalproduct>
        <drugauthorizationnumb>020539</drugauthorizationnumb>
        <drugdosagetext>125 MG/D</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>TINEA PEDIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5044110-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060616</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2006JP09256</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HALLUCINATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMISIL</medicinalproduct>
        <drugauthorizationnumb>20539</drugauthorizationnumb>
        <drugdosagetext>125 MG/D</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NAIL TINEA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060615</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060615</drugenddate>
        <drugtreatmentduration>1440</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5044111-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060602</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-ROCHE-450420</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>81</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>78</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BALANCE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORTHOSTATIC HYPOTENSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAROXYL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060326</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAROXYL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060405</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060417</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>COTAREG</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ESSENTIAL HYPERTENSION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060326</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RIVOTRIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MOGADON</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5044112-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2006JP09846</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>ALANINE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASPARTATE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD ALKALINE PHOSPHATASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHOLEDOCHOENTEROSTOMY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC FUNCTION ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMISIL</medicinalproduct>
        <drugauthorizationnumb>020539</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5044125-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060524</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-ROCHE-450352</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>22</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>60</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABORTION MISSED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIRACEPT</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060505</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060519</drugenddate>
        <drugtreatmentduration>15</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BIOVIR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN NOS</medicinalproduct>
        <drugdosagetext>DRUG NAME REPORTED AS POLYVITAMIN.</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FERROUS SULFATE TAB</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5044126-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060627</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2006JP09719</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>74</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HAEMATOCRIT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCYTOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RED BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMISIL</medicinalproduct>
        <drugauthorizationnumb>020539</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TALION</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TALION</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5044133-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060627</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20060605976</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>58.97</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>AGEUSIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVAQUIN</medicinalproduct>
        <drugauthorizationnumb>020634</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INFECTION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5044134-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060626</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20060606420</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DYSURIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FENTANYL TRANSDERMAL SYSTEM</medicinalproduct>
        <drugauthorizationnumb>019813</drugauthorizationnumb>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EFFEXOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NIGHT SWEATS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROTONIX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTRIC DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5044135-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060626</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20060606593</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>72.58</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>LOWER LIMB FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ROAD TRAFFIC ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TIBIA FRACTURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FENTANYL TRANSDERMAL SYSTEM</medicinalproduct>
        <drugadministrationroute>062</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FENTANYL TRANSDERMAL SYSTEM</medicinalproduct>
        <drugauthorizationnumb>019813</drugauthorizationnumb>
        <drugdosagetext>TWO-100 UG PATCHES TAKEN WITHIN 72 HOURS.</drugdosagetext>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANXIETY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5044136-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060627</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20060606769</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>57.15</patientweight>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>LUNG CANCER METASTATIC</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FENTANYL TRANSDERMAL SYSTEM</medicinalproduct>
        <drugauthorizationnumb>019813</drugauthorizationnumb>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCODONE HCL</medicinalproduct>
        <drugdosagetext>AS NEEDED</drugdosagetext>
        <drugindication>PAIN</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5044137-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060626</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-JNJFOC-20060606119</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>38</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>67</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEEP VEIN THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HALDOL</medicinalproduct>
        <drugauthorizationnumb>15923</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060220</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060407</drugenddate>
        <drugtreatmentduration>47</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAVOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AKINETON RET</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>JODTHYROX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5044138-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060529</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-NOVOPROD-253699</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>77</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>50</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANTI-INSULIN ANTIBODY POSITIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BASEN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>.9 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051203</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INNOLET 30R CHU</medicinalproduct>
        <drugauthorizationnumb>019991</drugauthorizationnumb>
        <drugdosagetext>26 IU, QD</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>INSULIN-REQUIRING TYPE II DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050921</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051030</drugenddate>
        <drugtreatmentduration>56160</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NOVORAPID 30 MIX CHU FLEXPEN</medicinalproduct>
        <drugdosagetext>26 IU, QD</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>INSULIN-REQUIRING TYPE II DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040909</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050920</drugenddate>
        <drugtreatmentduration>376</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NOVOLIN R</medicinalproduct>
        <drugdosagetext>28 IU, PRN</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>INSULIN-REQUIRING TYPE II DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051031</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>URSO</medicinalproduct>
        <drugdosagetext>300 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041225</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADALAT</medicinalproduct>
        <drugdosagetext>40 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040820</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BLOPRESS</medicinalproduct>
        <drugdosagetext>8 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>100 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030103</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGNESIUM                          /00552801/</medicinalproduct>
        <drugdosagetext>1 G, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050622</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MYSLEE</medicinalproduct>
        <drugdosagetext>5 MG, UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041215</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC                            /00972402/</medicinalproduct>
        <drugdosagetext>5 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030103</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMARYL</medicinalproduct>
        <drugdosagetext>6 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041224</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACTOS                              /01460202/</medicinalproduct>
        <drugdosagetext>15 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040824</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugdosagetext>30 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051014</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5044141-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060626</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-JNJFOC-20041006286</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>53</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>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 CREATINE PHOSPHOKINASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>C-REACTIVE PROTEIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHILLS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAMMA-GLUTAMYLTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC FUNCTION ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LISTERIOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARYNGOLARYNGEAL PAIN</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>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDONINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VOLTAREN</medicinalproduct>
        <drugadministrationroute>054</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MUCOSTA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PITAVASTATIN CALCIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERLIPIDAEMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORNOXICAM</medicinalproduct>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5044143-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060626</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20060505808</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</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>BUNDLE BRANCH BLOCK LEFT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFUSION RELATED REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN JAW</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY INCONTINENCE</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>ULTRAM</medicinalproduct>
        <drugdosagetext>DOSE IS ^50^</drugdosagetext>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE TAB</medicinalproduct>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugindication>BLOOD CHOLESTEROL</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYLENOL (CAPLET)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYLENOL (CAPLET)</medicinalproduct>
        <drugindication>PREMEDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENADRYL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENADRYL</medicinalproduct>
        <drugindication>PREMEDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRENTAL</medicinalproduct>
        <drugdosagetext>^400^</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5044156-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060623</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006AP02981</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>65</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XYLOCAINE</medicinalproduct>
        <drugauthorizationnumb>006488</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>LOCAL ANAESTHESIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060612</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060612</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XYLOCAINE</medicinalproduct>
        <drugauthorizationnumb>006488</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060615</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060615</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XYLOCAINE</medicinalproduct>
        <drugauthorizationnumb>006488</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060619</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060619</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RINDERON</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060612</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060612</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RINDERON</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060615</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060615</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RINDERON</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060619</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060619</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5044163-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0606USA05751</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ULCER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5044164-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CH-MERCK-0606CHE00015</companynumb>
    <primarysource>
      <reportercountry>SWITZERLAND</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5044165-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060621</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-MERCK-0606USA05695</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>75</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSED LEVEL OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIABETES MELLITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SHOCK</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>STROMECTOL</medicinalproduct>
        <drugauthorizationnumb>050742</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ACARODERMATITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060616</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060601</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLEGRA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ACARODERMATITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060616</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAKEPRON</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050901</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BASEN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050901</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYMMETREL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050901</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROCYLIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050901</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLYBURIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050901</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HARNAL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050901</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASTAT</medicinalproduct>
        <drugadministrationroute>061</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MYSER</medicinalproduct>
        <drugadministrationroute>061</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EURAX-H</medicinalproduct>
        <drugadministrationroute>061</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5044166-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060621</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-MERCK-0606USA05689</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>79</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>SHOCK</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COZAAR</medicinalproduct>
        <drugauthorizationnumb>20386</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM</medicinalproduct>
        <drugadministrationroute>051</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NAFAMOSTAT MESYLATE</medicinalproduct>
        <drugadministrationroute>051</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DALTEPARIN SODIUM</medicinalproduct>
        <drugadministrationroute>051</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5044167-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060530</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-MERCK-0606DEU00024</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>68</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FACIAL PALSY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA ORAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWELLING FACE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>20560</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060530</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHYLPREDNISOLONE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5044168-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060620</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ES-MERCK-0606ESP00018</companynumb>
    <primarysource>
      <reportercountry>SPAIN</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>45</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLINDNESS TRANSIENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLINDNESS UNILATERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CAROTID ARTERY OCCLUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RETINAL ISCHAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RETINOPATHY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MAXALT</medicinalproduct>
        <drugauthorizationnumb>20864</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MIGRAINE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060618</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060618</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5044169-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20051220</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0512USA03201</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>70</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>90</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>DEPRESSED LEVEL OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VYTORIN</medicinalproduct>
        <drugauthorizationnumb>021687</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051122</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ELAVIL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</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>ATENOLOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONAZEPAM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5044171-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060224</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-MERCK-0602FRA00093</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>70</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>AUTOIMMUNE HEPATITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROSCAR</medicinalproduct>
        <drugauthorizationnumb>20180</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BENIGN PROSTATIC HYPERPLASIA</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060222</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5044172-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060623</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-MERCK-0606USA05682</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>72</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ALANINE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASPARTATE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FACE OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEPCID</medicinalproduct>
        <drugauthorizationnumb>019462</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACTOS</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERCHOLESTEROLAEMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMARYL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SUCRALFATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HERBS (UNSPECIFIED)</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>[THERAPY UNSPECIFIED]</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5044175-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050111</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-391919</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>50</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL DISTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DUODENITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FUNGAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROENTERITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL INFLAMMATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GRAM STAIN POSITIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HIATUS HERNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PORTAL HYPERTENSIVE GASTROPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEG-INTERFERON ALFA 2A (RO 25-8310)</medicinalproduct>
        <drugdosagetext>FORM REPORTED AS SOLUTION.</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041012</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041214</drugenddate>
        <drugtreatmentduration>64</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RIBAVIRIN</medicinalproduct>
        <drugauthorizationnumb>021511</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041012</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041214</drugenddate>
        <drugtreatmentduration>64</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041028</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041211</drugenddate>
        <drugtreatmentduration>45</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
        <drugindication>HEADACHE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041206</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041206</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5044176-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041027</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-384601</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>19</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>63.5</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>COLITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLITIS ULCERATIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EPISTAXIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHOIDS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLAMMATORY BOWEL DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IRRITABLE BOWEL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTI-ORGAN DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NERVOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROCTITIS ULCERATIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROCTOCOLITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RECTAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>18662</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20011221</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020119</drugenddate>
        <drugtreatmentduration>30</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>018662</drugauthorizationnumb>
        <drugdosagetext>40 MG ALT WITH 80 MG QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020119</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMOCILLIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEPO-PROVERA SUSPENSION/INJ</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010809</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5044177-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20010206</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-ROCHE-254235</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>26</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG TOXICITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPHIL MORPHOLOGY ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRANSPLANT REJECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MYCOPHENOLATE MOFETIL</medicinalproduct>
        <drugauthorizationnumb>050723</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MYCOPHENOLATE MOFETIL</medicinalproduct>
        <drugauthorizationnumb>050723</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MYCOPHENOLATE MOFETIL</medicinalproduct>
        <drugauthorizationnumb>050723</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHYLPREDNISOLONE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NYSTATIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CO-TRIMOXAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACYCLOVIR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TACROLIMUS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5044178-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060627</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20060605900</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEAFNESS UNILATERAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugdosagetext>RECEIVING FOR APPROXIMATELY 2 YEARS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5044179-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050121</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-393380</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>14</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>54.4</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASCITES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASPARTATE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACTERIA URINE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CREATININE RENAL CLEARANCE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CREATININE URINE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CYSTITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EAR PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EMOTIONAL DISTRESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FOCAL GLOMERULOSCLEROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GLOMERULOSCLEROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATOMEGALY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HERPES ZOSTER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOACUSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERNAL INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>KIDNEY INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARYNGOLARYNGEAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROTEINURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUSITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VIRAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>18662</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ACNE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19970110</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19970615</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5044181-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-409504</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>27</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>74.8</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ACNE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLITIS ULCERATIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRY EYE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRY SKIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DUODENITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLAMMATORY BOWEL DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIP DRY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTI-ORGAN DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OESOPHAGITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROCTITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RECTAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>18662</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000714</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5044182-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050224</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-396709</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>19</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>54.4</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABORTION SPONTANEOUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ACNE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANHEDONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BILIARY DILATATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BREAST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CELLULITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLITIS ULCERATIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COSTOCHONDRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CROHN'S DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE BEFORE PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRY SKIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSMENORRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EAR PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EATING DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EMOTIONAL DISTRESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYSIPELAS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FACIAL BONES FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL STOMA COMPLICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGIC CYST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLAMMATORY BOWEL DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTESTINAL OBSTRUCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIP DRY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MAJOR DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOOD ALTERED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTI-ORGAN DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEPHROLITHIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA MOUTH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVARIAN CYST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POLYTRAUMATISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POUCHITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROCTITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RECTAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RETCHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SCOLIOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUS DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOFT TISSUE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPLENIC CYST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STRESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTH ABSCESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UPPER RESPIRATORY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UTERINE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VAGINAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VAGINITIS BACTERIAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>18662</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ACNE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990730</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19990915</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>018662</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19991029</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20000526</drugenddate>
        <drugtreatmentduration>211</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5044183-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20031016</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-349554</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>18</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ALANINE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASPARTATE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CHOLESTEROL INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD TRIGLYCERIDES INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLITIS ULCERATIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CROHN'S DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DERMATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISTURBANCE IN ATTENTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRY SKIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLAMMATORY BOWEL DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INGUINAL HERNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IRRITABLE BOWEL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIPOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENSTRUATION IRREGULAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OTITIS EXTERNA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>18662</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19921118</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19921215</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>018662</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19921215</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19930519</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>018662</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980617</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19990515</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADVIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DESOGEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALEVE (CAPLET)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5044186-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050623</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-408766</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>13</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>82.6</patientweight>
      <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>CYST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRY SKIN</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>RECTAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISION BLURRED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>18662</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ACNE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19880115</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19980715</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5044187-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-409415</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>23</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>73.5</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL ABSCESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAEMIA VITAMIN B12 DEFICIENCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CROHN'S DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL ANASTOMOTIC LEAK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HERNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLAMMATORY BOWEL DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTESTINAL OBSTRUCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTI-ORGAN DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEPHROLITHIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POLYARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RECTAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPONDYLOARTHROPATHY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>18662</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19890223</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19890615</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5044188-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041027</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-384683</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>14</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>47.6</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CAESAREAN SECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CELLULITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLITIS ULCERATIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CYSTITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DERMAL CYST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE BEFORE PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRY SKIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPEPSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EAR INFECTION</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>HUNGER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLAMMATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLAMMATORY BOWEL DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLUENZA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IRRITABLE BOWEL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JOINT STIFFNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>KELOID SCAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>KIDNEY INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIP DRY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METRORRHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTI-ORGAN DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAIL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NIGHT BLINDNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OTITIS EXTERNA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POLYARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POLYURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RAYNAUD'S PHENOMENON</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RECTAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ROAD TRAFFIC ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SIGMOIDITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUSITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STOMATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STRESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THIRST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UPPER RESPIRATORY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISION BLURRED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>18662</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ACNE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19930129</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19930715</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5044189-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-409447</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>36</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>67.6</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN LOWER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ACROCHORDON</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHROPOD STING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ATELECTASIS</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>CARDIAC FAILURE CONGESTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC HYPERTROPHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHOLECYSTITIS CHRONIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHOLELITHIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLITIS ULCERATIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONJUNCTIVITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CYST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CYSTITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIALYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRY EYE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRY SKIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DUPUYTREN'S CONTRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EAR INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GRANULOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATITIS C</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HIATUS HERNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMPAIRED HEALING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLAMMATORY BOWEL DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ISCHAEMIC HEPATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIMB INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG CONSOLIDATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MASS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENISCUS LESION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METABOLIC ACIDOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTI-ORGAN DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE STRAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUROPATHY PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANIC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARYNGITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARYNGOLARYNGEAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PILONIDAL CYST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA STAPHYLOCOCCAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY FIBROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PURPURA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RECTAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ROAD TRAFFIC ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SCAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SCIATICA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNOVIAL CYST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TENDONITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOTIC THROMBOCYTOPENIC PURPURA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UPPER RESPIRATORY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISION BLURRED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>18662</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19861016</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19870219</drugenddate>
        <drugtreatmentduration>127</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>018662</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19960710</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19961216</drugenddate>
        <drugtreatmentduration>160</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5044190-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050224</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-397552</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>16</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>83.9</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ALOPECIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAL FISTULA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>APPENDICECTOMY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASPARTATE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CAROTIDYNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CROHN'S DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRY EYE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRY SKIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPEPSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GRANULOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHOIDS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ILL-DEFINED DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLAMMATORY BOWEL DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIP DRY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPHADENITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTI-ORGAN DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NASAL DRYNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERIRECTAL ABSCESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POSTOPERATIVE ADHESION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS ANI</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RECTAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>18662</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ACNE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19920321</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19920815</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHYLPHENIDATE HCL</medicinalproduct>
        <drugdosagetext>PATIENT PURCHASED A PRESCRIPTION ON 26-MAR-98.</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RITALIN</medicinalproduct>
        <drugdosagetext>PATIENT PURCHASED NUMEROUS PRESCRIPTIONS BETWEEN 8-MAY-98 THROUGH 24-AUG-98.</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXTROSTAT</medicinalproduct>
        <drugdosagetext>PATIENT PURCHASED A PRESCRIPTION ON 15 OCTOBER 1998.</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXEDRINE</medicinalproduct>
        <drugdosagetext>PATIENT PURCHASED PRESCRIPTIONS BETWEEN 17-NOV-98 AND 10-DEC-98.</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADDERALL 10</medicinalproduct>
        <drugdosagetext>PATIENT PURCHASED PRESCRIPTIONS BETWEEN 9-JAN-99 AND 1-NOV-99.</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5044191-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060605</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>SE-ROCHE-450555</companynumb>
    <primarysource>
      <reportercountry>SWEDEN</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>ASTHMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG INFILTRATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEGASYS</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050315</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051015</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5044192-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20051216</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-ROCHE-428832</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>73</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>61.7</patientweight>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ESCHERICHIA URINARY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ISCHAEMIC STROKE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OESOPHAGITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPTIC SHOCK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CAPECITABINE</medicinalproduct>
        <drugbatchnumb>C208143-03, C212204</drugbatchnumb>
        <drugauthorizationnumb>20896</drugauthorizationnumb>
        <drugdosagetext>1650 MG TWICE DAILY FOR FOURTEEN DAYS EVERY THREE WEEKS.</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051129</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051214</drugenddate>
        <drugtreatmentduration>16</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVASTIN</medicinalproduct>
        <drugbatchnumb>M48683</drugbatchnumb>
        <drugauthorizationnumb>020896</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051129</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051214</drugenddate>
        <drugtreatmentduration>16</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXALIPLATIN</medicinalproduct>
        <drugbatchnumb>C216704-01, O522912</drugbatchnumb>
        <drugauthorizationnumb>020896</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051129</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051214</drugenddate>
        <drugtreatmentduration>16</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOFRAN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051129</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051202</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROCHLORPERAZINE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051129</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051214</drugenddate>
        <drugtreatmentduration>16</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5044193-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060531</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-ROCHE-451031</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>21</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>65.8</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>GINGIVAL RECESSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>018662</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ACNE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050913</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060415</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5044194-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060524</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-ROCHE-450352</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>22</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>60</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABORTION MISSED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIRACEPT</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060505</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060519</drugenddate>
        <drugtreatmentduration>15</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BIOVIR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN NOS</medicinalproduct>
        <drugdosagetext>DRUG NAME REPORTED AS POLYVITAMIN.</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FERROUS SULFATE TAB</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5044195-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060224</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-438218</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>28</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>81.6</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>EMOTIONAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLAMMATORY BOWEL DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERNAL INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IRRITABLE BOWEL SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>18662</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ACNE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030212</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030803</drugenddate>
        <drugtreatmentduration>173</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5044198-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060504</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-ROCHE-447080</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>19</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>67</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABORTION SPONTANEOUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE BEFORE PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UNWANTED PREGNANCY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ROACUTAN</medicinalproduct>
        <drugauthorizationnumb>18662</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ACNE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050815</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050915</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CONTRACEPTIVE NOS</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060223</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060223</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5044200-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-412370</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>20</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>68</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANAL FISSURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANHEDONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRONCHITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLITIS ULCERATIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHOIDS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAND FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC ENZYME INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLAMMATORY BOWEL DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IRON DEFICIENCY ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IRRITABLE BOWEL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG NEOPLASM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MICROCYTIC ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTI-ORGAN DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NASOPHARYNGITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARYNGOLARYNGEAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PILONIDAL CYST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTHAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>18662</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ACNE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990715</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19990915</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5044201-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060501</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-ROCHE-446795</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>45</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ALCOHOL USE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE CONGESTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG ABUSER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEG-INTERFERON A-2A (RO 25-8310)</medicinalproduct>
        <drugdosagetext>FORM = PRE-FILLED SYRINGE</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060410</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060419</drugenddate>
        <drugtreatmentduration>10</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RIBAVIRIN</medicinalproduct>
        <drugauthorizationnumb>021511</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060410</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060501</drugenddate>
        <drugtreatmentduration>22</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5044202-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060602</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-ROCHE-450420</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>81</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>78</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORTHOSTATIC HYPOTENSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAROXYL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060326</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAROXYL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060405</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060417</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>COTAREG</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ESSENTIAL HYPERTENSION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060326</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RIVOTRIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MOGADON</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5044203-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-433857</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>25</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>77.1</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>AGGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLITIS ULCERATIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CROHN'S DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLIGHT OF IDEAS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHOIDS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLAMMATORY BOWEL DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IRRITABLE BOWEL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JOINT DISLOCATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER FUNCTION TEST ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANIC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROCTITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>18662</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ACNE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19910201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19910815</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5044204-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060609</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-451526</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>21</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>NO ADVERSE EFFECT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PREGNANCY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>18662</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060215</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060305</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5044205-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060626</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20060505141</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>56.61</patientweight>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ACUTE RESPIRATORY DISTRESS SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD ALBUMIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ILEAL STENOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugdosagetext>AT WEEK 0, 2 AND 6.</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CROHN'S DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE TAB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE TAB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADVAIR DISKUS 100/50</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRILOSEC</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5044206-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060626</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20060502158</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>68.04</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYSTEMIC LUPUS ERYTHEMATOSUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugdosagetext>DOSE: ONCE EVERY 6 TO 8 WEEKS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CROHN'S DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DARVOCET</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMURAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLEGRA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EFFEXOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NIFEREX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5044207-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060327</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-442357</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>48</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>81.6</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENORRHAGIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEGASYS</medicinalproduct>
        <drugdosagetext>FORM WAS REPORTED AS PREFILLED SYRINGES. STRENGTH REPORTED AS 180MCG/0.5ML SYR.</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060122</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COPEGUS</medicinalproduct>
        <drugauthorizationnumb>021511</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060122</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>APRI</medicinalproduct>
        <drugdosagetext>BIRTH CONTROL PILLS.</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060221</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROTONIX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5044208-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060612</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-451792</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>80</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANGLE CLOSURE GLAUCOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KLONOPIN</medicinalproduct>
        <drugauthorizationnumb>17533</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030615</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EVISTA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EFFEXOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XALATAN</medicinalproduct>
        <drugdosagetext>AT BEDTIME.</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5044209-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060509</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>NL-ROCHE-448090</companynumb>
    <primarysource>
      <reportercountry>NETHERLANDS</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>40</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HEARING IMPAIRED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TINNITUS</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>20060210</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COPEGUS</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060210</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNSPECIFIED DRUG</medicinalproduct>
        <drugdosagetext>THE PATIENT PARTICIPATES IN A TRIAL CALLED POPS AND RECEIVES EITHER A PLACEBO OR AN ANTIDEPRESSANT +</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5044210-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060619</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-ROCHE-452557</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>36</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>68</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DYSPHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OESOPHAGEAL STENOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ROACCUTANE</medicinalproduct>
        <drugauthorizationnumb>18662</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ACNE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980515</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19980715</drugenddate>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5044211-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060626</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-ROCHE-453075</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ROAD TRAFFIC ACCIDENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VALIUM</medicinalproduct>
        <drugauthorizationnumb>013263</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>ANXIETY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5044221-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060630</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-ROCHE-453769</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>57</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>LUNG INFILTRATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELLCEPT</medicinalproduct>
        <drugauthorizationnumb>050722</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041205</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BLEOMYCIN</medicinalproduct>
        <drugdosagetext>30 MG PER MONTH.</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051005</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060102</drugenddate>
        <drugtreatmentduration>90</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREVISCAN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RAPAMUNE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CORTANCYL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5044222-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-453671</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>67</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>EMPHYSEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEGASYS</medicinalproduct>
        <drugdosagetext>ROUTE REPORTED AS INJ.</drugdosagetext>
        <drugadministrationroute>050</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060129</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RIBAVIRIN</medicinalproduct>
        <drugauthorizationnumb>021511</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060129</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5044224-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060522</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>NO-ROCHE-453631</companynumb>
    <primarysource>
      <reportercountry>NORWAY</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>25</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISTURBANCE IN ATTENTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRY EYE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRY MOUTH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EPISTAXIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JOINT STIFFNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSYCHOMOTOR SKILLS IMPAIRED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ROACCUTAN</medicinalproduct>
        <drugauthorizationnumb>18662</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ACNE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19841215</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19850415</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5044225-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-453494</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>41</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENORRHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEGASYS</medicinalproduct>
        <drugdosagetext>ROUTE REPORTED AS INJECTABLE.</drugdosagetext>
        <drugadministrationroute>050</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060516</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RIBAVIRIN</medicinalproduct>
        <drugauthorizationnumb>021511</drugauthorizationnumb>
        <drugdosagetext>DAILY.</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060516</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
        <drugindication>ANXIETY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5044226-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BE-ROCHE-453390</companynumb>
    <primarysource>
      <reportercountry>BELGIUM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>37</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>52</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PULMONARY FIBROSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEGASYS</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060324</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060617</drugenddate>
        <drugtreatmentduration>86</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COPEGUS</medicinalproduct>
        <drugauthorizationnumb>021511</drugauthorizationnumb>
        <drugdosagetext>DOSAGE REGIMEN REPORTED AS 4/DAY.</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060324</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060619</drugenddate>
        <drugtreatmentduration>88</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5044228-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060626</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-453352</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NO ADVERSE EFFECT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PREGNANCY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ISOTRETINOIN</medicinalproduct>
        <drugauthorizationnumb>018662</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060615</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5044229-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060626</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-ROCHE-453957</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>60</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATOCHEZIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BONIVA</medicinalproduct>
        <drugauthorizationnumb>021455</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060515</drugstartdate>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CA</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
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    </patient>
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  <safetyreport>
    <safetyreportid>5044230-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-ROCHE-453582</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>79</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HYPOKALAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPONATRAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RIVOTRIL</medicinalproduct>
        <drugauthorizationnumb>17533</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990615</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYANOCOBALAMINE</medicinalproduct>
        <drugdosagetext>ONE VIAL EVERY 15 HOURS</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010615</drugstartdate>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRACTAZIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060516</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TIAPRIDAL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060516</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVOTHYROX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19890615</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060517</drugenddate>
        <drugtreatmentduration>6181</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVOTHYROX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5044231-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ZA-ROCHE-453569</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>72</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>88.5</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INTERFERON ALFA-2A</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>NON-HODGKIN'S LYMPHOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030911</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030929</drugenddate>
        <drugtreatmentduration>19</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RITUXIMAB</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NON-HODGKIN'S LYMPHOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030911</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030929</drugenddate>
        <drugtreatmentduration>19</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5044237-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060626</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-BRISTOL-MYERS SQUIBB COMPANY-13432158</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>3</qualification>
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    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>53</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>SIMPLE PARTIAL SEIZURES</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ERBITUX</medicinalproduct>
        <drugdosagetext>1ST DOSE: 20SEP2005</drugdosagetext>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>OESOPHAGEAL SQUAMOUS CELL CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051221</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051221</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CISPLATIN</medicinalproduct>
        <drugauthorizationnumb>018057</drugauthorizationnumb>
        <drugdosagetext>1ST DOSE: 20SEP05</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>OESOPHAGEAL SQUAMOUS CELL CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051221</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051221</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOLINIC ACID</medicinalproduct>
        <drugdosagetext>1ST DOSE: 20SEP05</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>OESOPHAGEAL SQUAMOUS CELL CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051221</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051221</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUOROURACIL</medicinalproduct>
        <drugdosagetext>1ST DOSE: 20SEP05</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>OESOPHAGEAL SQUAMOUS CELL CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051221</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051221</drugenddate>
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    </patient>
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  <safetyreport>
    <safetyreportid>5044238-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060626</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-13428875</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
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    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <patientonsetage>16</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>RENAL CELL CARCINOMA STAGE UNSPECIFIED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREATMENT RELATED SECONDARY MALIGNANCY</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ETOPOSIDE</medicinalproduct>
        <drugauthorizationnumb>018768</drugauthorizationnumb>
        <drugindication>ACUTE PROMYELOCYTIC LEUKAEMIA</drugindication>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYTARABINE</medicinalproduct>
        <drugindication>ACUTE PROMYELOCYTIC LEUKAEMIA</drugindication>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>THIOGUANINE</medicinalproduct>
        <drugindication>ACUTE PROMYELOCYTIC LEUKAEMIA</drugindication>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DAUNORUBICIN HCL</medicinalproduct>
        <drugindication>ACUTE PROMYELOCYTIC LEUKAEMIA</drugindication>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE TAB</medicinalproduct>
        <drugindication>ACUTE PROMYELOCYTIC LEUKAEMIA</drugindication>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYTARABINE</medicinalproduct>
        <drugadministrationroute>037</drugadministrationroute>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
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    </patient>
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  <safetyreport>
    <safetyreportid>5044239-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060626</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ES-BRISTOL-MYERS SQUIBB COMPANY-13423918</companynumb>
    <primarysource>
      <reportercountry>SPAIN</reportercountry>
      <qualification>1</qualification>
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    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HYPERTENSIVE CRISIS</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAXOL</medicinalproduct>
        <drugauthorizationnumb>020262</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>LUNG NEOPLASM MALIGNANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060601</drugenddate>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARBOPLATIN</medicinalproduct>
        <drugauthorizationnumb>019880</drugauthorizationnumb>
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  <safetyreport>
    <safetyreportid>5044240-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060619</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-BRISTOL-MYERS SQUIBB COMPANY-13419791</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
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    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <patientonsetage>43</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ALANINE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASPARTATE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENDOXAN TABS</medicinalproduct>
        <drugauthorizationnumb>12141</drugauthorizationnumb>
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        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060413</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060511</drugenddate>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugauthorizationnumb>086358</drugauthorizationnumb>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060413</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060511</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUOROURACIL</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060413</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060511</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5044241-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060626</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ES-BRISTOL-MYERS SQUIBB COMPANY-13423900</companynumb>
    <primarysource>
      <reportercountry>SPAIN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANGINA PECTORIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSIVE CRISIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAXOL</medicinalproduct>
        <drugauthorizationnumb>020262</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>OVARIAN CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060601</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARBOPLATIN</medicinalproduct>
        <drugauthorizationnumb>019880</drugauthorizationnumb>
        <drugindication>OVARIAN CANCER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5044242-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20051228</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-BRISTOL-MYERS SQUIBB COMPANY-13230529</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>72</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>60</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ALANINE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANOREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASPARTATE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE MARROW FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COGNITIVE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FAECES DISCOLOURED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATEMESIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MELAENA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NASOPHARYNGITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RED BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREATMENT NONCOMPLIANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ERBITUX</medicinalproduct>
        <drugdosagetext>440 MG/M2 12DEC05 (DAY 1) 250 MG/M2 16JAN06</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLORECTAL CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051226</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051226</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IRINOTECAN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLORECTAL CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051212</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051226</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OPSO</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051226</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060105</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGNESIUM OXIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051226</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060102</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GASMOTIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051226</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060102</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LINTON</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051226</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060102</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NOVAMIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051226</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060102</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PURSENNIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051226</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060102</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORAZEPAM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051226</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060102</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAKEPRON</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051226</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060102</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCONTIN</medicinalproduct>
        <drugdosagetext>20-40 MG 2 TABS PER DAY ; 1 EVERY 12 HOURS, ORALLY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051226</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060102</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5044255-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060508</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-BRISTOL-MYERS SQUIBB COMPANY-13374822</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>69</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>TOOTH DISCOLOURATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMPHO-MORONAL LOZENGE</medicinalproduct>
        <drugauthorizationnumb>50341</drugauthorizationnumb>
        <drugindication>ORAL CANDIDIASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060428</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060508</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5044256-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060615</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2006US07861</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>13</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>49.886</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ATRIOVENTRICULAR BLOCK FIRST DEGREE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ELECTROCARDIOGRAM ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOCALIN XR</medicinalproduct>
        <drugauthorizationnumb>21802</drugauthorizationnumb>
        <drugdosagetext>10 MG, QD IN A.M.</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATTENTION DEFICIT/HYPERACTIVITY DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050801</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugdosagetext>125 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BIPOLAR DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050801</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
        <drugdosagetext>75 MG, QD IN THE A.M.</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050801</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEPAKOTE</medicinalproduct>
        <drugdosagetext>500 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>AFFECTIVE DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050801</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5044257-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060627</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AVENTIS-200615526US</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>AKINESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BALANCE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGIC STROKE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOCALISED INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RED BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPLENOMEGALY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARAVA</medicinalproduct>
        <drugbatchnumb>487</drugbatchnumb>
        <drugauthorizationnumb>020905</drugauthorizationnumb>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19970101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060509</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL SPIROS</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOPRESSOR</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MIRAPEX</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SINGULAIR</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROTONIX</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugdosagetext>DOSE: TAKES PROTONIX OR PREVACID-ONE OR THE OTHER</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREVACID</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugdosagetext>DOSE: TAKES PREVACID OR PROTONIX-TAKES ONE OR THE OTHER</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOTREMIN</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KLONIPIN</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLOVENT</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SEREVENT</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARDURA</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WELLBUTRIN</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060509</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5044259-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AVENTIS-200615541US</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>AMMONIA INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISORIENTATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROENTERITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER FUNCTION TEST ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARAVA</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>020905</drugauthorizationnumb>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARAVA</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>020905</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLEXERIL</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5044260-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AVENTIS-200616770GDDC</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD ELECTROLYTES ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LETHARGY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE TIGHTNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>STIMATE</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>017922</drugauthorizationnumb>
        <drugadministrationroute>055</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060601</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMINOCAPROIC ACID</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060601</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5044261-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060421</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-AVENTIS-200612478EU</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>85</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANGINA PECTORIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEVICE FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WRONG TECHNIQUE IN DRUG USAGE PROCESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NITROLINGUAL PUMPSPRAY</medicinalproduct>
        <drugbatchnumb>DIN02238998/ LOT 116676</drugbatchnumb>
        <drugauthorizationnumb>086132</drugauthorizationnumb>
        <drugadministrationroute>060</drugadministrationroute>
        <drugindication>ANGINA PECTORIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060328</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONAZEPAM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060201</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5044262-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060612</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-AVENTIS-200611811JP</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>23</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>47</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD ALKALINE PHOSPHATASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ENTEROCOLITIS HAEMORRHAGIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARAVA</medicinalproduct>
        <drugauthorizationnumb>20905</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050829</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050831</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARAVA</medicinalproduct>
        <drugauthorizationnumb>020905</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060105</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDONINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060105</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOXONIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060105</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MUCOSTA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTRITIS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060105</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MUCOSTA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060105</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5044263-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060619</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-AVENTIS-200612227FR</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>85</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>EXTRAPYRAMIDAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERAL PHYSICAL HEALTH DETERIORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUROLEPTIC MALIGNANT SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LASILIX</medicinalproduct>
        <drugauthorizationnumb>16273</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060520</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IXEL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060519</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LOXAPAC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060515</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060521</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SOTALOL HCL</medicinalproduct>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060519</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREVISCAN</medicinalproduct>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060518</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5044274-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060623</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2006IT09649</companynumb>
    <primarysource>
      <reportercountry>ITALY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>67</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PEMPHIGOID</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URTICARIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VOLTAREN</medicinalproduct>
        <drugauthorizationnumb>019201</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRALGIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060612</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060612</drugenddate>
        <drugtreatmentduration>1440</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5044287-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2006JP09849</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>CARDIAC ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYELID OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VOLTAREN</medicinalproduct>
        <drugauthorizationnumb>019201</drugauthorizationnumb>
        <drugadministrationroute>054</drugadministrationroute>
        <drugindication>BACK PAIN</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5044288-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060609</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2006JP08786</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>75</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DYSSTASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EMBOLISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPINAL DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VOLTAREN</medicinalproduct>
        <drugauthorizationnumb>19201</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALTREX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PARAESTHESIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5044289-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060626</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHFR2006GB02126</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>76</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD POTASSIUM INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRIC ULCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LETHARGY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>150 MG, QD</drugdosagetext>
        <drugindication>CARDIOVASCULAR DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN W/ CODEINE</medicinalproduct>
        <drugdosagetext>UNK, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
        <drugdosagetext>40 MBQ, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MYOCARDIAL ISCHAEMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
        <drugdosagetext>500 MG, TID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS NON-INSULIN-DEPENDENT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VOLTAREN</medicinalproduct>
        <drugauthorizationnumb>019201</drugauthorizationnumb>
        <drugdosagetext>UNK, TID</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NOVOMIX</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRONOLACTONE</medicinalproduct>
        <drugdosagetext>25 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MYOCARDIAL ISCHAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060516</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN B-12</medicinalproduct>
        <drugdosagetext>UNK, Q3MO</drugdosagetext>
        <drugadministrationroute>051</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5044304-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20020905</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BE-NOVOPROD-219893</companynumb>
    <primarysource>
      <reportercountry>BELGIUM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>28</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DIABETES MELLITUS INADEQUATE CONTROL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISEASE RECURRENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMMUNOSUPPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>REACTION TO DRUG EXCIPIENTS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACTRAPID? PENFILL? HM(GE) 3 ML</medicinalproduct>
        <drugauthorizationnumb>19938</drugauthorizationnumb>
        <drugdosagetext>26 IU, QD</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19890101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20021015</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACTRAPID? PENFILL? HM(GE) 3 ML</medicinalproduct>
        <drugauthorizationnumb>019938</drugauthorizationnumb>
        <drugdosagetext>16 IU, QD</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020830</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MONOTARD? HM(GE)</medicinalproduct>
        <drugdosagetext>45 IU, QD</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MONOTARD? HM(GE)</medicinalproduct>
        <drugdosagetext>63 IU, QD</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020830</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MONOTARD? HM(GE)</medicinalproduct>
        <drugdosagetext>55-60 IU /DAILY</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TENORMIN</medicinalproduct>
        <drugdosagetext>50 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN</medicinalproduct>
        <drugdosagetext>55-60 IU QD</drugdosagetext>
        <drugindication>HYPERGLYCAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5044305-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060531</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006AP02467</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>70</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>46</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ATRIAL FIBRILLATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ATRIOVENTRICULAR BLOCK THIRD DEGREE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRADYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROCEDURAL COMPLICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENTRICULAR TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ANAPEINE</medicinalproduct>
        <drugauthorizationnumb>20533</drugauthorizationnumb>
        <drugadministrationroute>008</drugadministrationroute>
        <drugindication>EPIDURAL ANAESTHESIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIPRIVAN</medicinalproduct>
        <drugauthorizationnumb>019627</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>GENERAL ANAESTHESIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYGEN</medicinalproduct>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>GENERAL ANAESTHESIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5044307-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060703</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006CG01146</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>71</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANAPHYLACTIC SHOCK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CREATINE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TINNITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RHINOCORT</medicinalproduct>
        <drugauthorizationnumb>20746</drugauthorizationnumb>
        <drugadministrationroute>045</drugadministrationroute>
        <drugindication>NASAL POLYPS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060617</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060617</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLAMOXYL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060617</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060617</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVLOCARDYL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIVARIUS</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRANXENE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5044308-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006SE03657</companynumb>
    <primarysource>
      <reportercountry>SOUTH AFRICA</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>AMNESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISTURBANCE IN ATTENTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugauthorizationnumb>020639</drugauthorizationnumb>
        <drugdosagetext>25 MG IN THE MORNING+25 MG DAYTIME+ 50 MG AT NIGHT</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BIPOLAR DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060612</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LAMICTAL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5044309-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060624</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2006IN09417</companynumb>
    <primarysource>
      <reportercountry>INDIA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>22</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ILEUS PARALYTIC</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VOVERAN</medicinalproduct>
        <drugauthorizationnumb>19201</drugauthorizationnumb>
        <drugdosagetext>TWO INJECTION AT A GAP OF 15 HOURS</drugdosagetext>
        <drugindication>PROCEDURAL PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RANITIDINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANTOPRAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KETAMINE HCL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5044320-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060705</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-SANOFI-SYNTHELABO-F01200601581</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>50</patientweight>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERAL PHYSICAL HEALTH DETERIORATION</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>STOMATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CALCIUM LEVOFOLINATE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051012</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051013</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUOROURACIL</medicinalproduct>
        <drugdosagetext>500 MG/BODY=349.7 MG/M2 IN BOLUS THEN 750 MG/BODY=524.5 MG/M2 AS INFUSION, D1+2</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051012</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051013</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXALIPLATIN</medicinalproduct>
        <drugauthorizationnumb>021492</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLON CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051012</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051012</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>805</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5044322-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060630</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006AC01224</companynumb>
    <primarysource>
      <reportercountry>NETHERLANDS</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>44</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugauthorizationnumb>021366</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030825</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5044323-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060511</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006PK01043</companynumb>
    <primarysource>
      <reportercountry>AUSTRIA</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>26994</patientonsetage>
      <patientonsetageunit>804</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MACULAR DEGENERATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARIMIDEX</medicinalproduct>
        <drugauthorizationnumb>020541</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051101</drugenddate>
        <drugtreatmentduration>33</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARIMIDEX</medicinalproduct>
        <drugauthorizationnumb>020541</drugauthorizationnumb>
        <drugdosagetext>RANDOMIZING</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051108</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5044324-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060626</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006AP02933</companynumb>
    <primarysource>
      <reportercountry>INDIA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>17691</patientonsetage>
      <patientonsetageunit>804</patientonsetageunit>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>DYSPHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GRAND MAL CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL INTAKE REDUCED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROAT IRRITATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IRESSA</medicinalproduct>
        <drugauthorizationnumb>021399</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>LIP AND/OR ORAL CAVITY CANCER RECURRENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050825</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTIVITAMIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MEDICAL DIET</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050821</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLOGEN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INFECTION PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050822</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM CHLORIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPOKALAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050823</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLOTRIMAZOLE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INFECTION PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060318</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TEGRETOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN IN JAW</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060320</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ELTROXIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPOTHYROIDISM</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060318</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5044325-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20030418</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GR-SANOFI-SYNTHELABO-A01200301867</companynumb>
    <primarysource>
      <reportercountry>GREECE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>33</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG ABUSER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG DEPENDENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG TOLERANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEMORY IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ROAD TRAFFIC ACCIDENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOLPIDEM TARTRATE</medicinalproduct>
        <drugauthorizationnumb>019908</drugauthorizationnumb>
        <drugdosagetext>1-2 TABLETS EVERY MORNING</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INSOMNIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOLPIDEM TARTRATE</medicinalproduct>
        <drugauthorizationnumb>019908</drugauthorizationnumb>
        <drugdosagetext>1-2 TABLETS EVERY MORNING</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>EUPHORIC MOOD</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOLPIDEM TARTRATE</medicinalproduct>
        <drugauthorizationnumb>019908</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOLPIDEM TARTRATE</medicinalproduct>
        <drugauthorizationnumb>019908</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5044337-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060601</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-SANOFI-SYNTHELABO-A03200603500</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>79</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANAPHYLACTIC SHOCK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>APNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIO-RESPIRATORY ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ELOXATIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>21492</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLORECTAL CANCER STAGE III</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060510</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060510</drugenddate>
        <drugtreatmentduration>10</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEUCOVORIN CALCIUM</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLORECTAL CANCER STAGE III</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUOROURACIL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLORECTAL CANCER STAGE III</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5044338-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060601</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-SANOFI-SYNTHELABO-A03200603496</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>67</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAPHYLACTIC SHOCK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIO-RESPIRATORY ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ELOXATIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>21492</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>HEPATIC NEOPLASM MALIGNANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060531</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060531</drugenddate>
        <drugtreatmentduration>30</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIGOXIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENALAPRIL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GEMCITABINE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>HEPATIC NEOPLASM MALIGNANT</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5044339-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006AP03013</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>65</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>LIVER FUNCTION TEST ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOGLOBIN URINE PRESENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POST PROCEDURAL COMPLICATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIPRIVAN</medicinalproduct>
        <drugauthorizationnumb>019627</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>INDUCTION OF ANAESTHESIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEVOFLURANE</medicinalproduct>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>MAINTENANCE OF ANAESTHESIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5044340-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060621</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006AP02867</companynumb>
    <primarysource>
      <reportercountry>ITALY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>23017</patientonsetage>
      <patientonsetageunit>804</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CAROTID ARTERY STENOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARIMIDEX</medicinalproduct>
        <drugauthorizationnumb>20541</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050615</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAVOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM SUPPLEMENTATION</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TORVAST</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5044341-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060601</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006PK01189</companynumb>
    <primarysource>
      <reportercountry>SWITZERLAND</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>80</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>61</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERAL PHYSICAL HEALTH DETERIORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOKALAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPONATRAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VAGINAL CANDIDIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TENERETIC MITE</medicinalproduct>
        <drugauthorizationnumb>18760</drugauthorizationnumb>
        <drugdosagetext>50/ 12.5 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ESSENTIAL HYPERTENSION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050515</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AUGMENTIN '125'</medicinalproduct>
        <drugdosagetext>875 /125 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ERYSIPELAS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050513</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050515</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5044342-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060616</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006AP02781</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>887</patientonsetage>
      <patientonsetageunit>802</patientonsetageunit>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>CEREBRAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC FUNCTION ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOLADEX</medicinalproduct>
        <drugauthorizationnumb>20578</drugauthorizationnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PROSTATE CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040811</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060606</drugenddate>
        <drugtreatmentduration>665</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOLADEX</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PROSTATE CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021120</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROSTAL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROSTATE CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021106</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060606</drugenddate>
        <drugtreatmentduration>1308</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5044343-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060609</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006SE03280</companynumb>
    <primarysource>
      <reportercountry>DENMARK</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>27544</patientonsetage>
      <patientonsetageunit>804</patientonsetageunit>
      <patientweight>121</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>COLONIC POLYP</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ROSUVASTATIN</medicinalproduct>
        <drugauthorizationnumb>21366</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CARDIOVASCULAR EVENT PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060309</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATACAND</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SERTRALINE HCL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19890101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMOZOP</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INSOMNIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19960101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060607</drugenddate>
        <drugtreatmentduration>10</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SEREPAX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PANIC DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19890101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5044344-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060626</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006SE03566</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>26211</patientonsetage>
      <patientonsetageunit>804</patientonsetageunit>
      <patientweight>51</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANAPHYLACTOID REACTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BLOPRESS TABLETS 4</medicinalproduct>
        <drugauthorizationnumb>20838</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060612</drugenddate>
        <drugtreatmentduration>13</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALTAN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLEGRA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060526</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060606</drugenddate>
        <drugtreatmentduration>12</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEPAS</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOID G</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTRIC ULCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060602</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GASTROM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTRIC ULCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060602</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLAKAY</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THYRADIN S</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDONINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CINAL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POSTERISAN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LAXOBERON</medicinalproduct>
        <drugdosagetext>AS NEEDED</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLINORIL</medicinalproduct>
        <drugdosagetext>AS NEEDED</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BACK PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060602</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VOLTAREN</medicinalproduct>
        <drugadministrationroute>054</drugadministrationroute>
        <drugindication>BACK PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060602</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EPOGEN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BLUTAL</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HEPARIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5044355-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060626</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2006ES09553</companynumb>
    <primarysource>
      <reportercountry>SPAIN</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>49</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BONE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTH EXTRACTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOLEDRONATE</medicinalproduct>
        <drugauthorizationnumb>21223</drugauthorizationnumb>
        <drugdosagetext>4 MG, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5044356-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060627</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2006AT09621</companynumb>
    <primarysource>
      <reportercountry>AUSTRIA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugauthorizationnumb>021223</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5044367-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060426</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHFR2006GB01566</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>75</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LETHARGY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROSTATIC SPECIFIC ANTIGEN INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugauthorizationnumb>021223</drugauthorizationnumb>
        <drugdosagetext>UNK, UNK</drugdosagetext>
        <drugindication>PROSTATE CANCER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5044368-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060627</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2006NO09615</companynumb>
    <primarysource>
      <reportercountry>NORWAY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugauthorizationnumb>021223</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5044369-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060624</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2006US08272</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BONE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DENTAL TREATMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MASTICATION DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOUTH ULCERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL INTAKE REDUCED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugauthorizationnumb>021223</drugauthorizationnumb>
        <drugdosagetext>UNK Q3MO</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PROSTATE CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051022</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PACLITAXEL + CARBOPLATIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DES</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051120</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARANESP</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060126</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEUPOGEN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060301</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5044370-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060613</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2006US07772</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>39</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BONE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG DOSE OMISSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN JAW</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTH LOSS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugauthorizationnumb>21223</drugauthorizationnumb>
        <drugdosagetext>4MG QMO</drugdosagetext>
        <drugindication>METASTASES TO BONE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020307</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NAVELBINE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030605</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030605</drugenddate>
        <drugtreatmentduration>1440</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XELODA</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030605</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030605</drugenddate>
        <drugtreatmentduration>1440</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XELODA</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030624</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040116</drugenddate>
        <drugtreatmentduration>207</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GEMZAR</medicinalproduct>
        <drugdosagetext>1000MG Q2WK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040409</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050311</drugenddate>
        <drugtreatmentduration>337</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CISPLATIN</medicinalproduct>
        <drugdosagetext>40MG Q2WK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040409</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050311</drugenddate>
        <drugtreatmentduration>337</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAXOTERE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020814</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050507</drugenddate>
        <drugtreatmentduration>998</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5044375-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050309</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHNR2005AU00628</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>57</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ACTINOMYCOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOCAL SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOMYELITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN JAW</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROSTHESIS IMPLANTATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PURULENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SECRETION DISCHARGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugauthorizationnumb>21223</drugauthorizationnumb>
        <drugdosagetext>4 MG, QMO</drugdosagetext>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAMIDRONATE DISODIUM</medicinalproduct>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050201</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5044385-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060626</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GR-JNJFOC-20060605586</companynumb>
    <primarysource>
      <reportercountry>GREECE</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>35</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>EPSTEIN-BARR VIRUS TEST POSITIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HODGKIN'S DISEASE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugdosagetext>WEEK 2</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugdosagetext>WEEK 0</drugdosagetext>
        <drugindication>CROHN'S DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugindication>CROHN'S DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MESALAZINE</medicinalproduct>
        <drugindication>CROHN'S DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHYLPREDNISONE</medicinalproduct>
        <drugindication>CROHN'S DISEASE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5044404-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060621</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-BRISTOL-MYERS SQUIBB COMPANY-13427844</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>5</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>BONE SARCOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LASTET</medicinalproduct>
        <drugauthorizationnumb>18768</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RETINOBLASTOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990225</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENDOXAN</medicinalproduct>
        <drugauthorizationnumb>012142</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RETINOBLASTOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990225</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARBOPLATIN</medicinalproduct>
        <drugauthorizationnumb>019880</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RETINOBLASTOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990225</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IFOSFAMIDE</medicinalproduct>
        <drugauthorizationnumb>019763</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RETINOBLASTOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>THERARUBICIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RETINOBLASTOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990225</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALKERAN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RETINOBLASTOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MABLIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RETINOBLASTOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>THIOTEPA</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RETINOBLASTOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990601</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5044405-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060523</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-13387675</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>67</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE CONGESTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
        <drugauthorizationnumb>9218</drugauthorizationnumb>
        <drugindication>CEREBROVASCULAR ACCIDENT</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5044406-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060627</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-13427216</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>ENDOPHTHALMITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KENALOG-40</medicinalproduct>
        <drugbatchnumb>5M01513</drugbatchnumb>
        <drugauthorizationnumb>014901</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5044407-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060426</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-13358148</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>76</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD ALBUMIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERALISED OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALNUTRITION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CISPLATIN</medicinalproduct>
        <drugauthorizationnumb>18057</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050125</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TS-1</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050125</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050211</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOFRAN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANTIEMETIC SUPPORTIVE CARE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050125</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COLACE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIARRHOEA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050118</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EMEND</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANTIEMETIC SUPPORTIVE CARE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050125</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050127</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIURETIC THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050125</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FENTANYL TRANSDERMAL SYSTEM</medicinalproduct>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050125</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5044408-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060501</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-13364633</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>28</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHORIOAMNIONITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CRANIAL SUTURES WIDENING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FOETAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FUNISITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYDROCEPHALUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTRAUTERINE INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MECONIUM ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEONATAL ASPIRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHLEBITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLACENTAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLACENTAL INSUFFICIENCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMOCYSTIS JIROVECI PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STILLBIRTH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZERIT</medicinalproduct>
        <drugauthorizationnumb>20412</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060109</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMBIVIR</medicinalproduct>
        <drugdosagetext>600/300</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051114</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060109</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIRACEPT</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051114</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EPIVIR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060109</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AZITHROMYCIN</medicinalproduct>
        <drugindication>ANTIBIOTIC PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACYCLOVIR</medicinalproduct>
        <drugindication>HERPES SIMPLEX</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5044409-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060504</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-13366323</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>71</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>113</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
        <drugbatchnumb>ETF35014</drugbatchnumb>
        <drugauthorizationnumb>9218</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
        <drugbatchnumb>ETF35014</drugbatchnumb>
        <drugauthorizationnumb>009218</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CORONARY ARTERY DISEASE</drugindication>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugindication>CORONARY ARTERY DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMDUR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANOXIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VYTORIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HUMULIN 70/30</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5044410-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060626</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IT-BRISTOL-MYERS SQUIBB COMPANY-13425079</companynumb>
    <primarysource>
      <reportercountry>ITALY</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>77</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>LYMPHOPROLIFERATIVE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NON-HODGKIN'S LYMPHOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREATMENT RELATED SECONDARY MALIGNANCY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugauthorizationnumb>86358</drugauthorizationnumb>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOSPORINE</medicinalproduct>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5044411-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
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    <receiptdate>20060531</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-BRISTOL-MYERS SQUIBB COMPANY-13399712</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>5</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>AUTOLOGOUS BONE MARROW TRANSPLANTATION THERAPY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE MARROW FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE SARCOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THERAPY NON-RESPONDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREATMENT RELATED SECONDARY MALIGNANCY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LASTET</medicinalproduct>
        <drugauthorizationnumb>18768</drugauthorizationnumb>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>RETINOBLASTOMA BILATERAL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990225</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19990501</drugenddate>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PARAPLATIN</medicinalproduct>
        <drugauthorizationnumb>019880</drugauthorizationnumb>
        <drugindication>RETINOBLASTOMA BILATERAL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990225</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19990501</drugenddate>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOPHOSPHAMIDE</medicinalproduct>
        <drugauthorizationnumb>012142</drugauthorizationnumb>
        <drugindication>RETINOBLASTOMA BILATERAL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990225</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19990501</drugenddate>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IFOSFAMIDE</medicinalproduct>
        <drugauthorizationnumb>019763</drugauthorizationnumb>
        <drugindication>RETINOBLASTOMA BILATERAL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19990601</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PIRARUBICIN HCL</medicinalproduct>
        <drugindication>RETINOBLASTOMA BILATERAL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990225</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19990501</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MELPHALAN</medicinalproduct>
        <drugindication>RETINOBLASTOMA BILATERAL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19990601</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MABLIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RETINOBLASTOMA BILATERAL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19991001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19991001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>THIOTEPA</medicinalproduct>
        <drugindication>RETINOBLASTOMA BILATERAL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19991001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19991001</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5044421-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060630</receiptdate>
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    <companynumb>PHHO2006IT10671</companynumb>
    <primarysource>
      <reportercountry>ITALY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>82</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>74</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ABDOMINAL OPERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTESTINAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ICL670A</medicinalproduct>
        <drugauthorizationnumb>21882</drugauthorizationnumb>
        <drugdosagetext>1500 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD IRON INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060526</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5044422-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060615</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AVENTIS-200615292US</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>109</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POOR QUALITY DRUG ADMINISTERED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>21081</drugauthorizationnumb>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
        <drugindication>DIABETES MELLITUS NON-INSULIN-DEPENDENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OPTICLIK (INSULIN INJECTION PEN)</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021081</drugauthorizationnumb>
        <drugindication>DIABETES MELLITUS NON-INSULIN-DEPENDENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5044423-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060607</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-AVENTIS-200611795JP</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>72</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANOREXIA</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 UREA INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BODY TEMPERATURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSED LEVEL OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GLYCOSYLATED HAEMOGLOBIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATOCRIT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROTEIN TOTAL DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RED BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY RATE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMARYL</medicinalproduct>
        <drugauthorizationnumb>20496</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS NON-INSULIN-DEPENDENT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CANDESARTAN CILEXETIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD PRESSURE MANAGEMENT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE BESYLATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD PRESSURE MANAGEMENT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>THROMBOSIS PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOXOPROFEN SODIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EPERISONE HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPOTONIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5044424-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060510</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-AVENTIS-200611369DE</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>72</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DEVICE FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEMORAL NECK FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FOREIGN BODY TRAUMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEDICAL DEVICE COMPLICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>21081</drugauthorizationnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060301</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5044425-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060519</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-AVENTIS-200611914FR</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>80</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE VASOVAGAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMARYL</medicinalproduct>
        <drugauthorizationnumb>20496</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS NON-INSULIN-DEPENDENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMARYL</medicinalproduct>
        <drugauthorizationnumb>020496</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMARYL</medicinalproduct>
        <drugauthorizationnumb>020496</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COAPROVEL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDIATENSYL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5044426-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060627</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IT-AVENTIS-200616871GDDC</companynumb>
    <primarysource>
      <reportercountry>ITALY</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CAESAREAN SECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EFFECT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRE-ECLAMPSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UNWANTED PREGNANCY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INSULIN GLARGINE</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>21081</drugauthorizationnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NPH INSULIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NPH INSULIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN NOS</medicinalproduct>
        <drugdosagetext>FREQUENCY: BEFORE MEALS</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5044427-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060627</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>SA-AVENTIS-200616831GDDC</companynumb>
    <primarysource>
      <reportercountry>SAUDI ARABIA</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABORTION</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>GLYCOSYLATED HAEMOGLOBIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INSULIN GLARGINE</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>21081</drugauthorizationnumb>
        <drugadministrationroute>058</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5044428-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060627</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>SA-AVENTIS-200616838GDDC</companynumb>
    <primarysource>
      <reportercountry>SAUDI ARABIA</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABNORMAL LABOUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABORTION</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>GLYCOSYLATED HAEMOGLOBIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INSULIN GLARGINE</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>21081</drugauthorizationnumb>
        <drugadministrationroute>058</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5044429-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060627</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>SA-AVENTIS-200616840GDDC</companynumb>
    <primarysource>
      <reportercountry>SAUDI ARABIA</reportercountry>
    </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>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FOETAL DISTRESS SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INSULIN GLARGINE</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>21081</drugauthorizationnumb>
        <drugadministrationroute>058</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5044430-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060627</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>SA-AVENTIS-200616841GDDC</companynumb>
    <primarysource>
      <reportercountry>SAUDI ARABIA</reportercountry>
    </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>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FOETAL DISTRESS SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INSULIN GLARGINE</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>21081</drugauthorizationnumb>
        <drugadministrationroute>058</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5044436-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060110</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHO2006FR00793</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>77</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>71</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AGRANULOCYTOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ICL670A</medicinalproduct>
        <drugauthorizationnumb>21882</drugauthorizationnumb>
        <drugdosagetext>1500 MG DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD IRON INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051122</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051224</drugenddate>
        <drugtreatmentduration>47520</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORAZEPAM</medicinalproduct>
        <drugdosagetext>1 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INSOMNIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19700101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
        <drugdosagetext>100 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19920101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MACROGOL</medicinalproduct>
        <drugdosagetext>2 DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONSTIPATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5044437-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040719</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0519849A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>33</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>114.5</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANGER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BREAST MASS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRUXISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG WITHDRAWAL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROOESOPHAGEAL REFLUX DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERACUSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTHYROIDISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSULIN RESISTANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERVERTEBRAL DISC PROTRUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEMORY IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NIGHTMARE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OBSESSIVE THOUGHTS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANIC ATTACK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHOTOSENSITIVITY REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEXUAL DYSFUNCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TINNITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
        <drugauthorizationnumb>20031</drugauthorizationnumb>
        <drugdosagetext>10MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANXIETY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19970501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19990801</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANXIETY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990801</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KLONOPIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INDERAL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5044438-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050503</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0558206A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <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>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISTURBANCE IN ATTENTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG WITHDRAWAL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE IRRITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HALLUCINATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOOD SWINGS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NIGHTMARE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANIC ATTACK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOCIAL PHOBIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TINNITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
        <drugauthorizationnumb>20031</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19960701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONAZEPAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SINGULAIR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPAMAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEPAKOTE ER</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5044439-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050509</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0558603A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>32</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CRYING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG WITHDRAWAL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HOMICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMPULSIVE BEHAVIOUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IRRITABILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSYCHOMOTOR HYPERACTIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEXUAL DYSFUNCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
        <drugauthorizationnumb>20031</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19970501</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAROXETINE HCL</medicinalproduct>
        <drugdosagetext>40MG UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BUSPIRONE HCL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5044440-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050509</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0558624A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>21</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>AGORAPHOBIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CRYING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG WITHDRAWAL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FRUSTRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HALLUCINATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOTION SICKNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE TWITCHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NERVOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAXIL CR</medicinalproduct>
        <drugauthorizationnumb>20936</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020801</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5044441-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050509</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0558625A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>64</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>AGGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BALANCE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMPUTERISED TOMOGRAM ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG WITHDRAWAL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ENCEPHALOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IRRITABILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEMORY IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENTAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MICROANGIOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOOD SWINGS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULAR WEAKNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUROLOGICAL SYMPTOM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERSONALITY CHANGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SENSATION OF BLOOD FLOW</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SENSORY DISTURBANCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAXIL CR</medicinalproduct>
        <drugauthorizationnumb>20936</drugauthorizationnumb>
        <drugdosagetext>12.5MG UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANXIETY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
        <drugauthorizationnumb>020710</drugauthorizationnumb>
        <drugdosagetext>10MG UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANXIETY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040804</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BEXTRA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KLONOPIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5044442-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050714</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0566535A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>24</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHILLS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CRYING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG WITHDRAWAL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSARTHRIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPEPSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING JITTERY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HALLUCINATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HOT FLUSH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERACUSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IRRITABILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOOD SWINGS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOTION SICKNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANIC ATTACK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAROSMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISION BLURRED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
        <drugauthorizationnumb>20031</drugauthorizationnumb>
        <drugdosagetext>10MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040701</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
        <drugauthorizationnumb>020710</drugauthorizationnumb>
        <drugdosagetext>7MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040801</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BEXTRA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PENTASA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ORTHO TRI-CYCLEN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5044443-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20051020</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0579020A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>16</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>EDUCATIONAL PROBLEM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDE ATTEMPT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREATMENT NONCOMPLIANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VICTIM OF CRIME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAXIL CR</medicinalproduct>
        <drugauthorizationnumb>20936</drugauthorizationnumb>
        <drugdosagetext>25MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANXIETY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021022</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030502</drugenddate>
        <drugtreatmentduration>194</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLONASE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLARITIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KLONOPIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEPO-PROVERA SUSPENSION/INJ</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BUSPAR</medicinalproduct>
        <drugdosagetext>5MG THREE TIMES PER DAY</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5044444-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060222</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0594804A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>39</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>85.5</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ADVAIR DISKUS 100/50</medicinalproduct>
        <drugauthorizationnumb>21077</drugauthorizationnumb>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISONE TAB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARBAMAZEPINE</medicinalproduct>
        <drugindication>CONVULSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5044445-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060224</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0595118A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>27</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>95.5</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FACIAL PARESIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEMIPLEGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULAR WEAKNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VASOSPASM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISION BLURRED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMITREX</medicinalproduct>
        <drugauthorizationnumb>20080</drugauthorizationnumb>
        <drugdosagetext>6MG SINGLE DOSE</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>MIGRAINE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050804</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050804</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5044447-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060403</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>8011022</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>58</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>110</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ALANINE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASPARTATE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATOCRIT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC NECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LETHARGY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POST PROCEDURAL COMPLICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZANTAC</medicinalproduct>
        <drugauthorizationnumb>18703</drugauthorizationnumb>
        <drugdosagetext>150MG SEE DOSAGE TEXT</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTROINTESTINAL DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050625</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050705</drugenddate>
        <drugtreatmentduration>11</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KEPPRA</medicinalproduct>
        <drugdosagetext>500MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONVULSION PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050616</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSPHENYTOIN SODIUM</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CONVULSION PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050628</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050629</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE TAB</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GABAPENTIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>CONVULSION PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050701</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5044448-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060518</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0606240A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>23</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEATH NEONATAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLACENTAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PREMATURE LABOUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMOTRIGINE</medicinalproduct>
        <drugauthorizationnumb>20241</drugauthorizationnumb>
        <drugdosagetext>300MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>EPILEPSY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPAMAX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5044449-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060525</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0606937A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>49</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>APHASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BASILAR ARTERY OCCLUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSKINESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FACIAL PALSY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLUENZA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOCKED-IN SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MIOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>20031</drugauthorizationnumb>
        <drugdosagetext>20MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19970101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PHENERGAN</medicinalproduct>
        <drugdosagetext>25MG SEE DOSAGE TEXT</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BIRTH CONTROL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5044451-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060613</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0608847A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>52</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>AGITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
        <drugauthorizationnumb>20936</drugauthorizationnumb>
        <drugdosagetext>37.5MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5044452-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesscongenitalanomali>1</seriousnesscongenitalanomali>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060613</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0609188B</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <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>CONGENITAL HYDRONEPHROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE VIA BREAST MILK</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMICTAL</medicinalproduct>
        <drugauthorizationnumb>20241</drugauthorizationnumb>
        <drugindication>SIMPLE PARTIAL SEIZURES</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060214</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRENATAL VITAMINS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COLACE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TUMS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5044453-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060620</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0609708A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>94</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>54.1</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANGER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BALANCE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HALLUCINATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOGORRHOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REQUIP</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>20658</drugauthorizationnumb>
        <drugdosagetext>1MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RESTLESS LEGS SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060606</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060620</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALPRAZOLAM</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>K-DUR 10</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROPRANOLOL</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZESTRIL</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DAYPRO</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5044455-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060627</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006-004757</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>19</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CATHETER SEPSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER FUNCTION TEST ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WRONG TECHNIQUE IN DRUG USAGE PROCESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLOLAN</medicinalproduct>
        <drugauthorizationnumb>020444</drugauthorizationnumb>
        <drugdosagetext>1.5MG CONTINUOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PULMONARY HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BOSENTAN</medicinalproduct>
        <drugindication>PULMONARY HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5044456-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060630</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0610916A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ACCIDENTAL EXPOSURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BUPROPION HYDROCHLORIDE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>018644</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CONCURRENT MEDICATIONS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5044457-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060630</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0610919A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
        <drugauthorizationnumb>020031</drugauthorizationnumb>
        <drugdosagetext>60MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIZZINESS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19950101</drugstartdate>
        <drugtreatmentduration>11</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5044458-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060703</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006UW10196</companynumb>
    <primarysource>
      <reportercountry>COLOMBIA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>ASTIGMATISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MACULOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH MACULAR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LITHIUM CARBONATE</medicinalproduct>
        <drugauthorizationnumb>016860</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BIPOLAR I DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>BIPOLAR I DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050830</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060115</drugenddate>
        <drugtreatmentduration>139</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALPROIC ACID</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HYPOTHYROIDISM</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORAZEPAM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>ANXIETY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5044459-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060703</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0610986A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>73</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOBILITY DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>12.5MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugtreatmentduration>30</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL SPIROS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANOXIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACEON</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5044461-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060703</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0611010A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HOMICIDE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
        <drugauthorizationnumb>020031</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROZAC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5044462-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006/00296</companynumb>
    <primarysource>
      <reportercountry>ARGENTINA</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>2.5</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTHERMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH PUSTULAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY DISTRESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMICTAL</medicinalproduct>
        <drugauthorizationnumb>020241</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALPROATE SODIUM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5044463-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060626</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-GLAXOSMITHKLINE-A0611048A</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>50</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>61</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLINDNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GLAUCOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BECLOSOL</medicinalproduct>
        <drugauthorizationnumb>19389</drugauthorizationnumb>
        <drugadministrationroute>045</drugadministrationroute>
        <drugindication>RHINITIS ALLERGIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5044464-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060627</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0611135A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>71.4</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABNORMAL DREAMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</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>DRUG WITHDRAWAL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERACUSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MANIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OBSESSIVE-COMPULSIVE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHOTOSENSITIVITY REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SLEEP DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
        <drugauthorizationnumb>020031</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANXIETY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
        <drugindication>PANIC DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INDERAL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FIORICET</medicinalproduct>
        <drugindication>HEADACHE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPAMAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5044465-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060630</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-GLAXOSMITHKLINE-A0611142A</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>23</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CYANOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTRA-UTERINE DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AEROLIN</medicinalproduct>
        <drugbatchnumb>FM0088V</drugbatchnumb>
        <drugauthorizationnumb>18473</drugauthorizationnumb>
        <drugdosagetext>2MG FOUR TIMES PER DAY</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PREMATURE LABOUR</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051105</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5044467-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060705</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0611151A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>75</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CONTUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMICTAL</medicinalproduct>
        <drugauthorizationnumb>020241</drugauthorizationnumb>
        <drugdosagetext>200MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NERVOUS SYSTEM DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060608</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060627</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLOMAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VESICARE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVODART</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMINS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5044468-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060705</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0611154A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>2</patientonsetage>
      <patientonsetageunit>803</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIOMYOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CRYING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LANOXIN</medicinalproduct>
        <drugauthorizationnumb>020405</drugauthorizationnumb>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NO CONCURRENT MEDICATION</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5044469-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060703</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0611189A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>LUNG NEOPLASM MALIGNANT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ADVAIR DISKUS 100/50</medicinalproduct>
        <drugauthorizationnumb>021077</drugauthorizationnumb>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CHEMOTHERAPY</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5044470-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20020618</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-GLAXOSMITHKLINE-B0271914A</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>25</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CONJUNCTIVAL SCAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONJUNCTIVITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRY EYE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLAMMATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>KERATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL INTAKE REDUCED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHOTOPHOBIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STEVENS-JOHNSON SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRICHIASIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMICTAL</medicinalproduct>
        <drugauthorizationnumb>20241</drugauthorizationnumb>
        <drugdosagetext>1UD PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>EPILEPSY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020227</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020318</drugenddate>
        <drugtreatmentduration>20</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CIRKAN</medicinalproduct>
        <drugindication>MEDICAL DIET</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020318</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDIATOR</medicinalproduct>
        <drugindication>MEDICAL DIET</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020318</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MINIDRIL</medicinalproduct>
        <drugindication>CONTRACEPTION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020318</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEPAKENE</medicinalproduct>
        <drugdosagetext>500MG THREE TIMES PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>EPILEPSY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HERBAL MEDICATION</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>MEDICAL DIET</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020318</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5044471-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050607</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-GLAXOSMITHKLINE-B0383952A</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>42</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FAECES DISCOLOURED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRIC ULCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC CIRRHOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VARICES OESOPHAGEAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EPIVIR</medicinalproduct>
        <drugauthorizationnumb>20564</drugauthorizationnumb>
        <drugdosagetext>150MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20011023</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIDEX EC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20011023</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTOVASE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20011023</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041111</drugenddate>
        <drugtreatmentduration>159</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NORVIR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20011023</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041111</drugenddate>
        <drugtreatmentduration>159</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NORVIR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050315</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REYATAZ</medicinalproduct>
        <drugdosagetext>400MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041112</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FACTOR VIII</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>FACTOR VIII DEFICIENCY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020401</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5044472-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050922</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CN-GLAXOSMITHKLINE-B0395279A</companynumb>
    <primarysource>
      <reportercountry>CHINA</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>25</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ALANINE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HBV DNA INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATITIS B E ANTIGEN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPTODIN</medicinalproduct>
        <drugauthorizationnumb>020564</drugauthorizationnumb>
        <drugdosagetext>100MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS B</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020920</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5044473-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060301</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-GLAXOSMITHKLINE-B0414648A</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>65</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>GLAUCOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RETINAL ISCHAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RETINAL VEIN OCCLUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL ACUITY REDUCED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DUTASTERIDE</medicinalproduct>
        <drugauthorizationnumb>21319</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NEOPLASM PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040723</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5044476-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060412</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IT-GLAXOSMITHKLINE-B0421029A</companynumb>
    <primarysource>
      <reportercountry>ITALY</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>31</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DERMATITIS ALLERGIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH MACULO-PAPULAR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AUGMENTIN '125'</medicinalproduct>
        <drugauthorizationnumb>050564</drugauthorizationnumb>
        <drugdosagetext>1G TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>COUGH</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060324</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060327</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5044477-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060510</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-JPN-A200601506</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>81</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>73</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DYSLALIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMODIALYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULAR WEAKNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL INTAKE REDUCED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VALTREX</medicinalproduct>
        <drugauthorizationnumb>20487</drugauthorizationnumb>
        <drugdosagetext>1000MG THREE TIMES PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HERPES ZOSTER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060506</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060510</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LOXONIN</medicinalproduct>
        <drugdosagetext>60MG THREE TIMES PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HERPES ZOSTER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060506</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060510</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MUCOSTA</medicinalproduct>
        <drugdosagetext>300MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060506</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060510</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </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>MICARDIS</medicinalproduct>
        <drugdosagetext>40MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EPADEL</medicinalproduct>
        <drugdosagetext>900MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERLIPIDAEMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>URINORM</medicinalproduct>
        <drugdosagetext>25MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERURICAEMIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5044478-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060626</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IN-GLAXOSMITHKLINE-B0423601B</companynumb>
    <primarysource>
      <reportercountry>INDIA</reportercountry>
      <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>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMOTRIGINE</medicinalproduct>
        <drugauthorizationnumb>020241</drugauthorizationnumb>
        <drugdosagetext>50MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PARTIAL SEIZURES</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051019</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5044479-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060516</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-GLAXOSMITHKLINE-B0423918A</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>49</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANGIONEUROTIC OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERALISED ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ILL-DEFINED DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLAMOXYL</medicinalproduct>
        <drugauthorizationnumb>62216</drugauthorizationnumb>
        <drugdosagetext>1G SINGLE DOSE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060117</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5044480-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060518</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-JPN-A200601640</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>81</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ILEUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
        <drugauthorizationnumb>20031</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060427</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060518</drugenddate>
        <drugtreatmentduration>22</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5044481-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060531</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-JPN-A200601819</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>55</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HYPERCHLORAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOKALAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHABDOMYOLYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEREVENT</medicinalproduct>
        <drugauthorizationnumb>20692</drugauthorizationnumb>
        <drugdosagetext>50MCG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060104</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060522</drugenddate>
        <drugtreatmentduration>139</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COLONEL</medicinalproduct>
        <drugdosagetext>1.2G THREE TIMES PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUTIDE DISKUS</medicinalproduct>
        <drugdosagetext>2U TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060117</drugstartdate>
        <drugtreatmentduration>56</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PL</medicinalproduct>
        <drugdosagetext>1G THREE TIMES PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GASMOTIN</medicinalproduct>
        <drugdosagetext>10MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050617</drugstartdate>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SHAKUYAKU-KANZO-TO</medicinalproduct>
        <drugdosagetext>2.5G THREE TIMES PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060307</drugstartdate>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KIPRES</medicinalproduct>
        <drugdosagetext>10MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010224</drugstartdate>
        <drugtreatmentduration>56</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VOLTAREN</medicinalproduct>
        <drugadministrationroute>054</drugadministrationroute>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
        <drugdosagetext>20MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050617</drugstartdate>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEILAX</medicinalproduct>
        <drugdosagetext>1MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030901</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEXOTAN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19840101</drugstartdate>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HUSTAZOL</medicinalproduct>
        <drugdosagetext>10MG THREE TIMES PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEPROMEL</medicinalproduct>
        <drugdosagetext>50MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050617</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SEDIEL</medicinalproduct>
        <drugdosagetext>10MG THREE TIMES PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060519</drugstartdate>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANDSEN</medicinalproduct>
        <drugdosagetext>1.5MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040701</drugstartdate>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADETPHOS</medicinalproduct>
        <drugdosagetext>3G PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050617</drugstartdate>
        <drugtreatmentduration>28</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHYLCOBAL</medicinalproduct>
        <drugdosagetext>750MCG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050617</drugstartdate>
        <drugtreatmentduration>28</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CEPHADOL</medicinalproduct>
        <drugdosagetext>75MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050117</drugstartdate>
        <drugtreatmentduration>28</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BUP-4</medicinalproduct>
        <drugdosagetext>20MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060106</drugstartdate>
        <drugtreatmentduration>60</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
        <drugdosagetext>5MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040423</drugstartdate>
        <drugtreatmentduration>30</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CEREKINON</medicinalproduct>
        <drugdosagetext>300MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000201</drugstartdate>
        <drugtreatmentduration>30</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PARIET</medicinalproduct>
        <drugdosagetext>10MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040213</drugstartdate>
        <drugtreatmentduration>30</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FERROMIA</medicinalproduct>
        <drugdosagetext>50MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010220</drugstartdate>
        <drugtreatmentduration>15</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5044482-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060607</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-GLAXOSMITHKLINE-B0426665A</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>68</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>COLOUR BLINDNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REQUIP</medicinalproduct>
        <drugauthorizationnumb>020658</drugauthorizationnumb>
        <drugdosagetext>4MG THREE TIMES PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PARKINSON'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060201</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5044483-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060614</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-GLAXOSMITHKLINE-B0427749A</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>1</patientonsetage>
      <patientonsetageunit>802</patientonsetageunit>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ACCIDENTAL OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AMMONIA INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CAESAREAN SECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBRAL ISCHAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSKINESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEEDING DISORDER NEONATAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERLACTACIDAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OXYGEN SUPPLEMENTATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALLOR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PREMATURE BABY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RETROVIR</medicinalproduct>
        <drugauthorizationnumb>19655</drugauthorizationnumb>
        <drugdosagetext>2.3MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANTIVIRAL PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060207</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060307</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EPIVIR</medicinalproduct>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VIRACEPT</medicinalproduct>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TENOFOVIR</medicinalproduct>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060201</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5044484-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060614</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BE-GLAXOSMITHKLINE-B0428209A</companynumb>
    <primarysource>
      <reportercountry>BELGIUM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>30</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>COMPLETED SUICIDE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMOTRIGINE</medicinalproduct>
        <drugauthorizationnumb>20241</drugauthorizationnumb>
        <drugdosagetext>200MG PER DAY</drugdosagetext>
        <drugindication>BIPOLAR DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LITHIUM CARBONATE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5044485-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060620</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-B0428314A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>71</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CEREBRAL ARTERITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBRAL ATROPHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBRAL ISCHAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GW679769</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PROPHYLAXIS OF NAUSEA AND VOMITING</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060607</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060607</drugenddate>
        <drugtreatmentduration>15</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOFRAN</medicinalproduct>
        <drugauthorizationnumb>020007</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PROPHYLAXIS OF NAUSEA AND VOMITING</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060607</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060607</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5044486-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060620</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-GLAXOSMITHKLINE-B0428990A</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>7</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD CREATINE PHOSPHOKINASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD LACTIC ACID INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG TOXICITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MITOCHONDRIAL TOXICITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOSITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAINFLUENZAE VIRUS INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EPIVIR</medicinalproduct>
        <drugauthorizationnumb>20564</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZIAGEN</medicinalproduct>
        <drugauthorizationnumb>020977</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEVIRAPINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5044487-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-GLAXOSMITHKLINE-B0429154A</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>78</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>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>AUGMENTIN '125'</medicinalproduct>
        <drugauthorizationnumb>50564</drugauthorizationnumb>
        <drugdosagetext>2G TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060517</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060519</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CORDARONE</medicinalproduct>
        <drugdosagetext>200MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060517</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060519</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIAMICRON</medicinalproduct>
        <drugdosagetext>30MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060517</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060518</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREVISCAN</medicinalproduct>
        <drugdosagetext>20MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060516</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060519</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIPARINE</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ROCEPHINE IV</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5044488-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-GLAXOSMITHKLINE-B0429290A</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FOOT FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAND FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREATMENT NONCOMPLIANCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLIXOTIDE</medicinalproduct>
        <drugauthorizationnumb>20548</drugauthorizationnumb>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SERETIDE</medicinalproduct>
        <drugauthorizationnumb>021077</drugauthorizationnumb>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ORAL STEROIDS</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEBULISER (UNKNOWN MEDICATIONS)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5044489-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-JPN-A200602387</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <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>PAXIL</medicinalproduct>
        <drugauthorizationnumb>020031</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OBSESSIVE-COMPULSIVE DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060516</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEPAS</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060601</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5044490-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-GLAXOSMITHKLINE-B0429561A</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>53</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HEPATIC NEOPLASM MALIGNANT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATITIS B</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EPIVIR</medicinalproduct>
        <drugauthorizationnumb>020564</drugauthorizationnumb>
        <drugdosagetext>300MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010927</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030331</drugenddate>
        <drugtreatmentduration>79</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EPIVIR</medicinalproduct>
        <drugauthorizationnumb>020564</drugauthorizationnumb>
        <drugdosagetext>150MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RETROVIR</medicinalproduct>
        <drugauthorizationnumb>019655</drugauthorizationnumb>
        <drugdosagetext>400MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020425</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030320</drugenddate>
        <drugtreatmentduration>47</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RETROVIR</medicinalproduct>
        <drugauthorizationnumb>019655</drugauthorizationnumb>
        <drugdosagetext>500MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051128</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZIAGEN</medicinalproduct>
        <drugauthorizationnumb>020977</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030320</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040331</drugenddate>
        <drugtreatmentduration>54</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZIAGEN</medicinalproduct>
        <drugauthorizationnumb>020977</drugauthorizationnumb>
        <drugdosagetext>300MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZERIT</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010927</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVIR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030320</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REYATAZ</medicinalproduct>
        <drugdosagetext>400MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040308</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIFLUCAN</medicinalproduct>
        <drugdosagetext>100MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CANDIDIASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOIPAN</medicinalproduct>
        <drugdosagetext>200MG THREE TIMES PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PANCREATITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060401</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5044492-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060630</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-GLAXOSMITHKLINE-B0429643A</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>40</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANAPHYLACTIC SHOCK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANGIONEUROTIC OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROAT IRRITATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AUGMENTIN '125'</medicinalproduct>
        <drugauthorizationnumb>050564</drugauthorizationnumb>
        <drugdosagetext>1G CUMULATIVE DOSE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060314</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DERINOX</medicinalproduct>
        <drugdosagetext>1UNIT CUMULATIVE DOSE</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060314</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5044493-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060630</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-GLAXOSMITHKLINE-B0429651A</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>29</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ALANINE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASPARTATE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAMMA-GLUTAMYLTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AUGMENTIN '125'</medicinalproduct>
        <drugauthorizationnumb>050564</drugauthorizationnumb>
        <drugdosagetext>4UNIT PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>WOUND</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060407</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060412</drugenddate>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRIFLUCAN</medicinalproduct>
        <drugdosagetext>1UNIT PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>WOUND</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060407</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060410</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5044494-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-JPN-A200602411</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>46</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ACUTE MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STENT PLACEMENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EPIVIR</medicinalproduct>
        <drugauthorizationnumb>020564</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020926</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RETROVIR</medicinalproduct>
        <drugauthorizationnumb>019655</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020926</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KALETRA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020926</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060313</drugenddate>
        <drugtreatmentduration>181</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVIR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060314</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REYATAZ</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060314</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHYCOOL</medicinalproduct>
        <drugdosagetext>500MCG PER DAY</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>SCIATICA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060126</drugenddate>
        <drugtreatmentduration>43</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
        <drugdosagetext>40MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060215</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEVALOTIN</medicinalproduct>
        <drugdosagetext>10MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060215</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>20060215</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5044496-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060704</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-GLAXOSMITHKLINE-B0429785A</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>45</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAPHYLACTIC SHOCK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRONCHOSPASM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CYANOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERALISED OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERIPHERAL ISCHAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY DISTRESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRYPTASE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AUGMENTIN '125'</medicinalproduct>
        <drugauthorizationnumb>050564</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060329</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACUPAN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060329</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROFENID</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060329</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METRONIDAZOLE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060329</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060329</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATARAX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIPRIVAN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060329</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SUFENTA</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060329</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DESFLURANE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060329</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5044497-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060704</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-GLAXOSMITHKLINE-B0429815A</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>58</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>55</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLAVENTIN</medicinalproduct>
        <drugauthorizationnumb>50590</drugauthorizationnumb>
        <drugdosagetext>3G FOUR TIMES PER DAY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060515</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060523</drugenddate>
        <drugtreatmentduration>9</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RAPIFEN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060513</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060523</drugenddate>
        <drugtreatmentduration>11</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LOVENOX</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060513</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060523</drugenddate>
        <drugtreatmentduration>11</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FUNGIZONE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>SINUSITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060512</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060517</drugenddate>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CATAPRES</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060513</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060515</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRAVASTATIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLOR</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DI-ANTALVIC</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FERROGRAD</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CONTRAST MEDIUM (UNSPECIFIED)</medicinalproduct>
        <drugindication>SCAN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060428</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060505</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5044498-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060626</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2005/350</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>72</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ANGIOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMOXICILLINE RPG</medicinalproduct>
        <drugauthorizationnumb>50542</drugauthorizationnumb>
        <drugdosagetext>1500MG PER DAY</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DYSPNOEA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051125</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
        <drugdosagetext>40MG PER DAY</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DYSPNOEA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051125</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HELICIDINE</medicinalproduct>
        <drugdosagetext>3SP PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DYSPNOEA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051125</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VASTAREL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5044499-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060630</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IT-GLAXOSMITHKLINE-B0429892A</companynumb>
    <primarysource>
      <reportercountry>ITALY</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>69</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>AMNESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMIGRAN</medicinalproduct>
        <drugauthorizationnumb>20080</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060410</drugenddate>
        <drugtreatmentduration>100</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </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>ASPIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM GLUCONATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENALAPRIL</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>OMEPRAZOLE</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>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5044500-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060703</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006/198</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>9</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PURPURA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMOXICILLIN</medicinalproduct>
        <drugauthorizationnumb>50542</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMOXICILLIN</medicinalproduct>
        <drugauthorizationnumb>050542</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060601</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5044501-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>20006094</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>72</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>81.5</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BRADYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY ARREST</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ROPINIROLE</medicinalproduct>
        <drugauthorizationnumb>20658</drugauthorizationnumb>
        <drugdosagetext>1MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RESTLESS LEGS SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060522</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060601</drugenddate>
        <drugtreatmentduration>11</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060509</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIPYRIDAMOLE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060509</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANSOPRAZOLE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BARRETT'S OESOPHAGUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030915</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5044502-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>062936</companynumb>
    <primarysource>
      <reportercountry>SWEDEN</reportercountry>
      <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>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RED BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SPEKTRAMOX</medicinalproduct>
        <drugauthorizationnumb>50564</drugauthorizationnumb>
        <drugdosagetext>7.5ML PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OTITIS MEDIA ACUTE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060519</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060528</drugenddate>
        <drugtreatmentduration>10</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5044504-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060630</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ES-GLAXOSMITHKLINE-B0430003A</companynumb>
    <primarysource>
      <reportercountry>SPAIN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DIABETIC FOOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5044505-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060627</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20060606671</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>8</patientonsetage>
      <patientonsetageunit>800</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUID RETENTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYLENOL (CAPLET)</medicinalproduct>
        <drugbatchnumb>23371</drugbatchnumb>
        <drugauthorizationnumb>019872</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYLENOL (CAPLET)</medicinalproduct>
        <drugbatchnumb>23371</drugbatchnumb>
        <drugauthorizationnumb>019872</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLENDIL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5044506-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060626</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>TR-SANOFI-SYNTHELABO-A01200604985</companynumb>
    <primarysource>
      <reportercountry>TURKEY</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>65</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEEP VEIN THROMBOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugauthorizationnumb>020839</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060602</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5044507-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060627</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-SANOFI-SYNTHELABO-A03200604140</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABNORMAL BEHAVIOUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AMNESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WRIST FRACTURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMBIEN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5044508-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060626</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-SANOFI-SYNTHELABO-A03200604172</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>ACUTE MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL NECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTUBATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TORSEMIDE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANOXIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARTIA XT</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020839</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5044510-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060516</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-SANOFI-SYNTHELABO-A03200603203</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>83.9</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ACTIVITIES OF DAILY LIVING IMPAIRED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AMNESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AORTIC DILATATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AORTIC VALVE SCLEROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ATRIOVENTRICULAR BLOCK FIRST DEGREE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CAROTID ARTERY STENOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DILATATION ATRIAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAND FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LETHARGY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MITRAL VALVE CALCIFICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENTRICULAR HYPERTROPHY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMBIEN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>21774</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INSOMNIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060221</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060222</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREVACID</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FEXOFENADINE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5044520-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060626</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-13424718</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>54</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>65</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTHYROIDISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERNATIONAL NORMALISED RATIO FLUCTUATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
        <drugauthorizationnumb>009218</drugauthorizationnumb>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
        <drugtreatmentduration>14</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>METHIMAZOLE</medicinalproduct>
        <drugindication>BASEDOW'S DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE TAB</medicinalproduct>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030818</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5044521-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060530</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-13393525</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>52</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>OVERDOSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GLUCOPHAGE XR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS NON-INSULIN-DEPENDENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060501</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KLONOPIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ELAVIL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5044522-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060627</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CO-BRISTOL-MYERS SQUIBB COMPANY-13425012</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>53</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CISPLATIN</medicinalproduct>
        <drugauthorizationnumb>018057</drugauthorizationnumb>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>GASTRIC CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060522</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060522</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUOROURACIL</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>GASTRIC CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060522</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060527</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PARACETAMOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALPRAZOLAM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INITIAL INSOMNIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5044523-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060626</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-BRISTOL-MYERS SQUIBB COMPANY-13426267</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>60</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DYSKINESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MICTURITION DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULAR WEAKNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FUNGIZONE</medicinalproduct>
        <drugauthorizationnumb>060517</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MENINGITIS CRYPTOCOCCAL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060524</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060616</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FUNGIZONE</medicinalproduct>
        <drugauthorizationnumb>060517</drugauthorizationnumb>
        <drugdosagetext>DOSAGE: 0.25 MG (1ST TIME) ON 26-MAY-2006.</drugdosagetext>
        <drugadministrationroute>029</drugadministrationroute>
        <drugindication>MENINGITIS CRYPTOCOCCAL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060526</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060616</drugenddate>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VFEND</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MENINGITIS CRYPTOCOCCAL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060418</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5044525-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-13428032</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>67</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BREAST CANCER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ESTRACE</medicinalproduct>
        <drugauthorizationnumb>084499</drugauthorizationnumb>
        <drugindication>MENOPAUSAL SYMPTOMS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
        <drugindication>MENOPAUSAL SYMPTOMS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ESTRADIOL</medicinalproduct>
        <drugauthorizationnumb>084499</drugauthorizationnumb>
        <drugindication>MENOPAUSAL SYMPTOMS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ESTRATEST</medicinalproduct>
        <drugindication>MENOPAUSAL SYMPTOMS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEPO-ESTRADIOL</medicinalproduct>
        <drugindication>MENOPAUSAL SYMPTOMS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5044526-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060616</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-BRISTOL-MYERS SQUIBB COMPANY-13415765</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>37</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>62</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>NEPHRITIS ALLERGIC</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAXOL</medicinalproduct>
        <drugauthorizationnumb>20262</drugauthorizationnumb>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060608</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060608</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EPIRUBICIN</medicinalproduct>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060504</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060504</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEULASTA</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060407</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARANESP</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060420</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WOBENZYM</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060406</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060616</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DAKTAR</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060528</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060616</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NYSTATIN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060516</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060616</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PERENTEROL</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060517</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5044527-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060627</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-BRISTOL-MYERS SQUIBB COMPANY-13431309</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>54</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEUKOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRODUCTIVE COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ETOPOSIDE</medicinalproduct>
        <drugauthorizationnumb>018768</drugauthorizationnumb>
        <drugindication>TESTICULAR NEOPLASM</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050319</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CISPLATIN</medicinalproduct>
        <drugauthorizationnumb>018057</drugauthorizationnumb>
        <drugindication>TESTICULAR NEOPLASM</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BLEOMYCIN</medicinalproduct>
        <drugindication>TESTICULAR NEOPLASM</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5044529-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060626</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-BRISTOL-MYERS SQUIBB COMPANY-13426952</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>74</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ATRIAL FIBRILLATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ERBITUX</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>OESOPHAGEAL SQUAMOUS CELL CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050513</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050513</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CISPLATIN</medicinalproduct>
        <drugauthorizationnumb>018057</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>OESOPHAGEAL SQUAMOUS CELL CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050513</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050513</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUOROURACIL</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>OESOPHAGEAL SQUAMOUS CELL CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050513</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050517</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5044530-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060626</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ES-BRISTOL-MYERS SQUIBB COMPANY-13425335</companynumb>
    <primarysource>
      <reportercountry>SPAIN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ABILIFY</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5044531-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20060401378</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>72.5</patientweight>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>INTESTINAL OBSTRUCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVARIAN CANCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLEURAL EFFUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YONDELIS</medicinalproduct>
        <drugauthorizationnumb>50286</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>OVARIAN CANCER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOXIL</medicinalproduct>
        <drugauthorizationnumb>050718</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>OVARIAN CANCER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCODONE HCL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DILAUDID</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COMPAZINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATIVAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOFRAN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5044532-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060626</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ES-BRISTOL-MYERS SQUIBB COMPANY-13425350</companynumb>
    <primarysource>
      <reportercountry>SPAIN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ABILIFY</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5044533-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-13428586</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METFORMIN HYDROCHLORIDE</medicinalproduct>
        <drugauthorizationnumb>021202</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5044535-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060428</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>EE-BRISTOL-MYERS SQUIBB COMPANY-13359815</companynumb>
    <primarysource>
      <reportercountry>IRELAND</reportercountry>
      <qualification>5</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>FEBRILE NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPTIC SHOCK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STOMATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CISPLATIN</medicinalproduct>
        <drugauthorizationnumb>18057</drugauthorizationnumb>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>GASTRIC CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060413</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060413</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUOROURACIL</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>GASTRIC CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060413</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060418</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GRANISETRON  HCL</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>VOMITING</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060413</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060417</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>APREPITANT</medicinalproduct>
        <drugdosagetext>DOSE: 125/80 MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>VOMITING</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060413</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060415</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE TAB</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>VOMITING</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060413</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060413</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE TAB</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060414</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060415</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOCLOPRAMIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>VOMITING</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060413</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060423</drugenddate>
        <drugtreatmentduration>11</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE TAB</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NAUSEA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060414</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060415</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5044567-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060627</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-JNJFOC-20060606763</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RETINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SPORANOX</medicinalproduct>
        <drugauthorizationnumb>020657</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLASTOMYCOSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTIVITAMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEGA-3 FATTY ACIDS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5044577-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060626</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-JNJFOC-20060606758</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>19</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOPAMAX</medicinalproduct>
        <drugauthorizationnumb>020505</drugauthorizationnumb>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BROMAZEPAM</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5044600-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060705</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0611131A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>COELIAC DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTESTINAL VILLI ATROPHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NONSPECIFIC REACTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ECOTRIN ADULT LOW STRENGTH TABLETS</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5044601-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060307</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-GLAXOSMITHKLINE-B0415147A</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>2</patientonsetage>
      <patientonsetageunit>802</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CHOKING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CIRCULATORY COLLAPSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHILDREN'S PANADOL COLOURFREE BABY DROPS</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PYREXIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060208</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060208</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VACCINATION</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060207</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5044605-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060625</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-SANOFI-SYNTHELABO-A03200604148</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ATRIOVENTRICULAR BLOCK SECOND DEGREE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DILATATION VENTRICULAR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMBIEN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>1 DF THREE TO FOUR TIMES/WEEK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INSOMNIA</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMBIEN</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051001</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5044606-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060627</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-GILEAD-2006-0009806</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HAEMODIALYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHABDOMYOLYSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIREAD</medicinalproduct>
        <drugauthorizationnumb>21356</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ACQUIRED IMMUNODEFICIENCY SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060601</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEZAFIBRATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DYSLIPIDAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060601</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LAMIVUDINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ACQUIRED IMMUNODEFICIENCY SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EFAVIRENZ</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ACQUIRED IMMUNODEFICIENCY SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050401</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5044607-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060623</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHO2006US10317</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>82</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>78.82</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEUKOCYTOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLEURAL EFFUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY GAS EXCHANGE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORADIL</medicinalproduct>
        <drugauthorizationnumb>20831</drugauthorizationnumb>
        <drugdosagetext>TREATMENT PHASE</drugdosagetext>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
        <drugdosagetext>18 UG, QD</drugdosagetext>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENOXAPARIN SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FELODIPINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLYBURIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IPRATROPIUM BROMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOSARTAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHYLPREDNISOLONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MOXIFLOXACIN HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM CHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVENOX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE TAB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5044609-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060614</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-SANOFI-SYNTHELABO-A04200600626</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>84</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOLYTIC URAEMIC SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PETECHIAE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUOROURACIL</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>COLON CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060511</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060511</drugenddate>
        <drugtreatmentduration>24</drugtreatmentduration>
        <drugtreatmentdurationunit>805</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ELOXATIN</medicinalproduct>
        <drugauthorizationnumb>021492</drugauthorizationnumb>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>COLON CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060511</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060511</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOLINIC ACID</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>COLON CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060511</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060511</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTIEMETICS</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PROPHYLAXIS OF NAUSEA AND VOMITING</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060501</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGNESIUM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PREMEDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060501</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM GLUCONATE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PREMEDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060501</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PREMEDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060501</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUID THERAPY</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PREMEDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060501</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5044610-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060519</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-SANOFI-SYNTHELABO-A02200601341</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>66</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ACUTE PRERENAL FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANOREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPONATRAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ABILIFY</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TEMESTA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SOLIAN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>STILNOX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEPTICUR</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEPAMIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ELOXATIN</medicinalproduct>
        <drugauthorizationnumb>021759</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLON CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060419</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060419</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CALCIUM FOLINATE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060419</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060419</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUOROURACIL</medicinalproduct>
        <drugadministrationroute>040</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060419</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060419</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUOROURACIL</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060419</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060421</drugenddate>
        <drugtreatmentduration>46</drugtreatmentduration>
        <drugtreatmentdurationunit>805</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5044618-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060328</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-13330402</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>48</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACTERIAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CULTURE URINE POSITIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CISPLATIN</medicinalproduct>
        <drugauthorizationnumb>18057</drugauthorizationnumb>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060307</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060307</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TS-1</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060307</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060320</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SINGULAIR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>WHEEZING</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMITRIPTYLINE HCL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>WHEEZING</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMBIEN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INSOMNIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
        <drugauthorizationnumb>009218</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060316</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5044619-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060607</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-BRISTOL-MYERS SQUIBB COMPANY-13406780</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>48</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>53</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIABETIC HYPERGLYCAEMIC COMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POLYDIPSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POLYURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ABILIFY</medicinalproduct>
        <drugdosagetext>DOSAGE: INITIATED AT 15 MG DAILY ON 10-OCT-2005; INCREASED TO 30 MG DAILY ON 27-MAR-2006</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PSYCHOTIC DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051010</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5044620-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060419</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-13352711</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>56</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ANORECTAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOPTYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHOIDS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALIGNANT NEOPLASM PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MASS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAXOL</medicinalproduct>
        <drugauthorizationnumb>20262</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060228</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060407</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PARAPLATIN</medicinalproduct>
        <drugauthorizationnumb>019880</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060228</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060407</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KYTRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DECADRON</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAGAMET</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENADRYL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MORPHINE SULFATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REGLAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHADONE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DILAUDID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORTAB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SENOKOT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATIVAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RADIATION THERAPY</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060206</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060303</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYGEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ROCEPHIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAALOX FAST BLOCKER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COMBIVENT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RADIATION THERAPY</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060206</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060301</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5044621-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060619</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-BRISTOL-MYERS SQUIBB COMPANY-13433701</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>59</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ENURESIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEUKOPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENDOXAN</medicinalproduct>
        <drugauthorizationnumb>12142</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060511</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060511</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOXORUBICIN HCL</medicinalproduct>
        <drugauthorizationnumb>062926</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060511</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060511</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAXOTERE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060511</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060511</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5044622-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-13264577</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>52</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ATELECTASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD ALBUMIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CALCIUM DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIOMEGALY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLITIS EROSIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSARTHRIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ELECTROCARDIOGRAM QT PROLONGED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ELECTROCARDIOGRAM ST SEGMENT ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING COLD</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRITIS EROSIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATEMESIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC LESION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOKALAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG INFILTRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OESOPHAGITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLEURAL EFFUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROCTITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROTEIN TOTAL DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY CONGESTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RED BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THERAPY NON-RESPONDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UTERINE ENLARGEMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UTERINE LEIOMYOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ORENCIA</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060109</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060124</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE TAB</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051129</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugauthorizationnumb>086358</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051129</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACTOS</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050501</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOPHAGE</medicinalproduct>
        <drugauthorizationnumb>021202</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050501</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19950101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN AND HYDROCODONE BITARTRATE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMBIEN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EFFEXOR XR</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SOTALOL HCL</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051220</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MICARDIS</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051230</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051220</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051201</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5044630-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20030530</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ABBOTT-03P-087-0221974-00</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ACUTE MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC FUNCTION ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERLIPIDAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KALETRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021226</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020926</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060313</drugenddate>
        <drugtreatmentduration>3</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>20020926</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMIVUDINE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020926</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERURICAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050308</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050328</drugenddate>
        <drugtreatmentduration>20</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MECOBALAMIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCIATICA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041108</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RITONAVIR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060314</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATAZANAVIR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060314</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRONOLACTONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CARDIAC FAILURE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060215</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALSARTAN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060215</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARVEDILOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CARDIAC FAILURE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060215</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FAMOTIDINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTRIC ULCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060215</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MECOBALAMIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041108</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060125</drugenddate>
        <drugtreatmentduration>443</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5044631-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060623</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-ABBOTT-06P-008-0336708-02</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>CARDIAC ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040702</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060503</drugenddate>
        <drugtreatmentduration>670</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5044632-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060627</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-ABBOTT-06P-062-0336928-00</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>53</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DIVERTICULITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOSPORINE</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>065003</drugauthorizationnumb>
        <drugindication>IMMUNOSUPPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHYLPREDNISOLONE</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugindication>IMMUNOSUPPRESSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5044633-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060627</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-ABBOTT-06P-167-0337151-00</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>56</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN LOWER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRITIS BACTERIAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIVERTICULITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PELVIC MASS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050223</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060102</drugenddate>
        <drugtreatmentduration>313</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALENDRONATE SODIUM</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ISOSORBIDE MONONITRATE</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NICARDIPINE</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REMEDEINE</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5044634-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20031205</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ABBOTT-03P-087-0244219-00</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD TRIGLYCERIDES INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD URIC ACID INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CACHEXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA PNEUMOCOCCAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KALETRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>21226</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021122</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMIVUDINE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021122</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>STAVUDINE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020930</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030123</drugenddate>
        <drugtreatmentduration>656</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>STAVUDINE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021122</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040517</drugenddate>
        <drugtreatmentduration>656</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PENTAMIDINE ISETHIONATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANTIBIOTIC PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020930</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030123</drugenddate>
        <drugtreatmentduration>115</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ABACAVIR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040518</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5044635-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060524</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-ABBOTT-06P-167-0334268-00</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>60</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DISEASE RECURRENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEUKOCYTOCLASTIC VASCULITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MANIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EPILIM</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>18081</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BIPOLAR DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EPILIM</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>018081</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OLANZAPINE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CHLORPROMAZINE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONAZEPAM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5044636-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060627</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-ABBOTT-06P-167-0337163-00</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>43</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLARITHROMYCIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>050662</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LANSOPRAZOLE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HELICOBACTER INFECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METRONIDAZOLE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RANITIDINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DYSPEPSIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5044637-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060627</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-ABBOTT-06P-062-0337051-00</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CHILLS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BIAXIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>50662</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HELICOBACTER INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060622</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060626</drugenddate>
        <drugtreatmentduration>4</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>20060622</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060626</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PANTOPRAZOLE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HELICOBACTER INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060622</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060627</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5044638-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20020509</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ABBOTT-02P-087-0192913-00</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ACUTE ABDOMEN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC FUNCTION ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEUKOPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KALETRA</medicinalproduct>
        <drugauthorizationnumb>21226</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010531</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040524</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIDANOSINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010522</drugenddate>
        <drugtreatmentduration>50</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>STAVUDINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010522</drugenddate>
        <drugtreatmentduration>50</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMPRENAVIR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010522</drugenddate>
        <drugtreatmentduration>50</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMIVUDINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010531</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ABACAVIR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010531</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020726</drugenddate>
        <drugtreatmentduration>421</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZIDOVUDINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010531</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ATAZANAVIR</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040525</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TEPRENONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLYCYRON</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010801</drugenddate>
        <drugtreatmentduration>121</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PENTAMIDINE ISETHIONATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANTIBIOTIC PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NICARDIPINE HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SODIUM ALGINATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010510</drugenddate>
        <drugtreatmentduration>38</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FAMOTIDINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20011107</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FAMOTIDINE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040525</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMPHOTERICIN B</medicinalproduct>
        <drugadministrationroute>002</drugadministrationroute>
        <drugindication>CANDIDIASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020411</drugenddate>
        <drugtreatmentduration>374</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RURIOPCTOCOG ALFA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>FACTOR VIII DEFICIENCY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTIHEMOPHILIC FACTOR (HUMAN)</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>FACTOR VIII DEFICIENCY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERURICAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMINS</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NUTRITIONAL SUPPORT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010510</drugenddate>
        <drugtreatmentduration>38</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MOSAPRIDE CITRATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTROINTESTINAL DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENZYME PREPARATIONS</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTROINTESTINAL DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010614</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>URSODEOXYCHOLIC ACID</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANSOPRAZOLE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTROINTESTINAL DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021108</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RIBAVIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050307</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050731</drugenddate>
        <drugtreatmentduration>145</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PEG-INTRON</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050307</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050731</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PEG-INTRON</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050801</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CAMOSTAT MESILATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050801</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIGESTIVE ENZYME PREPARATIOBS</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050822</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5044639-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060615</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IT-ABBOTT-06P-083-0336137-00</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>64</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>THROMBOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEPAKOTE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>18081</drugauthorizationnumb>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5044640-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060627</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IE-ABBOTT-06P-229-0337109-00</companynumb>
    <primarysource>
      <reportercountry>IRELAND</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>60</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>LOWER RESPIRATORY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050801</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5044641-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
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    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GR-ABBOTT-06P-066-0337183-00</companynumb>
    <primarysource>
      <reportercountry>GREECE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>70</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>CARDIAC ARREST</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060428</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060515</drugenddate>
        <drugtreatmentduration>17</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060528</drugenddate>
        <drugtreatmentduration>87</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060528</drugenddate>
        <drugtreatmentduration>87</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MELOXICAM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060520</drugenddate>
        <drugtreatmentduration>79</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RISEDRONATE SODIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060528</drugenddate>
        <drugtreatmentduration>87</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEKOVIT CA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060528</drugenddate>
        <drugtreatmentduration>87</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5044642-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-ABBOTT-06P-167-0337166-00</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>98</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CHROMATURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JAUNDICE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VALPROATE SODIUM</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>018081</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060418</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060515</drugenddate>
        <drugtreatmentduration>27</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEKOVIT CA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETYLSALICYLIC ACID SRT</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIPYRIDAMOLE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CHLORPROMAZINE</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051201</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5044643-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060627</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-ABBOTT-06P-056-0337139-00</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>38</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SERUM FERRITIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEPAKENE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>018081</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EUGYNON</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ORAL CONTRACEPTION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5044644-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060616</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-ABBOTT-06P-167-0336429-00</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>44</patientweight>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METASTATIC NEOPLASM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEOPLASM MALIGNANT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050426</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050524</drugenddate>
        <drugtreatmentduration>28</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>HYDROXYZINE HYDROCHLORIDE</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>METHOTREXATE</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>RESIDRONATE</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5044645-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060627</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-ABBOTT-06P-167-0337150-00</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>63</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FEMORAL NECK FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HIP ARTHROPLASTY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051220</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANSOPRAZOLE</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NIFEDIPINE</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BRUFEN</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5044646-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060626</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-ABBOTT-06P-056-0336880-00</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>26</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>AUTOMATISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAZE PALSY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GRAND MAL CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERSEVERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PETIT MAL EPILEPSY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STATUS EPILEPTICUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STEREOTYPIC MOVEMENT DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VALPROATE SODIUM</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>18081</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PARTIAL SEIZURES</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VALPROATE SODIUM</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>018081</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARBAMAZEPINE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PARTIAL SEIZURES</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIGABATRIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PARTIAL SEIZURES</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LAMOTRIGINE</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5044647-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060616</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-ABBOTT-06P-167-0336491-00</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>51</patientweight>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ACUTE MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTERIOSCLEROSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040607</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050222</drugenddate>
        <drugtreatmentduration>260</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AZATHIOPRINE</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>AMIODARONE HCL</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>ALENDRONATE SODIUM</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>GLICLAZIDE</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VERAPAMIL</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>5044648-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060626</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-ABBOTT-06P-167-0336921-00</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>4</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>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EPILIM</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>18081</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG EXPOSURE DURING PREGNANCY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5044649-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060626</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-ABBOTT-06P-167-0337112-00</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KALETRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021906</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LAMIVUDINE AND ZIDOVUDINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060301</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PHENOBARBIRANE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>EPILEPSY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PHENYTOIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>EPILEPSY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5044650-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060328</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-US174148</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KINERET</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>JUVENILE ARTHRITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5044651-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060413</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-US176284</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>10</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>30</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE VESICLES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KINERET</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>JUVENILE ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060327</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060407</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5044652-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060427</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-US177788</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JUVENILE ARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KINERET</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>JUVENILE ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060105</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5044653-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060504</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-US178588</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>62</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KINERET</medicinalproduct>
        <drugbatchnumb>P05205</drugbatchnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5044654-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060316</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-US172778</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <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>KINERET</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>JUVENILE ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5044655-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060227</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-US170422</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARYNGEAL OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TONGUE OEDEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KINERET</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>JUVENILE ARTHRITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5044656-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060226</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-US170414</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE SWELLING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KINERET</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>JUVENILE ARTHRITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5044657-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050609</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-US138069</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>55</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KINERET</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040801</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5044658-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050509</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-US132059</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>54.5</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ADVERSE DRUG REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JUVENILE ARTHRITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KINERET</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>JUVENILE ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050518</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5044659-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060215</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-US169045</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>TOOTH EROSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000912</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KINERET</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5044660-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060626</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-ABBOTT-06P-167-0337079-00</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>BLADDER DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CERVIX DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051116</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE SODIUM</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROXYCHLOROQUINE SULFATE</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</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>ATENOLOL</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PARACETAMOL</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRAVASTATIN</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PEPTAC</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>RISEDRONATE</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5044661-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060626</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CZ-ABBOTT-06P-217-0336909-00</companynumb>
    <primarysource>
      <reportercountry>CZECH REPUBLIC</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>66.5</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DISORIENTATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEMIPLEGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ISCHAEMIC STROKE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARESIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VERTIGO</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZEMPLAR</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020819</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>HYPERPARATHYROIDISM</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060405</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENALAPRIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASCORUTIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RENAL FAILURE CHRONIC</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETYLSALICYLIC ACID SRT</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PLATELET AGGREGATION INHIBITION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NITRENDIPINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TELMISARTAN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYNT</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SEVELAMER HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RENAL FAILURE CHRONIC</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM CARBONATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RENAL FAILURE CHRONIC</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SULODEXIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MYOCARDIAL ISCHAEMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CAPIVEN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>VENOUS INSUFFICIENCY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5044662-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060515</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-ABBOTT-06P-056-0333169-00</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>84</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CEREBRAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ECCHYMOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERIORBITAL OEDEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPANTHYL TABLETS</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>21203</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060404</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>017020</drugauthorizationnumb>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060115</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060404</drugenddate>
        <drugtreatmentduration>78</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060404</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>AMIODARONE HYDROCHLORIDE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLECAINIDE ACETATE</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5044663-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060626</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-ABBOTT-06P-167-0336920-00</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>4</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>EPILIM</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>18081</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5044664-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060519</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ABBOTT-06P-087-0334197-00</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>50.5</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ELECTROENCEPHALOGRAM ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KLARICID TABLETS</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>50662</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MYCOPLASMA INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060508</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060519</drugenddate>
        <drugtreatmentduration>11</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KLARICID TABLETS</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>050662</drugauthorizationnumb>
        <drugtreatmentduration>11</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ORCIPRENALINE SULFATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BRONCHITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060508</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060519</drugenddate>
        <drugtreatmentduration>11</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5044665-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060411</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-ABBOTT-06P-167-0331017-00</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INTOLERANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG RESISTANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KALETRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021226</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060301</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LAMIVUDINE AND ZIDOVUDINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060301</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PHENOBARBITANE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>EPILEPSY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PHENYTOIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>EPILEPSY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5044666-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-06P-163-0337135-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>104</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD POTASSIUM DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NORVIR</medicinalproduct>
        <drugauthorizationnumb>020945</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060301</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SAQUINAVIR MESILATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060301</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LAMIVUDINE AND ZIDOVUDINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060301</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>THYROID DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRONOLACTONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OEDEMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ESTRADIOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5044667-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060627</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2006-UK-02977UK</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>73</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CELLULITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL ISCHAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNOVIAL RUPTURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AGGRENOX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CEREBROVASCULAR ACCIDENT PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060515</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MICARDIS</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CEREBROVASCULAR ACCIDENT PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060515</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOPIDOGREL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CEREBROVASCULAR ACCIDENT PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060515</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5044668-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060317</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2006-BP-03061BP</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>81</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLINDNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CATARACT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IRIS DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISION BLURRED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VITREOUS FLOATERS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLOMAX</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>20579</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BENIGN PROSTATIC HYPERPLASIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMINS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREVACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRONOLACTONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REQUIP</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>QUININE SULFATE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5044669-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060320</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2006-BP-03140BP</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>72</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>21395</drugauthorizationnumb>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LABETALOL HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE TAB</medicinalproduct>
        <drugindication>OSTEOARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>K</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SEREVENT</medicinalproduct>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5044670-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060313</receiptdate>
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    <companynumb>US-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2006-BP-02810BP</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>EMPHYSEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUDDEN DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
        <drugbatchnumb>506324A</drugbatchnumb>
        <drugauthorizationnumb>21395</drugauthorizationnumb>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060216</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060228</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
        <drugbatchnumb>506324A</drugbatchnumb>
        <drugauthorizationnumb>021395</drugauthorizationnumb>
        <drugindication>EMPHYSEMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATROVENT</medicinalproduct>
        <drugadministrationroute>055</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL SPIROS</medicinalproduct>
        <drugadministrationroute>055</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SEREVENT</medicinalproduct>
        <drugadministrationroute>055</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5044671-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060630</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2006-BP-07598BP</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HIP FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMBIVENT</medicinalproduct>
        <drugbatchnumb>565068A,050593W</drugbatchnumb>
        <drugauthorizationnumb>020291</drugauthorizationnumb>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060301</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMBIVENT</medicinalproduct>
        <drugbatchnumb>565068A,050593W</drugbatchnumb>
        <drugauthorizationnumb>020291</drugauthorizationnumb>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>EMPHYSEMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060618</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
        <drugauthorizationnumb>021395</drugauthorizationnumb>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060618</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL SPIROS</medicinalproduct>
        <drugadministrationroute>055</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060618</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZYRTEC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060618</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5044672-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2006-BP-07417NB</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>71</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>GRANULOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEUKOPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MICARDIS</medicinalproduct>
        <drugauthorizationnumb>20850</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CARDIOVASCULAR DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060520</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060527</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALDACTONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5044673-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050805</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>MX-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2005-BP-13419MX</companynumb>
    <primarysource>
      <reportercountry>MEXICO</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>65</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE MYELOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MOBICOX 15.0 MG TABLETS</medicinalproduct>
        <drugbatchnumb>NR</drugbatchnumb>
        <drugauthorizationnumb>20938</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BACK PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050524</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050608</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN B-12</medicinalproduct>
        <drugindication>ANAEMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IRON</medicinalproduct>
        <drugindication>ANAEMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLIBENCLAMIDE / METFORMIN</medicinalproduct>
        <drugdosagetext>5/500 MG</drugdosagetext>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5044674-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060706</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2006-BP-07658BP</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>PLATELET AGGREGATION INHIBITION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TIPRANAVIR / RITONAVIR CAPSULES</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5044675-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060309</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2006-BP-02697BP</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>55</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>INFLAMMATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OESOPHAGITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ULCER HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MOBIC</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>20938</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050811</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060223</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOTREL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050811</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZETIA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050811</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5044676-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060602</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2006-BP-06419YA</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DERMATOMYOSITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HARNAL</medicinalproduct>
        <drugauthorizationnumb>20579</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060301</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5044677-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060417</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2006-BP-04362NB</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>78</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ATRIAL FIBRILLATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATOCHEZIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTESTINAL ISCHAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTESTINAL OBSTRUCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
        <drugauthorizationnumb>21395</drugauthorizationnumb>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>CHRONIC RESPIRATORY FAILURE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050725</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>THEO-DUR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CARDIAC ASTHMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031226</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060418</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADALAT</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031226</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060418</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MUCOSOLVAN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CARDIAC ASTHMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031226</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060418</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ONON</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CARDIAC ASTHMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040329</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060418</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIGOXIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARRHYTHMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060204</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060410</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RISPERDAL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INSOMNIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051225</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060410</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KALGUT</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CARDIAC FAILURE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040329</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060418</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5044678-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2006-BP-07524AU</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>65</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ASASANTIN CAPSULES</medicinalproduct>
        <drugbatchnumb>NR</drugbatchnumb>
        <drugauthorizationnumb>20884</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIABEX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5044679-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060619</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-MERCK-0606USA04474</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>82</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>41</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ALANINE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASPARTATE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAMMA-GLUTAMYLTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALDOMET</medicinalproduct>
        <drugauthorizationnumb>13400</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060602</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060615</drugenddate>
        <drugtreatmentduration>14</drugtreatmentduration>
        <drugtreatmentdurationunit></drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADALAT</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060529</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060531</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADALAT</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BLOPRESS</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060529</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060604</drugenddate>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BLOPRESS</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060606</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERLIPIDAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060529</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLPIDEM TARTRATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INSOMNIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060529</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VASOTEC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060605</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060605</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BASEN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060607</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060615</drugenddate>
        <drugtreatmentduration>9</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5044680-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050824</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0508USA04363</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BONE NEOPLASM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5044681-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060630</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-MERCK-0606FRA00085</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>81</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH MACULO-PAPULAR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZETIA</medicinalproduct>
        <drugauthorizationnumb>21445</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERCHOLESTEROLAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060320</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060414</drugenddate>
        <drugtreatmentduration>26</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PYGEUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060320</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060414</drugenddate>
        <drugtreatmentduration>26</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN LYSINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE AND LISINOPRIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE BESYLATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5044682-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060602</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-MERCK-0606USA01648</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>73</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INTERSTITIAL LUNG DISEASE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEPCID RPD</medicinalproduct>
        <drugauthorizationnumb>20752</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050629</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060531</drugenddate>
        <drugtreatmentduration>337</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BLOPRESS</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050629</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060531</drugenddate>
        <drugtreatmentduration>337</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050629</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060531</drugenddate>
        <drugtreatmentduration>337</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGNESIUM OXIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050629</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060531</drugenddate>
        <drugtreatmentduration>337</drugtreatmentduration>
        <drugtreatmentdurationunit></drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BEPRIDIL HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050629</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060531</drugenddate>
        <drugtreatmentduration>337</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>URSO</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050819</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060531</drugenddate>
        <drugtreatmentduration>286</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLYCYRON</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050629</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060531</drugenddate>
        <drugtreatmentduration>337</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SENNOSIDES</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050629</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060531</drugenddate>
        <drugtreatmentduration>337</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEPAKENE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050629</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060531</drugenddate>
        <drugtreatmentduration>337</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EVISTA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050629</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060531</drugenddate>
        <drugtreatmentduration>337</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BUP-4</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050629</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060531</drugenddate>
        <drugtreatmentduration>337</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050629</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060531</drugenddate>
        <drugtreatmentduration>337</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MUCOSTA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050629</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060531</drugenddate>
        <drugtreatmentduration>337</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALFACALCIDOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050629</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060531</drugenddate>
        <drugtreatmentduration>337</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FRANDOL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050629</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060531</drugenddate>
        <drugtreatmentduration>337</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5044683-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060530</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-MERCK-0605DEU00252</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>68</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>92</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ALANINE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD ALKALINE PHOSPHATASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAMMA-GLUTAMYLTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOLYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JAUNDICE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZETIA</medicinalproduct>
        <drugauthorizationnumb>21445</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CORONARY ARTERY DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051202</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060510</drugenddate>
        <drugtreatmentduration>160</drugtreatmentduration>
        <drugtreatmentdurationunit></drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZETIA</medicinalproduct>
        <drugauthorizationnumb>021445</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERCHOLESTEROLAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051202</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060510</drugenddate>
        <drugtreatmentduration>160</drugtreatmentduration>
        <drugtreatmentdurationunit></drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BISOPROLOL FUMARATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CORONARY ARTERY DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051002</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CORONARY ARTERY DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051118</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLOPIDOGREL BISULFATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051118</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RAMIPRIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CORONARY ARTERY DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051129</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5044684-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060616</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-MERCK-0606USA04174</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>9</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISSEMINATED INTRAVASCULAR COAGULATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC FUNCTION ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>REVERSIBLE POSTERIOR LEUKOENCEPHALOPATHY SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHABDOMYOLYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VARICELLA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEPCID</medicinalproduct>
        <drugauthorizationnumb>19510</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PROPHYLAXIS AGAINST GASTROINTESTINAL ULCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060606</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060611</drugenddate>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEPCID</medicinalproduct>
        <drugauthorizationnumb>019510</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060612</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060614</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEPCID</medicinalproduct>
        <drugauthorizationnumb>019510</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060615</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060615</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IRINOTECAN HCL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>NEUROBLASTOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060530</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060603</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PENTCILLIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>INFECTION PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060602</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060607</drugenddate>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KYTRIL</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NAUSEA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060529</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060612</drugenddate>
        <drugtreatmentduration>15</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5044685-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040929</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0410USA00021</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>68</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>58</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ORAL CAVITY FISTULA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>20560</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040901</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DEEP VEIN THROMBOSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KLONOPIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>ANXIETY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HYPERLIPIDAEMIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5044686-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-MERCK-0606AUS00198</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>75</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>39</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ALLERGIC OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOCAL SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARYNGEAL OEDEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060418</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060608</drugenddate>
        <drugtreatmentduration>52</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FAMOTIDINE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HYPERCHLORHYDRIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM CARBONATE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5044687-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060630</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0607USA00097</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>52</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL OEDEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060601</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELEXA</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CONCERTA</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5044688-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060630</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ES-MERCK-0607ESP00001</companynumb>
    <primarysource>
      <reportercountry>SPAIN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>53</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ONYCHOCLASIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZETIA</medicinalproduct>
        <drugauthorizationnumb>021445</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>TYPE IIA HYPERLIPIDAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATORVASTATIN CALCIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>TYPE IIA HYPERLIPIDAEMIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5044689-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060616</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-MERCK-0606USA05679</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>62</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>GYNAECOMASTIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COZAAR</medicinalproduct>
        <drugauthorizationnumb>20386</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040605</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060621</drugenddate>
        <drugtreatmentduration>747</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COZAAR</medicinalproduct>
        <drugauthorizationnumb>020386</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030227</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030426</drugenddate>
        <drugtreatmentduration>59</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COZAAR</medicinalproduct>
        <drugauthorizationnumb>020386</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030427</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040604</drugenddate>
        <drugtreatmentduration>405</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMLODIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030227</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060621</drugenddate>
        <drugtreatmentduration>1211</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5044690-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060606</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-MERCK-0606USA02216</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>74</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>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>HIGH DENSITY LIPOPROTEIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEPCID RPD</medicinalproduct>
        <drugauthorizationnumb>20752</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>STOMACH DISCOMFORT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060512</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060524</drugenddate>
        <drugtreatmentduration>13</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PANALDINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANGINA PECTORIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060511</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060522</drugenddate>
        <drugtreatmentduration>12</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NITOROL-R</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANGINA PECTORIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060510</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060526</drugenddate>
        <drugtreatmentduration>17</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BUFFERIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANGINA PECTORIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060410</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ISOSORBIDE MONONITRATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANGINA PECTORIS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060510</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5044691-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060602</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-MERCK-0606USA01304</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>53</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>69</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 LACTATE DEHYDROGENASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHROMATURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EPSTEIN-BARR VIRUS INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC STEATOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JAUNDICE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UPPER RESPIRATORY TRACT INFLAMMATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROPECIA</medicinalproduct>
        <drugauthorizationnumb>20788</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ALOPECIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060524</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROPECIA</medicinalproduct>
        <drugauthorizationnumb>020788</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060601</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5044692-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ES-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2006-DE-03305GD</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>49</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HEPATIC FIBROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEVIRAPINE</medicinalproduct>
        <drugauthorizationnumb>020636</drugauthorizationnumb>
        <drugindication>HIV INFECTION</drugindication>
        <drugtreatmentduration>13</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIDANOSINE</medicinalproduct>
        <drugindication>HIV INFECTION</drugindication>
        <drugtreatmentduration>62</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>STAVUDINE</medicinalproduct>
        <drugindication>HIV INFECTION</drugindication>
        <drugtreatmentduration>49</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5044693-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060601</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BW-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2006-DE-02863ZA</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>25</patientweight>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>STEVENS-JOHNSON SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEVIRAPINE</medicinalproduct>
        <drugauthorizationnumb>20933</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060508</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060521</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5044694-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060626</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2006-UK-02967UK</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>ALANINE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CREATINE PHOSPHOKINASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MITOCHONDRIAL TOXICITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOVEMENT DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEVIRAPINE</medicinalproduct>
        <drugauthorizationnumb>20933</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ATACAVIR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMIVUDINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5044695-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060413</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2006-FF-00288FF</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>75</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG LEVEL DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>APTIVUS</medicinalproduct>
        <drugauthorizationnumb>21814</drugauthorizationnumb>
        <drugdosagetext>TPV/RTV: 500/100 MG B.I.D.</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060322</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>APTIVUS</medicinalproduct>
        <drugauthorizationnumb>021814</drugauthorizationnumb>
        <drugdosagetext>TPV/RTV: 500/200 MG B.I.D.</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060323</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEPAKENE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUZEON</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WELLVONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5044696-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>NL-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2006-DE-03321GD</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CAESAREAN SECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PREMATURE BABY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PREMATURE RUPTURE OF MEMBRANES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TIPRANAVIR + RITONAVIR CO-ADMIN</medicinalproduct>
        <drugauthorizationnumb>21814</drugauthorizationnumb>
        <drugindication>PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TIPRANAVIR + RITONAVIR CO-ADMIN</medicinalproduct>
        <drugauthorizationnumb>021814</drugauthorizationnumb>
        <drugindication>HUMAN IMMUNODEFICIENCY VIRUS TRANSMISSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEVIRAPINE</medicinalproduct>
        <drugauthorizationnumb>020636</drugauthorizationnumb>
        <drugindication>HIV INFECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZIDOVUDINE</medicinalproduct>
        <drugauthorizationnumb>076844</drugauthorizationnumb>
        <drugindication>HIV INFECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZIDOVUDINE</medicinalproduct>
        <drugauthorizationnumb>076844</drugauthorizationnumb>
        <drugdosagetext>HIGH DOSE</drugdosagetext>
        <drugindication>PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZIDOVUDINE</medicinalproduct>
        <drugauthorizationnumb>076844</drugauthorizationnumb>
        <drugindication>HUMAN IMMUNODEFICIENCY VIRUS TRANSMISSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMIVUDINE</medicinalproduct>
        <drugindication>HIV INFECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMIVUDINE</medicinalproduct>
        <drugindication>PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMIVUDINE</medicinalproduct>
        <drugindication>HUMAN IMMUNODEFICIENCY VIRUS TRANSMISSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ABACAVIR</medicinalproduct>
        <drugindication>HIV INFECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ABACAVIR</medicinalproduct>
        <drugindication>PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ABACAVIR</medicinalproduct>
        <drugindication>HUMAN IMMUNODEFICIENCY VIRUS TRANSMISSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TENOFOVIR</medicinalproduct>
        <drugindication>PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TENOFOVIR</medicinalproduct>
        <drugindication>HUMAN IMMUNODEFICIENCY VIRUS TRANSMISSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENFUVIRTIDE</medicinalproduct>
        <drugindication>PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENFUVIRTIDE</medicinalproduct>
        <drugindication>HUMAN IMMUNODEFICIENCY VIRUS TRANSMISSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIDANOSINE</medicinalproduct>
        <drugindication>HIV INFECTION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5044697-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050719</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-US143199</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KINERET</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5044698-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050801</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-US144934</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE REACTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KINERET</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>JUVENILE ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050712</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5044699-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050718</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-US143147</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ARTHRITIS INFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STAPHYLOCOCCAL INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KINERET</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020129</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050615</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISONE TAB</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19900101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
        <drugadministrationroute>062</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5044700-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050915</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-US150445</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>CONTUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URTICARIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KINERET</medicinalproduct>
        <drugindication>JUVENILE ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5044701-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050929</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-US152381</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>STAPHYLOCOCCAL INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KINERET</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050825</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5044702-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050826</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-US148133</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE BRUISING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KINERET</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050808</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050822</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5044703-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050809</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-US145957</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE REACTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KINERET</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5044704-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20051018</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-US154785</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KINERET</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5044705-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050721</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-US143594</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URTICARIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KINERET</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>JUVENILE ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050303</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5044706-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20051223</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-US162778</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>47</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH GENERALISED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URTICARIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KINERET</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051114</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5044707-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20051222</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL162497</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KINERET</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>JUVENILE ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5044708-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20051222</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL162486</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE REACTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KINERET</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>JUVENILE ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5044709-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050815</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-US146528</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KINERET</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5044710-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050729</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-US144650</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KINERET</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5044711-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050722</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-US143769</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LATEX ALLERGY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URTICARIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KINERET</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050708</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050608</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041220</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051123</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040329</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041021</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050823</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040329</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5044712-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20051025</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-US155561</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>10</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KINERET</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>JUVENILE ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5044713-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0606USA05721</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>99</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>STOMATITIS NECROTISING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5044714-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060531</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-RB-3390-2006</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>70.37</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE CONGESTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOXIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BUPRENORPHINE HCL</medicinalproduct>
        <drugauthorizationnumb>20732</drugauthorizationnumb>
        <drugadministrationroute>060</drugadministrationroute>
        <drugindication>DRUG DEPENDENCE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060130</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060130</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BUPRENORPHINE HCL</medicinalproduct>
        <drugauthorizationnumb>020732</drugauthorizationnumb>
        <drugadministrationroute>060</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060131</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060131</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CHLORDIAZEPOXIDE HCL</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060131</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060131</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONIDINE</medicinalproduct>
        <drugindication>ALCOHOL WITHDRAWAL SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060131</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060131</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROMETHAZINE HCL</medicinalproduct>
        <drugindication>NAUSEA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060131</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060131</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060131</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060131</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PARACETAMOL</medicinalproduct>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060131</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060131</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROXYZINE EMBONATE</medicinalproduct>
        <drugindication>ANXIETY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060131</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060131</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5044715-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-JNJFOC-20060200322</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>69</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>90</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>LYMPH NODE TUBERCULOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPECIAFOLDINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CORTANCYL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERCHOLESTEROLAEMIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5044716-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-JNJFOC-20060504569</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>57</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>80</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSORIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH MACULO-PAPULAR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ANKYLOSING SPONDYLITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANKYLOSING SPONDYLITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>APRANAX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANKYLOSING SPONDYLITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANKYLOSING SPONDYLITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5044717-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060516</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2006JP07523</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>88</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>URINARY RETENTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VOLTAREN</medicinalproduct>
        <drugauthorizationnumb>19201</drugauthorizationnumb>
        <drugdosagetext>75 MG/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060508</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAGAMET</medicinalproduct>
        <drugdosagetext>400 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060508</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRORENAL</medicinalproduct>
        <drugdosagetext>15 UG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060407</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5044718-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060512</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2006JP07271</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>54</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CREATINE PHOSPHOKINASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTHYROIDISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOGLOBIN BLOOD PRESENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POLYMYOSITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOXONIN</medicinalproduct>
        <drugdosagetext>3 DF, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SPONDYLOLISTHESIS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYANOCOBALAMIN</medicinalproduct>
        <drugdosagetext>250 MG/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SPONDYLOLISTHESIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OPALMON</medicinalproduct>
        <drugdosagetext>15 DF/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SPONDYLOLISTHESIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEUROTROPIN</medicinalproduct>
        <drugdosagetext>4 DF/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SPONDYLOLISTHESIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SELBEX</medicinalproduct>
        <drugdosagetext>450 MG/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SPONDYLOLISTHESIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VOLTAREN</medicinalproduct>
        <drugauthorizationnumb>019201</drugauthorizationnumb>
        <drugdosagetext>25 MG, PRN</drugdosagetext>
        <drugadministrationroute>054</drugadministrationroute>
        <drugindication>SPONDYLOLISTHESIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050406</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5044719-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHFR2006GB02103</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>79</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>90</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DECUBITUS ULCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIALYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRIC ULCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VOLTAREN</medicinalproduct>
        <drugauthorizationnumb>019201</drugauthorizationnumb>
        <drugdosagetext>UNK, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060519</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5044720-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060602</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2006BR08530</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>75</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE DISCOLOURATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VOLTAREN</medicinalproduct>
        <drugauthorizationnumb>19201</drugauthorizationnumb>
        <drugdosagetext>75 MG, UNK</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>POSTOPERATIVE ANALGESIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060107</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060107</drugenddate>
        <drugtreatmentduration>1440</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5044723-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FI-JNJFOC-20060606158</companynumb>
    <primarysource>
      <reportercountry>FINLAND</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>5</patientonsetage>
      <patientonsetageunit>800</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ENCEPHALITIS HERPES</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5044731-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060622</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200611799BCC</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>70</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>81.6475</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRIC ULCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALEVE</medicinalproduct>
        <drugauthorizationnumb>20204</drugauthorizationnumb>
        <drugdosagetext>220 MG, BID, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRALGIA</drugindication>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5044739-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060104</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-SOLVAY-00206001645</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>25</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>GESTATIONAL DIABETES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLACENTAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>DAILY DOSE:  UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PSORIASIS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050902</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROMETRIUM</medicinalproduct>
        <drugauthorizationnumb>019781</drugauthorizationnumb>
        <drugdosagetext>DAILY DOSE: 400 MILLIGRAM(S)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRENATAL CARE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050906</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051129</drugenddate>
        <drugtreatmentduration>85</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5044740-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060622</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200612489BWH</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </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>CARDIAC FAILURE CONGESTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RIB FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXAVAR</medicinalproduct>
        <drugbatchnumb>5400LR4</drugbatchnumb>
        <drugauthorizationnumb>21923</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RENAL CELL CARCINOMA STAGE UNSPECIFIED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXAVAR</medicinalproduct>
        <drugbatchnumb>5400LR4</drugbatchnumb>
        <drugauthorizationnumb>21923</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RENAL CELL CARCINOMA STAGE UNSPECIFIED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060622</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INTERFERON</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOXYL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMIODARONE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROSCAR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMBIEN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5044745-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060626</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200610106BWH</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>55</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>56.246</patientweight>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACTERIAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD POTASSIUM DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD SODIUM DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIOMEGALY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLONIC POLYP</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CULTURE STOOL POSITIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DECREASED APPETITE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DECUBITUS ULCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALIGNANT NEOPLASM PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METASTATIC RENAL CELL CARCINOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OCCULT BLOOD POSITIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SORAFENIB</medicinalproduct>
        <drugauthorizationnumb>21923</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>METASTATIC RENAL CELL CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051215</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051229</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SORAFENIB</medicinalproduct>
        <drugauthorizationnumb>21923</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>METASTATIC RENAL CELL CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060120</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060121</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SORAFENIB</medicinalproduct>
        <drugauthorizationnumb>21923</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>METASTATIC RENAL CELL CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060203</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060410</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LUNESTA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PERCOCET</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COMPAZINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATIVAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DILAUDID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>K-DUR 10</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAZIDIME</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASCORBIC ACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN A</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZINC SULFATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCONTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DURAGESIC-100</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROTONIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCODONE HCL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5044748-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060619</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2641</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>31</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG DOSE OMISSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EFFECT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PREGNANCY ON ORAL CONTRACEPTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PREGNANCY TEST POSITIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMNESTEEM</medicinalproduct>
        <drugauthorizationnumb>75945</drugauthorizationnumb>
        <drugdosagetext>40MG, BID, PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ACNE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060605</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ETHINYL ESTRADIOL TAB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORGESTIMATE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5044749-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ABBOTT-06P-087-0337355-00</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HERPES ZOSTER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KALETRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021226</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KALETRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021226</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020709</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020829</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZIDOVUDINE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZIDOVUDINE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020709</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020829</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LAMIVUDINE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LAMIVUDINE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020709</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020829</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5044750-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060626</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2006ES09554</companynumb>
    <primarysource>
      <reportercountry>SPAIN</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>71</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <reaction>
        <reactionmeddrapt>BONE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOLYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTH EXTRACTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAMIDRONATE DISODIUM</medicinalproduct>
        <drugauthorizationnumb>20036</drugauthorizationnumb>
        <drugdosagetext>90 MG, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOLEDRONATE</medicinalproduct>
        <drugdosagetext>4 MG, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5044752-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060607</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2641</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>31</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG DOSE OMISSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PREGNANCY TEST POSITIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREATMENT NONCOMPLIANCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMNESTEEM</medicinalproduct>
        <drugauthorizationnumb>75945</drugauthorizationnumb>
        <drugdosagetext>40MG, BID, PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ACNE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060605</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ETHINYL ESTRADIOL TAB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORGESTIMATE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5044754-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060627</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>NO-JNJFOC-20060605884</companynumb>
    <primarysource>
      <reportercountry>NORWAY</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>OVERDOSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PARACETAMOL</medicinalproduct>
        <drugauthorizationnumb>19872</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PARACETAMOL</medicinalproduct>
        <drugauthorizationnumb>019872</drugauthorizationnumb>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5044755-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-JNJFOC-20060505455</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>69</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>SKIN EXFOLIATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMINYL</medicinalproduct>
        <drugauthorizationnumb>21169</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEMENTIA ALZHEIMER'S TYPE</drugindication>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CEREBROVASCULAR ACCIDENT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SECTRAL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KENZEN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FRACTAL LP</medicinalproduct>
        <drugindication>CEREBROVASCULAR ACCIDENT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NOVONORM</medicinalproduct>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TEMESTA</medicinalproduct>
        <drugindication>INSOMNIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5044756-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-JNJFOC-20060606470</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HYPOGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DURAGESIC-100</medicinalproduct>
        <drugauthorizationnumb>019813</drugauthorizationnumb>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5044757-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060627</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-JNJFOC-20050101097</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>77</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>54.43</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEPHROLITHIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NIGHTMARE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WRONG TECHNIQUE IN DRUG USAGE PROCESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DURAGESIC-100</medicinalproduct>
        <drugauthorizationnumb>19813</drugauthorizationnumb>
        <drugdosagetext>ONE HALF OF A 25 UG/HR PATCH, 1 IN 72 HOURS.</drugdosagetext>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>BACK PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040310</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DILTIAZEM CD</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COMBIVENT</medicinalproduct>
        <drugdosagetext>TWO PUFFS EVERY SIX HOURS.</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADVAIR DISKUS 100/50</medicinalproduct>
        <drugdosagetext>250 UG, TWO PUFFS TWICE DAILY.</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRAVASTATIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NITROGLYCERIN</medicinalproduct>
        <drugadministrationroute>062</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN B-12</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5044758-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060624</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-JNJFOC-20051205297</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>59</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ABNORMAL BEHAVIOUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLORECTAL CANCER METASTATIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DELIRIUM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSED LEVEL OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</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>
        <drugauthorizationnumb>019813</drugauthorizationnumb>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>CANCER PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MELOXICAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CODEINE PHOSPHATE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5044761-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060627</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-JNJFOC-20060606590</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>60</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>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>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ITRIZOLE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ITRIZOLE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ITRIZOLE</medicinalproduct>
        <drugauthorizationnumb>020083</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NAIL TINEA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENIDIPINE HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CANDESARTAN CILEXETIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5044762-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-JNJFOC-20060700043</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>23</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>SPEECH DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CONCERTA</medicinalproduct>
        <drugauthorizationnumb>021121</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATTENTION DEFICIT/HYPERACTIVITY DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5044763-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>MX-JNJFOC-20060605749</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>48</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DERMATITIS EXFOLIATIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHEEZING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAVANIC</medicinalproduct>
        <drugauthorizationnumb>20635</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051201</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5044764-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006US003162</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>50</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>68.8</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD ALKALINE PHOSPHATASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CALCIUM DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD POTASSIUM DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GLOBULINS INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOCAL SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARYNGEAL OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY CONGESTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH ERYTHEMATOUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWELLING FACE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URTICARIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALOXI</medicinalproduct>
        <drugauthorizationnumb>21372</drugauthorizationnumb>
        <drugdosagetext>0.25 MG, SINGLE, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PROPHYLAXIS OF NAUSEA AND VOMITING</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060516</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060516</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALOXI</medicinalproduct>
        <drugauthorizationnumb>21372</drugauthorizationnumb>
        <drugdosagetext>0.25 MG, SINGLE, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PROPHYLAXIS OF NAUSEA AND VOMITING</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060606</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060606</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ADRIAMYCIN PFS</medicinalproduct>
        <drugdosagetext>102 MG, SINGLE, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060516</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060516</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ADRIAMYCIN PFS</medicinalproduct>
        <drugdosagetext>102 MG, SINGLE, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060606</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060606</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYTOXAN</medicinalproduct>
        <drugdosagetext>1000 MG, SINGLE, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060516</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060516</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYTOXAN</medicinalproduct>
        <drugdosagetext>1000 MG, SINGLE, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060606</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060606</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DECADRON /00016001/ (DEXAMETHASONE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EMEND</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEUPOGEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CEFTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRILOSEC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASCORBIC ACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZANTAC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZYRTEC /00884302/ (CETIRIZINE HYDROCHLORIDE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORTRIPTYLINE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PERCOCET /00867901/ (OXYCODONE HYDROCHLORIDE, PARACETAMOL)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5044765-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060630</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-RB-3518-2006</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>2.51</patientweight>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART DISEASE CONGENITAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IRRITABILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POOR SUCKING REFLEX</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PREMATURE BABY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BUPRENORPHINE HCL</medicinalproduct>
        <drugauthorizationnumb>20732</drugauthorizationnumb>
        <drugdosagetext>DURING ALL PREGNANCY</drugdosagetext>
        <drugadministrationroute>064</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060426</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5044766-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060621</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2663</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>24</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMNESTEEM</medicinalproduct>
        <drugauthorizationnumb>75945</drugauthorizationnumb>
        <drugdosagetext>40 MG, QD, PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ACNE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060113</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060301</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5044767-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060626</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20060501572</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>73.48</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABORTION SPONTANEOUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANTEPARTUM HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UNINTENDED PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UTERINE POLYP</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ORTHO EVRA</medicinalproduct>
        <drugauthorizationnumb>021180</drugauthorizationnumb>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEXAPRO</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5044768-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060616</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2643</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>14</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ENTERITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL INFLAMMATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATOCHEZIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ILEITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROCTITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMNESTEEM</medicinalproduct>
        <drugauthorizationnumb>75945</drugauthorizationnumb>
        <drugdosagetext>40 MG QD PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ACNE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060509</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060606</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5044769-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060625</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-STX184322</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INNER EAR DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NERVOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUROLOGICAL SYMPTOM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNOVIAL CYST</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>P059028</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PSORIATIC ARTHROPATHY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYCLOSPORINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMURAN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5044770-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BE-JNJFOC-20060600037</companynumb>
    <primarysource>
      <reportercountry>BELGIUM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>52</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>60</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOPAMAX</medicinalproduct>
        <drugauthorizationnumb>20505</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MIGRAINE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5044771-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20060601555</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ACTIVATED PARTIAL THROMBOPLASTIN TIME PROLONGED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOPAMAX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOPAMAX</medicinalproduct>
        <drugauthorizationnumb>020505</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCODONE</medicinalproduct>
        <drugindication>ANALGESIC EFFECT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMBIEN</medicinalproduct>
        <drugindication>SLEEP DISORDER THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYCLOBENZAPRINE HCL</medicinalproduct>
        <drugindication>MUSCLE RELAXANT THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENICAR</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5044772-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-JNJFOC-20060700015</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MIGRAINE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCLONUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOPAMAX</medicinalproduct>
        <drugauthorizationnumb>020505</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OPIODS</medicinalproduct>
        <drugindication>PAIN</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5044773-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-JNJFOC-20060700019</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIAC ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOPAMAX</medicinalproduct>
        <drugauthorizationnumb>020505</drugauthorizationnumb>
        <drugdosagetext>125MG AM 100MG PM</drugdosagetext>
        <drugindication>EPILEPSY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5044774-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060626</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20040908135</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>115.67</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CONJUNCTIVITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIABETES MELLITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRIC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEPHROLITHIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCREATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARYNGITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUS TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERDAL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERDAL</medicinalproduct>
        <drugauthorizationnumb>020272</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MENTAL DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONIDINE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DILTIAZEM HCL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMARYL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZYRTEC</medicinalproduct>
        <drugdosagetext>AS NEEDED</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>RHINITIS ALLERGIC</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLEGRA</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>RHINITIS ALLERGIC</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5044775-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060626</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-JNJFOC-20060605883</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MUSCLE RIGIDITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERDAL</medicinalproduct>
        <drugauthorizationnumb>020272</drugauthorizationnumb>
        <drugindication>DRUG EXPOSURE DURING PREGNANCY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYLENOL W/ CODEINE NO. 3</medicinalproduct>
        <drugauthorizationnumb>085055</drugauthorizationnumb>
        <drugindication>DRUG EXPOSURE DURING PREGNANCY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5044776-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060626</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-JNJFOC-20060601998</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>AMNESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISTURBANCE IN ATTENTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISTURBANCE IN SOCIAL BEHAVIOUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSIVE CRISIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESTLESSNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERDAL</medicinalproduct>
        <drugbatchnumb>03AL243A;03AL253</drugbatchnumb>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERDAL</medicinalproduct>
        <drugbatchnumb>03AL243A;03AL253</drugbatchnumb>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERDAL</medicinalproduct>
        <drugbatchnumb>03AL243A;03AL253</drugbatchnumb>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERDAL</medicinalproduct>
        <drugbatchnumb>03AL243A;03AL253</drugbatchnumb>
        <drugauthorizationnumb>020272</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GINSENG</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5044777-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-JNJFOC-20060604628</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>70</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERDAL CONSTA</medicinalproduct>
        <drugauthorizationnumb>21346</drugauthorizationnumb>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>PSYCHOTIC DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEPAKOTE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>AFFECTIVE DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5044778-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060626</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-JNJFOC-20060300550</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CIRCULATORY COLLAPSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERDAL</medicinalproduct>
        <drugbatchnumb>02AL696</drugbatchnumb>
        <drugauthorizationnumb>20272</drugauthorizationnumb>
        <drugdosagetext>PATIENT RECEIVED ONLY 3 TABLETS</drugdosagetext>
        <drugindication>AGITATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORAZEPAM</medicinalproduct>
        <drugindication>AGITATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THYROXINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5044779-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060627</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-JNJFOC-20051104602</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HYPERPROLACTINAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFERTILITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERIDONE</medicinalproduct>
        <drugauthorizationnumb>020272</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERDAL CONSTA</medicinalproduct>
        <drugauthorizationnumb>021346</drugauthorizationnumb>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5044780-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060630</receiptdate>
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    <companynumb>CH-JNJFOC-20060700044</companynumb>
    <primarysource>
      <reportercountry>SWITZERLAND</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>34</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>LEUKOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERDAL</medicinalproduct>
        <drugauthorizationnumb>020272</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PSYCHOTIC DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060510</drugenddate>
        <drugtreatmentduration>71</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PSYCHOTIC DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5044781-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060516</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FRWYE631417MAY06</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>55</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>COLON CANCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RECTAL CANCER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugdosagetext>UNKNOWN</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PSORIATIC ARTHROPATHY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5044782-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-US184789</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>P063744</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PSORIATIC ARTHROPATHY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050520</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5044783-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060531</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006AP02437</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <patientonsetage>13303</patientonsetage>
      <patientonsetageunit>804</patientonsetageunit>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ACUTE MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugauthorizationnumb>21366</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>TYPE IIA HYPERLIPIDAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051215</drugenddate>
        <drugtreatmentduration>15</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugauthorizationnumb>021366</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051216</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060126</drugenddate>
        <drugtreatmentduration>42</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugauthorizationnumb>021366</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060127</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060309</drugenddate>
        <drugtreatmentduration>42</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugauthorizationnumb>021366</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060310</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060525</drugenddate>
        <drugtreatmentduration>78</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CHOLEBRINE</medicinalproduct>
        <drugdosagetext>STARTED BEFORE CRESTOR</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>TYPE IIA HYPERLIPIDAEMIA</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060525</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugdosagetext>STARTED BEFORE CRESTOR</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CARDIAC FAILURE</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060525</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALDACTONE</medicinalproduct>
        <drugdosagetext>STARTED BEFORE CRESTOR</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CARDIAC FAILURE</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060525</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NU-LOTAN</medicinalproduct>
        <drugdosagetext>STARTED BEFORE CRESTOR</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CARDIAC FAILURE</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060525</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARTIST</medicinalproduct>
        <drugdosagetext>STARTED BEFORE CRESTOR</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CARDIAC FAILURE</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060525</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANALDINE</medicinalproduct>
        <drugdosagetext>STARTED BEFORE CRESTOR</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANGINA PECTORIS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060525</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ISOSORBIDE MONONITRATE</medicinalproduct>
        <drugdosagetext>STARTED BEFORE CRESTOR</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANGINA PECTORIS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060525</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>STARTED BEFORE CRESTOR</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANGINA PECTORIS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060525</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GASTER D</medicinalproduct>
        <drugdosagetext>STARTED BEFORE CRESTOR</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>REFLUX OESOPHAGITIS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060525</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugindication>TYPE IIA HYPERLIPIDAEMIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5044784-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060321</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006PK00538</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>54</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugauthorizationnumb>20639</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050913</drugstartdate>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugauthorizationnumb>020639</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050914</drugstartdate>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugauthorizationnumb>020639</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050915</drugstartdate>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugauthorizationnumb>020639</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050916</drugstartdate>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugauthorizationnumb>020639</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050917</drugstartdate>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugauthorizationnumb>020639</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050918</drugstartdate>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugauthorizationnumb>020639</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050919</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050920</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugauthorizationnumb>020639</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050920</drugstartdate>
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        <drugenddate>20050921</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugauthorizationnumb>020639</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050921</drugstartdate>
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        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugauthorizationnumb>020639</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051013</drugstartdate>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugauthorizationnumb>020639</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051014</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051017</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugauthorizationnumb>020639</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051018</drugstartdate>
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        <drugenddate>20051020</drugenddate>
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        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
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        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051021</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5044785-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
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    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
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    <receiptdate>20060626</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-STX184305</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>BRONCHIOLITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060110</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060603</drugenddate>
      </drug>
    </patient>
  </safetyreport>
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    <safetyreportid>5044786-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
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    <serious>1</serious>
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    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060615</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ITWYE733415JUN06</companynumb>
    <primarysource>
      <reportercountry>ITALY</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
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        <reactionmeddrapt>DISEASE PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FUSARIUM INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PUSTULAR PSORIASIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PSORIASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060322</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060522</drugenddate>
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    </patient>
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  <safetyreport>
    <safetyreportid>5044787-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060701</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060315</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>2006-BP-00333BP(1)</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
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    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <patientonsetage>64</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRY MOUTH</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>DYSGEUSIA</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
        <drugbatchnumb>505645</drugbatchnumb>
        <drugauthorizationnumb>21395</drugauthorizationnumb>
        <drugdosagetext>18 MCG (18 MCG, 1 DAILY), IH</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
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        <drugstartdate>20040101</drugstartdate>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
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        <medicinalproduct>ATENOLOL</medicinalproduct>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
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      <drug>
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        <medicinalproduct>VALIUM</medicinalproduct>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYLENOL W/ CODEINE NO. 3</medicinalproduct>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRIAMTERENE AND HYDROCHLOROTHIAZIDE (DYAZIDE)</medicinalproduct>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLBEE (FOLIC ACID)</medicinalproduct>
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    </patient>
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  <safetyreport>
    <safetyreportid>5044788-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060701</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060324</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>2006-BP-00369BP(1)</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>60</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSGEUSIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
        <drugbatchnumb>405145</drugbatchnumb>
        <drugauthorizationnumb>21395</drugauthorizationnumb>
        <drugdosagetext>18 MCG (18 MCG), IH</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADVAIR (SERETIDE /01420901/)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5044789-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060623</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FRWYE771623JUN06</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BREAST CANCER FEMALE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugdosagetext>UNKNOWN</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050301</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugdosagetext>UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050301</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5044790-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060606</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-STX182198</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>SARCOIDOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>ANKYLOSING SPONDYLITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041004</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060223</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MOTRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLATE SODIUM</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040701</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5044791-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060614</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006GB01012</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>679</patientonsetage>
      <patientonsetageunit>802</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CUTANEOUS VASCULITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FELODIPINE</medicinalproduct>
        <drugauthorizationnumb>19834</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060501</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5044795-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060627</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-JNJFOC-20060605888</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>47</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>LUNG DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLEURAL EFFUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMOTHORAX</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5044807-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20051107</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2005CH16643</companynumb>
    <primarysource>
      <reportercountry>SWITZERLAND</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>90</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE SYSTOLIC INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENTRICULAR HYPERTROPHY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TEGRETOL</medicinalproduct>
        <drugauthorizationnumb>16608</drugauthorizationnumb>
        <drugdosagetext>200 MG, BID</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>TRIGEMINAL NEURALGIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040826</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>THIAZIDES</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CALCIUM CHANNEL BLOCKERS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACE INHIBITORS AND DIURETICS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PHYSIOTENS</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ATACAND</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040807</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040812</drugenddate>
        <drugtreatmentduration>8640</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ATACAND HCT</medicinalproduct>
        <drugdosagetext>16 MG/DAY</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040813</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040824</drugenddate>
        <drugtreatmentduration>17280</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARVEDILOL (NGX)</medicinalproduct>
        <drugdosagetext>12.5 MG/DAY</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040806</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040821</drugenddate>
        <drugtreatmentduration>23040</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TORASEMIDE (NGX)</medicinalproduct>
        <drugdosagetext>5 MG/DAY</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040820</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
        <drugdosagetext>10 MG/DAY</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040815</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NITRODERM</medicinalproduct>
        <drugdosagetext>10 MG/DAY</drugdosagetext>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>ANGINA PECTORIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RIVOTRIL</medicinalproduct>
        <drugdosagetext>1 MG/DAY</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>TRIGEMINAL NEURALGIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040827</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugdosagetext>75 MG/DAY</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOLVON</medicinalproduct>
        <drugdosagetext>30 MG/DAY</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040807</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SELIPRAN</medicinalproduct>
        <drugdosagetext>10 MG/DAY</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HYPERLIPIDAEMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>STILNOX</medicinalproduct>
        <drugdosagetext>7.5 MG/DAY</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>INSOMNIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5044808-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060612</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US200606002965</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>90</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>COLITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLITIS ISCHAEMIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYSTEMIC LUPUS ERYTHEMATOSUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENOUS THROMBOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugauthorizationnumb>21318</drugauthorizationnumb>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5044811-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
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    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060613</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US200606003360</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugauthorizationnumb>21318</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5044813-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060612</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US200606002967</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
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      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugauthorizationnumb>21318</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
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    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5044814-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060411</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006AP01712</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <patientonsetage>31177</patientonsetage>
      <patientonsetageunit>804</patientonsetageunit>
      <patientweight>43.5</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG DOSE OMISSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SICK SINUS SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugauthorizationnumb>21366</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERCHOLESTEROLAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060112</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060125</drugenddate>
        <drugtreatmentduration>14</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugauthorizationnumb>021366</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060209</drugstartdate>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MYOCARDIAL INFARCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040130</drugstartdate>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANALDINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MYOCARDIAL INFARCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040130</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BLOPRESS</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040130</drugstartdate>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GASTER D</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS AGAINST GASTROINTESTINAL ULCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040130</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FRANDOL</medicinalproduct>
        <drugindication>ANGINA PECTORIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040130</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIVALO</medicinalproduct>
        <drugdosagetext>PAST DRUG HISTORY</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5044815-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060612</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006AP02718</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>23503</patientonsetage>
      <patientonsetageunit>804</patientonsetageunit>
      <patientweight>55</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>RETROPERITONEAL FIBROSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TENORMIN</medicinalproduct>
        <drugauthorizationnumb>18240</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990109</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20000421</drugenddate>
        <drugtreatmentduration>469</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TENORMIN</medicinalproduct>
        <drugauthorizationnumb>018240</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000422</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060412</drugenddate>
        <drugtreatmentduration>2182</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5044816-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060424</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006SE02339</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>25636</patientonsetage>
      <patientonsetageunit>804</patientonsetageunit>
      <patientweight>67</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DIABETIC NEPHROPATHY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BLOPRESS</medicinalproduct>
        <drugauthorizationnumb>20838</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030225</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030304</drugenddate>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BLOPRESS</medicinalproduct>
        <drugauthorizationnumb>020838</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030325</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041220</drugenddate>
        <drugtreatmentduration>637</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BLOPRESS</medicinalproduct>
        <drugauthorizationnumb>020838</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041221</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051114</drugenddate>
        <drugtreatmentduration>329</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BLOPRESS</medicinalproduct>
        <drugauthorizationnumb>020838</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051115</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMARYL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS NON-INSULIN-DEPENDENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021024</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040112</drugenddate>
        <drugtreatmentduration>446</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TORSEMIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OEDEMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030325</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040120</drugenddate>
        <drugtreatmentduration>302</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERURICAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031018</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040323</drugenddate>
        <drugtreatmentduration>158</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLETAL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>THROMBOTIC STROKE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040120</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OEDEMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040120</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLELOCK</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG ERUPTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040323</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040417</drugenddate>
        <drugtreatmentduration>26</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>URINORM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GOUT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040713</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>URALYT</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GOUT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040713</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CONIEL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051129</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5044817-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060620</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006SE03525</companynumb>
    <primarysource>
      <reportercountry>FINLAND</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>15654</patientonsetage>
      <patientonsetageunit>804</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ALANINE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD ALKALINE PHOSPHATASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYSIPELAS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYELID OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FACE OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NERVE COMPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PURULENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SENSORY LOSS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STAPHYLOCOCCAL INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ATACAND</medicinalproduct>
        <drugauthorizationnumb>020838</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARCOXIA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRALGIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060529</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060602</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5044818-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006SE03654</companynumb>
    <primarysource>
      <reportercountry>DENMARK</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>17630</patientonsetage>
      <patientonsetageunit>804</patientonsetageunit>
      <patientweight>80</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FACE OEDEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PULMICORT</medicinalproduct>
        <drugauthorizationnumb>020441</drugauthorizationnumb>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>COUGH</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060523</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060524</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ELTROXIN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030221</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CORODIL COMP</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060303</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060601</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CORODIL COMP</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060601</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5044819-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060626</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006SE03567</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>51</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>C-REACTIVE PROTEIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC FUNCTION ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BLOPRESS TABLETS 4</medicinalproduct>
        <drugauthorizationnumb>20838</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060501</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOSAMAC(ALENDRONATE SODIUM HYDRATE)</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PENTASA</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BIOFERMIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BECLOMETHASONE DIPROPIONATE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5044820-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060619</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2676</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>21</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>LIPOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMNESTEEM</medicinalproduct>
        <drugauthorizationnumb>75945</drugauthorizationnumb>
        <drugdosagetext>40 MG BID PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ACNE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060213</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060329</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5044822-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060623</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006-06-1902</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OESOPHAGEAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROVENTIL</medicinalproduct>
        <drugauthorizationnumb>17559</drugauthorizationnumb>
        <drugdosagetext>2 PUFFS PRN ORAL AER INH</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROVENTIL</medicinalproduct>
        <drugauthorizationnumb>17559</drugauthorizationnumb>
        <drugdosagetext>2 PUFFS PRN ORAL AER INH</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>OBSTRUCTIVE AIRWAYS DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VENTOLIN</medicinalproduct>
        <drugindication>ASTHMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADVAIR DISKUS 100/50</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVELOX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5044824-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060623</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006-06-2128</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROVENTIL-HFA</medicinalproduct>
        <drugauthorizationnumb>20503</drugauthorizationnumb>
        <drugdosagetext>ORAL AER INH</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5044827-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-13429725</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ETOPOSIDE</medicinalproduct>
        <drugauthorizationnumb>018768</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5044828-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060526</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-BRISTOL-MYERS SQUIBB COMPANY-13391628</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>65</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CISPLATIN</medicinalproduct>
        <drugauthorizationnumb>018057</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>SMALL CELL LUNG CANCER STAGE UNSPECIFIED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060327</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060327</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOPOTECAN HCL</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>SMALL CELL LUNG CANCER STAGE UNSPECIFIED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060323</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060327</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL SUCCINATE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5044829-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesscongenitalanomali>1</seriousnesscongenitalanomali>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060627</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-BRISTOL-MYERS SQUIBB COMPANY-13426846</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>21</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>54</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ALPHA 1 FOETOPROTEIN AMNIOTIC FLUID INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MICROCEPHALY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPINA BIFIDA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ABILIFY</medicinalproduct>
        <drugdosagetext>REDUCED TO 15 MG DAILY ON 21-MAR-2006</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA, PARANOID TYPE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060308</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060308</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIPIPERON</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RESTLESSNESS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060308</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5044832-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060626</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006-06-1887</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>70</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE CONGESTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIOVASCULAR DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIABETES MELLITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMDUR</medicinalproduct>
        <drugauthorizationnumb>20225</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5044834-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006UW01340</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>61</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>79.5</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ESCHERICHIA INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLANK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STRESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VIRAL INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARIMIDEX</medicinalproduct>
        <drugauthorizationnumb>20541</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SINGULAIR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADVAIR DISKUS 100/50</medicinalproduct>
        <drugdosagetext>250/50</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENTYL</medicinalproduct>
        <drugindication>STOMACH DISCOMFORT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARAFATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZYRTEC</medicinalproduct>
        <drugindication>MULTIPLE ALLERGIES</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5044836-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesscongenitalanomali>1</seriousnesscongenitalanomali>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060519</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006UW09898</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>RETINAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL DISTURBANCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugauthorizationnumb>20639</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060501</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5044837-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006UW13677</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>45</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>104.3</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOPROL-XL</medicinalproduct>
        <drugauthorizationnumb>019962</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ATACAND</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOSAMAX</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>CALCIUM GLUCONATE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5044838-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060509</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-BRISTOL-MYERS SQUIBB COMPANY-13374491</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>51</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANAPHYLACTOID REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOXIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAXOL</medicinalproduct>
        <drugauthorizationnumb>020262</drugauthorizationnumb>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>GASTRIC CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060403</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060403</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TS-1</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CHLOR-TRIMETON</medicinalproduct>
        <drugindication>PREMEDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZANTAC</medicinalproduct>
        <drugindication>PREMEDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOFRAN</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>PREMEDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060403</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060403</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DECADRON</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>PREMEDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060403</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060403</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5044839-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060705</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-13432919</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>49</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>73</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
        <drugauthorizationnumb>9218</drugauthorizationnumb>
        <drugindication>MYOCARDIAL INFARCTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
        <drugauthorizationnumb>009218</drugauthorizationnumb>
        <drugindication>CORONARY ANGIOPLASTY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
        <drugauthorizationnumb>009218</drugauthorizationnumb>
        <drugindication>CORONARY ARTERIAL STENT INSERTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NSAID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE TAB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARAVA</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5044841-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060623</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006-06-2113</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>48</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLISTER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUID INTAKE REDUCED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GOITRE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMPAIRED WORK ABILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOVEMENT DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NASOPHARYNGEAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL INTAKE REDUCED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STRESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ULCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEG-INTRON (PEGINTERFERON ALFA-2B)</medicinalproduct>
        <drugdosagetext>SUBCUTANEOUS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051222</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RIBAVIRIN</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051222</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EFFEXOR</medicinalproduct>
        <drugindication>STRESS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEXAPRO</medicinalproduct>
        <drugindication>STRESS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5044846-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060616</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006UW12926</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>69</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>101</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ATRIAL FLUTTER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OESOPHAGITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL INTAKE REDUCED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RADIATION OESOPHAGITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUS TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SQUAMOUS CELL CARCINOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUPRAVENTRICULAR TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENTRICULAR EXTRASYSTOLES</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZD1839</medicinalproduct>
        <drugauthorizationnumb>21399</drugauthorizationnumb>
        <drugdosagetext>250 MG PO DAILY X 1 YR</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER STAGE III</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060322</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060417</drugenddate>
        <drugtreatmentduration>27</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOCATAXEL</medicinalproduct>
        <drugdosagetext>2.5 MG/M2 WEEKLY X 7 WEEKS</drugdosagetext>
        <drugindication>NON-SMALL CELL LUNG CANCER STAGE III</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060322</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060417</drugenddate>
        <drugtreatmentduration>27</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RADIATION THERAPY</medicinalproduct>
        <drugdosagetext>TOTAL DOSE 3600</drugdosagetext>
        <drugindication>NON-SMALL CELL LUNG CANCER STAGE III</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060322</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060417</drugenddate>
        <drugtreatmentduration>27</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLYBURIDE AND METFORMIN HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACTOS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALTACE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5044847-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060616</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006UW12937</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>22087</patientonsetage>
      <patientonsetageunit>804</patientonsetageunit>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ATELECTASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRONCHIECTASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEEP VEIN THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG TOXICITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERNATIONAL NORMALISED RATIO INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERSTITIAL LUNG DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERFORMANCE STATUS DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLEURAL EFFUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IRESSA</medicinalproduct>
        <drugauthorizationnumb>21399</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060214</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060417</drugenddate>
        <drugtreatmentduration>63</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAXOTERE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060214</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060328</drugenddate>
        <drugtreatmentduration>43</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RADIOTHERAPY</medicinalproduct>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060214</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060406</drugenddate>
        <drugtreatmentduration>52</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE TAB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLONASE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATROVENT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRILOSEC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARAFATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SUDAFED 12 HOUR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENADRYL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEGACE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5044855-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060307</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-BRISTOL-MYERS SQUIBB COMPANY-13309869</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>56</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MYELODYSPLASTIC SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREATMENT RELATED SECONDARY MALIGNANCY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VEPESID</medicinalproduct>
        <drugauthorizationnumb>18768</drugauthorizationnumb>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>STEM CELL TRANSPLANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20001128</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20001130</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENDOXAN</medicinalproduct>
        <drugauthorizationnumb>012142</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>LYMPHOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19970701</drugstartdate>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIDRAN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>STEM CELL TRANSPLANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20001127</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20001127</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYLOCIDE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>STEM CELL TRANSPLANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20001127</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20001130</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TESPAMIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>STEM CELL TRANSPLANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20001201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20001202</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RANDA</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>LYMPHOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000701</drugstartdate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DECADRON</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>LYMPHOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000701</drugstartdate>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADRIACIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990701</drugstartdate>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ONCOVIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19970701</drugstartdate>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDONINE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19970701</drugstartdate>
        <drugtreatmentduration>40</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5044856-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060627</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20060605929</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FIBROSARCOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CROHN'S DISEASE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5044857-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060627</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-JNJFOC-20060505926</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>44</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>TUBERCULOUS PLEURISY</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>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDONINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ONEALFA</medicinalproduct>
        <drugdosagetext>DOSE 1RG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GASTER D</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTRITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5044858-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060627</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-JNJFOC-20060205019</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>54</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HYPOGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugdosagetext>3 MG/KG</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugdosagetext>3 MG/KG</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AZELNIDIPINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VOLTAREN</medicinalproduct>
        <drugdosagetext>ROUTE=^PR^</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ONEALFA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VANCOMIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDONINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RHEUMATREX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIAMIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5044860-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060627</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-JNJFOC-20060202971</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>44</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL STRANGULATED HERNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERITONEAL TUBERCULOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TUBERCULOUS PLEURISY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDONINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDONINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RHEUMATREX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5044863-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060626</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-13428909</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>17</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>RENAL CELL CARCINOMA STAGE UNSPECIFIED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREATMENT RELATED SECONDARY MALIGNANCY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ETOPOSIDE</medicinalproduct>
        <drugauthorizationnumb>018768</drugauthorizationnumb>
        <drugindication>ACUTE MYELOID LEUKAEMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DAUNORUBICIN HCL</medicinalproduct>
        <drugindication>ACUTE MYELOID LEUKAEMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYTARABINE</medicinalproduct>
        <drugindication>ACUTE MYELOID LEUKAEMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>THIOGUANINE</medicinalproduct>
        <drugindication>ACUTE MYELOID LEUKAEMIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5044864-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060623</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2006JP09596</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>85</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD CREATININE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD UREA INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMISIL</medicinalproduct>
        <drugauthorizationnumb>020539</drugauthorizationnumb>
        <drugdosagetext>125 MG/D</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NAIL TINEA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060527</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060622</drugenddate>
        <drugtreatmentduration>38880</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5044865-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2006JP09845</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>56</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ALANINE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASPARTATE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC FUNCTION ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCYTOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMISIL</medicinalproduct>
        <drugauthorizationnumb>020539</drugauthorizationnumb>
        <drugdosagetext>125 MG/D</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NAIL TINEA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060610</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060621</drugenddate>
        <drugtreatmentduration>17280</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5044871-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2006JP09941</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>ELECTROCARDIOGRAM QT PROLONGED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARDENALIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANALDINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LENDORMIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOXONIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KALLIKREIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COAX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMISIL</medicinalproduct>
        <drugauthorizationnumb>020539</drugauthorizationnumb>
        <drugdosagetext>125 MG/D</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5044872-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20060606349</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>48</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ACUTE MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY THROMBOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REOPRO</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PERCUTANEOUS CORONARY INTERVENTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REOPRO</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ACUTE MYOCARDIAL INFARCTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HEPARIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5044873-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060626</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHRM2006FR01985</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>30</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BRADYCARDIA FOETAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CAESAREAN SECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SYNTOCINON</medicinalproduct>
        <drugauthorizationnumb>018245</drugauthorizationnumb>
        <drugdosagetext>1 IU, ONCE/SINGLE</drugdosagetext>
        <drugindication>TOCOLYSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060614</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060614</drugenddate>
        <drugtreatmentduration>200</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SYNTOCINON</medicinalproduct>
        <drugauthorizationnumb>018245</drugauthorizationnumb>
        <drugdosagetext>UNK, UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060614</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060614</drugenddate>
        <drugtreatmentduration>1080</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5044878-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060627</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20050605232</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CHOLANGITIS SCLEROSING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER TRANSPLANT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXTRA STRENGTH TYLENOL</medicinalproduct>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXTRA STRENGTH TYLENOL</medicinalproduct>
        <drugauthorizationnumb>019872</drugauthorizationnumb>
        <drugdosagetext>^AS DIRECTED ON PACKAGE^</drugdosagetext>
        <drugindication>CAESAREAN SECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXTRA STRENGTH TYLENOL</medicinalproduct>
        <drugauthorizationnumb>019872</drugauthorizationnumb>
        <drugindication>MIGRAINE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMITREX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5044879-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060627</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-JNJFOC-20060700004</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>41</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>LEUKOPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ITRIZOLE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ITRIZOLE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ITRIZOLE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ITRIZOLE</medicinalproduct>
        <drugauthorizationnumb>020083</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NAIL TINEA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5044882-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060627</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20060601126</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>103.42</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEEP VEIN THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FURUNCLE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STAPHYLOCOCCAL INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ORTHO EVRA</medicinalproduct>
        <drugauthorizationnumb>21180</drugauthorizationnumb>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>CONTRACEPTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050701</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BACTRIM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOXYCYCLINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5044883-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060627</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IT-JNJFOC-20060603699</companynumb>
    <primarysource>
      <reportercountry>ITALY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>77</patientweight>
      <reaction>
        <reactionmeddrapt>ARRHYTHMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY THROMBOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REOPRO</medicinalproduct>
        <drugbatchnumb>09330367</drugbatchnumb>
        <drugdosagetext>4.0 ML IN 50 ML DILUENT AT 3.9 ML/HR, TOTAL INFUSION 46.0 ML.</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REOPRO</medicinalproduct>
        <drugbatchnumb>09330367</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ACUTE MYOCARDIAL INFARCTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RETEPLASE</medicinalproduct>
        <drugbatchnumb>CT000807</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>5044884-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060523</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-ABBOTT-06P-056-0334140-00</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DELUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MAJOR DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VALPROATE SODIUM</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>18081</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BIPOLAR I DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051213</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060426</drugenddate>
        <drugtreatmentduration>133</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARIPIPRAZOLE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BIPOLAR I DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060119</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060426</drugenddate>
        <drugtreatmentduration>96</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5044886-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060627</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006-06-2047</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>49</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD POTASSIUM DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD SODIUM DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MIGRAINE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEG-INTRON</medicinalproduct>
        <drugdosagetext>SUBCUTANEOUS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060428</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RIBAVIRIN</medicinalproduct>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060428</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CITRUCEL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIPHENHYDRAMINE HYDROCHLORIDE TABLETS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUOXETINE HYDROCHLORIDE CAPSULES</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTIVITAMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAZODONE HYDROCHLORIDE TABLETS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5044887-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060623</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006-06-1995</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>45</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BODY TEMPERATURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARYNGOLARYNGEAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THYROID NEOPLASM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEG-INTRON</medicinalproduct>
        <drugdosagetext>SUBCUTANEOUS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060428</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBETOL</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060428</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN C CHEWABLE TABLETS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5044889-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060623</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US017836</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>SIMPLE PARTIAL SEIZURES</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROVIGIL</medicinalproduct>
        <drugauthorizationnumb>20717</drugauthorizationnumb>
        <drugdosagetext>50 MG BID ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5044891-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060627</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-JNJFOC-20060504779</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG WITHDRAWAL SYNDROME NEONATAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERDAL CONSTA</medicinalproduct>
        <drugauthorizationnumb>21346</drugauthorizationnumb>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLOSARIL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5044892-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060627</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BE-JNJFOC-20060606154</companynumb>
    <primarysource>
      <reportercountry>BELGIUM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIAC DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERDAL CONSTA</medicinalproduct>
        <drugauthorizationnumb>021346</drugauthorizationnumb>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5044893-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060626</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-JNJFOC-20060606193</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DRY SKIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IRRITABILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIP DRY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOOD ALTERED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL STIFFNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWELLING FACE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERDAL QUICKLETS</medicinalproduct>
        <drugauthorizationnumb>20272</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERDAL CONSTA</medicinalproduct>
        <drugauthorizationnumb>021346</drugauthorizationnumb>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HALOPERIDOL</medicinalproduct>
        <drugauthorizationnumb>015923</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5044894-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060621</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>TRP_0762_2006</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>46</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RED BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWELLING FACE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RIBASPHERE</medicinalproduct>
        <drugauthorizationnumb>76203</drugauthorizationnumb>
        <drugdosagetext>DF PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060303</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEG-INTRON              /PEGINTERFERON ALPHA-2B</medicinalproduct>
        <drugdosagetext>DF SC</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060303</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROPRANOLOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYROXYZINE HYDROCHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5044895-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060412</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>TRP_0752_2006</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HEART RATE IRREGULAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MANIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RIBASPHERE</medicinalproduct>
        <drugauthorizationnumb>77456</drugauthorizationnumb>
        <drugdosagetext>600 MG BID PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060226</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060307</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEGASYS</medicinalproduct>
        <drugdosagetext>180 MCG QWK SC</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060226</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060305</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5044896-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006UW13669</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DELAYED RECOVERY FROM ANAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EFFECT PROLONGED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEDICATION ERROR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARALYSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NESACAINE</medicinalproduct>
        <drugauthorizationnumb>009435</drugauthorizationnumb>
        <drugadministrationroute>008</drugadministrationroute>
        <drugindication>EPIDURAL ANAESTHESIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5044897-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060620</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>TRP_0798_2006</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>51</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEGASYS</medicinalproduct>
        <drugauthorizationnumb>76203</drugauthorizationnumb>
        <drugdosagetext>180 MCG QWK SC</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050501</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COPEGUS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RIBASPHERE</medicinalproduct>
        <drugauthorizationnumb>76203</drugauthorizationnumb>
        <drugdosagetext>VAR BID PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060525</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RIBASPHERE</medicinalproduct>
        <drugdosagetext>VAR BID PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5044899-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060627</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ZW-GILEAD-2006-0009797</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>39</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>52.2</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EMTRICITABINE</medicinalproduct>
        <drugauthorizationnumb>21500</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060320</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TENOFOVIR DISOPROXIL FUMARATE</medicinalproduct>
        <drugauthorizationnumb>021356</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060320</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEVIRAPINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060320</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5044900-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-AVENTIS-200612355FR</companynumb>
    <primarysource></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>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EPIDERMOLYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN NECROSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LOVENOX</medicinalproduct>
        <drugauthorizationnumb>20164</drugauthorizationnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PHLEBITIS SUPERFICIAL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060305</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060315</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREVISCAN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PHLEBITIS SUPERFICIAL</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060301</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5044901-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-AVENTIS-200616870GDDC</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>56</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CELLULITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SJOGREN'S SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN ULCER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARAVA</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>020905</drugauthorizationnumb>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5044902-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnesscongenitalanomali>1</seriousnesscongenitalanomali>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060614</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-AVENTIS-200613360EU</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>DEEP VEIN THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG DOSE OMISSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATEMESIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLEXANE</medicinalproduct>
        <drugauthorizationnumb>20164</drugauthorizationnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>POSTOPERATIVE CARE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060411</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060619</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PARACETAMOL</medicinalproduct>
        <drugindication>POSTOPERATIVE ANALGESIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAMADOL HCL</medicinalproduct>
        <drugindication>POSTOPERATIVE ANALGESIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugindication>POSTOPERATIVE ANALGESIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5044903-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060630</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-AVENTIS-200611920DE</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>87</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>85</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RETROPERITONEAL HAEMATOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SHOCK HAEMORRHAGIC</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLEXANE</medicinalproduct>
        <drugauthorizationnumb>20164</drugauthorizationnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>BRONCHOSCOPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060601</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLEXANE</medicinalproduct>
        <drugauthorizationnumb>020164</drugauthorizationnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>THROMBOSIS PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060601</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MARCUMAR</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5044904-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060626</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-BRISTOL-MYERS SQUIBB COMPANY-13432133</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>67</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ERBITUX</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>OESOPHAGEAL SQUAMOUS CELL CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060123</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CISPLATIN</medicinalproduct>
        <drugauthorizationnumb>018057</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>OESOPHAGEAL SQUAMOUS CELL CARCINOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOLINIC ACID</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>OESOPHAGEAL SQUAMOUS CELL CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060123</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUOROURACIL</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>OESOPHAGEAL SQUAMOUS CELL CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060123</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NAVOBAN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5044908-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-NOVOPROD-254496</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>42</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>65</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NOVOLIN 70/30</medicinalproduct>
        <drugbatchnumb>PZF0192</drugbatchnumb>
        <drugauthorizationnumb>019991</drugauthorizationnumb>
        <drugdosagetext>50 IU, QD</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>INSULIN-REQUIRING TYPE II DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060501</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NOVOLIN R RELI-ON</medicinalproduct>
        <drugdosagetext>UNK IU, QID</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>INSULIN-REQUIRING TYPE II DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060501</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAQUINOL TAB</medicinalproduct>
        <drugdosagetext>25 MG, TID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SYSTEMIC LUPUS ERYTHEMATOSUS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5044913-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-ABBOTT-06P-028-0337177-00</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>50</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HYPOTHERMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERICARDIAL EFFUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERICARDITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLEURAL EFFUSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VALPROIC ACID</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>018723</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LAMOTRIGINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5044914-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060424</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-ABBOTT-06P-056-0331672-00</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>60</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PROGRESSIVE MULTIFOCAL LEUKOENCEPHALOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL DISTURBANCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KALETRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>21226</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ACQUIRED IMMUNODEFICIENCY SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051115</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060323</drugenddate>
        <drugtreatmentduration>128</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NORVIR</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020945</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ACQUIRED IMMUNODEFICIENCY SYNDROME</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060301</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOSAMPRENAVIR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ACQUIRED IMMUNODEFICIENCY SYNDROME</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060301</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMPRENAVIR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ACQUIRED IMMUNODEFICIENCY SYNDROME</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060301</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRIZIVIR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ACQUIRED IMMUNODEFICIENCY SYNDROME</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060301</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENFUVIRTIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ACQUIRED IMMUNODEFICIENCY SYNDROME</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060301</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5044915-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060627</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-ABBOTT-06P-167-0337162-00</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>71</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>NECK PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KALETRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021226</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051118</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEVIRAPINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051118</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEVIRAPINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051220</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOPERAMIDE</medicinalproduct>
        <drugdosagetext>2MG BID (PRN)</drugdosagetext>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051118</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOMPERIDONE</medicinalproduct>
        <drugdosagetext>TDS (PRN)</drugdosagetext>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051118</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SEPTICIN</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051006</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GAVISCON</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051202</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051215</drugenddate>
        <drugtreatmentduration>13</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CHLORAMPHENICOL</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050324</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5044916-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060524</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-ABBOTT-06P-167-0334198-00</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>78.542</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>EXTRAVASATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KLARICID IV</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>50662</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MUCOSAL INFLAMMATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060524</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060527</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NYSTATIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PHARYNGOLARYNGEAL PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060522</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060529</drugenddate>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENZOCAINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PHARYNGOLARYNGEAL PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060522</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060529</drugenddate>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENZYDAMINE HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ORAL PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060522</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060529</drugenddate>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SOTALOL HCL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060524</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060529</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMOXICILLIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060524</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060524</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLAVULIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060525</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060528</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUCONAZOLE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060527</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060529</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5044917-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060405</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>NO-ABBOTT-06P-122-0330050-01</companynumb>
    <primarysource>
      <reportercountry>NORWAY</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>67</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE SYSTOLIC INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOPTYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG ABSCESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY TUBERCULOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THERAPY NON-RESPONDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PSORIATIC ARTHROPATHY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060109</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060321</drugenddate>
        <drugtreatmentduration>71</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PSORIATIC ARTHROPATHY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050711</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLSYE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>VITAMIN SUPPLEMENTATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050711</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALAYL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANTIPLATELET THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19930101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL SUCCINATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>THROMBOSIS PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19930101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACECLOFENAC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050209</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOPICLONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INSOMNIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050711</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ESOMEPRAZOLE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DYSPEPSIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TETRACYCLINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ROSACEA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19750101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERCHOLESTEROLAEMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ISONIAZID</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANTIBIOTIC PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051212</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5044918-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060405</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>NO-ABBOTT-06P-122-0330050-01</companynumb>
    <primarysource>
      <reportercountry>NORWAY</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>67</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HAEMOPTYSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PSORIATIC ARTHROPATHY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060109</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060321</drugenddate>
        <drugtreatmentduration>71</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PSORIATIC ARTHROPATHY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050711</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLSYE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>VITAMIN SUPPLEMENTATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050711</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALAYL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANTIPLATELET THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19930101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL SUCCINATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>THROMBOSIS PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19930101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACECLOFENAC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050209</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOPICLONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INSOMNIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050711</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ESOMEPRAZOLE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DYSPEPSIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TETRACYCLINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ROSACEA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19750101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERCHOLESTEROLAEMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ISONIAZID</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANTIBIOTIC PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051212</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5044919-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060626</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-ABBOTT-06P-020-0336902-00</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>70</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FRACTURE</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>20051101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CORTICOIDS</medicinalproduct>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNSPECIFIED MEDICATION</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5044920-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060615</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-ABBOTT-06P-167-0336130-00</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>40</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ACCIDENTAL OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG ADMINISTRATION ERROR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EPILIM CHRONO TABLETS</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>18081</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG ADMINISTRATION ERROR</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5044924-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20060606156</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BURNS THIRD DEGREE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugdosagetext>ON FOR ABOUT 6 MONTHS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PSORIASIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5044925-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060627</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20060503916</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>108.86</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOKINESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JOINT SWELLING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALEVE (CAPLET)</medicinalproduct>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE TAB</medicinalproduct>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5044926-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060627</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-JNJFOC-20050700268</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>55</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PNEUMOCYSTIS JIROVECI PNEUMONIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INFREE S</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VOLTAREN</medicinalproduct>
        <drugadministrationroute>054</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ISCOTIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANTIBIOTIC PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BONALON</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADALAT</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARDENALIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMARYL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5044927-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060627</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-JNJFOC-20060303745</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>46</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HEPATIC FUNCTION ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMOCYSTIS JIROVECI PNEUMONIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RHEUMATREX</medicinalproduct>
        <drugdosagetext>IMPROVEMENT WITH DISCONTINUATION OF DRUG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RHEUMATREX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RIMATIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RIMATIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOXONIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOXONIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDONINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDONINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDONINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SELBEX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SELBEX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENET</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ISCOTIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANTIBIOTIC PROPHYLAXIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5044935-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060220</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2006JP02844</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>68</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIC PURPURA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THYRADIN</medicinalproduct>
        <drugdosagetext>75 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPOTHYROIDISM</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050608</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
        <drugauthorizationnumb>021283</drugauthorizationnumb>
        <drugdosagetext>80 MG/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050428</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060210</drugenddate>
        <drugtreatmentduration>289</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5044936-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060703</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHRM2006FR01956</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>44</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD CREATININE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHLEBITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEORAL</medicinalproduct>
        <drugauthorizationnumb>050715</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GRAFT VERSUS HOST DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060327</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060520</drugenddate>
        <drugtreatmentduration>79200</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELLCEPT</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5044937-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060622</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2006NO09347</companynumb>
    <primarysource>
      <reportercountry>NORWAY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>46</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INADEQUATELY CONTROLLED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBRAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
        <drugauthorizationnumb>20665</drugauthorizationnumb>
        <drugdosagetext>80 MG/DAY</drugdosagetext>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20011227</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20021011</drugenddate>
        <drugtreatmentduration>289</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
        <drugauthorizationnumb>020665</drugauthorizationnumb>
        <drugdosagetext>160 MG/DAY</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021011</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20021111</drugenddate>
        <drugtreatmentduration>46080</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVAXIN</medicinalproduct>
        <drugdosagetext>0.15 MG/DAY</drugdosagetext>
        <drugindication>HYPOTHYROIDISM</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000301</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5044938-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20051107</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHNU2005DE03664</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>47</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>AGEUSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUID INTAKE REDUCED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL CANDIDIASIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>100 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NOVODIGAL</medicinalproduct>
        <drugdosagetext>0.4MG/DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BELOC ZOK</medicinalproduct>
        <drugdosagetext>95MG/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RANITIDINE</medicinalproduct>
        <drugdosagetext>300 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMMUNOSPORIN</medicinalproduct>
        <drugauthorizationnumb>050715</drugauthorizationnumb>
        <drugdosagetext>50 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PEMPHIGOID</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMMUNOSPORIN</medicinalproduct>
        <drugauthorizationnumb>050715</drugauthorizationnumb>
        <drugdosagetext>25 MG, BID</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5044939-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20020529</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2002JP06460</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>67</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANGIOGRAM ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD ALKALINE PHOSPHATASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD IMMUNOGLOBULIN E INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG LEVEL FLUCTUATING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EOSINOPHIL COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MACULAR DEGENERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MACULAR OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OPTIC NEUROPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAPILLOEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RETINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RETINOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SCOTOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL ACUITY REDUCED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL FIELD DEFECT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SANDIMMUNE</medicinalproduct>
        <drugauthorizationnumb>50625</drugauthorizationnumb>
        <drugdosagetext>200 MG/D</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DERMATITIS EXFOLIATIVE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010507</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SANDIMMUNE</medicinalproduct>
        <drugauthorizationnumb>050625</drugauthorizationnumb>
        <drugdosagetext>200 MG/D</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010704</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010711</drugenddate>
        <drugtreatmentduration>11520</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SANDIMMUNE</medicinalproduct>
        <drugauthorizationnumb>050625</drugauthorizationnumb>
        <drugdosagetext>100 MG/D</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010712</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010725</drugenddate>
        <drugtreatmentduration>20160</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SANDIMMUNE</medicinalproduct>
        <drugauthorizationnumb>050625</drugauthorizationnumb>
        <drugdosagetext>200 MG/D</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010726</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010912</drugenddate>
        <drugtreatmentduration>70560</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugdosagetext>70 MG/D</drugdosagetext>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>DERMATITIS EXFOLIATIVE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010323</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEORAL</medicinalproduct>
        <drugdosagetext>100 MG/D</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DERMATITIS EXFOLIATIVE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010913</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5044943-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060622</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200614279BWH</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>60</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ALOPECIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SQUAMOUS CELL CARCINOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXAVAR</medicinalproduct>
        <drugauthorizationnumb>21923</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RENAL CELL CARCINOMA STAGE UNSPECIFIED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050912</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXAVAR</medicinalproduct>
        <drugauthorizationnumb>21923</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RENAL CELL CARCINOMA STAGE UNSPECIFIED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RANITIDINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLOMAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FELODIPINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5044944-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060621</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200614258BWH</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>64</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>71.2</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CAROTID ARTERY STENOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBRAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBRAL ISCHAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEEP VEIN THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SORAFENIB</medicinalproduct>
        <drugauthorizationnumb>21923</drugauthorizationnumb>
        <drugdosagetext>400 MG, BID, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060604</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5044946-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060622</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200614278BWH</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>74</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PALMAR-PLANTAR ERYTHRODYSAESTHESIA SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SQUAMOUS CELL CARCINOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXAVAR</medicinalproduct>
        <drugauthorizationnumb>21923</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RENAL CELL CARCINOMA STAGE UNSPECIFIED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXAVAR</medicinalproduct>
        <drugauthorizationnumb>21923</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RENAL CELL CARCINOMA STAGE UNSPECIFIED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FENTANYL TRANSDERMAL SYSTEM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCODONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADVAIR DISKUS 100/50</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL SPIROS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COMPAZINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5044947-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060621</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200614232BWH</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>64</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>65.7716</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>GASTRIC ULCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATOCHEZIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RECTAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXAVAR</medicinalproduct>
        <drugauthorizationnumb>21923</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RENAL CELL CARCINOMA STAGE UNSPECIFIED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060626</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXAVAR</medicinalproduct>
        <drugauthorizationnumb>21923</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RENAL CELL CARCINOMA STAGE UNSPECIFIED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5044948-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060621</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200613969BWH</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>92.9874</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD PHOSPHORUS DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXAVAR</medicinalproduct>
        <drugauthorizationnumb>21923</drugauthorizationnumb>
        <drugdosagetext>400 MG, BID, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RENAL CELL CARCINOMA STAGE UNSPECIFIED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060509</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5044950-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060620</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200613954BWH</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>69</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VASCULAR INJURY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVELOX</medicinalproduct>
        <drugauthorizationnumb>21277</drugauthorizationnumb>
        <drugdosagetext>400 MG, TOTAL DAILY, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>LUNG INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060422</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060604</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TEQUIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMIDARONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYLENOL REGULAR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASCORBIC ACID</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5044952-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060616</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200613611BWH</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>54</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>67.2</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DIAPHRAGMATIC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA EXERTIONAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SORAFENIB</medicinalproduct>
        <drugauthorizationnumb>21923</drugauthorizationnumb>
        <drugdosagetext>400 MG, BID, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>METASTASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060513</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060517</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SORAFENIB</medicinalproduct>
        <drugauthorizationnumb>21923</drugauthorizationnumb>
        <drugdosagetext>400 MG, BID, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>TRANSITIONAL CELL CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060513</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060517</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCODONE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COMBIVENT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOCLOPRAMIDE HYDROHCLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCONTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MOTRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZITHROMAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLOMAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEGACE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5044955-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060626</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200612126BCC</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>74</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>71.6683</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GALLBLADDER DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HELICOBACTER INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ULCER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALEVE (CAPLET)</medicinalproduct>
        <drugauthorizationnumb>20204</drugauthorizationnumb>
        <drugdosagetext>SEE IAMGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>FIBROMYALGIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19960101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050501</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALEVE (CAPLET)</medicinalproduct>
        <drugauthorizationnumb>20204</drugauthorizationnumb>
        <drugdosagetext>SEE IAMGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>FIBROMYALGIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060513</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALEVE (CAPLET)</medicinalproduct>
        <drugauthorizationnumb>20204</drugauthorizationnumb>
        <drugdosagetext>SEE IAMGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>FIBROMYALGIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060519</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAGAMET</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TUMS [CALCIUM CARBONATE]</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5044959-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060613</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US200601004842</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>37</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEDICATION ERROR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMULIN 70/30</medicinalproduct>
        <drugbatchnumb>9RR84M</drugbatchnumb>
        <drugauthorizationnumb>18780</drugauthorizationnumb>
        <drugdosagetext>26 UNITS IN THE AM AND 18 UNITS IN THE EVENING</drugdosagetext>
        <drugadministrationroute>063</drugadministrationroute>
        <drugindication>GESTATIONAL DIABETES</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051121</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HUMULIN 70/30 PEN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5044961-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060613</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US200606003315</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABORTION SPONTANEOUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEATH NEONATAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMMATURE RESPIRATORY SYSTEM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POLYHYDRAMNIOS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PREMATURE BABY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMULIN 70/30</medicinalproduct>
        <drugbatchnumb>9RU60M</drugbatchnumb>
        <drugauthorizationnumb>18780</drugauthorizationnumb>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMULIN R</medicinalproduct>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMULIN N</medicinalproduct>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMALOG</medicinalproduct>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NOVOLOG</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5044962-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060612</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US200606002726</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>65</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HAEMATEMESIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGE INTRACRANIAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NERVOUS SYSTEM DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XIGRIS</medicinalproduct>
        <drugindication>SEPSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060509</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060612</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5044964-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060613</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US200604001201</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>58</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEDICAL DEVICE COMPLICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STREPTOCOCCAL INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMALOG PEN</medicinalproduct>
        <drugbatchnumb>9RP61M</drugbatchnumb>
        <drugauthorizationnumb>20563</drugauthorizationnumb>
        <drugdosagetext>PER SLIDING SCALE  PER FOOD INTAKE/MEALS</drugdosagetext>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5044965-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060613</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>USA0507102381</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>63</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CATARACT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEVICE FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RETINOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STOMACH DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISION BLURRED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL ACUITY REDUCED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMALOG</medicinalproduct>
        <drugbatchnumb>7SC03P</drugbatchnumb>
        <drugauthorizationnumb>20563</drugauthorizationnumb>
        <drugdosagetext>AS NEEDED</drugdosagetext>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19890101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HUMALOG PEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL SPIROS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADVAIR DISKUS 100/50</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5044966-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060613</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US200603007242</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>83</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>72.6</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD POTASSIUM DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FAECALOMA</reactionmeddrapt>
      </reaction>
      <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>20040920</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040927</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DARVON</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5044967-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060613</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US200606000343</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>39</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>151</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ALANINE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASPARTATE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY RETENTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>30 MG ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060503</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060510</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NSAID'S</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANGIOTENSIN II</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BETA BLOCKING AGENTS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPAMAX /AUS/ (TOPIRAMATE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WELLBUTRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ESTRADIOL COMBINATIONS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5044969-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060626</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006080871</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BREAST CANCER FEMALE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROVERA</medicinalproduct>
        <drugauthorizationnumb>11839</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19850101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20000701</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>19850101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20000701</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19850101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20000701</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5044971-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060627</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20060605822</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>113.4</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOBILITY DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5044972-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060627</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-JNJFOC-20060606392</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>49</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HOT FLUSH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFUSION RELATED REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCREATITIS ACUTE</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>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CROHN'S DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CROHN'S DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PENTASA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CROHN'S DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MARZULENE-S</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CROHN'S DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BIOFERMIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CROHN'S DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALPRAZOLAM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TETRAMIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORAMET</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARTIST</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALDACTONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HALFDIGOXIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIART</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BAKTAR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INFECTION PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANCREATIN TRIPLE STRENGTH CAP</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KAMAG G</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SOLANAX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPARA K</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMURAN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CROHN'S DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GASTER D</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CROHN'S DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ELENTAL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5044973-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060410</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHRM2006FR01329</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>59</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ASPERGILLOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CANDIDA SEPSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHILLS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEBRILE BONE MARROW APLASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HERPES ZOSTER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HISTIOCYTOSIS HAEMATOPHAGIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCYTOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DESFERAL</medicinalproduct>
        <drugauthorizationnumb>16267</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>HAEMOCHROMATOSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050505</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060307</drugenddate>
        <drugtreatmentduration>307</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEORECORMON ^ROCHE^</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NEUTROPENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050305</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060307</drugenddate>
        <drugtreatmentduration>368</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GRANOCYTE ^CHUGAI^</medicinalproduct>
        <drugindication>NEUTROPENIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5044974-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060404</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2006US04442</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>81</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>IRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MACULAR OEDEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIOCHOL-E</medicinalproduct>
        <drugbatchnumb>G433</drugbatchnumb>
        <drugauthorizationnumb>16211</drugauthorizationnumb>
        <drugdosagetext>UNK, ONCE/SINGLE</drugdosagetext>
        <drugadministrationroute>021</drugadministrationroute>
        <drugindication>CATARACT OPERATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060207</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060207</drugenddate>
        <drugtreatmentduration>1440</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BSS PLUS</medicinalproduct>
        <drugadministrationroute>021</drugadministrationroute>
        <drugindication>EYE IRRIGATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DECADRON</medicinalproduct>
        <drugadministrationroute>057</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CEFAZOLIN</medicinalproduct>
        <drugadministrationroute>057</drugadministrationroute>
        <drugindication>INFECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DUOVISC</medicinalproduct>
        <drugindication>EYE OPERATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5044975-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060404</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2006US04452</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>78</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>IRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MACULAR OEDEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIOCHOL-E</medicinalproduct>
        <drugbatchnumb>G433</drugbatchnumb>
        <drugauthorizationnumb>16211</drugauthorizationnumb>
        <drugdosagetext>UNK, ONCE/SINGLE</drugdosagetext>
        <drugadministrationroute>021</drugadministrationroute>
        <drugindication>CATARACT OPERATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060207</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060207</drugenddate>
        <drugtreatmentduration>1440</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BSS PLUS</medicinalproduct>
        <drugadministrationroute>021</drugadministrationroute>
        <drugindication>EYE IRRIGATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060207</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060207</drugenddate>
        <drugtreatmentduration>1440</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DUOVISC</medicinalproduct>
        <drugadministrationroute>021</drugadministrationroute>
        <drugindication>EYE OPERATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060207</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060207</drugenddate>
        <drugtreatmentduration>1440</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DECADRON /NET/</medicinalproduct>
        <drugadministrationroute>057</drugadministrationroute>
        <drugindication>INFLAMMATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060207</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060207</drugenddate>
        <drugtreatmentduration>1440</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CEFAZOLIN</medicinalproduct>
        <drugadministrationroute>057</drugadministrationroute>
        <drugindication>INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060207</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060207</drugenddate>
        <drugtreatmentduration>1440</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5044976-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060404</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2006US04446</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>84</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>IRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MACULAR OEDEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIOCHOL-E</medicinalproduct>
        <drugbatchnumb>G433</drugbatchnumb>
        <drugauthorizationnumb>16211</drugauthorizationnumb>
        <drugdosagetext>UNK, ONCE/SINGLE</drugdosagetext>
        <drugadministrationroute>021</drugadministrationroute>
        <drugindication>CATARACT OPERATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060207</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060207</drugenddate>
        <drugtreatmentduration>1440</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BSS PLUS</medicinalproduct>
        <drugadministrationroute>021</drugadministrationroute>
        <drugindication>EYE IRRIGATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DECADRON</medicinalproduct>
        <drugadministrationroute>057</drugadministrationroute>
        <drugindication>INFLAMMATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CEFAZOLIN</medicinalproduct>
        <drugadministrationroute>057</drugadministrationroute>
        <drugindication>INFECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DUOVISC</medicinalproduct>
        <drugindication>EYE OPERATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5044977-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060404</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2006US04459</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>73</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>IRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MACULAR OEDEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIOCHOL-E</medicinalproduct>
        <drugbatchnumb>G433</drugbatchnumb>
        <drugauthorizationnumb>16211</drugauthorizationnumb>
        <drugdosagetext>UNK, ONCE/SINGLE</drugdosagetext>
        <drugadministrationroute>021</drugadministrationroute>
        <drugindication>CATARACT OPERATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060207</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060207</drugenddate>
        <drugtreatmentduration>1440</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BSS PLUS</medicinalproduct>
        <drugadministrationroute>021</drugadministrationroute>
        <drugindication>EYE IRRIGATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DUOVISC</medicinalproduct>
        <drugadministrationroute>021</drugadministrationroute>
        <drugindication>EYE OPERATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DECADRON</medicinalproduct>
        <drugadministrationroute>057</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CEFAZOLIN</medicinalproduct>
        <drugadministrationroute>057</drugadministrationroute>
        <drugindication>INFECTION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5044978-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060404</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2006US04453</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>71</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>IRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MACULAR OEDEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIOCHOL-E</medicinalproduct>
        <drugbatchnumb>G433</drugbatchnumb>
        <drugauthorizationnumb>16211</drugauthorizationnumb>
        <drugdosagetext>UNK, ONCE/SINGLE</drugdosagetext>
        <drugadministrationroute>021</drugadministrationroute>
        <drugindication>CATARACT OPERATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060223</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060223</drugenddate>
        <drugtreatmentduration>1440</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BSS PLUS</medicinalproduct>
        <drugadministrationroute>021</drugadministrationroute>
        <drugindication>EYE IRRIGATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060124</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060124</drugenddate>
        <drugtreatmentduration>1440</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DUOVISC</medicinalproduct>
        <drugdosagetext>UNK, UNK</drugdosagetext>
        <drugadministrationroute>021</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060124</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060124</drugenddate>
        <drugtreatmentduration>1440</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DECADRON</medicinalproduct>
        <drugadministrationroute>057</drugadministrationroute>
        <drugindication>INFLAMMATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060124</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060124</drugenddate>
        <drugtreatmentduration>1440</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CEFAZOLIN</medicinalproduct>
        <drugadministrationroute>057</drugadministrationroute>
        <drugindication>INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060124</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060124</drugenddate>
        <drugtreatmentduration>1440</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5044979-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060404</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2006US04458</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>91</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>IRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MACULAR OEDEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIOCHOL-E</medicinalproduct>
        <drugbatchnumb>G433</drugbatchnumb>
        <drugauthorizationnumb>16211</drugauthorizationnumb>
        <drugdosagetext>UNK, ONCE/SINGLE</drugdosagetext>
        <drugadministrationroute>021</drugadministrationroute>
        <drugindication>CATARACT OPERATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060223</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060223</drugenddate>
        <drugtreatmentduration>1440</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BSS PLUS</medicinalproduct>
        <drugadministrationroute>021</drugadministrationroute>
        <drugindication>EYE IRRIGATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DUOVISC</medicinalproduct>
        <drugadministrationroute>021</drugadministrationroute>
        <drugindication>EYE OPERATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DECADRON</medicinalproduct>
        <drugadministrationroute>057</drugadministrationroute>
        <drugindication>INFLAMMATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CEFAZOLIN</medicinalproduct>
        <drugadministrationroute>057</drugadministrationroute>
        <drugindication>INFECTION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5044980-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060404</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2006US04455</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>69</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>IRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MACULAR OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIOCHOL-E</medicinalproduct>
        <drugbatchnumb>G433</drugbatchnumb>
        <drugauthorizationnumb>16211</drugauthorizationnumb>
        <drugdosagetext>UNK, ONCE/SINGLE</drugdosagetext>
        <drugadministrationroute>021</drugadministrationroute>
        <drugindication>CATARACT OPERATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060207</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060207</drugenddate>
        <drugtreatmentduration>1440</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BSS PLUS</medicinalproduct>
        <drugadministrationroute>021</drugadministrationroute>
        <drugindication>EYE IRRIGATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DUOVISC</medicinalproduct>
        <drugindication>EYE OPERATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DECADRON</medicinalproduct>
        <drugadministrationroute>057</drugadministrationroute>
        <drugindication>INFLAMMATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CEFAZOLIN</medicinalproduct>
        <drugadministrationroute>057</drugadministrationroute>
        <drugindication>INFECTION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5044981-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060601</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2006US07204</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>27</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>75.283</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 BILIRUBIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DUODENAL ULCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ULTRASOUND ABDOMEN ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXJADE</medicinalproduct>
        <drugauthorizationnumb>21882</drugauthorizationnumb>
        <drugdosagetext>1500 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD IRON INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060218</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060507</drugenddate>
        <drugtreatmentduration>79</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DESFERAL</medicinalproduct>
        <drugdosagetext>TWICE/WEEK</drugdosagetext>
        <drugindication>BLOOD IRON INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060304</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060507</drugenddate>
        <drugtreatmentduration>93600</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DESFERAL</medicinalproduct>
        <drugdosagetext>6 G, QD</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060508</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EFFEXOR</medicinalproduct>
        <drugdosagetext>UNK, PRN</drugdosagetext>
        <drugindication>HEADACHE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RELPAX</medicinalproduct>
        <drugdosagetext>UNK, PRN</drugdosagetext>
        <drugindication>HEADACHE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5044983-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060626</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006080873</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BREAST CANCER FEMALE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>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>20000701</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>19930101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20000701</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19930101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20000701</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCRIN</medicinalproduct>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19930101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20000701</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5044984-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060615</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US_0504115821</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>11</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>31.8</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AUTOIMMUNE HEPATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD ALBUMIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHRONIC HEPATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COAGULOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC FIBROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATITIS ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER PALPABLE SUBCOSTAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROTHROMBIN TIME PROLONGED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>STRATTERA</medicinalproduct>
        <drugauthorizationnumb>21411</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATTENTION DEFICIT/HYPERACTIVITY DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040615</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040930</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>STRATTERA</medicinalproduct>
        <drugauthorizationnumb>21411</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATTENTION DEFICIT/HYPERACTIVITY DISORDER</drugindication>
        <drugtreatmentduration>14</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>STRATTERA</medicinalproduct>
        <drugauthorizationnumb>21411</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATTENTION DEFICIT/HYPERACTIVITY DISORDER</drugindication>
        <drugtreatmentduration>14</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>STRATTERA</medicinalproduct>
        <drugauthorizationnumb>21411</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATTENTION DEFICIT/HYPERACTIVITY DISORDER</drugindication>
        <drugtreatmentduration>61</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5044985-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060619</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CERZ-11262</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>45</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>87</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>AGORAPHOBIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DELUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPHONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROOESOPHAGEAL REFLUX DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LARYNGEAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NIGHTMARE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL CANDIDIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARANOIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSYCHOTIC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RADICULOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOCAL CORD ATROPHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CEREZYME</medicinalproduct>
        <drugauthorizationnumb>20367</drugauthorizationnumb>
        <drugdosagetext>60 U/KG Q2WKS IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>GAUCHER'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010625</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CEREZYME</medicinalproduct>
        <drugdosagetext>18 U/KG Q2WKS IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>GAUCHER'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010625</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INHALED STEROID</medicinalproduct>
        <drugindication>BRONCHIAL HYPERREACTIVITY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BENZODIAZAPINE</medicinalproduct>
        <drugindication>ANXIETY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5044986-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060626</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006080881</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BREAST CANCER FEMALE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROVERA</medicinalproduct>
        <drugauthorizationnumb>11839</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19830101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020701</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>19830101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020701</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19830101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020701</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5044987-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060627</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006080974</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BREAST CANCER FEMALE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROVERA</medicinalproduct>
        <drugauthorizationnumb>11839</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19890101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19991201</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>19890101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19991201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19890101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19991201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMPRO</medicinalproduct>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19890101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19991201</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5044989-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060615</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US_0504115752</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>12</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>40.2</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ALPHA-1 ANTI-TRYPSIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANTINUCLEAR ANTIBODY INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC STEATOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATITIS ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATOCELLULAR DAMAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREATMENT NONCOMPLIANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>STRATTERA</medicinalproduct>
        <drugauthorizationnumb>21411</drugauthorizationnumb>
        <drugdosagetext>40 MG, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATTENTION DEFICIT/HYPERACTIVITY DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040831</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041007</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5044990-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060614</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US_0403101185</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>1</patientonsetage>
      <patientonsetageunit>804</patientonsetageunit>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE VIA BREAST MILK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JAUNDICE NEONATAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PREMATURE BABY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ILETIN</medicinalproduct>
        <drugauthorizationnumb>17931</drugauthorizationnumb>
        <drugdosagetext>TRANSPLACENTAL</drugdosagetext>
        <drugadministrationroute>064</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19930101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19940101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ILETIN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19930101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19940101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRENATAL VITAMINS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5044992-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060612</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US200606002932</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMALOG</medicinalproduct>
        <drugauthorizationnumb>20563</drugauthorizationnumb>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060415</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5044994-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060612</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US200606003059</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>52</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ARTERIAL RUPTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEVICE FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIMB INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UPPER LIMB FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WRONG TECHNIQUE IN DRUG USAGE PROCESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMALOG PEN</medicinalproduct>
        <drugbatchnumb>9RW38M</drugbatchnumb>
        <drugauthorizationnumb>20563</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMALOG PEN</medicinalproduct>
        <drugbatchnumb>FF5N74A</drugbatchnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMALOG PEN</medicinalproduct>
        <drugbatchnumb>9RW38M</drugbatchnumb>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20000101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HUMALOG PEN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5044997-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060622</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>MC200600420</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>79</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>80</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ACUTE MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ATRIOVENTRICULAR BLOCK THIRD DEGREE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRADYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC PROCEDURE COMPLICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIO-RESPIRATORY ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY OCCLUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STENT OCCLUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOSIS IN DEVICE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENTRICULAR FIBRILLATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ANGIOMAX</medicinalproduct>
        <drugauthorizationnumb>20873</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugindication>PERCUTANEOUS CORONARY INTERVENTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5044998-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060613</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US200606003083</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD CHOLESTEROL INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOMYELITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMALOG</medicinalproduct>
        <drugbatchnumb>9RL20M</drugbatchnumb>
        <drugauthorizationnumb>20563</drugauthorizationnumb>
        <drugdosagetext>3/D</drugdosagetext>
        <drugindication>GESTATIONAL DIABETES</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IBANDRONATE SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM GLUCONATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045000-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060613</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US200606003355</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ROAD TRAFFIC ACCIDENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugauthorizationnumb>21318</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045001-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060613</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US200605004254</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANOREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSEUDARTHROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugbatchnumb>FF5X10A</drugbatchnumb>
        <drugauthorizationnumb>21318</drugauthorizationnumb>
        <drugdosagetext>20 UG</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050926</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045002-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060621</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006-127</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>71</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPONATRAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CITALOPRAM</medicinalproduct>
        <drugauthorizationnumb>77232</drugauthorizationnumb>
        <drugdosagetext>20MG DAILY ORALLY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060511</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060512</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PENICILLAMINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045004-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060613</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US200606003419</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLEURAL EFFUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY FIBROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STOMACH DISCOMFORT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugbatchnumb>FF5Z25A</drugbatchnumb>
        <drugauthorizationnumb>21318</drugauthorizationnumb>
        <drugdosagetext>20 UG</drugdosagetext>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045005-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060116</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHNU2006DE00571</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPONATRAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER FUNCTION TEST ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MICTURITION DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY RETENTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRILEPTAL</medicinalproduct>
        <drugauthorizationnumb>21285</drugauthorizationnumb>
        <drugdosagetext>480 ML/D</drugdosagetext>
        <drugindication>EPILEPSY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRILEPTAL</medicinalproduct>
        <drugauthorizationnumb>021285</drugauthorizationnumb>
        <drugdosagetext>4 ML, BID</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VALPROATE SODIUM</medicinalproduct>
        <drugdosagetext>300 MG/D</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KEPPRA</medicinalproduct>
        <drugdosagetext>20 MG/KG BODY WEIGHT</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051201</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045006-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHNU2006DE02408</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>64</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BRAIN NEOPLASM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ROAD TRAFFIC ACCIDENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRILEPTAL</medicinalproduct>
        <drugauthorizationnumb>021014</drugauthorizationnumb>
        <drugdosagetext>150 MG, BID</drugdosagetext>
        <drugindication>EPILEPSY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045007-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060404</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2006US04460</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>79</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>IRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MACULAR OEDEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIOCHOL-E</medicinalproduct>
        <drugbatchnumb>G433</drugbatchnumb>
        <drugauthorizationnumb>16211</drugauthorizationnumb>
        <drugdosagetext>UNK, ONCE/SINGLE</drugdosagetext>
        <drugadministrationroute>021</drugadministrationroute>
        <drugindication>CATARACT OPERATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060223</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060223</drugenddate>
        <drugtreatmentduration>1440</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BSS PLUS</medicinalproduct>
        <drugadministrationroute>021</drugadministrationroute>
        <drugindication>EYE IRRIGATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DUOVISC</medicinalproduct>
        <drugadministrationroute>021</drugadministrationroute>
        <drugindication>EYE OPERATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DECADRON</medicinalproduct>
        <drugadministrationroute>057</drugadministrationroute>
        <drugindication>INFLAMMATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CEFAZOLIN</medicinalproduct>
        <drugadministrationroute>057</drugadministrationroute>
        <drugindication>INFECTION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045008-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060420</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2006JP05953</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>68</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ANAPHYLACTIC SHOCK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PH DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE IMMEASURABLE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIO-RESPIRATORY ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ELECTROMECHANICAL DISSOCIATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATOCRIT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTUBATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PCO2 DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PO2 INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROTHROMBIN TIME PROLONGED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY VALVE STENOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROAT IRRITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENTRICULAR FIBRILLATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENTRICULAR TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VOLTAREN</medicinalproduct>
        <drugauthorizationnumb>19201</drugauthorizationnumb>
        <drugdosagetext>25 MG, ONCE/SINGLE</drugdosagetext>
        <drugadministrationroute>054</drugadministrationroute>
        <drugindication>TOOTHACHE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060414</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060414</drugenddate>
        <drugtreatmentduration>1440</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENSURE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>D ALFA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYANOCOBALAMIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GASCON</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GASMOTIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MUCOSOLATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIGMART</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLYCLAMIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOXOPROFEN SODIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060413</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060424</drugenddate>
        <drugtreatmentduration>17280</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HARNAL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060420</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060420</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SELOKEN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060420</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045010-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060613</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US200606003423</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>87</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEVICE RELATED INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugbatchnumb>FF5T50A</drugbatchnumb>
        <drugauthorizationnumb>21318</drugauthorizationnumb>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060106</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045011-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2006TT09707</companynumb>
    <primarysource>
      <reportercountry>TRINIDAD AND TOBAGO</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>70</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HALLUCINATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LETHARGY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRILEPTAL</medicinalproduct>
        <drugauthorizationnumb>021014</drugauthorizationnumb>
        <drugdosagetext>300 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CARPAL TUNNEL SYNDROME</drugindication>
        <drugtreatmentduration>7200</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTIHYPERTENSIVES</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045012-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060404</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2006US04463</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>73</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>IRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MACULAR OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIOCHOL-E</medicinalproduct>
        <drugbatchnumb>G433</drugbatchnumb>
        <drugauthorizationnumb>16211</drugauthorizationnumb>
        <drugdosagetext>UNK, ONCE/SINGLE</drugdosagetext>
        <drugadministrationroute>021</drugadministrationroute>
        <drugindication>CATARACT OPERATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060207</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060207</drugenddate>
        <drugtreatmentduration>1440</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BSS PLUS</medicinalproduct>
        <drugadministrationroute>021</drugadministrationroute>
        <drugindication>EYE IRRIGATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DUOVISC</medicinalproduct>
        <drugadministrationroute>021</drugadministrationroute>
        <drugindication>EYE OPERATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DECADRON</medicinalproduct>
        <drugadministrationroute>057</drugadministrationroute>
        <drugindication>INFLAMMATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CEFAZOLIN</medicinalproduct>
        <drugadministrationroute>057</drugadministrationroute>
        <drugindication>INFECTION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045013-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2006GT09705</companynumb>
    <primarysource>
      <reportercountry>GUATEMALA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>60</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRILEPTAL</medicinalproduct>
        <drugauthorizationnumb>21014</drugauthorizationnumb>
        <drugdosagetext>300 MG, Q8H</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIOVAN HCT</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045014-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060613</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US200602004117</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>75</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>AMINO ACID LEVEL ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COGNITIVE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GROIN PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOBILITY DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WALKING AID USER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugbatchnumb>FF5J49A</drugbatchnumb>
        <drugauthorizationnumb>21318</drugauthorizationnumb>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045015-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060627</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CIP06001466</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>44</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>96.1</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>JAW DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOMYELITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS</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>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THEO-DUR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VERELAN (VERAPAMIL HYDROCHLORIDE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIGOXIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROVENTIL (SALBUTAMOL SULFATE)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045016-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060612</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US200606002964</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugauthorizationnumb>21318</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045018-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060612</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US200606002962</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CARCINOMA IN SITU OF EYE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugauthorizationnumb>21318</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045021-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060616</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US200604003265</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HIP ARTHROPLASTY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugauthorizationnumb>21318</drugauthorizationnumb>
        <drugindication>OSTEOPOROSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045022-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060621</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>0601756US</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>24</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABORTION SPONTANEOUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD HUMAN CHORIONIC GONADOTROPIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ULTRASOUND SCAN ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VAGINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAZORAC</medicinalproduct>
        <drugauthorizationnumb>21184</drugauthorizationnumb>
        <drugdosagetext>QD, TOPICAL</drugdosagetext>
        <drugadministrationroute>061</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060413</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060608</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045024-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060614</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US200602004309</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>29</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>117.9</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>CARDIO-RESPIRATORY ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIABETES MELLITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THIRST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OLANZAPINE</medicinalproduct>
        <drugauthorizationnumb>20592</drugauthorizationnumb>
        <drugdosagetext>10 MG, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990616</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040221</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OLANZAPINE</medicinalproduct>
        <drugauthorizationnumb>20592</drugauthorizationnumb>
        <drugdosagetext>10 MG, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19981118</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RISPERIDONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HALDOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROLIXIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COGENTIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045025-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060616</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US200606001711</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>89</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIABETIC COMPLICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMALOG</medicinalproduct>
        <drugauthorizationnumb>20563</drugauthorizationnumb>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045026-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060619</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006-126</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>17</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>COMPLETED SUICIDE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE DRUG OVERDOSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CITALOPRAM</medicinalproduct>
        <drugauthorizationnumb>77232</drugauthorizationnumb>
        <drugdosagetext>40MG DAILY ORALLY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051201</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045028-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060510</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHNU2006DE01927</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>73</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>87.5</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SCAPULA FRACTURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BORTEZOMIB</medicinalproduct>
        <drugdosagetext>10.8 MG/M2, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060403</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>DIABETES MELLITUS INSULIN-DEPENDENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENAHEXAL</medicinalproduct>
        <drugdosagetext>10 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRAVASIN</medicinalproduct>
        <drugdosagetext>20 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DILTAHEXAL</medicinalproduct>
        <drugdosagetext>120 MG/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugauthorizationnumb>021223</drugauthorizationnumb>
        <drugdosagetext>4 MG, QMO</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040528</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060413</drugenddate>
        <drugtreatmentduration>686</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045029-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060512</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHNR2006AU00747</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>62</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN JAW</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WOUND DEBRIDEMENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugauthorizationnumb>21223</drugauthorizationnumb>
        <drugdosagetext>4 MG, QMO</drugdosagetext>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060209</drugenddate>
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    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045030-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20051114</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHNU2005DE03765</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>62</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>75</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE TRIMMING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FACIAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMPAIRED HEALING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOCAL ANAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLASTIC SURGERY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTH EXTRACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>X-RAY ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FEMARA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugauthorizationnumb>021223</drugauthorizationnumb>
        <drugdosagetext>4 MG, QMO</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>METASTASES TO BONE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040323</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050802</drugenddate>
        <drugtreatmentduration>498</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RADIOTHERAPY</medicinalproduct>
        <drugdosagetext>40 IU, UNK</drugdosagetext>
        <drugadministrationroute>061</drugadministrationroute>
        <drugindication>METASTASES TO BONE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040503</drugenddate>
        <drugtreatmentduration>47520</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045031-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060627</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2006BR09746</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>51</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>54</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANAPHYLACTIC SHOCK</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEXOTAN</medicinalproduct>
        <drugdosagetext>3 MG/D</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INSOMNIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19960101</drugstartdate>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRILEPTAL</medicinalproduct>
        <drugauthorizationnumb>021014</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>EPILEPSY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NICOTINIC ACID</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>BLOOD TRIGLYCERIDES ABNORMAL</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045032-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060404</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2006US04461</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>86</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>EYE INFLAMMATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MACULAR OEDEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIOCHOL-E</medicinalproduct>
        <drugbatchnumb>G433</drugbatchnumb>
        <drugauthorizationnumb>16211</drugauthorizationnumb>
        <drugdosagetext>UNK, ONCE/SINGLE</drugdosagetext>
        <drugadministrationroute>021</drugadministrationroute>
        <drugindication>CATARACT OPERATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060126</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060126</drugenddate>
        <drugtreatmentduration>1440</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIOCHOL-E</medicinalproduct>
        <drugbatchnumb>G433</drugbatchnumb>
        <drugauthorizationnumb>016211</drugauthorizationnumb>
        <drugdosagetext>UNK, ONCE/SINGLE</drugdosagetext>
        <drugadministrationroute>021</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060214</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060214</drugenddate>
        <drugtreatmentduration>1440</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BSS PLUS</medicinalproduct>
        <drugadministrationroute>021</drugadministrationroute>
        <drugindication>EYE IRRIGATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DUOVISC</medicinalproduct>
        <drugadministrationroute>021</drugadministrationroute>
        <drugindication>EYE OPERATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DECADRON</medicinalproduct>
        <drugadministrationroute>057</drugadministrationroute>
        <drugindication>INFLAMMATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CEFAZOLIN</medicinalproduct>
        <drugadministrationroute>057</drugadministrationroute>
        <drugindication>INFECTION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045033-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2006US08480</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>50</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>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>TRILEPTAL</medicinalproduct>
        <drugauthorizationnumb>021014</drugauthorizationnumb>
        <drugdosagetext>300 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060323</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060608</drugenddate>
        <drugtreatmentduration>78</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOMIDE</medicinalproduct>
        <drugdosagetext>UNK, BID</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INFERGEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MERITAL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALDACTONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREVACID</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045034-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060207</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2006US01763</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>52</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>51.9</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ACUTE SINUSITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ALANINE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASPARTATE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLISTER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD ALKALINE PHOSPHATASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CALCIUM DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD GASES ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD POTASSIUM INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD SODIUM DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FACIAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL TUBE INSERTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATOCRIT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIFE SUPPORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPH NODE PALPABLE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOUTH ULCERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NUCLEAR MAGNETIC RESONANCE IMAGING BRAIN ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERIORBITAL OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROCTALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH ERYTHEMATOUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN EXFOLIATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPUTUM PURULENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STOMATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOXIC EPIDERMAL NECROLYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VAGINAL DISCHARGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VULVAL ULCERATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRILEPTAL</medicinalproduct>
        <drugauthorizationnumb>021014</drugauthorizationnumb>
        <drugindication>CONVULSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030129</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030131</drugenddate>
        <drugtreatmentduration>4320</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DILANTIN</medicinalproduct>
        <drugindication>CONVULSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACYCLOVIR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NYSTATIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRIAMCINOLONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PEPCID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOCUSATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CEFTRIAXONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUCONAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GYNE-LOTRIMIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045035-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060616</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US200606001587</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>RENAL CANCER METASTATIC</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMALOG MIX 75/25</medicinalproduct>
        <drugauthorizationnumb>20563</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMALOG</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045036-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060620</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006-125</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>38</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ALCOHOL USE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEDATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CITALOPRAM</medicinalproduct>
        <drugauthorizationnumb>77232</drugauthorizationnumb>
        <drugdosagetext>300MG ORALLY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045038-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060615</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US200603005883</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>66</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DIFFUSE LARGE B-CELL LYMPHOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMALOG PEN</medicinalproduct>
        <drugbatchnumb>7SC03M</drugbatchnumb>
        <drugauthorizationnumb>20563</drugauthorizationnumb>
        <drugindication>DIABETES MELLITUS INSULIN-DEPENDENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HUMALOG PEN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045039-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060612</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US200606002548</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>85</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>46.7</patientweight>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIVERTICULUM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ILEUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JOINT STIFFNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRESBYOESOPHAGUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugauthorizationnumb>21318</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DARVOCET-N 100</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAG-OX (MAGNESIUM OXIDE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MICRO-K (POTASSIUM CHLORIDE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE TAB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PULMICORT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IPRATROPIUM BROMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BUSPAR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX (FUROSEMIDE, FUROSEMIDE SODIUM)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SINGULAIR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM WITH VITAMIN D (CALCIUM PHOSPHATE, CALCIUM SODIUM LACTATE, ERG</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MYSOLINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIAMOX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EFFEXOR XR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XOPENEX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045040-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060613</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US200602005208</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE VIA BREAST MILK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEEDING DISORDER NEONATAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEDATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
        <drugauthorizationnumb>20592</drugauthorizationnumb>
        <drugdosagetext>TRANSPLACENTAL</drugdosagetext>
        <drugadministrationroute>064</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPAMAX /AUS/ (TOPIRAMATE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEXAPRO /USA/ (ESCITALOPRAM)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ABILIFY /USA/ (ARIPRAZOLE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REMERON</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045041-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060623</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>226647</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>45</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>87.5</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PANCREATITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NUTROPIN AQ</medicinalproduct>
        <drugauthorizationnumb>20522</drugauthorizationnumb>
        <drugdosagetext>0.6 MG, 7/WEEK, SUBCUTANEOUS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>HYPOPITUITARISM</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050714</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACIPHEX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EFFEXOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GEODON</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ROZEREM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045043-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060613</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US200606003029</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>72</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>51.7</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG CANCER METASTATIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMALOG PEN</medicinalproduct>
        <drugbatchnumb>9RW38M</drugbatchnumb>
        <drugauthorizationnumb>20563</drugauthorizationnumb>
        <drugdosagetext>AS NEEDED,</drugdosagetext>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTIHYPERTENSIVE AGENT (ANTIHYPERTENSIVE AGENT)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045046-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060612</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US200606002951</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>77</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FAILURE OF IMPLANT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HIP FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROCEDURAL COMPLICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TIBIA FRACTURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugauthorizationnumb>21318</drugauthorizationnumb>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040801</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045047-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060627</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ES-JNJFOC-20060501708</companynumb>
    <primarysource>
      <reportercountry>SPAIN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>65</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CYANOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFUSION RELATED REACTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOXORUBICIN HCL</medicinalproduct>
        <drugauthorizationnumb>50718</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTIEMETIC</medicinalproduct>
        <drugdosagetext>PREMEDICATION</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045048-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060627</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-JNJFOC-20060606033</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PALMAR-PLANTAR ERYTHRODYSAESTHESIA SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOXIC SKIN ERUPTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOXORUBICIN HCL</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOXORUBICIN HCL</medicinalproduct>
        <drugauthorizationnumb>050718</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045049-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060612</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US200606002701</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugauthorizationnumb>21318</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045051-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060612</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US200606002842</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>83</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>0</patientsex>
      <reaction>
        <reactionmeddrapt>FRACTURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EVISTA</medicinalproduct>
        <drugauthorizationnumb>20815</drugauthorizationnumb>
        <drugdosagetext>OTHER, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045052-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060612</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US200605005177</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BREAST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSSTASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL CHEST PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EVISTA</medicinalproduct>
        <drugauthorizationnumb>20815</drugauthorizationnumb>
        <drugdosagetext>60 MG, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RESORPTION BONE INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060510</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045053-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060612</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US200606002877</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLINDNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL ACUITY REDUCED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMULIN 70/30</medicinalproduct>
        <drugauthorizationnumb>18780</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045054-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060612</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US200606003225</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>84</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>INCORRECT DOSE ADMINISTERED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROZAC</medicinalproduct>
        <drugauthorizationnumb>18936</drugauthorizationnumb>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REMERON</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045055-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060615</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US200606003734</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugauthorizationnumb>21318</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045056-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060615</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US200606004371</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <patientonsetage>87</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HIP FRACTURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugauthorizationnumb>21318</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FORTEO PEN (250M G/ML)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045057-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060616</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
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      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
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    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugauthorizationnumb>21318</drugauthorizationnumb>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045058-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
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    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
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    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
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      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <patientonsetage>50</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMAN INSULIN</medicinalproduct>
        <drugauthorizationnumb>18780</drugauthorizationnumb>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INSULIN</medicinalproduct>
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        <drugstartdate>19720101</drugstartdate>
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    </patient>
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  <safetyreport>
    <safetyreportid>5045061-4</safetyreportid>
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    <receivedate>20060707</receivedate>
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    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>DRUG ABUSER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRAUMATIC BRAIN INJURY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FENTANYL TRANSDERMAL SYSTEM</medicinalproduct>
        <drugauthorizationnumb>19813</drugauthorizationnumb>
        <drugindication>INTENTIONAL DRUG MISUSE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HEROIN</medicinalproduct>
        <drugindication>INTENTIONAL DRUG MISUSE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045062-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CH-JNJFOC-20060604644</companynumb>
    <primarysource>
      <reportercountry>SWITZERLAND</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ARTHROPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SPORANOX</medicinalproduct>
        <drugauthorizationnumb>020083</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CUTANEOUS LEISHMANIASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050310</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050331</drugenddate>
        <drugtreatmentduration>22</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045063-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-JNJFOC-20060504076</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>4</patientonsetage>
      <patientonsetageunit>800</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ACUTE LEUKAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ITRACONAZOLE</medicinalproduct>
        <drugauthorizationnumb>20083</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NAIL TINEA</drugindication>
        <drugtreatmentduration>28</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045064-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20060700297</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANKLE FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BALANCE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEAD INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN LACERATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045065-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20060404038</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>59.88</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FOOT DEFORMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN ULCER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045068-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060613</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US200606003540</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABORTION SPONTANEOUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OLIGOHYDRAMNIOS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PREMATURE BABY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STILLBIRTH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMULIN 70/30</medicinalproduct>
        <drugauthorizationnumb>18780</drugauthorizationnumb>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NOVOLOG</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045078-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060613</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US200606003566</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>1.2</patientweight>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>DEATH NEONATAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMMATURE RESPIRATORY SYSTEM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PREMATURE BABY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMULIN N</medicinalproduct>
        <drugauthorizationnumb>18780</drugauthorizationnumb>
        <drugdosagetext>TRANSPLACENTAL</drugdosagetext>
        <drugadministrationroute>064</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMULIN R</medicinalproduct>
        <drugdosagetext>TRANSPLACENTAL</drugdosagetext>
        <drugadministrationroute>064</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NOVOLOG</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045080-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-JNJFOC-20050400081</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ATRIAL FLUTTER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EXTRASYSTOLES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE IRREGULAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MEBENDAZOLE</medicinalproduct>
        <drugbatchnumb>04AL795</drugbatchnumb>
        <drugauthorizationnumb>17481</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ENTEROBIASIS</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>VENTOLIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BUDESONIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POMOTEROL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045082-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060627</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20060605957</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>31.75</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>SPEECH DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STARING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CONCERTA</medicinalproduct>
        <drugauthorizationnumb>021121</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATTENTION DEFICIT/HYPERACTIVITY DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045083-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20060606556</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD ALKALINE PHOSPHATASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEUKOPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERDAL</medicinalproduct>
        <drugauthorizationnumb>020272</drugauthorizationnumb>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045085-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060612</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US200606003087</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>62</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SHOCK</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugbatchnumb>9RY88P</drugbatchnumb>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>60 MG</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060608</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUOXETINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045086-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060613</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US200606003214</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMULIN 70/30</medicinalproduct>
        <drugauthorizationnumb>18780</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045087-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060612</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US200606003218</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>57</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MENTAL DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROZAC</medicinalproduct>
        <drugauthorizationnumb>18936</drugauthorizationnumb>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADVAIR DISKUS (FLUTICASONE PROPIONATE, SALMETEROL XINAFOATE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORAZEPAM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045088-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
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    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US200606003100</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EVISTA</medicinalproduct>
        <drugauthorizationnumb>20815</drugauthorizationnumb>
        <drugdosagetext>60 MG, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045089-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
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    <companynumb>US200606002973</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>74</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BREAST CANCER FEMALE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRECTOMY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYSTERECTOMY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UNEVALUABLE EVENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EVISTA</medicinalproduct>
        <drugauthorizationnumb>20815</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL SULFATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADVAIR DISKUS 100/50</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VERAPAMIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KLOR-CON</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THEOPHYLLINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MECLIZINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREVACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DARVOCET-N 100</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BECONASE (BECLOMETASONE DIPROPIONATE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OSCAL (CALCIUM CARBONATE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMINS-MINERALS THERAPEUTIC (VITAMINS-MINERALS THERAPEUTIC UNKNOWN F</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045090-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060614</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US200606004406</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>75</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CRUSH INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEMUR FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULAR WEAKNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WRIST FRACTURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugauthorizationnumb>21318</drugauthorizationnumb>
        <drugindication>FRACTURE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugauthorizationnumb>21318</drugauthorizationnumb>
        <drugindication>FRACTURE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060517</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FORTEO PEN (FORTEO PEN)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045091-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060627</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20060606295</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>41</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>OVERDOSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOPAMAX</medicinalproduct>
        <drugdosagetext>100 MG IN THE MORNING AND 200 MG AT NIGHT</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOPAMAX</medicinalproduct>
        <drugdosagetext>100 MG IN THE MORNING AND 200 MG AT NIGHT</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOPAMAX</medicinalproduct>
        <drugauthorizationnumb>020505</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MIGRAINE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DILAUDID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCODONE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WELLBUTRIN</medicinalproduct>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE TAB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUTICASONE PROPIONATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SALMETEROL XINAFOATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOXEPIN</medicinalproduct>
        <drugindication>SLEEP DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DULOXETINE HYDROCHLORIDE</medicinalproduct>
        <drugindication>DEPRESSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045092-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesscongenitalanomali>1</seriousnesscongenitalanomali>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060627</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20060606396</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>3.04</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANOMALY OF EXTERNAL EAR CONGENITAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CLEFT LIP</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOPAMAX</medicinalproduct>
        <drugauthorizationnumb>020505</drugauthorizationnumb>
        <drugindication>DRUG EXPOSURE DURING PREGNANCY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTIBIOTIC</medicinalproduct>
        <drugindication>DRUG EXPOSURE DURING PREGNANCY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045093-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesscongenitalanomali>1</seriousnesscongenitalanomali>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20060606400</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>2.33</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PATENT DUCTUS ARTERIOSUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOPAMAX</medicinalproduct>
        <drugauthorizationnumb>020505</drugauthorizationnumb>
        <drugdosagetext>THROUGHOUT PREGNANCY</drugdosagetext>
        <drugindication>DRUG EXPOSURE DURING PREGNANCY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COPAXONE</medicinalproduct>
        <drugdosagetext>THROUGHOUT PREGNANCY</drugdosagetext>
        <drugadministrationroute>015</drugadministrationroute>
        <drugindication>DRUG EXPOSURE DURING PREGNANCY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045094-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-JNJFOC-20060603776</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>60</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABORTION SPONTANEOUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE BEFORE PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EPITOMAX</medicinalproduct>
        <drugauthorizationnumb>20844</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MIGRAINE PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLAMOXYL</medicinalproduct>
        <drugindication>BRONCHITIS ACUTE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ORELOX</medicinalproduct>
        <drugindication>BRONCHITIS ACUTE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AUGMENTIN '125'</medicinalproduct>
        <drugindication>BRONCHITIS ACUTE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045095-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060627</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-JNJFOC-20060700390</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>54</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG TOXICITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOPAMAX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOPAMAX</medicinalproduct>
        <drugauthorizationnumb>020505</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MIGRAINE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIZERILA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIZERILA</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LITIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045096-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060614</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US200606003535</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugauthorizationnumb>21318</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FORTEO PEN (FORTEO PEN)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045097-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060405</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006GB00766</companynumb>
    <primarysource>
      <reportercountry>MALTA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BRADYCARDIA NEONATAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CAESAREAN SECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CALCINOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CYANOSIS NEONATAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FOETAL GROWTH RETARDATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NASAL FLARING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEONATAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEONATAL TACHYPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLACENTAL DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugauthorizationnumb>20639</drugauthorizationnumb>
        <drugdosagetext>MOTHER STARTED SEROQUEL IN OCT-2004</drugdosagetext>
        <drugadministrationroute>064</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045098-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060705</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006CG01156</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>20</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEEP VEIN THROMBOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMIG</medicinalproduct>
        <drugauthorizationnumb>20768</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MIGRAINE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GESTODENE AND ETHINYL ESTRADIOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ORAL CONTRACEPTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INDORAMIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MIGRAINE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045099-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050331</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006GB00767</companynumb>
    <primarysource>
      <reportercountry>MALTA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>19</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ALBUMINURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CAESAREAN SECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CALCINOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FOETAL GROWTH RETARDATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLACENTAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VAGINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugauthorizationnumb>20639</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045100-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060626</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006PK01451</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>49</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABNORMAL BEHAVIOUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DELIRIUM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DELUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISORIENTATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FUMBLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HALLUCINATIONS, MIXED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESTLESSNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugauthorizationnumb>20639</drugauthorizationnumb>
        <drugdosagetext>100 TO 900 MG DAILY</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060104</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060122</drugenddate>
        <drugtreatmentduration>19</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugauthorizationnumb>020639</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060123</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060202</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NORTRIPTYLINE HCL</medicinalproduct>
        <drugdosagetext>25 - 200 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060104</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060124</drugenddate>
        <drugtreatmentduration>21</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NORTRIPTYLINE HCL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060125</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060202</drugenddate>
        <drugtreatmentduration>9</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NORTRIPTYLINE HCL</medicinalproduct>
        <drugdosagetext>150 MG - 75 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060203</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060204</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>MELNEURIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060130</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060201</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>MELNEURIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060202</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060210</drugenddate>
        <drugtreatmentduration>9</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>MELNEURIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060211</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060328</drugenddate>
        <drugtreatmentduration>46</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045101-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006UW13655</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugauthorizationnumb>020639</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>KETOCONAZOLE</medicinalproduct>
        <drugindication>TINEA PEDIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045102-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060626</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006PK01447</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>35</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG LEVEL FLUCTUATING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GRAND MAL CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREATMENT NONCOMPLIANCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugauthorizationnumb>20639</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>CLOZAPIN HEXAL</medicinalproduct>
        <drugdosagetext>12.5 MG- 400 MG</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060105</drugenddate>
        <drugtreatmentduration>48</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>CLOZAPIN HEXAL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060106</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060112</drugenddate>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>CLOZAPIN HEXAL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060113</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>HALDOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAVOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060104</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060105</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAVOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060106</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060108</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAVOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060109</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060109</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045104-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060705</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>NO-SANOFI-SYNTHELABO-F01200601588</companynumb>
    <primarysource>
      <reportercountry>NORWAY</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>C-REACTIVE PROTEIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOKALAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEUKOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VIRAL INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEVACIZUMAB OR PLACEBO</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040628</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040628</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CAPECITABINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040628</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040628</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXALIPLATIN</medicinalproduct>
        <drugauthorizationnumb>021492</drugauthorizationnumb>
        <drugdosagetext>Q3W</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLORECTAL CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040628</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040628</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>805</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045105-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060705</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>RU-SANOFI-SYNTHELABO-F01200601589</companynumb>
    <primarysource>
      <reportercountry>RUSSIAN FEDERATION</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVASTIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060605</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060605</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEUCOVORIN CALCIUM</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060203</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060204</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUOROURACIL</medicinalproduct>
        <drugdosagetext>400MG/M2 IV BOLUS AND 600MG/M2 CONTINUOUS INFUSION Q2W</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060203</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060204</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXALIPLATIN</medicinalproduct>
        <drugauthorizationnumb>021492</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLON CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060203</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060203</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045106-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060621</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CZ-SANOFI-SYNTHELABO-F01200601505</companynumb>
    <primarysource>
      <reportercountry>CZECH REPUBLIC</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>72</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>87</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ELOXATIN</medicinalproduct>
        <drugauthorizationnumb>21492</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLORECTAL CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050819</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050820</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEUCOVORIN CALCIUM</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLORECTAL CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050819</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUOROURACIL</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLORECTAL CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050819</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045107-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060613</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US200605005809</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>58</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DIPLOPIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL FIELD DEFECT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VITH NERVE PARALYSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CIALIS</medicinalproduct>
        <drugauthorizationnumb>21368</drugauthorizationnumb>
        <drugdosagetext>10 MG, AS NEEDED</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051231</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMINS NOS (VITAMINS NOS)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045108-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060627</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006BI009296</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>48</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</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>20010503</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>5045109-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060626</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006BI009213</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>52</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</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>20000601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060401</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045111-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060619</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006BI008830</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>52</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>81.6475</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA ORAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS GENERALISED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROAT TIGHTNESS</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>20030801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050413</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045112-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060619</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>8017476</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>62</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ILL-DEFINED DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STATUS EPILEPTICUS</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>20060601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEPAKOTE</medicinalproduct>
        <drugdosagetext>1500 MG PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONVULSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060601</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEPAKOTE</medicinalproduct>
        <drugdosagetext>1000 MG PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONVULSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060601</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEPACON</medicinalproduct>
        <drugdosagetext>IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CONVULSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMICTAL</medicinalproduct>
        <drugdosagetext>PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONVULSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045113-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060613</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US200606003224</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMULIN N</medicinalproduct>
        <drugauthorizationnumb>18780</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045115-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060619</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006BI008884</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>LYMPHOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALIGNANT NEOPLASM PROGRESSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZEVALIN</medicinalproduct>
        <drugbatchnumb>IN-111 ZEVALIN</drugbatchnumb>
        <drugdosagetext>1X; IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NON-HODGKIN'S LYMPHOMA</drugindication>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZEVALIN</medicinalproduct>
        <drugbatchnumb>Y-90 ZEVALIN</drugbatchnumb>
        <drugdosagetext>1X; IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NON-HODGKIN'S LYMPHOMA</drugindication>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RITUXIMAB</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045116-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060626</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006BI008149</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>38</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>72.1219</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BIPOLAR I DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</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>20010101</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>20051101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060621</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTIPLE MEDICATIONS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045117-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060626</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006BI007125</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>40</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL CELL CARCINOMA STAGE UNSPECIFIED</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>
      </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>20050330</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPROL-XL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ELAVIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DYAZIDE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045119-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060517</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-SANOFI-SYNTHELABO-F01200601233</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>48</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ALANINE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANGIOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASPARTATE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LARGE INTESTINAL ULCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LARGE INTESTINE PERFORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MELAENA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METASTASES TO LYMPH NODES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SHOCK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VASCULAR PSEUDOANEURYSM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CALCIUM LEVOFOLINATE</medicinalproduct>
        <drugdosagetext>100 MG/BODY=68 MG/M2</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051013</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051014</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUOROURACIL</medicinalproduct>
        <drugdosagetext>500 MG/BODY=340.1 MG/M2 IN BOLUS THEN 750 MG/BODY=510.2 MG/M2 AS INFUSION</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051013</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051014</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXALIPLATIN</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021492</drugauthorizationnumb>
        <drugdosagetext>100 MG/BODY=68 MG/M2</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLON CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051013</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051013</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>805</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045120-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060627</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>NL-SANOFI-SYNTHELABO-A01200604938</companynumb>
    <primarysource>
      <reportercountry>NETHERLANDS</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>78</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DEMENTIA ALZHEIMER'S TYPE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XATRAL XR</medicinalproduct>
        <drugauthorizationnumb>21287</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MICTURITION DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20001031</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045121-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060627</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GR-SANOFI-SYNTHELABO-A01200604939</companynumb>
    <primarysource>
      <reportercountry>GREECE</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>71</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD BILIRUBIN UNCONJUGATED INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERNATIONAL NORMALISED RATIO ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERNATIONAL NORMALISED RATIO INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEPHROLITHIASIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BIRACETAM</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MEMORY IMPAIRMENT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugauthorizationnumb>020839</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ISCHAEMIC STROKE</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060601</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugauthorizationnumb>020839</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANEURYSM</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060601</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugauthorizationnumb>020839</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>THROMBOSIS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060601</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045122-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060626</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006BI007614</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>62</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>72.5755</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BREAST CANCER FEMALE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CALCINOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEITIS DEFORMANS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugdosagetext>30 UG;QW;IM</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040801</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIBRAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOXYL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACIPHEX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ESTRACE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOCLOPRAMIDE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045123-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060615</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>USA040567738</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BREAST CANCER METASTATIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BREAST CANCER RECURRENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONTUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN EXFOLIATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN FRAGILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWELLING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EVISTA</medicinalproduct>
        <drugauthorizationnumb>20815</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045127-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060619</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006BI007630</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>111.1313</patientweight>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>APNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIO-RESPIRATORY ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBRAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROOESOPHAGEAL REFLUX DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HOMOCYSTINAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040723</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040730</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040820</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040827</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COZAAR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WELLBUTRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRILOSEC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045128-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060626</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006BI007764</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>39</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MENINGIOMA BENIGN</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>19980101</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>20001101</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>20031001</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045130-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060619</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006BI004665</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>60</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>79.3795</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE CONGESTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERICARDIAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENTRICULAR EXTRASYSTOLES</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugbatchnumb>P35045</drugbatchnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050917</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060311</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugbatchnumb>P35045</drugbatchnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugbatchnumb>P35057</drugbatchnumb>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COZAAR</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045131-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060621</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006BI000254</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>26</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>80.2867</patientweight>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ACINETOBACTER INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>APNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRONCHOPNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBRAL ISCHAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISEASE PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALSE POSITIVE LABORATORY RESULT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FOREIGN BODY TRAUMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCREASED BRONCHIAL SECRETION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENTAL STATUS CHANGES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE SCLEROSIS RELAPSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLEOCYTOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA ASPIRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY CONGESTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULSE ABSENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY DISTRESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPTIC SHOCK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPUTUM CULTURE POSITIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STAPHYLOCOCCAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VEIN DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NATALIZUMAB</medicinalproduct>
        <drugdosagetext>IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050201</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045133-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060612</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US200606002952</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>69</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PANCREATIC CARCINOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugauthorizationnumb>21318</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045134-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060627</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-SANOFI-SYNTHELABO-A01200604921</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>62</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>60</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>OESOPHAGEAL STENOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OESOPHAGEAL ULCER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAHOR</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugauthorizationnumb>020839</drugauthorizationnumb>
        <drugdosagetext>75 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060510</drugenddate>
        <drugtreatmentduration>40</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugauthorizationnumb>020839</drugauthorizationnumb>
        <drugdosagetext>75 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060620</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045135-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-SANOFI-SYNTHELABO-A01200605171</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>47</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HYPERKALAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HALOPERIDOL</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060215</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060219</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AZASETRON HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060215</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060219</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOCLOPRAMIDE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060215</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060219</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE TAB</medicinalproduct>
        <drugadministrationroute>040</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060215</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060219</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ONDANSETRON HCL</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060215</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060607</drugenddate>
        <drugtreatmentduration>113</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUOROURACIL</medicinalproduct>
        <drugadministrationroute>040</drugadministrationroute>
        <drugindication>LARGE INTESTINE CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060215</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUOROURACIL</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060215</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CALCIUM LEVOFOLINATE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>LARGE INTESTINE CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060215</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXALIPLATIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>LARGE INTESTINE CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060215</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060215</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>805</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045136-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060704</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-SANOFI-SYNTHELABO-A01200605127</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>VOCAL CORD PARALYSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ELOXATIN</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021492</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045137-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-SANOFI-SYNTHELABO-A02200601690</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>37</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INCORRECT ROUTE OF DRUG ADMINISTRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>STILNOX</medicinalproduct>
        <drugauthorizationnumb>19908</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>DRUG DEPENDENCE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUBUTEX</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045138-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060612</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US200606002528</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugauthorizationnumb>21318</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045139-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060612</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US200606002963</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>80</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VERTIGO</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugauthorizationnumb>21318</drugauthorizationnumb>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060320</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045140-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060614</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US_980807977</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ABORTION SPONTANEOUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTRA-UTERINE DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTH INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMULIN N</medicinalproduct>
        <drugauthorizationnumb>18780</drugauthorizationnumb>
        <drugdosagetext>TRANSPLACENTAL</drugdosagetext>
        <drugadministrationroute>064</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ILETIN</medicinalproduct>
        <drugdosagetext>TRANSPLACENTAL</drugdosagetext>
        <drugadministrationroute>064</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ILETIN</medicinalproduct>
        <drugdosagetext>TRANSPLACENTAL</drugdosagetext>
        <drugadministrationroute>064</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMULIN U</medicinalproduct>
        <drugdosagetext>TRANSPLACENTAL</drugdosagetext>
        <drugadministrationroute>064</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRENATAL VITAMINS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045141-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060613</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US200606003346</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>53</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>63.5</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ALANINE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASPARTATE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>60 MG</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060613</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYLENOL W/ CODEINE NO. 3</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXEDRINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ESTRACE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARICEPT /JPN/ (DONEPEZIL HYDROCHLORIDE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATIVAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOXYL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045144-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060622</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006BI005657</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BREAST CANCER FEMALE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FIBROMYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugdosagetext>30 UG;QW;IM</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20000201</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045145-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060621</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>M-06-0512</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>69</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE CONGESTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY FIBROSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PACERONE,                   UNKNOWN STRENGTH</medicinalproduct>
        <drugauthorizationnumb>75135</drugauthorizationnumb>
        <drugdosagetext>PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050601</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALTACE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZETIA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOXAZOSIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>K-DUR 10</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPROL-XL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOLAZONE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045146-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060626</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006BI006852</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>AGITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONTUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEMENTIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugdosagetext>30 UG;IM</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060401</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045147-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060622</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006BI009180</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>61</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLADDER CANCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>KIDNEY INFECTION</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>20011201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040516</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>20040516</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045149-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesscongenitalanomali>1</seriousnesscongenitalanomali>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060619</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2005BI018964</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>37</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABORTION INDUCED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONGENITAL ANOMALY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONGENITAL CENTRAL NERVOUS SYSTEM ANOMALY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PREGNANCY OF PARTNER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STILLBIRTH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRANSMISSION OF DRUG VIA SEMEN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugdosagetext>30 UG;QW</drugdosagetext>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040422</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALDOMET</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LABETALOL HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN AND MINERAL PRENATAL SUPPLEMENT W/ FOLIC ACID CAP</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLYBURIDE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045150-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060627</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-SANOFI-SYNTHELABO-A01200604846</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVERDOSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>STILNOX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>OVERDOSE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045151-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060627</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-SANOFI-SYNTHELABO-A03200604161</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020839</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045152-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060612</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-SANOFI-SYNTHELABO-A03200603794</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>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HUMULIN 70/30</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VYTORIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANOXIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMDUR</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020839</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CORONARY ARTERY DISEASE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045153-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060612</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US200606003071</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BALANCE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ILL-DEFINED DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugauthorizationnumb>21318</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045154-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060621</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006BI000254</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>26</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>80.2867</patientweight>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ACINETOBACTER INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>APNOEIC ATTACK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASPIRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE SYSTOLIC DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRONCHOPNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBRAL ISCHAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISEASE PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCREASED BRONCHIAL SECRETION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENTAL STATUS CHANGES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTI-ORGAN DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE SCLEROSIS RELAPSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NUCLEAR MAGNETIC RESONANCE IMAGING BRAIN ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAPLEGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLEOCYTOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROGRESSIVE MULTIFOCAL LEUKOENCEPHALOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY CONGESTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULSE ABSENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY DISTRESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPTIC SHOCK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPUTUM CULTURE POSITIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STAPHYLOCOCCAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NATALIZUMAB</medicinalproduct>
        <drugdosagetext>IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050201</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045155-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006BI009384</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>55</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MAMMOGRAM 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>20011101</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>5045157-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006BI009352</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>60</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>GASTRIC 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>20011015</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>20060501</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045158-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060612</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US200606003109</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>85</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIVERTICULITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugbatchnumb>FF5Z26A</drugbatchnumb>
        <drugauthorizationnumb>21318</drugauthorizationnumb>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045159-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060627</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006BI009318</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>52</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugdosagetext>30 UG QW IM</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19980101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugdosagetext>30 UG QW IM</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045161-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060613</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
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    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>50</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ARTHROPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMATROPE</medicinalproduct>
        <drugauthorizationnumb>19640</drugauthorizationnumb>
        <drugdosagetext>0.3 MG</drugdosagetext>
        <drugindication>PITUITARY TUMOUR REMOVAL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HUMATROPEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>STEROID ANTIBACTERIALS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045162-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
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    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
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    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
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    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
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      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ORTHOPEDIC PROCEDURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugauthorizationnumb>21318</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
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        <drugenddate>20060401</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045163-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060613</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US200606003377</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>25</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DIABETES MELLITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCREATIC CYST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCREATIC NEOPLASM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCREATITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
        <drugauthorizationnumb>20592</drugauthorizationnumb>
        <drugdosagetext>15 MG</drugdosagetext>
        <drugindication>SCHIZOPHRENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050101</drugenddate>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAZODONE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RISPERDAL /SWE/(RISPERIDONE)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045164-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
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    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US200606003379</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>98</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>AGITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSYCHOTIC DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
        <drugauthorizationnumb>20592</drugauthorizationnumb>
        <drugdosagetext>10 MG DAILY (1/D)</drugdosagetext>
        <drugindication>PSYCHOTIC DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
        <drugauthorizationnumb>20592</drugauthorizationnumb>
        <drugdosagetext>10 MG DAILY (1/D)</drugdosagetext>
        <drugindication>PSYCHOTIC DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060605</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEXAPRO /USA/ (ESCITALOPRAM)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COZAAR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EYE DROPS /USA/ (TETRYZOLINE HYDROCHLORIDE)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045165-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060612</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US200606003015</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>70</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugauthorizationnumb>21318</drugauthorizationnumb>
        <drugindication>OSTEOPOROSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045166-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060613</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US200606003274</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HIP FRACTURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EVISTA</medicinalproduct>
        <drugauthorizationnumb>20815</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
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    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045167-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
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    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060613</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US200606004138</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ARTERIAL THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EVISTA</medicinalproduct>
        <drugauthorizationnumb>20815</drugauthorizationnumb>
        <drugdosagetext>60 MG DAILY (1/D)</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045168-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060612</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US200606003011</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugauthorizationnumb>21318</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045170-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
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    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
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      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
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    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <patientonsetage>88</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>GASTRIC CANCER</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EVISTA</medicinalproduct>
        <drugauthorizationnumb>20815</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
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    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045171-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
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    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060620</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
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    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
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    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <patientonsetage>31</patientonsetage>
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      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>AMNESIA</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>THROMBOSIS</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KEPPRA</medicinalproduct>
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        <drugdosagetext>750 MG 2/D PO</drugdosagetext>
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        <drugindication>PETIT MAL EPILEPSY</drugindication>
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        <drugstartdate>20040601</drugstartdate>
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  <safetyreport>
    <safetyreportid>5045173-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
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    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
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    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>8016576</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
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    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>2.6</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DELAYED FONTANELLE CLOSURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GINGIVAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMANGIOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HIGH ARCHED PALATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTH DEVELOPMENT DISORDER</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KEPPRA</medicinalproduct>
        <drugauthorizationnumb>21035</drugauthorizationnumb>
        <drugdosagetext>750 MG TRP</drugdosagetext>
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        <drugindication>EPILEPSY</drugindication>
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        <drugstartdate>20041201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050831</drugenddate>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PHENOBARBITAL</medicinalproduct>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRENATAL VITAMINS</medicinalproduct>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZITHROMAX</medicinalproduct>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZANTAC</medicinalproduct>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN K</medicinalproduct>
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    </patient>
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  <safetyreport>
    <safetyreportid>5045174-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
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      <reportercountry>UNITED STATES</reportercountry>
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    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
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  <safetyreport>
    <safetyreportid>5045176-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
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      <reportercountry>UNITED STATES</reportercountry>
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      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <patientonsetage>86</patientonsetage>
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        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JOINT RANGE OF MOTION DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PELVIC FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>UPPER LIMB FRACTURE</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
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  <safetyreport>
    <safetyreportid>5045177-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060613</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US200605006795</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>62</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>110.7</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>B-CELL LYMPHOMA RECURRENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugbatchnumb>FF5T49A</drugbatchnumb>
        <drugauthorizationnumb>21318</drugauthorizationnumb>
        <drugdosagetext>20 UG DAILY (1/D)</drugdosagetext>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050531</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045178-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060626</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CLOF-10147</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>78</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE CONGESTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEBRILE NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENTRICULAR DYSFUNCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOFARABINE</medicinalproduct>
        <drugauthorizationnumb>21673</drugauthorizationnumb>
        <drugdosagetext>53 MG QD X 5 IA</drugdosagetext>
        <drugadministrationroute>013</drugadministrationroute>
        <drugindication>ACUTE MYELOID LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051003</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051007</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYTARABINE</medicinalproduct>
        <drugdosagetext>25 MG QD IA</drugdosagetext>
        <drugadministrationroute>013</drugadministrationroute>
        <drugindication>ACUTE MYELOID LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051003</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051016</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CIPRO</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VORICONAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALTREX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPROL-XL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RAMIPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HALDOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGNESIUM PROTEIN COMPLEX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROSCAR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>K-DUR 10</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDRALAZINE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMDUR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CANCIDAS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROTONIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALCYTE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRONOLACTONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEUPOGEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DARVON</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RESTORIL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045179-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060613</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>USA030434572</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>70</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>54.5</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABNORMAL SENSATION IN EYE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AMNESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AORTIC VALVE STENOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ATRIAL FIBRILLATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HERPES ZOSTER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE BRUISING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERNATIONAL NORMALISED RATIO INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NERVOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEURALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUPRAVENTRICULAR TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VASCULAR CALCIFICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISION BLURRED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugbatchnumb>FF2M22A</drugbatchnumb>
        <drugauthorizationnumb>21318</drugauthorizationnumb>
        <drugdosagetext>20 GU DAILY (1/D)</drugdosagetext>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030414</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050401</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVAPRO</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORAZEPAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045180-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040706</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0521360A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPENDENCE</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 OF DESPAIR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL SELF-INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LACERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOVEMENT DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
        <drugauthorizationnumb>20031</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000818</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20000926</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELEXA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000912</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RITALIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATTENTION DEFICIT/HYPERACTIVITY DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000922</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045181-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050503</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0558211A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>30</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>COLD SWEAT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISORIENTATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG WITHDRAWAL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HALLUCINATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDE ATTEMPT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
        <drugauthorizationnumb>20031</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045182-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050503</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0558212A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>44</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>69.5</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CHILLS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CRYING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG WITHDRAWAL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOOD SWINGS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NIGHTMARE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAXIL CR</medicinalproduct>
        <drugauthorizationnumb>20936</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030324</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAXZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VENTOLIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REGLAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>YASMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SINGULAIR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZELNORM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045183-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050714</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0566538A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>27</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>AMNESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLINDNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEREALISATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG WITHDRAWAL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NERVOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARANOIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
        <drugauthorizationnumb>20031</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANXIETY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIETARY SUPPLEMENT</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045184-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050714</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0566549A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>55</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>AMNESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANGER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISORIENTATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG WITHDRAWAL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING OF DESPAIR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ILL-DEFINED DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIBIDO DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOOD SWINGS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NIGHT SWEATS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
        <drugauthorizationnumb>20031</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010901</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE TAB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRINIVIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRILOSEC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WELLBUTRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYGEN</medicinalproduct>
        <drugadministrationroute>045</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045185-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060316</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>20060304663</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>56</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>54.5</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>APHASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSARTHRIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMITREX</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>20132</drugauthorizationnumb>
        <drugdosagetext>100MG AS REQUIRED</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MIGRAINE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060316</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060316</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOPAMAX</medicinalproduct>
        <drugdosagetext>250MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MIGRAINE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030501</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PAROXETINE HCL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045186-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060530</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0601739B</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>38</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>82.3</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GESTATIONAL DIABETES</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMBIVIR</medicinalproduct>
        <drugauthorizationnumb>20857</drugauthorizationnumb>
        <drugdosagetext>900MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VIRACEPT</medicinalproduct>
        <drugdosagetext>2500MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051201</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045187-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060425</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0603257A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>47</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG WITHDRAWAL CONVULSIONS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GRAND MAL CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ROAD TRAFFIC ACCIDENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>WELLBUTRIN XL</medicinalproduct>
        <drugauthorizationnumb>021515</drugauthorizationnumb>
        <drugdosagetext>300MG THREE TIMES PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
        <drugdosagetext>12MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANXIETY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EFFEXOR</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045188-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060501</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0604247A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>3.1</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CHORIOAMNIONITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FOETAL DISTRESS SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FUNISITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ISCHAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MECONIUM ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEONATAL ASPIRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHLEBITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLACENTAL NECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STILLBIRTH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMBIVIR</medicinalproduct>
        <drugauthorizationnumb>20857</drugauthorizationnumb>
        <drugdosagetext>2TAB PER DAY</drugdosagetext>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051117</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060109</drugenddate>
        <drugtreatmentduration>54</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EPIVIR</medicinalproduct>
        <drugauthorizationnumb>020564</drugauthorizationnumb>
        <drugdosagetext>300MGD UNKNOWN</drugdosagetext>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060106</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060403</drugenddate>
        <drugtreatmentduration>88</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VIRACEPT</medicinalproduct>
        <drugdosagetext>2500MGD UNKNOWN</drugdosagetext>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051114</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060403</drugenddate>
        <drugtreatmentduration>141</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZERIT</medicinalproduct>
        <drugdosagetext>80MGD UNKNOWN</drugdosagetext>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060106</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060403</drugenddate>
        <drugtreatmentduration>88</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVAQUIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVELOX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AZITHROMYCIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PITOCIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACYCLOVIR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BACTRIM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045189-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060530</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0607247A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>75</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ADVERSE EVENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>APHASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRY MOUTH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSGEUSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LACRIMATION INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENTAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARYNGOLARYNGEAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISION BLURRED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ADVAIR DISKUS 100/50</medicinalproduct>
        <drugbatchnumb>R226717</drugbatchnumb>
        <drugauthorizationnumb>021077</drugauthorizationnumb>
        <drugdosagetext>1PUFF PER DAY</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060525</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACIPHEX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN MEDICATION</medicinalproduct>
        <drugindication>HERNIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MYLANTA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PEPTO BISMOL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045190-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060607</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0608222A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>39</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>81.8</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>RESPIRATORY ARREST</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ADVAIR DISKUS 100/50</medicinalproduct>
        <drugauthorizationnumb>21077</drugauthorizationnumb>
        <drugdosagetext>1PUFF TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045191-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-GLAXOSMITHKLINE-A0610820A</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <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>MYDRIASIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VENTOLIN</medicinalproduct>
        <drugauthorizationnumb>18473</drugauthorizationnumb>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045192-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060622</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0610947A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG WITHDRAWAL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
        <drugauthorizationnumb>020031</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANXIETY DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19940101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KLONOPIN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19940101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045193-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060703</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0611001A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>79</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLINDNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISION BLURRED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045194-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060613</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US200606003272</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EVISTA</medicinalproduct>
        <drugauthorizationnumb>20815</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045195-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060705</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0611143A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>72</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>SMALL CELL LUNG CANCER STAGE UNSPECIFIED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ADVAIR DISKUS 100/50</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021077</drugauthorizationnumb>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NO CONCURRENT MEDICATION</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045196-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060703</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>452559</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>89</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HIP FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPONATRAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POSTOPERATIVE INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugauthorizationnumb>20297</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SPIRONOLACTONE</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CEFAZOLIN</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUTICASONE PROPIONATE</medicinalproduct>
        <drugauthorizationnumb>020121</drugauthorizationnumb>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PARACETAMOL</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIRTAZAPINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050315</drugenddate>
        <drugtreatmentduration>1096</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRAMADOL HCL</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOCUSATE 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>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FAMOTIDINE</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENOXAPARIN SODIUM</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISONE TAB</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FRUSEMIDE</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CEPHALEXIN</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MAGNESIUM CHLORIDE</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROPANTHELINE BROMIDE</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEXTRA</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LOSARTAN POTASSIUM</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMLODIPINE</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DARVOCET</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DUONEB</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050315</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VENLAFAXINE HCL</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050315</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRAZODONE HCL</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045197-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0611293A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMPLETED SUICIDE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDAL BEHAVIOUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
        <drugauthorizationnumb>020031</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAXIL CR</medicinalproduct>
        <drugauthorizationnumb>020936</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN MEDICATION</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045198-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060706</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0611334A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>2</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ACCIDENTAL OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE IRREGULAR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>WELLBUTRIN</medicinalproduct>
        <drugauthorizationnumb>018644</drugauthorizationnumb>
        <drugdosagetext>5TAB SINGLE DOSE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045199-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050929</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-JPN-A20052315</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>69</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>46</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CREATININE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PHOSPHORUS DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD POTASSIUM DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULAR WEAKNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPSERA</medicinalproduct>
        <drugdosagetext>10MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATIC CIRRHOSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050323</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051115</drugenddate>
        <drugtreatmentduration>34</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZEFIX</medicinalproduct>
        <drugauthorizationnumb>020564</drugauthorizationnumb>
        <drugdosagetext>100MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATIC CIRRHOSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020516</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051116</drugenddate>
        <drugtreatmentduration>183</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PYDOXAL</medicinalproduct>
        <drugdosagetext>1TAB PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>VITAMIN B6 DEFICIENCY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>URSO</medicinalproduct>
        <drugdosagetext>300MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATIC CIRRHOSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAURINE</medicinalproduct>
        <drugdosagetext>3UNIT PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATIC CIRRHOSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYANOCOBALAMIN</medicinalproduct>
        <drugdosagetext>3TAB PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NEUROPATHY PERIPHERAL</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGNESIUM OXIDE</medicinalproduct>
        <drugdosagetext>1G PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONSTIPATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugdosagetext>1TAB PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THYRADIN S</medicinalproduct>
        <drugdosagetext>1TAB PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPOTHYROIDISM</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALDACTONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAKEPRON</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045200-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-GLAXOSMITHKLINE-B0405760A</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>1</patientonsetage>
      <patientonsetageunit>802</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ALANINE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASPARTATE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD LACTIC ACID INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEBRILE CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPHOPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RETROVIR</medicinalproduct>
        <drugauthorizationnumb>019910</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANTIVIRAL PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040401</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMBIVIR</medicinalproduct>
        <drugauthorizationnumb>020857</drugauthorizationnumb>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040301</drugenddate>
        <drugtreatmentduration>9</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VIRACEPT</medicinalproduct>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040301</drugenddate>
        <drugtreatmentduration>9</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045201-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20051215</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-GLAXOSMITHKLINE-B0406990A</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>51</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABNORMAL BEHAVIOUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABNORMAL SLEEP-RELATED EVENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ACCIDENTAL OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AGGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ALCOHOL POISONING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AMNESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CIRCULATORY COLLAPSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COPROLALIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CRYING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING DRUNK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IRRITABILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOOD ALTERED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MORBID THOUGHTS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NIGHTMARE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SCREAMING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROXAT</medicinalproduct>
        <drugauthorizationnumb>20031</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>STRESS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040806</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALCOHOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050217</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MELITRACEN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040115</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUPENTHIXOL</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040115</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAZODONE HCL</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040115</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIAZEPAM</medicinalproduct>
        <drugdosagetext>2MG AT NIGHT</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040806</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045202-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060621</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CLOF-10254</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>67</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ATRIAL FIBRILLATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE CONGESTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ENCEPHALOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC FUNCTION ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERBILIRUBINAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEMORY IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENTAL STATUS CHANGES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL ISCHAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROTEIN URINE PRESENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESTRICTIVE CARDIOMYOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RIGHT VENTRICULAR SYSTOLIC PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINE SODIUM DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOFARABINE</medicinalproduct>
        <drugauthorizationnumb>21673</drugauthorizationnumb>
        <drugdosagetext>60 MG QD X 5 IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ACUTE MYELOID LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060405</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060409</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYTARABINE</medicinalproduct>
        <drugdosagetext>40 MG SC</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>ACUTE MYELOID LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060405</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060418</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYLENOL (CAPLET)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENADRYL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM CHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SILDENAFIL CITRATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDRALAZINE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ISOSORBIDE MONONITRATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ONDANSETRON HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROMETHAZINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ESOMEPRAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGNESIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>M.V.I.</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCODONE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CEFPFDOXIME PROXETIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NESIRITIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROPOXYPHENE HYDROCHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TEMAZEPAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIPHENOXYLATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXTROMETHORPHAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SENNA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEPERIDINE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALACYCLOVIR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VANCOMYCIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PIPERACILLIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLPIDEM TARTRATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MORPHINE SULFATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEUPOGEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THIAMINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACTIVASE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOFLOXACIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCORTISONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SEVELAMER</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045203-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060223</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-GLAXOSMITHKLINE-B0413532A</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>17</patientonsetage>
      <patientonsetageunit>804</patientonsetageunit>
      <patientweight>1.8</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>COLITIS ULCERATIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATOCHEZIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEUKOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NECROTISING COLITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMATOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RETROVIR</medicinalproduct>
        <drugauthorizationnumb>19910</drugauthorizationnumb>
        <drugdosagetext>1.5MGK TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANTIVIRAL PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050907</drugenddate>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN ANTIRETROVIRAL TREATMENT</medicinalproduct>
        <drugindication>ANTIVIRAL PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GENTALLINE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UN-ALPHA</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GARDENAL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLAFORAN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045204-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060223</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-GLAXOSMITHKLINE-B0413570A</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>28</patientonsetage>
      <patientonsetageunit>804</patientonsetageunit>
      <patientweight>1.6</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>COLITIS ULCERATIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATOCHEZIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEUKOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NECROTISING COLITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMATOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RETROVIR</medicinalproduct>
        <drugauthorizationnumb>19910</drugauthorizationnumb>
        <drugdosagetext>1.5MGK TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANTIVIRAL PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050907</drugenddate>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN ANTIRETROVIRAL TREATMENT</medicinalproduct>
        <drugindication>ANTIVIRAL PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLAFORAN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GENTALLINE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UN-ALPHA</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045205-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060324</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-GLAXOSMITHKLINE-B0417441A</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>84</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CERVIX DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEEP VEIN THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPARIN-INDUCED THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPONATRAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MELAENA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL INFARCT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINE OUTPUT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FRAXODI</medicinalproduct>
        <drugdosagetext>.6ML PER DAY</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060307</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060313</drugenddate>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARIXTRA</medicinalproduct>
        <drugauthorizationnumb>021345</drugauthorizationnumb>
        <drugdosagetext>2.5MG PER DAY</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>THROMBOSIS PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060314</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060317</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVENOX</medicinalproduct>
        <drugdosagetext>40MG PER DAY</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060313</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060313</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIGOXIN</medicinalproduct>
        <drugdosagetext>1UNIT PER DAY</drugdosagetext>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MANIDIPINE</medicinalproduct>
        <drugdosagetext>1TAB AT NIGHT</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COKENZEN</medicinalproduct>
        <drugdosagetext>1TAB IN THE MORNING</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060311</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LAMALINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATHYMIL</medicinalproduct>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060306</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREVISCAN</medicinalproduct>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060306</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NITROGLYCERIN</medicinalproduct>
        <drugindication>CHEST PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060314</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060314</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AUTOTRANSFUSION</medicinalproduct>
        <drugdosagetext>240ML PER DAY</drugdosagetext>
        <drugindication>HAEMORRHAGE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060314</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060314</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SECTRAL</medicinalproduct>
        <drugdosagetext>200MG TWICE PER DAY</drugdosagetext>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045206-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060330</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-GLAXOSMITHKLINE-B0419317A</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>65</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>82</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CATARACT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONJUNCTIVITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISION BLURRED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL ACUITY REDUCED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDAMET</medicinalproduct>
        <drugauthorizationnumb>21410</drugauthorizationnumb>
        <drugdosagetext>1TAB TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050901</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045207-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060407</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-GLAXOSMITHKLINE-B0420152A</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>12</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>41.5</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANISOCYTOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEUKOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCYTOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POIKILOCYTOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RED BLOOD CELL TARGET CELLS PRESENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RETROVIR</medicinalproduct>
        <drugauthorizationnumb>019655</drugauthorizationnumb>
        <drugdosagetext>250MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060412</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VIDEX</medicinalproduct>
        <drugdosagetext>200MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030930</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060529</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VIRACEPT</medicinalproduct>
        <drugdosagetext>750MG THREE TIMES PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030930</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BACTRIM DS</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>IMMUNODEFICIENCY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030930</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045208-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060502</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-GLAXOSMITHKLINE-B0421970A</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>83</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>48</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DUODENAL ULCER PERFORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARIXTRA</medicinalproduct>
        <drugauthorizationnumb>21345</drugauthorizationnumb>
        <drugdosagetext>2.5MG PER DAY</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060330</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060406</drugenddate>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NON STEROIDAL ANTI-INFLAMMATORY</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060331</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060401</drugenddate>
        <drugtreatmentduration>24</drugtreatmentduration>
        <drugtreatmentdurationunit>805</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASILIX</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060404</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUMAFER</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060403</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPALGIC (FRANCE)</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060403</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060406</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MOPRAL</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060406</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MYOLASTAN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060403</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DAFALGAN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060403</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045209-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060602</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-GLAXOSMITHKLINE-B0426618A</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>11</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>64</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HYPONATRAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INAPPROPRIATE ANTIDIURETIC HORMONE SECRETION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOPHREN</medicinalproduct>
        <drugauthorizationnumb>020007</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051114</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PLITICAN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ONCOVIN</medicinalproduct>
        <drugdosagetext>2MG CYCLIC</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051114</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARBOPLATIN</medicinalproduct>
        <drugdosagetext>913MG CYCLIC</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051114</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BACTRIM</medicinalproduct>
        <drugdosagetext>60MG THREE TIMES PER WEEK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ETOPOSIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051114</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045210-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060607</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>HK-GLAXOSMITHKLINE-B0426959A</companynumb>
    <primarysource>
      <reportercountry>HONG KONG</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>MENORRHAGIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GW679769</medicinalproduct>
        <drugdosagetext>30MG PER DAY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060509</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060509</drugenddate>
        <drugtreatmentduration>15</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ONDANSETRON HCL</medicinalproduct>
        <drugauthorizationnumb>020007</drugauthorizationnumb>
        <drugdosagetext>4MG PER DAY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060509</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060509</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045211-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060626</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-GLAXOSMITHKLINE-B0428769A</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>39</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD ALKALINE PHOSPHATASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>C-REACTIVE PROTEIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAMMA-GLUTAMYLTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATOMEGALY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRANSAMINASES INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYBAN</medicinalproduct>
        <drugauthorizationnumb>20711</drugauthorizationnumb>
        <drugdosagetext>150MG VARIABLE DOSE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045212-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060614</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US200606003335</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>72</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTOLERANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEMUR FRACTURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EVISTA</medicinalproduct>
        <drugauthorizationnumb>20815</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045213-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060623</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-JPN-A200602254</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>81</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>53</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANOREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CREATININE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD UREA INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSED LEVEL OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSLALIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYELID OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NERVOUS SYSTEM DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VALTREX</medicinalproduct>
        <drugauthorizationnumb>20487</drugauthorizationnumb>
        <drugdosagetext>2U THREE TIMES PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HERPES ZOSTER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060529</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060602</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BLOPRESS</medicinalproduct>
        <drugdosagetext>.5U PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060603</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>UNKNOWN MEDICATION</medicinalproduct>
        <drugdosagetext>1U PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060602</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugdosagetext>1U PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060602</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>UNKNOWN MEDICATION</medicinalproduct>
        <drugdosagetext>1U PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060602</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NESGEN</medicinalproduct>
        <drugdosagetext>.5U PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INSOMNIA</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060602</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NITRAZEPAM</medicinalproduct>
        <drugdosagetext>.5U PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INSOMNIA</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060602</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COSMEGEN</medicinalproduct>
        <drugdosagetext>1U PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HERPES ZOSTER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060529</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060602</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FURULMINE</medicinalproduct>
        <drugdosagetext>1U TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HERPES ZOSTER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060529</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060602</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALONAL</medicinalproduct>
        <drugdosagetext>1U TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HERPES ZOSTER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060529</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060602</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN MEDICATION</medicinalproduct>
        <drugdosagetext>1U TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HERPES ZOSTER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060529</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060602</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLPIDEM TARTRATE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060603</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045214-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060627</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-JPN-A200602299</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>60</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>TOXIC SKIN ERUPTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VALTREX</medicinalproduct>
        <drugauthorizationnumb>020487</drugauthorizationnumb>
        <drugdosagetext>1000MG THREE TIMES PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HERPES ZOSTER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060619</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060620</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEPAKENE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THEO-DUR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEVALOTIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GAISAL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MUCOSTA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLEANAL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GASRICK</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIATALIC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NARCARICIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045215-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-GLAXOSMITHKLINE-B0429458A</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>70</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ARRHYTHMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ATRIAL FIBRILLATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INADEQUATELY CONTROLLED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTHYROIDISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS NON-INSULIN-DEPENDENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060620</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOR</medicinalproduct>
        <drugdosagetext>200MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS NON-INSULIN-DEPENDENT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOPHAGE</medicinalproduct>
        <drugdosagetext>1000MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS NON-INSULIN-DEPENDENT</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045216-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-GLAXOSMITHKLINE-B0429487A</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>67</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>CARDIAC ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH GENERALISED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SHOCK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENTRICULAR FIBRILLATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENTRICULAR TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRACRIUM</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060530</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060530</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AUGMENTIN '125'</medicinalproduct>
        <drugauthorizationnumb>050564</drugauthorizationnumb>
        <drugdosagetext>2G SINGLE DOSE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HYPNOVEL</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060530</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060530</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RAPIFEN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060530</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060530</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROPOFOL</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060530</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060530</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045217-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060627</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DK-GLAXOSMITHKLINE-B0429501A</companynumb>
    <primarysource>
      <reportercountry>DENMARK</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>CONCUSSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SERETIDE</medicinalproduct>
        <drugauthorizationnumb>21077</drugauthorizationnumb>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045218-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>TR-GLAXOSMITHKLINE-B0429507A</companynumb>
    <primarysource>
      <reportercountry>TURKEY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>70</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>90</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY DISEASE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DUTASTERIDE</medicinalproduct>
        <drugauthorizationnumb>21319</drugauthorizationnumb>
        <drugdosagetext>.5MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BENIGN PROSTATIC HYPERPLASIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041001</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045219-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-JPN-A200602395</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>1</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PURPURA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AUGMENTIN '125'</medicinalproduct>
        <drugauthorizationnumb>050575</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OTITIS MEDIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045220-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060630</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-JPN-A200602391</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STILLBIRTH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
        <drugauthorizationnumb>020031</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060101</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045221-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060630</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-JPN-A200602401</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGIC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC FUNCTION ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
        <drugauthorizationnumb>020031</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060530</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045222-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-JPN-A200602408</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>31</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HAEMOPHILIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGIC DIATHESIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EPIVIR</medicinalproduct>
        <drugauthorizationnumb>020564</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990114</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RETROVIR</medicinalproduct>
        <drugauthorizationnumb>019655</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990114</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIRACEPT</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990202</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CONFACT F</medicinalproduct>
        <drugdosagetext>1000IU IN THE MORNING</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>FACTOR VIII DEFICIENCY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050401</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045223-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-JPN-A200602412</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>40</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ACUTE ABDOMEN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIPASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCREATIC ENZYMES INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCREATITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EPIVIR</medicinalproduct>
        <drugauthorizationnumb>020564</drugauthorizationnumb>
        <drugdosagetext>150MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040628</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZERIT</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050427</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REYATAZ</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040628</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RETROVIR</medicinalproduct>
        <drugauthorizationnumb>019655</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050428</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVIR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050822</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045224-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>SE-GLAXOSMITHKLINE-B0429701A</companynumb>
    <primarysource>
      <reportercountry>SWEDEN</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>85</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HYPONATRAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMICTAL</medicinalproduct>
        <drugauthorizationnumb>20241</drugauthorizationnumb>
        <drugdosagetext>75MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ERGENYL</medicinalproduct>
        <drugdosagetext>450MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SALURES-K</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060603</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRONOLAKTON</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TROMBYL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045225-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060703</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-GLAXOSMITHKLINE-B0429725A</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MYOCLONUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMOXIL</medicinalproduct>
        <drugauthorizationnumb>050542</drugauthorizationnumb>
        <drugdosagetext>500MG THREE TIMES PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060623</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PARACETAMOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATORVASTATIN CALCIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GABAPENTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN MEDICATION</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN MEDICATION</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUCLOXACILLIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045226-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060612</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US200606002881</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>82</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DECREASED APPETITE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PITUITARY TUMOUR RECURRENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMATROPE</medicinalproduct>
        <drugbatchnumb>FF5L04C</drugbatchnumb>
        <drugauthorizationnumb>19640</drugauthorizationnumb>
        <drugdosagetext>3 CLICKS PER DAY</drugdosagetext>
        <drugindication>BLOOD GROWTH HORMONE DECREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HUMATROPEN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045227-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060703</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-GLAXOSMITHKLINE-B0429730A</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLISTER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MALARONE</medicinalproduct>
        <drugauthorizationnumb>021078</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045228-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-GLAXOSMITHKLINE-B0429907A</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>55</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUS BRADYCARDIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEROXAT</medicinalproduct>
        <drugauthorizationnumb>20031</drugauthorizationnumb>
        <drugdosagetext>20MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060117</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060127</drugenddate>
        <drugtreatmentduration>11</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MEPRONIZINE</medicinalproduct>
        <drugdosagetext>1TAB PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060113</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060126</drugenddate>
        <drugtreatmentduration>14</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EPITOMAX</medicinalproduct>
        <drugindication>BIPOLAR DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROZAC</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045229-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050801</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-GLAXOSMITHKLINE-D0047203A</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>46</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>82</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD AMYLASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC ENZYME INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCREATIC ENZYMES INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOFRAN</medicinalproduct>
        <drugauthorizationnumb>020103</drugauthorizationnumb>
        <drugdosagetext>8MG UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS OF NAUSEA AND VOMITING</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXALIPLATIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NEOPLASM MALIGNANT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XELODA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NEOPLASM MALIGNANT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KEVATRIL</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PROPHYLAXIS OF NAUSEA AND VOMITING</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PASPERTIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045230-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060503</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-GLAXOSMITHKLINE-D0049586A</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>46</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>100</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ALCOHOL USE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CREATINE PHOSPHOKINASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>21071</drugauthorizationnumb>
        <drugdosagetext>8MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS NON-INSULIN-DEPENDENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060501</drugenddate>
        <drugtreatmentduration>16</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALCOHOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060101</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045231-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060704</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GXKR2006DE03760</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>3</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CRYING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISORIENTATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HALLUCINATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL STIFFNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NIGHTMARE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESTLESSNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CEFUHEXAL</medicinalproduct>
        <drugauthorizationnumb>50672</drugauthorizationnumb>
        <drugdosagetext>5ML TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060404</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060405</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OTOBACID</medicinalproduct>
        <drugadministrationroute>001</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060404</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060404</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045232-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060705</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-GLAXOSMITHKLINE-D0050218A</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIMB MALFORMATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMICTAL</medicinalproduct>
        <drugauthorizationnumb>020241</drugauthorizationnumb>
        <drugdosagetext>100MG THREE TIMES PER DAY</drugdosagetext>
        <drugindication>EPILEPSY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045233-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060705</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006012312</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>69</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>QUILONUM RETARD</medicinalproduct>
        <drugauthorizationnumb>18152</drugauthorizationnumb>
        <drugdosagetext>450MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045234-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060615</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US200606003715</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>55</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SHOCK HYPOGLYCAEMIC</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMULIN 70/30</medicinalproduct>
        <drugbatchnumb>9SC19M</drugbatchnumb>
        <drugauthorizationnumb>18780</drugauthorizationnumb>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045235-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060615</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US200606003831</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>53</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>81.2</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CHOLESTEROL INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUROPATHIC ARTHROPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOMYELITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN LACERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOE AMPUTATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMULIN N</medicinalproduct>
        <drugauthorizationnumb>18780</drugauthorizationnumb>
        <drugindication>DIABETES MELLITUS INSULIN-DEPENDENT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMULIN R</medicinalproduct>
        <drugindication>DIABETES MELLITUS INSULIN-DEPENDENT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMALOG</medicinalproduct>
        <drugindication>DIABETES MELLITUS INSULIN-DEPENDENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INSULIN</medicinalproduct>
        <drugindication>DIABETES MELLITUS INSULIN-DEPENDENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19780101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045236-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060626</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006AC01188</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>58</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISEASE PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSKINESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARKINSON'S DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROCEDURAL COMPLICATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROPOFOL</medicinalproduct>
        <drugauthorizationnumb>019627</drugauthorizationnumb>
        <drugindication>ANAESTHESIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARBIDOPA AND LEVODOPA</medicinalproduct>
        <drugdosagetext>100MG/800MG, STARTED 10 YEARS PRIOR TO EVENT, STOPPED NIGHT BEFORE SURGERY.</drugdosagetext>
        <drugindication>PARKINSON'S DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRAMIPEXOLE</medicinalproduct>
        <drugdosagetext>STOPPED NIGHT BEFORE SURGERY</drugdosagetext>
        <drugindication>PARKINSON'S DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMANTADINE HCL</medicinalproduct>
        <drugdosagetext>STOPPED NIGHT BEFORE SURGERY</drugdosagetext>
        <drugindication>PARKINSON'S DISEASE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045237-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060621</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CLOF-10255</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>76</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>CENTRAL LINE INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBRAL ISCHAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEMENTIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMODIALYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LETHARGY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG INFILTRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENTAL STATUS CHANGES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPTIC SHOCK</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOLAR</medicinalproduct>
        <drugauthorizationnumb>21673</drugauthorizationnumb>
        <drugdosagetext>61.5 MG QD X 5 IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ACUTE MYELOID LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050526</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050530</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOLAR</medicinalproduct>
        <drugauthorizationnumb>21673</drugauthorizationnumb>
        <drugdosagetext>61.5 MG QD X 5 IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MYELODYSPLASTIC SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050526</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050530</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYTARABINE</medicinalproduct>
        <drugdosagetext>41 MG QD SC</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>ACUTE MYELOID LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050526</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050608</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYTARABINE</medicinalproduct>
        <drugdosagetext>41 MG QD SC</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>MYELODYSPLASTIC SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050526</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050608</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AUGMENTIN '125'</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMBISOME</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALTREX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARICEPT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VERAPAMIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONIDINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>K-DUR 10</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREVACID</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045238-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060626</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006AC01220</companynumb>
    <primarysource>
      <reportercountry>NETHERLANDS</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>36</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>80</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FACIAL PALSY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEMIPARESIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCORRECT ROUTE OF DRUG ADMINISTRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OBSTRUCTIVE AIRWAYS DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ROPIVACAINE</medicinalproduct>
        <drugauthorizationnumb>20533</drugauthorizationnumb>
        <drugdosagetext>5 ML 1% ROPIVACAINE</drugdosagetext>
        <drugadministrationroute>056</drugadministrationroute>
        <drugindication>LOCAL ANAESTHESIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROPOFOL</medicinalproduct>
        <drugauthorizationnumb>019627</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>SEDATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROPOFOL</medicinalproduct>
        <drugauthorizationnumb>019627</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYBUPROCAINE</medicinalproduct>
        <drugdosagetext>0.4 %</drugdosagetext>
        <drugadministrationroute>047</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045239-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060612</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006AC01106</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>55</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BACTERAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD MAGNESIUM INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD POTASSIUM DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FUNGAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GINGIVAL SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSEUDOMONAS INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUPERINFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TORSADE DE POINTES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIDOCAINE</medicinalproduct>
        <drugauthorizationnumb>16801</drugauthorizationnumb>
        <drugindication>ARRHYTHMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUCONAZOLE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYTARABINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ETOPOSIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DAUNORUBICIN HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MERCAPTOPURINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMPICILLIN SODIUM SULBATAM SODIUM</medicinalproduct>
        <drugindication>BACTERAEMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMPHOTERICIN B</medicinalproduct>
        <drugindication>BACTERAEMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOBRAMYCIN</medicinalproduct>
        <drugindication>BACTERAEMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CEFOPERAZONE SDOIUM SULBACTAM SODIUM</medicinalproduct>
        <drugindication>BACTERAEMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMINOPHYLLINE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PNEUMONIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045240-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060530</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006AP02496</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>23097</patientonsetage>
      <patientonsetageunit>804</patientonsetageunit>
      <patientweight>62.8</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>CARDIAC ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERCALCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METASTASES TO BONE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY FIBROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL TUBULAR NECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPUTUM PURULENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STAPHYLOCOCCAL INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IRESSA</medicinalproduct>
        <drugauthorizationnumb>021399</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>LUNG ADENOCARCINOMA STAGE IV</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060429</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060509</drugenddate>
        <drugtreatmentduration>11</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTRIC ULCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060122</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060510</drugenddate>
        <drugtreatmentduration>109</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCONTIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CANCER PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060502</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060510</drugenddate>
        <drugtreatmentduration>9</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NAUZELIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NAUSEA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060502</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060510</drugenddate>
        <drugtreatmentduration>9</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NOVAMIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NAUSEA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060502</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060510</drugenddate>
        <drugtreatmentduration>9</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARBOPLATIN</medicinalproduct>
        <drugdosagetext>2 COURSES</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060202</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060323</drugenddate>
        <drugtreatmentduration>50</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PACLITAXEL</medicinalproduct>
        <drugdosagetext>2 COURSES</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060202</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060323</drugenddate>
        <drugtreatmentduration>50</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045241-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060613</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006SE03327</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>27966</patientonsetage>
      <patientonsetageunit>804</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>LARYNGEAL OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPHOCYTE STIMULATION TEST POSITIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BLOPRESS TABLETS 4</medicinalproduct>
        <drugauthorizationnumb>20838</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060210</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060519</drugenddate>
        <drugtreatmentduration>99</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCYLIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060210</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060410</drugenddate>
        <drugtreatmentduration>60</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLETAL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060210</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060210</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PURSENNID</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060210</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGNESIUM OXIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060210</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOXONIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060210</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VASOLAN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060210</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045242-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006PK01446</companynumb>
    <primarysource>
      <reportercountry>SWITZERLAND</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>34</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>LEUKOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugauthorizationnumb>020639</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ACUTE PSYCHOSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060511</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060519</drugenddate>
        <drugtreatmentduration>9</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERDAL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ACUTE PSYCHOSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060510</drugenddate>
        <drugtreatmentduration>71</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045244-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060614</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US200606004102</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>49</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ALANINE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASPARTATE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIABETES MELLITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATITIS A ANTIBODY POSITIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPHOCYTE COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHABDOMYOLYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
        <drugauthorizationnumb>20592</drugauthorizationnumb>
        <drugdosagetext>5 MG,; 10 MG</drugdosagetext>
        <drugindication>BIPOLAR DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041115</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051125</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
        <drugauthorizationnumb>20592</drugauthorizationnumb>
        <drugdosagetext>5 MG,; 10 MG</drugdosagetext>
        <drugindication>BIPOLAR DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040928</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYMBYAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIAZEPAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCODONE/APAP                                           (OXYCODONE, P</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PERCOCET</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045245-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060703</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-AVENTIS-200612370FR</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>13</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ACUTE RESPIRATORY DISTRESS SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CANDIDIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERAL PHYSICAL CONDITION ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NECK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OLIGURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY DISTRESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHINITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BIRODOGYL</medicinalproduct>
        <drugdosagetext>DOSE UNIT: UNITS</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>TOOTH ABSCESS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060603</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060607</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOLIPRANE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PYREXIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060610</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PYREXIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060610</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHINITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060610</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>COUGH</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060610</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HELICIDINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PYREXIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060610</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HELICIDINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHINITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060610</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HELICIDINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>COUGH</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060610</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>APRANAX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>TOOTH ABSCESS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060603</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060607</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045247-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060614</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US200606004417</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIOMEGALY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIABETES MELLITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
        <drugauthorizationnumb>20592</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045249-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060615</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US200606003554</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABNORMAL BEHAVIOUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EATING DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HALLUCINATION, AUDITORY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENTAL STATUS CHANGES</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
        <drugauthorizationnumb>20592</drugauthorizationnumb>
        <drugdosagetext>5 MG,; 20 MG, DAILY (1/D); 10 MG, 2/D</drugdosagetext>
        <drugindication>SCHIZOAFFECTIVE DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045250-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060613</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US200606003358</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugauthorizationnumb>21318</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045252-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060613</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US200606003717</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugauthorizationnumb>21318</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FORTEO PEN (250 MCG/ML) (FORTE PEN 250 MCG/ML (3ML)) PEN, DISPOSABLE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045253-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060612</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US200603000449</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>87</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL DISTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANGINA PECTORIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ATRIAL FIBRILLATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMPRESSION FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCORRECT ROUTE OF DRUG ADMINISTRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE HAEMATOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MESENTERIC VEIN THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOBILITY DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUPRAVENTRICULAR TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TENDERNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugbatchnumb>FF5L55A</drugbatchnumb>
        <drugauthorizationnumb>21318</drugauthorizationnumb>
        <drugdosagetext>20 UG, DAILY (1/D)</drugdosagetext>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050127</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060130</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DURAGESIC-100</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NITROGLYCERIN                    (NITROGLYCERIN UNKNOWN FORMULATION) U</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MYCOLOG          (GRAMICIDIN, NEOMYCIN SULFATE, NYSTATIN, TRIAMCINOLON</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BLOOD TRANSFUSION, AUXILIARY PRODUCTS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RED BLOOD CELLS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045255-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060612</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US200604001533</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>74</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANKLE FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugbatchnumb>FF5M44A</drugbatchnumb>
        <drugauthorizationnumb>21318</drugauthorizationnumb>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOTREL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045256-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060612</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US200604001664</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ARTHRITIS INFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVALESCENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugauthorizationnumb>21318</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045259-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>HK-GILEAD-2006-0009808</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD CREATININE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEPHROPATHY TOXIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROTEINURIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPSERA</medicinalproduct>
        <drugauthorizationnumb>021449</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS B</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045260-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-GILEAD-2006-0009823</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>50</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>45</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DIABETES MELLITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOMALACIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOPOROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL TUBULAR DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIREAD</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021008</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060413</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EPIVIR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SUSTIVA</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045261-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-GILEAD-2006-0009822</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>37</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ALPHA 1 GLOBULIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD BICARBONATE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CANDIDA SEROLOGY POSITIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DELIRIUM FEBRILE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERAL PHYSICAL HEALTH DETERIORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERGAMMAGLOBULINAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOALBUMINAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOCALCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOCAPNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOCHLORAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEUKOCYTOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METABOLIC ACIDOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL TUBULAR DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIREAD</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050131</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060214</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CRIXIVAN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041015</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060214</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NORVIR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060214</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EPIVIR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060214</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NOVOMIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVLOCARDYL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AERIUS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MIANSERINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FORTIMEL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045262-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060606</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-GILEAD-2006-0009703</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ALANINE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASPARTATE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPSERA</medicinalproduct>
        <drugauthorizationnumb>21449</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS B</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060119</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060501</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZEFFIX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS B</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020216</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEO-MINOPHAGEN C</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045264-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060614</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US200604002334</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>80</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DIABETES MELLITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GLYCOSURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MICTURITION URGENCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POLLAKIURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY INCONTINENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
        <drugauthorizationnumb>20592</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREVACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALTACE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EFFEXOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALPHAGAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANOXIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRAVACHOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PILOPINE HS (PILOCARPINE HYDROCHLORIDE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COMBIVENT /GFR/ (IPRATROPIUM BROMIDE, SALBUTAMOL SULFATE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PEPCID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIGOXIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NITROGLYCERIN TRANSDERMAL SYSTEM (GLYCERYL TRINITRATE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL (METOPROLOL)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045266-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060621</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CLOF-10256</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>67</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CHOLECYSTITIS ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOFARABINE</medicinalproduct>
        <drugauthorizationnumb>21673</drugauthorizationnumb>
        <drugdosagetext>60 MG QD X 5 IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ACUTE MYELOID LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051012</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051016</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYTARABINE</medicinalproduct>
        <drugdosagetext>40 MG QD SC</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>ACUTE MYELOID LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051012</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051225</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TEMAZEPAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGNESIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYLENOL (CAPLET)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENADRYL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SENNA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PIPERACILLIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANTOPRAZOLE SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CHOLECALCIFEROL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ONDANSETRON HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROMORPHONE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LINEZOLID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ERGOCALCIFEROL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045267-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060614</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US200606003440</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>32</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>97.1</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DIABETES MELLITUS NON-INSULIN-DEPENDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GLUCOSE TOLERANCE IMPAIRED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRESCRIBED OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
        <drugauthorizationnumb>20592</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010306</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20011022</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
        <drugauthorizationnumb>20592</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20011022</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20011205</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
        <drugauthorizationnumb>20592</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20011205</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040401</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
        <drugauthorizationnumb>20592</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040721</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
        <drugauthorizationnumb>20592</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040721</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050928</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045268-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060614</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US200604001968</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>63</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>95.7</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DECREASED ACTIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>KNEE ARTHROPLASTY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SURGERY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT LOSS POOR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
        <drugauthorizationnumb>20592</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19970101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045270-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060612</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US200604002432</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>68</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ALANINE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AMNESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASPARTATE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHILLS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLONIC POLYP</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CYTOMEGALOVIRUS INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISTURBANCE IN ATTENTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIVERTICULITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPEPSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROOESOPHAGEAL REFLUX DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GINGIVAL BLEEDING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHOIDS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC ENZYME INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ILEITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LARGE INTESTINAL ULCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENTAL IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOOD SWINGS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POLLAKIURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SELF INJURIOUS BEHAVIOUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VICODIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NABUMETONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALTACE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLIPIZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGNESIUM SULFATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SINGULAIR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>STOOL SOFTENER (DOCUSATE SODIUM)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FENTANYL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045271-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060612</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US200602005565</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>25</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>100.7</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DIABETES MELLITUS INSULIN-DEPENDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIABETIC COMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIABETIC KETOACIDOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SHOCK HYPOGLYCAEMIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TARDIVE DYSKINESIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
        <drugauthorizationnumb>20592</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19970327</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20000101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
        <drugauthorizationnumb>20592</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VISTARIL (HYDROXYZINE EMBONATE)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045272-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060615</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US200606003713</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUROPATHY PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN LACERATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMALOG</medicinalproduct>
        <drugauthorizationnumb>20563</drugauthorizationnumb>
        <drugdosagetext>24</drugdosagetext>
        <drugindication>DIABETES MELLITUS NON-INSULIN-DEPENDENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19960101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMULIN N</medicinalproduct>
        <drugdosagetext>16</drugdosagetext>
        <drugindication>DIABETES MELLITUS NON-INSULIN-DEPENDENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19960101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE TAB</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045273-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060614</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US200606001762</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>59</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>AKATHISIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIABETES MELLITUS NON-INSULIN-DEPENDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEDATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
        <drugauthorizationnumb>20592</drugauthorizationnumb>
        <drugdosagetext>5 MG, DAILY (1/D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020812</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYPREXA ZYDIS</medicinalproduct>
        <drugdosagetext>5 MG, AS NEEDED, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>AGITATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050420</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045274-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060614</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US200606003441</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>48</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>72.6</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ASPARTATE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD ALKALINE PHOSPHATASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD LACTATE DEHYDROGENASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIABETES MELLITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRESCRIBED OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
        <drugauthorizationnumb>20592</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19981016</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19990312</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
        <drugauthorizationnumb>20592</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990312</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040321</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
        <drugauthorizationnumb>20592</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040331</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040424</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
        <drugauthorizationnumb>20592</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040424</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SINEQUAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RISPERDAL /SWE/ (RISPERIDONE)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045276-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-KINGPHARMUSA00001-K200600852</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>14</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANGIONEUROTIC OEDEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLORINEF</medicinalproduct>
        <drugauthorizationnumb>010060</drugauthorizationnumb>
        <drugindication>HYPOTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045277-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-GILEAD-2006-0009829</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>43</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CHOLELITHIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATOMEGALY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYELONEPHRITIS ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIREAD</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060607</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIDEX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060607</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SUSTIVA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045281-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060626</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PT-BRISTOL-MYERS SQUIBB COMPANY-13432448</companynumb>
    <primarysource>
      <reportercountry>PORTUGAL</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>68</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>NEUROTOXICITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ERBITUX</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>SQUAMOUS CELL CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060502</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RADIOTHERAPY</medicinalproduct>
        <drugindication>SQUAMOUS CELL CARCINOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGNESIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GABAPENTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NIMESULIDE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045282-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060627</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-BRISTOL-MYERS SQUIBB COMPANY-13432489</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>RECTAL PERFORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN REACTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ERBITUX</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060301</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045283-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060623</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CZ-BRISTOL-MYERS SQUIBB COMPANY-13423215</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>56</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN EXFOLIATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IXABEPILONE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060613</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060613</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CAPECITABINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060613</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060620</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BONEFOS</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060425</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOREM</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SANDONORM</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19870101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENAP</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19870101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045284-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20051212</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-BRISTOL-MYERS SQUIBB COMPANY-13212410</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>57</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IXABEPILONE</medicinalproduct>
        <drugdosagetext>THERAPY START DATE 08-SEP-05. INTERRUPTED.</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CAPECITABINE</medicinalproduct>
        <drugdosagetext>THERAPY START DATE 09-SEP-05. INTERRUPTED.</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051202</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051207</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045285-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060623</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>HQWYE387126JUN06</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>67</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>106.4</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>KIDNEY TRANSPLANT REJECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RAPAMUNE</medicinalproduct>
        <drugbatchnumb>10981</drugbatchnumb>
        <drugauthorizationnumb>21110</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS AGAINST TRANSPLANT REJECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050405</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060609</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RAPAMUNE</medicinalproduct>
        <drugbatchnumb>10981</drugbatchnumb>
        <drugauthorizationnumb>21110</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS AGAINST TRANSPLANT REJECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060610</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060615</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RAPAMUNE</medicinalproduct>
        <drugbatchnumb>10981</drugbatchnumb>
        <drugauthorizationnumb>21110</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS AGAINST TRANSPLANT REJECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060621</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RAPAMUNE</medicinalproduct>
        <drugbatchnumb>2005P0792</drugbatchnumb>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZENAPAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MYCOPHENOLATE MOFETIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CORTICOSTEROID NOS (CORTICOSTEROID NOS)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045286-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060627</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>HQWYE101502MAR06</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABNORMAL DREAMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>APATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISTURBANCE IN ATTENTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG WITHDRAWAL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ILLUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMPAIRED WORK ABILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LAZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF LIBIDO</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENTAL IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NIGHTMARE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN DISCOLOURATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TINNITUS</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>20050601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060228</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>20060301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060305</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>20060306</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045287-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060619</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>APP200600167</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>35</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <reaction>
        <reactionmeddrapt>BRADYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIDAZOLAM HCL</medicinalproduct>
        <drugbatchnumb>401658</drugbatchnumb>
        <drugauthorizationnumb>75154</drugauthorizationnumb>
        <drugdosagetext>(2-4 MG ONCE), INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PREOPERATIVE CARE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060615</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060615</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIDAZOLAM HCL</medicinalproduct>
        <drugbatchnumb>401658</drugbatchnumb>
        <drugauthorizationnumb>75154</drugauthorizationnumb>
        <drugdosagetext>(2-4 MG ONCE), INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>SEDATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060615</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060615</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045288-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060622</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-STX184052</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BREAST MASS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060515</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARAVA</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045289-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060530</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FRWYE661830MAY06</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>56</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>87</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ARTERIOSCLEROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CAROTID ARTERY DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ISCHAEMIC STROKE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060312</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NOVATREX</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050717</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060312</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045290-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060624</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-STX184300</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLUENZA LIKE ILLNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>KNEE ARTHROPLASTY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE TIGHTNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>P063741</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19970101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045293-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050919</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GR-ABBOTT-05P-066-0311400-00</companynumb>
    <primarysource>
      <reportercountry>GREECE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>56</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>METRORRHAGIA</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>20040505</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050805</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050924</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALENDRONATE SODIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050301</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCITONIN</medicinalproduct>
        <drugadministrationroute>045</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050301</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALSARTAN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045294-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060328</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-ABBOTT-06P-167-0329214-00</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEAFNESS UNILATERAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EPILIM</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>18081</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060112</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045295-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-ABBOTT-06P-028-0337229-00</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>68.1</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HIP ARTHROPLASTY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050223</drugstartdate>
      </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>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CODEINE CONTIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CODEINE CONTIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTIVITAMIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IRON</medicinalproduct>
        <drugadministrationroute>050</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYANOCOBALAMIN</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARTHROTEC</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045296-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesscongenitalanomali>1</seriousnesscongenitalanomali>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-ABBOTT-06P-056-0337168-00</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>TRISOMY 21</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENTRICULAR HYPOPLASIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEPAKENE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>018081</drugauthorizationnumb>
        <drugindication>DRUG EXPOSURE DURING PREGNANCY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARBAMAZEPINE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>DRUG EXPOSURE DURING PREGNANCY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045297-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050919</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-ABBOTT-05P-008-0311775-00</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>32</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABORTION INDUCED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UNINTENDED PREGNANCY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REDUCTIL 15MG</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>20632</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045298-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20051105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ABBOTT-05P-087-0316765-00</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>42</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MIDDLE LOBE SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050428</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051012</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051125</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MELOXICAM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041210</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLURBIPROFEN</medicinalproduct>
        <drugdosagetext>ROUTE: ENDERMIC (TAP)</drugdosagetext>
        <drugadministrationroute>050</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050510</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETYLSALICYLIC ACID SRT</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>THROMBOPHLEBITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040110</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>URSODEOXYCHOLIC ACID</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BILIARY CIRRHOSIS PRIMARY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MARZULENE S</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS AGAINST GASTROINTESTINAL ULCER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RANITIDINE HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS AGAINST GASTROINTESTINAL ULCER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RISEDRONATE SODIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS AGAINST GASTROINTESTINAL ULCER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BETAMETHASONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRURITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050318</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMBROXOL HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRURITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050624</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045299-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060627</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>NL-ABBOTT-06P-114-0337066-00</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>82</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEMENTIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HIP FRACTURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BIPERIDEN HYDROCHLORIDE TAB</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>012003</drugauthorizationnumb>
        <drugindication>TREMOR</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUOXETINE</medicinalproduct>
        <drugdosagetext>NOT REPORTED</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROPRANOLOL</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045300-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-ABBOTT-06P-056-0337538-00</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABORTION INDUCED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEPAKENE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>018081</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>EPILEPSY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051102</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARBAMAZEPINE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>064</drugadministrationroute>
        <drugindication>EPILEPSY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051102</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONAZEPAM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>EPILEPSY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045301-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-ABBOTT-06P-167-0337289-00</companynumb>
    <primarysource>
      <reportercountry>IRELAND</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INTRACRANIAL ANEURYSM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040921</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051201</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEFLUNOMIDE</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>STEROIDS</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045302-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060306</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-ABBOTT-06P-028-0327263-00</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>120</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ARRHYTHMIA</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MERIDIA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>20632</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060303</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUOXETINE HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045303-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060627</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2006TR09914</companynumb>
    <primarysource>
      <reportercountry>TURKEY</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <patientonsetage>17</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLEPHAROSPASM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSED LEVEL OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCLONUS</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARBAMAZEPINE</medicinalproduct>
        <drugauthorizationnumb>016608</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>EPILEPSY</drugindication>
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    </patient>
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  <safetyreport>
    <safetyreportid>5045304-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060626</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHO2006BR10390</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>55</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>90</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESTLESSNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORADIL / FOR 258A / CGP 25827</medicinalproduct>
        <drugauthorizationnumb>20831</drugauthorizationnumb>
        <drugdosagetext>12 UG, BID</drugdosagetext>
        <drugindication>LUNG DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060624</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060625</drugenddate>
        <drugtreatmentduration>2880</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
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    </patient>
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  <safetyreport>
    <safetyreportid>5045305-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060623</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2006JP09593</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>19</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>60</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>COMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVERSION DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSED LEVEL OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRIC LAVAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDE ATTEMPT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BENZALIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BENZALIN</medicinalproduct>
        <drugdosagetext>6 TABLETS, ONCE/SINGLE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060621</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060621</drugenddate>
        <drugtreatmentduration>1440</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TEGRETOL</medicinalproduct>
        <drugauthorizationnumb>016608</drugauthorizationnumb>
        <drugdosagetext>49 TABLETS, ONCE/SINGLE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060621</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060621</drugenddate>
        <drugtreatmentduration>1440</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TEGRETOL</medicinalproduct>
        <drugauthorizationnumb>016608</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
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    </patient>
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  <safetyreport>
    <safetyreportid>5045306-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2006JP09731</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BONE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTI-ORGAN FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TEGRETOL</medicinalproduct>
        <drugauthorizationnumb>16608</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>METASTATIC PAIN</drugindication>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VOLTAREN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>METASTATIC PAIN</drugindication>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCONTIN</medicinalproduct>
        <drugindication>METASTATIC PAIN</drugindication>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DUROTEP</medicinalproduct>
        <drugindication>METASTATIC PAIN</drugindication>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MORPHINE</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>METASTATIC PAIN</drugindication>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FENTANEST</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>METASTATIC PAIN</drugindication>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DAV</medicinalproduct>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INTERFERON BETA</medicinalproduct>
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    </patient>
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  <safetyreport>
    <safetyreportid>5045307-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060701</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0607USA00084</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
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    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <patientonsetage>89</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>FLANK PAIN</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>GALLBLADDER DISORDER</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>INFLUENZA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VYTORIN</medicinalproduct>
        <drugauthorizationnumb>021687</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
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  <safetyreport>
    <safetyreportid>5045308-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
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    <receiptdate>20060614</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-MERCK-0606FRA00030</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
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    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <patientonsetage>8</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NIGHTMARE</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SINGULAIR</medicinalproduct>
        <drugauthorizationnumb>20830</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050701</drugstartdate>
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        <drugenddate>20060302</drugenddate>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SINGULAIR</medicinalproduct>
        <drugauthorizationnumb>020830</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060603</drugstartdate>
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        <drugenddate>20060607</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DESLORATADINE</medicinalproduct>
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        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SALMETEROL XINAFOATE</medicinalproduct>
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        <drugindication>ASTHMA</drugindication>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AZELASTINE HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>CONJUNCTIVITIS ALLERGIC</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045309-6</safetyreportid>
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    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
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    <receiptdate>20050829</receiptdate>
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    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
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    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <patientonsetage>38</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>TEMPOROMANDIBULAR JOINT SYNDROME</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
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        <drugstartdate>20040101</drugstartdate>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
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        <drugstartdate>20040101</drugstartdate>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
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        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PERCOCET</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SINGULAIR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADVAIR DISKUS 100/50</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROMETRIUM</medicinalproduct>
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  <safetyreport>
    <safetyreportid>5045310-2</safetyreportid>
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      <reportercountry>GERMANY</reportercountry>
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    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <patientonsetage>71</patientonsetage>
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      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHOLESTASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISORIENTATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG TOXICITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSSTASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC FIBROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATOCELLULAR DAMAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER DISORDER</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>ZETIA</medicinalproduct>
        <drugauthorizationnumb>21445</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERCHOLESTEROLAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060422</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060426</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZETIA</medicinalproduct>
        <drugauthorizationnumb>021445</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CORONARY ARTERY DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060422</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060426</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE BESYLATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN E ACETATE DL-FORM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GINKGO</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060320</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045311-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-MERCK-0607USA00080</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>47</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>72</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DEAFNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TINNITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROPECIA</medicinalproduct>
        <drugauthorizationnumb>020788</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MALE PATTERN BALDNESS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060511</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060611</drugenddate>
        <drugtreatmentduration>32</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROPECIA</medicinalproduct>
        <drugauthorizationnumb>020788</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060615</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045312-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20020812</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-MERCK-0208USA02378</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>51</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>50</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ALLERGIC GRANULOMATOUS ANGIITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SINGULAIR</medicinalproduct>
        <drugauthorizationnumb>20829</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020405</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020710</drugenddate>
        <drugtreatmentduration>97</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THEO-DUR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020322</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020611</drugenddate>
        <drugtreatmentduration>82</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KAKKON-TO-KA-SENKYU-SINI</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020405</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DASEN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020405</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020516</drugenddate>
        <drugtreatmentduration>42</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLOMOX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020405</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020409</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLOMOX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020610</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020614</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLARITHROMYCIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020615</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020619</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045313-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060630</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0607USA00106</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL ULCER HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>20560</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM (UNSPECIFIED)</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROTONIX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045314-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20051220</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0512USA03201</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>70</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>90</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 UREA INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VYTORIN</medicinalproduct>
        <drugauthorizationnumb>021687</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051122</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ELAVIL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</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>ATENOLOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONAZEPAM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045317-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060503</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006UW08827</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>29840</patientonsetage>
      <patientonsetageunit>804</patientonsetageunit>
      <patientweight>85.5</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANKLE FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE SYSTOLIC INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JOINT SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALLOR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY RATE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARIMIDEX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BREAST CANCER FEMALE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980320</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030318</drugenddate>
        <drugtreatmentduration>1825</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONAZEPAM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SLEEP DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADALAT</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANGINA UNSTABLE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010501</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045318-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060623</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AVENTIS-200616763GDDC</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>63</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>65.7</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANOREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOKALAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOMAGNESAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAXOTERE</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>020449</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>SQUAMOUS CELL CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060612</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060612</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CISPLATIN</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>SQUAMOUS CELL CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060612</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060612</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUOROURACIL</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>SQUAMOUS CELL CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060612</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060612</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</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>COLCHICINE</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KCL ELIXIR</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ROXICET</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LACTULOSE</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVAQUIN</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DECADRON</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REGLAN</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOFRAN</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045320-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>KR-AVENTIS-200616791GDDC</companynumb>
    <primarysource>
      <reportercountry>KOREA, REPUBLIC OF</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>61</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>59.4</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD CREATININE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEBRILE NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAXOTERE</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>020449</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060512</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060609</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CISPLATIN</medicinalproduct>
        <drugbatchnumb>YNK</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060512</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060609</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045321-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AVENTIS-200616785GDDC</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>50</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>61.7</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ACTIVATED PARTIAL THROMBOPLASTIN TIME PROLONGED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CREATININE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD UREA INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOVOLAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCYTOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROTHROMBIN TIME PROLONGED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAXOTERE</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>20449</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ADENOCARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060622</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060622</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ANTINEOPLASTIC AND IMMUNOSUPPRESSIVE AGENTS</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ADENOCARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060615</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060625</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DURAGESIC-100</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
        <drugadministrationroute>062</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DECADRON</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOFRAN</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045322-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-AVENTIS-200612360FR</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>69</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE MARROW FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIO-RESPIRATORY DISTRESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCREASED BRONCHIAL SECRETION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLEURAL EFFUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLEURISY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAXOTERE</medicinalproduct>
        <drugauthorizationnumb>20449</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BRONCHIAL CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060518</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060518</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CISPLATIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BRONCHIAL CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060518</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060518</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RADIOTHERAPY</medicinalproduct>
        <drugindication>BRONCHIAL CARCINOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREVISCAN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060521</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DAONIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060521</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FORADIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THEOSTAT</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060521</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLIXOTID</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OGAST</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045323-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060524</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>NL-AVENTIS-200615532GDDC</companynumb>
    <primarysource>
      <reportercountry>NETHERLANDS</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>62</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CIRCULATORY COLLAPSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY CONGESTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RECTAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUS TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOCETAXEL</medicinalproduct>
        <drugauthorizationnumb>20449</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PROSTATE CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060309</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060511</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISEDRONATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROSTATE CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060309</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060520</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISONE TAB</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROSTATE CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060309</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060520</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMNIC</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050422</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060520</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLADEX</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060320</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045324-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060516</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AVENTIS-200615302GDDC</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>60</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>39</patientweight>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>LARYNGEAL CANCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OBSTRUCTIVE AIRWAYS DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOCETAXEL</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>20449</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>SQUAMOUS CELL CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060508</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060508</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CODE UNBROKEN</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SQUAMOUS CELL CARCINOMA</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060514</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045325-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060627</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2006BR09884</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>51</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>54</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>AMNESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANGINA PECTORIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISTURBANCE IN ATTENTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMANGIOMA OF LIVER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEMORY IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENOPAUSAL SYMPTOMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METRORRHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSYCHOMOTOR SKILLS IMPAIRED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ROAD TRAFFIC ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TEGRETOL</medicinalproduct>
        <drugauthorizationnumb>020234</drugauthorizationnumb>
        <drugdosagetext>200 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>EPILEPSY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19960131</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TEGRETOL</medicinalproduct>
        <drugauthorizationnumb>020234</drugauthorizationnumb>
        <drugdosagetext>200 MG/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TEGRETOL</medicinalproduct>
        <drugauthorizationnumb>020234</drugauthorizationnumb>
        <drugdosagetext>200 MG, TID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051001</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045326-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20030113</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0392976A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LOTRONEX</medicinalproduct>
        <drugauthorizationnumb>21107</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>IRRITABLE BOWEL SYNDROME</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045327-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20030113</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0392982A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</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>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LOTRONEX</medicinalproduct>
        <drugauthorizationnumb>21107</drugauthorizationnumb>
        <drugdosagetext>1MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>IRRITABLE BOWEL SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000619</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
        <drugdosagetext>200MCG PER DAY</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045328-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20030317</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0400573A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>78</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LOTRONEX</medicinalproduct>
        <drugauthorizationnumb>21107</drugauthorizationnumb>
        <drugdosagetext>1MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>IRRITABLE BOWEL SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DICYCLOMINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FISH OIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FIBER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROBIOTIC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GRAPEFRUIT SEED EXTRACT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PEPPERMINT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045329-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20051103</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0580713A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EJACULATION DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LOTRONEX</medicinalproduct>
        <drugauthorizationnumb>021107</drugauthorizationnumb>
        <drugdosagetext>1TAB PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045330-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20051108</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0581449A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>50</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LOTRONEX</medicinalproduct>
        <drugbatchnumb>4ZP7534</drugbatchnumb>
        <drugauthorizationnumb>021107</drugauthorizationnumb>
        <drugdosagetext>1MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>IRRITABLE BOWEL SYNDROME</drugindication>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUOXETINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYLENOL W/ CODEINE NO. 3</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREMPRO</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMBIEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEPAKOTE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOSAMINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045331-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20051108</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0581453A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BONE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC ENZYME INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LOTRONEX</medicinalproduct>
        <drugauthorizationnumb>021107</drugauthorizationnumb>
        <drugdosagetext>1MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>IRRITABLE BOWEL SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZETIA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAXALT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADVAIR DISKUS 100/50</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NASACORT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045332-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20051114</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0582158A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>68</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LOTRONEX</medicinalproduct>
        <drugauthorizationnumb>021107</drugauthorizationnumb>
        <drugdosagetext>1TAB PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>IRRITABLE BOWEL SYNDROME</drugindication>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GLUCOPHAGE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIAVAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMARYL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEGACE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM SUPPLEMENT</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045333-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20051121</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0583295A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>74</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>THERAPEUTIC RESPONSE DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LOTRONEX</medicinalproduct>
        <drugauthorizationnumb>021107</drugauthorizationnumb>
        <drugdosagetext>1MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>IRRITABLE BOWEL SYNDROME</drugindication>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOMOTIL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045334-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20051129</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0583869A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>71</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LOTRONEX</medicinalproduct>
        <drugauthorizationnumb>021107</drugauthorizationnumb>
        <drugdosagetext>1MG THREE TIMES PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>IRRITABLE BOWEL SYNDROME</drugindication>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OPIUM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045335-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20051123</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0584155A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>68</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LOTRONEX</medicinalproduct>
        <drugbatchnumb>5ZP0261</drugbatchnumb>
        <drugauthorizationnumb>021107</drugauthorizationnumb>
        <drugdosagetext>.5MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MIACALCIN</medicinalproduct>
        <drugadministrationroute>045</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045336-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060111</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0588788A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IRRITABLE BOWEL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRESCRIBED OVERDOSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LOTRONEX</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021107</drugauthorizationnumb>
        <drugdosagetext>1MG THREE TIMES PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>IRRITABLE BOWEL SYNDROME</drugindication>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045337-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060120</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0590265A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>41</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>AMNESIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LOTRONEX</medicinalproduct>
        <drugauthorizationnumb>021107</drugauthorizationnumb>
        <drugdosagetext>1MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>IRRITABLE BOWEL SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031013</drugstartdate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARBATROL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045338-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060125</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0590900A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>16</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LOTRONEX</medicinalproduct>
        <drugbatchnumb>5ZP9038</drugbatchnumb>
        <drugauthorizationnumb>021107</drugauthorizationnumb>
        <drugdosagetext>1MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>IRRITABLE BOWEL SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LACTAID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMNIGEST EZ</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045339-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060131</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0591685A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>59</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LOTRONEX</medicinalproduct>
        <drugauthorizationnumb>021107</drugauthorizationnumb>
        <drugdosagetext>1MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060122</drugenddate>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045340-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060131</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0591981A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ADVERSE EVENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LOTRONEX</medicinalproduct>
        <drugauthorizationnumb>021107</drugauthorizationnumb>
        <drugdosagetext>1MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000622</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045341-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060131</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0591982A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ADVERSE EVENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LOTRONEX</medicinalproduct>
        <drugauthorizationnumb>021107</drugauthorizationnumb>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20001030</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EFFEXOR XR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACTOS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM CHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREVACID</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045342-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060131</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0592166A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ADVERSE EVENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LOTRONEX</medicinalproduct>
        <drugauthorizationnumb>021107</drugauthorizationnumb>
        <drugdosagetext>1MG UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045343-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060131</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0592167A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ADVERSE EVENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LOTRONEX</medicinalproduct>
        <drugauthorizationnumb>021107</drugauthorizationnumb>
        <drugdosagetext>1MG UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20001102</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACIPHEX</medicinalproduct>
        <drugdosagetext>20MG IN THE MORNING</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRIPHASIL-28</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045344-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
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    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0592168A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ADVERSE EVENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LOTRONEX</medicinalproduct>
        <drugauthorizationnumb>021107</drugauthorizationnumb>
        <drugdosagetext>1MG UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045345-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060131</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0592173A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ADVERSE EVENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LOTRONEX</medicinalproduct>
        <drugauthorizationnumb>021107</drugauthorizationnumb>
        <drugdosagetext>1MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>IRRITABLE BOWEL SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000511</drugstartdate>
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    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045346-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060131</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0592322A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ADVERSE EVENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LOTRONEX</medicinalproduct>
        <drugauthorizationnumb>021107</drugauthorizationnumb>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045347-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060131</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0592324A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ADVERSE EVENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LOTRONEX</medicinalproduct>
        <drugauthorizationnumb>021107</drugauthorizationnumb>
        <drugdosagetext>1MG UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000817</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045348-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
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    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0592327A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ADVERSE EVENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LOTRONEX</medicinalproduct>
        <drugauthorizationnumb>021107</drugauthorizationnumb>
        <drugdosagetext>1MG UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045349-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
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    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0592328A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ADVERSE EVENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LOTRONEX</medicinalproduct>
        <drugauthorizationnumb>021107</drugauthorizationnumb>
        <drugdosagetext>1MG UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045350-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
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    <companynumb>US-GLAXOSMITHKLINE-A0592541A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ADVERSE EVENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LOTRONEX</medicinalproduct>
        <drugauthorizationnumb>021107</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000828</drugstartdate>
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    </patient>
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  <safetyreport>
    <safetyreportid>5045351-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
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    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0592715A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ADVERSE EVENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LOTRONEX</medicinalproduct>
        <drugauthorizationnumb>021107</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>IRRITABLE BOWEL SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000817</drugstartdate>
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        <drugenddate>20000912</drugenddate>
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        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVSINEX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREVACID</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045352-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
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    <receiptdateformat>102</receiptdateformat>
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    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ADVERSE EVENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LOTRONEX</medicinalproduct>
        <drugauthorizationnumb>021107</drugauthorizationnumb>
        <drugdosagetext>1MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000810</drugstartdate>
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    </patient>
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  <safetyreport>
    <safetyreportid>5045353-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
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    <receiptdateformat>102</receiptdateformat>
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    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
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    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ADVERSE EVENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LOTRONEX</medicinalproduct>
        <drugauthorizationnumb>021107</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000821</drugstartdate>
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  <safetyreport>
    <safetyreportid>5045354-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
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    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
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    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
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      <reaction>
        <reactionmeddrapt>ADVERSE EVENT</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LOTRONEX</medicinalproduct>
        <drugauthorizationnumb>021107</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000912</drugstartdate>
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    </patient>
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  <safetyreport>
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    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
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    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060131</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0592724A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ADVERSE EVENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LOTRONEX</medicinalproduct>
        <drugauthorizationnumb>021107</drugauthorizationnumb>
        <drugdosagetext>1MG AS REQUIRED</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045356-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060131</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0592726A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ADVERSE EVENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LOTRONEX</medicinalproduct>
        <drugauthorizationnumb>021107</drugauthorizationnumb>
        <drugdosagetext>1MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20001120</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045357-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060214</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0593672A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>RETINAL ARTERY OCCLUSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LOTRONEX</medicinalproduct>
        <drugauthorizationnumb>021107</drugauthorizationnumb>
        <drugdosagetext>.5MG ALTERNATE DAYS</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045358-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060215</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0593881A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>82</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>90.5</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLADDER SPASM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LOTRONEX</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021107</drugauthorizationnumb>
        <drugdosagetext>1MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>IRRITABLE BOWEL SYNDROME</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ISOSORBIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACCUPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NITROSTAT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PHENERGAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DETROL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045359-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060216</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0594013A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>50</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LOTRONEX</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021107</drugauthorizationnumb>
        <drugdosagetext>1TAB PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>IRRITABLE BOWEL SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020101</drugenddate>
        <drugtreatmentduration>18</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOXYL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ESTRATEST</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045360-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060222</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0594771A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>51</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TENSION HEADACHE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LOTRONEX</medicinalproduct>
        <drugauthorizationnumb>021107</drugauthorizationnumb>
        <drugdosagetext>1MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>IRRITABLE BOWEL SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEXAPRO</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNIRETIC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045361-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060307</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0596525A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LOTRONEX</medicinalproduct>
        <drugauthorizationnumb>021107</drugauthorizationnumb>
        <drugdosagetext>1MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>IRRITABLE BOWEL SYNDROME</drugindication>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NO CONCURRENT MEDICATION</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045362-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060327</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0599173A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>62</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>52.7</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LOTRONEX</medicinalproduct>
        <drugauthorizationnumb>021107</drugauthorizationnumb>
        <drugdosagetext>1MG SEE DOSAGE TEXT</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>IRRITABLE BOWEL SYNDROME</drugindication>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LAMICTAL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORAZEPAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOTENSIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SOMA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VICODIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045363-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060410</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0601173A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>46</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LOTRONEX</medicinalproduct>
        <drugbatchnumb>5ZP9038</drugbatchnumb>
        <drugauthorizationnumb>021107</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>IRRITABLE BOWEL SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060228</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XIFAXAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045364-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060411</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0601363A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>51</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>IRRITABILITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LOTRONEX</medicinalproduct>
        <drugauthorizationnumb>021107</drugauthorizationnumb>
        <drugdosagetext>1MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>IRRITABLE BOWEL SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060329</drugstartdate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MENEST</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROGESTERONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ELAVIL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045365-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060413</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0601704A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>67</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>NIGHT SWEATS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LOTRONEX</medicinalproduct>
        <drugauthorizationnumb>021107</drugauthorizationnumb>
        <drugdosagetext>1MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>IRRITABLE BOWEL SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050401</drugstartdate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEXAPRO</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045366-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060420</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0603305A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>36</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL DISTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLATULENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LOTRONEX</medicinalproduct>
        <drugauthorizationnumb>021107</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>IRRITABLE BOWEL SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20001201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045367-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20030501</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0603425A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>41</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LOTRONEX</medicinalproduct>
        <drugauthorizationnumb>021107</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ABDOMINAL PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000427</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20001201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIBRAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRILOSEC</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045368-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060427</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0603911A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LOTRONEX</medicinalproduct>
        <drugauthorizationnumb>021107</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045369-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060512</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0605396A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>72</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE IRREGULAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LOTRONEX</medicinalproduct>
        <drugbatchnumb>5ZP9038</drugbatchnumb>
        <drugauthorizationnumb>021107</drugauthorizationnumb>
        <drugdosagetext>1MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>IRRITABLE BOWEL SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060501</drugstartdate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOVANCE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COZAAR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN B6</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CENTRUM SILVER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPROL-XL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIGOXIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENEFIBER</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045370-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060526</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0607083A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRY MOUTH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LOTRONEX</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021107</drugauthorizationnumb>
        <drugdosagetext>1MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>IRRITABLE BOWEL SYNDROME</drugindication>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045371-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060602</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0607742A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>73</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANOREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSGEUSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LOTRONEX</medicinalproduct>
        <drugauthorizationnumb>021107</drugauthorizationnumb>
        <drugdosagetext>1MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>IRRITABLE BOWEL SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060423</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONEX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM GLUCONATE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045372-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20001129</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0133303A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</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>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NERVOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LOTRONEX</medicinalproduct>
        <drugauthorizationnumb>021107</drugauthorizationnumb>
        <drugdosagetext>1MG ALTERNATE DAYS</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>IRRITABLE BOWEL SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000914</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20001127</drugenddate>
        <drugtreatmentduration>75</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045373-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20020301</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0362547A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL INJURY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LOTRONEX</medicinalproduct>
        <drugauthorizationnumb>021107</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000601</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045374-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20030501</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0607342A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>81.8</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BOWEL MOVEMENT IRREGULARITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIVERTICULUM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IRRITABLE BOWEL SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LOTRONEX</medicinalproduct>
        <drugauthorizationnumb>021107</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045375-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20030501</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0607344A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL INJURY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LOTRONEX</medicinalproduct>
        <drugauthorizationnumb>021107</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045376-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20030501</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0607345A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FAECALOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL INJURY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LOTRONEX</medicinalproduct>
        <drugauthorizationnumb>021107</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANUSOL HC</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045377-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20030501</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0607346A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL INJURY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LOTRONEX</medicinalproduct>
        <drugauthorizationnumb>021107</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045378-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20030501</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0607347A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL INJURY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LOTRONEX</medicinalproduct>
        <drugauthorizationnumb>021107</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045379-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20030501</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0607348A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL INJURY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LOTRONEX</medicinalproduct>
        <drugauthorizationnumb>021107</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045380-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20030501</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0607349A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL INJURY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LOTRONEX</medicinalproduct>
        <drugauthorizationnumb>021107</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045381-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20030501</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0607350A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL INJURY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
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        <reactionmeddrapt>GASTROINTESTINAL INJURY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LOTRONEX</medicinalproduct>
        <drugauthorizationnumb>021107</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045402-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20030501</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0607370A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL INJURY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LOTRONEX</medicinalproduct>
        <drugauthorizationnumb>021107</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045403-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20030501</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0607371A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL INJURY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LOTRONEX</medicinalproduct>
        <drugauthorizationnumb>021107</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045404-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20030501</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0607372A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL INJURY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LOTRONEX</medicinalproduct>
        <drugauthorizationnumb>021107</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045405-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20030501</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0607374A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL INJURY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LOTRONEX</medicinalproduct>
        <drugauthorizationnumb>021107</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045406-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060619</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ES-MERCK-0606ESP00011</companynumb>
    <primarysource>
      <reportercountry>SPAIN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>80</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ULCER HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SINGULAIR</medicinalproduct>
        <drugauthorizationnumb>20829</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060601</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NONSTEROIDAL ANTI-INFLAMMATORY DRUG (UNSPECIFIED)</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CORTISONE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>LUNG DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045407-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060626</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0606USA04656</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIAC DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HYZAAR</medicinalproduct>
        <drugauthorizationnumb>020387</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPROL-XL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045408-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060630</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0606USA05702</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>48</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>86</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VYTORIN</medicinalproduct>
        <drugauthorizationnumb>021687</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VYTORIN</medicinalproduct>
        <drugauthorizationnumb>021687</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060403</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACIPHEX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BARRETT'S OESOPHAGUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020201</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045409-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060405</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0604USA00824</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>41</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>89</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ARTERIOSCLEROSIS CORONARY ARTERY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL RUPTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VYTORIN</medicinalproduct>
        <drugauthorizationnumb>021687</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERLIPIDAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050817</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060301</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COZAAR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060303</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060301</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOVAN HCT</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050823</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060301</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPROL-XL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051110</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060301</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045411-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060627</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-MERCK-0606USA05694</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>30</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <reaction>
        <reactionmeddrapt>ANTINUCLEAR ANTIBODY INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SINGULAIR</medicinalproduct>
        <drugauthorizationnumb>020829</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050824</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060301</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUTIDE</medicinalproduct>
        <drugadministrationroute>055</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEPTIN</medicinalproduct>
        <drugadministrationroute>055</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNIPHYL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NOSCAPINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050926</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ONON</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050926</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045415-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060627</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-JNJFOC-20060502659</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>60.5</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPLENOMEGALY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugbatchnumb>5RMKA74208</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CROHN'S DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SOLU-CORTEF</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PREMEDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045417-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060321</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-NOVOPROD-251820</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>66</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>95</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PANCREATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugdosagetext>4 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVASTIN</medicinalproduct>
        <drugdosagetext>20 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERLIPIDAEMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZIAC</medicinalproduct>
        <drugdosagetext>5-6.25 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NOVOLOG</medicinalproduct>
        <drugdosagetext>35 U, QD</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRICOR</medicinalproduct>
        <drugdosagetext>145 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTIVERT ^PFIZER^</medicinalproduct>
        <drugdosagetext>14.5 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACTONEL</medicinalproduct>
        <drugdosagetext>25 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENAPRIL ^EXCELL^</medicinalproduct>
        <drugdosagetext>20 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ECOTRIN</medicinalproduct>
        <drugdosagetext>325 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INSULIN DETEMIR FLEXPEN</medicinalproduct>
        <drugauthorizationnumb>021536</drugauthorizationnumb>
        <drugdosagetext>41 U, QD</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>INSULIN-REQUIRING TYPE II DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060110</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060316</drugenddate>
        <drugtreatmentduration>93600</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INSULIN DETEMIR FLEXPEN</medicinalproduct>
        <drugauthorizationnumb>021536</drugauthorizationnumb>
        <drugdosagetext>41 U, QD</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060321</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045418-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IL-NOVOPROD-254500</companynumb>
    <primarysource>
      <reportercountry>ISRAEL</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>67</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NOVOSEVEN</medicinalproduct>
        <drugdosagetext>7.2 MG, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>AORTIC ANEURYSM RUPTURE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060523</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NOVOSEVEN</medicinalproduct>
        <drugdosagetext>7.2 UNK, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060523</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NOVOSEVEN</medicinalproduct>
        <drugdosagetext>7.2 UNK, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060523</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045419-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060627</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHO2006GB10483</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>38</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>97.8</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABSCESS DRAINAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CELLULITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERIANAL ABSCESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TEGASEROD</medicinalproduct>
        <drugauthorizationnumb>21200</drugauthorizationnumb>
        <drugdosagetext>4MG DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>IRRITABLE BOWEL SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19991115</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020314</drugenddate>
        <drugtreatmentduration>851</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045420-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060522</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-NOVOPROD-253568</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>36</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>83</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>POLYNEUROPATHY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVEMIR</medicinalproduct>
        <drugbatchnumb>RW52144</drugbatchnumb>
        <drugauthorizationnumb>21536</drugauthorizationnumb>
        <drugdosagetext>40 IU, QD</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060519</drugenddate>
        <drugtreatmentduration>107</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NOVORAPID FLEXPEN</medicinalproduct>
        <drugbatchnumb>RT60751</drugbatchnumb>
        <drugdosagetext>16 IU, QD</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060127</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060519</drugenddate>
        <drugtreatmentduration>112</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045421-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060626</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-NOVOPROD-254519</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GLUCAGEN</medicinalproduct>
        <drugbatchnumb>SW60023</drugbatchnumb>
        <drugauthorizationnumb>020918</drugauthorizationnumb>
        <drugdosagetext>1 MG, UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045422-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060626</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-NOVOPROD-254596</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>2</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>GLUCAGEN</medicinalproduct>
        <drugbatchnumb>SW60172</drugbatchnumb>
        <drugauthorizationnumb>020918</drugauthorizationnumb>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045423-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060626</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-NOVOPROD-254554</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>75</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BALLISMUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PENFILL 30R CHU</medicinalproduct>
        <drugauthorizationnumb>19991</drugauthorizationnumb>
        <drugdosagetext>36 IU, QD</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>INSULIN-REQUIRING TYPE II DIABETES MELLITUS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040116</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>100 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045424-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060531</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-NOVOPROD-253910</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>22</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>57</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVEMIR</medicinalproduct>
        <drugbatchnumb>RP51345</drugbatchnumb>
        <drugauthorizationnumb>21536</drugauthorizationnumb>
        <drugdosagetext>32 IU, QD</drugdosagetext>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NOVORAPID FLEXPEN</medicinalproduct>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045425-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060626</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-NOVOPROD-254511</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>2</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>CARDIAC ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GLUCAGEN</medicinalproduct>
        <drugbatchnumb>SW60172</drugbatchnumb>
        <drugauthorizationnumb>020918</drugauthorizationnumb>
        <drugdosagetext>1 MG, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>GLUCAGON TOLERANCE TEST</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060626</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060626</drugenddate>
        <drugtreatmentduration>1440</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
        <drugdosagetext>4 IU, UNK</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>DIABETES MELLITUS INSULIN-DEPENDENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050701</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045427-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060315</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-ABBOTT-06P-056-0328389-00</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>37</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ALPHA 1 GLOBULIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACTERIAL SEPSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CANDIDA SEROLOGY POSITIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CREATININE URINE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIABETES MELLITUS INSULIN-DEPENDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERAL PHYSICAL HEALTH DETERIORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC CIRRHOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERGAMMAGLOBULINAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOALBUMINAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOCALCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOCAPNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEUKOCYTOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METABOLIC ACIDOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPHILIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCREATITIS CHRONIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL TUBULAR DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UREA URINE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINE PHOSPHATE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINE URIC ACID DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NORVIR</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>20945</drugauthorizationnumb>
        <drugindication>HIV INFECTION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NORVIR</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020945</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NORVIR</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020945</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060214</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INDINIVIR SULFATE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INDINIVIR SULFATE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051015</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060214</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMIVUDINE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>HIV INFECTION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMIVUDINE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMIVUDINE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050614</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMIVUDINE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TENOFOVIR</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050614</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TENOFOVIR</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060131</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060214</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN</medicinalproduct>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROPRANOLOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DESLORATADINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MIANSERIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FORTIMEL</medicinalproduct>
        <drugindication>NUTRITIONAL SUPPORT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>STAVUDINE</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041001</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045428-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060308</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-06P-163-0327322-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>68.917</patientweight>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>CALCINOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENINGIOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OCUVITE</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>PREDNISONE TAB</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOBUNOLOL HYDROCHLORIDE</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>ALENDRONATE SODIUM</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045429-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060703</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006AP03029</companynumb>
    <primarysource>
      <reportercountry>INDONESIA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>25257</patientonsetage>
      <patientonsetageunit>804</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IRESSA</medicinalproduct>
        <drugauthorizationnumb>021399</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060623</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060630</drugenddate>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PARACETAMOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CANCER PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060615</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CODEINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CANCER PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060615</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CODEINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060615</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CEFOTAXIME</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060620</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACTRAPID HM</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060621</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045430-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060627</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006UW13770</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>53</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ELECTROCARDIOGRAM CHANGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTROPHIC CARDIOMYOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugauthorizationnumb>020639</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LAMICTAL</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045431-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060517</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006AP02290</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>13575</patientonsetage>
      <patientonsetageunit>804</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERVENTILATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOLADEX</medicinalproduct>
        <drugauthorizationnumb>19726</drugauthorizationnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>ENDOMETRIOSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060304</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060401</drugenddate>
        <drugtreatmentduration>29</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045432-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060511</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006SE02686</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>27951</patientonsetage>
      <patientonsetageunit>804</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSED LEVEL OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LARYNGEAL OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARYNGEAL OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOCAL CORD DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BLOPRESS</medicinalproduct>
        <drugauthorizationnumb>20838</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060430</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060501</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BLOPRESS</medicinalproduct>
        <drugauthorizationnumb>020838</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060502</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060502</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045433-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AVENTIS-200615548US</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>81.81</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>APHASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>APRAXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULAR WEAKNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALLEGRA-D - SLOW RELEASE</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>20786</drugauthorizationnumb>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SEASONAL ALLERGY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIRCETTE</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
        <drugindication>CONTRACEPTION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045434-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AVENTIS-200616762GDDC</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>66</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ATRIAL FIBRILLATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE CONGESTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLEURAL EFFUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLEURAL FIBROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY RATE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALLEGRA</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>20786</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CHRONIC SINUSITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CODE UNBROKEN</medicinalproduct>
        <drugdosagetext>DOSE: 2 PUFFS</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050214</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045435-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060127</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AVENTIS-200610952US</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>53</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>65.9</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ALANINE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASPARTATE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BILIARY TRACT DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BILIRUBIN CONJUGATED INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD BILIRUBIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHROMATURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COAGULOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC FIBROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERNATIONAL NORMALISED RATIO INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JAUNDICE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KETEK</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>21144</drugauthorizationnumb>
        <drugindication>SINUSITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060118</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060122</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROTONIX</medicinalproduct>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THIAZIDES</medicinalproduct>
        <drugdosagetext>DOSE: UNJK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREMPRO</medicinalproduct>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NAPROXEN</medicinalproduct>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045436-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060515</receiptdate>
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    <primarysource>
      <reportercountry>ITALY</reportercountry>
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    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <patientonsetage>34</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DERMATITIS</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZARIVIZ</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>50547</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>URINARY TRACT INFECTION</drugindication>
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        <drugstartdate>20060402</drugstartdate>
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        <drugenddate>20060403</drugenddate>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CONTRAMAL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045437-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
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      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>WEGENER'S GRANULOMATOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ATACAND</medicinalproduct>
        <drugauthorizationnumb>20838</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980101</drugstartdate>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIURETICS</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
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  <safetyreport>
    <safetyreportid>5045438-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060515</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-NOVOPROD-253397</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <patientonsetage>14</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>58</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NORDITROPIN</medicinalproduct>
        <drugauthorizationnumb>21148</drugauthorizationnumb>
        <drugdosagetext>1.8 MG, QD</drugdosagetext>
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        <drugindication>BODY HEIGHT BELOW NORMAL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000127</drugstartdate>
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    </patient>
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  <safetyreport>
    <safetyreportid>5045439-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
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    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
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    <primarysource>
      <reportercountry>AUSTRALIA</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>10</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>27</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DISEASE RECURRENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYDROCEPHALUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEDULLOBLASTOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NORDITROPIN</medicinalproduct>
        <drugauthorizationnumb>021148</drugauthorizationnumb>
        <drugdosagetext>.67 MG, QD</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>HYPOPITUITARISM</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050516</drugstartdate>
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        <drugtreatmentduration>373</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THYROXINE</medicinalproduct>
        <drugdosagetext>75 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031028</drugstartdate>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LUCRIN</medicinalproduct>
        <drugdosagetext>7.5 MG EVERY 3 MONTH</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050321</drugstartdate>
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    </patient>
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  <safetyreport>
    <safetyreportid>5045440-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
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    <companynumb>FR-NOVOPROD-254595</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GLUCAGEN</medicinalproduct>
        <drugbatchnumb>SW60172</drugbatchnumb>
        <drugauthorizationnumb>020918</drugauthorizationnumb>
        <drugindication>DIABETES MELLITUS</drugindication>
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    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045443-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
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    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>EC-JNJFOC-20060606177</companynumb>
    <primarysource>
      <reportercountry>ECUADOR</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <patientonsetage>28</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>80</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEAD INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARANOIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERDAL CONSTA</medicinalproduct>
        <drugauthorizationnumb>021346</drugauthorizationnumb>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RISPERIDONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALPROIC ACID</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045444-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
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    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
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    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-JNJFOC-20060606372</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PHARYNGEAL OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWELLING FACE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWOLLEN TONGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ORTHO EVRA</medicinalproduct>
        <drugauthorizationnumb>021180</drugauthorizationnumb>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
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    </patient>
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  <safetyreport>
    <safetyreportid>5045445-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
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    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
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    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20060604086</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>83.92</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ARTHROPOD BITE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ATELECTASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEEP VEIN THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GROIN PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERCOAGULATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMMOBILE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPHADENOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLEURAL EFFUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH PUSTULAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENOUS STENOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISION BLURRED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ORTHO EVRA</medicinalproduct>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>CONTRACEPTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ORTHO EVRA</medicinalproduct>
        <drugauthorizationnumb>021180</drugauthorizationnumb>
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        <drugindication>MENORRHAGIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030601</drugstartdate>
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        <drugenddate>20030801</drugenddate>
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  <safetyreport>
    <safetyreportid>5045447-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
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    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
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    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
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    <companynumb>CA-JNJFOC-20060304082</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLINDNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG ADMINISTRATION ERROR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MACULAR DEGENERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL FIELD DEFECT</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVAQUIN</medicinalproduct>
        <drugauthorizationnumb>20634</drugauthorizationnumb>
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        <drugindication>PNEUMONIA</drugindication>
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        <drugstartdate>20060215</drugstartdate>
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        <drugenddate>20060219</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HEPARIN</medicinalproduct>
        <drugindication>ANTICOAGULANT THERAPY</drugindication>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTROOESOPHAGEAL REFLUX DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
        <drugindication>MUSCULOSKELETAL PAIN</drugindication>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NITROGLYCERIN</medicinalproduct>
        <drugindication>ANGINA PECTORIS</drugindication>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORAZEPAM</medicinalproduct>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SALINE</medicinalproduct>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN E</medicinalproduct>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZINC</medicinalproduct>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LUTEIN</medicinalproduct>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SELENIUM SULFIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMINS B AND C AND B6</medicinalproduct>
      </drug>
    </patient>
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  <safetyreport>
    <safetyreportid>5045448-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
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    <receivedateformat>102</receivedateformat>
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      <reportercountry>UNITED STATES</reportercountry>
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    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
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      <patientonsetage>86</patientonsetage>
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        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
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      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
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        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXJADE</medicinalproduct>
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        <drugindication>BLOOD IRON INCREASED</drugindication>
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    <safetyreportid>5045449-1</safetyreportid>
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    <receivedateformat>102</receivedateformat>
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      <reportercountry>UNITED STATES</reportercountry>
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    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
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      <reaction>
        <reactionmeddrapt>BLOOD POTASSIUM INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARKINSON'S DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN ULCER</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>TARDIVE DYSKINESIA</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZARIL</medicinalproduct>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SERENTIL</medicinalproduct>
        <drugdosagetext>UNK, UNK</drugdosagetext>
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  <safetyreport>
    <safetyreportid>5045450-8</safetyreportid>
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      <reportercountry>UNITED STATES</reportercountry>
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    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <patientonsetage>66</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHRONIC LYMPHOCYTIC LEUKAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GALLBLADDER OPERATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXJADE</medicinalproduct>
        <drugauthorizationnumb>021882</drugauthorizationnumb>
        <drugdosagetext>1250 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD IRON INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060323</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045451-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060705</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2006US08623</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>COMPLETED SUICIDE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL OVERDOSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRILEPTAL</medicinalproduct>
        <drugauthorizationnumb>021014</drugauthorizationnumb>
        <drugdosagetext>300 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045452-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHFR2006GB02106</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>56</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL DISTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ALANINE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASPARTATE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD BROMIDE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CREATINE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CREATINE PHOSPHOKINASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD POTASSIUM DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD SODIUM DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD UREA INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>C-REACTIVE PROTEIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAMMA-GLUTAMYLTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER FUNCTION TEST ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
        <drugdosagetext>50 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051103</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENDROFLUAZIDE</medicinalproduct>
        <drugdosagetext>2.5 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051103</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENALAPRIL</medicinalproduct>
        <drugdosagetext>20 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051103</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DIABETES MELLITUS NON-INSULIN-DEPENDENT</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051103</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugdosagetext>20MG/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTROINTESTINAL DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051102</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051103</drugenddate>
        <drugtreatmentduration>2880</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DICLOFENAC</medicinalproduct>
        <drugauthorizationnumb>019201</drugauthorizationnumb>
        <drugdosagetext>50 MG, TID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GOUT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051103</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051103</drugenddate>
        <drugtreatmentduration>1440</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045453-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060626</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-NOVOPROD-254609</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>HEPATIC ENZYME INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NOVORAPID 30 MIX CHU FLEXPEN</medicinalproduct>
        <drugauthorizationnumb>21172</drugauthorizationnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>DIABETES MELLITUS INSULIN-DEPENDENT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NOVORAPID CHU FLEXPEN</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>DIABETES MELLITUS INSULIN-DEPENDENT</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045456-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060630</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2006BE10000</companynumb>
    <primarysource>
      <reportercountry>BELGIUM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>61</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABSCESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE LESION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugauthorizationnumb>021223</drugauthorizationnumb>
        <drugdosagetext>UNK, UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CHEMOTHERAPEUTICS,OTHER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CORTICOSTEROID NOS</medicinalproduct>
        <drugdosagetext>SHORT-TERM</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045457-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2006IT09882</companynumb>
    <primarysource>
      <reportercountry>ITALY</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>65</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WOUND DEBRIDEMENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugauthorizationnumb>021223</drugauthorizationnumb>
        <drugdosagetext>4 MG, WEEKLY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040202</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060202</drugenddate>
        <drugtreatmentduration>732</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045458-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060627</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2006NO09618</companynumb>
    <primarysource>
      <reportercountry>NORWAY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugauthorizationnumb>021223</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045459-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060627</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2006US08352</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>70</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DEAFNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POOR PERIPHERAL CIRCULATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugauthorizationnumb>021223</drugauthorizationnumb>
        <drugdosagetext>4MG Q3WKS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PROSTATE CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060425</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LUPRON</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORTAB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMITRIPTYLINE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CASODEX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PAPAVERIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATIVAN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045460-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHRM2006FR01978</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugauthorizationnumb>021223</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045461-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060627</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20060605936</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>50.4</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABORTION SPONTANEOUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugindication>CROHN'S DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ULTRAM</medicinalproduct>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMODIUM</medicinalproduct>
        <drugindication>DIARRHOEA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045462-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20060606192</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>94.35</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHILLS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFUSION RELATED REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OXYGEN SATURATION DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugdosagetext>^500 MG 2 DOSES^</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PSORIASIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE TAB</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PSORIASIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045467-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050601</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-AVENTIS-200511643JP</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>32</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>57</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DIABETIC RETINOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RETINAL ANEURYSM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RETINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VITREOUS HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
        <drugauthorizationnumb>021081</drugauthorizationnumb>
        <drugdosagetext>DOSE UNIT: UNITS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>DIABETES MELLITUS INSULIN-DEPENDENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040120</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OPTIPEN (INSULIN PUMP)</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040120</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HUMALOG</medicinalproduct>
        <drugdosagetext>DOSE UNIT: UNITS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>DIABETES MELLITUS INSULIN-DEPENDENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20011020</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045468-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060630</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IE-AVENTIS-200616904GDDC</companynumb>
    <primarysource>
      <reportercountry>IRELAND</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANIMAL SCRATCH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CELLULITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021081</drugauthorizationnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060424</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045469-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20051003</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200512816JP</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>43</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>61</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIABETIC RETINOPATHY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
        <drugauthorizationnumb>021081</drugauthorizationnumb>
        <drugdosagetext>DOSE UNIT: UNITS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>DIABETES MELLITUS INSULIN-DEPENDENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040227</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050624</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OPTIPEN (INSULIN PUMP)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NOVORAPID</medicinalproduct>
        <drugdosagetext>DOSE: 9 TO 11; DOSE UNIT: UNITS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>DIABETES MELLITUS INSULIN-DEPENDENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19991130</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TANATRIL</medicinalproduct>
        <drugdosagetext>DOSE: 1 TABLET</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETIC NEPHROPATHY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020809</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYANOCOBALAMIN</medicinalproduct>
        <drugdosagetext>DOSE: 3 TABLETS</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NERVE INJURY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19981211</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045470-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20051003</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200512823JP</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>30</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>56</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIABETIC RETINOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VITREOUS HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
        <drugauthorizationnumb>021081</drugauthorizationnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>DIABETES MELLITUS INSULIN-DEPENDENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040122</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OPTIPEN (INSULIN PUMP)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HUMALOG</medicinalproduct>
        <drugdosagetext>DOSE: 22-24 UNITS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>DIABETES MELLITUS INSULIN-DEPENDENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20011204</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045471-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20051003</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200512825JP</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>55</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DIABETIC RETINOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RETINAL ANEURYSM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RETINAL EXUDATES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RETINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
        <drugauthorizationnumb>021081</drugauthorizationnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>DIABETES MELLITUS INSULIN-DEPENDENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040120</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OPTIPEN (INSULIN PUMP)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NOVORAPID</medicinalproduct>
        <drugdosagetext>DOSE: 19-22 UNITS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>DIABETES MELLITUS INSULIN-DEPENDENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030610</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACECOL</medicinalproduct>
        <drugdosagetext>DOSE: 2 TABLETS</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030305</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
        <drugdosagetext>DOSE: 2 TABLETS</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031104</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045472-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20051116</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-AVENTIS-200513535JP</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>1</patientonsetage>
      <patientonsetageunit>805</patientonsetageunit>
      <patientweight>3.3</patientweight>
      <reaction>
        <reactionmeddrapt>CAESAREAN SECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOGLYCAEMIA NEONATAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
        <drugauthorizationnumb>021081</drugauthorizationnumb>
        <drugadministrationroute>058</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN LISPRO</medicinalproduct>
        <drugdosagetext>DOSE: 8-3-4; DOSE UNIT: UNITS</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NPH INSULIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045479-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060627</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHRM2006FR01906</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>35</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HEPATITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRASICOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045489-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060406</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-NOVOPROD-252279</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>36</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>73</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DIABETIC KETOACIDOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STILLBIRTH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVEMIR</medicinalproduct>
        <drugauthorizationnumb>021536</drugauthorizationnumb>
        <drugdosagetext>14 IU, QD</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>DIABETES MELLITUS INSULIN-DEPENDENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050728</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NOVORAPID PENFILL</medicinalproduct>
        <drugdosagetext>36 IU, QD</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>DIABETES MELLITUS INSULIN-DEPENDENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051115</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045490-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060221</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0594593A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>72</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HALLUCINATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVERDOSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>5K28</drugbatchnumb>
        <drugauthorizationnumb>21330</drugauthorizationnumb>
        <drugdosagetext>4MG SEE DOSAGE TEXT</drugdosagetext>
        <drugadministrationroute>002</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060220</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NICODERM CQ</medicinalproduct>
        <drugbatchnumb>0530612</drugbatchnumb>
        <drugauthorizationnumb>020165</drugauthorizationnumb>
        <drugdosagetext>21MG UNKNOWN</drugdosagetext>
        <drugadministrationroute>062</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060214</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLINDAMYCIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PHENYTOIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DILAUDID</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045498-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-JNJFOC-20060606736</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>20</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HODGKIN'S DISEASE NODULAR SCLEROSIS STAGE III</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NO THERAPEUTIC RESPONSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERDAL</medicinalproduct>
        <drugauthorizationnumb>020272</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OLANZAPINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045500-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060627</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-JNJFOC-20060700358</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>85</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRADYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSED LEVEL OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERDAL</medicinalproduct>
        <drugauthorizationnumb>020272</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>QUETIAPINE FUMARATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENALAPRIL MALEATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGNESIUM OXIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045501-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060526</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2006ES08091</companynumb>
    <primarysource>
      <reportercountry>SPAIN</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>26</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLINDNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DROWNING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSKINESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EXTRAPYRAMIDAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HALLUCINATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE RIGIDITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL ACUITY REDUCED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOGMATYL</medicinalproduct>
        <drugindication>MOTION SICKNESS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060518</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PARACETAMOL</medicinalproduct>
        <drugdosagetext>UNK, UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060518</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060520</drugenddate>
        <drugtreatmentduration>4320</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALPRAZOLAM</medicinalproduct>
        <drugdosagetext>1 DF, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060518</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060520</drugenddate>
        <drugtreatmentduration>4320</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TORECAN</medicinalproduct>
        <drugauthorizationnumb>012753</drugauthorizationnumb>
        <drugdosagetext>1 DF, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>VERTIGO</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060518</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060520</drugenddate>
        <drugtreatmentduration>4320</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TORECAN</medicinalproduct>
        <drugauthorizationnumb>012753</drugauthorizationnumb>
        <drugdosagetext>2 DF/D</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060519</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060519</drugenddate>
        <drugtreatmentduration>1440</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TORECAN</medicinalproduct>
        <drugauthorizationnumb>012753</drugauthorizationnumb>
        <drugdosagetext>1 DF, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060520</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060520</drugenddate>
        <drugtreatmentduration>1440</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045502-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040728</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHNU2004DE02665</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>65</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ACTINOMYCOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE DEBRIDEMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DENTAL OPERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FISTULA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FISTULA REPAIR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMPAIRED HEALING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTUBATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JAW DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOMYELITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOSYNTHESIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLASTIC SURGERY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEQUESTRECTOMY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WOUND DEBRIDEMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>X-RAY DENTAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AREDIA</medicinalproduct>
        <drugdosagetext>30 MG, QMO</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PLASMACYTOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
        <drugtreatmentduration>1825</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugauthorizationnumb>021223</drugauthorizationnumb>
        <drugdosagetext>4 MG, QMO</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045508-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>BR-JNJFOC-20060604793</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>82</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>59</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLATULENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NASAL DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMOSEC</medicinalproduct>
        <drugbatchnumb>J01079</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>FAECAL INCONTINENCE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMOSEC</medicinalproduct>
        <drugbatchnumb>J01079</drugbatchnumb>
        <drugauthorizationnumb>017694</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS OF NAUSEA AND VOMITING</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CHEMOTHERAPY</medicinalproduct>
        <drugindication>COLON CANCER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HOMEOPATHIC FORMULATON</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIARRHOEA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045513-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060614</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006GB01018</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CANDESARTAN</medicinalproduct>
        <drugauthorizationnumb>20838</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CARDIAC FAILURE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060425</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMIODARONE HCL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OEDEMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060424</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DYSPNOEA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060424</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045520-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060626</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-KINGPHARMUSA00001-K200600830</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>55</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DYSPHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROAT TIGHTNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALTACE</medicinalproduct>
        <drugauthorizationnumb>019901</drugauthorizationnumb>
        <drugdosagetext>5 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050209</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CIALIS ^GLAXOSMITHKLINE^</medicinalproduct>
        <drugdosagetext>20 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RIVOTRIL</medicinalproduct>
        <drugdosagetext>4 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CITALOPRAM</medicinalproduct>
        <drugdosagetext>80 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORAZEPAM</medicinalproduct>
        <drugdosagetext>1 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045530-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006AP03007</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>58</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>61</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BREAST CANCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OBLITERATIVE BRONCHIOLITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARIMIDEX</medicinalproduct>
        <drugauthorizationnumb>20541</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040810</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LOCHOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERCHOLESTEROLAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20011009</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040216</drugenddate>
        <drugtreatmentduration>20640</drugtreatmentduration>
        <drugtreatmentdurationunit>805</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LOCHOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040217</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RADIATION</medicinalproduct>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040212</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THYRADIN S</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GASTER</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045539-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041215</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ROCHE-389475</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>64</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEG-INTERFERON A-2A (RO 25-8310)</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040920</drugenddate>
        <drugtreatmentduration>204</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RIBAVIRIN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020312</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040826</drugenddate>
        <drugtreatmentduration>899</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045554-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050204</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-394804</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>26</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>81.6</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAL FISSURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLITIS ULCERATIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPEPSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLATULENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATOCHEZIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ILEUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMPINGEMENT SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLAMMATORY BOWEL DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IRRITABLE BOWEL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTI-ORGAN DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POST PROCEDURAL COMPLICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROCTALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS ANI</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSORIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RECTAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUS TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>18662</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ACNE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19860615</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19950615</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045556-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050825</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-ROCHE-415829</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>3</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CAESAREAN SECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NO ADVERSE EFFECT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NORMAL NEWBORN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PREGNANCY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ROACUTAN</medicinalproduct>
        <drugauthorizationnumb>18662</drugauthorizationnumb>
        <drugindication>ACNE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050615</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050715</drugenddate>
        <drugtreatmentduration>17</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045557-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050630</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CZ-ROCHE-409687</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>59</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASPARTATE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DERMATITIS EXFOLIATIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN EXFOLIATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STOMATITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CAPECITABINE</medicinalproduct>
        <drugauthorizationnumb>20896</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050516</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050522</drugenddate>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IXABEPILONE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050516</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050516</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045558-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050406</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-401297</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ACNE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD ALBUMIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD ALKALINE PHOSPHATASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD BILIRUBIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CALCIUM INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD THYROID STIMULATING HORMONE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CALCULUS BLADDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLITIS ULCERATIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA HAEMORRHAGIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISEASE RECURRENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRY EYE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRY SKIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATOCHEZIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLAMMATORY BOWEL DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTI-ORGAN DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE STRAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NECK INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NECK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHLEBITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RECTAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RED BLOOD CELL SEDIMENTATION RATE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ROAD TRAFFIC ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTH FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>18662</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19950518</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>018662</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19950615</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>018662</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19951215</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045559-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040818</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-378079</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>34</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>88.5</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHROPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLEPHARITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLEPHAROSPASM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CHOLESTEROL INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CANDIDIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHRONIC FATIGUE SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLITIS ULCERATIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CYSTITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE BEFORE PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ELECTROCARDIOGRAM T WAVE ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FIBROCYSTIC BREAST DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FOOD INTOLERANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FUNGAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLAMMATORY BOWEL DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METAL POISONING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OESOPHAGITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVARIAN CYST RUPTURED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POSTNASAL DRIP</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RECTAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SCLERODERMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUS TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TWIN PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VULVOVAGINAL MYCOTIC INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>18662</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ACNE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19930515</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19930615</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045560-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-385211</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>20</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>98</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANGIOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANHEDONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRONCHITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CELLULITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLITIS ULCERATIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISTURBANCE IN ATTENTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG ABUSER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHOIDS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLAMMATORY BOWEL DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTI-ORGAN DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NECK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POST PROCEDURAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROCTITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RECTAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHINITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEMEN ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEMEN VOLUME ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPERM COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TESTICULAR PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TONSILLITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VARICOCELE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VASODILATATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>18662</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ACNE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19971110</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19980615</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>018662</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980123</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045561-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060630</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-BRISTOL-MYERS SQUIBB COMPANY-13429568</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>80</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHEEZING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PARAPLATIN</medicinalproduct>
        <drugauthorizationnumb>019880</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>OVARIAN CANCER</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060517</drugenddate>
        <drugtreatmentduration>10</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAXOL</medicinalproduct>
        <drugauthorizationnumb>020262</drugauthorizationnumb>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060517</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FAMOTIDINE</medicinalproduct>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060517</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE SODIUM PHOSPHATE</medicinalproduct>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060517</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GRANISETRON HCL</medicinalproduct>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060517</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045562-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050928</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-419570</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>21</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>101.2</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLITIS ULCERATIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOKALAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLAMMATORY BOWEL DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROCTITIS ULCERATIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>18662</drugauthorizationnumb>
        <drugdosagetext>ADMINISTERED IN THE EVENINGS.</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ACNE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19960312</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19960815</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ERYTHROMYCIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ACNE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19960507</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19960703</drugenddate>
        <drugtreatmentduration>58</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045564-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060626</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-453305</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>51</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>69.4</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CLOSTRIDIAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XELODA</medicinalproduct>
        <drugauthorizationnumb>20896</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060626</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXALIPLATIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060626</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FENTANYL</medicinalproduct>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COLACE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060602</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060612</drugenddate>
        <drugtreatmentduration>11</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IRON</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060602</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060612</drugenddate>
        <drugtreatmentduration>11</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLAGYL</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060602</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060612</drugenddate>
        <drugtreatmentduration>11</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045565-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050121</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-393367</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>17</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>83.9</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLITIS ULCERATIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EPISCLERITIS</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>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RECTAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RED BLOOD CELL SEDIMENTATION RATE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN LESION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UVEITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>18662</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ACNE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19910125</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19910517</drugenddate>
        <drugtreatmentduration>113</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>018662</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19920124</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19920326</drugenddate>
        <drugtreatmentduration>63</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045566-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060113</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-432380</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>27</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>68</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANGINA PECTORIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>APPENDICECTOMY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHOLECYSTITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHOLELITHIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLITIS ULCERATIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FIBROUS HISTIOCYTOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROOESOPHAGEAL REFLUX DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC ENZYME INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLAMMATORY BOWEL DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IRRITABLE BOWEL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIP DRY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MELANOCYTIC NAEVUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCREATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POST-TRAUMATIC PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN HYPOPIGMENTATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>18662</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010123</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010410</drugenddate>
        <drugtreatmentduration>78</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>018662</drugauthorizationnumb>
        <drugdosagetext>40 MG A.M. AND 20 MG P.M</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000915</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010122</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045573-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060619</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-GILEAD-2006-0009757</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>69</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DIABETES MELLITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPSERA</medicinalproduct>
        <drugauthorizationnumb>21449</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS B</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040219</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040617</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPSERA</medicinalproduct>
        <drugauthorizationnumb>021449</drugauthorizationnumb>
        <drugindication>HEPATIC CIRRHOSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZEFFIX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATIC CIRRHOSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040617</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZEFFIX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010904</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040318</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LACTIC-ACID-PRODUCING ORGANISMS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>URSO</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLAKAY</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZYRTEC</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045574-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060405</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-443601</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>15</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>81.6</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>AMOEBIC DYSENTERY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLITIS ULCERATIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRY SKIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ECONOMIC PROBLEM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EMOTIONAL DISTRESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLAMMATORY BOWEL DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STRESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>018662</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19960227</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19960718</drugenddate>
        <drugtreatmentduration>143</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045575-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060510</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PT-ROCHE-447778</companynumb>
    <primarysource>
      <reportercountry>PORTUGAL</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>65</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>50</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>LARYNGEAL OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUCOSAL INFLAMMATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALMAR-PLANTAR ERYTHRODYSAESTHESIA SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY DISTRESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XELODA</medicinalproduct>
        <drugauthorizationnumb>20896</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>COLON CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060412</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060429</drugenddate>
        <drugtreatmentduration>18</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045576-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060523</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ROCHE-449564</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>68</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEMENTIA ALZHEIMER'S TYPE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERIODONTITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STOMATITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEGASYS</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060223</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060518</drugenddate>
        <drugtreatmentduration>85</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUTATHIONE</medicinalproduct>
        <drugdosagetext>1-2 DROPS, 3-5 TIMES A DAY DRUG REPORTED AS NEUTHIONE (GLUTATHIONE)</drugdosagetext>
        <drugadministrationroute>031</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYALURONATE SODIUM</medicinalproduct>
        <drugdosagetext>DRUG REPORTED AS EYECARE (HYALURONATE SODIUM) TAKE 1 DROP, 5-6 TIMES A DAY</drugdosagetext>
        <drugadministrationroute>031</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADESTAN</medicinalproduct>
        <drugdosagetext>DOSAGE ADJUSTED</drugdosagetext>
        <drugadministrationroute>061</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE TAB</medicinalproduct>
        <drugdosagetext>DOSAGE ADJUSTED REPORTED AS EURASON</drugdosagetext>
        <drugadministrationroute>049</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060213</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045577-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050809</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CN-GILEAD-2005-0008613</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>HEPATIC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER TRANSPLANT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTI-ORGAN FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OLIGURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POST PROCEDURAL COMPLICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROTHROMBIN TIME PROLONGED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ADEFOVIR DIPIVOXIL</medicinalproduct>
        <drugauthorizationnumb>21449</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS B</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030113</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050729</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045579-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060614</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ROCHE-451940</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>74</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ALANINE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASPARTATE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD BILIRUBIN ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD LACTATE DEHYDROGENASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PANALDINE</medicinalproduct>
        <drugauthorizationnumb>19979</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>THROMBOSIS PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060511</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060522</drugenddate>
        <drugtreatmentduration>12</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GASTER</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>STOMACH DISCOMFORT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060512</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060524</drugenddate>
        <drugtreatmentduration>13</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NITOROL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANGINA PECTORIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060510</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060525</drugenddate>
        <drugtreatmentduration>16</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BUFFERIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANGINA PECTORIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060410</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045580-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ROCHE-453330</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>68</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>INTERSTITIAL LUNG DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STOMACH DISCOMFORT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HORIZON</medicinalproduct>
        <drugauthorizationnumb>13263</drugauthorizationnumb>
        <drugdosagetext>TAKEN WHEN NEEDED</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INSOMNIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010615</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060620</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERLIPIDAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060315</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060615</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEPRICOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARRHYTHMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010615</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060615</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045581-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060509</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-447626</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>1.9</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PREMATURE LABOUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TORTICOLLIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COPEGUS</medicinalproduct>
        <drugauthorizationnumb>21511</drugauthorizationnumb>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040515</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041112</drugenddate>
        <drugtreatmentduration>182</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEG-INTERFERON ALFA NOS</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040515</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041112</drugenddate>
        <drugtreatmentduration>182</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HUMALOG</medicinalproduct>
        <drugdosagetext>1 DOSE IN THE MORNING, 1 DOSE IN THE EVENING.</drugdosagetext>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HUMULIN</medicinalproduct>
        <drugdosagetext>REPORTED AS HUMILIN.</drugdosagetext>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19890615</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN</medicinalproduct>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19890615</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRENATAL VITAMINS</medicinalproduct>
        <drugindication>PREGNANCY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041216</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045582-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060605</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-ROCHE-450511</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>52</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>50</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEPHROTIC SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CAPECITABINE</medicinalproduct>
        <drugauthorizationnumb>20896</drugauthorizationnumb>
        <drugdosagetext>GIVEN ON DAYS 1-14 OF 21 DAY CYCLE.</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050727</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVASTIN</medicinalproduct>
        <drugauthorizationnumb>020896</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050727</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MITOMYCIN</medicinalproduct>
        <drugauthorizationnumb>020896</drugauthorizationnumb>
        <drugdosagetext>4 DOSES GIVEN AS PER PROTOCOL. REPORTED THAT THE DOSE WAS REDUCED DUE TO THROMBOCYTOPENIA.</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050727</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN W/ CODEINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060601</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045583-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060527</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-449866</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>53</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>90.7</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ELECTROLYTE IMBALANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEGASYS</medicinalproduct>
        <drugbatchnumb>B0091</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060519</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060526</drugenddate>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEGASYS</medicinalproduct>
        <drugbatchnumb>B0091</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060616</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060623</drugenddate>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RIBAVIRIN</medicinalproduct>
        <drugauthorizationnumb>021511</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060519</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060526</drugenddate>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RIBAVIRIN</medicinalproduct>
        <drugauthorizationnumb>021511</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060616</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045584-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060113</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-432379</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>24</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>56.7</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CROHN'S DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DERMATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EMOTIONAL DISTRESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEMALE GENITAL TRACT FISTULA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHOIDS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC ENZYME INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLAMMATORY BOWEL DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLUENZA LIKE ILLNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IRRITABILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOOD ALTERED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>018662</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ACNE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980515</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19980806</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>018662</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980806</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19981015</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OVCON-35</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045585-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060626</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FI-ROCHE-452908</companynumb>
    <primarysource>
      <reportercountry>FINLAND</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>37</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANOREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BODY TEMPERATURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ILL-DEFINED DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LETHARGY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CAPECITABINE</medicinalproduct>
        <drugauthorizationnumb>20896</drugauthorizationnumb>
        <drugdosagetext>GIVEN TWICE DAILY DAYS 1-15 OF EACH 3-WEEK CYCLE. FIRST DOSE ADMINISTERED EVENING OF DAY 1 AND THE +</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060508</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOCETAXEL</medicinalproduct>
        <drugdosagetext>GIVEN ON DAY 1 OF THREE WEEK CYCLE AS PER PROTOCOL.</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060508</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KYTRIL</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXAMETASON</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045591-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060609</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-451854</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>49</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEMORY IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THYROID DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISION BLURRED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEGASYS</medicinalproduct>
        <drugdosagetext>DOSAGE ROUTE REPORTED AS INJECTABLE</drugdosagetext>
        <drugadministrationroute>050</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060615</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060615</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RIBAVIRIN</medicinalproduct>
        <drugauthorizationnumb>021511</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060615</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060615</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LITHIUM CARBONATE</medicinalproduct>
        <drugindication>BIPOLAR DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNSPECIFIED DRUG</medicinalproduct>
        <drugdosagetext>THE PATIENT STATED HE TOOK 11 OTHER DRUGS CONCOMITANTLY.</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045592-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060407</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-ROCHE-443808</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>41</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>85</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD CHOLESTEROL DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG WITHDRAWAL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RIVOTRIL</medicinalproduct>
        <drugauthorizationnumb>17533</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990615</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RIVOTRIL</medicinalproduct>
        <drugauthorizationnumb>017533</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FENERGAN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060615</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060615</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045593-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060626</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-453269</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>44</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>DRUG TOXICITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VALIUM</medicinalproduct>
        <drugauthorizationnumb>013263</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>ANXIETY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHADOSE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BACK PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050615</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045594-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-453604</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>SKIN DISCOLOURATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XELODA</medicinalproduct>
        <drugauthorizationnumb>020896</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045595-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060630</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-453813</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>47</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BONIVA</medicinalproduct>
        <drugauthorizationnumb>021455</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045596-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-453663</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>44</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PITUITARY TUMOUR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEGASYS</medicinalproduct>
        <drugdosagetext>ROUTE REPORTED AS INJECTABLE.</drugdosagetext>
        <drugadministrationroute>050</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060505</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060630</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RIBAVIRIN</medicinalproduct>
        <drugauthorizationnumb>021511</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060505</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060630</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045597-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060627</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-453437</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>34</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABORTION SPONTANEOUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PREGNANCY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COPEGUS</medicinalproduct>
        <drugauthorizationnumb>021511</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050315</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060415</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEGASYS</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050315</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060415</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045598-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-ROCHE-453609</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>70</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HYPERCALCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ROCALTROL</medicinalproduct>
        <drugauthorizationnumb>018044</drugauthorizationnumb>
        <drugdosagetext>LONG TERM TREATMENT PRIOR TO FEBRUARY 2006.</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ROCALTROL</medicinalproduct>
        <drugauthorizationnumb>018044</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060215</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MYFORTIC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEORAL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RENAGEL</medicinalproduct>
        <drugdosagetext>TAKEN IN THE MORNING</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPEGIC 1000</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FERROGRAD</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASILIX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MOPRAL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DILTIAZEM HCL</medicinalproduct>
        <drugdosagetext>DRUG REPORTED AS ^MONO-TILDIEM LP 300^</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045599-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-453682</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>56</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE CONGESTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FULL BLOOD COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY OEDEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEGASYS</medicinalproduct>
        <drugdosagetext>ROUTE REPORTED AS INJECTABLE AND SUBCUTANEOUS.</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060413</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060515</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RIBAVIRIN</medicinalproduct>
        <drugauthorizationnumb>021511</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060413</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060515</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045600-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060626</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-ROCHE-453595</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>3</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>15</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CHOLELITHIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCREATITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ROCEPHIN</medicinalproduct>
        <drugauthorizationnumb>50585</drugauthorizationnumb>
        <drugdosagetext>FORM REPORTED AS INJECTABLE SOLUTION.</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060519</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060524</drugenddate>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MEDIALIPIDE</medicinalproduct>
        <drugdosagetext>FORM REPORTED AS INJECTABLE SOLUTION.</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PARENTERAL NUTRITION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060423</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRIMENE</medicinalproduct>
        <drugindication>PARENTERAL NUTRITION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNSPECIFIED DRUG</medicinalproduct>
        <drugdosagetext>DRUG REPORTED AS HPV (VITAMINE).</drugdosagetext>
        <drugindication>PARENTERAL NUTRITION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NONAN</medicinalproduct>
        <drugdosagetext>GENERIC REPORTED AS OLIGO-ELEMENTS.</drugdosagetext>
        <drugindication>PARENTERAL NUTRITION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAG 2</medicinalproduct>
        <drugindication>PARENTERAL NUTRITION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PHOCYTAN</medicinalproduct>
        <drugindication>PARENTERAL NUTRITION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM GLUCONATE</medicinalproduct>
        <drugindication>PARENTERAL NUTRITION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RANIPLEX</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060415</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MOPRAL</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060415</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045603-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-453669</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>79</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BONIVA</medicinalproduct>
        <drugauthorizationnumb>021455</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051115</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060515</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045604-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ZA-ROCHE-453564</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>77</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UPPER RESPIRATORY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INTERFERON ALFA-2A</medicinalproduct>
        <drugdosagetext>UNIT = MU</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>NON-HODGKIN'S LYMPHOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030812</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RITUXIMAB</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NON-HODGKIN'S LYMPHOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030812</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LACTULOSE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030812</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PARACETAMOL</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030312</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030731</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045605-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060630</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-ROCHE-453799</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>26</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NO ADVERSE EFFECT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SELF-MEDICATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>018662</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>ACNE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>018662</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CONTRACEPTIVE NOS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045606-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-453681</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>39</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL DISTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ALOPECIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAIR TEXTURE ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEGASYS</medicinalproduct>
        <drugdosagetext>ROUTE REPORTED AS INJ. FORM REPORTED AS SHOT.</drugdosagetext>
        <drugadministrationroute>050</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060311</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COPEGUS</medicinalproduct>
        <drugauthorizationnumb>021511</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060311</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
        <drugindication>THYROID DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOPID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EFFEXOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VICODIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045607-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060627</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-453506</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>27</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DECOMPRESSION SICKNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>018662</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045608-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060627</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-ROCHE-453419</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>45</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BONE MARROW FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>APRANAX</medicinalproduct>
        <drugauthorizationnumb>18164</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEGASYS</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060618</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COPEGUS</medicinalproduct>
        <drugauthorizationnumb>021511</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060618</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045609-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060627</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-453495</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>43</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BREAST CYST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GINGIVAL SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATOCHEZIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENTAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWOLLEN TONGUE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEGASYS</medicinalproduct>
        <drugdosagetext>ROUTE REPORTED AS INJECTABLE.</drugdosagetext>
        <drugadministrationroute>050</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050915</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COPEGUS</medicinalproduct>
        <drugauthorizationnumb>021511</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050915</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REMERON</medicinalproduct>
        <drugindication>ANTIDEPRESSANT THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
        <drugindication>ANTIDEPRESSANT THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAZODONE HCL</medicinalproduct>
        <drugindication>ANTIDEPRESSANT THERAPY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045610-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ROCHE-453545</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>62</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>GRANULOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PANALDINE</medicinalproduct>
        <drugauthorizationnumb>19979</drugauthorizationnumb>
        <drugdosagetext>ADDITIONAL INDICATION: STENT PLACEMENT, ACUTE MYOCARDIAL INFARCTION</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>THROMBOSIS PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060513</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060609</drugenddate>
        <drugtreatmentduration>28</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GASTER</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045612-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060630</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-ROCHE-453892</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>88</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>52</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOVEMENT DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BONIVA</medicinalproduct>
        <drugauthorizationnumb>021455</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060515</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060515</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENALAPRIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INDAPAMIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045613-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-JNJFOC-20060700395</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>16</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DYSTONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HALDOL</medicinalproduct>
        <drugauthorizationnumb>015923</drugauthorizationnumb>
        <drugdosagetext>2 TABLETS OF AN UNSPECIFIED DOSE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INTENTIONAL DRUG MISUSE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045614-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060517</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ABBOTT-06P-087-0333434-00</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>10</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHROMATURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATOCHEZIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOLYTIC ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OCULAR ICTERUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALLOR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CEFZON</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>50739</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>UPPER RESPIRATORY TRACT INFLAMMATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060507</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060510</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CEFZON</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>050739</drugauthorizationnumb>
        <drugindication>PYREXIA</drugindication>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ANHIBA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>054</drugadministrationroute>
        <drugindication>UPPER RESPIRATORY TRACT INFLAMMATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060501</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ANHIBA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>054</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060502</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060508</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZITHROMAX</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>UPPER RESPIRATORY TRACT INFLAMMATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060502</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060504</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETYLCYSTEINE</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TIPEPIDINE HIBENZATE</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEQUITAZINE</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>STREPTOCOCCUS FAECALIS</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TULOBUTEROL HYDROCHLORIDE</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>STREPTOCOCCUS FAECALIS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045615-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060327</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ABBOTT-06P-087-0329098-00</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>75</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANAPHYLACTIC SHOCK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEVOFRANE LIQUID FOR INHALATION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>20478</drugauthorizationnumb>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>INDUCTION OF ANAESTHESIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060221</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060221</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEVOFRANE LIQUID FOR INHALATION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020478</drugauthorizationnumb>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>GENERAL ANAESTHESIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060307</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060307</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROPOFOL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>INDUCTION OF ANAESTHESIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060307</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060307</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROPOFOL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>MAINTENANCE OF ANAESTHESIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060307</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060307</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUXAMETHONIUM CHLORIDE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>INDUCTION OF ANAESTHESIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060221</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060221</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUXAMETHONIUM CHLORIDE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060307</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060307</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NITROUS OXIDE W/ OXYGEN</medicinalproduct>
        <drugindication>INDUCTION OF ANAESTHESIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060221</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060221</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NITROUS OXIDE W/ OXYGEN</medicinalproduct>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>MAINTENANCE OF ANAESTHESIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060307</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060307</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATROPINE SULFATE</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>ANAESTHETIC PREMEDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060307</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060307</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THALAMONAL</medicinalproduct>
        <drugindication>INDUCTION OF ANAESTHESIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060221</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060221</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THIAMYLAL SODIUM</medicinalproduct>
        <drugindication>INDUCTION OF ANAESTHESIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060221</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060221</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045616-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ZA-ABBOTT-06P-143-0337223-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>11</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD BILIRUBIN UNCONJUGATED INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ELECTROCARDIOGRAM QT CORRECTED INTERVAL PROLONGED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERBILIRUBINAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RITONAVIR SOFT GELATIN CAPSULES</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>20945</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060503</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060515</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RITONAVIR SOFT GELATIN CAPSULES</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020945</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060522</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATAZANAVIR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060503</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060515</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATAZANAVIR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060522</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>STAVUDINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060503</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060515</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>STAVUDINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060522</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BACTRIM</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTIVITAMIN</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LAMIVUDINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060503</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060515</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LAMIVUDINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060522</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045617-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-ABBOTT-06P-062-0337180-00</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>64</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>THYROID OPERATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060316</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060420</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060516</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060420</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060516</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NSAR</medicinalproduct>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOCORTICOIDS</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060615</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045618-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-ABBOTT-06P-062-0337184-00</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>63</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PULMONARY HYPERTENSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REDUCTIL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>20632</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TORSEMIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AQUAPHOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIGIMERCK PICO</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CANDESARTAN CILEXETIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRONOLACTONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045619-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060615</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IT-ABBOTT-06P-083-0336134-00</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>41</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CEREBRAL THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SENSORY LEVEL ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEPAKOTE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>18081</drugauthorizationnumb>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045620-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20050200328</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>47.17</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>B-CELL SMALL LYMPHOCYTIC LYMPHOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CROHN'S DISEASE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CROHN'S DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMODIUM</medicinalproduct>
        <drugauthorizationnumb>019487</drugauthorizationnumb>
        <drugindication>CROHN'S DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ANTIBIOTICS</medicinalproduct>
        <drugindication>CROHN'S DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISONE TAB</medicinalproduct>
        <drugindication>CROHN'S DISEASE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045621-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20031101356</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ACCIDENTAL OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COGNITIVE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG DISPENSING ERROR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEDICATION ERROR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOPAMAX</medicinalproduct>
        <drugauthorizationnumb>20505</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOPROL-XL</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045622-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesscongenitalanomali>1</seriousnesscongenitalanomali>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060627</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-JNJFOC-20041206038</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>2.19</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FOETAL GROWTH RETARDATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SMALL FOR DATES BABY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERDAL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERDAL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERDAL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERDAL</medicinalproduct>
        <drugauthorizationnumb>020272</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG EXPOSURE DURING PREGNANCY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYTOCIN</medicinalproduct>
        <drugindication>LABOUR INDUCTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HALDOL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG EXPOSURE DURING PREGNANCY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOPLICLONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG EXPOSURE DURING PREGNANCY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NITRAZEPAM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG EXPOSURE DURING PREGNANCY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045623-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060627</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20051104769</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>95.26</patientweight>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ASTHMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HERPES SIMPLEX</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ORTHO EVRA</medicinalproduct>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>CONTRACEPTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ORTHO EVRA</medicinalproduct>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>OFF LABEL USE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ORTHO EVRA</medicinalproduct>
        <drugauthorizationnumb>021180</drugauthorizationnumb>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>DYSMENORRHOEA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERLIPIDAEMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZYRTEC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALTREX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALTREX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HERPES VIRUS INFECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MERIDIA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MERIDIA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OBESITY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADVAIR DISKUS 100/50</medicinalproduct>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL SPIROS</medicinalproduct>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045624-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060609</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006UW12435</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>42</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD CREATINE PHOSPHOKINASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD URINE PRESENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EAR PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FACIAL PALSY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugauthorizationnumb>21366</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045625-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060222</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FRWYE422223FEB06</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>92</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>AORTIC DISSECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugdosagetext>50 MG TOTAL WEEKLY</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>ANKYLOSING SPONDYLITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050603</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060128</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INDOCID</medicinalproduct>
        <drugdosagetext>75 MG TOTAL DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANKYLOSING SPONDYLITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DI-ANTALVIC</medicinalproduct>
        <drugdosagetext>6 CAPSULES TOTAL DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANKYLOSING SPONDYLITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SECTRAL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>APROVEL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045626-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060623</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006SE03573</companynumb>
    <primarysource>
      <reportercountry>CROATIA (local name: Hrvatska)</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>15697</patientonsetage>
      <patientonsetageunit>804</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MANIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugdosagetext>TITRATION TO 300 MG DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BIPOLAR I DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060404</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060406</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060407</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060526</drugenddate>
        <drugtreatmentduration>50</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SORTIS</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERLIPIDAEMIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045627-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060630</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-ABBOTT-06P-062-0337299-00</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPTIC SHOCK</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060605</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHOTREXATE SODIUM</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060605</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060605</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060606</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060606</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060607</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060607</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060608</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060609</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060610</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060611</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060612</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELECOXIB</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045628-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060627</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-ABBOTT-06P-056-0337174-00</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>76</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>95</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DERMATITIS EXFOLIATIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH PRURITIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN EXFOLIATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPANTHYL TABLETS</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>21203</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DYSLIPIDAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060208</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACTOS</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS NON-INSULIN-DEPENDENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060210</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VAGOSTABYL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CARDIAC DISORDER</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060208</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CAPIVEN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>VENOUS INSUFFICIENCY</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060208</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIGLITOL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS NON-INSULIN-DEPENDENT</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060208</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NYSTATIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>FUNGAL INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060124</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060127</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NYSTATIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>ORAL FUNGAL INFECTION</drugindication>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS NON-INSULIN-DEPENDENT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BETAXOLOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NICARDIPINE HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MILNACIPRAN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060208</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MILNACIPRAN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060213</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PARACETAMOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060208</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRONOLACTONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ESSENTIAL HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>THROMBOSIS PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARBOCISTEINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>COUGH</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALPRAZOLAM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANXIETY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEGAMYLASE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060204</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FEXOFENADINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060204</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045629-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060509</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ABBOTT-06P-087-0332951-00</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC ENZYME INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLAMMATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRANSAMINASES INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KLARICID</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>50662</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BRONCHITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060403</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060412</drugenddate>
        <drugtreatmentduration>9</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CEFTRIAXONE SODIUM</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BRONCHITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060403</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060412</drugenddate>
        <drugtreatmentduration>9</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOSFOMYCIN</medicinalproduct>
        <drugindication>ANTIBIOTIC PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060412</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060421</drugenddate>
        <drugtreatmentduration>9</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CIPROFLOXACIN</medicinalproduct>
        <drugindication>ANTIBIOTIC PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060422</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060424</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>DIABETES MELLITUS MANAGEMENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060425</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLICLAZIDE</medicinalproduct>
        <drugindication>DIABETES MELLITUS NON-INSULIN-DEPENDENT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLIBENCLAMIDE</medicinalproduct>
        <drugindication>DIABETES MELLITUS NON-INSULIN-DEPENDENT</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045630-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060627</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-ABBOTT-06P-028-0337227-00</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>77.18</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>INGUINAL HERNIA REPAIR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050503</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060606</drugenddate>
        <drugtreatmentduration>399</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045631-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20010524</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ABBOTT-01P-087-0107353-00</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ACUTE ABDOMEN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AFFECT LABILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ALANINE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAEMIA</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>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRY SKIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NORVIR</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>20945</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000113</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20000118</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NORVIR</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020945</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000119</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010805</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NORVIR</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020945</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20011023</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041111</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NORVIR</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020945</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050315</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KALETRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021226</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010806</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20011014</drugenddate>
        <drugtreatmentduration>69</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIDANOSINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19991230</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIDANOSINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000113</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20000805</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIDANOSINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20011023</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIDANOSINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>STAVUDINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19991230</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>STAVUDINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000113</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010805</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>STAVUDINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20011015</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20011016</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INDINIVIR SULFATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19991230</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INDINIVIR SULFATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000119</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010805</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SAQUINAVIR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000113</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20000118</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SAQUINAVIR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20011023</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041111</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMIVUDINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20011023</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ABACAVIR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010806</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20011016</drugenddate>
        <drugtreatmentduration>71</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ATAZANAVIR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041112</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050314</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ATAZANAVIR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050315</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMPRENAVIR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20011015</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20011016</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EFAVIRENZ</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010806</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010930</drugenddate>
        <drugtreatmentduration>68</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EFAVIRENZ</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20011001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20011014</drugenddate>
        <drugtreatmentduration>68</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OCTOCOG ALFA</medicinalproduct>
        <drugindication>FACTOR VIII DEFICIENCY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19991101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19991206</drugenddate>
        <drugtreatmentduration>35</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RURIOCTOCOG ALFA</medicinalproduct>
        <drugindication>FACTOR VIII DEFICIENCY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19991207</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20000926</drugenddate>
        <drugtreatmentduration>293</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTIHEMOPHILIC FACTOR (HUMAN)</medicinalproduct>
        <drugindication>FACTOR VIII DEFICIENCY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000927</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTIVITAMIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000608</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERURICAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000829</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041104</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FAMOTIDINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTRIC ULCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040223</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041111</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FAMOTIDINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050118</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANSOPRAZOLE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTRIC ULCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041019</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041111</drugenddate>
        <drugtreatmentduration>23</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TEPRENONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTRIC ULCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041019</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRONOLACTONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEHYDRATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041109</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOPICLONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INSOMNIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050322</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045632-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-06P-163-0337145-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>16</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>INJURY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEPAKOTE ER</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>021168</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ABNORMAL BEHAVIOUR</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045633-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20030530</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ABBOTT-03P-087-0221911-00</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD AMYLASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAMMA-GLUTAMYLTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC NEOPLASM MALIGNANT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATITIS B</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERLIPIDAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NORVIR</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>20945</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030320</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040307</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NORVIR</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020945</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050324</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIDANOSINE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020717</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020717</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIDANOSINE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020718</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMIVUDINE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMIVUDINE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020425</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ABACAVIR SULFATE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030320</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMPRENAVIR</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020718</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040307</drugenddate>
        <drugtreatmentduration>598</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>20020401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020718</drugenddate>
        <drugtreatmentduration>107</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SANILVUDINE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZIDOVUDINE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020425</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030320</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZIDOVUDINE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051128</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>STAVUDINE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020425</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>STAVUDINE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030320</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051127</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUCONAZOLE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CANDIDIASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATAZANAVIR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040308</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050323</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATAZANAVIR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>URSODEOXYCHOLIC ACID</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>LIVER DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020904</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040909</drugenddate>
        <drugtreatmentduration>736</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MOSAPRIDE CITRATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NAUSEA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040408</drugenddate>
        <drugtreatmentduration>372</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CAMOSTAT MESILATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PANCREATITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030502</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045634-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-ABBOTT-06P-056-0337172-00</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ALANINE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASPARTATE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD UREA INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAMMA-GLUTAMYLTRANSFERASE ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPANTHYL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>19304</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERCHOLESTEROLAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19900101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060215</drugenddate>
        <drugtreatmentduration>16</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ETHANOLAMINE ACETYLLEUCINATE</medicinalproduct>
        <drugindication>MENIERE'S DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SILYMARIN</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARGININE HYDROCHLORIDE</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045635-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20060606161</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HIP FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugdosagetext>6 PREVIOUS DOSES-DATES NOT AVAILABLE</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CROHN'S DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AZASAN</medicinalproduct>
        <drugindication>CROHN'S DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IRON</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LONOX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRANDIN</medicinalproduct>
        <drugindication>DIABETES MELLITUS NON-INSULIN-DEPENDENT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLAGYL</medicinalproduct>
        <drugindication>CROHN'S DISEASE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045636-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20060606362</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045637-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20060606367</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>70.31</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFUSION RELATED REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TETANUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URTICARIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugdosagetext>WEEK 0;  FIRST RETREATMENT</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugdosagetext>4-5 INFUSIONS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CROHN'S DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASACOL</medicinalproduct>
        <drugindication>CROHN'S DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugindication>BONE DENSITOMETRY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ULTRAM</medicinalproduct>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM GLUCONATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DARVOCET</medicinalproduct>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE TAB</medicinalproduct>
        <drugindication>PREMEDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045638-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20060606376</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>5</patientonsetage>
      <patientonsetageunit>800</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLADDER CANCER RECURRENT</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>AZATHIOPRINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045639-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20050200328</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>47.17</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>B-CELL SMALL LYMPHOCYTIC LYMPHOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CROHN'S DISEASE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CROHN'S DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMODIUM</medicinalproduct>
        <drugauthorizationnumb>019487</drugauthorizationnumb>
        <drugindication>CROHN'S DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ANTIBIOTICS</medicinalproduct>
        <drugindication>CROHN'S DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISONE TAB</medicinalproduct>
        <drugindication>CROHN'S DISEASE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045640-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-JNJFOC-20060105559</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>35</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PANCYTOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY MYCOSIS</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>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RHEUMATREX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RHEUMATREX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RHEUMATREX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NABOAL SR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYTOTEC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MUCOSTA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDONINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDONINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045641-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20060606686</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>52.16</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE CONGESTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENTRICULAR TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE TAB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COZAAR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMIODARONE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROTONIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM GLUCONATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTIVITAMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
        <drugadministrationroute>055</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLOVENT</medicinalproduct>
        <drugadministrationroute>055</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045642-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20060502293</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>67.13</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>EXPRESSIVE LANGUAGE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PSORIATIC ARTHROPATHY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
        <drugindication>HYPOTHYROIDISM</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARAVA</medicinalproduct>
        <drugindication>ARTHRITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045643-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20060504870</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>52</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>54.43</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH MACULAR</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 TAB</medicinalproduct>
        <drugdosagetext>40-60 MG DAILY</drugdosagetext>
        <drugindication>CROHN'S DISEASE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045644-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050329</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>MX-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2005-BP-05239MX</companynumb>
    <primarysource>
      <reportercountry>MEXICO</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>53</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MOBICOX 15.0 MG TABLETS</medicinalproduct>
        <drugbatchnumb>NR</drugbatchnumb>
        <drugauthorizationnumb>20938</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NEUROPATHY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050107</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050127</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045645-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060703</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2006-BP-07576BR</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>65</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>THERAPEUTIC RESPONSE DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ATENSINA</medicinalproduct>
        <drugbatchnumb>5976</drugbatchnumb>
        <drugauthorizationnumb>17407</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060501</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OLCADIL</medicinalproduct>
        <drugindication>NERVOUSNESS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugindication>BLOOD CHOLESTEROL</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045646-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060614</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2006-BP-06723NB</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>40</patientweight>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRIC ULCER PERFORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATOCHEZIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERITONITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MOBIC</medicinalproduct>
        <drugauthorizationnumb>20938</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050106</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060601</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEPAS</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>TENSION HEADACHE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060106</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060601</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TERNELIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>TENSION HEADACHE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060106</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060601</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENZALIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INSOMNIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060601</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PURSENNID (SENNOSIDE)</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONSTIPATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060601</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>STOMACHIC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060601</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEUER</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060601</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045647-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050805</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>MX-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2005-BP-13419MX</companynumb>
    <primarysource>
      <reportercountry>MEXICO</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>65</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE MYELOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MOBICOX 15.0 MG TABLETS</medicinalproduct>
        <drugbatchnumb>NR</drugbatchnumb>
        <drugauthorizationnumb>20938</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BACK PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050524</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050608</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN B-12</medicinalproduct>
        <drugindication>ANAEMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IRON</medicinalproduct>
        <drugindication>ANAEMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLIBENCLAMIDE / METFORMIN</medicinalproduct>
        <drugdosagetext>5/500 MG</drugdosagetext>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045648-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060705</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2006-BP-07679NB</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>ATRIOVENTRICULAR BLOCK THIRD DEGREE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MICARDIS</medicinalproduct>
        <drugauthorizationnumb>020850</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045649-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>NL-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2006-DE-03329GD</companynumb>
    <primarysource></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>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PREMATURE BABY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TIPRANAVIR + RITONAVIR CO-ADMIN</medicinalproduct>
        <drugauthorizationnumb>21814</drugauthorizationnumb>
        <drugadministrationroute>015</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TIPRANAVIR + RITONAVIR CO-ADMIN</medicinalproduct>
        <drugauthorizationnumb>021814</drugauthorizationnumb>
        <drugindication>HUMAN IMMUNODEFICIENCY VIRUS TRANSMISSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEVIRAPINE</medicinalproduct>
        <drugauthorizationnumb>020636</drugauthorizationnumb>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZIDOVUDINE</medicinalproduct>
        <drugauthorizationnumb>076844</drugauthorizationnumb>
        <drugadministrationroute>015</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZIDOVUDINE</medicinalproduct>
        <drugauthorizationnumb>076844</drugauthorizationnumb>
        <drugdosagetext>HIGH DOSE</drugdosagetext>
        <drugadministrationroute>015</drugadministrationroute>
        <drugindication>HUMAN IMMUNODEFICIENCY VIRUS TRANSMISSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMIVUDINE</medicinalproduct>
        <drugadministrationroute>015</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMIVUDINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMIVUDINE</medicinalproduct>
        <drugindication>HUMAN IMMUNODEFICIENCY VIRUS TRANSMISSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ABACAVIR</medicinalproduct>
        <drugadministrationroute>015</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ABACAVIR</medicinalproduct>
        <drugindication>HUMAN IMMUNODEFICIENCY VIRUS TRANSMISSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TENOFOVIR</medicinalproduct>
        <drugadministrationroute>015</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TENOFOVIR</medicinalproduct>
        <drugindication>HUMAN IMMUNODEFICIENCY VIRUS TRANSMISSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENFUVIRTIDE</medicinalproduct>
        <drugadministrationroute>015</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENFUVIRTIDE</medicinalproduct>
        <drugindication>HUMAN IMMUNODEFICIENCY VIRUS TRANSMISSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BOOSTED LOPINAVIR</medicinalproduct>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045650-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060605</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2006-BP-06357AU</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>150</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RECTAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MOBIC</medicinalproduct>
        <drugbatchnumb>NR</drugbatchnumb>
        <drugauthorizationnumb>20938</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>POLYARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAQUENIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045651-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060428</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2006-BP-04931NB</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>62.4</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DISSEMINATED INTRAVASCULAR COAGULATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYELONEPHRITIS ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPTIC SHOCK</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MOBIC</medicinalproduct>
        <drugauthorizationnumb>20938</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060329</drugstartdate>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARIMIDEX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040624</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KELNAC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060329</drugstartdate>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PURSENNID (SENNOSIDE)</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
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    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045652-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
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    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
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    <receiptdate>20060223</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2006-BP-02063NB</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>64</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PANCREATITIS ACUTE</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MICARDIS</medicinalproduct>
        <drugauthorizationnumb>20850</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ESSENTIAL HYPERTENSION</drugindication>
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        <drugstartdate>20040305</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040814</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HANGE-BYAKUJUTSUTEMMA-TO  HANGE-BYAKUJUTSU-TEMMA-TO</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIZZINESS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031110</drugstartdate>
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        <drugenddate>20040814</drugenddate>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NEUROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020725</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040903</drugenddate>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MELEX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NEUROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040224</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040814</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOGMATYL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NEUROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040224</drugstartdate>
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        <drugenddate>20040814</drugenddate>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATARAX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NEUROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040224</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040814</drugenddate>
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    </patient>
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  <safetyreport>
    <safetyreportid>5045653-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
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    <seriousnesshospitalization>1</seriousnesshospitalization>
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    <receivedate>20060707</receivedate>
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    <receiptdate>20060630</receiptdate>
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    <companynumb>FR-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2006-BP-07667YA</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
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    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <patientonsetage>76</patientonsetage>
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      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>DYSPEPSIA</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>GASTRIC ULCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HERNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MONOPLEGIA</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>POST PROCEDURAL COMPLICATION</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
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        <drugcharacterization>1</drugcharacterization>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>UN-ALFA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VERCYTE</medicinalproduct>
        <drugindication>GLOBULINURIA</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060215</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19961201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRAVASTATIN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000801</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NITRODERM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045654-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060517</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2006-BP-05513NB</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>55</patientweight>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC FUNCTION ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MICARDIS</medicinalproduct>
        <drugauthorizationnumb>20850</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060322</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060501</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MUCOSOLVAN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THEOLONG</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RYTHMODAN R (DISOPYRAMIDE PHOSPHATE)</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARRHYTHMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ONON</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MYSLEE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INSOMNIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PARIET</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OESOPHAGITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045655-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060703</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2006-BP-07665YA</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>56</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HEPATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JAUNDICE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAMSULOSIN HCL</medicinalproduct>
        <drugauthorizationnumb>020579</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045656-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060704</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2006-BP-07623NB</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>29</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MEXITIL</medicinalproduct>
        <drugauthorizationnumb>018873</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CARDIAC FAILURE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060523</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060608</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MEXITIL</medicinalproduct>
        <drugauthorizationnumb>018873</drugauthorizationnumb>
        <drugindication>EXTRASYSTOLES</drugindication>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARICEPT</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060223</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLIMICRON</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041124</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041124</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANIRAPID</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041124</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060607</drugenddate>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALDACTONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041124</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060607</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIGOXIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060608</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045657-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060216</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>MX-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2006-BP-01836MX</companynumb>
    <primarysource>
      <reportercountry>MEXICO</reportercountry>
    </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>DRUG INEFFECTIVE</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MOBICOX 15.0 MG TABLETS</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>20938</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>LUMBAR HERNIA</drugindication>
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        <drugstartdate>20050415</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050515</drugenddate>
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    </patient>
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  <safetyreport>
    <safetyreportid>5045658-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2006-FF-00555PF</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>64</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <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>SPIRIVA</medicinalproduct>
        <drugauthorizationnumb>21395</drugauthorizationnumb>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
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        <drugstartdate>20060607</drugstartdate>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SINGULAIR</medicinalproduct>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SERETIDE</medicinalproduct>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
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    </patient>
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  <safetyreport>
    <safetyreportid>5045659-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
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    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-ABBOTT-06P-056-0337372-00</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
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    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <patientonsetage>69</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DIPLOPIA</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>MACULAR DEGENERATION</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060601</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
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    <safetyreportid>5045660-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
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    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
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    <companynumb>CA-ABBOTT-06P-028-0337228-00</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>5</qualification>
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    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <patientweight>61.29</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANGINA PECTORIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JOINT SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</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>20060126</drugstartdate>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NICOTINE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>061</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NAPROXEN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INDOMETHACINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALPRAZOLAM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROXYCHLOROQUINE PHOSPHATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM CHLORIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PARACETAMOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLOPIDOGREL BISULFATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETYLSALICYLIC ACID SRT</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
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    <safetyreportid>5045661-1</safetyreportid>
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    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
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      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
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    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HERPES ZOSTER</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>JAUNDICE</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
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        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020945</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
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        <drugstartdate>20050628</drugstartdate>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
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        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LAMIVUDINE AND ZIDOVUDINE</medicinalproduct>
        <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>
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        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
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    <safetyreportid>5045662-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
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    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>2</qualification>
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    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>GILBERT'S SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JAUNDICE</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>LETHARGY</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ERYTHROMYCIN</medicinalproduct>
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    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060627</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-ABBOTT-06P-056-0337011-00</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>APLASIA PURE RED CELL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEUKOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUSITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NORVIR</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>20945</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060315</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMIVUDINE AND ZIDOVUDINE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060315</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060515</drugenddate>
        <drugtreatmentduration>60</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMPRENAVIR</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060315</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SULFADIAZINE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CEREBRAL TOXOPLASMOSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PYRIMETHAMINE TAB</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CEREBRAL TOXOPLASMOSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BACTRIM</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CEREBRAL TOXOPLASMOSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AZITHROMYCIN</medicinalproduct>
        <drugindication>CEREBRAL TOXOPLASMOSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM FOLINATE</medicinalproduct>
        <drugindication>CEREBRAL TOXOPLASMOSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060403</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045664-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20051117</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ABBOTT-05P-087-0317736-00</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>47</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>METASTASES TO LIVER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METASTASES TO LYMPH NODES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMOCYSTIS JIROVECI PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RECTAL CANCER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KALETRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>21226</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041013</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060110</drugenddate>
        <drugtreatmentduration>454</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIDANOSINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041012</drugenddate>
        <drugtreatmentduration>193</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LAMIVUDINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041013</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060110</drugenddate>
        <drugtreatmentduration>454</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EFAVIRENZ</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041012</drugenddate>
        <drugtreatmentduration>193</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATAZANAVIR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041013</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060110</drugenddate>
        <drugtreatmentduration>454</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AZITHROMYCIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANTIBIOTIC PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041013</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060110</drugenddate>
        <drugtreatmentduration>454</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATOVAQUONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PNEUMOCYSTIS JIROVECI PNEUMONIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041104</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041125</drugenddate>
        <drugtreatmentduration>21</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PENTAMIDINE ISETHIONATE</medicinalproduct>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>ANTIBIOTIC PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041013</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060110</drugenddate>
        <drugtreatmentduration>649</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PENTAMIDINE ISETHIONATE</medicinalproduct>
        <drugadministrationroute>055</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041014</drugenddate>
        <drugtreatmentduration>649</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CEREBROVASCULAR ACCIDENT PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050112</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060110</drugenddate>
        <drugtreatmentduration>363</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ABACAVIR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041013</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060110</drugenddate>
        <drugtreatmentduration>454</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045665-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060323</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ABBOTT-06P-087-0328862-00</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HAEMODIALYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPIDIL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>19304</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERCHOLESTEROLAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060119</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060208</drugenddate>
        <drugtreatmentduration>20</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE BESYLATE</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031006</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CANDESARTAN CILEXETIL</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031006</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETYLSALICYLIC ACID SRT</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040412</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031006</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060118</drugenddate>
        <drugtreatmentduration>835</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLIBENCLAMIDE</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020826</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051123</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045666-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-06P-163-0337272-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>62</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STATUS EPILEPTICUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEPAKOTE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>018723</drugauthorizationnumb>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEPAKOTE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>018723</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEPAKOTE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>018723</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVETIRACETAM</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMOTRIGINE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045667-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060512</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-ABBOTT-06P-008-0333127-00</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANOREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GRAND MAL CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCREATITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EPILIM</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>18082</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MYOCLONIC EPILEPSY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EPILIM</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>018082</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060315</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EPILIM</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>018082</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060316</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EPILIM</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>018082</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>STIRIPENTOL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MYOCLONIC EPILEPSY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050501</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>STIRIPENTOL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060401</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLOBAZAM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045668-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060615</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-ABBOTT-06P-167-0336607-00</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>74</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UNEVALUABLE EVENT</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>20030501</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMIODIPINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENDRAFLUAZIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INDOMETHACIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045669-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060616</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-ABBOTT-06P-020-0336330-00</companynumb>
    <primarysource>
      <reportercountry>IRELAND</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>CARDIO-RESPIRATORY ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KALETRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>21226</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060116</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060608</drugenddate>
        <drugtreatmentduration>142</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>STAVUDINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060116</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIDANOSINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060116</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045670-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-ABBOTT-06P-167-0337287-00</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>72</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>PNEUMONITIS CHEMICAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051027</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <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>ACETAMINOPHEN W/ PROPOXYPHENE HCL</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>5045671-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060627</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ABBOTT-06P-087-0336923-00</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>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CEFZON</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>50739</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060616</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060617</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OSELTAMIVIR</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060616</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060617</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOSFOMYCIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>050</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060616</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060616</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COCARL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060616</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060619</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TIPEPIDINE HIBENZATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060616</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060619</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PARACETA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060619</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SG GRANULE</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060619</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TIPEPIDINE HIBENZATE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060616</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060617</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045672-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060614</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-ABBOTT-06P-028-0336041-00</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>147.5</patientweight>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>CARDIO-RESPIRATORY ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY FIBROSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060316</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE TAB</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19860101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060519</drugenddate>
        <drugtreatmentduration>20</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARBOCAL</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCODONE HYDROCHLORIDE</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONAZEPAM</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMITRIPTYLINE HCL</medicinalproduct>
        <drugdosagetext>25 MG 1 TAB AM/3 TABS QHS</drugdosagetext>
        <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>RISEDRONATE SODIUM</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUTICASONE PROPIONATE</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SALBUTAMOL</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HUMAN MIXTARD</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>OXYCODONE HYDROCHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SEROVENT</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEFLUNOMIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060109</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060520</drugenddate>
        <drugtreatmentduration>130</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROMORPHONE HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060518</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060520</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHYLPREDNISOLONE SODIUM SUCCINATE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PULMONARY FIBROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060515</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060521</drugenddate>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045673-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-ABBOTT-06P-167-0337288-00</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>78</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>SKIN ULCER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050816</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CODEINE</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>FOLATE SODIUM</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045674-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060327</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-ABBOTT-06P-062-0329158-00</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPH NODE TUBERCULOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISONE TAB</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AZATHIOPRINE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CORTISONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CORTISONE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AZATHIOPRINE</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM GLUCONATE</medicinalproduct>
        <drugindication>OSTEOPENIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ERGOCALCIFEROL</medicinalproduct>
        <drugindication>OSTEOPENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051001</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045675-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060624</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20060700500</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG DEPENDENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GLAUCOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FENTANYL TRANSDERMAL SYSTEM</medicinalproduct>
        <drugadministrationroute>062</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FENTANYL TRANSDERMAL SYSTEM</medicinalproduct>
        <drugauthorizationnumb>019813</drugauthorizationnumb>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCODONE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ROXICET</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE TAB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COLACE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONAZEPAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONIDINE</medicinalproduct>
        <drugindication>MUSCLE SPASMS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LACTULOSE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIDODERM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROSCAR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TIZANIDINE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRIAZOLAM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045676-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-06P-163-0337258-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>RENAL INJURY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GENGRAF</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>065003</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045677-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-MERCK-0606GBR00120</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>49</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>81</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>EPISTAXIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LETHARGY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugauthorizationnumb>019766</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051205</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060517</drugenddate>
        <drugtreatmentduration>164</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045678-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-MERCK-0602USA00527</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>86</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>27</patientweight>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>DRUG ADMINISTRATION ERROR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC FUNCTION ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>STROMECTOL</medicinalproduct>
        <drugauthorizationnumb>50742</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ACARODERMATITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060123</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060123</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>[THERAPY UNSPECIFIED]</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060118</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CEFAZOLIN SODIUM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PNEUMONIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060116</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060127</drugenddate>
        <drugtreatmentduration>12</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045679-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060619</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IL-MERCK-0606ISR00018</companynumb>
    <primarysource>
      <reportercountry>ISRAEL</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>71</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INVANZ</medicinalproduct>
        <drugauthorizationnumb>21337</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>ESCHERICHIA INFECTION</drugindication>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045680-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060630</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AT-MERCK-0607AUT00004</companynumb>
    <primarysource>
      <reportercountry>AUSTRIA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>55</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CANCIDAS</medicinalproduct>
        <drugauthorizationnumb>021227</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>SYSTEMIC MYCOSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060608</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060616</drugenddate>
        <drugtreatmentduration>9</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045681-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060530</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0605USA05113</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>73</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>OROPHARYNGEAL SPASM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRINIVIL</medicinalproduct>
        <drugauthorizationnumb>19558</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060501</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZESTRIL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045682-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060314</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0603USA02469</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>42</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>93</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ADJUSTMENT DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMPLETED SUICIDE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSED MOOD</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GUN SHOT WOUND</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC STEATOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENTAL IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RETCHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRANSAMINASES INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugauthorizationnumb>19766</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030501</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RESTORIL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031231</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045683-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PR-MERCK-0606USA05706</companynumb>
    <primarysource>
      <reportercountry>PUERTO RICO</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIOMYOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOPROTEINAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVEDO RETICULARIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCYTOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPLENOMEGALY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VYTORIN</medicinalproduct>
        <drugauthorizationnumb>021687</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060407</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060626</drugenddate>
        <drugtreatmentduration>81</drugtreatmentduration>
        <drugtreatmentdurationunit></drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045684-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060515</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BE-MERCK-0605BEL00015</companynumb>
    <primarysource>
      <reportercountry>BELGIUM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>60</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ARTERIOSCLEROSIS CORONARY ARTERY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>QUINAPRIL HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugauthorizationnumb>019766</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERCHOLESTEROLAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLYBURIDE AND METFORMIN HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLOPIDOGREL BISULFATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANGIOPATHY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN HUMAN ZINC, EXTENDED</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060123</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VENLAFAXINE HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE BESYLATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045685-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-MERCK-0607USA00413</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>70</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRIC CANCER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRIMAXIN</medicinalproduct>
        <drugauthorizationnumb>50587</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>SEPSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060615</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060615</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DYPHYLLINE</medicinalproduct>
        <drugadministrationroute>051</drugadministrationroute>
        <drugindication>RESPIRATORY FAILURE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060613</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060614</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FIRSTCIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>SEPSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060613</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060614</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045686-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060314</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0603USA02532</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>89</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>72</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>LYMPHOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>20560</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045687-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PT-MERCK-0607PRT00001</companynumb>
    <primarysource>
      <reportercountry>PORTUGAL</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>56</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>50</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL STIFFNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX PLUS D</medicinalproduct>
        <drugauthorizationnumb>021762</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060629</drugenddate>
        <drugtreatmentduration>29</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045688-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060703</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-MERCK-0607AUS00010</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>73</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>20560</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BUDESONIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>RESPIRATORY DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUTICASONE PROPIONATE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>RESPIRATORY DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALBUTEROL SULFATE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>RESPIRATORY DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IPRATROPIUM BROMIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>RESPIRATORY DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VITAMINS (UNSPECIFIED)</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>THEOPHYLLINE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>RESPIRATORY DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>RESPIRATORY DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045689-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060314</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0603USA02454</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>83</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>62</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>GASTRIC CANCER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>20560</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045690-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060616</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-MERCK-0606FRA00034</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>65</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>C-REACTIVE PROTEIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DERMATITIS BULLOUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG ERUPTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERCHOLESTEROLAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEUKOCYTOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEPHROTIC SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TYPE IV HYPERSENSITIVITY REACTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRIMAXIN</medicinalproduct>
        <drugauthorizationnumb>050587</drugauthorizationnumb>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>ERYSIPELAS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051021</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051108</drugenddate>
        <drugtreatmentduration>19</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRIMAXIN</medicinalproduct>
        <drugauthorizationnumb>050587</drugauthorizationnumb>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>FASCIITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051021</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051108</drugenddate>
        <drugtreatmentduration>19</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VANCOMYCIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>ERYSIPELAS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051021</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051113</drugenddate>
        <drugtreatmentduration>24</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ORNIDAZOLE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>ERYSIPELAS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051021</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051022</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ORNIDAZOLE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>FASCIITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051021</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051022</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045691-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060612</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-MERCK-0607USA00077</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>75</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>60</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ARRHYTHMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SINGULAIR</medicinalproduct>
        <drugauthorizationnumb>020829</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060525</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060530</drugenddate>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ONON</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060511</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060524</drugenddate>
        <drugtreatmentduration>14</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045692-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060703</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-MERCK-0607AUS00009</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>90</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BREAST CANCER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PHENYTOIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>CONVULSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19960101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATORVASTATIN CALCIUM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARFARIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045693-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesscongenitalanomali>1</seriousnesscongenitalanomali>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0606USA05760</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>0</patientonsetage>
      <patientonsetageunit>804</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>POLYDACTYLY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SINGULAIR</medicinalproduct>
        <drugauthorizationnumb>020829</drugauthorizationnumb>
        <drugindication>ASTHMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045694-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060411</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IT-MERCK-0604ITA00019</companynumb>
    <primarysource>
      <reportercountry>ITALY</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>57</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ACUTE FEBRILE NEUTROPHILIC DERMATOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugauthorizationnumb>019766</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERCHOLESTEROLAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060301</drugenddate>
        <drugtreatmentduration>182</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
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    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045695-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060627</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-MERCK-0607USA00073</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
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    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>79</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG ERUPTION</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEPCID</medicinalproduct>
        <drugauthorizationnumb>19462</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TARGOCID</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060612</drugstartdate>
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        <drugtreatmentduration>11</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TANATRIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALDACTONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANIRAPID</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FRANDOL TAPE S</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARTIST</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RYTHMODAN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOID G</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045696-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
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    <receiptdate>20060602</receiptdate>
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    <companynumb>JP-MERCK-0606USA01578</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>57</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HEPATIC FUNCTION ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTESTINAL OBSTRUCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEPCID RPD</medicinalproduct>
        <drugauthorizationnumb>20752</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTRIC ULCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060215</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060601</drugenddate>
        <drugtreatmentduration>107</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ETODOLAC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CANCER PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060215</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ETODOLAC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INTESTINAL OBSTRUCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060215</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BETAMETHASONE VALERATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INTESTINAL OBSTRUCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060215</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGNESIUM OXIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INTESTINAL OBSTRUCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060215</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ETIZOLAM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CANCER PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060215</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045697-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060503</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-MERCK-0605FRA00007</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>72</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>86</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EXTRASYSTOLES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EMEND</medicinalproduct>
        <drugauthorizationnumb>21549</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS OF NAUSEA AND VOMITING</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060202</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060204</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
        <drugadministrationroute>051</drugadministrationroute>
        <drugindication>PROPHYLAXIS OF NAUSEA AND VOMITING</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060202</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXCHLORPHENIRAMINE MALEATE</medicinalproduct>
        <drugadministrationroute>051</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060202</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060202</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IRINOTECAN HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLON CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060202</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060202</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ERBITUX</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLON CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060202</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060202</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATROPINE</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060202</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060202</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ONDANSETRON HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>051</drugadministrationroute>
        <drugindication>PROPHYLAXIS OF NAUSEA AND VOMITING</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060202</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060202</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045698-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-MERCK-0607USA00079</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>40</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ALLERGIC GRANULOMATOUS ANGIITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SINGULAIR</medicinalproduct>
        <drugauthorizationnumb>020829</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045699-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060706</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-RB-3546-2006</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>2</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>OVERDOSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUBOXONE</medicinalproduct>
        <drugauthorizationnumb>20733</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045700-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060703</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-SP-2006-01692</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CONJUNCTIVITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL CHEST PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMMUCYST</medicinalproduct>
        <drugbatchnumb>LOT NOT REP</drugbatchnumb>
        <drugadministrationroute>043</drugadministrationroute>
        <drugindication>BLADDER CANCER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMMUCYST</medicinalproduct>
        <drugbatchnumb>LOT NOT REP</drugbatchnumb>
        <drugadministrationroute>043</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045701-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060704</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-SP-2006-01714</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>61</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>POLLAKIURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYURIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMMUCYST</medicinalproduct>
        <drugbatchnumb>LOT NOT REP</drugbatchnumb>
        <drugadministrationroute>043</drugadministrationroute>
        <drugindication>CARCINOMA IN SITU OF BLADDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050729</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050901</drugenddate>
        <drugtreatmentduration>34</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ISONIAZID</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050729</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050903</drugenddate>
        <drugtreatmentduration>36</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045702-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20060606709</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BASAL CELL CARCINOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM GLUCONATE</medicinalproduct>
        <drugdosagetext>500 MG 3 TABLETS DAILY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TUMS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VICODIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ULTRACET</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045703-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-JNJFOC-20060503845</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>64</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY TUBERCULOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ANKYLOSING SPONDYLITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIGEN D</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045704-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DK-JNJFOC-20060606506</companynumb>
    <primarysource>
      <reportercountry>DENMARK</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>40</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>96</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PUSTULAR PSORIASIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TETANUS</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045706-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060519</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2006BR07708</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>15</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>55.5</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MICROALBUMINURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NIGHT SWEATS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROTEINURIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RITALIN</medicinalproduct>
        <drugauthorizationnumb>10187</drugauthorizationnumb>
        <drugdosagetext>10 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATTENTION DEFICIT/HYPERACTIVITY DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050301</drugstartdate>
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    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045707-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2006BR09916</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <patientonsetage>11</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>11</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONJUNCTIVITIS ALLERGIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHOTOPHOBIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZADITEN</medicinalproduct>
        <drugauthorizationnumb>021066</drugauthorizationnumb>
        <drugdosagetext>1 DRP, BID</drugdosagetext>
        <drugindication>CONJUNCTIVITIS ALLERGIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060105</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARMELLOSE</medicinalproduct>
        <drugdosagetext>UNK, Q2H</drugdosagetext>
        <drugadministrationroute>061</drugadministrationroute>
        <drugindication>CONJUNCTIVITIS ALLERGIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045718-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHNU2006DE02408</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>64</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BRAIN NEOPLASM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ROAD TRAFFIC ACCIDENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRILEPTAL</medicinalproduct>
        <drugauthorizationnumb>21014</drugauthorizationnumb>
        <drugdosagetext>150 MG, BID</drugdosagetext>
        <drugindication>EPILEPSY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045719-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060503</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHNU2006DE01851</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>38</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>80</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ELECTROLYTE IMBALANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPONATRAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIP DRY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWELLING FACE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRILEPTAL</medicinalproduct>
        <drugauthorizationnumb>21014</drugauthorizationnumb>
        <drugdosagetext>600 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>EPILEPSY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRILEPTAL</medicinalproduct>
        <drugbatchnumb>T5021</drugbatchnumb>
        <drugauthorizationnumb>021014</drugauthorizationnumb>
        <drugdosagetext>600 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060401</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRILEPTAL</medicinalproduct>
        <drugauthorizationnumb>021014</drugauthorizationnumb>
        <drugdosagetext>600 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRILEPTAL</medicinalproduct>
        <drugauthorizationnumb>021014</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045720-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060413</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHRM2006FR01362</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>84</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>66</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FISTULA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUCOSAL ULCERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugdosagetext>4 MG, QMO</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AREDIA</medicinalproduct>
        <drugauthorizationnumb>020036</drugauthorizationnumb>
        <drugdosagetext>90 MG EVERY 6 WEEKS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20011101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALKERAN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20011101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALKERAN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050801</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THALIDOMIDE</medicinalproduct>
        <drugdosagetext>200 MG/DAY</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050901</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045721-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060627</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHNU2006DE02414</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>69</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD CREATINE PHOSPHOKINASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE ATROPHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOSITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LOCOL</medicinalproduct>
        <drugauthorizationnumb>20261</drugauthorizationnumb>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CERTICAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRAVASTATIN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045722-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060606</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2006JP08671</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>78</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANTINUCLEAR ANTIBODY INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD SODIUM DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INAPPROPRIATE ANTIDIURETIC HORMONE SECRETION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HERBESSOR R</medicinalproduct>
        <drugdosagetext>1 DF, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060605</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAMSULOSIN HYDROCHLORIDE</medicinalproduct>
        <drugdosagetext>0.2 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLIVAS</medicinalproduct>
        <drugdosagetext>25 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SENNOSIDE</medicinalproduct>
        <drugdosagetext>4 DF, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGNESIUM OXIDE</medicinalproduct>
        <drugdosagetext>1 DF, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYANOCOBALAMIN</medicinalproduct>
        <drugdosagetext>1 DF, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EVIPROSTAT</medicinalproduct>
        <drugdosagetext>0.2 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060605</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
        <drugdosagetext>25 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CEROCRAL</medicinalproduct>
        <drugdosagetext>1 DF, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060605</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LOCHOL</medicinalproduct>
        <drugauthorizationnumb>020261</drugauthorizationnumb>
        <drugdosagetext>20 MG/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERCHOLESTEROLAEMIA</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060605</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045723-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2006TT09709</companynumb>
    <primarysource>
      <reportercountry>TRINIDAD AND TOBAGO</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>70</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABNORMAL BEHAVIOUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HALLUCINATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY TRACT DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRILEPTAL</medicinalproduct>
        <drugauthorizationnumb>021014</drugauthorizationnumb>
        <drugdosagetext>300 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETIC NEUROPATHY</drugindication>
        <drugtreatmentduration>4320</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045724-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2006DE09807</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>63</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD ALBUMIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CHOLESTEROL INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CREATININE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD UREA INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEPHRITIS INTERSTITIAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEPHROTIC SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROTEINURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL TUBULAR DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY CASTS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RADIOTHERAPY</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>BONE PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAMIDRONATE DISODIUM</medicinalproduct>
        <drugauthorizationnumb>020036</drugauthorizationnumb>
        <drugdosagetext>90 MG, EVERY 4 WEEKS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>METASTASES TO BONE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugdosagetext>40 MG/D</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BISOPROLOL FUMARATE</medicinalproduct>
        <drugdosagetext>5 MG/D</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LETROZOLE</medicinalproduct>
        <drugdosagetext>2.5 MG/D</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THYROXIN</medicinalproduct>
        <drugdosagetext>75 UG/D</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045725-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHO2006EG10485</companynumb>
    <primarysource>
      <reportercountry>EGYPT</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>18</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>53</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HEPATOMEGALY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYDRONEPHROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERINEPHRIC ABSCESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERINEPHRIC COLLECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ICL670A</medicinalproduct>
        <drugauthorizationnumb>21882</drugauthorizationnumb>
        <drugdosagetext>UNK, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HAEMOSIDEROSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045726-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060630</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2006US08522</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>73</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>51.247</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXJADE</medicinalproduct>
        <drugauthorizationnumb>021882</drugauthorizationnumb>
        <drugdosagetext>1250 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MYELODYSPLASTIC SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060316</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXJADE</medicinalproduct>
        <drugbatchnumb>F0009</drugbatchnumb>
        <drugauthorizationnumb>021882</drugauthorizationnumb>
        <drugdosagetext>2000 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060624</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045727-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2006US08480</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>50</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>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>TRILEPTAL</medicinalproduct>
        <drugauthorizationnumb>21014</drugauthorizationnumb>
        <drugdosagetext>300 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060323</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060608</drugenddate>
        <drugtreatmentduration>78</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOMIDE</medicinalproduct>
        <drugdosagetext>UNK, BID</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INFERGEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MERITAL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALDACTONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREVACID</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045731-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060620</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2006US08030</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>23</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD 25-HYDROXYCHOLECALCIFEROL DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT AND COLD</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERPARATHYROIDISM PRIMARY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEDIASTINAL MASS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MICTURITION URGENCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN JAW</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARATHYROID TUMOUR BENIGN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VITAMIN D DEFICIENCY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAMIDRONATE DISODIUM</medicinalproduct>
        <drugauthorizationnumb>20036</drugauthorizationnumb>
        <drugdosagetext>90 MG, ONCE/SINGLE</drugdosagetext>
        <drugindication>BLOOD CALCIUM INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060505</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060505</drugenddate>
        <drugtreatmentduration>1440</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045732-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060703</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHO2006JP10846</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>56</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>57</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METASTASES TO LIVER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RECTAL CANCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RECTAL CANCER METASTATIC</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LOCHOL</medicinalproduct>
        <drugauthorizationnumb>20261</drugauthorizationnumb>
        <drugdosagetext>30 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERCHOLESTEROLAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20011122</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060313</drugenddate>
        <drugtreatmentduration>1573</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MELBIN</medicinalproduct>
        <drugdosagetext>750 MG, UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010828</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060313</drugenddate>
        <drugtreatmentduration>1659</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045739-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060630</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-SOLVAY-00206002145</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>80</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORTHOSTATIC HYPOTENSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COVERSYL</medicinalproduct>
        <drugauthorizationnumb>20184</drugauthorizationnumb>
        <drugdosagetext>DAILY DOSE: 4 MILLIGRAM(S)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALDACTAZIDE</medicinalproduct>
        <drugdosagetext>DAILY DOSE:  UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PHYSIOTENS</medicinalproduct>
        <drugdosagetext>DAILY DOSE: 1 DOSAGE FORM</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EUPRESSYL</medicinalproduct>
        <drugdosagetext>DAILY DOSE:  UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045744-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2006JP09894</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>LEUKOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOBAR PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TEGRETOL</medicinalproduct>
        <drugauthorizationnumb>016608</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045754-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-JNJFOC-20060606503</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>45</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>LUNG DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ANKYLOSING SPONDYLITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045755-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-JNJFOC-20060606532</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>41</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DELUSIONAL DISORDER, PERSECUTORY TYPE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDE ATTEMPT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugdosagetext>8 INFUSIONS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ANKYLOSING SPONDYLITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045759-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060630</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20060700687</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>61</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REOPRO</medicinalproduct>
        <drugindication>ACUTE MYOCARDIAL INFARCTION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045766-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-KINGPHARMUSA00001-K200600855</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>72</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CORNEAL OPACITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HERPES SIMPLEX</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE ALLERGIES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL ACUITY REDUCED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIROPTIC SOLUTION</medicinalproduct>
        <drugauthorizationnumb>18299</drugauthorizationnumb>
        <drugdosagetext>2 GTT Q 7 HOURS</drugdosagetext>
        <drugadministrationroute>031</drugadministrationroute>
        <drugindication>HERPES VIRUS INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060620</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060627</drugenddate>
        <drugtreatmentduration>11520</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIROPTIC SOLUTION</medicinalproduct>
        <drugauthorizationnumb>018299</drugauthorizationnumb>
        <drugdosagetext>1 GTT, TID</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060627</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045772-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050331</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHNU2005DE01487</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>61</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE TRIMMING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DENTAL TREATMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GINGIVAL RECESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GINGIVITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLAMMATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOMYELITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLASTIC SURGERY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTH EXTRACTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAMOXIFEN</medicinalproduct>
        <drugdosagetext>20 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19991101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030901</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LETROZOLE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030901</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugdosagetext>4 MG, QMO</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>METASTASES TO BONE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050419</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AREDIA</medicinalproduct>
        <drugauthorizationnumb>020036</drugauthorizationnumb>
        <drugdosagetext>90 MG, QMO</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BREAST CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19991101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020701</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RADIOTHERAPY</medicinalproduct>
        <drugadministrationroute>061</drugadministrationroute>
        <drugindication>BREAST CANCER FEMALE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990901</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BONDRONAT</medicinalproduct>
        <drugdosagetext>6 MG, TIW</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050531</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045773-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20051115</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHNU2005DE03789</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>62</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>55</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BONE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLAMMATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUS DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTH DEPOSIT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTH DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTH EXTRACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WOUND DEHISCENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PULMICORT</medicinalproduct>
        <drugdosagetext>2 UNK, BID</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLINDAMYCIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugdosagetext>4 MG, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PANCREATIC CARCINOMA METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030213</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050518</drugenddate>
        <drugtreatmentduration>826</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AREDIA</medicinalproduct>
        <drugauthorizationnumb>020036</drugauthorizationnumb>
        <drugdosagetext>60 TO 90 MG, QMO</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PANCREATIC CARCINOMA METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020702</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030206</drugenddate>
        <drugtreatmentduration>220</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>STREPTOZOTOCIN</medicinalproduct>
        <drugdosagetext>500 MG/M2, UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PANCREATIC CARCINOMA METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUOROURACIL</medicinalproduct>
        <drugdosagetext>400 MG/M2, UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PANCREATIC CARCINOMA METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
        <drugdosagetext>200 MG/M2, UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PANCREATIC CARCINOMA METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INTERFERON ALFA</medicinalproduct>
        <drugdosagetext>2.5 MIU, UNK</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PANCREATIC CARCINOMA METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021202</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040801</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SANDOSTATIN LAR</medicinalproduct>
        <drugdosagetext>30 MG, QMO</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SANDOSTATIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020702</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NAVOBAN</medicinalproduct>
        <drugdosagetext>5 MG, UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
        <drugdosagetext>8 MG, UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VERGENTAN</medicinalproduct>
        <drugdosagetext>100 MG, UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050501</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugdosagetext>40 MG, QD</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
        <drugdosagetext>60 MG, QD</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETYLSALICYLIC ACID SRT</medicinalproduct>
        <drugdosagetext>100 MG, QD</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
        <drugdosagetext>800 MG, TID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SAROTEN</medicinalproduct>
        <drugdosagetext>75 MG, BID</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FENTANYL TRANSDERMAL SYSTEM</medicinalproduct>
        <drugdosagetext>75 UG, Q72H</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NOVALGIN</medicinalproduct>
        <drugdosagetext>30 UNK, Q4H</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MOVICOL</medicinalproduct>
        <drugdosagetext>1 DF, QD</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACC</medicinalproduct>
        <drugdosagetext>600 MG, QD</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROTAPHAN</medicinalproduct>
        <drugdosagetext>8 UNK, QD</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DIABETES MELLITUS INSULIN-DEPENDENT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACTRAPID HUMAN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DIABETES MELLITUS INSULIN-DEPENDENT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FERRO ^SANOL^</medicinalproduct>
        <drugdosagetext>30 UNK, BID</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMOXICILLIN</medicinalproduct>
        <drugdosagetext>750 MG, BID</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEFAX</medicinalproduct>
        <drugdosagetext>2 DF, TID</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045777-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-US184834</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MASS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTH ABSCESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>PSORIASIS</drugindication>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045778-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060627</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-US184525</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>91.7</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PALIFERMIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>STOMATITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060623</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VICODIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060519</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORAZEPAM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060613</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VIBRAMYCIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060616</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SUDAFED 12 HOUR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060616</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EQUATE</medicinalproduct>
        <drugadministrationroute>045</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060616</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORTAB</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045779-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20051129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2005US12982</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>1</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUROBLASTOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FEMARA</medicinalproduct>
        <drugauthorizationnumb>20726</drugauthorizationnumb>
        <drugadministrationroute>064</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045780-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060601</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-AMGEN-US181561</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PLEURAL EFFUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050223</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060503</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTIVITAMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM GLUCONATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EFFEXOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FAMVIR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SENOKOT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN/CODEINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BIAXIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060510</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060517</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045781-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20051219</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2005US13631</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>62</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN JAW</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CORTICOSTEROID NOS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CHEMOTHERAPEUTICS,OTHER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DECADRON</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AREDIA</medicinalproduct>
        <drugauthorizationnumb>020036</drugauthorizationnumb>
        <drugdosagetext>UNK, QMO</drugdosagetext>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050304</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050901</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAMIDRONATE DISODIUM</medicinalproduct>
        <drugauthorizationnumb>020036</drugauthorizationnumb>
        <drugdosagetext>UNK, QMO</drugdosagetext>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000804</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031002</drugenddate>
        <drugtreatmentduration>1155</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045783-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060622</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2006US08175</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>57</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>218</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABNORMAL BEHAVIOUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AGITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEEP VEIN THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRY THROAT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPARIN-INDUCED THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTUBATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSYCHOTIC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THERAPEUTIC AGENT TOXICITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEAN FROM VENTILATOR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENABLEX</medicinalproduct>
        <drugauthorizationnumb>21513</drugauthorizationnumb>
        <drugdosagetext>7.5 MG, UNK</drugdosagetext>
        <drugindication>HYPERTONIC BLADDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051206</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENABLEX</medicinalproduct>
        <drugauthorizationnumb>021513</drugauthorizationnumb>
        <drugdosagetext>15 MG, QD</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060622</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENABLEX</medicinalproduct>
        <drugauthorizationnumb>021513</drugauthorizationnumb>
        <drugdosagetext>15 MG /QDFIVE TIMES A WEEK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR                                 /NET/</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOXYL</medicinalproduct>
        <drugdosagetext>25 UG, QD</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LITHIUM CARBONATE</medicinalproduct>
        <drugdosagetext>300 MG, TID</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045784-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2006US08437</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>53</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>74.829</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD CREATINE PHOSPHOKINASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATOCRIT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHABDOMYOLYSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMISIL</medicinalproduct>
        <drugauthorizationnumb>020539</drugauthorizationnumb>
        <drugdosagetext>250 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NAIL TINEA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060527</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060622</drugenddate>
        <drugtreatmentduration>34560</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MIRALAX</medicinalproduct>
        <drugdosagetext>UNK, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONSTIPATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COLACE</medicinalproduct>
        <drugdosagetext>200 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONSTIPATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045785-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2006US08549</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>RHABDOMYOLYSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMISIL</medicinalproduct>
        <drugauthorizationnumb>020539</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>NAIL TINEA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045786-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2006JP09941</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>ELECTROCARDIOGRAM QT PROLONGED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARDENALIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANALDINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LENDORMIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOXONIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KALLIKREIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COAX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMISIL</medicinalproduct>
        <drugauthorizationnumb>020539</drugauthorizationnumb>
        <drugdosagetext>125 MG/D</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045787-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060704</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2006PT10096</companynumb>
    <primarysource>
      <reportercountry>PORTUGAL</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>71</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HCL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METAMIZOLE MAGNESIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060327</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CINNARIZINE</medicinalproduct>
        <drugdosagetext>75 MG/D</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DICLOFENAC SODIUM</medicinalproduct>
        <drugdosagetext>100 MG/D</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060327</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVASTATINA</medicinalproduct>
        <drugdosagetext>20 MG/D</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NIMODIPINE</medicinalproduct>
        <drugdosagetext>30 MG/D</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugdosagetext>40 MG/D</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060327</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FEMARA</medicinalproduct>
        <drugauthorizationnumb>020726</drugauthorizationnumb>
        <drugdosagetext>2.5 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060126</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060508</drugenddate>
        <drugtreatmentduration>103</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045789-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060706</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHRM2006FR01999</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>60</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERAL PHYSICAL HEALTH DETERIORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRANSAMINASES INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FEMARA</medicinalproduct>
        <drugauthorizationnumb>020726</drugauthorizationnumb>
        <drugdosagetext>2.5 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BREAST CANCER RECURRENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060501</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045790-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060626</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-STX184354</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>KNEE ARTHROPLASTY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>D061364</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045794-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060626</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IE-AMGEN-UK184386</companynumb>
    <primarysource>
      <reportercountry>IRELAND</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>30</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>COLITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HISTIOCYTOSIS HAEMATOPHAGIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VIRAL INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KINERET</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>JUVENILE ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051204</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060518</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FELDENE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INDOMETHACIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FERROUS FUMARATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCICHEW-D3</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045803-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-JNJFOC-20060606507</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ATYPICAL MYCOBACTERIAL INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugdosagetext>3 INFUSIONS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>VASCULITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045816-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060623</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006079467</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </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>ARRHYTHMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CHOLESTEROL INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROOESOPHAGEAL REFLUX DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugauthorizationnumb>20998</drugauthorizationnumb>
        <drugdosagetext>400 MG (200 MG, BID)</drugdosagetext>
        <drugindication>BACK PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19970101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045823-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060327</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-13328018</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>73</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>91</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE CONGESTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
        <drugauthorizationnumb>9218</drugauthorizationnumb>
        <drugdosagetext>DURATION: MANY YEARS</drugdosagetext>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060226</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugindication>ARTERIOSCLEROSIS CORONARY ARTERY</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060226</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045824-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20010626</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-BRISTOL-MYERS SQUIBB COMPANY-13433214</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>62</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>58</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ALOPECIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANOREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASCITES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AZOTAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CALCIUM DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CHLORIDE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CREATININE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD SODIUM DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BOWEL SOUNDS ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CATHETER PLACEMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTOLERANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPEPSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ELECTROCARDIOGRAM ST SEGMENT DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERUCTATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL MOTILITY DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HOSPITALISATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOKALAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEUKOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALIGNANT NEOPLASM PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALNUTRITION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULAR WEAKNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NASOPHARYNGITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEOPLASM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OLIGURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERFORMANCE STATUS DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERITONEAL CARCINOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROTEIN TOTAL DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHINITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SNEEZING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYARRHYTHMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</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>TAXOL</medicinalproduct>
        <drugauthorizationnumb>020262</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>OVARIAN CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990714</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19991110</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CISPLATIN</medicinalproduct>
        <drugauthorizationnumb>018057</drugauthorizationnumb>
        <drugindication>OVARIAN CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990714</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19991110</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ETHYOL</medicinalproduct>
        <drugindication>OVARIAN CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990714</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19991110</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAMOXIFEN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000301</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAMOXIFEN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000329</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20000524</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MEDROXYPROGESTERONE ACETATE</medicinalproduct>
        <drugindication>OVARIAN CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000324</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TREOSULFAN</medicinalproduct>
        <drugindication>OVARIAN CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000809</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOCLOPRAMIDE</medicinalproduct>
        <drugindication>GASTROINTESTINAL DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FORTECORTIN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LACTULOSE</medicinalproduct>
        <drugindication>CONSTIPATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN B COMPLEX CAP</medicinalproduct>
        <drugindication>HYPOAESTHESIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RANITIDINE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOCLOPRAMIDE</medicinalproduct>
        <drugindication>GASTROINTESTINAL PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20001101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOCLOPRAMIDE</medicinalproduct>
        <drugindication>NAUSEA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20001101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMPHO-MORONAL</medicinalproduct>
        <drugauthorizationnumb>060517</drugauthorizationnumb>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000901</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugindication>DYSPEPSIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000920</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000920</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRONOLACTONE</medicinalproduct>
        <drugindication>ASCITES</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20001004</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KALINOR</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20001129</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE TAB</medicinalproduct>
        <drugindication>ANOREXIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20001011</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANTOPRAZOLE</medicinalproduct>
        <drugindication>DYSPEPSIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20001011</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LACTULOSE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20001001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DULCOLAX</medicinalproduct>
        <drugindication>CONSTIPATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20001001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOPERAMIDE</medicinalproduct>
        <drugindication>DIARRHOEA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20001024</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
        <drugindication>BLOOD UREA INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20001025</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GRANOCYTE</medicinalproduct>
        <drugindication>LEUKOPENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20001030</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMOXICILLIN</medicinalproduct>
        <drugauthorizationnumb>061885</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20001103</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CIPROFLOXACIN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20001103</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
        <drugindication>OEDEMA PERIPHERAL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20001113</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUMIN 20%</medicinalproduct>
        <drugindication>PROTEIN TOTAL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20001219</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SALINE</medicinalproduct>
        <drugindication>FLUID REPLACEMENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20001219</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM GLUCONATE</medicinalproduct>
        <drugindication>BLOOD CALCIUM</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20001219</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045826-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060703</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-13431929</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BREAST CANCER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ESTRACE</medicinalproduct>
        <drugauthorizationnumb>084499</drugauthorizationnumb>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROVERA</medicinalproduct>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045831-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060602</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-13400536</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>55</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>110</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENITAL BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULSE ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY INCONTINENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARBOPLATIN</medicinalproduct>
        <drugbatchnumb>6B11104</drugbatchnumb>
        <drugauthorizationnumb>19880</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>OVARIAN CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060601</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DECADRON</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PREMEDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KYTRIL</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PREMEDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMINS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DULCOLAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYTOXAN</medicinalproduct>
        <drugauthorizationnumb>012142</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045832-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060630</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-BRISTOL-MYERS SQUIBB COMPANY-13432430</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>69</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>BLADDER PERFORATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MITOMYCIN</medicinalproduct>
        <drugauthorizationnumb>062336</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045833-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060613</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ES-BRISTOL-MYERS SQUIBB COMPANY-13410196</companynumb>
    <primarysource>
      <reportercountry>SPAIN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>67</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>50</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>COMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ENCEPHALITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MAXIPIME</medicinalproduct>
        <drugauthorizationnumb>50679</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CATHETER RELATED INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060530</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060531</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CEFTAZIDIME</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060531</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYCLOSPORINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045834-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060630</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-13431812</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>EYE INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KENALOG-40</medicinalproduct>
        <drugauthorizationnumb>014901</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045835-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060410</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-BRISTOL-MYERS SQUIBB COMPANY-13345178</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>88</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HYPERGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GATIFLOXACIN</medicinalproduct>
        <drugauthorizationnumb>21061</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BACTERIAL INFECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLOMOX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BACTERIAL INFECTION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045836-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IE-JNJFOC-20060606466</companynumb>
    <primarysource>
      <reportercountry>IRELAND</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>50</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFUSION RELATED REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugbatchnumb>9232558</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PIRITON</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PARACETAMOL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045837-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-13434808</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>EYE INFLAMMATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KENALOG-40</medicinalproduct>
        <drugauthorizationnumb>014901</drugauthorizationnumb>
        <drugadministrationroute>031</drugadministrationroute>
        <drugindication>RETINAL OEDEMA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045838-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-BRISTOL-MYERS SQUIBB COMPANY-13429485</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>65</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE CHRONIC</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REYATAZ</medicinalproduct>
        <drugauthorizationnumb>021567</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LAMIVUDINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ABACAVIR</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045840-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060612</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-NOVOPROD-254208</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>68</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIO-RESPIRATORY ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSED LEVEL OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISSEMINATED INTRAVASCULAR COAGULATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMODIALYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ISCHAEMIC HEPATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHABDOMYOLYSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GLUCAGON</medicinalproduct>
        <drugauthorizationnumb>20918</drugauthorizationnumb>
        <drugindication>GASTROINTESTINAL ENDOSCOPIC THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060602</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060602</drugenddate>
        <drugtreatmentduration>1440</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GASTER D</medicinalproduct>
        <drugdosagetext>40 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NAUSEA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060602</drugenddate>
        <drugtreatmentduration>1440</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GASMOTIN</medicinalproduct>
        <drugdosagetext>15 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NAUSEA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060602</drugenddate>
        <drugtreatmentduration>1440</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045845-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHO2006BE10722</companynumb>
    <primarysource>
      <reportercountry>BELGIUM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>83</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BILE DUCT OBSTRUCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHOLECYSTITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHOLELITHIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHOLESTASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DELUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER FUNCTION TEST ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENTAL IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH PRURITIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESTLESSNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASAFLOW</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DAFLON</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DYTENZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANOXIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXELON</medicinalproduct>
        <drugauthorizationnumb>020823</drugauthorizationnumb>
        <drugdosagetext>3 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEMENTIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051114</drugenddate>
        <drugtreatmentduration>228</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045846-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060420</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHO2006JP06671</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>23</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>52</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>CANDIDA SEPSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CANDIDIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EPSTEIN-BARR VIRUS INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HISTIOCYTOSIS HAEMATOPHAGIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCISIONAL DRAINAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>KIDNEY TRANSPLANT REJECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MELAENA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>REMOVAL OF RENAL TRANSPLANT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SMALL INTESTINAL PERFORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SMALL INTESTINE ULCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STAPHYLOCOCCAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STAPHYLOCOCCAL SEPSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SIMULECT</medicinalproduct>
        <drugdosagetext>20 MG, ONCE/SINGLE</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RENAL TRANSPLANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031021</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031021</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>20031025</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031025</drugenddate>
        <drugtreatmentduration>1440</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROGRAF</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RENAL TRANSPLANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031019</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031121</drugenddate>
        <drugtreatmentduration>48960</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELLCEPT</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RENAL TRANSPLANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031027</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031117</drugenddate>
        <drugtreatmentduration>31680</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SOLU-MEDROL</medicinalproduct>
        <drugindication>RENAL TRANSPLANT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MEDROL</medicinalproduct>
        <drugindication>RENAL TRANSPLANT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDONINE</medicinalproduct>
        <drugindication>RENAL TRANSPLANT</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045847-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060630</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006UW13824</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>80</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>45.4</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugauthorizationnumb>020639</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>UNEVALUABLE EVENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045854-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2006AT09711</companynumb>
    <primarysource>
      <reportercountry>AUSTRIA</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMPAIRED HEALING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOMYELITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SURGERY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTH EXTRACTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AREDIA</medicinalproduct>
        <drugauthorizationnumb>020036</drugauthorizationnumb>
        <drugindication>MULTIPLE MYELOMA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045855-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060310</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2006JP03879</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>66</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD ALBUMIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CALCIUM DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CHOLESTEROL INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CREATININE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD UREA INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD URINE PRESENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CREATININE RENAL CLEARANCE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FOCAL GLOMERULOSCLEROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEPHROTIC SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROTEINURIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARIMIDEX</medicinalproduct>
        <drugdosagetext>1 MG/D</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BREAST CANCER STAGE IV</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030801</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AREDIA</medicinalproduct>
        <drugauthorizationnumb>020036</drugauthorizationnumb>
        <drugdosagetext>90 MG EVERY 4 WEEKS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>METASTASES TO BONE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060220</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045856-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-BRISTOL-MYERS SQUIBB COMPANY-13428776</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>44</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>NEPHROLITHIASIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REYATAZ</medicinalproduct>
        <drugauthorizationnumb>021567</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ACQUIRED IMMUNODEFICIENCY SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050521</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045860-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050908</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>2005AC01313</companynumb>
    <primarysource>
      <reportercountry>BELGIUM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>18743</patientonsetage>
      <patientonsetageunit>804</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANOREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OESOPHAGITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IRESSA</medicinalproduct>
        <drugauthorizationnumb>21399</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>LIP AND/OR ORAL CAVITY CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050811</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050909</drugenddate>
        <drugtreatmentduration>30</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IRESSA</medicinalproduct>
        <drugauthorizationnumb>021399</drugauthorizationnumb>
        <drugdosagetext>RESTARTED AT REDUCED DOSE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050915</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ERBITUX</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>LIP AND/OR ORAL CAVITY CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050811</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050811</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ERBITUX</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050818</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050901</drugenddate>
        <drugtreatmentduration>15</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ERBITUX</medicinalproduct>
        <drugdosagetext>RESTARTED AT REDUCED DOSE</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050915</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DURAGESIC-100</medicinalproduct>
        <drugadministrationroute>003</drugadministrationroute>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MORPHINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045861-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006AC01231</companynumb>
    <primarysource>
      <reportercountry>BELGIUM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>13</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugauthorizationnumb>020639</drugauthorizationnumb>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugauthorizationnumb>020639</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugauthorizationnumb>020639</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIAZEPAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CHLOTIAPINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUANXOL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045862-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006PK01457</companynumb>
    <primarysource>
      <reportercountry>SWITZERLAND</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>55</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CHOLESTASIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugauthorizationnumb>020639</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BIPOLAR DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060405</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SOLIAN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BIPOLAR DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060121</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ESCITALOPRAM OXALATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BIPOLAR DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EDRONAX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BIPOLAR DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060302</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045863-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060630</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006AP03054</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>50</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IRESSA</medicinalproduct>
        <drugauthorizationnumb>021399</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>LUNG NEOPLASM MALIGNANT</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060401</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYANOCOBALAMIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045865-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006AP03008</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>22</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HYPOKALAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TONGUE PARALYSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSCAVIR</medicinalproduct>
        <drugauthorizationnumb>020068</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>HUMAN HERPESVIRUS 6 INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060616</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROGRAF</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060622</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ITRACONAZOLE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060610</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOVIRAX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060610</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OZEX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060613</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060617</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEUTROGIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060618</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060624</drugenddate>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
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    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045887-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060630</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AVENTIS-200615640US</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>19</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>HEPATIC FAILURE</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KETEK</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021144</drugauthorizationnumb>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
        <drugindication>PNEUMONIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060301</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045888-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060703</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-AVENTIS-200612375FR</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>AGRANULOCYTOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RIFATER</medicinalproduct>
        <drugdosagetext>DOSE UNIT: UNITS</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BONE TUBERCULOSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060202</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060320</drugenddate>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VASTEN</medicinalproduct>
        <drugauthorizationnumb>019901</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060320</drugenddate>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>STILNOX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060320</drugenddate>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MYAMBUTOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BONE TUBERCULOSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060202</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060320</drugenddate>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPEGIC 1000</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAMADOL HCL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
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    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045889-0</safetyreportid>
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    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
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    <receivedate>20060710</receivedate>
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    <receiptdate>20060313</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AVENTIS-200612419US</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>50</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN UPPER</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 ALBUMIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD ALKALINE PHOSPHATASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD BILIRUBIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRONCHITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BUDD-CHIARI SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATOCRIT INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC VEIN OCCLUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATOMEGALY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLEURAL EFFUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KETEK</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>21144</drugauthorizationnumb>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
        <drugindication>BRONCHITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACIPHEX</medicinalproduct>
        <drugindication>GASTROOESOPHAGEAL REFLUX DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROXYZINE</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
        <drugindication>URTICARIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMOXICILLIN</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMNICEF</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVELOX</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045890-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050407</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200511262FR</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>54</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>128</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ACUTE RESPIRATORY DISTRESS SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASCITES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRESSLER'S SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EOSINOPHILIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATOMEGALY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEUKOCYTOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOXIC SKIN ERUPTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KETEK</medicinalproduct>
        <drugauthorizationnumb>21144</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BRONCHIAL DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041029</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041118</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PYOSTACINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BRONCHIAL DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041118</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041126</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PYOSTACINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041118</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041126</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AUGMENTIN '125'</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BRONCHIAL DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041126</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041203</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045891-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060531</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-AVENTIS-200612028FR</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>39</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>80</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CYTOLYTIC HEPATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KETEK</medicinalproduct>
        <drugauthorizationnumb>21144</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060413</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060420</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CORTICOSTEROIDS</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AUGMENTIN '125'</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060406</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060413</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045892-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060619</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AVENTIS-200615359US</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ARRHYTHMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KETEK</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>21144</drugauthorizationnumb>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
        <drugindication>BRONCHITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KETEK</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021144</drugauthorizationnumb>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
        <drugindication>UPPER RESPIRATORY TRACT INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN DRUG</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045893-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060330</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AVENTIS-200613019US</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ALANINE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASPARTATE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BILIRUBIN CONJUGATED INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD ALKALINE PHOSPHATASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD BILIRUBIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CHLORIDE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CREATININE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD SODIUM DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD UREA DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHROMATURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JAUNDICE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPHOCYTE COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OCULAR ICTERUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RED BLOOD CELL SEDIMENTATION RATE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KETEK</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>21144</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SINUSITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060313</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060318</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugdosagetext>DOSE: UNKNOWN</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugdosagetext>DOSE: UNKNOWN</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLEGRA</medicinalproduct>
        <drugdosagetext>DOSE: UNKNOWN</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZYRTEC</medicinalproduct>
        <drugdosagetext>DOSE: UNKNOWN</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
        <drugdosagetext>DOSE: UNKNOWN</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
        <drugdosagetext>DOSE: UNKNOWN</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SSRI</medicinalproduct>
        <drugdosagetext>DOSE: UNKNOWN</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAXZIDE</medicinalproduct>
        <drugdosagetext>DOSE: UNKNOWN</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045898-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20060700391</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>ALANINE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXTRA STRENGTH TYLENOL</medicinalproduct>
        <drugbatchnumb>EDA041</drugbatchnumb>
        <drugauthorizationnumb>019872</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXTRA STRENGTH TYLENOL</medicinalproduct>
        <drugbatchnumb>EDA041</drugbatchnumb>
        <drugauthorizationnumb>019872</drugauthorizationnumb>
        <drugdosagetext>FOR UP TO 14 DAYS</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROMORPHONE HCL</medicinalproduct>
        <drugbatchnumb>03DLT21004</drugbatchnumb>
        <drugdosagetext>FOR UP TO 14 DAYS</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045899-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20060700392</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>ALANINE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASPARTATE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXTRA STRENGTH TYLENOL</medicinalproduct>
        <drugbatchnumb>EDA041</drugbatchnumb>
        <drugauthorizationnumb>019872</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXTRA STRENGTH TYLENOL</medicinalproduct>
        <drugbatchnumb>EDA041</drugbatchnumb>
        <drugauthorizationnumb>019872</drugauthorizationnumb>
        <drugdosagetext>FOR UP TO 14 DAYS</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045900-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060703</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AT-JNJFOC-20060700460</companynumb>
    <primarysource>
      <reportercountry>AUSTRIA</reportercountry>
      <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>CARDIAC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOXORUBICIN HCL</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOXORUBICIN HCL</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOXORUBICIN HCL</medicinalproduct>
        <drugauthorizationnumb>050718</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PAROXETINE HCL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXETACAINE/ALUMINUM HYDROXID</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BROTIZOLAM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INSOMNIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANTOPRAZOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CAPTOPRIL HYDROCHLOROTHIAZIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTONIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE/SPIRONOLACTONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ASCITES</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE/SPIRONOLACTONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTONIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETYLSALICYLIC ACID SRT</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CORONARY ARTERY DISEASE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045902-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060630</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-13430145</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>EYE INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KENALOG-40</medicinalproduct>
        <drugauthorizationnumb>014901</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045903-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-BRISTOL-MYERS SQUIBB COMPANY-13428347</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>59</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>LUNG INFECTION PSEUDOMONAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SHOCK</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MAXIPIME</medicinalproduct>
        <drugauthorizationnumb>050679</drugauthorizationnumb>
        <drugindication>FEBRILE NEUTROPENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051224</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045904-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060505</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>TH-GILEAD-2006-0009561</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>40</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ATRIAL TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CREATININE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOKALAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EMTRICITABINE/TENOFOVIR DISOPROXIL FUMARATE</medicinalproduct>
        <drugbatchnumb>72913</drugbatchnumb>
        <drugauthorizationnumb>21752</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060408</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EMTRICITABINE/TENOFOVIR DISOPROXIL FUMARATE</medicinalproduct>
        <drugbatchnumb>72913</drugbatchnumb>
        <drugauthorizationnumb>021752</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050919</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060407</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SAQUINAVIR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050919</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RITONAVIR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050919</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COTRIMOXAZOLE</medicinalproduct>
        <drugdosagetext>400/80 MG</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060124</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060405</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COTRIMOXAZOLE</medicinalproduct>
        <drugdosagetext>800/160 MG</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050820</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051221</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUCONAZOLE</medicinalproduct>
        <drugindication>INFECTION PROPHYLAXIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045907-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-JNJFOC-20060700013</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG WITHDRAWAL SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DURAGESIC-100</medicinalproduct>
        <drugauthorizationnumb>019813</drugauthorizationnumb>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>NEURALGIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GABAPENTIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>NEURALGIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045908-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20060701002</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>36</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>48.99</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG ADMINISTRATION ERROR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG WITHDRAWAL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THERAPEUTIC RESPONSE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DURAGESIC-100</medicinalproduct>
        <drugadministrationroute>062</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DURAGESIC-100</medicinalproduct>
        <drugadministrationroute>062</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DURAGESIC-100</medicinalproduct>
        <drugadministrationroute>062</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DURAGESIC-100</medicinalproduct>
        <drugauthorizationnumb>019813</drugauthorizationnumb>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCODONE</medicinalproduct>
        <drugdosagetext>FOUR TIMES PER DAY/ORAL</drugdosagetext>
        <drugindication>BREAKTHROUGH PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KLONIPIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPAMAX</medicinalproduct>
        <drugindication>NEURALGIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ROBAXIN</medicinalproduct>
        <drugindication>MUSCLE SPASMS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045909-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060630</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20060701049</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>74.84</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>OSTEOARTHRITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DURAGESIC-100</medicinalproduct>
        <drugbatchnumb>0604308</drugbatchnumb>
        <drugauthorizationnumb>019813</drugauthorizationnumb>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>PAIN</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045915-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-JNJFOC-20060700051</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>PSYCHOTIC DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMINYL</medicinalproduct>
        <drugauthorizationnumb>21169</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045916-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060630</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-JNJFOC-20060600046</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>71</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG ABUSER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN LACERATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HALDOL</medicinalproduct>
        <drugauthorizationnumb>15923</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045917-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060630</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-JNJFOC-20051006030</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>AGITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HALLUCINATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESTLESSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TIC</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CONCERTA</medicinalproduct>
        <drugauthorizationnumb>21121</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATTENTION DEFICIT/HYPERACTIVITY DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045918-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-JNJFOC-20060405321</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRADYCARDIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ITRACONAZOLE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ITRACONAZOLE</medicinalproduct>
        <drugauthorizationnumb>020083</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>FUNGAL SKIN INFECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARVEDILOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060418</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BENIDIPINE HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060418</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOXAZOSIN MESYLATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060418</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FAMOTIDINE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OLMESARTAN MEDOXOMIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060418</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOXOPROFEN SODIUM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060309</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CHLORHEXIDINE GLUCONATE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060309</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CEFOTIAM HEXETYL HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060309</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANOCONAZOLE</medicinalproduct>
        <drugadministrationroute>061</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060414</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045919-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-JNJFOC-20060504756</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>IRON DEFICIENCY ANAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ITRACONAZOLE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ITRACONAZOLE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ITRACONAZOLE</medicinalproduct>
        <drugauthorizationnumb>020083</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NAIL TINEA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045924-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060620</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006AP02879</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>25673</patientonsetage>
      <patientonsetageunit>804</patientonsetageunit>
      <patientweight>67</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD UREA INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE CONGESTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugauthorizationnumb>21366</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERCHOLESTEROLAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060120</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACTOS</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060125</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MYOCARDIAL INFARCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060117</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MYOCARDIAL INFARCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060117</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANCARON</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>VENTRICULAR TACHYCARDIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060118</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADJUST A</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONSTIPATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060120</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060303</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045925-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060703</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-JNJFOC-20060602240</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>78</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DEMENTIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPRINEL CAP</medicinalproduct>
        <drugauthorizationnumb>20897</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>URGE INCONTINENCE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CAPTOPRIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMARYL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OSYROL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CIBACEN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045926-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PL-JNJFOC-20060603502</companynumb>
    <primarysource>
      <reportercountry>POLAND</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABORTION SPONTANEOUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLACENTAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PREGNANCY ON ORAL CONTRACEPTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CILEST</medicinalproduct>
        <drugauthorizationnumb>19653</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONTRACEPTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOPAMAX</medicinalproduct>
        <drugauthorizationnumb>020505</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>EPILEPSY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BIOXETIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045927-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060630</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20060700414</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>32</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>90.72</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ORTHO EVRA</medicinalproduct>
        <drugauthorizationnumb>021180</drugauthorizationnumb>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045932-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-JNJFOC-20060606514</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>4</patientonsetage>
      <patientonsetageunit>800</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>C-REACTIVE PROTEIN INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugdosagetext>2 INFUSIONS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ANKYLOSING SPONDYLITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045933-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-JNJFOC-20060700097</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>51</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HODGKIN'S DISEASE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045934-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060627</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-JNJFOC-20060100163</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>127.01</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL DISTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ALCOHOLISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BIPOLAR DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHOLELITHIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIABETES MELLITUS NON-INSULIN-DEPENDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSLIPIDAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EXTRAPYRAMIDAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC ENZYME INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATOSPLENOMEGALY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SLUGGISHNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STOMACH DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDE ATTEMPT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UMBILICAL HERNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERDAL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERDAL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERDAL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERDAL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERDAL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERDAL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERDAL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERDAL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERDAL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERDAL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERDAL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERDAL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERDAL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERDAL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BIPOLAR DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERDAL</medicinalproduct>
        <drugauthorizationnumb>020272</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PSYCHOTIC DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LITHIUM CARBONATE</medicinalproduct>
        <drugindication>BIPOLAR DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LITHIUM CARBONATE</medicinalproduct>
        <drugdosagetext>DOSE INCREASED FROM 900 MG TO 1800 MG DAILY</drugdosagetext>
        <drugindication>MOOD ALTERED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PAROXETINE HCL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PAROXETINE HCL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PAROXETINE HCL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PAROXETINE HCL</medicinalproduct>
        <drugdosagetext>TOOK 10 OR MORE TABLETS</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PAROXETINE HCL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PAROXETINE HCL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PAROXETINE HCL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLURAZEPAM</medicinalproduct>
        <drugdosagetext>15-30 MG</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLURAZEPAM</medicinalproduct>
        <drugindication>INSOMNIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CITALOPRAM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORAZEPAM</medicinalproduct>
        <drugindication>ANXIETY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMOVANE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMOVANE</medicinalproduct>
        <drugdosagetext>TOOK 10 OR MORE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMOVANE</medicinalproduct>
        <drugdosagetext>TOOK 30 TABLETS</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMOVANE</medicinalproduct>
        <drugdosagetext>7.5 MG AT BEDTIME, AS NEEDED</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMOVANE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INSOMNIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugdosagetext>DOSAGE FROM 200 MG DAILY GRADUALLY INCREASED TO 1200 MG DAILY.</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUPHENAZINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUPHENAZINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUPHENAZINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOAFFECTIVE DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TEGRETOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WELLBUTRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
        <drugdosagetext>DOSE INCREASED FROM 50 MG TO 100 MG DAILY</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COGENTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COGENTIN</medicinalproduct>
        <drugindication>MUSCULOSKELETAL STIFFNESS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045935-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060627</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CH-JNJFOC-20060606094</companynumb>
    <primarysource>
      <reportercountry>SWITZERLAND</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>49</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>STATUS EPILEPTICUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERDAL</medicinalproduct>
        <drugauthorizationnumb>020272</drugauthorizationnumb>
        <drugindication>SCHIZOPHRENIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>QUETIAPINE FUMARATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BIPERIDEN HYDROCHLORIDE TAB</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045936-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-JNJFOC-20050804935</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABORTION SPONTANEOUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PROLACTIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIABETES MELLITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVERDOSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERDAL</medicinalproduct>
        <drugauthorizationnumb>20272</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045937-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-JNJFOC-20060606518</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>54.8</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>AGRANULOCYTOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEBRILE INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HOSPITALISATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERDAL</medicinalproduct>
        <drugauthorizationnumb>020272</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONFUSIONAL STATE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060427</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060503</drugenddate>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIFEDIPINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MELNEURIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONFUSIONAL STATE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045938-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060703</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-JNJFOC-20060700126</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>47</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD CREATININE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCYTOPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERDAL</medicinalproduct>
        <drugauthorizationnumb>020272</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060531</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060615</drugenddate>
        <drugtreatmentduration>16</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NOVATREX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TERCIAN</medicinalproduct>
        <drugdosagetext>DOSE INCREASED</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TERCIAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TEMESTA</medicinalproduct>
        <drugdosagetext>DOSE INCREASED</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TEMESTA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045939-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-JNJFOC-20060700140</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>5</patientonsetage>
      <patientonsetageunit>800</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD PROLACTIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GALACTORRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PITUITARY TUMOUR BENIGN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERDAL CONSTA</medicinalproduct>
        <drugauthorizationnumb>021346</drugauthorizationnumb>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045940-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060701</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-JNJFOC-20060700537</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG ABUSER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCORRECT ROUTE OF DRUG ADMINISTRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEDICATION ERROR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VERTIGO</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERDAL CONSTA</medicinalproduct>
        <drugauthorizationnumb>21346</drugauthorizationnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COCAINE</medicinalproduct>
        <drugadministrationroute>045</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SPEED</medicinalproduct>
        <drugadministrationroute>045</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045946-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060703</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>DE-JNJFOC-20060602202</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>77</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>SWELLING FACE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWOLLEN TONGUE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZALDIAR</medicinalproduct>
        <drugauthorizationnumb>21123</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045947-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060630</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-JNJFOC-20060401408</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>22</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>OSTEOPOROSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOPAMAX</medicinalproduct>
        <drugauthorizationnumb>20505</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>EPILEPSY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045948-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20060701146</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG WITHDRAWAL SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRAMADOL HCL</medicinalproduct>
        <drugauthorizationnumb>020281</drugauthorizationnumb>
        <drugindication>DRUG WITHDRAWAL SYNDROME</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045953-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050930</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHO2005JP15535</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>79</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>42</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERSTITIAL LUNG DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLEURAL EFFUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRODUCTIVE COUGH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
        <drugauthorizationnumb>21283</drugauthorizationnumb>
        <drugdosagetext>40MG DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040119</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040219</drugenddate>
        <drugtreatmentduration>46080</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BUFFERIN</medicinalproduct>
        <drugdosagetext>81MG DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010209</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ISOSORBIDE MONONITRATE</medicinalproduct>
        <drugdosagetext>40MG DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010209</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TICLOPIDINE HCL</medicinalproduct>
        <drugdosagetext>200MG DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010209</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045954-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060531</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHO2006JP08957</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>73</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
        <drugauthorizationnumb>20665</drugauthorizationnumb>
        <drugdosagetext>80 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030409</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TENORMIN</medicinalproduct>
        <drugdosagetext>50 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEVALOTIN</medicinalproduct>
        <drugdosagetext>10 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERCHOLESTEROLAEMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMARYL</medicinalproduct>
        <drugdosagetext>2 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LENDORMIN</medicinalproduct>
        <drugdosagetext>0.25 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INSOMNIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugdosagetext>20 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CARDIAC FAILURE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SELBEX</medicinalproduct>
        <drugdosagetext>1.5 G</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTRITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045955-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060329</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2006JP04850</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>68</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>65</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ATRIAL FIBRILLATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLEURAL EFFUSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
        <drugauthorizationnumb>21283</drugauthorizationnumb>
        <drugdosagetext>80 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060206</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060209</drugenddate>
        <drugtreatmentduration>5760</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
        <drugauthorizationnumb>021283</drugauthorizationnumb>
        <drugdosagetext>80 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060118</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060206</drugenddate>
        <drugtreatmentduration>28800</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045956-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060529</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2006JP08123</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>62</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDE ATTEMPT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
        <drugauthorizationnumb>21283</drugauthorizationnumb>
        <drugdosagetext>1200 MG, ONCE/SINGLE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CALBLOCK</medicinalproduct>
        <drugdosagetext>5 TABLETS IN ONCE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045962-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-AVENTIS-200612359FR</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>77</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CAUDA EQUINA SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EXTRADURAL HAEMATOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LOVENOX</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060123</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060127</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LOVENOX</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060128</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045963-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060704</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-AVENTIS-200612388FR</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>46</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>COLITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MELANOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARAVA</medicinalproduct>
        <drugauthorizationnumb>20905</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060529</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045964-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060607</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-AVENTIS-200612028JP</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>35</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PSEUDO-BARTTER SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugauthorizationnumb>016273</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045965-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060607</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-AVENTIS-200612027JP</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>31</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EATING DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERURICAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOKALAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE TWITCHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEPHROLITHIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSEUDO-BARTTER SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugauthorizationnumb>016273</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045966-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060705</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-AVENTIS-200611965DE</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABORTION INDUCED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARAVA</medicinalproduct>
        <drugauthorizationnumb>020905</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045967-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060525</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-AVENTIS-200612977EU</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG ABUSER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
        <drugauthorizationnumb>16273</drugauthorizationnumb>
        <drugdosagetext>DOSE: UNKNOWN DOSE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIURETIC THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
        <drugauthorizationnumb>016273</drugauthorizationnumb>
        <drugdosagetext>DOSE: UNKNOWN DOSE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>WEIGHT CONTROL</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LAXATIVES</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045968-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060621</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-AVENTIS-200611931JP</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>78</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PEMPHIGOID</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugauthorizationnumb>16273</drugauthorizationnumb>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050620</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugauthorizationnumb>016273</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050803</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045969-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-BRISTOL-MYERS SQUIBB COMPANY-13429154</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>76</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BRADYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERKALAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL ACUITY REDUCED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LOPRIL TABS</medicinalproduct>
        <drugauthorizationnumb>74472</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALDALIX</medicinalproduct>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060601</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIGOXIN</medicinalproduct>
        <drugdosagetext>DAILY DOSE: 0.20 MG ^1/4^ PER DAY</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060607</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060601</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LESCOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LERCAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVLOCARDYL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SINTROM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPEGIC 1000</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NOVOMIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VOLTAREN</medicinalproduct>
        <drugindication>BACK PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060603</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045970-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-13426945</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>51</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ORENCIA</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045971-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060404</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-13335708</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>87</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>AMNESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BALANCE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISORIENTATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL DISTURBANCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZERIT</medicinalproduct>
        <drugauthorizationnumb>20412</drugauthorizationnumb>
        <drugdosagetext>THERAPY START DATE: 1997 OR 1998</drugdosagetext>
        <drugindication>HIV INFECTION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030801</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIDEX</medicinalproduct>
        <drugauthorizationnumb>020154</drugauthorizationnumb>
        <drugdosagetext>THERAPY START DATE: 1997 OR 1998</drugdosagetext>
        <drugindication>HIV INFECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIRACEPT</medicinalproduct>
        <drugdosagetext>THERAPY START DATE: 1997 OR 1998</drugdosagetext>
        <drugindication>HIV INFECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EPIVIR</medicinalproduct>
        <drugindication>HIV INFECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIREAD</medicinalproduct>
        <drugindication>HIV INFECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CENTRUM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045983-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesscongenitalanomali>1</seriousnesscongenitalanomali>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060630</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-JNJFOC-20060700193</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABNORMAL PALMAR/PLANTAR CREASES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSMORPHISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSYCHOMOTOR RETARDATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEMAP</medicinalproduct>
        <drugindication>DRUG EXPOSURE DURING PREGNANCY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HALOPERIDOL</medicinalproduct>
        <drugauthorizationnumb>015923</drugauthorizationnumb>
        <drugadministrationroute>064</drugadministrationroute>
        <drugindication>DRUG EXPOSURE DURING PREGNANCY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUANXOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LARGACTIL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5045998-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060524</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-GILEAD-2006-0009641</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>63.2</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CENTRAL NERVOUS SYSTEM LESION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERAL PHYSICAL HEALTH DETERIORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMMUNE RECONSTITUTION SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPHOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOXOPLASMOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRUVADA</medicinalproduct>
        <drugauthorizationnumb>21752</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060410</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SAQUINAVIR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060410</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RITONAVIR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060410</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SEPTRA</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATIVAN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RISPERIDONE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060110</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5046019-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060630</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHNU2006DE02418</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>68</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ILEUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SURGERY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FEMARA</medicinalproduct>
        <drugauthorizationnumb>020726</drugauthorizationnumb>
        <drugdosagetext>2.5 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BREAST CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060530</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5046020-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060505</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHFR2006GB01643</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>64</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MUSCLE CONTRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL STIFFNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADALAT - SLOW RELEASE</medicinalproduct>
        <drugdosagetext>10MG DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MIZOLASTINE</medicinalproduct>
        <drugdosagetext>10MG/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LACTULOSE</medicinalproduct>
        <drugdosagetext>10 ML, TID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYMBICORT TURBUHALER</medicinalproduct>
        <drugdosagetext>2 OT, BID</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NASONEX</medicinalproduct>
        <drugdosagetext>2 OT, QD</drugdosagetext>
        <drugadministrationroute>061</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MIZOLASTINE</medicinalproduct>
        <drugdosagetext>10 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FEMARA</medicinalproduct>
        <drugauthorizationnumb>020726</drugauthorizationnumb>
        <drugdosagetext>4 MG, QD</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060503</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060504</drugenddate>
        <drugtreatmentduration>2880</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FEMARA</medicinalproduct>
        <drugauthorizationnumb>020726</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060515</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5046021-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHO2006DE10549</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG INFILTRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELLCEPT</medicinalproduct>
        <drugdosagetext>1000 MG/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RENAL TRANSPLANT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>URBASON</medicinalproduct>
        <drugdosagetext>10 MG/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RENAL TRANSPLANT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OPTORAL</medicinalproduct>
        <drugauthorizationnumb>050715</drugauthorizationnumb>
        <drugdosagetext>250 MG/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RENAL TRANSPLANT</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5046022-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060627</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2006IT10027</companynumb>
    <primarysource>
      <reportercountry>ITALY</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>58</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>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>CONJUNCTIVAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CYTOMEGALOVIRUS INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATOCRIT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATOTOXICITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HERPES ZOSTER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEPHROPATHY TOXIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RED BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL LYMPHOCELE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SCEDOSPORIUM INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN ULCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUBCUTANEOUS ABSCESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TENDON RUPTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOSPORINE</medicinalproduct>
        <drugauthorizationnumb>50574</drugauthorizationnumb>
        <drugdosagetext>3 MG/KG/D</drugdosagetext>
        <drugindication>RENAL TRANSPLANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19950201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISONE (NGX)</medicinalproduct>
        <drugdosagetext>8 MG/D</drugdosagetext>
        <drugindication>RENAL TRANSPLANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19950201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ANTITHYMOCYTE IMMUNOGLOBULIN (RABBIT)</medicinalproduct>
        <drugindication>RENAL TRANSPLANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19950201</drugstartdate>
        <drugtreatmentduration>10080</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VORICONAZOLE</medicinalproduct>
        <drugdosagetext>6 MG/KG, BID</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VORICONAZOLE</medicinalproduct>
        <drugdosagetext>3 MG/KG, BID</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VORICONAZOLE</medicinalproduct>
        <drugdosagetext>200 MG, BID</drugdosagetext>
        <drugtreatmentduration>91</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VORICONAZOLE</medicinalproduct>
        <drugdosagetext>150 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugtreatmentduration>91</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VORICONAZOLE</medicinalproduct>
        <drugdosagetext>150 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugtreatmentduration>91</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5046023-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060616</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2006US07899</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>50</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>MALIGNANT NEOPLASM PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTH EXTRACTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugauthorizationnumb>21223</drugauthorizationnumb>
        <drugindication>METASTASES TO BONE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CAMPTOSAR</medicinalproduct>
        <drugdosagetext>600MG Q6WK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5046024-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060614</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2006US07854</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>64</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>77.551</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BIOPSY KIDNEY ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CREATININE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIALYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEPHRITIS INTERSTITIAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugauthorizationnumb>021223</drugauthorizationnumb>
        <drugdosagetext>4 UNK, ONCE/SINGLE</drugdosagetext>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060405</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACTONEL</medicinalproduct>
        <drugdosagetext>35MG QWK</drugdosagetext>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060417</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRONOLACTONE</medicinalproduct>
        <drugdosagetext>100MG UNK</drugdosagetext>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060417</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLTX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FENTANYL TRANSDERMAL SYSTEM</medicinalproduct>
        <drugdosagetext>50MCG UNK</drugdosagetext>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060215</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060417</drugenddate>
        <drugtreatmentduration>89280</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVANDAMET</medicinalproduct>
        <drugdosagetext>200MG UNK</drugdosagetext>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060417</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5046028-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-GILEAD-2006-0009826</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>70</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>GENERAL PHYSICAL HEALTH DETERIORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METABOLIC ACIDOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIREAD</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060329</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060502</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZIAGEN</medicinalproduct>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060502</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KALETRA</medicinalproduct>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060502</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BACTRIM</medicinalproduct>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050601</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5046029-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060630</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IE-GILEAD-2006-0009825</companynumb>
    <primarysource>
      <reportercountry>IRELAND</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>17</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>37</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UNDERWEIGHT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRUVADA</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050705</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5046030-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060707</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-SANOFI-SYNTHELABO-F01200601615</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>66</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>53</patientweight>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>LEUKOPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TIENAM</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050322</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050322</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CALCIUM LEVOFOLINATE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060320</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060320</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUOROURACIL</medicinalproduct>
        <drugdosagetext>550MG/BODY/195MG/M2 IN BOLS FOLLOWED BY 3300 MG/BODY/2340 MG/M2 CONTINUOUS INFUSION</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060320</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060320</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXALIPLATIN</medicinalproduct>
        <drugauthorizationnumb>021492</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLON CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060320</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060320</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>805</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5046036-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060627</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-SANOFI-SYNTHELABO-A03200604192</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DELIRIUM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIALYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCLONUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEMEROL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>005010</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>COLITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VERAPAMIL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLEXERIL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FELDENE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5046037-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060619</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-SANOFI-SYNTHELABO-F01200601485</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL FISTULA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POST PROCEDURAL COMPLICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WOUND COMPLICATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CAPECITABINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060512</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060530</drugenddate>
        <drugtreatmentduration>19</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVASTIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060512</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060609</drugenddate>
        <drugtreatmentduration>29</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORTAB</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060530</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060530</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COLACE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060526</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060531</drugenddate>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREVACID</medicinalproduct>
        <drugbatchnumb>Y</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060615</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060511</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060531</drugenddate>
        <drugtreatmentduration>21</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXALIPLATIN</medicinalproduct>
        <drugauthorizationnumb>021492</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLORECTAL CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060512</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060609</drugenddate>
        <drugtreatmentduration>29</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5046038-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2006US08485</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugauthorizationnumb>021223</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AREDIA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5046039-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060622</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2006US08242</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>63</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BONE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FISTULA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GINGIVITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOFT TISSUE INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWELLING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugauthorizationnumb>21223</drugauthorizationnumb>
        <drugdosagetext>4 MG EVERY MONTH</drugdosagetext>
        <drugindication>METASTASES TO BONE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020531</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060331</drugenddate>
        <drugtreatmentduration>1401</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XELODA</medicinalproduct>
        <drugdosagetext>100 MG BID FOR 14 DAYS</drugdosagetext>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060331</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FEMARA</medicinalproduct>
        <drugdosagetext>2.5 MG, QD</drugdosagetext>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060331</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORTAB</medicinalproduct>
        <drugdosagetext>UNK, PRN</drugdosagetext>
        <drugindication>BACK PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20011001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALDACTONE</medicinalproduct>
        <drugdosagetext>UNK, QD</drugdosagetext>
        <drugindication>CARDIAC FAILURE CONGESTIVE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20011001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>UNK, QD</drugdosagetext>
        <drugindication>CORONARY ARTERY DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EFFEXOR</medicinalproduct>
        <drugdosagetext>75 MG, QD</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050701</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5046040-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060413</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHRM2006FR01362</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>84</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>66</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FISTULA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUCOSAL ULCERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugauthorizationnumb>21223</drugauthorizationnumb>
        <drugdosagetext>4 MG, QMO</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AREDIA</medicinalproduct>
        <drugdosagetext>90 MG EVERY 6 WEEKS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20011101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALKERAN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20011101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALKERAN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050801</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THALIDOMIDE</medicinalproduct>
        <drugdosagetext>200 MG/DAY</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050901</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5046041-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041210</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHO2004FI17572</companynumb>
    <primarysource>
      <reportercountry>FINLAND</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>71</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>60</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOLEDRONIC ACID VS PLACEBO</medicinalproduct>
        <drugauthorizationnumb>021223</drugauthorizationnumb>
        <drugdosagetext>DOUBLE-BLIND</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>OSTEOPOROTIC FRACTURE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041209</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KALCIPOS-D</medicinalproduct>
        <drugindication>OSTEOPOROTIC FRACTURE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5046042-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-SANOFI-SYNTHELABO-A02200601709</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GLOMERULONEPHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROTEINURIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugauthorizationnumb>020839</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5046047-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060704</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-SANOFI-SYNTHELABO-A02200601764</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>52</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>54</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>AGRANULOCYTOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VERAPAMIL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NOROXIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CYSTITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060527</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060531</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLINORAL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>COLON CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060529</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060529</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUOROURACILE TEVA</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLON CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060529</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060530</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ELOXATIN</medicinalproduct>
        <drugauthorizationnumb>021759</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLON CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060529</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060529</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5046048-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GR-SANOFI-SYNTHELABO-A01200604935</companynumb>
    <primarysource>
      <reportercountry>GREECE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>71</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>LEUKOCYTOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PETECHIAE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POLYARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugauthorizationnumb>020839</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CORONARY ARTERY DISEASE</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060601</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugauthorizationnumb>020839</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANGIOPLASTY</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060601</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5046049-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060601</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHO2006SE08798</companynumb>
    <primarysource>
      <reportercountry>SWEDEN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>89</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FEMORAL NECK FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HIP ARTHROPLASTY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOLEDRONIC ACID VS PLACEBO</medicinalproduct>
        <drugauthorizationnumb>21223</drugauthorizationnumb>
        <drugdosagetext>5 MG, ONCE YEARLY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>OSTEOPOROTIC FRACTURE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050905</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugdosagetext>5 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>POLYMYALGIA RHEUMATICA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM CARBONATE</medicinalproduct>
        <drugindication>OSTEOPOROTIC FRACTURE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
        <drugindication>OSTEOPOROTIC FRACTURE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
        <drugdosagetext>25 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5046050-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060626</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHNU2006DE02380</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>RESUSCITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugauthorizationnumb>021223</drugauthorizationnumb>
        <drugdosagetext>4 MG, ONCE/SINGLE</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugauthorizationnumb>021223</drugauthorizationnumb>
        <drugdosagetext>4 MG, ONCE/SINGLE</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060601</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5046066-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060707</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>76</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>72.5</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5046067-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006UW13628</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>80</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COORDINATION ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CASODEX</medicinalproduct>
        <drugauthorizationnumb>020498</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LUPRON</medicinalproduct>
        <drugdosagetext>EVERY FOUR MONTHS</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040401</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5046068-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060420</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006AP01857</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>26801</patientonsetage>
      <patientonsetageunit>804</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>INTERSTITIAL LUNG DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CASODEX</medicinalproduct>
        <drugauthorizationnumb>20498</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROSTATE CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060119</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060418</drugenddate>
        <drugtreatmentduration>90</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CASODEX</medicinalproduct>
        <drugauthorizationnumb>020498</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>METASTASES TO BONE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060119</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060418</drugenddate>
        <drugtreatmentduration>90</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEUPLIN</medicinalproduct>
        <drugdosagetext>THIRD INJECTION GIVEN ON 29 MARCH 2006</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PROSTATE CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060329</drugenddate>
        <drugtreatmentduration>57</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEUPLIN</medicinalproduct>
        <drugdosagetext>THIRD INJECTION GIVEN ON 29 MARCH 2006</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>METASTASES TO BONE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060329</drugenddate>
        <drugtreatmentduration>57</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GASTER</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MUCOSTA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NU-LOTAN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OEDEMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NEPHROTIC SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060314</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INTERSTITIAL LUNG DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060314</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5046069-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060707</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>60</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>99.6</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANGIONEUROTIC OEDEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5046070-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060707</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>54</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>73.8</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HEPATOTOXICITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CASPOFUNGIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5046071-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20060606712</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BASAL CELL CARCINOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>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>METHOTREXATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARAVA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NAPROSYN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADVAR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLOMAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZANTAC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORTAB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROZAC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE TAB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLARINEX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5046072-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20060606713</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </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>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM GLUCONATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCODONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE TAB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTIVITAMIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5046073-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20060606740</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>57</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CUTANEOUS TUBERCULOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5046074-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20060606743</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DISSEMINATED TUBERCULOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CROHN'S DISEASE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5046075-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20060606747</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5046076-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060228</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-GLAXOSMITHKLINE-B0413861A</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>57</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABNORMAL FAECES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FAECES DISCOLOURED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLATULENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NICABATE CQ 4MG LOZENGE</medicinalproduct>
        <drugbatchnumb>X2274</drugbatchnumb>
        <drugauthorizationnumb>21330</drugauthorizationnumb>
        <drugdosagetext>4MG SEVEN TIMES PER DAY</drugdosagetext>
        <drugadministrationroute>002</drugadministrationroute>
        <drugindication>SMOKING CESSATION THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060623</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VENTOLIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SERETIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NICOTINE</medicinalproduct>
        <drugadministrationroute>062</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060601</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5046077-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060707</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>62</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>94.8</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANGIONEUROTIC OEDEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5046078-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AVENTIS-200615580US</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIMB INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL CELL CARCINOMA STAGE UNSPECIFIED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021081</drugauthorizationnumb>
        <drugdosagetext>DOSE UNIT: UNITS</drugdosagetext>
        <drugindication>DIABETES MELLITUS NON-INSULIN-DEPENDENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OPTICLIK (INSULIN INJECTION PEN)</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021081</drugauthorizationnumb>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN DRUG</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5046079-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060630</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AVENTIS-200615649US</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>69</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE CONGESTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THIRST</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021081</drugauthorizationnumb>
        <drugdosagetext>DOSE UNIT: UNITS</drugdosagetext>
        <drugindication>DIABETES MELLITUS NON-INSULIN-DEPENDENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPROL-XL</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ISOSORBIDE</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOPHAGE</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOTROL</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5046080-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060605</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-AVENTIS-200611715JP</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>74</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOGLYCAEMIC COMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMARYL</medicinalproduct>
        <drugauthorizationnumb>20496</drugauthorizationnumb>
        <drugdosagetext>DOSE: 1 TABLET</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060603</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CIPROXAN</medicinalproduct>
        <drugdosagetext>DOSE: 3 TABLETS</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>POSTOPERATIVE WOUND INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060529</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060603</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CIPROXAN</medicinalproduct>
        <drugdosagetext>DOSE: 3 TABLETS</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060529</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060603</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACTOS</medicinalproduct>
        <drugdosagetext>DOSE: 1 TABLET</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugdosagetext>DOSE: 1 TABLET</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NU-LOTAN</medicinalproduct>
        <drugdosagetext>DOSE: 1 TABLET</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugdosagetext>DOSE: 1 TABLET</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERLIPIDAEMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VASOLAN</medicinalproduct>
        <drugdosagetext>DOSE: 3 TABLETS</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
        <drugdosagetext>DOSE: 2 TABLETS</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERURICAEMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANIRAPID</medicinalproduct>
        <drugdosagetext>DOSE: 1 TABLET</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CARDIAC FAILURE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5046081-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesscongenitalanomali>1</seriousnesscongenitalanomali>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050804</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200512795FR</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>3.22</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PREMATURE BABY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENTRICULAR SEPTAL DEFECT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
        <drugauthorizationnumb>21081</drugauthorizationnumb>
        <drugadministrationroute>064</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041102</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HUMALOG</medicinalproduct>
        <drugadministrationroute>064</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELESTENE</medicinalproduct>
        <drugadministrationroute>064</drugadministrationroute>
        <drugindication>PREMATURE LABOUR</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELESTENE</medicinalproduct>
        <drugadministrationroute>064</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROX</medicinalproduct>
        <drugindication>THYROID NEOPLASM</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5046082-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060313</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DK-AVENTIS-200612462GDDC</companynumb>
    <primarysource>
      <reportercountry>DENMARK</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>54</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>61</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>21081</drugauthorizationnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051104</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAIN-KILLERS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NOVORAPID</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041012</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHADONE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORAZEPAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCODONE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAMADOLE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5046083-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050601</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-AVENTIS-200511644JP</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>30</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>56</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DIABETIC RETINOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VITREOUS HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
        <drugauthorizationnumb>021081</drugauthorizationnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>DIABETES MELLITUS INSULIN-DEPENDENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031226</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OPTIPEN (INSULIN PUMP)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HUMALOG</medicinalproduct>
        <drugdosagetext>DOSE: 13 - 17 UNITS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20011005</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5046084-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060502</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0605USA00586</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>59</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>RETINAL DETACHMENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>20560</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060501</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IODINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPOTHYROIDISM</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROGESTERONE</medicinalproduct>
        <drugadministrationroute>061</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEGA-3 MARINE TRIGLYCERIDES</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>PREMARIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5046085-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060705</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0607USA00663</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>74</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PELVIC FRACTURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060401</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5046086-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0606USA05751</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>GASTRIC ULCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HELICOBACTER INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>20560</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5046087-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-MERCK-0607USA00151</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>85</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSED LEVEL OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOMPERIDONE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>NAUSEA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060626</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060630</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRIMAXIN</medicinalproduct>
        <drugauthorizationnumb>050587</drugauthorizationnumb>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>PNEUMONIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060614</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060628</drugenddate>
        <drugtreatmentduration>15</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VANCOMYCIN HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PNEUMONIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060619</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060627</drugenddate>
        <drugtreatmentduration>9</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5046088-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0606USA05353</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>55</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLINDNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL DISTURBANCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>[THERAPY UNSPECIFIED]</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SINGULAIR</medicinalproduct>
        <drugauthorizationnumb>020829</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHINITIS ALLERGIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5046089-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060615</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-MERCK-0606USA03241</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>60</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHROMATURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHABDOMYOLYSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugauthorizationnumb>19766</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERLIPIDAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060530</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060606</drugenddate>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060410</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NU-LOTAN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060529</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>[THERAPY UNSPECIFIED]</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060410</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060614</drugenddate>
        <drugtreatmentduration>66</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOXOPROFEN SODIUM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060410</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060614</drugenddate>
        <drugtreatmentduration>66</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MYONAL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060410</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060614</drugenddate>
        <drugtreatmentduration>66</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5046090-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060707</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>66.7</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>RHABDOMYOLYSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LOVASTATIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5046091-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060707</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>61</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>49.7</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANGIONEUROTIC OEDEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5046092-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060707</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>135</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CHILLS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OXYGEN SATURATION DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CISPLATIN</medicinalproduct>
        <drugdosagetext>50MG/M2 IV DAY 2 CYCLES REPEATED EVERY 3 WEEKS X6</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAXOL</medicinalproduct>
        <drugdosagetext>135 MG/M2 IV OVER 24 HOURS</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5046093-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20060606625</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>RENAL CELL CARCINOMA STAGE UNSPECIFIED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE TAB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BEXTRA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEVACOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARDURA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM GLUCONATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5046094-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20060606688</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>81.65</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIVERTICULITIS</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>HYDROCHLOROTHIAZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENICAR</medicinalproduct>
        <drugdosagetext>DOSE: 20/12</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5046095-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20060606710</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>NEPHROLITHIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN CANCER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONAZEPAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROPRANOLOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>STUDY MEDICATION.</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5046096-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20060606711</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BREAST CANCER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BONIVA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DHEA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-ENZYMES</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM GLUCONATE</medicinalproduct>
        <drugdosagetext>220 MG 5 TABLETS DAILY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOSAMINE/MSM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CHONDROITIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GROWTH HORMONE</medicinalproduct>
        <drugindication>CARDIAC DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XALATAN</medicinalproduct>
        <drugdosagetext>.005 DAILY</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5046097-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20060606580</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>LUNG NEOPLASM MALIGNANT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPROL-XL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SULFASALAZINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZANTAC</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>DARVOCET-N 100</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACTONEL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MIACALCIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MOBIC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5046098-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20060606620</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</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>DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NIFEDIPINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLEGRA</medicinalproduct>
        <drugindication>PREMEDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5046099-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-JNJFOC-20060606655</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>INFUSION RELATED REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYODERMA GANGRENOSUM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH PRURITIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URTICARIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugdosagetext>9TH INFUSION</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugdosagetext>8 INFUSIONS ON UNKNOWN DATES</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5046100-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20060604513</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5046101-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-JNJFOC-20060600349</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>62</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PUSTULAR PSORIASIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugindication>CROHN'S DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PARIET</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTRIC ULCER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDONINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BEHCET'S SYNDROME</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDONINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CROHN'S DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PENTASA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BEHCET'S SYNDROME</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PENTASA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CROHN'S DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MOBIC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRALGIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BENET</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LENDORMIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INSOMNIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5046102-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20060503287</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>80.29</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CATARACT OPERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CYSTITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSKINESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5046103-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060705</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0607USA00334</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5046104-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060627</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-MERCK-0606USA05694</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>30</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <reaction>
        <reactionmeddrapt>ALANINE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANTINUCLEAR ANTIBODY INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASPARTATE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD BILIRUBIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SINGULAIR</medicinalproduct>
        <drugauthorizationnumb>20829</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050824</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060301</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUTIDE</medicinalproduct>
        <drugadministrationroute>055</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEPTIN</medicinalproduct>
        <drugadministrationroute>055</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNIPHYL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NOSCAPINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050926</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ONON</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050926</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5046105-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060501</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0605USA00531</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>83</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>86</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ASPARTATE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMODIALYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATOTOXICITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHABDOMYOLYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WRONG TECHNIQUE IN DRUG USAGE PROCESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugauthorizationnumb>19766</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>LIPIDS INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060301</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVATOL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRILOSEC</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRINZIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPROL-XL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5046106-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20051114</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-MERCK-0511USA02270</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>44</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANGIONEUROTIC OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEUKOCYTOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SMALL INTESTINE CARCINOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRINIVIL</medicinalproduct>
        <drugauthorizationnumb>19558</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041005</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041005</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>QUINAPRIL HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19920101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040801</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5046109-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060707</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>49.5</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBRAL ISCHAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULAR WEAKNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5046113-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060707</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>12.4</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>BILIRUBIN CONJUGATED INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD BILIRUBIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATOMEGALY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JAUNDICE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENOOCCLUSIVE LIVER DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CISPLATIN</medicinalproduct>
        <drugdosagetext>43.4 MG</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOPHOSPHAMIDE</medicinalproduct>
        <drugdosagetext>800 MG</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ETOPOSIDE</medicinalproduct>
        <drugdosagetext>189 MG  (1,7MG/M2=21MG/DAY)</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VINCRISTINE SULFATE</medicinalproduct>
        <drugdosagetext>.8 MG GIVEN D1 AND D8</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5046116-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060630</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-JNJFOC-20060700057</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>22</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>71</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>C-REACTIVE PROTEIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HOT FLUSH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLAMMATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFUSION RELATED REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RADICULAR PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROAT TIGHTNESS</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>DAFALGAN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEBRIDAT</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRIMPERAN TAB</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RIVOTRIL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMUREL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5046118-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060630</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-JNJFOC-20060700117</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>101</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HUMERUS FRACTURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</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>ARCOXIA</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN W/ CODEINE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REMEDEINE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5046119-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20060700312</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOVEMENT DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugindication>PSORIATIC ARTHROPATHY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5046120-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20060700376</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>TEMPORAL ARTERITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5046121-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060707</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>93</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FEBRILE NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CISPLATIN</medicinalproduct>
        <drugdosagetext>75MG/M2 PER IV TOTAL 158MG</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAXOTERE</medicinalproduct>
        <drugdosagetext>75MG/M2 IV TOTAL 158 MG</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5046127-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060707</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>94</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BACTERIAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CATHETER RELATED INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEVACIZUMAB (GENENTECH)</medicinalproduct>
        <drugdosagetext>947MG  QOW   IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>GLIOBLASTOMA MULTIFORME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060518</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEVACIZUMAB (GENENTECH)</medicinalproduct>
        <drugdosagetext>947MG  QOW   IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>GLIOBLASTOMA MULTIFORME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEVACIZUMAB (GENENTECH)</medicinalproduct>
        <drugdosagetext>947MG  QOW   IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>GLIOBLASTOMA MULTIFORME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060615</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEVACIZUMAB (GENENTECH)</medicinalproduct>
        <drugdosagetext>947MG  QOW   IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>GLIOBLASTOMA MULTIFORME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060629</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IRINOTECAN (PFIZER)</medicinalproduct>
        <drugdosagetext>727MG  QOW   IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>GLIOBLASTOMA MULTIFORME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060518</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IRINOTECAN (PFIZER)</medicinalproduct>
        <drugdosagetext>727MG  QOW   IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>GLIOBLASTOMA MULTIFORME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IRINOTECAN (PFIZER)</medicinalproduct>
        <drugdosagetext>727MG  QOW   IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>GLIOBLASTOMA MULTIFORME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060615</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IRINOTECAN (PFIZER)</medicinalproduct>
        <drugdosagetext>727MG  QOW   IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>GLIOBLASTOMA MULTIFORME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060629</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DILANTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LAMICTAL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPAMAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEXAPRO</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMBIEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYLENOL (CAPLET)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PERCOCET</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMODIUM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5046132-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060707</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>70</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>77.1115</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MUSCULAR WEAKNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugdosagetext>20MG  1XDAILY   PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060110</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5046134-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060707</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>113</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CASTLEMAN'S DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CELLULITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HODGKIN'S DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOBILITY DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE NECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOSITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEPHROGENIC FIBROSING DERMOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NON-HODGKIN'S LYMPHOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GADOLINIUM MRI CONTRAST DYE</medicinalproduct>
        <drugindication>ABSCESS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060425</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060425</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GADOLINIUM MRI CONTRAST DYE</medicinalproduct>
        <drugindication>MUSCLE NECROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060425</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060425</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GADOLINIUM MRI CONTRAST DYE</medicinalproduct>
        <drugindication>ABSCESS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060521</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060521</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GADOLINIUM MRI CONTRAST DYE</medicinalproduct>
        <drugindication>MUSCLE NECROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060521</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060521</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5046137-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060707</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>35</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>83.9154</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BODY TEMPERATURE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING COLD</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NERVOUS SYSTEM DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANIC ATTACK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TENDON DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVAQUIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CIPRO</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5046141-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060707</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>49</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>86.1834</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THERAPEUTIC RESPONSE UNEXPECTED WITH DRUG SUBSTITUTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CITALOPRAM      20MG      AUROBINDO</medicinalproduct>
        <drugdosagetext>1   DAILY    PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SYNCOPE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060704</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060704</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5046144-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20060700255</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANGINA PECTORIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OBSTRUCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYLENOL (CAPLET)</medicinalproduct>
        <drugdosagetext>4 TABS AS NEEDED</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAALOX FAST BLOCKER</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5046145-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20060700256</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BREAST CANCER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </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>AVAPRO</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DYAZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ELAVIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPROL-XL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VICODIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XALATAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM GLUCONATE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5046146-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20060700257</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY DISEASE</reactionmeddrapt>
      </reaction>
      <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>AZULFADINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYZAAR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5046147-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060707</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>48</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>84.8226</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>AMNESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEMIPARESIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NICODERM CQ</medicinalproduct>
        <drugdosagetext>1 PATCH OF 21MG    1 PER DAY    TRANSDERMAL</drugdosagetext>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>SMOKING CESSATION THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060412</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060524</drugenddate>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5046150-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060707</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>2</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLISTER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN EXFOLIATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THERMAL BURN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EX-LAX MAXIMUM STRENGTH -BY PHON     SENNA 25 MG    NOVARTIS</medicinalproduct>
        <drugdosagetext>75 MG MAXIMUM    ONE TIME  PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ACCIDENTAL DRUG INTAKE BY CHILD</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060703</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060703</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5046153-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060707</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>40</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>70.3075</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JOINT SWELLING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVAQUIN</medicinalproduct>
        <drugdosagetext>500MG    1 PER DAY    PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060627</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060704</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5046158-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20060700278</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLINDNESS TRANSIENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTRAOCULAR PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL ACUITY REDUCED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOPAMAX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOPAMAX</medicinalproduct>
        <drugauthorizationnumb>020505</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MIGRAINE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZYRTEC</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5046159-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060630</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20060700846</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>16</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ORTHO EVRA</medicinalproduct>
        <drugauthorizationnumb>021180</drugauthorizationnumb>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040601</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5046173-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20060606583</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CEREBELLAR TUMOUR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADVIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OSCAL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5046174-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20060606621</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>113.4</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENINGITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPRINOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KLOR-CON</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHROID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MONOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE TAB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRONOLACTONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPROL-XL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROTONIX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5046175-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20060700232</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENAZEPRIL HYDROCHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NAPROXEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE TAB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CORAL CALCIUM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5046187-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20060606581</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY DISEASE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BONIVA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COZAAR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOXYL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NITROGLYCERIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACTOS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIABETA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROTONIX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5046188-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-JNJFOC-20060700320</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>57</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHILLS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFUSION RELATED REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</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>
        <drugdosagetext>DOSE NUMBER 4-8 GIVEN ON UNSPECIFIED DATES.</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>2</drugcharacterization>
        <medicinalproduct>METOLATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALESION</medicinalproduct>
        <drugdosagetext>1 TAB</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PREMEDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADRENAL HORMONE PREPARATIONS</medicinalproduct>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDONINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RIMATIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MUCOSTA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEPAS</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALFAROL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5046201-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20060606708</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>SQUAMOUS 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>PREDNISONE TAB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VICODIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MORPHINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KLONAPIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENADRYL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL SPIROS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5046203-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20060700231</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DIVERTICULITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NIFEDIPINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHROID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENALAPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOPHAGE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLIPIZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM WITH VITAMIN D</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN E</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROTONIX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5046218-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060707</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>25</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>57.6068</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH PAPULAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH PRURITIC</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOXYCYCLINE</medicinalproduct>
        <drugdosagetext>100 MG   ONE TIME DOSE   PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060606</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060606</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5046221-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060405</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006UW06066</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>26268</patientonsetage>
      <patientonsetageunit>804</patientonsetageunit>
      <patientweight>125</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BONE DENSITY DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CAROTID ARTERY STENOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMMINUTED FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FRACTURE DISPLACEMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UPPER LIMB FRACTURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugauthorizationnumb>020639</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SLEEP DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060226</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060228</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GABITRIL</medicinalproduct>
        <drugdosagetext>1 MG QAM,1MG QNOON,2MG QPM PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACTOS</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM CHLORIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KLONOPIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ULTRAM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HUMULIN 70/30</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOPID</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LUPRON</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5046225-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060707</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>59</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BALANCE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE ORTHOSTATIC ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISION BLURRED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SPIRONOLACTONE</medicinalproduct>
        <drugdosagetext>25 MG PO QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CARDIAC FAILURE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060414</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060428</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
        <drugdosagetext>40MG PO BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CARDIAC FAILURE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060414</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060428</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAZODONE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALDACTONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NITROGLYCERIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ISOSORBIDE DINITRATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZETIA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIGOXIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARVEDILOL</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>PREDNISONE TAPER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MUCINEX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5046229-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060707</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>58</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PANCYTOPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALEMTUZUMAB INJECTION   30MG</medicinalproduct>
        <drugdosagetext>30MG  MON-WED-FRI  SQ</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>CHRONIC LYMPHOCYTIC LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060310</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060412</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MORPHINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AZITHROMYCIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AUGMENTIN '125'</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALGANCICLOVIR HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOCUSATE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5046230-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20020926</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>12054714</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>17</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DIABETES MELLITUS INSULIN-DEPENDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERLIPIDAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCREATITIS HAEMORRHAGIC</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EFAVIRENZ</medicinalproduct>
        <drugauthorizationnumb>20972</drugauthorizationnumb>
        <drugdosagetext>STOPPED 20-SEP-2002 RESTARTED 13-MAR-2003.</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20001114</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIDEX</medicinalproduct>
        <drugauthorizationnumb>020154</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ACQUIRED IMMUNODEFICIENCY SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19991001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20000502</drugenddate>
        <drugtreatmentduration>215</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZERIT</medicinalproduct>
        <drugauthorizationnumb>020412</drugauthorizationnumb>
        <drugdosagetext>STOPPED FEB 17-1999, RESTARTED 12-SEP-1999</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ACQUIRED IMMUNODEFICIENCY SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19970911</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020920</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZERIT</medicinalproduct>
        <drugauthorizationnumb>020412</drugauthorizationnumb>
        <drugdosagetext>STOPPED FEB 17-1999, RESTARTED 12-SEP-1999</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19970911</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020920</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INVIRASE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ACQUIRED IMMUNODEFICIENCY SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990902</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20001113</drugenddate>
        <drugtreatmentduration>439</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NORVIR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ACQUIRED IMMUNODEFICIENCY SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990902</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20001113</drugenddate>
        <drugtreatmentduration>439</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMIVUDINE</medicinalproduct>
        <drugdosagetext>STOPPED 31OCT1999 STARTED 26JUN2000 TO 28JAN2000, STOPPED 20SEP2002 RESTARTED 27FEB2003</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19981101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOXONIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19970901</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SELBEX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19970901</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIFLUCAN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19950302</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BAKTAR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19950422</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FACTOR IX COMPLEX</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19981101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20000502</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZIDOVUDINE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030227</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CAMOSTAT MESYLATE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5046232-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060413</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-13347190</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>70</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>112</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN DISCOLOURATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URTICARIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEFINITY</medicinalproduct>
        <drugbatchnumb>4556-1</drugbatchnumb>
        <drugauthorizationnumb>21064</drugauthorizationnumb>
        <drugadministrationroute>040</drugadministrationroute>
        <drugindication>ULTRASOUND SCAN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060412</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BETAPACE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPROL-XL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARDIZEM</medicinalproduct>
        <drugdosagetext>ROUTE OF ADMINISTRATION: IV AND THEN ORAL.</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5046233-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060703</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-BRISTOL-MYERS SQUIBB COMPANY-13432299</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>79</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIVERTICULUM INTESTINAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROENTERITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROTHROMBIN LEVEL DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RECTAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SHOCK</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
        <drugauthorizationnumb>9218</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060612</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>CIFLOX</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>GASTROENTERITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060609</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060610</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>CIFLOX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060611</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060614</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5046235-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060704</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-BRISTOL-MYERS SQUIBB COMPANY-13434378</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>72</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>72</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>SPONTANEOUS HAEMATOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>APROVEL TABS 300 MG</medicinalproduct>
        <drugauthorizationnumb>20757</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DERMOVAL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ESIDRIX</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FONX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LOCOID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MYCOSTER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060601</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CIALIS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SINOVIAL</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060301</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5046237-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-13427463</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>35</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>COMPLETED SUICIDE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY RETENTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BUSPAR</medicinalproduct>
        <drugauthorizationnumb>018731</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5046238-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040323</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-BRISTOL-MYERS SQUIBB COMPANY-12546339</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>34</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD ALKALINE PHOSPHATASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CACHEXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CALCULUS URINARY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CREATININE RENAL CLEARANCE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ELECTROLYTE IMBALANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAMMA-GLUTAMYLTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERLIPIDAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EFAVIRENZ</medicinalproduct>
        <drugauthorizationnumb>20972</drugauthorizationnumb>
        <drugdosagetext>10-MAR-2000 TO 27-OCT-2000, RESTARTED 30-JAN-2001 CONTINUED</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000310</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INDINIVIR SULFATE</medicinalproduct>
        <drugdosagetext>2.4 GRAMS DAILY FROM 31-AUG-1998 TO 09-SEP-1998, RESTARTED 10-MAR-2000</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980831</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20001027</drugenddate>
        <drugtreatmentduration>242</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RITONAVIR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000310</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20001027</drugenddate>
        <drugtreatmentduration>232</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ABACAVIR SULFATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010130</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SULFAMETHOXAZOLE + TRIMETHOPRIM</medicinalproduct>
        <drugdosagetext>0.15GM19DEC00,0.6GM20DEC-00,0.7GM21-DEC-00,0.8GM22-DEC-00,960MG22-DEC-00,960MG3XDAY13JAN01TO19 MAR02</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20001219</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020319</drugenddate>
        <drugtreatmentduration>431</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LOPINAVIR + RITONAVIR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010130</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLARITHROMYCIN</medicinalproduct>
        <drugdosagetext>STOPPED 01-DEC-1998 AND RESTARTED AT 800 MG DAILY ON 28-OCT-2000</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MYCOBACTERIUM AVIUM COMPLEX INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19981008</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ETHAMBUTOL HYDROCHLORIDE</medicinalproduct>
        <drugdosagetext>500 MG DAILY 25-OCT-98 TO 01-DEC-98 AND 12-DEC-98 TO 14-JUN-99, 250 MG X2DAY 28-OCT-00 TO 2001</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MYCOBACTERIUM AVIUM COMPLEX INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19981025</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20011130</drugenddate>
        <drugtreatmentduration>399</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DENOSINE</medicinalproduct>
        <drugdosagetext>5 MGX2/D 2/15-3/6/2000, 5 MG/D 3/7-4/2/2000, 5 MGX2/D 4/3-4/24/2000, 5 MG/D 4/25-4/26/2000</drugdosagetext>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>CYTOMEGALOVIRUS CHORIORETINITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000215</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20000426</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSCAVIR</medicinalproduct>
        <drugdosagetext>180MG 25JAN-14FEB, 90MG 15FEB-03MAR2000, 98MG 04APR-06APR, 65MG 07APR-26APR2000</drugdosagetext>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>CYTOMEGALOVIRUS CHORIORETINITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000125</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20000426</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCORTISONE</medicinalproduct>
        <drugdosagetext>23JUN00TO27OCT00,03OCT00TO11MAY00,29OCT00TO02OCT01,12MAY02TO20AUG02,21AUG02TO18MAR03,19MAR03</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000407</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCORTISONE SODIUM PHOSPHATE</medicinalproduct>
        <drugdosagetext>22-MAR-00 TO 25-MAR-00, 26-MAR-00 TO 27-MAR-00, 28-MAR-00 TO 30-MAR-00, 31-MAR-00 TO 06-APR-00</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000322</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20000406</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROXYZINE HCL</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000102</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20000501</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LAMIVUDINE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000831</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20001118</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MORPHINE HCL</medicinalproduct>
        <drugdosagetext>^28-DEC-99 TO 14-MAR-00, 02-JAN-00 TO 01-MAY-00, 15-MAR-00 CONTINUED^</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19991228</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000310</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20000321</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RIFAMPIN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20001028</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010213</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ROXITHROMYCIN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000131</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20001027</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZIDOVUDINE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000831</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20000909</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CIPROFLOXACIN HCL</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20001119</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020220</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXTROSE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000102</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20000301</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXTROSE 5% + ELECTROLYTES</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000125</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010207</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5046240-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DK-BRISTOL-MYERS SQUIBB COMPANY-13434725</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>62</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ASPARTATE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD LACTATE DEHYDROGENASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISORIENTATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERNATIONAL NORMALISED RATIO INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SINEMET</medicinalproduct>
        <drugauthorizationnumb>019856</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PARKINSONISM</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060615</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5046241-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-BRISTOL-MYERS SQUIBB COMPANY-12630117</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>67</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CACHEXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLORECTAL CANCER METASTATIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPTIC SHOCK</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ERBITUX</medicinalproduct>
        <drugdosagetext>REC'D 5 INFUSIONS</drugdosagetext>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>COLORECTAL CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040525</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040622</drugenddate>
        <drugtreatmentduration>28</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IRINOTECAN</medicinalproduct>
        <drugdosagetext>REC'D 5 INFUSIONS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLORECTAL CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040525</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040622</drugenddate>
        <drugtreatmentduration>28</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5046242-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040917</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-BRISTOL-MYERS SQUIBB COMPANY-12711859</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>62</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>JAUNDICE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ERBITUX</medicinalproduct>
        <drugdosagetext>MOST RECENT INFUSION ON 09-SEP-04.</drugdosagetext>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>COLORECTAL CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040624</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IRINOTECAN</medicinalproduct>
        <drugdosagetext>MOST RECENT INFUSION ON 09-SEP-04.</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLORECTAL CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040902</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040902</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PARACETAMOL</medicinalproduct>
        <drugindication>PAIN</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040916</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5046246-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060707</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>55</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>74.8435</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD CHLORIDE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD SODIUM DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EPISTAXIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATOCRIT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOUTH HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUCOSAL INFLAMMATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL INTAKE REDUCED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RED BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TARCEVA</medicinalproduct>
        <drugbatchnumb>P424101</drugbatchnumb>
        <drugdosagetext>150MG PO QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>LARYNGEAL CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060702</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CISPLATIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5046254-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20051114</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHO2005US17849</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>64</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABSCESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYDRONEPHROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCISION SITE COMPLICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>KIDNEY TRANSPLANT REJECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERINEPHRIC COLLECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL ARTERY STENOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEROMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY RETENTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLOMAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOXAZOSIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TACROLIMUS</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RENAL TRANSPLANT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOSPORINE</medicinalproduct>
        <drugauthorizationnumb>050715</drugauthorizationnumb>
        <drugdosagetext>50 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RENAL TRANSPLANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050302</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MYCOPHENOLATE MOFETIL</medicinalproduct>
        <drugdosagetext>500 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RENAL TRANSPLANT</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050908</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MYCOPHENOLATE MOFETIL</medicinalproduct>
        <drugdosagetext>1000 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050302</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISONE TAB</medicinalproduct>
        <drugdosagetext>25 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RENAL TRANSPLANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050302</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050306</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050306</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050328</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCITRIOL</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050306</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARDURA</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050306</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LUNESTA</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050815</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREVACID</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050517</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050316</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLOTRIMAZOLE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050316</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050316</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SEPTRA</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050316</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GABAPENTIN</medicinalproduct>
        <drugdosagetext>UNK, UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050316</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5046255-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060627</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHO2006AU10389</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>65</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL DISTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HALLUCINATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ILEUS PARALYTIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>KIDNEY TRANSPLANT REJECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SURGERY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINE OUTPUT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NO TREATMENT RECEIVED NOMED</medicinalproduct>
        <drugdosagetext>NO TREATMENT</drugdosagetext>
        <drugindication>RENAL TRANSPLANT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEORAL</medicinalproduct>
        <drugauthorizationnumb>050715</drugauthorizationnumb>
        <drugdosagetext>800 MG / DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RENAL TRANSPLANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060620</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060626</drugenddate>
        <drugtreatmentduration>10080</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MYFORTIC</medicinalproduct>
        <drugdosagetext>720 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RENAL TRANSPLANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060620</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NITRAZEPAM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5046263-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060707</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>51</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>66.8</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALIGNANT NEOPLASM PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METASTASES TO CENTRAL NERVOUS SYSTEM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ERBITUX</medicinalproduct>
        <drugdosagetext>250MG/M2, IV WKLY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060614</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALIMTA</medicinalproduct>
        <drugdosagetext>500MG/M2, IV, Q3W</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060531</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5046269-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060707</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>67</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>50.8029</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEBRILE NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINE ANALYSIS ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GLEEVEC</medicinalproduct>
        <drugdosagetext>300 MG PO BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>LEIOMYOSARCOMA METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060523</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAXOL</medicinalproduct>
        <drugdosagetext>100 MG/M2 IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060523</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5046271-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060509</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2006JP06915</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>62</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>43</patientweight>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ALANINE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASPARTATE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD LACTATE DEHYDROGENASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISSEMINATED INTRAVASCULAR COAGULATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTI-ORGAN FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PURPURA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugauthorizationnumb>21223</drugauthorizationnumb>
        <drugdosagetext>4 MG, ONCE/SINGLE</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>METASTASES TO BONE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060428</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060428</drugenddate>
        <drugtreatmentduration>1440</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUOROURACIL</medicinalproduct>
        <drugdosagetext>500 MG, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>METASTASES TO LUNG</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060105</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060505</drugenddate>
        <drugtreatmentduration>121</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CISPLATIN</medicinalproduct>
        <drugdosagetext>5 MG, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>METASTASES TO LUNG</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060107</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060505</drugenddate>
        <drugtreatmentduration>119</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5046272-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20051114</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHNU2005DE03765</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>62</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>75</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE TRIMMING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FACIAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMPAIRED HEALING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOCAL ANAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLASTIC SURGERY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTH EXTRACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>X-RAY ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FEMARA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugdosagetext>4 MG, QMO</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>METASTASES TO BONE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040323</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050802</drugenddate>
        <drugtreatmentduration>498</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RADIOTHERAPY</medicinalproduct>
        <drugdosagetext>40 IU, UNK</drugdosagetext>
        <drugadministrationroute>061</drugadministrationroute>
        <drugindication>METASTASES TO BONE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040503</drugenddate>
        <drugtreatmentduration>47520</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5046273-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-JNJFOC-20060701195</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>6</patientonsetage>
      <patientonsetageunit>800</patientonsetageunit>
      <patientweight>70</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BREAST CANCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VAGINAL INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GYNO DAKTARIN</medicinalproduct>
        <drugauthorizationnumb>17450</drugauthorizationnumb>
        <drugdosagetext>SPORADIC USE</drugdosagetext>
        <drugadministrationroute>067</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMPICILLIN</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLINDAMYCIN HCL</medicinalproduct>
        <drugadministrationroute>067</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASCORBIC ACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN E</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
        <drugdosagetext>3-4 YEARS</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5046275-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060707</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>180.078</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>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5046280-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060707</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>56.6996</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ROXICODONE</medicinalproduct>
        <drugdosagetext>30 MG 2 PO TID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5046281-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060525</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-13390257</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>20</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ACUTE RESPIRATORY DISTRESS SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERSTITIAL LUNG DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NORMAL NEWBORN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PREGNANCY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ABILIFY</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BIPOLAR DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050321</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060226</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EFFEXOR</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>STEROIDS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5046282-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20060700311</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>60.78</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>TUBERCULOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugindication>CROHN'S DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>6-MP</medicinalproduct>
        <drugdosagetext>PRIOR USE AND LESS THAN 3 MONTHS</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5046295-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050815</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0508USA02593</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>54</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>59</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BONE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EXOSTOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>20560</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19981009</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050809</drugenddate>
        <drugtreatmentduration>2497</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5046296-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060614</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006GB01014</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>23665</patientonsetage>
      <patientonsetageunit>804</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugauthorizationnumb>021366</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERCHOLESTEROLAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060611</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060614</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CORONARY ARTERY DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PIOGLITAZONE HCL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060501</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INDAPAMIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EPROSARTAN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DYSPEPSIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLIMEPIRIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5046298-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006GB01114</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>56</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CIRCULATORY COLLAPSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPINAL COMPRESSION FRACTURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
        <drugauthorizationnumb>018240</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060419</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5046299-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060630</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006UW13863</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>21553</patientonsetage>
      <patientonsetageunit>804</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>GRAND MAL CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPONATRAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHABDOMYOLYSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugauthorizationnumb>21366</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040418</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051007</drugenddate>
        <drugtreatmentduration>538</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DITROPAN XL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCODONE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5046300-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060616</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006SE03433</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>684</patientonsetage>
      <patientonsetageunit>802</patientonsetageunit>
      <patientweight>80</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DYSGEUSIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BLOPRESS PLUS</medicinalproduct>
        <drugauthorizationnumb>21093</drugauthorizationnumb>
        <drugdosagetext>CANDESARTAN CILEXETIL 8 MG HYDROCHLOROTHIAZIDE 12.5 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050101</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BLOPRESS PLUS</medicinalproduct>
        <drugauthorizationnumb>021093</drugauthorizationnumb>
        <drugdosagetext>CANDESARTAN CILEXETIL 16 MG HYDROCHLOROTHIAZIDE 12.5 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5046317-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-MERCK-0607USA00128</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>81</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>GENERALISED OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>STROMECTOL</medicinalproduct>
        <drugauthorizationnumb>050742</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ACARODERMATITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060620</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060620</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CABASER</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PARKINSON'S DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SINEMET</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PARKINSON'S DISEASE</drugindication>
      </drug>
    </patient>
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  <safetyreport>
    <safetyreportid>5046318-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0606USA05810</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>63</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANGIONEUROTIC OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANTINUCLEAR ANTIBODY POSITIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN REACTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VYTORIN</medicinalproduct>
        <drugauthorizationnumb>021687</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACIPHEX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
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  <safetyreport>
    <safetyreportid>5046331-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0606USA05721</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <patientonsetage>99</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>86</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>STOMATITIS NECROTISING</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>20560</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5046332-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060209</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0602USA02465</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>AORTIC ANEURYSM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DECREASED ACTIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VYTORIN</medicinalproduct>
        <drugauthorizationnumb>21687</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050901</drugenddate>
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    </patient>
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  <safetyreport>
    <safetyreportid>5046333-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050819</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0508USA03377</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>70</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>52</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>GINGIVAL ULCERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOWER LIMB FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050201</drugenddate>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020101</drugenddate>
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  <safetyreport>
    <safetyreportid>5046334-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
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    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060518</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
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    <primarysource>
      <reportercountry>IRELAND</reportercountry>
      <qualification>1</qualification>
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    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <patientonsetage>45</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERONEAL NERVE PALSY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GLEEVEC</medicinalproduct>
        <drugauthorizationnumb>21588</drugauthorizationnumb>
        <drugdosagetext>600 MG/D</drugdosagetext>
        <drugindication>CHRONIC MYELOID LEUKAEMIA</drugindication>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GLEEVEC</medicinalproduct>
        <drugauthorizationnumb>021588</drugauthorizationnumb>
        <drugdosagetext>600 MG, QD</drugdosagetext>
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        <drugstartdate>20030701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031215</drugenddate>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GLEEVEC</medicinalproduct>
        <drugauthorizationnumb>021588</drugauthorizationnumb>
        <drugdosagetext>400 MG, QD</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031216</drugstartdate>
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    <safetyreportid>5046335-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
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    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
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    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
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    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>2</qualification>
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    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <patientonsetage>7</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <reaction>
        <reactionmeddrapt>ELECTROCARDIOGRAM ST-T SEGMENT ABNORMAL</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GLEEVEC</medicinalproduct>
        <drugauthorizationnumb>021588</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>ACUTE LYMPHOCYTIC LEUKAEMIA</drugindication>
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  <safetyreport>
    <safetyreportid>5046336-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
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    <companynumb>PHBS2006BE10031</companynumb>
    <primarysource>
      <reportercountry>BELGIUM</reportercountry>
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    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <patientonsetage>49</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMPLEX REGIONAL PAIN SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GLEEVEC</medicinalproduct>
        <drugauthorizationnumb>021588</drugauthorizationnumb>
        <drugdosagetext>400 MG/D</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CHRONIC MYELOID LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051202</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5046337-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20031107</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2003US10329</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>78</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BIOPSY BONE MARROW ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPHOPROLIFERATIVE DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GLEEVEC</medicinalproduct>
        <drugauthorizationnumb>21588</drugauthorizationnumb>
        <drugdosagetext>400 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CHRONIC MYELOID LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020901</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DARVOCET</medicinalproduct>
        <drugdosagetext>2 DF, Q4H</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RITUXAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5046338-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040604</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHO2004US08110</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>73</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>82.7</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN LOWER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ATRIAL FLUTTER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIVERTICULITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATOCRIT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC STEATOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTESTINAL RESECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RECTAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRANSAMINASES INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMATINIB VS PLACEBO</medicinalproduct>
        <drugauthorizationnumb>21588</drugauthorizationnumb>
        <drugdosagetext>600 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROSTATE CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040517</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040531</drugenddate>
        <drugtreatmentduration>21600</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMBIEN</medicinalproduct>
        <drugindication>INSOMNIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040416</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040516</drugenddate>
        <drugtreatmentduration>44640</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM GLUCONATE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031124</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031124</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugindication>OSTEOARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040105</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DECADRON</medicinalproduct>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040408</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DITROPAN XL</medicinalproduct>
        <drugindication>URINARY TRACT INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040416</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTIVITAMIN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030807</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRILOSEC</medicinalproduct>
        <drugindication>GASTROOESOPHAGEAL REFLUX DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040408</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCODONE HCL</medicinalproduct>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040510</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030807</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COMPAZINE</medicinalproduct>
        <drugindication>NAUSEA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040521</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAXOTERE</medicinalproduct>
        <drugdosagetext>30 MG/M2, QW</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PROSTATE CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040517</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040531</drugenddate>
        <drugtreatmentduration>21600</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5046339-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060630</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2006US08505</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>73</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL HERNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABSCESS INTESTINAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLOSTOMY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIVERTICULAR PERFORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ENTEROCOCCAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCISIONAL HERNIA REPAIR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERIORBITAL OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERITONITIS BACTERIAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SIGMOIDECTOMY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GLEEVEC</medicinalproduct>
        <drugauthorizationnumb>21588</drugauthorizationnumb>
        <drugdosagetext>400 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CHRONIC MYELOID LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GLEEVEC</medicinalproduct>
        <drugauthorizationnumb>021588</drugauthorizationnumb>
        <drugdosagetext>400 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050823</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
        <drugdosagetext>100 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
        <drugdosagetext>0.1 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPOTHYROIDISM</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
        <drugdosagetext>5 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COLCHICINE</medicinalproduct>
        <drugdosagetext>0.6 MG, Q2H PRN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREVACID</medicinalproduct>
        <drugdosagetext>30 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETYLSALICYLIC ACID SRT</medicinalproduct>
        <drugdosagetext>81 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTACID LIQUID PLUS SIMETHICONE</medicinalproduct>
        <drugdosagetext>30 ML, Q4-6H, PRN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COLACE</medicinalproduct>
        <drugdosagetext>100 MG, BID, PRN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5046341-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060622</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2006IT09558</companynumb>
    <primarysource>
      <reportercountry>ITALY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>39</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DIABETIC RETINOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEUKAEMIC RETINOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MACULAR OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RETINAL ISCHAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RETINAL NEOVASCULARISATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VITREOUS HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GLEEVEC</medicinalproduct>
        <drugauthorizationnumb>21588</drugauthorizationnumb>
        <drugdosagetext>400 MG/D</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CHRONIC MYELOID LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060504</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060518</drugenddate>
        <drugtreatmentduration>21600</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5046342-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060630</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2006JP09969</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>50</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>EOSINOPHILIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GLEEVEC</medicinalproduct>
        <drugauthorizationnumb>021588</drugauthorizationnumb>
        <drugdosagetext>400 MG/D</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CHRONIC MYELOID LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060417</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060608</drugenddate>
        <drugtreatmentduration>76320</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5046348-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-MERCK-0602USA02034</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>79</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>COLD TYPE HAEMOLYTIC ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCYTOPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEPCID RPD</medicinalproduct>
        <drugauthorizationnumb>20752</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>REFLUX OESOPHAGITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030228</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050816</drugenddate>
        <drugtreatmentduration>901</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEPCID RPD</medicinalproduct>
        <drugauthorizationnumb>020752</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050830</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060131</drugenddate>
        <drugtreatmentduration>155</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COZAAR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050823</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060131</drugenddate>
        <drugtreatmentduration>162</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MUCOSTA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030228</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060131</drugenddate>
        <drugtreatmentduration>1069</drugtreatmentduration>
        <drugtreatmentdurationunit></drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAKEPRON</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>REFLUX OESOPHAGITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030128</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060310</drugenddate>
        <drugtreatmentduration>1138</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5046349-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060704</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PT-MERCK-0607PRT00005</companynumb>
    <primarysource>
      <reportercountry>PORTUGAL</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>40</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>SKIN REACTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MONTELUKAST SODIUM</medicinalproduct>
        <drugauthorizationnumb>20829</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5046350-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-MERCK-0607USA00111</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>73</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DELIRIUM TREMENS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSED LEVEL OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HALLUCINATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERCALCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>STROMECTOL</medicinalproduct>
        <drugauthorizationnumb>50742</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ACARODERMATITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060517</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060517</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VITAMIN D (UNSPECIFIED)</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIMAS</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUVOXAMINE MALEATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PARLODEL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYMMETREL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GASCON</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BUFFERIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LENDORMIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PURSENNID</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RISPERDAL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SINEMET</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMOBAN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAKEPRON</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGNESIUM OXIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5046352-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060217</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHRM2006FR00829</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>74</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>OPTIC NEUROPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RETINAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RETINAL VASCULAR DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SCOTOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VASCULAR OCCLUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL ACUITY REDUCED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GLEEVEC</medicinalproduct>
        <drugauthorizationnumb>21588</drugauthorizationnumb>
        <drugdosagetext>400 MG DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CHRONIC MYELOID LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5046353-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060623</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHRM2006FR01983</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>60</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD CREATINE PHOSPHOKINASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER FUNCTION TEST ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHABDOMYOLYSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GLEEVEC</medicinalproduct>
        <drugauthorizationnumb>021588</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CHRONIC MYELOID LEUKAEMIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5046354-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060616</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHO2006TH09795</companynumb>
    <primarysource>
      <reportercountry>THAILAND</reportercountry>
      <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>HYPOGLYCAEMIC COMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GLEEVEC</medicinalproduct>
        <drugauthorizationnumb>021588</drugauthorizationnumb>
        <drugdosagetext>400MG DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTROINTESTINAL STROMAL TUMOUR</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050729</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060527</drugenddate>
        <drugtreatmentduration>303</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5046355-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041028</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHO2004US15330</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>65</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>CHEST TUBE INSERTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG INFILTRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMOTHORAX</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRODUCTIVE COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY DISTRESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRICUSPID VALVE INCOMPETENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHEEZING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PEPCID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVENOX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAXOTERE</medicinalproduct>
        <drugdosagetext>30 MG/M2</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PROSTATE CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040816</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041018</drugenddate>
        <drugtreatmentduration>92160</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMATINIB VS PLACEBO</medicinalproduct>
        <drugauthorizationnumb>021588</drugauthorizationnumb>
        <drugdosagetext>600 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROSTATE CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040816</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041022</drugenddate>
        <drugtreatmentduration>97920</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5046363-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060706</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>85</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>65</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>APHASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSED LEVEL OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGE INTRACRANIAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTRACRANIAL HAEMATOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
        <drugdosagetext>WARFARIN DOSE CHANGED EACH DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060628</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060704</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
        <drugdosagetext>WARFARIN DOSE CHANGED EACH DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CEREBROVASCULAR ACCIDENT PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060628</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060704</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN</medicinalproduct>
        <drugdosagetext>650 UNITA/HR SINCE 6/29 IV DRIP</drugdosagetext>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060629</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060703</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN</medicinalproduct>
        <drugdosagetext>650 UNITA/HR SINCE 6/29 IV DRIP</drugdosagetext>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>CEREBROVASCULAR ACCIDENT PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060629</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060703</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5046366-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060630</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-SANOFI-SYNTHELABO-F04200600125</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>54.3</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ENDOCARDITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEUKOCYTOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ELOXATIN</medicinalproduct>
        <drugauthorizationnumb>21492</drugauthorizationnumb>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>METASTATIC NEOPLASM</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060524</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060524</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CAPECITABINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>METASTATIC NEOPLASM</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060504</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060517</drugenddate>
        <drugtreatmentduration>14</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5046367-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-SANOFI-SYNTHELABO-A01200605183</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CEREBRAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUOROURACIL</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060623</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060623</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CALCIUM LEVOFOLINATE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060623</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060623</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXALIPLATIN</medicinalproduct>
        <drugauthorizationnumb>021492</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060623</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060623</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>805</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5046368-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060427</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>NL-SANOFI-SYNTHELABO-A01200605223</companynumb>
    <primarysource>
      <reportercountry>NETHERLANDS</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>38</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIOGENIC SHOCK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG RESISTANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STENT OCCLUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOSIS IN DEVICE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ACUTE MYOCARDIAL INFARCTION</drugindication>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugauthorizationnumb>020839</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ACUTE MYOCARDIAL INFARCTION</drugindication>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HEPARIN</medicinalproduct>
        <drugdosagetext>70 IU/KG</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5046369-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20051206</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-427646</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>49</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>AMMONIA INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASPARTATE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FUNGAL SKIN INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</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>
        <drugdosagetext>ROUTE REPORTED AS INJ.</drugdosagetext>
        <drugadministrationroute>050</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051105</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COPEGUS</medicinalproduct>
        <drugauthorizationnumb>021511</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051105</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COPEGUS</medicinalproduct>
        <drugauthorizationnumb>021511</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051210</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COPEGUS</medicinalproduct>
        <drugauthorizationnumb>021511</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROGRAF</medicinalproduct>
        <drugindication>TRANSPLANT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELLCEPT</medicinalproduct>
        <drugindication>TRANSPLANT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALCYTE</medicinalproduct>
        <drugindication>TRANSPLANT</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5046370-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-409415</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>23</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>73.5</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL ABSCESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAEMIA VITAMIN B12 DEFICIENCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CROHN'S DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL ANASTOMOTIC LEAK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HERNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLAMMATORY BOWEL DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTESTINAL OBSTRUCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTI-ORGAN DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEPHROLITHIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POLYARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RECTAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPONDYLOARTHROPATHY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>18662</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19890223</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19890615</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5046372-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060706</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>40</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>54.4316</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BEDRIDDEN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSSTASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL INTAKE REDUCED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CIPROFLOXACIN HCL</medicinalproduct>
        <drugdosagetext>250 MG BID PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ESCHERICHIA VAGINITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060629</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060701</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5046373-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060627</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20060601667</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>29</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEEP VEIN THROMBOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ORTHO EVRA</medicinalproduct>
        <drugauthorizationnumb>21180</drugauthorizationnumb>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>CONTRACEPTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5046374-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>JP-JNJFOC-20060600667</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CHOLESTASIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ITRACONAZOLE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ITRACONAZOLE</medicinalproduct>
        <drugauthorizationnumb>020083</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NAIL TINEA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIPYRIDAMOLE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOCOPHEROL CONCENTRATE CAP</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MECOBALAMIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ISOSORBIDE DINITRATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENALAPRIL MALEATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALFACALCIDOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM L-ASPARTATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALENDRONATE SODIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5046375-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20051103</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-423646</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>29</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>54.9</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANHEDONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BUNDLE BRANCH BLOCK RIGHT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLITIS ULCERATIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CROHN'S DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DECREASED APPETITE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ELECTROCARDIOGRAM P WAVE ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING GUILTY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELINGS OF WORTHLESSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMANGIOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC CYST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC ENZYME INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC LESION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCREASED APPETITE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLAMMATORY BOWEL DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IRRITABILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IRRITABLE BOWEL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEASLES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL ISCHAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NECK INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVARIAN CYST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERFORMANCE FEAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RIB FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOCIAL FEAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TENDONITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VASCULAR NEOPLASM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT FLUCTUATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>18662</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ACNE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19840115</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19840615</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5046376-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041111</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHO2004US16008</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>65</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>CHEST TUBE INSERTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG INFILTRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMOTHORAX</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY DISTRESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRICUSPID VALVE INCOMPETENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMATINIB VS PLACEBO</medicinalproduct>
        <drugauthorizationnumb>21588</drugauthorizationnumb>
        <drugdosagetext>600 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROSTATE CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040816</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041022</drugenddate>
        <drugtreatmentduration>97920</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAXOTERE</medicinalproduct>
        <drugdosagetext>30 MG/M2, QW</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PROSTATE CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040816</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041018</drugenddate>
        <drugtreatmentduration>92160</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PEPCID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVENOX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5046377-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050812</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-414410</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>20</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>69.9</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ALOPECIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CROHN'S DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRY SKIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ENDOMETRIOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EPISTAXIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FIBROADENOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLAMMATORY BOWEL DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IRRITABLE BOWEL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIP DRY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OESOPHAGITIS ULCERATIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVARIAN CYST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAPILLOMA VIRAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAROVARIAN CYST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UTERINE POLYP</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>18662</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ACNE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990721</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19990824</drugenddate>
        <drugtreatmentduration>35</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>018662</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990825</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20000110</drugenddate>
        <drugtreatmentduration>139</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5046378-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060405</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-443598</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>16</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>73.5</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLITIS ULCERATIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG DEPENDENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EMOTIONAL DISTRESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FISTULA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOKALAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLAMMATORY BOWEL DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIP DRY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERIRECTAL ABSCESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLEURAL EFFUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSYCHIATRIC SYMPTOM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SMALL INTESTINAL OBSTRUCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>018662</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ACNE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990416</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19990825</drugenddate>
        <drugtreatmentduration>132</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5046381-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060706</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>82.5547</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CONTUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EPISTAXIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugdosagetext>75 MG DAILY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RENAL ARTERY STENT PLACEMENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060606</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060628</drugenddate>
        <drugtreatmentduration>22</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5046387-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060706</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>56</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>108.8633</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLEPHARITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRY EYE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THERAPY NON-RESPONDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EMSAM</medicinalproduct>
        <drugdosagetext>1 PATCH DAILTY TRANSDERMAL</drugdosagetext>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060509</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060614</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5046391-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-434059</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>16</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NO ADVERSE EFFECT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PREGNANCY WITH CONTRACEPTIVE DEVICE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>18662</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050815</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060110</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5046392-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040818</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-378079</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>34</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>88.5</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CHRONIC FATIGUE SYNDROME</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>METAL POISONING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RECTAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>18662</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ACNE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19930515</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19930615</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5046393-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040115</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-356278</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>12</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>65.8</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>AGITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAEMIA MEGALOBLASTIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAL FISSURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AORTIC VALVE INCOMPETENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AUTOIMMUNE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BENIGN INTRACRANIAL HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CERVICOBRACHIAL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLITIS ULCERATIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CUSHING'S SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DERMAL CYST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSTHYMIC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ENCOPRESIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HALLUCINATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ILL-DEFINED DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLAMMATORY BOWEL DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERVERTEBRAL DISC DEGENERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IRRITABLE BOWEL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JOINT SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUPUS NEPHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEGACOLON</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MITRAL VALVE INCOMPETENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOPIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NASAL DRYNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NERVOUS SYSTEM DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCREATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCYTOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERICARDIAL EFFUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POLYP</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STAPHYLOCOCCAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYSTEMIC LUPUS ERYTHEMATOSUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRICUSPID VALVE INCOMPETENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UROGENITAL PROLAPSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VASCULITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VULVOVAGINAL MYCOTIC INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEGENER'S GRANULOMATOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>18662</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19961229</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19970221</drugenddate>
        <drugtreatmentduration>55</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5046394-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060706</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>61</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PSEUDOMEMBRANOUS COLITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PIPERACILLIN AND TAZOBACTAM</medicinalproduct>
        <drugdosagetext>2.25 GM IV Q8H</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>URINARY TRACT INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060403</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060410</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL SPIROS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DARBEPOETIN ALFA, RECOMBINANT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HUMULIN R</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IPRATROPIUM BR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL -PLAIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MORPHINE SULFATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROPOFOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5046395-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060418</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ROCHE-444658</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>71</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>76.5</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLUE TOE SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIOMEGALY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC ENZYME INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POST PROCEDURAL COMPLICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PURPURA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PANALDINE</medicinalproduct>
        <drugauthorizationnumb>19979</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20011012</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20011017</drugenddate>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PANALDINE</medicinalproduct>
        <drugauthorizationnumb>019979</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20011018</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20011112</drugenddate>
        <drugtreatmentduration>26</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RENIVACE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20011012</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SUNRYTHM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20011012</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HARNAL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20011012</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GASTER</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20011012</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLIMICRON</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20011013</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5046396-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060405</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-443542</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>14</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>59</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ACNE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ATTENTION DEFICIT/HYPERACTIVITY DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CHOLESTEROL INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CALCULUS URETERIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLITIS ULCERATIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISTURBANCE IN ATTENTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRY EYE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRY SKIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EAR INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EMOTIONAL DISTRESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA NODOSUM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FUNGAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROOESOPHAGEAL REFLUX DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HERPES SIMPLEX</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERKERATOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLAMMATORY BOWEL DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIP DRY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MELANOCYTIC NAEVUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENSTRUATION IRREGULAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENTAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NASAL DRYNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEPHROLITHIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NIGHT BLINDNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVARIAN CYST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANIC ATTACK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARVOVIRUS INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PETECHIAE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARYNGITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARYNGOLARYNGEAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PREGNANCY TEST POSITIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSORIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SACROILIITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN PAPILLOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STOMACH DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STRESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWELLING FACE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ULCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UPPER RESPIRATORY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VAGINAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VITREOUS FLOATERS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>018662</drugauthorizationnumb>
        <drugdosagetext>20 MG EVERY MORNING AND 40 MG EVERY EVENING.</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19961027</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19970327</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>018662</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19970328</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19970807</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OVCON-35</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ORAL CONTRACEPTION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5046397-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060630</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2006DK09998</companynumb>
    <primarysource>
      <reportercountry>DENMARK</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE ENZYME INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOSITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHABDOMYOLYSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GLEEVEC</medicinalproduct>
        <drugauthorizationnumb>21588</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5046398-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060622</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-453039</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>80</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>51.7</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIABETES MELLITUS INADEQUATE CONTROL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ELECTROLYTE IMBALANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FOREIGN BODY TRAUMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ODYNOPHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OESOPHAGEAL STENOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OESOPHAGITIS CHEMICAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BONIVA</medicinalproduct>
        <drugauthorizationnumb>21455</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060617</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060617</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BUSPAR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOPRESSOR</medicinalproduct>
        <drugdosagetext>REPORTED AS: 12.5 Q 12H</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACTOS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MIACALCIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN B-12</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PHENERGAN</medicinalproduct>
        <drugdosagetext>FREQUENTIE: REPORTED: Q6H PRN (EVERY 6 HOURS WHEN REQUIRED)</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5046399-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060627</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>GB-JNJFOC-20060604848</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG WITHDRAWAL SYNDROME NEONATAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERDAL CONSTA</medicinalproduct>
        <drugauthorizationnumb>21346</drugauthorizationnumb>
        <drugindication>DRUG EXPOSURE DURING PREGNANCY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLOZAPINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5046400-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060428</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-ROCHE-449521</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>46</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>62</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD CREATINE PHOSPHOKINASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHABDOMYOLYSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INVIRASE</medicinalproduct>
        <drugauthorizationnumb>20628</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060412</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060424</drugenddate>
        <drugtreatmentduration>13</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ANTIRETROVIRALS</medicinalproduct>
        <drugdosagetext>DRUG NAME REPORTED AS HAART.</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VIREAD</medicinalproduct>
        <drugindication>ANTI-INFECTIVE THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RITONAVIR</medicinalproduct>
        <drugindication>ANTI-INFECTIVE THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ABACAVIR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030822</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LAMIVUDINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030822</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EFAVIRENZ</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060409</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060412</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5046402-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060620</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-ROCHE-452451</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>76</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ACID BASE BALANCE ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERAL PHYSICAL HEALTH DETERIORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATOTOXICITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUCOSAL INFLAMMATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPTIC SHOCK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CAPECITABINE</medicinalproduct>
        <drugauthorizationnumb>20896</drugauthorizationnumb>
        <drugdosagetext>FIVE DAYS PER WEEK.</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RECTAL CANCER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXALIPLATIN</medicinalproduct>
        <drugauthorizationnumb>020896</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RECTAL CANCER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5046403-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060504</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-447084</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>44</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>67.7</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>DISEASE PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALIGNANT NEOPLASM PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL CANCER METASTATIC</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KYTRIL</medicinalproduct>
        <drugauthorizationnumb>20305</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NAUSEA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060125</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5046404-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060706</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>308.7</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAPHYLACTOID REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE SYSTOLIC DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OXYGEN SATURATION DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALLOR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URTICARIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BYETTA</medicinalproduct>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060524</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060622</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BYETTA</medicinalproduct>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060622</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060702</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPROL-XL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMARYL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRILOSEC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACCUPRIL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5046407-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060706</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>77.1115</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENTAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugbatchnumb>103579</drugbatchnumb>
        <drugdosagetext>ONE PER DAY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>LOW DENSITY LIPOPROTEIN INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060629</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060630</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5046410-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060706</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>POOR QUALITY DRUG ADMINISTERED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LORAZEPAM</medicinalproduct>
        <drugbatchnumb>026018</drugbatchnumb>
        <drugdosagetext>10 ML CONTINUOUS IV DRIP</drugdosagetext>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>SEDATIVE THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060704</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060704</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SODIUM CHLORIDE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5046412-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060607</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ROCHE-451183</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>60</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>45</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>APLASIA PURE RED CELL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELLCEPT</medicinalproduct>
        <drugauthorizationnumb>50722</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050615</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060607</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELLCEPT</medicinalproduct>
        <drugauthorizationnumb>050722</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060608</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EPOGEN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NEPHROGENIC ANAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060317</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060602</drugenddate>
        <drugtreatmentduration>78</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ESPO</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050916</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060303</drugenddate>
        <drugtreatmentduration>169</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDONINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060608</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060608</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060608</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PERSANTIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040615</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KREMEZIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040615</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMIYU</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060608</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5046414-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060513</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ROCHE-448075</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>32</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DELUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HALLUCINATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCORRECT DOSE ADMINISTERED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SCHIZOPHRENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UPPER RESPIRATORY TRACT INFLAMMATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEG-INTERFERON A-2A (RO 25-8310)</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060310</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060331</drugenddate>
        <drugtreatmentduration>22</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>20060416</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060421</drugenddate>
        <drugtreatmentduration>6</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>20060506</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060506</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SHAKUYAKU-KANZO-TO</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060314</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060407</drugenddate>
        <drugtreatmentduration>25</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLOBETASONE BUTYRATE</medicinalproduct>
        <drugadministrationroute>003</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060331</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5046415-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060706</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>56</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>65.7716</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HYPERTENSIVE CRISIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEXAPRO</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5046416-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060424</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-445415</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>43</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>62.6</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEG-INTERFERON A-2A (RO 25-8310)</medicinalproduct>
        <drugdosagetext>TAKEN FOR 8 MONTHS BEFORE SAE</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050726</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RIBAVIRIN</medicinalproduct>
        <drugauthorizationnumb>021511</drugauthorizationnumb>
        <drugdosagetext>TAKEN FOR 8 MONTHS BEFORE SAE</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050726</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugdosagetext>TAKEN FOR 3 MONTHS BEFORE SAE</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051202</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAZODONE HCL</medicinalproduct>
        <drugdosagetext>TAKEN AT NIGHT TAKEN FOR 8 MONTHS BEFORE SAE</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050926</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VIRAMUNE</medicinalproduct>
        <drugdosagetext>TAKEN FOR SEVERAL YEARS</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRUVADA</medicinalproduct>
        <drugdosagetext>TAKEN FOR 14 DAYS</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5046417-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060616</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ROCHE-452445</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PANCYTOPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VESANOID</medicinalproduct>
        <drugauthorizationnumb>20438</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ACUTE PROMYELOCYTIC LEUKAEMIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5046418-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060627</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-453646</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>23</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE BEFORE PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NO ADVERSE EFFECT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PREGNANCY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>018662</drugauthorizationnumb>
        <drugdosagetext>DOSAGE REGIMEN REPORTED: DAILY.</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060109</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060427</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMNESTEEM</medicinalproduct>
        <drugindication>ACNE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5046420-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ZM-ROCHE-453365</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>28</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>56</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD CREATININE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEPHROTIC SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MEFLOQUINE HCL</medicinalproduct>
        <drugauthorizationnumb>019591</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MALARIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051121</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051121</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5046421-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20030630</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0414361A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>38</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABNORMAL BEHAVIOUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AGGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANGER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHYSICAL ASSAULT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEXUAL DYSFUNCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDE ATTEMPT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
        <drugauthorizationnumb>20031</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20011029</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5046422-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0517403A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>AFFECT LABILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AGITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANGER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BIPOLAR DISORDER</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>FEAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MANIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEMORY IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OBSESSIVE-COMPULSIVE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARANOIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERFORMANCE STATUS DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSYCHOMOTOR HYPERACTIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPEECH DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THINKING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VERTIGO</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
        <drugauthorizationnumb>20031</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5046423-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0518181A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>32</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANXIETY</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>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IRRITABILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERFORMANCE STATUS DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
        <drugauthorizationnumb>20031</drugauthorizationnumb>
        <drugdosagetext>10MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PANIC ATTACK</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEXAPRO</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEXAPRO</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5046424-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050509</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0558612A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>28</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISSOCIATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG WITHDRAWAL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NERVOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
        <drugauthorizationnumb>20031</drugauthorizationnumb>
        <drugdosagetext>20MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MAJOR DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRIPHASIL-28</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5046425-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050509</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0558622A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</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>DRUG WITHDRAWAL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MIGRAINE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SELF MUTILATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAXIL CR</medicinalproduct>
        <drugauthorizationnumb>20936</drugauthorizationnumb>
        <drugdosagetext>25MG UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031001</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5046426-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20051130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>8013248</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>20</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>COMPLEX PARTIAL SEIZURES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PREMATURE LABOUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SIMPLE PARTIAL SEIZURES</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAXIL CR</medicinalproduct>
        <drugauthorizationnumb>20936</drugauthorizationnumb>
        <drugdosagetext>37.5MG PER DAY</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYRTEC</medicinalproduct>
        <drugdosagetext>10MG PER DAY</drugdosagetext>
        <drugindication>MULTIPLE ALLERGIES</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KEPPRA</medicinalproduct>
        <drugdosagetext>2000MG PER DAY</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050516</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DILANTIN</medicinalproduct>
        <drugindication>EPILEPSY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugdosagetext>50MG AS REQUIRED</drugdosagetext>
        <drugindication>SLEEP DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHYLCELLULOSE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
        <drugdosagetext>4MG PER DAY</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5046427-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnesscongenitalanomali>1</seriousnesscongenitalanomali>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20051130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>8013248</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ADRENAL INSUFFICIENCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ADRENOGENITAL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARNOLD-CHIARI MALFORMATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEVELOPMENTAL DELAY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MATERNAL CONDITION AFFECTING FOETUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PREMATURE BABY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAXIL CR</medicinalproduct>
        <drugauthorizationnumb>20936</drugauthorizationnumb>
        <drugdosagetext>37.5MG PER DAY</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYRTEC</medicinalproduct>
        <drugdosagetext>10MG PER DAY</drugdosagetext>
        <drugindication>MULTIPLE ALLERGIES</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KEPPRA</medicinalproduct>
        <drugdosagetext>2000MG PER DAY</drugdosagetext>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050516</drugenddate>
        <drugtreatmentduration>35</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DILANTIN</medicinalproduct>
        <drugindication>EPILEPSY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugdosagetext>50MG AS REQUIRED</drugdosagetext>
        <drugindication>SLEEP DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
        <drugdosagetext>4MG PER DAY</drugdosagetext>
        <drugindication>ANAEMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CITRUCEL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHYLCELLULOSE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5046428-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060328</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0599379A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>52</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIPASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCREATITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HYCAMTIN</medicinalproduct>
        <drugauthorizationnumb>20671</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060327</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NO CONCURRENT MEDICATION</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5046429-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060331</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0599933A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>64</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>APHONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG DISPENSING ERROR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ADVAIR DISKUS 100/50</medicinalproduct>
        <drugbatchnumb>5ZP7529</drugbatchnumb>
        <drugauthorizationnumb>21077</drugauthorizationnumb>
        <drugdosagetext>1PUFF TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAXAIR</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5046430-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060426</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0603380A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>37</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ACCIDENTAL OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHOKING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSED LEVEL OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEVICE MALFUNCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING JITTERY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ADVAIR DISKUS 100/50</medicinalproduct>
        <drugbatchnumb>5ZP4599</drugbatchnumb>
        <drugauthorizationnumb>21077</drugauthorizationnumb>
        <drugdosagetext>1PUFF TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL SPIROS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLEGRA</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5046431-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060622</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0610947A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG WITHDRAWAL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
        <drugauthorizationnumb>20031</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANXIETY DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19940101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KLONOPIN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19940101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ORTHO TRI-CYCLEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5046432-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060706</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>39</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>63.5036</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRY MOUTH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSGEUSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GLOSSODYNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOGEUSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRESCRIBED OVERDOSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KENALOG</medicinalproduct>
        <drugdosagetext>BI-ANNUALLY</drugdosagetext>
        <drugindication>DYSGEUSIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050820</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050820</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KENALOG</medicinalproduct>
        <drugdosagetext>BI-ANNUALLY</drugdosagetext>
        <drugindication>NEURALGIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050820</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050820</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KENALOG</medicinalproduct>
        <drugdosagetext>BI-ANNUALLY</drugdosagetext>
        <drugindication>DYSGEUSIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060516</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060516</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KENALOG</medicinalproduct>
        <drugdosagetext>BI-ANNUALLY</drugdosagetext>
        <drugindication>NEURALGIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060516</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060516</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TEMAZEPAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5046433-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060627</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0611135A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>71.4</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABNORMAL DREAMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</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>DRUG WITHDRAWAL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERACUSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MANIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OBSESSIVE-COMPULSIVE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHOTOSENSITIVITY REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SLEEP DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
        <drugauthorizationnumb>20031</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANXIETY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
        <drugindication>PANIC DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INDERAL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FIORICET</medicinalproduct>
        <drugindication>HEADACHE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPAMAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BUSPAR</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5046434-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060705</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0611177A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HYPOGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MEPRON</medicinalproduct>
        <drugauthorizationnumb>020500</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HIV TREATMENTS (UNSPECIFIED)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5046435-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060705</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0611296A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>COGNITIVE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSARTHRIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REQUIP</medicinalproduct>
        <drugauthorizationnumb>020658</drugauthorizationnumb>
        <drugdosagetext>.5MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RESTLESS LEGS SYNDROME</drugindication>
        <drugtreatmentduration>12</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPAMAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EFFEXOR</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5046436-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060705</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0611305A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>39</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>AGGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AGITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DELUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MANIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSYCHOTIC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMICTAL</medicinalproduct>
        <drugauthorizationnumb>020241</drugauthorizationnumb>
        <drugdosagetext>25MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BIPOLAR DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060601</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NO CONCURRENT MEDICATION</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5046437-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060706</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0611327A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>GOITRE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTHYROIDISM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>12.5MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRONOLACTONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FISH OIL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5046438-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060703</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0611476A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>19</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>AGITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AGORAPHOBIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC MURMUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CRYING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DELUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPERSONALISATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG WITHDRAWAL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HALLUCINATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HALLUCINATION, AUDITORY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IRRITABILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MANIA</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>OBSESSIVE-COMPULSIVE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARANOIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROSTATE EXAMINATION ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSYCHOTIC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SCHIZOPHRENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SELF MUTILATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SENSORY DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SLEEP TERROR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDE ATTEMPT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TINNITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRICHOTILLOMANIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
        <drugauthorizationnumb>020031</drugauthorizationnumb>
        <drugindication>ANXIETY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19930101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5046439-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060706</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-GLAXOSMITHKLINE-A0611500A</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>SICKLE CELL ANAEMIA WITH CRISIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5046440-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20051115</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-GLAXOSMITHKLINE-B0400698A</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>COMPLETED SUICIDE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROXAT</medicinalproduct>
        <drugauthorizationnumb>20031</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5046441-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-JPN-A200600005</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>55</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PANCREATITIS ACUTE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOVIRAX</medicinalproduct>
        <drugauthorizationnumb>18603</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041001</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5046442-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060228</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-GLAXOSMITHKLINE-B0413861A</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>57</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABNORMAL FAECES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FAECES DISCOLOURED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLATULENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NICABATE CQ 4MG LOZENGE</medicinalproduct>
        <drugbatchnumb>X2274</drugbatchnumb>
        <drugauthorizationnumb>21330</drugauthorizationnumb>
        <drugdosagetext>4MG SEVEN TIMES PER DAY</drugdosagetext>
        <drugadministrationroute>002</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060623</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VENTOLIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SERETIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NICOTINE</medicinalproduct>
        <drugadministrationroute>062</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060601</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5046443-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060410</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-GLAXOSMITHKLINE-B0420082A</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>65</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EMBOLISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERIPHERAL COLDNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOPOTECAN</medicinalproduct>
        <drugauthorizationnumb>20671</drugauthorizationnumb>
        <drugdosagetext>1MGM2 PER DAY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060323</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060327</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CISPLATIN</medicinalproduct>
        <drugdosagetext>.75MGM2 PER DAY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060327</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BELOC ZOK</medicinalproduct>
        <drugdosagetext>47.5MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SUPRAVENTRICULAR TACHYCARDIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5046444-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060502</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>NZ-GLAXOSMITHKLINE-B0423072A</companynumb>
    <primarysource>
      <reportercountry>NEW ZEALAND</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANGINA PECTORIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEREVENT</medicinalproduct>
        <drugauthorizationnumb>20236</drugauthorizationnumb>
        <drugadministrationroute>055</drugadministrationroute>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLIXOTIDE</medicinalproduct>
        <drugauthorizationnumb>020548</drugauthorizationnumb>
        <drugadministrationroute>055</drugadministrationroute>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VENTOLIN</medicinalproduct>
        <drugadministrationroute>055</drugadministrationroute>
        <drugtreatmentduration>12</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5046445-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060606</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-JPN-A200601894</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>71</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>40</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABNORMAL BEHAVIOUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</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>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UNRESPONSIVE TO STIMULI</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
        <drugauthorizationnumb>20031</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060424</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060511</drugenddate>
        <drugtreatmentduration>18</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERDAL</medicinalproduct>
        <drugdosagetext>.5MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060424</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060510</drugenddate>
        <drugtreatmentduration>17</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RIVOTRIL</medicinalproduct>
        <drugdosagetext>.5MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060424</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060510</drugenddate>
        <drugtreatmentduration>17</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5046446-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060609</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006JP001230</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>53</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>72</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EAR PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEAD TITUBATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE ANAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NECK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS GENERALISED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PUNCTURE SITE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SENSORY DISTURBANCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CEFAZOLIN</medicinalproduct>
        <drugdosagetext>1G FOUR TIMES PER DAY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ACUTE TONSILLITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060213</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060213</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CHONDROITINE SULFATE SODIUM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060213</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060213</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HARTMANNS</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060213</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060213</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLYCYRRHIZIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5046447-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060614</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-GLAXOSMITHKLINE-B0427725A</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>55</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>89</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HEPATITIS ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ROSIGLITAZONE MALEATE</medicinalproduct>
        <drugauthorizationnumb>21071</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060106</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060612</drugenddate>
        <drugtreatmentduration>158</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLOMOX</medicinalproduct>
        <drugdosagetext>100MG THREE TIMES PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>FURUNCLE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060608</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5046448-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060615</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-JPN-A200602080</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>91</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>35</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DYSARTHRIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HALLUCINATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOXIC INDUCED ENCEPHALOPATHY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VALTREX</medicinalproduct>
        <drugauthorizationnumb>020487</drugauthorizationnumb>
        <drugdosagetext>500MG THREE TIMES PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HERPES ZOSTER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060612</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060613</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THYRADIN S</medicinalproduct>
        <drugdosagetext>25MCG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>THYROID MASS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRONON</medicinalproduct>
        <drugdosagetext>150MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALTAN</medicinalproduct>
        <drugdosagetext>1.8G PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5046449-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060623</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-JPN-A200602254</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>81</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>53</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANOREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CREATININE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD UREA INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSED LEVEL OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSLALIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYELID OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NERVOUS SYSTEM DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VALTREX</medicinalproduct>
        <drugauthorizationnumb>20487</drugauthorizationnumb>
        <drugdosagetext>2U THREE TIMES PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HERPES ZOSTER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060529</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060602</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BLOPRESS</medicinalproduct>
        <drugdosagetext>.5U PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060603</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOCOPHEROL CONCENTRATE CAP</medicinalproduct>
        <drugdosagetext>1U PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060602</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugdosagetext>1U PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060602</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EPINASTINE HYDROCHLORIDE</medicinalproduct>
        <drugdosagetext>1U PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060602</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NESGEN</medicinalproduct>
        <drugdosagetext>.5U PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INSOMNIA</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060602</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NITRAZEPAM</medicinalproduct>
        <drugdosagetext>.5U PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INSOMNIA</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060602</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COSMEGEN</medicinalproduct>
        <drugdosagetext>1U PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HERPES ZOSTER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060529</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060602</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FURULMINE</medicinalproduct>
        <drugdosagetext>1U TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HERPES ZOSTER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060529</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060602</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALONAL</medicinalproduct>
        <drugdosagetext>1U TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HERPES ZOSTER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060529</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060602</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FAMOTIDINE</medicinalproduct>
        <drugdosagetext>1U TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HERPES ZOSTER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060529</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060602</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLPIDEM TARTRATE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060603</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5046450-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060706</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>37</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>59.8748</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRONCHITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ADVAIR DISKUS 100/50</medicinalproduct>
        <drugbatchnumb>R220270</drugbatchnumb>
        <drugdosagetext>100/50 MCG PER INHALATION    TWICE A DAY   PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060705</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5046451-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060623</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-JPN-A200602257</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>71</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>58</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANOREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CREATININE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</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>VALTREX</medicinalproduct>
        <drugauthorizationnumb>020487</drugauthorizationnumb>
        <drugdosagetext>500MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HERPES ZOSTER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060603</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060611</drugenddate>
        <drugtreatmentduration>9</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMARYL</medicinalproduct>
        <drugdosagetext>1MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020906</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060614</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIGMART</medicinalproduct>
        <drugdosagetext>5MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANGINA PECTORIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020906</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENALAPRIL</medicinalproduct>
        <drugdosagetext>5MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050228</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALSLOT</medicinalproduct>
        <drugdosagetext>10MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040618</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BLOPRESS</medicinalproduct>
        <drugdosagetext>8MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051104</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOXONIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060606</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SOLON</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060606</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARASENA-A</medicinalproduct>
        <drugadministrationroute>061</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060606</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5046452-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-GLAXOSMITHKLINE-B0429029A</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <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>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DUODENAL ULCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATEMESIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MELAENA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALLOR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEROXAT</medicinalproduct>
        <drugauthorizationnumb>20031</drugauthorizationnumb>
        <drugdosagetext>10MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060518</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CEREBROVASCULAR DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060407</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060518</drugenddate>
        <drugtreatmentduration>42</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DAFLON</medicinalproduct>
        <drugdosagetext>1TAB TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060518</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5046453-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060630</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-GLAXOSMITHKLINE-B0429643A</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>40</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANAPHYLACTIC SHOCK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANGIONEUROTIC OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROAT IRRITATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AUGMENTIN '125'</medicinalproduct>
        <drugauthorizationnumb>50564</drugauthorizationnumb>
        <drugdosagetext>1G CUMULATIVE DOSE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060314</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DERINOX</medicinalproduct>
        <drugdosagetext>1UNIT PER DAY</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060314</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5046454-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060627</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ES-GLAXOSMITHKLINE-B0429646A</companynumb>
    <primarysource>
      <reportercountry>SPAIN</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>7</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ENANTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EPSTEIN-BARR VIRUS ANTIBODY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA MULTIFORME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MONONUCLEOSIS SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PURPURA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH MACULAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH MACULO-PAPULAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN LESION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMOXICILLIN-CLAVULANIC ACID</medicinalproduct>
        <drugauthorizationnumb>50564</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PARACETAMOL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5046455-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060703</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>453385</companynumb>
    <primarysource>
      <reportercountry>PERU</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>48</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ERECTILE DYSFUNCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STRESS AT WORK</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DILATREND</medicinalproduct>
        <drugauthorizationnumb>20297</drugauthorizationnumb>
        <drugdosagetext>12.5MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051006</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060329</drugenddate>
        <drugtreatmentduration>175</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CILAZAPRIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051006</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5046456-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060630</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-GLAXOSMITHKLINE-B0430183A</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>29</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>100</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>LYMPHOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURIGO</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>REFUSAL OF TREATMENT BY PATIENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEROXAT</medicinalproduct>
        <drugauthorizationnumb>20031</drugauthorizationnumb>
        <drugdosagetext>20MG SEE DOSAGE TEXT</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060503</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060504</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TANGANIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060430</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROTHIADEN</medicinalproduct>
        <drugdosagetext>25MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060504</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060505</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5046457-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesscongenitalanomali>1</seriousnesscongenitalanomali>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060627</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-GLAXOSMITHKLINE-B0430222A</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DOUBLE OUTLET RIGHT VENTRICLE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STILLBIRTH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENTRICULAR SEPTAL DEFECT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMBIVIR</medicinalproduct>
        <drugauthorizationnumb>020857</drugauthorizationnumb>
        <drugdosagetext>1U TWICE PER DAY</drugdosagetext>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060306</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KALETRA</medicinalproduct>
        <drugdosagetext>3U TWICE PER DAY</drugdosagetext>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060306</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5046459-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060703</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>20001879</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>55</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>POSTMENOPAUSAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ROSIGLITAZONE</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060401</drugenddate>
        <drugtreatmentduration>60</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
        <drugdosagetext>500MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5046460-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060703</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ES-GLAXOSMITHKLINE-B0430238A</companynumb>
    <primarysource>
      <reportercountry>SPAIN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>78</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>AMAUROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLINDNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AUGMENTIN '125'</medicinalproduct>
        <drugauthorizationnumb>050564</drugauthorizationnumb>
        <drugdosagetext>1000MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060702</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5046461-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060704</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ES-GLAXOSMITHKLINE-B0430252A</companynumb>
    <primarysource>
      <reportercountry>SPAIN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>SKIN DISCOLOURATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIC PURPURA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KIVEXA</medicinalproduct>
        <drugauthorizationnumb>021652</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5046462-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060705</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006012357</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>25</patientonsetage>
      <patientonsetageunit>804</patientonsetageunit>
      <patientweight>3.9</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>SUPRAVENTRICULAR TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DARAPRIM</medicinalproduct>
        <drugauthorizationnumb>008578</drugauthorizationnumb>
        <drugdosagetext>3MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONGENITAL TOXOPLASMOSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060610</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060705</drugenddate>
        <drugtreatmentduration>26</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5046463-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060525</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-ROCHE-450429</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>17</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>C-REACTIVE PROTEIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL STIFFNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHOTOPHOBIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>18662</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060301</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5046464-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060626</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-453227</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRANSIENT ISCHAEMIC ATTACK</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KLONOPIN</medicinalproduct>
        <drugauthorizationnumb>017533</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5046465-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060607</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-ROCHE-451217</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>52</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>70</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BONE MARROW FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEGASYS</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060315</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEGASYS</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COPEGUS</medicinalproduct>
        <drugauthorizationnumb>021511</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060315</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SUBUTEX</medicinalproduct>
        <drugdosagetext>DOSAGE REPORTED AS 60 MG PER WEEK.</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5046466-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060609</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-ROCHE-451147</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>34</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>58</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABORTION SPONTANEOUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEGASYS</medicinalproduct>
        <drugdosagetext>SUBCUTANEOUS PEG-INTERFERON ALFA 2A (PEGASYS), 180 MCG AND ORAL RIBAVIRIN, 800MG.</drugdosagetext>
        <drugadministrationroute>050</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060519</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060608</drugenddate>
        <drugtreatmentduration>21</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5046468-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060706</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>24</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>72.1219</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABNORMAL BEHAVIOUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ALOPECIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANGER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANOREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CRYING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EATING DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IRRITABILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEMORY IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOCIAL AVOIDANT BEHAVIOUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLARAVIS</medicinalproduct>
        <drugdosagetext>40MG   TWICE DAILY   PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ACNE CYSTIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060303</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060629</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5046469-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-453667</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>62</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>RETINAL TEAR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEGASYS</medicinalproduct>
        <drugdosagetext>ROUTE REPORTED AS INJECTABLE.</drugdosagetext>
        <drugadministrationroute>050</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060419</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COPEGUS</medicinalproduct>
        <drugauthorizationnumb>021511</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060419</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5046470-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060627</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-ROCHE-453814</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>54</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HYPOPHYSITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTHALAMO-PITUITARY DISORDERS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTHYROIDISM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEG-INTERFERON ALFA 2A (RO 25-8310)</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RIBAVIRIN</medicinalproduct>
        <drugauthorizationnumb>021511</drugauthorizationnumb>
        <drugdosagetext>UNITS REPORTED MG/DAY</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5046471-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060630</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-453751</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD CREATININE INCREASED</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>
        <drugauthorizationnumb>021511</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5046472-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PE-ROCHE-453772</companynumb>
    <primarysource>
      <reportercountry>PERU</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>27</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>45</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CATHETER RELATED INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GOODPASTURE'S SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEGASYS</medicinalproduct>
        <drugdosagetext>STRENGTH REPORTED AS 135 MCRG.</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060121</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060606</drugenddate>
        <drugtreatmentduration>137</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEGASYS</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060616</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5046473-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-453661</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>20</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>OCULAR ICTERUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>YELLOW SKIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEGASYS</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060515</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COPEGUS</medicinalproduct>
        <drugauthorizationnumb>021511</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060515</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTIBIOTIC NOS</medicinalproduct>
        <drugindication>ACNE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5046475-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>19930122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-ROCHE-930803014001</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>20</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>018662</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ACNE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19920903</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19921203</drugenddate>
        <drugtreatmentduration>92</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ORAL CONTRACEPTIVE NOS</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5046476-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060630</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-453754</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FUZEON</medicinalproduct>
        <drugauthorizationnumb>021481</drugauthorizationnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5046477-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-ROCHE-453795</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>CATARACT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEGASYS</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5046479-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060706</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>37</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>79.3795</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>APATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISTRACTIBILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING GUILTY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ILL-DEFINED DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMPAIRED WORK ABILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEDICATION ERROR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SENSORY DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EFFEXOR</medicinalproduct>
        <drugbatchnumb>A90575</drugbatchnumb>
        <drugdosagetext>75MG    ONCE PER DAY</drugdosagetext>
        <drugindication>ANXIETY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19940510</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051230</drugenddate>
        <drugtreatmentduration>11</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5046483-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060706</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>35</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>74.8435</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABNORMAL BEHAVIOUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ACTIVITIES OF DAILY LIVING IMPAIRED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANGER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG WITHDRAWAL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMPAIRED DRIVING ABILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NIGHTMARE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OBSESSIVE-COMPULSIVE DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EFFEXOR</medicinalproduct>
        <drugindication>BIPOLAR DISORDER</drugindication>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EFFEXOR</medicinalproduct>
        <drugindication>DEPRESSION</drugindication>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5046485-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060706</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>29</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>48.9885</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ALOPECIA EFFLUVIUM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BENIGN INTRACRANIAL HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CENTRAL NERVOUS SYSTEM INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG PRESCRIBING ERROR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMMUNOSUPPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLUENZA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENSTRUATION IRREGULAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA CHLAMYDIAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POLYGLANDULAR DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUSITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISION BLURRED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SOMATROPIN    5 MG -APPROX- 15 IU    ELI LILLY</medicinalproduct>
        <drugdosagetext>USING INJECTION    ONCE DAILY   SQ</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>HYPOPITUITARISM</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030720</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031015</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SAIZEN</medicinalproduct>
        <drugdosagetext>USING INJECTION   ONCE DAILY   SQ</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031016</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040125</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5046486-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060602</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006UW11098</companynumb>
    <primarysource>
      <reportercountry>TRINIDAD AND TOBAGO</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>48</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>63.6</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD CREATINE PHOSPHOKINASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULAR WEAKNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOGLOBINURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugauthorizationnumb>021366</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERCHOLESTEROLAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060526</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5046487-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060707</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>69</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>68</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POST PROCEDURAL COMPLICATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HYDROMORPHONE HCL</medicinalproduct>
        <drugdosagetext>0.5 MG   Q 2-3 HOURS   IV BOLUS</drugdosagetext>
        <drugadministrationroute>040</drugadministrationroute>
        <drugindication>PROCEDURAL PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060704</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060704</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FENTANYL TRANSDERMAL SYSTEM</medicinalproduct>
        <drugdosagetext>25 MCG   Q 1-2 HOURS    IV BOLUS</drugdosagetext>
        <drugadministrationroute>040</drugadministrationroute>
        <drugindication>PROCEDURAL PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060626</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060704</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE TAB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAGAMET</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THEOPHYLLINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SOMA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VICODIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROVENTIL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5046488-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060705</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>63.05</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ELECTROCARDIOGRAM ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTHYROIDISM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RYTHMOL</medicinalproduct>
        <drugdosagetext>150MG  ONE BID   P.O.</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATRIAL FLUTTER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060616</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5046489-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060707</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>34</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>55.7924</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>IMPAIRED GASTRIC EMPTYING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRUVADA</medicinalproduct>
        <drugdosagetext>1 TAB    DAILY   PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060202</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060615</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5046490-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060705</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>104.3273</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>REACTION TO DRUG EXCIPIENTS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GENERIC MIDRIN</medicinalproduct>
        <drugdosagetext>TWO ONSET H/A  ONE PO QHR TO 5/24 HOURS</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MIGRAINE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5046493-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060707</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>60</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HAEMATOCRIT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MELAENA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
        <drugdosagetext>25MG  QD  PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060103</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060331</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL SPIROS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AZITHROMYCIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IRON SULFATETHIAMIN COMPOUND TAB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUNISOLIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GUAIFENESIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORATADINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MONTELUKAST</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NAPROXEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TERAZOSIN HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAMADOL HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAZODONE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALSARTAN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5046495-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060707</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>79</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>64</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CEREBRAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTRAVENTRICULAR HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LOVENOX</medicinalproduct>
        <drugdosagetext>60MG   Q24HR    SQ</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>DEEP VEIN THROMBOSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060629</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060701</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5046498-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060707</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>20</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>63.5036</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAPHYLACTIC REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLD SWEAT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE IRREGULAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULAR WEAKNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARYNGEAL OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TONGUE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISION BLURRED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVAQUIN</medicinalproduct>
        <drugindication>SINUSITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060703</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060703</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5046501-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060707</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>26</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>63.5</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN FIBROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN HYPERTROPHY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OMNISCAN</medicinalproduct>
        <drugdosagetext>40 CC   ONCE   IV BOLUS   (ONE TIME INJECTION)</drugdosagetext>
        <drugadministrationroute>040</drugadministrationroute>
        <drugindication>NEPHROGENIC FIBROSING DERMOPATHY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050919</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050919</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5046503-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060707</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>61</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HEART RATE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
        <drugdosagetext>100MG   BID   PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANGINA PECTORIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060221</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060411</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
        <drugdosagetext>100MG   BID   PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CORONARY ARTERY DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060221</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060411</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
        <drugdosagetext>100MG   BID   PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060221</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060411</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5046504-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesscongenitalanomali>1</seriousnesscongenitalanomali>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GILEAD-2006-0009809</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ASCITES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEATH NEONATAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYDROPS FOETALIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE CONGENITAL ABNORMALITIES</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRUVADA</medicinalproduct>
        <drugauthorizationnumb>021752</drugauthorizationnumb>
        <drugadministrationroute>064</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIRAMUNE</medicinalproduct>
        <drugadministrationroute>064</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RETROVIR</medicinalproduct>
        <drugadministrationroute>064</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060506</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060506</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5046505-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060705</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>23</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>66</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BRADYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIO-RESPIRATORY ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOPTYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENTRICULAR TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RITUXAN</medicinalproduct>
        <drugdosagetext>600 MG   X1    IVPB</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>KIDNEY TRANSPLANT REJECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060226</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5046507-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060705</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>83</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>87.5</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFUSION RELATED REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY DISTRESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYPNOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RITUXIMAB</medicinalproduct>
        <drugdosagetext>750MG   IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NON-HODGKIN'S LYMPHOMA RECURRENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040902</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RITUXIMAB</medicinalproduct>
        <drugdosagetext>750MG   IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NON-HODGKIN'S LYMPHOMA RECURRENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060419</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GABAPENTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HEPARIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GUAIFENESIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEMENTINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVAQUIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BACTRIM DS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAMADOL HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE TAB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENADRYL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5046509-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060707</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>64</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>81.6475</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FAECAL INCONTINENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HOT FLUSH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEMORY IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARBOPLATIN</medicinalproduct>
        <drugdosagetext>545 MG   EVERY MONTH    IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NEOPLASM MALIGNANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060609</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060706</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARBOPLATIN</medicinalproduct>
        <drugdosagetext>545 MG   EVERY MONTH    IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>SWEAT GLAND TUMOUR</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060609</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060706</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARBOPLATIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5046510-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060705</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>81</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>96.7</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHILLS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFUSION RELATED REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RITUXIMAB</medicinalproduct>
        <drugdosagetext>825MG  IV  IN NS  (THERAPY DATES: 4/18/06 + 5 PREV DATES)</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CHRONIC LYMPHOCYTIC LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060418</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EPO</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENADRYL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYLENOL (CAPLET)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>B12</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FES04</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>L-THYROXINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAMADOL HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PHENERGAN HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOPERAMIDE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5046518-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060706</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>73</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>RETROPERITONEAL HAEMATOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN</medicinalproduct>
        <drugdosagetext>1250 U /25 ML /HR CONTINOUS IV DRIP</drugdosagetext>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>PULMONARY EMBOLISM</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060413</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060430</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL SPIROS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CIPROFLOXACIN IN DEXTROSE 5%</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FENTANYL CITRATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYRINGE LEUR-LOK</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HEPARIN/SODUIM CHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCORTISONE SODIUM SUCCINATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HUMULIN R</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SODIUM CHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IPRATROPIUM BR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHYLCELLULOSE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NICOTINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NOREPINEPHRINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LACRILUBE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5046520-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060706</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>59</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>SWELLING FACE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENALAPRIL MALEATE</medicinalproduct>
        <drugdosagetext>5 MG BID PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060404</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060405</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMITIPTYLINE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLINDAMYCIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUNISOLIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GABAPENTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GUAIFENESIN DM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORATADINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MOXIFLOXACIN HCL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5046523-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060706</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>26</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>99.7913</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>AGGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRAIN DAMAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DELUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG DEPENDENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HALLUCINATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOOD SWINGS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ROBOTUSSIN DX</medicinalproduct>
        <drugdosagetext>WHOLE BOTTLE EVERY OTHER DAY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPENDENCE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5046524-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20051201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2005US13085</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BONE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTH EXTRACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTHACHE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAXOTERE</medicinalproduct>
        <drugdosagetext>70MG/M2</drugdosagetext>
        <drugindication>PROSTATE CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040712</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050119</drugenddate>
        <drugtreatmentduration>192</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE TAB</medicinalproduct>
        <drugdosagetext>5MG BID</drugdosagetext>
        <drugindication>PROSTATE CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040712</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050119</drugenddate>
        <drugtreatmentduration>192</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE TAB</medicinalproduct>
        <drugdosagetext>5MG BID</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050418</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050829</drugenddate>
        <drugtreatmentduration>134</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MITOXANTRONE</medicinalproduct>
        <drugdosagetext>12MG/M2</drugdosagetext>
        <drugindication>PROSTATE CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050418</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050829</drugenddate>
        <drugtreatmentduration>134</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugauthorizationnumb>021223</drugauthorizationnumb>
        <drugdosagetext>4MG Q3-4WK</drugdosagetext>
        <drugindication>PROSTATE CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040607</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050808</drugenddate>
        <drugtreatmentduration>428</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5046526-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060705</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>58</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>97.5</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA EXERTIONAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MELAENA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
        <drugdosagetext>OTC - PT SELF-ADMINISTRATION  (THERAPY DATES:  4 DAYS BEFORE ADMISSION)</drugdosagetext>
        <drugindication>SELF-MEDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FELODIPINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLIPIZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SERTRALINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VARDENAFIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HC CREAM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5046527-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060530</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GILEAD-2006-0009659</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>25</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>109.96</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CONGENITAL TERATOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PREGNANCY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIREAD</medicinalproduct>
        <drugauthorizationnumb>21356</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VIDEX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VIRACEPT</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5046529-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060706</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>56</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFUSION RELATED REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXALIPLATIN</medicinalproduct>
        <drugdosagetext>170 MG IV 5/9, 5/23 IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RECTAL CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060509</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060523</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEUCOVORIN CALCIUM</medicinalproduct>
        <drugdosagetext>400 MG IV 5/9, 5/23, 6/5, IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060509</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060523</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOFRAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEUCOVORIN CALCIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXTROSE 5%</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXALIPLATIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BELT, HOLLISTER, MED #7300 USE BELT-S</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENZOYL PEROXIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLAMP, DRAINAGE STOMA BAGE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIPHENHYDRAMINE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLANGE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MYLANTA/BENADRYL/XYLOCAINE VISC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POUCH, DRAINABLE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5046532-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060706</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>25</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>61.2356</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>AGGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ALOPECIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANGER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IRRITABILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENORRHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERFORMANCE STATUS DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVIANE-21</medicinalproduct>
        <drugdosagetext>1 TAB DAILY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONTRACEPTION</drugindication>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVIANE-21</medicinalproduct>
        <drugdosagetext>1 TAB DAILY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ENDOMETRIOSIS</drugindication>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5046534-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060706</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>67</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG PRESCRIBING ERROR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERNATIONAL NORMALISED RATIO INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MOXIFLOXACIN HCL</medicinalproduct>
        <drugdosagetext>400MG  PO  QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060421</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060424</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
        <drugdosagetext>1.75MG  QD  EXC  2.5MG TU-TH-SA</drugdosagetext>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADVAIR DISKUS 100/50</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FELODIPINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GABAPENTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ISOSORBIDE DINITRATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NAPROXEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SERTRALINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAMADL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALSARTAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5046536-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060705</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>45</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>81.3</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PLATELET DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PHENYTOIN</medicinalproduct>
        <drugdosagetext>100 MG  (AS PE) Q8H  IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CONVULSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060619</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060620</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LABETALOL HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5046538-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060705</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>57</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>87</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY ALVEOLAR HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STAPHYLOCOCCAL INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SIROLIMUS</medicinalproduct>
        <drugdosagetext>4MG  Q AM</drugdosagetext>
        <drugindication>IMMUNOSUPPRESSANT DRUG THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060612</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SIROLIMUS</medicinalproduct>
        <drugdosagetext>4MG  Q AM</drugdosagetext>
        <drugindication>RENAL TRANSPLANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060612</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COLCHICINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CACO3</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMDUR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5046540-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060428</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHNU2006DE01807</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISORIENTATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENTAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERSONALITY CHANGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SANDIMMUNE</medicinalproduct>
        <drugauthorizationnumb>50715</drugauthorizationnumb>
        <drugdosagetext>350 MG DAILY</drugdosagetext>
        <drugindication>APLASTIC ANAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SANDIMMUNE</medicinalproduct>
        <drugauthorizationnumb>050715</drugauthorizationnumb>
        <drugdosagetext>25 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SANDIMMUNE</medicinalproduct>
        <drugauthorizationnumb>050715</drugauthorizationnumb>
        <drugdosagetext>10 MG DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SANDIMMUNE</medicinalproduct>
        <drugauthorizationnumb>050715</drugauthorizationnumb>
        <drugdosagetext>125/0/100 MG/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5046541-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060630</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHO2006DE10754</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>37</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>INTERSTITIAL LUNG DISEASE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CERTICAN</medicinalproduct>
        <drugdosagetext>NO TREATMENT</drugdosagetext>
        <drugindication>RENAL TRANSPLANT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEORAL</medicinalproduct>
        <drugauthorizationnumb>050715</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RENAL TRANSPLANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051021</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5046542-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060614</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2006US07821</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>66</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN JAW</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTHACHE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugauthorizationnumb>21223</drugauthorizationnumb>
        <drugdosagetext>4 MG, UNK</drugdosagetext>
        <drugindication>METASTASES TO BONE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050901</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CASODEX</medicinalproduct>
        <drugdosagetext>50MG QD</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060420</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060520</drugenddate>
        <drugtreatmentduration>44640</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CISPLATIN</medicinalproduct>
        <drugdosagetext>UNK WKLY</drugdosagetext>
        <drugindication>NEOPLASM MALIGNANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LUPRON</medicinalproduct>
        <drugindication>PROSTATE CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060301</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5046543-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060705</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABNORMAL BEHAVIOUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOBILITY DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERFORMANCE STATUS DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FENTANYL TRANSDERMAL SYSTEM</medicinalproduct>
        <drugdosagetext>75 MCG   Q 2 1/2 DAY   DERMAL</drugdosagetext>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>COMPRESSION FRACTURE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FENTANYL TRANSDERMAL SYSTEM</medicinalproduct>
        <drugdosagetext>75 MCG   Q 2 1/2 DAY   DERMAL</drugdosagetext>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FENTANYL TRANSDERMAL SYSTEM</medicinalproduct>
        <drugdosagetext>75 MCG   Q 2 1/2 DAY   DERMAL</drugdosagetext>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>PAIN</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5046544-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060706</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>71</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>APHASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGIC STROKE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LETHARGY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>325MG   QD   PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ISCHAEMIC STROKE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060327</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060404</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUTICASONE  SALMETEROL ADVAIR INHALER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IPRATROPIUM BROMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NIFEDIPINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENALAPRIL MALEATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARVEDILOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THIAMINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUNISOLIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL MDI INHALER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENADRYL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLARITIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5046546-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060705</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>61</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>131.0895</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOPATHY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACTOPLUS MET</medicinalproduct>
        <drugdosagetext>15/500 TWICE DAILY ORALLY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060506</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060508</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPROL-XL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM CHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COMBIVENT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZYRTEC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOTROL XL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XOPENEX NEB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
        <drugdosagetext>500 MG BID</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5046548-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060706</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>127.0072</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MYDRIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISION BLURRED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VISINE-A</medicinalproduct>
        <drugbatchnumb>1002044</drugbatchnumb>
        <drugdosagetext>2 DROPS 4 HOURS OPHTHALMIC</drugdosagetext>
        <drugadministrationroute>047</drugadministrationroute>
        <drugindication>EYE PRURITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040610</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040610</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>805</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5046551-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060705</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>40</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>91.6266</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHROPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ILL-DEFINED DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE CONTRACTIONS INVOLUNTARY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN TIGHTNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHEELCHAIR USER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GADOLINIUM CONTRAST AGENT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BLOOD PRESSURE MEDICINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5046554-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060705</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>35</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE ABSCESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TUBERSOL</medicinalproduct>
        <drugdosagetext>5 US UNITS (0.1ML) X 1 INTRADERMALLY</drugdosagetext>
        <drugadministrationroute>023</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060509</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TUBERSOL</medicinalproduct>
        <drugbatchnumb>C2246AA</drugbatchnumb>
        <drugdosagetext>5 US UNITS (0.1 ML) X 1 INTRADERMALLY</drugdosagetext>
        <drugadministrationroute>023</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5046555-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060705</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>41</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>102.0593</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>AGEUSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANOSMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL INTAKE REDUCED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARYNGOLARYNGEAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SNEEZING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZICAM   15ML   ZICAM LLC</medicinalproduct>
        <drugbatchnumb>50015.001</drugbatchnumb>
        <drugdosagetext>ONE SQUIRT ONCE A DAY NASAL</drugdosagetext>
        <drugadministrationroute>045</drugadministrationroute>
        <drugindication>NASOPHARYNGITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060627</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060627</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5046559-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060705</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>63</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>99.7913</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>AGEUSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANOSMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAROSMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZICAM RAPIDMELT MARTIXX INITIATIVES, INC</medicinalproduct>
        <drugdosagetext>1 TABLET 1 TABLET EVERY 3 HR PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NASOPHARYNGITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050703</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5046560-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060627</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHNU2006DE02386</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD CREATINE PHOSPHOKINASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULAR WEAKNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOPATHY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SANDIMMUNE</medicinalproduct>
        <drugauthorizationnumb>050574</drugauthorizationnumb>
        <drugdosagetext>175MG/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ALPORT'S SYNDROME</drugindication>
        <drugtreatmentduration>547</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PARACETAMOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>JODID</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5046561-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060706</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>62</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>87</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>WINRHO</medicinalproduct>
        <drugdosagetext>4300 MCG IV ONE TIME</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>IDIOPATHIC THROMBOCYTOPENIC PURPURA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060615</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>WINRHO</medicinalproduct>
        <drugdosagetext>4300 MCG IV ONE TIME</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PLATELET COUNT DECREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060615</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5046564-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060705</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>65</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NASAL CONGESTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVITRA</medicinalproduct>
        <drugdosagetext>10 MG PRN PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ERECTILE DYSFUNCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060511</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5046567-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060706</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>87</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>66</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGE INTRACRANIAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TPA-ALTEPLASE- 10MG GENENTECH</medicinalproduct>
        <drugdosagetext>621 MGONCE IV DRIP</drugdosagetext>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>CEREBROVASCULAR ACCIDENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060703</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060703</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5046573-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060706</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>74</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ACUTE MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>APHASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBRAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY OCCLUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEMIPLEGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GAMMAGARD</medicinalproduct>
        <drugdosagetext>40 G/800 ML ONCE</drugdosagetext>
        <drugindication>CHRONIC INFLAMMATORY DEMYELINATING POLYRADICULONEUROPATHY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060419</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060419</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIPHENHYDRAMINE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMMUNE GLOBULIN (HUMAN)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5046575-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060705</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ACCIDENTAL EXPOSURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ACCIDENTAL NEEDLE STICK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN IRRITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THERAPEUTIC PRODUCT CONTAMINATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INJ IVOMEC PLUS</medicinalproduct>
        <drugdosagetext>INJ</drugdosagetext>
        <drugindication>DRUG ADMINISTRATION ERROR</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060609</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060609</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5046578-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060705</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ACCIDENTAL EXPOSURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOP TRESADERM</medicinalproduct>
        <drugdosagetext>TOP</drugdosagetext>
        <drugadministrationroute>061</drugadministrationroute>
        <drugindication>DRUG ADMINISTRATION ERROR</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060614</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060614</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5046584-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060706</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>71.2</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>METASTASES TO LIVER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METASTASES TO LUNG</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METASTASES TO LYMPH NODES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CISPLATIN</medicinalproduct>
        <drugdosagetext>89 MG</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOPOTECAN</medicinalproduct>
        <drugdosagetext>3.9 MG</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOFRAN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5046587-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060705</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>72.4</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>DYSURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EPISTAXIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FAECES DISCOLOURED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BUSULFAN</medicinalproduct>
        <drugdosagetext>12.8 MG</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOPHOSPHAMIDE</medicinalproduct>
        <drugdosagetext>3492 MG</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYTARABINE</medicinalproduct>
        <drugdosagetext>1253 MG</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DAUNORUBICIN HCL</medicinalproduct>
        <drugdosagetext>240 MG</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GEMTUZMAB OZOGAMICIN (MYLOTARG)</medicinalproduct>
        <drugdosagetext>10.7 MG</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5046590-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060706</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>71.2</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>LIVER DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPHADENOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPHIL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CISPLATIN</medicinalproduct>
        <drugdosagetext>89 MG</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOPOTECAN</medicinalproduct>
        <drugdosagetext>3.9 MG</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOFRAN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5046594-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060705</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>89.5</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD CREATININE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHILLS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINE OUTPUT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUOROURACIL</medicinalproduct>
        <drugdosagetext>6750 MG</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060626</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ELOXATIN</medicinalproduct>
        <drugdosagetext>400 MG</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060626</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5046597-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060706</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>102</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACTERIA BLOOD IDENTIFIED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OXYGEN SATURATION DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPTIC SHOCK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CISPLATIN</medicinalproduct>
        <drugbatchnumb>06C603</drugbatchnumb>
        <drugdosagetext>100 MG</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOXORUBICIN HYDROCHLORIDE</medicinalproduct>
        <drugbatchnumb>885391</drugbatchnumb>
        <drugdosagetext>90 MG</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAXOL</medicinalproduct>
        <drugbatchnumb>852791</drugbatchnumb>
        <drugdosagetext>320 MG</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5046603-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060705</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>101</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD BILIRUBIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISSEMINATED INTRAVASCULAR COAGULATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCREATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE TAB</medicinalproduct>
        <drugdosagetext>280 MG</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060619</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>L-ASPAAGINASE</medicinalproduct>
        <drugdosagetext>5</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060616</drugstartdate>
        <drugtreatmentduration>22</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5046605-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060707</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>59</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HAEMATOCHEZIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATOCRIT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOPTYSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GOODY'S POWDER ASPIRIN 500 MG/ACETAMINOPHEN325M</medicinalproduct>
        <drugdosagetext>2-4 PACKS DAILY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CHEST DISCOMFORT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060406</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060427</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL SULFATE AND IPRATROPIUM BROMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CODEINE 10 MG /GUAIFENESIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EPOETIN ALFA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEGESTROL ACETATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ONDANSETRON HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYMETAZOLINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5046606-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060705</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>62</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>105.8</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TERAZOSIN HCL</medicinalproduct>
        <drugdosagetext>5 MG QD HS</drugdosagetext>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060529</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
        <drugdosagetext>100 MG QD</drugdosagetext>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060526</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLINDAMYCIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLIPIZIDE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5046610-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AVENTIS-200616835GDDC</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>66</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>54.4</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL DISTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAXOTERE</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>020449</drugauthorizationnumb>
        <drugdosagetext>DOSE UNIT: MILLIGRAM PER MILLILITRE</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>OVARIAN CANCER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOPOTECAN</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugdosagetext>DOSE UNIT: MILLIGRAM PER MILLILITRE</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>OVARIAN CANCER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTIHYPERTENSIVES</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5046611-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060703</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-AVENTIS-200612384FR</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>68</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>SUBDURAL HAEMATOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAXOTERE</medicinalproduct>
        <drugauthorizationnumb>20449</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>LUNG NEOPLASM MALIGNANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060322</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060524</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREVISCAN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060503</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5046613-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060620</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-AVENTIS-200611908JP</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>75</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>44</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PANCREATITIS ACUTE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAXOTERE</medicinalproduct>
        <drugauthorizationnumb>20449</drugauthorizationnumb>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>URETHRAL CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050822</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050822</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAXOTERE</medicinalproduct>
        <drugauthorizationnumb>020449</drugauthorizationnumb>
        <drugadministrationroute>041</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060116</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060116</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAXOTERE</medicinalproduct>
        <drugauthorizationnumb>020449</drugauthorizationnumb>
        <drugadministrationroute>041</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060203</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060203</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GEMZAR</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>URETHRAL CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050822</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050822</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GEMZAR</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060116</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060116</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GEMZAR</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060203</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060203</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KYTRIL</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>URETHRAL CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060116</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060116</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KYTRIL</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060203</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060203</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DECADRON</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>URETHRAL CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060116</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060116</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DECADRON</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060203</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060203</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RADIOTHERAPY</medicinalproduct>
        <drugdosagetext>DOSE: 39.6 GY IN TOTAL</drugdosagetext>
        <drugindication>URETHRAL CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060320</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060419</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5046614-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-AVENTIS-200612006JP</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>GALLBLADDER CANCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG NEOPLASM MALIGNANT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA BACTERIAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA FUNGAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RADIATION PNEUMONITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAXOTERE</medicinalproduct>
        <drugauthorizationnumb>20449</drugauthorizationnumb>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CISPLATIN</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RADIOTHERAPY</medicinalproduct>
        <drugdosagetext>DOSE: 2 GY/DAY; 60 GY/TOTAL</drugdosagetext>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5046615-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060707</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>57</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>AGITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRADYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GRAND MAL CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPONATRAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SIMPLE PARTIAL SEIZURES</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXCARBAZEPINE</medicinalproduct>
        <drugdosagetext>600 MG PO QAM AND 900 MG QPM PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONVULSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041004</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060613</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXCARBAZEPINE</medicinalproduct>
        <drugdosagetext>600 MG PO QAM AND 900 MG QPM PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEMYELINATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041004</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060613</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSPHENYTOIN SODIUM</medicinalproduct>
        <drugdosagetext>1500 MG IV ONE IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CONVULSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060513</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060513</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSPHENYTOIN SODIUM</medicinalproduct>
        <drugdosagetext>1500 MG IV ONE IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>DEMYELINATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060513</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060513</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENALAPRIL MALEATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FELODIPINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADVAIR DISKUS 100/50</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL SPIROS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AZITHROMYCIN DOSEPAK</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GATIFLOXACIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRIAMTERENE AND HYDROCHLOROTHIAZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVALBUTEROL HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRILEPTAL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE TAPER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TIOTROPIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAMADOL HCL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5046623-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060707</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>35</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>59.2</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FEBRILE NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEUKOPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ABRAXANE</medicinalproduct>
        <drugdosagetext>429 MG EVERY 2 WEEKS IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060622</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060622</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AC CHEMOTHERAPY</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATIVAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COMPAZINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DECADRON</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOFRAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARANESP</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5046628-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060707</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>59</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>EPISTAXIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATOCRIT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERNATIONAL NORMALISED RATIO DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SULFAMETHOXAZOLE + TRIMETHOPRIM</medicinalproduct>
        <drugdosagetext>1 TABLET BID PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>AORTIC VALVE REPLACEMENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060418</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060422</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARANESP</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDRALAZINE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FESO4</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NITROGLYCERIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLONASE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COMBIVENT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COLACE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
        <drugdosagetext>5MG  HS  PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANTIBIOTIC PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060503</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060706</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
        <drugdosagetext>5MG  HS  PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NASAL CAVITY PACKING</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060503</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060706</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5046631-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060707</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>35</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HAEMATOCRIT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MELAENA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UPPER GASTROINTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GOODY'S POWDER</medicinalproduct>
        <drugdosagetext>ASA 500 MG/APAP 325 BID PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRALGIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
        <drugdosagetext>200 MG PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRALGIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RITONAVIR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LAMIVUDINE MG/BIVALIRUDIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATAZANAVIR</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5046634-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060707</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>54</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD CREATININE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG TOXICITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VANCOMYCIN</medicinalproduct>
        <drugdosagetext>1 GM IV Q12 H</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>SUBCUTANEOUS ABSCESS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060502</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060506</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRIMETHOPRIM + SULFAMETHOXAZOLE</medicinalproduct>
        <drugdosagetext>1 TABLET PO BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SUBCUTANEOUS ABSCESS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060506</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060517</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTI EMBOLISM STOCKING MEDIUM USE PAIR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLOTRIMAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HCTZ 50/TRIAMTERENE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NICOTINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>.</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAMADOL HCL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5046637-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060707</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>58</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>COLD SWEAT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING COLD</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMULIN 70/30</medicinalproduct>
        <drugdosagetext>-70 UNITS QAM, 48 UNITS QPM</drugdosagetext>
        <drugindication>DIABETES MELLITUS INSULIN-DEPENDENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051103</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060706</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>.</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GABAPENTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MIRTAZAPINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AQUAPHOR</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5046639-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060707</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>42</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATOCRIT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NAPROXEN</medicinalproduct>
        <drugdosagetext>500 MG PO BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MIGRAINE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060208</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060530</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL SULFATE AND IPRATROPIUM BROMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL SPIROS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SUMATRIPTAN SUCCINATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PFOMETHAZINE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MONTELUKAST NA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAMADOL HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GABAPENTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANTOPRAZOLE SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADVAIR DISKUS 100/50</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYCLOBENZAPRINE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NAPROXEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOCLOPRAMIDE HCL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5046645-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DK-BRISTOL-MYERS SQUIBB COMPANY-13434725</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>62</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ASPARTATE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD LACTATE DEHYDROGENASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISORIENTATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERNATIONAL NORMALISED RATIO INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SINEMET</medicinalproduct>
        <drugauthorizationnumb>19856</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PARKINSONISM</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060615</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5046646-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060704</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-BRISTOL-MYERS SQUIBB COMPANY-13432349</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>54</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ELECTROCARDIOGRAM ST SEGMENT DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUS TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COAPROVEL TABS 300MG/12.5MG</medicinalproduct>
        <drugauthorizationnumb>20758</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PARACETAMOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIAZEPAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALCOHOL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5046647-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-BRISTOL-MYERS SQUIBB COMPANY-13428768</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>43</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CHOLELITHIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATOMEGALY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYELONEPHRITIS ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIDEX EC</medicinalproduct>
        <drugauthorizationnumb>021183</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060607</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUSTIVA</medicinalproduct>
        <drugauthorizationnumb>020972</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIREAD</medicinalproduct>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060607</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5046648-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-BRISTOL-MYERS SQUIBB COMPANY-13435342</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>25</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DEPRESSED MOOD</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAZE PALSY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDE ATTEMPT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ABILIFY</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060622</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060627</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERIDONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060512</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOPICLONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INSOMNIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060512</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NITRAZEPAM</medicinalproduct>
        <drugdosagetext>20 MG, THEN DECR. TO 10 MG ON 07-JUN-2006, THEN DECR. TO 5 MG ON 22-JUN-2006.</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INSOMNIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060512</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060627</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRIHEXYPHENIDYL HCL</medicinalproduct>
        <drugdosagetext>6 MG, THEN DECR. 4 MG TO 14-JUN-2006, THEN DECR. TO 2 MG 21-JUN-2006</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>EXTRAPYRAMIDAL DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060512</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5046649-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060630</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-BRISTOL-MYERS SQUIBB COMPANY-13435920</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>83</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HEPATITIS B</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENDOXAN</medicinalproduct>
        <drugauthorizationnumb>12142</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDONINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5046650-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060703</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-13431911</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ERBITUX</medicinalproduct>
        <drugdosagetext>FIRST DOSE.</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060601</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
        <drugindication>PREMEDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060601</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIPHENHYDRAMINE HCL</medicinalproduct>
        <drugindication>PREMEDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060601</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYLENOL (CAPLET)</medicinalproduct>
        <drugindication>PREMEDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060601</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5046651-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-13428404</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>70</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARBOPLATIN</medicinalproduct>
        <drugauthorizationnumb>019880</drugauthorizationnumb>
        <drugindication>NEOPLASM MALIGNANT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAXOL</medicinalproduct>
        <drugauthorizationnumb>020262</drugauthorizationnumb>
        <drugindication>NEOPLASM MALIGNANT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALPRAZOLAM</medicinalproduct>
        <drugindication>ANXIETY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ATIVAN</medicinalproduct>
        <drugindication>ANXIETY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000214</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060531</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LUPRON</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040513</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NILANDRON</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040513</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPROL-XL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040513</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRICOR</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040514</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVASTATIN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040504</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASCORBIC ACID</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040514</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060531</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060420</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5046652-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060707</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMPAIRED GASTRIC EMPTYING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ABILIFY</medicinalproduct>
        <drugdosagetext>30 MGM DAILY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ABILIFY</medicinalproduct>
        <drugdosagetext>30 MGM DAILY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050301</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NOVOLOG</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5046653-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060707</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>64</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>63.5036</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REOPRO</medicinalproduct>
        <drugdosagetext>IV BOLUS 0.25 MG/KG IV DRIP 0.125 MG/KG/MIN</drugdosagetext>
        <drugadministrationroute>040</drugadministrationroute>
        <drugindication>CORONARY ANGIOPLASTY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060629</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REOPRO</medicinalproduct>
        <drugdosagetext>IV BOLUS 0.25 MG/KG IV DRIP 0.125 MG/KG/MIN</drugdosagetext>
        <drugadministrationroute>040</drugadministrationroute>
        <drugindication>CORONARY ARTERIAL STENT INSERTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060629</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN</medicinalproduct>
        <drugdosagetext>70 UNITS/KG</drugdosagetext>
        <drugindication>CORONARY ANGIOPLASTY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060629</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN</medicinalproduct>
        <drugdosagetext>70 UNITS/KG</drugdosagetext>
        <drugindication>CORONARY ARTERIAL STENT INSERTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060629</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IV CONTRAST MEDIUM (VISIPAQUE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MIDOZOLAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FENTANYL TRANSDERMAL SYSTEM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLOPIDOGREL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5046654-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060707</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>82</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>48.0813</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREGABALIN 50 MG PFIZER</medicinalproduct>
        <drugdosagetext>50 MG DAILY IN AM PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NEURALGIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060602</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060626</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5046655-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060707</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>61</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>INCREASED TENDENCY TO BRUISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERNATIONAL NORMALISED RATIO DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERNATIONAL NORMALISED RATIO INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
        <drugdosagetext>5 MG QHS PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY EMBOLISM</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060422</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060706</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYLENOL W/ CODEINE NO. 3</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>BENZATROPINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOCUSATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUOXETINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HALOPERIDOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IPRATROPIUM MDI</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOCARBAMOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOCLOPRAMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NAPROSYN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NITROGLYCERIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SORBITOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BISACODYL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PERCOCET</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MS CONTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5046657-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060707</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>75</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BRADYCARDIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
        <drugdosagetext>25GM PO BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060505</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060512</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FELODIPINE</medicinalproduct>
        <drugdosagetext>10MG PO BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050223</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060512</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOSINOPRIL SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MINOXIDIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARICEPT</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5046659-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060707</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>2.7216</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>AGITATION NEONATAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG WITHDRAWAL SYNDROME NEONATAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR NEONATAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
        <drugdosagetext>100MG DAILY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OBSESSIVE-COMPULSIVE DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060326</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060610</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5046662-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060707</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>41</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>43.9989</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CARPAL TUNNEL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFUSION SITE REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOVEMENT DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NERVE COMPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWELLING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BONIVA</medicinalproduct>
        <drugbatchnumb>MH68493 01</drugbatchnumb>
        <drugdosagetext>3CC Q 3 MONTHS IV BOLUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BARRETT'S OESOPHAGUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060629</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060629</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BONIVA</medicinalproduct>
        <drugbatchnumb>MH68493 01</drugbatchnumb>
        <drugdosagetext>3CC Q 3 MONTHS IV BOLUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>OSTEOPENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060629</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060629</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5046664-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060707</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>59</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EPISTAXIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATOCRIT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERNATIONAL NORMALISED RATIO DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
        <drugdosagetext>7.5 MG QD PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>AORTIC VALVE REPLACEMENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050525</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060415</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARANESP</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDRALAZINE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FESO4</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NITROGLYCERIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLONASE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COMBIVENT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COLACE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5046666-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-BRISTOL-MYERS SQUIBB COMPANY-13430947</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>44</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE AMBULATORY DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARTIAL SEIZURES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHOTOPSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POSTURAL ORTHOSTATIC TACHYCARDIA SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TINNITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SINEMET</medicinalproduct>
        <drugauthorizationnumb>017555</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PARKINSON'S DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LAMISIL</medicinalproduct>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060615</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AROPAX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5046668-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060705</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>47</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>145.151</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CHEST DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NASAL CONGESTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SNEEZING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OPTIRAY 350</medicinalproduct>
        <drugbatchnumb>L14101</drugbatchnumb>
        <drugindication>COMPUTERISED TOMOGRAM THORAX</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5046671-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060705</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>RESPIRATORY DISTRESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NICODERM CQ</medicinalproduct>
        <drugdosagetext>14 + 7 MG 1/DAY TRANSDERMAL</drugdosagetext>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>SMOKING CESSATION THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040212</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040609</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPAMAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KLONIPIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROVIGIL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5046672-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060705</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>48</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLIMARA</medicinalproduct>
        <drugdosagetext>0.1 MG</drugdosagetext>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020802</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020819</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLIMARA</medicinalproduct>
        <drugdosagetext>0.1 MG</drugdosagetext>
        <drugindication>POSTOPERATIVE CARE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020802</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020819</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>..</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5046674-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060705</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MECONIUM ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEONATAL ASPIRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEONATAL RESPIRATORY DISTRESS SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UMBILICAL CORD AROUND NECK</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NICOTINE</medicinalproduct>
        <drugdosagetext>21 MG, 1/DAY TRANS</drugdosagetext>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>SMOKING CESSATION THERAPY</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040301</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMBIEN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5046675-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060705</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>49.8957</patientweight>
      <patientsex>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>AMNESTEEM</medicinalproduct>
        <drugdosagetext>10 MG ONCE DAILY AM ORALLY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ACNE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060329</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMNESTEEM</medicinalproduct>
        <drugdosagetext>40 MG ONCE DAILY PM ORALLY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ACNE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060418</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5046677-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060705</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PREMATURE SEPARATION OF PLACENTA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NICODERM CQ</medicinalproduct>
        <drugdosagetext>14 MG/ 1 PER DAY/ TRANS</drugdosagetext>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>SMOKING CESSATION THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041124</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041221</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5046679-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060705</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PREMATURE BABY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SMALL FOR DATES BABY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TWIN PREGNANCY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NICODERM</medicinalproduct>
        <drugdosagetext>21 MG / QD/ TRANSDERMAL</drugdosagetext>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>SMOKING CESSATION THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050112</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050214</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5046681-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060705</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>72.5755</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ORTHO EVRA</medicinalproduct>
        <drugdosagetext>1 PATCH 1 PATCH/WK TRANSDERMAL</drugdosagetext>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>CONTRACEPTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050401</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5046683-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060705</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INDUCED LABOUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PREMATURE BABY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PREMATURE RUPTURE OF MEMBRANES</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NICODERM</medicinalproduct>
        <drugdosagetext>7MG QD TRANSDERMAL</drugdosagetext>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>SMOKING CESSATION THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050121</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050526</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5046684-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060705</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>41</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugdosagetext>10 MG Q DAY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060607</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060616</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5046686-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060705</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>45.3597</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DENTURE WEARER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEDICAL DEVICE COMPLICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOUTH ULCERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugindication>OSTEOPOROSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5046688-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060705</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>56.6996</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ALOPECIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAIR DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRAVACHOL</medicinalproduct>
        <drugdosagetext>20 MG QD PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERCHOLESTEROLAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060421</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5046690-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060705</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>54</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>68.0396</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NASAL CONGESTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CEPHALEXIN</medicinalproduct>
        <drugdosagetext>500 MG 4 PER DAY ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060508</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060515</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CEPHALEXIN</medicinalproduct>
        <drugdosagetext>500 MG 4 PER DAY ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>LIMB INJURY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060508</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060515</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5046692-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060705</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>67</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>50.8029</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEBRILE NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JUGULAR VEIN THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLEURAL EFFUSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GLEEVEC</medicinalproduct>
        <drugdosagetext>400 MG PO BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>METASTASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060523</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GLEEVEC</medicinalproduct>
        <drugdosagetext>400 MG PO BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SARCOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060523</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAXOL</medicinalproduct>
        <drugdosagetext>100 MG/M2 IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060525</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5046693-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060705</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>54</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>49.8957</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRY EYE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FEXOFENADINE HCL</medicinalproduct>
        <drugdosagetext>180 MG Q DAY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SEASONAL ALLERGY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060502</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5046695-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20051215</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>UG-GILEAD-2005-0009028</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
    </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>AZOTAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>REFUSAL OF TREATMENT BY PATIENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE CHRONIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWELLING FACE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TENOFOVIR DISOPROXIL FUMARATE</medicinalproduct>
        <drugauthorizationnumb>21356</drugauthorizationnumb>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031205</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051031</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TENOFOVIR DISOPROXIL FUMARATE</medicinalproduct>
        <drugauthorizationnumb>021356</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030822</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031127</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TENOFOVIR DISOPROXIL FUMARATE</medicinalproduct>
        <drugauthorizationnumb>021356</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030710</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030808</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COMBIVIR</medicinalproduct>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030822</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031127</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COMBIVIR</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030710</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030808</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LAMIVUDINE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031205</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051121</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>STAVUDINE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031205</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051121</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5046698-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060705</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>40</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>SINUS BRADYCARDIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIFLUCAN</medicinalproduct>
        <drugdosagetext>150 MG ORALLY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>TINEA INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060501</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TIMENTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PEPCID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOTRAMIN ULTRA**</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEUTRAPHOS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SOLU-MEDROL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACTIVAN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5046701-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060705</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>69</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>120.2032</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ACTIVITIES OF DAILY LIVING IMPAIRED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DELAYED RECOVERY FROM ANAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEMIPARESIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ISCHAEMIC CEREBRAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOBILITY DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POST PROCEDURAL COMPLICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRASYLOL</medicinalproduct>
        <drugdosagetext>1ML TEST DOSE, THEN 200ML BOLUS, THEN 50ML/HR X 200 ML</drugdosagetext>
        <drugadministrationroute>040</drugadministrationroute>
        <drugindication>CORONARY ARTERY BYPASS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060510</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SEE ATTACHED LIST</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5046706-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060705</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>78</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>126</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CEREBRAL ISCHAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POST PROCEDURAL COMPLICATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRASYLOL</medicinalproduct>
        <drugdosagetext>200 ML BOLUS PLUS 50 ML/HR X 200ML TOTAL 400 ML + TEST DOSE</drugdosagetext>
        <drugadministrationroute>040</drugadministrationroute>
        <drugindication>HAEMORRHAGE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060516</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRASYLOL</medicinalproduct>
        <drugdosagetext>200 ML BOLUS PLUS 50 ML/HR X 200ML TOTAL 400 ML + TEST DOSE</drugdosagetext>
        <drugadministrationroute>040</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060516</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SEE ATTACHED SHEET FOR OTHER MEDS GIVEN 5/16-5/21 BETWEEN SURGERY + ST</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5046710-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060705</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>MEDICATION ERROR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STOMACH DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WRONG DRUG ADMINISTERED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OCUPOWER MULTI-VITAMIN</medicinalproduct>
        <drugbatchnumb>25538</drugbatchnumb>
        <drugdosagetext>6 CAPSULES DAILY ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ROUTINE HEALTH MAINTENANCE</drugindication>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5046712-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060706</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>53</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>74.3899</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>INFUSION RELATED REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NO REACTION ON PREVIOUS EXPOSURE TO DRUG</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URTICARIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GAMMAGARD LIQUID</medicinalproduct>
        <drugbatchnumb>LE12F027AC</drugbatchnumb>
        <drugdosagetext>30 GM IV MONTHLY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>HYPOGAMMAGLOBULINAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060524</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GAMMAGARD LIQUID</medicinalproduct>
        <drugbatchnumb>LE12F028AC</drugbatchnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060622</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5046715-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060705</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENALAPRIL MALEATE</medicinalproduct>
        <drugbatchnumb>IRELAND</drugbatchnumb>
        <drugdosagetext>1 TAB 20 MGS 1 X A DAY</drugdosagetext>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060615</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5046719-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060705</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>73</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>79.8331</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CHROMATURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC ENZYME INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NO THERAPEUTIC RESPONSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMIODARONE HCL</medicinalproduct>
        <drugdosagetext>ORAL 150 MG BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060111</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMIODARONE HCL</medicinalproduct>
        <drugdosagetext>ORAL 150 MG BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060213</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INDOPAMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5046724-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060705</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>81.6475</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HYDROCODONE BITARTRATE + ACETAMINOPHEN</medicinalproduct>
        <drugbatchnumb>0966567-02340</drugbatchnumb>
        <drugindication>CERVIX OPERATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060602</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060611</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HYDROCODONE BITARTRATE + ACETAMINOPHEN</medicinalproduct>
        <drugbatchnumb>0966567-02340</drugbatchnumb>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060602</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060611</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5046734-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060705</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>70.3075</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ACCIDENTAL OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AMNESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SLEEP WALKING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMBIEN</medicinalproduct>
        <drugdosagetext>10 MG 1 Q NIGHT</drugdosagetext>
        <drugindication>INSOMNIA</drugindication>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5046739-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060705</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>55</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>52.1637</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EXTRASYSTOLES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTHYROIDISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
        <drugdosagetext>1 TABLET 1 PER DAY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>THYROIDECTOMY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060328</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060401</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
        <drugdosagetext>1 TABLET 1 PER DAY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>THYROIDECTOMY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060425</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060425</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5046743-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060705</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>72</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>78.0187</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BRONCHOSPASM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY ARREST</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ADENOSINE</medicinalproduct>
        <drugindication>CARDIAC STRESS TEST</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060508</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060508</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5046746-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060705</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>113.3993</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG WITHDRAWAL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THERAPEUTIC RESPONSE UNEXPECTED WITH DRUG SUBSTITUTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NICOTINE</medicinalproduct>
        <drugbatchnumb>3016346</drugbatchnumb>
        <drugdosagetext>21 MG QD TRANSDERMAL</drugdosagetext>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>SMOKING CESSATION THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060702</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060703</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NICODERM CQ</medicinalproduct>
        <drugdosagetext>21 MG QD TRANSDERMA</drugdosagetext>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>SMOKING CESSATION THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060618</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060702</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5046749-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060705</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>37</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>64.8644</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHILLS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CRYING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISSOCIATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG WITHDRAWAL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE IRRITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLUENZA LIKE ILLNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTESTINAL SPASM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEMORY IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOOD SWINGS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NIGHTMARE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESTLESSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHINORRHOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EFFEXOR XR</medicinalproduct>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANXIETY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060301</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EFFEXOR XR</medicinalproduct>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060301</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EFFEXOR XR</medicinalproduct>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANXIETY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060302</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060601</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EFFEXOR XR</medicinalproduct>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060302</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060601</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5046752-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060705</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>60</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>88.4514</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANGIONEUROTIC OEDEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugdosagetext>5 MG -1/2 TAB- DAILY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060127</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060130</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL SPIROS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONAZEPAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUNISOLIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCODONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM CITRATED</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SERTRALINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAZODONE HCL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5046755-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060705</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>51</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>82.5547</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BACTERIA SPUTUM IDENTIFIED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG INFILTRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYCOBACTERIUM AVIUM COMPLEX INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NIGHT SWEATS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THERAPY NON-RESPONDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ETANERCEPT 50 MG</medicinalproduct>
        <drugdosagetext>50 MG PREFILLED CONTINUES 50 M WEEKLY SQ</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>ANKYLOSING SPONDYLITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060130</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREVACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORFLEX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ULTRACET</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MIACALCIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WELLBUTRIN SR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM GLUCONATE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5046759-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060705</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>82</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>81</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CLOSTRIDIAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FAECES DISCOLOURED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STAPHYLOCOCCAL INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ROCEPHIN</medicinalproduct>
        <drugdosagetext>1 GRAM DAILY IM</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>PNEUMONIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060624</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060628</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCITRIOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEPAKOTE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TUMS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>APAP TAB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEXAPRO</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NAMENDA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZANTAC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SALSALATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EXELON</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5046760-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060705</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>48</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>80.6</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHOTODERMATOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH PAPULAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN EXFOLIATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URTICARIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ETODOLAC</medicinalproduct>
        <drugdosagetext>400 MG THREE TIMES DAILY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PATELLOFEMORAL PAIN SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060505</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060612</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5046765-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060705</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>60.3284</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THERAPEUTIC RESPONSE UNEXPECTED WITH DRUG SUBSTITUTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DURAGESIC-100</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5046769-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060705</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>75</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>88.4</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHILLS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSKINESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HALLUCINATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SENSIPAR</medicinalproduct>
        <drugdosagetext>30 MG DAILY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HAEMODIALYSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060502</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SENSIPAR</medicinalproduct>
        <drugdosagetext>30 MG DAILY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERPARATHYROIDISM SECONDARY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060502</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SENSIPAR</medicinalproduct>
        <drugdosagetext>30 MG DAILY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RENAL FAILURE CHRONIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060502</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5046784-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060705</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>78.9259</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FEELING JITTERY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALBUTEROL</medicinalproduct>
        <drugdosagetext>2.5 MG QID AND Q4H PRN-HS NEBULIZER</drugdosagetext>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060601</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5046786-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060705</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>85</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>60</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANGIONEUROTIC OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY DISTRESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
        <drugdosagetext>80 MG PO DAILY 3-5 DAYS</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5046789-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060705</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>7.2576</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FAECES DISCOLOURED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATOCHEZIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UNEVALUABLE EVENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OMNICEF</medicinalproduct>
        <drugdosagetext>1/2 TSP Q 12 HRS PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OTITIS MEDIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060208</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060213</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNITHIST</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XIRAHIST</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5046792-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060705</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALBUTEROL HFA-</medicinalproduct>
        <drugdosagetext>2 PUFFS Q 4-6 HR PRN</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5046796-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060705</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>60</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>106</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD CREATININE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EJECTION FRACTION DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMODYNAMIC INSTABILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINE OUTPUT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRASYLOL</medicinalproduct>
        <drugdosagetext>TEST DOSE , 200 ML BOLUS AND THEN 50 ML /HR X 4 HRS</drugdosagetext>
        <drugadministrationroute>040</drugadministrationroute>
        <drugindication>HAEMORRHAGE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060523</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRASYLOL</medicinalproduct>
        <drugdosagetext>TEST DOSE , 200 ML BOLUS AND THEN 50 ML /HR X 4 HRS</drugdosagetext>
        <drugadministrationroute>040</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060523</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COMBIVENT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NITROPRESS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMIODARONE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOBUTAMINE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOCUSATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HESPAN</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>MILRINONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MORPHINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NITRO-BID 2%</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PEPCID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM CHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NOVOLIN R</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRECEDEX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RESTORIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOFRAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMBIEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANCEF</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BACTROBAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BUMEX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM CHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARDIZEM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEMEROL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLTX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HEPARIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HIBICLENS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANOXIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVAQUIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIDOCAINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MUCOMYST</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANCURONIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PHENERGAN HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROTAMINE SULFATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PAPAVERINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SUBLIAMAZE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>URISPAS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VANCOMYCIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VERSED</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOSYN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5046798-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040510</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IL-SANOFI-SYNTHELABO-F01200401057</companynumb>
    <primarysource>
      <reportercountry>ISRAEL</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD CALCIUM DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD POTASSIUM DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEBRILE NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERAL PHYSICAL HEALTH DETERIORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCYTOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STAPHYLOCOCCAL INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040129</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAMADOL HCL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040129</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL FUMARATE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990615</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NIFEDIPINE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19890615</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAALOX FAST BLOCKER</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040129</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CAPECITABINE</medicinalproduct>
        <drugdosagetext>2150 MG FROM D1 TO D15, Q3W</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040219</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040303</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVASTIN</medicinalproduct>
        <drugdosagetext>5 MG/KG OR PLACEBO</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXALIPLATIN</medicinalproduct>
        <drugauthorizationnumb>021492</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLORECTAL CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040219</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040219</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>805</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5046802-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060705</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>85</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>51</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEMIPLEGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POST PROCEDURAL COMPLICATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRASYLOL</medicinalproduct>
        <drugdosagetext>200 ML IV PRN</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CORONARY ARTERY BYPASS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060512</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRASYLOL</medicinalproduct>
        <drugdosagetext>200 ML IV PRN</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>POST PROCEDURAL HAEMORRHAGE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060512</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRASYLOL</medicinalproduct>
        <drugdosagetext>200 ML IV PRN</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060512</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SUBLIMAZE PRESERVATIVE FREE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MUCOMYST</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUMINAR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYLENOL (CAPLET)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRECEDEX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HEPARIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIDOCAINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGNESIUM SULFATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VERSED</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NITROGLYCERIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEO-SYNEPHRINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PAPAVERINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROTAMINE SULFATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOBUTREX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOPAMINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORCURAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETYLCYSTEINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANGIOMAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEMEROL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HALDOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRANDATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MILK OF MAGNESIA TAB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FORONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LACTATED RINGER'S</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORMAL SALINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NOVOLIN INSULIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VANCOMYCIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SOLU-MEDROL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PEPCID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLASMA-LYTE 56 AND DEXTROSE 5% IN PLASTIC CONTAINER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MANNITOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MORPHINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SULAR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOFRAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROTONIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROMETHAZINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROPOXYPHENE HYDROCHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SODIUM BICARBONATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TEMAZEPAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5046805-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060705</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>33</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugdosagetext>ORAL; 20.0 MILLIGRAM</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060502</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060505</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5046809-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060705</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>62</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>UROXATRAL</medicinalproduct>
        <drugdosagetext>10 MG QD PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BENIGN PROSTATIC HYPERPLASIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060321</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060502</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RABEPRAZOLE SODIUM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5046812-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060705</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>58</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>LETHARGY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>UROXATRAL</medicinalproduct>
        <drugdosagetext>10MG QD PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060207</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060428</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VARDENAFIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACYCLOVIR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>QUETIAPINE FUMARATE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5046814-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060705</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>66</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>NASAL CONGESTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIAGRA</medicinalproduct>
        <drugdosagetext>10MG PRN PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ERECTILE DYSFUNCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051105</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060124</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVITRA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MYLANTA</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5046816-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060705</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>61</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>69.1</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ACUTE MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ETOPOSIDE</medicinalproduct>
        <drugdosagetext>172 MG IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NON-HODGKIN'S LYMPHOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060213</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060215</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CISPLATIN</medicinalproduct>
        <drugdosagetext>45 MG IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NON-HODGKIN'S LYMPHOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060213</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060215</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5046819-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060705</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>74</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FRAGMIN</medicinalproduct>
        <drugdosagetext>5000 UNIT DAILY SUBCUTANEOUS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060524</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060601</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5046821-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060705</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>54</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANGIONEUROTIC OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWOLLEN TONGUE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CODEINE PHOSPHATE AND ACETAMINOPHEN</medicinalproduct>
        <drugdosagetext>10ML QHS PRN PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>COUGH</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060328</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060412</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLARITHROMYCIN</medicinalproduct>
        <drugdosagetext>500MG PO BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PNEUMONIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060404</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060412</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SALINE NASAL SPRAY</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5046824-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060630</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2006IN09990</companynumb>
    <primarysource>
      <reportercountry>INDIA</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HYPERCHLORHYDRIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VOVERAN</medicinalproduct>
        <drugauthorizationnumb>19201</drugauthorizationnumb>
        <drugindication>GINGIVAL PAIN</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5046825-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060630</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2006JP09950</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>74</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANAPHYLACTOID SHOCK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSED LEVEL OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOXIC ENCEPHALOPATHY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VOLTAREN</medicinalproduct>
        <drugauthorizationnumb>019201</drugauthorizationnumb>
        <drugdosagetext>25 MG/DAY</drugdosagetext>
        <drugadministrationroute>054</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050301</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5046826-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060705</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>3</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DECREASED APPETITE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALBUTEROL</medicinalproduct>
        <drugdosagetext>2.5MG Q3-4H PRN INHAL</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050818</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060404</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUTICASONE PROPIONATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CETIRIZINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5046830-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060705</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>79</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CHEMICAL EYE INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DERMATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MACUGEN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>MACULAR DEGENERATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5046831-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060705</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>67</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVITRA</medicinalproduct>
        <drugdosagetext>5MG PRN PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ERECTILE DYSFUNCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050802</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051227</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLIPIZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5046832-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060705</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>83</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>GLOMERULONEPHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN</medicinalproduct>
        <drugdosagetext>TITRATED</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060411</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060416</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5046835-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060705</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>48</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUS CONGESTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THERAPEUTIC RESPONSE DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVITRA</medicinalproduct>
        <drugdosagetext>500-100 PRN PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ERECTILE DYSFUNCTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIAGRA</medicinalproduct>
        <drugindication>ERECTILE DYSFUNCTION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5046838-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060705</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>59</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugdosagetext>40MG QHS PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060324</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060420</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM WITH VITAMIN D</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5046840-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060705</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>70</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANTIBODY TEST POSITIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ATRIAL THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPARIN-INDUCED THROMBOCYTOPENIA TEST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MASS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN</medicinalproduct>
        <drugdosagetext>TITRATED</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060315</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060401</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5046845-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060705</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>68</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>158.759</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE CONGESTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ILL-DEFINED DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMIODARONE HCL</medicinalproduct>
        <drugdosagetext>2 TABLETS 3 TIMES A DAY X 1WK THEN 2 TAB 2 TIMES A DAY FOR 1WK THEN 2 TABLETS DAILY</drugdosagetext>
        <drugindication>HEART RATE IRREGULAR</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050208</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050314</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5046849-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060705</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>26</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>97.5234</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENOMETRORRHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENSTRUATION IRREGULAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THERAPEUTIC RESPONSE UNEXPECTED WITH DRUG SUBSTITUTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CRYSELLE</medicinalproduct>
        <drugbatchnumb>MULTIPLE</drugbatchnumb>
        <drugdosagetext>ONE TABLET ONCE DAILY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MENSTRUATION IRREGULAR</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060630</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CRYSELLE</medicinalproduct>
        <drugbatchnumb>MULTIPLE</drugbatchnumb>
        <drugdosagetext>ONE TABLET ONCE DAILY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>POLYCYSTIC OVARIES</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060630</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5046853-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060705</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>63.5036</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>NEUROTOXICITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVAQUIN</medicinalproduct>
        <drugindication>EAR INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060410</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVAQUIN</medicinalproduct>
        <drugindication>PHARYNGITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060410</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5046856-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060705</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>46</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>52.1637</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>LOSS OF LIBIDO</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEXUAL DYSFUNCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
        <drugindication>ANXIETY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060703</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
        <drugindication>PANIC DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060703</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5046859-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060705</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>35</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>122.4712</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ATRIOVENTRICULAR BLOCK</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HALOPERIDOL</medicinalproduct>
        <drugdosagetext>20 MG DAILY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5046861-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060705</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>47</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>102.9665</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CLONUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSED LEVEL OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH GENERALISED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugdosagetext>500 MG    HS     PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTRIGLYCERIDAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060403</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060405</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GEMFIBROZIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INDOMETHACIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5046864-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060705</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>61.2356</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>EOSINOPHILIC PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MINOCYCLINE HCL</medicinalproduct>
        <drugdosagetext>TWO PILLS DAILY  PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ACNE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041028</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MINOCYCLINE HCL</medicinalproduct>
        <drugdosagetext>TWO PILLS DAILY  PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041028</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5046866-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060705</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>71</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>119</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>RASH ERYTHEMATOUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URTICARIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVAQUIN</medicinalproduct>
        <drugbatchnumb>38-038-JT</drugbatchnumb>
        <drugdosagetext>500 MG QDAY IV [1 DOSE]</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ESCHERICHIA URINARY TRACT INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060702</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060702</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5046868-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060705</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>49</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>60.3284</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIOVASCULAR DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN LESION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KETEK</medicinalproduct>
        <drugdosagetext>1 TABLET PER DAY 1 WEEK</drugdosagetext>
        <drugindication>BRONCHITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060102</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060106</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5046870-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060705</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>57</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>83.9154</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEUKOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ERBITUX</medicinalproduct>
        <drugdosagetext>250 MG/M2 ONCE /WEEK IV DRIP</drugdosagetext>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>TONSIL CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060515</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060710</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARBOPLATIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAXOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RADIATION THERAPY</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5046872-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060630</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-06P-163-0337357-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>77.225</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIOSPASM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BIAXIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>050662</drugauthorizationnumb>
        <drugindication>SINUSITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMITREX</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>MIGRAINE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RAMIPRIL</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VERAPAMIL</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5046873-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060630</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CL-ABBOTT-06P-034-0337373-00</companynumb>
    <primarysource>
      <reportercountry>CHILE</reportercountry>
      <qualification>1</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>ANAPHYLACTIC REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIO-RESPIRATORY ARREST</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEVOFLURANE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020478</drugauthorizationnumb>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>INDUCTION OF ANAESTHESIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060627</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060627</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROPOFOL</medicinalproduct>
        <drugindication>INDUCTION OF ANAESTHESIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060627</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060627</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FENTANYL TRANSDERMAL SYSTEM</medicinalproduct>
        <drugindication>ANAESTHESIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060627</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060627</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATRACURIUM BESYLATE</medicinalproduct>
        <drugindication>ANAESTHESIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060627</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060627</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEOSTIGMINE</medicinalproduct>
        <drugindication>ANAESTHESIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060627</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060627</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5046874-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060615</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-06P-163-0336309-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5046875-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060602</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-ABBOTT-06P-167-0335179-00</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>69.8</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CHOKING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOWER RESPIRATORY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ERYTHROMYCIN STEARATE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>60359</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ROSACEA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19940101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060526</drugenddate>
        <drugtreatmentduration>12</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FINASTERIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BENIGN PROSTATIC HYPERPLASIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BETAHISTINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>LABYRINTHITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SALBUTAMOL W/IPRATROPIUM</medicinalproduct>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5046876-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060623</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PT-ABBOTT-06P-130-0336906-00</companynumb>
    <primarysource>
      <reportercountry>PORTUGAL</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>60</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>LUNG NEOPLASM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5046877-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060615</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-ABBOTT-06P-167-0336514-00</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>79.5</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HAEMATOLOGY TEST ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOCHROMATOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</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>20040524</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040901</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROPRANOLOL HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETYLSALICYLIC ACID SRT</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENTERCEPT</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050303</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5046878-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060602</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-ABBOTT-06P-056-0335146-00</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MONONAXY</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>50662</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BRONCHITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060424</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060424</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETYLCYSTEINE</medicinalproduct>
        <drugindication>BRONCHITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060424</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FENSPIRIDE HYDROCHLORIDE</medicinalproduct>
        <drugindication>BRONCHITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060424</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060424</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5046879-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20051103</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-ABBOTT-05P-167-0316515-00</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>64.4</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>SALMONELLOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STAPHYLOCOCCAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WRIST FRACTURE</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>20050601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051001</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19920801</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE TAB</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19910401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19920801</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANSOPRAZOLE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5046880-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060612</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ABBOTT-06P-087-0335723-00</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HEPATOCELLULAR DAMAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOXIC EPIDERMAL NECROLYSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CEFZON FINE GRANULE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>50749</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PHARYNGITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040616</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040618</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ANHIBA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>054</drugadministrationroute>
        <drugindication>PYREXIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040626</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040626</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CEFPODOXIME PROXETIL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040627</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PARACETAMOL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040627</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5046881-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060630</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-ABBOTT-06P-167-0337376-00</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>69</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>RHEUMATOID NODULE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050314</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051208</drugenddate>
        <drugtreatmentduration>269</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELECOXIB</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>ESOMEPRAZOLE</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>THYROXINE</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5046882-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20051107</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ABBOTT-05P-087-0316732-00</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>24</patientonsetage>
      <patientonsetageunit>802</patientonsetageunit>
      <patientweight>11.4</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HYPOTHERMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLARITH DRY SYRUP</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>50698</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OTITIS MEDIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050302</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050303</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OSELTAMIVIR PHOSPHATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INFLUENZA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050302</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050303</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OSELTAMIVIR PHOSPHATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050223</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050226</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KETOTIFEN FUMARATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OTITIS MEDIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARBOCISTEINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OTITIS MEDIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5046883-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060328</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-ABBOTT-06P-062-0329479-00</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>JAUNDICE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER FUNCTION TEST ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEVOFLURANE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>20478</drugauthorizationnumb>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>ANAESTHESIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051230</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051230</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CONCEPLAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONTRACEPTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060101</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN-FRACTION, SODIUM SALT</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>THROMBOSIS PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROPOFOL</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ANAESTHESIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051230</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051230</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REMIFENTANIL HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ANAESTHESIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051230</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051230</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5046902-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060510</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0605USA01873</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>BLOOD POTASSIUM ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRINIVIL</medicinalproduct>
        <drugauthorizationnumb>019558</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5046903-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060704</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-MERCK-0607USA00877</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>56</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>SHOCK</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SINGULAIR</medicinalproduct>
        <drugauthorizationnumb>020829</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVELOX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMBROXOL HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LYSOZYME CHLORIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5046904-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060630</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-MERCK-0607USA00884</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>45</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>LIVER DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEPCID RPD</medicinalproduct>
        <drugauthorizationnumb>020752</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>[THERAPY UNSPECIFIED]</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5046905-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060616</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-MERCK-0606USA05679</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>62</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>GYNAECOMASTIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COZAAR</medicinalproduct>
        <drugauthorizationnumb>20386</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040605</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060621</drugenddate>
        <drugtreatmentduration>747</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COZAAR</medicinalproduct>
        <drugauthorizationnumb>020386</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030227</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030426</drugenddate>
        <drugtreatmentduration>59</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COZAAR</medicinalproduct>
        <drugauthorizationnumb>020386</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030427</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040604</drugenddate>
        <drugtreatmentduration>405</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMLODIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030227</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060621</drugenddate>
        <drugtreatmentduration>1211</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5046906-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
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    <receiptdate>20060314</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-MERCK-0603FRA00047</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>37</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BACTERIAL SEPSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METABOLIC ACIDOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL TUBULAR DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CRIXIVAN</medicinalproduct>
        <drugauthorizationnumb>20685</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060214</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CRIXIVAN</medicinalproduct>
        <drugauthorizationnumb>020685</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060221</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RITONAVIR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060214</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RITONAVIR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060221</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMIVUDINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060214</drugenddate>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TENOFOVIR DISOPROXIL FUMARATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060131</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060214</drugenddate>
        <drugtreatmentduration>15</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN ASPART, BIPHASIC ISOPHANE [INJECTION]</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>DIABETES MELLITUS INSULIN-DEPENDENT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROPRANOLOL HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DESLORATADINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MIANSERIN HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NUTRITIONAL SUPPLEMENTS</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5046910-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
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    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060630</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-MERCK-0607USA00329</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
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    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <patientonsetage>94</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSED LEVEL OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIALYSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRIMAXIN</medicinalproduct>
        <drugauthorizationnumb>50587</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PNEUMONIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060620</drugstartdate>
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        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMINOPHYLLINE</medicinalproduct>
        <drugadministrationroute>051</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
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  <safetyreport>
    <safetyreportid>5046911-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
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    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ES-MERCK-0605ESP00027</companynumb>
    <primarysource>
      <reportercountry>SPAIN</reportercountry>
      <qualification>1</qualification>
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    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <patientonsetage>12</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>EYELID OEDEMA</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>FACE OEDEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SINGULAIR</medicinalproduct>
        <drugauthorizationnumb>020830</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060601</drugenddate>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SINGULAIR</medicinalproduct>
        <drugauthorizationnumb>020830</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060501</drugenddate>
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    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5046912-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060314</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-MERCK-0603FRA00046</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>3</qualification>
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    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <patientonsetage>74</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>85</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>NORMOCHROMIC NORMOCYTIC ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRIMAXIN</medicinalproduct>
        <drugauthorizationnumb>050587</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>STAPHYLOCOCCAL INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060111</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060204</drugenddate>
        <drugtreatmentduration>25</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LINEZOLID</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>STAPHYLOCOCCAL INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060111</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060204</drugenddate>
        <drugtreatmentduration>25</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060204</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COLCHICINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060204</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BUMETANIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CARDIAC FAILURE</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060204</drugenddate>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARVEDILOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CARDIAC FAILURE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATORVASTATIN CALCIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERLIPIDAEMIA</drugindication>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRONOLACTONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLOPIDOGREL BISULFATE</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>ALLOPURINOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
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  <safetyreport>
    <safetyreportid>5047012-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060622</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006078974</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
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    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <patientsex>0</patientsex>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>HAEMATOCHEZIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SERTRALINE</medicinalproduct>
        <drugauthorizationnumb>19839</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ALCOHOLISM</drugindication>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SERTRALINE</medicinalproduct>
        <drugauthorizationnumb>19839</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MAJOR DEPRESSION</drugindication>
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    </patient>
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  <safetyreport>
    <safetyreportid>5047013-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
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    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
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    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
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    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
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    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <patientsex>0</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
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      <reaction>
        <reactionmeddrapt>ARRHYTHMIA</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEXTRA</medicinalproduct>
        <drugauthorizationnumb>21341</drugauthorizationnumb>
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    </patient>
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  <safetyreport>
    <safetyreportid>5047015-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
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    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
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      <reportercountry>UNITED STATES</reportercountry>
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    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <patientsex>0</patientsex>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEXTRA</medicinalproduct>
        <drugauthorizationnumb>21341</drugauthorizationnumb>
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    <safetyreportid>5047016-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
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      <reportercountry>UNITED STATES</reportercountry>
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    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIAC ARREST</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEXTRA</medicinalproduct>
        <drugauthorizationnumb>21341</drugauthorizationnumb>
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    <safetyreportid>5047017-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
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      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <patientsex>0</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
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      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEXTRA</medicinalproduct>
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    <safetyreportid>5047018-6</safetyreportid>
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      <reportercountry>UNITED STATES</reportercountry>
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    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
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      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEXTRA</medicinalproduct>
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      <reportercountry>UNITED STATES</reportercountry>
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      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
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        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>INJURY</reactionmeddrapt>
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    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060622</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006080817</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>SWOLLEN TONGUE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CADUET</medicinalproduct>
        <drugauthorizationnumb>21540</drugauthorizationnumb>
        <drugdosagetext>5/10 MG (1 IN 1 D)</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060608</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047024-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060623</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006080818</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>76</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>77.1115</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BURSITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOKINESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TENDONITIS</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>20000501</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTIHYPERTENSIVES</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047025-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060626</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006081235</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>42</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>90.7194</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA FACIAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
        <drugauthorizationnumb>19839</drugauthorizationnumb>
        <drugdosagetext>50 MG (50 MG, 1 IN 1 D)</drugdosagetext>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060626</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RISPERDAL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NIMOTOP</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMBIEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREVACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRAVACHOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZETIA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALL OTHER THERAPEUTIC PRODUCTS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047026-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060619</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006078049</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>0</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG LEVEL INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DILANTIN</medicinalproduct>
        <drugauthorizationnumb>8762</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047027-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060620</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006078318</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ACTIVITIES OF DAILY LIVING IMPAIRED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COGNITIVE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SURGERY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GEODON</medicinalproduct>
        <drugauthorizationnumb>20825</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047028-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060622</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006078977</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>0</patientsex>
      <reaction>
        <reactionmeddrapt>GENERAL PHYSICAL HEALTH DETERIORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SERTRALINE</medicinalproduct>
        <drugauthorizationnumb>19839</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ALCOHOLISM</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SERTRALINE</medicinalproduct>
        <drugauthorizationnumb>19839</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MAJOR DEPRESSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047029-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060621</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006078342</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>81</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>URINARY RETENTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DETROL LA</medicinalproduct>
        <drugauthorizationnumb>21228</drugauthorizationnumb>
        <drugdosagetext>4 MG, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTONIC BLADDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060614</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060614</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
        <drugdosagetext>5 MG, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060601</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047030-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060622</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006078975</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>0</patientsex>
      <reaction>
        <reactionmeddrapt>ALCOHOLISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SERTRALINE</medicinalproduct>
        <drugauthorizationnumb>19839</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ALCOHOLISM</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SERTRALINE</medicinalproduct>
        <drugauthorizationnumb>19839</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MAJOR DEPRESSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047031-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060622</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006080725</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ARRHYTHMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEXTRA</medicinalproduct>
        <drugauthorizationnumb>21341</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030909</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047032-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060622</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006080776</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>0</patientsex>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEXTRA</medicinalproduct>
        <drugauthorizationnumb>21341</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047033-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060622</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006080775</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>0</patientsex>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEXTRA</medicinalproduct>
        <drugauthorizationnumb>21341</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047034-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060622</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006080771</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>0</patientsex>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEXTRA</medicinalproduct>
        <drugauthorizationnumb>21341</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047035-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060622</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006080755</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>0</patientsex>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEXTRA</medicinalproduct>
        <drugauthorizationnumb>21341</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047036-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060622</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006080761</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEXTRA</medicinalproduct>
        <drugauthorizationnumb>21341</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047037-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060622</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006080766</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>0</patientsex>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEXTRA</medicinalproduct>
        <drugauthorizationnumb>21341</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047038-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060622</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006008685</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</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>ACUTE LYMPHOCYTIC LEUKAEMIA RECURRENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUROGENIC BLADDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUROPATHY PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OBSTRUCTIVE UROPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUCONAZOLE</medicinalproduct>
        <drugauthorizationnumb>19949</drugauthorizationnumb>
        <drugdosagetext>800 MG (100 MG, BID), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CANDIDIASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050928</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051125</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VINCRISTINE</medicinalproduct>
        <drugdosagetext>2 MG (CYCLICAL), INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ACUTE LYMPHOCYTIC LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051025</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051109</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047039-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060621</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006018248</companynumb>
    <primarysource>
      <reportercountry>IRELAND</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>77</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>CYST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC STEATOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JOINT SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL STIFFNESS</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>CEREBROVASCULAR DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANTOPRAZOLE SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CENTYL K (BENDROFLUMETHIAZIDE, POTASSIUM CHLORIDE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MESULID (NIMESULIDE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOGEN (ATENOLOL)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047040-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060623</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2005143692</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>92</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>URINARY RETENTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOLTERODINE TARTRATE</medicinalproduct>
        <drugauthorizationnumb>20771</drugauthorizationnumb>
        <drugdosagetext>4 MG (2 MG, 2 IN 1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NEUROGENIC BLADDER</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050926</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MUSARIL (TETRAZEPAM)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BACLOFEN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047041-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060619</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2005085537</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>79</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CYST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG DISPENSING ERROR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERIARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TINNITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
        <drugauthorizationnumb>20235</drugauthorizationnumb>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047042-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060622</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2005107396</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>73</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYELASH THICKENING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRIC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GROWTH OF EYELASHES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCORRECT DOSE ADMINISTERED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTRAOCULAR PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHOTOPSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TONGUE COATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VITREOUS FLOATERS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XALATAN</medicinalproduct>
        <drugauthorizationnumb>20597</drugauthorizationnumb>
        <drugdosagetext>1 DROP RIGHT EYE (1 DROP, 1 IN 1 D), OPHTHALMIC</drugdosagetext>
        <drugadministrationroute>047</drugadministrationroute>
        <drugindication>INTRAOCULAR PRESSURE INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050630</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTIVITAMIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047043-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060623</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2005119555</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>78</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>83.9154</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD URINE PRESENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POLLAKIURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROSTATIC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TINNITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUPRIL</medicinalproduct>
        <drugauthorizationnumb>19885</drugauthorizationnumb>
        <drugdosagetext>20 MG (20 MG, 1 IN 1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>QUINAPRIL HCL</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOPROL-XL</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047044-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060622</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006080737</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>0</patientsex>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEXTRA</medicinalproduct>
        <drugauthorizationnumb>21341</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047045-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060620</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006078285</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>74</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>79.5</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD ALBUMIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD FIBRINOGEN ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD THYROID STIMULATING HORMONE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COAGULOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FIBRIN D DIMER INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERNATIONAL NORMALISED RATIO INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENTAL STATUS CHANGES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROTHROMBIN TIME PROLONGED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUTENT</medicinalproduct>
        <drugauthorizationnumb>21968</drugauthorizationnumb>
        <drugdosagetext>50 MG (50 MG, FREQUENCY: QD, INTERVAL: EVERY 28 DAYS), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RENAL CELL CARCINOMA STAGE UNSPECIFIED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060202</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060608</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HUMULIN N</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HUMULIN R</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047046-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060620</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006078436</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>64</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>71.2147</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANGIOPLASTY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROSTATIC SPECIFIC ANTIGEN INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugauthorizationnumb>20702</drugauthorizationnumb>
        <drugdosagetext>10 MG (10 MG, DAILY)</drugdosagetext>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060415</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE/LISINOPRIL (AMLODIPINE, LISINOPRIL)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047047-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060619</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006078439</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>49</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>65.7716</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BODY HEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARPAL TUNNEL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HOT FLUSH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL STIFFNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AROMASIN</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>20060401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAMOXIFEN CITRATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EFFEXOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CENTRUM (MINERALS NOS, VITAMINS NOS)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN E</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM (CALCIUM)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047048-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060621</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006078450</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>92.9874</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANTICONVULSANT DRUG LEVEL DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROSTATE CANCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DILANTIN KAPSEAL</medicinalproduct>
        <drugauthorizationnumb>84349</drugauthorizationnumb>
        <drugdosagetext>500 MG (100 MG, 3 IN 1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GRAND MAL CONVULSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROVIGIL</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMIODARONE (AMIODARONE)</medicinalproduct>
        <drugindication>ARRHYTHMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ROCEPHIN</medicinalproduct>
        <drugindication>URINARY TRACT INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XOPONEX (LEVOSALBUTAMOL)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LAMICTAL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENICAR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADVAIR DISKUS 100/50</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XOPENEX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047049-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060621</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006078609</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>77</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>54.4316</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BALANCE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYSTERECTOMY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugauthorizationnumb>21446</drugauthorizationnumb>
        <drugdosagetext>75  MG (75 MG, 1 IN 1 D)</drugdosagetext>
        <drugindication>HYPOAESTHESIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060501</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugauthorizationnumb>21446</drugauthorizationnumb>
        <drugdosagetext>75  MG (75 MG, 1 IN 1 D)</drugdosagetext>
        <drugindication>NEUROPATHY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060501</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XALATAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACTONEL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047050-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060620</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006078625</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>70.3075</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THERAPY REGIMEN CHANGED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
        <drugauthorizationnumb>20235</drugauthorizationnumb>
        <drugdosagetext>1800 MG (600 MG, 3 IN 1 D)</drugdosagetext>
        <drugindication>PAIN IN EXTREMITY</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060601</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INSULIN</medicinalproduct>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMULIN (INSULIN HUMAN, INSULIN ISOPHANE, HUMAN BIOSYNTHETIC)</medicinalproduct>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MOBIC</medicinalproduct>
        <drugindication>ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060601</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDAMET</medicinalproduct>
        <drugdosagetext>2000 MG (1000 MG, 2 IN 1 D)</drugdosagetext>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EVISTA</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>LASIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENAZEPRIL (BENAZEPRIL)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZANTAC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMDUR</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047051-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060405</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-443574</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>20</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>72.6</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ALANINE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANGER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLITIS ULCERATIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CROHN'S DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CUSHINGOID</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DERMATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSGEUSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPAREUNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPHORIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ECONOMIC PROBLEM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FUNGUS STOOL IDENTIFIED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHOIDS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLAMMATORY BOWEL DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IRRITABILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NECK INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POLYTRAUMATISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROCTITIS ULCERATIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RECTAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TONGUE DISCOLOURATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>018662</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ACNE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19950515</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19950717</drugenddate>
        <drugtreatmentduration>64</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047052-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060620</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006078592</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>72.5755</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLINDNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MACULAR DEGENERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL ACUITY REDUCED</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>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugauthorizationnumb>20998</drugauthorizationnumb>
        <drugdosagetext>200 MG (200 MG, 1 IN 1 D)</drugdosagetext>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEXTRA</medicinalproduct>
        <drugdosagetext>20 MG (20 MG, 1 IN 1 D)</drugdosagetext>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMINS (VITAMINS)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADVIL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047053-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060620</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006078679</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>78</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugauthorizationnumb>21446</drugauthorizationnumb>
        <drugdosagetext>100 MG (50 MG, 2 IN 1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047054-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060622</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006078826</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>40</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>86.637</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD CREATININE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT 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>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GEMFIBROZIL</medicinalproduct>
        <drugindication>BLOOD TRIGLYCERIDES INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060501</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GENGRAF (CICLOSPORIN)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROTONIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONIDINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARDIZEM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPROL-XL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SEPTRA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMBIEN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047055-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060619</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-ABBOTT-06P-167-0336582-00</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>DEEP VEIN THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVARIAN NEOPLASM</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>20040301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060201</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RISEDRONATE SODIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047056-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060621</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-ABBOTT-06P-167-0336826-00</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>83</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSORIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PSORIATIC ARTHROPATHY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060315</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMITRIPTYLINE HCL</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>FELODIPINE</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>LANSOPRAZOLE</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOSARTAN</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAMADOL HCL</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047057-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060630</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-ABBOTT-06P-167-0337377-00</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>71</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>PULMONARY FIBROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STAPHYLOCOCCAL SEPSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040219</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041215</drugenddate>
        <drugtreatmentduration>300</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>ATENOLOL</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DYAZIDE</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>NAPROXEN</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>TRAMADOL HCL</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047058-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060622</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006078920</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>77.1115</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HIP ARTHROPLASTY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INADEQUATE ANALGESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</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>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COLACE (DOCUSATE SODIUM)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047059-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060622</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006078938</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>70</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>107.5025</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLISTER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIMB INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN EXFOLIATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEXTRA</medicinalproduct>
        <drugauthorizationnumb>21341</drugauthorizationnumb>
        <drugindication>LIMB INJURY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEXTRA</medicinalproduct>
        <drugauthorizationnumb>21341</drugauthorizationnumb>
        <drugindication>ROTATOR CUFF SYNDROME</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMINS (VITAMINS)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREVACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEGA 3 (FISH OIL)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZYRTEC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOTENSIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VERAPAMIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGNESIUM OXIDE (MAGNESIUM OXIDE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACTOS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047060-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-ROCHE-453566</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ACNE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AGEUSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANOSMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRY EYE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRY SKIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IRRITABILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NASAL DRYNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NASOPHARYNGITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SENSORY DISTURBANCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>018662</drugauthorizationnumb>
        <drugdosagetext>THE PATIENT RECEIVED ONE 40MG CAPSULE ONCE PER DAY, AND TWO 10MG CAPSULES ONCE PER DAY.</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ACNE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030613</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030702</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>018662</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030702</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031115</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047061-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060620</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006072912</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>78</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>63.5036</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BREAST CANCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BREAST MASS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIPLOPIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EFFECT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMPAIRED DRIVING ABILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METASTASES TO CENTRAL NERVOUS SYSTEM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NERVOUS SYSTEM DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
        <drugauthorizationnumb>20235</drugauthorizationnumb>
        <drugdosagetext>1200 MG (300 MG, 4 IN 1 D)</drugdosagetext>
        <drugindication>NEURALGIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060501</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugdosagetext>(75 MG), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NEURALGIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060529</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060530</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRIHEXYPHENIDYL HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DYAZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047062-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20051110</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-05P-163-0317612-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>5</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>19</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BRAIN DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHABDOMYOLYSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEVOFLURANE</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>20478</drugauthorizationnumb>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>ANAESTHESIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ISOFLURANE</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>MAINTENANCE OF ANAESTHESIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NITROUS OXIDE W/ OXYGEN</medicinalproduct>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>ANAESTHESIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VECURONIUM BROMIDE</medicinalproduct>
        <drugdosagetext>NOT REPORTED</drugdosagetext>
        <drugindication>MAINTENANCE OF ANAESTHESIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYGEN</medicinalproduct>
        <drugdosagetext>NOT REPORTED</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>ANAESTHESIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYGEN</medicinalproduct>
        <drugdosagetext>NOT REPORTED</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MIVACURIUM</medicinalproduct>
        <drugdosagetext>NOT REPORTED</drugdosagetext>
        <drugindication>HYPOTONIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FENTANYL TRANSDERMAL SYSTEM</medicinalproduct>
        <drugdosagetext>NOT REPORTED</drugdosagetext>
        <drugindication>MAINTENANCE OF ANAESTHESIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEOSTIGMINE</medicinalproduct>
        <drugdosagetext>NOT REPORTED</drugdosagetext>
        <drugindication>NEUROMUSCULAR BLOCKADE REVERSAL</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLYCOPYRRONIUM BROMIDE</medicinalproduct>
        <drugdosagetext>NOT REPORTED</drugdosagetext>
        <drugindication>NEUROMUSCULAR BLOCKADE REVERSAL</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047063-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060622</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006070893</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>47</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR</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>DILANTIN</medicinalproduct>
        <drugauthorizationnumb>84349</drugauthorizationnumb>
        <drugdosagetext>290 MG (1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONVULSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEPAKOTE - SLOW RELEASE (VALPROATE SEMISODIUM)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047064-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060620</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006074277</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>67</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>89.5</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTHERMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTHYROIDISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUTENT</medicinalproduct>
        <drugauthorizationnumb>21968</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>METASTATIC RENAL CELL CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040817</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041220</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUTENT</medicinalproduct>
        <drugauthorizationnumb>21968</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>METASTATIC RENAL CELL CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041221</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050909</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUTENT</medicinalproduct>
        <drugauthorizationnumb>21968</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>METASTATIC RENAL CELL CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050919</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORAZEPAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN C (VITAMIN C)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN E</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DILTIAZEM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADVIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOPERAMIDE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRILOSEC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047065-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060619</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006076974</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>57</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>96.6162</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENOUS THROMBOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>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>20020409</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047066-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060619</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006077765</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANAPHYLACTIC SHOCK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWOLLEN TONGUE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GEODON</medicinalproduct>
        <drugauthorizationnumb>20825</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047067-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060620</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006077807</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>51</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>156.491</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CELLULITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CYANOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OXYGEN SATURATION DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RIGHT VENTRICULAR FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THERAPEUTIC RESPONSE UNEXPECTED WITH DRUG SUBSTITUTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SILDENAFIL (PAH)  (SILDENAFIL)</medicinalproduct>
        <drugauthorizationnumb>21845</drugauthorizationnumb>
        <drugdosagetext>180 MG (60 MG, 3 IN 1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DARVOCET</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BUMEX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLEXERIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEXAPRO</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADVAIR DISKUS 100/50</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALL OTHER THERAPEUTIC PRODUCTS (ALL OTHER THERAPEUTIC PRODUCTS)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLERGY MEDICATION (ALLERGY MEDICATION)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047068-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060623</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006054682</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</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>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ANGIOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIOVASCULAR DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBRAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugauthorizationnumb>20998</drugauthorizationnumb>
        <drugdosagetext>(2 IN 1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040223</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugauthorizationnumb>20998</drugauthorizationnumb>
        <drugdosagetext>(2 IN 1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN IN EXTREMITY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040223</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047069-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060623</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006054899</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>44</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>81.6475</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CEREBRAL ARTERY OCCLUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBRAL ARTERY STENOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENTRICULAR HYPERTROPHY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEXTRA</medicinalproduct>
        <drugauthorizationnumb>21341</drugauthorizationnumb>
        <drugdosagetext>20 MG (20 MG, 1 IN 1 D)</drugdosagetext>
        <drugindication>ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020808</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047070-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060621</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006051352</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>57</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>99.7913</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIAC PACEMAKER MALFUNCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HIP ARTHROPLASTY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG NEOPLASM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FUNCTION TEST ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TIKOSYN</medicinalproduct>
        <drugauthorizationnumb>20931</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARRHYTHMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TIKOSYN</medicinalproduct>
        <drugauthorizationnumb>20931</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARRHYTHMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTIVITAMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEORAL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM (POTASSIUM)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE TAB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZESTRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN B (VITAMIN B)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HERB-LAX (SENNA)</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>IRON (IRON)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047071-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060626</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006061702</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
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      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INADEQUATELY CONTROLLED</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>NEOPLASM SKIN</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>SWELLING</reactionmeddrapt>
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      <drug>
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      <drug>
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        <medicinalproduct>TIAZAC</medicinalproduct>
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      <drug>
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        <medicinalproduct>NITROGLYCERIN</medicinalproduct>
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      <drug>
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        <medicinalproduct>PRILOSEC</medicinalproduct>
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      <drug>
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        <medicinalproduct>BENTYL</medicinalproduct>
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      <drug>
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        <medicinalproduct>SERAX</medicinalproduct>
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      <drug>
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        <medicinalproduct>CELEXA</medicinalproduct>
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      <drug>
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        <medicinalproduct>ASPIRIN</medicinalproduct>
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      <drug>
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        <medicinalproduct>TOPROL-XL</medicinalproduct>
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      <drug>
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      <drug>
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      <drug>
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        <medicinalproduct>ZETIA</medicinalproduct>
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      <drug>
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        <medicinalproduct>LISINOPRIL</medicinalproduct>
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    <transmissiondateformat>102</transmissiondateformat>
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      <reportercountry>FRANCE</reportercountry>
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    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
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      <patientweight>70</patientweight>
      <patientsex>1</patientsex>
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        <reactionmeddrapt>AGRANULOCYTOSIS</reactionmeddrapt>
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      <drug>
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        <medicinalproduct>DAFALGAN</medicinalproduct>
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        <drugstartdate>20060101</drugstartdate>
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      <drug>
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      <drug>
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      <drug>
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        <drugstartdate>20060101</drugstartdate>
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      <reportercountry>UNITED KINGDOM</reportercountry>
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    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
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      <patientsex>1</patientsex>
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        <reactionmeddrapt>SUICIDE ATTEMPT</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>THERMAL BURN</reactionmeddrapt>
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    <transmissiondateformat>102</transmissiondateformat>
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    <sender>
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    <patient>
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        <reactionmeddrapt>BLEEDING VARICOSE VEIN</reactionmeddrapt>
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        <reactionmeddrapt>HEPATIC FAILURE</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>HEPATIC FIBROSIS</reactionmeddrapt>
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      <drug>
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      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
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        <reactionmeddrapt>HEPATIC FAILURE</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>HEPATIC FIBROSIS</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>PORTAL VEIN THROMBOSIS</reactionmeddrapt>
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      <drug>
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      <drug>
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    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
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        <reactionmeddrapt>HEPATIC FIBROSIS</reactionmeddrapt>
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        <reactionmeddrapt>LIVER DISORDER</reactionmeddrapt>
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      <drug>
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      <drug>
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        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
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    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
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    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
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        <reactionmeddrapt>ASCITES</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>BLEEDING VARICOSE VEIN</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>ENCEPHALOPATHY</reactionmeddrapt>
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        <reactionmeddrapt>HEPATIC FAILURE</reactionmeddrapt>
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        <reactionmeddrapt>HEPATIC FIBROSIS</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>PORTAL VEIN THROMBOSIS</reactionmeddrapt>
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      <drug>
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      <drug>
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      <senderorganization>FDA-Public Use</senderorganization>
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    <patient>
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        <reactionmeddrapt>HEPATIC FIBROSIS</reactionmeddrapt>
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        <reactionmeddrapt>LIVER DISORDER</reactionmeddrapt>
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      <drug>
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    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <patient>
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        <reactionmeddrapt>HEPATIC FIBROSIS</reactionmeddrapt>
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        <drugdosagetext>20 MG (20 MG, 1 IN 1 D),</drugdosagetext>
        <drugindication>NERVE INJURY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040302</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEXTRA</medicinalproduct>
        <drugauthorizationnumb>21341</drugauthorizationnumb>
        <drugdosagetext>20 MG (20 MG, 1 IN 1 D),</drugdosagetext>
        <drugindication>PAIN IN EXTREMITY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040302</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047081-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060328</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2006-BP-03726PF</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>81.65</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>AORTIC VALVE REPLACEMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DENTAL DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIABETIC NEUROPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HIGH DENSITY LIPOPROTEIN DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>21395</drugauthorizationnumb>
        <drugindication>DYSPNOEA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugindication>MYOCARDIAL INFARCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19960101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NITROSTAT</medicinalproduct>
        <drugadministrationroute>060</drugadministrationroute>
        <drugindication>CHEST PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugindication>DIABETIC NEUROPATHY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROZAC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ISOSORBIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL SPIROS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM GLUCONATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047082-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2006-BP-07417NB</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>AGRANULOCYTOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MICARDIS</medicinalproduct>
        <drugauthorizationnumb>20850</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060520</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060527</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060527</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060527</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALDACTONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060527</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALESION</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060527</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047083-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ES-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2006-DE-03315GD</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>54</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ASCITES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC FIBROSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEVIRAPINE</medicinalproduct>
        <drugauthorizationnumb>020636</drugauthorizationnumb>
        <drugindication>HIV INFECTION</drugindication>
        <drugtreatmentduration>10</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIDANOSINE</medicinalproduct>
        <drugindication>HIV INFECTION</drugindication>
        <drugtreatmentduration>51</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>STAVUDINE</medicinalproduct>
        <drugindication>HIV INFECTION</drugindication>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047084-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060420</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2006-BP-04730NB</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD URINE PRESENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MICARDIS</medicinalproduct>
        <drugauthorizationnumb>20850</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050907</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERLIPIDAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050907</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DORNER</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTERIOSCLEROSIS OBLITERANS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050913</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PANALDINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTERIOSCLEROSIS OBLITERANS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050913</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMARYL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050907</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050907</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROTECADIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTERIOSCLEROSIS OBLITERANS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050913</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTERIOSCLEROSIS OBLITERANS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051217</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACTOS</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050907</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050907</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DORNER</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANALDINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050913</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047085-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ES-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2006-DE-03317GD</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>37</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ASCITES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLEEDING VARICOSE VEIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC FIBROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PORTAL VEIN THROMBOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEVIRAPINE</medicinalproduct>
        <drugauthorizationnumb>020636</drugauthorizationnumb>
        <drugindication>HIV INFECTION</drugindication>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIDANOSINE</medicinalproduct>
        <drugindication>HIV INFECTION</drugindication>
        <drugtreatmentduration>60</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>STAVUDINE</medicinalproduct>
        <drugindication>HIV INFECTION</drugindication>
        <drugtreatmentduration>60</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047086-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ES-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2006-DE-03314GD</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>57</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ASCITES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLEEDING VARICOSE VEIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC FIBROSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEVIRAPINE</medicinalproduct>
        <drugauthorizationnumb>020636</drugauthorizationnumb>
        <drugindication>HIV INFECTION</drugindication>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIDANOSINE</medicinalproduct>
        <drugindication>HIV INFECTION</drugindication>
        <drugtreatmentduration>22</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>STAVUDINE</medicinalproduct>
        <drugindication>HIV INFECTION</drugindication>
        <drugtreatmentduration>23</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047087-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ES-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2006-DE-03312GD</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>36</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ASCITES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PORTAL VEIN THROMBOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEVIRAPINE</medicinalproduct>
        <drugauthorizationnumb>020636</drugauthorizationnumb>
        <drugindication>HIV INFECTION</drugindication>
        <drugtreatmentduration>56</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIDANOSINE</medicinalproduct>
        <drugindication>HIV INFECTION</drugindication>
        <drugtreatmentduration>51</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>STAVUDINE</medicinalproduct>
        <drugindication>HIV INFECTION</drugindication>
        <drugtreatmentduration>41</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047088-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ES-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2006-DE-03307GD</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>52</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ASCITES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLEEDING VARICOSE VEIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ENCEPHALOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC FIBROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PORTAL VEIN THROMBOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEVIRAPINE</medicinalproduct>
        <drugauthorizationnumb>020636</drugauthorizationnumb>
        <drugindication>HIV INFECTION</drugindication>
        <drugtreatmentduration>21</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIDANOSINE</medicinalproduct>
        <drugindication>HIV INFECTION</drugindication>
        <drugtreatmentduration>71</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>STAVUDINE</medicinalproduct>
        <drugindication>HIV INFECTION</drugindication>
        <drugtreatmentduration>21</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HYDROXYUREA</medicinalproduct>
        <drugauthorizationnumb>074476</drugauthorizationnumb>
        <drugindication>HIV INFECTION</drugindication>
        <drugtreatmentduration>21</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047089-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ES-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2006-DE-03296GD</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>51</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HEPATIC FIBROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEVIRAPINE</medicinalproduct>
        <drugauthorizationnumb>20636</drugauthorizationnumb>
        <drugindication>HIV INFECTION</drugindication>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIDANOSINE</medicinalproduct>
        <drugindication>HIV INFECTION</drugindication>
        <drugtreatmentduration>33</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>STAVUDINE</medicinalproduct>
        <drugindication>HIV INFECTION</drugindication>
        <drugtreatmentduration>13</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RITONAVIR</medicinalproduct>
        <drugindication>HIV INFECTION</drugindication>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047090-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060705</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2006-BP-07622BP</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>21.82</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ACCIDENTAL EXPOSURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRADYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LETHARGY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CATAPRES</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>017407</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060503</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060503</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLARITIN</medicinalproduct>
        <drugindication>SEASONAL ALLERGY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MODAFINIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATTENTION DEFICIT/HYPERACTIVITY DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051222</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047091-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060626</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004039790</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG DOSE OMISSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HIP ARTHROPLASTY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TIKOSYN</medicinalproduct>
        <drugauthorizationnumb>20931</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047092-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060621</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006026024</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>65</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>80</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>AKINESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARRHYTHMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ATRIAL FIBRILLATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ATRIAL FLUTTER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC VENTRICULAR DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIOMYOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENTRICULAR DYSFUNCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUTENT</medicinalproduct>
        <drugauthorizationnumb>21968</drugauthorizationnumb>
        <drugdosagetext>50 MG (50 MG, 1 IN 1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RENAL CELL CARCINOMA STAGE UNSPECIFIED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060202</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060216</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUTENT</medicinalproduct>
        <drugauthorizationnumb>21968</drugauthorizationnumb>
        <drugdosagetext>50 MG (50 MG, 1 IN 1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RENAL CELL CARCINOMA STAGE UNSPECIFIED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060221</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLODRONATE DISODIUM (CLODRONATE DISODIUM)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GAVISCON</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047093-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060607</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PT-BRISTOL-MYERS SQUIBB COMPANY-13403811</companynumb>
    <primarysource>
      <reportercountry>PORTUGAL</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>OROPHARYNGEAL CANCER STAGE UNSPECIFIED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>STAVUDINE</medicinalproduct>
        <drugauthorizationnumb>20412</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NELFINAVIR</medicinalproduct>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047094-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-BRISTOL-MYERS SQUIBB COMPANY-13429519</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>51</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>COMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE FRACTURES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDE ATTEMPT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ABILIFY</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060401</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEPONEX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060401</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047095-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060623</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006028034</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>47</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ARRHYTHMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BREAST ENLARGEMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC VALVE DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FIBROCYSTIC BREAST DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GALACTORRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERPROLACTINAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESTLESS LEGS SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CABERGOLINE</medicinalproduct>
        <drugauthorizationnumb>20664</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RESTLESS LEGS SYNDROME</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051201</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047096-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060622</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2005136582</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>APHASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BALANCE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EFFECT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE IRRITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLATULENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERVENTILATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NARDIL</medicinalproduct>
        <drugauthorizationnumb>11909</drugauthorizationnumb>
        <drugdosagetext>(15 MG)</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAZODONE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ANTIDEPRESSANTS (ANTIDEPRESSANTS)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>WELLBUTRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EFFEXOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRICYCLIC ANTIDEPRESSANTS (TRICYCLIC ANTIDEPRESSANTS)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SSRI (SSRI)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047097-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060620</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2005142324</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>56</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANGINA PECTORIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARRHYTHMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTERIOSCLEROSIS CORONARY ARTERY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ATRIOVENTRICULAR BLOCK THIRD DEGREE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY OCCLUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ECHOCARDIOGRAM ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HERNIA REPAIR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOWER LIMB FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MITRAL VALVE INCOMPETENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MITRAL VALVE PROLAPSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROSTATE CANCER</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>20031013</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041010</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREVACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELEXA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLEGRA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOXAZOSIN (DOXAZOSIN)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047098-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060619</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006025029</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>83</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG EFFECT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEMORY IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRIGEMINAL NEURALGIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DETROL LA</medicinalproduct>
        <drugauthorizationnumb>21228</drugauthorizationnumb>
        <drugdosagetext>4 MG (4 MG, 1 IN 1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MICTURITION URGENCY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DETROL LA</medicinalproduct>
        <drugauthorizationnumb>21228</drugauthorizationnumb>
        <drugdosagetext>4 MG (4 MG, 1 IN 1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>POLLAKIURIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047099-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060622</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006002619</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>62</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>97.977</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD IRON DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONCOMITANT DISEASE PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EFFECT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PEPTIC ULCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIAGRA</medicinalproduct>
        <drugauthorizationnumb>20895</drugauthorizationnumb>
        <drugdosagetext>100 MG (AS NECESSARY), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ERECTILE DYSFUNCTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FENTANYL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047100-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060620</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006004942</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>32.659</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NARCOLEPSY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIAGRA</medicinalproduct>
        <drugauthorizationnumb>20895</drugauthorizationnumb>
        <drugdosagetext>50 (50 MG, AS NECESSARY),</drugdosagetext>
        <drugindication>ERECTILE DYSFUNCTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCONTIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047101-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060626</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006045206</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>4</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>16.6924</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CERUMEN IMPACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONJUNCTIVAL HYPERAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EAR OPERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE ALLERGY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POSTNASAL DRIP</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHINITIS ALLERGIC</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYRTEC</medicinalproduct>
        <drugauthorizationnumb>20346</drugauthorizationnumb>
        <drugdosagetext>10 MG (10 MG, 1 IN 1 D),</drugdosagetext>
        <drugindication>HYPERSENSITIVITY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PULMICORT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SINGULAIR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTI-ASTHMATICS (ANTI-ASTHMATICS)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTIBIOTICS (ANTIBIOTICS)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047102-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060621</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006051115</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BIPOLAR DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DELUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SCHIZOPHRENIA, PARANOID TYPE</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>FIBROMYALGIA</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20021101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
        <drugauthorizationnumb>20235</drugauthorizationnumb>
        <drugindication>PAIN</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20021101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
        <drugauthorizationnumb>20235</drugauthorizationnumb>
        <drugindication>FIBROMYALGIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990801</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
        <drugauthorizationnumb>20235</drugauthorizationnumb>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990801</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047103-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060624</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006038197</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>51</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD CHOLESTEROL INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD TRIGLYCERIDES INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHRONIC SINUSITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HIGH DENSITY LIPOPROTEIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOW DENSITY LIPOPROTEIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE ALLERGIES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NASAL DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URTICARIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYRTEC</medicinalproduct>
        <drugauthorizationnumb>19835</drugauthorizationnumb>
        <drugindication>MULTIPLE ALLERGIES</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYRTEC</medicinalproduct>
        <drugauthorizationnumb>19835</drugauthorizationnumb>
        <drugindication>URTICARIA</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MONTELUKAST (MONTELUKAST)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHADONE (METHADONE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCODONE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATIVAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PAXIL CR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLONASE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AFRIN SINUS (OXYMETAZOLINE HYDROCHLORIDE)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047104-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060622</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>226606</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>83</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD CREATINE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD URINE PRESENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RITUXAN</medicinalproduct>
        <drugindication>MANTLE CELL LYMPHOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYCLOPHOSPHAMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOXORUBICIN HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VINCRISTINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE TAB</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047105-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060623</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>233978K06USA</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBIF</medicinalproduct>
        <drugdosagetext>44 MCG, 3 IN 1 WEEKS, SUBCUTANEOUS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BLOOD PRESSURE MEDICATION</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN (INSULIN /00030501/)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047106-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060619</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>233843K06USA</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>59</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ATRIAL FIBRILLATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CHOLESTEROL INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BODY TEMPERATURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE SCLEROSIS RELAPSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBIF</medicinalproduct>
        <drugdosagetext>44 MCG, 3 IN 1 WEEKS, SUBCUTANEOUS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050501</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PNEUMONIA SHOT (PNEUMOCOCCAL VACCINE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLU SHOT (INFLUENZA VIRUS VACCINE POLYVALENT)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYLENOL (COTYLENOL)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047107-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060623</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>230157K06USA</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>54</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIAC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIABETES MELLITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBIF</medicinalproduct>
        <drugdosagetext>44 MCG,</drugdosagetext>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041221</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GABAPENTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DARVOCET</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KETOCONAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEMEROL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047108-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060622</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>226253</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>45</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FACIAL PALSY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RAPTIVA</medicinalproduct>
        <drugdosagetext>0.6 ML, SUBCUTANEOUS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PSORIASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060302</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047109-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060626</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006-06-2052</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>53</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUS TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEG-INTRON</medicinalproduct>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060317</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBETOL</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060317</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHYLTESTOSTERONE TABLETS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047110-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060621</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ABWIS-06-0312</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>69</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>78.9259</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ALANINE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASPARTATE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ABRAXANE</medicinalproduct>
        <drugauthorizationnumb>21660</drugauthorizationnumb>
        <drugdosagetext>250 MG/M2 RECEIVED TWICE (250 MG/M2, SCHEDULED FOR EVERY 3 WEEKS), INTRAVENOUS DRIP</drugdosagetext>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>BREAST CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060508</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060621</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047111-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060622</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>226603</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>67</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD POTASSIUM DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEBRILE NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUID INTAKE REDUCED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATOCRIT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOTHORAX</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALIGNANT NEOPLASM PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL INTAKE REDUCED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLEURAL EFFUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RED BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY RATE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVASTIN</medicinalproduct>
        <drugdosagetext>1170 MG, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060531</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARBOPLATIN</medicinalproduct>
        <drugdosagetext>517 MG, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060531</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOCETAXEL (DOCETAXEL)</medicinalproduct>
        <drugdosagetext>143 MG, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060531</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMBIEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DARVON</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOFRAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROMETHEZINE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CEFEPIME (CEFEPIME)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROTONIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MORPHINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047112-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060411</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-RB-3110-2006</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>35</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>74</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSED LEVEL OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORTHOSTATIC HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BUPRENORPHINE HCL</medicinalproduct>
        <drugauthorizationnumb>20732</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060326</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060512</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALCOHOL</medicinalproduct>
        <drugdosagetext>DOSAGE UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047113-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060707</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GR-RB-3552-2006</companynumb>
    <primarysource>
      <reportercountry>GREECE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>40</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>40</patientweight>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>TUBERCULOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BUPRENORPHINE HCL</medicinalproduct>
        <drugauthorizationnumb>020732</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051102</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060605</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047114-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060503</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-SP-2006-01038</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>18</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ROAD TRAFFIC ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MENACTRA</medicinalproduct>
        <drugbatchnumb>U1662A</drugbatchnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>IMMUNISATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060502</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TUBERSOL</medicinalproduct>
        <drugbatchnumb>C2214A</drugbatchnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>IMMUNISATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060502</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047116-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060621</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006078704</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CIRCULATORY COLLAPSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugauthorizationnumb>21446</drugauthorizationnumb>
        <drugdosagetext>300 MG (75 MG,4 IN 1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047117-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060620</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006078706</companynumb>
    <primarysource>
      <reportercountry>FINLAND</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>53</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARYNGEAL OEDEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugauthorizationnumb>21446</drugauthorizationnumb>
        <drugdosagetext>225 MG (75 MG, 3 IN 1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>POLYNEUROPATHY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060601</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047118-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060621</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006078845</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>77</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>GLOMERULAR FILTRATION RATE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMODIALYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
        <drugauthorizationnumb>19787</drugauthorizationnumb>
        <drugdosagetext>10 MG (10 MG, DAILY), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051123</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INDERAL LA</medicinalproduct>
        <drugdosagetext>80 MG, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DARBEPOETIN ALFA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETYLSALICYLIC ACID SRT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATORVASTATIN CALCIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTIVITAMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VENOFER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COVERSYL (PERINDOPRIL)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EXTRA STRENGTH TYLENOL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047119-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060623</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006078869</companynumb>
    <primarysource>
      <reportercountry>PHILIPPINES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>48</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEAD INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN LACERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZMAX</medicinalproduct>
        <drugauthorizationnumb>50797</drugauthorizationnumb>
        <drugdosagetext>2 GRAM (2 GRAM, 1 IN 1 TOTAL), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>UPPER RESPIRATORY TRACT INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060622</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060622</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SINUTAB</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047120-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060621</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006078839</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>70</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STENOTROPHOMONAS INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYVOX</medicinalproduct>
        <drugauthorizationnumb>21131</drugauthorizationnumb>
        <drugdosagetext>1200 MG (600 MG,2 IN 1 D), INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PNEUMONIA STAPHYLOCOCCAL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060607</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060617</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TIENAM (IMIPENEM/CILASTATIN) (CILASTATIN, IMIPENEM)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRODIF (FOSFLUCONAZOLE) (FOSFLUCONAZOLE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ELASPOL (SIVELESTAT SODIUM HYDRATE) (SIVELESTAT)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SOLU-MEDROL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047121-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060621</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006078880</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>58</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>UNASYN</medicinalproduct>
        <drugauthorizationnumb>50608</drugauthorizationnumb>
        <drugdosagetext>1.5 GRAM (1.5 GRAM,1 IN 1 D), INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ENDOCARDITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060618</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MINOCYCLINE HYDROCHLORIDE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047122-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060622</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006067219</companynumb>
    <primarysource>
      <reportercountry>ARGENTINA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>56</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>82</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CREATINE PHOSPHOKINASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD UREA INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG DOSE OMISSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC ENCEPHALOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATOCELLULAR DAMAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INAPPROPRIATE SCHEDULE OF DRUG ADMINISTRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROTHROMBIN TIME PROLONGED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUTENT</medicinalproduct>
        <drugbatchnumb>N0401490</drugbatchnumb>
        <drugauthorizationnumb>21968</drugauthorizationnumb>
        <drugdosagetext>50 MG (50 MG, INTERVAL: DAILY X 4 WEEKS), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RENAL CELL CARCINOMA STAGE UNSPECIFIED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060417</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060515</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KLOSIDOL (DEXTROPROPOXYPHENE, METAMIZOLE SODIUM)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047123-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060622</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006067299</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>68</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ALANINE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>C-REACTIVE PROTEIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EOSINOPHILIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAMMA-GLUTAMYLTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH MACULO-PAPULAR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAHOR (ATORVASTATIN)</medicinalproduct>
        <drugauthorizationnumb>20702</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060213</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060220</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENOXAPARIN SODIUM</medicinalproduct>
        <drugdosagetext>SUBCUTANEOUS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060213</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060217</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARVEDILOL</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060213</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060220</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PERINDOPRIL ERBUMINE</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060213</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060220</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IODIXANOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLOPIDOGREL BISULFATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EPTIFIBATIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CETIRIZINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047124-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060622</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006076729</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>0</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE CONGESTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugauthorizationnumb>21446</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>AFFECTIVE DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051001</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047125-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060622</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006077217</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>62</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BREAST SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METRORRHAGIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugauthorizationnumb>20702</drugauthorizationnumb>
        <drugdosagetext>10 MG, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERCHOLESTEROLAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060403</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060615</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047126-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060621</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006074450</companynumb>
    <primarysource>
      <reportercountry>BELGIUM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>57</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DIPLOPIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPEECH DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STRESS URINARY INCONTINENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugauthorizationnumb>21446</drugauthorizationnumb>
        <drugdosagetext>450 MG (150 MG, 3 IN 1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NEURALGIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047127-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060623</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006078217</companynumb>
    <primarysource>
      <reportercountry>SPAIN</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>54</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>COLD SWEAT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVARIAN CANCER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARDYL  (ATORVASTATIN)</medicinalproduct>
        <drugauthorizationnumb>20702</drugauthorizationnumb>
        <drugdosagetext>40 MG (40 MG, DAILY), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERCHOLESTEROLAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORAZEPAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLPIDEM TARTRATE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047128-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060622</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006078147</companynumb>
    <primarysource>
      <reportercountry>HUNGARY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>62</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>COMA HEPATIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC CIRRHOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ATORVASTATIN CALCIUM</medicinalproduct>
        <drugauthorizationnumb>20702</drugauthorizationnumb>
        <drugdosagetext>20 MG (40 MG, 1 IN 1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERCHOLESTEROLAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030823</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060508</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BETALOC (METOPROLOL TARTRATE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENALAPRIL MALEATE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047129-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060620</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006078402</companynumb>
    <primarysource>
      <reportercountry>ARGENTINA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>66</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>72</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEMIPARESIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SU-011,248 (SUNITINIB MALEATE)</medicinalproduct>
        <drugbatchnumb>505684</drugbatchnumb>
        <drugauthorizationnumb>21968</drugauthorizationnumb>
        <drugdosagetext>50 MG (50 MG,QD - INTERVAL: EVERY DAY), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RENAL CELL CARCINOMA STAGE UNSPECIFIED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060512</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060609</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHYLPREDNISONE (MEPREDNISONE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RANITIDINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NYSTATIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ETHYLMORPHINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047130-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060619</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006078302</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>55</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PETIT MAL EPILEPSY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
        <drugauthorizationnumb>20235</drugauthorizationnumb>
        <drugindication>EPILEPSY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047131-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060621</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006078342</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>81</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>URINARY RETENTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DETROL LA</medicinalproduct>
        <drugauthorizationnumb>21228</drugauthorizationnumb>
        <drugdosagetext>4 MG, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTONIC BLADDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060614</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060614</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
        <drugdosagetext>5 MG, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060601</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047132-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060622</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006065196</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>70</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>68.5</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ATRIAL FIBRILLATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIOMEGALY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTHYROIDISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCYTOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THYROIDITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUTENT</medicinalproduct>
        <drugauthorizationnumb>21968</drugauthorizationnumb>
        <drugdosagetext>50 MG (50 MG, DAILY - INTERVAL:  EVERDAY), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RENAL CELL CARCINOMA STAGE UNSPECIFIED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060307</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060515</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BETAMETHASONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PETROLATUM (PETROLATUM)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047133-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060621</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006061789</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>73</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>53.5244</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA ORAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MIDDLE INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWOLLEN TONGUE</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>20041228</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060602</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PHENOBARBITAL TAB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALL OTHER THERAPEUTIC PRODUCTS (ALL OTHER THERAPEUTIC PRODUCTS)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMDUR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047134-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060619</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006034468</companynumb>
    <primarysource>
      <reportercountry>BELGIUM</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>54</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>85</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BRADYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>C-REACTIVE PROTEIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CRYING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FOAMING AT MOUTH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERAL PHYSICAL HEALTH DETERIORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GRAND MAL CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEPHROTIC SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMOTHORAX</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATION ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SILDENAFIL (PAH)  (SILDENAFIL)</medicinalproduct>
        <drugauthorizationnumb>21845</drugauthorizationnumb>
        <drugdosagetext>240 MG (80 MG, 3 IN 1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030903</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLOLAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRACLEER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LESCOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM CARBONATE (CALCIUM CARBONATE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGNESIUM CARBONATE (MAGNESIUM CARBONATE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SODIUM HYDROGEN CARBONATE (SODIUM BICARBONATE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SACCHAROMYCES BOULARDII (SACCHAROMYCES BOULARDII)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EPOETIN BETA (EPOETIN BETA)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MYOLASTAN (TETRAZEPAM)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTIVITAMINS, COMBINATIONS (MULTIVITAMINS, COMBINATIONS)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENGERIX-B</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOPERAMIDE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IRON PREPARATIONS (IRON PREPARATIONS)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LITICAN (ALIZAPRIDE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYOSCINE HBR HYT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZESTRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANTOZOL (PANTOPRAZOLE SODIUM)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PHENPROCOUMON (PHENPROCOUMON)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HERBAL NOS/VITAMINS NOS (HERBAL NOS, VITAMINS NOS)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METRONIDAZOLE (MITRONIDAZOLE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TREPROSTINOL (TREPROSTINOL)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047135-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060608</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006042528</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>49</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ALOPECIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CUTANEOUS LUPUS ERYTHEMATOSUS</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>20040901</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
        <drugdosagetext>3 YEARS AGO</drugdosagetext>
        <drugindication>DIABETES MELLITUS NON-INSULIN-DEPENDENT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SILDENAFIL CITRATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047136-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060619</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006072140</companynumb>
    <primarysource>
      <reportercountry>SOUTH AFRICA</reportercountry>
      <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>EXTRAPYRAMIDAL DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GEODON</medicinalproduct>
        <drugauthorizationnumb>20919</drugauthorizationnumb>
        <drugdosagetext>20 MG (STAT), INTRAMUSCULAR</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060512</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060515</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ETOMINE (CLOTIAPINE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATIVAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HALOPERIDOL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047137-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060622</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006072237</companynumb>
    <primarysource>
      <reportercountry>NORWAY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FUNGAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERCALCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERPHOSPHATAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POSTOPERATIVE WOUND COMPLICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN GRAFT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYMPATHOMIMETIC EFFECT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WOUND DEHISCENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYVOX</medicinalproduct>
        <drugauthorizationnumb>21131</drugauthorizationnumb>
        <drugdosagetext>1200 MG (600 MG, 2 IN 1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEVICE RELATED INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060327</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REMERON</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIFLUCAN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047138-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060622</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006059672</companynumb>
    <primarysource>
      <reportercountry>SPAIN</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>50</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>70</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ANOREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GALLBLADDER DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GRANULOMATOUS LIVER DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATITIS CHOLESTATIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TUBERCULOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
        <drugauthorizationnumb>19787</drugauthorizationnumb>
        <drugdosagetext>5 MG (5 MG, EVERY DAY), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MALIGNANT HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050429</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MEGESTROL ACETATE</medicinalproduct>
        <drugdosagetext>320 MG (160 MG, EVERY DAY), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANOREXIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050429</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
        <drugdosagetext>40 MG (40 MG, EVERY DAY), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RENAL DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050429</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
        <drugdosagetext>40 MG (40 MG, EVERY DAY), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>URETERAL DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050429</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047139-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060622</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006057938</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>39</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>56.7</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD CREATINE PHOSPHOKINASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISEASE PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG TOXICITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTHYROIDISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALMAR-PLANTAR ERYTHRODYSAESTHESIA SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUTENT</medicinalproduct>
        <drugauthorizationnumb>21968</drugauthorizationnumb>
        <drugdosagetext>50 MG (50 MG, DAILY  INTERVAL CYCLIC), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RENAL CELL CARCINOMA STAGE UNSPECIFIED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050712</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047140-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060619</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006029505</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>68</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>69.5</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>APHASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BALANCE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC ENCEPHALOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NERVOUS SYSTEM DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROTHROMBIN TIME RATIO INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUTENT</medicinalproduct>
        <drugauthorizationnumb>21938</drugauthorizationnumb>
        <drugdosagetext>50 MG (50 MG, 4 WEEKS), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATIC NEOPLASM MALIGNANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060217</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060224</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LACTULOSE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GINKOR FORT (GINKGO BILOBA, HEPTAMINOL HYDROCHLORIDE, TROXERUTIN)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALDACTONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XATRAL (ALFUZOSIN)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRASICOR (OXPRENOLOL HYDROCHLORIDE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM CHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PERMIXON (SERENOA REPENS)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047141-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060620</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006050311</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>78</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHABDOMYOLYSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIGLITOL TABLET (MIGLITOL)</medicinalproduct>
        <drugauthorizationnumb>20682</drugauthorizationnumb>
        <drugdosagetext>150 MG (1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060125</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060211</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047142-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060620</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006050181</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>54</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ATRIOVENTRICULAR BLOCK FIRST DEGREE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BORRELIA INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BUNDLE BRANCH BLOCK RIGHT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STRESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIAGRA</medicinalproduct>
        <drugauthorizationnumb>20895</drugauthorizationnumb>
        <drugdosagetext>25 MG (1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ERECTILE DYSFUNCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047143-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060623</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006081268</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>ASPARTATE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHILLS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAMMA-GLUTAMYLTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC STEATOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLUENZA LIKE ILLNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NASOPHARYNGITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ATORVASTATIN CALCIUM</medicinalproduct>
        <drugauthorizationnumb>20702</drugauthorizationnumb>
        <drugdosagetext>(10 MG, 1 IN 1 D),</drugdosagetext>
        <drugindication>HYPERCHOLESTEROLAEMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLOPIDOGREL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047144-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060623</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006080850</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>15</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>EYE SWELLING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CETIRIZINE HCL</medicinalproduct>
        <drugauthorizationnumb>19835</drugauthorizationnumb>
        <drugdosagetext>10 MG (10 MG, 1 IN 1 D),</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060622</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047145-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060624</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006080852</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ILL-DEFINED DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REACTINE SYRUP (CETIRIZINE)</medicinalproduct>
        <drugauthorizationnumb>20346</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060624</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047146-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060621</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006081320</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>50</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MUCOSAL INFLAMMATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOSITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PETECHIAE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PURPURA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUTENT</medicinalproduct>
        <drugauthorizationnumb>21938</drugauthorizationnumb>
        <drugdosagetext>50 MG (INTERVAL:  EVERY DAY),</drugdosagetext>
        <drugindication>GASTROINTESTINAL STROMAL TUMOUR</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060616</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047147-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060529</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006080782</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>61</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PANCREATITIS ACUTE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYRTEC</medicinalproduct>
        <drugauthorizationnumb>19835</drugauthorizationnumb>
        <drugdosagetext>(1 IN 1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERSENSITIVITY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030324</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030408</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENALAPRIL MALEATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYMETAZOLINE HYDROCHLORIDE (OXYMETAZOLINE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POLYVIDONE (POLYVIDONE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ETIDRONATE DISODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ESTRADIOL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047148-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060621</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006-142680-NL</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>45</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BRUXISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRISMUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIRTAZAPINE</medicinalproduct>
        <drugauthorizationnumb>76308</drugauthorizationnumb>
        <drugdosagetext>45 MG/60 MG</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
        <drugtreatmentduration>36</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GABAPENTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOCLOPRAMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONAZEPAM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047149-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060622</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>111149ISR</companynumb>
    <primarysource>
      <reportercountry>ITALY</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>71</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HEPATITIS ACUTE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
        <drugauthorizationnumb>21842</drugauthorizationnumb>
        <drugdosagetext>1000 MILLIGRAM ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060126</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060605</drugenddate>
        <drugtreatmentduration>131</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOSINOPRIL SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLICLAZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ISOSORBIDE MONONITRATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAMSULOSIN HYDROCHLORIDE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047150-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>THQ2006A00556</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>76</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CEREBRAL ATROPHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHOREA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EXTRAPYRAMIDAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEUKOENCEPHALOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERIPHERAL SENSORY NEUROPATHY</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>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20011217</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ATACAND</medicinalproduct>
        <drugdosagetext>8 MG (8 MG, 1 IN 1 D) PER ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20011217</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VERAPAMIL</medicinalproduct>
        <drugdosagetext>360 MG (120 MG, 3 IN 1 D) PER ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20011217</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060609</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugdosagetext>75 MG (75 MG, 1 IN 1 D) PER ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20011217</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOLPIDEM TARTRATE</medicinalproduct>
        <drugdosagetext>5 MG (5 MG, 1 IN 1 D)</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20011217</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FONZYLANE    (BUFLOMEDIL HYDROCHLORIDE) (TABLETS)</medicinalproduct>
        <drugdosagetext>900 MG (300 MG, 3 IN 1 D), PER ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20011217</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GAVISCON</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRANSIPEG                     (MACROGOL)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MODOPAR (MADOPAR)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARTANE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047151-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060616</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>111070ISR</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>78</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>NON-HODGKIN'S LYMPHOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LACTULOSE</medicinalproduct>
        <drugauthorizationnumb>73685</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LANSOPRAZOLE</medicinalproduct>
        <drugdosagetext>15 MILLIGRAM, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>QUININE SULFATE</medicinalproduct>
        <drugdosagetext>300 MILLIGRAM, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SALBUTAMOL</medicinalproduct>
        <drugdosagetext>4 MILLIGRAM, RESPIRATORY</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AQUEOUS CREAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE 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>1</drugcharacterization>
        <medicinalproduct>SENNA</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SERETIDE (FLUTICASONE PROPINATE AND SALMETEROL XINAFOATE)</medicinalproduct>
        <drugdosagetext>RESPIRATORY</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
        <drugdosagetext>RESPIRATORY</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047152-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060609</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>6023328</companynumb>
    <primarysource>
      <reportercountry>FINLAND</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>56</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>EAR DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEARING IMPAIRED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TINNITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BISOPROLOL FUMARATE</medicinalproduct>
        <drugauthorizationnumb>75474</drugauthorizationnumb>
        <drugdosagetext>2,5 MG (2,5 MG, 1 IN 1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041006</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060606</drugenddate>
        <drugtreatmentduration>608</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOVAN COMP FORTE                     (HYDROCHLOROTHIAZIDE, VALSARTAN)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZANIDIP                (LERCANIDIPINE HYDROCHLORIDE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THYROXIN                     (LEVOTHYROXINE SODIUM)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047153-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060621</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006P1000350</companynumb>
    <primarysource>
      <reportercountry>ITALY</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>57</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY DISEASE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RETEPLASE (RETEPLASE)</medicinalproduct>
        <drugdosagetext>IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ACUTE MYOCARDIAL INFARCTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REOPRO</medicinalproduct>
        <drugdosagetext>IV</drugdosagetext>
        <drugindication>ACUTE MYOCARDIAL INFARCTION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047154-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060621</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006P1000349</companynumb>
    <primarysource>
      <reportercountry>ITALY</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>72</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <reaction>
        <reactionmeddrapt>ARRHYTHMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE SYSTOLIC INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RETEPLASE          (RETEPLASE)</medicinalproduct>
        <drugbatchnumb>CT000807</drugbatchnumb>
        <drugdosagetext>5 IU; X2; IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ACUTE MYOCARDIAL INFARCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060319</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REOPRO</medicinalproduct>
        <drugbatchnumb>09330367</drugbatchnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>040</drugadministrationroute>
        <drugindication>ACUTE MYOCARDIAL INFARCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060319</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060319</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REOPRO</medicinalproduct>
        <drugbatchnumb>09330367</drugbatchnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>040</drugadministrationroute>
        <drugindication>ACUTE MYOCARDIAL INFARCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060319</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060319</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047155-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060621</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006P1000253</companynumb>
    <primarysource>
      <reportercountry>POLAND</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>51</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ARTERIOSCLEROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY STENOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MITRAL VALVE INCOMPETENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOPHLEBITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VASCULAR PSEUDOANEURYSM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RETEPLASE (RETEPLASE)</medicinalproduct>
        <drugdosagetext>IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ACUTE MYOCARDIAL INFARCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060202</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REOPRO</medicinalproduct>
        <drugdosagetext>IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ACUTE MYOCARDIAL INFARCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060202</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRANDOLARPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BISOPROLOL FUMARATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATORVASTATIN CALCIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FAMOTIDINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLOPIDOGREL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLEXANE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TICLODIPINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047156-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060620</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006P1000329</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>78</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>78</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ARTERIAL INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY OCCLUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERICARDIAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RETEPLASE (RETEPLASE)</medicinalproduct>
        <drugdosagetext>IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ACUTE MYOCARDIAL INFARCTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REOPRO</medicinalproduct>
        <drugdosagetext>IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ACUTE MYOCARDIAL INFARCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060104</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BISOPROLOL FUMARATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLOPIDOGREL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATORVASTATIN CALCIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANSOPRAZOLE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047157-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060620</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006P1000301</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE CONGESTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRANSIENT ISCHAEMIC ATTACK</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RETEPLASE (RETEPLASE)</medicinalproduct>
        <drugdosagetext>IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ACUTE MYOCARDIAL INFARCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060423</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060423</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REOPRO</medicinalproduct>
        <drugdosagetext>IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ACUTE MYOCARDIAL INFARCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060423</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060423</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETYLSALICYLIC ACID SRT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RAMIPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATORVASTATIN CALCIUM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047158-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060626</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006P1000265</companynumb>
    <primarysource>
      <reportercountry>POLAND</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>64</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BRONCHITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RETEPLASE (RETEPLASE)</medicinalproduct>
        <drugdosagetext>IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ACUTE MYOCARDIAL INFARCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050921</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050921</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REOPRO</medicinalproduct>
        <drugdosagetext>IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ACUTE MYOCARDIAL INFARCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050921</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FENOTEROL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM CHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VERAPAMIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INDAPAMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TICLOPIDINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUTICASONE PROPIONATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FORMOTEROL FUMARATE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047159-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060620</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006081367</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL STIFFNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AROMASIN</medicinalproduct>
        <drugauthorizationnumb>20753</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047160-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060622</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006073654</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>45</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>NO ADVERSE EFFECT</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>20060424</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060508</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTIHYPERTENSIVES (ANTIHYPERTENSIVES)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTI-DIABETICS (ANTI-DIABETICS)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047161-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060619</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006074064</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>48</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DELIRIUM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ELECTROCARDIOGRAM QT PROLONGED</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>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060614</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047162-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060622</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006072393</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>43</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ACTINOMYCOTIC PULMONARY INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRONCHIAL ULCERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIOVASCULAR DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBRAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHOLECYSTITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CYST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSED LEVEL OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIVERTICULUM INTESTINAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC ATROPHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC STEATOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERALBUMINAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALIGNANT NEOPLASM PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METASTASES TO ADRENALS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METASTASES TO BONE MARROW</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METASTASES TO GALLBLADDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METASTASES TO GASTROINTESTINAL TRACT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METASTASES TO HEART</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METASTASES TO KIDNEY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METASTASES TO LIVER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METASTASES TO LYMPH NODES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METASTASES TO PLEURA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METASTASES TO SPLEEN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METASTASES TO UTERUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYDRIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPHIL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OBSTRUCTIVE AIRWAYS DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVARIAN ATROPHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PELVIC MASS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLEURAL EFFUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PUPILLARY REFLEX IMPAIRED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYELECTASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STAPHYLOCOCCAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUPERIOR VENA CAVAL OCCLUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THYROID ATROPHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRACHEAL STENOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UTERINE HYPOPLASIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IRINOTECAN HCL</medicinalproduct>
        <drugauthorizationnumb>20571</drugauthorizationnumb>
        <drugdosagetext>(DAY 1, 8, 15 OF EACH 4-WEEKS COURSE), INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CHLOROMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CISPLATIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DESMOPRESSIN ACETATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THEOPHYLLINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HUSTAGIN (PLANTAGO MAJOR)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CODEINE PHOSPHATE (CODEINE PHOSPHATE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGNESIUM OXIDE (MAGNESIUM OXIDE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRIMPERAN TAB</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047163-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060609</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006080793</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>69</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>STEVENS-JOHNSON SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYRTEC</medicinalproduct>
        <drugauthorizationnumb>19835</drugauthorizationnumb>
        <drugdosagetext>10 MG, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DERMATITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060508</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BUDESONIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MONTELUKAST SODIUM (MONTELUKAST SODIUM)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIFLUPREDNATE (DIFLUPREDNATE)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047164-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060613</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006080769</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>COORDINATION ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMPAIRED DRIVING ABILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
        <drugauthorizationnumb>20235</drugauthorizationnumb>
        <drugdosagetext>100 MG, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NEURALGIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047165-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060613</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006080799</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ECCHYMOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHROBLASTOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FOETAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FOETAL DISTRESS SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INDUCED LABOUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTRA-UTERINE DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LISTERIOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLACENTAL DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ATARAX</medicinalproduct>
        <drugauthorizationnumb>10392</drugauthorizationnumb>
        <drugdosagetext>25 MG, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>TACHYCARDIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060416</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060422</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ELEVIT PRONATAL (MINERALS NOS, VITAMINS  NOS)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FERROUS SULFATE TAB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGNESIUM (MAGNESIUM)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UVEDOSE (COLCALCIFEROL)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SALBUTAMOL (SALBUTAMOL)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047166-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060619</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006080801</companynumb>
    <primarysource>
      <reportercountry>MONACO</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>74</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>AGITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEDICATION ERROR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY DEPRESSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ATARAX</medicinalproduct>
        <drugauthorizationnumb>11111</drugauthorizationnumb>
        <drugdosagetext>INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PREMEDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047167-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060613</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006080796</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>AMNIOTIC CAVITY DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTRA-UTERINE DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLACENTAL DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ATARAX</medicinalproduct>
        <drugauthorizationnumb>10392</drugauthorizationnumb>
        <drugdosagetext>25 MG, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>TACHYCARDIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060412</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060422</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ELEVIT PRONATAL (MINERALS NOS, VITAMINS NOS)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FERROUS SULFATE TAB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGNESIUM (MAGNESIUM)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COLECALCIFEROL (COLECALCIFEROL)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SALBUTAMOL (SALBUTAMOL)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047168-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060623</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006080924</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>RED BLOOD CELL ABNORMALITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugbatchnumb>U</drugbatchnumb>
        <drugauthorizationnumb>20998</drugauthorizationnumb>
        <drugdosagetext>200 MG (100 MG, 2 IN 1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047169-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060621</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006080738</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>30</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST DISCOMFORT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CETIRIZINE HCL</medicinalproduct>
        <drugauthorizationnumb>19835</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CETIRIZINE HCL AND PSEUDOEPHEDRINE HCL</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047170-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060621</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006060375</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>GASTRIC ULCER HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERVERTEBRAL DISC COMPRESSION</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>20030507</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047172-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060623</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CHPA2006US06193</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>50</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>68.9</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG ABUSER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NO ADVERSE DRUG EFFECT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVERDOSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXCEDRIN (MIGRAINE)</medicinalproduct>
        <drugbatchnumb>6A4007A</drugbatchnumb>
        <drugauthorizationnumb>20802</drugauthorizationnumb>
        <drugdosagetext>2 DF, EVERY 4-5 HOURS, QD, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MIGRAINE</drugindication>
        <drugtreatmentduration>91</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047174-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060622</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>T200600699</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>47</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ALANINE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AREFLEXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASPARTATE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CREATINE PHOSPHOKINASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRADYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ELECTROCARDIOGRAM QRS COMPLEX SHORTENED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ISCHAEMIC HEPATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PCO2 INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PO2 INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHABDOMYOLYSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUOXETINE CAPSULES (FLUOXETINE) CAPSULE, 10MG</medicinalproduct>
        <drugauthorizationnumb>75658</drugauthorizationnumb>
        <drugdosagetext>10 MG</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMITRIPTYLINE)AMITRIPTYLINE) 50MG</medicinalproduct>
        <drugdosagetext>50 MG</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LORAZEPAM(LORAZEPAM) 0.5MG</medicinalproduct>
        <drugdosagetext>0.5 MG</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OLANZAPINE(OLANZAPINE) 10 MG</medicinalproduct>
        <drugdosagetext>10 MG</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VENLAFAXINE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL (METOPROLOL) SOLUTION</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCODONE BITARTRATE/APAP (HYDROCODONE BITARTRATE, ACETAMINOPHEN TAB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANTOPRAZOLE SODIUM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047175-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060627</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006US000895</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>66</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>101.6</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ARTERIOSPASM CORONARY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC PROCEDURE COMPLICATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ADENOSCAN</medicinalproduct>
        <drugauthorizationnumb>20059</drugauthorizationnumb>
        <drugdosagetext>58.9 MG, TOTAL DOSE, PARENTERAL</drugdosagetext>
        <drugadministrationroute>051</drugadministrationroute>
        <drugindication>SCAN MYOCARDIAL PERFUSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THALLIUM (201 TL) (THALLIUM (20 TL))</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>URECHOLINE (BETANECHOL CHLORIDE)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047176-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060620</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006077820</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CAUSTIC INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VISINE II EYE DROPS</medicinalproduct>
        <drugbatchnumb>0104481</drugbatchnumb>
        <drugauthorizationnumb>19407</drugauthorizationnumb>
        <drugdosagetext>OPHTHALMIC</drugdosagetext>
        <drugadministrationroute>047</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047177-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060621</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006038683</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>17</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>58.9676</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWELLING FACE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URTICARIA GENERALISED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NASALCROM</medicinalproduct>
        <drugbatchnumb>PF05014</drugbatchnumb>
        <drugauthorizationnumb>20463</drugauthorizationnumb>
        <drugdosagetext>1 SPRAY IN EACH PASSAGE ONCE, NASAL</drugdosagetext>
        <drugadministrationroute>045</drugadministrationroute>
        <drugindication>NASAL CONGESTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060318</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060318</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047178-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060621</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006078449</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CAUSTIC INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRY SKIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THERMAL BURN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WOUND SECRETION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>YELLOW SKIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ROGAINE</medicinalproduct>
        <drugauthorizationnumb>20834</drugauthorizationnumb>
        <drugdosagetext>2 ML OR LESS 2XDAY, TOPICAL</drugdosagetext>
        <drugadministrationroute>061</drugadministrationroute>
        <drugindication>ALOPECIA AREATA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047179-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060615</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DSA_81615_2006</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>30</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>72.5755</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>AFFECTIVE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD ALKALINE PHOSPHATASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CALCIUM DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRADYPHRENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPHORIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELINGS OF WORTHLESSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLAT AFFECT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HALLUCINATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HOMICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ILLUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MORBID THOUGHTS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE DRUG OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NERVOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OBSESSIVE THOUGHTS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANIC ATTACK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARANOIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSYCHOTIC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SLEEP DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMATIC DELUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STRESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDE ATTEMPT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUSPICIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XYREM</medicinalproduct>
        <drugauthorizationnumb>21196</drugauthorizationnumb>
        <drugdosagetext>4 G TWICE NIGHTLY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SLEEP DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALLEGRA</medicinalproduct>
        <drugdosagetext>DF</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COUGH MEDICINE (NOT SPECIFIED)</medicinalproduct>
        <drugdosagetext>DF</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XYREM</medicinalproduct>
        <drugdosagetext>3 G TWICE NIGHTLY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SLEEP DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
        <drugdosagetext>0.25 MG TID PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PSYCHOTIC DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ESTROGEN CREAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMBIEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ROBAXIN           /00047901/</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RELPAX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047180-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060622</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006001169</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>64</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BILE DUCT OBSTRUCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISEASE PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC LESION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ERLOTINIB (TABLET)</medicinalproduct>
        <drugbatchnumb>X101862</drugbatchnumb>
        <drugdosagetext>100 MG (QD), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BREAST CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060223</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060515</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EVEROLIMUS (EVEROLIMUS) (TABLET)</medicinalproduct>
        <drugbatchnumb>X1240504</drugbatchnumb>
        <drugdosagetext>2.5 MG (QD), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BREAST CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060223</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060515</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOSARTAN POTASSIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ESCITALOPRAM OXALATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORAZEPAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ONDANSETRON HYDROCHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROCHLOPERAZINE (PROCHLORPERAZINE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PACLITAXEL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYZAAR</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047181-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060621</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006066741</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>74</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ALANINE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASPARTATE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ATRIOVENTRICULAR BLOCK SECOND DEGREE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AZOTAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD POTASSIUM ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRADYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BUNDLE BRANCH BLOCK RIGHT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC MURMUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBRAL ATROPHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DECREASED APPETITE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIABETIC NEPHROPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIPLOPIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISORIENTATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTOLERANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG TOXICITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING DRUNK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUID OVERLOAD</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAZE PALSY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HALLUCINATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HALLUCINATION, VISUAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERKALAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENTAL STATUS CHANGES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METABOLIC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NERVOUS SYSTEM DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL INTAKE REDUCED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHABDOMYOLYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TENDERNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugauthorizationnumb>21446</drugauthorizationnumb>
        <drugdosagetext>150 MG (75 MG, 2 IN 1 D)</drugdosagetext>
        <drugindication>POST HERPETIC NEURALGIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060410</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060412</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZETIA</medicinalproduct>
        <drugdosagetext>10 MG (10 MG, 1 IN 1 D)</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARDIZEM CD</medicinalproduct>
        <drugdosagetext>180 MG (180 MG, 1 IN 1 D)</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROCARDIA XL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZESTORETIC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KETAMINE (KETAMINE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GABAPENTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BACLOFEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONIDINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIDOCAINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCONTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALL OTHER THERAPEUTIC PRODUCTS (ALL OTHER THERAPEUTIC PRODUCTS)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SENOKOT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMINS (VITAMINS)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLAXSEED OIL (LINSEED OIL)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BUDESONIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NITROSTAT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOSAMINE (GLUCOSAMINE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETYLSALICYLIC ACID SRT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DISOPYRAMIDE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047182-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060627</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006BI009284</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>57</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>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>20020101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugdosagetext>30 UG;QW;IM</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047183-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060627</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006BI009286</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>48</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>RENAL CELL CARCINOMA STAGE UNSPECIFIED</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>20040315</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>5047184-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060627</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006BI009297</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>61</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>OVARIAN CANCER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugdosagetext>30 UG;QW;IM</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
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        <drugstartdate>19980101</drugstartdate>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugdosagetext>30 UG;QW;IM</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047185-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006BI009346</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MULTIPLE SCLEROSIS RELAPSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugdosagetext>30 UG;QW;IM</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047186-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060616</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006BI009366</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <patientonsetage>37</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>SARCOIDOSIS</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>20051201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060501</drugenddate>
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  <safetyreport>
    <safetyreportid>5047187-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060622</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
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      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
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    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>APLASIA PURE RED CELL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHRONIC LYMPHOCYTIC LEUKAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALIGNANT NEOPLASM PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THYMOMA</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RITUXAN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051018</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051129</drugenddate>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugdosagetext>40000 UNIT, 1/WEEK, SUBCUTANEOUS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>CHRONIC LYMPHOCYTIC LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051013</drugstartdate>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051019</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051110</drugenddate>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CHEMOTHERAPY TREATMENTS NOS (ANTINEOPLASTIC AGENT NOS)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047192-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060619</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006077685</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>STEVENS-JOHNSON SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEXTRA</medicinalproduct>
        <drugauthorizationnumb>21341</drugauthorizationnumb>
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    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047193-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060615</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>220002M06FRA</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <patientonsetage>16</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>83.3</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CARPAL TUNNEL SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SAIZEN</medicinalproduct>
        <drugauthorizationnumb>19764</drugauthorizationnumb>
        <drugdosagetext>1.6 MG, 1 IN 1 DAYS, SUBCUTANEOUS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>GROWTH HORMONE DEFICIENCY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050730</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060228</drugenddate>
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    </patient>
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  <safetyreport>
    <safetyreportid>5047194-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060619</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>EM2006-0340</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
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    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <patientonsetage>44</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>55</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INFLUENZA LIKE ILLNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROLEUKIN</medicinalproduct>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060213</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060217</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROLEUKIN</medicinalproduct>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060410</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060414</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROLEUKIN</medicinalproduct>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060612</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060616</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EMTRIVA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VIDEX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SUSTIVA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROZAC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047195-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060627</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>EM2006-0335</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>39</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>60</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>RETINAL DETACHMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL ACUITY REDUCED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROLEUKIN</medicinalproduct>
        <drugdosagetext>9 MIU, QD, SUBCUTAN.</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021202</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20021206</drugenddate>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROLEUKIN</medicinalproduct>
        <drugdosagetext>9 MIU, QD, SUBCUTAN.</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030217</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030221</drugenddate>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROLEUKIN</medicinalproduct>
        <drugdosagetext>9 MIU, QD, SUBCUTAN.</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030414</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030418</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROLEUKIN</medicinalproduct>
        <drugdosagetext>9 MIU, QD, SUBCUTAN.</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031105</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031109</drugenddate>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROLEUKIN</medicinalproduct>
        <drugdosagetext>9 MIU, QD, SUBCUTAN.</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040409</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040413</drugenddate>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROLEUKIN</medicinalproduct>
        <drugdosagetext>9 MIU, QD, SUBCUTAN.</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040705</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040709</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROLEUKIN</medicinalproduct>
        <drugdosagetext>9 MIU, QD, SUBCUTAN.</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050527</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050531</drugenddate>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROLEUKIN</medicinalproduct>
        <drugdosagetext>9 MIU, QD, SUBCUTAN.</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051001</drugenddate>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEG INTERFERON (INTERFERON ALFA) SOLUTION FOR INJECTION</medicinalproduct>
        <drugdosagetext>180 UG, QW</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041103</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041130</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RIBAVIRIN (RIBAVIRIN) TABLET</medicinalproduct>
        <drugdosagetext>1200 MG, QD</drugdosagetext>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041103</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041130</drugenddate>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EMTRIVA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VIREAD</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KALETRA</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047196-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060622</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FRP06000669</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>92</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PELVIC FRACTURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIDRONEL</medicinalproduct>
        <drugauthorizationnumb>17831</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040301</drugenddate>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MOTILIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SERECOR (HYDROQUINIDINE HYDROCHLORIDE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CORVASAL (MOLSIDOMINE)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047197-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060621</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US017636</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
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    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <patientonsetage>84</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>C-REACTIVE PROTEIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISSEMINATED INTRAVASCULAR COAGULATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOKALAEMIA</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>MALIGNANT NEOPLASM PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THERAPY NON-RESPONDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT DECREASED</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRISENOX</medicinalproduct>
        <drugauthorizationnumb>21248</drugauthorizationnumb>
        <drugdosagetext>4.1 MG QD, INTRAVENOUS DRIP</drugdosagetext>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>ACUTE PROMYELOCYTIC LEUKAEMIA</drugindication>
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        <drugstartdate>20060228</drugstartdate>
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        <drugenddate>20060320</drugenddate>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRISENOX</medicinalproduct>
        <drugdosagetext>3.94 MG QD INTRAVENOUS DRIP</drugdosagetext>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>ACUTE PROMYELOCYTIC LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060411</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060511</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
        <drugdosagetext>40 MG QD ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060221</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060511</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEXILETINE HYDROCHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NIFEDIPINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>L-ASPARTATE POTASSIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NIZATIDINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047198-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060623</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US016291</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>64</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ALANINE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASPARTATE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD ALKALINE PHOSPHATASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ELECTROCARDIOGRAM QT PROLONGED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAMMA-GLUTAMYLTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRISENOX</medicinalproduct>
        <drugauthorizationnumb>21248</drugauthorizationnumb>
        <drugdosagetext>8.76 MG QD INTRAVENOUS DRIP</drugdosagetext>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>ACUTE PROMYELOCYTIC LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050208</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050217</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRISENOX</medicinalproduct>
        <drugdosagetext>8.76 MG QD INTRAVENOUS DRIP</drugdosagetext>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>ACUTE PROMYELOCYTIC LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050223</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050227</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRISENOX</medicinalproduct>
        <drugdosagetext>7.875 MG QD INTRAVENOUS DRIP</drugdosagetext>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>ACUTE PROMYELOCYTIC LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050626</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050718</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYTARABINE</medicinalproduct>
        <drugdosagetext>160 MG QD INTRAVENOUS DRIP</drugdosagetext>
        <drugadministrationroute>041</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050626</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050630</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IDARUBICIN HCL</medicinalproduct>
        <drugdosagetext>20 MG QD INTRAVENOUS DRIP</drugdosagetext>
        <drugadministrationroute>041</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050626</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050628</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEXILETINE HYDROCHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GABEXATE MESILATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMIKACIN SULFATE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047199-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060623</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US017649</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>54</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>C-REACTIVE PROTEIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRISENOX</medicinalproduct>
        <drugauthorizationnumb>21248</drugauthorizationnumb>
        <drugdosagetext>12 MG QD INTRAVENOUS DRIP</drugdosagetext>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>ACUTE PROMYELOCYTIC LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051222</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060219</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHYLPREDNISOLONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DALTEPARIN SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MICAFUNGIN SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACYCLOVIR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMIKACIN SULFATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAZOBACTAM PIPERACILLIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CEFTAZIDIME</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047200-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060622</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006JP001463</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>51</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>56</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BRADYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMODIALYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTRAVASCULAR HAEMOLYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SHOCK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENTRICULAR TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FUNGUARD (MICAFUNGIN) INJECTION</medicinalproduct>
        <drugauthorizationnumb>21506</drugauthorizationnumb>
        <drugdosagetext>150 MG, UID/QD, IV DRIP</drugdosagetext>
        <drugadministrationroute>041</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060508</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060509</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VFEND (VORICONAZOLE) INJECTION</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VFEND (VORICONAZOLE) TABLET</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TARGOCID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CIPROXAN (CIPROFLOXACIN HYDROCHLORIDE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEROPEN (MEROPENEM)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEUART</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ORGARAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HUMULIN (INSULIN HUMAN INJECTION, ISOPHANE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SOL MEDROL (METHYLPREDNISOLONE, SUCCINATE SODIUM)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GASTER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDOPA (DOPAMINE HYDROCHLORIDE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FENTANYL CITRATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIPRIVAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EPIQUICK (EPINEPHRINE)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047201-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060622</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006066542</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>74</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>81.1939</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ACUTE MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTERIOSCLEROSIS CORONARY ARTERY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARYNGOLARYNGEAL PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUTENT</medicinalproduct>
        <drugauthorizationnumb>21968</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>METASTATIC RENAL CELL CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060131</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060228</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUTENT</medicinalproduct>
        <drugauthorizationnumb>21968</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>METASTATIC RENAL CELL CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060314</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060411</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUTENT</medicinalproduct>
        <drugauthorizationnumb>21968</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>METASTATIC RENAL CELL CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060425</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060521</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCODONE BITARTRATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SENNA (SENNA)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COMPAZINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047202-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060619</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006063551</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>58</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>88.905</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ARTERIOSCLEROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BASAL CELL CARCINOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CHOLESTEROL INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEEP VEIN THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ELECTROCARDIOGRAM ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VASCULAR INJURY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEXTRA</medicinalproduct>
        <drugauthorizationnumb>21341</drugauthorizationnumb>
        <drugdosagetext>20 MG (20 MG, 1 IN 1 D)</drugdosagetext>
        <drugindication>BACK PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040401</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREVIDENT (SODIUM FLUORIDE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOTENSIN HCT (BENAZEPRIL HYDROCHLORIDE, HYDROCHLOROTHIAZIDE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACIPHEX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047203-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060622</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006060197</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>63</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>58.2</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE CONTRACTIONS INVOLUNTARY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL STIFFNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUSITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUTENT</medicinalproduct>
        <drugauthorizationnumb>21938</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTROINTESTINAL STROMAL TUMOUR</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060202</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060301</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUTENT</medicinalproduct>
        <drugauthorizationnumb>21938</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTROINTESTINAL STROMAL TUMOUR</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060323</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060419</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEULASTA</medicinalproduct>
        <drugdosagetext>SUBCUTANEOUS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>SINUSITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060503</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060503</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEVAQUIN (LEVOFLOXACIN)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047204-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060618</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006PV015791</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>54</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL DISTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ATRIAL FIBRILLATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ATRIAL FLUTTER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DECREASED APPETITE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GLYCOSYLATED HAEMOGLOBIN INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BYETTA</medicinalproduct>
        <drugbatchnumb>9SF13M</drugbatchnumb>
        <drugauthorizationnumb>21773</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>DIABETES MELLITUS NON-INSULIN-DEPENDENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BYETTA</medicinalproduct>
        <drugbatchnumb>9SF13M</drugbatchnumb>
        <drugauthorizationnumb>21773</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>DIABETES MELLITUS NON-INSULIN-DEPENDENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>STARLIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACTOS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HUMALOG</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMIODARONE HCL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047205-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060618</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006PV015749</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>59</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>81.6475</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BASOPHIL COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EXTRASYSTOLES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROOESOPHAGEAL REFLUX DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HELICOBACTER GASTRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPHOCYTE COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BYETTA</medicinalproduct>
        <drugbatchnumb>9SF15M</drugbatchnumb>
        <drugauthorizationnumb>21773</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>DIABETES MELLITUS NON-INSULIN-DEPENDENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060425</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060522</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BYETTA</medicinalproduct>
        <drugbatchnumb>9SF15M</drugbatchnumb>
        <drugauthorizationnumb>21773</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>DIABETES MELLITUS NON-INSULIN-DEPENDENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060523</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060615</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BYETTA</medicinalproduct>
        <drugbatchnumb>9SF15M</drugbatchnumb>
        <drugauthorizationnumb>21773</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>DIABETES MELLITUS NON-INSULIN-DEPENDENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060616</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COLACE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047206-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060617</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006PV015748</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>27</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>137.4399</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ACCIDENT AT WORK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ENERGY INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE BRUISING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE MASS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BYETTA</medicinalproduct>
        <drugbatchnumb>9RY71M</drugbatchnumb>
        <drugauthorizationnumb>21773</drugauthorizationnumb>
        <drugdosagetext>5 MCG; BID; SC</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>INSULIN RESISTANCE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060511</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BYETTA</medicinalproduct>
        <drugbatchnumb>9RY71M</drugbatchnumb>
        <drugauthorizationnumb>21773</drugauthorizationnumb>
        <drugdosagetext>5 MCG; BID; SC</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>INSULIN RESISTANCE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060520</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047207-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060622</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FRP06000172</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>94</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>33</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BREAST CANCER FEMALE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BREAST MASS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACTONEL</medicinalproduct>
        <drugauthorizationnumb>20835</drugauthorizationnumb>
        <drugdosagetext>35, 1/WEEK, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CACIT D3(CALCIUM CARBONATE, COLECALCIFEROL)</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MOTILIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SEERECOR (HYDROQUINIDINE HYDROCHLORIDE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CORVASAL (MOLSIDOMINE)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047208-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060619</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A-JP2005-10689</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>59</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>47.5</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG ERUPTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EOSINOPHILIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERALISED ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH GENERALISED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRACLEER</medicinalproduct>
        <drugauthorizationnumb>21290</drugauthorizationnumb>
        <drugdosagetext>62.5  MG, BID, ORAL; 62.5 MG, QD, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050906</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050914</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRACLEER</medicinalproduct>
        <drugauthorizationnumb>21290</drugauthorizationnumb>
        <drugdosagetext>62.5  MG, BID, ORAL; 62.5 MG, QD, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050915</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050916</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENEXATE HYDROCHLORIDE BETADEX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOCOPHERYL NICOTINATE (TOCOPHERYL NICOTINATE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FERROUS CITRATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOXOPROFEN (LOXOPROFEN)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BERAPROST SODIUM (BERAPROST SODIUM)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FEXOFENADINE HYDROCHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCORTISONE SODIUM SUCCINATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROXYZINE PAMOATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRONOLACTONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYGEN (OXYGEN)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FAMOTIDNE (FAMOTIDINE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047209-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060622</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>225777</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>71</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CORNEAL OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LATEX ALLERGY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROCEDURAL COMPLICATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVASTIN</medicinalproduct>
        <drugbatchnumb>20061705</drugbatchnumb>
        <drugdosagetext>1 MG, INTRAVITREAL</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GENTAMICIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047211-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060623</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006000898</companynumb>
    <primarysource>
      <reportercountry>FINLAND</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANAPHYLACTOID REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARYNGEAL ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TARCEVA</medicinalproduct>
        <drugauthorizationnumb>21743</drugauthorizationnumb>
        <drugdosagetext>150 MG (QD), ORAL; 100 MG (QD), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SQUAMOUS CELL CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060301</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047212-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060622</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>225778</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>81</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CORNEAL OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NONSPECIFIC REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVASTIN</medicinalproduct>
        <drugbatchnumb>20061705</drugbatchnumb>
        <drugdosagetext>1 MG, SINGLE, INTRAVITREAL</drugdosagetext>
        <drugindication>MACULAR DEGENERATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GENTAMICIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047213-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060621</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2005EU002413</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>56</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG TOXICITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATORENAL SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FK506 (TACROLIMUS) CAPSULE</medicinalproduct>
        <drugauthorizationnumb>50708</drugauthorizationnumb>
        <drugdosagetext>3.00 MG, UID/QD,  ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>LIVER TRANSPLANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041229</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050126</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MYCOPHENOLATE MOFETIL</medicinalproduct>
        <drugdosagetext>1000.00 BID, IV NOS;  1000.00 MG, BID, ORAL</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>LIVER TRANSPLANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041228</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041231</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MYCOPHENOLATE MOFETIL</medicinalproduct>
        <drugdosagetext>1000.00 BID, IV NOS;  1000.00 MG, BID, ORAL</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>LIVER TRANSPLANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHYLPREDNISOLONE</medicinalproduct>
        <drugdosagetext>250.00 MG, UID/QD</drugdosagetext>
        <drugindication>LIVER TRANSPLANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041229</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050119</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISONE TAB</medicinalproduct>
        <drugdosagetext>20.00 MG, UID/QD</drugdosagetext>
        <drugindication>LIVER TRANSPLANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050119</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAZOCILLINE (PIPERACILLIN SODIUM, TAZOBACTAM SODIUM)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047214-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060620</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>226558</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>47</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ARTERIAL RUPTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTERIAL THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PENILE VASCULAR DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVASTIN</medicinalproduct>
        <drugindication>COLORECTAL CANCER METASTATIC</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047215-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060613</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004JP002271</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>52</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>42</patientweight>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>DEPRESSED LEVEL OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ENGRAFTMENT SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGIC CEREBRAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFECTION IN AN IMMUNOCOMPROMISED HOST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOTIC MICROANGIOPATHY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROGRAF</medicinalproduct>
        <drugauthorizationnumb>50709</drugauthorizationnumb>
        <drugdosagetext>CONTINUOUS, IV DRIP</drugdosagetext>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>BONE MARROW TRANSPLANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040323</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOVIRAX (ACICLOVIR) TABLET</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GASTER D TABLET</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MUCOSTA (REBAMIPIDE) TABLET</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>URSO (URSODEOXYCHOLIC ACID) TABLET</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUNGUARD (MICAFUNGIN) INJECTION</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VANCOMYCIN (VANCOMYCIN HYDROCHLORIDE) INJECTION</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEROPEN (MEROPENEM) INJECTION</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEUPOGEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SOL MEDROL (METHYLPREDNISOLONE, SUCCINATE SODIUM) INJECTION</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOY (GABEXATE MESILATE) INJECTION</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047216-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060620</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006EU001858</companynumb>
    <primarysource>
      <reportercountry>SWITZERLAND</reportercountry>
      <qualification>1</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>SQUAMOUS CELL CARCINOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROTOPIC</medicinalproduct>
        <drugauthorizationnumb>50777</drugauthorizationnumb>
        <drugdosagetext>DF, BID, TOPICAL</drugdosagetext>
        <drugadministrationroute>061</drugadministrationroute>
        <drugindication>ECZEMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051111</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051220</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047217-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>0600942US</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>53</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALESION TABLET (EPINASTINE HYDROCHLORIDE) TABLET, 10MG</medicinalproduct>
        <drugauthorizationnumb>21565</drugauthorizationnumb>
        <drugdosagetext>20 MG, QD, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SEASONAL ALLERGY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060308</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060401</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MEFENAMIC ACID</medicinalproduct>
        <drugdosagetext>750 MG, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>TONSILLITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060417</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060420</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMOXICILLIN</medicinalproduct>
        <drugdosagetext>750 MG, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>TONSILLITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060417</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060420</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LYSOZYME HYDROCHLORIDE(LYSOZYME HYDROCHLORIDE)</medicinalproduct>
        <drugdosagetext>750 MG, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>TONSILLITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060417</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060420</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIPOLAZIN(MEQUITAZINE)</medicinalproduct>
        <drugdosagetext>6 MG, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SEASONAL ALLERGY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060308</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060401</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047218-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>USA-2006-0024393</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>52</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>63.5</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CANNABINOIDS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD POTASSIUM DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRONCHITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISORIENTATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISTURBANCE IN ATTENTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG ABUSER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG SCREEN POSITIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG WITHDRAWAL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSKINESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATOCRIT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE BRUISING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE INDURATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE URTICARIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEMORY IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULAR WEAKNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RED BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SCREAMING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPEECH DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MS CONTIN</medicinalproduct>
        <drugauthorizationnumb>19516</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050925</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEG-INTRON (PEGINTERFERON ALFA-2B)</medicinalproduct>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050925</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RIBASPHERE</medicinalproduct>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050925</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BUSPAR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM GLUCONATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOSAMINE W/CHONDROITIN SULFATES (ASCORBIC ACID, MANGANESE, CHONDROI</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROMORPHONE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LECITHIN (LECITHIN)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTIVITAMINS (NICOTINAMIDE, RIBOFLAVIN, THIAMINE HYDROCHLORIDE, RETIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEGA-3 (OMEGA-3 TRIGLYCERIDES)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROMETHAZINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN A+D (ERGOCALCIFEROL, RETINOL)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN B COMPLEX CAP</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASCORBIC ACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN E</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WELLBUTRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL SULFATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLAXSEED OIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INDERAL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM GLUCONATE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047219-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060622</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006-06-1011</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>53</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEG-INTERFERON ALFA-2B REDIPEN</medicinalproduct>
        <drugdosagetext>150 MCG QWK SUBCUTANEOUS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060525</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>20060525</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROZAC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct> PSORIASIS TREATMENT TOPICAL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047220-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060622</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006-02-0235</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>49</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>75</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ASCITES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD URINE PRESENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DECREASED APPETITE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATOCRIT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC CIRRHOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOALBUMINAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOVOLAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERSTITIAL LUNG DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPHOID TISSUE HYPERPLASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPHOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLEURAL EFFUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROTEINURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STREPTOCOCCAL SEROLOGY POSITIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEG-INTRON</medicinalproduct>
        <drugdosagetext>100 MCG QW SUBCUTANEOUS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060112</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBETOL</medicinalproduct>
        <drugdosagetext>800 MG ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060119</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>URSOO</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047221-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060620</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>06H-144-0308519-00</companynumb>
    <primarysource>
      <reportercountry>SPAIN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>65</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HEPATITIS ACUTE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROPOFOL</medicinalproduct>
        <drugauthorizationnumb>77908</drugauthorizationnumb>
        <drugindication>SEDATIVE THERAPY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047222-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060620</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006031909</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>80</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>83.5526</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>AMNESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BUNDLE BRANCH BLOCK RIGHT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE CONGESTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CATARACT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBRAL ATROPHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COORDINATION ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG TOXICITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FACIAL PALSY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERKALAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENTAL STATUS CHANGES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUSITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRANSIENT ISCHAEMIC ATTACK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VASODILATATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugauthorizationnumb>21446</drugauthorizationnumb>
        <drugdosagetext>225 MG (75 MG, 3 IN 1 D),</drugdosagetext>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060210</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VERELAN (VERAPAMIL HYDROCHLORIDE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE TAB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WELLBUTRIN SR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREVACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COLCHICUM JTL LIQ</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FERROUS SULFATE TAB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NASONEX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADVAIR DISKUS 100/50</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DUONEB (IPRATROPIUM BRMOIDE, SALBUTAMOL SULFATE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DURAGESIC-100</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ULTRAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PENTOXIFYLLINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GAVISCON</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZANTAC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMDUR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>K-DUR 10</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047223-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060615</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200606IM000358</companynumb>
    <primarysource>
      <reportercountry>AUSTRIA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AZOTAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GLOMERULONEPHRITIS PROLIFERATIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERICARDIAL EFFUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLEURAL EFFUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROTEINURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYSTEMIC LUPUS ERYTHEMATOSUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INTERFERON GAMMA-1B</medicinalproduct>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19861001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19880801</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INTERFERON GAMMA-1B</medicinalproduct>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19890501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19900201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INTERFERON GAMMA-1B</medicinalproduct>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19860401</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047224-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060627</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006-06-1206</companynumb>
    <primarysource>
      <reportercountry>ITALY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>76</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>74</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CATARACT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEG-INTRON</medicinalproduct>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050317</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047225-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060623</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006-06-1730</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HYPERTHYROIDISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SQUAMOUS CELL CARCINOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THYROID DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TONGUE NEOPLASM MALIGNANT STAGE UNSPECIFIED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEG-INTERFERON (PEGINTERFERON ALFA-2B) INJECTABLE POWDER</medicinalproduct>
        <drugdosagetext>100 MCG QW SUBCUTANEOUS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060502</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBETOL</medicinalproduct>
        <drugdosagetext>800 MG ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060502</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047226-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060627</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006-06-0816</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>46</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>62</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HAEMOLYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JAUNDICE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEG-INTRON</medicinalproduct>
        <drugdosagetext>100 MCG QW SUBCUTANEOUS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060526</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBETOL</medicinalproduct>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060526</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060601</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBETOL</medicinalproduct>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060602</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROMAC (POLAPREZINC)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LACTOFERRIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047227-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060621</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>163-20785-06060703</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>67</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>THALOMID</medicinalproduct>
        <drugauthorizationnumb>20785</drugauthorizationnumb>
        <drugdosagetext>1 IN 1 D, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060512</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060501</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047228-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060619</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006RR-02715</companynumb>
    <primarysource>
      <reportercountry>GREECE</reportercountry>
    </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>
      <reaction>
        <reactionmeddrapt>TENDONITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CIPROFLOXACIN</medicinalproduct>
        <drugauthorizationnumb>75747</drugauthorizationnumb>
        <drugdosagetext>500 MG, BID, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PNEUMONIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047230-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060623</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>163-20785-05090276</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>59</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CANDIDIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPHONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EXCESSIVE EXERCISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUROPATHY PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ROTATOR CUFF SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>THALOMID</medicinalproduct>
        <drugauthorizationnumb>20785</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>THALOMID</medicinalproduct>
        <drugauthorizationnumb>20785</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DECADRON</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047231-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060616</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>222422</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>62</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>57</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CYSTITIS HAEMORRHAGIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUID INTAKE REDUCED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATOCRIT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JC VIRUS INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT DECREASED</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>785 MG, Q4W, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CHRONIC LYMPHOCYTIC LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051103</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUDARABINE</medicinalproduct>
        <drugdosagetext>40 MG, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CHRONIC LYMPHOCYTIC LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051103</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOPHOSPHAMIDE</medicinalproduct>
        <drugdosagetext>390 MG, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CHRONIC LYMPHOCYTIC LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051103</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060221</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BACTRIM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALTREX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUCONAZOLE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047232-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060621</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>163-20785-05100357</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>57</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PREGNANCY TEST FALSE POSITIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>THALOMID</medicinalproduct>
        <drugauthorizationnumb>20785</drugauthorizationnumb>
        <drugdosagetext>4 IN 1 D, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050929</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060526</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047233-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060621</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>226587</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>28</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CEREBRAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MABTHERA (RITUXIMAB) CONC FOR SOLUTION FOR INFUSION</medicinalproduct>
        <drugindication>IDIOPATHIC THROMBOCYTOPENIC PURPURA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047234-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060621</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>226592</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>49</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>98</patientweight>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>APHASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE MARROW FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRAIN COMPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CANDIDA SEPSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBRAL HAEMATOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ENTEROBACTER SEPSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEMIPARESIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTHERMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCYTOPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MABTHERA (RITUXIMAB) CONC FOR SOLUTION FOR INFUSION</medicinalproduct>
        <drugdosagetext>INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NON-HODGKIN'S LYMPHOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060119</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060428</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060118</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060329</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOXORUBICIN HCL</medicinalproduct>
        <drugdosagetext>INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060119</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060328</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ETOPOPHOS (ETOPOSIDE)</medicinalproduct>
        <drugdosagetext>INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060429</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060503</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOPHOSPHAMIDE</medicinalproduct>
        <drugdosagetext>INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060119</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060328</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYTARABINE</medicinalproduct>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060118</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060503</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047235-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060623</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>163-20785-06030633</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>83</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <reaction>
        <reactionmeddrapt>BRONCHITIS ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRONCHOSPASM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY TOXICITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHINITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHINITIS ALLERGIC</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>THALOMID</medicinalproduct>
        <drugauthorizationnumb>20785</drugauthorizationnumb>
        <drugdosagetext>100 MG, DAILY, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050329</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060302</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TEMODAR</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZITHROMAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOXYCYCLINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLONASE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZYRTEC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATROVENT (IPRATROPIUM BROMIDE) (NASAL DROPS (INCLUDING NASAL SPRAY)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYTRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GPM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALTACE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047236-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060617</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006PV015091</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>49</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>117.9352</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL DISTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY OCCLUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BYETTA</medicinalproduct>
        <drugbatchnumb>9RY67M</drugbatchnumb>
        <drugauthorizationnumb>21773</drugauthorizationnumb>
        <drugdosagetext>5 MCG; BID; SC</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>DIABETES MELLITUS NON-INSULIN-DEPENDENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060519</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060605</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACE INHIBITOR NOS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047237-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060616</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006PV015699</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>63</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>106.5953</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CHOLELITHIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BYETTA</medicinalproduct>
        <drugauthorizationnumb>21773</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE, SC</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>DIABETES MELLITUS NON-INSULIN-DEPENDENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BYETTA</medicinalproduct>
        <drugauthorizationnumb>21773</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE, SC</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>DIABETES MELLITUS NON-INSULIN-DEPENDENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047238-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060618</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006PV015746</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>63</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>136.0791</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IRON DEFICIENCY ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SMALL INTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BYETTA</medicinalproduct>
        <drugbatchnumb>9SC15M</drugbatchnumb>
        <drugauthorizationnumb>21773</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE, PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS NON-INSULIN-DEPENDENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050701</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BYETTA</medicinalproduct>
        <drugbatchnumb>9SC15M</drugbatchnumb>
        <drugauthorizationnumb>21773</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE, PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS NON-INSULIN-DEPENDENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLIPIZIDE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047239-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060621</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>225990</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>55</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>77.2</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ACTIVATED PARTIAL THROMBOPLASTIN TIME PROLONGED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEEP VEIN THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SENSORY DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENA CAVA THROMBOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RITUXAN</medicinalproduct>
        <drugdosagetext>687 MG, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NON-HODGKIN'S LYMPHOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060511</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUDARABINE</medicinalproduct>
        <drugdosagetext>70 MG, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>LYMPHOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060511</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060515</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALONAL (ACETAMINOPHEN)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POLARAMINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CHLORPHENIRAMINE MALEATE (CHLORPHENIRAMINE MALEATE)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047240-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060622</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006BI009058</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </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>ACTIVITIES OF DAILY LIVING IMPAIRED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCONTINENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASTICITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SECONDARY PROGRESSIVE 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>19980401</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>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047241-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060621</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006026178</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>61</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>66.2252</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARYNGOLARYNGEAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUTENT</medicinalproduct>
        <drugauthorizationnumb>21968</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RENAL CELL CARCINOMA STAGE UNSPECIFIED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051027</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051115</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUTENT</medicinalproduct>
        <drugauthorizationnumb>21968</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RENAL CELL CARCINOMA STAGE UNSPECIFIED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051208</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060104</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUTENT</medicinalproduct>
        <drugauthorizationnumb>21968</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RENAL CELL CARCINOMA STAGE UNSPECIFIED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060119</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060216</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCONTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARANESP</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUCONAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROTONIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALUMINUM HYDROXIDE AND MAGNESIUM TRISILICATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CREON</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMBIEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVALIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORTAB</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047242-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060615</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>230052M05FRA</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>42</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>70</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>SUBCUTANEOUS HAEMATOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBIF</medicinalproduct>
        <drugdosagetext>44 MCG, 2 IN 1 WEEKS, SUBCUTANEOUS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050930</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETYLSALICYLIC ACID SRT</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047243-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060626</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>430001E06DEU</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </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>BRONCHOPULMONARY ASPERGILLOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FULL BLOOD COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG INFILTRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPTIC SHOCK</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NOVANTRONE</medicinalproduct>
        <drugauthorizationnumb>19297</drugauthorizationnumb>
        <drugindication>ACUTE MYELOID LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041021</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041027</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GEMTUZUMAB OZOGAMICIN (GEMTUZUMAB OZOGAMICIN)</medicinalproduct>
        <drugdosagetext>12 MG</drugdosagetext>
        <drugindication>ACUTE MYELOID LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041013</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041013</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYTARABINE</medicinalproduct>
        <drugindication>ACUTE MYELOID LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041021</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041027</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ETOPOSIDE</medicinalproduct>
        <drugindication>ACUTE MYELOID LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041021</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041027</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047244-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060623</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006-06-1755</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>78</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>NON-HODGKIN'S LYMPHOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SALBUTAMOL (ALBUTEROL) ORAL AEROSOL</medicinalproduct>
        <drugauthorizationnumb>20503</drugauthorizationnumb>
        <drugdosagetext>2PUFFS Q4HPRN ORAL AER I</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SPIRIVA (TIOTROPIUM BROMIDE) INHALATION SOLUTION</medicinalproduct>
        <drugdosagetext>18 MCG QD INHALATION</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE TAB</medicinalproduct>
        <drugdosagetext>4MG AM ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LACTULOSE</medicinalproduct>
        <drugdosagetext>10-20ML BID</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LANSOPRAZOLE</medicinalproduct>
        <drugdosagetext>15 MG AM ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
        <drugdosagetext>1GM QID ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>QUININE SULFATE</medicinalproduct>
        <drugdosagetext>300MG PM ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SENNA</medicinalproduct>
        <drugdosagetext>7.5MG 1-2/PM ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SERETIDE (SALMETEROL XINAFOATE/FLUTICASONE PROPIONAT</medicinalproduct>
        <drugdosagetext>250MCG BID INHALATION</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CETOSTEARYL ALCOHOL TOPICALS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047246-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060620</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>THYR-10305</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>72</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>55</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BALANCE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRAIN SCAN ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CALCINOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBELLAR SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NYSTAGMUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VERTIGO</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISION BLURRED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>THYROGEN</medicinalproduct>
        <drugauthorizationnumb>20898</drugauthorizationnumb>
        <drugdosagetext>0.9 MG DAILY IM</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>DIAGNOSTIC PROCEDURE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060123</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060124</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047247-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060616</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006RL000221</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>80</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BRADYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVERDOSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROPAFENONE HCL</medicinalproduct>
        <drugauthorizationnumb>19151</drugauthorizationnumb>
        <drugdosagetext>70 MG; TID; IV;  150 MG; PO</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047248-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060619</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006RL000205</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ATRIAL FLUTTER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTHYROIDISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERNATIONAL NORMALISED RATIO INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROPAFENONE HCL</medicinalproduct>
        <drugauthorizationnumb>19151</drugauthorizationnumb>
        <drugdosagetext>150 MG; TID</drugdosagetext>
        <drugindication>ATRIAL FLUTTER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMIODARONE (AMIODARONE)</medicinalproduct>
        <drugdosagetext>LOADING DOSE (NOS); PO;  200 MG; QD; PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATRIAL FLUTTER</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060501</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMIODARONE (AMIODARONE)</medicinalproduct>
        <drugdosagetext>LOADING DOSE (NOS); PO;  200 MG; QD; PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATRIAL FLUTTER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
        <drugdosagetext>5 TO 6 MG DAILY; 3 TO 4 MG DAILY;  4 MG; QD</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
        <drugdosagetext>5 TO 6 MG DAILY; 3 TO 4 MG DAILY;  4 MG; QD</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
        <drugdosagetext>5 TO 6 MG DAILY; 3 TO 4 MG DAILY;  4 MG; QD</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060501</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIGOXIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATORVASTATIN CALCIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CANDESARTAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THYROXINE SODIUM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047249-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060621</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-2006-013213</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>42</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CEREBRAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGIC STROKE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUBDURAL HAEMATOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BETASERON</medicinalproduct>
        <drugdosagetext>EVERY 2D, SUBCUTANEOUS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RELAPSING-REMITTING MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETYLSALICYLIC ACID SRT</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047250-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060620</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006RR-02724</companynumb>
    <primarysource>
      <reportercountry>SPAIN</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>63</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CHOLESTASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC STEATOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMOXICILLIN-ACIDO CLAVULANICO CINFA 500/125MG EFG(CLAVULANIC ACID, AMO</medicinalproduct>
        <drugauthorizationnumb>65102</drugauthorizationnumb>
        <drugdosagetext>500 MG, TID</drugdosagetext>
        <drugindication>UPPER RESPIRATORY TRACT INFECTION</drugindication>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOXAZOSIN (DOXAZOSIN)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHYLPREDNISOLONE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047251-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060626</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006-06-0751</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>53</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>89</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCYTOPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEG-INTRON</medicinalproduct>
        <drugdosagetext>150 MCG QW SUBCUTANEOUS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060330</drugstartdate>
      </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>20060330</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTIHYPERTENSIVE AGENT (NOS)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047253-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>OSCN-NO-0303S-0081</companynumb>
    <primarysource>
      <reportercountry>DENMARK</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>55</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ALOPECIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FIBROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERAL PHYSICAL HEALTH DETERIORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMODIALYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMMOBILE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANNICULITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUBCUTANEOUS NODULE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OMNISCAN</medicinalproduct>
        <drugauthorizationnumb>20123</drugauthorizationnumb>
        <drugdosagetext>50 ML, SINGLE DOSE, I.V.</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RENAL CYST</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020108</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020108</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OMNISCAN</medicinalproduct>
        <drugauthorizationnumb>20123</drugauthorizationnumb>
        <drugdosagetext>50 ML, SINGLE DOSE, I.V.</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RENAL TRANSPLANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020108</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020108</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047255-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060627</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006-141437-NL</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>64</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIAC TAMPONADE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEUKAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DANAPAROID SODIUM</medicinalproduct>
        <drugdosagetext>2500 ANTI_XA</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>DISSEMINATED INTRAVASCULAR COAGULATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060324</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060404</drugenddate>
        <drugtreatmentduration>12</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GABEXATE MESILATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMIKACIN SULFATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PIPERACILLIN SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IDARUBICIN HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYTARABINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEROPENEM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOBRAMYCIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTITHROMBIN III</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TIENAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUCONAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ITRACONAZOLE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047256-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060622</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006-143478-NL</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>77</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CATHETER RELATED COMPLICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FIBRIN D DIMER INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PELVIC FLUID COLLECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DANAPAROID SODIUM</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>DISSEMINATED INTRAVASCULAR COAGULATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060421</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060427</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GABEXATE MESILATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTITHROMBIN III</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BROMHEXINE HYDROCHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOPAMINE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOBUTAMINE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORADRENALINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUMIN (HUMAN)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TIENAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLINDAMYCIN PALMITATE HYDROCHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PHENOBARBITAL TAB</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047257-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060626</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006-143734-NL</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>64</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DANAPAROID SODIUM</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>DISSEMINATED INTRAVASCULAR COAGULATION</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>DIAZEPAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE TAB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FAMOTIDINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MIDAZOLAM HYDROCHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYTARABINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CEFTAZIDIME</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RAMOSETRON HYDROCHLORIDE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047259-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060621</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006-141712-NL</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>RENAL TUBULAR NECROSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIRTAZAPINE</medicinalproduct>
        <drugdosagetext>DF</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VENLAFAXINE HCL</medicinalproduct>
        <drugdosagetext>150 MG QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OLANZAPINE</medicinalproduct>
        <drugdosagetext>10 MG QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIMESULIDE</medicinalproduct>
        <drugdosagetext>100 MG BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047261-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060619</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>111090ISR</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>49</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>APHASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>APLASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE MARROW FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRAIN OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CANDIDA SEPSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBRAL HAEMATOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBRAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ENTEROBACTER SEPSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERAL PHYSICAL HEALTH DETERIORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEMIPARESIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTHERMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLAMMATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCYTOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugdosagetext>24 GRAM</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060118</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060329</drugenddate>
        <drugtreatmentduration>10</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOXORUBICIN HCL</medicinalproduct>
        <drugdosagetext>400 MILLIGRAM</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060119</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060328</drugenddate>
        <drugtreatmentduration>9</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VINCRISTINE</medicinalproduct>
        <drugdosagetext>8 MILLIGRAM</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060119</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060328</drugenddate>
        <drugtreatmentduration>9</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MABTHERA (RITUXIMAB)</medicinalproduct>
        <drugdosagetext>3.75 MILLIGRAM</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060119</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060428</drugenddate>
        <drugtreatmentduration>14</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ETOPOSIDE</medicinalproduct>
        <drugdosagetext>1.6 GRAM</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060429</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060503</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOPHOSPHAMIDE</medicinalproduct>
        <drugdosagetext>6 GRAM</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060119</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060328</drugenddate>
        <drugtreatmentduration>9</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYTARABINE</medicinalproduct>
        <drugdosagetext>24.5 GRAM</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060118</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060503</drugenddate>
        <drugtreatmentduration>15</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047263-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060630</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-JNJFOC-20060700077</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>25</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>46</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PERIPHERAL SENSORY NEUROPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL DISTURBANCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugdosagetext>7TH INFUSION</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugdosagetext>7 INFUSIONS ADMINISTERED.</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CROHN'S DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SEROPRAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMUREL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CROHN'S DISEASE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047264-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-JNJFOC-20060602804</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>42</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>TUBERCULOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BLINDED; INFLIXIMAB, RECOMBINANT</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PLACEBO</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RHEUMATREX</medicinalproduct>
        <drugdosagetext>START DATE BEFORE 24-NOV-05</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugdosagetext>START DATE BEFORE 19-JAN-06</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VOLTAREN</medicinalproduct>
        <drugdosagetext>START DATE BEFORE 19-JAN-06</drugdosagetext>
        <drugadministrationroute>054</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORCAM</medicinalproduct>
        <drugdosagetext>START DATE BEFORE 19-JAN-06</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAGAMET</medicinalproduct>
        <drugdosagetext>START DATE BEFORE 19-JAN-06</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS AGAINST GASTROINTESTINAL ULCER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMOBAN</medicinalproduct>
        <drugdosagetext>START DATE BEFORE 19-JAN-06</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INSOMNIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SANCOBA</medicinalproduct>
        <drugindication>CATARACT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CATALIN</medicinalproduct>
        <drugindication>CATARACT</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047265-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20060700466</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>58.06</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>B-CELL LYMPHOMA STAGE I</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>FOLATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BEXTRA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRILOSEC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYLENOL (CAPLET)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VICODEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM GLUCONATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOTENSIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047267-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20060700467</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>73.03</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DIFFUSE LARGE B-CELL LYMPHOMA STAGE III</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>PREDNISONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CORTISONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEFLUNOMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047268-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060619</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>02100-JPN-06-0244</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>77</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BALANCE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DECREASED APPETITE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSED LEVEL OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSKINESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSSTASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARALYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CILOSTAZOL</medicinalproduct>
        <drugdosagetext>200 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CEREBRAL INFARCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060522</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060524</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FAMOTIDINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRAVASTATIN SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUVOXAMINE MALEATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGNESIUM OXIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ETIZOLAM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047270-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060620</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ABILP-06-0256</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>62</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FACIAL PALSY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ABRAXANE</medicinalproduct>
        <drugdosagetext>430 MG DAY/EVERY 3 WEEKS/18 DOSES (EVERY 3 WEEKS)</drugdosagetext>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050602</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EFFEXOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BEXTRA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMBIEN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047273-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060626</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006-141817-NL</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>80</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>EPISTAXIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIRTAZAPINE</medicinalproduct>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060307</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIRTAZAPINE</medicinalproduct>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060308</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060325</drugenddate>
        <drugtreatmentduration>18</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORAZEPAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYAMEMAZINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOPICLONE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047277-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060620</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DEU-2006-0002162</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>46</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>51</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG TOXICITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSSTASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ENCEPHALOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE CONTRACTIONS INVOLUNTARY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXYCODON 10MG / NALOXON 5MG (NALOXONE HYDROCHLORIDE, OXYCODONE HYDROCH</medicinalproduct>
        <drugauthorizationnumb>20553</drugauthorizationnumb>
        <drugdosagetext>10 MG, BID, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BACK PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060321</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KATADOLON (FLUPIRTINE MALEATE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACTIVELLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BELOC-ZOK MITE (METOPROLOL SUCCINATE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EDRONAX (REBOXETINE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NACOM ^DUPONT PHARMA^ (CARBIDOPA, LEVODOPA)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SULPIRIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COPAXONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALPRAZOLAM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047278-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060223</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006AP00944</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>46</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>40.1</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>TOXIC EPIDERMAL NECROLYSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OMEPRAL</medicinalproduct>
        <drugauthorizationnumb>19810</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTRIC ULCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060126</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060207</drugenddate>
        <drugtreatmentduration>13</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEO-MINOPHAGEN C</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060118</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060221</drugenddate>
        <drugtreatmentduration>35</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMEDIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060111</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060213</drugenddate>
        <drugtreatmentduration>34</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LACTULOSE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060118</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060120</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047279-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060613</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006AP02772</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>51</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HYPOCALCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOMAGNESAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOPARATHYROIDISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TETANY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LOSEC</medicinalproduct>
        <drugauthorizationnumb>019810</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BARRETT'S OESOPHAGUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BARRETT'S OESOPHAGUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM SUPPLEMENT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TELMISARTAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RANITIDINE</medicinalproduct>
        <drugindication>REFLUX OESOPHAGITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047280-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006GB01117</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>29</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ERECTILE DYSFUNCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugauthorizationnumb>19810</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ABDOMINAL PAIN UPPER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060508</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060601</drugenddate>
        <drugtreatmentduration>25</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047281-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060627</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>NSADSS2001019365</companynumb>
    <primarysource>
      <reportercountry>ISRAEL</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>31</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PNEUMONITIS</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>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047282-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060627</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>NSADSS2001019368</companynumb>
    <primarysource>
      <reportercountry>ISRAEL</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>44</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HYPOTHYROIDISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>FISTULA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>CROHN'S DISEASE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047283-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20060700394</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DISEASE RECURRENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TUBERCULOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugdosagetext>RECEIVED TWO DOSES</drugdosagetext>
        <drugindication>PSORIASIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047284-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20060700595</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BREAST CANCER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugdosagetext>RECEIVED 3 TREATMENTS(5 MG/KG)</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugdosagetext>RECEIVED 3 TREATMENTS(5 MG/KG)</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugindication>PSORIASIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047285-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-JNJFOC-20030701842</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>57</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CD4 LYMPHOCYTES DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CD4/CD8 RATIO DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CYTOMEGALOVIRUS CHORIORETINITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAMMA-GLUTAMYLTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPHOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RETINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VITREOUS OPACITIES</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>SPONDYLOARTHROPATHY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOPHOSPHAMIDE</medicinalproduct>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugtreatmentduration>12</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AZATHIOPRINE</medicinalproduct>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugtreatmentduration>12</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047286-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060615</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>226713</companynumb>
    <primarysource>
      <reportercountry>SPAIN</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>60</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CACHEXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERCATABOLISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ILEUS PARALYTIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVASTIN</medicinalproduct>
        <drugdosagetext>INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060420</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060420</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ELOXATIN</medicinalproduct>
        <drugdosagetext>INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060419</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060420</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUOROURACIL</medicinalproduct>
        <drugdosagetext>INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060419</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060420</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BUSCAPINA (SCOPOLAMINE BUTYLBROMIDE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OCTREOTIDE ACETATE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047287-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060613</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>225628</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>70</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD CREATINE PHOSPHOKINASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRONCHITIS BACTERIAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BUNDLE BRANCH BLOCK RIGHT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY STENOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EJECTION FRACTION DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ELECTROCARDIOGRAM REPOLARISATION ABNORMALITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ELECTROCARDIOGRAM ST SEGMENT DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOPHILUS INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSIVE HEART DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MORAXELLA INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLEURAL EFFUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY CONGESTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUS TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPUTUM CULTURE POSITIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STREPTOCOCCAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRACHEOBRONCHITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TROPONIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENTRICULAR HYPERTROPHY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVASTIN</medicinalproduct>
        <drugdosagetext>502 MG, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RECTAL CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060119</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CAPECITABINE (CAPECITABINE)</medicinalproduct>
        <drugdosagetext>3000 MG, QD, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RECTAL CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060119</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RAMIPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BISOPROLOL FUMARATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LERCANIDIPINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XIPAMID (XIPAMIDE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANTOPRAZOLE SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNSPECIFIED DRUG (GENERIC COMPONENT(S))</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BIPHASIC INSULIN (INSULIN, INSULIN SUSPENSION), ISOPHANE, INSULIN ZINC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENALAPRIL MALEATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLIMEPIRIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUTICASONE (FLUTICASONE PROPIONATE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SALMETEROL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BERLINSULIN H (INSULIN HUMAN, NPH HUMAN INSULIN ISOPHANE SUSPENSION)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047288-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060621</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>12437034</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ECZEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATITIS FULMINANT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SERZONE</medicinalproduct>
        <drugauthorizationnumb>20152</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047289-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060621</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2005-01081</companynumb>
    <primarysource>
      <reportercountry>SPAIN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>72</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>57</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ABDOMINAL DISTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AGITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACTERIA URINE IDENTIFIED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD BICARBONATE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CALCIUM DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PH INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PHOSPHORUS DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD POTASSIUM INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD UREA INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BREATH SOUNDS ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRONCHIAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CANDIDIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST X-RAY ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONTUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CREPITATIONS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEMYELINATING POLYNEUROPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISORIENTATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA AT REST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ESCHERICHIA INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLATULENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FOOD INTOLERANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL HYPOMOTILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERAL PHYSICAL CONDITION ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERAL PHYSICAL HEALTH DETERIORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART SOUNDS ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOREFLEXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERSTITIAL LUNG DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEUKOCYTURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUCOUS STOOLS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE ATROPHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULAR WEAKNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NERVOUS SYSTEM DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUROPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUROPATHY PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OXYGEN SATURATION DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PCO2 DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PO2 DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POLYNEUROPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RALES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUPERINFECTION LUNG</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VELCADE</medicinalproduct>
        <drugauthorizationnumb>21602</drugauthorizationnumb>
        <drugdosagetext>2.00 MG, 2/WEEK, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041221</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050415</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MELPHALAN (MELPHALAN) VIAL</medicinalproduct>
        <drugdosagetext>14.00 MG</drugdosagetext>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050405</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050408</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISONE (PREDNISONE) VIAL</medicinalproduct>
        <drugdosagetext>90.00 MG</drugdosagetext>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050405</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050408</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FENTANYL TRANSDERMAL SYSTEM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOFLOXACIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRETERAX (INDAPAMIDE, PERINDOPRIL ERBUMINE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VORICONAZOLE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047290-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060621</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004-00841</companynumb>
    <primarysource>
      <reportercountry>SPAIN</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>76</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>60</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ACUTE RESPIRATORY DISTRESS SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CREATINE PHOSPHOKINASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CREATINE PHOSPHOKINASE MB INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD SODIUM DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATOCRIT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTI-ORGAN FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPTIC SHOCK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUPRAVENTRICULAR TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THERAPY NON-RESPONDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENTRICULAR FIBRILLATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VELCADE</medicinalproduct>
        <drugbatchnumb>LYB010A2</drugbatchnumb>
        <drugauthorizationnumb>21602</drugauthorizationnumb>
        <drugdosagetext>2.06 MG, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041108</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041118</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISONE (PREDNISONE) VIAL</medicinalproduct>
        <drugdosagetext>95.00 MG, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041108</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041111</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MELPHALAN (MELPHALAN) VIAL</medicinalproduct>
        <drugdosagetext>14.00 MG, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041108</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041111</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM (CALCIUM)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047291-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060622</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006-01584</companynumb>
    <primarysource>
      <reportercountry>NEW ZEALAND</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>40</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DISEASE PROGRESSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VELCADE</medicinalproduct>
        <drugauthorizationnumb>21602</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047292-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2005SE04284</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>28622</patientonsetage>
      <patientonsetageunit>804</patientonsetageunit>
      <patientweight>74</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DECREASED APPETITE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOPHILUS INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERSTITIAL LUNG DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA BACTERIAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BLOPRESS TABLETS 4</medicinalproduct>
        <drugauthorizationnumb>20838</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000530</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040930</drugenddate>
        <drugtreatmentduration>1585</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BLOPRESS TABLETS 4</medicinalproduct>
        <drugauthorizationnumb>020838</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BASEN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS NON-INSULIN-DEPENDENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000728</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040930</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARDENALIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000205</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMARYL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS NON-INSULIN-DEPENDENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000530</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047293-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060524</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006AP02346</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>66</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>COMPLETED SUICIDE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DROWNING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG LEVEL ABOVE THERAPEUTIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TENORMIN</medicinalproduct>
        <drugauthorizationnumb>18240</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SUICIDE ATTEMPT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060521</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060521</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
        <drugdosagetext>15 TABLETS</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SUICIDE ATTEMPT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060521</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060521</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CALBLOCK</medicinalproduct>
        <drugdosagetext>15 TABLETS</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SUICIDE ATTEMPT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060521</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060521</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047294-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060524</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006AP02343</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>62</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCORRECT DOSE ADMINISTERED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDE ATTEMPT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TENORMIN</medicinalproduct>
        <drugauthorizationnumb>18240</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SUICIDE ATTEMPT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060521</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060521</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SUICIDE ATTEMPT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060521</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060521</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CALBLOCK</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SUICIDE ATTEMPT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060521</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060521</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047295-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006PK01460</companynumb>
    <primarysource>
      <reportercountry>SWITZERLAND</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>35</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>79</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATOCELLULAR DAMAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JAUNDICE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugauthorizationnumb>020639</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050503</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060524</drugenddate>
        <drugtreatmentduration>387</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXJADE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>IRON METABOLISM DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060405</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060524</drugenddate>
        <drugtreatmentduration>50</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ESCITALOPRAM OXALATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060524</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047296-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060622</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DEU-2006-0002129</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>75</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>90.2</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HUMERUS FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMMOBILE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXY CR TAB 20 MG (OXYCODONE HYDROCHLORIDE) PROLONGED-RELEASE TABLET</medicinalproduct>
        <drugauthorizationnumb>20553</drugauthorizationnumb>
        <drugdosagetext>40 MG, DAILY, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BACK PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060327</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060405</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GABAPENTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MOVICOL (SODIUM CHLORIDE, SODIUM BICARBONATE, POTASSIUM CHLORIDE, MACR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACTONEL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COLECALCIFEROL (COLECALCIFEROL)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLYBURIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORATADINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047297-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060620</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DEU-2006-0002278</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>48</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>122</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENTAL DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXY CR TAB 10 MG (OXY CR TAB 10 MG) (OXYCODONE HYDROCHLORIDE) PROLONGE</medicinalproduct>
        <drugauthorizationnumb>20553</drugauthorizationnumb>
        <drugdosagetext>10 MG, BID, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051102</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051104</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAMADOL OR PROLONGED-RELEASE TABLET</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMITRIPTYLINE (AMITRIPTYLINE)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047298-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060620</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DEU-2006-0002279</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>50</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>56</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXYGESIC 5 MG (OXY CR TAB 5 MG) (OXYCODONE HYDROCHLORIDE)PROLONGED-REL</medicinalproduct>
        <drugauthorizationnumb>20553</drugauthorizationnumb>
        <drugdosagetext>5 MG, Q12H, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BACK PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060410</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060427</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTIDEPRESSANTS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANALGESICS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIPYRONE TAB</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047299-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060623</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006-01153</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>59</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>65.5</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>LEUKOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URETHRAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VELCADE</medicinalproduct>
        <drugauthorizationnumb>21602</drugauthorizationnumb>
        <drugdosagetext>2.40 MG INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060425</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060505</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOPHOSPHAMIDE</medicinalproduct>
        <drugdosagetext>2800.00 MG, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060425</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060505</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATORVASTATIN CALCIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RAMIPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM (POTASSIUM)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RANITIDIN (RANITIDINE HYDROCHLORIDE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALERIAN ROOT (VALERIANA OFFICINALIS ROOT)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENZBROMARONE (BENZBROMARONE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ESIDRIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENOXAPARIN SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANTOPRAZOLE SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TEMAZEPAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FENTANYL (FENTANYL CITRATE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NIFEDIPINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LACTULOSE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047302-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060623</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006-01545</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>38</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <reaction>
        <reactionmeddrapt>PERONEAL NERVE PALSY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VELCADE</medicinalproduct>
        <drugauthorizationnumb>21602</drugauthorizationnumb>
        <drugdosagetext>INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOXORUBICIN HCL</medicinalproduct>
        <drugindication>MULTIPLE MYELOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
        <drugindication>MULTIPLE MYELOMA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047304-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20060700258</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>89.81</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HERPES ZOSTER OPHTHALMIC</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>ATENOLOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOXYL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZESTRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZETIA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMBIEN</medicinalproduct>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM GLUCONATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WELLBUTRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047305-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060703</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>SE-JNJFOC-20060601940</companynumb>
    <primarysource>
      <reportercountry>SWEDEN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HYPERCAPNIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugdosagetext>THREE INFUSIONS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLITIS ULCERATIVE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047306-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20030919</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2003AP03335</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>871</patientonsetage>
      <patientonsetageunit>802</patientonsetageunit>
      <patientweight>50</patientweight>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ACUTE MYELOID LEUKAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE MARROW FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYELODYSPLASTIC SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA BACTERIAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUBDURAL HAEMATOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NOLVADEX</medicinalproduct>
        <drugauthorizationnumb>17970</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19981216</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030901</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAKEPRON</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030901</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ADALAT</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030901</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CEROCRAL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030901</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MYSLEE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEPAS</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SALIVEHT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RADIOTHERAPY</medicinalproduct>
        <drugdosagetext>50 GY</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990104</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19990208</drugenddate>
        <drugtreatmentduration>36</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047307-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060704</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006AP03043</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>34</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ACUTE RESPIRATORY FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SHOCK</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugauthorizationnumb>20639</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LODOPIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BROMAZEPAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUNITRAZEPAM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047308-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006AP03050</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <patientonsetage>68</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CHOKING SENSATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALLOR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARYNGEAL OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHEEZING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XYLOCAINE</medicinalproduct>
        <drugauthorizationnumb>8816</drugauthorizationnumb>
        <drugadministrationroute>045</drugadministrationroute>
        <drugindication>ANAESTHESIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060628</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060628</drugenddate>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRIVINA</medicinalproduct>
        <drugadministrationroute>045</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060628</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060628</drugenddate>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XYLOCAINE</medicinalproduct>
        <drugadministrationroute>045</drugadministrationroute>
        <drugindication>ANAESTHESIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060628</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060628</drugenddate>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XYLOCAINE</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060628</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060628</drugenddate>
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    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047309-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006AP02956</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>80</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HYPOCALCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOMAGNESAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOPARATHYROIDISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TETANY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LOSEC</medicinalproduct>
        <drugauthorizationnumb>019810</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTROOESOPHAGEAL REFLUX DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TELMISARTAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM SUPPLEMENTS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047310-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006GB01113</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>76</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEDICATION ERROR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WRONG DRUG ADMINISTERED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOLADEX</medicinalproduct>
        <drugauthorizationnumb>020578</drugauthorizationnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060621</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047311-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006SE03691</companynumb>
    <primarysource>
      <reportercountry>SOUTH AFRICA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>70</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DIPLOPIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NAROPIN</medicinalproduct>
        <drugauthorizationnumb>020533</drugauthorizationnumb>
        <drugadministrationroute>053</drugadministrationroute>
        <drugindication>NERVE BLOCK</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047312-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060623</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006SE03573</companynumb>
    <primarysource>
      <reportercountry>CROATIA (local name: Hrvatska)</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>15697</patientonsetage>
      <patientonsetageunit>804</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MANIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugauthorizationnumb>20639</drugauthorizationnumb>
        <drugdosagetext>TITRATION TO 300 MG DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BIPOLAR I DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060404</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060406</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugauthorizationnumb>020639</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060407</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060526</drugenddate>
        <drugtreatmentduration>50</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SORTIS</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERLIPIDAEMIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047313-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060703</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006SE03768</companynumb>
    <primarysource>
      <reportercountry>SWEDEN</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>30114</patientonsetage>
      <patientonsetageunit>804</patientonsetageunit>
      <patientweight>108</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BRADYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METOPROLOL SUCCINATE</medicinalproduct>
        <drugauthorizationnumb>019962</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060626</drugenddate>
        <drugtreatmentduration>10</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>METOPROLOL SUCCINATE</medicinalproduct>
        <drugauthorizationnumb>019962</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CARDIAC FAILURE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060626</drugenddate>
        <drugtreatmentduration>10</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>DIGOXIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CARDIAC FAILURE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060626</drugenddate>
        <drugtreatmentduration>10</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENALAPRIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060626</drugenddate>
        <drugtreatmentduration>10</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENALAPRIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060703</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARAN</medicinalproduct>
        <drugdosagetext>2.5 TO 5 MG/ DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CARDIAC FAILURE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060626</drugenddate>
        <drugtreatmentduration>10</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRONOLAKTON</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIURETIC THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060626</drugenddate>
        <drugtreatmentduration>10</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIURETIC THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060626</drugenddate>
        <drugtreatmentduration>10</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060703</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047315-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060619</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>9039997-2006-00043</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>URINARY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMINOLEVULINIC ACID - POWDER</medicinalproduct>
        <drugauthorizationnumb>20965</drugauthorizationnumb>
        <drugdosagetext>6%, 8%, OR 10%, ONCE, INSTI</drugdosagetext>
        <drugindication>BLADDER CANCER</drugindication>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>805</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047318-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060619</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>9039997-2006-00044</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>5-AMINOLEVULINIC ACID</medicinalproduct>
        <drugauthorizationnumb>20965</drugauthorizationnumb>
        <drugdosagetext>20MG/KG, ONCE, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MALIGNANT GLIOMA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047320-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060621</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>226555</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>68</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>63.9</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ATELECTASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD BILIRUBIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CALCIUM DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CREATINE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD SODIUM DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRONCHIAL OBSTRUCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOPTYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEDIASTINAL MASS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEOPLASM PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVASTIN</medicinalproduct>
        <drugbatchnumb>M58984</drugbatchnumb>
        <drugdosagetext>1009 MG, Q3W, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ELOXATIN</medicinalproduct>
        <drugbatchnumb>0580936</drugbatchnumb>
        <drugdosagetext>197 MG, Q3W, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALIMTA</medicinalproduct>
        <drugbatchnumb>ET000767</drugbatchnumb>
        <drugdosagetext>820 MG, Q3W, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVAPRO</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROTONIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRAVACHOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL INHALER (ALBUTEROL/ALBUTEROL SULFATE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NITROGLYCERIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XALATAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SONATA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYANOCOBALAMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047322-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060619</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>9039997-2006-00045</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>5-AMINOLEVULINIC ACID</medicinalproduct>
        <drugauthorizationnumb>20965</drugauthorizationnumb>
        <drugdosagetext>20 MG/KG, ONCE, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MALIGNANT GLIOMA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047324-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060619</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>9039997-2006-00046</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>5-AMINOLEVULINIC ACID</medicinalproduct>
        <drugauthorizationnumb>20965</drugauthorizationnumb>
        <drugdosagetext>20 MG/KG, ONCE, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MALIGNANT GLIOMA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047325-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060623</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CIP06001457</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>69</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>LIMB CRUSHING INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOWER LIMB FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ROAD TRAFFIC ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THERAPY NON-RESPONDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACTONEL</medicinalproduct>
        <drugauthorizationnumb>20835</drugauthorizationnumb>
        <drugdosagetext>ONCE WEEKLY, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050305</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN E</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SELENIUM (SELENIUM)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOSAMINE W/CHONDROITIN (GLUCOSAMINE, CHONDROITIN SULFATE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTIVIT (VITAMINS NOS)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047328-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060622</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006BI009073</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>27</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugbatchnumb>P01081</drugbatchnumb>
        <drugdosagetext>30 UG; QW; IM</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990701</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047330-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060622</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-2006-016823</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>30</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>70</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEPHROLITHIASIS</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>20060401</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047332-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060621</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006BI009081</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugdosagetext>IM</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047333-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-2006-017285</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>2</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>YASMIN</medicinalproduct>
        <drugauthorizationnumb>21098</drugauthorizationnumb>
        <drugindication>CONTRACEPTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047335-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060623</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006BI009107</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugdosagetext>IM</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047337-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060623</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006BI009153</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>47</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>VISION BLURRED</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>STEROIDS (NOS)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047339-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060619</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>9039997-2006-00048</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>0</patientsex>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>5-AMINOLEVULINIC ACID</medicinalproduct>
        <drugauthorizationnumb>20965</drugauthorizationnumb>
        <drugdosagetext>20 MG/KG, ONCE, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MALIGNANT GLIOMA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047341-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060626</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006BI009215</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>54</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INTERVERTEBRAL DISC DEGENERATION</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>19990701</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>5047343-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060626</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006-01388</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>66</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRONCHIOLITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORTHOSTATIC HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VELCADE</medicinalproduct>
        <drugauthorizationnumb>21602</drugauthorizationnumb>
        <drugdosagetext>1.40 MG/M2</drugdosagetext>
        <drugindication>MULTIPLE MYELOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047344-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060619</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006BI009222</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>58</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <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>20020426</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047345-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060623</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-2006-016952</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>23</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>VARICOSE VEIN OPERATION</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>20050401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060613</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047347-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060620</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GXKR2006TW02022</companynumb>
    <primarysource>
      <reportercountry>TAIWAN, PROVINCE OF CHINA</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>67</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE DIASTOLIC DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC MURMUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LONG QT SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE RIGIDITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULSE ABSENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY RATE INCREASED</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>VENTRICULAR TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HYDROXYCHLOROQUINE SULFATE</medicinalproduct>
        <drugauthorizationnumb>40104</drugauthorizationnumb>
        <drugdosagetext>200 MG, QD</drugdosagetext>
        <drugindication>SYSTEMIC LUPUS ERYTHEMATOSUS</drugindication>
        <drugtreatmentduration>365</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THEOPHYLLINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047348-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060621</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GXKR2006AR03529</companynumb>
    <primarysource>
      <reportercountry>ARGENTINA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>66</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BINOCULAR EYE MOVEMENT DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEROTONIN SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRISMUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRIFLUOPERAZINE HCL</medicinalproduct>
        <drugauthorizationnumb>40153</drugauthorizationnumb>
        <drugdosagetext>20 MG</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LORAZEPAM</medicinalproduct>
        <drugdosagetext>10 MG</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUOXETINE</medicinalproduct>
        <drugdosagetext>60 MG</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRANYLCYPROMINE SULFATE</medicinalproduct>
        <drugdosagetext>100 MG</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMIFENTANIL(REMIFENTANIL)</medicinalproduct>
        <drugdosagetext>5.7 A, AUG, X KG, X H, INFUSION</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047349-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060620</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ABILP-06-0256</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>62</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>65.9</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FACIAL PALSY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ABRAXANE</medicinalproduct>
        <drugauthorizationnumb>21660</drugauthorizationnumb>
        <drugdosagetext>430 MG DAY/EVERY 3 WEEKS/18 DOSES (EVERY 3 WEEKS), INTRAVENOUS DRIP</drugdosagetext>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050602</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EFFEXOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BEXTRA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMBIEN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047350-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060623</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>226655</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>80</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>69.8</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HERCEPTIN</medicinalproduct>
        <drugdosagetext>140 MG/KG, 1/WEEK, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BREAST CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040205</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047351-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060619</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GXKR2006ES03455</companynumb>
    <primarysource>
      <reportercountry>SPAIN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>81</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABNORMAL BEHAVIOUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANOREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CATATONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DELUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIET REFUSAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MAJOR DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUTISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POSTURE ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>REFUSAL OF TREATMENT BY PATIENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPEECH DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AZITHROMYCIN</medicinalproduct>
        <drugauthorizationnumb>65209</drugauthorizationnumb>
        <drugdosagetext>500 MG, QD</drugdosagetext>
        <drugindication>TRACHEOBRONCHITIS</drugindication>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMOXICILLIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047355-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060620</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GXKR2006ES03503</companynumb>
    <primarysource>
      <reportercountry>SPAIN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>63</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ACHOLIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD ALBUMIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHOLESTASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC STEATOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROTHROMBIN TIME PROLONGED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH PRURITIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMOXICILLIN-CLAVULANIC ACID (NGX) (AMOXICILLI, CLAVULANTE)</medicinalproduct>
        <drugauthorizationnumb>65063</drugauthorizationnumb>
        <drugdosagetext>500 MG, TID</drugdosagetext>
        <drugindication>UPPER RESPIRATORY TRACT INFECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOXAZOSIN (DOXAZOSIN)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHYLPREDNISOLONE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047356-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060626</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2002-03-1008</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>46</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>74.3899</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DIALYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POLYTRAUMATISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDE ATTEMPT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEG-INTRON</medicinalproduct>
        <drugdosagetext>96 MCG QWK SUBCUTANEOUS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20011123</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020208</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>20011123</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020215</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
        <drugdosagetext>100 MG QD ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047358-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060626</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-2006-016860</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ALANINE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASPARTATE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAMMA-GLUTAMYLTRANSFERASE INCREASED</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>19990101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOMPERIDONE (DOMPERIDONE)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047359-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060627</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006-06-1038</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>58</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>77.1115</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>IMPAIRED HEALING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN ULCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WOUND COMPLICATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEG-INTRON</medicinalproduct>
        <drugdosagetext>120 MCQ QWK SUBCUTANEOUS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060310</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RIBASPHERE</medicinalproduct>
        <drugdosagetext>1000 MG QD ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060310</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SULFATRIM DS TABLETS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZIAC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMITRIPTYLINE HCL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047360-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060630</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHRM2006FR02000</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>16</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG ABUSER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCORRECT ROUTE OF DRUG ADMINISTRATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RITALIN</medicinalproduct>
        <drugauthorizationnumb>021284</drugauthorizationnumb>
        <drugdosagetext>90 MG/DAY PRESCRIBED</drugdosagetext>
        <drugindication>DRUG DETOXIFICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047361-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060609</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2006NO08688</companynumb>
    <primarysource>
      <reportercountry>NORWAY</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>17</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>AKATHISIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ALANINE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>APHASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASPARTATE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ATRIAL THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBRAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONGESTIVE CARDIOMYOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CYANOSIS CENTRAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EJECTION FRACTION DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FIBRIN D DIMER INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEMIPLEGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC CONGESTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC NECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATOMEGALY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLUENZA LIKE ILLNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERNATIONAL NORMALISED RATIO INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEUKOCYTOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MITRAL VALVE INCOMPETENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPHIL COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORTHOPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OXYGEN SATURATION DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POOR PERIPHERAL CIRCULATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULSE ABSENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUS TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN DISCOLOURATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENTRICULAR HYPOKINESIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHYLPHENIDATE HCL</medicinalproduct>
        <drugauthorizationnumb>10187</drugauthorizationnumb>
        <drugdosagetext>15 MG, TID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATTENTION DEFICIT/HYPERACTIVITY DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047362-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060424</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2006JP06261</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>85</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>60</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>AGGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLISTER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRAIN NATRIURETIC PEPTIDE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SECRETION DISCHARGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN ULCER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RITALIN</medicinalproduct>
        <drugauthorizationnumb>10187</drugauthorizationnumb>
        <drugdosagetext>10 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEMENTIA ALZHEIMER'S TYPE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060413</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060425</drugenddate>
        <drugtreatmentduration>18720</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GANATON</medicinalproduct>
        <drugdosagetext>50 MG/D</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060412</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060425</drugenddate>
        <drugtreatmentduration>20160</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XANBON</medicinalproduct>
        <drugdosagetext>80 MG/D</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CEREBRAL INFARCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060412</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060425</drugenddate>
        <drugtreatmentduration>20160</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XANBON</medicinalproduct>
        <drugdosagetext>160 MG/D</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060416</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060424</drugenddate>
        <drugtreatmentduration>12960</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DESYREL</medicinalproduct>
        <drugdosagetext>25 MG/D</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INSOMNIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060412</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DESYREL</medicinalproduct>
        <drugdosagetext>50 MG/D</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MYSLEE</medicinalproduct>
        <drugdosagetext>5 MG/D</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INSOMNIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060412</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PHYSIOSOL 3</medicinalproduct>
        <drugdosagetext>1000 ML/D</drugdosagetext>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>EATING DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060412</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060424</drugenddate>
        <drugtreatmentduration>18720</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PURSENNID</medicinalproduct>
        <drugdosagetext>24 MG/D</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONSTIPATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060414</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047363-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060623</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-2006-016554</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>61</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>62</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CSF TEST ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DELIRIUM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROCEDURAL COMPLICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WRONG TECHNIQUE IN DRUG USAGE PROCESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MAGNEVIST</medicinalproduct>
        <drugauthorizationnumb>19596</drugauthorizationnumb>
        <drugdosagetext>1 DOSE, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NUCLEAR MAGNETIC RESONANCE IMAGING</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060405</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060405</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047364-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060623</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006-06-0361</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>59</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>96.6162</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE FLUCTUATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPINAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ULNAR NERVE INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEG-INTRON</medicinalproduct>
        <drugdosagetext>SUBCUTANEOUS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050710</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RIBAVIRIN</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050710</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060531</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOTREL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMINS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NASONEX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYLENOL TABLETS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047365-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060623</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>TH-2006-016400</companynumb>
    <primarysource>
      <reportercountry>THAILAND</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>64</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANAPHYLACTIC SHOCK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NO REACTION ON PREVIOUS EXPOSURE TO DRUG</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULSE ABSENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY ARREST</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ULTRAVIST 300</medicinalproduct>
        <drugbatchnumb>54023</drugbatchnumb>
        <drugauthorizationnumb>20220</drugauthorizationnumb>
        <drugdosagetext>100 ML, 1 DOSE, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COMPUTERISED TOMOGRAM ABDOMEN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060607</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060607</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047366-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060626</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006-06-1247</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>50</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLISTER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HOT FLUSH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE ANAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAROSMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH ERYTHEMATOUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH PRURITIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN EXFOLIATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VARICOSE VEIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VEIN PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEG-INTRON</medicinalproduct>
        <drugdosagetext>180 MCG QWK</drugdosagetext>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050815</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060527</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RIBAVIRIN</medicinalproduct>
        <drugdosagetext>400 MG QD ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050815</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060527</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATIVAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROCHLORPERAZINE MALEATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047367-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060619</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-2006-013923</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>42</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>AUTOIMMUNE THYROIDITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HUMAN HERPES VIRUS 6 SEROLOGY POSITIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCYTOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URTICARIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CAMPATH</medicinalproduct>
        <drugdosagetext>3/10/30 MG/D, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CHRONIC LYMPHOCYTIC LEUKAEMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYCLOPHOSPHAMIDE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047368-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060621</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FABR-11562</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>35</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>75</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>TENDON RUPTURE</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>20031001</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047369-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060620</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>HU-2006-013383</companynumb>
    <primarysource>
      <reportercountry>HUNGARY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>71</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ANAPHYLACTIC SHOCK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANEURYSM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ATELECTASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRONCHIOLITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRONCHITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIOPULMONARY FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CIRCULATORY COLLAPSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONTRAST MEDIA REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CYANOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTESTINAL ISCHAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEDICAL DEVICE COMPLICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MELAENA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL ISCHAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRACHEOBRONCHITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TYPE IV HYPERSENSITIVITY REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENTRICULAR HYPERTROPHY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ULTRAVIST 370</medicinalproduct>
        <drugbatchnumb>61516B</drugbatchnumb>
        <drugauthorizationnumb>21425</drugauthorizationnumb>
        <drugdosagetext>50 ML, 1 DOSE, X 10, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COMPUTERISED TOMOGRAM ABDOMEN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060516</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060516</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047371-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060619</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-2006-016311</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>29</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CEREBRAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROCEDURAL COMPLICATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ULTRAVIST 300</medicinalproduct>
        <drugauthorizationnumb>20220</drugauthorizationnumb>
        <drugdosagetext>INTRA-ARTERIAL</drugdosagetext>
        <drugadministrationroute>013</drugadministrationroute>
        <drugindication>ANGIOGRAM</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047373-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060620</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006RR-02717</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>45</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG RESISTANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENTAL STATUS CHANGES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTI-ORGAN FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUCONAZOLE</medicinalproduct>
        <drugauthorizationnumb>76386</drugauthorizationnumb>
        <drugdosagetext>800 MG, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>LIVER ABSCESS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VANCOMYCIN HYDROCHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GATIFLOXACIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047374-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060710</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>55.3388</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URTICARIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GAMMAGARD LIQUID</medicinalproduct>
        <drugbatchnumb>LE12E026AA</drugbatchnumb>
        <drugdosagetext>20 GM 4 DAYS MONTHLY IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060702</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060705</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GAMMAGARD LIQUID</medicinalproduct>
        <drugbatchnumb>LE12E042AC</drugbatchnumb>
        <drugdosagetext>7.5  MG 4 DAY MONTHLY IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060702</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060705</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047376-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2006JP09730</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>20</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MALIGNANT NEOPLASM PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THIRST</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SANDOSTATIN</medicinalproduct>
        <drugauthorizationnumb>19667</drugauthorizationnumb>
        <drugdosagetext>120 UG/D</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>INTESTINAL OBSTRUCTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOCLOPRAMIDE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047377-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060619</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006078389</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>46</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>57.2</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CEREBRAL HAEMATOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBRAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TUMOUR HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUTENT</medicinalproduct>
        <drugauthorizationnumb>21968</drugauthorizationnumb>
        <drugdosagetext>50 MG (50 MG, 1 IN 1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>METASTATIC RENAL CELL CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060412</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060613</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047378-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060710</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>13</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>78.8</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>INFUSION RELATED REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NO THERAPEUTIC RESPONSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OXYGEN SATURATION DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROCEDURAL COMPLICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROCEDURAL HYPOTENSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ANTI-THYMOCYTE GLOBULIN-RABBIT 25 MG SANGSTAT</medicinalproduct>
        <drugbatchnumb>TH111-01</drugbatchnumb>
        <drugdosagetext>100 MG ONE DOSE IV DRIP</drugdosagetext>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>OBESITY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060613</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060613</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ANTI-THYMOCYTE GLOBULIN-RABBIT 25 MG SANGSTAT</medicinalproduct>
        <drugbatchnumb>TH111-01</drugbatchnumb>
        <drugdosagetext>100 MG ONE DOSE IV DRIP</drugdosagetext>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>RENAL TRANSPLANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060613</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060613</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047379-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060620</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006078399</companynumb>
    <primarysource>
      <reportercountry>ITALY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>64</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>79</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERCREATININAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPONATRAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUTENT</medicinalproduct>
        <drugauthorizationnumb>21968</drugauthorizationnumb>
        <drugdosagetext>50 MG (50 MG, 1 IN 1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RENAL CELL CARCINOMA STAGE UNSPECIFIED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060602</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060618</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047380-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-2005-024040</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BREAST CANCER FEMALE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIRENA</medicinalproduct>
        <drugbatchnumb>33530C</drugbatchnumb>
        <drugauthorizationnumb>21225</drugauthorizationnumb>
        <drugdosagetext>20 UG/DAY, CONT, INTRA-UTERINE</drugdosagetext>
        <drugadministrationroute>015</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040816</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051020</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047381-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060621</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006078638</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>44</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANOREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>APHASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EMOTIONAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GEODON</medicinalproduct>
        <drugauthorizationnumb>20825</drugauthorizationnumb>
        <drugdosagetext>80 MG (80 MG, 1X/DAY:  EVERYDAY), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MENTAL DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060501</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUOXETINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047382-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060623</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006072596</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>62</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>AGGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOOD ALTERED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TINNITUS</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>HYPERCHOLESTEROLAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060625</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047383-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060619</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006075455</companynumb>
    <primarysource>
      <reportercountry>SPAIN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INCORRECT DOSE ADMINISTERED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZELDOX (CAPSULES)  (ZIPRASIDONE)</medicinalproduct>
        <drugauthorizationnumb>20825</drugauthorizationnumb>
        <drugdosagetext>120 MG (60 MG, 2 IN 1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>AFFECT LABILITY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLORAZEPATE DIPOTASSIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEPAKENE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047385-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060621</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-2006-016440</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>31</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>COLITIS</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>INJECTION SITE SWELLING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BETASERON</medicinalproduct>
        <drugdosagetext>2 MIU, EVERY 2D, SUBCUTANEOUS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RELAPSING-REMITTING MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020607</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047387-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060620</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006076268</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>46</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYVOX</medicinalproduct>
        <drugauthorizationnumb>21131</drugauthorizationnumb>
        <drugdosagetext>1200 MG, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060524</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060526</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047389-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060621</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006077310</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>57</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD BILIRUBIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE SYSTOLIC INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOKALAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREATMENT NONCOMPLIANCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugauthorizationnumb>20702</drugauthorizationnumb>
        <drugdosagetext>10 MG, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060604</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>JUVELA (TOCOPHEROL)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTIHYPERTENSIVES (ANTIHYPERTENSIVES)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047390-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060615</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-2006-015677</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>23</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CONTUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONTROL OF LEGS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ROAD TRAFFIC ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BETASERON</medicinalproduct>
        <drugbatchnumb>VA7952A</drugbatchnumb>
        <drugdosagetext>6 MIU, EVERY 2D, SUBCUTANEOUS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RELAPSING-REMITTING MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060511</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047391-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060619</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006077368</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
    </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>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JOINT STIFFNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEUKOCYTOCLASTIC VASCULITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEURITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RADICULITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
        <drugauthorizationnumb>20235</drugauthorizationnumb>
        <drugdosagetext>300 MG (FREQUENCY:  ONCE), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NEURALGIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060126</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060126</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
        <drugdosagetext>100 MG (FREQUENCY:  QD), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ESSENTIAL HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060121</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EUTHYRAL (LEVOTHYROXINE SODIUM, LIOTHYRONINE SODIUM)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EFFEXOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LERCANIDIPINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047393-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060615</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-2006-010982</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>56</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>78</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ATRIAL FIBRILLATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ATRIAL FLUTTER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN 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>20050308</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIGOXIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RYTHMOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZYRTEC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ESTRATEST H.S.</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CITRICAL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047394-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060620</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006077439</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>57</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>56</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUTENT</medicinalproduct>
        <drugauthorizationnumb>21938</drugauthorizationnumb>
        <drugdosagetext>(37.5 MG, ONCE DAILY INTERVAL:  DURING 28 DAYS), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060614</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060618</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MODURETIC 5-50</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047395-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060609</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006001214</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>66</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TARCEVA</medicinalproduct>
        <drugauthorizationnumb>21743</drugauthorizationnumb>
        <drugdosagetext>150 MG (QD), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047396-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060619</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-2006-002403</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>62</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>91</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HIP FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCISION SITE INFECTION</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>20030220</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047398-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060620</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006001255</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>60</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PURPURA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TARCEVA</medicinalproduct>
        <drugauthorizationnumb>21743</drugauthorizationnumb>
        <drugdosagetext>150 MG (QD), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>LUNG NEOPLASM MALIGNANT</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047400-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060620</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-2006-007359</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>64</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>59</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>LIVER FUNCTION TEST ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG CANCER METASTATIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METASTASES TO BONE</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>20040901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TARCEVA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CORTICOSTEROIDS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047401-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060622</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006001280</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD AMYLASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIPASE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TARCEVA</medicinalproduct>
        <drugauthorizationnumb>21743</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060315</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047402-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060618</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-2006-012712</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>54</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSGEUSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEPHROLITHIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BETASERON</medicinalproduct>
        <drugdosagetext> SEE IMAGE</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060515</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060601</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BETASERON</medicinalproduct>
        <drugdosagetext> SEE IMAGE</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060601</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047403-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060620</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006079469</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>26</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRY MOUTH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SENSITIVITY OF TEETH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LISTERINE (MENTHOL, METHYL SALICYLATE, EUCALYPTOL, THYMOL)</medicinalproduct>
        <drugdosagetext>UNSPECIFIED AMOUNT 4 TIMES</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047404-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060630</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20060700384</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047405-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060630</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AR-JNJFOC-20060602970</companynumb>
    <primarysource>
      <reportercountry>ARGENTINA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>7</patientonsetage>
      <patientonsetageunit>800</patientonsetageunit>
      <patientweight>70</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENINGITIS TUBERCULOUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047406-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060615</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>033-14</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>76</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TEVETEN HCT</medicinalproduct>
        <drugauthorizationnumb>21268</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060524</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETYLSALICYLIC ACID SRT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALTACE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATIVAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BISOPROLOL FUMARATE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047407-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060621</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006078778</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>52.1637</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG ABUSER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLATULENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCONTINENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
        <drugauthorizationnumb>19839</drugauthorizationnumb>
        <drugdosagetext>50 MG (50 MG, 1 IN 1 D)</drugdosagetext>
        <drugindication>HOT FLUSH</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERDAL</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MOTRIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047408-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060710</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>59</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>102.3</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEEP VEIN THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE BRUISING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERNATIONAL NORMALISED RATIO ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENISCUS LESION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LOVENOX</medicinalproduct>
        <drugdosagetext>100 MG BID SQ</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>DEEP VEIN THROMBOSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051215</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051221</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047409-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060621</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>25179</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>44</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DIABETES MELLITUS NON-INSULIN-DEPENDENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NICOTINIC ACID</medicinalproduct>
        <drugauthorizationnumb>20381</drugauthorizationnumb>
        <drugdosagetext>6 G QD PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DYSLIPIDAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19971101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19980701</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATORVASTATIN CALCIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FENOFIBRATE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047410-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060710</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>65.7716</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugdosagetext>5000 UNITS 2 WEEKS CUTANEOUS</drugdosagetext>
        <drugadministrationroute>003</drugadministrationroute>
        <drugindication>ANAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060707</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047412-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060623</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>6023628F</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>65</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</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>20060501</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATORVASTATIN CALCIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETYLSALICYLIC ACID SRT</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047416-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060622</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006-01064</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>63</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>78</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROENTERITIS VIRAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HERPES ZOSTER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEUKOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VELCADE</medicinalproduct>
        <drugbatchnumb>YB005A1</drugbatchnumb>
        <drugauthorizationnumb>21602</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>LYMPHOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060328</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060501</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VELCADE</medicinalproduct>
        <drugbatchnumb>YB005A1</drugbatchnumb>
        <drugauthorizationnumb>21602</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>LYMPHOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060519</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VICODIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALTREX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047417-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060630</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHNU2006SI02419</companynumb>
    <primarysource>
      <reportercountry>SLOVENIA</reportercountry>
      <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>ABNORMAL BEHAVIOUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERSONALITY CHANGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PETIT MAL EPILEPSY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSYCHOTIC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDE ATTEMPT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEPONEX</medicinalproduct>
        <drugdosagetext>UP TO 300 MG/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PSYCHOTIC DISORDER</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060629</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEPONEX</medicinalproduct>
        <drugdosagetext>UP TO 325 MG/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060630</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TEGRETOL</medicinalproduct>
        <drugauthorizationnumb>016608</drugauthorizationnumb>
        <drugdosagetext>200 MG, TID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PETIT MAL EPILEPSY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060501</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLOPIXOL</medicinalproduct>
        <drugdosagetext>1 DF, ONCE/SINGLE</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060624</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060624</drugenddate>
        <drugtreatmentduration>1440</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EPILEPSIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047418-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060704</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2006JP10110</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>HYPERAMMONAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TEGRETOL</medicinalproduct>
        <drugauthorizationnumb>16608</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PURSENNID</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047419-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHNU2006DE02415</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>45</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>LUNG INFILTRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLEURISY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CO-DIOVAN FORTE</medicinalproduct>
        <drugauthorizationnumb>20818</drugauthorizationnumb>
        <drugdosagetext>UNK, UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047420-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2006BR09963</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>64</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>73</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIOVAN HCT</medicinalproduct>
        <drugauthorizationnumb>020818</drugauthorizationnumb>
        <drugdosagetext>VALS 160 / HCT 12.5 MG/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SELOZOK</medicinalproduct>
        <drugdosagetext>1 TABLET/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SILIMALON</medicinalproduct>
        <drugdosagetext>2 TABLETS/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060601</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047421-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060710</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>73</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>54.4316</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLINDNESS UNILATERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE INFLAMMATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYELID FUNCTION DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVASTIN</medicinalproduct>
        <drugindication>MACULAR DEGENERATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047423-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060616</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006-01168</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>57</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>79.8</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ATRIOVENTRICULAR BLOCK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDUCTION DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VELCADE</medicinalproduct>
        <drugauthorizationnumb>21602</drugauthorizationnumb>
        <drugdosagetext>1.60 MG/M2, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>SMALL CELL LUNG CANCER STAGE UNSPECIFIED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060127</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060505</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOPOTECAN (TOPOTECAN)</medicinalproduct>
        <drugdosagetext>3.00 MG/M2, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>SMALL CELL LUNG CANCER STAGE UNSPECIFIED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060127</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060505</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOFRAN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047426-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060710</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>65</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DIABETES MELLITUS NON-INSULIN-DEPENDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMMUNE SYSTEM DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL CAVITY FISTULA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUS PERFORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN EXFOLIATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN GRAFT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTH DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ADALIMUMAB  40MG</medicinalproduct>
        <drugdosagetext>40MG EVERY 14 DAYS SQ</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050120</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060622</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugdosagetext>15MG WEEKLY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040419</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060404</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CITALOPRAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLEXERIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NASALIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLYBURIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAXZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VICODIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROXYCHLOROQUINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047429-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060710</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>67</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD POTASSIUM INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VALSARTAN</medicinalproduct>
        <drugdosagetext>160MG PO QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROTEINURIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060327</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060619</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENALAPRIL MALEATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONIDINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOLAZONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLIPIZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONAZEPAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TERAZOSIN HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PHENYTOIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CITALOPRAM HYDROBROMIDE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047430-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060710</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>95.709</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD TRIGLYCERIDES INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOW DENSITY LIPOPROTEIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHABDOMYOLYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREATMENT NONCOMPLIANCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugdosagetext>60 MG HS PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CORONARY ARTERY DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050504</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060112</drugenddate>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugdosagetext>60 MG HS PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERLIPIDAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050504</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060112</drugenddate>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GEMFIBROZIL</medicinalproduct>
        <drugdosagetext>600 MG BID PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD TRIGLYCERIDES INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051216</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060112</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047431-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060626</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-2006-016958</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>51</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>77.1</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DYSKINESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE TWITCHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VAGINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YAZ</medicinalproduct>
        <drugauthorizationnumb>21676</drugauthorizationnumb>
        <drugdosagetext>1 TAB(S), 1X/DAY, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MENSTRUATION IRREGULAR</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060608</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060616</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOXYL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMBIEN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047434-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060622</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006069987</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>75</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CATARACT OPERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MACULAR OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UVEITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL DISTURBANCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XALATAN</medicinalproduct>
        <drugauthorizationnumb>20597</drugauthorizationnumb>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CORTICOSTEROIDS (CORTICOSTEROIDS)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DORZOLAMIDE (DORZOLAMIDE)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047435-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060710</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>72</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>56.6996</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PANCYTOPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugdosagetext>2 CAPSULES  DAILY X 21/28 DAYS PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060320</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060517</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugdosagetext>1 CAPSULE  DAILY X 21/28 DAYS PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060320</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060517</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047438-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060623</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006074323</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>15</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD CREATININE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG LEVEL INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VERTIGO</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugauthorizationnumb>20998</drugauthorizationnumb>
        <drugdosagetext>8 DOSE FORMS, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060515</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060515</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PONSTYL (MEFENAMIC ACID)</medicinalproduct>
        <drugdosagetext>20 DOSE FORMS, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060515</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060515</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
        <drugdosagetext>8 DOSE FORMS, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060515</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060515</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN AND TRAMADOL HCL</medicinalproduct>
        <drugdosagetext>10 DOSE FORMS, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060515</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060515</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PHARMATON (CAFFEINE, DISODIUM METHANEARSONATE, NICOTINAMIDE, PYRIDOXIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047439-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060710</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>63</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANTIBODY TEST POSITIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPARIN-INDUCED THROMBOCYTOPENIA TEST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN</medicinalproduct>
        <drugdosagetext>5000 UNITS SQQ12H</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>THROMBOSIS PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060623</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060625</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PIPERACILLIN AND TAZOBACTAM</medicinalproduct>
        <drugdosagetext>3.375GM IV Q6H</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>WOUND INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060621</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060626</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASCORBIC ACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLOTRIMAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYANOCOBALAMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENALAPRIL MALEATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ETODOLAC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FERROUS SULFATE TAB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGNESIUM HYDROXIDE TAB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHYLCELLULOSE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEOSPORIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCODONE AND ACETAMINOPHEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PENTOXIFYLLINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047441-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060619</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GXKR2006US03463</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG ABUSER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG DEPENDENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG TOXICITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCORRECT DOSE ADMINISTERED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LETHARGY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEMORY IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY RETENTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MEPERIDINE HCL</medicinalproduct>
        <drugauthorizationnumb>70886</drugauthorizationnumb>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MORPHINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXYCODONE HYDROCHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLONIDINE HCL</medicinalproduct>
        <drugdosagetext>OCCLUSIVE</drugdosagetext>
        <drugadministrationroute>046</drugadministrationroute>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARISOPRODOL</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIAZEPAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LORAZEPAM TABLETS USP (NGX) (LORAZEPAM) TABLET</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHADON HEXAL (NGX) (METHADONE)</medicinalproduct>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugindication>DRUG WITHDRAWAL MAINTENANCE THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEXTROPROPOXYPHENE (DEXTROPROPOXYPHENE)</medicinalproduct>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ETHCHLORVYNOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMPHETAMINE SULFATE</medicinalproduct>
        <drugindication>MEDICAL DIET</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047442-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060620</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006074385</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>67</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUTENT</medicinalproduct>
        <drugauthorizationnumb>21968</drugauthorizationnumb>
        <drugdosagetext>25 MG (25 MG, CYCLIC), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RENAL CELL CARCINOMA STAGE UNSPECIFIED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060331</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TINZAPARIN SODIUM (HEPARIN-FRACTION, SODIUM SALT)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MORPHINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ORAMORPH SR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL (ALLOPURNINOL)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOCLOPRAMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENSURE (AMINO ACIDS NOS, MINERALS NOS, VITAMIN NOS)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DICLOFENAC SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROCHLORPERAZINE MALEATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MOVICOL (MACROGOL, POTASSIUM CHLORIDE, SODIUM BICARBONATE, SODIUM CHLO</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047444-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060704</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2006BR10095</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>37</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>73</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ACNE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FURUNCLE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH MACULAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN EXFOLIATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TEGRETOL</medicinalproduct>
        <drugauthorizationnumb>020234</drugauthorizationnumb>
        <drugdosagetext>200 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LITHIUM CARBONATE</medicinalproduct>
        <drugdosagetext>90 MG/DAY</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>BIPOLAR DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047445-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060620</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006074433</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>80</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>COMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISORIENTATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLAMMATION</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>ILL-DEFINED DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060411</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060411</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KETOPROFEN</medicinalproduct>
        <drugdosagetext>150 MG (1 IN 1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060411</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060411</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MORPHINE</medicinalproduct>
        <drugdosagetext>60 MCG</drugdosagetext>
        <drugindication>BONE PAIN</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047446-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060710</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>MEDICATION ERROR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VINCRISTINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VINCRISTINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047447-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060620</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GXKR2006US03509</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>17</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>GLOMERULONEPHRITIS PROLIFERATIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MASS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METASTASES TO LYMPH NODES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEPHRECTOMY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL CANCER METASTATIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL NECROSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISONE (NGX)(PREDNISONE) UNKNOWN</medicinalproduct>
        <drugauthorizationnumb>80336</drugauthorizationnumb>
        <drugdosagetext>20 MG, QD, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>SYSTEMIC LUPUS ERYTHEMATOSUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOPHOSPHAMIDE</medicinalproduct>
        <drugdosagetext>1000 MG, EVERY 6 WEEKS, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>SYSTEMIC LUPUS ERYTHEMATOSUS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047448-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060602</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006066731</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>26</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ACNE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBRAL ASPERGILLOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COAGULATION FACTOR V LEVEL DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMPLICATIONS OF TRANSPLANTED LIVER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC ENCEPHALOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATITIS FULMINANT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER TRANSPLANT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROTHROMBIN LEVEL INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SURGICAL PROCEDURE REPEATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRANSPLANT FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIRLIX (CETIRIZINE)</medicinalproduct>
        <drugauthorizationnumb>19835</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060118</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060223</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ATARAX</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060112</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060223</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIRENA</medicinalproduct>
        <drugdosagetext>OTHER</drugdosagetext>
        <drugindication>CONTRACEPTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050928</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060225</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HERBAL PREPARATION (HERBAL PREPARATION)</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060223</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MEQUITAZINE (MEQUITAZINE)</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060103</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060118</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CANOL (HERBAL EXTRACTS NOS)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALACYCLOVIR</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047450-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060620</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GXKR2006US03510</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>16</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG TOXICITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METASTASES TO LYMPH NODES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEPHRECTOMY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL CELL CARCINOMA STAGE UNSPECIFIED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE CHRONIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUDDEN DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
        <drugauthorizationnumb>80399</drugauthorizationnumb>
        <drugdosagetext>2 2-WEEK COURSES</drugdosagetext>
        <drugindication>ACUTE PROMYELOCYTIC LEUKAEMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ETOPOSIDE (NGX) (ETOPOSIDE)</medicinalproduct>
        <drugdosagetext>180 MG</drugdosagetext>
        <drugindication>ACUTE PROMYELOCYTIC LEUKAEMIA</drugindication>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYTARABINE</medicinalproduct>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>037</drugadministrationroute>
        <drugindication>ACUTE PROMYELOCYTIC LEUKAEMIA</drugindication>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYTARABINE</medicinalproduct>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>037</drugadministrationroute>
        <drugindication>ACUTE PROMYELOCYTIC LEUKAEMIA</drugindication>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TIOGUANINE (TIOGUANINE)</medicinalproduct>
        <drugdosagetext>180 MG</drugdosagetext>
        <drugindication>ACUTE PROMYELOCYTIC LEUKAEMIA</drugindication>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DAUNORUBICIN HCL</medicinalproduct>
        <drugdosagetext>38 MG</drugdosagetext>
        <drugindication>ACUTE PROMYELOCYTIC LEUKAEMIA</drugindication>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047452-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060619</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006078575</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FOETAL GROWTH RETARDATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UTERINE DILATION AND CURETTAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOSTINEX</medicinalproduct>
        <drugauthorizationnumb>20664</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047454-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060619</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006078587</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FOETAL GROWTH RETARDATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UTERINE DILATION AND CURETTAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOSTINEX</medicinalproduct>
        <drugauthorizationnumb>20664</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047456-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060620</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006078702</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>60</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOSTINEX</medicinalproduct>
        <drugauthorizationnumb>20664</drugauthorizationnumb>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047457-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060710</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>MEDICATION ERROR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BYETTA</medicinalproduct>
        <drugbatchnumb>A198381</drugbatchnumb>
        <drugdosagetext>SQ</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047458-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060620</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2006US09334</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>6</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>NEPHROBLASTOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NODULE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL MASS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL NECROSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOSPORINE</medicinalproduct>
        <drugauthorizationnumb>40194</drugauthorizationnumb>
        <drugindication>CORD BLOOD TRANSPLANT THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHYLPREDNISOLONE</medicinalproduct>
        <drugindication>CORD BLOOD TRANSPLANT THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYCLOPHOSPHAMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ANTITHYMOCYTE IMMUNOGLOBULIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IRRADIATION</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047459-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060630</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-JNJFOC-20060700088</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>82</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPONATRAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MOTILIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060519</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060524</drugenddate>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRAMADOL HCL</medicinalproduct>
        <drugauthorizationnumb>020281</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060519</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060524</drugenddate>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PARACETAMOL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060519</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MORPHINE SULFATE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060520</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060521</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SERESTA</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVENOX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060526</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047461-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2006NL09722</companynumb>
    <primarysource>
      <reportercountry>NETHERLANDS</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEPRESSED MOOD</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EMSELEX EXTENDED RELEASE</medicinalproduct>
        <drugauthorizationnumb>21513</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047462-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060701</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2006US08632</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>PARTIAL SEIZURES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THERAPEUTIC RESPONSE UNEXPECTED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRILEPTAL</medicinalproduct>
        <drugauthorizationnumb>021014</drugauthorizationnumb>
        <drugdosagetext>150 MG, TID</drugdosagetext>
        <drugindication>BIPOLAR DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ABILIFY</medicinalproduct>
        <drugdosagetext>5 MG, QD</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LITHIUM CARBONATE</medicinalproduct>
        <drugdosagetext>300 MG, BID</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047463-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060418</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2006US05523</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>NEOPLASM MALIGNANT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENABLEX</medicinalproduct>
        <drugauthorizationnumb>21513</drugauthorizationnumb>
        <drugindication>HYPERTONIC BLADDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047464-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060516</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2006JP07228</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>72</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>OSTEOMYELITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PURULENT DISCHARGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEQUESTRECTOMY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTH LOSS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTH REPAIR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANAESTHETICS, LOCAL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060518</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AREDIA</medicinalproduct>
        <drugauthorizationnumb>020036</drugauthorizationnumb>
        <drugdosagetext>30 MG,</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>METASTASES TO BONE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020314</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047466-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060621</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-2006-016324</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>50</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BACK INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BIPOLAR DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE SCLEROSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BETASERON(INTERFERON BETA - 1B) INJECTION, 250UG</medicinalproduct>
        <drugdosagetext>8 MIU, EVERY 2D, SUBCUTANEOUSS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030723</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047467-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060710</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>55</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ARRHYTHMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD POTASSIUM DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEDICATION TAMPERING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POOR QUALITY DRUG ADMINISTERED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WOLFF-PARKINSON-WHITE SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METOPROLOL</medicinalproduct>
        <drugdosagetext>ONCE A DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugtreatmentduration>10</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047468-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060620</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>430025M06USA</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>57</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>111.1</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>PANCYTOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPTIC SHOCK</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NOVANTRONE</medicinalproduct>
        <drugauthorizationnumb>19297</drugauthorizationnumb>
        <drugdosagetext>18  MG, 1 IN 1 DAYS, INTRAVENOUS (NOT OTHERWISE SPECIFIED)</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ACUTE MYELOID LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060310</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060315</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NOVANTRONE</medicinalproduct>
        <drugauthorizationnumb>19297</drugauthorizationnumb>
        <drugdosagetext>18  MG, 1 IN 1 DAYS, INTRAVENOUS (NOT OTHERWISE SPECIFIED)</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ACUTE MYELOID LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060331</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060404</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CEP-701 (INVESTIGATIONAL DRUG)</medicinalproduct>
        <drugdosagetext>80 MG, 2 IN 1 DAYS, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060317</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060424</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ETOPOSIDE</medicinalproduct>
        <drugdosagetext>230 MG, 1 IN 1 DAYS, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060310</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060315</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ETOPOSIDE</medicinalproduct>
        <drugdosagetext>230 MG, 1 IN 1 DAYS, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060331</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060404</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYTARABINE</medicinalproduct>
        <drugdosagetext>2.3 MG, 1 IN 1 DAYS, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060310</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060315</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYTARABINE</medicinalproduct>
        <drugdosagetext>2.3 MG, 1 IN 1 DAYS, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060331</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060404</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACYCLOVIR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AZTREONAM (AZTREONAM)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METRONIDAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VANCOMYCIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMILALIN (AMPICILLIN TRIHYDRATE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMPHOTERICIN B</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AZITHROMYCIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CASPOFUNGIN (CASPOFUNGIN)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LINEZOLID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>STREPTOMYCIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NYSTATIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CIPROFLOXACIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEUPOGEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIPHENHYDRAMINE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ESOMEPRAZOLE (ESOMEPRAZOLE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOPERAMIDE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN SUPPLEMENTS (VITAMINS)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047469-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060622</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>233677K06USA</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>50</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CHEST DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FOOT FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA FACIAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLUENZA LIKE ILLNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER FUNCTION TEST ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOUTH BREATHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE SCLEROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NASAL CONGESTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBIF</medicinalproduct>
        <drugdosagetext>SEE IMAGE, SUBCUTANEOUS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051117</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051117</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBIF</medicinalproduct>
        <drugdosagetext>SEE IMAGE, SUBCUTANEOUS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051209</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051226</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBIF</medicinalproduct>
        <drugdosagetext>SEE IMAGE, SUBCUTANEOUS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051226</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBIF</medicinalproduct>
        <drugdosagetext>SEE IMAGE, SUBCUTANEOUS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060217</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060302</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBIF</medicinalproduct>
        <drugdosagetext>SEE IMAGE, SUBCUTANEOUS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060303</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060601</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVALIDE (KARVEA HCT)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047470-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060621</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A-US2005-09618</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>55</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>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, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030401</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>20030401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050325</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>20050519</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050627</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE TAB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VIAGRA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047471-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060623</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006001296</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>72</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>75.7</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BAND NEUTROPHIL PERCENTAGE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIVERTICULAR PERFORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTESTINAL OBSTRUCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEPHROLITHIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY MASS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ERLOTINIB (TABLET) (ERLOTINIB HC1)</medicinalproduct>
        <drugauthorizationnumb>21743</drugauthorizationnumb>
        <drugdosagetext>150 MG (QD), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060412</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEVACIZUMAB (INJECTION FOR INFUSION)</medicinalproduct>
        <drugdosagetext>15 MG/KG (QD), INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060412</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047472-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060627</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20060700522</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>77.11</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SCAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDE ATTEMPT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THERMAL BURN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DURAGESIC-100</medicinalproduct>
        <drugauthorizationnumb>019813</drugauthorizationnumb>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYLENOL (CAPLET)</medicinalproduct>
        <drugauthorizationnumb>019872</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYLENOL (CAPLET)</medicinalproduct>
        <drugauthorizationnumb>019872</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047476-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060621</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006BI007266</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>72</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABSCESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CELLULITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOSITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STREPTOCOCCAL 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>20010501</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACTONEL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMBIEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HERBAL SUPPLEMENTS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047481-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060428</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHO2006US07039</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>74</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>103</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CREATININE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRADYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BURSITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA AT REST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA EXERTIONAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOBAR PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG INFILTRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL INTAKE REDUCED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORTHOSTATIC HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRODUCTIVE COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL TUBULAR NECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPUTUM DISCOLOURED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TENDONITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHEEZING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXYCONTIN</medicinalproduct>
        <drugdosagetext>15 MG,Q4-6H</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060602</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EPOGEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXJADE</medicinalproduct>
        <drugauthorizationnumb>021882</drugauthorizationnumb>
        <drugdosagetext>2000 MG DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD IRON INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051207</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060423</drugenddate>
        <drugtreatmentduration>138</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTIVITAMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CORAL CALCIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PAROXETINE HYDROCHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FISH OIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COMBIVENT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADVAIR DISKUS 100/50</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AZITHROMYCIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANTOPRAZOLE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047483-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060630</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-JNJFOC-20050400081</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ATRIAL FLUTTER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EXTRASYSTOLES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE IRREGULAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MEBENDAZOLE</medicinalproduct>
        <drugbatchnumb>04AL795</drugbatchnumb>
        <drugauthorizationnumb>17481</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ENTEROBIASIS</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>VENTOLIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BUDESONIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POMOTEROL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047484-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060701</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-JNJFOC-20060700186</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>75</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDE ATTEMPT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMODIUM</medicinalproduct>
        <drugauthorizationnumb>19487</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DICLOFENAC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUOXETINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047485-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060704</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GR-JNJFOC-20060700178</companynumb>
    <primarysource>
      <reportercountry>GREECE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>55</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>95</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DISSEMINATED TUBERCULOSIS</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>PSORIATIC ARTHROPATHY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047486-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060704</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-JNJFOC-20060300690</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>58</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>LUNG NEOPLASM MALIGNANT</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>NOVATREX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047487-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060630</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20060700377</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>62</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BREAST CANCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BREAST CANCER FEMALE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047488-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060630</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-JNJFOC-20060700811</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>28</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>45</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEPHROLITHIASIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ORTHO EVRA</medicinalproduct>
        <drugauthorizationnumb>021180</drugauthorizationnumb>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>CONTRACEPTION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047490-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060626</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006BI007382</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>58</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>OVARIAN 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>20041029</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047493-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060621</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006BI007481</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>36</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>GUN SHOT WOUND</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPINAL CORD INJURY CAUDA EQUINA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDE ATTEMPT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19960901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020601</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugdosagetext>SEE IMAGE</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>P35066</drugbatchnumb>
        <drugdosagetext>30 UG;Q5D;IM</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030901</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047495-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060626</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006BI006719</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>62</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CHOLECYSTITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIPOMA 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>20051202</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047497-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-JNJFOC-20060700101</companynumb>
    <primarysource>
      <reportercountry>IRELAND</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>3</patientonsetage>
      <patientonsetageunit>800</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HOSPITALISATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERDAL CONSTA</medicinalproduct>
        <drugauthorizationnumb>021346</drugauthorizationnumb>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047498-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060630</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20060700406</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BREAST CANCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL STIFFNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERDAL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERDAL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERDAL</medicinalproduct>
        <drugauthorizationnumb>020272</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BORDERLINE PERSONALITY DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047499-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060710</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>135</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>AIR EMBOLISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHILLS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROCEDURAL COMPLICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CISPLATIN</medicinalproduct>
        <drugdosagetext>100 MG</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAXOL</medicinalproduct>
        <drugdosagetext>270 MG</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047504-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060620</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2005BI015061</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>59</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugbatchnumb>P01061</drugbatchnumb>
        <drugdosagetext>30 UG;QW;IM</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020205</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>5047505-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060621</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006BI008931</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>58</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>61.2356</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CYSTITIS PSEUDOMONAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSYCHOMOTOR SKILLS IMPAIRED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY RETENTION</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>20000101</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>20050401</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047506-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060710</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>91</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL DISTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CREATININE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE SYSTOLIC DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD UREA INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BODY TEMPERATURE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS POSTURAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPHIL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL INTAKE REDUCED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINE OUTPUT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAXOTERE</medicinalproduct>
        <drugdosagetext>70 MG</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060626</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LOVENOX</medicinalproduct>
        <drugdosagetext>320 MG</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060703</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CAMPTOSAR</medicinalproduct>
        <drugdosagetext>100 MG</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060626</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047507-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060620</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006BI009016</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>64</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>DEATH</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>
        <drugbatchnumb>P35068</drugbatchnumb>
        <drugdosagetext>30 UG;QW;IM</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047510-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060622</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>USA-2006-0024167</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>61</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ACUTE RESPIRATORY DISTRESS SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRAIN NATRIURETIC PEPTIDE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC MURMUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG DEPENDENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG WITHDRAWAL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</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>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOKINESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG INFILTRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEDICATION ERROR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MITRAL VALVE INCOMPETENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALLOR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RALES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY DISTRESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THERAPY REGIMEN CHANGED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TROPONIN T INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENTRICULAR HYPOKINESIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXYCONTIN</medicinalproduct>
        <drugauthorizationnumb>20553</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugindication>PREOPERATIVE CARE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXYCODONE HCL</medicinalproduct>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HYDROMORPHONE HCL</medicinalproduct>
        <drugdosagetext>4 MG, TID PRN</drugdosagetext>
        <drugindication>BREAKTHROUGH PAIN</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047512-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060710</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>75.5</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOPHOSPHAMIDE</medicinalproduct>
        <drugdosagetext>700 MG</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOXORUBICIN HYDROCHLORIDE</medicinalproduct>
        <drugdosagetext>43 MG</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>G-CSF (FILGRASTIM, AMGEN)</medicinalproduct>
        <drugdosagetext>1500 MCG</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BACTRIM DS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047516-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060710</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>122.4712</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MOBIC</medicinalproduct>
        <drugdosagetext>7.5 MG 1 PO QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050408</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047517-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20030623</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>233979K06USA</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </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>REBIF</medicinalproduct>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047520-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060616</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FRWYE747019JUN06</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BURNS SECOND DEGREE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUNBURN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PSORIATIC ARTHROPATHY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047521-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060627</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-STX184638</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HERPES ZOSTER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>KNEE ARTHROPLASTY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UPPER RESPIRATORY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>D063328</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19960101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047523-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DEWYE850828JUN06</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>73</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ACUTE MYOCARDIAL INFARCTION</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>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>UNKNOWN</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PSORIATIC ARTHROPATHY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugdosagetext>UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MOBIC</medicinalproduct>
        <drugdosagetext>UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047524-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060622</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>430002K06USA</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>42</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEBRILE NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NOVANTRONE</medicinalproduct>
        <drugauthorizationnumb>19297</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051228</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051228</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NOVANTRONE</medicinalproduct>
        <drugauthorizationnumb>19297</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060425</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060425</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BACLOFEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DITROPAN XL (OXYBUTYNIN)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REBIF</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047525-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060710</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>122.4712</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THERAPEUTIC RESPONSE UNEXPECTED WITH DRUG SUBSTITUTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXYCONTIN</medicinalproduct>
        <drugdosagetext>80 MG TWO PO Q8H PRN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047528-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060626</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006BI008040</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>47</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HIP ARTHROPLASTY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SHOULDER ARTHROPLASTY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugdosagetext>30 U G; QW; IM</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19971101</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>XANAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BUSPAR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARDURA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZANTAC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREVACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REGLAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMBIEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIMBITROL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZYRTEC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRIMETHOPRIM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MED PRO X</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ESTRADIAL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACTONEL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PHENERGAN HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COLACE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047531-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060710</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>122.4712</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRIC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THERAPEUTIC RESPONSE UNEXPECTED WITH DRUG SUBSTITUTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXYCONTIN</medicinalproduct>
        <drugdosagetext>80 MG ONE PO Q8 H PRN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047532-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006BI008256</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>41</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>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>20021017</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041201</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>20050106</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047534-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060620</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006BI008573</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>47</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>122.4712</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPINAL FUSION 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>20000101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030701</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>20040801</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugbatchnumb>P01080</drugbatchnumb>
        <drugdosagetext>30 UG; QW; IM</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040901</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047535-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060710</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>79</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>75</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CENTRAL LINE INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXALIPLATIN 130 MG/M2 IV DAY 1 Q 3 WKS</medicinalproduct>
        <drugdosagetext>243 MG IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MALIGNANT NEOPLASM OF AMPULLA OF VATER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060615</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CAPECITABINE 1500 MG/M2 PO X 14DAYS</medicinalproduct>
        <drugdosagetext>1500 MG PO BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060615</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DILANTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIAZEPAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROTONIX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047536-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-US184835</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>SPLENIC RUPTURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047537-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060623</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006BI007893</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>76</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ACUTE MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BEDRIDDEN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE CONGESTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CATARACT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CATHETERISATION CARDIAC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLONIC POLYP</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL FUNGAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HALLUCINATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOBILITY DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULAR WEAKNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEPHRECTOMY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROSTATE EXAMINATION ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL CELL CARCINOMA STAGE UNSPECIFIED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRANSIENT ISCHAEMIC ATTACK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugdosagetext>30  UG; QW; IM</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990719</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>AMBIEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KLONOPIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MIACALCIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLGARD</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVAPRO</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALDACTONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOXAZOSIN MESYLATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VYTORIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM GLUCONATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SOLU-MEDROL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047538-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060710</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>78</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>80</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DELIRIUM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENTAL STATUS CHANGES</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXYCODONE AND ACETAMINOPHEN</medicinalproduct>
        <drugdosagetext>5/325 MG BID PRN PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060206</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060303</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GABAPENTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOCLOPRAMIDE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LACTASE ENZYME</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM CHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRECISION QID TEST STRIPS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SILDENAFIL CITRATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUOXETINE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COLON ELECTROLYTE LAVAGE PDW FOR SOLN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAZODONE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROPOXYPHENE-N-100 + APAP</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047539-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060626</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006BI007972</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>54</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DECUBITUS ULCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugdosagetext>30 UG; QW; IM</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000601</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>5047540-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060626</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006BI007977</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>37</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FIBULA FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMPAIRED HEALING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TIBIA 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>20000601</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047541-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20051011</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FRWYE053413OCT05</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>91</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CREATININE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CERVICAL CORD COMPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERAL PHYSICAL HEALTH DETERIORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MASS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE MYELOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAPARESIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHINITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050801</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARAVA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugdosagetext>UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19890101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NOVATREX</medicinalproduct>
        <drugdosagetext>10MG TO 15MG TOTAL WEEKLY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050121</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050801</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CORTANCYL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047542-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060626</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CHWYE809026JUN06</companynumb>
    <primarysource>
      <reportercountry>SWITZERLAND</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DERMATITIS BULLOUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG ERUPTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PEMPHIGOID</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>ANKYLOSING SPONDYLITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060401</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047543-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060620</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GBWYE756120JUN06</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWELLING FACE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWOLLEN TONGUE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060616</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047545-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060705</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>72.5755</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG ONCE A WEEK SQ</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060315</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060601</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047546-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060620</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006078808</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>85</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIALYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSARTHRIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENTAL STATUS CHANGES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugauthorizationnumb>21446</drugauthorizationnumb>
        <drugdosagetext>100  MG (50 MG, 2 IN 1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047548-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060705</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>41</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>65.7716</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEPRESSED LEVEL OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SLEEP TERROR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TEMPERATURE REGULATION DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMBIEN</medicinalproduct>
        <drugdosagetext>1/2 PILL ONCE PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INSOMNIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060613</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060613</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIDRIN CARACO</medicinalproduct>
        <drugdosagetext>2 TABLETS ONCE PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MIGRAINE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060613</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060613</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZANAFLEX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IBUPROFIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047549-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060621</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>13419510</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HEPATIC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER TRANSPLANT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SERZONE</medicinalproduct>
        <drugauthorizationnumb>20152</drugauthorizationnumb>
        <drugdosagetext>200 MILLIGRAM, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19970701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047550-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060705</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>73</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>90.7194</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>APHASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMMUNICATION DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ROAD TRAFFIC ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SURGERY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugdosagetext>1 TABLET DAILY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19950301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060704</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047552-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060627</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-STX184610</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC PACEMAKER INSERTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOVEMENT DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOE DEFORMITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>P063744</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PSORIASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050627</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047553-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060627</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-STX184510</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BRONCHITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN LESION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNOVIAL CYST</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>JUVENILE ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAQUENIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047554-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060622</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>163-C5013-06030548</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>78</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>67.7</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BRONCHOSPASM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OESOPHAGITIS ULCERATIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CC-5013 (LENALIDOMIDE) (CAPSULES)</medicinalproduct>
        <drugauthorizationnumb>21880</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060304</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CC-5013 (LENALIDOMIDE) (CAPSULES)</medicinalproduct>
        <drugauthorizationnumb>21880</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060215</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060215</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060301</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>325 MG, QD, ON DAYS 1-28, OF EACH CYCLE, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>THROMBOSIS PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMPAZINE</medicinalproduct>
        <drugdosagetext>PRN</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVENOX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047555-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060619</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>163-21880-06020413</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>71</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH MACULO-PAPULAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN LESION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugauthorizationnumb>21880</drugauthorizationnumb>
        <drugdosagetext>1 IN 1 D, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MYELODYSPLASTIC SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugauthorizationnumb>21880</drugauthorizationnumb>
        <drugdosagetext>1 IN 1 D, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MYELODYSPLASTIC SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060209</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060220</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOPRESSOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMDUR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MONOPRIL (FOSINIOPRIL SODIUM)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRAVACHOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAMADOL HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALPRO (VALPROATE SODIUM)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047556-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060705</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>74</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>78</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METOCLOPRAMIDE</medicinalproduct>
        <drugdosagetext>10 MG EVERY 12 HOURS PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>IMPAIRED GASTRIC EMPTYING</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060516</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060614</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047557-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060705</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>54</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>100</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CHEST DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHOKING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSKINESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSTONIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060403</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047558-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060522</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>HQWYE526024MAY06</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>51</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>COMPRESSION FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA PNEUMOCOCCAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPINAL COMPRESSION FRACTURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060111</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060502</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDONINE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROGRAF</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051214</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060601</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PARIET</medicinalproduct>
        <drugdosagetext>UNSPEXCIFIED DOSE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ISCOTIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANTIBIOTIC PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050824</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047559-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060614</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-STX183094</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HIP ARTHROPLASTY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOPOROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERICARDIAL EFFUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPINAL FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SURGERY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047560-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060627</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GBWYE840927JUN06</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEEP VEIN THROMBOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047561-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20021125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FI-AMGEN-03010021</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>31</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>IRIDOCYCLITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugindication>JUVENILE ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20000801</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugindication>POLYARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047562-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060707</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2006US08712</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>36</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXJADE</medicinalproduct>
        <drugauthorizationnumb>021882</drugauthorizationnumb>
        <drugdosagetext>1500 MG, QD</drugdosagetext>
        <drugindication>IRON DEFICIENCY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060419</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047563-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060705</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>34</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>58.0604</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CHOKING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FOREIGN BODY ASPIRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALBUTEROL</medicinalproduct>
        <drugindication>ASTHMA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047565-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060705</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>24</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>63.5036</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>APATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COGNITIVE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISSOCIATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EMOTIONAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF LIBIDO</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALE ORGASMIC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SENSORY DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEXUAL DYSFUNCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
        <drugdosagetext>50 MG ONE TABLE PER DAY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANXIETY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030501</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047567-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060619</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>163-21880-06060627</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>52</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugauthorizationnumb>21880</drugauthorizationnumb>
        <drugdosagetext>1 IN 1 D, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060502</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060501</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047569-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060705</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>57</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>89.3586</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BEDRIDDEN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOVEMENT DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOPATHY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACTOS</medicinalproduct>
        <drugdosagetext>15/500 TWICE DAILY ORALLY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060216</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060315</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LABETALOL HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOTROL XL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOTREL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047571-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060621</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>163-20785-06060751</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>76</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>CARDIAC DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>THALOMID</medicinalproduct>
        <drugbatchnumb>0312X</drugbatchnumb>
        <drugauthorizationnumb>20785</drugauthorizationnumb>
        <drugdosagetext>1 IN 1 D, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MYELODYSPLASTIC SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060113</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060201</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047573-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041018</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHFR2004GB03896</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>50</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ENDOSCOPY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EOSINOPHIL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HERNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTESTINAL FUNCTIONAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROSTATE EXAMINATION ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SIGMOIDOSCOPY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZARIL</medicinalproduct>
        <drugdosagetext>400MG/DAY</drugdosagetext>
        <drugindication>SCHIZOPHRENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980910</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047574-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060619</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>163-21880-06040504</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>NO ADVERSE EFFECT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugauthorizationnumb>21880</drugauthorizationnumb>
        <drugindication>MYELODYSPLASTIC SYNDROME</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047575-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060630</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHO2006JP10816</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>PLEURAL EFFUSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
        <drugauthorizationnumb>021283</drugauthorizationnumb>
        <drugdosagetext>80 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040325</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050420</drugenddate>
        <drugtreatmentduration>392</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugindication>HYPERCHOLESTEROLAEMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GASMOTIN</medicinalproduct>
        <drugindication>GASTRIC ATONY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIART</medicinalproduct>
        <drugindication>OEDEMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INNOLET</medicinalproduct>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047576-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060710</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-RB-3559-2006</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>37</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BIOPSY LUNG ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEDICATION RESIDUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BUPRENORPHINE HCL</medicinalproduct>
        <drugauthorizationnumb>020732</drugauthorizationnumb>
        <drugdosagetext>DOSAGE  UNKNOWN</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOLPIDEM TARTRATE</medicinalproduct>
        <drugdosagetext>DOSAGE UNKNOWN</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047577-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040310</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHFR2004GB01399</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>32</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HIP ARTHROPLASTY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HIP FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UPPER LIMB FRACTURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HALOPERIDOL</medicinalproduct>
        <drugdosagetext>10 MG, TID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020501</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZARIL</medicinalproduct>
        <drugauthorizationnumb>019758</drugauthorizationnumb>
        <drugdosagetext>700MG/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021213</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047578-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060630</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHNU2006DE02409</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>47</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASCITES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAMMA-GLUTAMYLTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERITONEAL CARCINOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ULTRASOUND SCAN ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEPONEX</medicinalproduct>
        <drugauthorizationnumb>19758</drugauthorizationnumb>
        <drugdosagetext>UP TO 100 MG/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19950101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047579-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060630</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2006BR09973</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>42</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>77</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ILLUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SURGERY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEPONEX</medicinalproduct>
        <drugauthorizationnumb>19758</drugauthorizationnumb>
        <drugdosagetext>250 MG/D</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051001</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047580-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060511</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHO2006JP07829</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>72</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BRONCHITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRIC ULCER HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOPTYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRODUCTIVE COUGH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
        <drugauthorizationnumb>21283</drugauthorizationnumb>
        <drugdosagetext>80 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030314</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060308</drugenddate>
        <drugtreatmentduration>1091</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
        <drugindication>MYOCARDIAL INFARCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030115</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugdosagetext>10 MG/DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERCHOLESTEROLAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030311</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARTIST</medicinalproduct>
        <drugdosagetext>5 MG/DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030311</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047581-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060630</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20060700482</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>76.66</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>LUPUS-LIKE SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugdosagetext>4 VIALS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047582-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060627</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ES-JNJFOC-20060606471</companynumb>
    <primarysource>
      <reportercountry>SPAIN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PARANOIA</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>5047583-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060619</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>163-21880-06050633</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>71</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERNATIONAL NORMALISED RATIO INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE CHRONIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugbatchnumb>0077A-A</drugbatchnumb>
        <drugauthorizationnumb>21880</drugauthorizationnumb>
        <drugdosagetext>25 MG, DAILY, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060413</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060401</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugbatchnumb>0077A-A</drugbatchnumb>
        <drugauthorizationnumb>21880</drugauthorizationnumb>
        <drugdosagetext>25 MG, DAILY, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060526</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugbatchnumb>427924</drugbatchnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047587-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060705</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>60.3284</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEPHROGENIC FIBROSING DERMOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH ERYTHEMATOUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYSTEMIC LUPUS ERYTHEMATOSUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OMNISCAN</medicinalproduct>
        <drugdosagetext>40 CC ONCE IV BOLUS [ONE TIME INJECTION]</drugdosagetext>
        <drugadministrationroute>040</drugadministrationroute>
        <drugindication>NEPHROGENIC FIBROSING DERMOPATHY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050512</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050512</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047591-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-BRISTOL-MYERS SQUIBB COMPANY-13430236</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>45</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>85</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>COMPLETED SUICIDE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ABILIFY</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PSYCHOTIC DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050901</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047592-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060704</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-BRISTOL-MYERS SQUIBB COMPANY-13434907</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>70</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>LACTIC ACIDOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METFORMIN HYDROCHLORIDE</medicinalproduct>
        <drugauthorizationnumb>021202</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS NON-INSULIN-DEPENDENT</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060416</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060416</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GOUT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000617</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060416</drugenddate>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060416</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATORVASTATIN CALCIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20011001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060416</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BISOPROLOL FUMARATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060416</drugenddate>
        <drugtreatmentduration>745</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOXAZOSIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060416</drugenddate>
        <drugtreatmentduration>562</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SILDENAFIL CITRATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ERECTILE DYSFUNCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060416</drugenddate>
        <drugtreatmentduration>319</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047593-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050427</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHNU2005DE01778</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>48</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ACTINOMYCOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DENTAL OPERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EXCESSIVE GRANULATION TISSUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMPAIRED HEALING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALIGNANT NEOPLASM PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUCOSAL ULCERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA MUCOSAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL SURGERY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOMYELITIS CHRONIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN JAW</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PURULENT DISCHARGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SECRETION DISCHARGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTH DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTH EXTRACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WOUND DEBRIDEMENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TEGRETOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>EPILEPSY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LAMICTAL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>EPILEPSY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RADIOTHERAPY</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugauthorizationnumb>021223</drugauthorizationnumb>
        <drugdosagetext>4 MG, QMO</drugdosagetext>
        <drugindication>METASTASES TO BONE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050201</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047594-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060630</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2006BE09997</companynumb>
    <primarysource>
      <reportercountry>BELGIUM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugauthorizationnumb>021223</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PROSTATE CANCER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047595-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHRM2006FR01929</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTH EXTRACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WOUND DEBRIDEMENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CORTICOSTEROID NOS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugauthorizationnumb>021223</drugauthorizationnumb>
        <drugdosagetext>4 MG, QMO</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041001</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047596-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHRM2006FR01918</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>51</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTH DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTH EXTRACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WOUND DEBRIDEMENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NAVELBINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugauthorizationnumb>021223</drugauthorizationnumb>
        <drugdosagetext>4 MG, QMO</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>METASTASES TO BONE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040301</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047597-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHRM2006FR01924</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DENTAL DISORDER PROPHYLAXIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTH DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTH LOSS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugauthorizationnumb>021223</drugauthorizationnumb>
        <drugdosagetext>4 MG, QMO</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040201</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047598-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060630</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2006BE10001</companynumb>
    <primarysource>
      <reportercountry>BELGIUM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugauthorizationnumb>021223</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047599-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHRM2006FR01921</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>IMPAIRED HEALING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTH EXTRACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WOUND DEBRIDEMENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugauthorizationnumb>021223</drugauthorizationnumb>
        <drugdosagetext>4 MG, QMO</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047603-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060627</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006-02619</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>76</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIAC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIVERTICULITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIVERTICULUM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DICYCLOMINE</medicinalproduct>
        <drugauthorizationnumb>85082</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLONASE</medicinalproduct>
        <drugdosagetext>2 SPRAYS, DAILY, NASAL</drugdosagetext>
        <drugadministrationroute>045</drugadministrationroute>
        <drugindication>EAR DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARTIA XT</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060601</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THYROXINE SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FIBER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOMOTIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MIDRIN (PARACETAMOL)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047605-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006-02654</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>74</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL HYPOMOTILITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DILACOR XR</medicinalproduct>
        <drugauthorizationnumb>20092</drugauthorizationnumb>
        <drugdosagetext>120 MG, QID, ORAL (SEE IMAGE)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMIODARONE (AMIODARONE)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047609-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006-02648</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>65</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>51.2</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAPHYLACTIC REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CATHETER RELATED COMPLICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMOTHORAX</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RETCHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FERRLECIT</medicinalproduct>
        <drugauthorizationnumb>20955</drugauthorizationnumb>
        <drugdosagetext>250 MG, 100CC/HR INC 200CC/HR, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>IRON DEFICIENCY ANAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060626</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047611-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060705</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>NO THERAPEUTIC RESPONSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DALESTROGEN</medicinalproduct>
        <drugbatchnumb>4L79131</drugbatchnumb>
        <drugdosagetext>IM</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060413</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060531</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047612-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060612</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006-06-1796</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>BLINDNESS UNILATERAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLARITIN</medicinalproduct>
        <drugauthorizationnumb>19658</drugauthorizationnumb>
        <drugdosagetext>QD ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060608</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060610</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047614-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHRM2006FR01936</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DENTAL DISORDER PROPHYLAXIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugauthorizationnumb>021223</drugauthorizationnumb>
        <drugdosagetext>4 MG, QMO</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>METASTASES TO BONE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030301</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047615-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHRM2006FR01939</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>77</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DENTAL CARIES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMPAIRED HEALING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRIMARY SEQUESTRUM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTH DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTH EXTRACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WOUND DEBRIDEMENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugauthorizationnumb>021223</drugauthorizationnumb>
        <drugdosagetext>4 MG, QMO</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>METASTASES TO BONE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040813</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047616-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHRM2006FR01930</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALATAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WOUND DEBRIDEMENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugauthorizationnumb>021223</drugauthorizationnumb>
        <drugdosagetext>4 MG, QMO</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>METASTASES TO BONE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040901</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047617-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060703</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006-502</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>19</patientonsetage>
      <patientonsetageunit>802</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>URTICARIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HIBICLENS</medicinalproduct>
        <drugauthorizationnumb>17768</drugauthorizationnumb>
        <drugdosagetext>TOPICAL ANTISEPTIC</drugdosagetext>
        <drugadministrationroute>061</drugadministrationroute>
        <drugindication>ANTI-INFECTIVE THERAPY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047619-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHRM2006FR01934</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>86</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRIMARY SEQUESTRUM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTH EXTRACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WOUND DEBRIDEMENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugauthorizationnumb>021223</drugauthorizationnumb>
        <drugdosagetext>4 MG, QMO</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VASTAREL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SOLUPRED</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047621-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060703</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006-516</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>80</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ACCIDENTAL EXPOSURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HIBICLENS</medicinalproduct>
        <drugauthorizationnumb>17768</drugauthorizationnumb>
        <drugdosagetext>TOPICAL ANTISEPTIC</drugdosagetext>
        <drugadministrationroute>061</drugadministrationroute>
        <drugindication>LOCAL ANTIBACTERIAL THERAPY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047624-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060626</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>233388K06USA</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>47</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLON NEOPLASM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CRYING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SLEEP 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>20060320</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060601</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047627-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060619</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006US003163</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>65</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AORTIC THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALOXI</medicinalproduct>
        <drugauthorizationnumb>21372</drugauthorizationnumb>
        <drugdosagetext>0.25 MG, Q2WK, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PROPHYLAXIS OF NAUSEA AND VOMITING</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060102</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060428</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
        <drugdosagetext>10 MG, Q2WK, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PROPHYLAXIS OF NAUSEA AND VOMITING</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060102</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060428</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXALIPLATIN(OXALIPLATIN)</medicinalproduct>
        <drugdosagetext>125 MG, 65 MG/M^2, Q2WK, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MALIGNANT NEOPLASM OF ISLETS OF LANGERHANS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060428</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060428</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUOROURACIL</medicinalproduct>
        <drugdosagetext>620MG + 1870MG, 320MG/M^2 + 960 MG/M^2, Q2WK, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MALIGNANT NEOPLASM OF ISLETS OF LANGERHANS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060426</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060428</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEUCOVORIN CALCIUM</medicinalproduct>
        <drugdosagetext>390 MG, 200 MG/M^2, Q2WK, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MALIGNANT NEOPLASM OF ISLETS OF LANGERHANS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060428</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060428</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVASTIN</medicinalproduct>
        <drugdosagetext>375 MG, 5 MG/KG, Q2WK, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MALIGNANT NEOPLASM OF ISLETS OF LANGERHANS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060428</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060428</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VICODIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANCREASE /00150201/ (PANCRELIPASE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELEXA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COMPAZINE /00013304/ (PROCHLORPERAZINE MALEATE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATIVAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KYTRIL /01178101/ (GRANISETRON)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLORZIDE (HYDROCHLOROTHIAZIDE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COLACE (DOCUSATE SODIUM)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCONTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROTONIX /01263201/ (PANTOPRAZOLE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARAFATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORAVASC /00972401/ (AMLODIPINE)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047630-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060710</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-RB-3558-2006</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIO-RESPIRATORY ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WRONG DRUG ADMINISTERED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BUPRENORPHINE HCL</medicinalproduct>
        <drugauthorizationnumb>020732</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLORAZEPATE DIPOTASSIUM</medicinalproduct>
        <drugdosagetext>DOSAGE UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047631-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060705</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>12</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>56.6996</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INADEQUATELY CONTROLLED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC HYPERTROPHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CONCERTA</medicinalproduct>
        <drugdosagetext>75 MG DAILY</drugdosagetext>
        <drugindication>ATTENTION DEFICIT/HYPERACTIVITY DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060406</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047633-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060705</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>117.9352</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>AGITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COUNTERFEIT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POOR QUALITY DRUG ADMINISTERED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESTLESSNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMBIEN</medicinalproduct>
        <drugdosagetext>10 MG NIGHTLY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INSOMNIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020131</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050703</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047634-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060619</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PAR_0646_2006</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>49</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>115.6672</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIAC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TONGUE BLISTERING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TONGUE DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DECADRON</medicinalproduct>
        <drugauthorizationnumb>88160</drugauthorizationnumb>
        <drugdosagetext>0.75 MG QDAY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060601</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ESTRADIOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAVIK</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047635-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060619</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DSA_28356_2006</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>55</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRIC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCORRECT DOSE ADMINISTERED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUCOSAL DRYNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUS DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THERAPEUTIC RESPONSE UNEXPECTED WITH DRUG SUBSTITUTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WRONG TECHNIQUE IN DRUG USAGE PROCESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ATIVAN</medicinalproduct>
        <drugbatchnumb>BIOVAIL'S</drugbatchnumb>
        <drugauthorizationnumb>17794</drugauthorizationnumb>
        <drugdosagetext>VAR PRN PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>STRESS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ATIVAN</medicinalproduct>
        <drugbatchnumb>BIOVAIL'S</drugbatchnumb>
        <drugdosagetext>VAR PRN PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>STRESS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ATIVAN</medicinalproduct>
        <drugbatchnumb>WYETH'S</drugbatchnumb>
        <drugdosagetext>VAR PRN PO/A FEW YEARS</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>STRESS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LORAZEPAM</medicinalproduct>
        <drugdosagetext>VAR PRN PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>STRESS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PEPCID AC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THEOPHYLLINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROVENTIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GAS X</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>..</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047636-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060621</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US017845</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>46</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>88.905</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>AORTIC VALVE DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DENTAL CARIES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EATING DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MASTICATION DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTH INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTHACHE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACTIQ</medicinalproduct>
        <drugauthorizationnumb>20747</drugauthorizationnumb>
        <drugdosagetext>800 MG PRN BUCCAL</drugdosagetext>
        <drugadministrationroute>002</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060301</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCONTIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047638-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060619</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DSA_28362_2006</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>57</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MENTAL DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LORAZEPAM</medicinalproduct>
        <drugauthorizationnumb>17794</drugauthorizationnumb>
        <drugdosagetext>DF</drugdosagetext>
        <drugindication>INSOMNIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050501</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUOXETINE HYDROCHLORIDE</medicinalproduct>
        <drugdosagetext>DF</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUTICASONE PROPIONATE + SALMETEROL XINAFOATE</medicinalproduct>
        <drugdosagetext>2 PUFF(S) Q DAY H</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060412</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060505</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047641-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060619</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200601996</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>32</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MYELITIS TRANSVERSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BOTOX</medicinalproduct>
        <drugauthorizationnumb>1145</drugauthorizationnumb>
        <drugdosagetext>SINGLE, INTRAMUSCULAR</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MUSCLE SPASTICITY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060215</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060215</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047642-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060705</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>62</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>65.7716</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FEMARA</medicinalproduct>
        <drugdosagetext>2.5 MG 1XDAY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060506</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060619</drugenddate>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047644-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060706</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHNU2006DE02475</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
    </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>ALOPECIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANOREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLATULENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUID RETENTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRIC OPERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRIC PERFORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRIC ULCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATEMESIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEARING IMPAIRED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IRRITABILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OESOPHAGEAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VOLTAREN DOLO</medicinalproduct>
        <drugauthorizationnumb>020142</drugauthorizationnumb>
        <drugdosagetext>0.5 DF, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BACK PAIN</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047645-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060704</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2006BR09980</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>EMBOLISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HALLUCINATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CODATEN</medicinalproduct>
        <drugauthorizationnumb>19201</drugauthorizationnumb>
        <drugdosagetext>2 TAB/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051114</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051114</drugenddate>
        <drugtreatmentduration>1440</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CODATEN</medicinalproduct>
        <drugauthorizationnumb>019201</drugauthorizationnumb>
        <drugdosagetext>1 TAB/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051115</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051115</drugenddate>
        <drugtreatmentduration>1440</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047647-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060705</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>68.4</patientweight>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>BACTERIA BLOOD IDENTIFIED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE MARROW FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONTUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EPSTEIN-BARR VIRUS TEST POSITIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEBRILE NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IDIOSYNCRATIC DRUG REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEUKOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENTAL STATUS CHANGES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPUTUM CULTURE POSITIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STAPHYLOCOCCAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THERAPY NON-RESPONDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SYMBYAX</medicinalproduct>
        <drugdosagetext>6 MG OOLANZAPINE/25 MG FLUOXETINE  DAILY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BIPOLAR DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060515</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060605</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CEFEPIME</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOFLOXACIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUCONAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VANCOMCYIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ESOMEPRAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROPOFOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NOREPINEPHRINE BITARTRATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEUPOGEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FERRIC SODIUM GLUCONATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EPOETIN ALPHA</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047650-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060705</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>58</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>89</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZINC SULFATE</medicinalproduct>
        <drugdosagetext>220 MG DAILY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROMOTION OF WOUND HEALING</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060621</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060628</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047652-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>HQ5161311NOV2002</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>73</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>52</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ASCITES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CHLORIDE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIOMEGALY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CATHETER RELATED INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISEASE PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEBRILE NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFUSION RELATED REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MIGRAINE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERICARDIAL EFFUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERITONEAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLEURAL EFFUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPLENOMEGALY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MYLOTARG</medicinalproduct>
        <drugauthorizationnumb>21174</drugauthorizationnumb>
        <drugdosagetext>17 MG 1X PER 1 DAY, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ACUTE MYELOID LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020924</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020924</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE TAB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREVACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SENOKOT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMINS NOS (VITAMINS NOS)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOSYN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DE-GAS (SIMETHICONE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIFLUCAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVAQUIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLYBURIDE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047654-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060622</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>HQWYE348123JUN06</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>74</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD CREATINE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE MARROW FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GRANULOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IRON DEFICIENCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCYTOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SERUM FERRITIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VITAMIN B12 DEFICIENCY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CORDARONE</medicinalproduct>
        <drugauthorizationnumb>18972</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BUMETANIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEUPROLIDE ACETATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOSARTAN POTASSIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRONOLACTONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAMSULOSIN HYDROCHLORIDE (TAMSULOSIN HYDROCHLORIDE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTIVITAMINS (ASCORBIC ACID/ERGOCALCIFEROL/FOLIC ACID/NICOTINAMIDE/PA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IRON (IRON)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047655-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060701</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AVENTIS-200615644US</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>18</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KETEK</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>21144</drugauthorizationnumb>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047656-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060424</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-AVENTIS-200614397GDDC</companynumb>
    <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>COLITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA HAEMORRHAGIC</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOPREC</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugdosagetext>DOSE: 4 DF DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PYREXIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060224</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060225</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NASACORT</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>020468</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060224</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060225</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BIRODOGYL</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugdosagetext>DOSE: 6 DF DAILY</drugdosagetext>
        <drugindication>ALVEOLITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060224</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060225</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EFFERALGAN CODEINE</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugdosagetext>DOSE: 6 DF DAILY</drugdosagetext>
        <drugindication>PYREXIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060224</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060225</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VOGALENE</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugindication>NAUSEA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060224</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060225</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VOGALENE</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugindication>VOMITING</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060224</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060225</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047657-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060703</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-AVENTIS-200612058JP</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>38</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ALOPECIA AREATA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALLEGRA</medicinalproduct>
        <drugauthorizationnumb>020872</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>URTICARIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060701</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047658-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060622</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-AVENTIS-200612278FR</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>67</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA HAEMORRHAGIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE VASOVAGAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KETEK</medicinalproduct>
        <drugauthorizationnumb>021144</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BRONCHITIS ACUTE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060519</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IRON NOS</medicinalproduct>
        <drugindication>ANAEMIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047659-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060522</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AVENTIS-200614589US</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>STEVENS-JOHNSON SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DDAVP</medicinalproduct>
        <drugbatchnumb>402336004T</drugbatchnumb>
        <drugauthorizationnumb>19955</drugauthorizationnumb>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ENURESIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051001</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047660-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060705</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THERAPY NON-RESPONDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MARCAINE</medicinalproduct>
        <drugbatchnumb>34045DD</drugbatchnumb>
        <drugdosagetext>ONE TIME SPINAL</drugdosagetext>
        <drugadministrationroute>024</drugadministrationroute>
        <drugindication>ANAESTHESIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060622</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060622</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047661-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060630</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>HQWYE690407APR06</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>55</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>81.2</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ASPARTATE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD ALKALINE PHOSPHATASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIVERTICULUM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG DOSE OMISSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRITIS EROSIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROENTERITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHOIDS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>REFLUX OESOPHAGITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RAPAMUNE</medicinalproduct>
        <drugbatchnumb>2002P1332</drugbatchnumb>
        <drugauthorizationnumb>21083</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugindication>PROPHYLAXIS AGAINST TRANSPLANT REJECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040330</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060402</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RAPAMUNE</medicinalproduct>
        <drugbatchnumb>2002P1332</drugbatchnumb>
        <drugauthorizationnumb>21083</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugindication>PROPHYLAXIS AGAINST TRANSPLANT REJECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060404</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RAPAMUNE</medicinalproduct>
        <drugbatchnumb>2005P0180</drugbatchnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELLCEPT</medicinalproduct>
        <drugbatchnumb>2005P0180</drugbatchnumb>
        <drugdosagetext>500 MG 2X PER 1 DAY</drugdosagetext>
        <drugindication>PROPHYLAXIS AGAINST TRANSPLANT REJECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030124</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE TAB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE BESYLATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TENORMIN (TENORMIN (ATENOLOL)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREVACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM CARBONATE (CALCIUM CARBONATE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM CHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTIVITAMINS (ASCORBIC ACID/ERGOCALCIFEROL/FOLIC ACID/NICOTAMIDE/PANT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047662-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060706</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>67</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>76</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ATRIAL FIBRILLATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE SYSTOLIC INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ELECTROCARDIOGRAM QT PROLONGED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEAD INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>REFUSAL OF TREATMENT BY PATIENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUS BRADYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SOTALOL HCL</medicinalproduct>
        <drugdosagetext>80 MG Q12 H PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060523</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060525</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SOTALOL HCL</medicinalproduct>
        <drugdosagetext>80 MG Q12 H PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060526</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060528</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SOTALOL HCL</medicinalproduct>
        <drugdosagetext>40 MG Q 12 H PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060525</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060526</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047663-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060706</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>66</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>0.074</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE SYSTOLIC INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORBITAL OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OXYGEN SATURATION DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROCEDURAL COMPLICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROCEDURAL HYPOTENSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ULTRAVIST 150</medicinalproduct>
        <drugdosagetext>175 ML IV X 1</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CATHETERISATION CARDIAC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060620</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047665-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060703</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-NOVOPROD-254601</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>72</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>59</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CEREBRAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENTAL IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PHENYTOIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CONVULSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NOVOSEVEN</medicinalproduct>
        <drugdosagetext>1 DOSE</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CEREBRAL HAEMORRHAGE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060625</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060625</drugenddate>
        <drugtreatmentduration>1440</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ONDANSETRON HCL</medicinalproduct>
        <drugdosagetext>4 MG, QD</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>VOMITING</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060625</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
        <drugdosagetext>650 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PYREXIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060627</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060627</drugenddate>
        <drugtreatmentduration>1440</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047667-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060706</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>60</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>180.3</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANGIONEUROTIC OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE SYSTOLIC INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BODY TEMPERATURE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPEECH DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWOLLEN TONGUE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSINOPRIL SODIUM</medicinalproduct>
        <drugdosagetext>20 MG DAILY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060601</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047668-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060621</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>HQWYE620301JUN06</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>77</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>61.2</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CREATININE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD UREA INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COAGULOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGIC ARTERIOVENOUS MALFORMATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERNATIONAL NORMALISED RATIO INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RAPAMUNE</medicinalproduct>
        <drugbatchnumb>2004 P1031, P1982</drugbatchnumb>
        <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>20060403</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELLCEPT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE TAB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZENAPAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SULFONAMIDES (SULFONAMIDES)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROTONIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANOXIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047671-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060706</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>57</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>136.2</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD CREATININE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE DIASTOLIC INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INADEQUATELY CONTROLLED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRADYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GOUT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERICARDIAL EFFUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MINOXIDIL</medicinalproduct>
        <drugdosagetext>10 MG BID PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060601</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047673-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060706</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>87</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>87.6</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD THYROID STIMULATING HORMONE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CELLULITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DECREASED APPETITE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EXCORIATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GLYCOSYLATED HAEMOGLOBIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOMYELITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STAPHYLOCOCCAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VANCOMYCIN</medicinalproduct>
        <drugdosagetext>1250 MG Q48H IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>OSTEOMYELITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060512</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060525</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PIPERACILLIN AND TAZOBACTAM</medicinalproduct>
        <drugdosagetext>2.25 MG Q6H IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>OSTEOMYELITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060510</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060515</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PIPERACILLIN AND TAZOBACTAM</medicinalproduct>
        <drugdosagetext>2.25 MG Q6H IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>OSTEOMYELITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060518</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060525</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047674-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060626</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>HQWYE123712JUN06</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ACUTE RESPIRATORY DISTRESS SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY ALVEOLAR HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EFFEXOR XR</medicinalproduct>
        <drugauthorizationnumb>20699</drugauthorizationnumb>
        <drugdosagetext>300 MG 1X PER 1 DAY, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE TAB</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047675-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060706</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>83.0083</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PHENYTOIN</medicinalproduct>
        <drugdosagetext>300 MG PO BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONVULSION</drugindication>
        <drugtreatmentduration>10</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047676-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060706</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>35</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>71.6683</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BILIARY COLIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIPASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRANSAMINASES INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KETEK</medicinalproduct>
        <drugbatchnumb>1093510</drugbatchnumb>
        <drugdosagetext>800 MG PO QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PHARYNGITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060531</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KETEK</medicinalproduct>
        <drugbatchnumb>1093510</drugbatchnumb>
        <drugdosagetext>800 MG PO QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PHARYNGITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KETEK</medicinalproduct>
        <drugbatchnumb>1093510</drugbatchnumb>
        <drugdosagetext>800 MG PO QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PHARYNGITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060602</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047677-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060706</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>65.318</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ECONOMIC PROBLEM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCORRECT DOSE ADMINISTERED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FENTANYL</medicinalproduct>
        <drugdosagetext>75 MCG PATCH EVERY 3 DAYS APPLY TO SKIN</drugdosagetext>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047680-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060706</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>81</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>61.2356</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POOR QUALITY DRUG ADMINISTERED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COSOPT</medicinalproduct>
        <drugbatchnumb>0760330</drugbatchnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugindication>GLAUCOMA</drugindication>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>807</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047682-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060706</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>69</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>61.8</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CREATINE PHOSPHOKINASE MB INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC ENZYMES INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG TOXICITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EXCORIATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERNATIONAL NORMALISED RATIO ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERNATIONAL NORMALISED RATIO INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OCCULT BLOOD POSITIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TROPONIN INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060208</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060628</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047684-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060706</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>60</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>115</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANGIONEUROTIC OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BODY TEMPERATURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHOKING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FOREIGN BODY TRAUMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATEMESIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PENILE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PENILE SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSINOPRIL SODIUM</medicinalproduct>
        <drugdosagetext>40MG BID PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060625</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VANCOMYCIN</medicinalproduct>
        <drugdosagetext>1500MG  X1  IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060624</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GENTAMICIN</medicinalproduct>
        <drugdosagetext>90MG  X1  IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060624</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047687-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060706</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>54.4316</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DERMATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GLOSSODYNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOUTH ULCERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUCOSAL INFLAMMATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PURPURA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RADIATION SKIN INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN EXFOLIATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STOMATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TONGUE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TONGUE ULCERATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ERBITUX</medicinalproduct>
        <drugdosagetext>392.5 MG   WEEKLY  IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NEOPLASM MALIGNANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060412</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060626</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PACLITAXEL</medicinalproduct>
        <drugdosagetext>62.8 MG   WEEKLY   IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NEOPLASM MALIGNANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060515</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060626</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARBOPLATIN</medicinalproduct>
        <drugdosagetext>127MG   WEEKLY  IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NEOPLASM MALIGNANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060515</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060626</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RADIATION  7500CGY + 5 WEEKS/ 2100-2700CGY WEEKS 6-8</medicinalproduct>
        <drugdosagetext>5 DAYS A WEEK</drugdosagetext>
        <drugindication>NEOPLASM MALIGNANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060515</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060630</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047688-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060706</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>86</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>85.5</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>IDIOPATHIC THROMBOCYTOPENIC PURPURA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THERAPY NON-RESPONDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VANCOMYCIN</medicinalproduct>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugindication>CELLULITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060621</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047690-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060706</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>81.1939</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MELANOCYTIC NAEVUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN LESION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>25 MG SUBCU 2 X WK</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PSORIATIC ARTHROPATHY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030219</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugdosagetext>7.5 MG PO WEEKLY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PSORIATIC ARTHROPATHY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047693-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060706</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>57.6068</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZANTAC</medicinalproduct>
        <drugdosagetext>PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTROOESOPHAGEAL REFLUX DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060621</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047694-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060630</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2006US08539</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>51</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>68.027</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIABETES MELLITUS INADEQUATE CONTROL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSGEUSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEURALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TEMPERATURE REGULATION DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMISIL</medicinalproduct>
        <drugauthorizationnumb>020539</drugauthorizationnumb>
        <drugdosagetext>250 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NAIL TINEA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060520</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060601</drugenddate>
        <drugtreatmentduration>18720</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047695-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060627</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2006JP09712</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>33</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>71</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ACUTE GENERALISED EXANTHEMATOUS PUSTULOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CANDIDIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG ERUPTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRIC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERALISED ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENITAL PRURITUS MALE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PIGMENTATION DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH PUSTULAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN ULCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TONSILLAR DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TONSILLITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOXIC SKIN ERUPTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMISIL</medicinalproduct>
        <drugauthorizationnumb>20539</drugauthorizationnumb>
        <drugdosagetext>125 MG/D</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>TINEA PEDIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060530</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060603</drugenddate>
        <drugtreatmentduration>7200</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PEKIRON</medicinalproduct>
        <drugadministrationroute>061</drugadministrationroute>
        <drugindication>TINEA PEDIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060530</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060605</drugenddate>
        <drugtreatmentduration>10080</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047697-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060613</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2006JP08946</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>41</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>68</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RED BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UTERINE LEIOMYOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMISIL</medicinalproduct>
        <drugauthorizationnumb>20539</drugauthorizationnumb>
        <drugdosagetext>125 MG/D</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NAIL TINEA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060628</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMISIL</medicinalproduct>
        <drugauthorizationnumb>020539</drugauthorizationnumb>
        <drugdosagetext>125 MG/D</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060513</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060613</drugenddate>
        <drugtreatmentduration>46080</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047700-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060706</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>56</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>73.9363</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INADEQUATE ANALGESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THERAPEUTIC RESPONSE UNEXPECTED WITH DRUG SUBSTITUTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXYCONTIN</medicinalproduct>
        <drugdosagetext>PO Q12 HRS</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BACK PAIN</drugindication>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXYCONTIN</medicinalproduct>
        <drugdosagetext>PO Q12 HRS</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NEUROPATHY</drugindication>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXYCONTIN</medicinalproduct>
        <drugdosagetext>PO Q12 HRS</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN IN EXTREMITY</drugindication>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047717-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060710</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>50</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>NON-CARDIAC CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLEURAL EFFUSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXALIPLATIN</medicinalproduct>
        <drugdosagetext>85 MG/M2 DAYS 1+15</drugdosagetext>
        <drugindication>LUNG NEOPLASM MALIGNANT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOCETAXEL</medicinalproduct>
        <drugdosagetext>30 MG/M2  DAY 1+8</drugdosagetext>
        <drugindication>LUNG NEOPLASM MALIGNANT</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047720-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060710</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>83</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>61.2356</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INTERNATIONAL NORMALISED RATIO INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROTHROMBIN TIME PROLONGED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
        <drugbatchnumb>E4A011A</drugbatchnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugindication>THROMBOSIS PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THEO-DUR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CANDESARTAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOCUSATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FESO4</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DILTIAZEM HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MORPHINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCODONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ONDANSETRON HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047722-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>SP-200001624</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>77</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BURKITT'S LYMPHOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000426</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000426</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000426</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19930101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMURAN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMYTRIPTYLINE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANOXIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLYBURIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047723-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>SP-200000531</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>70</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>NON-HODGKIN'S LYMPHOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000208</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INDOCIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047724-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>SP-200002119</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>29</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HODGKIN'S DISEASE NODULAR SCLEROSIS STAGE UNSPECIFIED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLEURAL EFFUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH PRURITIC</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19981204</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>CROHN'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19981204</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MECHLORETAMINE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADRIAMYCIN PFS</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VINCRISTINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROCARBAZINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DACARBAZINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VINBLASTINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BLEOMYCIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>5-ASA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METRONIDAZOLE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047725-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PRIUSA2000012416</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>68</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>B-CELL LYMPHOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047726-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20060700239</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>HODGKIN'S DISEASE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CROHN'S DISEASE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047727-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20060700247</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>43</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HODGKIN'S DISEASE NODULAR SCLEROSIS STAGE UNSPECIFIED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CROHN'S DISEASE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047728-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20060700248</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>34</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DIFFUSE LARGE B-CELL LYMPHOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CROHN'S DISEASE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047729-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20060700249</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>73</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>LYMPHOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MANTLE CELL LYMPHOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047731-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060710</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>81.1939</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLISTER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CEFEPIME</medicinalproduct>
        <drugdosagetext>2GM  Q12H  IVPB</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ESCHERICHIA SEPSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060613</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060615</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CEFEPIME</medicinalproduct>
        <drugdosagetext>2GM  Q12H  IVPB</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>UROSEPSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060613</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060615</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CEFEPIME</medicinalproduct>
        <drugdosagetext>2GM  Q12H  IVPB</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ESCHERICHIA SEPSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060615</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CEFEPIME</medicinalproduct>
        <drugdosagetext>2GM  Q12H  IVPB</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>UROSEPSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060615</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047735-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060710</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>90</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>61</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOSYN</medicinalproduct>
        <drugdosagetext>3.375GM  Q8H  IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PNEUMONIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060603</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOSYN</medicinalproduct>
        <drugdosagetext>3.375GM  Q8H  IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>SEPSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060603</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLAGYL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VANCOMYCIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047737-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060710</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>61</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>88.1</patientweight>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>HEPATIC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSEUDOMONAS INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STAPHYLOCOCCAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ASPARAGENASE</medicinalproduct>
        <drugdosagetext>10,000 INT'L UNITS IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ACUTE LYMPHOCYTIC LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060329</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060404</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DAUNORUBICIN HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VINCRISTINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047739-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060621</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-AVENTIS-200611916JP</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>58</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>57</patientweight>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC FUNCTION ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTI-ORGAN FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAXOTERE</medicinalproduct>
        <drugauthorizationnumb>20449</drugauthorizationnumb>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>LIP AND/OR ORAL CAVITY CANCER STAGE III</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060605</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060605</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BRIPLATIN</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>LIP AND/OR ORAL CAVITY CANCER STAGE III</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060605</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060605</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTINEOPLASTIC AND IMMUNOSUPPRESSIVE AGENTS</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>LIP AND/OR ORAL CAVITY CANCER STAGE III</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060117</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060522</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047740-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060630</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AVENTIS-200616922GDDC</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>57</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>78.9</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERKALAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORTHOSTATIC HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAXOTERE</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>020449</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060629</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060629</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CISPLATIN</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060629</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060629</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE TAB</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugdosagetext>DOSE: 8 MG 12 HOURS AND 1 HOUR PRIOR TO CHEMO AND 12 HOURS POST CHEMO</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COMPAZINE</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COMPAZINE</medicinalproduct>
        <drugdosagetext>DOSE: 10 MG EVERY 6 HOURS FOR 48 HOURS</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047741-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>KR-AVENTIS-200616791GDDC</companynumb>
    <primarysource>
      <reportercountry>KOREA, REPUBLIC OF</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>61</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>59.4</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD CREATININE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEBRILE NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAXOTERE</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>20449</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060512</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060609</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CISPLATIN</medicinalproduct>
        <drugbatchnumb>YNK</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060512</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060609</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047742-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060524</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-AVENTIS-200611598JP</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>74</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ALANINE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AORTIC ARTERIOSCLEROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASPARTATE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE MARROW FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISSEMINATED INTRAVASCULAR COAGULATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ESCHERICHIA INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOLYTIC ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGIC DIATHESIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERKALAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JAUNDICE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER ABSCESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTI-ORGAN FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL TUBULAR NECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SHOCK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENTRICULAR FIBRILLATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAXOTERE</medicinalproduct>
        <drugauthorizationnumb>20449</drugauthorizationnumb>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>GASTRIC CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060317</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060317</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAXOTERE</medicinalproduct>
        <drugauthorizationnumb>020449</drugauthorizationnumb>
        <drugadministrationroute>041</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060421</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060421</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZANTAC</medicinalproduct>
        <drugdosagetext>DOSE: 1 AMPULE</drugdosagetext>
        <drugindication>PREMEDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SEROTONE</medicinalproduct>
        <drugdosagetext>DOSE: 1 AMPULE</drugdosagetext>
        <drugindication>PREMEDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DECADRON</medicinalproduct>
        <drugdosagetext>DOSE: 3 AMPLES</drugdosagetext>
        <drugindication>PREMEDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047743-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060710</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>69</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>JOINT SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FERRLECIT</medicinalproduct>
        <drugbatchnumb>056373</drugbatchnumb>
        <drugdosagetext>250MG  QWK  IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ANAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060707</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047744-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060710</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>59</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>61.2356</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FERRLECIT</medicinalproduct>
        <drugbatchnumb>05637</drugbatchnumb>
        <drugdosagetext>250MG  WEEKLY  IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ANAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060629</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047745-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060710</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>83.2804</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>RETINAL VEIN OCCLUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISION BLURRED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SILDENAFIL CITRATE</medicinalproduct>
        <drugdosagetext>25 MG  AS NEEDED  ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050614</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060302</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACCU-CHEK COMFORT CV (GLUCOSE) TEST STRIP</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CITALOPRAM HYDROBROMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLYBURIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORATADINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MELOXICAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HYDROCHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RANITIDINE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SILDENAFIL CITRATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047747-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060710</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>77</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ACUTE MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE CONGESTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY RETENTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARBIDOPA AND LEVODOPA</medicinalproduct>
        <drugdosagetext>ONE-HALF TABLET PO QAM</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PARKINSONIAN GAIT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060616</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060627</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARVEDILOL</medicinalproduct>
        <drugdosagetext>PO BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CARDIAC FAILURE CONGESTIVE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060621</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060627</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BICALUTAMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BISACODYL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARBIDOPA AND LEVODOPA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARVEDILOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CITALOPRAM HYDROBROMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYANOCOBALAMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOCUSATE NA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ISOSORBIDE DINITRATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORAZEPAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NITROGLYCERIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047748-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060505</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IT-AVENTIS-200614893GDDC</companynumb>
    <primarysource>
      <reportercountry>ITALY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>18</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANAPHYLACTIC SHOCK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONGENITAL HYPEREXTENSION OF SPINE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIPLOPIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEUKOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NERVOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NUCHAL RIGIDITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STARING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URTICARIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VERTIGO</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KETEK</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021144</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SINUSITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060413</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060419</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047751-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060710</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>84</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>66</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ATRIAL TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY FUNCTION TEST ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESTRICTIVE PULMONARY DISEASE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMIODARONE HCL</medicinalproduct>
        <drugdosagetext>200 MG QDAY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMIODARONE HCL -PACERONE-</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOCUSATE NA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ISOSORBIDE DINITRATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KETOCONAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TAR</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047754-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060710</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>56</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH ERYTHEMATOUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH PRURITIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UROSEPSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CIPROFLOXACIN</medicinalproduct>
        <drugdosagetext>750MG PO BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PERINEAL ABSCESS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060429</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060506</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CIPRO</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLAGYL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COLACE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047757-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060710</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>59</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>54.4316</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ALOPECIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOPAMAX</medicinalproduct>
        <drugindication>MIGRAINE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020302</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060704</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047759-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060131</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DK-BRISTOL-MYERS SQUIBB COMPANY-13353222</companynumb>
    <primarysource>
      <reportercountry>IRELAND</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>41</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PANCREATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>STAVUDINE</medicinalproduct>
        <drugauthorizationnumb>20412</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047760-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060710</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>76</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>65</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPONATRAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MAXZIDE</medicinalproduct>
        <drugdosagetext>PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047761-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060710</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>38</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>106</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BIPOLAR DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CHOLESTEROL ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARBAMAZEPINE</medicinalproduct>
        <drugdosagetext>100 MG -1/2 TAB- BID PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BIPOLAR DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060412</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060515</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugdosagetext>20 MG -1/2 TAB- QHS PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERLIPIDAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060425</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060515</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARBAMAZEPINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HYDROCHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRECISION XTRA -GLUCOSE- TEST STRIP</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRECISION XTRA METER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047764-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060710</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>37</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>118</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ILL-DEFINED DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URTICARIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URTICARIA GENERALISED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHEEZING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugdosagetext>2.5 MG QDAY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060412</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060501</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLOPIDOGREL BISULFATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>....</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRECISION XTRA -GLUCOSE- TEST STRIP</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SODIUM CHLORIDE 0.65% NASAL SOLN SPRAY</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRECISION XTRA METER</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047765-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060710</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>70</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>58.514</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANGIONEUROTIC OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EOSINOPHILIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWELLING FACE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWOLLEN TONGUE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugdosagetext>5 MG QD PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060623</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060707</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047766-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060517</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BE-AVENTIS-200612836EU</companynumb>
    <primarysource>
      <reportercountry>BELGIUM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>29</patientonsetage>
      <patientonsetageunit>803</patientonsetageunit>
      <patientweight>1.35</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD CREATININE ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD UREA ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEUKOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEONATAL RESPIRATORY DISTRESS SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA NEONATAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POLYURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WRONG TECHNIQUE IN DRUG USAGE PROCESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugauthorizationnumb>016363</drugauthorizationnumb>
        <drugdosagetext>DOSE: 10MG/KG</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>OEDEMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOBUTAMINE HCL</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CARDIAC FAILURE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060513</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOPAMINE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CARDIAC FAILURE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060513</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MORPHINE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>SEDATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060513</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047767-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060405</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-AVENTIS-200610951DE</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANURIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugauthorizationnumb>16363</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047768-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060502</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-AVENTIS-200611278DE</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABORTION INDUCED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRANSMISSION OF DRUG VIA SEMEN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARAVA</medicinalproduct>
        <drugauthorizationnumb>020905</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047769-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060530</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-AVENTIS-200611590DE</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABORTION INDUCED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLEXANE</medicinalproduct>
        <drugauthorizationnumb>20164</drugauthorizationnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PELVIC VENOUS THROMBOSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060501</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047770-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060701</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2006US08554</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>BLADDER MASS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMPUTERISED TOMOGRAM ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIVELLE-DOT</medicinalproduct>
        <drugauthorizationnumb>020538</drugauthorizationnumb>
        <drugdosagetext>0.0375 MG/DAY, BIW</drugdosagetext>
        <drugadministrationroute>062</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047771-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060710</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>58</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>81.1939</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BRONCHITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEBRILE NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOCALCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NASAL CONGESTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EPIRUBICIN</medicinalproduct>
        <drugdosagetext>90 MG/M2 EVERY 3 WEEKS IV BOLUS</drugdosagetext>
        <drugadministrationroute>040</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060210</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060414</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOPHOSPHAMIDE</medicinalproduct>
        <drugdosagetext>600 MG /M2 EVERY 3 WEEKS IV DRIP</drugdosagetext>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060210</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060414</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVAQUIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORAZEPAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COMPAZINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TESSALON</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047772-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060622</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>HQWYE824816FEB06</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>67</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>68.1</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ACUTE CORONARY SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AGITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD THYROID STIMULATING HORMONE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD TRIGLYCERIDES INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIOMYOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CAROTID ARTERY ATHEROMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CAROTID ARTERY STENOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEEP VEIN THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ELECTROCARDIOGRAM ST SEGMENT DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ELECTROCARDIOGRAM T WAVE INVERSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HIGH DENSITY LIPOPROTEIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL ISCHAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY RATE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RALOXIFENE, CONTROL FOR BAZEDOXIFENE ACETATE, CAPSULE)</medicinalproduct>
        <drugdosagetext>60 MG 1X PER 1 DAY, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020801</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTIVITAMINS, PLAIN (MULTIMVITAMINS, PLAIN)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</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>5047773-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060710</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>65</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>75</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LENALIDOMIDE 10 MG CELGENE</medicinalproduct>
        <drugdosagetext>10 MG QDX 21DAYS Q 28 DAYS PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MYELODYSPLASTIC SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060220</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060323</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LENALIDOMIDE 5 MG CELGENE</medicinalproduct>
        <drugdosagetext>5 MG QD 21 DAYS , Q28 DAYS PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MYELODYSPLASTIC SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060407</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060707</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047776-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060710</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>49</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CREATININE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE DIASTOLIC DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCORRECT DOSE ADMINISTERED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERIDONE</medicinalproduct>
        <drugdosagetext>8 MG PO QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060329</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BUPROPION HCL</medicinalproduct>
        <drugdosagetext>600 MG PO QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060329</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN 300 MG/CODEINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BUPROPION HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BUPROPION HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONIDINE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GATIFLOXACIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMIQUIMOD CREAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LABETALOL HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MINOXIDIL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047782-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060703</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-GILEAD-2006-0009833</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ACUTE CORONARY SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ACUTE MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FANCONI SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRUVADA</medicinalproduct>
        <drugindication>HIV INFECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TMC114</medicinalproduct>
        <drugindication>HIV INFECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TMC125</medicinalproduct>
        <drugindication>HIV INFECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>T20</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047789-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060626</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006-06-2089</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MEDICATION RESIDUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OBSTRUCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SCAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STENT PLACEMENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ISOSORBIDE MONONITRATE</medicinalproduct>
        <drugauthorizationnumb>20225</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047792-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060619</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>APP200600172</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>101</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <reaction>
        <reactionmeddrapt>BRADYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIDAZOLAM HCL</medicinalproduct>
        <drugbatchnumb>401658</drugbatchnumb>
        <drugauthorizationnumb>75154</drugauthorizationnumb>
        <drugdosagetext>2-4 MG, ONCE, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>SEDATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060616</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060616</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047794-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060516</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>06061784</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>72</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ALANINE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASPARTATE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CREATINE PHOSPHOKINASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD UREA INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHROMATURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOGLOBIN BLOOD INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOGLOBIN URINE PRESENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMIODARONE HYDROCHLORIDE</medicinalproduct>
        <drugauthorizationnumb>75424</drugauthorizationnumb>
        <drugdosagetext>200MG, QD, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CORONARY ARTERY BYPASS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040710</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040921</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugdosagetext>80MG, QD, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040813</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040921</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENALAPRIL MALEATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLIMEPIRIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047797-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060710</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>70</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>77.1115</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BONE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN JAW</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CREST WHITENING EXPRESSIONS TOOT PROCTOR AND GAMBLE</medicinalproduct>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047798-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060516</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>06061783</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>69</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY ALVEOLAR HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMIODARONE HYDROCHLORIDE</medicinalproduct>
        <drugauthorizationnumb>75424</drugauthorizationnumb>
        <drugdosagetext>200MG, QD, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARRHYTHMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANSOPRAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOCARBAMOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCODONE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RISPERIDONE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047801-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060710</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>47</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>99.4</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>RHABDOMYOLYSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DAPTOMYCIN 600 MG</medicinalproduct>
        <drugdosagetext>600 MG DAILY IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>DEVICE RELATED INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060525</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060531</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ERTAPENEM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047805-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060710</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>55</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>111.5849</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ACUTE RESPIRATORY DISTRESS SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DECREASED APPETITE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FAECES DISCOLOURED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMODIALYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATOTOXICITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JAUNDICE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEUKOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL INTAKE REDUCED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALLOR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA LEGIONELLA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>REFUSAL OF TREATMENT BY RELATIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARAVA</medicinalproduct>
        <drugdosagetext>20 MG EVERY OTHER DAY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PSORIATIC ARTHROPATHY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugdosagetext>25 MG EVERY DAY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PSORIATIC ARTHROPATHY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047807-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060710</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>67.1324</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>LETHARGY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOTIC THROMBOCYTOPENIC PURPURA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEPTRA DS</medicinalproduct>
        <drugdosagetext>1 TABLET BID PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>URINARY TRACT INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060605</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060607</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047810-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060710</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>59</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>EPISTAXIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATOCRIT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERNATIONAL NORMALISED RATIO DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENOXAPARIN SODIUM</medicinalproduct>
        <drugdosagetext>90 MG SQ Q12H</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>AORTIC VALVE REPLACEMENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060418</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060421</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
        <drugdosagetext>5 MG DAILY</drugdosagetext>
        <drugindication>AORTIC VALVE REPLACEMENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060418</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060421</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVENOX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AFRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BACTRIM DS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAXOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARANESP</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDRALAZINE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IRON SULFATETHIAMIN COMPOUND TAB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NITROGLYCERIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COLACE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047812-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060710</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>75</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>64</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOPTYSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TARGRETIN</medicinalproduct>
        <drugbatchnumb>PHANO48</drugbatchnumb>
        <drugdosagetext>675 MG QD PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MESOTHELIOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060608</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060705</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TARGRETIN</medicinalproduct>
        <drugbatchnumb>PHANO48</drugbatchnumb>
        <drugdosagetext>675 MG QD PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>METASTASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060608</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060705</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOCETAXOL 10 MG /CC AVENTIS</medicinalproduct>
        <drugbatchnumb>D6A207</drugbatchnumb>
        <drugdosagetext>62 MG Q WEEKSX3/4 WEEK IV DRIP</drugdosagetext>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>MESOTHELIOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060608</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060705</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOCETAXOL 10 MG /CC AVENTIS</medicinalproduct>
        <drugbatchnumb>D6A207</drugbatchnumb>
        <drugdosagetext>62 MG Q WEEKSX3/4 WEEK IV DRIP</drugdosagetext>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>METASTASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060608</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060705</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVENOX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVAQUIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047814-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060626</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-US184248</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEULASTA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>CHEMOTHERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060616</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOCETAXEL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOXORUBICIN HYDROCHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYCLOPHOSPHAMIDE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047815-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060626</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-US183514</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ARTERIOVENOUS FISTULA SITE HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EPOETIN ALFA</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>DIALYSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050725</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060612</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047816-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060710</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>62</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>EXCORIATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN OF SKIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH PRURITIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN EXFOLIATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMOXICILLIN + CLAVULANATE POTASSIUM</medicinalproduct>
        <drugdosagetext>PO BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CELLULITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060606</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060610</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KEFLEX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AUGMENTIN '125'</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LACTULOSE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRONOLACTONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM CHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALADERM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZINC OXIDE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047818-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060710</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>48</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>67.3</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VANCOMYCIN</medicinalproduct>
        <drugdosagetext>1 GM Q 12 HOURS IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ARTHRITIS INFECTIVE</drugindication>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VANCOMYCIN</medicinalproduct>
        <drugdosagetext>1 GM Q 12 HOURS IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>STAPHYLOCOCCAL INFECTION</drugindication>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047819-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060710</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>76</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>60.3284</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD SODIUM DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BARIUM</medicinalproduct>
        <drugdosagetext>1 QUART W/O CONTRATE</drugdosagetext>
        <drugindication>GASTRIC DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060615</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060615</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BARIUM</medicinalproduct>
        <drugdosagetext>1 QUART W/O CONTRATE</drugdosagetext>
        <drugindication>NASOPHARYNGEAL DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060615</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060615</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047820-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060710</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>85</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>90</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METOPROLOL SUCCINATE</medicinalproduct>
        <drugdosagetext>75 MG -1+ 1/2 TAB- BID PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060523</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060526</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUT/IPRATROP-COMBIVENT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CIPROFLOXACIN HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLIPIZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GUAIFENESIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HYDROCHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MOMETASONE FUROATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRAZOSIN HCL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047821-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20051209</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FI-AMGEN-UK161340</companynumb>
    <primarysource>
      <reportercountry>FINLAND</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>48</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARANESP</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RENAL FAILURE CHRONIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050517</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MYFORTIC</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050407</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060123</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELLCEPT</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050316</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050406</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COZAAR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050511</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ETALPHA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050726</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FURESIS</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051102</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KALCIPOS</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050511</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LESCOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050511</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDROL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050906</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IRON</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050511</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SOMAC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050511</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047822-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060626</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>SPV1-2006-00123</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANOREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BINGE EATING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG DEPENDENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG TOLERANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EUPHORIC MOOD</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IRRITABILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ADDERALL 10</medicinalproduct>
        <drugauthorizationnumb>11522</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047823-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060620</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AVENTIS-200615353US</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>50</patientweight>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRAIN DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG PRESCRIBING ERROR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOGLYCAEMIC COMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEDICATION ERROR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMARYL</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>20496</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060318</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMINYL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047824-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-AVENTIS-200611987JP</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>26</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CAESAREAN SECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CALCINOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FOETAL GROWTH RETARDATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLACENTAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLACENTAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
        <drugauthorizationnumb>021081</drugauthorizationnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>DIABETES MELLITUS INSULIN-DEPENDENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040720</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NOVORAPID</medicinalproduct>
        <drugdosagetext>DOSE: 58-64 UNITS/DAY</drugdosagetext>
        <drugindication>DIABETES MELLITUS INSULIN-DEPENDENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040517</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047825-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060417</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AVENTIS-200613789US</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE FLUCTUATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRONCHITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE CONGESTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY OEDEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021081</drugauthorizationnumb>
        <drugdosagetext>DOSE UNIT: UNITS</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OPTICLIK (INSULIN INJECTION PEN)</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021081</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047826-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060626</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006AL001604</companynumb>
    <primarysource>
      <reportercountry>TAIWAN, PROVINCE OF CHINA</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>68</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>NEUROLEPTIC MALIGNANT SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHABDOMYOLYSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMANTADINE HCL</medicinalproduct>
        <drugauthorizationnumb>77659</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLONAZEPAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRAZODONE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VENLAFAXINE HCL</medicinalproduct>
        <drugdosagetext>75 MG;QD</drugdosagetext>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUOXETINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BUSPIRONE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROPRANOLOL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047827-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060710</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>83.5</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSGEUSIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORMOTEROL 12 MCG SCHERING</medicinalproduct>
        <drugdosagetext>ONE CAPSULE BID PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050225</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060301</drugenddate>
        <drugtreatmentduration>12</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047830-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060327</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006BH011483</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>58</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE CONGESTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEDICAL DEVICE COMPLICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIANEAL</medicinalproduct>
        <drugauthorizationnumb>17512</drugauthorizationnumb>
        <drugdosagetext>IP</drugdosagetext>
        <drugadministrationroute>033</drugadministrationroute>
        <drugindication>DIALYSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047832-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060710</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>84</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>66</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ATRIAL FIBRILLATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ATRIAL TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY FUNCTION TEST DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESTRICTIVE PULMONARY DISEASE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMIODARONE HCL</medicinalproduct>
        <drugdosagetext>200 MG QDAY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PACERONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOCUSATE SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ISOSORBIDE DINITRATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KETOCONAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047836-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060626</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-AMGEN-US184257</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CHOLESTASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROENTERITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER FUNCTION TEST ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CINACALCET</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERPARATHYROIDISM SECONDARY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051209</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047839-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060706</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>59</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>97.977</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANGER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLISTER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER FUNCTION TEST ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FUNCTION TEST ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWELLING FACE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URTICARIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ADVAIR DISKUS 250/50</medicinalproduct>
        <drugbatchnumb>5ZP5059</drugbatchnumb>
        <drugdosagetext>250/50     2 TIMES A DAY   OROPHARINGE</drugdosagetext>
        <drugadministrationroute>049</drugadministrationroute>
        <drugindication>CHEST DISCOMFORT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060419</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060420</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ADVAIR DISKUS 250/50</medicinalproduct>
        <drugbatchnumb>5ZP5059</drugbatchnumb>
        <drugdosagetext>250/50     2 TIMES A DAY   OROPHARINGE</drugdosagetext>
        <drugadministrationroute>049</drugadministrationroute>
        <drugindication>COUGH</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060419</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060420</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047843-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060706</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>81</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLANK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATOCRIT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERNATIONAL NORMALISED RATIO INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RETROPERITONEAL HAEMATOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
        <drugdosagetext>WARFARIN 5MG PO QHS, EXCEPT  7.5MG ON MO + FR</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050422</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060303</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADVAIR DISKUS 100/50</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>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047845-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060706</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>42</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>89.8122</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ACTIVITIES OF DAILY LIVING IMPAIRED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISORIENTATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG DOSE OMISSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG WITHDRAWAL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EFFEXOR</medicinalproduct>
        <drugdosagetext>75MG   ONCE   PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MIGRAINE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060601</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047849-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060706</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SENSORCAINE</medicinalproduct>
        <drugbatchnumb>LP2245</drugbatchnumb>
        <drugdosagetext>EPIDURAL</drugdosagetext>
        <drugadministrationroute>008</drugadministrationroute>
        <drugindication>EPIDURAL ANAESTHESIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060630</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047851-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060706</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>54</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>79.3795</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MEDICATION ERROR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POOR QUALITY DRUG ADMINISTERED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPEECH DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TARDIVE DYSKINESIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>THIORIDAZINE HCL</medicinalproduct>
        <drugdosagetext>1 TABLET BY MOUTH AT BEDTIME   AT NIGHT</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BIPOLAR DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047852-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060627</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>007869</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BREAST CANCER FEMALE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MEDROXYPROGESTERONE</medicinalproduct>
        <drugauthorizationnumb>40159</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20000901</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMPHASE (PREMARIN;CYCRIN 14/14)</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20000901</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMPRO</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20000901</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047855-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060626</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>007873</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>71</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BREAST CANCER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MEDROXYPROGESTERONE ACETATE</medicinalproduct>
        <drugauthorizationnumb>40159</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19830101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010501</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19830101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010501</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROVERA</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19830101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010501</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047856-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060706</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>71</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>95.2554</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARRHYTHMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUS TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVAQUIN</medicinalproduct>
        <drugdosagetext>500 MG  QD  PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PNEUMONIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060508</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060517</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047858-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060626</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>007864</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>52</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BREAST CANCER FEMALE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MEDROXYPROGESTERONE ACETATE</medicinalproduct>
        <drugauthorizationnumb>40159</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19950101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20000901</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19950101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20000901</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROVERA</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19950101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20000901</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047860-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060706</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>70</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INADEQUATE ANALGESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCORRECT DOSE ADMINISTERED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LETHARGY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHADONE HCL</medicinalproduct>
        <drugdosagetext>20MG Q4-5H    PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BACK PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051025</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060705</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXYCODONE AND ACETAMINOPHEN</medicinalproduct>
        <drugdosagetext>2 PO  BID       PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BACK PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060307</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060705</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARFARIN NA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOSINOPRIL NA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM CHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GEMFIBROZIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HYDROCHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GABAPENTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARBIDOPA AND LEVODOPA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FINASTERIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOCUSATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MECLIZINE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHYLCELLULOSE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047863-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060619</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-2006-010290</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>66</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>DEPRESSED LEVEL OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POST PROCEDURAL COMPLICATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BETASERON</medicinalproduct>
        <drugdosagetext>SUBCUTANEOUS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19950316</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REBIF</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAZODONE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BACLOFEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DITROPAN XL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047864-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060706</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>79</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>48.5349</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANGIONEUROTIC OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugdosagetext>5 MG     DAILY    PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PAROXETINE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DILANTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALPROIC ACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MIRTAZAPINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TERAZOSIN HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM CHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IPRATROPIUM NEB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUNISOLIDE MDI</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>ALBUTEROL NEB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SUCRALFATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IPRATROPIUM BROMIDE MDI</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOCUSATE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047867-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060626</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>007879</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>56</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BREAST CANCER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MEDROXYPROGESTERONE ACETATE</medicinalproduct>
        <drugauthorizationnumb>40159</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19930101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020301</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMPRO</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19930101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020301</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19930101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020301</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROVERA</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19930101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020301</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ESTRADIOL</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19930101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020301</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ESTRACE</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19930101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020301</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047869-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
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    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
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    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>55</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BREAST CANCER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MEDROXYPROGESTERONE ACETATE</medicinalproduct>
        <drugauthorizationnumb>40159</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19960101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020301</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMPRO</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19960101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020301</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROVERA</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19960101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020301</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ESTRATAB</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19960101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020301</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047872-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060626</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>007865</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BREAST CANCER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MEDROXYPROGESTERONE ACETATE</medicinalproduct>
        <drugauthorizationnumb>40159</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19970101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030301</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19970101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030301</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROVERA</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19970101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030301</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMPHASE (PREMARIN;CYCRIN 14/14)</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19970101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030301</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMPRO</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19970101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030301</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047874-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060622</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006080727</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEXTRA</medicinalproduct>
        <drugauthorizationnumb>21341</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047878-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060616</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006SP002449</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>60</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>63.5036</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANOREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRONCHITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUID RETENTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XOPENEX</medicinalproduct>
        <drugauthorizationnumb>20837</drugauthorizationnumb>
        <drugdosagetext>0.63 MG;QID;INHALATION</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XOPENEX</medicinalproduct>
        <drugauthorizationnumb>20837</drugauthorizationnumb>
        <drugdosagetext>0.63 MG;QID;INHALATION</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IPRATROPIUM BROMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLOVENT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACTONEL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYGEN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047880-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060710</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>32</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>81.6475</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG DEPENDENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG WITHDRAWAL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IRRITABILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARANOIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREATMENT NONCOMPLIANCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EFFEXOR XR</medicinalproduct>
        <drugdosagetext>DONT REMEMBER 1X DAY PO [SEVERAL YEARS]</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EFFEXOR XR</medicinalproduct>
        <drugdosagetext>DONT REMEMBER 1X DAY PO [SEVERAL YEARS]</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG WITHDRAWAL SYNDROME</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
        <drugdosagetext>2 TABLETS -INITIALLY- 1X DAY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PARANOIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020815</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060701</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047882-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060622</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006SP002202</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>41</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MENINGITIS ASEPTIC</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LUNESTA</medicinalproduct>
        <drugauthorizationnumb>21476</drugauthorizationnumb>
        <drugdosagetext>2 MG;HS;ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060510</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ADVIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XYREM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047885-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040917</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0526206A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>20</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>60</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>COMPLETED SUICIDE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GUN SHOT WOUND</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEAD INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREATMENT NONCOMPLIANCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
        <drugauthorizationnumb>20936</drugauthorizationnumb>
        <drugdosagetext>12.5MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040719</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADDERALL XR 10</medicinalproduct>
        <drugdosagetext>30MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATTENTION DEFICIT/HYPERACTIVITY DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020228</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047886-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050509</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0558603A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>32</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CRYING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG WITHDRAWAL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRY MOUTH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERECTILE DYSFUNCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HOMICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMPULSIVE BEHAVIOUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IRRITABILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSYCHOMOTOR HYPERACTIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEXUAL DYSFUNCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
        <drugauthorizationnumb>20031</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19970501</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAROXETINE HCL</medicinalproduct>
        <drugauthorizationnumb>020031</drugauthorizationnumb>
        <drugdosagetext>40MG UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BUSPIRONE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALTREX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047887-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050817</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0570763A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>20</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>61.4</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>COMPLETED SUICIDE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SELF MUTILATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
        <drugauthorizationnumb>20031</drugauthorizationnumb>
        <drugdosagetext>10MG AT NIGHT</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANXIETY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010723</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAXIL CR</medicinalproduct>
        <drugauthorizationnumb>020936</drugauthorizationnumb>
        <drugdosagetext>12.5MG UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TENEX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADDERALL 10</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CONCERTA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VERELAN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047888-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060228</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0595530A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>74</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLINDNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CATARACT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CUSHINGOID</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPHONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GOITRE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARYNGOLARYNGEAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLOVENT</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>20548</drugauthorizationnumb>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20011101</drugstartdate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLOVENT</medicinalproduct>
        <drugbatchnumb>0027</drugbatchnumb>
        <drugauthorizationnumb>021433</drugauthorizationnumb>
        <drugadministrationroute>055</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THEOPHYLLINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACIPHEX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BLOOD PRESSURE MEDICINES</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047889-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060710</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>124.7392</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GLIPIZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIGOXIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DILTIAZEM HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPRAL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONADINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SULAR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARDURA</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047890-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060323</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0598824A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>64</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL DISTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE ATROPHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEURALGIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VALTREX</medicinalproduct>
        <drugauthorizationnumb>020487</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HERPES ZOSTER</drugindication>
        <drugtreatmentduration>90</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047891-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesscongenitalanomali>1</seriousnesscongenitalanomali>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060522</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0606554A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>0.4</patientweight>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PREMATURE LABOUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRISOMY 18</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRIZIVIR</medicinalproduct>
        <drugauthorizationnumb>21205</drugauthorizationnumb>
        <drugdosagetext>1TAB TWICE PER DAY</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060131</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KALETRA</medicinalproduct>
        <drugdosagetext>2U TWICE PER DAY</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060131</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BACTRIM</medicinalproduct>
        <drugdosagetext>1U THREE TIMES PER WEEK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060131</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZIDOVUDINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047892-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060518</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0606832A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>30</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABORTION SPONTANEOUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEXIVA</medicinalproduct>
        <drugauthorizationnumb>21548</drugauthorizationnumb>
        <drugdosagetext>700MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMBIVIR</medicinalproduct>
        <drugauthorizationnumb>020857</drugauthorizationnumb>
        <drugdosagetext>2TAB PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060412</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRUVADA</medicinalproduct>
        <drugdosagetext>1TAB PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RITONAVIR</medicinalproduct>
        <drugdosagetext>100MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KALETRA</medicinalproduct>
        <drugdosagetext>6CAP PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060412</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047893-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesscongenitalanomali>1</seriousnesscongenitalanomali>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060519</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0606847A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>3</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEVELOPMENTAL DELAY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE MOVEMENT DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRISOMY 15</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRIZIVIR</medicinalproduct>
        <drugauthorizationnumb>21205</drugauthorizationnumb>
        <drugdosagetext>1500MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050330</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050525</drugenddate>
        <drugtreatmentduration>57</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMBIVIR</medicinalproduct>
        <drugauthorizationnumb>020857</drugauthorizationnumb>
        <drugdosagetext>900MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050603</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051227</drugenddate>
        <drugtreatmentduration>208</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RETROVIR</medicinalproduct>
        <drugauthorizationnumb>019655</drugauthorizationnumb>
        <drugdosagetext>600MG PER DAY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051103</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051103</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</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>20050603</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051227</drugenddate>
        <drugtreatmentduration>208</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NORVIR</medicinalproduct>
        <drugdosagetext>100MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040316</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050330</drugenddate>
        <drugtreatmentduration>380</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KALETRA</medicinalproduct>
        <drugdosagetext>996MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050330</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050525</drugenddate>
        <drugtreatmentduration>57</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>20040316</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050330</drugenddate>
        <drugtreatmentduration>380</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRUVADA</medicinalproduct>
        <drugdosagetext>500MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040316</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050330</drugenddate>
        <drugtreatmentduration>380</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRIMETHOPRIM + SULFAMETHOXAZOLE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047894-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060612</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2005-127269-NL</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>89</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HIP FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPONATRAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POSTOPERATIVE INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ADVAIR DISKUS 100/50</medicinalproduct>
        <drugauthorizationnumb>21077</drugauthorizationnumb>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ANCEF</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYLENOL (CAPLET)</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMERON</medicinalproduct>
        <drugdosagetext>15MG AT NIGHT</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050315</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ULTRAM</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOCUSATE SODIUM</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEPCID</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LOVENOX</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALDACTONE</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KEFLEX</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SLOW-MAG</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRO-BANTHINE</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEXTRA</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COZAAR</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DARVOCET</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DUONEB</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050315</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EFFEXOR XR</medicinalproduct>
        <drugdosagetext>225MG PER DAY</drugdosagetext>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050315</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRAZODONE HCL</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUTICASONE PROPIONATE</medicinalproduct>
        <drugadministrationroute>055</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047895-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060619</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0609567A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>49</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISTURBANCE IN ATTENTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG WITHDRAWAL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANIC ATTACK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>20031</drugauthorizationnumb>
        <drugdosagetext>10MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MAJOR DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980101</drugstartdate>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
        <drugauthorizationnumb>020710</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMBIEN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047896-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060622</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0610011A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>55</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>59.1</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANGIONEUROTIC OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH PAPULAR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MEPRON</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020500</drugauthorizationnumb>
        <drugdosagetext>750MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BABESIOSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060608</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060615</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AZITHROMYCIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BABESIOSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060608</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060615</drugenddate>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047897-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060703</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>452559</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>89</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HIP FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPONATRAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POSTOPERATIVE INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugauthorizationnumb>20297</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SPIRONOLACTONE</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CEFAZOLIN</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUTICASONE PROPIONATE</medicinalproduct>
        <drugauthorizationnumb>020121</drugauthorizationnumb>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PARACETAMOL</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIRTAZAPINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050315</drugenddate>
        <drugtreatmentduration>1096</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRAMADOL HCL</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOCUSATE 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>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FAMOTIDINE</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENOXAPARIN SODIUM</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CEPHALEXIN</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MAGNESIUM CHLORIDE</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROPANTHELINE BROMIDE</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEXTRA</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LOSARTAN POTASSIUM</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMLODIPINE</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DARVOCET</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DUONEB</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050315</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VENLAFAXINE HCL</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050315</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRAZODONE HCL</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047899-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060706</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0611302A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OESOPHAGEAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVODART</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021319</drugauthorizationnumb>
        <drugdosagetext>.5MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BENIGN PROSTATIC HYPERPLASIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060401</drugenddate>
        <drugtreatmentduration>17</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLOMAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAMBOCOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMINE E</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>K-DUR 10</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALTRATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CENTRUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMINE C</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN B-12</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROTONIX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047900-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060705</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0611483A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>10</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRY EYE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MADAROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SCAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STEVENS-JOHNSON SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMICTAL</medicinalproduct>
        <drugauthorizationnumb>020241</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>EPILEPSY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19950101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047901-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060707</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0611614A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CAECUM OPERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC OPERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIALYSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LOTRONEX</medicinalproduct>
        <drugauthorizationnumb>021107</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>IRRITABLE BOWEL SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OTHER MEDICATIONS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047902-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060710</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0611644A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>59</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CATATONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>WELLBUTRIN</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021515</drugauthorizationnumb>
        <drugdosagetext>300MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KLONOPIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047903-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060710</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0611659A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>AGGRESSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLOVENT</medicinalproduct>
        <drugauthorizationnumb>020121</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047904-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060707</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-GLAXOSMITHKLINE-A0611660A</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>57</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HEPATIC CIRRHOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>4MG UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047905-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BE-GLAXOSMITHKLINE-B0408239A</companynumb>
    <primarysource>
      <reportercountry>BELGIUM</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>22</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>52</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANOREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISTURBANCE IN ATTENTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEARNING DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MIDDLE INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALLOR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROXAT</medicinalproduct>
        <drugauthorizationnumb>20031</drugauthorizationnumb>
        <drugdosagetext>20MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051206</drugstartdate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047906-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060403</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-JPN-A200601127</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>33</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>41</patientweight>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BUPROPION HCL</medicinalproduct>
        <drugauthorizationnumb>21515</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050906</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060220</drugenddate>
        <drugtreatmentduration>168</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047907-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060428</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-JPN-A200601447</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>67</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>57</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD LACTATE DEHYDROGENASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHILLS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CYANOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERSTITIAL LUNG DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
        <drugauthorizationnumb>20031</drugauthorizationnumb>
        <drugdosagetext>10MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANXIETY DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060303</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060330</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HYPEN</medicinalproduct>
        <drugdosagetext>200MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CERVICAL MYELOPATHY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060222</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060330</drugenddate>
        <drugtreatmentduration>37</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CERCINE</medicinalproduct>
        <drugdosagetext>5MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANXIETY DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060309</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060330</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MUCOSTA</medicinalproduct>
        <drugdosagetext>100MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060222</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060330</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LENDORMIN</medicinalproduct>
        <drugdosagetext>.25MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INSOMNIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060222</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060330</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLOMAX</medicinalproduct>
        <drugdosagetext>300MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>UPPER RESPIRATORY TRACT INFLAMMATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060328</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060330</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PL</medicinalproduct>
        <drugdosagetext>3G PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>UPPER RESPIRATORY TRACT INFLAMMATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060328</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060330</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047908-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060505</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BE-GLAXOSMITHKLINE-B0423280A</companynumb>
    <primarysource>
      <reportercountry>BELGIUM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>60</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>NORMAL DELIVERY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROXAT</medicinalproduct>
        <drugauthorizationnumb>20031</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MAJOR DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047909-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060518</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-JPN-A200601640</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>81</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>31</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ILEUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTESTINAL OBSTRUCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
        <drugauthorizationnumb>20031</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060427</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060518</drugenddate>
        <drugtreatmentduration>22</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THYRADIN S</medicinalproduct>
        <drugdosagetext>25MCG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPOTHYROIDISM</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060512</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047910-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060524</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-B0425208A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>34</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>78</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHILLS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALATAL OEDEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOFRAN</medicinalproduct>
        <drugauthorizationnumb>20007</drugauthorizationnumb>
        <drugdosagetext>4MG SINGLE DOSE</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PROPHYLAXIS OF NAUSEA AND VOMITING</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060523</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060523</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PLACEBO</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PROPHYLAXIS OF NAUSEA AND VOMITING</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060523</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060523</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047911-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060605</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHC2-006</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>74</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ALOPECIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANOREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEILITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MONOCYTE COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</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>STOMATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NOGITECAN HYDROCHLORIDE</medicinalproduct>
        <drugauthorizationnumb>20671</drugauthorizationnumb>
        <drugdosagetext>1MGM2 PER DAY</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060120</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060523</drugenddate>
        <drugtreatmentduration>124</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CISPLATIN</medicinalproduct>
        <drugdosagetext>60MGM2 PER DAY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>SMALL CELL CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060120</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060519</drugenddate>
        <drugtreatmentduration>120</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047912-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060608</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-JPN-A200601918</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>35</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <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>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>C-REACTIVE PROTEIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAMMA-GLUTAMYLTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
        <drugauthorizationnumb>020031</drugauthorizationnumb>
        <drugdosagetext>40MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INSOMNIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060501</drugstartdate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALPRAZOLAM</medicinalproduct>
        <drugdosagetext>1.2MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INSOMNIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HORIZON</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INSOMNIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEDOLPER</medicinalproduct>
        <drugdosagetext>.25MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INSOMNIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN MEDICATION</medicinalproduct>
        <drugdosagetext>10MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INSOMNIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VEGETAMIN A</medicinalproduct>
        <drugdosagetext>3U PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INSOMNIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEPAS</medicinalproduct>
        <drugdosagetext>1MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INSOMNIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RESLIN</medicinalproduct>
        <drugdosagetext>50MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INSOMNIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060606</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACTIT</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>DEHYDRATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060606</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060618</drugenddate>
        <drugtreatmentduration>13</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOSE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>DEHYDRATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060606</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060612</drugenddate>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN MEDICATION</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>HYPOPHOSPHATAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060606</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060612</drugenddate>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047913-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>T200600706</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>57</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URTICARIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MD-GASTROVIEW(DIATRIZOATE MEGLUMINE, DIATRIZOATE SODIUM) SOLUTION, 120</medicinalproduct>
        <drugbatchnumb>L187A</drugbatchnumb>
        <drugauthorizationnumb>87388</drugauthorizationnumb>
        <drugdosagetext>60 ML, SINGLE, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>COMPUTERISED TOMOGRAM ABDOMEN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060624</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060624</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREVACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOPRESSOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ESZOPICLONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEXAPRO</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VYTORIN (SIMVASTATIN, EZETIMIBE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRICOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX /00032601/ (FUROSEMIDE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WELLBUTRIN /00700501/ (BUPROPION)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NITRO (GLYCERYL TRINITRATE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METANX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PACERONE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047914-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060613</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-JPN-A200602044</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>28</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HYPERPHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCREASED APPETITE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIBIDO INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
        <drugauthorizationnumb>020031</drugauthorizationnumb>
        <drugdosagetext>20MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060530</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060613</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047915-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060610</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ES-GLAXOSMITHKLINE-B0427639A</companynumb>
    <primarysource>
      <reportercountry>SPAIN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>72</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCREATITIS ACUTE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVODART</medicinalproduct>
        <drugauthorizationnumb>21319</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BENIGN PROSTATIC HYPERPLASIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050926</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060110</drugenddate>
        <drugtreatmentduration>107</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RENITEC</medicinalproduct>
        <drugdosagetext>20MG IN THE MORNING</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARDYL</medicinalproduct>
        <drugdosagetext>20MG AT NIGHT</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RYTHMOL</medicinalproduct>
        <drugdosagetext>150MG IN THE MORNING</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NIVADOR</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047917-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060621</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-JPN-A200602223</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>71</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>54</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SHOCK</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZANTAC</medicinalproduct>
        <drugauthorizationnumb>18703</drugauthorizationnumb>
        <drugdosagetext>4ML PER DAY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060620</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060620</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DECADRON</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SEISHOKU</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047918-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060705</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-GLAXOSMITHKLINE-B0429933A</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HEPATIC FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTUM</medicinalproduct>
        <drugauthorizationnumb>50578</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CEFTRIAXONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OTHER MEDICATIONS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047919-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060626</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-JPN-A200602275</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>52</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>76</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HALLUCINATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NERVOUS SYSTEM DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOVIRAX</medicinalproduct>
        <drugauthorizationnumb>020089</drugauthorizationnumb>
        <drugdosagetext>400MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HERPES ZOSTER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060623</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060625</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WYTENS</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADALAT</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARTIST</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRECIPITATED CALCIUM CARBONATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARDENALIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RENAGEL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALFAROL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRAVIT</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047920-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060703</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-JPN-A200602440</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>64</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DIABETES MELLITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZEFIX</medicinalproduct>
        <drugauthorizationnumb>20564</drugauthorizationnumb>
        <drugdosagetext>100MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS B</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041201</drugstartdate>
        <drugtreatmentduration>18</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CONIEL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEVALOTIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BASEN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047921-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060704</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-JPN-A200602472</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BONE MARROW FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOVIRAX</medicinalproduct>
        <drugauthorizationnumb>018603</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047922-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060705</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-GLAXOSMITHKLINE-B0430176A</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>ASTHMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLIXONASE</medicinalproduct>
        <drugauthorizationnumb>20121</drugauthorizationnumb>
        <drugadministrationroute>045</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNSPECIFIED INHALER</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047923-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060630</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-GLAXOSMITHKLINE-B0430269A</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>THROMBOCYTHAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HYCAMTIN</medicinalproduct>
        <drugauthorizationnumb>020671</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>OVARIAN CANCER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047924-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060701</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>EG-GLAXOSMITHKLINE-B0430365A</companynumb>
    <primarysource>
      <reportercountry>EGYPT</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>50</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HYCAMTIN</medicinalproduct>
        <drugauthorizationnumb>020671</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>OVARIAN CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060615</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060620</drugenddate>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047925-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060705</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IT-GLAXOSMITHKLINE-B0430397A</companynumb>
    <primarysource>
      <reportercountry>ITALY</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>75</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ALKALOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ATRIAL FIBRILLATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA MULTIFORME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AUGMENTIN '125'</medicinalproduct>
        <drugauthorizationnumb>050564</drugauthorizationnumb>
        <drugdosagetext>3G PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CELLULITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060607</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060615</drugenddate>
        <drugtreatmentduration>9</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
        <drugdosagetext>150MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RENAL FAILURE</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060619</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MOXIFLOXACIN HCL</medicinalproduct>
        <drugdosagetext>400MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CELLULITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060607</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060615</drugenddate>
        <drugtreatmentduration>9</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RAMIPRIL</medicinalproduct>
        <drugdosagetext>5MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RENAL FAILURE</drugindication>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047926-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060706</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IT-GLAXOSMITHKLINE-B0430408A</companynumb>
    <primarysource>
      <reportercountry>ITALY</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>61</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PEMPHIGOID</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MALARONE</medicinalproduct>
        <drugauthorizationnumb>021078</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MALARIA PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060108</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060121</drugenddate>
        <drugtreatmentduration>14</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLARITHROMYCIN</medicinalproduct>
        <drugdosagetext>500MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>TOOTH ABSCESS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060108</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060115</drugenddate>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047927-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060706</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CH-GLAXOSMITHKLINE-B0430409A</companynumb>
    <primarysource>
      <reportercountry>SWITZERLAND</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>71</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DERMATITIS EXFOLIATIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EOSINOPHILIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTAM</medicinalproduct>
        <drugauthorizationnumb>50578</drugauthorizationnumb>
        <drugdosagetext>2G THREE TIMES PER DAY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BACTERIAL INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060420</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060424</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMIKIN</medicinalproduct>
        <drugdosagetext>1G PER DAY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BACTERIAL INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060420</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060424</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COLISTIN</medicinalproduct>
        <drugdosagetext>1MU TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>BACTERIAL INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060420</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060424</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047928-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060710</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>55</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>142.8831</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>APPLICATION SITE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>APPLICATION SITE REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANIC ATTACK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SHOCK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ICYHOT EXTRA STRENGTH CHATTEM, INC, BOX 2219 CHATTANOOGA TN, 37409-021</medicinalproduct>
        <drugdosagetext>I USED A 1.2 INCH  ONCE TOP</drugdosagetext>
        <drugindication>BACK PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060707</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ICYHOT EXTRA STRENGTH CHATTEM, INC, BOX 2219 CHATTANOOGA TN, 37409-021</medicinalproduct>
        <drugdosagetext>I USED A 1.2 INCH  ONCE TOP</drugdosagetext>
        <drugindication>INTERVERTEBRAL DISC DEGENERATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060707</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>STEROID</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047929-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060710</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>39</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>79.3795</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGIC STROKE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVELOX</medicinalproduct>
        <drugdosagetext>400 MG ONCE DAILY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SINUSITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050618</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050623</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047930-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060710</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>68.0396</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH GENERALISED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
        <drugdosagetext>15 UNITS DAILY SQ</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>DIABETES MELLITUS INADEQUATE CONTROL</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047933-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060621</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>THYR-10318</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>39</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>THYROGEN</medicinalproduct>
        <drugauthorizationnumb>20898</drugauthorizationnumb>
        <drugdosagetext>0.9 MG ONCE IM</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>DIAGNOSTIC PROCEDURE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060619</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060620</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEMEROL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PHENERGAN HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DURAGESIC-100</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACIPHEX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MS CONTIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047934-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060710</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>97</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>GLAUCOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MACULAR OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSEUDOPHAKIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RETINAL DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ROSIGLITAZONE</medicinalproduct>
        <drugdosagetext>4 MG Q AM PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030909</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060615</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLENDIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047937-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060221</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006RL000228</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ELECTROCARDIOGRAM QT PROLONGED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVERDOSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RYTHMOL</medicinalproduct>
        <drugauthorizationnumb>19151</drugauthorizationnumb>
        <drugdosagetext>150 MG PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047940-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060622</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>226611</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>59</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HEPATITIS FULMINANT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RITUXAN</medicinalproduct>
        <drugindication>LYMPHOMA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047942-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060621</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>226599</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFUSION RELATED REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARTIAL SEIZURES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH PRURITIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWOLLEN TONGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URTICARIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RITUXAN</medicinalproduct>
        <drugindication>SYSTEMIC LUPUS ERYTHEMATOSUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060612</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELLCEPT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE TAB</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047956-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060710</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>58</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>96.1626</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BALANCE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CHOLESTEROL INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONTUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEMORY IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MIGRAINE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE ATROPHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN LACERATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugdosagetext>20 MG 1 PER DAY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040820</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060410</drugenddate>
        <drugtreatmentduration>20</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CRESTOR 10 MG -TO BE CUT IN HALF GLACO KLINE-</medicinalproduct>
        <drugdosagetext>5 MG 1 PER DAY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060520</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060523</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047958-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060710</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>55</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ALCOHOLISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROOESOPHAGEAL REFLUX DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERMITTENT CLAUDICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRESBYACUSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRESBYOPIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RIB FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOBACCO USER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WALKING AID USER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LORAZEPAM</medicinalproduct>
        <drugdosagetext>0.5 MG HS PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANXIETY</drugindication>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LORAZEPAM</medicinalproduct>
        <drugdosagetext>0.5 MG HS PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SLEEP DISORDER</drugindication>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMITRIPTYLINE HCL</medicinalproduct>
        <drugdosagetext>50 MG HS PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATROPINE 0.025 /DIPHENOXYLATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FIKUC ACUD</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRILOSEC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCODONE 7.5 /ACETAMINOPHEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORAZEPAM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047960-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060710</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>29</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>63.5036</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>AMNESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ROAD TRAFFIC ACCIDENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMBIEN</medicinalproduct>
        <drugdosagetext>5MG  ONCE DAILY ORALLY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SLEEP DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060628</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANCREASE FORTE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CITRACEL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRILOSEC OTC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EFFEXOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BUSPAR</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047963-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060705</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-BRISTOL-MYERS SQUIBB COMPANY-13432471</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>55</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INTESTINAL PERFORATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CISPLATIN</medicinalproduct>
        <drugauthorizationnumb>018057</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>GASTRIC CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060612</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060612</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUOROURACIL</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>GASTRIC CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060612</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060617</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SERTRALINE HCL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANXIETY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047964-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20021227</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DK-BRISTOL-MYERS SQUIBB COMPANY-13353115</companynumb>
    <primarysource>
      <reportercountry>BELGIUM</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>45</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCREATITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>STAVUDINE</medicinalproduct>
        <drugauthorizationnumb>020412</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMIVUDINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047965-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060117</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-13248331</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>74</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ACUTE MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ATRIAL FIBRILLATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CISPLATIN</medicinalproduct>
        <drugauthorizationnumb>18057</drugauthorizationnumb>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051214</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051214</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TS-1</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051214</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051227</drugenddate>
        <drugtreatmentduration>14</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZETIA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERCHOLESTEROLAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRICOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERCHOLESTEROLAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010901</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COZAAR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
        <drugauthorizationnumb>073318</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047966-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040531</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DK-BRISTOL-MYERS SQUIBB COMPANY-13353198</companynumb>
    <primarysource>
      <reportercountry>ESTONIA</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>51</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PANCREATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PURULENT PERICARDITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>STAVUDINE</medicinalproduct>
        <drugauthorizationnumb>20412</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMIVUDINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047970-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-BRISTOL-MYERS SQUIBB COMPANY-12854030</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>58</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>56</patientweight>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALIGNANT NEOPLASM PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ERBITUX</medicinalproduct>
        <drugdosagetext>INITIATED ON 26-OCT-04 (LD=600MG). D/C STUDY ON 23-NOV-04. PT REC'D 2 DOSES.</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLORECTAL CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041123</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOFLOXACIN</medicinalproduct>
        <drugindication>COUGH</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041021</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041123</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOSINOPRIL SODIUM</medicinalproduct>
        <drugauthorizationnumb>019915</drugauthorizationnumb>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19960101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041123</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RENEDIL</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19960101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041123</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATORVASTATIN CALCIUM</medicinalproduct>
        <drugindication>HYPERCHOLESTEROLAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041123</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047971-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060131</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DK-BRISTOL-MYERS SQUIBB COMPANY-13353255</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>46</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PANCREATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIDANOSINE</medicinalproduct>
        <drugauthorizationnumb>20154</drugauthorizationnumb>
        <drugindication>HIV INFECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>STAVUDINE</medicinalproduct>
        <drugauthorizationnumb>020412</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047972-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060131</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DK-BRISTOL-MYERS SQUIBB COMPANY-13353321</companynumb>
    <primarysource>
      <reportercountry>PORTUGAL</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>64</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCREATITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>STAVUDINE</medicinalproduct>
        <drugauthorizationnumb>020412</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMIVUDINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZIDOVUDINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047973-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060630</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-BRISTOL-MYERS SQUIBB COMPANY-13429766</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>38</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIO-RESPIRATORY ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SHOCK</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAXOL</medicinalproduct>
        <drugauthorizationnumb>020262</drugauthorizationnumb>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>OVARIAN CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060627</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060627</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HERCEPTIN</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>OVARIAN CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060626</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060626</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047974-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060131</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DK-BRISTOL-MYERS SQUIBB COMPANY-13414511</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>51</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CHOLECYSTITIS ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC ENCEPHALOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATITIS B VIRUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCREATITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>STAVUDINE</medicinalproduct>
        <drugauthorizationnumb>20412</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIDANOSINE</medicinalproduct>
        <drugauthorizationnumb>020154</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMIVUDINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ABACAVIR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TENOFOVIR</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047975-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060131</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DK-BRISTOL-MYERS SQUIBB COMPANY-13353271</companynumb>
    <primarysource>
      <reportercountry>LUXEMBOURG</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>48</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PANCREATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>T-CELL LYMPHOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIDANOSINE</medicinalproduct>
        <drugauthorizationnumb>20154</drugauthorizationnumb>
        <drugindication>HIV INFECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMIVUDINE</medicinalproduct>
        <drugindication>HIV INFECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZIDOVUDINE</medicinalproduct>
        <drugindication>HIV INFECTION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047980-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060710</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>86</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>58.9676</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugdosagetext>ONCE WEEKLY ORALLY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050601</drugenddate>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARDIZEM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FESO4</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047982-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060710</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <patientonsetage>92</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>72.5755</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INADEQUATELY CONTROLLED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG THERAPY CHANGED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL DISTURBANCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BENICAR</medicinalproduct>
        <drugdosagetext>20MG  ONCE DAILY ORALLY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060201</drugenddate>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIGOXIN</medicinalproduct>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DARVOCET</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACIPHEX</medicinalproduct>
      </drug>
    </patient>
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  <safetyreport>
    <safetyreportid>5047987-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
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    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
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    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>59</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>52.6173</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NERVOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANIC ATTACK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POOR QUALITY DRUG ADMINISTERED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMITRIPTYLINE HYDROCHLORIDE 25MG YELLOW TAB</medicinalproduct>
        <drugdosagetext>75MG X1  PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060606</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060706</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047988-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041103</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHNU2004DE03728</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>58</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ORAL SURGERY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOMYELITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERIODONTITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYOGENIC GRANULOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTH EXTRACTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHEMOTHERAPEUTICS,OTHER</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>BREAST CANCER METASTATIC</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIGITOXIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MICARDIS</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BISOPROLOL FUMARATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BISPHOSPHONATES</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugauthorizationnumb>021223</drugauthorizationnumb>
        <drugdosagetext>UNK, UNK</drugdosagetext>
        <drugindication>BREAST CANCER METASTATIC</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047989-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060523</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2006US06825</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>67</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BONE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DENTAL CARIES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DENTAL EXAMINATION ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GINGIVAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOCAL SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPH NODE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPHADENOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOMYELITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN JAW</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERIODONTAL DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POOR PERSONAL HYGIENE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOFT TISSUE INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTH EXTRACTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
        <drugdosagetext>10 MG, PRIOR TO CHEMO ONLY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE BESYLATE</medicinalproduct>
        <drugdosagetext>5 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMARYL</medicinalproduct>
        <drugdosagetext>4 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugdosagetext>6.25 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRINIVIL</medicinalproduct>
        <drugdosagetext>20 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PIOGLITAZONE HYDROCHLORIDE</medicinalproduct>
        <drugdosagetext>45 MG, QD PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAXOL</medicinalproduct>
        <drugdosagetext>160 MG, IVPB Q WEEK</drugdosagetext>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050418</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugauthorizationnumb>021223</drugauthorizationnumb>
        <drugdosagetext>4 MG MONTHLY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>METASTASES TO BONE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060410</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047990-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060605</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2006US07255</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>82</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BONE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREVENGE</medicinalproduct>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ELIGARD</medicinalproduct>
        <drugindication>PROSTATE CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040831</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DES</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050613</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMBIEN</medicinalproduct>
        <drugdosagetext>10MG UNK</drugdosagetext>
        <drugindication>INSOMNIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041210</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCODONE HCL</medicinalproduct>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041210</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050601</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALEVE (CAPLET)</medicinalproduct>
        <drugdosagetext>2TABS UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041210</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugdosagetext>200MG UNK</drugdosagetext>
        <drugindication>ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041007</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041202</drugenddate>
        <drugtreatmentduration>82080</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
        <drugdosagetext>25MG UNK</drugdosagetext>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050601</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADALAT</medicinalproduct>
        <drugdosagetext>90MG UNK</drugdosagetext>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugauthorizationnumb>021223</drugauthorizationnumb>
        <drugdosagetext>4MG UNK</drugdosagetext>
        <drugindication>METASTASES TO BONE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031219</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050106</drugenddate>
        <drugtreatmentduration>385</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047993-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060710</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>50</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>TONSIL CANCER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugdosagetext>COUPLE OF YEARS</drugdosagetext>
        <drugindication>ANKYLOSING SPONDYLITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugdosagetext>PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047995-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060710</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>57</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CHILLS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROAT IRRITATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HERCEPTIN</medicinalproduct>
        <drugdosagetext>IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5047998-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060710</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>EGYPT</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>77</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>88</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ATRIOVENTRICULAR BLOCK SECOND DEGREE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUS BRADYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUPRAVENTRICULAR EXTRASYSTOLES</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAMSULOSIN HCL</medicinalproduct>
        <drugdosagetext>0.4MG  ONCE DAILY  BUCCAL</drugdosagetext>
        <drugadministrationroute>002</drugadministrationroute>
        <drugindication>PROSTATE EXAMINATION ABNORMAL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060612</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060707</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048001-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060710</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>51</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>90.7194</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>AGITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ALCOHOLISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANGER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CRYING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSED MOOD</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISTURBANCE IN ATTENTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG WITHDRAWAL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EMOTIONAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FOOD CRAVING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HALLUCINATION, AUDITORY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMPAIRED WORK ABILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EFFEXOR</medicinalproduct>
        <drugdosagetext>75MG  ONE PER DAY  PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIVORCED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060610</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048004-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041103</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHNU2004DE03729</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>60</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MALIGNANT NEOPLASM PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERIODONTITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEQUESTRECTOMY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUS PERFORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTH EXTRACTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugauthorizationnumb>21223</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>METASTASES TO BONE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048005-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060619</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-NOVOPROD-254330</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>61</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>60</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD IMMUNOGLOBULIN E INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC ENCEPHALOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE INDURATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PENFILL R CHU</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>19938</drugauthorizationnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>INSULIN-REQUIRING TYPE II DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060526</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PENFILL 50R CHU</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>INSULIN-REQUIRING TYPE II DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060526</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MILFADIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060501</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIAMIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANAEMIA</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060501</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADONA</medicinalproduct>
        <drugdosagetext>30 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANAEMIA</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060501</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RIKAVARIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANAEMIA</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060501</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RADEN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTRITIS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060501</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMOBAN</medicinalproduct>
        <drugdosagetext>7.5 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060501</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC                            /00972401/</medicinalproduct>
        <drugdosagetext>5 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060501</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAL</medicinalproduct>
        <drugdosagetext>20 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060501</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LACTULOSE</medicinalproduct>
        <drugdosagetext>30 ML, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060507</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZYRTEC</medicinalproduct>
        <drugdosagetext>10 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060508</drugenddate>
        <drugtreatmentduration>10080</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTEBATE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060501</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WHITE PETROLEUM</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060501</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIVACT                             /00847901/</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060513</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLELOCK</medicinalproduct>
        <drugdosagetext>10 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060525</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060601</drugenddate>
        <drugtreatmentduration>10080</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RESTAMIN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060525</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SENNOSIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060527</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HUMACART-N</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060527</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMINOLEBAN                         /00957801/</medicinalproduct>
        <drugdosagetext>UNK, UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060507</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048010-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060710</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>49</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>70.3</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PROCEDURAL COMPLICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>REMOVAL OF FOREIGN BODY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAXUS EXPRESS     PACLITAXEL CORONARY STENT SYSTEM</medicinalproduct>
        <drugbatchnumb>845432</drugbatchnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048013-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060710</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>99.7913</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CHEST DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSGEUSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOVENTILATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYDRIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NASAL DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STOMACH DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URTICARIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL BRIGHTNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CORDIS   CYPHER SIROLIMUS-ELUTING CORONARY STENT</medicinalproduct>
        <drugbatchnumb>A0506038</drugbatchnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060625</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048017-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060710</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>28</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANAESTHETIC COMPLICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MARCAINE</medicinalproduct>
        <drugbatchnumb>3404500</drugbatchnumb>
        <drugdosagetext>2 ML  ONE TIME     OTHER</drugdosagetext>
        <drugadministrationroute>050</drugadministrationroute>
        <drugindication>CAESAREAN SECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060706</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060706</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048020-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060505</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHFR2006GB01617</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>MALIGNANT NEOPLASM PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE MASS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugauthorizationnumb>21223</drugauthorizationnumb>
        <drugdosagetext>4 MG</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>METASTASES TO BONE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048022-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060710</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>66</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>73.1</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL DISTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL TENDERNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLATULENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL PERFORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SELF-MEDICATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALIMTA</medicinalproduct>
        <drugdosagetext>540MG Q2WEEKS  IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BLADDER CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060420</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060629</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAXOTERE</medicinalproduct>
        <drugdosagetext>45MG  Q2WEEKS  IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060420</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060629</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE TAB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZANTAC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLARITIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048023-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060710</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>67</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>79.8</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>NO ADVERSE EFFECT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ERBITUX</medicinalproduct>
        <drugdosagetext>2 MG/ML</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048024-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060710</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>68</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>58.0604</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JOINT STIFFNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JOINT SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL STIFFNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BONIVA</medicinalproduct>
        <drugdosagetext>1 TABLET    ONCE A MONTH</drugdosagetext>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060124</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060524</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048025-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060710</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>65</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>74.5</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANOREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASCITES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG CONSOLIDATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALIGNANT NEOPLASM PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALIGNANT PERITONEAL NEOPLASM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METASTASES TO LIVER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCREATIC CARCINOMA METASTATIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLEURAL EFFUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ERBITUX</medicinalproduct>
        <drugdosagetext>400 MG/M2   ONCE     IV DRIP; 250 MG/M2 WEEKLY IV DRIP</drugdosagetext>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>PANCREATIC CARCINOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYCLOPHOSPHAMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOGENEIC PANCREATIC CANCER VACCINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048027-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060710</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>51</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>76</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>BODY TEMPERATURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEEP VEIN THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISEASE PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JAUNDICE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CETUXIMAB      2 MG/ML      BRISTOL-MYERS SQUIBB</medicinalproduct>
        <drugdosagetext>400 MG/M2    WEEKLY    IV DRIP</drugdosagetext>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>PANCREATIC CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060419</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060419</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOGENEIC PANCREATIC CANCER VACCINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYCLOPHOSPHAMIDE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048038-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060621</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-MERCK-0606USA05688</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>35</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ADVERSE EVENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOLYTIC ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALDOMET</medicinalproduct>
        <drugauthorizationnumb>013400</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048039-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060706</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0607USA00836</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>84</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>RASH PRURITIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN DISCOLOURATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugauthorizationnumb>019766</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVAPRO</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048040-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060706</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>TH-MERCK-0607THA00005</companynumb>
    <primarysource>
      <reportercountry>THAILAND</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>19</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PURPURA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SINGULAIR</medicinalproduct>
        <drugauthorizationnumb>020829</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>URTICARIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060702</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060703</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048041-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060518</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0605USA03725</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>HEPATIC ENZYME INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATOMEGALY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SINGULAIR</medicinalproduct>
        <drugauthorizationnumb>20829</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KETEK</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048042-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060626</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CZ-MERCK-0606CZE00011</companynumb>
    <primarysource>
      <reportercountry>CZECH REPUBLIC</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>33</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABORTION SPONTANEOUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SINGULAIR</medicinalproduct>
        <drugauthorizationnumb>020829</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CORTICOSTEROIDS (UNSPECIFIED)</medicinalproduct>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048043-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050815</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0508USA02593</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>54</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>59</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BONE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EXOSTOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>20560</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19981009</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050809</drugenddate>
        <drugtreatmentduration>2497</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048044-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060706</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0607USA00813</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>BLOOD CREATINE PHOSPHOKINASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZETIA</medicinalproduct>
        <drugauthorizationnumb>021445</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060615</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREVACID</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>[THERAPY UNSPECIFIED]</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048045-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060515</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BE-MERCK-0605BEL00015</companynumb>
    <primarysource>
      <reportercountry>BELGIUM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>60</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ARTERIOSCLEROSIS CORONARY ARTERY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL ISCHAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>QUINAPRIL HCL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugauthorizationnumb>019766</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERCHOLESTEROLAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLYBURIDE AND METFORMIN HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLOPIDOGREL BISULFATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANGIOPATHY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN HUMAN ZINC, EXTENDED</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060123</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VENLAFAXINE HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE BESYLATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048046-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060710</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>61.2356</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANOREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG WITHDRAWAL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERACUSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOKINESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NIGHTMARE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL INTAKE REDUCED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN OF SKIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAROSMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHOTOPHOBIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POOR QUALITY SLEEP</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SLEEP DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STOMACH DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TINNITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VAGINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EFFEXOR XR</medicinalproduct>
        <drugdosagetext>TAPERED FROM 150 MG    PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugtreatmentduration>10</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048049-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060710</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>58</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>61.2356</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>EMOTIONAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERALISED ANXIETY DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LARIAM</medicinalproduct>
        <drugdosagetext>1 PILL   WEEKLY</drugdosagetext>
        <drugindication>MALARIA PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010630</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048052-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060710</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>63</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>67.1324</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANOREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISTURBANCE IN ATTENTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NERVOUSNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CIPRO</medicinalproduct>
        <drugdosagetext>1      2X DAY   PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIARRHOEA HAEMORRHAGIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060627</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060704</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLAGYL</medicinalproduct>
        <drugdosagetext>1    4X DAY   PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIARRHOEA HAEMORRHAGIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060627</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060704</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048053-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060710</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>35</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>72.5755</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHENOPIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISION BLURRED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL DISTURBANCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOPAMAX</medicinalproduct>
        <drugdosagetext>25MG     ONCE DAILY   ORALLY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEADACHE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060618</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060627</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ULTRAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FIORICET</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAZODONE HCL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048054-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060710</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>48</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>87.0906</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CANDIDIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DECREASED APPETITE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUCOSAL INFLAMMATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ODYNOPHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARYNGOLARYNGEAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TARCEVA</medicinalproduct>
        <drugdosagetext>100 MG DAILY  ORALLY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NEOPLASM MALIGNANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060603</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVASTIN</medicinalproduct>
        <drugdosagetext>10 MG/KG EVERY 2 WEEKS</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060517</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVASTIN</medicinalproduct>
        <drugdosagetext>10 MG/KG EVERY 2 WEEKS</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060531</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVASTIN</medicinalproduct>
        <drugdosagetext>10 MG/KG EVERY 2 WEEKS</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060614</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVASTIN</medicinalproduct>
        <drugdosagetext>10 MG/KG EVERY 2 WEEKS</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060628</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CISPLATIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EXTERNAL BEAM RADIATION</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AUGMENTIN '125'</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NYSTATIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DURAGESIC-100</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048055-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060710</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>61</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DYSPNOEA EXERTIONAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUS CONGESTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GLEEVEC</medicinalproduct>
        <drugdosagetext>500 MG BID</drugdosagetext>
        <drugindication>GLIOBLASTOMA MULTIFORME</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HYDROXYUREA</medicinalproduct>
        <drugdosagetext>500 MG QD</drugdosagetext>
        <drugindication>GLIOBLASTOMA MULTIFORME</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PTK</medicinalproduct>
        <drugdosagetext>750MG BID</drugdosagetext>
        <drugindication>GLIOBLASTOMA MULTIFORME</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPROL-XL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALTACE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZETIA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DECADRON</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEUPOGEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CITALOPRAM HYDROBROMIDE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048056-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060710</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>45</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>73.4827</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TARCEVA</medicinalproduct>
        <drugbatchnumb>B424101</drugbatchnumb>
        <drugdosagetext>150MG PO QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>TONGUE NEOPLASM MALIGNANT STAGE UNSPECIFIED</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060706</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CISPLATIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RADIATION THERAPY</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048057-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060710</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>100.6985</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE FLUCTUATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DECREASED APPETITE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GLEEVEC</medicinalproduct>
        <drugdosagetext>600MG  QD  PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GLIOBLASTOMA MULTIFORME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060624</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060706</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HYDROXYUREA</medicinalproduct>
        <drugdosagetext>500MG  BID  PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GLIOBLASTOMA MULTIFORME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060624</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060706</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DECADRON</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ELAVIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NASONEX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCODONE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRANDIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROZAC</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048059-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060614</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US200606005556</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BONE MARROW DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VAGINITIS BACTERIAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMULIN 70/30</medicinalproduct>
        <drugauthorizationnumb>18780</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19910101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMALOG</medicinalproduct>
        <drugdosagetext>3/D, PER SLIDIING SCALE</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048062-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060113</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-432358</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>27</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>61.2</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ACNE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLITIS ULCERATIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRY EYE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPEPSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EPISTAXIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRIC ULCER HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRIC ULCER PERFORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRITIS EROSIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROOESOPHAGEAL REFLUX DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHOIDS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ILL-DEFINED DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLAMMATORY BOWEL DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIP DRY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>REFLUX OESOPHAGITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>18662</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20001222</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010219</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>018662</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010220</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010615</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048063-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050701</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-ROCHE-409685</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>56</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ACUTE RESPIRATORY DISTRESS SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ALVEOLITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLEURAL EFFUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RED BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CAPECITABINE</medicinalproduct>
        <drugauthorizationnumb>20896</drugauthorizationnumb>
        <drugdosagetext>GIVEN FROM DAYS ONE TWO FOURTEEN WITH ONE WEEK REST.</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050419</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CAPECITABINE</medicinalproduct>
        <drugauthorizationnumb>020896</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050510</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050524</drugenddate>
        <drugtreatmentduration>15</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CAPECITABINE</medicinalproduct>
        <drugauthorizationnumb>020896</drugauthorizationnumb>
        <drugdosagetext>DOSE WAS REDUCED.</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050418</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050510</drugenddate>
        <drugtreatmentduration>23</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048064-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-384417</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>28</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>66.2</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANGINA PECTORIS</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>BLOOD CHOLESTEROL INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD TRIGLYCERIDES INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC MURMUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CLOSTRIDIAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLITIS ULCERATIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CYST RUPTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DUODENITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EPICONDYLITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FOREIGN BODY IN EYE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROOESOPHAGEAL REFLUX DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATOCRIT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHOIDS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLAMMATORY BOWEL DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERNAL INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIGAMENT RUPTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIP ULCERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUCOSAL MEMBRANE HYPERPLASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTI-ORGAN DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOFASCITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAIL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NECK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL MUCOSA EROSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANIC ATTACK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PECTUS EXCAVATUM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLEURISY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSEUDOMEMBRANOUS COLITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RECTAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ROAD TRAFFIC ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ROTATOR CUFF SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STRESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TELANGIECTASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TENDON INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UMBILICAL HERNIA REPAIR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>18662</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ACNE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19940516</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19941213</drugenddate>
        <drugtreatmentduration>212</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>018662</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19960708</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19960907</drugenddate>
        <drugtreatmentduration>62</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048065-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-454067</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEAD INJURY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>018662</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048066-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050204</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-394799</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>68</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANHEDONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHROMATURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CROHN'S DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ECONOMIC PROBLEM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ESCHERICHIA INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FAECES DISCOLOURED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRIC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATOCHEZIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATOCRIT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLAMMATORY BOWEL DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MICTURITION URGENCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTI-ORGAN DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NECK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RECTAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RED BLOOD CELLS URINE POSITIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT 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>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>18662</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980715</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19990315</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048068-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050208</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-394881</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>44</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>56.7</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL DISTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABSCESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ALOPECIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AMENORRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANOREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANTINUCLEAR ANTIBODY POSITIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AUTOIMMUNE HEPATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARBUNCLE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIOVASCULAR DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHANGE OF BOWEL HABIT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHAPPED LIPS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPEPSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPHONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ECZEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERUCTATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE IRRITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FAECES PALE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FIBROMYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLATULENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FUNGAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FURUNCLE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROOESOPHAGEAL REFLUX DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GRANULOMATOUS LIVER DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC FUNCTION ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATOCELLULAR DAMAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATOTOXICITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HISTOPLASMOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMMUNE SYSTEM DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMPAIRED WORK ABILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLAMMATORY BOWEL DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IRRITABLE BOWEL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LARYNGEAL OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LARYNGITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPHADENOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE TIGHTNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OESOPHAGITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARYNGOLARYNGEAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SENSORY LOSS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUSITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SMOOTH MUSCLE ANTIBODY POSITIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPLENOMEGALY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STAPHYLOCOCCAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYSTEMIC LUPUS ERYTHEMATOSUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URTICARIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISION BLURRED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL ACUITY REDUCED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOCAL CORD CYST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOCAL CORD INFLAMMATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>18662</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ACNE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040204</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040313</drugenddate>
        <drugtreatmentduration>39</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMNESTEEM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>ACNE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040315</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOXYL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOMIG</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPAMAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BROMPHEN</medicinalproduct>
        <drugdosagetext>REPORTED AS BROMPHEN PD.</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZYRTEC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PONSTEL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOXYCYCLINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VERAPAMIL</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041203</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
        <drugindication>HYPOTHYROIDISM</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041015</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041115</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>1 CONCOMITANT DRUG</medicinalproduct>
        <drugdosagetext>DRUG REPORTED AS PROPOXY.</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041015</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYMAX</medicinalproduct>
        <drugindication>IRRITABLE BOWEL SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050515</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLEXERIL</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050615</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RHINOCORT</medicinalproduct>
        <drugindication>SINUSITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050615</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MUCINEX</medicinalproduct>
        <drugindication>SINUSITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050615</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIFLUCAN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19850615</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040615</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVAQUIN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030615</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050615</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TEQUIN</medicinalproduct>
        <drugdosagetext>AS NEEDED 2004 AND 2005.</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLINDAMYCIN</medicinalproduct>
        <drugdosagetext>FOR TWO WEEKS.</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050115</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CIPRO</medicinalproduct>
        <drugdosagetext>FOR TWO WEEKS. REPORTED AS CIPRO XR.</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050115</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VICODIN</medicinalproduct>
        <drugdosagetext>FOR THREE WEEKS.</drugdosagetext>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050115</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CULTURELLE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041215</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050115</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROBIOTIC</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041215</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050115</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BROMFENAC</medicinalproduct>
        <drugindication>SINUSITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040115</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041015</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAGAMET</medicinalproduct>
        <drugdosagetext>REPORTED AS TAGAMENT HB. FOR ONE DAY.</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040615</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BEXTRA</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030915</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENDOCET</medicinalproduct>
        <drugdosagetext>IN NOVEMBER 2001 AND JANUARY 2005.</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RANITIDINE</medicinalproduct>
        <drugindication>SINUSITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041015</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>1 CONCOMITANT DRUG</medicinalproduct>
        <drugindication>HYPOTHYROIDISM</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19910615</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041015</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ELIDEL</medicinalproduct>
        <drugindication>ECZEMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040615</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIFFERIN</medicinalproduct>
        <drugindication>ACNE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040215</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROTONIX</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031115</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040215</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>1 CONCOMITANT DRUG</medicinalproduct>
        <drugdosagetext>REPORTED AS TRIACINOLONE ACETONIDE.</drugdosagetext>
        <drugindication>ECZEMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040215</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>JOINTFLEX</medicinalproduct>
        <drugadministrationroute>061</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031215</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIQUIBID</medicinalproduct>
        <drugindication>LARYNGITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041115</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041115</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACIPHEX</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041115</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADVAIR DISKUS 100/50</medicinalproduct>
        <drugindication>LARYNGITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041015</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041115</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PAMINE</medicinalproduct>
        <drugindication>IRRITABLE BOWEL SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040915</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040915</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALEVE (CAPLET)</medicinalproduct>
        <drugdosagetext>AS NEEDED.</drugdosagetext>
        <drugindication>HEADACHE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ST. JOHN'S WORT</medicinalproduct>
        <drugdosagetext>FOR PAST YEAR.</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048069-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20030825</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-345207</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>24</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>73.5</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANAL FISSURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANGER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASCITES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CHOLESTEROL INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CAT SCRATCH DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CELLULITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHAPPED LIPS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHOLELITHIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLITIS ULCERATIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DECREASED APPETITE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ENCEPHALOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLATULENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FUNGAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROENTERITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GRANULOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAND FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HIATUS HERNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ILEUS PARALYTIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLAMMATORY BOWEL DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEGIONELLA INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPHADENITIS BACTERIAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPHADENOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NIGHT SWEATS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OCULAR HYPERAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POST PROCEDURAL COMPLICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POUCHITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RECTAL TENESMUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEROMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUBCUTANEOUS ABSCESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>18662</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ACNE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19950622</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19951019</drugenddate>
        <drugtreatmentduration>120</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048070-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060703</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHNR2006AU00870</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>LEIOMYOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GLEEVEC</medicinalproduct>
        <drugauthorizationnumb>021588</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048071-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2006US08530</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>47</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>EXPOSURE TO TOXIC AGENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HERPETIC STOMATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIP HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCYTOPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GLEEVEC</medicinalproduct>
        <drugauthorizationnumb>021588</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CHRONIC MYELOID LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048072-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060531</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2006US07119</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>50</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>90.702</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANAEMIA OF MALIGNANT DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE DENSITY DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ECZEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOPOROSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GLEEVEC</medicinalproduct>
        <drugauthorizationnumb>21588</drugauthorizationnumb>
        <drugdosagetext>800 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CHRONIC MYELOID LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030801</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048073-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050217</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CL-ROCHE-395776</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>63</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEBRILE NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPONATRAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG INFILTRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLEURAL EFFUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY RETENTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CAPECITABINE</medicinalproduct>
        <drugauthorizationnumb>20896</drugauthorizationnumb>
        <drugdosagetext>GIVEN FOR FOURTEEN DAYS OUT OF TWENTY-ONE DAY CYCLE.</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041229</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050108</drugenddate>
        <drugtreatmentduration>11</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IXABEPILONE</medicinalproduct>
        <drugdosagetext>GIVEN ON DAY ONE OF A 21 DAY CYCLE.</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041229</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041229</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040615</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048074-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-454135</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>33</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABORTION THREATENED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PREGNANCY WITH CONTRACEPTIVE DEVICE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRANSMISSION OF DRUG VIA SEMEN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COPEGUS</medicinalproduct>
        <drugauthorizationnumb>021511</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051215</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEGASYS</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051215</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048075-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060309</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-439869</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>46</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ALOPECIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DECREASED APPETITE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS POSTURAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ROAD TRAFFIC ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEGASYS</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051202</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COPEGUS</medicinalproduct>
        <drugauthorizationnumb>021511</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051202</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048077-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060614</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US200606003434</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>62</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLINDNESS UNILATERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIABETIC RETINOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL ACUITY REDUCED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMULIN R</medicinalproduct>
        <drugbatchnumb>9RA44X</drugbatchnumb>
        <drugauthorizationnumb>18780</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19960101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048081-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060614</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US200606003331</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>85</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMULIN N</medicinalproduct>
        <drugauthorizationnumb>18780</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048085-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060616</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US200606001420</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>67</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>CARDIOVASCULAR DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIABETES MELLITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SLEEP APNOEA SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMULIN R</medicinalproduct>
        <drugauthorizationnumb>18780</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048087-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060614</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US200606003302</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCREASED TENDENCY TO BRUISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE BRUISING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMULIN N</medicinalproduct>
        <drugbatchnumb>9RY16M</drugbatchnumb>
        <drugauthorizationnumb>18780</drugauthorizationnumb>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPRAL (SULTOPRIDE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARDIZEM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZESTRIL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048091-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060614</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US200606003312</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GLYCOSYLATED HAEMOGLOBIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGE URINARY TRACT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ROAD TRAFFIC ACCIDENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMULIN N</medicinalproduct>
        <drugauthorizationnumb>18780</drugauthorizationnumb>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060605</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>STARLIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CORTICOSTEROID NOS (CORTICOSTEROID NOS)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048095-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060616</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US200606004072</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>85</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA ORAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCORRECT DOSE ADMINISTERED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMULIN 70/30</medicinalproduct>
        <drugbatchnumb>9SF40M</drugbatchnumb>
        <drugauthorizationnumb>18780</drugauthorizationnumb>
        <drugdosagetext>25 U, 2/D</drugdosagetext>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COZAAR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOTREL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048097-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060613</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US200605001967</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>73</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>51.2</patientweight>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>FEMUR FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TIBIA FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TERIPARATIDE (TERIPARATIDE)PEN, DISPOSABLE</medicinalproduct>
        <drugauthorizationnumb>21318</drugauthorizationnumb>
        <drugdosagetext>20 UG, DAILY (1/D), SUBCUTANEOUS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050222</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051215</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FORTEO PEN (FORTEO PEN) PEN, DISPOSABLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZYRTEC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRICOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLIPIZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MOBIC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCODONE BITARTRATE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048099-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060419</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2006US05196</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>71</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>111.11</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ACTINOMYCOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHILLS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DECREASED APPETITE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL SURGERY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOMYELITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROTEINURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUSITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AREDIA</medicinalproduct>
        <drugauthorizationnumb>20036</drugauthorizationnumb>
        <drugdosagetext>90 MG, QMO</drugdosagetext>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030109</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugdosagetext>75 MG, QD</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRICOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VASOTEC</medicinalproduct>
        <drugdosagetext>5 MG, BID</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FORTAMET</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugdosagetext>10 MG, QD</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
        <drugdosagetext>0.125 MG, QD</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>81 MG, QD</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VICODIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TESTOSTERONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREVACID</medicinalproduct>
        <drugdosagetext>UNK, QD</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SEREVENT</medicinalproduct>
        <drugdosagetext>BID, PRN</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLOVENT</medicinalproduct>
        <drugdosagetext>110MCG/ BID</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PEN-VEE K</medicinalproduct>
        <drugdosagetext>500 MG, QID</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048101-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060620</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>SPVI-2006-00094</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>6</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>18.1</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABNORMAL BEHAVIOUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GLAUCOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ADDERALL 10</medicinalproduct>
        <drugauthorizationnumb>21303</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugindication>DISTURBANCE IN ATTENTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060501</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ADDERALL 10</medicinalproduct>
        <drugauthorizationnumb>21303</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugindication>DISTURBANCE IN ATTENTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060601</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ADDERALL 10</medicinalproduct>
        <drugauthorizationnumb>21303</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugindication>DISTURBANCE IN ATTENTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060601</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048102-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060614</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US200606003420</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>80</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PELVIC FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugauthorizationnumb>21318</drugauthorizationnumb>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060301</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048103-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060616</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006CG01163</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>30</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANAESTHETIC COMPLICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XYLOCAINE 2% ADRENALINE</medicinalproduct>
        <drugbatchnumb>9919305</drugbatchnumb>
        <drugauthorizationnumb>6488</drugauthorizationnumb>
        <drugadministrationroute>008</drugadministrationroute>
        <drugindication>EPIDURAL ANAESTHESIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NAROPIN</medicinalproduct>
        <drugauthorizationnumb>020533</drugauthorizationnumb>
        <drugadministrationroute>008</drugadministrationroute>
        <drugindication>EPIDURAL ANAESTHESIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048104-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006UW02053</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>40</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABORTION SPONTANEOUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOLADEX</medicinalproduct>
        <drugauthorizationnumb>019726</drugauthorizationnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>UTERINE LEIOMYOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060105</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048105-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060515</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006UW09482</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>79</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>55.3</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>AMYOTROPHIC LATERAL SCLEROSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugauthorizationnumb>21366</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060201</drugenddate>
        <drugtreatmentduration>21</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOSINOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048106-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006UW13664</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>72</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>METASTASES TO LUNG</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL CANCER METASTATIC</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NOLVADEX</medicinalproduct>
        <drugauthorizationnumb>017970</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BREAST CANCER FEMALE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048107-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060317</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006UW04637</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>86</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>36.4</patientweight>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUID RETENTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOOD SWINGS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARYNGEAL OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>REACTION TO DRUG EXCIPIENTS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWELLING FACE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugauthorizationnumb>020639</drugauthorizationnumb>
        <drugdosagetext>ONE AND ONE HALF TABLET</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HALLUCINATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050803</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugauthorizationnumb>020639</drugauthorizationnumb>
        <drugdosagetext>HALF TABLET</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugauthorizationnumb>020639</drugauthorizationnumb>
        <drugdosagetext>BROKE INTO QUARTER TABLET</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugauthorizationnumb>020639</drugauthorizationnumb>
        <drugdosagetext>1/16 OF AS TABLET</drugdosagetext>
        <drugadministrationroute>002</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MIRAPEX</medicinalproduct>
        <drugdosagetext>1/32 OF A TABLET</drugdosagetext>
        <drugindication>PARKINSON'S DISEASE</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060315</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARBIDOPA W/LEVODOPA</medicinalproduct>
        <drugindication>PARKINSON'S DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARBIDOPA W/LEVODOPA</medicinalproduct>
        <drugdosagetext>ONE EIGHT 10/100</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REQUIP</medicinalproduct>
        <drugindication>PARKINSON'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060316</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GELATIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048108-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060614</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US200606000509</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>63</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY STENOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CIALIS</medicinalproduct>
        <drugauthorizationnumb>21368</drugauthorizationnumb>
        <drugindication>OFF LABEL USE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060520</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOXYL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048112-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060614</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US200606004025</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>10</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>STRATTERA</medicinalproduct>
        <drugauthorizationnumb>21411</drugauthorizationnumb>
        <drugdosagetext>80 MG,</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048115-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060615</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US200606003796</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>57</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HEPATIC ENZYME INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>30 MG, 2/D,</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048118-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060703</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-JNJFOC-20060501476</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>53</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>BRONCHOPNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL ISCHAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SULFASALAZINE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCICHEW</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DF118</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GTN SPRAY</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMDUR</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INDOMETHACIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RABEPRAZOLE SODIUM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048119-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060630</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20060700592</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY OCCLUSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048122-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060615</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US200606004808</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>67</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HEPATIC ENZYME INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048125-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060614</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US200606003783</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>61</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DISABILITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EVISTA</medicinalproduct>
        <drugauthorizationnumb>20815</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048127-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060615</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US200606003784</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>76</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BREAST CANCER FEMALE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BREAST CANCER METASTATIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BREAST DISCOLOURATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BREAST DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BREAST INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPHOEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METASTASES TO LYMPH NODES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POST PROCEDURAL OEDEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EVISTA</medicinalproduct>
        <drugauthorizationnumb>20815</drugauthorizationnumb>
        <drugdosagetext>60 MG, DAILY (1/D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031001</drugstartdate>
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    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048131-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060630</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20060700373</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>46</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048133-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060630</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20060700378</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>73</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>SQUAMOUS 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>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048134-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060630</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20060601337</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>76.66</patientweight>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CROHN'S DISEASE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048135-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IE-JNJFOC-20060606466</companynumb>
    <primarysource>
      <reportercountry>IRELAND</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <patientonsetage>50</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFUSION RELATED REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugbatchnumb>9232558</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PIRITON</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PARACETAMOL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048139-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060613</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
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    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
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    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <patientonsetage>21189</patientonsetage>
      <patientonsetageunit>804</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugauthorizationnumb>021366</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERLIPIDAEMIA</drugindication>
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        <drugstartdate>20060216</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060316</drugenddate>
        <drugtreatmentduration>29</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PIOGLITAZONE HCL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS NON-INSULIN-DEPENDENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050207</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050725</drugenddate>
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        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANXIETY</drugindication>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COLACE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ABDOMINAL HERNIA</drugindication>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CARDIOVASCULAR EVENT PROPHYLAXIS</drugindication>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARDURA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYZAAR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERLIPIDAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050518</drugstartdate>
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        <drugenddate>20060215</drugenddate>
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        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
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  <safetyreport>
    <safetyreportid>5048140-0</safetyreportid>
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    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
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    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>53</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DISSEMINATED TUBERCULOSIS</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>STEROID</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEUKERIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PENTASA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CROHN'S DISEASE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048141-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060630</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20060700379</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>62</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BREAST CANCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CLEAR CELL CARCINOMA OF THE KIDNEY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PSORIATIC ARTHROPATHY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048142-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060630</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20060700484</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PHLEBITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RETINAL VASCULAR THROMBOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugdosagetext>TOTAL OF 3 INFUSIONS ON UNKNOWN DATES</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CROHN'S DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMURAN</medicinalproduct>
        <drugindication>CROHN'S DISEASE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048143-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060630</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-JNJFOC-20060700583</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>63</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>50</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHILLS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CYANOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugdosagetext>3.0 MG/KG, 3 INFUSIONS ON UNKNOWN DATES</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RHEUMATREX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048150-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060706</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-JNJFOC-20060701321</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>19</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>60</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NASOPHARYNGITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HALDOL</medicinalproduct>
        <drugauthorizationnumb>015923</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NERVOUS SYSTEM DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN MEDICATION</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RIVOTRIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PANIC DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048151-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060703</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BE-JNJFOC-20060700357</companynumb>
    <primarysource>
      <reportercountry>BELGIUM</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG ABUSER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG DEPENDENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMODIUM</medicinalproduct>
        <drugauthorizationnumb>017694</drugauthorizationnumb>
        <drugdosagetext>APPROXIMATELY 10 CAPS PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DAFALGAN CODEINE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048158-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060630</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20060200238</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>86.64</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>SMALL INTESTINAL OBSTRUCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </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>MERCAPTOPURINE</medicinalproduct>
        <drugindication>CROHN'S DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MESALAMINE</medicinalproduct>
        <drugindication>CROHN'S DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugindication>CROHN'S DISEASE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048159-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060621</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20060504545</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFUSION RELATED REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWOLLEN TONGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROAT TIGHTNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugindication>CROHN'S DISEASE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048160-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060703</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-JNJFOC-20060700738</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>38</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERDAL</medicinalproduct>
        <drugauthorizationnumb>020272</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048161-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060515</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-ROCHE-448060</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>23</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABORTION INDUCED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ROACCUTAN</medicinalproduct>
        <drugauthorizationnumb>18662</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060115</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048162-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060518</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ROCHE-448943</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>67</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>60</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ECZEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA MULTIFORME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEGASYS</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050615</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEGASYS</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060227</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050127</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060530</drugenddate>
        <drugtreatmentduration>489</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048163-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060414</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ROCHE-444542</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>74</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BONE MARROW FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYELODYSPLASTIC SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCYTOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DENOSINE IV</medicinalproduct>
        <drugauthorizationnumb>19661</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CYTOMEGALOVIRUS INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060302</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060310</drugenddate>
        <drugtreatmentduration>9</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENDOXAN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GOODPASTURE'S SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060208</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060212</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENDOXAN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060212</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060220</drugenddate>
        <drugtreatmentduration>9</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDONINE</medicinalproduct>
        <drugdosagetext>FROM 26 FEBRUARY 2006, THE DOSE WAS REDUCED BY 5MG EVERY FIVE DAYS.</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060204</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BAKTAR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060204</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FRESH FROZEN PLASMA</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060207</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060207</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUNGIZONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060226</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEROPEN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060302</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>STEROID NOS</medicinalproduct>
        <drugdosagetext>REPORTED AS: STEROID (ADRENAL HORMONE PREPARATIONS).</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BLOOD, PACKED RED CELLS</medicinalproduct>
        <drugdosagetext>ADMINISTERED FIVE TIMES IN TOTAL.</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060320</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060510</drugenddate>
        <drugtreatmentduration>52</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEUTROGIN</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060325</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060328</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUNGUARD</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060325</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060329</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048164-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060324</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>SI-ROCHE-441668</companynumb>
    <primarysource>
      <reportercountry>SLOVENIA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>52</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>76</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALMAR-PLANTAR ERYTHRODYSAESTHESIA SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STOMATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VAGINAL INFLAMMATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CAPECITABINE</medicinalproduct>
        <drugauthorizationnumb>20896</drugauthorizationnumb>
        <drugdosagetext>TWICE DAILY ON DAYS 1-14 EVERY THREE WEEKS.</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060228</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060313</drugenddate>
        <drugtreatmentduration>14</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CAPECITABINE</medicinalproduct>
        <drugauthorizationnumb>020896</drugauthorizationnumb>
        <drugdosagetext>TWICE DAILY ON DAYS 1-14 EVERY THREE WEEKS.</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060404</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048170-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060630</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IE-ROCHE-453860</companynumb>
    <primarysource>
      <reportercountry>IRELAND</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>49</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XENICAL</medicinalproduct>
        <drugauthorizationnumb>020766</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARVEDILOL</medicinalproduct>
        <drugauthorizationnumb>020766</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SC-66110</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BUMETANIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BURAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATORVASTATIN CALCIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EZETIMIBE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NICORANDIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALSARTAN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048171-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060630</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ROCHE-453836</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>43</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PULMONARY FIBROSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEGASYS</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050818</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060610</drugenddate>
        <drugtreatmentduration>297</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048172-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050624</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-408803</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>57</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>AMNESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANOREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD ALBUMIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD ALKALINE PHOSPHATASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD BILIRUBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CALCIUM DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CHLORIDE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CREATININE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD MAGNESIUM DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PHOSPHORUS DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD POTASSIUM DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE SYSTOLIC INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD SODIUM DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD UREA DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>C-REACTIVE PROTEIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARBOHYDRATE ANTIGEN 125 INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATOCRIT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAPTOGLOBIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPONATRAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEUKOCYTOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENTAL STATUS CHANGES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METABOLIC ENCEPHALOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL ISCHAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVARIAN CYST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALLOR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERITONEAL TUBERCULOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POOR PERIPHERAL CIRCULATION</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>SERUM FERRITIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUS TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STARING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUPRAVENTRICULAR EXTRASYSTOLES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEG-INTERFERON ALFA 2A (RO 25-8310)</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041110</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050608</drugenddate>
        <drugtreatmentduration>211</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEG-INTERFERON ALFA 2A (RO 25-8310)</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050614</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050719</drugenddate>
        <drugtreatmentduration>36</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RIBAVIRIN</medicinalproduct>
        <drugauthorizationnumb>021511</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041110</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050608</drugenddate>
        <drugtreatmentduration>211</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RIBAVIRIN</medicinalproduct>
        <drugauthorizationnumb>021511</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050614</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050719</drugenddate>
        <drugtreatmentduration>36</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYLENOL (CAPLET)</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041110</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLIPIZIDE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050707</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TENORMIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050725</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLYBURIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CHROMAGEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ISONIAZID</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050818</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PIRAZINAMIDE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050818</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ETHAMBUTOL HCL</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050818</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RIFAMPIN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050818</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN B6</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050818</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048173-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060612</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ROCHE-451904</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>76</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>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>ROCEPHIN</medicinalproduct>
        <drugauthorizationnumb>50585</drugauthorizationnumb>
        <drugdosagetext>ROUTE REPORTED AS INTRAVENOUS (NOT OTHERWISE SPECIFIED).</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PNEUMONIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060602</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060609</drugenddate>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GASMOTIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050715</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOMPERIDONE</medicinalproduct>
        <drugdosagetext>REPORTED AS SELOVASE.</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050715</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FAMOTIDINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050715</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MYSLEE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050715</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
        <drugdosagetext>REPORTED AS NEUFAN.</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGLAX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMBROXOL HYDROCHLORIDE</medicinalproduct>
        <drugdosagetext>REPORTED AS GRINKOOL.</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048174-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060630</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-ROCHE-453733</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>2</patientonsetage>
      <patientonsetageunit>802</patientonsetageunit>
      <patientweight>4.7</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HYPOTONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEPHROCALCINOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ROCEPHIN</medicinalproduct>
        <drugauthorizationnumb>050585</drugauthorizationnumb>
        <drugdosagetext>FORMULATION: INJECTABLE SOLUTION.</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PYELONEPHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060605</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060612</drugenddate>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMIKLIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PYELONEPHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060605</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060606</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048175-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060630</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-ROCHE-453735</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>24</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANAPHYLACTIC REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANGIONEUROTIC OEDEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ROCEPHIN</medicinalproduct>
        <drugauthorizationnumb>050585</drugauthorizationnumb>
        <drugdosagetext>FORM REPORTED AS INJECTABLE SOLUTION.</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>ACUTE TONSILLITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060315</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060315</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048176-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060630</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-JNJFOC-20060700492</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>4</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>4.7</patientweight>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ASPIRATION BRONCHIAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOPAMAX</medicinalproduct>
        <drugbatchnumb>05HS103/U</drugbatchnumb>
        <drugauthorizationnumb>020505</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONVULSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PHENOBARBITAL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONVULSION</drugindication>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EPELIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONVULSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMETHICONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ABDOMINAL PAIN</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048177-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060630</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20060700895</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>56</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>114.76</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ALOPECIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NIGHT SWEATS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOPAMAX</medicinalproduct>
        <drugauthorizationnumb>020505</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEADACHE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
        <drugindication>FLUID RETENTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVAPRO</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTROOESOPHAGEAL REFLUX DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>ANTICOAGULANT THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MS CONTIN</medicinalproduct>
        <drugindication>BACK PAIN</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048178-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050301</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-ROCHE-397027</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>43</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>62.2</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HEPATIC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATITIS C</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATOTOXICITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VALGANCICLOVIR HCL</medicinalproduct>
        <drugbatchnumb>C0270A001</drugbatchnumb>
        <drugauthorizationnumb>21304</drugauthorizationnumb>
        <drugdosagetext>DATE OF LAST DOSE PRIOR TO SAE WAS 28 FEB 2005</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050215</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050228</drugenddate>
        <drugtreatmentduration>14</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MMF</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20011201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050815</drugenddate>
        <drugtreatmentduration>1354</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugdosagetext>22 APR 1995 TO 24 FEB 2005 THE PATIENT RECEIVED 7.5 MG.</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19950422</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CIPROFLOXACIN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050225</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050303</drugenddate>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RANITIDINE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050226</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050305</drugenddate>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LACTULOSE SOLUTION</medicinalproduct>
        <drugdosagetext>REPORTED AS LACTULONE.</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050228</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050302</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NISTATIN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050225</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050302</drugenddate>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048179-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060626</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-ROCHE-453164</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>36</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HYPERPROLACTINAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RIVOTRIL</medicinalproduct>
        <drugauthorizationnumb>17533</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048180-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060523</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-ROCHE-449034</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>71</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>68</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>GLIOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INTERFERON ALFA-2A</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>METASTATIC RENAL CELL CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051006</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060522</drugenddate>
        <drugtreatmentduration>229</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVASTIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>METASTATIC RENAL CELL CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051006</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060522</drugenddate>
        <drugtreatmentduration>229</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PARACETAMOL</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051006</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060515</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATACAND</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060115</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050808</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060418</drugenddate>
        <drugtreatmentduration>254</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048181-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060704</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-JNJFOC-20060701459</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYLENOL (CAPLET)</medicinalproduct>
        <drugauthorizationnumb>019872</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYLENOL (CAPLET)</medicinalproduct>
        <drugauthorizationnumb>019872</drugauthorizationnumb>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EXTRA STRENGTH TYLENOL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048182-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20051220</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ROCHE-429300</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>61</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CHROMATURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CYTOLYTIC HEPATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC FUNCTION ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATITIS CHOLESTATIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JAUNDICE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PANALDINE</medicinalproduct>
        <drugauthorizationnumb>19979</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CEREBRAL INFARCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051102</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051122</drugenddate>
        <drugtreatmentduration>21</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BLOPRESS</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BEZATOL SR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048187-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060605</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-ROCHE-450475</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>68</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEBRILE NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERAL PHYSICAL HEALTH DETERIORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERIPHERAL SENSORY NEUROPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STOMATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CAPECITABINE</medicinalproduct>
        <drugauthorizationnumb>20896</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060517</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060525</drugenddate>
        <drugtreatmentduration>9</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IXABEPILONE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060517</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060517</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048188-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-ROCHE-453405</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEAFNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMEVENE</medicinalproduct>
        <drugauthorizationnumb>19661</drugauthorizationnumb>
        <drugdosagetext>INITIAL DOSE.</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMEVENE</medicinalproduct>
        <drugauthorizationnumb>019661</drugauthorizationnumb>
        <drugdosagetext>DOSAGE REDUCED.</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048189-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060606</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CN-ROCHE-450768</companynumb>
    <primarysource>
      <reportercountry>CHINA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>40</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>70</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>LOWER MOTOR NEURONE LESION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ROFERON-A</medicinalproduct>
        <drugdosagetext>STRENGTH REPORTED AS ^3 MILLION IU/VIAL^ DOSAGE REGIMEN: 3 MILLIONIU/2 DAY</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060526</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060528</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROLEUKIN</medicinalproduct>
        <drugdosagetext>DRUG NAME REPORTED AS QUAN QI STRENGTH REPORTED AS ^2 MILLION IU/VIAL^ DOSAGE REGIMEN REPORTED AS 2+</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060525</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060527</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048190-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060607</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-ROCHE-450904</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>72</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>92</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG TOXICITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SCLERODERMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CAPECITABINE</medicinalproduct>
        <drugauthorizationnumb>20896</drugauthorizationnumb>
        <drugdosagetext>ON DAYS ONE TO FOURTEEN EVERY THREE WEEKS</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060206</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVASTIN</medicinalproduct>
        <drugauthorizationnumb>020896</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060206</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVASTIN</medicinalproduct>
        <drugauthorizationnumb>020896</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PERINDOPRIL ERUMINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060222</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060421</drugenddate>
        <drugtreatmentduration>59</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INDAPAMIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060222</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060421</drugenddate>
        <drugtreatmentduration>59</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRONOLACTONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060226</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060322</drugenddate>
        <drugtreatmentduration>25</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PAROXETINE HCL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060228</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLARAMAX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060605</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PYROXIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060605</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN W/ CODEINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048191-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060621</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ROCHE-452573</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>81</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>AGRANULOCYTOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TORSEMIDE</medicinalproduct>
        <drugauthorizationnumb>20136</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PANALDINE</medicinalproduct>
        <drugauthorizationnumb>019979</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>THROMBOSIS PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060425</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060612</drugenddate>
        <drugtreatmentduration>49</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALDACTONE</medicinalproduct>
        <drugauthorizationnumb>019979</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAKEPRON</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>STENT PLACEMENT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPOVAS</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ACUTE MYOCARDIAL INFARCTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BLOPRESS</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048192-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060703</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GR-ROCHE-453936</companynumb>
    <primarysource>
      <reportercountry>GREECE</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BONIVA</medicinalproduct>
        <drugauthorizationnumb>021455</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060630</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048193-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060619</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-ROCHE-454117</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>69</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>56.4</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CREATININE RENAL CLEARANCE DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BONIVA</medicinalproduct>
        <drugbatchnumb>MH6802504</drugbatchnumb>
        <drugauthorizationnumb>21858</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060327</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060606</drugenddate>
        <drugtreatmentduration>72</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>THALIDOMIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060327</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048194-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060703</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-ROCHE-454076</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>22</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>APPENDICITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERITONITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ROACUTAN</medicinalproduct>
        <drugauthorizationnumb>18662</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ACNE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060215</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060403</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048195-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060704</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GR-ROCHE-454315</companynumb>
    <primarysource>
      <reportercountry>GREECE</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ARRHYTHMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHILLS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLUENZA LIKE ILLNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BONIVA</medicinalproduct>
        <drugauthorizationnumb>021455</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060702</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048196-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060630</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-ROCHE-454146</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>55</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>95.3</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XENICAL</medicinalproduct>
        <drugauthorizationnumb>020766</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OBESITY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060616</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048200-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060706</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-ROCHE-454343</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>42</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>53</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POST PROCEDURAL HAEMATOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MYCOPHENOLATE MOFETIL</medicinalproduct>
        <drugauthorizationnumb>50722</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050923</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TACROLIMUS</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050923</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MOPRAL</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050920</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SOLU-MEDROL</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050920</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050920</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TARDYFERON</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050923</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLODIL</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050925</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048201-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060704</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>RU-ROCHE-453863</companynumb>
    <primarysource>
      <reportercountry>RUSSIAN FEDERATION</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>75</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XELODA</medicinalproduct>
        <drugauthorizationnumb>020896</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>COLORECTAL CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060701</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XELODA</medicinalproduct>
        <drugauthorizationnumb>020896</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060702</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060702</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XELODA</medicinalproduct>
        <drugauthorizationnumb>020896</drugauthorizationnumb>
        <drugdosagetext>DRUG WAS DECHALLENGED AFTER 18 TABLETS WERE TAKEN.</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060703</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060703</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048202-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050501</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0578473A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMITREX</medicinalproduct>
        <drugauthorizationnumb>020132</drugauthorizationnumb>
        <drugdosagetext>100MG AS REQUIRED</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MIGRAINE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048203-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050830</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A572897A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>32</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMITREX</medicinalproduct>
        <drugauthorizationnumb>020132</drugauthorizationnumb>
        <drugdosagetext>100MG UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048204-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060131</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A591807A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ILL-DEFINED DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMITREX</medicinalproduct>
        <drugauthorizationnumb>020132</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048205-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060630</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20060700387</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048216-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060616</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-452298</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>55</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISORIENTATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EMPHYSEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCREASED APPETITE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERIPHERAL COLDNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEGASYS</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060331</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COPEGUS</medicinalproduct>
        <drugauthorizationnumb>021511</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060331</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048233-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060530</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-KINGPHARMUSA00001-K200600696</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>48</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OPTIC ISCHAEMIC NEUROPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAPILLOEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL DISTURBANCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALTACE</medicinalproduct>
        <drugauthorizationnumb>19901</drugauthorizationnumb>
        <drugdosagetext>5 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060320</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060523</drugenddate>
        <drugtreatmentduration>93600</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
        <drugdosagetext>25 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060407</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060523</drugenddate>
        <drugtreatmentduration>67680</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSIDON ^CIBA-GEIGY^</medicinalproduct>
        <drugdosagetext>150 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VOLTAREN DISPERS ^GEIGY^</medicinalproduct>
        <drugdosagetext>3</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRALGIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060315</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060412</drugenddate>
        <drugtreatmentduration>41760</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048237-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20051024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IT-ROCHE-422349</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>53</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEUKOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUCOSAL INFLAMMATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STEVENS-JOHNSON SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CAPECITABINE</medicinalproduct>
        <drugauthorizationnumb>20896</drugauthorizationnumb>
        <drugdosagetext>UNKNOWN FREQUENCY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050831</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050908</drugenddate>
        <drugtreatmentduration>9</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZANIDIP</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030615</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048243-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060710</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>NL-BRISTOL-MYERS SQUIBB COMPANY-13436613</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>68</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>2</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>GASTROENTERITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ILEUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALIGNANT NEOPLASM PROGRESSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CISPLATIN</medicinalproduct>
        <drugauthorizationnumb>018057</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051102</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051102</drugenddate>
        <drugtreatmentduration>83</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>20051102</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051102</drugenddate>
        <drugtreatmentduration>83</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DICLOFENAC</medicinalproduct>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PARACETAMOL</medicinalproduct>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACENOCOUMAROL</medicinalproduct>
        <drugindication>PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
        <drugindication>FLUID RETENTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050829</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOSEC</medicinalproduct>
        <drugindication>PROPHYLAXIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048244-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-BRISTOL-MYERS SQUIBB COMPANY-13429550</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>66</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CYANOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAXOL</medicinalproduct>
        <drugauthorizationnumb>020262</drugauthorizationnumb>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060615</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060615</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DECADRON</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PREMEDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060615</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060615</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RESTAMIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PREMEDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060615</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060615</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KYTRIL</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PREMEDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060615</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060615</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048245-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20051228</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-SANOFI-SYNTHELABO-F01200502887</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>BLOOD ALKALINE PHOSPHATASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD SODIUM INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD UREA INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GANGRENE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SHOCK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN ULCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRANSIENT ISCHAEMIC ATTACK</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCODONE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMBIEN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYLENOL (CAPLET)</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVASTIN</medicinalproduct>
        <drugdosagetext>DOSE NOT REPORTED</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050907</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOLINIC ACID</medicinalproduct>
        <drugdosagetext>UNKNOWN</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUOROURACIL</medicinalproduct>
        <drugdosagetext>UNKNOWN</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXALIPLATIN</medicinalproduct>
        <drugdosagetext>UNKNOWN</drugdosagetext>
        <drugindication>COLORECTAL CANCER METASTATIC</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048246-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20030114</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>12157335</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>60</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>DISEASE PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EPISTAXIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERAL PHYSICAL HEALTH DETERIORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IDIOPATHIC THROMBOCYTOPENIC PURPURA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG SQUAMOUS CELL CARCINOMA STAGE UNSPECIFIED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PARAPLATIN</medicinalproduct>
        <drugauthorizationnumb>19880</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>LUNG SQUAMOUS CELL CARCINOMA STAGE UNSPECIFIED</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020311</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAXOTERE</medicinalproduct>
        <drugindication>LUNG SQUAMOUS CELL CARCINOMA STAGE UNSPECIFIED</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020311</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RADIOTHERAPY</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048247-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060704</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-BRISTOL-MYERS SQUIBB COMPANY-13434873</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>55</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>AGGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AGITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG DEPENDENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIBIDO INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SINEMET</medicinalproduct>
        <drugauthorizationnumb>17555</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19960815</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>STALEVO 100</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050408</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SIFROL</medicinalproduct>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060407</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELANCE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19960615</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048248-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-BRISTOL-MYERS SQUIBB COMPANY-13437702</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>85</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HYPOGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GATIFLOXACIN</medicinalproduct>
        <drugauthorizationnumb>021061</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANGIOGRAM PULMONARY ABNORMAL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060602</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060605</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GATIFLOXACIN</medicinalproduct>
        <drugauthorizationnumb>021061</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>C-REACTIVE PROTEIN INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060602</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060605</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANALDINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DILTIAZEM HCL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEXITIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLIMICRON</medicinalproduct>
        <drugdosagetext>INTERRUPTED ON 04-JUN-2006/06-JUN-2006</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAKEPRON</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGMITT</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BIOFERMIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FRANDOL</medicinalproduct>
        <drugadministrationroute>062</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TORSEMIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALDACTONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048249-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060621</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-13421672</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>3</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYELID PTOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYELID PTOSIS CONGENITAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYDROCELE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ULTRASOUND SCAN ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EFAVIRENZ</medicinalproduct>
        <drugauthorizationnumb>20972</drugauthorizationnumb>
        <drugdosagetext>MOTHER INITIATED ORAL EFAVIRENZ THERAPY ON 28-FEB-2001</drugdosagetext>
        <drugadministrationroute>064</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMBIVIR</medicinalproduct>
        <drugdosagetext>MOTHER INITIATED ORAL THERAPY ON 22-JAN-1998 AND CONTINUED THERAPY AFTER DELIVERY.</drugdosagetext>
        <drugadministrationroute>064</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060122</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NELFINAVIR</medicinalproduct>
        <drugdosagetext>MOTHER'S ORAL THERAPY REMAINED ONGOING AFTER DELIVERY.</drugdosagetext>
        <drugadministrationroute>064</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050916</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060122</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZIDOVUDINE</medicinalproduct>
        <drugdosagetext>MOTHER RECEIVED THERAPY INTRAVENOUSLY.</drugdosagetext>
        <drugadministrationroute>064</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060119</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060122</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZIDOVUDINE</medicinalproduct>
        <drugadministrationroute>064</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060119</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060122</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048250-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-SANOFI-SYNTHELABO-F01200600278</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>68</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>65</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>LEUKOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUOROURACIL</medicinalproduct>
        <drugdosagetext>600MG/BODY =368.1MG/M2 IN BOLUS ON DAY 1 THEN 3800MG/BODY=2331.3MG/M2 AS CONTINUOUS INFUSION ON D</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLON CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050826</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050827</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXALIPLATIN</medicinalproduct>
        <drugauthorizationnumb>021492</drugauthorizationnumb>
        <drugdosagetext>135MG/BODY=82.8MG/M2 IN INFUSION ON DAY 1</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLON CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050826</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050826</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>805</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CALCIUM LEVOFOLINATE</medicinalproduct>
        <drugdosagetext>300MG/BODY=184.1MG/M2 IN INFUSION ON DAY 1</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLON CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050826</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050827</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048256-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060117</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-SANOFI-SYNTHELABO-F01200600112</companynumb>
    <primarysource>
      <reportercountry>SWITZERLAND</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CULTURE URINE POSITIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ESCHERICHIA INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ISCHAEMIC STROKE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OESOPHAGITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPTIC SHOCK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVASTIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051129</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051129</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CAPECITABINE</medicinalproduct>
        <drugdosagetext>1650 MG TWICE DAILY FOR 14 DAYS, Q3W</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051129</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051211</drugenddate>
        <drugtreatmentduration>13</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROCHLORPERAZINE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051129</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXALIPLATIN</medicinalproduct>
        <drugauthorizationnumb>021492</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLON CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051129</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051129</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOFRAN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051129</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048257-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040811</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-SANOFI-SYNTHELABO-F01200402422</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY FIBROSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BECOTIDE INHALER</medicinalproduct>
        <drugdosagetext>2 PUFFS</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040608</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugdosagetext>40 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040702</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CAPECITABINE</medicinalproduct>
        <drugdosagetext>2000 MG TWICE A DAY PER ORAL FROM D1 TO D15</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040209</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040730</drugenddate>
        <drugtreatmentduration>173</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXALIPLATIN</medicinalproduct>
        <drugauthorizationnumb>021492</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLORECTAL CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040209</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040802</drugenddate>
        <drugtreatmentduration>176</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VENTOLIN</medicinalproduct>
        <drugdosagetext>2 PUFFS</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040608</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048258-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060614</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-SANOFI-SYNTHELABO-F01200601439</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>80.27</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>GLOBAL AMNESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPHOCYTE PERCENTAGE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPHIL PERCENTAGE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GAVISCON</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALTACE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050613</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAMSULOSIN HCL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050613</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050523</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPROL-XL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041221</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOPIDOGREL</medicinalproduct>
        <drugauthorizationnumb>020839</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>ACUTE CORONARY SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050524</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FISH OIL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051011</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060524</drugenddate>
        <drugtreatmentduration>226</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048259-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060630</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-SANOFI-SYNTHELABO-A01200605010</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>STILNOCT</medicinalproduct>
        <drugauthorizationnumb>19908</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048260-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060503</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-SANOFI-SYNTHELABO-A02200601185</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>AGRANULOCYTOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPTIC SHOCK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SHOCK</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>STENT PLACEMENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugauthorizationnumb>020839</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>STENT PLACEMENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060401</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048261-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ES-SANOFI-SYNTHELABO-A01200605125</companynumb>
    <primarysource>
      <reportercountry>SPAIN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>AMNESIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ISCOVER</medicinalproduct>
        <drugauthorizationnumb>20839</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048266-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060327</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-SANOFI-SYNTHELABO-A03200601860</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>90.7</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE CONGESTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020839</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CORONARY ARTERIAL STENT INSERTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048267-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-SANOFI-SYNTHELABO-A03200604259</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>85.71</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020839</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SINGULAIR</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEXAPRO</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048268-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-SANOFI-SYNTHELABO-A03200604229</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>73</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD ALKALINE PHOSPHATASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METASTASES TO BONE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROSTATIC SPECIFIC ANTIGEN INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ELIGARD</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021343</drugauthorizationnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048269-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-SANOFI-SYNTHELABO-A03200604258</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>AMNESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMPAIRED DRIVING ABILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ROAD TRAFFIC ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SLEEP WALKING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMBIEN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021774</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060606</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048270-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060630</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-SANOFI-SYNTHELABO-A03200604253</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>49</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>IMPAIRED DRIVING ABILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ROAD TRAFFIC ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUDDEN ONSET OF SLEEP</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMBIEN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>2 DF BEFORE DRIVING</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048271-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060630</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-SANOFI-SYNTHELABO-A03200604255</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HOMICIDE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JUDGEMENT IMPAIRED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POISONING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>AMBIEN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048288-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060530</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>HQWYE578131MAY06</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>71</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ALANINE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASPARTATE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMOCYSTIS JIROVECI PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA BACTERIAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060509</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060526</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050628</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NABOAL - SLOW RELEASE</medicinalproduct>
        <drugdosagetext>UNSPECIFIED DOSE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060411</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OLMETEC</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050628</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDONINE</medicinalproduct>
        <drugdosagetext>UNSPECIFIED DOSE</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RHEUMATREX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060221</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SELBEX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050601</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048294-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHO2005CN11647</companynumb>
    <primarysource>
      <reportercountry>CHINA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>66</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>70</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>LIFE SUPPORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEORAL</medicinalproduct>
        <drugauthorizationnumb>50715</drugauthorizationnumb>
        <drugdosagetext>100 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RENAL TRANSPLANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050428</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ERL080A VS MMF</medicinalproduct>
        <drugdosagetext>CODE NOT BROKEN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RENAL TRANSPLANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050429</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050619</drugenddate>
        <drugtreatmentduration>74880</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ERL080A VS MMF</medicinalproduct>
        <drugdosagetext>DRUG DOSE DECREASED</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050620</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050703</drugenddate>
        <drugtreatmentduration>20160</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048295-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060704</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-BRISTOL-MYERS SQUIBB COMPANY-13434857</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>47</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SINEMET</medicinalproduct>
        <drugauthorizationnumb>17555</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060426</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060530</drugenddate>
        <drugtreatmentduration>35</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROPRAM</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040115</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REQUIP</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050208</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>STILNOX</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040115</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048320-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060619</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-GILEAD-2006-0009776</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ALANINE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASPARTATE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD ALKALINE PHOSPHATASE 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>LIVER DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRUVADA</medicinalproduct>
        <drugauthorizationnumb>21752</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050528</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EMTRIVA</medicinalproduct>
        <drugauthorizationnumb>021500</drugauthorizationnumb>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050528</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RETROVIR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050527</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EPIVIR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050527</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NORVIR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050528</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>STOCRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050527</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REYATAZ</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050528</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048321-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060428</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2006-BP-04857NB</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>80.5</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>LIVER DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MICARDIS</medicinalproduct>
        <drugauthorizationnumb>20850</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040224</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040315</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PANALDINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>THROMBOSIS PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040224</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040315</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040224</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040315</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERURICAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040224</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040315</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ISOSORBIDE MONONITRATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MYOCARDIAL ISCHAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040224</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040315</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOCHOL (FLUVASTATIN SODIUM)</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERLIPIDAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040224</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040315</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040224</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040315</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>THROMBOSIS PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040224</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040315</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048322-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2006-DE-03324GD</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>73</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE CONGESTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSIVE CRISIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLONIDINE</medicinalproduct>
        <drugauthorizationnumb>17407</drugauthorizationnumb>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
        <drugauthorizationnumb>088587</drugauthorizationnumb>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LOSARTAN</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>POTASSIUM SUPPLEMENTS</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048323-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060707</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2006-FF-00586FF</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>79</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>COORDINATION ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STRABISMUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
        <drugauthorizationnumb>021395</drugauthorizationnumb>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>RESPIRATORY FAILURE</drugindication>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CORTISONE</medicinalproduct>
        <drugindication>WEGENER'S GRANULOMATOSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048324-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2006-DE-03323GD</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>37</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ADRENAL NEOPLASM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSIVE CRISIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSIVE ENCEPHALOPATHY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLONIDINE</medicinalproduct>
        <drugauthorizationnumb>17407</drugauthorizationnumb>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
        <drugauthorizationnumb>018823</drugauthorizationnumb>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LABETALOL HCL</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IRBESARTAN</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>QUINAPRIL</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MINOXIDIL</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>POTASSIUM SUPPLEMENTS</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048325-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060626</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2006-FF-00537FF</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>59</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>EPILEPSY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
        <drugauthorizationnumb>21395</drugauthorizationnumb>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060521</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SERETIDE</medicinalproduct>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040501</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>STILNOX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INSOMNIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048326-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060320</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2006-BP-03140BP</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>72</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERIAL STENT INSERTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>21395</drugauthorizationnumb>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LABETALOL HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugindication>OSTEOARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>K</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SEREVENT</medicinalproduct>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048327-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060704</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2006-UK-03068UK</companynumb>
    <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>AGGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ALOPECIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIXARIT</medicinalproduct>
        <drugauthorizationnumb>017407</drugauthorizationnumb>
        <drugdosagetext>2/1 DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATTENTION DEFICIT/HYPERACTIVITY DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RITALIN</medicinalproduct>
        <drugdosagetext>1/1 PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATTENTION DEFICIT/HYPERACTIVITY DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BECOTIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SALBUTAMOL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048328-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060630</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2006-FF-00558FF</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>52</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERAL PHYSICAL HEALTH DETERIORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH MACULO-PAPULAR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIRAMUNE</medicinalproduct>
        <drugauthorizationnumb>020636</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ACQUIRED IMMUNODEFICIENCY SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060427</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIRAMUNE</medicinalproduct>
        <drugauthorizationnumb>020636</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060502</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COMBIVIR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048329-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060606</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2006-BP-06520BP</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>47</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>63.96</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>REFUSAL OF TREATMENT BY PATIENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>APTIVUS/RITONAVIR CAPSULES</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>21814</drugauthorizationnumb>
        <drugdosagetext>TPV 1000MG / RTV ?</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050622</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050714</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>APTIVUS/RITONAVIR CAPSULES</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>021814</drugauthorizationnumb>
        <drugindication>ACQUIRED IMMUNODEFICIENCY SYNDROME</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLINDAMYCIN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050714</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DARAPRIM</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050714</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DAPSONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050714</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPORANOX</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050507</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050714</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZITHROMAX</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050309</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050714</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEUCOVORIN CALCIUM</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050714</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRUVADA</medicinalproduct>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050714</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048330-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060615</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2006-BP-06845BP</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULAR WEAKNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUSITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
        <drugbatchnumb>601798</drugbatchnumb>
        <drugauthorizationnumb>21395</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048331-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060706</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2006-BP-07754NB</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>70</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HAEMODIALYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POSTRENAL FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
        <drugauthorizationnumb>021395</drugauthorizationnumb>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060414</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060704</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALDACTONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUTIDE</medicinalproduct>
        <drugadministrationroute>055</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SEREVENT</medicinalproduct>
        <drugadministrationroute>055</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KLARICID</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048332-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060710</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2006-BP-07843BP</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DYSPHONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHEUMATOID ARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISION BLURRED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>021395</drugauthorizationnumb>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>021395</drugauthorizationnumb>
        <drugindication>ASTHMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SINGULAIR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048333-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060603</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2006-BP-06693NB</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>85</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CEREBRAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MICARDIS</medicinalproduct>
        <drugauthorizationnumb>020850</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060411</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060518</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>URSO</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19960213</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACTOS</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOBAY</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050425</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048334-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060706</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2006-BP-07749BP</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>75</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MEXILETINE HYDROCHLORIDE</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>18873</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048335-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060703</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2006-FF-00563FF</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>50</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DERMATITIS EXFOLIATIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPHADENOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIRAMUNE</medicinalproduct>
        <drugauthorizationnumb>020636</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040601</drugstartdate>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COMBIVIR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010830</drugstartdate>
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    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048336-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060704</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BE-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2006-DE-03382GD</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <patientonsetage>66</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CEREBELLAR HAEMATOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POST PROCEDURAL COMPLICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUBDURAL HAEMATOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIPYRIDAMOLE</medicinalproduct>
        <drugauthorizationnumb>012836</drugauthorizationnumb>
        <drugindication>ANTIPLATELET THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIPYRIDAMOLE</medicinalproduct>
        <drugauthorizationnumb>012836</drugauthorizationnumb>
        <drugindication>ISCHAEMIC STROKE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>ANTIPLATELET THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>ISCHAEMIC STROKE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048337-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060608</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2006-FF-00447FF</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>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
        <drugauthorizationnumb>021395</drugauthorizationnumb>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060604</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060608</drugenddate>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATROVENT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BRICANYL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EUPHYLINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048338-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060704</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2006-DE-03519DE</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>64</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>69</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>EMPHYSEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
        <drugauthorizationnumb>021395</drugauthorizationnumb>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060102</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
        <drugauthorizationnumb>021395</drugauthorizationnumb>
        <drugindication>EMPHYSEMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOREM 10</medicinalproduct>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KINZALKOMB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACC LONG</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BETA-2-AGONIST SHORT-ACTING</medicinalproduct>
        <drugindication>RESPIRATORY THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BETA-2-AGONIST LONG-ACTING [+ CORTICOID INHALATIVE]</medicinalproduct>
        <drugindication>RESPIRATORY THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>[BETA-2-AGONIST LONG-ACTING] + CORTICOID INHALATIVE</medicinalproduct>
        <drugadministrationroute>055</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048339-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060704</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2006-BP-07605NB</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DYSGEUSIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
        <drugauthorizationnumb>021395</drugauthorizationnumb>
        <drugadministrationroute>055</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048340-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ES-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2006-DE-03309GD</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>43</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ASCITES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLEEDING VARICOSE VEIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC ENCEPHALOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC FIBROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PORTAL VEIN THROMBOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEVIRAPINE</medicinalproduct>
        <drugauthorizationnumb>20636</drugauthorizationnumb>
        <drugindication>HIV INFECTION</drugindication>
        <drugtreatmentduration>13</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIDANOSINE</medicinalproduct>
        <drugindication>HIV INFECTION</drugindication>
        <drugtreatmentduration>47</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>STAVUDINE</medicinalproduct>
        <drugindication>HIV INFECTION</drugindication>
        <drugtreatmentduration>12</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HYDROXYUREA</medicinalproduct>
        <drugauthorizationnumb>074476</drugauthorizationnumb>
        <drugindication>HIV INFECTION</drugindication>
        <drugtreatmentduration>12</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
    </patient>
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  <safetyreport>
    <safetyreportid>5048341-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060601</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>TH-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2006-DE-02847GD</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>ALANINE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASPARTATE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACTERIAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CACHEXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CRYPTOCOCCOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATOTOXICITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYCOBACTERIUM AVIUM COMPLEX INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STEVENS-JOHNSON SYNDROME</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEVIRAPINE</medicinalproduct>
        <drugauthorizationnumb>20636</drugauthorizationnumb>
        <drugdosagetext>200 MG ONCE DAILY FOR 2 WEEKS, FOLLOWED BY 200 MG TWICE DAILY</drugdosagetext>
        <drugindication>HIV INFECTION</drugindication>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUCONAZOLE</medicinalproduct>
        <drugauthorizationnumb>076213</drugauthorizationnumb>
        <drugdosagetext>400 MG/WEEK</drugdosagetext>
        <drugindication>CRYPTOCOCCOSIS</drugindication>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUCONAZOLE</medicinalproduct>
        <drugauthorizationnumb>076213</drugauthorizationnumb>
        <drugindication>PROPHYLAXIS</drugindication>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ANTIRETROVIRAL DRUGS</medicinalproduct>
        <drugindication>HIV INFECTION</drugindication>
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    </patient>
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  <safetyreport>
    <safetyreportid>5048342-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060630</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2006-BP-07523NB</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
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    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>76</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT DECREASED</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MICARDIS</medicinalproduct>
        <drugauthorizationnumb>020850</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060629</drugenddate>
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    </patient>
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  <safetyreport>
    <safetyreportid>5048343-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
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    <companynumb>FR-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2006-FF-00555PF</companynumb>
    <primarysource>
      <qualification>1</qualification>
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    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>65</patientweight>
      <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>SPIRIVA</medicinalproduct>
        <drugauthorizationnumb>21395</drugauthorizationnumb>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060607</drugstartdate>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SINGULAIR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SERETIDE</medicinalproduct>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAHOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMBROXOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AUGMENTIN '125'</medicinalproduct>
        <drugindication>BRONCHITIS</drugindication>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SOLUPRED</medicinalproduct>
        <drugindication>BRONCHITIS</drugindication>
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    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048344-7</safetyreportid>
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    <transmissiondate>20061208</transmissiondate>
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    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
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    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>HIV INFECTION</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEVIRAPINE</medicinalproduct>
        <drugauthorizationnumb>020636</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEVIRAPINE</medicinalproduct>
        <drugauthorizationnumb>020636</drugauthorizationnumb>
        <drugindication>HUMAN IMMUNODEFICIENCY VIRUS TRANSMISSION</drugindication>
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  <safetyreport>
    <safetyreportid>5048345-9</safetyreportid>
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    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>MYCOBACTERIUM AVIUM COMPLEX INFECTION</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEVIRAPINE</medicinalproduct>
        <drugauthorizationnumb>20636</drugauthorizationnumb>
        <drugdosagetext>200 MG ONCE DAILY FOR 2 WEEKS, FOLLOWED BY 200 MG TWICE DAILY</drugdosagetext>
        <drugindication>HIV INFECTION</drugindication>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUCONAZOLE</medicinalproduct>
        <drugauthorizationnumb>076213</drugauthorizationnumb>
        <drugdosagetext>400 MG PER WEEK</drugdosagetext>
        <drugindication>CRYPTOCOCCOSIS</drugindication>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUCONAZOLE</medicinalproduct>
        <drugauthorizationnumb>076213</drugauthorizationnumb>
        <drugindication>PROPHYLAXIS</drugindication>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ANTIRETROVIRAL DRUGS</medicinalproduct>
        <drugindication>HIV INFECTION</drugindication>
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    <safetyreportid>5048346-0</safetyreportid>
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    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEVIRAPINE</medicinalproduct>
        <drugauthorizationnumb>20636</drugauthorizationnumb>
        <drugdosagetext>200 MG ONCE DAILY FOR 2 WEEKS, FOLLOWED BY 200 MG TWICE DAILY</drugdosagetext>
        <drugindication>HIV INFECTION</drugindication>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ANTIRETROVIRAL DRUGS</medicinalproduct>
        <drugindication>HIV INFECTION</drugindication>
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    <safetyreportid>5048347-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
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    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>HIV INFECTION</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEVIRAPINE</medicinalproduct>
        <drugauthorizationnumb>020636</drugauthorizationnumb>
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        <drugindication>PROPHYLAXIS</drugindication>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEVIRAPINE</medicinalproduct>
        <drugauthorizationnumb>020636</drugauthorizationnumb>
        <drugindication>HUMAN IMMUNODEFICIENCY VIRUS TRANSMISSION</drugindication>
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      <drug>
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        <medicinalproduct>ZIDOVUDINE</medicinalproduct>
        <drugauthorizationnumb>076844</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZIDOVUDINE</medicinalproduct>
        <drugauthorizationnumb>076844</drugauthorizationnumb>
        <drugindication>HUMAN IMMUNODEFICIENCY VIRUS TRANSMISSION</drugindication>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
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    <safetyreportid>5048348-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
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      <reportercountry>JAPAN</reportercountry>
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    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
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        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
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      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE ACUTE</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY ARREST</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>TENDON RUPTURE</reactionmeddrapt>
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      <drug>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
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        <drugadministrationroute>048</drugadministrationroute>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYMMETREL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PARKINSON'S DISEASE</drugindication>
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        <drugstartdate>20021106</drugstartdate>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
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        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANGINA PECTORIS</drugindication>
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        <drugenddate>20051119</drugenddate>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIGMART</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANGINA PECTORIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
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        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGLAX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DYSPEPSIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030205</drugstartdate>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GASMOTIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DYSPEPSIA</drugindication>
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        <drugenddate>20051119</drugenddate>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SELBEX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DYSPEPSIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PSYCHIATRIC SYMPTOM</drugindication>
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        <drugstartdate>20021213</drugstartdate>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BUFFERIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MYOCARDIAL INFARCTION</drugindication>
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        <drugenddate>20051119</drugenddate>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
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        <drugenddate>20051119</drugenddate>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RYTHMODAN R (DISOPYRAMIDE PHOSPHATE)</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANGINA PECTORIS</drugindication>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PURSENNID (SENNOSIDE)</medicinalproduct>
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        <drugstartdate>20021213</drugstartdate>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEPAS</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INSOMNIA</drugindication>
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      <drug>
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        <drugadministrationroute>048</drugadministrationroute>
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      <drug>
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    <safetyreportid>5048351-4</safetyreportid>
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      <reportercountry>AUSTRALIA</reportercountry>
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    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
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        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
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      <reaction>
        <reactionmeddrapt>CARDIAC ARREST</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
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      <drug>
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      <senderorganization>FDA-Public Use</senderorganization>
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        <patientdeathdate></patientdeathdate>
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        <drugenddate>20050623</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RISEDRONATE SODIUM</medicinalproduct>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROXYCHLOROQUINE</medicinalproduct>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040901</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TERBUTALINE SULFATE</medicinalproduct>
        <drugindication>ASTHMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031030</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048354-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060616</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-ABBOTT-06P-167-0336422-00</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>65</patientweight>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>OVARIAN MASS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOPHLEBITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040415</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060223</drugenddate>
        <drugtreatmentduration>679</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>RISEDRONATE</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048355-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060703</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-ABBOTT-06P-167-0337594-00</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>56</patientweight>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>BRONCHOPNEUMONIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051005</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060316</drugenddate>
        <drugtreatmentduration>162</drugtreatmentduration>
        <drugtreatmentdurationunit>804</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>SULFASALAZINE</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROXYCHLOROQUINE</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RISEDRONATE</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CITALOPRAM</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TEMAZEPAM</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>FERROUS SULFATE TAB</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048356-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060322</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-ABBOTT-06P-056-0328853-00</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHLEBITIS</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>20040104</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051115</drugenddate>
        <drugtreatmentduration>681</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COMMERCIAL HUMIRA</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031110</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEFLUNOMIDE</medicinalproduct>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051101</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHYLPREDNISOLONE</medicinalproduct>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051207</drugenddate>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DICLOFENAC</medicinalproduct>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MISOPROSTOL</medicinalproduct>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TIANEPTINE</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LERCANIDIPINE HYDROCHLORIDE</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOPICLONE</medicinalproduct>
        <drugindication>INSOMNIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BROMAZEPAM</medicinalproduct>
        <drugindication>ANXIETY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IRBESARTAN</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19960101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RILMENIDINE</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugindication>GASTROOESOPHAGEAL REFLUX DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IZOLOX</medicinalproduct>
        <drugindication>PYREXIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051118</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051119</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048405-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060703</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CG-MERCK-0607USA00708</companynumb>
    <primarysource>
      <reportercountry>CONGO</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>42</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ADVERSE EVENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>STROMECTOL</medicinalproduct>
        <drugauthorizationnumb>050742</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060512</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060512</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048406-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060221</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-MERCK-0602CAN00121</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>52</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ACUTE CORONARY SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTERIOSCLEROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CREATINE PHOSPHOKINASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG TOXICITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOPATHY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZETIA</medicinalproduct>
        <drugauthorizationnumb>21445</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030924</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031105</drugenddate>
        <drugtreatmentduration>43</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ATORVASTATIN CALCIUM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20001201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ATORVASTATIN CALCIUM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031105</drugenddate>
      </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>CLOPIDOGREL BISULFATE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RAMIPRIL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048407-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060602</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-MERCK-0606FRA00002</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>76</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>56</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD LACTATE DEHYDROGENASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOLYTIC ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERNATIONAL NORMALISED RATIO INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALLOR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NOROXIN</medicinalproduct>
        <drugauthorizationnumb>19384</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CYSTITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060413</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060416</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HYPOTHYROIDISM</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACENOCOUMAROL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HEART VALVE REPLACEMENT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIGOXIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>ARRHYTHMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRAVASTATIN SODIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DYSLIPIDAEMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALPROMIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CITALOPRAM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXAZEPAM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADRAFINIL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROXYZINE HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048408-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040329</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0403USA02556</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>79</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>76</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL DISTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EAR PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRIC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROOESOPHAGEAL REFLUX DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOWER EXTREMITY MASS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN JAW</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARATHYROID DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARYNGOLARYNGEAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SLEEP APNOEA SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STOMACH DISCOMFORT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SINGULAIR</medicinalproduct>
        <drugauthorizationnumb>20829</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHINITIS ALLERGIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SINGULAIR</medicinalproduct>
        <drugauthorizationnumb>020829</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060601</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SINGULAIR</medicinalproduct>
        <drugauthorizationnumb>020829</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>FOOD ALLERGY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SINGULAIR</medicinalproduct>
        <drugauthorizationnumb>020829</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060601</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUGH, COLD, AND FLU THERAPIES (UNSPECIFIED)</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENADRYL</medicinalproduct>
        <drugadministrationroute>051</drugadministrationroute>
        <drugindication>HYPERSENSITIVITY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATIVAN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRILOSEC</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARISTOCORT</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DILAUDID</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048409-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060704</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-MERCK-0607GBR00013</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>60</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANAPHYLACTIC SHOCK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZETIA</medicinalproduct>
        <drugauthorizationnumb>021445</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERCHOLESTEROLAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060619</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060703</drugenddate>
        <drugtreatmentduration>15</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ESOMEPRAZOLE MAGNESIUM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HERNIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048410-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060630</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0607USA00562</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>74</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CLOSTRIDIUM DIFFICILE COLITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLEURAL EFFUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHABDOMYOLYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THERAPEUTIC AGENT TOXICITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugauthorizationnumb>19766</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATORVASTATIN CALCIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOSPORINE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AZATHIOPRINE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048411-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060515</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BE-MERCK-0605BEL00015</companynumb>
    <primarysource>
      <reportercountry>BELGIUM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>60</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ARTERIOSCLEROSIS CORONARY ARTERY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>QUINAPRIL HCL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugauthorizationnumb>019766</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERCHOLESTEROLAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLYBURIDE AND METFORMIN HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLOPIDOGREL BISULFATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANGIOPATHY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN HUMAN ZINC, EXTENDED</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060123</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VENLAFAXINE HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE BESYLATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048413-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060616</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006080874</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BREAST CANCER FEMALE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROVERA</medicinalproduct>
        <drugauthorizationnumb>11839</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19871201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20011101</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>19871201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20011101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMARIN (ESTROGENS CONGJUATED)</medicinalproduct>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19871201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20011101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMPRO</medicinalproduct>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19871201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20011101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048414-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060626</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006080878</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BREAST CANCER FEMALE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROVERA</medicinalproduct>
        <drugauthorizationnumb>11839</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19921101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020901</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>19921101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020901</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19921101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020901</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMPRO</medicinalproduct>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19921101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020901</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048415-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060615</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US200606005147</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>69</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GLYCOSYLATED HAEMOGLOBIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VITRECTOMY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMALOG MIX 75/25</medicinalproduct>
        <drugbatchnumb>FF6D29A</drugbatchnumb>
        <drugauthorizationnumb>20563</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMALOG MIX 75/25</medicinalproduct>
        <drugbatchnumb>FF6D29A</drugbatchnumb>
        <drugauthorizationnumb>20563</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HUMALOG MIX 75/25</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048416-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060616</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US200606003884</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>62</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ARTERIAL STENOSIS LIMB</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN DISCOLOURATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VASCULAR GRAFT OCCLUSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMALOG</medicinalproduct>
        <drugbatchnumb>FF5N74A</drugbatchnumb>
        <drugauthorizationnumb>20563</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugindication>BLOOD GLUCOSE INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HUMALOG PEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NOVOLOG (INSULIN APART)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048417-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060615</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US200605003510</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>61</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE FLUCTUATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCORRECT DOSE ADMINISTERED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEDICAL DEVICE COMPLICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMALOG PEN</medicinalproduct>
        <drugauthorizationnumb>20563</drugauthorizationnumb>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMALOG</medicinalproduct>
        <drugbatchnumb>9RT37M</drugbatchnumb>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HUMALOG PEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048418-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060614</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US200603007068</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>46</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE FLUCTUATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CELLULITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFECTED SKIN ULCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEG AMPUTATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMALOG</medicinalproduct>
        <drugauthorizationnumb>20563</drugauthorizationnumb>
        <drugdosagetext>SUB. PUMP</drugdosagetext>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ILETIN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19740101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048419-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060614</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US200606003542</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>49</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLINDNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMALOG PEN</medicinalproduct>
        <drugauthorizationnumb>20563</drugauthorizationnumb>
        <drugindication>DIABETES MELLITUS NON-INSULIN-DEPENDENT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048420-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060614</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US200606004015</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMALOG</medicinalproduct>
        <drugauthorizationnumb>20563</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048421-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060623</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>225986</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>58</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CONDUCTIVE DEAFNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEAFNESS UNILATERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TINNITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XOLAIR</medicinalproduct>
        <drugindication>ASTHMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060418</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060531</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VERAPAMIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XOPENEX</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>KEPPRA</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048422-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060623</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>224625</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>40</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HEAD DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MIDDLE INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XOLAIR</medicinalproduct>
        <drugdosagetext>150 MG,</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060301</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE TAB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADVAIR DISKUS 100/50</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048423-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060622</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006-06-0163</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>13</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABNORMAL BEHAVIOUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NIGHT SWEATS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NIGHTMARE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSYCHOTIC DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MOMETASONE FUROATE</medicinalproduct>
        <drugbatchnumb>5JS1</drugbatchnumb>
        <drugauthorizationnumb>21067</drugauthorizationnumb>
        <drugdosagetext>INHALATION</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060406</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060419</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL SPIROS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RHINOCORT</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048424-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060622</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006-06-1619</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>64</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ALANINE AMINOTRANSFERASE ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INTRON A</medicinalproduct>
        <drugdosagetext>3-6 MIU* TIW SUBCUTANEOUS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>METASTATIC RENAL CELL CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060504</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060531</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUTENT</medicinalproduct>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>METASTATIC RENAL CELL CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060504</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060510</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUTENT</medicinalproduct>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>METASTATIC RENAL CELL CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060504</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060531</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUTENT</medicinalproduct>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>METASTATIC RENAL CELL CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060511</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060531</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ECOTRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTIVITAMIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048425-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060621</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006AL001623</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>AKATHISIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRAIN DAMAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSKINESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EMOTIONAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERNAL INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOVEMENT DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL STIFFNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUROLOGICAL SYMPTOM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TARDIVE DYSKINESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METOCLOPRAMIDE</medicinalproduct>
        <drugauthorizationnumb>70581</drugauthorizationnumb>
        <drugdosagetext>10 MG; PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ABDOMINAL PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040411</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040611</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROZAC</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048426-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060627</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006AL001622</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG LEVEL DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANIC ATTACK</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LORAZEPAM</medicinalproduct>
        <drugbatchnumb>907K51</drugbatchnumb>
        <drugauthorizationnumb>71404</drugauthorizationnumb>
        <drugdosagetext>1 MG; PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANXIETY</drugindication>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048427-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060626</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006AL001603</companynumb>
    <primarysource>
      <reportercountry>TAIWAN, PROVINCE OF CHINA</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>21</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DERMATITIS EXFOLIATIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIABETES MELLITUS INSULIN-DEPENDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIABETIC KETOACIDOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG ERUPTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG RASH WITH EOSINOPHILIA AND SYSTEMIC SYMPTOMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EOSINOPHILIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FACE OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HUMAN HERPESVIRUS 6 INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPEROSMOLAR STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSULIN C-PEPTIDE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEUKOCYTOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LICHENOID KERATOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIP EROSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPHOCYTOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METABOLIC ACIDOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NORMOCHROMIC NORMOCYTIC ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCREATIC ENZYMES INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROTHROMBIN TIME PROLONGED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH PAPULAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH PRURITIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TONSILLITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DICLOFENAC SODIUM</medicinalproduct>
        <drugauthorizationnumb>75910</drugauthorizationnumb>
        <drugindication>PHARYNGOLARYNGEAL PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
        <drugindication>PHARYNGOLARYNGEAL PAIN</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048428-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060627</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>SUS1-2006-00477</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>9</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>29.9</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ABNORMAL BEHAVIOUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD POTASSIUM DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRAIN DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRAIN STEM SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBRAL ISCHAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIABETES INSIPIDUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROENTERITIS VIRAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPONATRAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTHERMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENTAL STATUS CHANGES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMOTHORAX</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TIC</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ADDERALL XR 15</medicinalproduct>
        <drugauthorizationnumb>21303</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugindication>ATTENTION DEFICIT/HYPERACTIVITY DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050701</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ADDERALL XR 15</medicinalproduct>
        <drugauthorizationnumb>21303</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugindication>ATTENTION DEFICIT/HYPERACTIVITY DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060422</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GUANFACINE HYDROCHLORIDE XR (GUANFACINE HYDROCHLORIDE)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048429-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060612</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US200606003185</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>58</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ALOPECIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYSTERECTOMY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN DISCOLOURATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMULIN 70/30</medicinalproduct>
        <drugauthorizationnumb>18780</drugauthorizationnumb>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048430-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060623</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006079838</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ACTIVITIES OF DAILY LIVING IMPAIRED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GRUNTING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSYCHOMOTOR HYPERACTIVITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEPO-PROVERA</medicinalproduct>
        <drugauthorizationnumb>20246</drugauthorizationnumb>
        <drugdosagetext>INTRAMUSCULAR</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM (POTASSIUM)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM (CALCIUM)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMINS (VITAMINS)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TEGRETOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ABILIFY(ARIPRAZOLE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METRONIDAZOLE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048431-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060626</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006080863</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BREAST CANCER FEMALE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>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>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMPRO</medicinalproduct>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ESTRACE</medicinalproduct>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048432-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060626</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006080868</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BREAST CANCER FEMALE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROVERA</medicinalproduct>
        <drugauthorizationnumb>11839</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020601</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MEDROXYPROGESTERONE ACETATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020601</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MEDROXYPROGESTERON ACETATE TABLET (MEDROXYPROGESTERONE ACETATE)</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020601</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020601</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCRIN</medicinalproduct>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020601</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMPRO</medicinalproduct>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020601</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048433-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060626</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006080869</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BREAST CANCER FEMALE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROVERA</medicinalproduct>
        <drugauthorizationnumb>11839</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020601</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MEDROXYPROGESTERONE</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020601</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>19980201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020601</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020601</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048434-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060623</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006079410</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>0</patientsex>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugauthorizationnumb>21446</drugauthorizationnumb>
        <drugdosagetext>25 MG (1 D)</drugdosagetext>
        <drugindication>RENAL IMPAIRMENT</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048435-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060623</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006040636</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>55</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>85</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DIALYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUTENT</medicinalproduct>
        <drugauthorizationnumb>21968</drugauthorizationnumb>
        <drugdosagetext>50 MG (50 MG 1 IN 1 D) ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RENAL CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060118</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060208</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELLCEPT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROGRAF</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLYBURIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZAROXOLYN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE TAB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARDURA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KEFLEX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PERCOCET</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMBIEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTIVITAMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORAZEPAM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048436-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060614</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US200606003652</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>65</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HIP FRACTURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugauthorizationnumb>21318</drugauthorizationnumb>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FORTEO PEN (FORTEO PEN)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048437-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesscongenitalanomali>1</seriousnesscongenitalanomali>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060630</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>USA-2006-0024438</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>APGAR SCORE LOW</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CAESAREAN SECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE VIA BREAST MILK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG SCREEN POSITIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HERNIA CONGENITAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PREMATURE BABY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXYCODONE HYDROCHLORIDE</medicinalproduct>
        <drugauthorizationnumb>20553</drugauthorizationnumb>
        <drugdosagetext>TRANSPLACENTAL</drugdosagetext>
        <drugadministrationroute>064</drugadministrationroute>
        <drugindication>DRUG EXPOSURE DURING PREGNANCY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048438-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060620</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>USA-2006-0024403</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>20</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ACCIDENTAL DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANOREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG DEPENDENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG TOXICITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEGLECT OF PERSONAL APPEARANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUBSTANCE ABUSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXYCODONE HYDROCHLORIDE</medicinalproduct>
        <drugauthorizationnumb>20553</drugauthorizationnumb>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PERCOCET</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MARJUANA (CANNABIS)</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEROIN (DIAMORPHINE)</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048439-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060626</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>226132</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>65</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>79.7</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ENTEROCOCCAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>KLEBSIELLA INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL COLIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ERLOTINIB(ERLOTINIB) TABLET</medicinalproduct>
        <drugdosagetext>15 MG/KG, Q3W, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060517</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVASTIN</medicinalproduct>
        <drugdosagetext>150 MG, QD, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060405</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CIPROFLOXACIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE/IRBESARTAN (HYDROCHLOROTHIAZDE/IRBESARTAN)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICATION (INGREDIENT) (GENERIC COMPONENT (S)  NOT KNOWN)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MYLANTA (ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, SIMETHICONE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRILOSEC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048440-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060619</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>23100292</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>ACTIVATED PARTIAL THROMBOPLASTIN TIME PROLONGED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCORRECT DRUG ADMINISTRATION RATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFUSION SITE HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARGATROBAN</medicinalproduct>
        <drugauthorizationnumb>20883</drugauthorizationnumb>
        <drugdosagetext>250 MG/ML ONCE IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>805</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048441-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060622</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>225779</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>78</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ADVERSE DRUG REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CORNEAL OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LATEX ALLERGY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVASTIN</medicinalproduct>
        <drugbatchnumb>20061705</drugbatchnumb>
        <drugdosagetext>1 MG, SINGLE, INTRAVITREAL</drugdosagetext>
        <drugindication>MACULAR DEGENERATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GENTAMICIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048442-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060621</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2005161680</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ARTERIOSCLEROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIO-RESPIRATORY ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIOVASCULAR DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CAROTID ARTERY DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ISCHAEMIC CEREBRAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENTAL STATUS CHANGES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOSIS</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>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010604</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugauthorizationnumb>20998</drugauthorizationnumb>
        <drugdosagetext>200 MG (200 MG, 1 IN 1 D)</drugdosagetext>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010604</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEXTRA</medicinalproduct>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugdosagetext>25 MG (25 MG, 1 IN 1 D)</drugdosagetext>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048443-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060622</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2005125860</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BONE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRIGGER FINGER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugauthorizationnumb>20702</drugauthorizationnumb>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048444-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060703</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060620</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2005130011</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>61</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>53.978</patientweight>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</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>20041025</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041216</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONIDINE (CLONIDINE0</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOTREL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZANAFLEX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPROL-XL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAZODONE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TIZANIDINE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVAQUIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LABETALOL HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEPAKOTE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CIPROFLOXACIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDRALAZINE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPAMAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MITRAZAPINE (MIRTAZAPINE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DITROPAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORECET PLUS (HYDOCODONE BITARTRATE, PARACTAMOL)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHADONE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PERCOCET</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PHENAZOPYRIDINE (PHENAZOPYRIDINE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ULTRACET (PARACEMATOL, TRAMADOL HYDROCHLORIDE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MORPHINE</medicinalproduct>
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      <drug>
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  <safetyreport>
    <safetyreportid>5048445-3</safetyreportid>
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      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
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        <reactionmeddrapt>ANAPHYLACTIC REACTION</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RITUXIMAB (RITUXIMAB)CONC FOR SOLUTION FOR INFUSION</medicinalproduct>
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    <receiver></receiver>
    <patient>
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      <reaction>
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      <drug>
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        <reactionmeddrapt>BREAST CANCER FEMALE</reactionmeddrapt>
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      <drug>
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    <patient>
      <patientsex>2</patientsex>
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        <reactionmeddrapt>BREAST CANCER FEMALE</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>CELLULITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEMENTIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMATROPE</medicinalproduct>
        <drugauthorizationnumb>19640</drugauthorizationnumb>
        <drugindication>PITUITARY TUMOUR</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041201</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048458-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060614</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US200604003887</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>75</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HIP FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugbatchnumb>FF5L56B</drugbatchnumb>
        <drugauthorizationnumb>21318</drugauthorizationnumb>
        <drugdosagetext>20 UG, DAILY (1/D)</drugdosagetext>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048459-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060614</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US200604004563</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>NEPHROLITHIASIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugbatchnumb>FF5T49A</drugbatchnumb>
        <drugauthorizationnumb>21318</drugauthorizationnumb>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CITRACAL (CALCIUM CITRATE)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048460-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060612</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US200606002943</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DYSPHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JAW FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JAW OPERATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>120 MG</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTIPSYCHOTICS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENZODIAZEPINE DERIVATIVES</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048461-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060614</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>EG200602004700</companynumb>
    <primarysource>
      <reportercountry>EGYPT</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>35</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CHILLS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TERIPARATIDE(TERIPARATIDE) PEN,DISPOSABLE</medicinalproduct>
        <drugbatchnumb>FF 4H20A</drugbatchnumb>
        <drugauthorizationnumb>21318</drugauthorizationnumb>
        <drugdosagetext>20 UG, DAILY (1/D), SUBCUTANEOUS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060204</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060218</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FORTEO PEN (FORTEO PEN)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BLOOD TRANSFUSION, AUXILIARY PRODUCTS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048462-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060613</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GR200603005882</companynumb>
    <primarysource>
      <reportercountry>GREECE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>59</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>73</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPHOCYTE PERCENTAGE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORSTEO (TERIPARATIDE) PEN,DISPOSABLE</medicinalproduct>
        <drugauthorizationnumb>21318</drugauthorizationnumb>
        <drugdosagetext>20 UG, DAILY (1/D), SUBCUTANEOUS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050222</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FORTEO PEN (FORTEO PEN)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SALOSPIR (ACETYLSALICYLIC ACID)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PACTENS (BISOPROLOL FUMARATE)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048463-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060613</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR200603002747</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>77</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ESCHERICHIA SEPSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYELONEPHRITIS ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WRIST FRACTURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORSTEO(TERIPARATIDE) PEN,DISPOSABLE</medicinalproduct>
        <drugauthorizationnumb>21318</drugauthorizationnumb>
        <drugdosagetext>20 UG, DAILY (1/D), SUBCUTANEOUS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050928</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FORTEO PEN (FORTEO PEN)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SECTRAL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE TAB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>STRUCTUM (CHONDROITIN SULFATE SODIUM)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREVISCAN (FLUINDIONE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE BESYLATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EUPRESSYL (URAPIDIL)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VASTAREL (TRIMETAZIDINE HYDROCHLORIDE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ESOMEPRAZOLE (ESOMEPRAZOLE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CACIT D3 (CALCIUM CARBONATE, COLECALCIFEROL)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048464-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060619</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2005BI020805</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>LINEAR IGA DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STEVENS-JOHNSON SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZEVALIN</medicinalproduct>
        <drugbatchnumb>Y-90 YTRACIS</drugbatchnumb>
        <drugdosagetext>1X; IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NON-HODGKIN'S LYMPHOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RITUXIMAB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CHEMOTHERAPY</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048465-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060621</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>8017546</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>1.9</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CAESAREAN SECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE VIA BREAST MILK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SMALL FOR DATES BABY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KEPPRA</medicinalproduct>
        <drugauthorizationnumb>21035</drugauthorizationnumb>
        <drugdosagetext>1500 MG 2/D TRP</drugdosagetext>
        <drugindication>EPILEPSY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051004</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060603</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KEPPRA</medicinalproduct>
        <drugdosagetext>1500 MG 2/D TRM</drugdosagetext>
        <drugindication>EPILEPSY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060609</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060613</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLOBAZAM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048466-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060621</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>8017550</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>2.35</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CAESAREAN SECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE BEFORE PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE VIA BREAST MILK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SMALL FOR DATES BABY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KEPPRA</medicinalproduct>
        <drugauthorizationnumb>21035</drugauthorizationnumb>
        <drugdosagetext>1500 MG 2/D TRP</drugdosagetext>
        <drugindication>EPILEPSY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051004</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060603</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KEPPRA</medicinalproduct>
        <drugdosagetext>1500 MG 2/D TRM</drugdosagetext>
        <drugindication>EPILEPSY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060609</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060613</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLOBAZAM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048467-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060619</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>8017553</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>LUNG DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KEPPRA</medicinalproduct>
        <drugauthorizationnumb>21035</drugauthorizationnumb>
        <drugdosagetext>1000 MG IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>EPILEPSY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIAZEPAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALPROIC ACID</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048468-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060703</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-JNJFOC-20060700138</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>53</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FEMORAL NECK FRACTURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AZATHIOPRINE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIDRONEL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ISONIAZID</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048469-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060703</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-JNJFOC-20060505952</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>73</patientweight>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>COLON NEOPLASM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN W/ CODEINE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FERROUS SULFATE TAB</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANSOPRAZOL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYBUTANIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048470-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060630</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20060403705</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>78.47</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BRONCHITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BURSITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EPICONDYLITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUROPATHY PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLEURAL EFFUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY TRACT 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>LIPITOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WATER PILL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENECAR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SULFADIAZINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BUMEX</medicinalproduct>
        <drugindication>DIURETIC THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACTENOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGNESIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADVAIR DISKUS 100/50</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDRALAZINE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SULFASALAZINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLEXERIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TEMAZEPAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDA/APPA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN E</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM CHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NIACIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AZMACORT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SEREVENT</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048471-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060621</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>8017352</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>27</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CAESAREAN SECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TWIN PREGNANCY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KEPPRA</medicinalproduct>
        <drugauthorizationnumb>21035</drugauthorizationnumb>
        <drugdosagetext>1500 MG 2/D PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONVULSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KEPPRA</medicinalproduct>
        <drugauthorizationnumb>21035</drugauthorizationnumb>
        <drugdosagetext>1500 MG 2/D PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>EPILEPSY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLOBAZAM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048472-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060626</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200611549GDS</companynumb>
    <primarysource>
      <reportercountry>UKRAINE</reportercountry>
      <qualification>3</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>ACUTE MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTERIOSCLEROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE CHRONIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRY SKIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RED BLOOD CELL SEDIMENTATION RATE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SORAFENIB</medicinalproduct>
        <drugbatchnumb>CT2089/2</drugbatchnumb>
        <drugauthorizationnumb>21923</drugauthorizationnumb>
        <drugdosagetext>400 MG, BID, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RENAL CELL CARCINOMA STAGE UNSPECIFIED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051005</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060412</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048473-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060621</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200610687BYL</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>52</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY RATE INCREASED</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>20060502</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PL GRAN.</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MUCOSOLVAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MUCOSTA</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048474-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060619</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200610607BFR</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>75</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>KERATOACANTHOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SORAFENIB</medicinalproduct>
        <drugauthorizationnumb>21923</drugauthorizationnumb>
        <drugdosagetext>400 MG, BID, ORAL - SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATIC NEOPLASM MALIGNANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030502</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030527</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SORAFENIB</medicinalproduct>
        <drugauthorizationnumb>21923</drugauthorizationnumb>
        <drugdosagetext>400 MG, BID, ORAL - SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATIC NEOPLASM MALIGNANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030528</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030623</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SORAFENIB</medicinalproduct>
        <drugauthorizationnumb>21923</drugauthorizationnumb>
        <drugdosagetext>400 MG, BID, ORAL - SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATIC NEOPLASM MALIGNANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030624</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030723</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SORAFENIB</medicinalproduct>
        <drugauthorizationnumb>21923</drugauthorizationnumb>
        <drugdosagetext>400 MG, BID, ORAL - SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATIC NEOPLASM MALIGNANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030724</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030904</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SORAFENIB</medicinalproduct>
        <drugauthorizationnumb>21923</drugauthorizationnumb>
        <drugdosagetext>400 MG, BID, ORAL - SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATIC NEOPLASM MALIGNANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030807</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030904</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SORAFENIB</medicinalproduct>
        <drugauthorizationnumb>21923</drugauthorizationnumb>
        <drugdosagetext>400 MG, BID, ORAL - SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATIC NEOPLASM MALIGNANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030905</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031002</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SORAFENIB</medicinalproduct>
        <drugauthorizationnumb>21923</drugauthorizationnumb>
        <drugdosagetext>400 MG, BID, ORAL - SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATIC NEOPLASM MALIGNANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031003</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031106</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SORAFENIB</medicinalproduct>
        <drugauthorizationnumb>21923</drugauthorizationnumb>
        <drugdosagetext>400 MG, BID, ORAL - SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATIC NEOPLASM MALIGNANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031107</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031128</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SORAFENIB</medicinalproduct>
        <drugauthorizationnumb>21923</drugauthorizationnumb>
        <drugdosagetext>400 MG, BID, ORAL - SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATIC NEOPLASM MALIGNANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031129</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031219</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SORAFENIB</medicinalproduct>
        <drugauthorizationnumb>21923</drugauthorizationnumb>
        <drugdosagetext>400 MG, BID, ORAL - SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATIC NEOPLASM MALIGNANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031220</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040112</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SORAFENIB</medicinalproduct>
        <drugauthorizationnumb>21923</drugauthorizationnumb>
        <drugdosagetext>400 MG, BID, ORAL - SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATIC NEOPLASM MALIGNANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040113</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040213</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SORAFENIB</medicinalproduct>
        <drugauthorizationnumb>21923</drugauthorizationnumb>
        <drugdosagetext>400 MG, BID, ORAL - SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATIC NEOPLASM MALIGNANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040214</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040308</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SORAFENIB</medicinalproduct>
        <drugauthorizationnumb>21923</drugauthorizationnumb>
        <drugdosagetext>400 MG, BID, ORAL - SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATIC NEOPLASM MALIGNANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040309</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040406</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SORAFENIB</medicinalproduct>
        <drugauthorizationnumb>21923</drugauthorizationnumb>
        <drugdosagetext>400 MG, BID, ORAL - SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATIC NEOPLASM MALIGNANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040407</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040717</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SORAFENIB</medicinalproduct>
        <drugauthorizationnumb>21923</drugauthorizationnumb>
        <drugdosagetext>400 MG, BID, ORAL - SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATIC NEOPLASM MALIGNANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040730</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050512</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SORAFENIB</medicinalproduct>
        <drugauthorizationnumb>21923</drugauthorizationnumb>
        <drugdosagetext>400 MG, BID, ORAL - SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATIC NEOPLASM MALIGNANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040512</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050517</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SORAFENIB</medicinalproduct>
        <drugauthorizationnumb>21923</drugauthorizationnumb>
        <drugdosagetext>400 MG, BID, ORAL - SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATIC NEOPLASM MALIGNANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050517</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048475-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060621</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0428200A</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>28</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCLONUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMICTAL</medicinalproduct>
        <drugauthorizationnumb>20241</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CITALOPRAM (FORMULATION UNKNOWN) (CITALOPRAM)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048476-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060627</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0428643A</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>32</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BIOPSY SKIN ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLISTER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD LACTATE DEHYDROGENASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG ERUPTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EPSTEIN-BARR VIRUS ANTIBODY POSITIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PETECHIAE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN TEST POSITIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMOXIL</medicinalproduct>
        <drugauthorizationnumb>50754</drugauthorizationnumb>
        <drugdosagetext>SINGLE DOSE / ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RESPIRATORY TRACT INFECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIPYRONE INJ</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048477-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060627</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200610848BYL</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>3</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>ASPIRIN</medicinalproduct>
        <drugauthorizationnumb>21317</drugauthorizationnumb>
        <drugdosagetext>100 MG, QD, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ACUTE MYOCARDIAL INFARCTION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060401</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048478-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200610779BNE</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>69</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>NEUTROPENIC SEPSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SORAFENIB</medicinalproduct>
        <drugauthorizationnumb>21923</drugauthorizationnumb>
        <drugdosagetext>400 MG, BID, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>METASTATIC MALIGNANT MELANOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060511</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060625</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DACARBAZINE</medicinalproduct>
        <drugdosagetext>INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>METASTATIC MALIGNANT MELANOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060609</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048479-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060627</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200611270GDS</companynumb>
    <primarysource>
      <reportercountry>POLAND</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>57</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>82</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ASCITES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OLIGURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SORAFENIB</medicinalproduct>
        <drugbatchnumb>111850</drugbatchnumb>
        <drugauthorizationnumb>21923</drugauthorizationnumb>
        <drugdosagetext>400 MG, BID, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RENAL CELL CARCINOMA STAGE UNSPECIFIED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060207</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060325</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048480-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060622</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0428935A</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>63</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DEPRESSED LEVEL OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSARTHRIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSSTASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GUILLAIN-BARRE SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMODIALYSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOVIRAX</medicinalproduct>
        <drugauthorizationnumb>18603</drugauthorizationnumb>
        <drugindication>FACIAL PALSY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048481-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060621</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>8017368</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>39</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>125</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KEPPRA</medicinalproduct>
        <drugauthorizationnumb>21035</drugauthorizationnumb>
        <drugdosagetext>750 MG 2/D PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>EPILEPSY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048482-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060623</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006BI008914</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>43</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DUODENITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL INFECTION</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>20051020</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048483-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060621</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006BI003747</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>52</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>OESOPHAGEAL 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>20060103</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060223</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VIAGRA</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048484-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060621</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006BI001264</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>63</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>75</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANAL FISTULA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERIANAL ABSCESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SURGICAL PROCEDURE REPEATED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugdosagetext>30 UG;QW;</drugdosagetext>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050901</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048485-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060623</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006BI009119</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>48</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENTRICULAR EXTRASYSTOLES</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugdosagetext>30 UG;QW;IM</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</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>20060501</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048486-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060618</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>8017561</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>GRAND MAL CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HALLUCINATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL DISTURBANCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KEPPRA</medicinalproduct>
        <drugauthorizationnumb>21035</drugauthorizationnumb>
        <drugdosagetext>2500 MG /D PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>EPILEPSY</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060611</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KEPPRA</medicinalproduct>
        <drugdosagetext>1500 MG 2/D PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>EPILEPSY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060612</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060619</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KEPPRA</medicinalproduct>
        <drugdosagetext>2750 MG PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>EPILEPSY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060620</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ERGENYL CHRONO</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VPA CHRONO</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048487-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060619</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>8017444</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>32</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSED LEVEL OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG RESISTANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EPILEPTIC AURA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GRAND MAL CONVULSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KEPPRA</medicinalproduct>
        <drugauthorizationnumb>21035</drugauthorizationnumb>
        <drugdosagetext>3 G/D</drugdosagetext>
        <drugindication>PARTIAL SEIZURES</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOPIRAMATE</medicinalproduct>
        <drugdosagetext>550 MG/D</drugdosagetext>
        <drugindication>PARTIAL SEIZURES</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOPIRAMATE</medicinalproduct>
        <drugdosagetext>150 MG/D</drugdosagetext>
        <drugindication>PARTIAL SEIZURES</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOPIRAMATE</medicinalproduct>
        <drugdosagetext>50 MG/D</drugdosagetext>
        <drugindication>PARTIAL SEIZURES</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048488-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060615</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>8017469</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>BRAIN OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEBRILE CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GRAND MAL CONVULSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>THEOPHYLLINE</medicinalproduct>
        <drugauthorizationnumb>87942</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048489-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060619</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GBR-2006-0002358</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>45</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DECREASED APPETITE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERKALAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEPHROPATHY TOXIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY RETENTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXYCONTIN</medicinalproduct>
        <drugauthorizationnumb>20553</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060524</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060526</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXYCODONE HCL</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060524</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060526</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MORPHINE</medicinalproduct>
        <drugdosagetext>100 MG, DAILY, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060526</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060527</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KYTRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SOLU-MEDROL (METHYLPRESNISOLONE SODIUM SUCCINATE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRANXENE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CHLORPROMAZINE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGNESIUM SULFATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SOLUPRED (PREDNISOLONE SODIUM SULFOBENZOATE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FERO-GRAD (FERROUS SULFATE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONAZEPAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KETAMINE (KETAMINE)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048490-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060619</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GBR-2006-0002365</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>59</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIPLOPIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EPILEPSY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NERVOUS SYSTEM DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HYDROMORPHONE HYDROCHLORIDE</medicinalproduct>
        <drugauthorizationnumb>21044</drugauthorizationnumb>
        <drugdosagetext>1 DF, DAILY, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051206</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060418</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUOROURACIL</medicinalproduct>
        <drugdosagetext>INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>LYMPHADENOPATHY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051206</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060418</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVASTIN</medicinalproduct>
        <drugdosagetext>300 MG, SINGLE</drugdosagetext>
        <drugindication>LYMPHADENOPATHY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051206</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060418</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOLPIDEM TARTRATE</medicinalproduct>
        <drugdosagetext>10 MG</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051206</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CAMPTOSAR</medicinalproduct>
        <drugdosagetext>305 MG, SINGLE</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051206</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048491-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>0601978US</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>76</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALESION TABLET(EPINASTINE HYDROCHLORIDE) TABLET, 10MG</medicinalproduct>
        <drugauthorizationnumb>21565</drugauthorizationnumb>
        <drugdosagetext>20 MG, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PSORIASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060501</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048492-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060626</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006-06-0870</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>49</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ALOPECIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHILLS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONTUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ECCHYMOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EPISTAXIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEBRILE NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCYTOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PETECHIAE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TEMODAL</medicinalproduct>
        <drugauthorizationnumb>21029</drugauthorizationnumb>
        <drugdosagetext>245 MG ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OLIGODENDROGLIOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060521</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACTONEL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM/VITAMIN D</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLOBAZAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALPROIC ACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROXYZINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048493-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060621</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006-06-1622</companynumb>
    <primarysource>
      <reportercountry>COLOMBIA</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>20</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>AMNESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLARITIN</medicinalproduct>
        <drugauthorizationnumb>20641</drugauthorizationnumb>
        <drugdosagetext>5ML BID ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHINITIS ALLERGIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060608</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060608</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048494-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060622</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>226584</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>4</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANOREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NUTROPIN AQ</medicinalproduct>
        <drugauthorizationnumb>20522</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>TURNER'S SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060426</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048495-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060623</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006-06-0645</companynumb>
    <primarysource>
      <reportercountry>POLAND</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>48</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STRESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MOMETASONE FUROATE</medicinalproduct>
        <drugauthorizationnumb>19625</drugauthorizationnumb>
        <drugdosagetext>0.1% TOP-DERM</drugdosagetext>
        <drugindication>DERMATOSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060518</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060518</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048496-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060622</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006-06-1918</companynumb>
    <primarysource>
      <reportercountry>ITALY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>38</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEWIS-SUMNER SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULAR WEAKNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TONGUE ATROPHY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INTERFERON ALFA-2B INJECTABLE</medicinalproduct>
        <drugauthorizationnumb>20903</drugauthorizationnumb>
        <drugdosagetext>100 UG QW</drugdosagetext>
        <drugindication>HEPATITIS C</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RIBAVIRIN</medicinalproduct>
        <drugdosagetext>1000 MG QD</drugdosagetext>
        <drugindication>HEPATITIS C</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048497-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060623</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006-06-0979</companynumb>
    <primarysource>
      <reportercountry>INDIA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>47</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>52</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PURPURA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TEMOZOLOMIDE CAPSULES</medicinalproduct>
        <drugbatchnumb>5WH101</drugbatchnumb>
        <drugauthorizationnumb>21029</drugauthorizationnumb>
        <drugdosagetext>250 MG ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DISEASE RECURRENCE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060505</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TEMOZOLOMIDE CAPSULES</medicinalproduct>
        <drugbatchnumb>5WH101</drugbatchnumb>
        <drugauthorizationnumb>21029</drugauthorizationnumb>
        <drugdosagetext>250 MG ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GLIOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060505</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALPROATE SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RADIATION THERAPY</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048498-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060619</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PAR_0679_2006</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>17</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ELECTROCARDIOGRAM CHANGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERAL PHYSICAL HEALTH DETERIORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENTAL IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDE ATTEMPT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ISOPTIN</medicinalproduct>
        <drugauthorizationnumb>19152</drugauthorizationnumb>
        <drugdosagetext>2400 MG ONCE PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OVERDOSE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060529</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060529</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ISOPTIN</medicinalproduct>
        <drugauthorizationnumb>19152</drugauthorizationnumb>
        <drugdosagetext>2400 MG ONCE PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SUICIDE ATTEMPT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060529</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060529</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALCOHOLIC FOOD</medicinalproduct>
        <drugdosagetext>DF ONCE PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SUICIDE ATTEMPT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AXURA</medicinalproduct>
        <drugdosagetext>100 MG ONCE PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OVERDOSE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060529</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060529</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AXURA</medicinalproduct>
        <drugdosagetext>100 MG ONCE PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SUICIDE ATTEMPT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060529</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060529</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048499-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>APP200600158</companynumb>
    <primarysource>
      <reportercountry>ITALY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>30</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABORTION INDUCED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AMAUROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NUCLEAR MAGNETIC RESONANCE IMAGING BRAIN ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUPERIOR SAGITTAL SINUS THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENOUS THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHORIONIC GONADORTOPIN INJ</medicinalproduct>
        <drugauthorizationnumb>17067</drugauthorizationnumb>
        <drugdosagetext>(5000 IU, ONCE), INJECTION</drugdosagetext>
        <drugindication>INFERTILITY FEMALE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DECAPEPTYL (GONADORELIN)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PUREGON (FOLLITROPIN ALFA)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROGESTERONE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048500-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060622</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>VNL_0158_2006</companynumb>
    <primarysource>
      <reportercountry>NETHERLANDS</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>58</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HAEMOLYTIC ANAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>APO-GO</medicinalproduct>
        <drugauthorizationnumb>21264</drugauthorizationnumb>
        <drugdosagetext>6 MG/HR INFUSION SC</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PARKINSON'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031110</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040510</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PERGOLIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVODOPA COMB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVODOPA 125 HBS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVODOPA COMB 125 CR</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048501-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060625</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>USA-2006-0024455</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>73</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>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>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CEFDITOREN PIVOXIL (SIMILAR TO NDA 21-222) (CEFDITOREN PIVOXIL) UNKNOW</medicinalproduct>
        <drugauthorizationnumb>21222</drugauthorizationnumb>
        <drugdosagetext>300 MG, DAILY, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BRONCHITIS ACUTE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060609</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060610</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVOFLOXACIN</medicinalproduct>
        <drugdosagetext>300 MG, DAILY, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BRONCHITIS ACUTE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060603</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060606</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOXONIN (LOXOPROFEN SODIUM)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048502-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060626</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006-06-1895</companynumb>
    <primarysource>
      <reportercountry>TAIWAN, PROVINCE OF CHINA</reportercountry>
      <qualification>1</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>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUBARACHNOID HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEG-INTRON</medicinalproduct>
        <drugdosagetext>80 MCG QW SUBCUTANEOUS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060105</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RIBAVIRIN</medicinalproduct>
        <drugdosagetext>400 MG BID ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060105</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048503-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060626</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006-06-1738</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BRONCHOSPASM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INTERFERON INJECTABLE</medicinalproduct>
        <drugauthorizationnumb>20903</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RIBAVIRIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048504-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060626</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006-06-1878</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>58</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOWER LIMB FRACTURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEG-INTRON</medicinalproduct>
        <drugdosagetext>100 MCG QW SUBCUTANEOUS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060407</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBETOL</medicinalproduct>
        <drugdosagetext>400 MG ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060407</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048505-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060620</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CERZ-11238</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>54</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PNEUMOCOCCAL INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CEREZYME</medicinalproduct>
        <drugauthorizationnumb>20367</drugauthorizationnumb>
        <drugindication>GAUCHER'S DISEASE</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060518</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048506-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060630</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006-05-2320</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>60</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CHOLECYSTITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHOLELITHOTOMY</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>20060328</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060101</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>20060101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBETOL</medicinalproduct>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBETOL</medicinalproduct>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060328</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBETOL</medicinalproduct>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048507-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060613</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE200606003194</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CHOLELITHIASIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>90 MG, DAILY (1/D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060517</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RANITIDIN ^ISIS^ (RANITIDINE HYDROCHLORIDE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NOVAMINSULFON-RATIOPHARM (METAMIZOLE SODIUM)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048508-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060614</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP200606003674</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>50</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANTI-INSULIN ANTIBODY POSITIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE FLUCTUATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CASTLEMAN'S DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GLYCOSYLATED HAEMOGLOBIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSULIN RESISTANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPHADENOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PETECHIAE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RETINOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMALOG</medicinalproduct>
        <drugauthorizationnumb>20563</drugauthorizationnumb>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMULIN R</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048509-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060612</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AT200606003023</companynumb>
    <primarysource>
      <reportercountry>AUSTRIA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>16</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>LEUKOPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
        <drugauthorizationnumb>20592</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANOREXIA NERVOSA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040517</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040618</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
        <drugauthorizationnumb>20592</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANOREXIA NERVOSA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040619</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040620</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
        <drugauthorizationnumb>20592</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANOREXIA NERVOSA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040621</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040802</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
        <drugauthorizationnumb>20592</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANOREXIA NERVOSA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040803</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAZODONE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONAZEPAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENEFIBER (GUAR GUM)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CAL-D-VITA (CALCIUM CARBONATE, COLECALCIFEROL)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAXI-KALZ (CALCIUM CITRATE)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048510-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060612</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AT200606003022</companynumb>
    <primarysource>
      <reportercountry>AUSTRIA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>18</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>LEUKOPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
        <drugauthorizationnumb>20592</drugauthorizationnumb>
        <drugdosagetext>10 MG, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060123</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060123</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048511-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060616</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR200606002263</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>68</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERICARDITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URTICARIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugauthorizationnumb>21318</drugauthorizationnumb>
        <drugdosagetext>20 UG, DAILY (1/D), SUBCUTANEOUS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051016</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060505</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048512-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060616</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA200606004276</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>75</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>RENAL IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugbatchnumb>FF5X10A</drugbatchnumb>
        <drugauthorizationnumb>21318</drugauthorizationnumb>
        <drugdosagetext>20 UG, DAILY (1/D)</drugdosagetext>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DESYREL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CITALOPRAM HYDROBROMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MELOXICAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVAPRO</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048513-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060622</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006-06-1642</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>64</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ALANINE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASPARTATE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD ALKALINE PHOSPHATASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRIC ULCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THYROID FUNCTION TEST ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLARITIN</medicinalproduct>
        <drugauthorizationnumb>19658</drugauthorizationnumb>
        <drugdosagetext>10 MG ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERSENSITIVITY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050717</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060615</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SERENAL</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060616</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DICLOFENAC SODIUM</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060616</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CEPHADOL</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060616</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>STRONG NEO-MINOPHAGEN C</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTI-INFLAMMATORY AGENT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REBAMIPIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPARTATE POTASSIUM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048514-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060621</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006S1000145</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>AGITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DELUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEREALISATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISORIENTATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACITRETIN</medicinalproduct>
        <drugauthorizationnumb>19821</drugauthorizationnumb>
        <drugdosagetext>PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>KERATOSIS FOLLICULAR</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048515-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060705</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006AP03107</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>9</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIAC ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBRAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEMORY IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVERDOSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XYLOCAINE</medicinalproduct>
        <drugauthorizationnumb>006488</drugauthorizationnumb>
        <drugadministrationroute>051</drugadministrationroute>
        <drugindication>LOCAL ANAESTHESIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048516-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060630</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006AC01221</companynumb>
    <primarysource>
      <reportercountry>BELGIUM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>44</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>101</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DIABETES MELLITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSLIPIDAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OBESITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugauthorizationnumb>020639</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOAFFECTIVE DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021110</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CAMCOLIT</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOAFFECTIVE DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020202</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048517-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060619</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006AP02845</companynumb>
    <primarysource>
      <reportercountry>THAILAND</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>16</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>63.6</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BRADYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUPRAVENTRICULAR EXTRASYSTOLES</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>0.5% MARCAINE SPINAL HEAVY</medicinalproduct>
        <drugbatchnumb>GI12358</drugbatchnumb>
        <drugauthorizationnumb>71202</drugauthorizationnumb>
        <drugadministrationroute>037</drugadministrationroute>
        <drugindication>CAESAREAN SECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060503</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060503</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>0.5% MARCAINE SPINAL HEAVY</medicinalproduct>
        <drugbatchnumb>GI12358</drugbatchnumb>
        <drugauthorizationnumb>071202</drugauthorizationnumb>
        <drugadministrationroute>037</drugadministrationroute>
        <drugindication>SALPINGOPLASTY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060503</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060503</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>0.5% MARCAINE SPINAL HEAVY</medicinalproduct>
        <drugbatchnumb>GI12358</drugbatchnumb>
        <drugauthorizationnumb>071202</drugauthorizationnumb>
        <drugadministrationroute>037</drugadministrationroute>
        <drugindication>APPENDICECTOMY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060503</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060503</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MORPHINE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ANALGESIC EFFECT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060503</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060503</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048518-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060531</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006AP02546</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>67</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>56</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIPRIVAN</medicinalproduct>
        <drugauthorizationnumb>19627</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>INDUCTION OF ANAESTHESIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYGEN</medicinalproduct>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>INDUCTION OF ANAESTHESIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SEVOFLURANE</medicinalproduct>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>INDUCTION OF ANAESTHESIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FENTANYL TRANSDERMAL SYSTEM</medicinalproduct>
        <drugindication>INDUCTION OF ANAESTHESIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MORPHINE</medicinalproduct>
        <drugadministrationroute>008</drugadministrationroute>
        <drugindication>EPIDURAL ANAESTHESIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048519-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060703</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006AC01238</companynumb>
    <primarysource>
      <reportercountry>NETHERLANDS</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSED MOOD</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERAL PHYSICAL HEALTH DETERIORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SELOKEEN ZOC</medicinalproduct>
        <drugauthorizationnumb>19962</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048520-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060322</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006CG00558</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>16140</patientonsetage>
      <patientonsetageunit>804</patientonsetageunit>
      <patientweight>48</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ARTERIAL RUPTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CATHETER SITE HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MARCAINE</medicinalproduct>
        <drugauthorizationnumb>18304</drugauthorizationnumb>
        <drugadministrationroute>053</drugadministrationroute>
        <drugindication>LOCAL ANAESTHESIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060313</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060316</drugenddate>
        <drugtreatmentduration>4260</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MARCAINE</medicinalproduct>
        <drugauthorizationnumb>018304</drugauthorizationnumb>
        <drugadministrationroute>053</drugadministrationroute>
        <drugindication>POSTOPERATIVE ANALGESIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060313</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060316</drugenddate>
        <drugtreatmentduration>4260</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MARCAINE RACHIANESTHESIE</medicinalproduct>
        <drugadministrationroute>037</drugadministrationroute>
        <drugindication>SPINAL ANAESTHESIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060313</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060313</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PARACETAMOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANALGESIC EFFECT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060313</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060317</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DICLOFENAC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060313</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060317</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MORPHINE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ANALGESIC EFFECT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060313</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060313</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVENOX</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>ANTICOAGULANT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060313</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060406</drugenddate>
        <drugtreatmentduration>25</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048521-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060707</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006UW14120</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>47</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>VOCAL CORD PARALYSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FASLODEX</medicinalproduct>
        <drugauthorizationnumb>021344</drugauthorizationnumb>
        <drugadministrationroute>030</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060504</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048522-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060630</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006SE03669</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>61</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>OEDEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BLOPRESS</medicinalproduct>
        <drugauthorizationnumb>20838</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048523-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060512</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>MEDI-0002171</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <patientonsetage>12</patientonsetage>
      <patientonsetageunit>802</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRONCHITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LARYNGEAL STENOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STRIDOR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SYNAGIS</medicinalproduct>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>ANTIVIRAL PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031021</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031021</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SYNAGIS</medicinalproduct>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>ANTIVIRAL PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040309</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040309</drugenddate>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SYNAGIS</medicinalproduct>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>ANTIVIRAL PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031120</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SYNAGIS</medicinalproduct>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>ANTIVIRAL PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031218</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SYNAGIS</medicinalproduct>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>ANTIVIRAL PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040116</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SYNAGIS</medicinalproduct>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>ANTIVIRAL PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040210</drugstartdate>
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    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048524-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
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    <receiptdateformat>102</receiptdateformat>
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    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
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    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <patientonsetage>7</patientonsetage>
      <patientonsetageunit>802</patientonsetageunit>
      <patientweight>5.87</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRONCHIOLITIS</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SYNAGIS</medicinalproduct>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>ANTIVIRAL PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051016</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051118</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SYNAGIS</medicinalproduct>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>ANTIVIRAL PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051016</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SYNAGIS</medicinalproduct>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>ANTIVIRAL PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051216</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SYNAGIS</medicinalproduct>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>ANTIVIRAL PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060113</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SYNAGIS</medicinalproduct>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>ANTIVIRAL PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060210</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048525-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060516</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>MEDI-0004500</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>26</patientonsetage>
      <patientonsetageunit>802</patientonsetageunit>
      <patientweight>14</patientweight>
      <patientsex>0</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHMATIC CRISIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SYNAGIS</medicinalproduct>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>ANTIVIRAL PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051109</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060127</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SYNAGIS</medicinalproduct>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>ANTIVIRAL PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051109</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SYNAGIS</medicinalproduct>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>ANTIVIRAL PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051202</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SYNAGIS</medicinalproduct>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>ANTIVIRAL PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060104</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048526-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060511</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>MEDI-0004378</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>4</patientonsetage>
      <patientonsetageunit>802</patientonsetageunit>
      <patientweight>4.5</patientweight>
      <patientsex>0</patientsex>
      <reaction>
        <reactionmeddrapt>BRONCHIOLITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SYNAGIS</medicinalproduct>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>ANTIVIRAL PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051005</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051102</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SYNAGIS</medicinalproduct>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>ANTIVIRAL PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060225</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060225</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SYNAGIS</medicinalproduct>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>ANTIVIRAL PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051005</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SYNAGIS</medicinalproduct>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>ANTIVIRAL PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051230</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SYNAGIS</medicinalproduct>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>ANTIVIRAL PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060128</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048527-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060620</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>8017551</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PNEUMOTHORAX</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STATUS EPILEPTICUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KEPPRA</medicinalproduct>
        <drugauthorizationnumb>21035</drugauthorizationnumb>
        <drugdosagetext>1750 MG 2/D PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>EPILEPSY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048528-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060619</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GBR-2005-0001758</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>77</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>MESOTHELIOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXYCODONE HCL</medicinalproduct>
        <drugauthorizationnumb>20553</drugauthorizationnumb>
        <drugdosagetext>20 MG, BID</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METOCLOPRAMIDE</medicinalproduct>
        <drugdosagetext>10 MG, TID</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DILTIAZEM HCL</medicinalproduct>
        <drugdosagetext>60 MG, BID</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMBIVENT</medicinalproduct>
        <drugdosagetext>QID, INHALATION</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030617</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040513</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SPIRIVA (TIOTROPIUM BROMIDE) CAPSULE</medicinalproduct>
        <drugdosagetext>18 MCG, DAILY, INHALATION</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030617</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040513</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SALBUTAMOL (SALBUTAMOL)</medicinalproduct>
        <drugdosagetext>100 MCG, BID, PRN, INHALATION</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>75 MG, DAILY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ATORVASTATIN CALCIUM</medicinalproduct>
        <drugdosagetext>10 MG, DAILY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BECLOMETHASONE DIPROPIONATE</medicinalproduct>
        <drugdosagetext>100 MCG, BID, INHALATION</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FRUMIL (AMILORIDE HYDROCHLORIDE, FUROSEMIDE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
        <drugdosagetext>2 MG, DAILY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOSULEPIN (DOSULEPIN)</medicinalproduct>
        <drugdosagetext>75.MG, NOCTE</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
        <drugdosagetext>13.80 MG, DAILY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GAVISCON</medicinalproduct>
        <drugdosagetext>10 ML, QID</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LACTULOSE</medicinalproduct>
        <drugdosagetext>3.35G/5ML</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LANSOPRAZOLE</medicinalproduct>
        <drugdosagetext>30 MG, DAILY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NITROLINGUAL (GLYCERYL TRINITRATE)</medicinalproduct>
        <drugdosagetext>400 MG, DAILY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NOZINAN (LEVOMEPROMAZINE)</medicinalproduct>
        <drugdosagetext>25 MG, QID</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXYGEN (OXYGEN)</medicinalproduct>
        <drugdosagetext>INHALATION</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SPIRONOLACTONE</medicinalproduct>
        <drugdosagetext>50 MG, DAILY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SYMBICORT (FORMOTEROL)</medicinalproduct>
        <drugdosagetext>1-2 PUFF, BID, INHALATION</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TEMAZEPAM</medicinalproduct>
        <drugdosagetext>1-2 AT NIGHT</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048529-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060627</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006-03-2051</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>48</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>61</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>OPTIC ISCHAEMIC NEUROPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEG-INTRON</medicinalproduct>
        <drugdosagetext>100 MCG QW SUBCUTANEOUS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050717</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060310</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBETOL</medicinalproduct>
        <drugdosagetext>1000 MCG QD ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050717</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060310</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048530-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006-06-1537</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>12</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>44</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FLUID RETENTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JOINT SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOVEMENT DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEG-INTRON</medicinalproduct>
        <drugdosagetext>22 MCG QWK SUBCUTANEOUS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>BONE SARCOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060526</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060616</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOXORUBICIN HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CISPLATIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KEPINOL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048531-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060407</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-AVENTIS-200611292FR</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>17</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DERMATITIS BULLOUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENTAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUNCHAUSEN'S SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOXIC SKIN ERUPTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BIRODOGYL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>TOOTH EXTRACTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060216</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060220</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PONSTYL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>TOOTH EXTRACTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060216</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060220</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048532-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060703</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>GB-JNJFOC-20060504783</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>85</patientweight>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <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>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMITRIPTYLINE HCL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PAMIDRONATE DISODIUM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANSOPRAZOLE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048533-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060703</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-JNJFOC-20060603840</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</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>T-CELL LYMPHOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CROHN'S DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AZATHIOPRINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048534-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060626</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>0601904US</companynumb>
    <primarysource>
      <reportercountry>BELGIUM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>RESIDUAL URINE VOLUME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BOTOX</medicinalproduct>
        <drugdosagetext>INTRAMUSCULAR</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>HYPERTONIC BLADDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048535-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesscongenitalanomali>1</seriousnesscongenitalanomali>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060109</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>0601957US</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>1</patientonsetage>
      <patientonsetageunit>804</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CAESAREAN SECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LARYNGOMALACIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BOTOX</medicinalproduct>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugindication>SKIN WRINKLING</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040728</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040728</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BOTOX</medicinalproduct>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugindication>SKIN WRINKLING</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040818</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040818</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROXOCOBALAMIN (HYDROXOCOBALAMIN)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASACOL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048536-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060622</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ST-2006-009103</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>53</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STEVENS-JOHNSON SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OLMETEC</medicinalproduct>
        <drugauthorizationnumb>21286</drugauthorizationnumb>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051107</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LOXONIN</medicinalproduct>
        <drugindication>ARTHRALGIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051107</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PABRON GOLD</medicinalproduct>
        <drugindication>PYREXIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051118</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PABRON                   /00520201/</medicinalproduct>
        <drugindication>PYREXIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051118</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PL GRAN.</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051120</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MUCOSTA</medicinalproduct>
        <drugindication>ARTHRALGIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051107</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RIMATIL</medicinalproduct>
        <drugindication>ARTHRALGIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051107</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLOMOX</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051120</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GASTER</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051120</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PANIMYCIN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051125</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VITAMIN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051125</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048537-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060622</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ST-2006-009046</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>68</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>57.4</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ALCOHOL USE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANOREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG ERUPTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAMMA-GLUTAMYLTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC FUNCTION ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC STEATOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</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>20060110</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060120</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CHOLEBRINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EPADEL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SINLESTAL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALBLOCK</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048538-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060612</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA200603001551</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>49</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>68</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRESCRIBED OVERDOSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>STRATTERA</medicinalproduct>
        <drugauthorizationnumb>21411</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATTENTION DEFICIT/HYPERACTIVITY DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050304</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050317</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>STRATTERA</medicinalproduct>
        <drugauthorizationnumb>21411</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATTENTION DEFICIT/HYPERACTIVITY DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050318</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060406</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>STRATTERA</medicinalproduct>
        <drugauthorizationnumb>21411</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATTENTION DEFICIT/HYPERACTIVITY DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050629</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALCOHOL (ETHANOL)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048539-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060612</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE200604000615</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>15</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>60</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>COMPLEX PARTIAL SEIZURES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMANGIOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>STRATTERA</medicinalproduct>
        <drugauthorizationnumb>21411</drugauthorizationnumb>
        <drugdosagetext>40 MG, DAILY (1/D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATTENTION DEFICIT/HYPERACTIVITY DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060207</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048540-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060612</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB200606002823</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>74</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD ELECTROLYTES DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048541-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060612</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DO200606003362</companynumb>
    <primarysource>
      <reportercountry>DOMINICAN REPUBLIC</reportercountry>
      <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>DULOXETINE HYDROCHLORIDE (DULOXETINE HYDROCHLORIDE) CAPSULE</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>60 MG, DAILY (1/D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048544-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060621</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006BL003513</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>55</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>AMYOTROPHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULAR WEAKNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERIPHERAL COLDNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SENSORY DISTURBANCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARTEOLOL HYDROCHLORIDE</medicinalproduct>
        <drugauthorizationnumb>75546</drugauthorizationnumb>
        <drugdosagetext>1 DROP;DAILY;OPHTHALMIC</drugdosagetext>
        <drugadministrationroute>047</drugadministrationroute>
        <drugindication>GLAUCOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARTEOLOL HYDROCHLORIDE</medicinalproduct>
        <drugdosagetext>1 DROP;DAILY;OPHTHALMIC</drugdosagetext>
        <drugadministrationroute>047</drugadministrationroute>
        <drugindication>GLAUCOMA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048545-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060616</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DSA_28370_2006</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ARRHYTHMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENALAPRIL MALEATE</medicinalproduct>
        <drugauthorizationnumb>18998</drugauthorizationnumb>
        <drugdosagetext>5 MG Q DAY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIGMART</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GASMOTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ISOSORBIDE MONONITRATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HERBESSER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THYRADIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048546-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060619</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DSA_28354_2006</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>ACCIDENTAL DRUG INTAKE BY CHILD</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ACCIDENTAL OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NO ADVERSE EFFECT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RENIVACE</medicinalproduct>
        <drugauthorizationnumb>18998</drugauthorizationnumb>
        <drugdosagetext>15 MG ONCE PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060613</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060613</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048547-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060616</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DSA_28367_2006</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>68</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HALLUCINATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROTHROMBIN TIME PROLONGED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAVOR</medicinalproduct>
        <drugauthorizationnumb>17794</drugauthorizationnumb>
        <drugdosagetext>DF ONCE PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060615</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060615</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MARCUMAR</medicinalproduct>
        <drugdosagetext>DF</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060615</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060615</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SAROTEN</medicinalproduct>
        <drugdosagetext>DF ONCE PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060615</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060615</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ADUMBRAN</medicinalproduct>
        <drugdosagetext>10 MG Q DAY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METOPROLOL</medicinalproduct>
        <drugdosagetext>50 MG BID PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RAMIPRIL</medicinalproduct>
        <drugdosagetext>2.5 MG Q DAY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MST</medicinalproduct>
        <drugdosagetext>30 MG BID PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048548-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060623</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>MEDI-0004704</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>CARDIAC DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SYNAGIS</medicinalproduct>
        <drugindication>RESPIRATORY SYNCYTIAL VIRUS INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048549-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060623</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>MEDI-0004705</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>LUNG DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SYNAGIS</medicinalproduct>
        <drugindication>RESPIRATORY SYNCYTIAL VIRUS INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048550-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060615</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR200606003726</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>75</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ACUTE PULMONARY OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE VASOVAGAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugauthorizationnumb>21318</drugauthorizationnumb>
        <drugdosagetext>20 UG, DAILY (1/D), SUBCUTANEOUS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050728</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZESTRIL /USA/ (LISINOPRIL)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CORDARONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREVISCAN (FLUINDIONE)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048552-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006AP03013</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>65</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ALANINE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASPARTATE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CREATINE PHOSPHOKINASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER FUNCTION TEST ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOGLOBIN URINE PRESENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIPRIVAN</medicinalproduct>
        <drugauthorizationnumb>19627</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>INDUCTION OF ANAESTHESIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SEVOFLURANE</medicinalproduct>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>MAINTENANCE OF ANAESTHESIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048553-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060630</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006AP03056</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>25673</patientonsetage>
      <patientonsetageunit>804</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CEREBRAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NOLVADEX</medicinalproduct>
        <drugauthorizationnumb>017970</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020327</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051215</drugenddate>
        <drugtreatmentduration>1359</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARIMIDEX</medicinalproduct>
        <drugauthorizationnumb>020541</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051216</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060624</drugenddate>
        <drugtreatmentduration>191</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMOBAN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONSTIPATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020311</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMOBAN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INSOMNIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020311</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMOBAN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020621</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMOBAN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020621</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPARA-CA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020311</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOXOPROFEN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CHEST PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050407</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MARZULENE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTROINTESTINAL DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050407</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OPALMON</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SPINAL COLUMN STENOSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYANOCOBALAMIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SPINAL COLUMN STENOSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051001</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048554-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060630</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006AP03067</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>62</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHABDOMYOLYSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OMEPRAL</medicinalproduct>
        <drugauthorizationnumb>19810</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>REFLUX OESOPHAGITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041214</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060630</drugenddate>
        <drugtreatmentduration>564</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19961001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048555-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060621</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006AP02886</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>25302</patientonsetage>
      <patientonsetageunit>804</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERSTITIAL LUNG DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPUTUM RETENTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UPPER RESPIRATORY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OMEPRAL</medicinalproduct>
        <drugauthorizationnumb>19810</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTRIC ULCER HELICOBACTER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060427</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060503</drugenddate>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMOLIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTRIC ULCER HELICOBACTER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060427</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060503</drugenddate>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLARITHROMYCIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTRIC ULCER HELICOBACTER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060427</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060503</drugenddate>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060403</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060501</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRAVIT</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BRONCHITIS ACUTE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060424</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060427</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRAVIT</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BRONCHITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060424</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060427</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRAVIT</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060506</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060501</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRAVIT</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060506</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060501</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SAWATENE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BRONCHITIS ACUTE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060424</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060427</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SAWATENE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BRONCHITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060424</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060427</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SAWATENE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060506</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060501</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SAWATENE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060506</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060501</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ETICALM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANXIETY DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060424</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060501</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048556-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060406</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006GB00590</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ILL-DEFINED DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN EXFOLIATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugauthorizationnumb>19810</drugauthorizationnumb>
        <drugdosagetext>REDUCED TO 10MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIATUS HERNIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19960101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010101</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugauthorizationnumb>019810</drugauthorizationnumb>
        <drugdosagetext>REDUCED FROM 20MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048557-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060613</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IT200606002808</companynumb>
    <primarysource>
      <reportercountry>ITALY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>42</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BENIGN INTRACRANIAL HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD BILIRUBIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD LACTATE DEHYDROGENASE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOCHROMIC ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAPILLOEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RETINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SOMATROPIN (SOMATROPIN)</medicinalproduct>
        <drugauthorizationnumb>19640</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugindication>GROWTH HORMONE DEFICIENCY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19960101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SOMATROPIN (SOMATROPIN)</medicinalproduct>
        <drugauthorizationnumb>19640</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugindication>GROWTH HORMONE DEFICIENCY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040901</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TESTOSTERONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048559-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060615</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IN200606003994</companynumb>
    <primarysource>
      <reportercountry>INDIA</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>13</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>36</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>GRAND MAL CONVULSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ATOMOXETINE HYDROCHLORIDE (ATOMOXETINE HYDROCHLORIDE)</medicinalproduct>
        <drugauthorizationnumb>21411</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048561-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060615</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>TW200605002524</companynumb>
    <primarysource>
      <reportercountry>TAIWAN, PROVINCE OF CHINA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>82</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>61</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD CREATINE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD POTASSIUM DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD SODIUM DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD UREA INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DECREASED APPETITE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSED LEVEL OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ENTEROCOCCAL BACTERAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JAUNDICE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALIMTA</medicinalproduct>
        <drugauthorizationnumb>21462</drugauthorizationnumb>
        <drugdosagetext>850 MG/M2, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>LUNG NEOPLASM MALIGNANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060420</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060420</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE TAB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYANOCOBALAMIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048563-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060615</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>HU200606003489</companynumb>
    <primarysource>
      <reportercountry>HUNGARY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>67</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DULOXETINE HYDROCHLORIDE (DULOXETINE HYDROCHLORIDE) CAPSULE</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>60 MG, DAILY (1/D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048565-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060614</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA200603000691</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DIARRHOEA HAEMORRHAGIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISORIENTATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PELVIC FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RIB FRACTURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugauthorizationnumb>21318</drugauthorizationnumb>
        <drugdosagetext>20 UG, DAILY (1/D)</drugdosagetext>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040925</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060211</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048567-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060613</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA200606003779</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>AMNESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLD SWEAT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMULIN L</medicinalproduct>
        <drugbatchnumb>9RH09T</drugbatchnumb>
        <drugauthorizationnumb>18780</drugauthorizationnumb>
        <drugdosagetext>AS NEEDED, SUBCUTANEOUS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19930101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COZAAR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DILANTIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048568-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060626</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200612681GDS</companynumb>
    <primarysource>
      <reportercountry>POLAND</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>109</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>CEREBRAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUDDEN DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SORAFENIB</medicinalproduct>
        <drugauthorizationnumb>21923</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugindication>METASTATIC RENAL CELL CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060519</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048569-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060706</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-NOVOPROD-254675</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>60</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CEREBELLAR ATAXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVERDOSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIXTARD HUMAN 70/30</medicinalproduct>
        <drugauthorizationnumb>019991</drugauthorizationnumb>
        <drugdosagetext>60 U, BID</drugdosagetext>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048571-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060622</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>WAES 0605USA03854</companynumb>
    <primarysource>
      <reportercountry>PORTUGAL</reportercountry>
    </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>HEPATIC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC NECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPTIC SHOCK</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CANCIDAS</medicinalproduct>
        <drugauthorizationnumb>21227</drugauthorizationnumb>
        <drugdosagetext>50 MG/DAILY IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BRONCHOPULMONARY ASPERGILLOSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060511</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060516</drugenddate>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INJ ACETAMINOPHEN</medicinalproduct>
        <drugdosagetext>1 GM/1X IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060427</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060427</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INJ ACETAMINOPHEN</medicinalproduct>
        <drugdosagetext>1 GM/1X IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060508</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060508</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INJ ACETAMINOPHEN</medicinalproduct>
        <drugdosagetext>1 GM/1X IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060510</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060510</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INJ ACETAMINOPHEN</medicinalproduct>
        <drugdosagetext>1 GM/1X IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060511</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060511</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INJ ACETAMINOPHEN</medicinalproduct>
        <drugdosagetext>1 GM/1X IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060512</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060512</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INJ ACETAMINOPHEN</medicinalproduct>
        <drugdosagetext>1 GM/1X IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060514</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060514</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INJ ACETAMINOPHEN</medicinalproduct>
        <drugdosagetext>1 GM/1X IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060515</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060515</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INJ ACETAMINOPHEN</medicinalproduct>
        <drugdosagetext>1 GM/1X IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060516</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060516</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
        <drugdosagetext>500 MG/1X PO; 1 GM/1X PO; 1 GM/1X PO; 1 GM1X PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060430</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060430</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
        <drugdosagetext>500 MG/1X PO; 1 GM/1X PO; 1 GM/1X PO; 1 GM1X PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060501</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
        <drugdosagetext>500 MG/1X PO; 1 GM/1X PO; 1 GM/1X PO; 1 GM1X PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060502</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060502</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
        <drugdosagetext>500 MG/1X PO; 1 GM/1X PO; 1 GM/1X PO; 1 GM1X PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060503</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060503</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMIKACIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYTARABINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PIPERACILLIN SODIUM (+) TAZOBACTAM SODIU</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048573-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060622</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>WAES 0605USA03680</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>49</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ENTEROCOCCAL SEPSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CANCIDAS</medicinalproduct>
        <drugauthorizationnumb>21227</drugauthorizationnumb>
        <drugdosagetext>70 MG/1X</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BRONCHOPULMONARY ASPERGILLOSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051124</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051124</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRIMAXIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LINEZOLID</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048578-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060614</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>530#5#2006-00028</companynumb>
    <primarysource>
      <reportercountry>UKRAINE</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>66</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>.</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROVASTATIN 40 UG (ALPROSTADIL (PAOD))</medicinalproduct>
        <drugdosagetext>2 X 40 UG PER DAY</drugdosagetext>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>PERIPHERAL ISCHAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040719</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040720</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLYBURIDE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048582-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>TCI2005A04742</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>81</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERSTITIAL LUNG DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEUPROLIDE ACETATE</medicinalproduct>
        <drugdosagetext>11.25 MG</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>METASTASES TO BONE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051104</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEUPROLIDE ACETATE</medicinalproduct>
        <drugdosagetext>11.25 MG</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PROSTATE CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051104</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CASODEX</medicinalproduct>
        <drugdosagetext>80 MG (80 MG 1 IN 1 D)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROSTATE CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051017</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051118</drugenddate>
        <drugtreatmentduration>33</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOXONIN (LOXOPROFEN SODIUM)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SELBEX (TEPRENONE)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048584-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060620</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>HQWYE336621JUN06</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
    </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>DEPRESSED MOOD</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FACIAL PALSY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ILL-DEFINED DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POLLAKIURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS GENERALISED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RALOXIFENE, CONTROL FOR BAZEDOXIFENE ACETATE (RALOXIFENE, CONTROL FOR </medicinalproduct>
        <drugdosagetext>60 MG 1X PER 1 DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030805</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060619</drugenddate>
        <drugtreatmentduration>1050</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ORPHENADRINE CITRATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIPYRONE (METAMIZOLE SODIUM)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CAFFEINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DICLOFENAC SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETYLSALICYLIC ACID SRT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALUMINUM HYDROXIDE GEL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048586-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060619</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DEWYE848928JUN06</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>26</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HALLUCINATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VENLAFAXINE HCL</medicinalproduct>
        <drugauthorizationnumb>20151</drugauthorizationnumb>
        <drugdosagetext>37.5 MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANXIETY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051107</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VENLAFAXINE HCL</medicinalproduct>
        <drugauthorizationnumb>20151</drugauthorizationnumb>
        <drugdosagetext>37.5 MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051107</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SOLIAN (AMISULPRIDE, , 0)</medicinalproduct>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PSYCHOTIC DISORDER</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051023</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SOLIAN (AMISULPRIDE, , 0)</medicinalproduct>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PSYCHOTIC DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051024</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRUXAL (CHLORPROTHIXENE HYDROCHLORIDE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TEGRETOL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048588-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DEWYE853328JUN06</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>75</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>VITH NERVE PARALYSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VENLAFAXINE HCL</medicinalproduct>
        <drugauthorizationnumb>20699</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048589-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060627</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DEWYE828827JUN06</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>14</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG SCREEN POSITIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EXTRAPYRAMIDAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE DRUG OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VENLAFAXINE HCL</medicinalproduct>
        <drugauthorizationnumb>20151</drugauthorizationnumb>
        <drugdosagetext>OVERDOSE AMOUNT</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060626</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060626</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHADONE HCL</medicinalproduct>
        <drugdosagetext>OVERDOSE AMOUNT</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060626</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060626</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MIRTAZAPINE</medicinalproduct>
        <drugdosagetext>OVERDOSE AMOUNT</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060626</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060626</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OPIOIDS</medicinalproduct>
        <drugdosagetext>OVERDOSE AMOUNT</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060626</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060626</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAXILAN (PERAZINE, , 0)</medicinalproduct>
        <drugdosagetext>OVERDOSE AMOUNT</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060626</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060626</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOPICLONE (ZOPICLONE, , 0)</medicinalproduct>
        <drugdosagetext>OVERDOSE AMOUNT</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060626</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060626</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048606-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060703</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-JNJFOC-20060400069</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>84</patientweight>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ALVEOLITIS FIBROSING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE CONGESTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATORVASTATIN CALCIUM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYPROMELLOSE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INDOCID</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KAPAKE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIVIAL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048607-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060703</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20060700758</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>OPEN WOUND</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STAPHYLOCOCCAL INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CROHN'S DISEASE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048609-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060703</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20060700773</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>74.84</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POLLAKIURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY INCONTINENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugdosagetext>FIRST INFUSION ON UNKNOWN DATE</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ULTRACET</medicinalproduct>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOSAMINE</medicinalproduct>
        <drugindication>ARTHRITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048620-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesscongenitalanomali>1</seriousnesscongenitalanomali>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060614</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU200606003955</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>0</patientsex>
      <reaction>
        <reactionmeddrapt>CONGENITAL HAND MALFORMATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
        <drugauthorizationnumb>20592</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048621-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060613</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB200606003260</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>13</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>66.4</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISORIENTATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER TENDERNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYDRIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>STRATTERA</medicinalproduct>
        <drugauthorizationnumb>21411</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATTENTION DEFICIT/HYPERACTIVITY DISORDER</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060523</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PENICILLIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRIAMCINOLONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRIMETHOPRIM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048622-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060614</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR200606002489</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>63</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>LUNG ADENOCARCINOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLEURISY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugauthorizationnumb>21318</drugauthorizationnumb>
        <drugdosagetext>20 UG, DAILY (1/D), SUBCUTANEOUS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060324</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FORTEO PEN (FORTEO PEN)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048625-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060707</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2006MX10254</companynumb>
    <primarysource>
      <reportercountry>MEXICO</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>96</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>GASTRIC ULCER HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MELAENA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIOVAN HCT</medicinalproduct>
        <drugauthorizationnumb>020818</drugauthorizationnumb>
        <drugdosagetext>VALS 160 / HCT 25 MG/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051208</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060424</drugenddate>
        <drugtreatmentduration>138</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048626-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060614</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA200606003775</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>61</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HIP FRACTURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugauthorizationnumb>21318</drugauthorizationnumb>
        <drugdosagetext>20 UG, OTHER</drugdosagetext>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060117</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060527</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FORTEO PEN (FORTEO PEN)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ESOMEPRAZOLE (ESOMEPRAZOLE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLOPIDOGREL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RANITIDINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DILTIAZEM HYDROCHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NITROGLYCERIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROCHLORPERAZINE MALEATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HOMATROPINE (HOMATROPINE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE ACETATE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048630-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060418</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHNU2006DE01694</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>79</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>76.5</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HUMERUS FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERIPHERAL VASCULAR DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRAUMATIC HAEMATOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BELOC ZOK</medicinalproduct>
        <drugdosagetext>23.8-0-47.5 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
        <drugdosagetext>425-0-425MG/DAY</drugdosagetext>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>STARLIX</medicinalproduct>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIOVAN HCT</medicinalproduct>
        <drugauthorizationnumb>020818</drugauthorizationnumb>
        <drugdosagetext>1 DF, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NOVODIGAL</medicinalproduct>
        <drugdosagetext>0.1 UNK, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FUROSEMIDE ^RATIOPHARM^</medicinalproduct>
        <drugdosagetext>UNK, ONCE/SINGLE</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060315</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060315</drugenddate>
        <drugtreatmentduration>1440</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048635-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060613</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>NL200606003369</companynumb>
    <primarysource>
      <reportercountry>NETHERLANDS</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>85</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEURALGIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugauthorizationnumb>21318</drugauthorizationnumb>
        <drugdosagetext>20 UG, SUBCUTANEOUS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060515</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FORTEO PEN (FORTEO PEN)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORTRILEN (NORTRIPTYLINE HYDROCHLORIDE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADALAT OROS (NIFEDIPINE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARBASALATE CALCIUM (CARBASALATE CALCIUM)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHENAMINE (METHENAMINE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MOVICOLON (MACROGOL, POTASSIUM CHLORIDE, SODIUM BICARBONATE, SODIUM CH</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048637-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060614</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB200606003699</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>82</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ATRIOVENTRICULAR EXTRASYSTOLES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BALANCE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSARTHRIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OLANZAPINE</medicinalproduct>
        <drugauthorizationnumb>20592</drugauthorizationnumb>
        <drugdosagetext>5 MG, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PSYCHOTIC DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060512</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060515</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048639-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-KINGPHARMUSA00001-K200600844</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>57</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BASE EXCESS NEGATIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CREATININE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD GASES ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD UREA INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LACTIC ACIDOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALTACE</medicinalproduct>
        <drugauthorizationnumb>19901</drugauthorizationnumb>
        <drugdosagetext>10 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060513</drugenddate>
        <drugtreatmentduration>183</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LOSARTAN POSTASSIUM</medicinalproduct>
        <drugdosagetext>50 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060513</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
        <drugdosagetext>1 G, TID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS NON-INSULIN-DEPENDENT</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060513</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>75 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060513</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
        <drugdosagetext>50 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060513</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
        <drugdosagetext>80 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060513</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MOXONIDINE</medicinalproduct>
        <drugdosagetext>300 UG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060513</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048640-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060615</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>8017470</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>0</patientsex>
      <reaction>
        <reactionmeddrapt>COMPUTERISED TOMOGRAM ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEBRILE CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NERVOUS SYSTEM DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>THEOPHYLLINE</medicinalproduct>
        <drugauthorizationnumb>87942</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048641-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060630</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2006JP10012</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>63</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>EOSINOPHIL COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EOSINOPHILIC PNEUMONIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMISIL</medicinalproduct>
        <drugauthorizationnumb>20539</drugauthorizationnumb>
        <drugdosagetext>125 MG/D</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NAIL TINEA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MINOCYCLINE HCL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OREN-GEDOKU-TO</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048642-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20051006</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2005US11227</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>67</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>70.748</patientweight>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ACUTE RESPIRATORY FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CALCIUM DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHILLS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</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>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISSEMINATED INTRAVASCULAR COAGULATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EOSINOPHILIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EXFOLIATIVE RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERAL PHYSICAL HEALTH DETERIORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERNATRAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTHERMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LETHARGY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEUKOCYTOCLASTIC VASCULITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEUKOCYTOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALNUTRITION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTI-ORGAN FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARYNGOLARYNGEAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PITTING OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROTHROMBIN TIME PROLONGED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYELONEPHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH ERYTHEMATOUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH GENERALISED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RECTAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPTIC SHOCK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URTICARIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHEEZING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugdosagetext>4 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMDUR</medicinalproduct>
        <drugdosagetext>60 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
        <drugdosagetext>300 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR                                 /NET/</medicinalproduct>
        <drugdosagetext>20 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
        <drugdosagetext>60 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLEGRA</medicinalproduct>
        <drugdosagetext>180 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KLONOPIN</medicinalproduct>
        <drugdosagetext>0.5 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMISIL</medicinalproduct>
        <drugauthorizationnumb>020539</drugauthorizationnumb>
        <drugdosagetext>250 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NAIL TINEA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040617</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048644-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060613</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP200606003946</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>71</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EVISTA</medicinalproduct>
        <drugauthorizationnumb>20815</drugauthorizationnumb>
        <drugdosagetext>60 MG, DAILY (1/D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051102</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060607</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048645-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-KINGPHARMUSA00001-K200600846</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>75</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ACUTE MYELOID LEUKAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALTACE</medicinalproduct>
        <drugauthorizationnumb>019901</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020926</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060303</drugenddate>
        <drugtreatmentduration>1255</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MICARDIS</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020926</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLIBENCLAMIDE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048647-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060613</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE200605000312</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>55</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>80</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD PROLACTIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BREAST ABSCESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MASTITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YENTREVE(DULOXETINE HYDROCHLORIDE) CAPSULE</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>40 MG, 2/D, ORAL</drugdosagetext>
        <drugindication>URINARY INCONTINENCE</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060404</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MICARDIS HCT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL SUCCINATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ROSIGLITAZONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BAYMYCARD (NISOLDIPINE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FERRO-SANOL DUODENAL (FERROUS SULFATE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARCOXIA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HCL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048652-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060614</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FI200606003821</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>37</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AGGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHILLS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPEPSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING COLD</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLATULENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>90 MG, DAILY (1/D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060309</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>QUETIAPINE FUMARATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOPICLONE (ZOPICLONE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROPRANOLOL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048653-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060613</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR200606003763</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>78</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ASCITES</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YENTREVE(DULOXETINE HYDROCHLORIDE)</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>60 MG, DAILY (1/D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060315</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MOSCONTIN (MORPHINE SULFATE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MORPHINE SULFATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COVERSYL (PERINDOPRIL)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CORDARONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DISCOTRINE (GLYCERYL TRINITRATE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048655-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060703</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-KINGPHARMUSA00001-K200600865</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>69</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>COMPLETED SUICIDE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARANOIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALTACE</medicinalproduct>
        <drugauthorizationnumb>19901</drugauthorizationnumb>
        <drugdosagetext>2.5 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060523</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TERCIAN</medicinalproduct>
        <drugdosagetext>1 U, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DELUSIONAL DISORDER, PERSECUTORY TYPE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060516</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060523</drugenddate>
        <drugtreatmentduration>11520</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TERCIAN</medicinalproduct>
        <drugdosagetext>IU, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060516</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060523</drugenddate>
        <drugtreatmentduration>11520</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GLUCOPHAGE</medicinalproduct>
        <drugdosagetext>1700 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060523</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAHOR</medicinalproduct>
        <drugdosagetext>40 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060523</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugdosagetext>20 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060523</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROPLEX</medicinalproduct>
        <drugdosagetext>10 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANTIDEPRESSANT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060222</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060516</drugenddate>
        <drugtreatmentduration>84</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASILIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048656-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060613</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ES200606003697</companynumb>
    <primarysource>
      <reportercountry>SPAIN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>56</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROTHROMBIN LEVEL INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>60 MG, DAILY (1/D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060509</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SINTROM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048659-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060614</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR200606003193</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>63</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>LUNG DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugauthorizationnumb>21318</drugauthorizationnumb>
        <drugdosagetext>20  UG, DAILY (1/D), SUBCUTANEOUS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050411</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060607</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FORTEO PEN (FORTEO PEN) PEN, DISPOSABLE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048660-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060614</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR200606001302</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>76</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST X-RAY ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RED BLOOD CELL SEDIMENTATION RATE INCREASED</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, DAILY (1/D), SUBCUTANEOUS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060317</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060612</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FORTEO PEN (FORTEO PEN) PEN, DISPOSABLE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048661-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060616</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA200605006546</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>88</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BREAST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ELECTROCARDIOGRAM AMBULATORY ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugbatchnumb>FF5S35E</drugbatchnumb>
        <drugauthorizationnumb>21318</drugauthorizationnumb>
        <drugdosagetext>20 UG, DAILY (1/D)</drugdosagetext>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050309</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FORTEO PEN (FORTEO PEN) PEN, DISPOSABLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IRBESARTAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FERROUS FUMARATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM (CALCIUM)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048662-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060615</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP200605005321</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>69</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>BACTERIA URINE IDENTIFIED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INADEQUATELY CONTROLLED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBRAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GLYCOSYLATED HAEMOGLOBIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
        <drugauthorizationnumb>20592</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RESTLESSNESS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040715</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
        <drugauthorizationnumb>20592</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RESTLESSNESS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060525</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048663-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060614</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP200606003676</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>71</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PULMONARY TUBERCULOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GEMZAR</medicinalproduct>
        <drugauthorizationnumb>20509</drugauthorizationnumb>
        <drugdosagetext>1000 MG, OTHER, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PANCREATIC CARCINOMA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048666-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060621</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE200606004503</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>C-REACTIVE PROTEIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTHERMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTHAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VASCULITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GEMZAR</medicinalproduct>
        <drugauthorizationnumb>20509</drugauthorizationnumb>
        <drugdosagetext>1000 MG/M2, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PAPILLARY THYROID CANCER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOFRAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MCP (METOCLOPRAMIDE HYDROCHLORIDE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KREON (PANCREATIN)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048668-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060623</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>111146ISR</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>71</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EXTRAVASATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE DISCHARGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WRONG TECHNIQUE IN DRUG USAGE PROCESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUOROURACIL</medicinalproduct>
        <drugdosagetext>3490 MILLIGRAM, INTRAVENOUS (NOS)</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>GASTRIC CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060419</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLINIC ACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CISPLATIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048670-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060614</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE200606003709</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>60</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC ENZYME ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>30 MG, DAILY (1/D), ORAL; SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060501</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>30 MG, DAILY (1/D), ORAL; SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060523</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>STANGYL /GFR/ (TRIMIPRAMINE MALEATE)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048671-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060614</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BE200606003660</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>80</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>SUBARACHNOID HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DULOXETINE HYDROCHLORIDE (DULOXETINE HYDROCHLORIDE) CAPSULE</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>60 MG, DAILY (1/D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MOTENS (LACIDIPINE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MOXON (MOXONIDINE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLICLAZIDE (GLICLAZIDE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANTOPRAZOLE SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EFEXOR /USA/ (VENLAFAXINE HYDROCHLORIDE)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048673-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060630</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FRWYE778925JUN06</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>18</patientonsetage>
      <patientonsetageunit>802</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BONE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CELLULITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EAR INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METATARSALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOMYELITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH GENERALISED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ADVIL</medicinalproduct>
        <drugauthorizationnumb>20589</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>EAR INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060331</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060404</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CEFPODOXIME PROXETIL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048675-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060614</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IE200606003729</companynumb>
    <primarysource>
      <reportercountry>IRELAND</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>62</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUCOSAL INFLAMMATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALIMTA</medicinalproduct>
        <drugauthorizationnumb>21462</drugauthorizationnumb>
        <drugindication>MESOTHELIOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CISPLATIN (CISPLATIN UNKNOWN MANUFACTURER)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYANOCOBALAMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048676-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060630</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20060700675</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>18</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <reaction>
        <reactionmeddrapt>DELIRIUM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVAQUIN</medicinalproduct>
        <drugauthorizationnumb>20634</drugauthorizationnumb>
        <drugindication>ANTIBIOTIC PROPHYLAXIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048677-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060706</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20060700806</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANGIONEUROTIC OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONNECTIVE TISSUE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FACIAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NERVOUS SYSTEM DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POLYNEUROPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TENDON DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TENDONITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VASODILATATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVAQUIN</medicinalproduct>
        <drugauthorizationnumb>020634</drugauthorizationnumb>
        <drugindication>SINUSITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048678-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-JNJFOC-20060601998</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>AMNESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISTURBANCE IN ATTENTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISTURBANCE IN SOCIAL BEHAVIOUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSIVE CRISIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESTLESSNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERDAL</medicinalproduct>
        <drugbatchnumb>03AL243A;03AL253</drugbatchnumb>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERDAL</medicinalproduct>
        <drugbatchnumb>03AL243A;03AL253</drugbatchnumb>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERDAL</medicinalproduct>
        <drugbatchnumb>03AL243A;03AL253</drugbatchnumb>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERDAL</medicinalproduct>
        <drugbatchnumb>03AL243A;03AL253</drugbatchnumb>
        <drugauthorizationnumb>020272</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GINSENG</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048679-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060630</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20060700793</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>63.5</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD POTASSIUM DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DECREASED APPETITE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISORIENTATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DUODENITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEURALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FENTANYL TRANSDERMAL SYSTEM</medicinalproduct>
        <drugbatchnumb>0607200</drugbatchnumb>
        <drugauthorizationnumb>019813</drugauthorizationnumb>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATIVAN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MUSCLE SPASMS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHADONE HCL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PENTASA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTRIC DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>FLUID RETENTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANTICOAGULANT THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAQUENIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SYSTEMIC LUPUS ERYTHEMATOSUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREVACID</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERCHLORHYDRIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZANAFLEX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MUSCLE SPASMS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>K-DUR 10</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD POTASSIUM</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIDODERM</medicinalproduct>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAZODONE HCL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SLEEP DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAZODONE HCL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PHENERGAN HCL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NAUSEA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048680-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060705</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20060701442</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>63.5</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG WITHDRAWAL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCREATITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FENTANYL TRANSDERMAL SYSTEM</medicinalproduct>
        <drugauthorizationnumb>019813</drugauthorizationnumb>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CARDIAC FAILURE CONGESTIVE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FERROUS SULFATE TAB</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANAEMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARIMIDEX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SINGULAIR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANXIETY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SINEMET</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PARKINSON'S DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRANDIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PERCOCET</medicinalproduct>
        <drugdosagetext>10 MG OXYCODONE HYDROCHLORIDE / 325 MG ACETAMINOPHEN, 2 IN 1 DAY, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048681-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FRWYE859128JUN06</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>45</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CHOLESTASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CYTOLYTIC HEPATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DERMATITIS EXFOLIATIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG RASH WITH EOSINOPHILIA AND SYSTEMIC SYMPTOMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ADVIL</medicinalproduct>
        <drugauthorizationnumb>18989</drugauthorizationnumb>
        <drugdosagetext>400 MG 2X PER 1 DAY, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>WOUND</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060303</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060306</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXTRANASE (BROMELAINS, , 0)</medicinalproduct>
        <drugdosagetext>3 TABLET 3X PER 1 DAY, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>WOUND</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060303</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060306</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PYOSTACINE (PRISTINAMYCIN, , 0)</medicinalproduct>
        <drugdosagetext>1 G 2X PER 1 DAY, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>WOUND</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060303</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060303</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALSARTAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORAZEPAM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048682-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060705</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20060701578</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>58.51</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THYROIDITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DURAGESIC-100</medicinalproduct>
        <drugbatchnumb>0542323</drugbatchnumb>
        <drugauthorizationnumb>019813</drugauthorizationnumb>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048683-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060706</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20060701581</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>NEOPLASM MALIGNANT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DURAGESIC-100</medicinalproduct>
        <drugauthorizationnumb>019813</drugauthorizationnumb>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>PAIN</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048684-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060604</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-STX181855</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HYSTERECTOMY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>P055681</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PSORIASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYLENOL W/ CODEINE NO. 3</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORETHINDRONE AND ETHINYL ESTRADIOL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048685-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AUWYE062410JUL06</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>41</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>82</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>LIVER FUNCTION TEST ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>ANKYLOSING SPONDYLITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050501</drugstartdate>
        <drugtreatmentduration>14</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048687-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060623</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FRWYE778925JUN06</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>18</patientonsetage>
      <patientonsetageunit>802</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BONE SCAN ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CELLULITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METATARSALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOMYELITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH GENERALISED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ADVIL</medicinalproduct>
        <drugauthorizationnumb>20589</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>EAR INFECTION</drugindication>
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        <drugstartdate>20060331</drugstartdate>
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        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CEFPODOXIME PROXETIL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048689-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
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    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060518</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
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    <primarysource>
      <reportercountry>NETHERLANDS</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>AGGRESSION</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EFFEXOR</medicinalproduct>
        <drugauthorizationnumb>20151</drugauthorizationnumb>
        <drugdosagetext>75 MG 1X PER 1 DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALCOHOL (ETHANOL, , 0)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METAMFETAMINE (METAMFETAMINE, , 0)</medicinalproduct>
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    </patient>
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  <safetyreport>
    <safetyreportid>5048691-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
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    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060518</receiptdate>
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    <companynumb>NLWYE638919MAY06</companynumb>
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      <reportercountry>NETHERLANDS</reportercountry>
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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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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EFFEXOR</medicinalproduct>
        <drugauthorizationnumb>20151</drugauthorizationnumb>
        <drugdosagetext>75 MG 1X PER 1 DAY</drugdosagetext>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALCOHOL (ETHANOL, , 0)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METAMFETAMINE (METAMFETAMINE, , 0)</medicinalproduct>
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    </patient>
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  <safetyreport>
    <safetyreportid>5048692-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060704</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
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    <primarysource>
      <reportercountry>CHILE</reportercountry>
      <qualification>5</qualification>
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    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <patientonsetage>52</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LARGE INTESTINE PERFORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZELMAC / HTF 919A</medicinalproduct>
        <drugauthorizationnumb>21200</drugauthorizationnumb>
        <drugdosagetext>6 MG, BID</drugdosagetext>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLINDAMYCIN</medicinalproduct>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METRONIDAZOLE</medicinalproduct>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RANITIDINE</medicinalproduct>
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    </patient>
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  <safetyreport>
    <safetyreportid>5048693-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
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    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2006US08714</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
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    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <patientonsetage>94</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>58.956</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ATRIOVENTRICULAR BLOCK THIRD DEGREE</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>CARDIAC PACEMAKER INSERTION</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZELNORM</medicinalproduct>
        <drugauthorizationnumb>021200</drugauthorizationnumb>
        <drugdosagetext>6 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>IRRITABLE BOWEL SYNDROME</drugindication>
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        <drugstartdate>20060101</drugstartdate>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
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    </patient>
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  <safetyreport>
    <safetyreportid>5048694-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060630</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-US185224</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
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    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CHOLELITHIASIS</reactionmeddrapt>
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      <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>20060306</drugenddate>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19870101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050101</drugenddate>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONAZEPAM</medicinalproduct>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
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    </patient>
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  <safetyreport>
    <safetyreportid>5048695-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060317</receiptdate>
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    <companynumb>HQWYE479423MAR06</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
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    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PLEURAL EFFUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLEURISY</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050621</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060601</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDONINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060124</drugenddate>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RHEUMATREX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
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  <safetyreport>
    <safetyreportid>5048697-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
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    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060630</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006GB01128</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CONJUNCTIVAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER FUNCTION TEST ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URTICARIA</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LOSEC</medicinalproduct>
        <drugauthorizationnumb>019810</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTROOESOPHAGEAL REFLUX DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060501</drugenddate>
        <drugtreatmentduration>883</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PHENYTOIN SODIUM CAP</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>EPILEPSY</drugindication>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TEMAZEPAM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
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  <safetyreport>
    <safetyreportid>5048698-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
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    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
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    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>SEWYE891329JUN06</companynumb>
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      <reportercountry>SWEDEN</reportercountry>
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    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <patientonsetage>26</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>TOXIC SHOCK SYNDROME</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
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    </patient>
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  <safetyreport>
    <safetyreportid>5048700-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060626</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DEWYE799626JUN06</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
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    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <patientonsetage>45</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>HALLUCINATION, VISUAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ILL-DEFINED DISORDER</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUS TACHYCARDIA</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>VERTIGO</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VENLAFAXINE HCL</medicinalproduct>
        <drugauthorizationnumb>20699</drugauthorizationnumb>
        <drugdosagetext>75 MG, ORAL</drugdosagetext>
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        <drugstartdate>20060117</drugstartdate>
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        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROMETHAZINE</medicinalproduct>
        <drugdosagetext>100 MG, ORAL</drugdosagetext>
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        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060116</drugstartdate>
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        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIRTAZAPINE</medicinalproduct>
        <drugdosagetext>SEE IMAGE, ORAL</drugdosagetext>
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        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051017</drugstartdate>
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        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
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        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051018</drugstartdate>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIRTAZAPINE</medicinalproduct>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
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        <drugstartdate>20051025</drugstartdate>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
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        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051122</drugstartdate>
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        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
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        <medicinalproduct>SOLIAN (AMISULPRIDE)</medicinalproduct>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORAZEPAM</medicinalproduct>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>STAURODORM NEU (FLURAZEPAM)</medicinalproduct>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
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    <safetyreportid>5048701-9</safetyreportid>
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    <companynumb>HQWYE347923JUN06</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
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    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
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      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PLEURAL EFFUSION</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ANCARON (AMIODARONE, TABLET)</medicinalproduct>
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  <safetyreport>
    <safetyreportid>5048702-0</safetyreportid>
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      <reportercountry>ARGENTINA</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>41</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY ANASTOMOTIC LEAK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RAPAMUNE</medicinalproduct>
        <drugauthorizationnumb>21110</drugauthorizationnumb>
        <drugdosagetext>10 MG 1X PER 1 DAY ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS AGAINST TRANSPLANT REJECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060329</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060611</drugenddate>
        <drugtreatmentduration>75</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATORVASTATIN CALCIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEPREDNISONE                               (MEPREDNISONE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MYCOPHENOLATE MOFETIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EPOGEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BACTRIM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEUCOVORIN (LEUCOVORIN)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NIFEDIPINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048703-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060621</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>HQWYE322921JUN06</companynumb>
    <primarysource>
      <reportercountry>IRAN (ISLAMIC REPUBLIC OF)</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>40</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ARTERIAL THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMPLICATIONS OF TRANSPLANTED KIDNEY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>KIDNEY TRANSPLANT REJECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOSPORINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048704-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060704</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-JNJFOC-20060505187</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>72</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PROSTATE CANCER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CORTANCYL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARAVA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048705-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060704</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-JNJFOC-20060700578</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>70</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>68</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HEPATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUPUS-LIKE SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLITIS ULCERATIVE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>POLYARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATACAND</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VERAPAMIL</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SORTIS</medicinalproduct>
        <drugindication>HYPERCHOLESTEROLAEMIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048706-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060630</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2006US08483</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>21</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>85.714</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GRAND MAL CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENTAL STATUS CHANGES</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZELNORM</medicinalproduct>
        <drugauthorizationnumb>021200</drugauthorizationnumb>
        <drugdosagetext>6 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONSTIPATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060621</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060622</drugenddate>
        <drugtreatmentduration>2880</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048707-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060630</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-US184902</companynumb>
    <primarysource>
      <qualification>3</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>PROCRIT</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugindication>ANAEMIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048708-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060515</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ES-AMGEN-UK179500</companynumb>
    <primarysource>
      <reportercountry>SPAIN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>25</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>38</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>APLASIA PURE RED CELL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARANESP</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RENAL FAILURE CHRONIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040316</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060425</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AZATHIOPRINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19880526</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENALAPRIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030204</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19880526</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATORVASTATIN CALCIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040719</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYANOCOBALAMIN/FOLIC ACID</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060124</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FERRO-GRADUMET</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060124</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROGRAF</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048709-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060627</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-AMGEN-UK184534</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>PHLEBITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DARBEPOETIN ALFA</medicinalproduct>
        <drugauthorizationnumb>8223</drugauthorizationnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>ANAEMIA OF MALIGNANT DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060328</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060530</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048711-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060621</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>NLWYE717312JUN06</companynumb>
    <primarysource>
      <reportercountry>NETHERLANDS</reportercountry>
      <qualification>3</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>RAPAMUNE</medicinalproduct>
        <drugauthorizationnumb>21083</drugauthorizationnumb>
        <drugdosagetext>8 MG 1X PER 1 DAY; SEE IMAGE</drugdosagetext>
        <drugindication>RENAL TRANSPLANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060101</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RAPAMUNE</medicinalproduct>
        <drugauthorizationnumb>21083</drugauthorizationnumb>
        <drugdosagetext>8 MG 1X PER 1 DAY; SEE IMAGE</drugdosagetext>
        <drugindication>RENAL TRANSPLANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060101</drugenddate>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RAPAMUNE</medicinalproduct>
        <drugauthorizationnumb>21083</drugauthorizationnumb>
        <drugdosagetext>8 MG 1X PER 1 DAY; SEE IMAGE</drugdosagetext>
        <drugindication>RENAL TRANSPLANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE TAB</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048713-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060622</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>HQWYE348823JUN06</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>48</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>INTRA-ABDOMINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RAPAMUNE</medicinalproduct>
        <drugauthorizationnumb>21110</drugauthorizationnumb>
        <drugdosagetext>13 UNITS NOT PROVIDED/DAILY ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS AGAINST TRANSPLANT REJECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060503</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060608</drugenddate>
        <drugtreatmentduration>37</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MYCOPHENOLATE MOFETIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE TAB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BACTRIM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALTREX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NISTATIN (NYSTATIN)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANTOPRAZOLE SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NIFEDIPINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IRBESARTAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRAZOSIN GITS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048715-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>HQWYE485429JUN06</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG EFFECT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOWER RESPIRATORY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SHOCK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENTRICULAR TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMIODARONE HCL</medicinalproduct>
        <drugauthorizationnumb>18972</drugauthorizationnumb>
        <drugdosagetext>400 MG 1X PER 1 DAY; SEE IMAGE; (FOR 7 YEARS AT A DOSE OF 200 MG DAILY FOR MOST OF THE TIME)</drugdosagetext>
        <drugindication>VENTRICULAR TACHYCARDIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048716-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060621</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>HQWYE192512JUN06</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>33</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>VASCULITIS GASTROINTESTINAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RAPAMUNE</medicinalproduct>
        <drugauthorizationnumb>21083</drugauthorizationnumb>
        <drugdosagetext>2 MG PO OD ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RENAL TRANSPLANT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALTACE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE TAB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TACROLIMUS (TACROLIMUS)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PALAFER (FERROUS FUMARATE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARDIZEM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TUMS (CALCIUM CARBONATE/MAGNESIUM CARBONATE/MAGNESIUM TRISILICATE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SODIUM BICARBONATE IN PLASTIC CONTAINER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARANESP</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048717-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060627</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>HQWYE442628JUN06</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>78</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>INTERSTITIAL LUNG DISEASE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ETODOLAC</medicinalproduct>
        <drugauthorizationnumb>18922</drugauthorizationnumb>
        <drugdosagetext>400 MG 1X PER 1 DAY ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060525</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FAMOTIDINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE BESYLATE</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>TAMSULOSIN HYDROCHLORIDE (TAMSULOSIN HYDROCHLORIDE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ETIZOLAM (ETIZOLAM)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANTETHINE (PANTETHINE)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048719-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060627</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-US184893</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>ANAEMIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048720-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-US184899</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>REFUSAL OF TREATMENT BY PATIENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048721-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-US184890</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>ANAEMIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048722-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060622</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>HQWYE417122MAY06</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>68</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE CONGESTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEBRILE NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERURICAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOALBUMINAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOKALAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPONATRAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERSTITIAL LUNG DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MYLOTARG</medicinalproduct>
        <drugauthorizationnumb>21174</drugauthorizationnumb>
        <drugdosagetext>A SINGLE 9 MG/M^2 DOSE INTRAVENOUS DRIP; SEE IMAGE</drugdosagetext>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>ACUTE MYELOID LEUKAEMIA RECURRENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060328</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060328</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MYLOTARG</medicinalproduct>
        <drugauthorizationnumb>21174</drugauthorizationnumb>
        <drugdosagetext>A SINGLE 9 MG/M^2 DOSE INTRAVENOUS DRIP; SEE IMAGE</drugdosagetext>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>ACUTE MYELOID LEUKAEMIA RECURRENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060411</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060411</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MUCOSTA (REBAMIPIDE)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048724-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060614</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IL200606003411</companynumb>
    <primarysource>
      <reportercountry>ISRAEL</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GEMZAR</medicinalproduct>
        <drugauthorizationnumb>20509</drugauthorizationnumb>
        <drugdosagetext>1000 MG/M2, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>OVARIAN EPITHELIAL CANCER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048725-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060612</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IT200606001262</companynumb>
    <primarysource>
      <reportercountry>ITALY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>47</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ALANINE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASPARTATE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRANSAMINASES INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>1 D/F, DAILY (1/D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060301</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORAZEPAM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048726-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060612</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB200602003667</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>29</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>48</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABORTION SPONTANEOUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PREGNANCY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUOXETINE</medicinalproduct>
        <drugauthorizationnumb>18936</drugauthorizationnumb>
        <drugdosagetext>40 MG, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>POSTPARTUM DEPRESSION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051231</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048727-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060627</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200612717GDS</companynumb>
    <primarysource>
      <reportercountry>AUSTRIA</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>59</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>GASTROENTERITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCYTOPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXAVAR</medicinalproduct>
        <drugauthorizationnumb>21923</drugauthorizationnumb>
        <drugdosagetext>400 MG, BID, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>METASTATIC MALIGNANT MELANOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DACARBAZINE</medicinalproduct>
        <drugdosagetext>900 MG, TOTAL DAILY</drugdosagetext>
        <drugindication>METASTATIC MALIGNANT MELANOMA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048728-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-2006-016009</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>42</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>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>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048729-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060626</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-2006-017291</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>33</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DIPLOPIA</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>20060201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>POLIVITAMINE (VITAMINS NOS)</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048730-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060613</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB200604003506</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>23</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
        <drugauthorizationnumb>20592</drugauthorizationnumb>
        <drugdosagetext>20 MG, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050601</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048731-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060612</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PL-AVENTIS-200616289GDDC</companynumb>
    <primarysource>
      <reportercountry>POLAND</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>70</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>63</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRANSAMINASES INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARAVA</medicinalproduct>
        <drugbatchnumb>509</drugbatchnumb>
        <drugauthorizationnumb>20905</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050824</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060523</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRESTARIUM</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BETALOC ZOK</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACARD</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048732-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060615</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>VE200605003676</companynumb>
    <primarysource>
      <reportercountry>VENEZUELA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>70</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLINDNESS TRANSIENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLINDNESS UNILATERAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CIALIS</medicinalproduct>
        <drugauthorizationnumb>21368</drugauthorizationnumb>
        <drugdosagetext>20 MG, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ERECTILE DYSFUNCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060401</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048733-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060626</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-2006-016784</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLINDNESS UNILATERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRADYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC NEUROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSYCHOSOMATIC DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SENSATION OF FOREIGN BODY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPEECH DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PETIBELLE 30 (21 (DROSPIRENONE, ETHINYLESTRADIOL), FILM TABLET</medicinalproduct>
        <drugauthorizationnumb>21098</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060620</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048734-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060615</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>HU200606000593</companynumb>
    <primarysource>
      <reportercountry>HUNGARY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>33</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OLANZAPINE</medicinalproduct>
        <drugauthorizationnumb>21253</drugauthorizationnumb>
        <drugdosagetext>10 MG, 2/D, INTRAMUSCULAR</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>PSYCHOTIC DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060522</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060527</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EDNYT (ENALAPRIL MALEATE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HALOPERIDOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULATARD NPH HUMAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACTRAPID HUMAN (INSULIN HUMAN)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048735-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060622</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE200605001943</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>65</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CREATININE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD LACTATE DEHYDROGENASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARCINOID TUMOUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRIC HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOLYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSIVE CRISIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY OEDEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GEMZAR</medicinalproduct>
        <drugauthorizationnumb>20509</drugauthorizationnumb>
        <drugdosagetext>1000 MG/M2, DAILY (1/D), INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PANCREATIC CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTIHYPERTENSIVES</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RAMIPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HCT (HYDROCHLOROTHIAZIDE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL SUCCINATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALDACTONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOXAZOSIN (DOXAZOSIN)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048736-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060627</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IT-2006-013522</companynumb>
    <primarysource>
      <reportercountry>ITALY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>86</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CRYPTOGENIC ORGANISING PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERSTITIAL LUNG DISEASE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SOTALOL HYDROCHLORIDE</medicinalproduct>
        <drugauthorizationnumb>19865</drugauthorizationnumb>
        <drugdosagetext>80 MG, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ISCHAEMIC CARDIOMYOPATHY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060501</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALSARTAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNIPRIL (RAMIPRIL)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARDIRENE (ACETYLSALICYLATE LYSINE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LUVION (CANRENOIC ACID)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048737-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060613</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR200606003508</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>77</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BALANCE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERAL PHYSICAL HEALTH DETERIORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERCALCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NERVOUS SYSTEM DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROSTRATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugauthorizationnumb>21318</drugauthorizationnumb>
        <drugdosagetext>20 UG, DAILY (1/D), SUBCUTANEOUS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060513</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060522</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FORTEO PEN (FORTEO PEN) PEN, DISPOSABLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CACIT (CALCIUM CARBONATE, CITRIC ACID)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FENOFIBRATE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048738-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060612</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR200606002795</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>56</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugauthorizationnumb>21318</drugauthorizationnumb>
        <drugdosagetext>20 UG, DAILY (1/D), SUBCUTANEOUS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060422</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FORTEO PEN (FORTEO PEN) PEN, DISPOSABLE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048739-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060620</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>E2020-00170-SPO-FR</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>84</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ATRIAL FIBRILLATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ATRIOVENTRICULAR BLOCK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRADYARRHYTHMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</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>20040901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050318</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>20050326</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMINE (METFORMIN)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RAMIPRIL (TRIATEC) (RAMIPRIL)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DL-LYSINE ACETHYLSALICYLATE (ASPEGIC) (ACETYLSALICYLATE LYSINE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FENOFIBRATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRINITRINE (NITRIDERM) (GLYCERYL TRINITRATE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARDENSIEL (BISOPROLOL) (BISOPROLOL)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MOPROL (OMEPRAZOLE) (OMEPRAZOLE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KARDEGIC (DL-LYSINE ACETHYLSALICYLATE) (ACETYLSALICYLATE LYSINE)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048740-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060614</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ES200606001266</companynumb>
    <primarysource>
      <reportercountry>SPAIN</reportercountry>
      <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>CEREBROVASCULAR DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SCHIZOPHRENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VASODILATATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
        <drugauthorizationnumb>20592</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
        <drugauthorizationnumb>20592</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
        <drugauthorizationnumb>20592</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
        <drugauthorizationnumb>20592</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENZODIAZEPINE DERIVATIVES</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HALOPERIDOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLORAZEPATE DIPOTASSIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AKINETON</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048741-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060614</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ES200606001039</companynumb>
    <primarysource>
      <reportercountry>SPAIN</reportercountry>
      <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>BRONCHOSPASM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HUNGER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SCHIZOPHRENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
        <drugauthorizationnumb>20592</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
        <drugauthorizationnumb>20592</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
        <drugauthorizationnumb>20592</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051125</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AKINETON</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HALOPERIDOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RISPERIDONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ETUMINA (CLOTIAPINE)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048742-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesscongenitalanomali>1</seriousnesscongenitalanomali>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060313</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-06P-163-0327697-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FOETAL CHROMOSOME ABNORMALITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRISOMY 21</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KALETRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>21226</drugauthorizationnumb>
        <drugindication>DRUG EXPOSURE DURING PREGNANCY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIDANOSINE</medicinalproduct>
        <drugindication>DRUG EXPOSURE DURING PREGNANCY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMIVUDINE</medicinalproduct>
        <drugindication>DRUG EXPOSURE DURING PREGNANCY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEVIRAPINE</medicinalproduct>
        <drugindication>DRUG EXPOSURE DURING PREGNANCY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048743-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060627</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>E2020-00122-SPO-JP</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>84</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>70</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COORDINATION ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DELIRIUM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HALLUCINATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOTONIA CONGENITA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUROLEPTIC MALIGNANT SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSYCHOMOTOR HYPERACTIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESTLESSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</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>20051008</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060602</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOTOP-L (NIFEDIPINE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PENSELIN (DIPYRIDAMOLE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MOBIC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NIZATIDINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MADOPAR</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048744-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060703</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-ABBOTT-06P-167-0337585-00</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>63</patientweight>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ATRIAL FIBRILLATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC VALVE DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HIATUS HERNIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040615</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050215</drugenddate>
        <drugtreatmentduration>245</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GOLD</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>ACETYLSALICYLIC ACID SRT</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ETIDRONATE DISODIUM</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>CARBAMAZEPINE</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANSOPRAZOLE</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048745-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060703</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2006BR10002</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>90</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORASEQ</medicinalproduct>
        <drugauthorizationnumb>20831</drugauthorizationnumb>
        <drugindication>BRONCHITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048746-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060613</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP200606003392</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>63</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>70</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LISPRO (LISPRO 25LIS75NPL) CARTRIDGE</medicinalproduct>
        <drugauthorizationnumb>20563</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugindication>DIABETES MELLITUS NON-INSULIN-DEPENDENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050920</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051111</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LISPRO (LISPRO 25LIS75NPL) CARTRIDGE</medicinalproduct>
        <drugauthorizationnumb>20563</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugindication>DIABETES MELLITUS NON-INSULIN-DEPENDENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051112</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060216</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM POLYSTYRENE SULFONATE (CALCIUM POLYSTYRENE SULFONATE) JELLY</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIFLUCAN (FLUCONAZOLE) CAPSULE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOFLOXACIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BACTRIM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZANTAC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PURSENNID (SENNOSIDE A+B, SENNOSIDE A+B CALCIUM) TABLET</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NINJIN-TO (GINSENG)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048747-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060627</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>E2020-00202-SPO-JP</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>AGGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANGER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHILD ABUSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPOUSAL ABUSE</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>20060301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060401</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>20060401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060501</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048748-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060622</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>HQWYE360616MAR06</companynumb>
    <primarysource>
      <reportercountry>NETHERLANDS</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PANTOPRAZOLE SODIUM</medicinalproduct>
        <drugauthorizationnumb>20987</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ABDOMINAL PAIN UPPER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060209</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PANTOPRAZOLE SODIUM</medicinalproduct>
        <drugauthorizationnumb>20987</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTROOESOPHAGEAL REFLUX DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060209</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048749-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060622</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GBWYE719412JUN06</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>CARDIAC DISORDER</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>5048750-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060622</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>HQWYE346322JUN06</companynumb>
    <primarysource>
      <reportercountry>POLAND</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>48</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANAPHYLACTIC REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMODYNAMIC INSTABILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CONTROLOC (PANTOPRAZOLE, TABLET, DELAYED RELEASE)</medicinalproduct>
        <drugauthorizationnumb>20987</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HELICOBACTER INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060115</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060125</drugenddate>
        <drugtreatmentduration>11</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CONTROLOC (PANTOPRAZOLE, TABLET, DELAYED RELEASE)</medicinalproduct>
        <drugauthorizationnumb>20987</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HELICOBACTER INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060126</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060209</drugenddate>
        <drugtreatmentduration>15</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOLPERIS (TOLPERISONE, )</medicinalproduct>
        <drugdosagetext>100 MG 3X PER 1 DAY, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BACK PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060202</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060209</drugenddate>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMOXICILLIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLARITHROMYCIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048751-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060623</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>HQWYE349515MAY06</companynumb>
    <primarysource>
      <reportercountry>ARGENTINA</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>28</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CYTOMEGALOVIRUS INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEORAL</medicinalproduct>
        <drugdosagetext>350 MG 1X PER 1 DAY, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS AGAINST TRANSPLANT REJECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060308</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MYCOPHENOLATE MOFETIL</medicinalproduct>
        <drugdosagetext>1000 MG 1X PER 1 DAY,  ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS AGAINST TRANSPLANT REJECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060516</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE TAB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACYCLOVIR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BACTRIM DS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANTOPRAZOLE SODIUM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048752-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060626</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DEWYE799226JUN06</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>50</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABNORMAL BEHAVIOUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DELIRIUM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DELUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG WITHDRAWAL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SLEEP DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VENLAFAXINE HCL</medicinalproduct>
        <drugauthorizationnumb>20699</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050119</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050124</drugenddate>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VENLAFAXINE HCL</medicinalproduct>
        <drugauthorizationnumb>20699</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050125</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050201</drugenddate>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VENLAFAXINE HCL</medicinalproduct>
        <drugauthorizationnumb>20699</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050206</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050208</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VENLAFAXINE HCL</medicinalproduct>
        <drugauthorizationnumb>20699</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050209</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050213</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VENLAFAXINE HCL</medicinalproduct>
        <drugauthorizationnumb>20699</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050214</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050214</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LORAZEPAM</medicinalproduct>
        <drugdosagetext>SEE  IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050119</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050127</drugenddate>
        <drugtreatmentduration>9</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LORAZEPAM</medicinalproduct>
        <drugdosagetext>SEE  IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050128</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050128</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LORAZEPAM</medicinalproduct>
        <drugdosagetext>SEE  IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050129</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050131</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MELPERONE (MELPERONE)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048753-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060630</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200612609GDS</companynumb>
    <primarysource>
      <reportercountry>SWITZERLAND</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>67</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ALANINE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUID INTAKE REDUCED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEPHRITIS INTERSTITIAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugauthorizationnumb>21317</drugauthorizationnumb>
        <drugdosagetext>PRN, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEADACHE</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060407</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
        <drugdosagetext>PRN, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEADACHE</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060407</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PARACETAMOL/DEXTROMETHORPHAN (DEXTROMETHORPHAN W/PARACETAMOL/PSEUDOEPH</medicinalproduct>
        <drugdosagetext>PRN, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEADACHE</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060407</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HERCEPTIN</medicinalproduct>
        <drugdosagetext>200 MG, TOTAL DAILY, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050803</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060405</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMILORID MEPHA (AMILORID, HYDROCHLOROTHIAZIDE)</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060407</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARIMIDEX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NAVOBAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE TAB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PASPERTIN [METOCLOPRAMIDE HYDROCHLORIDE]</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARVEDILOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COLECALCIFEROL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACTONEL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALPEROS D3</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRETUVAL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048754-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060622</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>HQWYE347923JUN06</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>65</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PLEURAL EFFUSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ANCARON (AMIODARONE, TABLET)</medicinalproduct>
        <drugauthorizationnumb>18972</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048755-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060621</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FRWYE767722JUN06</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>39</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CYTOMEGALOVIRUS INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ENTEROCOCCAL SEPSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HISTIOCYTOSIS HAEMATOPHAGIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JAUNDICE CHOLESTATIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSEUDOMONAL SEPSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSEUDOMONAS INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPTIC SHOCK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SHOCK HAEMORRHAGIC</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYGACIL</medicinalproduct>
        <drugauthorizationnumb>21821</drugauthorizationnumb>
        <drugdosagetext>INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ACINETOBACTER BACTERAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060107</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060120</drugenddate>
        <drugtreatmentduration>14</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYGACIL</medicinalproduct>
        <drugauthorizationnumb>21821</drugauthorizationnumb>
        <drugdosagetext>INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BRONCHOPNEUMONIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060107</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060120</drugenddate>
        <drugtreatmentduration>14</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYGACIL</medicinalproduct>
        <drugauthorizationnumb>21821</drugauthorizationnumb>
        <drugdosagetext>INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ENTEROCOCCAL BACTERAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060107</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060120</drugenddate>
        <drugtreatmentduration>14</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYGACIL</medicinalproduct>
        <drugauthorizationnumb>21821</drugauthorizationnumb>
        <drugdosagetext>INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PSEUDOMONAL BACTERAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060107</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060120</drugenddate>
        <drugtreatmentduration>14</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYGACIL</medicinalproduct>
        <drugauthorizationnumb>21821</drugauthorizationnumb>
        <drugdosagetext>INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>STENOTROPHOMONAS INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060107</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060120</drugenddate>
        <drugtreatmentduration>14</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYGACIL</medicinalproduct>
        <drugauthorizationnumb>21821</drugauthorizationnumb>
        <drugdosagetext>INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ACINETOBACTER BACTERAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060206</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060223</drugenddate>
        <drugtreatmentduration>18</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYGACIL</medicinalproduct>
        <drugauthorizationnumb>21821</drugauthorizationnumb>
        <drugdosagetext>INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BRONCHOPNEUMONIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060206</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060223</drugenddate>
        <drugtreatmentduration>18</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYGACIL</medicinalproduct>
        <drugauthorizationnumb>21821</drugauthorizationnumb>
        <drugdosagetext>INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ENTEROCOCCAL BACTERAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060206</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060223</drugenddate>
        <drugtreatmentduration>18</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYGACIL</medicinalproduct>
        <drugauthorizationnumb>21821</drugauthorizationnumb>
        <drugdosagetext>INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PSEUDOMONAL BACTERAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060206</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060223</drugenddate>
        <drugtreatmentduration>18</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYGACIL</medicinalproduct>
        <drugauthorizationnumb>21821</drugauthorizationnumb>
        <drugdosagetext>INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>STENOTROPHOMONAS INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060206</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060223</drugenddate>
        <drugtreatmentduration>18</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>...</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZYVOX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLAVENTIN (CLAVULANATE POTASSIUM/TICARCILLIN DISODIUM)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOBRAMYCIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TIENAM (CILASTATIN/IMIPENEM)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMIKIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048756-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060619</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>111066ISR</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>37</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>SUDDEN DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VINCRISTINE</medicinalproduct>
        <drugdosagetext>INTRAVENOUS (NOS)</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060215</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060418</drugenddate>
        <drugtreatmentduration>9</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VELCADE</medicinalproduct>
        <drugdosagetext>INTRAVENOUS (NOS)</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060418</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060421</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOXORUBICIN HYDROCHLORIDE</medicinalproduct>
        <drugdosagetext>INTRAVENOUS (NOS)</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060215</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060418</drugenddate>
        <drugtreatmentduration>9</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXRAZOXANE HYDROCHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CEFTAZIDIME PENTAHYDRATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CIPROFLOXACIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AUGMENTIN '125'</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048757-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060626</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200612628GDS</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>66</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>APLASIA PURE RED CELL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THERAPY NON-RESPONDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugauthorizationnumb>21317</drugauthorizationnumb>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIGOSIN (DIGOXIN [DIGOXIN])</medicinalproduct>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ERYTHROPOEITIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048758-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060615</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR200606003406</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>76</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>80</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENINGORRHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XIGRIS</medicinalproduct>
        <drugdosagetext>INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>SEPTIC SHOCK</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060410</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060413</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE BESYLATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM CHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CEFTAZIDIME PENTAHYDRATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CIFLOX (CIPROFLOXACIN)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048759-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060616</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB200602001778</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>63</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>NEOPLASM MALIGNANT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugauthorizationnumb>21318</drugauthorizationnumb>
        <drugdosagetext>20 UG, DAILY (1/D)</drugdosagetext>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048760-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060627</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>13950</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>43</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>67</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUOROURACIL</medicinalproduct>
        <drugauthorizationnumb>8107</drugauthorizationnumb>
        <drugdosagetext>720 MG OTH IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLON CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060215</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUOROURACIL</medicinalproduct>
        <drugdosagetext>4320 MG OTH IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLON CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060215</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IRINOTECAN HYDROCHLORIDE</medicinalproduct>
        <drugdosagetext>324 MG OTH IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLON CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060215</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEUCOVORIN CALCIUM</medicinalproduct>
        <drugdosagetext>360 MG OTHER IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLON CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060215</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUNITINIB MALATE</medicinalproduct>
        <drugdosagetext>50 MG DAILY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>COLON CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060217</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048761-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060616</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR200605003760</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>68</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>75</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANGIONEUROTIC OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIOMEGALY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROENTERITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLAMMATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERICARDIAL EFFUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERICARDITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VIRAL PERICARDITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugauthorizationnumb>21318</drugauthorizationnumb>
        <drugdosagetext>20 UG, DAILY (1/D), SUBCUTANEOUS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051016</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060505</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZANIDIP (LERCANIDIPINE HYDROCHLORIDE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OROCAL D (3) (CALCIUM CARBONATE, COLECALCIFEROL)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRIATEC</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048762-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060616</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA200605005251</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>59</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CLOSTRIDIUM DIFFICILE COLITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIMB INJURY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugauthorizationnumb>21318</drugauthorizationnumb>
        <drugdosagetext>20 U G, DAILY (1/D)</drugdosagetext>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050427</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048763-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060614</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>HU200605002374</companynumb>
    <primarysource>
      <reportercountry>HUNGARY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>55</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMULIN N</medicinalproduct>
        <drugauthorizationnumb>18780</drugauthorizationnumb>
        <drugdosagetext>16 IU, DAILY (1/D), SUBCUTANEOUS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060407</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMULIN R</medicinalproduct>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060407</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMULIN 70/30</medicinalproduct>
        <drugdosagetext>16 IU, DAILY; 6 IU DAILY (1/D); 12 IU, DAILY (1/D)</drugdosagetext>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULATARD NPH HUMAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MIXTARD (INSULIN INJECTION, ISOPHANE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN ASPART (INSULIN ASPART)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL (METOPROLOL)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALPRAZOLAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PIRACETAM (PIRACETAM)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NITROGLYCERIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENALAPRIL MALEATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NIFEDIPINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LACTULOSE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACARBOSE (ACARBOSE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THEOPHYLLIN - SLOW RELEASE (THEOPHYLLINE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOMPERIDONE (DOMPERIDONE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMILORIDE (AMILORIDE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORATADINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VINPOCETINE (VINPOCENTINE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIPYRONE TAB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASCORBIC ACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TIMOLOL MALEATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUOROMETHOLONE (FLUOROMETHOLONE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXTRAN 70 (DEXTRAN 70)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048764-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060614</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE_051017240</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>12</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>42</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>AGGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AMNESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BIPOLAR I DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERSONALITY CHANGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>STRATTERA</medicinalproduct>
        <drugauthorizationnumb>21411</drugauthorizationnumb>
        <drugdosagetext>40 MG, DAILY (1/D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATTENTION DEFICIT/HYPERACTIVITY DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050707</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051006</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048765-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060614</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BE200602004698</companynumb>
    <primarysource>
      <reportercountry>BELGIUM</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>11</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>APPENDICITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>B4Z-MC-LYBX COMORBID ODD IN PEDS (ATOMOXETINE HYDROCHLORIDE) CAPSULE</medicinalproduct>
        <drugauthorizationnumb>21411</drugauthorizationnumb>
        <drugdosagetext>65 MG, DAILY (1/D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATTENTION DEFICIT/HYPERACTIVITY DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040610</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048766-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060626</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006080885</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>80</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BRONCHITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OESOPHAGEAL OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY FIBROSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOXAZOSIN (DOXAZOSIN)</medicinalproduct>
        <drugauthorizationnumb>19668</drugauthorizationnumb>
        <drugindication>BENIGN PROSTATIC HYPERPLASIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048768-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060627</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>14239</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>57</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>112</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIO-RESPIRATORY ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLD SWEAT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ANZATAX</medicinalproduct>
        <drugbatchnumb>SO36854</drugbatchnumb>
        <drugauthorizationnumb>76131</drugauthorizationnumb>
        <drugdosagetext>160 MG IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BREAST CANCER METASTATIC</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060609</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOFRAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE TAB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GEMZAR</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048769-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060622</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>14307</companynumb>
    <primarysource>
      <reportercountry>SPAIN</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>71</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PACLITAXEL</medicinalproduct>
        <drugauthorizationnumb>76517</drugauthorizationnumb>
        <drugindication>OVARIAN EPITHELIAL CANCER RECURRENT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARBOPLATIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SALBUTAMOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IPRATROPIUM BROMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BUDESONIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FENTANYL TRANSDERMAL SYSTEM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORAZEPAM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048770-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060626</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006080907</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>0</patientsex>
      <reaction>
        <reactionmeddrapt>DEAFNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STRESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWELLING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALDACTONE</medicinalproduct>
        <drugauthorizationnumb>12151</drugauthorizationnumb>
        <drugdosagetext>25 MG (INTERVAL: EVERY OTHER DAY), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060529</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048771-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2005150682</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>58</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>52</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BRADYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHOLECYSTITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHOLELITHIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION POTENTIATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG LEVEL INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OXYGEN SATURATION DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHLEBITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESTLESSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SHOCK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUS ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THERAPY NON-RESPONDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARDENALIN (DOXAZOSIN)</medicinalproduct>
        <drugauthorizationnumb>19668</drugauthorizationnumb>
        <drugdosagetext>8 MG (4 MG, BID), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051021</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051031</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DILTIAZEM HYDROCHLORIDE</medicinalproduct>
        <drugdosagetext>36 MG, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051031</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051031</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMLODIPINE</medicinalproduct>
        <drugdosagetext>10 MG (5 MG, BID, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051017</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051031</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PERDIPINE (NICARDIPINE HYDROCHLORIDE)</medicinalproduct>
        <drugdosagetext>500 MG (500 MG,QD), INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051017</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051031</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CALSLOT (MANIDIPINE HYDROCHLORIDE)</medicinalproduct>
        <drugdosagetext>40 MG (20 MG,BID), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051021</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051031</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIFEDIPINE</medicinalproduct>
        <drugdosagetext>60 MG, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051018</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051031</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARVEDILOL</medicinalproduct>
        <drugdosagetext>20 MG, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051018</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051031</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048772-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060619</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>14273</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
    </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>GASTRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOUTH ULCERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCYTOPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHOTREXATE SODIUM</medicinalproduct>
        <drugauthorizationnumb>11719</drugauthorizationnumb>
        <drugdosagetext>20 MG OTH</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060421</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISEDRONATE</medicinalproduct>
        <drugdosagetext>35 MG WEEKLY</drugdosagetext>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060421</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCICHEW D3</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048773-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060614</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ES200605003952</companynumb>
    <primarysource>
      <reportercountry>SPAIN</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY OEDEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugauthorizationnumb>21318</drugauthorizationnumb>
        <drugdosagetext>20 UG, DAILY (1/D), SUBCUTANEOUS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060509</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060513</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048774-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060612</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE200605003953</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>67</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>90</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANOREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COGNITIVE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLATULENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOKINESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>60 MG, DAILY (1/D)</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060511</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060511</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIORESAL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MICTONORM (PROPIVERINE)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048775-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060621</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP200603002244</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>88</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>NO ADVERSE EFFECT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RALOXIFENE HCL</medicinalproduct>
        <drugauthorizationnumb>20815</drugauthorizationnumb>
        <drugdosagetext>60 MG, DAILY (1/D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS POSTMENOPAUSAL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041226</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050115</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ONE-ALPHA (ALFACALCIDOL)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048776-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060626</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>14304</companynumb>
    <primarysource>
      <reportercountry>KOREA, DEMOCRATIC PEOPLE'S REPUBLIC OF</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>64</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANOREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CRYPTOGENIC ORGANISING PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EMPHYSEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERAL PHYSICAL CONDITION NORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY FIBROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUOROURACIL</medicinalproduct>
        <drugauthorizationnumb>8107</drugauthorizationnumb>
        <drugindication>GASTRIC CANCER RECURRENT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUOROURACIL</medicinalproduct>
        <drugindication>GASTRIC CANCER RECURRENT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEUCOVORIN CALCIUM</medicinalproduct>
        <drugindication>GASTRIC CANCER RECURRENT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEUCOVORIN CALCIUM</medicinalproduct>
        <drugindication>GASTRIC CANCER RECURRENT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ELOXATIN</medicinalproduct>
        <drugindication>GASTRIC CANCER RECURRENT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ELOXATIN</medicinalproduct>
        <drugindication>GASTRIC CANCER RECURRENT</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048777-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060619</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP200604000017</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>82</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>BRONCHITIS ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RALOXIFENE HCL</medicinalproduct>
        <drugauthorizationnumb>20815</drugauthorizationnumb>
        <drugdosagetext>60 MG, DAILY (1/D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS POSTMENOPAUSAL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050704</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051102</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ELCITONIN (ELCATONIN)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INDERAL LA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOSARTAN POTASSIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LACTEC (CALCIUM CHLORIDE ANHYDROUS, POTASSIUM CHLORIDE, SODIUM CHLORID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZITHROMAX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048778-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060619</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP200604000330</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>84</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CEREBRAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RALOXIFENE HCL</medicinalproduct>
        <drugauthorizationnumb>20815</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS POSTMENOPAUSAL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050711</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050818</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RALOXIFENE HCL</medicinalproduct>
        <drugauthorizationnumb>20815</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS POSTMENOPAUSAL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051219</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ELCITONIN (ELCATONIN)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPARA-CA (ASPARTATE CALCIUM)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ROCORNAL (TRAPIDIL)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYMMETREL /NET/ (AMANTADINE HYDROCHLORIDE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NIFEDIPINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048779-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060612</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP200604004048</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>67</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>49.4</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EOSINOPHILIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMULIN R</medicinalproduct>
        <drugauthorizationnumb>18780</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>ALLERGENIC DESENSITISATION PROCEDURE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051107</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMULIN R</medicinalproduct>
        <drugauthorizationnumb>18780</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>ALLERGENIC DESENSITISATION PROCEDURE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051202</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051204</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMACART REGULAR (HUMAN INSULIN (RDNA ORIGIN) REGULAR) PEN, DISPOSABLE</medicinalproduct>
        <drugdosagetext>2 U, DAILY (1/D), SUBCUTANEOUS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>ALLERGENIC DESENSITISATION PROCEDURE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051205</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HUMULIN R PEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HYDROCHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MITIGLINIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KINEDAK (EPALRESTAT)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHYCOBAL (MECOBALAMIN)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BISOPROLOL FUMARATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATELEC (CILNIDIPINE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RIZE (CLOTIAZEPAM)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048780-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060619</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>224365</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>57</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY STENOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EJECTION FRACTION DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVASTIN</medicinalproduct>
        <drugdosagetext>10 MG/KG, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RENAL CELL CARCINOMA STAGE UNSPECIFIED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050515</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060515</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048781-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060615</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>8017471</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>0</patientsex>
      <reaction>
        <reactionmeddrapt>CLONIC CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEBRILE CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NERVOUS SYSTEM DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY OEDEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>THEOPHYLLINE</medicinalproduct>
        <drugauthorizationnumb>87942</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048782-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060615</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>8017472</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>0</patientsex>
      <reaction>
        <reactionmeddrapt>FEBRILE CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY OEDEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>THEOPHYLLINE</medicinalproduct>
        <drugauthorizationnumb>87942</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048783-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060615</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>8017463</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>0</patientsex>
      <reaction>
        <reactionmeddrapt>FEBRILE CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NERVOUS SYSTEM DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY OEDEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>THEOPHYLLINE</medicinalproduct>
        <drugauthorizationnumb>87942</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048784-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060626</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200612630GDS</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>76</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CATHETER RELATED COMPLICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHOLECYSTITIS ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHOLELITHIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOBILIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugauthorizationnumb>21317</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048785-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060615</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>8017466</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>0</patientsex>
      <reaction>
        <reactionmeddrapt>CLONIC CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEBRILE CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NERVOUS SYSTEM DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY OEDEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>THEOPHYLLINE</medicinalproduct>
        <drugauthorizationnumb>87942</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048786-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060615</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>8017468</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <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>FEBRILE CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NERVOUS SYSTEM DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>THEOPHYLLINE</medicinalproduct>
        <drugauthorizationnumb>87942</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048787-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060626</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200612691GDS</companynumb>
    <primarysource>
      <reportercountry>ITALY</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>26</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>GASTRIC ULCER PERFORATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugauthorizationnumb>21317</drugauthorizationnumb>
        <drugdosagetext>500 MG, QD, ORAL;  500 MG, BID, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INFLUENZA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060606</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugauthorizationnumb>21317</drugauthorizationnumb>
        <drugdosagetext>500 MG, QD, ORAL;  500 MG, BID, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INFLUENZA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060607</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048788-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060614</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB200606003467</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>60</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>LEUKOCYTOCLASTIC VASCULITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MANIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OLANZAPINE</medicinalproduct>
        <drugauthorizationnumb>20592</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EPILIM (VALPROATE SODIUM)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CHLORPROMAZINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONAZEPAM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048789-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060613</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE200606003173</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>48</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>LEUKOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRESCRIBED OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
        <drugauthorizationnumb>20592</drugauthorizationnumb>
        <drugdosagetext>10 MG, DAILY (1/D), ORAL; SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOAFFECTIVE DISORDER</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060401</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
        <drugauthorizationnumb>20592</drugauthorizationnumb>
        <drugdosagetext>10 MG, DAILY (1/D), ORAL; SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOAFFECTIVE DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060511</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LITHIUM (LITHIUM)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORAZEPAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HALDOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MELPERONE (MELPERONE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AKINETON/AUS/(BIPERIDEN HYDROCHLORIDE)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048790-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060613</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP200606004435</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>24</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>GRANULOCYTE COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
        <drugauthorizationnumb>20592</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048791-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060621</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>RENA-11701</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>57</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>RASH GENERALISED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PHOSBLOCK 250 MG TABLETS</medicinalproduct>
        <drugauthorizationnumb>21179</drugauthorizationnumb>
        <drugdosagetext>1500 MG, DAILY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERPHOSPHATAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051213</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060228</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SUCRALFATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AZELNIDIPINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOXAZOSIN MESYLATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FAMOTIDINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALFACALCIDOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EPOETIN ALFA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CHONDROITIN SULFATE - IRON COLLOID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLYCYRRHIZINATE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048792-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060623</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>RENA-11808</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>71</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>INTESTINAL OBSTRUCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RENAGEL</medicinalproduct>
        <drugauthorizationnumb>21179</drugauthorizationnumb>
        <drugdosagetext>2 G TID PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERPHOSPHATAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040729</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050404</drugenddate>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RENAGEL</medicinalproduct>
        <drugdosagetext>2 G TID PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERPHOSPHATAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031222</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040606</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048793-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060614</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CN200606003480</companynumb>
    <primarysource>
      <reportercountry>CHINA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>70</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>LUNG INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALIGNANT NEOPLASM PROGRESSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GEMZAR</medicinalproduct>
        <drugauthorizationnumb>20509</drugauthorizationnumb>
        <drugdosagetext>1.4 G, (DAYS 1, 8, Q3W), INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARBOPLATIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048794-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060614</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IL200606003412</companynumb>
    <primarysource>
      <reportercountry>ISRAEL</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GEMCITABINE HYDROCHLORIDE (GEMCITABINE HYDROCHLORIDE)</medicinalproduct>
        <drugauthorizationnumb>20509</drugauthorizationnumb>
        <drugdosagetext>1000 MG/M2, OTHER, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>OVARIAN EPITHELIAL CANCER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048795-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060626</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006070603</companynumb>
    <primarysource>
      <reportercountry>BELGIUM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>57</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>75</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>GRAND MAL CONVULSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AROMASIN</medicinalproduct>
        <drugauthorizationnumb>20753</drugauthorizationnumb>
        <drugdosagetext>25 MG (25 MG), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051106</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LAMICTAL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KEPPRA</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048796-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060620</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006RR-02744</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARYNGEAL OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH MACULAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUS CONGESTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUS DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWELLING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUCONAZOLE</medicinalproduct>
        <drugauthorizationnumb>76386</drugauthorizationnumb>
        <drugdosagetext>150 MG, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CANDIDIASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060515</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060515</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048797-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060622</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006077568</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>60</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG ERUPTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ECZEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA MULTIFORME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PURPURA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SCAR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
        <drugauthorizationnumb>19787</drugauthorizationnumb>
        <drugdosagetext>2.5 MG, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060309</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060607</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048798-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060619</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA200603005820</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>61</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>LUNG CONSOLIDATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</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>20051207</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048799-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060616</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP200606004433</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>54</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEOPLASM PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STENT OCCLUSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GEMZAR</medicinalproduct>
        <drugauthorizationnumb>20509</drugauthorizationnumb>
        <drugdosagetext>INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>TRACHEAL CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050128</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051202</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048800-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060620</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006RR-02741</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>49</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>104.5</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ATRIAL FIBRILLATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LORATADINE</medicinalproduct>
        <drugauthorizationnumb>76134</drugauthorizationnumb>
        <drugdosagetext>10 MG, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SEASONAL ALLERGY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DISPERSIBLE ASPIRIN TABLETS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATORVASTATIN CALCIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048801-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060613</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PL200606002998</companynumb>
    <primarysource>
      <reportercountry>POLAND</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>66</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>86</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ERYSIPELAS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VARICOSE VEIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMULIN 70/30</medicinalproduct>
        <drugauthorizationnumb>18780</drugauthorizationnumb>
        <drugdosagetext>30 U, DAILY (1/D), SUBCUTANEOUS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ISOSORBIDE MONONITRATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACARD (ACETYLSALICYLIC ACID)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BISOCARD (BISOPROLOL)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NAPROXEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLOPIN (AMLODIPINE BESILATE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENALAPRIL MALEATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RUTAVIT (RUTOSIDE )</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TULIP (FLURBIPROFEN)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048802-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060612</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU200606004436</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>SUBARACHNOID HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XIGRIS</medicinalproduct>
        <drugindication>MENINGOCOCCAL SEPSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060601</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048803-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060620</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006RR-02727</companynumb>
    <primarysource>
      <reportercountry>ARGENTINA</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>66</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>COMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE MOVEMENT DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE DRUG OVERDOSE INTENTIONAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUROLEPTIC MALIGNANT SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEROTONIN SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUOXETINE</medicinalproduct>
        <drugauthorizationnumb>76165</drugauthorizationnumb>
        <drugdosagetext>60 MG</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRIFLUOPERAZINE(TRIFLUOPERAZINE)</medicinalproduct>
        <drugdosagetext>20 MG</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LORAZEPAM</medicinalproduct>
        <drugdosagetext>60 MG</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRANYLCYPROMINE (TRANYLCYPROMINE)</medicinalproduct>
        <drugdosagetext>100 MG</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048804-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060620</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200611966GDS</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>44</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DUODENITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATOCHEZIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMODYNAMIC INSTABILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RECTAL ULCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SCAR</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>20040728</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040823</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXTRAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLYCEOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLETAL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAKEPRON</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048805-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060627</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200612711GDS</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</reportercountry>
    </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>LEVITRA</medicinalproduct>
        <drugauthorizationnumb>21400</drugauthorizationnumb>
        <drugdosagetext>PRN, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ERECTILE DYSFUNCTION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048806-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200612706GDS</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>0</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA HAEMORRHAGIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRASYLOL</medicinalproduct>
        <drugauthorizationnumb>20304</drugauthorizationnumb>
        <drugdosagetext>10 ML, TOTAL DAILY, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANTOPRAZOLE SODIUM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048807-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FRWYE927330JUN06</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>44</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RAPAMUNE</medicinalproduct>
        <drugauthorizationnumb>21110</drugauthorizationnumb>
        <drugdosagetext>7 MG TOTAL DAILY AT THE TIME OF THE EVENT ONSET ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS AGAINST TRANSPLANT REJECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030429</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048808-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060619</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB200605000267</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>58</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>70.1</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ACTIVATED PARTIAL THROMBOPLASTIN TIME PROLONGED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANOREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASCITES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ATELECTASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ATRIAL FIBRILLATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BILE DUCT OBSTRUCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CULTURE POSITIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHOLANGITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COAGULOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CULTURE POSITIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISEASE PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ENTEROCOCCAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATEMESIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>KLEBSIELLA INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LETHARGY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER ABSCESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG CONSOLIDATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPHIL COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLEURAL EFFUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROTHROMBIN TIME PROLONGED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GEMCITABINE</medicinalproduct>
        <drugauthorizationnumb>20509</drugauthorizationnumb>
        <drugdosagetext>1000 MG/M2</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060214</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CO-DYDRAMOL (DIHYDROCODEINE BITARTRATE, PARACETAMOL)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOCLOPRAMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEGACE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NOVORAPID /DEN/ (INSULIN ASPART)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048809-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060615</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP200605006044</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>59</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GEMZAR</medicinalproduct>
        <drugauthorizationnumb>20509</drugauthorizationnumb>
        <drugdosagetext>400 MG, OTHER, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PANCREATIC CARCINOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THERAPEUTIC RADIOPHARMACEUTICALS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048810-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>THQ2005A00466</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>78</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>NON-HODGKIN'S LYMPHOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LANSOPRAZOLE</medicinalproduct>
        <drugauthorizationnumb>20406</drugauthorizationnumb>
        <drugdosagetext>15 MG PER ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
        <drugdosagetext>18 MCG (18 MCG, 1 IN 1 D) INHALATION</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE TAB</medicinalproduct>
        <drugdosagetext>4 MG (3 IN 1 D) PER ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LACTULOSE (SOLUTION)</medicinalproduct>
        <drugdosagetext>(10 - 20 ML TWICE DAILY, 3.4 G/5 ML)</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
        <drugdosagetext>4 G (1 G, 4 IN 1 D) PER ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>QUININE SULFATE</medicinalproduct>
        <drugdosagetext>1 IN 1 D PER ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SALBUTAMOL</medicinalproduct>
        <drugdosagetext>5 MG/2.5 ML FOUR TIMES DAILY INHALATION</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SENNA ALEXANDRINA</medicinalproduct>
        <drugdosagetext>1 - 2 ONCE A NIGHT</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SERETIDE (FLUTICASONE PROPIONATE W/SALMETEROL)</medicinalproduct>
        <drugdosagetext>2 IN 1 D INHALATION</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AQUEOUS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048811-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060619</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE200604004079</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>54</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCYTOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARANEOPLASTIC SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYSTEMIC LUPUS ERYTHEMATOSUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GEMZAR</medicinalproduct>
        <drugauthorizationnumb>20509</drugauthorizationnumb>
        <drugdosagetext>1000 MG/M2, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PANCREATIC CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060214</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KREON (PANCREATIN)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048812-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060612</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP200606000466</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>75</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PANCREATITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GEMZAR</medicinalproduct>
        <drugauthorizationnumb>20509</drugauthorizationnumb>
        <drugdosagetext>800 MG, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PANCREATIC CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060220</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060520</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048813-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060619</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE200606000536</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ARRHYTHMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIO-RESPIRATORY ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIOPULMONARY FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CYTOMEGALOVIRUS INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTHYROIDISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA PRIMARY ATYPICAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GEMCITABINE HYDROCHLORIDE (GEMCITABINE HYDROCHLORIDE)</medicinalproduct>
        <drugauthorizationnumb>20509</drugauthorizationnumb>
        <drugdosagetext>1200 MG/M2, OTHER, INTRAVENOUS; SEE IMAGE</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VINORELBINE TARTRATE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048814-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>TCI2006A02286</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>77</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CHOLESTASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JAUNDICE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEUPROLIDE ACETATE</medicinalproduct>
        <drugauthorizationnumb>19010</drugauthorizationnumb>
        <drugdosagetext>1 IN 28 D SUBCUTANEOUS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PROSTATE CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060405</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060501</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHLORMADINONE ACETATE TAB</medicinalproduct>
        <drugdosagetext>100 MG (50 MG, 2 IN 1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROSTATE CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060403</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060523</drugenddate>
        <drugtreatmentduration>50</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALLOPURINOL TAB</medicinalproduct>
        <drugdosagetext>PER ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GOUT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060523</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>URIEF (SILODOSIN)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NITOROL R (TABLETS)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGNEISUM OXIDE (PREPARATION FOR ORAL USE (NOS))</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NICORANDIS (NICORANDIL) (TABLETS)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048815-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-AVENTIS-200616824GDDC</companynumb>
    <primarysource>
      <reportercountry>IRELAND</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>74</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ADENOCARCINOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROSTATE CANCER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INSULIN GLARGINE</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugdosagetext>DOSE UNIT: UNITS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050222</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OPTIPEN (INSULIN PUMP)</medicinalproduct>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CODE UNBROKEN</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugdosagetext>DOSE: UNKNOWN</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050222</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRAVASTATIN</medicinalproduct>
        <drugindication>DYSLIPIDAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RAMIPRIL</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BISOPROLOL FUMARATE</medicinalproduct>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040601</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048816-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FRWYE242705AUG03</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>31</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ARTERIOVENOUS FISTULA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ESCHERICHIA URINARY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMMUNOSUPPRESSANT DRUG LEVEL INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POLLAKIURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYELONEPHRITIS ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TACROLIMUS, CONTROL FOR SIROLIMUS (TACROLIMUS, CONTROL FOR SIROLIMUS, </medicinalproduct>
        <drugauthorizationnumb>50708</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS AGAINST TRANSPLANT REJECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030313</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030313</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TACROLIMUS, CONTROL FOR SIROLIMUS (TACROLIMUS, CONTROL FOR SIROLIMUS, </medicinalproduct>
        <drugauthorizationnumb>50708</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS AGAINST TRANSPLANT REJECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030314</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030701</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TACROLIMUS, CONTROL FOR SIROLIMUS (TACROLIMUS, CONTROL FOR SIROLIMUS, </medicinalproduct>
        <drugauthorizationnumb>50708</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS AGAINST TRANSPLANT REJECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030701</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TACROLIMUS, CONTROL FOR SIROLIMUS (TACROLIMUS, CONTROL FOR SIROLIMUS, </medicinalproduct>
        <drugauthorizationnumb>50708</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS AGAINST TRANSPLANT REJECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>APROVEL (IRBESARTAN, , 0)</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELLCEPT</medicinalproduct>
        <drugdosagetext>1.5 G 1 X PER 1 DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS AGAINST TRANSPLANT REJECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030313</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CORTANCYL (PREDNISONE, , 0)</medicinalproduct>
        <drugdosagetext>10 MG 1X PER 1 DAY ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS AGAINST TRANSPLANT REJECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030629</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CHLORMADINONE ACETATE TAB</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048817-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060626</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>HQWYE388926JUN06</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>67</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PANTOPRAZOLE SODIUM</medicinalproduct>
        <drugauthorizationnumb>20987</drugauthorizationnumb>
        <drugdosagetext>^4 TIME (S) 1 DF^ ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>REFLUX OESOPHAGITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYANOCOBALAMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FERROUS GLUCONATE (FERROUS GLUCONATE)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048818-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060623</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ATWYE775125JUN06</companynumb>
    <primarysource>
      <reportercountry>AUSTRIA</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>60</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIAC ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EFECTIN (VENLAFAXINE HYDROCHLORIDE, TABLET, 0)</medicinalproduct>
        <drugauthorizationnumb>20151</drugauthorizationnumb>
        <drugdosagetext>50 MG 2X PER 1 DAY</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAZODONE HCL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048819-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060626</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DEWYE800826JUN06</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>67</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DELIRIUM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISORIENTATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISTURBANCE IN ATTENTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEMORY IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESTLESSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SLEEP DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPEECH DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THINKING ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VENLAFAXINE HCL</medicinalproduct>
        <drugauthorizationnumb>20699</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050715</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050715</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VENLAFAXINE HCL</medicinalproduct>
        <drugauthorizationnumb>20699</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050716</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050802</drugenddate>
        <drugtreatmentduration>18</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VENLAFAXINE HCL</medicinalproduct>
        <drugauthorizationnumb>20699</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050803</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050803</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AKINETON</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050816</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050818</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARICEPT</medicinalproduct>
        <drugdosagetext>5 MG</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050816</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050823</drugenddate>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CIPRALEX (ESCITALOPRAM, , 0)</medicinalproduct>
        <drugdosagetext>5 MG</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050805</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050808</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HYPNOREX (LITHIUM CARBONATE, , 0)</medicinalproduct>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19940101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050731</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HYPNOREX (LITHIUM CARBONATE, , 0)</medicinalproduct>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050806</drugenddate>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HYPNOREX (LITHIUM CARBONATE, , 0)</medicinalproduct>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050807</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050807</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HYPNOREX (LITHIUM CARBONATE, , 0)</medicinalproduct>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050808</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050808</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050708</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050720</drugenddate>
        <drugtreatmentduration>13</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050721</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050731</drugenddate>
        <drugtreatmentduration>11</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050801</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050802</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050802</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050803</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050804</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050805</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050807</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050808</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050808</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050816</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050821</drugenddate>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050822</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRESOMEN (ESTROGENS CONJUGATED)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IODIDE (IODIDE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORAZEPAM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048820-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>TCI2006A02571</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>74</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DISSEMINATED INTRAVASCULAR COAGULATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OCULOMUCOCUTANEOUS SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</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>ULCER HAEMORRHAGE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060603</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060616</drugenddate>
        <drugtreatmentduration>13</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SELBEX (TEPRENONE) (PREPARATION FOR ORAL USE (NOS))</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ULCERLMIN (SUCRALFATE) (PREPARATION FOR ORAL USE (NOS))</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARFARIN (WARFARIN POTASSIUM) (TABLETS)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LENDORMIN (BROTIZOLAM) (TABLETS)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GENTACIN (GENTAMICIN SULFATE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MUCODYNE (CARBOCISTEINE) (PREPARATION FOR ORAL USE (NOS))</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BIOFERMIN (BIOFERMIN) (PREPARATION FOR ORAL USE (NOS))</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANIRAPID (METILDIGOXIN) (TABLETS)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048821-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060627</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FRWYE832827JUN06</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>42</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ALANINE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASPARTATE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD ALKALINE PHOSPHATASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CHOLESTEROL INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD TRIGLYCERIDES INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAMMA-GLUTAMYLTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATOMEGALY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCREATITIS ACUTE</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>
        <drugindication>BIPOLAR I DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060301</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRAZEPAM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048822-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>HQWYE488829JUN06</companynumb>
    <primarysource>
      <reportercountry>SWEDEN</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>77</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DYSURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CORDARONE</medicinalproduct>
        <drugauthorizationnumb>18972</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>TACHYARRHYTHMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040901</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CORDARONE</medicinalproduct>
        <drugauthorizationnumb>18972</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>TACHYARRHYTHMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060301</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XALATAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TIMOSINE (TIMOLOL MALEATE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOPICLONE (ZOPICLONE)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048823-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060704</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>HQWY284810JAN06</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>3</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HAEMOPTYSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHILDREN'S ADVIL</medicinalproduct>
        <drugauthorizationnumb>20589</drugauthorizationnumb>
        <drugdosagetext>ONE DOSE FOR 20 KG ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PYREXIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060107</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060107</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048824-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060623</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2006NO09520</companynumb>
    <primarysource>
      <reportercountry>NORWAY</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>85</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROCEDURAL COMPLICATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VISUDYNE</medicinalproduct>
        <drugauthorizationnumb>21119</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048834-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060626</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>213108</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>47</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERNATIONAL NORMALISED RATIO INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG CONSOLIDATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MABTHERA             (RITUXIMAB)</medicinalproduct>
        <drugdosagetext>375 AUG/M2, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>LYMPHOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041125</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041125</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUCONAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACYCLOVIR SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SULFAMETHOXAZOLE + TRIMETHOPRIM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048837-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060704</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BE-JNJFOC-20060700591</companynumb>
    <primarysource>
      <reportercountry>BELGIUM</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>PUSTULAR PSORIASIS</reactionmeddrapt>
      </reaction>
      <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>5048838-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060626</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>104266</companynumb>
    <primarysource>
      <reportercountry>SPAIN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>66</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>HEPATIC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATITIS ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATITIS CHOLESTATIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATITIS TOXIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSEUDOMONAL SEPSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MABTHERA (RITUXIMAB)</medicinalproduct>
        <drugdosagetext>375 MG/M2, SINGLE, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>B-CELL LYMPHOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020205</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020205</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORAZEPAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CITALOPRAM HYDROBROMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ETOPOSIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYTARABINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MELPHALAN (MELPHALAN)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048839-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060620</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>225723</companynumb>
    <primarysource>
      <reportercountry>SOUTH AFRICA</reportercountry>
      <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>ACUTE MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY DISEASE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MABTHERA                  (RITUXIMAB)       CONC FOR SOLUTION FOR INFU</medicinalproduct>
        <drugindication>B-CELL LYMPHOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010222</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010608</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOPHOSPHAMIDE</medicinalproduct>
        <drugindication>B-CELL LYMPHOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010222</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010608</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOXORUBICIN HCL</medicinalproduct>
        <drugindication>B-CELL LYMPHOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010222</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010608</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VINCRISTINE</medicinalproduct>
        <drugindication>B-CELL LYMPHOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010222</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010608</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISONE TAB</medicinalproduct>
        <drugindication>B-CELL LYMPHOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010222</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010608</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048840-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060622</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>226846</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RITUXAN</medicinalproduct>
        <drugdosagetext>INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>LYMPHOMA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048841-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060705</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FI-AVENTIS-200617056GDDC</companynumb>
    <primarysource>
      <reportercountry>FINLAND</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>65</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CYSTITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISORIENTATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVERDOSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOCETAXEL</medicinalproduct>
        <drugauthorizationnumb>20449</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060412</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060531</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FENTANYL TRANSDERMAL SYSTEM</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050809</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCODONE HYDROCHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIAZEPAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANTOPRAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LACTULOSE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLODRONATE DISODIUM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048842-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060705</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-AVENTIS-200612410FR</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>BRADYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERKALAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAXOTERE</medicinalproduct>
        <drugauthorizationnumb>020449</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PROSTATE CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060621</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060621</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048843-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-AVENTIS-200612003JP</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>MESENTERIC ARTERY THROMBOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAXOTERE</medicinalproduct>
        <drugauthorizationnumb>20449</drugauthorizationnumb>
        <drugadministrationroute>041</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CISPLATIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048844-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A-CH2006-12087</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>5</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>15</patientweight>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>HYPERTRICHOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYCOBACTERIUM AVIUM COMPLEX INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZAVESCA</medicinalproduct>
        <drugauthorizationnumb>21348</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INTERFERON GAMMA RECEPTOR DEFICIENCY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZAVESCA</medicinalproduct>
        <drugauthorizationnumb>21348</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INTERFERON GAMMA RECEPTOR DEFICIENCY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZAVESCA</medicinalproduct>
        <drugauthorizationnumb>21348</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INTERFERON GAMMA RECEPTOR DEFICIENCY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060527</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048845-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060620</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A-US2006-12524</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>35</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>97</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ACUTE PULMONARY OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RIGHT VENTRICULAR FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRACLEER</medicinalproduct>
        <drugauthorizationnumb>21290</drugauthorizationnumb>
        <drugdosagetext>62.5 MG, BID, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060513</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060616</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048846-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060623</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A-JP2006-12366</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>39</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>52</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ALANINE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASPARTATE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CATHETER RELATED INFECTION</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>TRACLEER</medicinalproduct>
        <drugauthorizationnumb>21290</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051125</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051208</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>20051209</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051219</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>20051220</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060104</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>20060105</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060201</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>20060202</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060216</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>20060217</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060405</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>20060406</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060510</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>20060511</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060518</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVOFLOXACIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EPOPROSTENOL SODIUM                         (EPOPROSTENOL SODIUM)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYGEN                                                (OXYGEN)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CHINESE HERB</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048847-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060704</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006AP03041</companynumb>
    <primarysource>
      <reportercountry>KOREA, REPUBLIC OF</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>21686</patientonsetage>
      <patientonsetageunit>804</patientonsetageunit>
      <patientweight>42.9</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HAEMOPTYSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IRESSA</medicinalproduct>
        <drugauthorizationnumb>021399</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060328</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060426</drugenddate>
        <drugtreatmentduration>30</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GEMZAR</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060116</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060116</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GEMZAR</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060307</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060307</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHYLON</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040504</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THEOLAN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040804</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRITACE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040826</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MADIPINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041230</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048848-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2006BE09625</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>AGEUSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEORAL</medicinalproduct>
        <drugauthorizationnumb>050737</drugauthorizationnumb>
        <drugdosagetext>5 MG/KG, QD</drugdosagetext>
        <drugindication>PSORIASIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048850-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2006HR09738</companynumb>
    <primarysource>
      <reportercountry>CROATIA (local name: Hrvatska)</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>30</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTERIOSCLEROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BILE DUCT OBSTRUCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BILIARY ANASTOMOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BILIARY DILATATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLINDNESS UNILATERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD ALKALINE PHOSPHATASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CHOLESTEROL INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CREATININE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD TRIGLYCERIDES INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD URIC ACID INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>C-REACTIVE PROTEIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHILLS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHOLANGITIS CHRONIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHOLECYSTECTOMY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHOLECYSTITIS CHRONIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHOLEDOCHOLITHOTOMY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHOLELITHIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATOCRIT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RED BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RED BLOOD CELL SEDIMENTATION RATE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RETICULOCYTE COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RETINAL VEIN THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOSPORINE</medicinalproduct>
        <drugauthorizationnumb>50574</drugauthorizationnumb>
        <drugdosagetext>100 MG, BID</drugdosagetext>
        <drugindication>RENAL TRANSPLANT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISONE (NGX)</medicinalproduct>
        <drugindication>RENAL TRANSPLANT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AZATHIOPRINE</medicinalproduct>
        <drugindication>RENAL TRANSPLANT</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048851-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060630</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PK-AVENTIS-200616955GDDC</companynumb>
    <primarysource>
      <reportercountry>PAKISTAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>85</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CHILLS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLD SWEAT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CYANOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OXYGEN SATURATION DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METRONIDAZOLE</medicinalproduct>
        <drugbatchnumb>0809</drugbatchnumb>
        <drugauthorizationnumb>020743</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ENTERITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060629</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060629</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048852-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20021212</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0389044A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>55</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMITREX</medicinalproduct>
        <drugauthorizationnumb>20132</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MIGRAINE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMITREX</medicinalproduct>
        <drugauthorizationnumb>020080</drugauthorizationnumb>
        <drugadministrationroute>058</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMITREX</medicinalproduct>
        <drugauthorizationnumb>020626</drugauthorizationnumb>
        <drugadministrationroute>045</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040918</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048853-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060630</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AVENTIS-200615618US</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>73</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL DISTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASCITES</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KETEK</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021144</drugauthorizationnumb>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
        <drugindication>PNEUMONIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LITHIUM CARBONATE</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EFFEXOR</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONAZEPAM</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048854-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040331</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0505399A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>75</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STOMACH DISCOMFORT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMITREX</medicinalproduct>
        <drugauthorizationnumb>20132</drugauthorizationnumb>
        <drugdosagetext>25MG AS REQUIRED</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MIGRAINE</drugindication>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZESTRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAMOXIFEN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048855-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060615</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AVENTIS-200615297US</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STAPHYLOCOCCAL INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KETEK</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>21144</drugauthorizationnumb>
        <drugindication>BRONCHIECTASIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARDIZEM</medicinalproduct>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048856-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040510</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0510326A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ADVERSE EVENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMITREX</medicinalproduct>
        <drugbatchnumb>5ZP1182A,R160896</drugbatchnumb>
        <drugauthorizationnumb>20132</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MIGRAINE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048857-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060413</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-13346200</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>58</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NO ADVERSE EFFECT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VEPESID</medicinalproduct>
        <drugauthorizationnumb>19557</drugauthorizationnumb>
        <drugtreatmentduration>10</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MORPHINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HALDOL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048858-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040602</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0513046A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>52</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMITREX</medicinalproduct>
        <drugauthorizationnumb>20132</drugauthorizationnumb>
        <drugdosagetext>25MG AS REQUIRED</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MIGRAINE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030920</drugenddate>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMITREX</medicinalproduct>
        <drugauthorizationnumb>020080</drugauthorizationnumb>
        <drugdosagetext>25MG AS REQUIRED</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020522</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020522</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NO CONCURRENT MEDICATION</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048859-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060630</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-BRISTOL-MYERS SQUIBB COMPANY-13431739</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>3</qualification>
    </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>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE CONTRACTIONS INVOLUNTARY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LITALIR</medicinalproduct>
        <drugauthorizationnumb>16295</drugauthorizationnumb>
        <drugindication>GLIOBLASTOMA</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060501</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GLEEVEC</medicinalproduct>
        <drugindication>GLIOBLASTOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060501</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE TAB</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060317</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANTOPRAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LAMOTRIGINE</medicinalproduct>
        <drugindication>CONVULSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KEPPRA</medicinalproduct>
        <drugindication>CONVULSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KALINOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048860-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050101</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0550848A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>40</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>79.1</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLITIS ISCHAEMIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATOCHEZIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMITREX</medicinalproduct>
        <drugauthorizationnumb>20132</drugauthorizationnumb>
        <drugdosagetext>100MG AS REQUIRED</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MIGRAINE</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050101</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SERZONE</medicinalproduct>
        <drugdosagetext>200MG PER DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WELLBUTRIN XL</medicinalproduct>
        <drugdosagetext>300MG PER DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORTRIPTYLINE HCL</medicinalproduct>
        <drugdosagetext>100MG AT NIGHT</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZETIA</medicinalproduct>
        <drugdosagetext>10MG PER DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugdosagetext>1000MG PER DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN B COMPLEX CAP</medicinalproduct>
        <drugdosagetext>1TAB PER DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROTONIX</medicinalproduct>
        <drugdosagetext>40MG PER DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EXCEDRIN (MIGRAINE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAMADOL HCL</medicinalproduct>
        <drugdosagetext>50MG AS REQUIRED</drugdosagetext>
        <drugindication>HEADACHE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM GLUCONATE</medicinalproduct>
        <drugdosagetext>600MG PER DAY</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048862-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060630</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-BRISTOL-MYERS SQUIBB COMPANY-13429915</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>28</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABORTION SPONTANEOUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PREGNANCY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ABILIFY</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048863-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050325</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0551283A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>19</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COORDINATION ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISABILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMITREX</medicinalproduct>
        <drugauthorizationnumb>20132</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MIGRAINE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048864-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050601</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0560744A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>40</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN DISCOLOURATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMITREX</medicinalproduct>
        <drugauthorizationnumb>020132</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MIGRAINE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MESOTHERAPY</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048865-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050603</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0561127A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMITREX</medicinalproduct>
        <drugauthorizationnumb>020132</drugauthorizationnumb>
        <drugdosagetext>100MG AS REQUIRED</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MIGRAINE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048866-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050602</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0561132A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>48</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMITREX</medicinalproduct>
        <drugauthorizationnumb>020132</drugauthorizationnumb>
        <drugdosagetext>100MG AS REQUIRED</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MIGRAINE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050602</drugstartdate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NO CONCURRENT MEDICATION</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048867-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050601</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0561165A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DYSPHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEDICATION RESIDUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMITREX</medicinalproduct>
        <drugauthorizationnumb>020132</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MIGRAINE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048868-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050606</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0561410A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ORTHOSTATIC HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMITREX</medicinalproduct>
        <drugauthorizationnumb>020132</drugauthorizationnumb>
        <drugdosagetext>100MG AS REQUIRED</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MIGRAINE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050501</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NO CONCURRENT MEDICATION</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048869-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050607</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0561872A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>48</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CEREBELLAR INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBRAL ISCHAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMITREX</medicinalproduct>
        <drugauthorizationnumb>020132</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MIGRAINE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048870-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050610</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0562098A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>30</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMITREX</medicinalproduct>
        <drugauthorizationnumb>020132</drugauthorizationnumb>
        <drugdosagetext>50MG AS REQUIRED</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MIGRAINE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050609</drugstartdate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NO CONCURRENT MEDICATION</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048871-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050613</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0562393A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>35</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MIGRAINE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMITREX</medicinalproduct>
        <drugauthorizationnumb>020132</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MIGRAINE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOTENSIN</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048872-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050613</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0562397A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>54</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEAFNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMITREX</medicinalproduct>
        <drugauthorizationnumb>020132</drugauthorizationnumb>
        <drugdosagetext>25MG AS REQUIRED</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MIGRAINE</drugindication>
        <drugtreatmentduration>11</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VANQUISH</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KLONOPIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WELLBUTRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INDERAL LA</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048873-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050613</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0562432A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>28</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMITREX</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020132</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MIGRAINE</drugindication>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NO CONCURRENT MEDICATION</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048874-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050614</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0562700A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMITREX</medicinalproduct>
        <drugauthorizationnumb>020132</drugauthorizationnumb>
        <drugdosagetext>100MG AS REQUIRED</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEADACHE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048875-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050616</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0562993A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>90.9</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CHEST DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL STIFFNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROAT IRRITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROAT TIGHTNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMITREX</medicinalproduct>
        <drugbatchnumb>3ZP1107,3ZP2525A</drugbatchnumb>
        <drugauthorizationnumb>020132</drugauthorizationnumb>
        <drugdosagetext>50MG AS REQUIRED</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MIGRAINE</drugindication>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BIRTH CONTROL PILL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048876-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050616</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0563010A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>30</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FACE OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWELLING FACE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMITREX</medicinalproduct>
        <drugauthorizationnumb>020132</drugauthorizationnumb>
        <drugdosagetext>50MG VARIABLE DOSE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MIGRAINE</drugindication>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048877-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050616</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0563013A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>41</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMITREX</medicinalproduct>
        <drugauthorizationnumb>020132</drugauthorizationnumb>
        <drugdosagetext>50MG AS REQUIRED</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MIGRAINE</drugindication>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NO CONCURRENT MEDICATION</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048878-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050620</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0563383A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>58</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>62.7</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMITREX</medicinalproduct>
        <drugauthorizationnumb>020132</drugauthorizationnumb>
        <drugdosagetext>100MG AS REQUIRED</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MIGRAINE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19950101</drugstartdate>
        <drugtreatmentduration>10</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NO CONCURRENT MEDICATION</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048879-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050620</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0563408A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>26</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NECK PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMITREX</medicinalproduct>
        <drugauthorizationnumb>020132</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MIGRAINE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050615</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BIRTH CONTROL PILLS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048880-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050621</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0563613A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>42</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>SENSATION OF HEAVINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SENSATION OF PRESSURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMITREX</medicinalproduct>
        <drugauthorizationnumb>020132</drugauthorizationnumb>
        <drugdosagetext>100MG AS REQUIRED</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MIGRAINE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050621</drugstartdate>
        <drugtreatmentduration>20</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048881-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050622</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0563795A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>35</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PAIN OF SKIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMITREX</medicinalproduct>
        <drugbatchnumb>4ZP2801A</drugbatchnumb>
        <drugauthorizationnumb>020132</drugauthorizationnumb>
        <drugdosagetext>100MG AS REQUIRED</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MIGRAINE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050320</drugstartdate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WELLBUTRIN XL</medicinalproduct>
        <drugdosagetext>300MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048882-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050621</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0563952A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMITREX</medicinalproduct>
        <drugauthorizationnumb>020132</drugauthorizationnumb>
        <drugdosagetext>100MG AS REQUIRED</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MIGRAINE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IRON</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048883-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050627</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0564304A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>59</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMITREX</medicinalproduct>
        <drugbatchnumb>4ZP8284A</drugbatchnumb>
        <drugauthorizationnumb>020132</drugauthorizationnumb>
        <drugdosagetext>25MG AS REQUIRED</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MIGRAINE</drugindication>
        <drugtreatmentduration>15</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN MEDICATION</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPROL-XL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048884-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050628</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0564512A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>41</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>SENSATION OF HEAVINESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMITREX</medicinalproduct>
        <drugauthorizationnumb>020132</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MIGRAINE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050628</drugstartdate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ORTHO-NOVUM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048885-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050706</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0565192A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG TOLERANCE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMITREX</medicinalproduct>
        <drugauthorizationnumb>020132</drugauthorizationnumb>
        <drugdosagetext>50MG UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MIGRAINE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMITREX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048886-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050706</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0565193A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>60</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CHEST DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE TIGHTNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMITREX</medicinalproduct>
        <drugauthorizationnumb>020132</drugauthorizationnumb>
        <drugdosagetext>50MG AS REQUIRED</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MIGRAINE</drugindication>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANOXIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048887-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050711</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0565739A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>34</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMITREX</medicinalproduct>
        <drugbatchnumb>4ZP2804A</drugbatchnumb>
        <drugauthorizationnumb>020132</drugauthorizationnumb>
        <drugdosagetext>100MG VARIABLE DOSE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MIGRAINE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990101</drugstartdate>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALAN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048888-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050711</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0565754A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMITREX</medicinalproduct>
        <drugauthorizationnumb>020132</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MIGRAINE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048889-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050713</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0565993A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>42</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DYSPHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROAT TIGHTNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMITREX</medicinalproduct>
        <drugauthorizationnumb>020132</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048890-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050715</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0566471A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BACTERIAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMITREX</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020132</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MIGRAINE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMITREX</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020080</drugauthorizationnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugtreatmentduration>15</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNSPECIFIED MEDICATIONS</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048891-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050720</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0567042A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>68</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLINDNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMITREX</medicinalproduct>
        <drugauthorizationnumb>020132</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MIGRAINE</drugindication>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048892-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050721</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0567234A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMITREX</medicinalproduct>
        <drugauthorizationnumb>020132</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CLUSTER HEADACHE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048893-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050722</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0567404A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMITREX</medicinalproduct>
        <drugauthorizationnumb>020132</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048894-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050725</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0567632A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STOMACH DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THERAPEUTIC RESPONSE DELAYED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMITREX</medicinalproduct>
        <drugauthorizationnumb>020132</drugauthorizationnumb>
        <drugdosagetext>100MG AS REQUIRED</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MIGRAINE</drugindication>
        <drugtreatmentduration>10</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048895-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050725</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0567637A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMITREX</medicinalproduct>
        <drugauthorizationnumb>020132</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MIGRAINE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048896-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050725</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0567792A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>57</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMITREX</medicinalproduct>
        <drugbatchnumb>4ZP0941A</drugbatchnumb>
        <drugauthorizationnumb>020132</drugauthorizationnumb>
        <drugdosagetext>25MG FOUR TIMES PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MIGRAINE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040801</drugstartdate>
        <drugtreatmentduration>11</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADVIL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048898-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050728</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0568131A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>52</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG ADMINISTRATION ERROR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING DRUNK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEAD DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NIGHTMARE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMITREX</medicinalproduct>
        <drugbatchnumb>4ZP8355A</drugbatchnumb>
        <drugauthorizationnumb>020132</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MIGRAINE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMITREX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONAZEPAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORAZEPAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMBIEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUOXETINE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCODONE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PAIN MEDICATION</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048899-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050729</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0568289A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>16</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>80</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VASODILATATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMITREX</medicinalproduct>
        <drugauthorizationnumb>020132</drugauthorizationnumb>
        <drugdosagetext>25MG AS REQUIRED</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MIGRAINE</drugindication>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLEGRA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048900-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050801</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0568446A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>28</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMITREX</medicinalproduct>
        <drugbatchnumb>5ZP5711A</drugbatchnumb>
        <drugauthorizationnumb>020132</drugauthorizationnumb>
        <drugdosagetext>25MG EIGHT TIMES PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050725</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NO CONCURRENT MEDICATION</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048901-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050801</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0568473A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>17</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>JOINT SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMITREX</medicinalproduct>
        <drugauthorizationnumb>020132</drugauthorizationnumb>
        <drugdosagetext>25MG AS REQUIRED</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MIGRAINE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050605</drugstartdate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NO CONCURRENT MEDICATION</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048902-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050801</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0568481A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEDICATION RESIDUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MIGRAINE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMITREX</medicinalproduct>
        <drugauthorizationnumb>020132</drugauthorizationnumb>
        <drugdosagetext>50MG AS REQUIRED</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MIGRAINE</drugindication>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048903-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050803</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0568820A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>27</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>68.2</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CHEST DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMITREX</medicinalproduct>
        <drugauthorizationnumb>020132</drugauthorizationnumb>
        <drugdosagetext>100MG SINGLE DOSE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MIGRAINE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050701</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NO CONCURRENT MEDICATIONS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048904-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050802</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0568848A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>57</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PAIN IN JAW</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMITREX</medicinalproduct>
        <drugauthorizationnumb>020132</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048905-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050802</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0568886A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CHILLS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMITREX</medicinalproduct>
        <drugauthorizationnumb>020132</drugauthorizationnumb>
        <drugdosagetext>50MG AS REQUIRED</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MIGRAINE</drugindication>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048906-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050804</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0568958A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>17</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RETCHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMITREX</medicinalproduct>
        <drugauthorizationnumb>020132</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MIGRAINE</drugindication>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048907-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050804</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0568983A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMITREX</medicinalproduct>
        <drugauthorizationnumb>020132</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MIGRAINE</drugindication>
        <drugtreatmentduration>10</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NO CONCURRENT MEDICATION</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048908-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050804</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0568985A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN JAW</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMITREX</medicinalproduct>
        <drugauthorizationnumb>020132</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MIGRAINE</drugindication>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048909-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050804</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0568991A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>54</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMITREX</medicinalproduct>
        <drugbatchnumb>5ZP7561A</drugbatchnumb>
        <drugauthorizationnumb>020132</drugauthorizationnumb>
        <drugdosagetext>50MG AS REQUIRED</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MIGRAINE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048910-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050805</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0569118A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>44</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THERAPEUTIC RESPONSE DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMITREX</medicinalproduct>
        <drugauthorizationnumb>020132</drugauthorizationnumb>
        <drugdosagetext>100MG AS REQUIRED</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MIGRAINE</drugindication>
        <drugtreatmentduration>18</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WELLBUTRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCODONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLEGRA</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048911-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050809</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0569510A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROOESOPHAGEAL REFLUX DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMITREX</medicinalproduct>
        <drugauthorizationnumb>020132</drugauthorizationnumb>
        <drugdosagetext>50MG AS REQUIRED</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MIGRAINE</drugindication>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048912-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050809</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0569533A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>EUPHORIC MOOD</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMITREX</medicinalproduct>
        <drugauthorizationnumb>020132</drugauthorizationnumb>
        <drugdosagetext>50MG AS REQUIRED</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MIGRAINE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ULTRACET</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048913-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050810</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0569684A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DYSPEPSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMITREX</medicinalproduct>
        <drugauthorizationnumb>020132</drugauthorizationnumb>
        <drugdosagetext>100MG AS REQUIRED</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MIGRAINE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19960101</drugstartdate>
        <drugtreatmentduration>9</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMINS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>B-12</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PHENERGAN HCL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048914-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050811</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0569847A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMITREX</medicinalproduct>
        <drugbatchnumb>5ZP3370A</drugbatchnumb>
        <drugauthorizationnumb>020132</drugauthorizationnumb>
        <drugdosagetext>50MG AS REQUIRED</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MIGRAINE</drugindication>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NO CONCURRENT MEDICATION</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048915-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050809</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0570142A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>50</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMITREX</medicinalproduct>
        <drugauthorizationnumb>020132</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMITREX</medicinalproduct>
        <drugauthorizationnumb>020626</drugauthorizationnumb>
        <drugadministrationroute>045</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048916-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050815</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0570264A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>76</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SENSATION OF FOREIGN BODY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMITREX</medicinalproduct>
        <drugauthorizationnumb>020132</drugauthorizationnumb>
        <drugdosagetext>100MG AS REQUIRED</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MIGRAINE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19960101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THYROID TAB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FIORICET</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048917-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050816</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0570444A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>32</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMITREX</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020132</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MIGRAINE</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>NO CONCURRENT MEDICATION</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048918-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050816</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0570459A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRANCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMITREX</medicinalproduct>
        <drugauthorizationnumb>020132</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048919-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050819</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0570937A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>25</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEAFNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMITREX</medicinalproduct>
        <drugauthorizationnumb>20132</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MIGRAINE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NO CONCURRENT MEDICATION</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048920-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050819</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0570938A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>TEMPERATURE INTOLERANCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMITREX</medicinalproduct>
        <drugauthorizationnumb>020132</drugauthorizationnumb>
        <drugdosagetext>100MG AS REQUIRED</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MIGRAINE</drugindication>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPAMAX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048921-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050819</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0570939A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>TEMPERATURE INTOLERANCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMITREX</medicinalproduct>
        <drugauthorizationnumb>020132</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MIGRAINE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048922-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050819</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0570968A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>58</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMITREX</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020132</drugauthorizationnumb>
        <drugdosagetext>100MG AS REQUIRED</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MIGRAINE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYLENOL (CAPLET)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADVIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACIPHEX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RANITIDINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VYTORIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCODONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MYLANTA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COQ10</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYLENOL (CAPLET)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMITREX</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CAFFEINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048923-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050819</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0571069A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMITREX</medicinalproduct>
        <drugauthorizationnumb>020132</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MIGRAINE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048925-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050822</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0571359A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>MIGRAINE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHONOPHOBIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHOTOPHOBIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMITREX</medicinalproduct>
        <drugauthorizationnumb>020132</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MIGRAINE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048926-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050823</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0571432A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>44</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMITREX</medicinalproduct>
        <drugauthorizationnumb>020132</drugauthorizationnumb>
        <drugdosagetext>50MG AS REQUIRED</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MIGRAINE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ORAL CONTRACEPTIVE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMITREX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048927-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050824</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0571676A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMITREX</medicinalproduct>
        <drugauthorizationnumb>020132</drugauthorizationnumb>
        <drugdosagetext>100MG UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>MIGRAINE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050824</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRASICOR</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048928-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050825</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0571855A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMITREX</medicinalproduct>
        <drugauthorizationnumb>020132</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>MIGRAINE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048929-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050825</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0571857A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMITREX</medicinalproduct>
        <drugauthorizationnumb>020132</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMITREX</medicinalproduct>
        <drugauthorizationnumb>020080</drugauthorizationnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NO CONCURRENT MEDICATION</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048930-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050825</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0571863A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>60</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMITREX</medicinalproduct>
        <drugbatchnumb>4ZP8284A,B131648</drugbatchnumb>
        <drugauthorizationnumb>020132</drugauthorizationnumb>
        <drugdosagetext>25MG AS REQUIRED</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MIGRAINE</drugindication>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORTRIPTYLINE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALPROIC ACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048931-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050825</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0571877A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CONTUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MIGRAINE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMITREX</medicinalproduct>
        <drugauthorizationnumb>020132</drugauthorizationnumb>
        <drugdosagetext>100MG AS REQUIRED</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MIGRAINE</drugindication>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MERIDIA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048932-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050824</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0571932A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG SCREEN POSITIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMITREX</medicinalproduct>
        <drugauthorizationnumb>020132</drugauthorizationnumb>
        <drugdosagetext>100MG AS REQUIRED</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MIGRAINE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050809</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMITRIPTYLINE HCL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040707</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BUTALBITAL, ACETAMINOPHEN, CAFFEINE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040709</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROMETHAZINE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040709</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AXERT</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040709</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHYLPREDNISOLONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041014</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INDOMETHACIN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041014</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCODONE BITARTRATE + ACETAMINOPHEN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041027</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BEXTRA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041027</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROPOXYPHENE HCL AND ACETAMINOPHEN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041102</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYCLOBENZAPRINE HCL</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041202</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROFEN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041224</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENZONATATE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041224</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050112</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CIPROFLOXACIN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050112</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GABAPENTIN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050125</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DURAGESIC-100</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050125</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FENTANYL TRANSDERMAL SYSTEM</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050203</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ULTRACET</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041202</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048933-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050829</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0572219A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>32</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMITREX</medicinalproduct>
        <drugauthorizationnumb>020132</drugauthorizationnumb>
        <drugdosagetext>100MCG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MIGRAINE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050829</drugstartdate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NO CONCURRENT MEDICATION</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048934-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050901</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0572738A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>21</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DYSARTHRIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EUPHORIC MOOD</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCOHERENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMITREX</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020132</drugauthorizationnumb>
        <drugdosagetext>50MG AS REQUIRED</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MIGRAINE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREVACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACIPHEX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048935-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050902</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0572888A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>61</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>102.3</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULAR WEAKNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SENSATION OF HEAVINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISION BLURRED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMITREX</medicinalproduct>
        <drugauthorizationnumb>020132</drugauthorizationnumb>
        <drugdosagetext>100MG AS REQUIRED</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MIGRAINE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALAN</medicinalproduct>
        <drugdosagetext>240MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>K-DUR 10</medicinalproduct>
        <drugdosagetext>20MEQ ALTERNATE DAYS</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugdosagetext>40MG ALTERNATE DAYS</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
        <drugdosagetext>.625MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MENOPAUSE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugdosagetext>200MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
        <drugdosagetext>12.5MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugdosagetext>40MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048936-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050901</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0572924A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMITREX</medicinalproduct>
        <drugauthorizationnumb>020132</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048937-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050906</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0573124A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>32</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MIGRAINE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWELLING FACE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMITREX</medicinalproduct>
        <drugauthorizationnumb>020132</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MIGRAINE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050903</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050903</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NO CONCURRENT MEDICATION</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048938-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050907</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0573330A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>74</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STOMACH DISCOMFORT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMITREX</medicinalproduct>
        <drugbatchnumb>5ZP2820A</drugbatchnumb>
        <drugauthorizationnumb>020132</drugauthorizationnumb>
        <drugdosagetext>25MG AS REQUIRED</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MIGRAINE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048939-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050908</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0573499A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>26</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ALCOHOL INTOLERANCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMITREX</medicinalproduct>
        <drugauthorizationnumb>020132</drugauthorizationnumb>
        <drugdosagetext>50MG AS REQUIRED</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MIGRAINE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ELAVIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMBIEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KLONOPIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BIRTH CONTROL PILL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROZAC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EFFEXOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTABUSE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048940-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050913</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0574044A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>46</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JOINT STIFFNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RAYNAUD'S PHENOMENON</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMITREX</medicinalproduct>
        <drugauthorizationnumb>020132</drugauthorizationnumb>
        <drugdosagetext>50MG AS REQUIRED</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MIGRAINE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19950101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACIPHEX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMINS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048941-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050914</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0574236A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>OFF LABEL USE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THERAPEUTIC RESPONSE DELAYED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMITREX</medicinalproduct>
        <drugauthorizationnumb>020132</drugauthorizationnumb>
        <drugdosagetext>100MG AS REQUIRED</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHERGINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048943-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050915</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0574423A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>41</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMITREX</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020132</drugauthorizationnumb>
        <drugdosagetext>25MG VARIABLE DOSE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MIGRAINE</drugindication>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SULFATRIM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASCORBIC ACID</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048944-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050916</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0574498A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMITREX</medicinalproduct>
        <drugauthorizationnumb>020132</drugauthorizationnumb>
        <drugdosagetext>25MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MIGRAINE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040923</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048945-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050916</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0574561A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARYNGOLARYNGEAL PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMITREX</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020132</drugauthorizationnumb>
        <drugdosagetext>100MG AS REQUIRED</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MIGRAINE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048946-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050916</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0574562A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANAPHYLACTIC REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARYNGEAL OEDEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMITREX</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020132</drugauthorizationnumb>
        <drugdosagetext>100MG AS REQUIRED</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MIGRAINE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048947-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050919</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0574822A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>66</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DYSPEPSIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMITREX</medicinalproduct>
        <drugbatchnumb>5ZP6233A</drugbatchnumb>
        <drugauthorizationnumb>020132</drugauthorizationnumb>
        <drugdosagetext>50MG AS REQUIRED</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MIGRAINE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050801</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048948-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050921</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0575212A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>34</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMITREX</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020132</drugauthorizationnumb>
        <drugdosagetext>50MG AS REQUIRED</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MIGRAINE</drugindication>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRILOSEC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAZODONE HCL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048949-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050921</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0575213A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>48</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLATULENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMITREX</medicinalproduct>
        <drugbatchnumb>5ZP6237A</drugbatchnumb>
        <drugauthorizationnumb>020132</drugauthorizationnumb>
        <drugdosagetext>100MG THREE TIMES PER WEEK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MIGRAINE</drugindication>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NASONEX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZYRTEC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RELPAX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048950-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050921</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0575218A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>56</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CHEST DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMITREX</medicinalproduct>
        <drugbatchnumb>NOT AVAIL.</drugbatchnumb>
        <drugauthorizationnumb>020132</drugauthorizationnumb>
        <drugdosagetext>50MG AS REQUIRED</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MIGRAINE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050919</drugstartdate>
        <drugtreatmentduration>18</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EVISTA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DYAZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048951-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050921</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0575229A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>79</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMITREX</medicinalproduct>
        <drugauthorizationnumb>020132</drugauthorizationnumb>
        <drugdosagetext>50MG AS REQUIRED</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MIGRAINE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050916</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050916</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLOMAX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048952-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050923</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0575676A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMITREX</medicinalproduct>
        <drugauthorizationnumb>020132</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MIGRAINE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048953-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050922</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0575760A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>49</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMITREX</medicinalproduct>
        <drugauthorizationnumb>020132</drugauthorizationnumb>
        <drugdosagetext>1TAB AS REQUIRED</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048954-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050927</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0576062A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>65</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MICTURITION DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMITREX</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020132</drugauthorizationnumb>
        <drugdosagetext>50MG AS REQUIRED</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MIGRAINE</drugindication>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048955-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050927</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0576093A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>TENDONITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMITREX</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020132</drugauthorizationnumb>
        <drugdosagetext>100MG AS REQUIRED</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MIGRAINE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN MEDICATION</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048956-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050928</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0576244A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>36</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMITREX</medicinalproduct>
        <drugbatchnumb>5ZP7572A</drugbatchnumb>
        <drugauthorizationnumb>020132</drugauthorizationnumb>
        <drugdosagetext>100MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MIGRAINE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TEGRETOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DETROL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATIVAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLARITIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048957-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050928</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0576260A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMITREX</medicinalproduct>
        <drugauthorizationnumb>020132</drugauthorizationnumb>
        <drugdosagetext>1TAB AS REQUIRED</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MIGRAINE</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050911</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMITREX</medicinalproduct>
        <drugbatchnumb>5ZP7571A</drugbatchnumb>
        <drugauthorizationnumb>020132</drugauthorizationnumb>
        <drugdosagetext>100MG AS REQUIRED</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPAMAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROZAC</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048958-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050929</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0576369A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>55</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMITREX</medicinalproduct>
        <drugauthorizationnumb>020132</drugauthorizationnumb>
        <drugdosagetext>100MG AS REQUIRED</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MIGRAINE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTI-INFLAMMATORY</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048959-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050927</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0576445A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMITREX</medicinalproduct>
        <drugauthorizationnumb>020132</drugauthorizationnumb>
        <drugdosagetext>50MG AS REQUIRED</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048960-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050926</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0576491A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMITREX</medicinalproduct>
        <drugauthorizationnumb>020132</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MIGRAINE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048961-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20051003</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0576694A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>46</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>50.5</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ARTERIOSPASM CORONARY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMITREX</medicinalproduct>
        <drugbatchnumb>5ZP7563</drugbatchnumb>
        <drugauthorizationnumb>20132</drugauthorizationnumb>
        <drugdosagetext>100MG AS REQUIRED</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MIGRAINE</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050920</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NO CONCURRENT MEDICATION</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048962-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20051006</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0577250A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMITREX</medicinalproduct>
        <drugauthorizationnumb>020132</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048963-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20051006</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0577373A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>65</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMITREX</medicinalproduct>
        <drugbatchnumb>4ZP7227A</drugbatchnumb>
        <drugauthorizationnumb>020132</drugauthorizationnumb>
        <drugdosagetext>100MG AS REQUIRED</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MIGRAINE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19950101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMICTAL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020241</drugauthorizationnumb>
        <drugdosagetext>300MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>POST-TRAUMATIC STRESS DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEXAPRO</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNITHROID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLEGRA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOPID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SANCTURA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACTONEL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAZODONE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COMPAZINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZANTAC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREVACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMBIEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ROBAXIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VICODIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMITREX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAXALT</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048964-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20051007</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0577684A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>VERTIGO</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMITREX</medicinalproduct>
        <drugauthorizationnumb>020132</drugauthorizationnumb>
        <drugdosagetext>100MG AS REQUIRED</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MIGRAINE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048965-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20051010</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0577711A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVERDOSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMITREX</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020132</drugauthorizationnumb>
        <drugdosagetext>100MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MIGRAINE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NO CONCURRENT MEDICATION</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048966-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20051011</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0577818A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>31</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>TRANSIENT ISCHAEMIC ATTACK</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMITREX</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020132</drugauthorizationnumb>
        <drugdosagetext>100MG AS REQUIRED</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MIGRAINE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19920101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050903</drugenddate>
        <drugtreatmentduration>13</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LITHIUM CARBONATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEPAKOTE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INDERAL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROZAC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PHENOBARBITAL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KLONOPIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048967-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20051011</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0577840A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>38</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NERVOUSNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMITREX</medicinalproduct>
        <drugauthorizationnumb>020132</drugauthorizationnumb>
        <drugdosagetext>100MG VARIABLE DOSE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MIGRAINE</drugindication>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PERIACTIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048968-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20051011</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0577841A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>34</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>THROAT TIGHTNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMITREX</medicinalproduct>
        <drugauthorizationnumb>020132</drugauthorizationnumb>
        <drugdosagetext>50MG AS REQUIRED</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MIGRAINE</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040101</drugenddate>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NO CONCURRENT MEDICATION</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048969-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20051014</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0578274A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMITREX</medicinalproduct>
        <drugauthorizationnumb>020132</drugauthorizationnumb>
        <drugdosagetext>50MG AS REQUIRED</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MIGRAINE</drugindication>
        <drugtreatmentduration>11</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ORAL CONTRACEPTIVES</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048970-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20051018</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0578634A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMITREX</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020132</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MIGRAINE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048971-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20051024</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0579379A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>16</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABNORMAL SENSATION IN EYE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MIGRAINE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMITREX</medicinalproduct>
        <drugauthorizationnumb>020132</drugauthorizationnumb>
        <drugdosagetext>100MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MIGRAINE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051013</drugstartdate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NO CONCURRENT MEDICATION</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048972-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20051025</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0579599A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ADVERSE EVENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMITREX</medicinalproduct>
        <drugauthorizationnumb>020132</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MIGRAINE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048973-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20051021</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0579761A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>25</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>91.8</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMITREX</medicinalproduct>
        <drugauthorizationnumb>020132</drugauthorizationnumb>
        <drugdosagetext>100MG AS REQUIRED</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MIGRAINE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NO CONCURRENT MEDICATION</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048974-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20051025</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0579793A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>25</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MUSCLE TIGHTNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NECK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN JAW</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMITREX</medicinalproduct>
        <drugbatchnumb>B117416</drugbatchnumb>
        <drugauthorizationnumb>020132</drugauthorizationnumb>
        <drugdosagetext>50MG SINGLE DOSE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MIGRAINE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RANITIDINE</medicinalproduct>
        <drugdosagetext>150MG TWICE PER DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROPRANOLOL</medicinalproduct>
        <drugdosagetext>10MG TWICE PER DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
        <drugdosagetext>600MG TWICE PER DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WELLBUTRIN</medicinalproduct>
        <drugdosagetext>200MG TWICE PER DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SINGULAIR</medicinalproduct>
        <drugdosagetext>10MG PER DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONAZEPAM</medicinalproduct>
        <drugdosagetext>1MG AT NIGHT</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MICROGESTIN FE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELEXA</medicinalproduct>
        <drugdosagetext>40MG PER DAY</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048975-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20051027</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0579899A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>33</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANAPHYLACTIC REACTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMITREX</medicinalproduct>
        <drugauthorizationnumb>020132</drugauthorizationnumb>
        <drugdosagetext>100MG AS REQUIRED</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MIGRAINE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051001</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048976-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20051027</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0579935A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>43</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMITREX</medicinalproduct>
        <drugauthorizationnumb>020132</drugauthorizationnumb>
        <drugdosagetext>50MG AS REQUIRED</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CLUSTER HEADACHE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN MEDICATION</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADVAIR DISKUS 100/50</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EYE DROPS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NASONEX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREVACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZANTAC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EFFEXOR XR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPAMAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATIVAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ESTRADIOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRED FORTE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAMADOL HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DARVOCET-N 100</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048977-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20051028</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0580107A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG ADMINISTRATION ERROR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN NODULE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWELLING FACE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMITREX</medicinalproduct>
        <drugauthorizationnumb>020132</drugauthorizationnumb>
        <drugdosagetext>50MG AS REQUIRED</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MIGRAINE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051025</drugstartdate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REQUIP</medicinalproduct>
        <drugauthorizationnumb>020658</drugauthorizationnumb>
        <drugdosagetext>1MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RESTLESS LEGS SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051023</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REQUIP</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VICODIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FENTANYL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREVACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOPRESSOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BACLOFEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORCO</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAZODONE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048978-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20051028</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0580118A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>56</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMITREX</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>20132</drugauthorizationnumb>
        <drugdosagetext>100MG AS REQUIRED</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MIGRAINE</drugindication>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROMETRIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GYNODIOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALTRATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORAZEPAM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048979-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20051101</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0580507A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>61</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMITREX</medicinalproduct>
        <drugbatchnumb>NOT AVAIL</drugbatchnumb>
        <drugauthorizationnumb>020132</drugauthorizationnumb>
        <drugdosagetext>100MG AS REQUIRED</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MIGRAINE</drugindication>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</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>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMBIEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MOBIC</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048980-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20051031</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0580629A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMITREX</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020132</drugauthorizationnumb>
        <drugdosagetext>100MG AS REQUIRED</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MIGRAINE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048981-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20051102</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0580666A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>29</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HEARING IMPAIRED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMITREX</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>020132</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MIGRAINE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NO CONCURRENT MEDICATION</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048982-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20051103</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0580850A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>63</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMITREX</medicinalproduct>
        <drugauthorizationnumb>20132</drugauthorizationnumb>
        <drugdosagetext>50MG AS REQUIRED</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MIGRAINE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYLENOL (CAPLET)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048983-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20051104</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0580903A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>49</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ARRHYTHMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMITREX</medicinalproduct>
        <drugbatchnumb>5ZP6411A</drugbatchnumb>
        <drugauthorizationnumb>020132</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MIGRAINE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051103</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048984-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20051104</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0580941A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMITREX</medicinalproduct>
        <drugauthorizationnumb>020132</drugauthorizationnumb>
        <drugdosagetext>100MG UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MIGRAINE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048985-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20051107</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0581231A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>25</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMITREX</medicinalproduct>
        <drugbatchnumb>UNAVAIL</drugbatchnumb>
        <drugauthorizationnumb>020132</drugauthorizationnumb>
        <drugdosagetext>100MG AS REQUIRED</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MIGRAINE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051102</drugstartdate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NO CONCURRENT MEDICATION</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048986-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20051107</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0581243A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>45</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMITREX</medicinalproduct>
        <drugbatchnumb>5ZP4731A</drugbatchnumb>
        <drugauthorizationnumb>020132</drugauthorizationnumb>
        <drugdosagetext>100MG VARIABLE DOSE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MIGRAINE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPAMAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INDERAL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048987-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20051107</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0581245A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CYSTITIS INTERSTITIAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMITREX</medicinalproduct>
        <drugauthorizationnumb>020132</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MIGRAINE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048988-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20051107</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0581248A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLINDNESS TRANSIENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMITREX</medicinalproduct>
        <drugauthorizationnumb>020132</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MIGRAINE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048989-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20051107</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0581462A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>41</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>61.4</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMITREX</medicinalproduct>
        <drugbatchnumb>UNAVAILABLE</drugbatchnumb>
        <drugauthorizationnumb>020132</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MIGRAINE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051101</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048990-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20051108</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0581694A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>45</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CHROMATURIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMITREX</medicinalproduct>
        <drugauthorizationnumb>020132</drugauthorizationnumb>
        <drugdosagetext>100MG SINGLE DOSE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MIGRAINE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051107</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048991-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20051111</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0581942A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>38</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>71.8</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN JAW</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMITREX</medicinalproduct>
        <drugauthorizationnumb>020132</drugauthorizationnumb>
        <drugdosagetext>100MG AS REQUIRED</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MIGRAINE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051109</drugstartdate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREVACID</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048992-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20051111</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0581971A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMITREX</medicinalproduct>
        <drugauthorizationnumb>020132</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048993-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20051115</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0582364A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>62</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG ADMINISTRATION ERROR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMITREX</medicinalproduct>
        <drugbatchnumb>2ZP0980,2ZP1402</drugbatchnumb>
        <drugauthorizationnumb>020132</drugauthorizationnumb>
        <drugdosagetext>100MG AS REQUIRED</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MIGRAINE</drugindication>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMITREX</medicinalproduct>
        <drugauthorizationnumb>020080</drugauthorizationnumb>
        <drugdosagetext>6MG AS REQUIRED</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMINS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048994-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20051116</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0582577A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>52</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CRYING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOOD SWINGS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMITREX</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020132</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MIGRAINE</drugindication>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BIRTH CONTROL PILLS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRENATAL VITAMINS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048995-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20051117</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0582760A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>30</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMITREX</medicinalproduct>
        <drugauthorizationnumb>020132</drugauthorizationnumb>
        <drugdosagetext>50MG AS REQUIRED</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MIGRAINE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050101</drugenddate>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEMEROL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL SPIROS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048996-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20051117</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0582770A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>62</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMITREX</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020132</drugauthorizationnumb>
        <drugdosagetext>50MG AS REQUIRED</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MIGRAINE</drugindication>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VAGIFEM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048997-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20051111</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0582881A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>53</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE TIGHTNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMITREX</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020132</drugauthorizationnumb>
        <drugdosagetext>50MG AS REQUIRED</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MIGRAINE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NO CONCURRENT MEDICATION</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048998-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20051111</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0583099A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>48</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMITREX</medicinalproduct>
        <drugauthorizationnumb>020132</drugauthorizationnumb>
        <drugdosagetext>50MG THREE TIMES PER WEEK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MIGRAINE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5048999-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20051121</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0583429A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STOMACH DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMITREX</medicinalproduct>
        <drugauthorizationnumb>020132</drugauthorizationnumb>
        <drugdosagetext>100MG AS REQUIRED</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MIGRAINE</drugindication>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMITREX</medicinalproduct>
        <drugauthorizationnumb>020626</drugauthorizationnumb>
        <drugdosagetext>20MG AS REQUIRED</drugdosagetext>
        <drugadministrationroute>045</drugadministrationroute>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NO CONCURRENT MEDICATION</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049000-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20051122</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0583443A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>36</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DYSURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POLLAKIURIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMITREX</medicinalproduct>
        <drugauthorizationnumb>020132</drugauthorizationnumb>
        <drugdosagetext>100MG AS REQUIRED</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MIGRAINE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051121</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051121</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NO CONCURRENT MEDICATION</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049001-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20051122</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0583448A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>58</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INITIAL INSOMNIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMITREX</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>20132</drugauthorizationnumb>
        <drugdosagetext>50MG AS REQUIRED</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPAMAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PSEUDOEPHEDRINE HCL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049002-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20051128</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0583662A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>52</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMITREX</medicinalproduct>
        <drugauthorizationnumb>020132</drugauthorizationnumb>
        <drugdosagetext>50MG AS REQUIRED</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MIGRAINE</drugindication>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MIDRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ORTHO TRI-CYCLEN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049003-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20051128</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0583705A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INTOLERANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MIGRAINE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMITREX</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020132</drugauthorizationnumb>
        <drugdosagetext>100MG AS REQUIRED</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MIGRAINE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049004-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20051123</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0583714A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MIGRAINE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMITREX</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020132</drugauthorizationnumb>
        <drugdosagetext>100MG AS REQUIRED</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MIGRAINE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NO CONCURRENT MEDICATION</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049005-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20051129</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0583831A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMITREX</medicinalproduct>
        <drugauthorizationnumb>020132</drugauthorizationnumb>
        <drugdosagetext>100MG UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051128</drugstartdate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049006-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20051201</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0584292A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>43</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG ADMINISTRATION ERROR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMITREX</medicinalproduct>
        <drugbatchnumb>4ZP8058A</drugbatchnumb>
        <drugauthorizationnumb>020132</drugauthorizationnumb>
        <drugdosagetext>100MG AS REQUIRED</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MIGRAINE</drugindication>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BIRTH CONTROL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049007-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20051209</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0585270A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>45</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ALOPECIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG ADMINISTRATION ERROR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMITREX</medicinalproduct>
        <drugauthorizationnumb>020132</drugauthorizationnumb>
        <drugdosagetext>75MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MIGRAINE</drugindication>
        <drugtreatmentduration>12</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRILOSEC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EXCEDRIN (MIGRAINE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TUMS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049008-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20051206</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0585342A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>EUPHORIC MOOD</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMITREX</medicinalproduct>
        <drugauthorizationnumb>020132</drugauthorizationnumb>
        <drugdosagetext>50MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MIGRAINE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049009-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20051215</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0585956A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>26</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CONTUSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMITREX</medicinalproduct>
        <drugbatchnumb>5ZP4726A</drugbatchnumb>
        <drugauthorizationnumb>020132</drugauthorizationnumb>
        <drugdosagetext>50MG AS REQUIRED</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051212</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051213</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ABILIFY</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EFFEXOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KLONOPIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BUSPAR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LITHIUM CARBONATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COGENTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LUNESTA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BIRTH CONTROL PILLS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INDERAL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AXERT</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049010-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20001113</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-BRISTOL-MYERS SQUIBB COMPANY-13417753</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>65</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEUKOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAXOL</medicinalproduct>
        <drugauthorizationnumb>20262</drugauthorizationnumb>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CISPLATIN</medicinalproduct>
        <drugauthorizationnumb>018057</drugauthorizationnumb>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RADIOTHERAPY</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049011-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20051215</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0585980A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>48</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PANIC ATTACK</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMITREX</medicinalproduct>
        <drugauthorizationnumb>020132</drugauthorizationnumb>
        <drugdosagetext>50MG AS REQUIRED</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MIGRAINE</drugindication>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACIPHEX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049012-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060630</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-BRISTOL-MYERS SQUIBB COMPANY-13435961</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>76</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DERMATITIS EXFOLIATIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG ERUPTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EOSINOPHILIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA MULTIFORME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METFORMIN HYDROCHLORIDE</medicinalproduct>
        <drugauthorizationnumb>21202</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060429</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMISIL</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060310</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060311</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAREG</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060429</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIAMICRON</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060429</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KERLONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060429</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060405</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049013-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20051216</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0586104A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>36</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>EYE SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMITREX</medicinalproduct>
        <drugauthorizationnumb>020132</drugauthorizationnumb>
        <drugdosagetext>100MG AS REQUIRED</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MIGRAINE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051214</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051214</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VICODIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049014-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20051216</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0586109A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA FACIAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NECK PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMITREX</medicinalproduct>
        <drugauthorizationnumb>020132</drugauthorizationnumb>
        <drugdosagetext>100MG AS REQUIRED</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MIGRAINE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051201</drugstartdate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049015-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20051215</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0586530A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MIGRAINE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMITREX</medicinalproduct>
        <drugauthorizationnumb>020132</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MIGRAINE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049016-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20051221</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0586632A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMITREX</medicinalproduct>
        <drugbatchnumb>5ZP5723A</drugbatchnumb>
        <drugauthorizationnumb>020132</drugauthorizationnumb>
        <drugdosagetext>25MG AS REQUIRED</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MIGRAINE</drugindication>
        <drugtreatmentduration>10</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SINGULAIR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLEGRA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTIDEPRESSANT</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BLOOD PRESSURE MEDICATION</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049017-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20051221</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0586658A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>70</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMITREX</medicinalproduct>
        <drugbatchnumb>UNAVAILABLE</drugbatchnumb>
        <drugauthorizationnumb>20132</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MIGRAINE</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>BLOOD PRESSURE MEDICATION</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTI-CHOLESTEROL MEDICATION</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049019-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20051227</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0587033A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>50</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DEAFNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TINNITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMITREX</medicinalproduct>
        <drugauthorizationnumb>020132</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MIGRAINE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049020-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20051227</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0587039A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>47</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HEART RATE ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMITREX</medicinalproduct>
        <drugauthorizationnumb>020132</drugauthorizationnumb>
        <drugdosagetext>100MG AS REQUIRED</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MIGRAINE</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051216</drugenddate>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NO CONCURRENT MEDICATION</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049021-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20051230</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0587317A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>63</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMITREX</medicinalproduct>
        <drugauthorizationnumb>020132</drugauthorizationnumb>
        <drugdosagetext>100MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MIGRAINE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NO CONCURRENT MEDICATION</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049022-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20051229</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0587338A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THERAPEUTIC RESPONSE UNEXPECTED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMITREX</medicinalproduct>
        <drugauthorizationnumb>020132</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MIGRAINE</drugindication>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMBIEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYLENOL (CAPLET)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049023-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060110</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0588566A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMITREX</medicinalproduct>
        <drugbatchnumb>5ZP4721A</drugbatchnumb>
        <drugauthorizationnumb>020132</drugauthorizationnumb>
        <drugdosagetext>25MG UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MIGRAINE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049024-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060111</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0588803A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMITREX</medicinalproduct>
        <drugauthorizationnumb>020132</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049025-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060113</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0589212A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>48</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREATMENT NONCOMPLIANCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMITREX</medicinalproduct>
        <drugauthorizationnumb>020132</drugauthorizationnumb>
        <drugdosagetext>500MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MIGRAINE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMITREX</medicinalproduct>
        <drugauthorizationnumb>020080</drugauthorizationnumb>
        <drugadministrationroute>058</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACTONEL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FIORICET</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HORMONES</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049026-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060113</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0589214A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>47</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>TINNITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMITREX</medicinalproduct>
        <drugbatchnumb>5ZP4737A</drugbatchnumb>
        <drugauthorizationnumb>020132</drugauthorizationnumb>
        <drugdosagetext>100MG AS REQUIRED</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MIGRAINE</drugindication>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOXYL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TETRACYCLINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENADRYL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049027-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060113</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0589225A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMITREX</medicinalproduct>
        <drugauthorizationnumb>020132</drugauthorizationnumb>
        <drugdosagetext>100MG AS REQUIRED</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049028-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060116</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0589416A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>63</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG WITHDRAWAL SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMITREX</medicinalproduct>
        <drugauthorizationnumb>020132</drugauthorizationnumb>
        <drugdosagetext>100MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MIGRAINE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19950101</drugstartdate>
        <drugtreatmentduration>10</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACTONEL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049029-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060113</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0589904A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMITREX</medicinalproduct>
        <drugauthorizationnumb>020132</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEADACHE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049030-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060113</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0589906A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMITREX</medicinalproduct>
        <drugauthorizationnumb>020132</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEADACHE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049031-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060123</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0590544A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FEELING OF RELAXATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMMOBILE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THINKING ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMITREX</medicinalproduct>
        <drugauthorizationnumb>020132</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MIGRAINE</drugindication>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049032-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060125</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0590896A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>48</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMITREX</medicinalproduct>
        <drugbatchnumb>R185273</drugbatchnumb>
        <drugauthorizationnumb>020132</drugauthorizationnumb>
        <drugdosagetext>100MG AS REQUIRED</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MIGRAINE</drugindication>
        <drugtreatmentduration>10</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREVACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEXAPRO</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRILEPTAL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THYROID TAB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049033-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060125</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0590911A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG ADMINISTRATION ERROR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMITREX</medicinalproduct>
        <drugauthorizationnumb>020132</drugauthorizationnumb>
        <drugdosagetext>100MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MIGRAINE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060123</drugstartdate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOTROL XL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYLENOL (CAPLET)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049034-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060125</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0590926A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>61</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMITREX</medicinalproduct>
        <drugbatchnumb>5ZP2344A</drugbatchnumb>
        <drugauthorizationnumb>020132</drugauthorizationnumb>
        <drugdosagetext>50MG AS REQUIRED</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEADACHE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030701</drugstartdate>
        <drugtreatmentduration>30</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DICLOFENAC POTASSIUM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049035-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060126</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0591170A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMITREX</medicinalproduct>
        <drugauthorizationnumb>020132</drugauthorizationnumb>
        <drugdosagetext>25MG AS REQUIRED</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEADACHE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049036-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060127</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0591309A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>NECK PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMITREX</medicinalproduct>
        <drugauthorizationnumb>020132</drugauthorizationnumb>
        <drugdosagetext>50MG UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MIGRAINE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049037-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060130</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0591478A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>58</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN DISCOLOURATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMITREX</medicinalproduct>
        <drugbatchnumb>5ZP2353A</drugbatchnumb>
        <drugauthorizationnumb>020132</drugauthorizationnumb>
        <drugdosagetext>25MG AS REQUIRED</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MIGRAINE</drugindication>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEFAZODONE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROTONIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RED YEAST RICE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049038-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060130</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0591496A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>49</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMITREX</medicinalproduct>
        <drugauthorizationnumb>020132</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MIGRAINE</drugindication>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PHENOBARBITAL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPAMAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEXAPRO</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMITRIPTYLINE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAMADOL HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALPRAZOLAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROVIGIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EVISTA</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049039-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060130</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0591528A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>43</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMITREX</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020132</drugauthorizationnumb>
        <drugdosagetext>50MG AS REQUIRED</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MIGRAINE</drugindication>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WELLBUTRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOXEPIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PERCOCET</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DONNATAL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAGAMET</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ROBAXIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049040-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060131</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0591738A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>59</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE TIGHTNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMITREX</medicinalproduct>
        <drugbatchnumb>5ZP2353A</drugbatchnumb>
        <drugauthorizationnumb>020132</drugauthorizationnumb>
        <drugdosagetext>25MG AS REQUIRED</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MIGRAINE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZESTRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLOMAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROTONIX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049041-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060201</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0591788A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>5</patientonsetage>
      <patientonsetageunit>802</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DECREASED ACTIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE VIA BREAST MILK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERSONALITY CHANGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STARING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMITREX</medicinalproduct>
        <drugauthorizationnumb>020132</drugauthorizationnumb>
        <drugdosagetext>50MG SINGLE DOSE</drugdosagetext>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049042-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060201</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0591934A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>55</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SENSATION OF HEAVINESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMITREX</medicinalproduct>
        <drugauthorizationnumb>020132</drugauthorizationnumb>
        <drugdosagetext>100MG AS REQUIRED</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MIGRAINE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KLONOPIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MIDRIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049043-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060201</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0591956A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>41</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING DRUNK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMITREX</medicinalproduct>
        <drugbatchnumb>5ZP0249</drugbatchnumb>
        <drugauthorizationnumb>020132</drugauthorizationnumb>
        <drugdosagetext>100MG VARIABLE DOSE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MIGRAINE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060201</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SEASONALE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049044-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060207</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0592674A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>46</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUFFOCATION FEELING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URTICARIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMITREX</medicinalproduct>
        <drugbatchnumb>5ZP1390A</drugbatchnumb>
        <drugauthorizationnumb>020132</drugauthorizationnumb>
        <drugdosagetext>50MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MIGRAINE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060202</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060202</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BUSPAR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEXAPRO</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049045-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060209</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0593044A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>45</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMITREX</medicinalproduct>
        <drugauthorizationnumb>020132</drugauthorizationnumb>
        <drugdosagetext>100MG AS REQUIRED</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MIGRAINE</drugindication>
        <drugtreatmentduration>18</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPAMAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN B-12</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGNESIUM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049046-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060209</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0593047A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMITREX</medicinalproduct>
        <drugbatchnumb>5ZP3364A</drugbatchnumb>
        <drugauthorizationnumb>020132</drugauthorizationnumb>
        <drugdosagetext>100MGK AS REQUIRED</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MIGRAINE</drugindication>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049047-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060210</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0593261A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <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>DRUG EXPOSURE VIA BREAST MILK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ECZEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VIRAL INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMITREX</medicinalproduct>
        <drugauthorizationnumb>020132</drugauthorizationnumb>
        <drugdosagetext>50MG AS REQUIRED</drugdosagetext>
        <drugindication>MIGRAINE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NO CONCURRENT MEDICATION</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049048-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060213</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0593451A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMITREX</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>020132</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MIGRAINE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NO CONCURRENT MEDICATION</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049049-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060213</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0593479A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>57</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMITREX</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>20132</drugauthorizationnumb>
        <drugdosagetext>1TAB AS REQUIRED</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MIGRAINE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYLENOL (CAPLET)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DILANTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PHENOBARBITAL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049050-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060213</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0593480A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMITREX</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020132</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MIGRAINE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049051-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060213</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0593496A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMITREX</medicinalproduct>
        <drugbatchnumb>NAV</drugbatchnumb>
        <drugauthorizationnumb>020132</drugauthorizationnumb>
        <drugdosagetext>100MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MIGRAINE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060210</drugstartdate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NO CONCURRENT MEDICATION</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049052-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060214</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0593664A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>62</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MIGRAINE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMITREX</medicinalproduct>
        <drugauthorizationnumb>020132</drugauthorizationnumb>
        <drugdosagetext>100MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MIGRAINE</drugindication>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCODONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EPIDURAL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049053-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060214</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0593754A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMITREX</medicinalproduct>
        <drugauthorizationnumb>020132</drugauthorizationnumb>
        <drugdosagetext>100MG AS REQUIRED</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MIGRAINE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049054-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060215</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0593873A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>TRISMUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMITREX</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020132</drugauthorizationnumb>
        <drugdosagetext>50MG UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MIGRAINE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060201</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049055-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060216</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0594004A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMITREX</medicinalproduct>
        <drugauthorizationnumb>020132</drugauthorizationnumb>
        <drugdosagetext>100MG AS REQUIRED</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MIGRAINE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049056-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060220</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0594467A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMITREX</medicinalproduct>
        <drugauthorizationnumb>020132</drugauthorizationnumb>
        <drugdosagetext>100MG UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPAMAX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INDERAL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049057-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060222</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0594818A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>56</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CHEST DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMITREX</medicinalproduct>
        <drugauthorizationnumb>020132</drugauthorizationnumb>
        <drugdosagetext>50MG AS REQUIRED</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MIGRAINE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19950101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049058-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060227</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0595321A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ARTERIOSCLEROSIS CORONARY ARTERY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMITREX</medicinalproduct>
        <drugauthorizationnumb>020132</drugauthorizationnumb>
        <drugdosagetext>100MG THREE TIMES PER WEEK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MIGRAINE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19950101</drugstartdate>
        <drugtreatmentduration>10</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049059-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060301</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0595736A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>39</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMITREX</medicinalproduct>
        <drugauthorizationnumb>020132</drugauthorizationnumb>
        <drugdosagetext>100MG AS REQUIRED</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MIGRAINE</drugindication>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMITRIPTYLINE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EXCEDRIN (MIGRAINE)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049060-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060228</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0596146A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MIGRAINE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STRESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMITREX</medicinalproduct>
        <drugauthorizationnumb>020132</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MIGRAINE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060219</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060219</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049061-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060306</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0596294A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>THROAT TIGHTNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMITREX</medicinalproduct>
        <drugauthorizationnumb>020132</drugauthorizationnumb>
        <drugdosagetext>100MG AS REQUIRED</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MIGRAINE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NO CONCURRENT MEDICATION</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049063-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060703</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-BRISTOL-MYERS SQUIBB COMPANY-13432364</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>65</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PURPURA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAXOL</medicinalproduct>
        <drugauthorizationnumb>020262</drugauthorizationnumb>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>LUNG ADENOCARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060529</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060529</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMOBAN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060527</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060625</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SENNA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060526</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060625</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZYRTEC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060526</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060625</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MUCODYNE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060526</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060625</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MUCOSOLVAN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060526</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060625</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BIOFERMIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060527</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060625</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RINDERON</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060527</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060625</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZANTAC</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060607</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060607</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SOLU-MEDROL</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060608</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060630</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049064-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060620</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-BRISTOL-MYERS SQUIBB COMPANY-13418694</companynumb>
    <primarysource>
      <reportercountry>SWITZERLAND</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>NEPHRITIS INTERSTITIAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ATAZANAVIR</medicinalproduct>
        <drugauthorizationnumb>21567</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049065-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-13434790</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>EYE INFLAMMATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KENALOG-40</medicinalproduct>
        <drugauthorizationnumb>014901</drugauthorizationnumb>
        <drugadministrationroute>031</drugadministrationroute>
        <drugindication>RETINAL OEDEMA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049066-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-13434782</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>EYE INFLAMMATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KENALOG-40</medicinalproduct>
        <drugauthorizationnumb>014901</drugauthorizationnumb>
        <drugadministrationroute>031</drugadministrationroute>
        <drugindication>RETINAL OEDEMA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049067-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060710</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-13437041</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>68</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
        <drugauthorizationnumb>9218</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049068-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2006JP09838</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>CONCOMITANT DISEASE AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTROPHIC CARDIOMYOPATHY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEORAL</medicinalproduct>
        <drugauthorizationnumb>050715</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049069-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-13426606</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>EYE INFLAMMATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KENALOG-40</medicinalproduct>
        <drugauthorizationnumb>014901</drugauthorizationnumb>
        <drugadministrationroute>031</drugadministrationroute>
        <drugindication>RETINAL OEDEMA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049071-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060623</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006080832</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>0</patientsex>
      <reaction>
        <reactionmeddrapt>PALMAR-PLANTAR ERYTHRODYSAESTHESIA SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUTENT</medicinalproduct>
        <drugauthorizationnumb>21938</drugauthorizationnumb>
        <drugdosagetext>50 MG 50 MG</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049072-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060626</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006080853</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>78</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>PANCYTOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYSTEMIC CANDIDA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYVOX</medicinalproduct>
        <drugauthorizationnumb>21131</drugauthorizationnumb>
        <drugdosagetext>1200 MG, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060417</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060501</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIGOXIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARVEDILOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOSARTAN POTASSIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOBUTAMINE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOPAMINE HYDROCHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NOREPINEPHRINE BITARTRATE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049073-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060627</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006080866</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE ABSCESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MEDROXYPROGESTERONE ACETATE</medicinalproduct>
        <drugauthorizationnumb>20246</drugauthorizationnumb>
        <drugdosagetext>MOST RECENT INJECTION, INTRAMUSCULAR</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>CONTRACEPTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060401</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049074-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060623</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006080926</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>0</patientsex>
      <reaction>
        <reactionmeddrapt>RED BLOOD CELL ABNORMALITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugauthorizationnumb>20998</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049075-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060627</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006081329</companynumb>
    <primarysource>
      <reportercountry>AUSTRIA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>80</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ISCHAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FRAGMIN</medicinalproduct>
        <drugauthorizationnumb>20287</drugauthorizationnumb>
        <drugdosagetext>5000 I.U. (5000 I.U., QD), SUBCUTANEOUS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>ULCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DILZEM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALDACTONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BERODUAL (FENOTEROL HYDROBROMIDE, IPRATROPIUM BROMIDE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MARCUMAR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ISOMONAT (ISOSORBIDE MONONITRATE)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049076-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060626</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006081331</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>24</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE BEFORE PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTRA-UTERINE DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL PAIN</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>20060221</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060221</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>20060521</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060521</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049077-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060627</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006081407</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BREAST CANCER FEMALE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MEDROXYPROGESTERONE ACETATE</medicinalproduct>
        <drugauthorizationnumb>11839</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010401</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010401</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049078-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060626</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006068315</companynumb>
    <primarysource>
      <reportercountry>PHILIPPINES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>94</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DIFFICULT TO WEAN FROM VENTILATOR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG ADMINISTRATION ERROR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEEDING TUBE COMPLICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>REFUSAL OF TREATMENT BY RELATIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY DISTRESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STUPOR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUPRAVENTRICULAR EXTRASYSTOLES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENTRICULAR EXTRASYSTOLES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WRONG TECHNIQUE IN DRUG USAGE PROCESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AZITHROMYCIN</medicinalproduct>
        <drugauthorizationnumb>50733</drugauthorizationnumb>
        <drugdosagetext>INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>SEPSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CEPHALOSPORIN C (CEPHALOSPORIN C)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049079-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060623</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006081404</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NERVOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</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>20020101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020101</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>20050101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050101</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>20060603</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060603</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049080-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060627</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006081437</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>70</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HEPATIC FUNCTION ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AROMASIN</medicinalproduct>
        <drugauthorizationnumb>20753</drugauthorizationnumb>
        <drugdosagetext>25 MG (1 IN 1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060501</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049082-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060627</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006081447</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>AURA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AROMASIN</medicinalproduct>
        <drugauthorizationnumb>20753</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARBAMAZEPINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049083-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060627</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006081453</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>61</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>70</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANTINUCLEAR ANTIBODY INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AROMASIN</medicinalproduct>
        <drugauthorizationnumb>20753</drugauthorizationnumb>
        <drugdosagetext>DAILY, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060220</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060427</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HERCEPTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049085-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060623</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006069566</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>71</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CATARACT OPERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VITREOUS DETACHMENT</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>19980101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATORVASTATIN CALCIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049086-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060623</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006069957</companynumb>
    <primarysource>
      <reportercountry>NORWAY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>25</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABNORMAL BEHAVIOUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AGGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ALCOHOL USE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG ABUSER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCORRECT DOSE ADMINISTERED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENTAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OBSESSIVE THOUGHTS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugauthorizationnumb>21446</drugauthorizationnumb>
        <drugdosagetext>600 MG (300 MG, 2 IN 1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PARALYSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COCAINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ROHYPNOL (FLUNITRAZEPAM)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIAZEPAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VIVAL (DIAZEPAM)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMPHETAMINE (AMFETAMINE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARISOPRODOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONAZEPAM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049087-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060626</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006070764</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EAR INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING COLD</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH GENERALISED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugauthorizationnumb>21446</drugauthorizationnumb>
        <drugdosagetext>600 MG (200 MG, 3 IN 1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>TRIGEMINAL NEURALGIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050814</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051230</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>TRIGEMINAL NEURALGIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030301</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYRTEC</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051203</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051230</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ATARAX</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051230</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051207</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051230</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LANSOPRAZOLE</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051207</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051230</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALL OTHER THERAPEUTIC PRODUCTS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ESCITALOPRAM OXALATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CEFAXLEXIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049088-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060623</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006038531</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>70</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EPISTAXIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUCOSAL INFLAMMATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NASOPHARYNGITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUTENT</medicinalproduct>
        <drugauthorizationnumb>21938</drugauthorizationnumb>
        <drugdosagetext>50 MG (50 MG,4 WEEKS INTERVAL: 7 WEEKS), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATIC NEOPLASM MALIGNANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060218</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060315</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CERVOXAN (VINBURNINE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GINKOR (GINKGO BILOBA EXTRACT, TROXERUTIN)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRAVASTATIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AUGMENTIN '125'</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELESTONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COALGAN (CALCIUM ALGINATE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MICONAZOLE NITRATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUCONAZOLE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049089-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060623</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006074513</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>56</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>93</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD BILIRUBIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEBRILE NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCYTOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUTENT</medicinalproduct>
        <drugauthorizationnumb>21968</drugauthorizationnumb>
        <drugdosagetext>50 MG (50 MG, DAILY - INTERVAL: EVERY DAY), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>METASTATIC RENAL CELL CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060516</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALL OTHER THERAPEUTIC PRODUCTS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETYLSALICYLIC ACID SRT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOCLOPRAMIDE HYDROCHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENALAPRIL MALEATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ISOSORBIDE MONONITRATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049090-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060623</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006076343</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>78</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>80</patientweight>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>RESPIRATORY FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WRONG DRUG ADMINISTERED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHYLPREDNISOLONE ACETATE</medicinalproduct>
        <drugauthorizationnumb>11757</drugauthorizationnumb>
        <drugdosagetext>120 MG (40 MG, 3 IN 1 D), INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050615</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049091-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060623</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006077746</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPHAGIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PHENYTOIN SODIUM</medicinalproduct>
        <drugauthorizationnumb>84349</drugauthorizationnumb>
        <drugdosagetext>600 MG (1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049092-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060620</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006078603</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PNEUMONIA ASPIRATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugauthorizationnumb>21446</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049094-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060623</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006079370</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>71</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HEPATOTOXICITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JAUNDICE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRANSAMINASES INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOXEPIN HCL</medicinalproduct>
        <drugauthorizationnumb>16798</drugauthorizationnumb>
        <drugdosagetext>75 MG (1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TEMODAL</medicinalproduct>
        <drugdosagetext>135 MG (1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GLIOBLASTOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060316</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VOLMAC (SALBUTAMOL SULFATE)</medicinalproduct>
        <drugdosagetext>8 MG (1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049095-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060623</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006079438</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>92</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MULTIPLE DRUG OVERDOSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HALCION</medicinalproduct>
        <drugauthorizationnumb>17892</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEPAS (ETIZOLAM)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEPROMEL (FLUVOXAMINE MALEATE)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049096-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060328</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US200602005264</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>29</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>JAW DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE CONTRACTIONS INVOLUNTARY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>30 MG, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN IN EXTREMITY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060217</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060222</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREGABALIN (PREGABALIN)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049097-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060623</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006079521</companynumb>
    <primarysource>
      <reportercountry>POLAND</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>74</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>65</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY RETENTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLINDAMYCIN HCL</medicinalproduct>
        <drugauthorizationnumb>50162</drugauthorizationnumb>
        <drugdosagetext>1200 MG (300 MG, 4 IN 1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INFECTION PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060504</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060505</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EFFOX LONG (ISOSORBIDE MONONITRATE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MOLSIDOMINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVACARD (SIMVASTATIN)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>APO-PENTOXIFYLLINE (PENTOXIFYLLINE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALL OTHER THERAPEUTIC PRODUCTS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049099-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060626</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006079741</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>74</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>DISSEMINATED INTRAVASCULAR COAGULATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC FUNCTION ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
        <drugauthorizationnumb>19787</drugauthorizationnumb>
        <drugdosagetext>5 MG, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060623</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TIZANIDINE HYDROCHLORIDE</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060623</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEPAS (ETIZOLAM)</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060623</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049100-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060623</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006079793</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>54</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>90</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATOCELLULAR DAMAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERKALAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALIGNANT NEOPLASM PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METASTASES TO LIVER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUTENT</medicinalproduct>
        <drugauthorizationnumb>21968</drugauthorizationnumb>
        <drugdosagetext>50 MG (50 MG, 1 IN 1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>METASTATIC RENAL CELL CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060331</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060606</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RANEZIDE                        (BEVANTOLOL HYDROCHLORIDE, HYDROCHLORO</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RANITIDINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEPHROTRANS (SODIUM BICARBONATE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACTRAPID INSULIN NOVO (INSULIN)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DICLAC (DICLOFENAC SODIUM)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RED BLOOD CELLS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOBAY</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049102-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060623</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006079818</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>89</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DIABETES MELLITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUROGENIC BLADDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY RETENTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOLTERODINE TARTRATE</medicinalproduct>
        <drugauthorizationnumb>20771</drugauthorizationnumb>
        <drugdosagetext>4 MG, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>POLLAKIURIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060612</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060614</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049104-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060623</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006079833</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>75</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>61</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISEASE PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERAL PHYSICAL HEALTH DETERIORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUTENT</medicinalproduct>
        <drugauthorizationnumb>21968</drugauthorizationnumb>
        <drugdosagetext>50 MG (50 MG, 1 IN 1 D), ORAL; SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>METASTATIC RENAL CELL CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060413</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060511</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUTENT</medicinalproduct>
        <drugauthorizationnumb>21968</drugauthorizationnumb>
        <drugdosagetext>50 MG (50 MG, 1 IN 1 D), ORAL; SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>METASTATIC RENAL CELL CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060524</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALFACALCIDOL                    (ALFACALCIDOL)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VERAPAMIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NOVALGIN (METAMIZOLE SODIUM)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARNIGEN FORTE                (OXILOFRINE HYDROCHLORIDE)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049106-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060626</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006079850</companynumb>
    <primarysource>
      <reportercountry>SPAIN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>33</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HYDROCEPHALUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GENOTROPIN</medicinalproduct>
        <drugauthorizationnumb>20280</drugauthorizationnumb>
        <drugdosagetext>0.4 MG (0.4 MG, 1 IN 1 D), SUBCUTANEOUS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>HYPOPITUITARISM</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030428</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060428</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TESTOSTERONE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049108-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060626</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006080269</companynumb>
    <primarysource>
      <reportercountry>SWEDEN</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>30</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIAC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEPO-PROVERA SUSPENSION/INJ</medicinalproduct>
        <drugauthorizationnumb>20246</drugauthorizationnumb>
        <drugdosagetext>INTRAMUSCULAR</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>CONTRACEPTION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049109-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060626</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006080112</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>0</patientsex>
      <reaction>
        <reactionmeddrapt>DUODENAL STENOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VFEND</medicinalproduct>
        <drugauthorizationnumb>21266</drugauthorizationnumb>
        <drugindication>ASPERGILLOSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049110-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060608</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006080389</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>19</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ALCOHOL USE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE DRUG OVERDOSE INTENTIONAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDE ATTEMPT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ATARAX</medicinalproduct>
        <drugauthorizationnumb>11459</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALCOHOL         (ETHANOL)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049111-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060623</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006080608</companynumb>
    <primarysource>
      <reportercountry>TURKEY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>69</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>COORDINATION ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROENTERITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCLONUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GABAPENTIN</medicinalproduct>
        <drugauthorizationnumb>20235</drugauthorizationnumb>
        <drugdosagetext>900 MG (1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060619</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMITRIPTYLINE (AMITRIPTYLINE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CANDESARTAN CILEXETIL (CANDESARTAN CILEXETIL)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAMADOL HCL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049112-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060623</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006082326</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>72</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ALANINE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASPARTATE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FACE OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NASOPHARYNGITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugauthorizationnumb>20702</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERCHOLESTEROLAEMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACTOS</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FAMOTIDINE</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMARYL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SUCRALFATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>YOKUKAN-SAN          (HERBAL EXTRACTS NOS)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049115-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060626</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006081731</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>45</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEROTONIN SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUS TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
        <drugauthorizationnumb>19839</drugauthorizationnumb>
        <drugdosagetext>150 MG (1 IN 1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051025</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060116</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VENLAFAXINE HCL</medicinalproduct>
        <drugdosagetext>75 MG (1 IN 1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060117</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060117</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIRTAZAPINE</medicinalproduct>
        <drugdosagetext>45 MG (1 IN 1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051017</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROMETHAZINE</medicinalproduct>
        <drugdosagetext>100 MG (1 IN 1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060116</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SOLIAN (AMISULPRIDE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORAZEPAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>STAURODORM (FLURAZEPAM)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049116-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060627</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006071147</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>28</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AMENORRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>APPENDICITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSGEUSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ENDOMETRIOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENSTRUAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENSTRUATION IRREGULAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UTERINE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VAGINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEPO-PROVERA SUSPENSION/INJ</medicinalproduct>
        <drugauthorizationnumb>20246</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>CONTRACEPTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEPO-PROVERA SUSPENSION/INJ</medicinalproduct>
        <drugauthorizationnumb>20246</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>CONTRACEPTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060522</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060522</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ANALGESICS (ANALGESICS)</medicinalproduct>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060601</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049117-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050413</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2005FR05175</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>64</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD IMMUNOGLOBULIN E INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DERMATITIS BULLOUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PEMPHIGOID</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EUPANTOL</medicinalproduct>
        <drugdosagetext>40 MG/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050114</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050124</drugenddate>
        <drugtreatmentduration>15840</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>THIOCOLCHICOSIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050114</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050124</drugenddate>
        <drugtreatmentduration>15840</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZAMUDOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050114</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050124</drugenddate>
        <drugtreatmentduration>15840</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXEN</medicinalproduct>
        <drugdosagetext>100 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050114</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050124</drugenddate>
        <drugtreatmentduration>15840</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FRACTAL</medicinalproduct>
        <drugauthorizationnumb>020261</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049118-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006071553</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>75</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ATRIOVENTRICULAR BLOCK</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
        <drugauthorizationnumb>19787</drugauthorizationnumb>
        <drugdosagetext>5 MG (DAILY), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SELOKEN L (METOPROLOL TARTRATE)</medicinalproduct>
        <drugdosagetext>20 MG (DAILY), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049119-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060623</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006073200</companynumb>
    <primarysource>
      <reportercountry>ITALY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>73</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL DISTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATOTOXICITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FELDENE</medicinalproduct>
        <drugauthorizationnumb>18147</drugauthorizationnumb>
        <drugdosagetext>20 MG (20 MG, 1 IN 1 D), INTRAMUSCULAR</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>BACK PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060601</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FELDENE</medicinalproduct>
        <drugauthorizationnumb>18147</drugauthorizationnumb>
        <drugdosagetext>20 MG (20 MG, 1 IN 1 D), INTRAMUSCULAR</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>DISCOGRAM ABNORMAL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060601</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CO-EFFERALGAN                (CODEINE PHOSPHATE, PARACETAMOL)</medicinalproduct>
        <drugdosagetext>1500 MG (500 MG, 3 IN 1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BACK PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060522</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060601</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CO-EFFERALGAN                (CODEINE PHOSPHATE, PARACETAMOL)</medicinalproduct>
        <drugdosagetext>1500 MG (500 MG, 3 IN 1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DISCOGRAM ABNORMAL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060522</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060601</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORAZEPAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTIGREG (TICLOPIDINE HYDROCHLORIDE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOTALIP (ATORVASTATIN)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MUSCORIL (THIOCOLCHICOSIDE)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049120-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060623</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006073956</companynumb>
    <primarysource>
      <reportercountry>SPAIN</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>53</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>57.2</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUTENT</medicinalproduct>
        <drugauthorizationnumb>21968</drugauthorizationnumb>
        <drugdosagetext>50 MG (50 MG, 1 IN 1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>METASTATIC RENAL CELL CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060119</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MORPHINE SULFATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MORPHINE SULFATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GABAPENTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORMETAZEPAM (LORMETAZEPAM)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PYRIDOSTIGMINE (PYRIDOSTIGMINE)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049121-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060614</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2005168377</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHROMATURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE FATIGUE</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>ILL-DEFINED DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLPIDEM TARTRATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEPAS (ETIZOLAM)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049122-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060425</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHO2006JP06843</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>40</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>65</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CHOLECYSTITIS ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATITIS C ANTIBODY POSITIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>KIDNEY TRANSPLANT REJECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER FUNCTION TEST ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SIMULECT</medicinalproduct>
        <drugdosagetext>20 MG, DAY 0</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RENAL TRANSPLANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050701</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>20050705</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050705</drugenddate>
        <drugtreatmentduration>1440</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOSPORINE</medicinalproduct>
        <drugdosagetext>500 MG/DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RENAL TRANSPLANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELLCEPT</medicinalproduct>
        <drugdosagetext>2000 MG/DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RENAL TRANSPLANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050807</drugenddate>
        <drugtreatmentduration>54720</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugdosagetext>60 MG/DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RENAL TRANSPLANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BAKTAR</medicinalproduct>
        <drugdosagetext>1DF</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PNEUMONIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050716</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>URSO</medicinalproduct>
        <drugdosagetext>3DF</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CHOLELITHIASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050813</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BLOPRESS</medicinalproduct>
        <drugdosagetext>1DF</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050821</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BREDININ</medicinalproduct>
        <drugdosagetext>100 MG/DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RENAL TRANSPLANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050808</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PARIET</medicinalproduct>
        <drugdosagetext>1DF</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ULCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050703</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIN</medicinalproduct>
        <drugdosagetext>2DF</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050801</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049123-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060626</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004033553</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>23</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>52</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABORTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AGGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AGITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ALCOHOLISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AMENORRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AMNESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANOREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACTERIAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISEASE RECURRENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSKINESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EUPHORIC MOOD</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYELID PTOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLATULENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GALACTORRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HORMONE LEVEL ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA FACIAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTHYROIDISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLUENZA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IRRITABILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MANIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENSTRUATION IRREGULAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOOD ALTERED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEBORRHOEIC DERMATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUSITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN DISCOLOURATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDE ATTEMPT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VAGINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VAGINAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</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>BIPOLAR DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060401</drugenddate>
      </drug>
      <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>BIPOLAR I DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060401</drugenddate>
      </drug>
      <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>20000101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060401</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROVERA</medicinalproduct>
        <drugdosagetext>20 MG (10 MG, 2 IN 1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>UTERINE HAEMORRHAGE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050810</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TINIDAZOLE/TIOCONAZOLE (TIOCONAZOLE, TINADAZOLE)</medicinalproduct>
        <drugdosagetext>VAGINAL</drugdosagetext>
        <drugadministrationroute>067</drugadministrationroute>
        <drugindication>VAGINITIS BACTERIAL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050825</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLONAZEPAM</medicinalproduct>
        <drugdosagetext>3 MG (3 MG, 1 IN 1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BIPOLAR DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050803</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIANE (CYPROTERONE ACETATE, ETHINYLESTRADIOL)</medicinalproduct>
        <drugdosagetext>DAILY, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ORAL CONTRACEPTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAROXETINE</medicinalproduct>
        <drugindication>BIPOLAR DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PIROXICAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ROHYPNOL (FLUNITRAZEPAM)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>L-LYSINE (LYSINE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMPLICTIL (CHLORPROMAZINE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HERBAL PREPARATION</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BETAGAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALL OTHER THERAPEUTIC PRODUCTS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MIDAZOLAM HYDROCHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMINS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049124-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060306</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0596299A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>40</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HEART RATE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MIGRAINE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMITREX</medicinalproduct>
        <drugauthorizationnumb>20132</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MIGRAINE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020101</drugenddate>
        <drugtreatmentduration>105</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMITREX</medicinalproduct>
        <drugauthorizationnumb>020080</drugauthorizationnumb>
        <drugadministrationroute>058</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAXALT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VICODIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049125-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060306</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0596314A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>37</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMITREX</medicinalproduct>
        <drugbatchnumb>5ZP0249</drugbatchnumb>
        <drugauthorizationnumb>020132</drugauthorizationnumb>
        <drugdosagetext>100MG AS REQUIRED</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MIGRAINE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060305</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMBIEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORTAB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SOMA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REQUIP</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RELPAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENADRYL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049126-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060307</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0596536A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>46</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>78.6</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ADVERSE DRUG REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MIGRAINE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STOMACH DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THERAPEUTIC RESPONSE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMITREX</medicinalproduct>
        <drugbatchnumb>5ZP4726A</drugbatchnumb>
        <drugauthorizationnumb>020132</drugauthorizationnumb>
        <drugdosagetext>50MG UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MIGRAINE</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060301</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NO CONCURRENT MEDICATION</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049127-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060308</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0596775A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>SWOLLEN TONGUE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMITREX</medicinalproduct>
        <drugauthorizationnumb>020132</drugauthorizationnumb>
        <drugdosagetext>100MG SINGLE DOSE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MIGRAINE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060301</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NO CONCURRENT MEDICATION</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049128-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060308</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0596919A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>60</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMITREX</medicinalproduct>
        <drugauthorizationnumb>020132</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MIGRAINE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOMIG</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN MEDICATION</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049129-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060309</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0597154A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMITREX</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020132</drugauthorizationnumb>
        <drugdosagetext>50MG AS REQUIRED</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MIGRAINE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060301</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NO CONCURRENT MEDICATION</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049130-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060302</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0597408A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG ADMINISTRATION ERROR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EFFECT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MIGRAINE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMITREX</medicinalproduct>
        <drugauthorizationnumb>020132</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049131-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060314</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0597519A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>45</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMITREX</medicinalproduct>
        <drugauthorizationnumb>020132</drugauthorizationnumb>
        <drugdosagetext>50MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MIGRAINE</drugindication>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049132-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060314</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0597524A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>57</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POOR QUALITY DRUG ADMINISTERED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMITREX</medicinalproduct>
        <drugauthorizationnumb>020132</drugauthorizationnumb>
        <drugdosagetext>50MG AS REQUIRED</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MIGRAINE</drugindication>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMITREX</medicinalproduct>
        <drugbatchnumb>C074814</drugbatchnumb>
        <drugauthorizationnumb>020080</drugauthorizationnumb>
        <drugdosagetext>1INJ AS REQUIRED</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VYTORIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049133-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060315</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0597708A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>58</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRY MOUTH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRESCRIBED OVERDOSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMITREX</medicinalproduct>
        <drugauthorizationnumb>020132</drugauthorizationnumb>
        <drugdosagetext>25MG AS REQUIRED</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MIGRAINE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19920101</drugstartdate>
        <drugtreatmentduration>14</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMITREX</medicinalproduct>
        <drugauthorizationnumb>020132</drugauthorizationnumb>
        <drugdosagetext>100MG AS REQUIRED</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19920101</drugstartdate>
        <drugtreatmentduration>14</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMITREX</medicinalproduct>
        <drugauthorizationnumb>020080</drugauthorizationnumb>
        <drugdosagetext>6MG AS REQUIRED</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19920101</drugstartdate>
        <drugtreatmentduration>14</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANACIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049134-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060313</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0597854A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>43</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN JAW</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMITREX</medicinalproduct>
        <drugauthorizationnumb>020132</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MIGRAINE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060113</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060213</drugenddate>
        <drugtreatmentduration>32</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049135-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060313</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0597949A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMITREX</medicinalproduct>
        <drugauthorizationnumb>020132</drugauthorizationnumb>
        <drugindication>MIGRAINE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049136-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060310</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0598059A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>39</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMITREX</medicinalproduct>
        <drugauthorizationnumb>020132</drugauthorizationnumb>
        <drugdosagetext>100MG AS REQUIRED</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MIGRAINE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FIORICET</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BIRTH CONTROL</medicinalproduct>
        <drugadministrationroute>061</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049137-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060320</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0598238A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMITREX</medicinalproduct>
        <drugbatchnumb>5ZP9486A,R183084,Z190403</drugbatchnumb>
        <drugauthorizationnumb>020132</drugauthorizationnumb>
        <drugdosagetext>100MG AS REQUIRED</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MIGRAINE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049138-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060315</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0598285A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG ADMINISTRATION ERROR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMITREX</medicinalproduct>
        <drugauthorizationnumb>020132</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049139-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060322</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0598602A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>58</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPHONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARYNGOLARYNGEAL PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMITREX</medicinalproduct>
        <drugbatchnumb>5ZP2349A</drugbatchnumb>
        <drugauthorizationnumb>020132</drugauthorizationnumb>
        <drugdosagetext>50MG AS REQUIRED</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MIGRAINE</drugindication>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZYRTEC</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049140-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060323</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0598812A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMITREX</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020132</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MIGRAINE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060319</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEXAPRO</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAZODONE HCL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049141-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060324</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0598988A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMITREX</medicinalproduct>
        <drugauthorizationnumb>020132</drugauthorizationnumb>
        <drugdosagetext>100MG VARIABLE DOSE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MIGRAINE</drugindication>
        <drugtreatmentduration>14</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPAMAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMITRIPTYLINE HCL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049142-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060327</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0599158A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>60</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMITREX</medicinalproduct>
        <drugauthorizationnumb>020132</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MIGRAINE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19960101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMITREX</medicinalproduct>
        <drugauthorizationnumb>020626</drugauthorizationnumb>
        <drugadministrationroute>045</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NO CONCURRENT MEDICATION</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049143-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060327</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0599176A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>53</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THERAPEUTIC RESPONSE DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMITREX</medicinalproduct>
        <drugauthorizationnumb>020132</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MIGRAINE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19950101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYLENOL W/ CODEINE NO. 3</medicinalproduct>
        <drugdosagetext>100MG AS REQUIRED</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPROL-XL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ORPHENADRINE</medicinalproduct>
        <drugindication>BRUXISM</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049144-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060328</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0599346A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>54</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>SENSATION OF HEAVINESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMITREX</medicinalproduct>
        <drugauthorizationnumb>020132</drugauthorizationnumb>
        <drugdosagetext>100MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MIGRAINE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060327</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FIORINAL W/CODEINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049145-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060323</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0599395A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ADVERSE EVENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMITREX</medicinalproduct>
        <drugauthorizationnumb>020132</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049146-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060329</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0599502A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>54</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DERMATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC ENZYME INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMITREX</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020132</drugauthorizationnumb>
        <drugdosagetext>25MG AS REQUIRED</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MIGRAINE</drugindication>
        <drugtreatmentduration>15</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NO CONCURRENT MEDICATION</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049147-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060330</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0599739A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>53</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CHEST DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG ADMINISTRATION ERROR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SENSATION OF HEAVINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMITREX</medicinalproduct>
        <drugauthorizationnumb>020132</drugauthorizationnumb>
        <drugdosagetext>100MG AS REQUIRED</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MIGRAINE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060330</drugstartdate>
        <drugtreatmentduration>20</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MOTRIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049148-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060330</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0599744A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>48</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG ADMINISTRATION ERROR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMITREX</medicinalproduct>
        <drugbatchnumb>5ZP9486A,5ZP1428</drugbatchnumb>
        <drugauthorizationnumb>020132</drugauthorizationnumb>
        <drugdosagetext>100MG VARIABLE DOSE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MIGRAINE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NO CONCURRENT MEDICATION</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049149-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060330</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0599906A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMITREX</medicinalproduct>
        <drugauthorizationnumb>020132</drugauthorizationnumb>
        <drugdosagetext>100MG AS REQUIRED</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MIGRAINE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MELATONIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049150-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060329</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0599921A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PANCREATITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMITREX</medicinalproduct>
        <drugauthorizationnumb>020132</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049151-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060331</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0599925A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMITREX</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020132</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MIGRAINE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049152-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060404</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0600351A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>28</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMITREX</medicinalproduct>
        <drugauthorizationnumb>020132</drugauthorizationnumb>
        <drugdosagetext>100MG AS REQUIRED</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MIGRAINE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060307</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060307</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTI-INFLAMMATORY</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049153-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060406</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0600777A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>52</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMITREX</medicinalproduct>
        <drugbatchnumb>5ZP7577A</drugbatchnumb>
        <drugauthorizationnumb>020132</drugauthorizationnumb>
        <drugdosagetext>100MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MIGRAINE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMITRIPTYLINE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LAMICTAL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOXYL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049154-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060410</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0601162A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>46</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMITREX</medicinalproduct>
        <drugauthorizationnumb>020132</drugauthorizationnumb>
        <drugdosagetext>100MG AS REQUIRED</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MIGRAINE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EXCEDRIN (MIGRAINE)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049155-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060412</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0601593A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMITREX</medicinalproduct>
        <drugauthorizationnumb>020132</drugauthorizationnumb>
        <drugdosagetext>50MG AS REQUIRED</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MIGRAINE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049156-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060410</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0601918A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EPISTAXIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMITREX</medicinalproduct>
        <drugbatchnumb>5ZP4738A</drugbatchnumb>
        <drugauthorizationnumb>020132</drugauthorizationnumb>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049157-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060413</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0602344A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>35</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMITREX</medicinalproduct>
        <drugauthorizationnumb>020132</drugauthorizationnumb>
        <drugdosagetext>50MG AS REQUIRED</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MIGRAINE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049158-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060419</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0602804A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>41</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>100</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ARTERIOSPASM CORONARY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLD SWEAT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALLOR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMITREX</medicinalproduct>
        <drugauthorizationnumb>020132</drugauthorizationnumb>
        <drugdosagetext>100MG UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MIGRAINE</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYZAAR</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>YASMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLARINEX</medicinalproduct>
        <drugindication>MULTIPLE ALLERGIES</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049159-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060421</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0602816A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>62</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMITREX</medicinalproduct>
        <drugbatchnumb>5ZP229A</drugbatchnumb>
        <drugauthorizationnumb>20132</drugauthorizationnumb>
        <drugdosagetext>100MG AS REQUIRED</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MIGRAINE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060415</drugstartdate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMITREX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049160-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060421</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0602825A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG SCREEN FALSE POSITIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMITREX</medicinalproduct>
        <drugauthorizationnumb>020132</drugauthorizationnumb>
        <drugdosagetext>50MG AS REQUIRED</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MIGRAINE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NASONEX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENADRYL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049161-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060421</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0602875A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMITREX</medicinalproduct>
        <drugauthorizationnumb>020132</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMITREX</medicinalproduct>
        <drugauthorizationnumb>020080</drugauthorizationnumb>
        <drugadministrationroute>030</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049162-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060421</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0603085A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMITREX</medicinalproduct>
        <drugauthorizationnumb>020132</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MIGRAINE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMITREX</medicinalproduct>
        <drugauthorizationnumb>020080</drugauthorizationnumb>
        <drugadministrationroute>030</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049163-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060426</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0603385A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>52</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMITREX</medicinalproduct>
        <drugauthorizationnumb>020132</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MIGRAINE</drugindication>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049164-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060425</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0603409A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>45</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPHADENOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL STIFFNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NERVOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN JAW</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMITREX</medicinalproduct>
        <drugbatchnumb>4ZP5746A,5ZP7572A</drugbatchnumb>
        <drugauthorizationnumb>020132</drugauthorizationnumb>
        <drugdosagetext>100MG AS REQUIRED</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MIGRAINE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19900101</drugstartdate>
        <drugtreatmentduration>15</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049165-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060427</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0603555A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMITREX</medicinalproduct>
        <drugbatchnumb>C067413</drugbatchnumb>
        <drugauthorizationnumb>020132</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>MIGRAINE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NO CONCURRENT MEDICATION</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049166-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060426</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0603618A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMITREX</medicinalproduct>
        <drugauthorizationnumb>020132</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MIGRAINE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049167-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060428</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0603639A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DYSARTHRIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING DRUNK</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMITREX</medicinalproduct>
        <drugauthorizationnumb>020132</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MIGRAINE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049168-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060426</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0603668A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG EFFECT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMITREX</medicinalproduct>
        <drugauthorizationnumb>020132</drugauthorizationnumb>
        <drugdosagetext>100MG AS REQUIRED</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MIGRAINE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049169-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060426</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0603698A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG EFFECT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMITREX</medicinalproduct>
        <drugauthorizationnumb>020132</drugauthorizationnumb>
        <drugdosagetext>100MG AS REQUIRED</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MIGRAINE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049171-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060426</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0603701A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>53</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>THERAPEUTIC RESPONSE DELAYED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMITREX</medicinalproduct>
        <drugauthorizationnumb>020132</drugauthorizationnumb>
        <drugdosagetext>100MG AS REQUIRED</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MIGRAINE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOMIG</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MIGRAINE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049172-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060426</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0603705A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THERAPEUTIC RESPONSE DELAYED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMITREX</medicinalproduct>
        <drugauthorizationnumb>020132</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MIGRAINE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19930101</drugstartdate>
        <drugtreatmentduration>13</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049173-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060501</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0603844A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMITREX</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020132</drugauthorizationnumb>
        <drugdosagetext>100MG AS REQUIRED</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MIGRAINE</drugindication>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADVIL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049174-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060501</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0603860A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>44</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMITREX</medicinalproduct>
        <drugbatchnumb>5ZP1428A</drugbatchnumb>
        <drugauthorizationnumb>020132</drugauthorizationnumb>
        <drugdosagetext>100MG AS REQUIRED</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MIGRAINE</drugindication>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NO CONCURRENT MEDICATION</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049175-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060501</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0603875A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>45</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMITREX</medicinalproduct>
        <drugbatchnumb>R181561</drugbatchnumb>
        <drugauthorizationnumb>020132</drugauthorizationnumb>
        <drugdosagetext>100MG AS REQUIRED</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MIGRAINE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049176-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060501</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0604132A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>48</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMITREX</medicinalproduct>
        <drugauthorizationnumb>020132</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MIGRAINE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMITREX</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049177-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060502</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0604225A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMITREX</medicinalproduct>
        <drugauthorizationnumb>020132</drugauthorizationnumb>
        <drugdosagetext>100MG UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MIGRAINE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049178-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060504</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0604385A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>75</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMITREX</medicinalproduct>
        <drugauthorizationnumb>020132</drugauthorizationnumb>
        <drugdosagetext>25MG AS REQUIRED</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MIGRAINE</drugindication>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INDERAL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049179-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060504</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0604405A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>44</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERCHLORHYDRIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSYCHOMOTOR HYPERACTIVITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMITREX</medicinalproduct>
        <drugbatchnumb>5ZP3873A</drugbatchnumb>
        <drugauthorizationnumb>020132</drugauthorizationnumb>
        <drugdosagetext>50MG AS REQUIRED</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MIGRAINE</drugindication>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NO CONCURRENT MEDICATION</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049180-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060508</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0604661A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>41</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMITREX</medicinalproduct>
        <drugbatchnumb>5ZP4731A,R202010</drugbatchnumb>
        <drugauthorizationnumb>020132</drugauthorizationnumb>
        <drugdosagetext>50MG AS REQUIRED</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MIGRAINE</drugindication>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049181-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060508</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0604720A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DYSGEUSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WRONG TECHNIQUE IN DRUG USAGE PROCESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMITREX</medicinalproduct>
        <drugauthorizationnumb>020132</drugauthorizationnumb>
        <drugdosagetext>100MG AS REQUIRED</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MIGRAINE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIDODERM GEL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049182-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060509</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0604856A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG ADMINISTRATION ERROR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMITREX</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020132</drugauthorizationnumb>
        <drugdosagetext>50MG AS REQUIRED</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MIGRAINE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLEGRA</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049183-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060509</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0604884A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>36</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>147.7</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CHEST DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ELECTROCARDIOGRAM ST-T CHANGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMITREX</medicinalproduct>
        <drugauthorizationnumb>020132</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MIGRAINE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060419</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049184-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060505</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0604951A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DRUG ADMINISTRATION ERROR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMITREX</medicinalproduct>
        <drugauthorizationnumb>020132</drugauthorizationnumb>
        <drugdosagetext>200MG SEE DOSAGE TEXT</drugdosagetext>
        <drugindication>MIGRAINE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049185-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060511</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0605238A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>34</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LETHARGY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMITREX</medicinalproduct>
        <drugbatchnumb>5ZP6131</drugbatchnumb>
        <drugauthorizationnumb>020132</drugauthorizationnumb>
        <drugdosagetext>100MG AS REQUIRED</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MIGRAINE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060511</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYLENOL (CAPLET)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049186-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060512</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0605410A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>53</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAIL DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMITREX</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020132</drugauthorizationnumb>
        <drugdosagetext>100MG AS REQUIRED</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MIGRAINE</drugindication>
        <drugtreatmentduration>14</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SINUS MEDICATION</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMINS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049187-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060512</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0605416A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMITREX</medicinalproduct>
        <drugauthorizationnumb>020132</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MIGRAINE</drugindication>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049188-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060512</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0605427A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>36</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMITREX</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020132</drugauthorizationnumb>
        <drugdosagetext>100MG AS REQUIRED</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MIGRAINE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19970101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010101</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049189-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060515</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0605618A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>36</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MIOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMITREX</medicinalproduct>
        <drugauthorizationnumb>020132</drugauthorizationnumb>
        <drugdosagetext>100MG AS REQUIRED</drugdosagetext>
        <drugindication>MIGRAINE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049190-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060622</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006053881</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>77</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ABNORMAL FAECES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ACUTE RESPIRATORY DISTRESS SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASCITES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE IMMEASURABLE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BODY TEMPERATURE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CACHEXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CANCER PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DECREASED APPETITE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCOHERENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERSTITIAL LUNG DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPHANGIOSIS CARCINOMATOSA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALIGNANT NEOPLASM PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALNUTRITION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOUTH BREATHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYDRIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLEURAL EFFUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PO2 DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY RATE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRACHEAL DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IRINOTECAN HCL</medicinalproduct>
        <drugauthorizationnumb>20571</drugauthorizationnumb>
        <drugdosagetext>100 MG (100 MG, DAILY), INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLON CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060330</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060330</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TEGAFUR/GIMERACIL/OTERACIL POTASSIUM (TEGAFUR/GIMERACIL/OTERACIL POTAS</medicinalproduct>
        <drugdosagetext>80 MG (40 MG, 2 IN 1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>COLON CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060330</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060402</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MUCOSTA (REBAMIPIDE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGNESIUM OXIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MORPHINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FENTANYL TRANSDERMAL SYSTEM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MOBIC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRIMPERAN TAB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOGMATYL (SULPIRIDE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANSOPRAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>JUSO (SODIUM BICARBONATE)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049191-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060515</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0605797A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NASAL DISCOMFORT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMITREX</medicinalproduct>
        <drugauthorizationnumb>020132</drugauthorizationnumb>
        <drugdosagetext>100MG AS REQUIRED</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MIGRAINE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049192-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060516</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0605806A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>53</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>THERAPEUTIC RESPONSE DELAYED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMITREX</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020132</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MIGRAINE</drugindication>
        <drugtreatmentduration>30</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRICOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEPAKOTE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049193-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060517</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0606045A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>26</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>59.1</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMITREX</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>020132</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MIGRAINE</drugindication>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NO CONCURRENT MEDICATION</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049194-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060517</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0606064A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>41</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMITREX</medicinalproduct>
        <drugauthorizationnumb>020132</drugauthorizationnumb>
        <drugdosagetext>50MG AS REQUIRED</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MIGRAINE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049195-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060531</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0607444A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>39</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMITREX</medicinalproduct>
        <drugbatchnumb>5ZP3887A</drugbatchnumb>
        <drugauthorizationnumb>020132</drugauthorizationnumb>
        <drugdosagetext>100MG AS REQUIRED</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MIGRAINE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060516</drugstartdate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRIPHASIL-28</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049196-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060531</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0607473A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>30</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMITREX</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020132</drugauthorizationnumb>
        <drugdosagetext>50MG AS REQUIRED</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MIGRAINE</drugindication>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049197-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060530</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>S2006US08947</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMITREX</medicinalproduct>
        <drugauthorizationnumb>020132</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049198-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060704</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BE-JNJFOC-20060700606</companynumb>
    <primarysource>
      <reportercountry>BELGIUM</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>PUSTULAR PSORIASIS</reactionmeddrapt>
      </reaction>
      <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>5049199-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060626</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006057185</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>36</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>101</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BRONCHIAL OBSTRUCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOPTYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UNEVALUABLE EVENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VFEND</medicinalproduct>
        <drugauthorizationnumb>21266</drugauthorizationnumb>
        <drugdosagetext>400 MG, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BRONCHOPULMONARY ASPERGILLOSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060419</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060425</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMPHOTERICIN B</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THEOPHYLLINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALL OTHER THERAPEUTIC PRODUCTS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049200-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060623</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006061589</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>19</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>37.4</patientweight>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ALOPECIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD ALBUMIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD BICARBONATE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CALCIUM DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD SODIUM DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATOCRIT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOWER RESPIRATORY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLEURAL EFFUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSEUDOMONAS INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RED BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STAPHYLOCOCCAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WOUND INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUTENT</medicinalproduct>
        <drugauthorizationnumb>21968</drugauthorizationnumb>
        <drugdosagetext>50 MG (50 MG, CYCLIC), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RENAL CELL CARCINOMA STAGE UNSPECIFIED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060114</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE TAB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FENTANYL TRANSDERMAL SYSTEM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049201-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060623</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006062236</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>61</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>67.2</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CACHEXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIALYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEMIPARESIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATOTOXICITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METABOLIC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OPPORTUNISTIC INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TUMOUR LYSIS SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUTENT</medicinalproduct>
        <drugbatchnumb>505160</drugbatchnumb>
        <drugauthorizationnumb>21968</drugauthorizationnumb>
        <drugdosagetext>50 MG (50 MG, 1 IN 1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>METASTATIC RENAL CELL CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060505</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060509</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLIBENCLAMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MINOXIDIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM ACETATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENALAPRIL MALEATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IRBESARTAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FERROUS SULFATE TAB</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049203-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060623</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006066121</companynumb>
    <primarysource>
      <reportercountry>INDIA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ACUTE RESPIRATORY DISTRESS SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTI-ORGAN FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY ALVEOLAR HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MAGNEX (SULBACTAM, CEFOPERAZONE)</medicinalproduct>
        <drugauthorizationnumb>50551</drugauthorizationnumb>
        <drugdosagetext>2 GRAM (1 GRAM, 2 IN 1 D), INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CIPRAN (CIPROFLOXACIN)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049204-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060626</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006068926</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>85</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>GENERAL PHYSICAL HEALTH DETERIORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY RETENTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugauthorizationnumb>21446</drugauthorizationnumb>
        <drugdosagetext>75 MG (25 MG, 3 IN 1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NEURALGIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049206-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060327</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-GILEAD-2006-0009369</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ACCIDENTAL OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMODIALYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERCAPILLARY GLOMERULOSCLEROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERSTITIAL LUNG DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL TUBULAR NECROSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIREAD</medicinalproduct>
        <drugauthorizationnumb>21356</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060316</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060320</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KALETRA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060316</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060320</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LOXONIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NASOPHARYNGITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060318</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060320</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EPIVIR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060316</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060320</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ISALON</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060318</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060320</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049207-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060621</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>003#3#2006-00072</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHEEZING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEPONIT-5                   (GLYCERYL TRINITRATE)</medicinalproduct>
        <drugauthorizationnumb>89774</drugauthorizationnumb>
        <drugdosagetext>5 MG</drugdosagetext>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>ANGINA PECTORIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060517</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060517</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AQUEOUS CREAM   (EMULSIFYING WAX, PARAFFIN, LIQUID, WHIE SOFT PARAFFIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BISOPROLOL FUMARATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DICLOFENAC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOVOBET (CALCIPOTRIOL)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GTN (GLYCERYL TRINITRATE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ISOSORBIDE MONONITRATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MELOXICAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PAROXETINE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RAMIPRIL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049209-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041116</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FRWYE288809SEP03</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>47</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD LACTATE DEHYDROGENASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG TOXICITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAPTOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOTIC MICROANGIOPATHY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROGRAF</medicinalproduct>
        <drugauthorizationnumb>50708</drugauthorizationnumb>
        <drugdosagetext>4 MG 1X PER 1 DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS AGAINST TRANSPLANT REJECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021229</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030903</drugenddate>
        <drugtreatmentduration>248</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELLCEPT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE TAB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPEGIC 1000</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROPRANOLOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EUCALCIC          (CALCIUM CARBONATE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRAVASTATIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALACYCLOVIR</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049212-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060621</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>TCI2006A02269</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>75</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ASCITES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERALISED OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLEURAL EFFUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACTOS</medicinalproduct>
        <drugauthorizationnumb>21073</drugauthorizationnumb>
        <drugdosagetext>15 MG (15 MG, 1 IN 1 D)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS NON-INSULIN-DEPENDENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060118</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060512</drugenddate>
        <drugtreatmentduration>113</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRAVASTATIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MICARDIS</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049213-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060622</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>TCI2006A01772</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>61</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSED LEVEL OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ELECTROENCEPHALOGRAM ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERAMMONAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METASTASES TO LIVER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACTOS</medicinalproduct>
        <drugauthorizationnumb>21073</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050510</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060214</drugenddate>
        <drugtreatmentduration>280</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</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060215</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060221</drugenddate>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BASEN                          (VOGLIBOSE)</medicinalproduct>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040622</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040719</drugenddate>
        <drugtreatmentduration>27</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BASEN                          (VOGLIBOSE)</medicinalproduct>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040720</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040802</drugenddate>
        <drugtreatmentduration>13</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BASEN                          (VOGLIBOSE)</medicinalproduct>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040803</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060401</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMARYL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>URSO 250</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KELNAC (PLAUNOTOL)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EXCELASE (ENZYMES NOS)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049215-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060705</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20060701027</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>56.7</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HALLUCINATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCORRECT DOSE ADMINISTERED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVAQUIN</medicinalproduct>
        <drugauthorizationnumb>020634</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PNEUMONIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugindication>ANTICOAGULANT THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVASTATIN</medicinalproduct>
        <drugindication>BLOOD CHOLESTEROL DECREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugindication>BLOOD PRESSURE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NICARDIPINE</medicinalproduct>
        <drugindication>ANGINA PECTORIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIPYRIDAMOLE</medicinalproduct>
        <drugindication>ANTICOAGULANT THERAPY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049216-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060705</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20060700736</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG ADMINISTRATION ERROR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VAGINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
        <drugauthorizationnumb>17463</drugauthorizationnumb>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060602</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060621</drugenddate>
        <drugtreatmentduration>20</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYLENOL (CAPLET)</medicinalproduct>
        <drugauthorizationnumb>019872</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYLENOL (CAPLET)</medicinalproduct>
        <drugauthorizationnumb>019872</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIDOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIDOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049217-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060705</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20060403968</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>86.18</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MYOPIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RETINAL TEAR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOPAMAX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOPAMAX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOPAMAX</medicinalproduct>
        <drugauthorizationnumb>020505</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MIGRAINE PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RHINACORT</medicinalproduct>
        <drugindication>SEASONAL ALLERGY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049218-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060703</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-JNJFOC-20060604842</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ACUTE CORONARY SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DURAGESIC-50</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>19813</drugauthorizationnumb>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>PAIN</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049220-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060621</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>THQ2006A00290</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>77</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL ABSCESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASCITES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ATELECTASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACTERIAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BILE DUCT CANCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BILE DUCT STENOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BILIARY SEPSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHOLELITHIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ENTEROBACTER INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERAL PHYSICAL HEALTH DETERIORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC ENCEPHALOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC MASS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUS TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEUPROLIDE ACETATE</medicinalproduct>
        <drugauthorizationnumb>19010</drugauthorizationnumb>
        <drugdosagetext>22.5 MG (22.5 MG,1 IN 3 M)</drugdosagetext>
        <drugindication>PROSTATE CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051108</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060214</drugenddate>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLEDRONIC ACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NITRATE PATCH     (GLYCERYL TRINITRATE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELECOXIB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SALBUTAMOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NICORANDIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VASOCARDOL CD                  (DILTIAZEM HYDROCHLORIDE)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049223-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060627</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>THQ2006A00559</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>65</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>SKIN INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THERMAL BURN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOXIC EPIDERMAL NECROLYSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LANSOPRAZOLE</medicinalproduct>
        <drugauthorizationnumb>20406</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040301</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VANCOMYCIN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040301</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049224-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006-144880-NL</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>2</patientonsetage>
      <patientonsetageunit>802</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>OPERATIVE HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DANAPAROID SODIUM</medicinalproduct>
        <drugauthorizationnumb>20430</drugauthorizationnumb>
        <drugindication>SURGERY</drugindication>
        <drugtreatmentduration>37</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HEPARIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049228-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006-06-1609</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>59</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLEURISY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY OEDEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEG-INTRON</medicinalproduct>
        <drugdosagetext>SUBCUTANEOUS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060407</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060530</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RIBAVIRIN</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060407</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060530</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GABAPENTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN/OXYCODONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>QUININE SULFATE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049231-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060626</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006-06-2086</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>67</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLINDNESS UNILATERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSGEUSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPEPSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RED BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUNBURN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEG-INTRON</medicinalproduct>
        <drugdosagetext>SUBCUTANEOUS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060120</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060623</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RIBAVIRIN</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060120</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060623</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOTREL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049233-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006-06-0385</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>70</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>81.6475</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BALANCE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CSF PROTEIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMPAIRED DRIVING ABILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPEECH DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INTRON A</medicinalproduct>
        <drugdosagetext>9 MIU QOD</drugdosagetext>
        <drugindication>RENAL CELL CARCINOMA STAGE UNSPECIFIED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051117</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060612</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEXAPRO</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAZODONE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049234-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060630</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006-06-0305</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>91</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>POTASSIUM CHLORIDE</medicinalproduct>
        <drugauthorizationnumb>19439</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049236-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060630</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>USA-2006-0024552</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>41</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DYSPHORIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INADEQUATE ANALGESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MORPHINE SULFATE</medicinalproduct>
        <drugauthorizationnumb>19516</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049238-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060626</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>06H-163-0308550-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>74</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BONE MARROW FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GRANULOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCYTOPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMIODARONE HCL</medicinalproduct>
        <drugauthorizationnumb>75955</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BUMETANIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEUPROLIDE ACETATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOSARTAN POTASSIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRONOLACTONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAMSULOSIN HCL (TAMSULOSIN HYDROCHLORIDE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTIVITAMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IRON (IRON)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYANOCOBALAMIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049240-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>E2020-00206-SPO-JP</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>74</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EPILEPSY</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>3 MG, 1 IN 1 D; ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEMENTIA ALZHEIMER'S TYPE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040616</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040629</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NIFEDIPINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIVALO (PITAVASTATIN)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RISPERDAL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049241-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060624</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006010297</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>95.2554</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG DEPENDENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCORRECT DOSE ADMINISTERED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>UNISOM SLEEPGELS (DIPHENHYDRAMINE)</medicinalproduct>
        <drugbatchnumb>0106070</drugbatchnumb>
        <drugdosagetext>2 TO 3 LIQUIDCAPS EVERY NIGHT, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INSOMNIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PAROXETINE HCL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049243-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060623</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006080010</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>42</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>71.6683</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG WITHDRAWAL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BENADRYL</medicinalproduct>
        <drugauthorizationnumb>5845</drugauthorizationnumb>
        <drugdosagetext>18 TABS/DAY, THEN ABOUT 10 TABS/NIGHT, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SLEEP DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049245-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2006US08480</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>50</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>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>TRILEPTAL</medicinalproduct>
        <drugauthorizationnumb>21014</drugauthorizationnumb>
        <drugdosagetext>150 MG Q 12 HR</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>TRIGEMINAL NEURALGIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060323</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060608</drugenddate>
        <drugtreatmentduration>78</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOMIDE</medicinalproduct>
        <drugdosagetext>UNK, BID</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INFERGEN</medicinalproduct>
        <drugindication>HEPATITIS C</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MERITAL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALDACTONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREVACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RIBAVIRIN</medicinalproduct>
        <drugindication>HEPATITIS C</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049246-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060623</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>TRP_0800_2006</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>57</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>74.8435</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RED BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RIBASPHERE</medicinalproduct>
        <drugauthorizationnumb>76203</drugauthorizationnumb>
        <drugdosagetext>VAR BID PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEG-INTRON</medicinalproduct>
        <drugdosagetext>5 QWK SC</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060201</drugstartdate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEG-INTRON</medicinalproduct>
        <drugdosagetext>3.5 QWK SC</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060601</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SOMA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMITRIPTYLINE HCL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049248-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060622</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>TPA2006A01032</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>39</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>97.5234</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ACCIDENTAL EXPOSURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ROZEREM</medicinalproduct>
        <drugbatchnumb>C11661</drugbatchnumb>
        <drugauthorizationnumb>21782</drugauthorizationnumb>
        <drugdosagetext>8 MG, QHS, PER ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INSOMNIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060622</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YASMIN</medicinalproduct>
        <drugdosagetext>1 IN 1 D, PER ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONTRACEPTION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049249-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060627</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>E2020-00203-SPO-JP</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>83</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>LARYNGEAL OEDEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARICEPT</medicinalproduct>
        <drugauthorizationnumb>20690</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049251-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnesscongenitalanomali>1</seriousnesscongenitalanomali>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060622</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>8013248</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>6.9</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ADRENAL INSUFFICIENCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARNOLD-CHIARI MALFORMATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KEPPRA</medicinalproduct>
        <drugauthorizationnumb>21035</drugauthorizationnumb>
        <drugdosagetext>2000 MG TRP</drugdosagetext>
        <drugadministrationroute>064</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050516</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DILANTIN</medicinalproduct>
        <drugdosagetext>400 MG /D TRP</drugdosagetext>
        <drugadministrationroute>064</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DILANTIN</medicinalproduct>
        <drugdosagetext>10 MG 2/D TRP</drugdosagetext>
        <drugadministrationroute>064</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYRTEC</medicinalproduct>
        <drugdosagetext>10 MG /D TRP</drugdosagetext>
        <drugadministrationroute>064</drugadministrationroute>
        <drugindication>HYPERSENSITIVITY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
        <drugdosagetext>37.5 MG /D TRP</drugdosagetext>
        <drugadministrationroute>064</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugdosagetext>50 MG PRN TRP</drugdosagetext>
        <drugadministrationroute>064</drugadministrationroute>
        <drugindication>SOMNOLENCE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CITRUCEL</medicinalproduct>
        <drugdosagetext>TRP</drugdosagetext>
        <drugadministrationroute>064</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
        <drugdosagetext>4 MG /D TRP</drugdosagetext>
        <drugadministrationroute>064</drugadministrationroute>
        <drugindication>ANAEMIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049252-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesscongenitalanomali>1</seriousnesscongenitalanomali>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060622</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>8017524</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>0</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIMB HYPOPLASIA CONGENITAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ULTRASOUND ANTENATAL SCREEN ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KEPPRA</medicinalproduct>
        <drugauthorizationnumb>21035</drugauthorizationnumb>
        <drugdosagetext>TRP</drugdosagetext>
        <drugadministrationroute>064</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049253-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060626</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AZAUS200600227</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>SPLENIC RUPTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPLENOMEGALY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIDAZA</medicinalproduct>
        <drugauthorizationnumb>50794</drugauthorizationnumb>
        <drugdosagetext>SUBCUTANEOUS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049254-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>EM2005-0069</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>16</patientonsetage>
      <patientonsetageunit>802</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DISEASE RECURRENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSEUDOMONAS INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOBI</medicinalproduct>
        <drugauthorizationnumb>50753</drugauthorizationnumb>
        <drugdosagetext>300 MG, BID; INHALATION, REGIMEN 2</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>LUNG INFECTION PSEUDOMONAL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041103</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041129</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOBI</medicinalproduct>
        <drugauthorizationnumb>50753</drugauthorizationnumb>
        <drugdosagetext>300 MG, BID; INHALATION, REGIMEN 2</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>LUNG INFECTION PSEUDOMONAL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050107</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050121</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ELOBACT (CEFUROXIME AXETIL)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049255-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060626</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>T200600717</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>74</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANAPHYLACTIC REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>APNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MD-GASTROVIEW</medicinalproduct>
        <drugbatchnumb>L187A</drugbatchnumb>
        <drugauthorizationnumb>87388</drugauthorizationnumb>
        <drugdosagetext>60 ML, SINGLE, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>COMPUTERISED TOMOGRAM ABDOMEN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060623</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060623</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPROL-XL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONAZEPAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VERAPAMIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VICODIN (PARACETAMOL, HYDROCODONE BITARTATE)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049256-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006-06-2188</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</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>TEMODAR</medicinalproduct>
        <drugauthorizationnumb>21029</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049257-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>EM2006-0337</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>43</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>70</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIOMEGALY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DILATATION VENTRICULAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EJECTION FRACTION DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ENDOCARDITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MITRAL VALVE INCOMPETENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLEURAL EFFUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENTRICULAR HYPOKINESIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROLEUKIN</medicinalproduct>
        <drugdosagetext>6 MIU, BID; SUBCUTAN.</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060522</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060523</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRIZIVIR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZYRTEC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049258-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060627</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>226825</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>7</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>28.7</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROENTERITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NUTROPIN AQ</medicinalproduct>
        <drugauthorizationnumb>20522</drugauthorizationnumb>
        <drugdosagetext>1 MG, 7/WEEK, SUBCUTANEOUS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>OPTIC NERVE HYPOPLASIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020523</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CORTEF</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049259-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060622</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>35456</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>33</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>EYE IRRITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OCCUPATIONAL PROBLEM ENVIRONMENTAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OCULAR HYPERAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEVANAC</medicinalproduct>
        <drugauthorizationnumb>21862</drugauthorizationnumb>
        <drugdosagetext>1 GTT OS BID OPHT</drugdosagetext>
        <drugadministrationroute>047</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060328</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060328</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VIGAMOX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLAREX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049261-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060622</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>35455</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>40</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>EYE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCORRECT DOSE ADMINISTERED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLAMMATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEVANAC</medicinalproduct>
        <drugauthorizationnumb>21862</drugauthorizationnumb>
        <drugdosagetext>1 GTT OU BID OPHT</drugdosagetext>
        <drugadministrationroute>047</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060314</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060314</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VIGAMOX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLAREX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049262-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060622</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>34797</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>41</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>EYE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE IRRITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLAMMATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POST PROCEDURAL COMPLICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SENSATION OF FOREIGN BODY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEVANAC</medicinalproduct>
        <drugauthorizationnumb>21862</drugauthorizationnumb>
        <drugdosagetext>1 GTT OS BID OPHT</drugdosagetext>
        <drugadministrationroute>047</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060301</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VIGAMOX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLAREX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049263-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060620</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHNU2006DE02022</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>61</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>133</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ARRHYTHMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIABETIC NEPHROPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYSIPELAS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAMMA-GLUTAMYLTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GOITRE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC CONGESTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SANDIMMUNE</medicinalproduct>
        <drugauthorizationnumb>65063</drugauthorizationnumb>
        <drugdosagetext>150/O/175MG/DAY; ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEART TRANSPLANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19930101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMOXICILLIN TRIHYDRATE+POTASSIUM CLAVULANATE SANDOZ (NGX) (AMOXICILLIN</medicinalproduct>
        <drugdosagetext>500 MG, TID; ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ERYSIPELAS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060309</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XANEF (ENALAPRIL MALEATE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CONCOR COR (BISOPROLOL)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>L-THYROXINE (LEVOTHYROXINE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METAMIZOLE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049264-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060622</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>35460</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>37</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>EYE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FOREIGN BODY TRAUMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLAMMATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POST PROCEDURAL COMPLICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROCEDURAL COMPLICATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEVANAC</medicinalproduct>
        <drugauthorizationnumb>21862</drugauthorizationnumb>
        <drugdosagetext>1 GTT OS BID OPHT</drugdosagetext>
        <drugadministrationroute>047</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060222</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060222</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VIGAMOX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLAREX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049265-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060627</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006080629</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>68</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>INTERSTITIAL LUNG DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STOMACH DISCOMFORT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugauthorizationnumb>20702</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERCHOLESTEROLAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIAZEPAM</medicinalproduct>
        <drugdosagetext>(AS NEEDED); ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INSOMNIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BEPRICOR (BEPRIDIL)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049266-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060622</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>35459</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>42</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>EYE INFLAMMATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OCCUPATIONAL PROBLEM ENVIRONMENTAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OCULAR HYPERAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEVANAC</medicinalproduct>
        <drugauthorizationnumb>21862</drugauthorizationnumb>
        <drugdosagetext>1 GTT OS BID OPHT</drugdosagetext>
        <drugadministrationroute>047</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060222</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060222</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VIGAMOX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLAREX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049267-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060622</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>35458</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>35</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>IATROGENIC INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLAMMATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHOTOPHOBIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POST PROCEDURAL COMPLICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISION BLURRED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEVANAC</medicinalproduct>
        <drugauthorizationnumb>21862</drugauthorizationnumb>
        <drugdosagetext>1 GTT OS BID OPHT</drugdosagetext>
        <drugadministrationroute>047</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060322</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060322</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VIGAMOX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLAREX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049269-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060517</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006080757</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>26</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CHILLS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSED LEVEL OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CETIRIZINE HCL</medicinalproduct>
        <drugauthorizationnumb>19835</drugauthorizationnumb>
        <drugdosagetext>10 MG (10 MG, 1 IN 1 D); ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060425</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060425</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049270-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060623</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006S1004662</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>37</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG WITHDRAWAL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCORRECT DRUG ADMINISTRATION DURATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FENTANYL TRANSDERMAL SYSTEM</medicinalproduct>
        <drugbatchnumb>6N0146</drugbatchnumb>
        <drugauthorizationnumb>76258</drugauthorizationnumb>
        <drugdosagetext>50 UG/HR;Q3D;TRANS</drugdosagetext>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>BACK PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060601</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FENTANYL TRANSDERMAL SYSTEM</medicinalproduct>
        <drugbatchnumb>6N0146</drugbatchnumb>
        <drugauthorizationnumb>76258</drugauthorizationnumb>
        <drugdosagetext>50 UG/HR;Q3D;TRANS</drugdosagetext>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>NECK PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060601</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PARACETAMOL/HYDROCODONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BITARTRATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049273-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060623</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006S1002634</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>49</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>157.3982</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>AMMONIA INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTERIXIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DELIRIUM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSED LEVEL OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG LEVEL INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG TOXICITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC FUNCTION ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEDATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZAPINE</medicinalproduct>
        <drugauthorizationnumb>75417</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOAFFECTIVE DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060322</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZAPINE</medicinalproduct>
        <drugauthorizationnumb>75417</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOAFFECTIVE DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060325</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN ASPART</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPIRAMATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BUSPIRONE HCL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049275-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060622</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A-CH2006-12279</companynumb>
    <primarysource>
      <reportercountry>NETHERLANDS</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>68</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>99</patientweight>
      <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</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060119</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060215</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>20060216</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060420</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARBASALATE CALCIUM (CARBASALATE CALCIUM)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUMETERIDE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049277-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060621</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A-CH2006-12251</companynumb>
    <primarysource>
      <reportercountry>SWEDEN</reportercountry>
    </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>
      <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>20051213</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060109</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>20060110</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060301</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM CHANNEL BLOCKERS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049278-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060622</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A-CH2006-12068</companynumb>
    <primarysource>
      <reportercountry>NETHERLANDS</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>71</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>66</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ALANINE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASPARTATE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER FUNCTION TEST ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRACLEER</medicinalproduct>
        <drugauthorizationnumb>21290</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051209</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060322</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>20060323</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060330</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>20060425</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060509</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIRTAZAPINE</medicinalproduct>
        <drugdosagetext>15 MG, OD,</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060228</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060323</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRONOLACTONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FRISIUM (CLOBAZAM)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049280-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060606</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006SE03199</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>27993</patientonsetage>
      <patientonsetageunit>804</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DUODENAL ULCER HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATEMESIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ESOMEPRAZOLE</medicinalproduct>
        <drugauthorizationnumb>21689</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PEPTIC ULCER HAEMORRHAGE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060530</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060530</drugenddate>
        <drugtreatmentduration>30</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ESOMEPRAZOLE</medicinalproduct>
        <drugauthorizationnumb>021689</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060530</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060602</drugenddate>
        <drugtreatmentduration>4290</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ESOMEPRAZOLE</medicinalproduct>
        <drugauthorizationnumb>021153</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060602</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TORSEMIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIURETIC THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAMAL LONG</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANALGESIC THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RAMIPRIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049281-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060621</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>220022</companynumb>
    <primarysource>
      <reportercountry>SPAIN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>37</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>63</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUDDEN DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVASTIN</medicinalproduct>
        <drugdosagetext>270 MG, Q2W, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLORECTAL CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050606</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051109</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CAPECITABINE (CAPECITABINE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IRINOTECAN HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RINOBANEDIF (ANTAZOLINE NOS, BACITRACIN ZINC, EUCALYPTOL, NEOMYCIN SUL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DARBEPOETIN ALFA (DARBEPOETIN ALFA)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICATION (INGREDIENT) (GENERIC COMPONENT (S))</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049282-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060620</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>226809</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>46</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>78</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVASTIN</medicinalproduct>
        <drugdosagetext>7.5 MG/KG, Q3W, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLORECTAL CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060607</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CAPECITABINE (CAPECITABINE)</medicinalproduct>
        <drugdosagetext>2000 MG/M2, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>COLORECTAL CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060607</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IRINOTECAN HCL</medicinalproduct>
        <drugdosagetext>200 MG/M2, Q3W, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLORECTAL CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060607</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049283-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060621</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>226576</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>80</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>CARDIAC ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE ROLLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASTICITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METALYSE (TENECTEPLASE)PWDR + SOLVENT, INJUECTION SOLN, 50MG</medicinalproduct>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ACUTE MYOCARDIAL INFARCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060610</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060610</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049286-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060620</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006-01622</companynumb>
    <primarysource>
      <reportercountry>INDIA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>78</patientweight>
      <reaction>
        <reactionmeddrapt>FLUID RETENTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENOUS PRESSURE JUGULAR INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VELCADE</medicinalproduct>
        <drugauthorizationnumb>21602</drugauthorizationnumb>
        <drugdosagetext>1.30 MG/M2, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060526</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060605</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049288-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060620</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006-01391</companynumb>
    <primarysource>
      <reportercountry>CZECH REPUBLIC</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>67</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>GENERAL PHYSICAL HEALTH DETERIORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERFORMANCE STATUS DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VELCADE</medicinalproduct>
        <drugauthorizationnumb>21602</drugauthorizationnumb>
        <drugdosagetext>1.30 MG/M2,</drugdosagetext>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051007</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060418</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOXIL</medicinalproduct>
        <drugdosagetext>30.00 MG/M2,</drugdosagetext>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051010</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060410</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KALNORMIN (POTASSIUM CHLORIDE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VASOCARDIN (METOPROLOL TARTRATE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRESTARIUM (PERINDOPRIL)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049289-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060630</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHRM2006FR01988</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>76</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTH EXTRACTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugauthorizationnumb>021223</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARANESP</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049290-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060630</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHNU2006DE02420</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTH DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugauthorizationnumb>021223</drugauthorizationnumb>
        <drugdosagetext>4 MG, QMO</drugdosagetext>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040708</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060601</drugenddate>
        <drugtreatmentduration>694</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049291-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006-144891-NL</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>2</patientonsetage>
      <patientonsetageunit>802</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENA CAVA THROMBOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DANAPAROID</medicinalproduct>
        <drugauthorizationnumb>20430</drugauthorizationnumb>
        <drugdosagetext>200 ANTI_XA Q1HR INTRAVENOUS (NOS)</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>THROMBECTOMY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HEPARIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049292-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060622</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006AP02889</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>67</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ALVEOLITIS ALLERGIC</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MEROPEN</medicinalproduct>
        <drugauthorizationnumb>50706</drugauthorizationnumb>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>ACUTE MYELOID LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060207</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060311</drugenddate>
        <drugtreatmentduration>33</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049293-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060627</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006AP02945</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>69</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANOREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AUTOIMMUNE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CREATINE PHOSPHOKINASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOKALAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARALYSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugauthorizationnumb>021366</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERCHOLESTEROLAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060606</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060626</drugenddate>
        <drugtreatmentduration>21</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALBLOCK</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NU-LOTAN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RIZE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GRANDAXIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>JUVELA NICOTINATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049294-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060703</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006CG01147</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>78</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>70</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERKALAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HYTACAND</medicinalproduct>
        <drugauthorizationnumb>21093</drugauthorizationnumb>
        <drugdosagetext>16 + 12.5 MG DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19920101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>ALDACTONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19920101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060409</drugenddate>
        <drugtreatmentduration>14</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19920101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19920101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19920101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060409</drugenddate>
        <drugtreatmentduration>14</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CREON</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060409</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049295-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060707</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006CG01185</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>1</patientonsetage>
      <patientonsetageunit>805</patientonsetageunit>
      <patientweight>2.8</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>AMNIOCENTESIS ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>APNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION NEONATAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GRAND MAL CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFANTILE APNOEIC ATTACK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYDRIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEONATAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALLOR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIDOCAINE</medicinalproduct>
        <drugauthorizationnumb>006488</drugauthorizationnumb>
        <drugadministrationroute>064</drugadministrationroute>
        <drugindication>LOCAL ANAESTHESIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060422</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060422</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049296-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060703</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006CG01148</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>40</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>71</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HAEMATURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEUKOCYTURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OESOPHAGITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH MACULO-PAPULAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugauthorizationnumb>21153</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060604</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060606</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ORBENINE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060529</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060606</drugenddate>
        <drugtreatmentduration>9</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TERCIAN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>AGITATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060602</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>UMULINE</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060531</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HYPNOVEL</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>SEDATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060529</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FENTANYL TRANSDERMAL SYSTEM</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>SEDATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060529</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MOPRAL</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060602</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060604</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVENOX</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060602</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GENTAMICIN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060529</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060603</drugenddate>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049297-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060531</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006AP02797</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>25255</patientonsetage>
      <patientonsetageunit>804</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD ALKALINE PHOSPHATASE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IRESSA</medicinalproduct>
        <drugauthorizationnumb>021399</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>LUNG ADENOCARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060503</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060511</drugenddate>
        <drugtreatmentduration>9</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEPAKENE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060412</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ULCERMIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060421</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GASTER</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060421</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RADIOTHERAPY</medicinalproduct>
        <drugdosagetext>31 GRAYS TO WHOLE BRAIN</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060403</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060419</drugenddate>
        <drugtreatmentduration>17</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049298-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060707</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006CG01204</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>3.2</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>APGAR SCORE LOW</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION NEONATAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTONIA NEONATAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFANTILE APNOEIC ATTACK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE RIGIDITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYDRIASIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XYLOCAINE</medicinalproduct>
        <drugauthorizationnumb>6488</drugauthorizationnumb>
        <drugadministrationroute>064</drugadministrationroute>
        <drugindication>LOCAL ANAESTHESIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050216</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ANTASOL</medicinalproduct>
        <drugadministrationroute>064</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050215</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050215</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CUTIDINE</medicinalproduct>
        <drugadministrationroute>064</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060215</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060215</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NARCAN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050216</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050216</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049299-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060704</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006PK01477</companynumb>
    <primarysource>
      <reportercountry>AUSTRIA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>27102</patientonsetage>
      <patientonsetageunit>804</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ADNEXA UTERI CYST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ENDOMETRIAL DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NOLVADEX</medicinalproduct>
        <drugauthorizationnumb>017970</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031219</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051206</drugenddate>
        <drugtreatmentduration>719</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARIMIDEX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051207</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BETASERC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIZZINESS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NYZOC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERCHOLESTEROLAEMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRITTICO RETARD</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EBRANTIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HALCION</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SLEEP DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SEROPRAM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049300-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060616</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2006JP09093</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>47</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>77</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BODY TEMPERATURE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOVENTILATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIFE SUPPORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALLOR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY ARREST</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VOLTAREN</medicinalproduct>
        <drugauthorizationnumb>19201</drugauthorizationnumb>
        <drugdosagetext>100 MG, ONCE/SINGLE</drugdosagetext>
        <drugadministrationroute>054</drugadministrationroute>
        <drugindication>PROCEDURAL PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050215</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050215</drugenddate>
        <drugtreatmentduration>1440</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049301-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060703</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2006GT09883</companynumb>
    <primarysource>
      <reportercountry>GUATEMALA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>90</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD AMYLASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIPASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCREATITIS ACUTE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORADIL</medicinalproduct>
        <drugauthorizationnumb>20831</drugauthorizationnumb>
        <drugdosagetext>UNK, QD</drugdosagetext>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIFLONIDE</medicinalproduct>
        <drugdosagetext>UNK, QD</drugdosagetext>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>APROVEL</medicinalproduct>
        <drugdosagetext>300 MG/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAFIL</medicinalproduct>
        <drugdosagetext>0.5 MG/DAY</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049302-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060424</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2006CH06397</companynumb>
    <primarysource>
      <reportercountry>SWITZERLAND</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>67</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABSCESS JAW</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DENTURE WEARER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FISTULA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEURALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN JAW</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERIODONTAL DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTH EXTRACTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugauthorizationnumb>21223</drugauthorizationnumb>
        <drugdosagetext>UNK, QMO</drugdosagetext>
        <drugindication>METASTASES TO BONE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031010</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041215</drugenddate>
        <drugtreatmentduration>433</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MORPHINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NSAID'S</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FEMARA</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030318</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049303-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FRWYE283804SEP03</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>52</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>KIDNEY TRANSPLANT REJECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROTEINURIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RAPAMUNE</medicinalproduct>
        <drugauthorizationnumb>21110</drugauthorizationnumb>
        <drugdosagetext>10 MG 1X PER 1 DAY ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS AGAINST TRANSPLANT REJECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030425</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELLCEPT</medicinalproduct>
        <drugdosagetext>1.5 G 1X PER 1 DAY ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS AGAINST TRANSPLANT REJECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030425</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CORTANCYL (PREDNISONE, , 0)</medicinalproduct>
        <drugdosagetext>10 MG 1X PER 1 DAY ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS AGAINST TRANSPLANT REJECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030425</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RAMIPRIL</medicinalproduct>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030814</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049304-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FRWYE927730JUN06</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>57</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BONE PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RAPAMUNE</medicinalproduct>
        <drugauthorizationnumb>21110</drugauthorizationnumb>
        <drugdosagetext>12 MG TOTAL DAILY AT THE TIME OF THE EVENT ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS AGAINST TRANSPLANT REJECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021230</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MYCOPHENOLATE MOFETIL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049305-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060630</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006AP03024</companynumb>
    <primarysource>
      <reportercountry>CHINA</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>56</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>RED BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IRESSA</medicinalproduct>
        <drugauthorizationnumb>21399</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060620</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN DRUG</medicinalproduct>
        <drugindication>WHITE BLOOD CELL COUNT INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN DRUG</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GEMCITABINE</medicinalproduct>
        <drugdosagetext>4 COURSES</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060530</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060601</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CHINESE HERBAL MEDICINE</medicinalproduct>
        <drugindication>WHITE BLOOD CELL COUNT INCREASED</drugindication>
        <drugtreatmentduration>10</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049306-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060623</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006-144557-NL</companynumb>
    <primarysource>
      <reportercountry>SWITZERLAND</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>45</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIRTAZAPINE</medicinalproduct>
        <drugauthorizationnumb>21208</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHADONE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EFAVIRENZ</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TENOFOVIR DISOPROXIL FUMARATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LAMIVUDINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BACTRIM DS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049307-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060623</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006-144358-NL</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>IMPLANT SITE FIBROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJURY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NUVARING</medicinalproduct>
        <drugauthorizationnumb>21187</drugauthorizationnumb>
        <drugdosagetext>DF</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049308-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060622</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>TCI2006A02637</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>66</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ALANINE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASPARTATE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD BILIRUBIN 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>REFUSAL OF TREATMENT BY RELATIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACTOS</medicinalproduct>
        <drugauthorizationnumb>21073</drugauthorizationnumb>
        <drugdosagetext>30 MG (30 MG, 1 D) PER ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS NON-INSULIN-DEPENDENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060406</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060622</drugenddate>
        <drugtreatmentduration>77</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049309-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050311</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FRWYE881429JUN06</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>49</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>IMMUNOSUPPRESSANT DRUG LEVEL INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SIROLIMUS                                  (SIROLIMUS, SOLUTION)</medicinalproduct>
        <drugauthorizationnumb>21083</drugauthorizationnumb>
        <drugdosagetext>8 MG 1X PER 1 DAY ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RENAL TRANSPLANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020915</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20021017</drugenddate>
        <drugtreatmentduration>33</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SIROLIMUS                                  (SIROLIMUS, SOLUTION)</medicinalproduct>
        <drugauthorizationnumb>21083</drugauthorizationnumb>
        <drugdosagetext>8 MG 1X PER 1 DAY ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RENAL TRANSPLANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021020</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20021023</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049311-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>HQWYE480629JUN06</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>75</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD CREATININE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRADYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISORIENTATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THERAPEUTIC AGENT TOXICITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</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>1</drugcharacterization>
        <medicinalproduct>DIGOXIN</medicinalproduct>
        <drugdosagetext>0.125 MG 1X PER 1 DAY ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060412</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060527</drugenddate>
        <drugtreatmentduration>46</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LACTULOSE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FENOFIBRATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRIMPERAN TAB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRANSIPEG (MACROGOL)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GELOX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVENOX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049312-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060603</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200610861BYL</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>72</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>20050601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050801</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049314-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060623</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>VNL_0122_2006</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>68</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ARTERIAL OCCLUSIVE DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERIPHERAL COLDNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>APO-GO</medicinalproduct>
        <drugauthorizationnumb>21264</drugauthorizationnumb>
        <drugdosagetext>4 MG/HR INFUSION SC</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PARKINSON'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MADOPAR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MADOPAR L T</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MADOPAR DEPOT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PARKOTIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALMIRID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MIRTAZAPINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUNITRAZEPAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEURONTN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MOBIC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MOTILIUM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049316-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060620</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>S06-FRA-02612-01</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>47</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>EMPHYSEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EXPOSURE TO TOXIC AGENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL SELF-INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERSTITIAL LUNG DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLEURAL EFFUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDE ATTEMPT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROPLEX (ESCITALOPRAM)</medicinalproduct>
        <drugauthorizationnumb>21323</drugauthorizationnumb>
        <drugdosagetext>25 TABLET ONCE PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DYSTHYMIC DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060501</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROPLEX (ESCITALOPRAM)</medicinalproduct>
        <drugdosagetext>1.5 UNITS QD PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DYSTHYMIC DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060131</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060501</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROPLEX (ESCITALOPRAM)</medicinalproduct>
        <drugindication>DYSTHYMIC DISORDER</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060609</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049317-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060706</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0607USA00506</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>76</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>80</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD CREATINE PHOSPHOKINASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULAR WEAKNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZETIA</medicinalproduct>
        <drugauthorizationnumb>021445</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050314</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060621</drugenddate>
        <drugtreatmentduration>465</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLYBURIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050901</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HALDOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050501</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAZODONE HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030806</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049318-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060310</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-MERCK-0603FRA00036</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>71</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>AORTIC DISSECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INDOCIN</medicinalproduct>
        <drugauthorizationnumb>16059</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANKYLOSING SPONDYLITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>ANKYLOSING SPONDYLITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050601</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049319-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060706</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-MERCK-0607DEU00098</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>84</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BREAST CANCER MALE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROSCAR</medicinalproduct>
        <drugauthorizationnumb>020180</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BENIGN PROSTATIC HYPERPLASIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051001</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049320-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060707</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0607USA00949</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>80</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIAC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC PACEMAKER INSERTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL MUCOSAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTH LOSS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19960101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALPRAZOLAM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049321-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060627</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>NZ-MERCK-0606NZL00026</companynumb>
    <primarysource>
      <reportercountry>NEW ZEALAND</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>49</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD BILIRUBIN INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZETIA</medicinalproduct>
        <drugauthorizationnumb>021445</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HYPERLIPIDAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060601</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CILAZAPRIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DILTIAZEM HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRIMETHOPRIM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049322-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060620</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>S06-CAN-02486-01</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>0</patientsex>
      <reaction>
        <reactionmeddrapt>BRADYCARDIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TIAZAC</medicinalproduct>
        <drugauthorizationnumb>20401</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049323-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060621</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-MERCK-0606USA05689</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>79</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>38</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANAPHYLACTIC SHOCK</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COZAAR</medicinalproduct>
        <drugauthorizationnumb>20386</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM</medicinalproduct>
        <drugadministrationroute>051</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050816</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NAFAMOSTAT MESYLATE</medicinalproduct>
        <drugadministrationroute>051</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DALTEPARIN SODIUM</medicinalproduct>
        <drugadministrationroute>051</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CEREBROVASCULAR DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THEOLONG</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANPLAG</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTERIOSCLEROSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OPALMON</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTERIOSCLEROSIS OBLITERANS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGNESIUM OXIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM POLYCARBOPHIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONSTIPATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049324-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060705</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0607USA00511</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MOVEMENT DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULAR WEAKNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZETIA</medicinalproduct>
        <drugauthorizationnumb>021445</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOPHAGE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPROL-XL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMARYL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049326-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060620</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>S06-FRA-01780-01</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>81</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>68</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>NEPHROTIC SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EBIXA (MEMANTINE)</medicinalproduct>
        <drugauthorizationnumb>21487</drugauthorizationnumb>
        <drugdosagetext>20  MG QD PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEMENTIA ALZHEIMER'S TYPE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060126</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COVERSYL (PERINDOPRIL)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SECTRAL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049328-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060619</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>226781</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLISTER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN REACTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HERCEPTIN</medicinalproduct>
        <drugindication>BREAST CANCER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAXOTERE</medicinalproduct>
        <drugindication>BREAST CANCER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049329-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060622</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>226651</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>25</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISEASE RECURRENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA AT REST</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XOLAIR</medicinalproduct>
        <drugdosagetext>150 MG, SINGLE, SUBCUTANEOUS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060614</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060614</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DECORTIN (PREDNISONE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AZATHIOPRINE SODIUM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049331-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060707</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AVENTIS-200615700US</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLINDNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE OPERATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
        <drugbatchnumb>N313</drugbatchnumb>
        <drugauthorizationnumb>021081</drugauthorizationnumb>
        <drugindication>DIABETES MELLITUS INSULIN-DEPENDENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REGULAR INSULIN</medicinalproduct>
        <drugdosagetext>DOSE: SLIDING SCALE</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049332-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060517</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-AVENTIS-200611556JP</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>68</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>62</patientweight>
      <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>DAONIL</medicinalproduct>
        <drugauthorizationnumb>17532</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19970101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031208</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KLARICID</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HELICOBACTER INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031206</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031208</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OMEPRAZON</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HELICOBACTER INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031206</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031208</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMOXICILLIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HELICOBACTER INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031206</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031208</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>URALYT</medicinalproduct>
        <drugdosagetext>DOSE: 1 TABLET</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CALCULUS URETERIC</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031208</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031208</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031208</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BUFFERIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031208</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049333-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060621</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PAR_0686_2006</companynumb>
    <primarysource>
      <reportercountry>SPAIN</reportercountry>
    </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>PYREXIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
        <drugauthorizationnumb>70481</drugauthorizationnumb>
        <drugdosagetext>400 MG PRN PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MIGRAINE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060501</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ANTALGIN</medicinalproduct>
        <drugdosagetext>550 MG PRN PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MIGRAINE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060501</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOPAMAX</medicinalproduct>
        <drugdosagetext>DF PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MIGRAINE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060404</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060504</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALMOGRAN</medicinalproduct>
        <drugdosagetext>25 MG QDAY</drugdosagetext>
        <drugindication>MIGRAINE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060404</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060504</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049334-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060627</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>S06-USA-02282-01</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>52</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD THYROID STIMULATING HORMONE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING JITTERY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYASTHENIA GRAVIS CRISIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TEMPERATURE INTOLERANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRI-IODOTHYRONINE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRI-IODOTHYRONINE UPTAKE DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>THYROLAR-1</medicinalproduct>
        <drugbatchnumb>100510</drugbatchnumb>
        <drugauthorizationnumb>16807</drugauthorizationnumb>
        <drugdosagetext>1.25 TABLET QD PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPOTHYROIDISM</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>THYROLAR-1</medicinalproduct>
        <drugbatchnumb>100510</drugbatchnumb>
        <drugdosagetext>1.25 TABLET PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPOTHYROIDISM</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>THYROLAR-1</medicinalproduct>
        <drugbatchnumb>100510</drugbatchnumb>
        <drugdosagetext>1 TABLET TIW PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPOTHYROIDISM</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>THYROLAR-1</medicinalproduct>
        <drugbatchnumb>100510</drugbatchnumb>
        <drugdosagetext>1.25 TABLET PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPOTHYROIDISM</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>THYROLAR-1</medicinalproduct>
        <drugbatchnumb>100510</drugbatchnumb>
        <drugdosagetext>1 TABLET TIW PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPOTHYROIDISM</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>THYROLAR-1</medicinalproduct>
        <drugbatchnumb>100510</drugbatchnumb>
        <drugdosagetext>1.25 TABLET PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPOTHYROIDISM</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>THYROLAR-1</medicinalproduct>
        <drugbatchnumb>100510</drugbatchnumb>
        <drugdosagetext>1 TABLET TIW PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPOTHYROIDISM</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>THYROID TAB</medicinalproduct>
        <drugdosagetext>15 MG QD PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPOTHYROIDISM</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TIKOSYN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MESTINON</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049335-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060529</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DEWYE657629MAY06</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CIRCULATORY COLLAPSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROENTERITIS ROTAVIRUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPHADENITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>JUVENILE ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000316</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060517</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060227</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AZATHIOPRINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049336-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060627</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>S06-USA-02478-01</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>50</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>AMNESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLITIS ISCHAEMIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTHYROIDISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH PRURITIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URTICARIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEXAPRO</medicinalproduct>
        <drugauthorizationnumb>21323</drugauthorizationnumb>
        <drugindication>NERVOUSNESS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEGASYS</medicinalproduct>
        <drugdosagetext>180 MCG QW SC</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040102</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040617</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RIBAVIRIN</medicinalproduct>
        <drugdosagetext>800 MG QD PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040102</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040617</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049337-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060627</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>HQWYE456629APR05</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>56</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ATELECTASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRADYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBRAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISSEMINATED INTRAVASCULAR COAGULATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ISCHAEMIC STROKE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROSTATE CANCER METASTATIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY TRACT INFECTION ENTEROCOCCAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MYLOTARG</medicinalproduct>
        <drugauthorizationnumb>21174</drugauthorizationnumb>
        <drugdosagetext>18.9 MG 1X PER 1 DAY, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ACUTE MYELOID LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050421</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050421</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMPICILLIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOFLOXACIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CEFEPIME (CEFEPIME)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRETINOIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRETINOIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VANCOMYCIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANTOPRAZOLE SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANTOPRAZOLE SODIUM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049338-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20020425</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0367026A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>42</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>54.1</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL DISTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANOREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIABETIC GASTROPARESIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIABETIC NEUROPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISEASE RECURRENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG DEPENDENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPEPSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FAECES DISCOLOURED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLATULENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTESTINAL OBSTRUCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LETHARGY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NIGHT SWEATS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LOTRONEX</medicinalproduct>
        <drugauthorizationnumb>021107</drugauthorizationnumb>
        <drugdosagetext>1MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>IRRITABLE BOWEL SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20000901</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KLONOPIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RESTORIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HUMULIN N</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRILOSEC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EXLAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MORPHINE</medicinalproduct>
        <drugdosagetext>30MG TWICE PER DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HALCION</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARDIZEM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACTOS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049339-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050302</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0548238A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>48</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>77.7</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ARTERIOSPASM CORONARY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD POTASSIUM DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRADYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC ENZYMES INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERICARDITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMITREX</medicinalproduct>
        <drugauthorizationnumb>20132</drugauthorizationnumb>
        <drugdosagetext>50MG AS REQUIRED</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020226</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049340-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060310</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0597159A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>64</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HEART RATE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SENSORY DISTURBANCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REQUIP</medicinalproduct>
        <drugauthorizationnumb>20658</drugauthorizationnumb>
        <drugdosagetext>.25MG SINGLE DOSE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RESTLESS LEGS SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060303</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060303</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM GLUCONATE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049341-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060328</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0599379A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>52</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISEASE PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIPASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METASTASES TO PANCREAS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCREATITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HYCAMTIN</medicinalproduct>
        <drugauthorizationnumb>20671</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060327</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NO CONCURRENT MEDICATION</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049342-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060325</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0599987A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ADVAIR DISKUS 100/50</medicinalproduct>
        <drugauthorizationnumb>21077</drugauthorizationnumb>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
        <drugtreatmentduration>9</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL SPIROS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049343-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060420</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0602623A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>68</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEPRESSED MOOD</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISSOCIATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EMOTIONAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOOD ALTERED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
        <drugauthorizationnumb>020031</drugauthorizationnumb>
        <drugdosagetext>20MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN MEDICATION</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPAMAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KLONOPIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049344-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060504</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0604727A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>50</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD CATECHOLAMINES INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY BYPASS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT AND COLD</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>WELLBUTRIN</medicinalproduct>
        <drugauthorizationnumb>18644</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060224</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBIF</medicinalproduct>
        <drugdosagetext>44MCG THREE TIMES PER WEEK</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040322</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049345-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060526</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0607084A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>79</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG ADMINISTRATION ERROR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POOR QUALITY DRUG ADMINISTERED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRANSIENT ISCHAEMIC ATTACK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ADVAIR DISKUS 100/50</medicinalproduct>
        <drugbatchnumb>5ZP3678</drugbatchnumb>
        <drugauthorizationnumb>021077</drugauthorizationnumb>
        <drugdosagetext>1PUFF TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL SPIROS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IPRATROPIUM BROMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NADOLOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REQUIP</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONAZEPAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHADOSE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049346-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060613</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0608831A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>50</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>79.5</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BALANCE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COORDINATION ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISORIENTATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HALLUCINATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEMORY IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN EXFOLIATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMICTAL</medicinalproduct>
        <drugauthorizationnumb>20241</drugauthorizationnumb>
        <drugdosagetext>200MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BIPOLAR DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060109</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060308</drugenddate>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHYLPHENIDATE HCL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049347-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060619</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-GLAXOSMITHKLINE-A0609613A</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>62</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VASCULAR BYPASS GRAFT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>21071</drugauthorizationnumb>
        <drugdosagetext>4MG AT NIGHT</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADALAT</medicinalproduct>
        <drugdosagetext>60MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
        <drugdosagetext>100MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugdosagetext>20MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>81MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLICLAZIDE</medicinalproduct>
        <drugdosagetext>80MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
        <drugdosagetext>850MG THREE TIMES PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049348-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060626</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>HQWYE640005APR06</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>79</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ATELECTASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE SYSTOLIC INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DECREASED APPETITE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EMPHYSEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEBRILE NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOBAR PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG NEOPLASM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSEUDOMONAL BACTERAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY RATE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MYLOTARG</medicinalproduct>
        <drugauthorizationnumb>21174</drugauthorizationnumb>
        <drugdosagetext>15 MG, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ACUTE MYELOID LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050601</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MYLOTARG</medicinalproduct>
        <drugauthorizationnumb>21174</drugauthorizationnumb>
        <drugdosagetext>15 MG, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ACUTE MYELOID LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050616</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050616</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AUGMENTIN '125'</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOCUSATE (DOCUSATE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COMPAZINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM CHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROPRANOLOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTIVITAMINS, PLAIN (MULTIVITAMINS, PLAIN)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM (CALCIUM)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FIBRE, DIETARY (FIBRE, DIETARY)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049349-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060626</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0610527A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>58</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugauthorizationnumb>20297</drugauthorizationnumb>
        <drugdosagetext>6.25MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050801</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049350-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060707</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0611450A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>12</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCREASED UPPER AIRWAY SECRETION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARYNGOLARYNGEAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ADVAIR DISKUS 100/50</medicinalproduct>
        <drugbatchnumb>6ZP9710</drugbatchnumb>
        <drugauthorizationnumb>021077</drugauthorizationnumb>
        <drugdosagetext>1PUFF TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL SPIROS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049351-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060707</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0611494A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>32</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OLIGOHYDRAMNIOS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PREGNANCY INDUCED HYPERTENSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMICTAL</medicinalproduct>
        <drugauthorizationnumb>020241</drugauthorizationnumb>
        <drugdosagetext>50MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PANIC ATTACK</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRENATAL VITAMINS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049352-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060707</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0611494B</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>3.3</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMICTAL</medicinalproduct>
        <drugauthorizationnumb>020241</drugauthorizationnumb>
        <drugdosagetext>50MG PER DAY</drugdosagetext>
        <drugindication>EPILEPSY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRENATAL VITAMINS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049353-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060710</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0611631A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>79</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CATARACT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GLOSSITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GLOSSODYNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TONGUE DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>6.25MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORAZEPAM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049354-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060706</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0611685A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>22</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>COMPLETED SUICIDE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>WELLBUTRIN</medicinalproduct>
        <drugauthorizationnumb>018644</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050610</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050601</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049355-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060710</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006-05-1546</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>51</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EMOTIONAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
        <drugauthorizationnumb>020031</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEORAL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM + VITAMIN D</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELLCEPT</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGNESIUM OXIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>URSODEOXYCHOLIC ACID</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROTONIX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049356-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060710</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0611711A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAXIL CR</medicinalproduct>
        <drugauthorizationnumb>020936</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049357-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060424</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-JPN-A200601345</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>73</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>58</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAZE PALSY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERACUSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULAR WEAKNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NERVE INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPEECH DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VALTREX</medicinalproduct>
        <drugauthorizationnumb>20487</drugauthorizationnumb>
        <drugdosagetext>1000MG THREE TIMES PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HERPES ZOSTER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060423</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060423</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANDEL</medicinalproduct>
        <drugdosagetext>40MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990428</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NU-LOTAN</medicinalproduct>
        <drugdosagetext>50MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000412</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugdosagetext>20MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030124</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>JUVELA N</medicinalproduct>
        <drugdosagetext>200MG THREE TIMES PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NEUROPATHY PERIPHERAL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19840705</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NITOROL R</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANGINA PECTORIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19991006</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FERROMIA</medicinalproduct>
        <drugdosagetext>50MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19970929</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THYRADIN S</medicinalproduct>
        <drugdosagetext>25MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPOTHYROIDISM</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041110</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOXONIN</medicinalproduct>
        <drugdosagetext>60MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PHARYNGOLARYNGEAL PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050922</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARDENALIN</medicinalproduct>
        <drugdosagetext>.5MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060322</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NOVORAPID</medicinalproduct>
        <drugdosagetext>12IU THREE TIMES PER DAY</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020426</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN</medicinalproduct>
        <drugdosagetext>10IU PER DAY</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19941104</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARASENA-A</medicinalproduct>
        <drugdosagetext>300MG PER DAY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>HERPES ZOSTER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060420</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ISOTONIC SODIUM CHLORIDE SOLUTION</medicinalproduct>
        <drugdosagetext>250ML PER DAY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060420</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060422</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYANOCOBALAMIN</medicinalproduct>
        <drugdosagetext>500MCG THREE TIMES PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NEUROPATHY PERIPHERAL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060420</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060423</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANDERM</medicinalproduct>
        <drugadministrationroute>003</drugadministrationroute>
        <drugindication>HERPES ZOSTER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060420</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060423</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049358-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060524</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-GLAXOSMITHKLINE-B0425959A</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>42</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>79.5</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARYNGEAL OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SENSATION OF FOREIGN BODY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROAT TIGHTNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PIRITON SYRUP</medicinalproduct>
        <drugbatchnumb>BN60013A</drugbatchnumb>
        <drugdosagetext>10ML TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060515</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060520</drugenddate>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GAVISCON</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SALINE STERIPOULES</medicinalproduct>
        <drugdosagetext>1AMP THREE TIMES PER DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SALBUTAMOL INHALER</medicinalproduct>
        <drugdosagetext>2PUFF AS REQUIRED</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PARACETAMOL</medicinalproduct>
        <drugdosagetext>2TAB FOUR TIMES PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASMANEX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYGEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CEFIXIME CHEWABLE</medicinalproduct>
        <drugdosagetext>1TAB TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALENDRONIC ACID</medicinalproduct>
        <drugdosagetext>70MG WEEKLY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RANITIDINE</medicinalproduct>
        <drugdosagetext>1TAB TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BETNESOL N</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EPIPEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CINNARIZINE</medicinalproduct>
        <drugdosagetext>2TAB THREE TIMES PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FORMOTEROL POWDER</medicinalproduct>
        <drugdosagetext>2PUFF THREE TIMES PER DAY</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENDROFLUAZIDE</medicinalproduct>
        <drugdosagetext>1TAB PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASMANEX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYGEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CEFIXIME CHEWABLE</medicinalproduct>
        <drugdosagetext>200MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALENDRONIC ACID</medicinalproduct>
        <drugdosagetext>70MG WEEKLY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CHLORPHENAMINE</medicinalproduct>
        <drugdosagetext>4MG THREE TIMES PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049359-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060530</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-JPN-A200601807</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>75</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>45</patientweight>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ANOREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLISTER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSED LEVEL OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULAR WEAKNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALLOR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SCAB</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUDDEN DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VIRAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VIRAL MYOCARDITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VALTREX</medicinalproduct>
        <drugauthorizationnumb>20487</drugauthorizationnumb>
        <drugdosagetext>1000MG VARIABLE DOSE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HERPES ZOSTER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060518</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060525</drugenddate>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DECADRON</medicinalproduct>
        <drugdosagetext>.25MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUTIDE</medicinalproduct>
        <drugdosagetext>200MCG PER DAY</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLEANAL</medicinalproduct>
        <drugdosagetext>1200MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNIPHYL</medicinalproduct>
        <drugdosagetext>400MCG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MICARDIS</medicinalproduct>
        <drugdosagetext>20MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031110</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOGMATYL</medicinalproduct>
        <drugdosagetext>150MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031006</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRIMPERAN TAB</medicinalproduct>
        <drugdosagetext>3U PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050409</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049360-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060607</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-JPN-A200601905</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>66</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>54</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COORDINATION ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DELUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIPLOPIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSARTHRIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HALLUCINATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULAR WEAKNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPEECH DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOXIC INDUCED ENCEPHALOPATHY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VALTREX</medicinalproduct>
        <drugauthorizationnumb>20487</drugauthorizationnumb>
        <drugdosagetext>500MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HERPES ZOSTER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060603</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYANOCOBALAMIN</medicinalproduct>
        <drugdosagetext>1.5MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HERPES ZOSTER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060605</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRAVIT</medicinalproduct>
        <drugdosagetext>100MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RENAL FAILURE CHRONIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060530</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060603</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NAPROXEN</medicinalproduct>
        <drugdosagetext>600MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HERPES ZOSTER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060605</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALINAMIN-F</medicinalproduct>
        <drugdosagetext>75MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HERPES ZOSTER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060605</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROMAC</medicinalproduct>
        <drugdosagetext>1G PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RENAL FAILURE CHRONIC</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAKEPRON</medicinalproduct>
        <drugdosagetext>15MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RENAL FAILURE CHRONIC</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>100MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RENAL FAILURE CHRONIC</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ISOSORBIDE MONONITRATE</medicinalproduct>
        <drugdosagetext>40MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RENAL FAILURE CHRONIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060330</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIGMART</medicinalproduct>
        <drugdosagetext>15MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060330</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>URSO</medicinalproduct>
        <drugdosagetext>300MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RENAL FAILURE CHRONIC</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BIO THREE</medicinalproduct>
        <drugdosagetext>3U PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RENAL FAILURE CHRONIC</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALTAN</medicinalproduct>
        <drugdosagetext>3G PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RENAL FAILURE CHRONIC</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GOSHA-JINKI-GAN</medicinalproduct>
        <drugdosagetext>7.5G PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RENAL FAILURE CHRONIC</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEXITIL</medicinalproduct>
        <drugdosagetext>150MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RENAL FAILURE CHRONIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060514</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANALDINE</medicinalproduct>
        <drugdosagetext>200MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CAROTID ARTERY STENOSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060227</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049362-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060619</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-JPN-A200602148</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>38</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>59</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEPRESSED LEVEL OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG TOXICITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IRRITABILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDE ATTEMPT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
        <drugauthorizationnumb>20031</drugauthorizationnumb>
        <drugdosagetext>10MG SEE DOSAGE TEXT</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060529</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060617</drugenddate>
        <drugtreatmentduration>20</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN DRUG</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEILAX</medicinalproduct>
        <drugdosagetext>1MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060529</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060611</drugenddate>
        <drugtreatmentduration>14</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GASMOTIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEILAX</medicinalproduct>
        <drugdosagetext>2MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060612</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060617</drugenddate>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049363-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060626</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-JPN-A200602285</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>83</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VALTREX</medicinalproduct>
        <drugauthorizationnumb>020487</drugauthorizationnumb>
        <drugdosagetext>1000MG THREE TIMES PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HERPES ZOSTER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060621</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060626</drugenddate>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYANOCOBALAMIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NAPROXEN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRICOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPIDIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MUCOSTA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049364-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-JPN-A200602387</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <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>PAXIL</medicinalproduct>
        <drugauthorizationnumb>20031</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OBSESSIVE-COMPULSIVE DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060516</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEPAS</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060601</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049365-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060703</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-GLAXOSMITHKLINE-B0429459A</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANAPHYLACTIC SHOCK</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PIRITON TABLETS</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049366-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060630</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-JPN-A200602401</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>EPISTAXIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGE SUBCUTANEOUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC FUNCTION ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
        <drugauthorizationnumb>20031</drugauthorizationnumb>
        <drugdosagetext>20MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060530</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060629</drugenddate>
        <drugtreatmentduration>30</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDONINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARTIST</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>URALYT</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEVALOTIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SELBEX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEPAS</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEILAX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGNESIUM OXIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049367-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060703</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-JPN-A200602471</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CORNEAL EPITHELIUM DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IRIS DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOVIRAX</medicinalproduct>
        <drugauthorizationnumb>018603</drugauthorizationnumb>
        <drugadministrationroute>047</drugadministrationroute>
        <drugindication>KERATITIS HERPETIC</drugindication>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049368-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060630</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-JPN-A200602483</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>24</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HEMIPLEGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMIGRAN</medicinalproduct>
        <drugauthorizationnumb>20132</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049369-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060706</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-JPN-A200602516</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>22</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANAPHYLACTIC SHOCK</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
        <drugauthorizationnumb>20031</drugauthorizationnumb>
        <drugdosagetext>20MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PANIC DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060703</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NAUZELIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEILAX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049370-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060710</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-GLAXOSMITHKLINE-B0430384A</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>9</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERNATIONAL NORMALISED RATIO INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLAMOXYL</medicinalproduct>
        <drugauthorizationnumb>50754</drugauthorizationnumb>
        <drugdosagetext>1G THREE TIMES PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060613</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060619</drugenddate>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACENOCOUMAROL</medicinalproduct>
        <drugdosagetext>1TAB SEE DOSAGE TEXT</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060618</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEROXAT</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060619</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXEOL</medicinalproduct>
        <drugdosagetext>1UNIT PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060619</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOLIPRANE</medicinalproduct>
        <drugdosagetext>6UNIT PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060619</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HEMIGOXINE NATIVELLE</medicinalproduct>
        <drugdosagetext>.125MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060619</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANTOPRAZOLE SODIUM</medicinalproduct>
        <drugdosagetext>40MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060619</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TEMESTA</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRIATEC</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIFFU K</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060619</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASILIX</medicinalproduct>
        <drugdosagetext>500MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASILIX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060620</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060623</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049371-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060704</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-GLAXOSMITHKLINE-B0430569A</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>4</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>12</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CRYOGLOBULINAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CUTANEOUS VASCULITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ECCHYMOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOE AMPUTATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VENTOLIN</medicinalproduct>
        <drugauthorizationnumb>018473</drugauthorizationnumb>
        <drugindication>ASTHMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060301</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLIXOTIDE</medicinalproduct>
        <drugauthorizationnumb>020121</drugauthorizationnumb>
        <drugdosagetext>50MCG PER DAY</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060301</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MOTILIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VFEND</medicinalproduct>
        <drugdosagetext>50MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040501</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BACTRIM</medicinalproduct>
        <drugdosagetext>5ML THREE TIMES PER WEEK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INFECTION PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020501</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GRANOCYTE</medicinalproduct>
        <drugdosagetext>13.4IU6 THREE TIMES PER WEEK</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GAVISCON</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049372-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060706</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IT-GLAXOSMITHKLINE-B0430681A</companynumb>
    <primarysource>
      <reportercountry>ITALY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>POLYCYTHAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMICTAL</medicinalproduct>
        <drugauthorizationnumb>020241</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BIPOLAR DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTIHYPERTENSIVE</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049373-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060707</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-GLAXOSMITHKLINE-D0050246A</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PREMATURE LABOUR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RETROVIR</medicinalproduct>
        <drugauthorizationnumb>019655</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049374-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060707</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-GLAXOSMITHKLINE-D0050246B</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>7</patientonsetage>
      <patientonsetageunit>804</patientonsetageunit>
      <patientweight>19.8</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>NECROTISING COLITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RETROVIR</medicinalproduct>
        <drugauthorizationnumb>19655</drugauthorizationnumb>
        <drugdosagetext>3MG FOUR TIMES PER DAY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ANTIVIRAL PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030614</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030623</drugenddate>
        <drugtreatmentduration>10</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RETROVIR</medicinalproduct>
        <drugindication>HIV INFECTION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030614</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049375-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060613</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-STX182777</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NECK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>P055679</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROTONIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZETIA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYLENOL (CAPLET)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM GLUCONATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ISORDIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOMOTIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREMPRO 14/14</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTIVITAMIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049376-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060626</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>HQWYE390726JUN06</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>81</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MALLORY-WEISS SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OESOPHAGEAL ULCER HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CORDARONE</medicinalproduct>
        <drugauthorizationnumb>18972</drugauthorizationnumb>
        <drugindication>ARRHYTHMIA</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMDUR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SOTALOL (SOTALOL)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049377-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060630</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>HQWYE526130JUN06</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BREAST CANCER FEMALE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOPOROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHEUMATOID ARTHRITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INDERAL</medicinalproduct>
        <drugauthorizationnumb>16418</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049379-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060525</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-STX180875</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>93.9</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC FIBROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATITIS C</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HERPES ZOSTER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER FUNCTION TEST ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PSORIASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050126</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050731</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19800101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050731</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040325</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060531</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049381-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060626</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>HQWYE867006OCT05</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>68</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>88.9</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>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERAL PHYSICAL HEALTH DETERIORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC ENZYME INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOVOLAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL TUBULAR NECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL VEIN THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MYLOTARG</medicinalproduct>
        <drugauthorizationnumb>21174</drugauthorizationnumb>
        <drugdosagetext>18 MG 1X PER 1 DAY, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ACUTE MYELOID LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050922</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050922</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BACTRIM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CIPRO</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COMPAZINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACYCLOVIR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUCONAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCONTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCODONE 2.5/APAP 500</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COMBIVENT (IPRATROPIUM BROMIDE/SALBUTAMOL SUFATE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MOMETASONE (MOMETASONE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPROL-XL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRONOLACTONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049383-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060627</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200612716BCC</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>52</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>70.3075</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABORTION SPONTANEOUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ONE A DAY ESSENTIALS</medicinalproduct>
        <drugbatchnumb>5PB0541</drugbatchnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>VITAMIN SUPPLEMENTATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060509</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ONE A DAY ESSENTIALS</medicinalproduct>
        <drugbatchnumb>5PB0541</drugbatchnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>VITAMIN SUPPLEMENTATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060523</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060605</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CITRUCEL PRENATAL VITAMINS (METHYLCELLULOSE)</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060509</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060614</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049386-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060705</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>NO-JNJFOC-20060605884</companynumb>
    <primarysource>
      <reportercountry>NORWAY</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HEPATOCELLULAR DAMAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVERDOSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PARACETAMOL</medicinalproduct>
        <drugauthorizationnumb>19872</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PARACETAMOL</medicinalproduct>
        <drugauthorizationnumb>019872</drugauthorizationnumb>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049387-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060626</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200610621BFR</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
    </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>DISEASE PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERCALCAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXAVAR</medicinalproduct>
        <drugauthorizationnumb>21923</drugauthorizationnumb>
        <drugdosagetext>200 MG, BID, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>METASTATIC RENAL CELL CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060512</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCONTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZELITREX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPEGIC 1000</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FORLAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FRAXIPARINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049388-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060623</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200610610BFR</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>65</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SORAFENIB</medicinalproduct>
        <drugauthorizationnumb>21923</drugauthorizationnumb>
        <drugdosagetext>400 MG, BID, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RENAL CELL CARCINOMA STAGE UNSPECIFIED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060103</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060504</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SORAFENIB</medicinalproduct>
        <drugauthorizationnumb>21923</drugauthorizationnumb>
        <drugdosagetext>400 MG, BID, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RENAL CELL CARCINOMA STAGE UNSPECIFIED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060519</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060614</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TIORFAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOPERAMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLAMOXYL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPALGIC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RIVOTRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRIMPERAN TAB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HALDOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NON STEROID ANTI-INFLAMMATORY</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CORTICOSTEROIDS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049391-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200610577BNE</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>59</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>88.6</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGIC STROKE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SORAFENIB</medicinalproduct>
        <drugauthorizationnumb>21923</drugauthorizationnumb>
        <drugdosagetext>400 MG, BID, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>METASTATIC MALIGNANT MELANOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060502</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060504</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DACARBAZINE</medicinalproduct>
        <drugdosagetext>2070 MG, TOTAL DAILY, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>METASTATIC MALIGNANT MELANOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060502</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOCLOPRAMIDE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049393-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200610494BFR</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>49</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>55</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEBRILE NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SORAFENIB</medicinalproduct>
        <drugauthorizationnumb>21923</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RENAL CELL CARCINOMA STAGE UNSPECIFIED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060324</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060421</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SORAFENIB</medicinalproduct>
        <drugauthorizationnumb>21923</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RENAL CELL CARCINOMA STAGE UNSPECIFIED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060421</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060427</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SORAFENIB</medicinalproduct>
        <drugauthorizationnumb>21923</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RENAL CELL CARCINOMA STAGE UNSPECIFIED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060512</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060526</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MONO-TILDIEM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRIATEC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FONZYLANE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CORDIPATCH</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEXOMIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOLIPRANE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASILIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>URBANYL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AUGMENTIN '125'</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRIMPERAN TAB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VOGALIB</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049395-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200610486BVD</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>68</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>AORTIC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEEP VEIN THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MASS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEOPLASM PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL CELL CARCINOMA STAGE UNSPECIFIED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENOUS STENOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SORAFENIB</medicinalproduct>
        <drugauthorizationnumb>21923</drugauthorizationnumb>
        <drugdosagetext>400 MG, BID, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>METASTATIC RENAL CELL CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060117</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049397-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060623</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200610392BYL</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>94</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>39.5</patientweight>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>MULTI-ORGAN FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PURPURA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVELOX</medicinalproduct>
        <drugauthorizationnumb>21085</drugauthorizationnumb>
        <drugdosagetext>400 MG, QD, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PNEUMONIA STAPHYLOCOCCAL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060306</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060309</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TIAPRIM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPOBLOCK</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NIKORANMART</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GASPORT-D</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METLIGINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TWINPAL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MICROFILLIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BELLAMITOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SEFIROM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049399-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060630</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200610307BVD</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>78</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>71</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ABDOMINAL ADHESIONS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTERIAL OCCLUSIVE DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD BILIRUBIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD LACTATE DEHYDROGENASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FIBRIN D DIMER INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTESTINAL ISCHAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTI-ORGAN FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SORAFENIB</medicinalproduct>
        <drugauthorizationnumb>21923</drugauthorizationnumb>
        <drugdosagetext>400 MG, BID, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATIC NEOPLASM MALIGNANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051128</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060203</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZANTAC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOCITON</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TIKLYD</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FALKAMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LACTULOSE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BERLINSULIN [INSULIN HUMAN INJECTION, ISOPHANE]</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BASALINSULIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANTOZOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KONAKION</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NOVALGIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PASPERTIN [METOCLOPRAMIDE HYDROCHLORIDE]</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KABIVEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SODIUM CHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DORMICUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NATRIUMCARBONAT</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049403-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060703</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200510610BYL</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>84</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>INTERSTITIAL LUNG DISEASE</reactionmeddrapt>
      </reaction>
      <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>20030801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031001</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049405-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060711</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>127.3</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLISTER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG ERUPTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EOSINOPHIL COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STASIS DERMATITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MOXIFLOXACIN HCL</medicinalproduct>
        <drugdosagetext>400MG DAILY  IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>TRACHEAL OPERATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060530</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060604</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLINDAMYCIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL / IPRATROP</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANOXIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DILTIAZEM HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOCUSATE CA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GUAIFENESIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KETOCONAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RANITIDINE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TERAZOSIN HCL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049407-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060711</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>73</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>80.2867</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>GLOMERULONEPHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL TUBULAR NECROSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GADOLINIUM</medicinalproduct>
        <drugdosagetext>X1   IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ENCEPHALITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACYCLOVIR</medicinalproduct>
        <drugdosagetext>1000MG   Q12H    IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ENCEPHALITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060503</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060509</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOXYCCCLINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HALOPERIDOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ISOSORBIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORAZEPAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NITROGLYCERIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROMETHAZINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RANITIDINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZIPRASIDONE HCL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049408-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060711</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>57</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>55</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOPTYSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BUSIPIRONE  10MG</medicinalproduct>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DYSPNOEA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060522</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060524</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BUSIPIRONE  10MG</medicinalproduct>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DYSPNOEA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060525</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060601</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAVASTAN GTT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ROBITUSSIN AC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VICODIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COMBIVENT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TESSALAN PERLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MORPHINE SULFATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>.</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049409-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060711</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>35</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>92.9874</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>EYE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COUNTERFEIT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POOR QUALITY DRUG ADMINISTERED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMOXICILLIN</medicinalproduct>
        <drugbatchnumb>RX#579275</drugbatchnumb>
        <drugdosagetext>500 MG   3     PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SINUSITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060710</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049411-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060711</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>81</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>83.9154</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ADVERSE DRUG REACTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NATRECOR</medicinalproduct>
        <drugdosagetext>INTO KIDNEY    IV BOLUS</drugdosagetext>
        <drugadministrationroute>040</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051117</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051117</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049412-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060711</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>120</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>GAMMA-GLUTAMYLTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMOTRIGINE</medicinalproduct>
        <drugdosagetext>100MG  QHS   PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BIPOLAR I DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051013</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060504</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>APAP TAB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROTONIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAZODONE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EFFEXOR</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049414-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060711</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>85</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>62.5964</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>AMNESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CRYING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEAD INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LACERATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMBIEN CR</medicinalproduct>
        <drugindication>SLEEP DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060704</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049416-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060711</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>60</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>87.0906</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DEEP VEIN THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>THALIDOMIDE     150 MG      CELGENE</medicinalproduct>
        <drugdosagetext>150 MG   EVERY DAY  PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060120</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060606</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE    20 MG</medicinalproduct>
        <drugdosagetext>20 MG   EVERY DAY FOR 4 DA  PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060120</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060606</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049419-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060706</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006AP03103</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>30277</patientonsetage>
      <patientonsetageunit>804</patientonsetageunit>
      <patientweight>65</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HEPATITIS ACUTE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROPOFOL</medicinalproduct>
        <drugauthorizationnumb>19627</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060506</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060508</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CEFTRIAXONE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060506</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060509</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENOXAPARIN SODIUM</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060506</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060508</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METRONIDAZOLE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060506</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060509</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PARACETAMOL</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060506</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060509</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRAMADOL HCL</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060507</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060507</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ESOMEPRAZOLE MAGNESIUM TRIHYDRATE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAXOLON</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060506</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NILSTAT</medicinalproduct>
        <drugadministrationroute>055</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060506</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORADRENALINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MORPHINE SULFATE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049420-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060621</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006AP02917</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>73</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BREAST CANCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METASTASES TO BONE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CASODEX</medicinalproduct>
        <drugauthorizationnumb>20498</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROSTATE CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEUPLIN</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PROSTATE CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021001</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049421-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060706</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006AP03120</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>29856</patientonsetage>
      <patientonsetageunit>804</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HYPOTHERMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugauthorizationnumb>020639</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PSYCHOTIC DISORDER</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060406</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OLANZAPINE</medicinalproduct>
        <drugindication>PSYCHOTIC DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049422-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060307</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006CG00453</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>59</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BALANCE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CREATINE PHOSPHOKINASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISTURBANCE IN ATTENTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYELID FUNCTION DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugauthorizationnumb>21366</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERCHOLESTEROLAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050801</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugauthorizationnumb>021366</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTRIGLYCERIDAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050801</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugauthorizationnumb>021366</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050801</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugauthorizationnumb>021366</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050801</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugauthorizationnumb>021366</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060201</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugauthorizationnumb>021366</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060201</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugauthorizationnumb>021366</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060226</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugauthorizationnumb>021366</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060226</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SERETIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MEPRONIZINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZESTRIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19960101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049423-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060707</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006CG01207</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>3.3</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANAESTHETIC COMPLICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ELECTROENCEPHALOGRAM ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTONIA NEONATAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XYLOCAINE</medicinalproduct>
        <drugauthorizationnumb>6488</drugauthorizationnumb>
        <drugadministrationroute>064</drugadministrationroute>
        <drugindication>LOCAL ANAESTHESIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050309</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050309</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ANTASOL</medicinalproduct>
        <drugadministrationroute>064</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050309</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050309</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049424-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050407</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DK-ROCHE-401214</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>54</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FEBRILE NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WRIST FRACTURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CAPECITABINE</medicinalproduct>
        <drugauthorizationnumb>20896</drugauthorizationnumb>
        <drugdosagetext>2900 (UNITS NOT PROVIDED)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041110</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IXABEPILONE</medicinalproduct>
        <drugdosagetext>61 (UNITS NOT PROVIDED)</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041110</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049428-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-431089</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>55</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROOESOPHAGEAL REFLUX DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HIATUS HERNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALNUTRITION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH PRURITIC</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEGASYS</medicinalproduct>
        <drugdosagetext>ROUTE REPORTED AS: INJ.</drugdosagetext>
        <drugadministrationroute>050</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COPEGUS</medicinalproduct>
        <drugauthorizationnumb>021511</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051025</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051215</drugenddate>
        <drugtreatmentduration>52</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049429-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050504</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DK-ROCHE-403924</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>70</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CAPECITABINE</medicinalproduct>
        <drugauthorizationnumb>20896</drugauthorizationnumb>
        <drugdosagetext>CYCLE IMMEDIATELY PRIOR TO EVENTS STARTED ON 25 FEBRUARY 2005.</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BONDRONAT</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040902</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANTOPRAZOLE SODIUM</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040118</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049430-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060619</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-ROCHE-452351</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE BEFORE PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NO ADVERSE EFFECT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PREGNANCY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>18662</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050915</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060330</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049431-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050510</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AR-ROCHE-404263</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>72</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>59</patientweight>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>FEBRILE NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STOMATITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CAPECITABINE</medicinalproduct>
        <drugauthorizationnumb>20896</drugauthorizationnumb>
        <drugdosagetext>DOSE EQUATES TO 3000MG.  TWO WEEKS TREATMENT FOLLOWED BY ONE WEEK REST.</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050304</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IXABEPILONE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050304</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOFLOXACIN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050415</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050417</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PARACETAMOL</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050414</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RANITIDINE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050415</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049432-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060428</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-446191</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>53</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>96.4</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>AUTOIMMUNE HEPATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLD SWEAT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORTHOSTATIC HYPOTENSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEG-INTERFERON ALFA 2A (RO 25-8310)</medicinalproduct>
        <drugbatchnumb>B0085, B009201, B0087</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060303</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEG-INTERFERON ALFA 2A (RO 25-8310)</medicinalproduct>
        <drugbatchnumb>B0085, B009201, B0087</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060427</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEG-INTERFERON ALFA 2A (RO 25-8310)</medicinalproduct>
        <drugbatchnumb>B0085, B009201, B0087</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060505</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060531</drugenddate>
        <drugtreatmentduration>27</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RIBAVIRIN</medicinalproduct>
        <drugbatchnumb>U5051, U6006</drugbatchnumb>
        <drugauthorizationnumb>021511</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060303</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RIBAVIRIN</medicinalproduct>
        <drugbatchnumb>U5051, U6006</drugbatchnumb>
        <drugauthorizationnumb>021511</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060427</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RIBAVIRIN</medicinalproduct>
        <drugbatchnumb>U5051, U6006</drugbatchnumb>
        <drugauthorizationnumb>021511</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060429</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LABETALOL HCL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060303</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060428</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM GLUCONATE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051118</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051118</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060525</drugenddate>
        <drugtreatmentduration>189</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BACTRIM</medicinalproduct>
        <drugdosagetext>REPORTED AS '160/WEEK'</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051118</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VICODIN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051118</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALCYTE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051121</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAMADOL HCL</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051128</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGNESIUM</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051205</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LACTULOSE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051207</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugdosagetext>ON 03 JUNE 2006 DOSE WAS INCREASED TO 40 MG/DAY.</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051210</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACIPHEX</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051229</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NYSTATIN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060130</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060501</drugenddate>
        <drugtreatmentduration>92</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYCLOSPORINE</medicinalproduct>
        <drugdosagetext>DOSE REDUCED TO 175 MG ON 13 MAY 2006.</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060405</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060512</drugenddate>
        <drugtreatmentduration>38</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060301</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060301</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060412</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DESYREL</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060413</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CIPRO</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060425</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060430</drugenddate>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049433-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060630</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CH-ROCHE-453728</companynumb>
    <primarysource>
      <reportercountry>SWITZERLAND</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>43</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>75</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>AFFECT LABILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AGGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>APATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISSOCIATIVE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ROACCUTAN</medicinalproduct>
        <drugauthorizationnumb>18662</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ACNE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050415</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060515</drugenddate>
        <drugtreatmentduration>13</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049434-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060620</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-452691</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>47</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>69.9</patientweight>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERAMMONAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XELODA</medicinalproduct>
        <drugauthorizationnumb>20896</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XELODA</medicinalproduct>
        <drugauthorizationnumb>020896</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049435-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050922</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-ROCHE-418550</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>48</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>85</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CHOLECYSTITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEG-INTERFERON ALFA 2A (RO 25-8310)</medicinalproduct>
        <drugbatchnumb>B0020</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040715</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040930</drugenddate>
        <drugtreatmentduration>78</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEG-INTERFERON ALFA 2A (RO 25-8310)</medicinalproduct>
        <drugbatchnumb>B0020</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041007</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051031</drugenddate>
        <drugtreatmentduration>390</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RIBAVIRIN</medicinalproduct>
        <drugbatchnumb>C207863</drugbatchnumb>
        <drugauthorizationnumb>021511</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040715</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050910</drugenddate>
        <drugtreatmentduration>423</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RIBAVIRIN</medicinalproduct>
        <drugbatchnumb>C207863</drugbatchnumb>
        <drugauthorizationnumb>021511</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050913</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051108</drugenddate>
        <drugtreatmentduration>57</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BISOPROLOL FUMARATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANTOZOL</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051005</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049436-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060703</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FI-ROCHE-453793</companynumb>
    <primarysource>
      <reportercountry>FINLAND</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>26</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HODGKIN'S DISEASE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ROACCUTAN</medicinalproduct>
        <drugauthorizationnumb>18662</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ACNE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050515</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050915</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ROACCUTAN</medicinalproduct>
        <drugauthorizationnumb>018662</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020615</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020615</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049438-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060711</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>63.05</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN LOWER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE MARROW FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FAECALOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOVOLAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEUKOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERFORMANCE STATUS DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARBOPLATIN</medicinalproduct>
        <drugdosagetext>198.4MG  DAY 1  IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>SMALL CELL LUNG CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031219</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040206</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CPT-11</medicinalproduct>
        <drugdosagetext>64MG   DAYS 1 + 9   IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>SMALL CELL LUNG CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031219</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040206</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPROL-XL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COMBIVENT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADVAIR DISK</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DURAGESIC-100</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEMECLOCYCLINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MSO4 IMMEDIATE RELEASE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORAZEPAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SENNA</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049439-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060214</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ROCHE-437137</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>3</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>17</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>NEPHROTIC SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAMIFLU</medicinalproduct>
        <drugauthorizationnumb>21246</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060206</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060211</drugenddate>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MUCOSAL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060208</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060211</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELESTAMINE TAB</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060208</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060211</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZESULAN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060208</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060211</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049440-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060609</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-451168</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>70</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>108.4</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ATELECTASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG SCREEN POSITIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATOCRIT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOKALAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOURICAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPHIL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RED BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RIB FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ROAD TRAFFIC ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN LACERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRANSIENT ISCHAEMIC ATTACK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ULNA FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CAPECITABINE</medicinalproduct>
        <drugauthorizationnumb>20896</drugauthorizationnumb>
        <drugdosagetext>ON DAYS 1 TO 14 EVERY 3 WEEKS FOR 4 CYCLES</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060413</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060527</drugenddate>
        <drugtreatmentduration>45</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOCETAXEL</medicinalproduct>
        <drugdosagetext>REPEAT EVERY THREE WEEKS FOR FOUR CYCLES</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060413</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060612</drugenddate>
        <drugtreatmentduration>61</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOXORUBICIN HCL</medicinalproduct>
        <drugdosagetext>REPEAT EVERY THREE WEEKS FOR FOUR CYCLES</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOPHOSPHAMIDE</medicinalproduct>
        <drugdosagetext>REPEAT EVERY THREE WEEKS FOR FOUR CYCLES</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONIDINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INDERAL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>K-DUR 10</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACTOS</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDRALAZINE HCL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GOUT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COMPAZINE</medicinalproduct>
        <drugdosagetext>10MG 4 TIMES A DAY OR PRN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NAUSEA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060309</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PERCOCET</medicinalproduct>
        <drugdosagetext>DOSE REPORTED AS 10/325, 1-2 TABLETS 4 TIMES A DAY.  PRN PAIN.</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060511</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060607</drugenddate>
        <drugtreatmentduration>28</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCODONE</medicinalproduct>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRANQUILIZER NOS</medicinalproduct>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE TAB</medicinalproduct>
        <drugdosagetext>AS PER STUDY PROTOCOL: DEXAMETHASONE (8MG ORAL) GIVEN THE NIGHT BEFORE DOCETAXEL ADMINISTRATION.</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060412</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE TAB</medicinalproduct>
        <drugdosagetext>AS PER STUDY PROTOCOL: DEXAMETHASONE (10MG I.V.) ADMINISTERED 30 MINUTES PRIOR TO ANY DOCETAXEL.</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060413</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049441-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060407</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-443845</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>56</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CALCINOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CRYING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRY MOUTH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EMOTIONAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IRRITABILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOOD SWINGS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL STIFFNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THINKING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VERTIGO POSITIONAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEGASYS</medicinalproduct>
        <drugdosagetext>ROUTE REPORTED AS ^INJ^.</drugdosagetext>
        <drugadministrationroute>050</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060303</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060407</drugenddate>
        <drugtreatmentduration>36</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEGASYS</medicinalproduct>
        <drugdosagetext>ROUTE REPORTED AS ^INJ^.</drugdosagetext>
        <drugadministrationroute>050</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060407</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060414</drugenddate>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEGASYS</medicinalproduct>
        <drugadministrationroute>050</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060526</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060609</drugenddate>
        <drugtreatmentduration>15</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COPEGUS</medicinalproduct>
        <drugauthorizationnumb>021511</drugauthorizationnumb>
        <drugdosagetext>DOSAGE REGIMEN REPORTED AS 3 IN AM, 2 IN PM.</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060303</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060403</drugenddate>
        <drugtreatmentduration>32</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COPEGUS</medicinalproduct>
        <drugauthorizationnumb>021511</drugauthorizationnumb>
        <drugdosagetext>2 IN AN, 2 IN PM.</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060403</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060414</drugenddate>
        <drugtreatmentduration>12</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COPEGUS</medicinalproduct>
        <drugauthorizationnumb>021511</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060526</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060614</drugenddate>
        <drugtreatmentduration>20</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EFFEXOR</medicinalproduct>
        <drugindication>ANTIDEPRESSANT THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELEXA</medicinalproduct>
        <drugindication>ANTIDEPRESSANT THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALEVE (CAPLET)</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049442-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060127</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ROCHE-434564</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>28</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>64</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ASPIRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAMIFLU</medicinalproduct>
        <drugauthorizationnumb>21087</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060126</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060126</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CRAVIT</medicinalproduct>
        <drugdosagetext>FORM REPORTED AS ORAL FORMULATION.</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INFECTION PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060126</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060126</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DECADRON</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060126</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEOPHYLLIN</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060126</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KIPRES</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MUCODYNE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THEO-DUR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>QVAR 40</medicinalproduct>
        <drugadministrationroute>055</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040515</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYPEN</medicinalproduct>
        <drugdosagetext>TAKEN AS NEEDED</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040815</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RISUMIC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050816</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLARITHROMYCIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060126</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049443-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060705</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-454401</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>OVERDOSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KLONOPIN</medicinalproduct>
        <drugauthorizationnumb>17533</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEROIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049444-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060703</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>HU-ROCHE-453827</companynumb>
    <primarysource>
      <reportercountry>HUNGARY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>65</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINE ANALYSIS ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINE OUTPUT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BONIVA</medicinalproduct>
        <drugauthorizationnumb>021455</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060621</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049445-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060706</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-ROCHE-454161</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>49</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>94</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CATARACT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GLAUCOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RETINAL OEDEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MYCOPHENOLATE MOFETIL</medicinalproduct>
        <drugauthorizationnumb>050722</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051004</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051007</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VALTREX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051008</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TACROLIMUS</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051004</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051011</drugenddate>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BACTRIM DS</medicinalproduct>
        <drugindication>PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugindication>METABOLIC DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SOMAC</medicinalproduct>
        <drugindication>OESOPHAGEAL DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049446-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060706</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ROCHE-454510</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>50</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELLCEPT</medicinalproduct>
        <drugauthorizationnumb>050722</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049447-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060705</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GR-ROCHE-454127</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>46</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>EJECTION FRACTION DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CAPECITABINE</medicinalproduct>
        <drugauthorizationnumb>20896</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050426</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAPATINIB</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050426</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049448-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060703</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-ROCHE-453984</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DERMATITIS BULLOUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEGASYS</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051015</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBETOL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051015</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049449-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060711</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>42</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>60.782</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>APHTHOUS STOMATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ADRIAMYCIN PFS</medicinalproduct>
        <drugdosagetext>60 MG/M2</drugdosagetext>
        <drugindication>SYNOVIAL SARCOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060622</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060624</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IFOSFAMIDE</medicinalproduct>
        <drugdosagetext>2.5 MG/M2</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060622</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060624</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE TAB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KYTRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COMPAZINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049453-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060711</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>55.9</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ERBITUX</medicinalproduct>
        <drugdosagetext>405 MG   EVERY WEEK  IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BREAST CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060621</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARBOPLATIN</medicinalproduct>
        <drugdosagetext>174 MG   EVERY WEEK X 3WK   IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060621</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MORPHINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049454-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060711</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIHYDROPYRIMIDINE DEHYDROGENASE DEFICIENCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN EXFOLIATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUOROURACIL</medicinalproduct>
        <drugdosagetext>IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLON CANCER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049455-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060705</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-ROCHE-454399</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>SIGMOIDITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XENICAL</medicinalproduct>
        <drugauthorizationnumb>020766</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049456-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060711</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>59</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>97.5234</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENALAPRIL MALEATE</medicinalproduct>
        <drugbatchnumb>EM05130D</drugbatchnumb>
        <drugdosagetext>1 TABLET BY MOUTH TWICE DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060501</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049458-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060711</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>49</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>86.1834</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACTOPLUS MET</medicinalproduct>
        <drugbatchnumb>A11591</drugbatchnumb>
        <drugdosagetext>TAKE ONE TABLET TWICE A DAY</drugdosagetext>
        <drugindication>DIABETES MELLITUS NON-INSULIN-DEPENDENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049460-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060711</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>73</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>99.7913</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>APPLICATION SITE WARMTH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ATRIAL FIBRILLATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FENTANYL</medicinalproduct>
        <drugbatchnumb>0604308</drugbatchnumb>
        <drugdosagetext>APPLY 1 PATCH EVERY 72 HOURS</drugdosagetext>
        <drugindication>SPINAL OPERATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049462-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060711</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>ACTIVITIES OF DAILY LIVING IMPAIRED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSED LEVEL OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ENCEPHALOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERAMMONAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METABOLIC ACIDOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPEECH DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOPIRAMATE</medicinalproduct>
        <drugdosagetext>100 MG   BID   PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONVULSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VALPROIC ACID</medicinalproduct>
        <drugdosagetext>500 MG   BID   PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049465-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060711</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>69</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URTICARIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHEEZING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOSYN</medicinalproduct>
        <drugdosagetext>3.375 MG Q6H IV BOLUS</drugdosagetext>
        <drugadministrationroute>040</drugadministrationroute>
        <drugindication>INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060604</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060605</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049466-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060711</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>32</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>83.0083</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEAD INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIMB INJURY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>WELLBUTRIN XL</medicinalproduct>
        <drugdosagetext>300 MG DAILY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SMOKING CESSATION THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060506</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060513</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LAMISIL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049467-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060711</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>46</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>63.5036</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>APPLICATION SITE REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CAPZASIN HP  (CAPSAICIN)</medicinalproduct>
        <drugbatchnumb>05E308</drugbatchnumb>
        <drugdosagetext>ONCE TOP</drugdosagetext>
        <drugadministrationroute>061</drugadministrationroute>
        <drugindication>ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060710</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060710</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CAPZASIN HP  (CAPSAICIN)</medicinalproduct>
        <drugbatchnumb>05E308</drugbatchnumb>
        <drugdosagetext>ONCE TOP</drugdosagetext>
        <drugadministrationroute>061</drugadministrationroute>
        <drugindication>MUSCLE SPASMS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060710</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060710</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CAPZASIN HP</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049468-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060711</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>116</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DIABETES INSIPIDUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCONTINENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MICTURITION URGENCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NOCTURIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LITHIUM CARBONATE</medicinalproduct>
        <drugdosagetext>300MG/600MG DAILY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BIPOLAR DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060317</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060504</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BETHANECHOL</medicinalproduct>
        <drugdosagetext>50MG TID PRN PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INCONTINENCE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060411</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060506</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAZODONE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROZAC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BUPROPION HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALPROIC ACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TEMAZEPAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONAZEPAM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049469-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060711</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>50</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>84.369</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEEP VEIN THROMBOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BONIVA</medicinalproduct>
        <drugdosagetext>150MG MONTHLY PO  ONE TIME DOSE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060614</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060614</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049470-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060405</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-443569</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>18</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>73.5</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEILITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CROHN'S DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHOIDS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLAMMATORY BOWEL DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>018662</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000309</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20000611</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>018662</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000612</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20001121</drugenddate>
        <drugtreatmentduration>163</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049471-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060711</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>96.9</patientweight>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>DISEASE RECURRENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERAL PHYSICAL HEALTH DETERIORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUDARABINE</medicinalproduct>
        <drugdosagetext>45MG DAILY IV DRIP</drugdosagetext>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>STEM CELL TRANSPLANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060517</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060521</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BUSULFAN</medicinalproduct>
        <drugdosagetext>237 MG DAILY IV DRIP</drugdosagetext>
        <drugadministrationroute>041</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060518</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060521</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CAMPATH</medicinalproduct>
        <drugdosagetext>20 MG DAILY IV DRIP</drugdosagetext>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>STEM CELL TRANSPLANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060517</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060521</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROVERA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREVACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROXEUREA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ISOTRETINOIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRONOLACTONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CASPOFUNGIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049472-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060711</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>81</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>97.5234</patientweight>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BEDRIDDEN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FACE OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULAR WEAKNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DECADRON</medicinalproduct>
        <drugdosagetext>4 MG DOWN TO .5MG  4X PER DAY TO 1 PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BRAIN OEDEMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060427</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060703</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DECADRON</medicinalproduct>
        <drugdosagetext>.5MG  1 IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049473-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060711</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>57</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>55</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FAECES DISCOLOURED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARYNGOLARYNGEAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RADIATION INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BUSPIRONE HCL</medicinalproduct>
        <drugdosagetext>10MG  1 QD X3 DAYS PO  ; 10MG BID PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DYSPNOEA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060522</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060524</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BUSPIRONE HCL</medicinalproduct>
        <drugdosagetext>10MG  1 QD X3 DAYS PO  ; 10MG BID PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DYSPNOEA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060525</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060601</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAVATAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ROBITUSSIN AC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COMBIVENT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TESSALAN PERLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FENTANYL TRANSDERMAL SYSTEM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XYLOCAINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAALOX FAST BLOCKER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXAMETHASOME</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049474-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060711</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>77</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>89.1</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTOLERANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALENDRONATE SODIUM</medicinalproduct>
        <drugbatchnumb>F4948</drugbatchnumb>
        <drugdosagetext>70MG  ONCE A WEEK  PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060502</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060710</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049475-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060711</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>56</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD CREATININE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACYCLOVIR</medicinalproduct>
        <drugdosagetext>700 MG Q8H  IV DRIP</drugdosagetext>
        <drugadministrationroute>041</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060619</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060622</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049476-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060711</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>70</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>90.2658</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>LOCAL SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWELLING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLAGYL</medicinalproduct>
        <drugdosagetext>100 ML  IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>DIVERTICULITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060303</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060304</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049477-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060711</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HYDROMORPHONE HCL</medicinalproduct>
        <drugindication>PAIN</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049478-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060711</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>59</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HAEMODIALYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugdosagetext>80 MG QHS PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERLIPIDAEMIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049479-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060711</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>39</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANGIONEUROTIC OEDEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugdosagetext>20 MG QDAY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060609</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060610</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LOSARTAN POTASSIUM</medicinalproduct>
        <drugdosagetext>100 MG QDAY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060609</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060610</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049481-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060711</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>60</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>58.9676</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>STEVENS-JOHNSON SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MOBIC</medicinalproduct>
        <drugdosagetext>ONE DAILY , 25 MG EVERY DAY</drugdosagetext>
        <drugindication>ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051206</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MOBIC</medicinalproduct>
        <drugdosagetext>ONE DAILY , 25 MG EVERY DAY</drugdosagetext>
        <drugindication>FIBROMYALGIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051206</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049482-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060711</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>75</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>93.441</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BONE MARROW DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOPTYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPLENOMEGALY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BACTRIM DS</medicinalproduct>
        <drugdosagetext>2 TABLETS  BID PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BACTERIAL INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060220</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060228</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BACTRIM DS</medicinalproduct>
        <drugdosagetext>2 TABLETS  BID PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CELLULITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060220</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060228</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049483-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060706</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006AC01268</companynumb>
    <primarysource>
      <reportercountry>SPAIN</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>HYPERKALAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHABDOMYOLYSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROPOFOL</medicinalproduct>
        <drugauthorizationnumb>019627</drugauthorizationnumb>
        <drugdosagetext>1%</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060515</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060517</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RTFPI CODE NOT BROKEN</medicinalproduct>
        <drugindication>PNEUMONIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060512</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060516</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCORTISONE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060512</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MIDAZOLAM</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060512</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MORPHINE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060512</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORADRENALINE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060512</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060513</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RANITIDINE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060512</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLEXANE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060519</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RIFAMPICIN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060517</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CEFTRIAXONE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060512</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOFLOXACIN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060512</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049484-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060622</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006AP02888</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>67</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>50</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>SHOCK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MEROPENEM</medicinalproduct>
        <drugauthorizationnumb>50706</drugauthorizationnumb>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>CHOLECYSTITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060419</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060420</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049485-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060711</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>49.9</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXALIPLATIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CAPECITABINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATIVAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALTRATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DECADRON</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DILAUDID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHADONE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OLANZAPINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOFRAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049486-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060711</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>54</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD CALCIUM INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSED LEVEL OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISEASE PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISORIENTATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OXYGEN SATURATION DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUSITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GEMCITABINE</medicinalproduct>
        <drugdosagetext>3000</drugdosagetext>
        <drugindication>TONGUE NEOPLASM MALIGNANT STAGE UNSPECIFIED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060522</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GEMCITABINE</medicinalproduct>
        <drugdosagetext>3000</drugdosagetext>
        <drugindication>TONGUE NEOPLASM MALIGNANT STAGE UNSPECIFIED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060605</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GEMCITABINE</medicinalproduct>
        <drugdosagetext>3000</drugdosagetext>
        <drugindication>TONGUE NEOPLASM MALIGNANT STAGE UNSPECIFIED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060619</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PACLITAXEL</medicinalproduct>
        <drugdosagetext>150</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060522</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PACLITAXEL</medicinalproduct>
        <drugdosagetext>150</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060605</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PACLITAXEL</medicinalproduct>
        <drugdosagetext>150</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060619</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE TAB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOFRAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENADRYL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FAMITODINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DURAGESIC-100</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORTAB</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049487-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060711</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>93.8946</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ILEUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XELODA</medicinalproduct>
        <drugdosagetext>1500MG/M2  BID  DAYS 1-7 AND 15-21</drugdosagetext>
        <drugindication>TESTICULAR CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060608</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XELODA</medicinalproduct>
        <drugdosagetext>1500MG/M2  BID  DAYS 1-7 AND 15-21</drugdosagetext>
        <drugindication>TESTICULAR CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060609</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XELODA</medicinalproduct>
        <drugdosagetext>1500MG/M2  BID  DAYS 1-7 AND 15-21</drugdosagetext>
        <drugindication>TESTICULAR CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060610</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XELODA</medicinalproduct>
        <drugdosagetext>1500MG/M2  BID  DAYS 1-7 AND 15-21</drugdosagetext>
        <drugindication>TESTICULAR CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060611</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOFRAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREVACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENADRYL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049488-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060711</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>81</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>63.5036</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD CREATINE PHOSPHOKINASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CREATININE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD UREA INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CREATININE RENAL CLEARANCE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOGLOBIN BLOOD INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CUBICIN</medicinalproduct>
        <drugdosagetext>250MG   Q24H    IVPB</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>SKIN INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060503</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060507</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CUBICIN</medicinalproduct>
        <drugdosagetext>250MG   Q24H    IVPB</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>SOFT TISSUE INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060503</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060507</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROTONIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVAPRO</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EFFEXOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLEGRA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVENOX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMDUR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOSYN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OSCAL D</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMARYL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049490-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060711</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>11.7935</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ACUTE LYMPHOCYTIC LEUKAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ELIDEL</medicinalproduct>
        <drugdosagetext>DAILY FOR 1 WEEK</drugdosagetext>
        <drugindication>DERMATITIS ATOPIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030813</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030821</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049491-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060613</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0608783A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>47</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDUCTION DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EXERCISE TOLERANCE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FIBROMYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MONOPLEGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOVEMENT DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE TIGHTNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUROPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WRIST FRACTURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SENSODYNE-F</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugindication>SENSITIVITY OF TEETH</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049492-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060619</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0610622A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>46</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GOODY'S POWDER</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugindication>PAIN</drugindication>
        <drugtreatmentduration>25</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049493-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060702</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0611576A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>48</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPENDENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NICORETTE (MINT)</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>018612</drugauthorizationnumb>
        <drugdosagetext>2MG SEE DOSAGE TEXT</drugdosagetext>
        <drugadministrationroute>002</drugadministrationroute>
        <drugindication>SMOKING CESSATION THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NICORETTE (MINT)</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>018612</drugauthorizationnumb>
        <drugdosagetext>2MG SEE DOSAGE TEXT</drugdosagetext>
        <drugadministrationroute>002</drugadministrationroute>
        <drugindication>SMOKING CESSATION THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MONOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEXAPRO</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CORTEF</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049494-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060524</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-GLAXOSMITHKLINE-B0425959A</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>42</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>79.5</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARYNGEAL OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SENSATION OF FOREIGN BODY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROAT TIGHTNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PIRITON SYRUP</medicinalproduct>
        <drugbatchnumb>BN60013A</drugbatchnumb>
        <drugdosagetext>10ML TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060515</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060520</drugenddate>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GAVISCON</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SALINE STERIPOULES</medicinalproduct>
        <drugdosagetext>1AMP THREE TIMES PER DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SALBUTAMOL INHALER</medicinalproduct>
        <drugdosagetext>2PUFF AS REQUIRED</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PARACETAMOL</medicinalproduct>
        <drugdosagetext>2TAB FOUR TIMES PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASMANEX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYGEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CEFIXIME CHEWABLE</medicinalproduct>
        <drugdosagetext>1TAB TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALENDRONIC ACID</medicinalproduct>
        <drugdosagetext>70MG WEEKLY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RANITIDINE</medicinalproduct>
        <drugdosagetext>1TAB TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BETNESOL N</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EPIPEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CINNARIZINE</medicinalproduct>
        <drugdosagetext>2TAB THREE TIMES PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FORMOTEROL POWDER</medicinalproduct>
        <drugdosagetext>2PUFF THREE TIMES PER DAY</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENDROFLUAZIDE</medicinalproduct>
        <drugdosagetext>1TAB PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASMANEX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYGEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CEFIXIME CHEWABLE</medicinalproduct>
        <drugdosagetext>200MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALENDRONIC ACID</medicinalproduct>
        <drugdosagetext>70MG WEEKLY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CHLORPHENAMINE</medicinalproduct>
        <drugdosagetext>4MG THREE TIMES PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049495-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060616</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-GLAXOSMITHKLINE-B0428083A</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>36</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEPENDENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIQUITIN CQ 2MG LOZENGE</medicinalproduct>
        <drugauthorizationnumb>21330</drugauthorizationnumb>
        <drugdosagetext>2MG SEE DOSAGE TEXT</drugdosagetext>
        <drugadministrationroute>002</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040601</drugstartdate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BOOTS NICASSIST 1MG LOZENGE</medicinalproduct>
        <drugdosagetext>1MG UNKNOWN</drugdosagetext>
        <drugadministrationroute>002</drugadministrationroute>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HOMEOPATHIC REMEDY</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MANDRAKE ROOT</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049496-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060626</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>HK-GLAXOSMITHKLINE-B0428712A</companynumb>
    <primarysource>
      <reportercountry>HONG KONG</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABORTION SPONTANEOUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PANADOL ACTIFAST</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060601</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049497-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060703</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-GLAXOSMITHKLINE-B0429459A</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANAPHYLACTIC SHOCK</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PIRITON TABLETS</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049498-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060711</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>71.6683</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MIGRAINE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STOMACH DISCOMFORT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FIORICET W/ CODEINE</medicinalproduct>
        <drugdosagetext>ONE T.I.D. WITH MIGRAINE</drugdosagetext>
        <drugindication>MIGRAINE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049500-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060711</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>71.6683</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MIGRAINE</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>ATIVAN</medicinalproduct>
        <drugdosagetext>1MG  ONE QHS</drugdosagetext>
        <drugindication>PARKINSON'S DISEASE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049502-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060711</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>64</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>62.5964</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>EXTRAVASATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NECROSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYVOX</medicinalproduct>
        <drugdosagetext>600 MG   Q 12 HOURS   IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>STAPHYLOCOCCAL INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060324</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060413</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049503-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060619</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006RR-02737</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>40</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>BLOOD ALCOHOL INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSED LEVEL OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG LEVEL INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY DEPRESSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUOXETINE</medicinalproduct>
        <drugauthorizationnumb>76165</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OLANZAPINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIAZEPAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TEMAZEPAM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049505-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060711</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>50.1225</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ACNE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE SYSTOLIC DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY RATE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TARCEVA</medicinalproduct>
        <drugbatchnumb>X101862</drugbatchnumb>
        <drugdosagetext>100MG   PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060526</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOCETAXE   -   25MG/M2  -   AVENTIS</medicinalproduct>
        <drugbatchnumb>D5H102</drugbatchnumb>
        <drugdosagetext>25MG/M2    D1, D8, D15 X 6 CYCLES EVERY 28 D   IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060526</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049507-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060711</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>190.5108</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULAR WEAKNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugdosagetext>40 MG  DAILY   PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DYSLIPIDAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060201</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049509-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060711</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>97.5234</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MEDICATION TAMPERING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COUNTERFEIT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RESTASIS</medicinalproduct>
        <drugindication>MEGACOLON</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RESTASIS</medicinalproduct>
        <drugindication>PORPHYRIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RESTASIS</medicinalproduct>
        <drugindication>SCOLIOSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RESTASIS</medicinalproduct>
        <drugindication>SICCA SYNDROME</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RESTASIS</medicinalproduct>
        <drugindication>SPINA BIFIDA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CONTRAST MEDIUM</medicinalproduct>
        <drugindication>PORPHYRIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049513-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060711</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GAMUNEX</medicinalproduct>
        <drugbatchnumb>ALL LOTS</drugbatchnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GAMUNEX</medicinalproduct>
        <drugbatchnumb>ALL LOTS</drugbatchnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049514-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060530</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-NOVOPROD-253738</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>21</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STATUS EPILEPTICUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PENFILL 30R CHU</medicinalproduct>
        <drugauthorizationnumb>19991</drugauthorizationnumb>
        <drugdosagetext>5-15 IU</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>DIABETES MELLITUS INSULIN-DEPENDENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010808</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20011214</drugenddate>
        <drugtreatmentduration>128</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PENFILL 50R CHU</medicinalproduct>
        <drugdosagetext>10 IU</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>DIABETES MELLITUS INSULIN-DEPENDENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010824</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20011205</drugenddate>
        <drugtreatmentduration>103</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PENFILL 50R CHU</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20011221</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEUQUINON</medicinalproduct>
        <drugdosagetext>150 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MELAS SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20011214</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FURSULTIAMINE</medicinalproduct>
        <drugdosagetext>150 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MELAS SYNDROME</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20011214</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYTOREST</medicinalproduct>
        <drugdosagetext>3 CAPS</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MELAS SYNDROME</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALEVIATIN                          /00017401/</medicinalproduct>
        <drugdosagetext>1-2 TABLETS</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MELAS SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20011214</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049515-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-NOVOPROD-250176</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>64</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>63</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>GRANULOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PENFILL R CHU</medicinalproduct>
        <drugauthorizationnumb>19938</drugauthorizationnumb>
        <drugdosagetext>30 IU, QD</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051215</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HUMULIN 70/30</medicinalproduct>
        <drugdosagetext>5 IU, QD</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051215</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAKEPRON</medicinalproduct>
        <drugdosagetext>30 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051215</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM</medicinalproduct>
        <drugdosagetext>10000 IU, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051215</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOPRESOR                           /00376902/</medicinalproduct>
        <drugdosagetext>60 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANGINA PECTORIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TANATRIL</medicinalproduct>
        <drugdosagetext>5 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ULCERLMIN</medicinalproduct>
        <drugdosagetext>1 G, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NITOROL</medicinalproduct>
        <drugdosagetext>15 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049516-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-NOVOPROD-254542</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NOVOSEVEN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>1.2 MG, SINGLE</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>SUBDURAL HAEMORRHAGE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049517-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060419</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-NOVOPROD-252686</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>23</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>75</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALLOR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NORDITROPIN SIMPLEXX</medicinalproduct>
        <drugauthorizationnumb>21148</drugauthorizationnumb>
        <drugdosagetext>.3 MG, QD</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>GROWTH HORMONE DEFICIENCY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050210</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROX</medicinalproduct>
        <drugdosagetext>200 UG, QD</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19841001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCORTISONE</medicinalproduct>
        <drugdosagetext>4 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MINRIN</medicinalproduct>
        <drugdosagetext>0,4MG QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19841001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANDROTARDYL</medicinalproduct>
        <drugdosagetext>250 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19970901</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049518-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060612</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-NOVOPROD-254209</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <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>LEVEMIR</medicinalproduct>
        <drugbatchnumb>RQ50243</drugbatchnumb>
        <drugauthorizationnumb>21536</drugauthorizationnumb>
        <drugdosagetext>32 IU, QD</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060109</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060328</drugenddate>
        <drugtreatmentduration>78</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HUMALOG                            /00030501/</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049519-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060711</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>17</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>67</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INFUSION RELATED REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENINGITIS ASEPTIC</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IVIG  -BRAND NOT LISTED-</medicinalproduct>
        <drugdosagetext>60G    ONE TIME   IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060623</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060623</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049521-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060711</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>COAGULATION FACTOR VIII LEVEL INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHESUS ANTIBODIES</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RHOGAM UF</medicinalproduct>
        <drugdosagetext>300 MG</drugdosagetext>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060320</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049523-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060711</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>116</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CLUMSINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DECREASED APPETITE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSARTHRIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING DRUNK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCONTINENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCORRECT DOSE ADMINISTERED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THIRST</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BETHANECHOL</medicinalproduct>
        <drugdosagetext>50 MG TID PRN PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INCONTINENCE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060411</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060506</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLONAZEPAM</medicinalproduct>
        <drugdosagetext>0.5 MG TID PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANXIETY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060331</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060512</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLONAZEPAM</medicinalproduct>
        <drugdosagetext>0.5 MG TID PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PANIC DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060331</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060512</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAZODONE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LITHIUM CARBONATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROZAC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BUPROPION HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALPROIC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TEMAZEPAM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049526-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-NOVOPROD-254541</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>CATHETER RELATED COMPLICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEVICE OCCLUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENOUS OCCLUSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NOVOSEVEN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>1.2 MG, UNK</drugdosagetext>
        <drugindication>CEREBRAL HAEMORRHAGE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049527-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060711</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>52</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>873.1743</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PHOTOSENSITIVITY REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZETIA</medicinalproduct>
        <drugdosagetext>10 MG DAILY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERCHOLESTEROLAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060612</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060703</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049529-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060711</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>35</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>90.7194</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>AGITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HALLUCINATIONS, MIXED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESTLESSNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EFFEXOR</medicinalproduct>
        <drugdosagetext>25 MG DAILY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EFFEXOR</medicinalproduct>
        <drugdosagetext>25 MG DAILY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OBSESSIVE-COMPULSIVE DISORDER</drugindication>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LUVOX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BUSPAR</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049532-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060711</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>4.3</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ABDOMINAL DISTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BOWEL SOUNDS ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CLOSTRIDIAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISEASE PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOWER GASTROINTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NECROTISING FASCIITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPENIC SEPSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSEUDOMONAS INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RECTAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>REFUSAL OF TREATMENT BY RELATIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY DISTRESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPTIC SHOCK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUS TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THERAPY NON-RESPONDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOPHOSPHAMIDE</medicinalproduct>
        <drugdosagetext>250 MG</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060619</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYTARABINE</medicinalproduct>
        <drugdosagetext>45 MG</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060629</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DAUNORUBICIN HCL</medicinalproduct>
        <drugdosagetext>17.2 MG</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060616</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HYDROCORTISONE</medicinalproduct>
        <drugdosagetext>225 MG</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060629</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>L-ASPARAGINASE</medicinalproduct>
        <drugdosagetext>10500 UNIT</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugdosagetext>225 MG</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060629</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHYLPREDNISOLONE</medicinalproduct>
        <drugdosagetext>143.1 MG</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060703</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VINCRISTINE</medicinalproduct>
        <drugdosagetext>.53 MG</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060629</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINO</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATIVAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BACTRIM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOPAMINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EPINEPHRINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FENTANYL TRANSDERMAL SYSTEM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEUPOGEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHADONE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROPOFUL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HEPARIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049534-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060621</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006RI-02761</companynumb>
    <primarysource>
      <reportercountry>NEPAL</reportercountry>
      <qualification>2</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>AMOXICILLIN-CLAVULANATE POTASSIUM  (CLAVULANIC ACID, AMOXICILLIN TRIHY</medicinalproduct>
        <drugbatchnumb>9121837</drugbatchnumb>
        <drugauthorizationnumb>65132</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049535-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060620</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006P1000348</companynumb>
    <primarysource>
      <reportercountry>DENMARK</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>79</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANGINA PECTORIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE CONGESTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARPAL TUNNEL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RETEPLASE (RETEPLASE)</medicinalproduct>
        <drugdosagetext>IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ACUTE MYOCARDIAL INFARCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060206</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REOPRO</medicinalproduct>
        <drugdosagetext>IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ACUTE MYOCARDIAL INFARCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060206</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060206</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBYL-ENTEROSOLUBILE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLOPIDOGREL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIGOXIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM CHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ESOMEPRAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL SUCCINATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOSAMINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IRON</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049537-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060711</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>HYPERGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMULIN R</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049540-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-NOVOPROD-254656</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>22</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>42</patientweight>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>BACTERIAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTI-ORGAN FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PENFILL R CHU</medicinalproduct>
        <drugauthorizationnumb>19938</drugauthorizationnumb>
        <drugdosagetext>27 IU, QD</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>DIABETES MELLITUS INSULIN-DEPENDENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050901</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049541-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20030122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHNU2003DE00661</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>78</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>85.5</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>AGEUSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANOSMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROENTERITIS BACTERIAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA ASPIRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>REFLUX OESOPHAGITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMISIL</medicinalproduct>
        <drugauthorizationnumb>20539</drugauthorizationnumb>
        <drugdosagetext>250 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NAIL TINEA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020829</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020911</drugenddate>
        <drugtreatmentduration>20160</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AUGMENTIN '125'</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>GASTROENTERITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020911</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020919</drugenddate>
        <drugtreatmentduration>12960</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049547-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060626</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006P1000318</companynumb>
    <primarysource>
      <reportercountry>POLAND</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>62</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RETEPLASE (RETEPLASE)</medicinalproduct>
        <drugbatchnumb>CT001626</drugbatchnumb>
        <drugdosagetext>5 IU; 2X; IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ACUTE MYOCARDIAL INFARCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060414</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060414</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REOPRO</medicinalproduct>
        <drugbatchnumb>CT000800</drugbatchnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugindication>ACUTE MYOCARDIAL INFARCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060414</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060414</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REOPRO</medicinalproduct>
        <drugbatchnumb>CT000800</drugbatchnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugindication>ACUTE MYOCARDIAL INFARCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060414</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060414</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HEPARIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HEPARIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049548-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060329</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2006JP04864</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>56</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>46</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>GLOSSITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GLOSSODYNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA ORAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOFRANIL</medicinalproduct>
        <drugauthorizationnumb>011838</drugauthorizationnumb>
        <drugindication>PANIC DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOFRANIL</medicinalproduct>
        <drugauthorizationnumb>011838</drugauthorizationnumb>
        <drugdosagetext>10 MG/D</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050430</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051209</drugenddate>
        <drugtreatmentduration>224</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEILAX</medicinalproduct>
        <drugdosagetext>1 MG/D</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PANIC DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049549-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060622</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>POMP-10764</companynumb>
    <primarysource>
      <reportercountry>HONG KONG</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ASPARTATE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD LACTATE DEHYDROGENASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRADYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL ISCHAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NODAL ARRHYTHMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MYOZYME</medicinalproduct>
        <drugindication>GLYCOGEN STORAGE DISEASE TYPE II</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060613</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049550-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060622</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>06-000588</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>29</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ADRENAL SUPPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ADRENOCORTICAL INSUFFICIENCY ACUTE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TACLONEX</medicinalproduct>
        <drugauthorizationnumb>21852</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049551-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060627</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>E2090-00038-SPO-JP</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZONISAMIDE</medicinalproduct>
        <drugauthorizationnumb>20789</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTERIOVENOUS FISTULA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTIHYPERTENSIVE (ANTIHYPERTENSIVES)</medicinalproduct>
      </drug>
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  <safetyreport>
    <safetyreportid>5049553-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060623</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>226266</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>15</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BRAIN MASS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NUTROPIN AQ</medicinalproduct>
        <drugauthorizationnumb>20522</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugindication>GROWTH HORMONE DEFICIENCY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040601</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NUTROPIN AQ</medicinalproduct>
        <drugauthorizationnumb>20522</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugindication>GROWTH HORMONE DEFICIENCY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049567-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060619</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ES-BRISTOL-MYERS SQUIBB COMPANY-13415898</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>77</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>74</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD CREATININE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PACLITAXEL</medicinalproduct>
        <drugauthorizationnumb>20262</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060411</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060531</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARBOPLATIN</medicinalproduct>
        <drugauthorizationnumb>019880</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060411</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060531</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060404</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAMADOL HCL</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060315</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MORPHINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060304</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DARBEPOETIN ALFA</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060510</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOCLOPRAMIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060411</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049568-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-13435029</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>OBSTRUCTIVE AIRWAYS DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URTICARIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEFINITY</medicinalproduct>
        <drugauthorizationnumb>021064</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060601</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049569-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060705</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-13437488</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BREAST CANCER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ESTRACE</medicinalproduct>
        <drugauthorizationnumb>084499</drugauthorizationnumb>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROVERA</medicinalproduct>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049570-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060705</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-13437470</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BREAST CANCER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ESTRACE</medicinalproduct>
        <drugauthorizationnumb>084499</drugauthorizationnumb>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROVERA</medicinalproduct>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049571-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060605</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BH-BRISTOL-MYERS SQUIBB COMPANY-13400809</companynumb>
    <primarysource>
      <reportercountry>EGYPT</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>77</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>COMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ABILIFY</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MOOD DISORDER DUE TO A GENERAL MEDICAL CONDITION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARBAMAZEPINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049572-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060705</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-13433891</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>OVARIAN CANCER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ESTRACE</medicinalproduct>
        <drugauthorizationnumb>084499</drugauthorizationnumb>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROVERA</medicinalproduct>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMPRO</medicinalproduct>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLIMARA</medicinalproduct>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049573-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060706</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CH-BRISTOL-MYERS SQUIBB COMPANY-13434634</companynumb>
    <primarysource>
      <reportercountry>SWITZERLAND</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>8</patientonsetage>
      <patientonsetageunit>800</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>AGITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSED LEVEL OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG TOXICITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HALLUCINATION, VISUAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCLONUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>COAPROVEL TABS 150MG/12.5MG</medicinalproduct>
        <drugauthorizationnumb>20758</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSIVE HEART DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060316</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060331</drugenddate>
        <drugtreatmentduration>16</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>COAPROVEL TABS 150MG/12.5MG</medicinalproduct>
        <drugauthorizationnumb>020758</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CARDIAC FAILURE CONGESTIVE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060316</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060331</drugenddate>
        <drugtreatmentduration>16</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>FOSITEN</medicinalproduct>
        <drugauthorizationnumb>019915</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSIVE HEART DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060316</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060331</drugenddate>
        <drugtreatmentduration>16</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
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      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>FOSITEN</medicinalproduct>
        <drugauthorizationnumb>019915</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CARDIAC FAILURE CONGESTIVE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060316</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060331</drugenddate>
        <drugtreatmentduration>16</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>ALDOZONE</medicinalproduct>
        <drugdosagetext>DOSAGE: 50 MG / 5 MG DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSIVE HEART DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060316</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060321</drugenddate>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>ALDOZONE</medicinalproduct>
        <drugdosagetext>DOSAGE: 50 MG / 5 MG DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CARDIAC FAILURE CONGESTIVE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060316</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060321</drugenddate>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MS CONTIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRALGIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060330</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060331</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSIVE HEART DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060316</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060331</drugenddate>
        <drugtreatmentduration>16</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CARDIAC FAILURE CONGESTIVE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060316</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060331</drugenddate>
        <drugtreatmentduration>16</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>TORSEMIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSIVE HEART DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060321</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060330</drugenddate>
        <drugtreatmentduration>10</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>TORSEMIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CARDIAC FAILURE CONGESTIVE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060321</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060330</drugenddate>
        <drugtreatmentduration>10</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VIBRAMYCIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PNEUMONIA BACTERIAL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060316</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060321</drugenddate>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZINNAT</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PNEUMONIA BACTERIAL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060321</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049574-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>19980623</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-BRISTOL-MYERS SQUIBB COMPANY-13432653</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>73</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>LEUKOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PACKED RED BLOOD CELL TRANSFUSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAXOL</medicinalproduct>
        <drugauthorizationnumb>020262</drugauthorizationnumb>
        <drugindication>OESOPHAGEAL CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980326</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CISPLATIN</medicinalproduct>
        <drugauthorizationnumb>018057</drugauthorizationnumb>
        <drugindication>OESOPHAGEAL CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19970501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19970601</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ETOPOSIDE</medicinalproduct>
        <drugauthorizationnumb>018768</drugauthorizationnumb>
        <drugindication>OESOPHAGEAL CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19970501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19970601</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
        <drugindication>OESOPHAGEAL CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19970501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19970601</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUOROURACIL</medicinalproduct>
        <drugindication>OESOPHAGEAL CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19970501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19970601</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049575-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060515</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-BRISTOL-MYERS SQUIBB COMPANY-13386040</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>83</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ARRHYTHMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG ERUPTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GATIFLOXACIN</medicinalproduct>
        <drugauthorizationnumb>21061</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BRONCHITIS ACUTE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060410</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060412</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CEFXON</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>BRONCHITIS ACUTE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060410</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060410</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHISTA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060410</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060412</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ISOTONIC SODIUM CHLORIDE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060411</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060412</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049577-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060127</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BE-BRISTOL-MYERS SQUIBB COMPANY-13266770</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>72</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERAL PHYSICAL HEALTH DETERIORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STAPHYLOCOCCAL INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ERBITUX</medicinalproduct>
        <drugdosagetext>MOST RECENT INFUSION 17-JAN-05. DELAYED.</drugdosagetext>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>NEOPLASM MALIGNANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051026</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GEFITINIB</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NEOPLASM MALIGNANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051026</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>L-THYROXINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BISOPROLOL FUMARATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MINOCYCLINE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZYRTEC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUCIDINE CREAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOBRADEX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049584-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060630</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-BRISTOL-MYERS SQUIBB COMPANY-13431671</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>TOOTH DISCOLOURATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMPHO-MORONAL LOZENGE</medicinalproduct>
        <drugauthorizationnumb>50341</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049585-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060705</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-13434097</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>56</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MUCOSAL INFLAMMATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ERBITUX</medicinalproduct>
        <drugindication>SQUAMOUS CELL CARCINOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARBOPLATIN</medicinalproduct>
        <drugauthorizationnumb>019880</drugauthorizationnumb>
        <drugdosagetext>INITIAL DOSE: 15MAY06</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>SQUAMOUS CELL CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060626</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060626</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RADIATION THERAPY</medicinalproduct>
        <drugdosagetext>DOSAGE FORM = CGY  2100-2700 CGY WEEKS 6-8</drugdosagetext>
        <drugindication>SQUAMOUS CELL CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060630</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060630</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049586-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060619</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GR-BRISTOL-MYERS SQUIBB COMPANY-13424072</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PNEUMOTHORAX</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ERBITUX</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLORECTAL CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060320</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060504</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXALIPLATIN</medicinalproduct>
        <drugindication>COLORECTAL CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060503</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUOROURACIL</medicinalproduct>
        <drugindication>COLORECTAL CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060503</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060504</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEUCOVORIN CALCIUM</medicinalproduct>
        <drugindication>COLORECTAL CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060503</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060504</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ONDANSETRON HCL</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060503</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060504</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049587-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060705</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-BRISTOL-MYERS SQUIBB COMPANY-13432570</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GRANULOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEUKOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUROTOXICITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UROGENITAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CISPLATIN</medicinalproduct>
        <drugauthorizationnumb>18057</drugauthorizationnumb>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARBOPLATIN</medicinalproduct>
        <drugauthorizationnumb>019880</drugauthorizationnumb>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VINORELBINE</medicinalproduct>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049588-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060630</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ES-BRISTOL-MYERS SQUIBB COMPANY-13430293</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>59</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEBRILE NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IRINOTECAN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060425</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060425</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ERBITUX</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060607</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060607</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TEGAFUR</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060607</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060607</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CPT-11</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060607</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060607</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049589-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060705</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-13433586</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>46</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIAC TAMPONADE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHRONIC MYELOMONOCYTIC LEUKAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERICARDIAL EFFUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLEURAL EFFUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREATMENT RELATED SECONDARY MALIGNANCY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYTOXAN</medicinalproduct>
        <drugauthorizationnumb>012142</drugauthorizationnumb>
        <drugindication>BREAST CANCER</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060401</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOXORUBICIN HCL</medicinalproduct>
        <drugauthorizationnumb>062926</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAXOTERE</medicinalproduct>
        <drugindication>BREAST CANCER</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060401</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE TAB</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049590-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060705</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-13434147</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ACUTE RESPIRATORY DISTRESS SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEEP VEIN THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EMPYEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>KETOACIDOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METABOLIC ACIDOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHABDOMYOLYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TEQUIN</medicinalproduct>
        <drugauthorizationnumb>021061</drugauthorizationnumb>
        <drugdosagetext>THERAPY DATE: ON OR ABOUT 06-DEC-2003</drugdosagetext>
        <drugindication>SINUSITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031201</drugstartdate>
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    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049591-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
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    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-13434931</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
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    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>70</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>EYE INFLAMMATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KENALOG-40</medicinalproduct>
        <drugbatchnumb>6C18416</drugbatchnumb>
        <drugauthorizationnumb>014901</drugauthorizationnumb>
        <drugadministrationroute>031</drugadministrationroute>
        <drugindication>MACULAR OEDEMA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049592-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
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    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060703</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-13431333</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
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    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <patientonsetage>50</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>EYE INFLAMMATION</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KENALOG-40</medicinalproduct>
        <drugbatchnumb>6C18416</drugbatchnumb>
        <drugauthorizationnumb>014901</drugauthorizationnumb>
        <drugadministrationroute>031</drugadministrationroute>
        <drugindication>MACULAR OEDEMA</drugindication>
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    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049594-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060328</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-BRISTOL-MYERS SQUIBB COMPANY-13336961</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
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    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <patientonsetage>77</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOGLYCAEMIA</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GATIFLOXACIN</medicinalproduct>
        <drugauthorizationnumb>21061</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BRONCHITIS</drugindication>
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        <drugstartdate>20060301</drugstartdate>
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        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BASEN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060116</drugstartdate>
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        <drugtreatmentduration>46</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GLUFAST</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060116</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060302</drugenddate>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIVACT</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELTECT</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PENTOXYVERINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GASLON N</medicinalproduct>
      </drug>
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  <safetyreport>
    <safetyreportid>5049595-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
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    <receiptdateformat>102</receiptdateformat>
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      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
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    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <patientonsetage>10</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>EYE INFLAMMATION</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KENALOG-40</medicinalproduct>
        <drugbatchnumb>6C18416</drugbatchnumb>
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        <drugadministrationroute>031</drugadministrationroute>
        <drugindication>MACULAR OEDEMA</drugindication>
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    </patient>
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  <safetyreport>
    <safetyreportid>5049596-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060607</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
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    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>3</qualification>
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    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <patientonsetage>7</patientonsetage>
      <patientonsetageunit>800</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>SHOCK</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAXOL</medicinalproduct>
        <drugauthorizationnumb>20262</drugauthorizationnumb>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>LUNG NEOPLASM MALIGNANT</drugindication>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARBOPLATIN</medicinalproduct>
        <drugauthorizationnumb>019880</drugauthorizationnumb>
        <drugindication>LUNG NEOPLASM MALIGNANT</drugindication>
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    </patient>
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  <safetyreport>
    <safetyreportid>5049597-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
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    <receivedateformat>102</receivedateformat>
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    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041019</receiptdate>
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      <reportercountry>UNITED STATES</reportercountry>
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    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <patientonsetage>47</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
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      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DIABETES MELLITUS INSULIN-DEPENDENT</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
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        <drugindication>PNEUMONIA STREPTOCOCCAL</drugindication>
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        <drugstartdate>20010301</drugstartdate>
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        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
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  <safetyreport>
    <safetyreportid>5049598-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
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    <receivedateformat>102</receivedateformat>
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    <receiptdateformat>102</receiptdateformat>
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    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-13434972</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
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    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>EYE INFLAMMATION</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KENALOG-40</medicinalproduct>
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        <drugauthorizationnumb>014901</drugauthorizationnumb>
        <drugadministrationroute>031</drugadministrationroute>
        <drugindication>MACULAR OEDEMA</drugindication>
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    </patient>
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  <safetyreport>
    <safetyreportid>5049599-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
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    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
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      <reportercountry>UNITED STATES</reportercountry>
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    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>EYE INFLAMMATION</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KENALOG-40</medicinalproduct>
        <drugbatchnumb>6C18416</drugbatchnumb>
        <drugauthorizationnumb>014901</drugauthorizationnumb>
        <drugadministrationroute>031</drugadministrationroute>
        <drugindication>MACULAR OEDEMA</drugindication>
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  <safetyreport>
    <safetyreportid>5049600-9</safetyreportid>
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    <serious>1</serious>
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    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060705</receiptdate>
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      <reportercountry>UNITED STATES</reportercountry>
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    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ENDOPHTHALMITIS</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KENALOG-40</medicinalproduct>
        <drugauthorizationnumb>014901</drugauthorizationnumb>
        <drugadministrationroute>031</drugadministrationroute>
        <drugindication>MACULAR OEDEMA</drugindication>
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        <drugstartdate>20060621</drugstartdate>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KENALOG-40</medicinalproduct>
        <drugauthorizationnumb>014901</drugauthorizationnumb>
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        <drugindication>MACULAR DEGENERATION</drugindication>
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        <drugstartdate>20060621</drugstartdate>
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  <safetyreport>
    <safetyreportid>5049601-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
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      <reportercountry>UNITED STATES</reportercountry>
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    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <patientonsetage>57</patientonsetage>
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      <reaction>
        <reactionmeddrapt>ALANINE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>ASPARTATE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
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      <drug>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXCARBAZEPINE</medicinalproduct>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BACLOFEN</medicinalproduct>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PARACETAMOL</medicinalproduct>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VASOBRAL</medicinalproduct>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZALDIAR</medicinalproduct>
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        <drugstartdate>20060504</drugstartdate>
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  <safetyreport>
    <safetyreportid>5049602-2</safetyreportid>
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      <reportercountry>UNITED STATES</reportercountry>
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    <receiver></receiver>
    <patient>
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        <reactionmeddrapt>BREAST CANCER</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
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        <drugcharacterization>1</drugcharacterization>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ESTRATEST</medicinalproduct>
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        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMPRO</medicinalproduct>
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      <drug>
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      <reportercountry>UNITED STATES</reportercountry>
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      <reaction>
        <reactionmeddrapt>OESTROGEN RECEPTOR ASSAY POSITIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROGESTERONE RECEPTOR ASSAY POSITIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ESTRACE</medicinalproduct>
        <drugauthorizationnumb>084499</drugauthorizationnumb>
        <drugindication>MENOPAUSAL SYMPTOMS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROVERA</medicinalproduct>
        <drugindication>MENOPAUSAL SYMPTOMS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049605-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060703</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-13434956</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>40</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>EYE INFLAMMATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KENALOG-40</medicinalproduct>
        <drugbatchnumb>6C18416</drugbatchnumb>
        <drugauthorizationnumb>014901</drugauthorizationnumb>
        <drugadministrationroute>031</drugadministrationroute>
        <drugindication>MACULAR OEDEMA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049617-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060621</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AND_0361_2006</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>74</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIOGENIC SHOCK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISSEMINATED INTRAVASCULAR COAGULATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMODIALYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LACTIC ACIDOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTI-ORGAN FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SHOCK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL ACUITY REDUCED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
        <drugauthorizationnumb>75961</drugauthorizationnumb>
        <drugdosagetext>DF</drugdosagetext>
        <drugindication>DIABETES MELLITUS NON-INSULIN-DEPENDENT</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049620-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060621</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>SPV1-2006-00021</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>63</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CHOLECYSTITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHOLELITHIASIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LANTHANUM CARBONATE(LANTHANUM CARBONATE) TABLET CHEWABLE</medicinalproduct>
        <drugauthorizationnumb>21468</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERPHOSPHATAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050314</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050424</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LANTHANUM CARBONATE(LANTHANUM CARBONATE) TABLET CHEWABLE</medicinalproduct>
        <drugauthorizationnumb>21468</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERPHOSPHATAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050425</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060601</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FAMOTIDINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALFAROL (ALFACALCIDOL)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMOBAN (ZOPICLONE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EPOGEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HEPARIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IRON (IRON)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049623-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060622</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GXKR2006GB03687</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>59</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ATRIOVENTRICULAR BLOCK FIRST DEGREE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUS BRADYCARDIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIRTAZAPINE</medicinalproduct>
        <drugauthorizationnumb>76189</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049626-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060619</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2006DE09624</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>8</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>B-CELL LYMPHOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EPSTEIN-BARR VIRUS INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>KIDNEY TRANSPLANT REJECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPHOPROLIFERATIVE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OESOPHAGEAL CARCINOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POST PROCEDURAL COMPLICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TONSILLITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOSPORINE</medicinalproduct>
        <drugauthorizationnumb>80336</drugauthorizationnumb>
        <drugindication>RENAL TRANSPLANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
        <drugtreatmentduration>28</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugindication>RENAL TRANSPLANT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MYCOPHENOLATE MOFETIL</medicinalproduct>
        <drugindication>RENAL TRANSPLANT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TACROLIMUS (TACROLIMUS)</medicinalproduct>
        <drugindication>RENAL TRANSPLANT</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049630-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060620</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2006FR09246</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>61</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ALANINE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASPARTATE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ECCHYMOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EPISTAXIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERKERATOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH MACULAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VITAMIN C DEFICIENCY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEORAL</medicinalproduct>
        <drugauthorizationnumb>80336</drugauthorizationnumb>
        <drugdosagetext>50 MG, BID, UNK</drugdosagetext>
        <drugindication>LIVER TRANSPLANT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugdosagetext>2 MG PER DAY, UNK</drugdosagetext>
        <drugindication>LIVER TRANSPLANT</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049633-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060623</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GXKR2006PL03616</companynumb>
    <primarysource>
      <reportercountry>POLAND</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>44</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLUENZA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VITILIGO</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RIBAVIRIN (NGX)(RIBAVIRIN) UNKNOWN</medicinalproduct>
        <drugauthorizationnumb>76192</drugauthorizationnumb>
        <drugdosagetext>1000 MG, QD, UNK</drugdosagetext>
        <drugindication>HEPATITIS C</drugindication>
        <drugtreatmentduration>336</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEGASYS</medicinalproduct>
        <drugdosagetext>180 UG, QW, UNK</drugdosagetext>
        <drugindication>HEPATITIS</drugindication>
        <drugtreatmentduration>336</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049636-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060620</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>8017551</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PNEUMOTHORAX</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STATUS EPILEPTICUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KEPPRA</medicinalproduct>
        <drugauthorizationnumb>21035</drugauthorizationnumb>
        <drugdosagetext>1750 MG 2/D PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>EPILEPSY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049638-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200612762GDS</companynumb>
    <primarysource>
      <reportercountry>COLOMBIA</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>80</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>50</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ARRHYTHMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSARTHRIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STUPOR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</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>20060627</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049648-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006-06-2199</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>38</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ALOPECIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEG-INTRON</medicinalproduct>
        <drugdosagetext>SUBCUTANEOUS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060306</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RIBAVIRIN</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060306</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHADONE HYDROCHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REGLAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EFFEXOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049660-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060627</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006BI008165</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>49</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>70.3075</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FAECAL INCONTINENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLUENZA LIKE ILLNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEMORY IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPINAL COLUMN STENOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STRESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</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>20000101</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>5049661-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060626</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200610817BVD</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>51</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>75</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ATRIOVENTRICULAR BLOCK THIRD DEGREE</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>20060516</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060525</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLONIDINE HCL</medicinalproduct>
        <drugdosagetext>1500 UG, TOTAL DAILY, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ALCOHOL WITHDRAWAL SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060521</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060529</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049662-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060703</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-06P-163-0337346-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>97.5</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE SODIUM</medicinalproduct>
        <drugadministrationroute>050</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>NAPROXEN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DARVOCET</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049663-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060703</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-ABBOTT-06P-167-0337589-00</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>74</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051220</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</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>DICLOFENAC</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTIVITAMIN</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049664-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060705</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-06P-163-0337336-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>99</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021402</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>THYROIDECTOMY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060504</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PHENYTOIN SODIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONVULSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19860101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PHENOBARBITAL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONVULSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19860101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>FLUID RETENTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE BESYLATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049665-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060703</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IT-ABBOTT-06P-083-0337353-01</companynumb>
    <primarysource>
      <reportercountry>ITALY</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>64</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLADDER CANCER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041006</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060629</drugenddate>
        <drugtreatmentduration>631</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040831</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIBASE</medicinalproduct>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060410</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KERAFLOX</medicinalproduct>
        <drugindication>INFECTION PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060613</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060620</drugenddate>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060625</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM FOLINATE</medicinalproduct>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060623</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHYLPREDNISOLONE</medicinalproduct>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UREICON</medicinalproduct>
        <drugindication>CHOLELITHIASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051206</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NETRIXIA</medicinalproduct>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060202</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049666-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060703</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-ABBOTT-06P-167-0337593-00</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>160</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DIABETES MELLITUS NON-INSULIN-DEPENDENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</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>ETORICOXIB</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</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>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049667-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060307</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ES-ABBOTT-06P-144-0327354-00</companynumb>
    <primarysource>
      <reportercountry>SPAIN</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>CEREBRAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYDROCEPHALUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RITONAVIR SOFT GELATIN CAPSULES</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>20945</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050317</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060314</drugenddate>
        <drugtreatmentduration>399</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RITONAVIR SOFT GELATIN CAPSULES</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020945</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060314</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060421</drugenddate>
        <drugtreatmentduration>399</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TIPRANAVIR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050317</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060314</drugenddate>
        <drugtreatmentduration>399</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TIPRANAVIR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060314</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060421</drugenddate>
        <drugtreatmentduration>399</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIDANOSINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051228</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060421</drugenddate>
        <drugtreatmentduration>113</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TENOFOVIR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050723</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060421</drugenddate>
        <drugtreatmentduration>272</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049668-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060705</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>NL-ABBOTT-06P-114-0337688-00</companynumb>
    <primarysource>
      <reportercountry>NETHERLANDS</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>41</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MANIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLARITHROMYCIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>050662</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ERYSIPELAS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060517</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060623</drugenddate>
        <drugtreatmentduration>37</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORTRILEN TABLET</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049669-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060619</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-ABBOTT-06P-062-0336433-00</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ACUTE ABDOMEN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ACUTE RESPIRATORY DISTRESS SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANTITHROMBIN III DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CREATININE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>C-REACTIVE PROTEIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GALLBLADDER DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060516</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060615</drugenddate>
        <drugtreatmentduration>30</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE SODIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SULFASALAZINE</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060516</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049670-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060621</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-ABBOTT-06P-062-0336791-00</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ERYTHRODERMIC PSORIASIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>ERYTHRODERMIC PSORIASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060515</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060614</drugenddate>
        <drugtreatmentduration>30</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>PSORIATIC ARTHROPATHY</drugindication>
        <drugtreatmentduration>30</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DICLOFENAC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DICLOFENAC</medicinalproduct>
        <drugindication>PSORIATIC ARTHROPATHY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049671-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesscongenitalanomali>1</seriousnesscongenitalanomali>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060703</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-ABBOTT-06P-167-0337577-00</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABNORMAL BEHAVIOUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FOETAL ANTICONVULSANT SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCONTINENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SCREAMING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPEECH DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPEECH DISORDER DEVELOPMENTAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UNEVALUABLE EVENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EPILIM</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>18081</drugauthorizationnumb>
        <drugindication>DRUG EXPOSURE DURING PREGNANCY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049672-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060627</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006BI007970</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>48</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ARTHROPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIOMEGALY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERIPHERAL VASCULAR DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROSTATE EXAMINATION ABNORMAL</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>20041014</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041101</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>20041101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049673-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060622</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006108263BYL</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>69</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>52</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>INTERSTITIAL LUNG DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLEURAL EFFUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY OEDEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CIPROFLOXACIN</medicinalproduct>
        <drugauthorizationnumb>19847</drugauthorizationnumb>
        <drugdosagetext>300 MG, BID, INTRAVENOUS DRIP</drugdosagetext>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>PNEUMONIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060602</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060612</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BLOPRESS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TIENAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEU-UP</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DECADRON PHOSPHAT [CREATININE, DEXAMETHASONE SODIUM PHOSPHATE]</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NASEA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GASTER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAXOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PARAPLATIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAXIPIME</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049674-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060619</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DSA_70915_2006</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>89</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>68.221</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD CREATININE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HIP FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPONATRAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POSTOPERATIVE INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DARVOCET</medicinalproduct>
        <drugauthorizationnumb>17122</drugauthorizationnumb>
        <drugdosagetext>DF</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KEFLEX</medicinalproduct>
        <drugdosagetext>DF</drugdosagetext>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REMERON</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EFFEXOR XR</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>ACETAMINOPHEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOCUSATE SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PEPCID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVENOX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE TAB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANCEF</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAZODONE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALDACTONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SLO-MAG</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRO-BANTHINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BEXTRA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COZAAR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DUONEB</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049675-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200610920GDS</companynumb>
    <primarysource>
      <reportercountry>POLAND</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>80</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>80</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROTEINURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SORAFENIB</medicinalproduct>
        <drugbatchnumb>111382</drugbatchnumb>
        <drugauthorizationnumb>21923</drugauthorizationnumb>
        <drugdosagetext>400 MG, BID, ORAL; SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RENAL CELL CARCINOMA STAGE UNSPECIFIED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051215</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060207</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SORAFENIB</medicinalproduct>
        <drugbatchnumb>111382</drugbatchnumb>
        <drugauthorizationnumb>21923</drugauthorizationnumb>
        <drugdosagetext>400 MG, BID, ORAL; SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RENAL CELL CARCINOMA STAGE UNSPECIFIED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060209</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MILURIT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THEOSPIREX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLOZEK</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049676-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060620</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200611693GDS</companynumb>
    <primarysource>
      <reportercountry>POLAND</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>64</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>82</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD MAGNESIUM DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PHOSPHORUS DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOCALCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTHYROIDISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEPHROGENIC ANAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SORAFENIB</medicinalproduct>
        <drugbatchnumb>110092</drugbatchnumb>
        <drugauthorizationnumb>21923</drugauthorizationnumb>
        <drugdosagetext>400 MG, QD, ORAL; SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RENAL CELL CARCINOMA STAGE UNSPECIFIED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050621</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050816</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SORAFENIB</medicinalproduct>
        <drugbatchnumb>110092</drugbatchnumb>
        <drugauthorizationnumb>21923</drugauthorizationnumb>
        <drugdosagetext>400 MG, QD, ORAL; SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RENAL CELL CARCINOMA STAGE UNSPECIFIED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050620</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SORAFENIB</medicinalproduct>
        <drugbatchnumb>110633</drugbatchnumb>
        <drugdosagetext>400 MG, QD, ORAL; SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050818</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051018</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SORAFENIB</medicinalproduct>
        <drugbatchnumb>110633</drugbatchnumb>
        <drugdosagetext>400 MG, QD, ORAL; SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050817</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SORAFENIB</medicinalproduct>
        <drugdosagetext>400 MG, QD, ORAL; SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051020</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051213</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SORAFENIB</medicinalproduct>
        <drugdosagetext>400 MG, QD, ORAL; SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051019</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SORAFENIB</medicinalproduct>
        <drugdosagetext>400 MG, QD, ORAL; SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060429</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SORAFENIB</medicinalproduct>
        <drugbatchnumb>111347</drugbatchnumb>
        <drugdosagetext>400 MG, QD, ORAL; SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051215</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051221</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SORAFENIB</medicinalproduct>
        <drugbatchnumb>111347</drugbatchnumb>
        <drugdosagetext>400 MG, QD, ORAL; SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051214</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SORAFENIB</medicinalproduct>
        <drugbatchnumb>111834</drugbatchnumb>
        <drugdosagetext>400 MG, BID, ORAL; SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051222</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060214</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SORAFENIB</medicinalproduct>
        <drugbatchnumb>111834</drugbatchnumb>
        <drugdosagetext>400 MG, BID, ORAL; SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060214</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060420</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SORAFENIB</medicinalproduct>
        <drugbatchnumb>111834</drugbatchnumb>
        <drugdosagetext>400 MG, BID, ORAL; SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060421</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BISOCARD</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BLOCARD</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GENSULIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLOPIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KREON</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EUTHYROX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOPERAMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SODIUM CHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARTRESAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METIZOL [THIAMAZOLE]</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KALIPOZ</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALFADIOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRONOL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049677-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060612</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>COT_0620_2006</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>76</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>59.8748</patientweight>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ANIMAL SCRATCH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CELLULITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COR PULMONALE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ELECTROCARDIOGRAM T WAVE ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUDDEN CARDIAC DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VENTAVIS</medicinalproduct>
        <drugauthorizationnumb>21779</drugauthorizationnumb>
        <drugdosagetext>5 MCG 6TO9X/DAY IH</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>PULMONARY HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050823</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATARAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRONOLACTONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TIMOLOL MALEATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTIVITAMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN B COMPLEX CAP</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLOVENT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LUMIGAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIGOXIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYGEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL SPIROS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOXYL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMBIEN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049678-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200611960GDS</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>47</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>61.5</patientweight>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>AGITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBRAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISEASE PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GRAND MAL CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE TWITCHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUROPATHY PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UNRESPONSIVE TO STIMULI</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SORAFENIB</medicinalproduct>
        <drugbatchnumb>100535</drugbatchnumb>
        <drugauthorizationnumb>21923</drugauthorizationnumb>
        <drugdosagetext>400 MG, BID, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MALIGNANT MELANOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060602</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FENTANYL TRANSDERMAL SYSTEM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MS CONTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GABAPENTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ORDINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE TAB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOTHIEPIN HYDROCHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BRUFEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRAMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRIMETHOPRIM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SOMAC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORAZEPAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KETAMINE HCL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049679-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060626</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200612703GDS</companynumb>
    <primarysource>
      <reportercountry>SWEDEN</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>62</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULAR WEAKNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SORAFENIB</medicinalproduct>
        <drugbatchnumb>101835</drugbatchnumb>
        <drugauthorizationnumb>21923</drugauthorizationnumb>
        <drugdosagetext>800 MG, TOTAL DAILY, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RENAL CELL CARCINOMA STAGE UNSPECIFIED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060524</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYNORM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCORTISONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXOFEN [DEXCHLORPHENIRAMINE MALEATE]</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALVEDON</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049680-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060622</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200612657GDS</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>70</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>53.978</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD CREATININE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH ERYTHEMATOUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH MACULAR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SORAFENIB</medicinalproduct>
        <drugauthorizationnumb>21923</drugauthorizationnumb>
        <drugdosagetext>400 MG, BID, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RENAL CELL CARCINOMA STAGE UNSPECIFIED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060531</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060613</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYZAAR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZANTAC</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049681-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060615</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2473</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>17</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABORTION INDUCED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PREGNANCY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMNESTEEM</medicinalproduct>
        <drugauthorizationnumb>75945</drugauthorizationnumb>
        <drugdosagetext>20 MG, QD, PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060120</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060302</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049682-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060626</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200610777BYL</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>66</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>56</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>EOSINOPHILIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GLUCOBAY</medicinalproduct>
        <drugauthorizationnumb>20482</drugauthorizationnumb>
        <drugdosagetext>50 MG, TID, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060404</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060529</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>100 MG, QD, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANGINA PECTORIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060329</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060529</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FAMOTIDINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIBETOS B</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TICLOPIDINE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARTIST</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NU-LOTAN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049683-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060301</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>163-20785-06030290</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>58</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD CREATININE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEEP VEIN THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PEPTIC ULCER HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>THALOMID</medicinalproduct>
        <drugauthorizationnumb>20785</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20011025</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>THALOMID</medicinalproduct>
        <drugauthorizationnumb>20785</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010927</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20011005</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>THALOMID</medicinalproduct>
        <drugauthorizationnumb>20785</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20011005</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20011025</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>THALOMID</medicinalproduct>
        <drugauthorizationnumb>20785</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20011231</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>THALOMID</medicinalproduct>
        <drugauthorizationnumb>20785</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020422</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049684-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060627</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>163-20785-06040662</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>63</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>DISEASE PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYELODYSPLASTIC SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYELOMA RECURRENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUROPATHY PERIPHERAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>THALOMID</medicinalproduct>
        <drugauthorizationnumb>20785</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030201</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>20010901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>THALOMID</medicinalproduct>
        <drugauthorizationnumb>20785</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051001</drugstartdate>
      </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>20051001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>THALOMID</medicinalproduct>
        <drugauthorizationnumb>20785</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
      </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>20060101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MYELODYSPLASTIC SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MYELODYSPLASTIC SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VELCADE</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VELCADE</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MYELODYSPLASTIC SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049685-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060626</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>145057USA</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>48</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL DISTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BURSA DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FIBROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE ATROPHY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COPAXONE</medicinalproduct>
        <drugauthorizationnumb>20622</drugauthorizationnumb>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WELLBUTRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KLONOPIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049686-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060627</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>163-20785-06020061</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>78</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>CARDIAC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG DISORDER</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>20030801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050801</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049687-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PERC20060021</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>40</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>106.5953</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ACCIDENTAL DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRONCHOPNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIO-RESPIRATORY ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCORRECT DOSE ADMINISTERED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE DRUG OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL STIFFNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENDOCET         10MG/(APAP-UNK)       ENDO</medicinalproduct>
        <drugauthorizationnumb>40341</drugauthorizationnumb>
        <drugdosagetext>PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DURAGESIC-100</medicinalproduct>
        <drugdosagetext>OTHR</drugdosagetext>
        <drugadministrationroute>050</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051114</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HYDROCODONE</medicinalproduct>
        <drugindication>PAIN</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CANNABIS</medicinalproduct>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOPAMAX  50 MG J+J</medicinalproduct>
        <drugdosagetext>2 TABS DAILY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NEURALGIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041029</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049688-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060626</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CAPT20060001</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>8</patientonsetage>
      <patientonsetageunit>802</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CRYING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EOSINOPHILIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEEDING DISORDER OF INFANCY OR EARLY CHILDHOOD</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER PALPABLE SUBCOSTAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG INFILTRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSYCHOMOTOR HYPERACTIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY RATE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY SYNCYTIAL VIRUS INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHINORRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHINOVIRUS INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINE OUTPUT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CAPTOPRIL</medicinalproduct>
        <drugauthorizationnumb>74418</drugauthorizationnumb>
        <drugdosagetext>1 MG TID PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INCREASED VENTRICULAR AFTERLOAD</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020905</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020919</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIGOXIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOCLOPRAMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMOXICILLIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049689-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060614</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2006-BP-06783NB</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DELIRIUM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BI-SIFROL TABLETS</medicinalproduct>
        <drugauthorizationnumb>20667</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PARKINSON'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051122</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060427</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEPAS</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANXIETY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051122</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGNESIUM OXIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONSTIPATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051122</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PURSENNID (SENNOSIDE)</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONSTIPATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051122</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PARIET</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060414</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060425</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MENESIT</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PARKINSON'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051022</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYMMETREL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PARKINSON'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051022</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060427</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049690-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2006-FF-00554PF</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>71</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DERMATITIS ALLERGIC</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
        <drugauthorizationnumb>021395</drugauthorizationnumb>
        <drugadministrationroute>055</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049691-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20051024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2005-BP-18844YA</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>61</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ASBESTOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLOMAX</medicinalproduct>
        <drugauthorizationnumb>20579</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
        <drugauthorizationnumb>021395</drugauthorizationnumb>
        <drugadministrationroute>055</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CALCICHEW D3</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SALBUTAMOL</medicinalproduct>
        <drugauthorizationnumb>075129</drugauthorizationnumb>
        <drugadministrationroute>055</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SERETIDE</medicinalproduct>
        <drugadministrationroute>055</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049692-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060704</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2006-FF-00570FF</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>55</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>AGGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG DEPENDENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EUPHORIC MOOD</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIBIDO INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PATHOLOGICAL GAMBLING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SIFROL</medicinalproduct>
        <drugauthorizationnumb>20667</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PARKINSON'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060411</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>STALEVO 100</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PARKINSON'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060408</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SINEMET</medicinalproduct>
        <drugdosagetext>25 MG/ 100 MG DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PARKINSON'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19960615</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELANCE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PARKINSON'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19960615</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049693-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060228</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BE-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2006-BL-00076BL</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>59</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DELUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HALLUCINATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIRAPEXIN</medicinalproduct>
        <drugauthorizationnumb>20667</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PARKINSON'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SELOZOK</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CORUNO</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049694-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060710</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2006-BP-07914YA</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>66</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>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>TAMSULOSIN HYDROCHLORIDE</medicinalproduct>
        <drugauthorizationnumb>20579</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROSTATISM</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060530</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060606</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DILTIAZEM HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RANITIDINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ROSUVASTATIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049695-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060605</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2006-BP-06339BP</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>74</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GUILLAIN-BARRE SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROSTATE CANCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STAPHYLOCOCCAL INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLOMAX</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>20579</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BENIGN PROSTATIC HYPERPLASIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOXAZOSIN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060509</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060528</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADVAIR DISKUS 100/50</medicinalproduct>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DUONEB</medicinalproduct>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049696-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060706</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2006-BP-07724BP</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>APTIVUS/RITONAVIR CAPSULES</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>21814</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MARAVIROX</medicinalproduct>
        <drugindication>HIV INFECTION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049697-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesscongenitalanomali>1</seriousnesscongenitalanomali>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2006-BP-07474BP</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>1.36</patientweight>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>CHROMOSOME ABNORMALITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONGENITAL ANOMALY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEATH NEONATAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYDROPS FOETALIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MATERNAL CONDITION AFFECTING FOETUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIRAMUNE</medicinalproduct>
        <drugauthorizationnumb>020636</drugauthorizationnumb>
        <drugadministrationroute>015</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRUVADA</medicinalproduct>
        <drugadministrationroute>015</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZIDOVUDINE</medicinalproduct>
        <drugauthorizationnumb>076844</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060506</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060506</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049698-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060707</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2006-DE-03478DE</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>53</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ALCOHOL USE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG ABUSER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDE ATTEMPT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BUSCOPAN</medicinalproduct>
        <drugauthorizationnumb>63277</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CODEINE</medicinalproduct>
        <drugdosagetext>HALF A BOTTLE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PARACETAMOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049699-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060531</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BE-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2006-BL-00146BL</companynumb>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>91</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>EYE ABSCESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OCULAR HYPERAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIRAPEXIN</medicinalproduct>
        <drugauthorizationnumb>20667</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PARKINSON'S DISEASE</drugindication>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALPRAZOLAM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANXIETY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOGIMAT</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049700-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060616</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2006-FF-00498FF</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>90</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD HOMOCYSTEINE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GROIN ABSCESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEUKOCYTOCLASTIC VASCULITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURIGO</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSEUDOMONAS INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STAPHYLOCOCCAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOPHLEBITIS SUPERFICIAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VARICOSE VEIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIRAMUNE</medicinalproduct>
        <drugauthorizationnumb>20636</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS AGAINST HIV INFECTION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010101</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TENORMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EFFEXOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LYPANTHYL</medicinalproduct>
        <drugindication>DYSLIPIDAEMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LUTENYL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COMBIVIR</medicinalproduct>
        <drugindication>PROPHYLAXIS AGAINST HIV INFECTION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049701-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060621</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-2006-013530</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>59</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>47</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CYSTITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BETASERON</medicinalproduct>
        <drugbatchnumb>VAU399A</drugbatchnumb>
        <drugdosagetext>9 MIU, EVERY 2D; SUBCUTANEOUS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CORTICOSTEROIDS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049702-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060615</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2005US000222</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>T-CELL LYMPHOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROTOPIC</medicinalproduct>
        <drugauthorizationnumb>50777</drugauthorizationnumb>
        <drugdosagetext>TOPICAL</drugdosagetext>
        <drugadministrationroute>061</drugadministrationroute>
        <drugindication>ECZEMA</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIPROLENE CREAM (BETAMETHASONE DIPROPIONATE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ELIDEL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049703-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060615</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2005US000165</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>12</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MALIGNANT MELANOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROTOPIC</medicinalproduct>
        <drugauthorizationnumb>50777</drugauthorizationnumb>
        <drugdosagetext>TOPICAL</drugdosagetext>
        <drugadministrationroute>061</drugadministrationroute>
        <drugindication>MOLLUSCUM CONTAGIOSUM</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040801</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049704-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060623</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-2006-004746</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>61</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>71</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BACTERAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BAND NEUTROPHIL PERCENTAGE INCREASED</reactionmeddrapt>
      </reaction>
      <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>CENTRAL LINE INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COOMBS TEST POSITIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIFFUSE LARGE B-CELL LYMPHOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GRAFT VERSUS HOST DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATOCRIT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOLYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAPTOGLOBIN ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPHADENOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPHOPROLIFERATIVE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MONOCYTE PERCENTAGE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPHIL PERCENTAGE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUSITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STEM CELL TRANSPLANT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRANSFUSION REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY TRACT INFECTION BACTERIAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CAMPATH</medicinalproduct>
        <drugdosagetext>50 MG D-7 TO D-3; INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BONE MARROW CONDITIONING REGIMEN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050527</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050531</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUDARABINE</medicinalproduct>
        <drugdosagetext>25 MG/M2 D-5 TO D; INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BONE MARROW CONDITIONING REGIMEN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050529</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050602</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEUKINE</medicinalproduct>
        <drugdosagetext>250 UG/DAY D+3 UNTIL ANC}1000, SUBCUTANEOUS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>COLONY STIMULATING FACTOR PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050606</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MESNA</medicinalproduct>
        <drugdosagetext>12 MG/KG (DAILY DOSE 48MG/KG), UNK</drugdosagetext>
        <drugindication>BONE MARROW CONDITIONING REGIMEN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050530</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOPHOSPHAMIDE</medicinalproduct>
        <drugdosagetext>45MG/KG</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BONE MARROW CONDITIONING REGIMEN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050530</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050531</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYCLOSPORINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CIDOFOVIR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ELECTROLYTE SOLUTIONS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IV SOLUTIONS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACYCLOVIR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACYCLOVIR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PENTAMIDINE ISETHIONATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SUDAFED 12 HOUR</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049705-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060427</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006S1000082</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>61</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>63.2</patientweight>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING COLD</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUID OVERLOAD</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGE INTRACRANIAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OCCULT BLOOD POSITIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OXYGEN SATURATION DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALLOR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLEURAL EFFUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY DISTRESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRACHEAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINE OUTPUT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INOMAX</medicinalproduct>
        <drugbatchnumb>5AP001-05</drugbatchnumb>
        <drugauthorizationnumb>20845</drugauthorizationnumb>
        <drugdosagetext>40 PPM; CONT; INH</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>VENTRICULAR ASSIST DEVICE INSERTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060421</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060422</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIPYRIDAMOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NIZATIDINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOSYN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEXAPRO</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANGIOMAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOPAMINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MILRINONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CEFUROXIME</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUCONAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VANCOMYCIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROPOFOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FENTANYL TRANSDERMAL SYSTEM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TIOTROPRIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL SPIROS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NYSTATIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM CHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGNESIUM SULFATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCODONE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HEXTEND</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ETOMIDATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SUCCINYCHOLINE CHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM CHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTIVITAMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FERROUS SULFATE TAB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLASMANATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DESITIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM CHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>...........</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOSYN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SODIUM CHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BIVALIRUDIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TESTOSTERONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NYSTATIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>.............</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>...................</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIPYRIDAMOLE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049706-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060615</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2005US000346</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>73</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BASAL CELL CARCINOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROTOPIC</medicinalproduct>
        <drugauthorizationnumb>50777</drugauthorizationnumb>
        <drugdosagetext>BID, TOPICAL</drugdosagetext>
        <drugadministrationroute>061</drugadministrationroute>
        <drugindication>SEBORRHOEIC DERMATITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040201</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049707-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
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    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
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      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
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    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBIF</medicinalproduct>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
      </drug>
    </patient>
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  <safetyreport>
    <safetyreportid>5049708-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
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    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060626</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
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    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
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    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>76</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FEBRILE NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFUSION RELATED REACTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NOVANTRONE</medicinalproduct>
        <drugauthorizationnumb>19297</drugauthorizationnumb>
        <drugdosagetext>50.4 MG, 1 IN 1 DAYS,</drugdosagetext>
        <drugindication>ACUTE MYELOID LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050910</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050910</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GEMTUZUMAB OZOGAMICIN</medicinalproduct>
        <drugdosagetext>10 MG, 1 IN 1 DAYS, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ACUTE MYELOID LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050909</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050909</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYTARABINE</medicinalproduct>
        <drugdosagetext>3.36 G, 2 IN 1 DAYS,</drugdosagetext>
        <drugindication>ACUTE MYELOID LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050910</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050910</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049709-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060615</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2005US000531</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>48</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>61.2</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CHRONIC LYMPHOCYTIC LEUKAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROTOPIC</medicinalproduct>
        <drugauthorizationnumb>50777</drugauthorizationnumb>
        <drugdosagetext>PRN, TOPICAL</drugdosagetext>
        <drugadministrationroute>061</drugadministrationroute>
        <drugindication>DERMATITIS ATOPIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049710-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060627</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>226807</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>62</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>85.3</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVASTIN</medicinalproduct>
        <drugbatchnumb>M58984, M52227</drugbatchnumb>
        <drugdosagetext>100 MG, 500 MG</drugdosagetext>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060414</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ELOXATIN</medicinalproduct>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060414</drugstartdate>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALIMTA</medicinalproduct>
        <drugbatchnumb>CT000767</drugbatchnumb>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060414</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049711-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060623</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006BI009077</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <patientonsetage>51</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>45.3597</patientweight>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>CARDIAC ARREST</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>20051111</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRICOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ECOTRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN B12 INJECTION</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049712-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060627</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>224720</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>50</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>68.9</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>GASTRIC ULCER PERFORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEOPLASM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERITONITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVASTIN</medicinalproduct>
        <drugdosagetext>600 MG, 1/WEEK; INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PANCREATIC CARCINOMA</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060414</drugenddate>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GEMZAR</medicinalproduct>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NSAIDS (NON-STEROIDAL ANTI-INFLAMMATORY DRUG NOS)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049713-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060622</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006BI008989</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <patientonsetage>61</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>61.6892</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FIBROMYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE IRREGULAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEURALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA ASPIRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESTLESS LEGS SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THYROID DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugdosagetext>30 UG;QW;IM</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
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        <drugstartdate>20000101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040101</drugenddate>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUTICASONE PROPIONATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADVAIR DISKUS 100/50</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
      </drug>
    </patient>
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  <safetyreport>
    <safetyreportid>5049714-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
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    <receiptdate>20060622</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>35457</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <patientonsetage>46</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>EYE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GLARE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLAMMATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POST PROCEDURAL COMPLICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISION BLURRED</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEVANAC</medicinalproduct>
        <drugauthorizationnumb>21862</drugauthorizationnumb>
        <drugdosagetext>1 GTT OS BID, OPHT</drugdosagetext>
        <drugadministrationroute>047</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060314</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060314</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEXAPRO</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VIGAMOX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLAREX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLARITIN-D</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049715-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060626</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006BI007906</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>53</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>77.1115</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>COMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ELECTROENCEPHALOGRAM ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE SCLEROSIS RELAPSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugdosagetext>30 UG;QW;IM</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049716-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060627</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006BI009291</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>58</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANKLE FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugdosagetext>30 UG;QW;IM</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19971201</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>5049717-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060626</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006BI009271</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugdosagetext>IM</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19991201</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049718-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060623</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006079740</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>51</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>90.7194</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABNORMAL DREAMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HALLUCINATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCORRECT DOSE ADMINISTERED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NICOTROL</medicinalproduct>
        <drugbatchnumb>GH349-A</drugbatchnumb>
        <drugauthorizationnumb>20714</drugauthorizationnumb>
        <drugdosagetext>4 CARTRIDGES IN ONE, INHALATION</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>SMOKING CESSATION THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060622</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060622</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NICOTINE</medicinalproduct>
        <drugdosagetext>3 PIECES, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SMOKING CESSATION THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060622</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FENOFIBRATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049719-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060627</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006BI009293</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>52</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>COLITIS ULCERATIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugdosagetext>30 UG;QW;IM</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19991010</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>5049720-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060621</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>226601</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>64</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HAEMOLYTIC ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERSTITIAL LUNG DISEASE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVASTIN (BEVACIZUMAB) PWDR + SOLVENT, INFUSION SOLN, 100MG</medicinalproduct>
        <drugindication>COLORECTAL CANCER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUOROURACIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEUCOVORIN CALCIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXALIPLATIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049721-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060626</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2005BI009459</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>53</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>60.3284</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BALANCE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CHOLESTEROL INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CAROTID BRUIT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CATARACT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTHYROIDISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INITIAL INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MACULAR DEGENERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE SCLEROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASTICITY</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>19981201</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>PLAVIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROTONIX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049722-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006BI009261</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>55</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>72.5755</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD CHOLESTEROL INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY OCCLUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLUENZA LIKE ILLNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NERVE INJURY</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>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>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049723-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060627</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006BI006853</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>42</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>65.7716</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSYCHOTIC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SCHIZOPHRENIA</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>20040301</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049724-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060623</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>TRP_0801_2006</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>59</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>77.1115</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>IMPAIRED HEALING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN ULCER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RIBASPHERE</medicinalproduct>
        <drugauthorizationnumb>76203</drugauthorizationnumb>
        <drugdosagetext>VAR BID PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060310</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEG-INTRON</medicinalproduct>
        <drugdosagetext>120 MCG QWK SC</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060310</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SULFATRIM-DS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZIAC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMITRIPYTLINE HYDROCHLORIDE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049725-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060626</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006BI006082</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>COLORECTAL CANCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE SCLEROSIS</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>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040311</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049726-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060621</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>TRP_0799_2006</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>47</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BALANCE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOCALISED INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERIPHERAL MOTOR NEUROPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RED BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RIBASPHERE</medicinalproduct>
        <drugauthorizationnumb>76203</drugauthorizationnumb>
        <drugdosagetext>DF PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060412</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEG-INTRON</medicinalproduct>
        <drugdosagetext>DF SC</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060412</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CAPOTEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOTROL XL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LAMICTAL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROTONIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HERBAL MEDICATION</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049727-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060627</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006BI005086</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>48</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>83.0083</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BILE DUCT OBSTRUCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD POTASSIUM DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCREATIC DUCT OBSTRUCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCREATIC NEOPLASM</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>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>HYDROCHLOROTHIAZIDE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049728-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060626</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006BI004789</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>59</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>KNEE ARTHROPLASTY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE SCLEROSIS RELAPSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugdosagetext>30 UG; QW; IM</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19960801</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049729-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>T200600581</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>76</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>VENTRICULAR FIBRILLATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OPTIRAY 320</medicinalproduct>
        <drugbatchnumb>L140E</drugbatchnumb>
        <drugauthorizationnumb>19710</drugauthorizationnumb>
        <drugdosagetext>8 ML, SINGLE, INTRA-ARTERIAL</drugdosagetext>
        <drugadministrationroute>013</drugadministrationroute>
        <drugindication>CATHETERISATION CARDIAC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060522</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060522</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOPRESSOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049730-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060626</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006BI007644</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>60</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CHOLECYSTECTOMY</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>19980801</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROVIGIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZESTRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049731-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060705</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>5891</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>49</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>117.9352</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIAC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>5% MINOXIDIL TOPICAL SOLUTION</medicinalproduct>
        <drugbatchnumb>4LK0234</drugbatchnumb>
        <drugauthorizationnumb>75598</drugauthorizationnumb>
        <drugdosagetext>1ML/BID/TOPICAL</drugdosagetext>
        <drugadministrationroute>061</drugadministrationroute>
        <drugindication>ALOPECIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19960609</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060609</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOTREL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049732-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060627</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006BI007098</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>57</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FACIAL PALSY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE SCLEROSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugbatchnumb>P35059</drugbatchnumb>
        <drugdosagetext>30 UG; QW; IM</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060303</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049733-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060624</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006081207</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>30</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>93.8946</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCORRECT ROUTE OF DRUG ADMINISTRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOTION SICKNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARYNGOLARYNGEAL PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CALADRYL</medicinalproduct>
        <drugbatchnumb>01915L</drugbatchnumb>
        <drugdosagetext>5 TO 15 ML INJECTED TWICE DAILY</drugdosagetext>
        <drugindication>DERMATITIS CONTACT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060613</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060624</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PIRBUTEROL ACETATE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049734-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060627</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006BI007046</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>58</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>58.0604</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD SODIUM DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COORDINATION ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLUENZA LIKE ILLNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOBILITY DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE RIGIDITY</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>19980101</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>5049735-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060623</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006079745</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>18</patientonsetage>
      <patientonsetageunit>802</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ACCIDENTAL DRUG INTAKE BY CHILD</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EAR PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EPISTAXIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY RATE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUDAFED (PSEUDOEOPHEDRINE)</medicinalproduct>
        <drugdosagetext>AT LEAST 3 TABLETS ONCE, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ACCIDENTAL EXPOSURE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060623</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060623</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049736-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060626</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006BI007038</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>64</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUBDURAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRAUMATIC BRAIN INJURY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugbatchnumb>P01069</drugbatchnumb>
        <drugdosagetext>30 UG; QW; IM</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19960101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049737-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060627</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006BI009259</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>49</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PITUITARY TUMOUR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugbatchnumb>P35068</drugbatchnumb>
        <drugdosagetext>30 UG; QW; IM</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051001</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049738-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060705</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20060502416</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>52</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BASAL CELL CARCINOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLITIS ULCERATIVE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>6-MP</medicinalproduct>
        <drugindication>COLITIS ULCERATIVE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049739-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060627</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006BI009219</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>58</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>64.8644</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>EYE IRRITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLUENZA LIKE ILLNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPINAL CORD DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPINAL OSTEOARTHRITIS</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>20030705</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>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BLOOD PRESSURE MEDICATION</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049740-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060626</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200612719BCC</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SURGERY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ULCER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALEVE</medicinalproduct>
        <drugauthorizationnumb>20204</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049741-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060627</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006BI004638</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>43</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>COMA</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>20051111</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049742-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060626</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006BI004724</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>90.7194</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLADDER DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUID RETENTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROOESOPHAGEAL REFLUX DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HALLUCINATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE SCLEROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NERVOUS SYSTEM DISORDER</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>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXTROMETHORPHAN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049743-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060621</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-2006-001664</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>43</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>58.5</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ALANINE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASPARTATE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ELECTROCARDIOGRAM ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATOCRIT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEUKOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MARROW HYPERPLASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MONOCYTE PERCENTAGE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPHIL PERCENTAGE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RECTAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RED BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE VASOVAGAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENTRICULAR DYSFUNCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT DECREASED</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>20020430</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMITREX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPAMAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ESTRADERM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049744-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060627</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006BI004330</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>50</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVARIAN CYST</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>20011215</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>5049745-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060626</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-2006-003024</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>41</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL ABSCESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABSCESS RUPTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLADDER REPAIR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENITAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLUENZA LIKE ILLNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENORRHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POST PROCEDURAL COMPLICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POST PROCEDURAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POSTOPERATIVE INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROCEDURAL PAIN</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>20051013</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049746-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060623</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006BI003725</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>66</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>59.4212</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD CHOLESTEROL INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</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>19980101</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>20060207</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>20060301</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IPROTRAPION ASTHMA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SINGULAIR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL SPIROS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COMBIVENTS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEVACORE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049747-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060627</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2005BI019476</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CATARACT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugdosagetext>30 UG; QW; IM</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020307</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049748-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060704</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-JNJFOC-20060700981</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>59</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>THYROID CANCER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INFLIXIMAB, RECOMBINANT</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INFLIXIMAB, RECOMBINANT</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INFLIXIMAB, RECOMBINANT</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RHEUMATREX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIAMIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ADVERSE DRUG REACTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYPEN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SELBEX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTROINTESTINAL DISORDER THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AZULFIDINE EN-TABS</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDONINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BONALON</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ISCOTIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANTIBIOTIC PROPHYLAXIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049749-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060602</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-SANOFI-SYNTHELABO-A01200604315</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>52</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CHOLELITHIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC FUNCTION ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MYSLEE</medicinalproduct>
        <drugauthorizationnumb>19908</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060420</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060601</drugenddate>
        <drugtreatmentduration>43</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049750-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060620</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>TR-SANOFI-SYNTHELABO-F01200601490</companynumb>
    <primarysource>
      <reportercountry>TURKEY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>CATHETER RELATED COMPLICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBRAL ISCHAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CALCIUM FOLINATE</medicinalproduct>
        <drugdosagetext>300 MG 2 X PER 2 WEEK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLORECTAL CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060424</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060424</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUOROURACIL</medicinalproduct>
        <drugdosagetext>1600 MG 2 X PER 2 WEEK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLORECTAL CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060424</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060424</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVASTIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLORECTAL CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060424</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060424</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXALIPLATIN</medicinalproduct>
        <drugauthorizationnumb>021492</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLORECTAL CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060424</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060424</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049751-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060711</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-SANOFI-SYNTHELABO-F01200601627</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ACID BASE BALANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERAL PHYSICAL HEALTH DETERIORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGIC STROKE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUCOSAL INFLAMMATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPTIC SHOCK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CAPECITABINE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXALIPLATIN</medicinalproduct>
        <drugauthorizationnumb>021492</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RECTAL CANCER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049752-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060626</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006BI005750</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>64</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MULTIPLE SCLEROSIS RELAPSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugdosagetext>30 UG; QW; IM</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049753-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-2006-017306</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BEDRIDDEN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMPAIRED WORK ABILITY</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>20051201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060313</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049754-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060620</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006PV015924</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>76</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>119.296</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANGINA PECTORIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BUNDLE BRANCH BLOCK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CAROTID ARTERY OCCLUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY STENOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ELECTROCARDIOGRAM POOR R-WAVE PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERMITTENT CLAUDICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL ISCHAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BYETTA</medicinalproduct>
        <drugauthorizationnumb>21773</drugauthorizationnumb>
        <drugdosagetext>10 + 5 MCG; BID; SC</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>DIABETES MELLITUS NON-INSULIN-DEPENDENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BYETTA</medicinalproduct>
        <drugauthorizationnumb>21773</drugauthorizationnumb>
        <drugdosagetext>10 + 5 MCG; BID; SC</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>DIABETES MELLITUS NON-INSULIN-DEPENDENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPROL-XL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROCARDIA XL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOPHAGE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRINIVIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLIPIZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLOMAX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049755-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060621</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-2006-016482</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>57</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BURNS SECOND DEGREE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SLEEP ATTACKS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</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>20060418</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049756-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060623</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006PV016241</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>60</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>89.8122</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DECREASED APPETITE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUS TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THERAPEUTIC RESPONSE UNEXPECTED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BYETTA</medicinalproduct>
        <drugauthorizationnumb>21773</drugauthorizationnumb>
        <drugdosagetext>5 MCG; QD;SC</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>DIABETES MELLITUS NON-INSULIN-DEPENDENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060111</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060205</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BYETTA</medicinalproduct>
        <drugauthorizationnumb>21773</drugauthorizationnumb>
        <drugdosagetext>5 MCG; QD;SC</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>DIABETES MELLITUS NON-INSULIN-DEPENDENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060320</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060514</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BYETTA</medicinalproduct>
        <drugauthorizationnumb>21773</drugauthorizationnumb>
        <drugdosagetext>5 MCG; QD;SC</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>DIABETES MELLITUS NON-INSULIN-DEPENDENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060515</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACTOS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ISOSORBIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049757-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060622</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-2006-016501</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>43</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE MASS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SURGERY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WALKING AID USER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WRONG TECHNIQUE IN DRUG USAGE PROCESS</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>19980302</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049758-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060623</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006PV011508</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>61</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>74.8435</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ACIDOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANION GAP INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOCONCENTRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERNATRAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BYETTA</medicinalproduct>
        <drugauthorizationnumb>21773</drugauthorizationnumb>
        <drugdosagetext>5 MCG; BID; SC</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>DIABETES MELLITUS NON-INSULIN-DEPENDENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051029</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051102</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NOVOLIN 70/30</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOPHAGE XR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLYBURIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THYROID TAB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049759-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesscongenitalanomali>1</seriousnesscongenitalanomali>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060704</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-SANOFI-SYNTHELABO-A02200601765</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>0</patientonsetage>
      <patientonsetageunit>804</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EAR MALFORMATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FACIAL PALSY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GROWTH RETARDATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CORTICOID NOS</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>064</drugadministrationroute>
        <drugindication>SYSTEMIC LUPUS ERYTHEMATOSUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PLAQUENIL</medicinalproduct>
        <drugauthorizationnumb>009768</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>064</drugadministrationroute>
        <drugindication>SYSTEMIC LUPUS ERYTHEMATOSUS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049760-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060704</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-SANOFI-SYNTHELABO-A02200601776</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>ACUTE PROMYELOCYTIC LEUKAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ELOXATIN</medicinalproduct>
        <drugauthorizationnumb>21492</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLON CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19950101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19950101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM FOLINATE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLON CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19950101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19950101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUOROURACIL</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLON CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19950101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19950101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IRINOTECAN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLON CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19950101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19950101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049761-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060706</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PT-SANOFI-SYNTHELABO-A01200605247</companynumb>
    <primarysource>
      <reportercountry>PORTUGAL</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>45</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUOROURACIL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060703</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOFOLINATE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060703</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ELOXATIN</medicinalproduct>
        <drugauthorizationnumb>021492</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RECTAL CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060703</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060703</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>805</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049762-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060707</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-SANOFI-SYNTHELABO-A01200605293</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>17</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CIRCULATORY COLLAPSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANIC ATTACK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UNRESPONSIVE TO STIMULI</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SERTRALINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARALEN</medicinalproduct>
        <drugdosagetext>ONCE WEEKLY TIMES 3 WEEKS</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049763-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060630</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IT-SANOFI-SYNTHELABO-A06200600229</companynumb>
    <primarysource>
      <reportercountry>ITALY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HYPOGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENEXOL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLINA</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>EUTIROX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPOTHYROIDISM</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOPHAGE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS NON-INSULIN-DEPENDENT</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060609</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ELOPRAM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060620</drugenddate>
        <drugtreatmentduration>202</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugauthorizationnumb>020839</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANGIOPLASTY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060530</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049764-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060704</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-SANOFI-SYNTHELABO-A01200605080</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>62</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DELIRIUM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DELUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HALLUCINATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MYSLEE</medicinalproduct>
        <drugauthorizationnumb>19908</drugauthorizationnumb>
        <drugdosagetext>10 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INSOMNIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060531</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060531</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049765-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060622</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006PV016169</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>51</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>126.5536</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ATRIAL FIBRILLATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ATRIOVENTRICULAR BLOCK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERUCTATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLATULENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUID RETENTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ILL-DEFINED DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT FLUCTUATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BYETTA</medicinalproduct>
        <drugauthorizationnumb>21773</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>DIABETES MELLITUS NON-INSULIN-DEPENDENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050701</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BYETTA</medicinalproduct>
        <drugauthorizationnumb>21773</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>DIABETES MELLITUS NON-INSULIN-DEPENDENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BYETTA</medicinalproduct>
        <drugauthorizationnumb>21773</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>DIABETES MELLITUS NON-INSULIN-DEPENDENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLIPIZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HUMALOG</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BETAPACE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049766-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060623</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-2006-004746</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>61</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>71</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>CENTRAL LINE INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIFFUSE LARGE B-CELL LYMPHOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATOCRIT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOLYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPHADENOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPHOPROLIFERATIVE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPHIL PERCENTAGE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POOR VENOUS ACCESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUSITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STEM CELL TRANSPLANT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TONSILLAR DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TONSILLAR HYPERTROPHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRANSFUSION REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY TRACT INFECTION BACTERIAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CAMPATH</medicinalproduct>
        <drugdosagetext>50 MG D-7 TO D-3, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BONE MARROW CONDITIONING REGIMEN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050527</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050531</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUDARABINE</medicinalproduct>
        <drugdosagetext>25 MG/M2 D-5 TO D, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BONE MARROW CONDITIONING REGIMEN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050529</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050602</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEUKINE</medicinalproduct>
        <drugdosagetext>250 UG/DAY D+3 UNTIL ANC} 1000, SUBCUTANEOUS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>COLONY STIMULATING FACTOR PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050606</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOPHOSPHAMIDE</medicinalproduct>
        <drugdosagetext>45 MG/KG D-4, -3, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BONE MARROW CONDITIONING REGIMEN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050530</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050531</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MESNA</medicinalproduct>
        <drugdosagetext>12 MG/KG (DAILY DOSE 48MG/KG)</drugdosagetext>
        <drugindication>BONE MARROW CONDITIONING REGIMEN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050530</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYCLOSPORINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CIDOFOVIR (CIDOFOVIR)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ELECTROLYTE SOLUTIONS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>I.V. SOLUTIONS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACYCLOVIR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PENTAMIDINE (PENTAMIDINE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SUDAFED 12 HOUR</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049767-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060621</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006PV016102</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>54</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>96.1626</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD URINE PRESENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CALCULUS URETERIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CULTURE URINE POSITIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ESCHERICHIA INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GOUT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JOINT SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEPHROLITHIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL COLIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BYETTA</medicinalproduct>
        <drugauthorizationnumb>21773</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>DIABETES MELLITUS NON-INSULIN-DEPENDENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BYETTA</medicinalproduct>
        <drugauthorizationnumb>21773</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>DIABETES MELLITUS NON-INSULIN-DEPENDENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACTOS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLYBURIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOXYL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZESTRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRICOR</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049768-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060622</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-2006-007013</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>42</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL DISTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC VALVE DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</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>20020615</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049769-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060624</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006PV016257</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>46</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL INTAKE REDUCED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BYETTA</medicinalproduct>
        <drugbatchnumb>9SF00M</drugbatchnumb>
        <drugauthorizationnumb>21773</drugauthorizationnumb>
        <drugdosagetext>5 MCG; BID; SC</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>DIABETES MELLITUS NON-INSULIN-DEPENDENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060427</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060608</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BYETTA</medicinalproduct>
        <drugbatchnumb>9SF00M</drugbatchnumb>
        <drugauthorizationnumb>21773</drugauthorizationnumb>
        <drugdosagetext>5 MCG; BID; SC</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>DIABETES MELLITUS NON-INSULIN-DEPENDENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060619</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049770-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060624</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006PV016246</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>71</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>77.1115</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BYETTA</medicinalproduct>
        <drugauthorizationnumb>21773</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>DIABETES MELLITUS NON-INSULIN-DEPENDENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060601</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BYETTA</medicinalproduct>
        <drugauthorizationnumb>21773</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>DIABETES MELLITUS NON-INSULIN-DEPENDENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060601</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049771-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060627</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>163-21880-06060034</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>63</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>BLAST CELL CRISIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISEASE PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYELODYSPLASTIC SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugauthorizationnumb>21880</drugauthorizationnumb>
        <drugdosagetext>10 MG, 1 IN 1 D, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MYELODYSPLASTIC SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060414</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060520</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049772-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060624</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006PV016415</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>85</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>94.3482</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BYETTA</medicinalproduct>
        <drugbatchnumb>9RW65M</drugbatchnumb>
        <drugauthorizationnumb>21773</drugauthorizationnumb>
        <drugdosagetext>5 MCG; BID; SC</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>DIABETES MELLITUS NON-INSULIN-DEPENDENT</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060622</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CORTISONE</medicinalproduct>
        <drugdosagetext>X1</drugdosagetext>
        <drugindication>ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060614</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060614</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CORTISONE</medicinalproduct>
        <drugdosagetext>X1</drugdosagetext>
        <drugindication>ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060621</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060621</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049773-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060622</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>163-21800-06040900</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>76</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>MALIGNANT NEOPLASM PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE MYELOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugauthorizationnumb>21880</drugauthorizationnumb>
        <drugdosagetext>1 IN 1 D, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060228</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060420</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARANESP</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LACTULOSE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCODONE 2.5/APAP 500</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORAZEPAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DETROL LA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ETOPOSIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEULASTA</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049774-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060627</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>163-21880-06050472</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>61</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ENTEROBACTER INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCYTOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARYNGEAL ULCERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPUTUM CULTURE POSITIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STOMATITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugauthorizationnumb>21880</drugauthorizationnumb>
        <drugdosagetext>10 MG, 1 IN 1 D, ORAL; 5 MG, 1 IN 1 D, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugauthorizationnumb>21880</drugauthorizationnumb>
        <drugdosagetext>10 MG, 1 IN 1 D, ORAL; 5 MG, 1 IN 1 D, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MYELODYSPLASTIC SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugauthorizationnumb>21880</drugauthorizationnumb>
        <drugdosagetext>10 MG, 1 IN 1 D, ORAL; 5 MG, 1 IN 1 D, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060413</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060421</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugauthorizationnumb>21880</drugauthorizationnumb>
        <drugdosagetext>10 MG, 1 IN 1 D, ORAL; 5 MG, 1 IN 1 D, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MYELODYSPLASTIC SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060413</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060421</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EXJADE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRILOSEC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROXYZINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049775-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060622</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ABCOL-06-0313</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>45</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>72.5755</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CATHETER RELATED INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUCOSAL INFLAMMATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL MUCOSAL BLISTERING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ABRAXANE</medicinalproduct>
        <drugauthorizationnumb>21660</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>BREAST CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060126</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060321</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ABRAXANE</medicinalproduct>
        <drugauthorizationnumb>21660</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>BREAST CANCER METASTATIC</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060321</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARBOPLATIN</medicinalproduct>
        <drugdosagetext>500 MG (EVERY 3 WEEKS), INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BREAST CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060126</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060321</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEULASTA</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060127</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049776-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060622</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ABILP-06-0225</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>63</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>77.5</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYELID PTOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FACIAL PALSY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HERPES SIMPLEX</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUROPATHY PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TONGUE DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ABRAXANE</medicinalproduct>
        <drugauthorizationnumb>21660</drugauthorizationnumb>
        <drugdosagetext>400 MG DAY/EVERY 3 WEEKS 8 DOSES (220 MG/M2, EVERY 3 WEEKS), INTRAVENOUS DRIP</drugdosagetext>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>BREAST CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051122</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060421</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HORMONAL AGENTS (OTHER HORMONES)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FENTANYL CITRATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRILOSEC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACCUPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOPHAGE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLYBURIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FERROUS SULFATE TAB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REGLAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EFFEXOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KYTRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DECADRON</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COMPAZINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049777-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060627</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>S06-USA-02479-01</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>55</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>COMPLETED SUICIDE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ECONOMIC PROBLEM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GUN SHOT WOUND</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREATMENT NONCOMPLIANCE</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>20060301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060501</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALIUM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049778-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060627</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>S06-USA-01820-01</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>88</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>68.7199</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE CONGESTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE CHRONIC</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>AMNESIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NAMENDA</medicinalproduct>
        <drugdosagetext>5 MG BID PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>AMNESIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NAMENDA</medicinalproduct>
        <drugdosagetext>15 MG QD PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>AMNESIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NAMENDA</medicinalproduct>
        <drugdosagetext>10 MG BID PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>AMNESIA</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050501</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NAMENDA</medicinalproduct>
        <drugdosagetext>5 MG BID PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>AMNESIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050501</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
        <drugdosagetext>10 MG QD PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060418</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATACAND</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOPRESSOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONIDINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLIPIZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROSCAR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLOMAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLENDIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NITROGLYCERIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARIPIPRAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMDUR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLYTROL (ENTERAL NUTRITION)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METAMUCIL (PSYLLIUM)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COLACE (DOCUSATE SODIUM)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PHENERGAN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049779-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060622</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006CL000678</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>60</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>107.94</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA HAEMORRHAGIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROENTERITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHOIDAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BYETTA</medicinalproduct>
        <drugauthorizationnumb>21773</drugauthorizationnumb>
        <drugdosagetext>10 MCG; SC;  5 MCG; BID; SC</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>DIABETES MELLITUS NON-INSULIN-DEPENDENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060228</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060327</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BYETTA</medicinalproduct>
        <drugauthorizationnumb>21773</drugauthorizationnumb>
        <drugdosagetext>10 MCG; SC;  5 MCG; BID; SC</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>DIABETES MELLITUS NON-INSULIN-DEPENDENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060328</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HUMAPEN ERGO</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYZAAR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROSCAR</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049780-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060622</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006-BP-07139RO</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LITHIUM CARBONATE</medicinalproduct>
        <drugauthorizationnumb>17812</drugauthorizationnumb>
        <drugdosagetext>PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BIPOLAR I DISORDER</drugindication>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049781-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060623</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006-UK-02955UK</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>75</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>95</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ATRIOVENTRICULAR BLOCK SECOND DEGREE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC MURMUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEMENTIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORTHOSTATIC HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AGGRENOX</medicinalproduct>
        <drugdosagetext>400MG/50MG, PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CEREBROVASCULAR ACCIDENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060113</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AGGRENOX</medicinalproduct>
        <drugdosagetext>400MG/50MG, PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060113</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MICARDIS</medicinalproduct>
        <drugdosagetext>80 MG, PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CEREBROVASCULAR ACCIDENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060113</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MICARDIS</medicinalproduct>
        <drugdosagetext>80 MG, PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060113</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOPIDOGREL</medicinalproduct>
        <drugdosagetext>75 MG, PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CEREBROVASCULAR ACCIDENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060113</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOPIDOGREL</medicinalproduct>
        <drugdosagetext>75 MG, PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060113</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PLACEBO (BLIND)</medicinalproduct>
        <drugdosagetext>BLINDED STUDY DRUG, PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CEREBROVASCULAR ACCIDENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060113</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PLACEBO (BLIND)</medicinalproduct>
        <drugdosagetext>BLINDED STUDY DRUG, PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060113</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VASOTEC</medicinalproduct>
        <drugdosagetext>20 MG, PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
        <drugdosagetext>6.25 MG, PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060602</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049782-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060621</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006-DE-03210GD</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>77</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ACTIVATED PARTIAL THROMBOPLASTIN TIME PROLONGED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ACUTE RESPIRATORY DISTRESS SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ALVEOLITIS ALLERGIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD LACTATE DEHYDROGENASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CIRCULATORY COLLAPSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COAGULOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FUNGAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC ENZYME INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HISTOPLASMOSIS DISSEMINATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMMUNODEFICIENCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPHOCYTOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROTHROMBIN TIME PROLONGED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SMEAR SITE UNSPECIFIED ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISONE TAB</medicinalproduct>
        <drugauthorizationnumb>80352</drugauthorizationnumb>
        <drugdosagetext>20 MG,</drugdosagetext>
        <drugindication>ALVEOLITIS ALLERGIC</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CORTICOSTEROIDS (CORTICOSTEROIDS)</medicinalproduct>
        <drugdosagetext>PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049783-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060621</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006-BP-07093RO</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>61</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABSCESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHILLS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HISTOPLASMOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ILL-DEFINED DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLAMMATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LARGE INTESTINAL ULCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERICARDITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLEURAL EFFUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISONE TAB</medicinalproduct>
        <drugauthorizationnumb>80352</drugauthorizationnumb>
        <drugdosagetext>5 MG DAILY (5 MG),</drugdosagetext>
        <drugindication>PROPHYLAXIS AGAINST TRANSPLANT REJECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MYCOPHENOLATE MOFETIL</medicinalproduct>
        <drugdosagetext>1000 MG BID (1000 MG),</drugdosagetext>
        <drugindication>PROPHYLAXIS AGAINST TRANSPLANT REJECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TACROLIMUS (TACROLIMUS)</medicinalproduct>
        <drugdosagetext>2 MG BID (2 MG)</drugdosagetext>
        <drugindication>PROPHYLAXIS AGAINST TRANSPLANT REJECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MESALAMINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAMSULOSIN HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYBUTYNIN (OXYBUTYNIN)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049784-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060620</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006-DE-03203GD</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>58</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSKINESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARKINSON'S DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROCEDURAL COMPLICATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRAMIPEXOLE DIHYDROCHLORIDE</medicinalproduct>
        <drugauthorizationnumb>20667</drugauthorizationnumb>
        <drugdosagetext>6 MG</drugdosagetext>
        <drugindication>PARKINSON'S DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMANTADINE HCL</medicinalproduct>
        <drugdosagetext>400 MG</drugdosagetext>
        <drugindication>PARKINSON'S DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIDAZOLAM HYDROCHLORIDE</medicinalproduct>
        <drugdosagetext>1 MG</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SINEMET</medicinalproduct>
        <drugdosagetext>CARBIDOPA 100 MG, LEVODOPA 800 MG</drugdosagetext>
        <drugindication>PARKINSON'S DISEASE</drugindication>
        <drugtreatmentduration>10</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049785-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060627</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CHPA2006US06345</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>62</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>83</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NICOTINE</medicinalproduct>
        <drugauthorizationnumb>20076</drugauthorizationnumb>
        <drugdosagetext>21 MG, QD, TRANSDERMAL</drugdosagetext>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>SMOKING CESSATION THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060627</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060627</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049786-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060623</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CHNY2006AR01931</companynumb>
    <primarysource>
      <reportercountry>ARGENTINA</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NICOTINELL TTS (NCH)(NICOTINE) TRANS-THERAPEUTIC-SYSTEM</medicinalproduct>
        <drugauthorizationnumb>20076</drugauthorizationnumb>
        <drugdosagetext>21 MG, QD, TRANSDERMAL</drugdosagetext>
        <drugadministrationroute>062</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060616</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060621</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049787-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060623</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006080733</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>69.8539</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG EFFECT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POOR PERIPHERAL CIRCULATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GABAPENTIN</medicinalproduct>
        <drugauthorizationnumb>20235</drugauthorizationnumb>
        <drugdosagetext>1600 MG (800 MG, 2 IN 1 D)</drugdosagetext>
        <drugindication>NEUROPATHY PERIPHERAL</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CAMPRAL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROMETRIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NITROFURAN (NITROFURANTOIN)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049788-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060626</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006080734</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>VASCULITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugauthorizationnumb>21446</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049789-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060626</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CHPA2006US06029</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRANSDERM SCOP</medicinalproduct>
        <drugbatchnumb>0527556</drugbatchnumb>
        <drugauthorizationnumb>17874</drugauthorizationnumb>
        <drugdosagetext>TRANSDERMAL</drugdosagetext>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>MOTION SICKNESS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049790-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060626</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006080743</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>53</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>85.7298</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEAD DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERCEPTED DRUG DISPENSING ERROR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
        <drugauthorizationnumb>19839</drugauthorizationnumb>
        <drugdosagetext>200 MG, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRIAMTERENE (TRIAMTERENE)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049791-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060623</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006081230</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLISTER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRIC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTI-ORGAN DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN ULCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWELLING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugauthorizationnumb>21446</drugauthorizationnumb>
        <drugindication>NERVE INJURY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049792-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060626</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006081283</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>63</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>62.5964</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANGIOPLASTY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NECK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL DISTURBANCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugauthorizationnumb>20702</drugauthorizationnumb>
        <drugdosagetext>80 MG (80 MG, 1 IN 1 D); 4 - 10 YEARS AGO - 06/21/2006</drugdosagetext>
        <drugindication>BLOOD CHOLESTEROL</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060621</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZETIA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARTIA XT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALL OTHER THERAPEUTIC PRODUCTS (ALL OTHER THERAPEUTIC PRODUCTS)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMINS (VITAMINS)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CORGARD</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049793-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CHPA2006US06347</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>59</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>63.5</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG ABUSER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG DEPENDENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THERAPEUTIC RESPONSE DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXCEDRIN EXTRA STRENGTH (NCH)(CAFFEINE CITRATE,ACETYLSALICYLIC ACID, A</medicinalproduct>
        <drugbatchnumb>5G4009A</drugbatchnumb>
        <drugauthorizationnumb>20802</drugauthorizationnumb>
        <drugdosagetext>2 DF, BID, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEADACHE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXCEDRIN EXTRA STRENGTH (NCH)(CAFFEINE CITRATE,ACETYLSALICYLIC ACID, A</medicinalproduct>
        <drugdosagetext>3-4 TIMES A WEEK, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049794-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060627</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006081341</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BREAST CANCER FEMALE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROVERA</medicinalproduct>
        <drugauthorizationnumb>11839</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19830101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19901001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19830101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19901001</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049795-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CHPA2006US06317</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG ABUSER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INAPPROPRIATE SCHEDULE OF DRUG ADMINISTRATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXCEDRIN EXTRA STRENGTH (NCH)(CAFFEINE CITRATE, ACETYLSALICYLIC ACID, </medicinalproduct>
        <drugauthorizationnumb>20802</drugauthorizationnumb>
        <drugdosagetext>2 DF, Q4H , ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049796-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060703</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CG-MERCK-0607USA00747</companynumb>
    <primarysource>
      <reportercountry>CONGO</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>59</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ADVERSE EVENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>STROMECTOL</medicinalproduct>
        <drugauthorizationnumb>050742</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060519</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060519</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit></drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049797-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20051220</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0512USA03201</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>70</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>90</patientweight>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ABDOMINAL HERNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ALANINE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AMMONIA INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASPARTATE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD BILIRUBIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD UREA INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GALLBLADDER DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESTLESSNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VYTORIN</medicinalproduct>
        <drugauthorizationnumb>021687</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051122</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ELAVIL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</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>ATENOLOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONAZEPAM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049798-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060710</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0607USA01640</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>80</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BONE NEOPLASM MALIGNANT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049799-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060707</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0607USA01072</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZETIA</medicinalproduct>
        <drugauthorizationnumb>21445</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>[THERAPY UNSPECIFIED]</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049800-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060613</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BE-MERCK-0606BEL00013</companynumb>
    <primarysource>
      <reportercountry>BELGIUM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>57</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>93</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ATRIAL FIBRILLATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRONCHITIS ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY STENOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERMITTENT CLAUDICATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugauthorizationnumb>019766</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERCHOLESTEROLAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020901</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BISOPROLOL FUMARATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000901</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALSARTAN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060116</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000901</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049801-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060710</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ES-MERCK-0607ESP00013</companynumb>
    <primarysource>
      <reportercountry>SPAIN</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>5</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PATHOLOGICAL FRACTURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SINGULAIR</medicinalproduct>
        <drugauthorizationnumb>20830</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SINGULAIR</medicinalproduct>
        <drugauthorizationnumb>020830</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HOUSE DUST ALLERGY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BUDESONIDE</medicinalproduct>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BUDESONIDE</medicinalproduct>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>HOUSE DUST ALLERGY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL SULFATE</medicinalproduct>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL SULFATE</medicinalproduct>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>HOUSE DUST ALLERGY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049802-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060705</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0607USA00457</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CROHN'S DISEASE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VYTORIN</medicinalproduct>
        <drugauthorizationnumb>021687</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERCHOLESTEROLAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060628</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASACOL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CIPROFLOXACIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060602</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060703</drugenddate>
        <drugtreatmentduration>32</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049803-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060627</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CHPA2006US06306</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>21</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>70.3</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEAD INJURY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXCEDRIN EXTRA STRENGTH (NCH)(CAFFEINE CITRATE, ACETYLSALICYLIC ACID, </medicinalproduct>
        <drugbatchnumb>6C4007A</drugbatchnumb>
        <drugauthorizationnumb>20802</drugauthorizationnumb>
        <drugdosagetext>1 DF, ONCE/SINGLE, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CHEST PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060626</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060626</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049804-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060703</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-MERCK-0607AUS00013</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>62</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CARPAL TUNNEL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEEP VEIN THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERTRIGO</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERVERTEBRAL DISC PROTRUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUMBAR SPINAL STENOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUROPATHY PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMINS (UNSPECIFIED)</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SERTRALINE HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</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>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARFARIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANTOPRAZOLE SODIUM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATORVASTATIN CALCIUM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYBUTYNIN CHLORIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOSAMINE SULFATE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IRON (UNSPECIFIED)</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040701</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELECOXIB</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049805-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060630</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-MERCK-0606AUS00200</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>63</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>JAW FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESORPTION BONE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060501</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049806-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060627</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006081375</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BREAST CANCER FEMALE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROVERA</medicinalproduct>
        <drugauthorizationnumb>11839</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19830101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19900901</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>19830101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19900901</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19830101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19900901</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049807-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060627</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CHPA2006US06352</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>40</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>56.7</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOTOR DYSFUNCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>WALMART/EQUATE (NCH)(NICOTINE) TRANS-THERAPEUTIC-SYSTEM</medicinalproduct>
        <drugbatchnumb>21173301</drugbatchnumb>
        <drugauthorizationnumb>20076</drugauthorizationnumb>
        <drugdosagetext>21 MG, QD, TRANSDERMAL</drugdosagetext>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>SMOKING CESSATION THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060618</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060620</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>WALMART/EQUATE (NCH)(NICOTINE) TRANS-THERAPEUTIC-SYSTEM</medicinalproduct>
        <drugbatchnumb>21173301</drugbatchnumb>
        <drugauthorizationnumb>20076</drugauthorizationnumb>
        <drugdosagetext>21 MG, QD, TRANSDERMAL</drugdosagetext>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>SMOKING CESSATION THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060626</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060626</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TIAZAC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEMULEN (ETHINYLESTRADIOL, ETYNODIOL DIACETATE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENTOCORT (BUDESONIDE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HALCION</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FIORICET</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMERGE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049808-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesscongenitalanomali>1</seriousnesscongenitalanomali>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006-BP-07474BP</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>1.36</patientweight>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYDROPS FOETALIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE CONGENITAL ABNORMALITIES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PREMATURE BABY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIRAMUNE</medicinalproduct>
        <drugauthorizationnumb>20636</drugauthorizationnumb>
        <drugdosagetext>400 MG (NR), IU</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRUVADA</medicinalproduct>
        <drugdosagetext>SEE TEXT (NR,200MG/300MG), IU</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZIDOVUDINE</medicinalproduct>
        <drugdosagetext>SEE TEXT (NR,2MG/KG X 1 HOUR), IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060506</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060506</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049809-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060623</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006BI009192</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>41</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLADDER OPERATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugdosagetext>IM</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000907</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugdosagetext>IM</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049810-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060622</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006BI009072</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>37</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CELLULITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugbatchnumb>P35076</drugbatchnumb>
        <drugdosagetext>30 UG;QW;IM</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060501</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049811-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060630</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>NL-MERCK-0607NLD00006</companynumb>
    <primarysource>
      <reportercountry>NETHERLANDS</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>29</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ASPERGILLOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTI-ORGAN FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CANCIDAS</medicinalproduct>
        <drugauthorizationnumb>021227</drugauthorizationnumb>
        <drugadministrationroute>041</drugadministrationroute>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CANCIDAS</medicinalproduct>
        <drugauthorizationnumb>021227</drugauthorizationnumb>
        <drugadministrationroute>041</drugadministrationroute>
        <drugtreatmentduration>23</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYCLOSPORINE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049812-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060710</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-MERCK-0607FRA00016</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>46</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FACE OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARYNGEAL OEDEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRIMAXIN</medicinalproduct>
        <drugauthorizationnumb>050587</drugauthorizationnumb>
        <drugadministrationroute>051</drugadministrationroute>
        <drugindication>URINARY TRACT INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060609</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060609</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049813-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060524</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>MY-MERCK-0605MYS00009</companynumb>
    <primarysource>
      <reportercountry>MALAYSIA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>47</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>50</patientweight>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>PULMONARY HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CANCIDAS</medicinalproduct>
        <drugauthorizationnumb>21227</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>SYSTEMIC MYCOSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060523</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060523</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CANCIDAS</medicinalproduct>
        <drugauthorizationnumb>021227</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>FUNGAL INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060523</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060523</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VORICONAZOLE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMPHOTERICIN B</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049814-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060626</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006BI009212</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CHEST DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</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>19970701</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>20060401</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049815-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>S06-USA-01131-02</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>3.2886</patientweight>
      <reaction>
        <reactionmeddrapt>APGAR SCORE LOW</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFANTILE APNOEIC ATTACK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PREMATURE BABY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEXAPRO</medicinalproduct>
        <drugauthorizationnumb>21323</drugauthorizationnumb>
        <drugdosagetext>40 MG QD TRANSPLACENTAL</drugdosagetext>
        <drugadministrationroute>064</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060316</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEXAPRO</medicinalproduct>
        <drugdosagetext>40 MG QD BF</drugdosagetext>
        <drugadministrationroute>063</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060316</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049816-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>S06-USA-01131-01</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>35</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PREMATURE LABOUR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEXAPRO</medicinalproduct>
        <drugauthorizationnumb>21323</drugauthorizationnumb>
        <drugdosagetext>40 MG QD PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OBSESSIVE-COMPULSIVE DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049817-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>S06-USA-02483-01</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD AMYLASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIPASE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELEXA</medicinalproduct>
        <drugauthorizationnumb>20822</drugauthorizationnumb>
        <drugdosagetext>10 MG QD PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANXIETY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060620</drugenddate>
      </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>PREVACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATIVAN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049818-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>S06-USA-02027-01</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>80</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCOHERENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STAPHYLOCOCCAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THERAPEUTIC PRODUCT CONTAMINATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VERBAL ABUSE</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>20060301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NAMENDA</medicinalproduct>
        <drugauthorizationnumb>21487</drugauthorizationnumb>
        <drugdosagetext>5 MG QD PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NORMAL PRESSURE HYDROCEPHALUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NAMENDA</medicinalproduct>
        <drugdosagetext>5 MG BID PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEMENTIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NAMENDA</medicinalproduct>
        <drugdosagetext>5 MG BID PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NORMAL PRESSURE HYDROCEPHALUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NAMENDA</medicinalproduct>
        <drugdosagetext>15 MG QD PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEMENTIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NAMENDA</medicinalproduct>
        <drugdosagetext>15 MG QD PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NORMAL PRESSURE HYDROCEPHALUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NAMENDA</medicinalproduct>
        <drugdosagetext>10 MG BID PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEMENTIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060623</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NAMENDA</medicinalproduct>
        <drugdosagetext>10 MG BID PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NORMAL PRESSURE HYDROCEPHALUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060623</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HUMULIN 70/30</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMARYL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049819-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>S06-USA-02237-01</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>81</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GLYCOSYLATED HAEMOGLOBIN INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NAMENDA</medicinalproduct>
        <drugauthorizationnumb>21487</drugauthorizationnumb>
        <drugdosagetext>10 MG BID PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEMENTIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060607</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060611</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NAMENDA</medicinalproduct>
        <drugdosagetext>5 MG QD PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEMENTIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060517</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060523</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NAMENDA</medicinalproduct>
        <drugdosagetext>5 MG BID PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEMENTIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060524</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060530</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NAMENDA</medicinalproduct>
        <drugdosagetext>15 MG QD PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEMENTIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060531</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060606</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HUMULIN 70/30 (HUMAN INSULIN NPH/REGULAR 70/30)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VERAPAMIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CAPTOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NITROCAP (NITROGLYCERIN)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARBIDOPA AND LEVODOPA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COSOPT (DORZOLAMIDE/TIMOLOL)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAVATAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONAZEPAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIGOXIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM CHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUOXETINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCODONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOXYL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049820-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060626</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>TPA2006A00848</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>55</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>77.1115</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ROZEREM</medicinalproduct>
        <drugauthorizationnumb>21782</drugauthorizationnumb>
        <drugdosagetext>8 MG, PER ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060401</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACIPHEX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM D</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ESTRATEST</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KETOPROFEN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049821-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060621</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>TPA2006A01031</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>65</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INTERCEPTED DRUG DISPENSING ERROR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACTOS</medicinalproduct>
        <drugbatchnumb>C10704</drugbatchnumb>
        <drugauthorizationnumb>21073</drugauthorizationnumb>
        <drugdosagetext>15 MG, 1 IN 1 D, PER ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS NON-INSULIN-DEPENDENT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049822-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>226554</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>18</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>27.7</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>STAPHYLOCOCCAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUBCUTANEOUS ABSCESS</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>20051010</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NASONEX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADVAIR DISKUS 100/50</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL (ALBUTEROL/ALBUTEROL SULFATE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SINGULAIR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ELOCON</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049823-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>USA-2003-0009608</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>55</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BODY TEMPERATURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHILLS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISTURBANCE IN ATTENTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG DEPENDENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG WITHDRAWAL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EJACULATION DELAYED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GINGIVAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INADEQUATE ANALGESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JOINT RANGE OF MOTION DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENTAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MICTURITION DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NECK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERIARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SENSITIVITY OF TEETH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SENSORY DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TENDERNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TESTICULAR PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THIRST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXYCODONE HCL</medicinalproduct>
        <drugauthorizationnumb>20553</drugauthorizationnumb>
        <drugdosagetext>40 MG, BID, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ELAVIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALPRAZOLAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EFFEXOR</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049824-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060626</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>USA-2006-0023571</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>32</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXYCONTIN TABLETS  (OXYCODONE HYDROCHLORIDE) PROLONGED-RELEASE TABLETS</medicinalproduct>
        <drugauthorizationnumb>20553</drugauthorizationnumb>
        <drugdosagetext>80 MG, Q12H,</drugdosagetext>
        <drugindication>BACK PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMBIEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BUSPAR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROZAC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZANAFLEX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FIORICET</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DICLOFENAC (DICLOFENAC)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PERCOCET</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMITREX ^GLAXO-WELLCOME^ (SUMATRIPTAN SUCCINATE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SOMA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPAMAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROMETHAZINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049825-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060703</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>USA-2006-0024167</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>61</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ACUTE RESPIRATORY DISTRESS SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRAIN NATRIURETIC PEPTIDE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG DEPENDENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG DOSE OMISSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG WITHDRAWAL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EJECTION FRACTION DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ELECTROCARDIOGRAM ST SEGMENT ELEVATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG INFILTRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MITRAL VALVE INCOMPETENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALLOR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RALES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY DISTRESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TROPONIN T INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENTRICULAR HYPOKINESIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXYCODONE HCL</medicinalproduct>
        <drugauthorizationnumb>20553</drugauthorizationnumb>
        <drugdosagetext>SEE TEXT</drugdosagetext>
        <drugindication>PREOPERATIVE CARE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXYCODONE HCL</medicinalproduct>
        <drugdosagetext>SEE TEXT</drugdosagetext>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HYDROMORPHONE HCL</medicinalproduct>
        <drugdosagetext>4 MG, TID PRN,</drugdosagetext>
        <drugindication>BREAKTHROUGH PAIN</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049826-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>USA-2006-0024339</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>31</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG ABUSER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INADEQUATE ANALGESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXYCODONE HCL</medicinalproduct>
        <drugauthorizationnumb>20553</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugindication>BACK PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXYCODONE HCL</medicinalproduct>
        <drugauthorizationnumb>20553</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugindication>BACK PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060125</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORCO</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049827-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060621</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006S1005718</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>13</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDITIS BACTERIAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARYNGITIS STREPTOCOCCAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRESCRIBED OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUDDEN DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ADDERALL XR 10</medicinalproduct>
        <drugauthorizationnumb>70317</drugauthorizationnumb>
        <drugdosagetext>20 MG; BID; ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATTENTION DEFICIT/HYPERACTIVITY DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060301</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLONIDINE HCL</medicinalproduct>
        <drugdosagetext>0.6 MG; HS; ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INSOMNIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060325</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROZAC</medicinalproduct>
        <drugdosagetext>20 MG; QD; ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060301</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMOXICILLIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049828-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060621</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006S1005732</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>35</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>116.892</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NESIRITIDE - BLINDED INJECTION (0.01 UG/KG)</medicinalproduct>
        <drugbatchnumb>CR0042A</drugbatchnumb>
        <drugauthorizationnumb>18487</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugindication>CARDIAC FAILURE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060207</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NESIRITIDE - BLINDED INJECTION (0.01 UG/KG)</medicinalproduct>
        <drugbatchnumb>CR0042A</drugbatchnumb>
        <drugauthorizationnumb>18487</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugindication>CARDIAC FAILURE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060207</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
        <drugdosagetext>20 MG; QD; ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIURETIC EFFECT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051117</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060304</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETYLSALICYLIC ACID SRT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARVEDILOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRANDOLAPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMIODARONE HYDROCHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDRALAZINE HYDROCHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ISOSORBIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENAZEPRIL HYDROCHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDRALAZINE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ISOSORBIDE DINITRATE/HYDRALAZINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049829-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060621</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006S1004174</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>71</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>39.9165</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CYSTITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EFFECT INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FENTANYL TRANSDERMAL SYSTEM</medicinalproduct>
        <drugbatchnumb>6N0057</drugbatchnumb>
        <drugauthorizationnumb>76258</drugauthorizationnumb>
        <drugdosagetext>50 UG/HR; Q3D; TRANS</drugdosagetext>
        <drugindication>NEUROPATHY PERIPHERAL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060425</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060501</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL SUCCINATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IRBESARTAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORATADINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN GLARGINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN HUMAN/INSULIN HUMAN INJECTION, ISOPHANE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GUAIFENESIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049830-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060623</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>226661</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>DIALYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RITUXAN</medicinalproduct>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049837-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060627</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006081499</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BREAST CANCER FEMALE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROVERA</medicinalproduct>
        <drugauthorizationnumb>11839</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19970101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030301</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>19970101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030301</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19970101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030301</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMPHASE (PREMARIN;CYCRIN 14/14)</medicinalproduct>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19970101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030301</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMPRO</medicinalproduct>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19970101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030301</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049838-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060627</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006081507</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BREAST CANCER FEMALE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROVERA</medicinalproduct>
        <drugauthorizationnumb>11839</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19840101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19970501</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>19840101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19970501</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19840101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19970501</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ESTRATEST</medicinalproduct>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19840101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19970501</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049839-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060627</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006081541</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </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>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19900101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19960101</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>19900101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19960101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19900101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19960101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMPRO</medicinalproduct>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19900101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19960101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049840-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060627</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006081552</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BREAST CANCER FEMALE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>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>20000101</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>20000101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OGEN</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19800101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20000101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19800101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20000101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCRIN</medicinalproduct>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19800101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20000101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ESTROPIPATE</medicinalproduct>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19800101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20000101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049841-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060626</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006069023</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INFERTILITY FEMALE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVARIAN ATROPHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVARIAN DISORDER</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>19850101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19850101</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>20040101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049842-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060627</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006069091</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>6</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ADENOIDECTOMY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOCHONDROMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TONSILLECTOMY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GENOTROPIN</medicinalproduct>
        <drugauthorizationnumb>20280</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE, SUBCUTANEOUS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PRADER-WILLI SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20001101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049843-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060621</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>146322USA</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>17</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HAEMATURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL CELL CARCINOMA STAGE UNSPECIFIED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DAUNORUBICIN HCL</medicinalproduct>
        <drugauthorizationnumb>65035</drugauthorizationnumb>
        <drugindication>ACUTE MYELOID LEUKAEMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ETOPOSIDE</medicinalproduct>
        <drugindication>ACUTE MYELOID LEUKAEMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYTARABINE</medicinalproduct>
        <drugindication>ACUTE MYELOID LEUKAEMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TIOGUANINE</medicinalproduct>
        <drugindication>ACUTE MYELOID LEUKAEMIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049844-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060626</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>225303</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>38</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ALANINE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD ALKALINE PHOSPHATASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE DIASTOLIC INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD SODIUM DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC MURMUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ENCEPHALOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA STREPTOCOCCAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVASTIN</medicinalproduct>
        <drugdosagetext>5MG/KG, Q2W; INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLORECTAL CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060510</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060510</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUOROURACIL</medicinalproduct>
        <drugdosagetext>2400 MG/M2</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLORECTAL CANCER METASTATIC</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXALIPLATIN (OXALIPLATIN)</medicinalproduct>
        <drugdosagetext>85 MG/M2, Q2W; INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLORECTAL CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060510</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060510</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEUCOVORIN CALCIUM</medicinalproduct>
        <drugdosagetext>200 MG/M2, Q2W; INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLORECTAL CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060510</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060510</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CALCIUM/MAGNESIUM OR PLACEBO (CALCIUM/MAGNESIUM OR PLACEBO)</medicinalproduct>
        <drugdosagetext>1 UNIT, Q2W; INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLORECTAL CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060510</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060510</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE TAB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLYBURIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORAZEPAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COMPAZINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOLASETRON (DOLASETRON MESYLATE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049845-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060621</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>226942</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>64</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HAEMOLYTIC ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERSTITIAL LUNG DISEASE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVASTIN</medicinalproduct>
        <drugindication>COLORECTAL CANCER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUOROURACIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEUCOVORIN CALCIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXALIPLATIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049846-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060623</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>226648</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>48</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD ALBUMIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CHLORIDE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD SODIUM DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPHIL COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINE FLOW DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINE KETONE BODY PRESENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ERLOTINIB</medicinalproduct>
        <drugdosagetext>100 MG, QD; ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>TONSIL CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060603</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVASTIN</medicinalproduct>
        <drugdosagetext>10 MG/KG, Q2W; INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>TONSIL CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060517</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RADIATION THERAPY</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049847-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060627</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>231628K06USA</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>50</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD CATECHOLAMINES INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT AND COLD</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBIF</medicinalproduct>
        <drugdosagetext>44 MCG, 3 IN 1 WEEKS, SUBCUTANEOUS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040322</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WELLBUTRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EFFEXOR</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049848-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>233846K06USA</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>55</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ACUTE MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANGINA PECTORIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTHYROIDISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VASOSPASM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENTRICULAR DYSFUNCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBIF</medicinalproduct>
        <drugdosagetext>30 MCG, 3 IN 1 WEEKS; SUBCUTANEOUS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030310</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049850-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>232672K06USA</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>72</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>101.6057</patientweight>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>CAROTID ARTERY OCCLUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POST PROCEDURAL COMPLICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUBARACHNOID HAEMORRHAGE</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>20040301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060110</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049852-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060620</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>COT_0609_2006</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>61</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>89.8122</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>EAR HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LETHARGY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEUKAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VENTAVIS</medicinalproduct>
        <drugauthorizationnumb>21779</drugauthorizationnumb>
        <drugdosagetext>5 MCG 6XD, IH</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>PULMONARY HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050629</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HUMALOG</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NPH ILETIN I (BEEF-PORK)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRONOLACTONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIGOXIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM CHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADVAIR DISKUS 100/50</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OCEAN NASAL SPRAY</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGNESIUM OXIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROTONIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYGEN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049853-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060623</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>226659</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>51</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>74.4</patientweight>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERICARDITIS CONSTRICTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERIPHERAL COLDNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULSE ABSENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RITUXAN</medicinalproduct>
        <drugbatchnumb>M16142</drugbatchnumb>
        <drugdosagetext>500 MG, DAYS 1+15, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060323</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN PUMP (INSULIN)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE TAB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CAPTOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENTERIC COATED ASPIRIN (ASPIRIN)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALPHAGAN P</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049854-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060621</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>226561</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>57</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MALIGNANT MELANOMA IN SITU</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RITUXIMAB (RITUXIMAB) CONC FOR SOLUTION FOR INDFUSION</medicinalproduct>
        <drugdosagetext>1000 MG, DAYS 1+15, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060104</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060117</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISONE TAB</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060104</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060119</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>20060104</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060117</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELEXA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOXYL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPAMAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLATE (FOLATE SODIUM)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049855-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060627</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>USA-2006-0024457</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>40</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>106.6</patientweight>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>BOWEL MOVEMENT IRREGULARITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMPLETED SUICIDE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPEPSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWELLING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXYCONTIN</medicinalproduct>
        <drugauthorizationnumb>20553</drugauthorizationnumb>
        <drugdosagetext>40 MG, BID,</drugdosagetext>
        <drugindication>PAIN</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049857-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>USA-2006-0024532</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXYIR CAPSULE 5MG (OXYCODONE HYDROCHLORIDE) CAPSULES, HARD</medicinalproduct>
        <drugdosagetext>10 MG, TID,</drugdosagetext>
        <drugindication>BACK PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DURAGESIC-100</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REMERON</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRILOSEC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRILOSEC</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049859-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060622</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A-US2006-12498</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>47</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>70.3</patientweight>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ACUTE PSYCHOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ADRENAL INSUFFICIENCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CALCIUM DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD POTASSIUM DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD SODIUM DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CYANOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DELUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSED LEVEL OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIABETES MELLITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISTURBANCE IN ATTENTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HALLUCINATION, AUDITORY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC CONGESTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERKALAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPONATRAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERNATIONAL NORMALISED RATIO INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MANIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OXYGEN CONSUMPTION DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARANOIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>REFUSAL OF TREATMENT BY PATIENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESTLESSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RIGHT VENTRICULAR FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREATMENT NONCOMPLIANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</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>20051201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060405</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>20060406</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060604</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMARYL</medicinalproduct>
        <drugdosagetext>4 MG, QAM,</drugdosagetext>
        <drugindication>DIABETES MELLITUS NON-INSULIN-DEPENDENT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SILDENAFIL CITRATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>K-DUR 10</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRONOLACTONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CORTEF</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANOXIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZAROXOLYN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REGLAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PHENERGAN (PROMETHAZINE HYDROCHLORIDE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EFFEXOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATIVAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENADRYL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HALDOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRILAFON</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KAY CIEL DURA-TABS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KAYEXALATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOSE (GLUCOSE)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049861-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060623</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A-US2006-12463</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>77</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>72.6</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PANCYTOPENIA</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>20060207</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060306</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>20060307</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CAPTOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EVISTA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDRALAZINE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVAPRO</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BUMETANIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOXYL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MECLOZINE (MECLOZINE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCODONE BITARTRATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYGEN (OXYGEN)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049862-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060622</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A-US2006-12445</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>59</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANGINA PECTORIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANIC ATTACK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</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>20060505</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060601</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>20060601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060601</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049863-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060621</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>146317USA</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>16</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>METASTATIC NEOPLASM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL MASS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUDDEN DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DAUNORUBICIN</medicinalproduct>
        <drugauthorizationnumb>65035</drugauthorizationnumb>
        <drugdosagetext>38 MILLIGRAM INTRAVENOUS (NOS)</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ACUTE PROMYELOCYTIC LEUKAEMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE TAB</medicinalproduct>
        <drugdosagetext>380 MILLIGRAM INTRAVENOUS (NOS)</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ACUTE PROMYELOCYTIC LEUKAEMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYTARABINE</medicinalproduct>
        <drugdosagetext>180 MILLIGRAM INTRAVENOUS (NOS)</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ACUTE PROMYELOCYTIC LEUKAEMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TIOGUANINE</medicinalproduct>
        <drugdosagetext>180 MILLIGRAM INTRAVENOUS (NOS)</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ACUTE PROMYELOCYTIC LEUKAEMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ETOPOSIDE</medicinalproduct>
        <drugindication>ACUTE PROMYELOCYTIC LEUKAEMIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049866-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060626</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>007881</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>58</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BREAST CANCER FEMALE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MEDROXYPROGESTERONE ACETATE</medicinalproduct>
        <drugauthorizationnumb>40159</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19960101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20000501</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMPRO</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19960101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20000501</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19960101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20000501</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049867-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060622</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GXKR2006US03514</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>43</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EMOTIONAL DISTRESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HALLUCINATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HALLUCINATION, VISUAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BUPROPION (NGX) (BUPROPION)</medicinalproduct>
        <drugauthorizationnumb>75584</drugauthorizationnumb>
        <drugdosagetext>450 MG, QD</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RILUZOLE (RILUZOLE)</medicinalproduct>
        <drugdosagetext>50 MG, BID</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MEMANTINE HCL</medicinalproduct>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LITHIUM CARBONATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMOXAPINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TIAGABINE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIAZEPAM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049868-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060622</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GXKR2006US03513</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>54</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>65</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTHYROIDISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERNATIONAL NORMALISED RATIO FLUCTUATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>THIAMAZOLE (NGX) (THIAMAZOLE)</medicinalproduct>
        <drugauthorizationnumb>40196</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugindication>BASEDOW'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030306</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030728</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>THIAMAZOLE (NGX) (THIAMAZOLE)</medicinalproduct>
        <drugauthorizationnumb>40196</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugindication>BASEDOW'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030728</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030819</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>THIAMAZOLE (NGX) (THIAMAZOLE)</medicinalproduct>
        <drugauthorizationnumb>40196</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugindication>BASEDOW'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030824</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030828</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>THIAMAZOLE (NGX) (THIAMAZOLE)</medicinalproduct>
        <drugauthorizationnumb>40196</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugindication>BASEDOW'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030828</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031105</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>THIAMAZOLE (NGX) (THIAMAZOLE)</medicinalproduct>
        <drugauthorizationnumb>40196</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugindication>BASEDOW'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031105</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040324</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
        <drugdosagetext>5 MG, QD</drugdosagetext>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030306</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030826</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
        <drugdosagetext>5 MG, QD</drugdosagetext>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030828</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030908</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
        <drugdosagetext>5 MG, QD</drugdosagetext>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030908</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040113</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE TAB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049869-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060626</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200614331BWH</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLINDNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EMOTIONAL DISTRESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTRACRANIAL PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENTAL DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CIPRO</medicinalproduct>
        <drugauthorizationnumb>19537</drugauthorizationnumb>
        <drugindication>CYSTITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049870-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060622</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200614255BWH</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>60</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUROPATHY PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXAVAR</medicinalproduct>
        <drugauthorizationnumb>21923</drugauthorizationnumb>
        <drugdosagetext>200 MG, BID, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ADENOID CYSTIC CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060607</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060601</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049871-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060615</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200614143BWH</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANAL DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RECTAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVELOX</medicinalproduct>
        <drugauthorizationnumb>21085</drugauthorizationnumb>
        <drugdosagetext>400 MG, QD, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>LUNG INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060605</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ASPIRIN TAB</medicinalproduct>
        <drugdosagetext>81 MG, QD, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060611</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049872-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060626</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200614142BWH</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>76</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>57.3347</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BRAIN MASS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METASTASES TO CENTRAL NERVOUS SYSTEM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SORAFENIB</medicinalproduct>
        <drugauthorizationnumb>21923</drugauthorizationnumb>
        <drugdosagetext>400 MG, BID, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>METASTATIC MALIGNANT MELANOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060519</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060609</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049874-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060622</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200612906BWH</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>AMNESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BREAST INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CANDIDIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CERVIX CARCINOMA RECURRENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COGNITIVE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSSTASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EMOTIONAL DISTRESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMMUNODEFICIENCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMPAIRED WORK ABILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULAR WEAKNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL CANDIDIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SENSORY LOSS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPEECH DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISION BLURRED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VITAMIN B COMPLEX DEFICIENCY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVELOX</medicinalproduct>
        <drugauthorizationnumb>21085</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RESPIRATORY TRACT INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060404</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060408</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049877-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060621</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200606IM000367</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>57</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>BREAST CANCER FEMALE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACTIMMUNE</medicinalproduct>
        <drugbatchnumb>403840</drugbatchnumb>
        <drugdosagetext>200 UG, TIW; SUBCUTANEOUS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>IDIOPATHIC PULMONARY FIBROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040503</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060619</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049879-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060622</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200606IM000369</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>68</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACTIMMUNE</medicinalproduct>
        <drugbatchnumb>403837</drugbatchnumb>
        <drugdosagetext>200 UG, TIW; SUBCUTANEOUS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>IDIOPATHIC PULMONARY FIBROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021218</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049883-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060614</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006-06-1033</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>54</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CAROTID ARTERY STENOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</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>20051230</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060601</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RIBAVIRIN</medicinalproduct>
        <drugdosagetext>600 MG BID; ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051230</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060601</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENADRYL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE TABLETS 25MG ORAL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL TABLETS 20 MG ORAL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYLENOL TABLETS 325 MG ORAL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CHOLESTEROL LOWERING AGENT</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049885-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060621</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>226815</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>81</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DECREASED APPETITE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STOMATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVASTIN</medicinalproduct>
        <drugdosagetext>325 MG, Q2W, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLORECTAL CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060524</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060524</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXALIPLATIN (OXALIPLATIN)</medicinalproduct>
        <drugdosagetext>145 MG, Q2W; INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLORECTAL CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060524</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060524</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CAPECITABINE (CAPECITABINE)</medicinalproduct>
        <drugdosagetext>5000 MG, QD; ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>COLORECTAL CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060524</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060531</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049887-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060622</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>226614</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>70</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLAMMATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVASTIN</medicinalproduct>
        <drugdosagetext>1248 MG, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060605</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARBOPLATIN</medicinalproduct>
        <drugdosagetext>608 MG, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>036</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060605</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOCETAXEL (DOCETAXEL)</medicinalproduct>
        <drugdosagetext>145 MG; INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060605</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049888-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060622</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>226682</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>GASTRIC VARICES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATEMESIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVASTIN</medicinalproduct>
        <drugindication>PANCREATIC CARCINOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GEMCITABINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049890-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060623</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200612670BCC</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>73</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>70.7611</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>METRORRHAGIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALEVE</medicinalproduct>
        <drugauthorizationnumb>20204</drugauthorizationnumb>
        <drugdosagetext>440 MG, TOTAL DAILY; ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRALGIA</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060622</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMPRO</medicinalproduct>
        <drugindication>HORMONE THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZESTRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROZAC</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049892-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060627</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200612718BCC</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>26</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>72.5755</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>EAR DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOACUSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GENUINE BAYER TABLETS (ACETYLSALICYLIC ACID)</medicinalproduct>
        <drugbatchnumb>218725P</drugbatchnumb>
        <drugdosagetext>650 MG, TOTAL DAILY; ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEADACHE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060625</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060626</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049897-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>TAP2006Q01070</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>42</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>130</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CSF OLIGOCLONAL BAND PRESENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CSF WHITE BLOOD CELL COUNT POSITIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NUCLEAR MAGNETIC RESONANCE IMAGING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NUCLEAR MAGNETIC RESONANCE IMAGING BRAIN ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RED BLOOD CELLS CSF POSITIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPINAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VITAMIN B12 DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VITAMIN B6 DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VITAMIN D DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREVACID</medicinalproduct>
        <drugauthorizationnumb>21428</drugauthorizationnumb>
        <drugdosagetext>30 MG, 1 IN 1 D, PER ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BARRETT'S OESOPHAGUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THYROID TAB</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049899-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060619</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006-132</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>75</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CHOLELITHIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GALLBLADDER DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATOTOXICITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AZITHROMYCIN</medicinalproduct>
        <drugauthorizationnumb>65223</drugauthorizationnumb>
        <drugdosagetext>500MG DAILY ORALLY 3 DAYS</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RESPIRATORY TRACT INFECTION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049908-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060621</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>007787</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>51</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PETIT MAL EPILEPSY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRIAMTERENE + HYDROCHLOROTHIAZIDE(TRIAMTERENE, HYDROCHLOROTHIAZIDE) CA</medicinalproduct>
        <drugauthorizationnumb>75052</drugauthorizationnumb>
        <drugdosagetext>1 CAPS, QD, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DILANTIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049911-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060626</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>007885</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>72</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BREAST CANCER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MEDROXYPROGESTERONE ACETATE</medicinalproduct>
        <drugauthorizationnumb>40159</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19710101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20021201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19710101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20021201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROVERA</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19710101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20021201</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049912-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060626</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>007884</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>54</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BREAST CANCER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MEDROXYPROGESTERONE ACETATE</medicinalproduct>
        <drugauthorizationnumb>40159</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMPRO</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMPHASE (PREMARIN;CYCRIN 14/14)</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROVERA</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031201</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049915-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060626</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>007886</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>58</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BREAST CANCER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MEDROXYPROGESTERONE ACETATE</medicinalproduct>
        <drugauthorizationnumb>40159</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19900101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMPRO</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19900101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19900101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROVERA</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19900101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049916-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060626</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>007887</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>66</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BREAST CANCER FEMALE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MEDROXYPROGESTERONE ACETATE</medicinalproduct>
        <drugauthorizationnumb>40159</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19910101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19910101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROVERA</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19910101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCRIN</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19910101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010201</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049921-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200611664BCC</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>94</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>54.4316</patientweight>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALEVE</medicinalproduct>
        <drugauthorizationnumb>20204</drugauthorizationnumb>
        <drugdosagetext>440 MG, OM, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRITIS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031017</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049923-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>29464</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>56</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>APPLICATION SITE DRYNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>APPLICATION SITE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>APPLICATION SITE PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>APPLICATION SITE REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING COLD</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENTAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANIC ATTACK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VAGINAL DISCHARGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALDARA</medicinalproduct>
        <drugauthorizationnumb>20723</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>061</drugadministrationroute>
        <drugindication>ANOGENITAL WARTS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060404</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060408</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALDARA</medicinalproduct>
        <drugauthorizationnumb>20723</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>061</drugadministrationroute>
        <drugindication>ANOGENITAL WARTS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060531</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060606</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COQ-10</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LUTEINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMINS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049924-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060630</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>007914</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BREAST CANCER FEMALE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MEDROXYPROGESTERONE ACETATE</medicinalproduct>
        <drugauthorizationnumb>40159</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCRIN</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROVERA</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049930-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060616</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>002#4#2006-00212</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>75</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>54.4316</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERVERTEBRAL DISC PROTRUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEDICATION RESIDUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SCIATICA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ISOSORBIDE-MONONITRATE-60MG-EXTENDED-RELEASE-TABLETS (ISOSORBIDE MONON</medicinalproduct>
        <drugauthorizationnumb>75155</drugauthorizationnumb>
        <drugdosagetext>60MG, 1 IN 1 D, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANGINA PECTORIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATORVASTATIN CALCIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALSARTAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE BESYLATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLOPIDOGREL BISULFATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREGABALIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MORPHINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCODONE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049931-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060630</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200612430BWH</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>54</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>74.3899</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEBRILE NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATOCRIT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPHOCYTE PERCENTAGE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RED BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RED CELL DISTRIBUTION WIDTH INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>REFUSAL OF TREATMENT BY PATIENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUDDEN DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UPPER RESPIRATORY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SORAFENIB</medicinalproduct>
        <drugauthorizationnumb>21923</drugauthorizationnumb>
        <drugdosagetext>200 MG, BID, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>METASTATIC MALIGNANT MELANOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060120</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060308</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SORAFENIB</medicinalproduct>
        <drugauthorizationnumb>21923</drugauthorizationnumb>
        <drugdosagetext>200 MG, BID, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>METASTATIC MALIGNANT MELANOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060526</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060608</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PACLITAXEL</medicinalproduct>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060119</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060307</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PACLITAXEL</medicinalproduct>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060525</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARBOPLATIN</medicinalproduct>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060119</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060307</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARBOPLATIN</medicinalproduct>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060525</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PEPCID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENADRYL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DECADRON</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AUGMENTIN '125'</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGNESIUM OXIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RHINOCORT AQUA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CEFEPIME</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOFRAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COMPAZINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCONTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEUPOGEN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049932-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060703</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200611331BWH</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>158.759</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISEASE PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HOT FLUSH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXAVAR</medicinalproduct>
        <drugauthorizationnumb>21923</drugauthorizationnumb>
        <drugdosagetext>400 MG, BID, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RENAL CELL CARCINOMA STAGE UNSPECIFIED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHADONE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COLACE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IRON</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREVACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TENORMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049934-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060627</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200612725BCC</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>71</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>63.5036</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CONTUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG NEOPLASM MALIGNANT</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>19950101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060606</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060607</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZETIA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049936-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060623</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200612670BCC</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>73</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>70.7611</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>VAGINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALEVE</medicinalproduct>
        <drugauthorizationnumb>20204</drugauthorizationnumb>
        <drugdosagetext>440 MG, TOTAL DAILY, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRALGIA</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060622</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROZAC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMPRO</medicinalproduct>
        <drugindication>HORMONE THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZESTRIL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049940-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060627</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>224413</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>54</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>93.9</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANAPHYLACTIC REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BREATH SOUNDS ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALLOR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYPNOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XOLAIR</medicinalproduct>
        <drugbatchnumb>M69170</drugbatchnumb>
        <drugdosagetext>300 MG, SUBCUTANEOUS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060425</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EFFEXOR XR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPROL-XL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONIDINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THEOPHYLLINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SINGULAIR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADVAIR DISKUS 100/50</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLONASE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZYRTEC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACIPHEX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL (ALBUTEROL/ALBUTEROL SULFATE)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049942-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060627</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>226073</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>41</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>78</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HERPES SIMPLEX</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XOLAIR</medicinalproduct>
        <drugdosagetext>150, Q4W, SUBCUTANEOUS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060525</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>STEROIDS NOS (STEROID NOS)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COMBIVENT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLONASE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049943-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060623</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>226644</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>34</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>42.9</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABORTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABORTION SPONTANEOUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD HUMAN CHORIONIC GONADOTROPIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE BEFORE PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PREGNANCY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OMALIZUMAB (OMALIZUMAB)PWDR + SOLVENT, INJECTION SOLN,150MG</medicinalproduct>
        <drugdosagetext>300 MG, Q2W, SUBCUTANEOUS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050802</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CORTICOSTEROIDS (CORTICOSTEROID NOS)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MOTRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PAIN MEDICATION (ANALGESIC NOS)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049946-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060627</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>226306</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>40</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLADDER DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLADDER PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD SODIUM DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>KIDNEY INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYELONEPHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XOLAIR</medicinalproduct>
        <drugdosagetext>150 MG, 1/MONTH,</drugdosagetext>
        <drugindication>ASTHMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060412</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROVENTIL (ALBUTEROL/ALBUTEROL SULFATE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADVAIR DISKUS 100/50</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLEGRA-D (FEXOFENADINE HYDROCHLORIDE, PSEUDOEPHEDRINE HYDROCHLORIDE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREVACID</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049948-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060622</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>225831</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>73</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANAPHYLACTIC REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NECK PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XOLAIR</medicinalproduct>
        <drugdosagetext>375 MG, SUBCUTANEOUS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060512</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060526</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SINGULAIR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOTREL (AMLODIPINE BESYLATE, BENAZEPRIL HYDROCHLORIDE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049949-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060622</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>226646</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>68</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <reaction>
        <reactionmeddrapt>CHRONIC LYMPHOCYTIC LEUKAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RAPTIVA</medicinalproduct>
        <drugindication>PSORIASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050803</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049951-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060626</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>0602008US</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>13</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BOTULISM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BOTOX</medicinalproduct>
        <drugdosagetext>INTRAMUSCULAR</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MUSCLE SPASTICITY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049953-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060703</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>USA-2006-0023486</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>58</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>136.1</patientweight>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>DRUG TOXICITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN DISCOLOURATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THERAPEUTIC AGENT TOXICITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MORPHINE SULFATE</medicinalproduct>
        <drugauthorizationnumb>19516</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BUTALBITAL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ETHANOL (ETHANOL)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049957-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060623</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006US001395</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>19</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>KLEBSIELLA INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYELONEPHRITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROGRAF</medicinalproduct>
        <drugauthorizationnumb>50708</drugauthorizationnumb>
        <drugindication>PROPHYLAXIS AGAINST TRANSPLANT REJECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040928</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040929</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROGRAF</medicinalproduct>
        <drugauthorizationnumb>50708</drugauthorizationnumb>
        <drugindication>PROPHYLAXIS AGAINST TRANSPLANT REJECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050525</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DACLIXIMAB (DACLIZUMAB)</medicinalproduct>
        <drugdosagetext>70 MG, TOTAL DOSE, IV NOS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RENAL TRANSPLANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050329</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050329</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NU-IRON (POLYSACCHARIDE-IRON COMPLEX)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SEPTRA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SINGULAIR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREVACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049959-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060626</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006US-02719</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>24</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAL ULCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD BILIRUBIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CAROTENE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLITIS</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>FOLATE DEFICIENCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIP EROSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALLOR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SCAB</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STOMATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VITAMIN B12 DEFICIENCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ISOTRETINOIN</medicinalproduct>
        <drugauthorizationnumb>76041</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLATE SUPPLEMENT</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049961-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060626</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006US-02718</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>27</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DERMATITIS PAPILLARIS CAPILLITII</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTROPHIC SCAR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ISOTRETINOIN</medicinalproduct>
        <drugauthorizationnumb>76041</drugauthorizationnumb>
        <drugdosagetext>40 MG, QD,</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049962-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060630</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>145334USA</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>59</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>66.6788</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>BACTERIAL SEPSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBRAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FAECALOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LARGE INTESTINE PERFORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZAPINE</medicinalproduct>
        <drugauthorizationnumb>74949</drugauthorizationnumb>
        <drugdosagetext>175 MILLIGRAM HS ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOAFFECTIVE DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060321</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EFFEXOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMBIEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RITALIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMITRIPTYLINE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREVACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOTENSIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049965-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060626</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006-01601</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VELCADE</medicinalproduct>
        <drugauthorizationnumb>21602</drugauthorizationnumb>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060320</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049967-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>146386USA</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>18</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>COLLAPSE OF LUNG</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA BACTERIAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SULFAMETHOXAZOLE + TRIMETHOPRIM</medicinalproduct>
        <drugauthorizationnumb>70037</drugauthorizationnumb>
        <drugindication>ACNE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060407</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049969-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060621</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200612718BWH</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>76</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>88.4</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANGINA PECTORIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ATRIOVENTRICULAR BLOCK FIRST DEGREE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY OCCLUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MITRAL VALVE INCOMPETENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL ISCHAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERICARDIAL EFFUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENTRICULAR DYSFUNCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SORAFENIB OR PLACEBO (UNCODEABLE ^INVESTIGATIONAL DRUG^)</medicinalproduct>
        <drugauthorizationnumb>17575</drugauthorizationnumb>
        <drugdosagetext>400 MG, BID, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>METASTATIC MALIGNANT MELANOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060130</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060426</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DACARBAZINE</medicinalproduct>
        <drugdosagetext>Q3WK, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>METASTATIC MALIGNANT MELANOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060130</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060410</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLOMAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VYTORIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LECITHIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASCORBIC ACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYLENOL (CAPLET)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE TAB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORAZEPAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GRANISETRON  HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COMPAZINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KYTRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALEVE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049974-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060622</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006S1005351</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>42</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>122.4712</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DERMOGRAPHISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS GENERALISED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWELLING FACE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URTICARIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PIROXICAM</medicinalproduct>
        <drugbatchnumb>3N1424</drugbatchnumb>
        <drugauthorizationnumb>74102</drugauthorizationnumb>
        <drugdosagetext>20 MG;X1;ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRALGIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060525</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060525</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PIROXICAM</medicinalproduct>
        <drugbatchnumb>3N1424</drugbatchnumb>
        <drugauthorizationnumb>74102</drugauthorizationnumb>
        <drugdosagetext>20 MG;X1;ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060525</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060525</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARBAMAZEPINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN AND OXYCODONE HCL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049976-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060623</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006S1005228</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>45</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZAPINE</medicinalproduct>
        <drugauthorizationnumb>75417</drugauthorizationnumb>
        <drugdosagetext>100 MG;QAM;ORAL     500 MG;HS;ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>AFFECTIVE DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19991201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZAPINE</medicinalproduct>
        <drugauthorizationnumb>75417</drugauthorizationnumb>
        <drugdosagetext>100 MG;QAM;ORAL     500 MG;HS;ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PSYCHOTIC DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19991201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZAPINE</medicinalproduct>
        <drugauthorizationnumb>75417</drugauthorizationnumb>
        <drugdosagetext>100 MG;QAM;ORAL     500 MG;HS;ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>TRAUMATIC BRAIN INJURY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19991201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RISPERIDONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUOXETINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049978-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060622</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006S1005749</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>36</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>95.2554</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG WITHDRAWAL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INADEQUATE ANALGESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WRONG TECHNIQUE IN DRUG USAGE PROCESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FENTANYL TRANSDERMAL SYSTEM</medicinalproduct>
        <drugbatchnumb>6N0117</drugbatchnumb>
        <drugauthorizationnumb>76258</drugauthorizationnumb>
        <drugdosagetext>50 UG/HR;Q3D;TRANS</drugdosagetext>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>FLANK PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FENTANYL TRANSDERMAL SYSTEM</medicinalproduct>
        <drugbatchnumb>6N0117</drugbatchnumb>
        <drugauthorizationnumb>76258</drugauthorizationnumb>
        <drugdosagetext>50 UG/HR;Q3D;TRANS</drugdosagetext>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FENTANYL TRANSDERMAL SYSTEM</medicinalproduct>
        <drugbatchnumb>6N0124</drugbatchnumb>
        <drugdosagetext>100 UG/HR;Q3D;TRANS</drugdosagetext>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>FLANK PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FENTANYL TRANSDERMAL SYSTEM</medicinalproduct>
        <drugbatchnumb>6N0124</drugbatchnumb>
        <drugdosagetext>100 UG/HR;Q3D;TRANS</drugdosagetext>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MORPHINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049980-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060622</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006S1005082</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>55</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZAPINE</medicinalproduct>
        <drugauthorizationnumb>75417</drugauthorizationnumb>
        <drugdosagetext>50 MG;QAM;ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BIPOLAR DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060111</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZAPINE</medicinalproduct>
        <drugauthorizationnumb>75417</drugauthorizationnumb>
        <drugdosagetext>50 MG;QAM;ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060111</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZAPINE</medicinalproduct>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BIPOLAR DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060111</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZAPINE</medicinalproduct>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060111</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FERROUS GLUCONATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANSOPRAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORAZEPAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENZTROPINE MESYLATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOCUSATE SODIUM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049982-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060627</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>226830</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <patientonsetage>63</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANAPHYLACTIC REACTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HERCEPTIN</medicinalproduct>
        <drugdosagetext>1/WEEK, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BREAST CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060627</drugstartdate>
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    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049985-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060626</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>230107M06USA</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>36</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POST PROCEDURAL HYPOTHYROIDISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THYROID CANCER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBIF</medicinalproduct>
        <drugdosagetext>44 MCG, 3 IN 1 WEEKS, SUBCUTANEOUS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060325</drugstartdate>
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    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049986-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060626</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>234025K06USA</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>33</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>104</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CHILLS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</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>REBIF</medicinalproduct>
        <drugdosagetext>44 MCG, 3 IN 1 WEEKS, SUBCUTANEOUS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051101</drugstartdate>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZANAFLEX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPAMAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEXAPRO</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRIAMTERENE/HYDROCHLOROTHIAZIDE (DYAZIDE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SOLU-MEDROL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5049987-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060605</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>9482</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DYSGEUSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA ORAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEPTOCAINE</medicinalproduct>
        <drugauthorizationnumb>20971</drugauthorizationnumb>
        <drugdosagetext>1 CARTRIDGE INJECTED</drugdosagetext>
        <drugindication>LOCAL ANAESTHESIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEPTOCAINE</medicinalproduct>
        <drugauthorizationnumb>20971</drugauthorizationnumb>
        <drugdosagetext>1 CARTRIDGE INJECTED</drugdosagetext>
        <drugindication>TOOTH DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050008-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060704</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-JNJFOC-20060700737</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PARAPSORIASIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>INFLAMMATORY BOWEL DISEASE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050009-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060704</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>LT-JNJFOC-20060604428</companynumb>
    <primarysource>
      <reportercountry>LITHUANIA</reportercountry>
      <qualification>3</qualification>
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    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CHRONIC MYELOID LEUKAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugdosagetext>8 INFUSIONS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ANKYLOSING SPONDYLITIS</drugindication>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHYLPREDNISOLONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANKYLOSING SPONDYLITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050301</drugstartdate>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELECOXIB</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANKYLOSING SPONDYLITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050301</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MELOXICAM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANKYLOSING SPONDYLITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050301</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANKYLOSING SPONDYLITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050301</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANKYLOSING SPONDYLITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050301</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050010-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060706</receiptdate>
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    <companynumb>2006AP03098</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</reportercountry>
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    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <patientonsetage>18959</patientonsetage>
      <patientonsetageunit>804</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANAPHYLACTIC REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALLOR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHEEZING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROPOFOL</medicinalproduct>
        <drugauthorizationnumb>19627</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>SENSORY DISTURBANCE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060311</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060311</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ROCURONIUM BROMIDE</medicinalproduct>
        <drugindication>SENSORY DISTURBANCE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060311</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060311</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CEFTRIAXONE</medicinalproduct>
        <drugindication>PREMEDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060311</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060311</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIDAZOLAM HYDROCHLORIDE</medicinalproduct>
        <drugindication>SENSORY DISTURBANCE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060311</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060311</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FENTANYL TRANSDERMAL SYSTEM</medicinalproduct>
        <drugindication>SENSORY DISTURBANCE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060311</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060311</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE TAB</medicinalproduct>
        <drugindication>SENSORY DISTURBANCE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060311</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060311</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
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    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050011-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
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    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060614</receiptdate>
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    <companynumb>2006UW12698</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
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    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>47</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>74.1</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>TENOSYNOVITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRIGGER FINGER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARIMIDEX</medicinalproduct>
        <drugauthorizationnumb>20541</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050816</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOLADEX</medicinalproduct>
        <drugauthorizationnumb>019726</drugauthorizationnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VICODIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALTRATE W/ VITAMIN D</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SALSALATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAMADOL HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMBIEN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050012-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006PK01406</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>22773</patientonsetage>
      <patientonsetageunit>804</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INTESTINAL ISCHAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALIGNANT NEOPLASM PROGRESSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IRESSA</medicinalproduct>
        <drugauthorizationnumb>21399</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SQUAMOUS CELL CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050705</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060623</drugenddate>
        <drugtreatmentduration>354</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RADIOTHERAPY</medicinalproduct>
        <drugindication>SQUAMOUS CELL CARCINOMA</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060623</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CISPLATIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>SQUAMOUS CELL CARCINOMA</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060623</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ESIDRIX</medicinalproduct>
        <drugindication>OEDEMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANTOZOL</medicinalproduct>
        <drugindication>GASTRIC ULCER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAVEGIL</medicinalproduct>
        <drugindication>RASH PRURITIC</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MG VERLA</medicinalproduct>
        <drugindication>HYPOMAGNESAEMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>L-THYROXIN</medicinalproduct>
        <drugindication>HYPOTHYROIDISM</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050017-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060704</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-JNJFOC-20060205839</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>45</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>76</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MALIGNANT MELANOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugdosagetext>FIRST INFUSION THREE YEARS AGO</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugdosagetext>FIRST INFUSION THREE YEARS AGO</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugdosagetext>FIRST INFUSION THREE YEARS AGO</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugdosagetext>FIRST INFUSION THREE YEARS AGO</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugdosagetext>FIRST INFUSION THREE YEARS AGO</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ANKYLOSING SPONDYLITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BIPROFENID</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050019-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060706</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-SANOFI-SYNTHELABO-A02200601787</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>80</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>COMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEUCOVORIN CALCIUM</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLON CANCER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUOROURACIL</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLON CANCER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ELOXATIN</medicinalproduct>
        <drugauthorizationnumb>021492</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLON CANCER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050023-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060704</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006UW13930</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>56</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>88.5</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DIABETES MELLITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HALLUCINATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCREATITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugauthorizationnumb>020639</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050701</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENADRYL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPROL-XL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ABILIFY</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRIFLUOPERAZINE HCL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050024-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060703</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2006CL09956</companynumb>
    <primarysource>
      <reportercountry>CHILE</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>65</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BUNDLE BRANCH BLOCK</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAREG D</medicinalproduct>
        <drugauthorizationnumb>20818</drugauthorizationnumb>
        <drugdosagetext>VALS 160 MG/ HCT 12.5 MG/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DILATREND</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CEFALMIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050025-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060320</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2006JP04341</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>45</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>60</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ALANINE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASPARTATE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EOSINOPHIL COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HUMAN HERPES VIRUS 6 SEROLOGY POSITIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIP EROSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPHADENOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPHOCYTE STIMULATION TEST POSITIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL MUCOSA EROSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RED BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN EXFOLIATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN TEST POSITIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STAPHYLOCOCCAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWELLING FACE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TEGRETOL</medicinalproduct>
        <drugauthorizationnumb>016608</drugauthorizationnumb>
        <drugdosagetext>100 MG, TID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050106</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050407</drugenddate>
        <drugtreatmentduration>92</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CONTOMIN</medicinalproduct>
        <drugdosagetext>300 MG/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AKINETON</medicinalproduct>
        <drugdosagetext>3 MG/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050062-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060417</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-06P-163-0330897-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>56.75</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FAECALOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HERNIA REPAIR</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>20051001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRAVASTATIN SODIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RANITIDINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETYLSALICYLIC ACID SRT</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050063-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesscongenitalanomali>1</seriousnesscongenitalanomali>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060519</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-06P-163-0333902-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>APNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BODY TEMPERATURE FLUCTUATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONGENITAL GENITAL MALFORMATION MALE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONGENITAL TORTICOLLIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CYANOSIS NEONATAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEVELOPMENTAL DELAY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ELECTROENCEPHALOGRAM ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEEDING DISORDER NEONATAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEEDING DISORDER OF INFANCY OR EARLY CHILDHOOD</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MELANOCYTIC NAEVUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MICROCEPHALY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCLONUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEONATAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OXYGEN SATURATION DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PETECHIAE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY DISTRESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKULL MALFORMATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRISOMY 15</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRISOMY 21</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISION ABNORMAL NEONATAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL TRACKING TEST ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KALETRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>21226</drugauthorizationnumb>
        <drugindication>DRUG EXPOSURE DURING PREGNANCY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NORVIR</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020945</drugauthorizationnumb>
        <drugindication>DRUG EXPOSURE DURING PREGNANCY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ATAZANAVIR</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>DRUG EXPOSURE DURING PREGNANCY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TENOFOVIR DISOPROXIL FUMARATE/EMTRICITABINE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>DRUG EXPOSURE DURING PREGNANCY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRIZIVIR</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>DRUG EXPOSURE DURING PREGNANCY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NELFINAVIR MESILATE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>DRUG EXPOSURE DURING PREGNANCY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMIVUDINE + ZIDOVUDINE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>DRUG EXPOSURE DURING PREGNANCY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZIDOVUDINE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>DRUG EXPOSURE DURING PREGNANCY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050065-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060705</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20060505005</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>106.14</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HYPERTHYROIDISM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DURAGESIC-100</medicinalproduct>
        <drugauthorizationnumb>19813</drugauthorizationnumb>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NABUMETONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BACK PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GABITRIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NERVOUSNESS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORTRIPTYLINE HCL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NERVOUSNESS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONAZEPAM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANXIETY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIAZEPAM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MUSCLE SPASMS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050066-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060703</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20060203231</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>106.6</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>BRONCHOPNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE DRUG OVERDOSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DURAGESIC-100</medicinalproduct>
        <drugauthorizationnumb>19813</drugauthorizationnumb>
        <drugdosagetext>(5) 50 MEQ AT ONE TIME</drugdosagetext>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>ENDOCET</medicinalproduct>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>TOPAMAX</medicinalproduct>
        <drugauthorizationnumb>020505</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NEURALGIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>HYDROCODONE</medicinalproduct>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>CANNABIS</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050069-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060621</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006S1005880</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYSTEMIC LUPUS ERYTHEMATOSUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MERCAPTAMINE BITARTRATE (MERCAPTAMINE BITARTRATE)</medicinalproduct>
        <drugauthorizationnumb>20392</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050077-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060703</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>SE-JNJFOC-20060604477</companynumb>
    <primarysource>
      <reportercountry>SWEDEN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>3</patientonsetage>
      <patientonsetageunit>800</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>EPILEPSY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SPORANOX</medicinalproduct>
        <drugauthorizationnumb>20083</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050078-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060705</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-JNJFOC-20060700619</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>25</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HALLUCINATION, VISUAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CONCERTA</medicinalproduct>
        <drugauthorizationnumb>021121</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATTENTION DEFICIT/HYPERACTIVITY DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIDOCAIN</medicinalproduct>
        <drugindication>TOOTH EXTRACTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FENTANYL TRANSDERMAL SYSTEM</medicinalproduct>
        <drugindication>TOOTH EXTRACTION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050079-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060704</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-JNJFOC-20060606361</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>CARDIOVASCULAR DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CONCERTA</medicinalproduct>
        <drugauthorizationnumb>21121</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050080-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060705</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-JNJFOC-20060701008</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>16</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PRIAPISM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CONCERTA</medicinalproduct>
        <drugauthorizationnumb>021121</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATTENTION DEFICIT/HYPERACTIVITY DISORDER</drugindication>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050086-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060623</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006US-02711</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>36</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENTAL IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOOD SWINGS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ISOTRETINOIN</medicinalproduct>
        <drugauthorizationnumb>76041</drugauthorizationnumb>
        <drugdosagetext>40 MG,BID</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060328</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060621</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050090-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060622</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006US-02707</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>17</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>AGITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ALCOHOLISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISTURBANCE IN ATTENTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EDUCATIONAL PROBLEM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EMOTIONAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMPATIENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IRRITABILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOCIAL AVOIDANT BEHAVIOUR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ISOTRETINOIN</medicinalproduct>
        <drugauthorizationnumb>76041</drugauthorizationnumb>
        <drugdosagetext>40 MG, BID</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060622</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050091-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060623</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006US-02709</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>18</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PREGNANCY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ISOTRETINOIN</medicinalproduct>
        <drugauthorizationnumb>76041</drugauthorizationnumb>
        <drugdosagetext>BID</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050092-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060623</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PAR_0681_2006</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEMENTIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENTAL STATUS CHANGES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHYSICAL ASSAULT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MEGACE ES</medicinalproduct>
        <drugauthorizationnumb>21778</drugauthorizationnumb>
        <drugdosagetext>DF PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050093-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>E2090-00032-SPO-US</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>41</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>AMNESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANGER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COORDINATION ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIPLOPIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSARTHRIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRANSIENT ISCHAEMIC ATTACK</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZONEGRAN</medicinalproduct>
        <drugauthorizationnumb>20789</drugauthorizationnumb>
        <drugdosagetext>400 MG, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PARTIAL SEIZURES</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20001001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LAMICTAL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TEGRETOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONAZEPAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAZODONE HCL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050094-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060704</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-AVENTIS-200612426FR</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>58</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>55</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LOVENOX</medicinalproduct>
        <drugauthorizationnumb>20164</drugauthorizationnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060513</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060523</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RAPIFEN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ANAESTHESIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060513</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060523</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLAVENTIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060515</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060523</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FUNGIZONE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ASPERGILLOSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060512</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060517</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CATAPRES</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060513</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060515</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRAVASTATIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLOR</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DI-ANTALVIC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FERROGRAD</medicinalproduct>
        <drugindication>IRON DEFICIENCY ANAEMIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050095-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060705</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ES-AVENTIS-200616953GDDC</companynumb>
    <primarysource>
      <reportercountry>SPAIN</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>41</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>COMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPONATRAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DDAVP</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>018938</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050096-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060705</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-AVENTIS-200616905GDDC</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>9</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DESMOPRESSIN</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>19955</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ENURESIS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060522</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050097-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060705</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AVENTIS-200615661US</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABNORMAL BEHAVIOUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AUTISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CRANIOSYNOSTOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEVELOPMENTAL DELAY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IRON DEFICIENCY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LOVENOX</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>020164</drugauthorizationnumb>
        <drugindication>FACTOR V LEIDEN MUTATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050098-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060707</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-AVENTIS-200612438FR</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>83</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>RENAL CELL CARCINOMA STAGE UNSPECIFIED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARAVA</medicinalproduct>
        <drugauthorizationnumb>020905</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050099-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060626</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>225424</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>51</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>106.6</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DIABETES MELLITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GLYCOSYLATED HAEMOGLOBIN INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NUTROPIN AQ                         (SOMATROPIN)</medicinalproduct>
        <drugauthorizationnumb>20522</drugauthorizationnumb>
        <drugdosagetext>0.4 MG, 7/WEEK, SUBCUTANEOUS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>EMPTY SELLA SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041115</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACTONEL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DHEA                           (DEHYDROEPIANDROSTERONE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EFFEXOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MIACALCIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050100-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060622</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200612272BWH</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>78</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVELOX</medicinalproduct>
        <drugbatchnumb>BXA0ZF4 [NAV]</drugbatchnumb>
        <drugauthorizationnumb>21277</drugauthorizationnumb>
        <drugdosagetext>400 MG, QD, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BRONCHITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060408</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060410</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOSYN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LINEZOLID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>D51/2NS KCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>D5NS KCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>D10</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>D5 1/2NS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE TAB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXTROSE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050101-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200610281BWH</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>47</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>60</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ENTERITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ODYNOPHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SORAFENIB</medicinalproduct>
        <drugauthorizationnumb>21923</drugauthorizationnumb>
        <drugdosagetext>200 MG, BID, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>METASTATIC RENAL CELL CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051208</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051230</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COLACE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROMORPHONE HYDROCHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHADONE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FENTANYL TRANSDERMAL SYSTEM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050102-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060622</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-2006-016821</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHOLANGITIS SCLEROSING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CAMPATH</medicinalproduct>
        <drugindication>CHRONIC LYMPHOCYTIC LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050425</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050823</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050103-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060703</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHNU2006DE02432</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>APHASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBRAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEPONEX</medicinalproduct>
        <drugauthorizationnumb>19758</drugauthorizationnumb>
        <drugdosagetext>100 MG/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050104-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060703</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-JNJFOC-20060500664</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>47</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>AUTOIMMUNE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMARTHROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENINGITIS ASEPTIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugdosagetext>THIRD INFUSION</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ANKYLOSING SPONDYLITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EFFERALGAN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANKYLOSING SPONDYLITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAREG</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MOPRAL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>APRANAX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANKYLOSING SPONDYLITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050105-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060621</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-2006-016190</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>59</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>61.2</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>EYE HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NERVOUS SYSTEM DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUDARABINE</medicinalproduct>
        <drugauthorizationnumb>20038</drugauthorizationnumb>
        <drugdosagetext>40 MG, 1X/DAY, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>WALDENSTROM'S MACROGLOBULINAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060228</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060426</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACYCLOVIR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CO-TRIMOXAZOLE (CO-TRIMOXAZOLE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYCLOPHOSPHAMIDE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050107-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060627</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-2006-012514</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>BLOOD CREATININE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSED LEVEL OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIABETES MELLITUS INADEQUATE CONTROL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIALYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUID OVERLOAD</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GLASGOW COMA SCALE ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTESTINAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MIOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTI-ORGAN FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL ISCHAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEPHROPATHY TOXIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SHOCK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SLEEP DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ULTRAVIST (PHARMACY BULK)</medicinalproduct>
        <drugauthorizationnumb>20220</drugauthorizationnumb>
        <drugdosagetext>ML</drugdosagetext>
        <drugindication>COMPUTERISED TOMOGRAM ABDOMEN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050418</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050418</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GADOVIST 1.0 (GADOBUTROL) SOLUTION</medicinalproduct>
        <drugdosagetext>ML</drugdosagetext>
        <drugindication>NUCLEAR MAGNETIC RESONANCE IMAGING</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050421</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050421</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NALOXONE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050628</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050628</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050108-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060707</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006UW14072</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>X-RAY ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IRESSA</medicinalproduct>
        <drugauthorizationnumb>021399</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050110-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060623</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-2006-016955</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>66</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HAEMATURIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BETASERON</medicinalproduct>
        <drugdosagetext>8 MIU, SUBCUTANEOUS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>SECONDARY PROGRESSIVE MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010417</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050111-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20051212</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-NOVOPROD-249223</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>62</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>55</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BODY TEMPERATURE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPONATRAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOPHLEBITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NOVOSEVEN</medicinalproduct>
        <drugdosagetext>80 UG/KG, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CEREBRAL HAEMORRHAGE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051125</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051125</drugenddate>
        <drugtreatmentduration>1440</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ESOMEPRAZOLE</medicinalproduct>
        <drugdosagetext>40 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051125</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugdosagetext>20 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051129</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CEFOTAXIME</medicinalproduct>
        <drugdosagetext>6 G, QD</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051130</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051208</drugenddate>
        <drugtreatmentduration>11520</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LUVASED</medicinalproduct>
        <drugdosagetext>2 TAB, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051130</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PARACETAMOL</medicinalproduct>
        <drugdosagetext>1 G, QD</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051130</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051204</drugenddate>
        <drugtreatmentduration>5760</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050112-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050523</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-SOLVAY-00205001748</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>551</patientonsetage>
      <patientonsetageunit>802</patientonsetageunit>
      <patientweight>104.5</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>AGGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONJUNCTIVITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAIR GROWTH ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>KIDNEY INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEUKOCYTOCLASTIC VASCULITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCREATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RETINAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URTICARIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL DISTURBANCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYCLOSPORINE</medicinalproduct>
        <drugdosagetext>DAILY DOSE:  UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BEHCET'S SYNDROME</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ANDROGEL</medicinalproduct>
        <drugauthorizationnumb>021015</drugauthorizationnumb>
        <drugdosagetext>DAILY DOSE: 5 GRAM(S)</drugdosagetext>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>ACCIDENTAL EXPOSURE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050301</drugenddate>
        <drugtreatmentduration>11</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ANDROGEL</medicinalproduct>
        <drugauthorizationnumb>021015</drugauthorizationnumb>
        <drugdosagetext>DAILY DOSE: 10 GRAM(S)</drugdosagetext>
        <drugadministrationroute>062</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050501</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMURAN</medicinalproduct>
        <drugdosagetext>DAILY DOSE:  UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>LEUKOCYTOCLASTIC VASCULITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041231</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORTAB</medicinalproduct>
        <drugdosagetext>DAILY DOSE:  UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050101</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISONE TAB</medicinalproduct>
        <drugdosagetext>DAILY DOSE: 60 MILLICURIE(S)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>LEUKOCYTOCLASTIC VASCULITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050201</drugenddate>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISONE TAB</medicinalproduct>
        <drugdosagetext>DAILY DOSE:  UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050501</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DABSON</medicinalproduct>
        <drugdosagetext>DAILY DOSE:  UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>LEUKOCYTOCLASTIC VASCULITIS</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>ANDRODERM</medicinalproduct>
        <drugdosagetext>DAILY DOSE: 2.5 MILLIGRAM(S)</drugdosagetext>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>ACCIDENTAL EXPOSURE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041201</drugenddate>
        <drugtreatmentduration>15</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugdosagetext>DAILY DOSE:  UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>LEUKOCYTOCLASTIC VASCULITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041001</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALDREX</medicinalproduct>
        <drugdosagetext>DAILY DOSE:  UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>LEUKOCYTOCLASTIC VASCULITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040701</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050113-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>HQWYE432719JAN06</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY ARTERY ANEURYSM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051209</drugstartdate>
        <drugtreatmentduration>40</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DECADRON</medicinalproduct>
        <drugdosagetext>UNKNOWN</drugdosagetext>
        <drugadministrationroute>051</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XYLOCAINE</medicinalproduct>
        <drugdosagetext>UNKNOWN</drugdosagetext>
        <drugadministrationroute>051</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RINDERON-VG</medicinalproduct>
        <drugdosagetext>UNKNOWN</drugdosagetext>
        <drugadministrationroute>061</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SELBEX</medicinalproduct>
        <drugdosagetext>UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugdosagetext>UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADOFEED</medicinalproduct>
        <drugdosagetext>UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYALURONATE SODIUM</medicinalproduct>
        <drugdosagetext>UNKNOWN</drugdosagetext>
        <drugadministrationroute>051</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROGRAF</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051122</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060118</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SOLETON</medicinalproduct>
        <drugdosagetext>UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050115-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060619</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GBWYE744419JUN06</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>68</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ISCHAEMIC STROKE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>25MG FREQUENCY UNKNOWN</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
        <drugdosagetext>UNKNOWN</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PERINDOPRIL ERUMINE</medicinalproduct>
        <drugdosagetext>UNKNOWN</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ISMN</medicinalproduct>
        <drugdosagetext>UNKNOWN</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RISEDRONATE</medicinalproduct>
        <drugdosagetext>UNKNOWN</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugdosagetext>UNKNOWN</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CODEINE PHOSPHATE/PARACETAMOL</medicinalproduct>
        <drugdosagetext>UNKNOWN</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
        <drugdosagetext>UNKNOWN</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
        <drugdosagetext>UNKNOWN</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050116-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060707</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2006US08729</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>68</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>EYE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAIR METAL TEST ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OPHTHALMOLOGICAL EXAMINATION ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OPTIC NERVE DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIACALCIN</medicinalproduct>
        <drugauthorizationnumb>020313</drugauthorizationnumb>
        <drugdosagetext>200 IU, QD</drugdosagetext>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19970101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19990101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIACALCIN</medicinalproduct>
        <drugauthorizationnumb>020313</drugauthorizationnumb>
        <drugdosagetext>200 IU, QD</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ELMIRON</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ESTROGENS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050117-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-AMGEN-UK184685</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>63</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ALVEOLITIS ALLERGIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CAMPYLOBACTER INTESTINAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUCOSAL INFLAMMATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VAGINAL EXFOLIATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEULASTA</medicinalproduct>
        <drugbatchnumb>N1046AF02</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>CHEMOTHERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060501</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIFFLAM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MUCAINE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENOXAPARIN SODIUM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ORAMORPH SR</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLARITHROMYCIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUCONAZOLE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLURBIPROFEN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SENNA</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SODIUM BICARBONATE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TEMAZEPAM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SLOW-K</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EPIRUBICIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYCLOPHOSPHAMIDE</medicinalproduct>
        <drugadministrationroute>040</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugadministrationroute>040</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUOROURACIL</medicinalproduct>
        <drugadministrationroute>040</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACYCLOVIR</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CEFTAZIDIME</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GENTAMICIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050119-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060627</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-2006-012514</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>BLOOD CREATININE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSED LEVEL OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIABETES MELLITUS INADEQUATE CONTROL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIALYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUID OVERLOAD</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GLASGOW COMA SCALE ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTESTINAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MIOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTI-ORGAN FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL ISCHAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEPHROPATHY TOXIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SLEEP DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ULTRAVIST (PHARMACY BULK)</medicinalproduct>
        <drugauthorizationnumb>20220</drugauthorizationnumb>
        <drugdosagetext>ML</drugdosagetext>
        <drugindication>COMPUTERISED TOMOGRAM ABDOMEN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050418</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050418</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GADOVIST 1.0 (GADOBUTROL) SOLUTION</medicinalproduct>
        <drugdosagetext>ML</drugdosagetext>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050421</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050421</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GADOVIST 1.0 (GADOBUTROL) SOLUTION</medicinalproduct>
        <drugdosagetext>ML</drugdosagetext>
        <drugindication>NUCLEAR MAGNETIC RESONANCE IMAGING</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050421</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050421</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NALOXONE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050628</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050628</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050122-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060621</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-2006-016190</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>59</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>61.2</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>EYE HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NERVOUS SYSTEM DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUDARABINE</medicinalproduct>
        <drugauthorizationnumb>20038</drugauthorizationnumb>
        <drugdosagetext>40 MG, 1X/DAY, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>WALDENSTROM'S MACROGLOBULINAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060228</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060426</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACYCLOVIR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CO-TRIMOXAZOLE (CO-TRIMOXAZOLE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYCLOPHOSPHAMIDE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050124-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-US184698</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARANESP</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>ANAEMIA OF MALIGNANT DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060428</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060512</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050125-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060504</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PT-AMGEN-UK178742</companynumb>
    <primarysource>
      <reportercountry>PORTUGAL</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>46</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABASIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIMPARA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERPARATHYROIDISM SECONDARY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060526</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060530</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN B COMPLEX CAP</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040306</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARANESP</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041209</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040306</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TICLODIPINE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040327</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZEMPLAR</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050822</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050127-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060621</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>230001K06DEU</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DIABETES MELLITUS NON-INSULIN-DEPENDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERAL PHYSICAL CONDITION ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATOCELLULAR DAMAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEURALGIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBIF</medicinalproduct>
        <drugindication>SECONDARY PROGRESSIVE MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CORTICOSTEROID NOS</medicinalproduct>
        <drugdosagetext>2 IN 1 MONTHS</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050401</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMITRIPTYLINE HYDROCHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREGABALIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALORON N /00628301/</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050128-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060627</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>430010M05FRA</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>56</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>GRANULOMA ANNULARE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NOVANTRONE</medicinalproduct>
        <drugauthorizationnumb>19297</drugauthorizationnumb>
        <drugindication>BREAST CANCER FEMALE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>5-FLUOROURACIL (FLUOROURACIL /00098801/)</medicinalproduct>
        <drugdosagetext>INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BREAST CANCER FEMALE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOPHOSPHAMIDE</medicinalproduct>
        <drugdosagetext>INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BREAST CANCER FEMALE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050130-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060421</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GXKR2006DE02293</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>51</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>60</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ACTIVATED PARTIAL THROMBOPLASTIN TIME PROLONGED</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>ATELECTASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BASE EXCESS INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD BICARBONATE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRADYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>C-REACTIVE PROTEIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHILLS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDUCTION DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTOLERANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ELECTROCARDIOGRAM T WAVE INVERSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EMBOLISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERVENTILATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOKALAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEUKOCYTOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OXYGEN SATURATION DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLEURAL EFFUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PO2 DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROTHROMBIN TIME PROLONGED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY CONGESTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUS TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPEECH DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STOMATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VASODILATATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VOLTAREN</medicinalproduct>
        <drugauthorizationnumb>19201</drugauthorizationnumb>
        <drugdosagetext>50 MG, BID</drugdosagetext>
        <drugadministrationroute>054</drugadministrationroute>
        <drugindication>POSTOPERATIVE ANALGESIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060401</drugenddate>
        <drugtreatmentduration>1440</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EMBOLEX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DULCOLAX</medicinalproduct>
        <drugdosagetext>2 DF, QD</drugdosagetext>
        <drugadministrationroute>054</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060401</drugenddate>
        <drugtreatmentduration>1440</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugdosagetext>200 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060331</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060331</drugenddate>
        <drugtreatmentduration>1440</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HORMONES</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANAESTHETICS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HEPARIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REFLUDAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAXOBERAL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050131-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060522</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>HQWYE526024MAY06</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>51</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>COMPRESSION FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA PNEUMOCOCCAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060111</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060502</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDONINE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROGRAF</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051214</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060601</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ISCOTIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANTIBIOTIC PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050824</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PARIET</medicinalproduct>
        <drugdosagetext>UNSPEXCIFIED DOSE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALFAROL</medicinalproduct>
        <drugdosagetext>UNSPECIFIED DOSE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HARNAL</medicinalproduct>
        <drugdosagetext>UNSPECIFIED DOSE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PYDOXAL</medicinalproduct>
        <drugdosagetext>UNSPECIFIED DOSE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANALDINE</medicinalproduct>
        <drugdosagetext>UNSPECIFIED DOSE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGNESIUM OXIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MYONAL</medicinalproduct>
        <drugdosagetext>UNSPECIFIED DOSE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CEROCRAL</medicinalproduct>
        <drugdosagetext>UNSPECIFIED DOSE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VOLTAREN</medicinalproduct>
        <drugdosagetext>UNSPECIFIED DOSE</drugdosagetext>
        <drugadministrationroute>054</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACTONEL</medicinalproduct>
        <drugdosagetext>UNSPECIFIED DOSE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ELCITONIN</medicinalproduct>
        <drugdosagetext>UNSPECIFIED DOSE VIA INJECTION (UNSPECIFIED)</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050132-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060627</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006081561</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BREAST CANCER</reactionmeddrapt>
      </reaction>
      <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>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMPRO</medicinalproduct>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MEDROXYPROGESTERONE</medicinalproduct>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050133-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060622</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006081751</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>51</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONGESTIVE CARDIOMYOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIABETES MELLITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HALCION</medicinalproduct>
        <drugauthorizationnumb>17892</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050135-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060626</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006081930</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BREAST CANCER</reactionmeddrapt>
      </reaction>
      <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>PREMARIN</medicinalproduct>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMPRO</medicinalproduct>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050138-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060623</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2005141755</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>69</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>113.3993</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIOVASCULAR DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUROLOGICAL SYMPTOM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugauthorizationnumb>20998</drugauthorizationnumb>
        <drugdosagetext>400 MG (200 MG, 2 IN 1 D),</drugdosagetext>
        <drugindication>ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050122</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugauthorizationnumb>20998</drugauthorizationnumb>
        <drugdosagetext>400 MG (200 MG, 2 IN 1 D),</drugdosagetext>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050122</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050139-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2006AT09711</companynumb>
    <primarysource>
      <reportercountry>AUSTRIA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>81</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>BONE DEBRIDEMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FISTULA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMPAIRED HEALING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOMYELITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PURULENT DISCHARGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SURGERY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTH EXTRACTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AREDIA</medicinalproduct>
        <drugauthorizationnumb>20036</drugauthorizationnumb>
        <drugdosagetext>120 MG, QN</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990419</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030107</drugenddate>
        <drugtreatmentduration>1360</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
        <drugdosagetext>5 MG/D</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050141-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060623</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006077582</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>84</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAL DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSGEUSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FACIAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENITAL PRURITUS FEMALE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GLOSSODYNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL INTAKE REDUCED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS ANI</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RED BLOOD CELL COUNT ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STOMATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VAGINAL BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUTENT</medicinalproduct>
        <drugauthorizationnumb>21968</drugauthorizationnumb>
        <drugdosagetext>25 MG (25 MG, DAILY), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RENAL CELL CARCINOMA STAGE UNSPECIFIED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060317</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NUTRITIONAL SUPPLEMENT (GENERAL NUTRIENTS)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTIHYPERTENSIVES (ANTIHYPERTENSIVES)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050143-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060623</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006079948</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>50</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>108.4097</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>AMNESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL ACUITY REDUCED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEXTRA</medicinalproduct>
        <drugauthorizationnumb>21341</drugauthorizationnumb>
        <drugdosagetext>(1 IN 1 D)</drugdosagetext>
        <drugindication>ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEXTRA</medicinalproduct>
        <drugauthorizationnumb>21341</drugauthorizationnumb>
        <drugdosagetext>(1 IN 1 D)</drugdosagetext>
        <drugindication>CARPAL TUNNEL SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041201</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050144-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060623</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006080041</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>59</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>81.6475</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY BYPASS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART VALVE REPLACEMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugauthorizationnumb>20998</drugauthorizationnumb>
        <drugdosagetext>200 MG (200 MG, 1 IN 1 D),</drugdosagetext>
        <drugindication>OSTEOARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050145-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060626</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006080668</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CHILLS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EFFECT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NERVOUS SYSTEM DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
        <drugauthorizationnumb>19839</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050146-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060707</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHRM2006FR02022</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AREDIA</medicinalproduct>
        <drugauthorizationnumb>020036</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050147-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060420</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHRM2006FR01380</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>59</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD CREATININE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOCALISED OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL TUBULAR DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPECIAFOLDINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FONZYLANE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAHOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EZETROL</medicinalproduct>
        <drugindication>HYPERCHOLESTEROLAEMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASILIX</medicinalproduct>
        <drugdosagetext>125 MG PER DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELLCEPT</medicinalproduct>
        <drugdosagetext>1 G, BID</drugdosagetext>
        <drugindication>RENAL TRANSPLANT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CORTANCYL</medicinalproduct>
        <drugdosagetext>10 MG DAILY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROGRAF</medicinalproduct>
        <drugdosagetext>6 MG DAILY</drugdosagetext>
        <drugindication>RENAL TRANSPLANT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN B-12</medicinalproduct>
        <drugdosagetext>1 DF, QW</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIPARINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN MIXTARD</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OGAST</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EPINEPHRINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AREDIA</medicinalproduct>
        <drugauthorizationnumb>020036</drugauthorizationnumb>
        <drugdosagetext>30 MG, ONCE/SINGLE</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>HYPERCALCAEMIA OF MALIGNANCY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060415</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060415</drugenddate>
        <drugtreatmentduration>1440</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050149-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060627</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006081389</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BREAST CANCER FEMALE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>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>20000401</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>19870101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20000401</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19870101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20000401</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMPHASE (PREMARIN;CYCRIN 14/14)</medicinalproduct>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19870101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20000401</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050152-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
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      <reportercountry>UNITED STATES</reportercountry>
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    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BREAST CANCER</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROVERA</medicinalproduct>
        <drugauthorizationnumb>11839</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
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        <drugstartdate>19880101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19990901</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>19880101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19990901</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19880101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19990901</drugenddate>
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    <safetyreportid>5050153-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
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      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
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    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BREAST CANCER</reactionmeddrapt>
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      <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>19880101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20001101</drugenddate>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MEDROXYPROGESTERONE ACETATE</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19880101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20001101</drugenddate>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19880101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20001101</drugenddate>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMPRO</medicinalproduct>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19880101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20001101</drugenddate>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMPHASE (PREMARIN;CYCRIN 14/14)</medicinalproduct>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19880101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20001101</drugenddate>
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    <transmissiondate>20061208</transmissiondate>
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    <seriousnessother>1</seriousnessother>
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    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
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      <reportercountry>UNITED STATES</reportercountry>
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    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HYSTERECTOMY</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>OVARIAN CANCER</reactionmeddrapt>
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      <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>19910301</drugenddate>
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      <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>19910301</drugenddate>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19800101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19910301</drugenddate>
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    </patient>
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  <safetyreport>
    <safetyreportid>5050167-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
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      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
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    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BREAST CANCER</reactionmeddrapt>
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      <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>19940901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19970101</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>19940901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19970101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19940901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19970101</drugenddate>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMPRO</medicinalproduct>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19940901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19970101</drugenddate>
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    </patient>
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  <safetyreport>
    <safetyreportid>5050169-3</safetyreportid>
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    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
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    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
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      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BREAST CANCER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROVERA</medicinalproduct>
        <drugauthorizationnumb>11839</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010401</drugenddate>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MEDROXYPROGESTERONE ACETATE</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010401</drugenddate>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010401</drugenddate>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMPRO</medicinalproduct>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010401</drugenddate>
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    </patient>
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  <safetyreport>
    <safetyreportid>5050173-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
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    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
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    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BREAST CANCER</reactionmeddrapt>
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      <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>19980101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20000901</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMPRO</medicinalproduct>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20000901</drugenddate>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMPHASE (PREMARIN;CYCRIN 14/14)</medicinalproduct>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20000901</drugenddate>
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    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050175-9</safetyreportid>
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    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
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    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
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      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
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    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BREAST CANCER</reactionmeddrapt>
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      <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>19970401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19980801</drugenddate>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19970401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19980801</drugenddate>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMPRO</medicinalproduct>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19970401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19980801</drugenddate>
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    </patient>
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    <safetyreportid>5050180-2</safetyreportid>
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    <transmissiondate>20061208</transmissiondate>
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    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
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    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060701</receiptdate>
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    <companynumb>GB-SOLVAY-00206002158</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>3</qualification>
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    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <patientonsetage>69</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>60</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>METABOLIC ACIDOSIS</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACARBOSE</medicinalproduct>
        <drugdosagetext>DAILY DOSE:  UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COVERSYL</medicinalproduct>
        <drugauthorizationnumb>020184</drugauthorizationnumb>
        <drugdosagetext>DAILY DOSE:  UNKNOWN</drugdosagetext>
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        <drugindication>DIABETIC NEPHROPATHY</drugindication>
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        <drugenddate>20060208</drugenddate>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCICHEW</medicinalproduct>
        <drugdosagetext>DAILY DOSE:  UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
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        <drugdosagetext>DAILY DOSE:  UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS NON-INSULIN-DEPENDENT</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060208</drugenddate>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FERROUS SULFATE TAB</medicinalproduct>
        <drugdosagetext>DAILY DOSE:  UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
        <drugdosagetext>DAILY DOSE:  UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLICLAZIDE</medicinalproduct>
        <drugdosagetext>DAILY DOSE:  UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
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    <safetyreportid>5050192-9</safetyreportid>
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    <receiptdate>20060705</receiptdate>
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      <reportercountry>FRANCE</reportercountry>
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    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <patientonsetage>57</patientonsetage>
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        <reactionmeddrapt>ACUTE PULMONARY OEDEMA</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>HYPERTROPHIC CARDIOMYOPATHY</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>LARYNGEAL CANCER</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
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        <drugstartdate>20050615</drugstartdate>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RIVOTRIL</medicinalproduct>
        <drugdosagetext>5 DF, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050615</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VASOBRAL</medicinalproduct>
        <drugdosagetext>11 DF, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040615</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COPAXONE</medicinalproduct>
        <drugdosagetext>20 MG, QD</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040615</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050193-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2006JP09844</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>49</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PNEUMOMEDIASTINUM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugdosagetext>25 MG/D</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOSPORINE</medicinalproduct>
        <drugauthorizationnumb>050574</drugauthorizationnumb>
        <drugdosagetext>100 MG/D</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DERMATOMYOSITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050194-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2006JP09843</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>52</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PNEUMOMEDIASTINUM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOSPORINE</medicinalproduct>
        <drugauthorizationnumb>050574</drugauthorizationnumb>
        <drugdosagetext>150 MG/D</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>POLYMYOSITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugdosagetext>50 MG/D</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>POLYMYOSITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050202-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20020521</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-11870003</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>43</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>95</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ILLOGICAL THINKING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENTAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROLIXIN DECANOATE</medicinalproduct>
        <drugauthorizationnumb>16727</drugauthorizationnumb>
        <drugdosagetext>DOSAGE DECREASED FROM 25MG/WK TO 12.5MG/WK ^2 MONTHS AGO^</drugdosagetext>
        <drugindication>SCHIZOPHRENIA</drugindication>
        <drugtreatmentduration>24</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RISPERDAL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
        <drugdosagetext>FOR A SHORT TIME</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COGENTIN</medicinalproduct>
        <drugdosagetext>^FOR MANY YEARS^</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050210-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050615</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-13011804</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>57</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>59</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SINEMET CR</medicinalproduct>
        <drugauthorizationnumb>19856</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PARKINSON'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19930101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ELDEPRYL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PARKINSON'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19930101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050211-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050816</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-13078647</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>65</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SINEMET CR</medicinalproduct>
        <drugauthorizationnumb>019856</drugauthorizationnumb>
        <drugindication>PARKINSON'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040517</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REQUIP</medicinalproduct>
        <drugdosagetext>DURATION OF THERAPY:  ^YEARS^</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DYAZIDE</medicinalproduct>
        <drugdosagetext>DOSE VALUE:  37.5/25.  DURATION OF THERAPY:  ^YEARS^</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELEXA</medicinalproduct>
        <drugdosagetext>DURATION OF THERAPY:  ^YEARS^</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050212-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050823</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-13092598</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>AGITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESTLESSNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SINEMET</medicinalproduct>
        <drugauthorizationnumb>019856</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RESTLESS LEGS SYNDROME</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050213-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050907</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-13102603</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SINEMET CR</medicinalproduct>
        <drugauthorizationnumb>019856</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050214-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050928</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-13125653</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HALLUCINATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARANOIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SINEMET CR</medicinalproduct>
        <drugauthorizationnumb>019856</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PARKINSONISM</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSPRA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COZAAR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACTONEL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050215-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20051004</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-13131354</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>55</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>91</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANAL DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAINFUL DEFAECATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SINEMET CR</medicinalproduct>
        <drugauthorizationnumb>019856</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050901</drugstartdate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUOXETINE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONAZEPAM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050216-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20051103</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-13168430</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SINEMET CR</medicinalproduct>
        <drugauthorizationnumb>019856</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050217-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20051206</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-13205919</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>74</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>73</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SINEMET</medicinalproduct>
        <drugauthorizationnumb>019856</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PARKINSON'S DISEASE</drugindication>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVAPRO</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050218-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060126</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-13260914</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>66</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DYSKINESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARBIDOPA + LEVODOPA CR TABS 50/200MG</medicinalproduct>
        <drugauthorizationnumb>19856</drugauthorizationnumb>
        <drugdosagetext>CARBIDOPA/LEVODOPA: TOOK 50/200 CR FOR 1 WEEK IN NOV 2005; RESTARTED ON SAME DOSE 01-JAN-06-ONGOING.</drugdosagetext>
        <drugindication>PARKINSON'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMTAN</medicinalproduct>
        <drugdosagetext>COMTAN: 200MG TABLET TID FROM 4/05 TO 11/05; STOPPED FOR 1 WEEK, THEN RESTARTED 11/05 TO 12/31/05</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PARKINSON'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051231</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050219-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060228</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-13298872</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>69</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>54</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HALLUCINATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SINEMET</medicinalproduct>
        <drugauthorizationnumb>019856</drugauthorizationnumb>
        <drugindication>PARKINSON'S DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MIRAPEX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050220-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060531</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-13397070</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMATOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SINEMET CR</medicinalproduct>
        <drugauthorizationnumb>019856</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PARKINSON'S DISEASE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050221-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060615</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHO2006VE09870</companynumb>
    <primarysource>
      <reportercountry>VENEZUELA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>39</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>42</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTESTINAL OBSTRUCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEORAL</medicinalproduct>
        <drugauthorizationnumb>050715</drugauthorizationnumb>
        <drugdosagetext>150 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>TRANSPLANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980221</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METICORTEN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980221</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMURAN</medicinalproduct>
        <drugdosagetext>50 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980221</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050222-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050616</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2005AC00914</companynumb>
    <primarysource>
      <reportercountry>NETHERLANDS</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>21168</patientonsetage>
      <patientonsetageunit>804</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>UTERINE POLYP</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VAGINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARIMIDEX</medicinalproduct>
        <drugauthorizationnumb>020541</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19981213</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030122</drugenddate>
        <drugtreatmentduration>1502</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050229-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060606</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-AVENTIS-200612037FR</companynumb>
    <primarysource></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>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VASCULAR PURPURA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BIRODOGYL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GINGIVITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060410</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060411</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050230-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060704</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHO2006DE10802</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>61</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>80</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>LIFE SUPPORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUROLOGICAL SYMPTOM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOSPORINE</medicinalproduct>
        <drugauthorizationnumb>050573</drugauthorizationnumb>
        <drugdosagetext>200 MG, BID</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>LIVER TRANSPLANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060610</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050245-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060705</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-06P-163-0337432-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>81.72</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRICOR</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021656</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CARDIAC DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19920101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060630</drugenddate>
        <drugtreatmentduration>14</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLIPIZIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19920101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATORVASTATIN CALCIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19920101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OBETROL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19920101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19920101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE BESYLATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19920101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050249-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060621</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AVENTIS-200616580GDDC</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>10</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>33</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD ALKALINE PHOSPHATASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ECCHYMOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEAD INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOGLYCAEMIC SEIZURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POST CONCUSSION SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>APIDRA</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugdosagetext>DOSE UNIT: UNITS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>DIABETES MELLITUS INSULIN-DEPENDENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060405</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AUTOPEN INSULIN INJECTION PEN</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060405</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
        <drugbatchnumb>1E552</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>DIABETES MELLITUS INSULIN-DEPENDENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060405</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OPTIPEN (INSULIN PUMP)</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060405</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050253-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060703</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHO2006EC10795</companynumb>
    <primarysource>
      <reportercountry>ECUADOR</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>50</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CONJUNCTIVAL HYPERAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRY MOUTH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRY SKIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS GENERALISED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN EXFOLIATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GLEEVEC</medicinalproduct>
        <drugauthorizationnumb>021588</drugauthorizationnumb>
        <drugdosagetext>600 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CHRONIC MYELOID LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GLEEVEC</medicinalproduct>
        <drugauthorizationnumb>021588</drugauthorizationnumb>
        <drugdosagetext>300 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051010</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060630</drugenddate>
        <drugtreatmentduration>264</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050254-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060704</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2006TR09935</companynumb>
    <primarysource>
      <reportercountry>TURKEY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>GASTRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEPHROTIC SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GLEEVEC</medicinalproduct>
        <drugauthorizationnumb>021588</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTROINTESTINAL STROMAL TUMOUR</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050255-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060706</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>SE-ABBOTT-06P-150-0337665-00</companynumb>
    <primarysource>
      <reportercountry>SWEDEN</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>42</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050913</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN W/ CODEINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NAPROXEN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050256-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060707</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0611396A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>78</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CITRUCEL SUGAR-FREE SUSPENSION ORANGE</medicinalproduct>
        <drugbatchnumb>05M050</drugbatchnumb>
        <drugdosagetext>1TSP IN THE MORNING</drugdosagetext>
        <drugindication>GASTROINTESTINAL DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19910101</drugstartdate>
        <drugtreatmentduration>15</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE TAB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN E</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM WITH VITAMIN D</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VISION FORMULA</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050257-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060711</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0611760A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>RECTAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CITRUCEL SUGAR-FREE SUSPENSION ORANGE</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050258-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060708</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-GLAXOSMITHKLINE-A0611862A</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>43</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NERVOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALLOR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIQUITIN</medicinalproduct>
        <drugauthorizationnumb>20165</drugauthorizationnumb>
        <drugdosagetext>21MG UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>SMOKING CESSATION THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060708</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PAROXETINE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GINKO BILOBA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VERTIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORAX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050259-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060626</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006US001397</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>15</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>KIDNEY TRANSPLANT REJECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POLYOMAVIRUS-ASSOCIATED NEPHROPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROGRAF</medicinalproduct>
        <drugauthorizationnumb>50708</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS AGAINST TRANSPLANT REJECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MYCOPHENOLATE SODIUM (MYCOPHENOLATE SODIUM)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZENAPAX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050260-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060531</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2006NL08144</companynumb>
    <primarysource>
      <reportercountry>NETHERLANDS</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>77</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>60</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BRADYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNAPAUSE E3</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXELON</medicinalproduct>
        <drugauthorizationnumb>020823</drugauthorizationnumb>
        <drugdosagetext>3 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HALLUCINATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060425</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060531</drugenddate>
        <drugtreatmentduration>53280</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
        <drugdosagetext>25 MG, BID</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SOLIFENACIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050262-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060626</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006US001393</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>19</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BK VIRUS INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CREATININE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POLYOMAVIRUS-ASSOCIATED NEPHROPATHY</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>20060401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MYCOPHENOLATE MOFETIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE TAB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZENAPAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYCLOSPORINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050263-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060627</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006JP000375</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>82</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JOINT SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NASOPHARYNGITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OXYGEN SATURATION DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMOCYSTIS JIROVECI PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA BACTERIAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TACROLIMUS CAPSULES (TACROLIMUS CAPSULES)</medicinalproduct>
        <drugauthorizationnumb>50708</drugauthorizationnumb>
        <drugdosagetext>1.5 MG, UID/QD, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051111</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060215</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RHEUMATREX</medicinalproduct>
        <drugdosagetext>8 MG, WEEKLY, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060215</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugdosagetext>5 MG, UID/QD, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060214</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugdosagetext>5 MG, UID/QD, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060215</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MUCOSTA (REBAMIPIDE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MOBIC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RISEDRONATE SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HEAVY KAMA G (MAGNESIUM OXIDE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALBLOCK</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OLMETEC (OLMESARTAN MEDOXOMIL)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BISOPROLOL FUMARATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIGMART (NOCORANDIL)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALDACTONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIVALO (PITAVASTATIN CALCIUM)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050265-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>HQWYE513330JUN06</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ARTHRITIS BACTERIAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSED LEVEL OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEVICE RELATED INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STAPHYLOCOCCAL INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050808</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SULFASALAZINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BUCILLAMINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050266-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060113</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-AMGEN-UK164916</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANTI-ERYTHROPOIETIN ANTIBODY POSITIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>APLASIA PURE RED CELL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THERAPY NON-RESPONDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARANESP</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RENAL FAILURE CHRONIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050418</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051213</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROPAFENONE HCL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ISOSORBIDE MONONITRATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALFUZOSIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RED BLOOD CELLS</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050501</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050267-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060525</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BEWYE657429MAY06</companynumb>
    <primarysource>
      <reportercountry>BELGIUM</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>GUTTATE PSORIASIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PSORIASIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050268-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-US165417</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>79.9</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>METASTASES TO BONE MARROW</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOSITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DARBEPOETIN ALFA</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugauthorizationnumb>8223</drugauthorizationnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>ANAEMIA OF MALIGNANT DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051221</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051221</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VYTORIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEULASTA</medicinalproduct>
        <drugauthorizationnumb>008223</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>CHEMOTHERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADRIAMYCIN PFS</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYTOXAN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAXOTERE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DECADRON</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALOXI</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INFLUENZA VACCINE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050269-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-US184736</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RECTAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN DISCOLOURATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARANESP</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugindication>ANAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INTRON A</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050270-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060704</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>LT-JNJFOC-20060604428</companynumb>
    <primarysource>
      <reportercountry>LITHUANIA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CHRONIC MYELOID LEUKAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugdosagetext>8 INFUSIONS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ANKYLOSING SPONDYLITIS</drugindication>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHYLPREDNISOLONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANKYLOSING SPONDYLITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050301</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELECOXIB</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANKYLOSING SPONDYLITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050301</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MELOXICAM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANKYLOSING SPONDYLITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050301</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANKYLOSING SPONDYLITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050301</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANKYLOSING SPONDYLITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050301</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050271-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060630</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-STX184957</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>KNEE ARTHROPLASTY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>KNEE OPERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PATELLA FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POST PROCEDURAL COMPLICATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>P047082</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050401</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050272-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060703</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-US185200</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>WEGENER'S GRANULOMATOSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031110</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050273-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>HK-GILEAD-2006-0009805</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>21</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ALANINE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATITIS B</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POOR QUALITY DRUG ADMINISTERED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPSERA</medicinalproduct>
        <drugbatchnumb>TEP022</drugbatchnumb>
        <drugauthorizationnumb>21449</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS B</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060301</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050274-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041027</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GILEAD-2004-0007666</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>3.133</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ALANINE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAEMIA MACROCYTIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASPARTATE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD AMYLASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CREATINE PHOSPHOKINASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD POTASSIUM INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD URIC ACID INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOLYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPHIL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TENOFOVIR DISOPROXIL FUMARATE</medicinalproduct>
        <drugauthorizationnumb>21356</drugauthorizationnumb>
        <drugadministrationroute>064</drugadministrationroute>
        <drugindication>PROPHYLAXIS AGAINST HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040924</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040924</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AZT</medicinalproduct>
        <drugadministrationroute>064</drugadministrationroute>
        <drugindication>PROPHYLAXIS AGAINST HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040924</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040924</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AZT</medicinalproduct>
        <drugadministrationroute>064</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040924</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040924</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZIAGEN</medicinalproduct>
        <drugadministrationroute>064</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040602</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040923</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VIRAMUNE</medicinalproduct>
        <drugadministrationroute>064</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040602</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040923</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COMBIVIR</medicinalproduct>
        <drugadministrationroute>064</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040602</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040923</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050275-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006-04-0387</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>57</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>99</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>COLON CANCER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIRAFERON MULTIDOSE PEN (INTERFERON ALFA-2B)</medicinalproduct>
        <drugauthorizationnumb>20903</drugauthorizationnumb>
        <drugdosagetext>3 MU TIW SUBCUTANEOUS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19981101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19991101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBETOL</medicinalproduct>
        <drugdosagetext>600 MG BD ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19981101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19991101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050276-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2005-12-1063</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>60</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE NECROSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEG-INTRON</medicinalproduct>
        <drugdosagetext>100 MCG QW SUBCUTANEOUS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050615</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBETOL</medicinalproduct>
        <drugdosagetext>200 MG ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050615</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050277-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060623</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DEU-2006-0002275</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>62</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>61</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>EPISTAXIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXY CR TAB 10 MG (OXY CR TAB 10 MG) (OXYCODONE HYDROCHLORIDE) PROLONGE</medicinalproduct>
        <drugauthorizationnumb>20553</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MORPHINE SULFATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050278-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060529</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ES-AMGEN-UK181077</companynumb>
    <primarysource>
      <reportercountry>SPAIN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>75</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FACIAL PALSY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEUPOGEN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PERIPHERAL BLOOD STEM CELL APHERESIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060428</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060529</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050279-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060707</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006CG01218</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>846</patientonsetage>
      <patientonsetageunit>802</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>TENDON RUPTURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugauthorizationnumb>21366</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERCHOLESTEROLAEMIA</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060609</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATACAND</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEPAKOTE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ESIDRIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOXAPAC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORMISON</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIVARIUS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SERESTA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SULFARLEM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050280-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060705</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006CG01155</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>26</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORTHOSTATIC HYPOTENSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ATACAND</medicinalproduct>
        <drugauthorizationnumb>020838</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ESSENTIAL HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051216</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051226</drugenddate>
        <drugtreatmentduration>11</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRAZEPAM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DYSTHYMIC DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANOS</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050281-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060622</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DEU-2006-0002296</companynumb>
    <primarysource>
      <reportercountry>SLOVAKIA (Slovak Republic)</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>53</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>74</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CHOLECYSTITIS ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHOLELITHIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPEPSIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXYCODONE HCL/NALOXONE HCL CR TAB/2010MG (NALOXONE HYDROCHLORIDE, OXYC</medicinalproduct>
        <drugauthorizationnumb>20553</drugauthorizationnumb>
        <drugdosagetext>20 MG, BID, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BACK PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060307</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060603</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DICLOBENE (DICLOFENAC SODIUM)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALTRATE (CALCIUM CARBONATE)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050282-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060504</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-AMGEN-UK178594</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>3</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>13</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD CREATININE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CYSTITIS HAEMORRHAGIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROTEINURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL TUBULAR DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEUPOGEN</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>CHEMOTHERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051230</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060310</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ETOPOSIDE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051227</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060226</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CISPLATIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060106</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060216</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOPHOSPHAMIDE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060116</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060225</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VINCRISTINE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051227</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060310</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARBOPLATIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051227</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060206</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050283-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060630</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006AC01224</companynumb>
    <primarysource>
      <reportercountry>NETHERLANDS</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>15949</patientonsetage>
      <patientonsetageunit>804</patientonsetageunit>
      <patientweight>87</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>CARDIAC ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NASAL CONGESTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugauthorizationnumb>21366</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERCHOLESTEROLAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050801</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASCAL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THYRAX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPOTHYROIDISM</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AERIUS</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060620</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050284-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060619</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006SE03455</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>27684</patientonsetage>
      <patientonsetageunit>804</patientonsetageunit>
      <patientweight>64</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>AMMONIA INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG DOSE OMISSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BLOPRESS TABLETS 8</medicinalproduct>
        <drugauthorizationnumb>20838</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060407</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060519</drugenddate>
        <drugtreatmentduration>43</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYPOCA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19921029</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPOVAS</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERLIPIDAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19950811</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050285-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060526</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-US180951</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>72.6</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IRON DEFICIENCY ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WOUND</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EPOGEN</medicinalproduct>
        <drugbatchnumb>P057695</drugbatchnumb>
        <drugindication>DIALYSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RENAGEL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060512</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATACAND</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN ENTERIC COATED K.P.</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060512</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONIDINE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060512</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060512</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREVACID</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060512</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COZAAR</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DILANTIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060106</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCODONE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060106</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SENSIPAR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060106</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060501</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>QUININE SULFATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060106</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050286-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>T05-JPN-04481-01</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>80</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>56.7</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CARPAL TUNNEL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISEASE RECURRENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPHADENOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERIARTHRITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MEMANTINE HCL</medicinalproduct>
        <drugauthorizationnumb>21487</drugauthorizationnumb>
        <drugdosagetext>20 MG QD PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEMENTIA ALZHEIMER'S TYPE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050623</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051026</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MEMANTINE HCL</medicinalproduct>
        <drugindication>DEMENTIA ALZHEIMER'S TYPE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050428</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050622</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LATANOPROST</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DORZOLAMIDE HYDROCHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TIMOLOL MATEATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOXOPROFEN SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TERPRENONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MECOBALAMIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050287-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060622</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>S06-CAN-02645-01</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>RHINITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MEMANTINE HCL</medicinalproduct>
        <drugauthorizationnumb>21487</drugauthorizationnumb>
        <drugdosagetext>10 MG QD PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARICEPT</medicinalproduct>
        <drugdosagetext>10 MG QD PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>QUININE SULFATE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050288-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060627</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006-DE-02854GD</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>75</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HEPATIC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CITALOPRAM HYDROBROMIDE</medicinalproduct>
        <drugauthorizationnumb>77041</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050289-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060710</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-AVENTIS-200612444FR</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>56</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>78</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD CREATININE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLAGYL</medicinalproduct>
        <drugauthorizationnumb>20743</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>EXTRADURAL ABSCESS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060524</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060602</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLAGYL</medicinalproduct>
        <drugauthorizationnumb>020743</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>STREPTOCOCCAL INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060524</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060602</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLAMOXYL</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>EXTRADURAL ABSCESS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060523</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060605</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLAMOXYL</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>STREPTOCOCCAL INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060523</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060605</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPALGIC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050290-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060426</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-AVENTIS-200611591FR</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>71</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BONE MARROW FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCYTOPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KETEK</medicinalproduct>
        <drugauthorizationnumb>21144</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PNEUMONIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060401</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050291-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060223</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AVENTIS-200611791US</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>16</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLINDNESS TRANSIENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISION BLURRED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL DISTURBANCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KETEK</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>21144</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>UPPER RESPIRATORY TRACT INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060203</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060203</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADVAIR DISKUS 100/50</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
        <drugindication>ASTHMA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050292-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AVENTIS-200610704US</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MACULAR OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RETINAL OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RETINOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISION BLURRED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL ACUITY REDUCED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KETEK</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>21144</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SINUSITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051228</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KETEK</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021144</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>COUGH</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051228</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050293-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060705</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-AVENTIS-200617023GDDC</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HEPATIC FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLAFORAN</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>050547</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CEFTAZIDIME</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050294-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060704</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-AVENTIS-200612400FR</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <patientonsetage>50</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>LEUKOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPHOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RIFADIN</medicinalproduct>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060331</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LOVENOX</medicinalproduct>
        <drugauthorizationnumb>020164</drugauthorizationnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060331</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CIFLOX</medicinalproduct>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060331</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COLCHICINE</medicinalproduct>
        <drugindication>GOUT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060303</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060318</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050295-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060630</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-AMGEN-UK185032</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>55</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANTI-ERYTHROPOIETIN ANTIBODY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARANESP</medicinalproduct>
        <drugbatchnumb>N1052AL,N0929AD,N1066AL</drugbatchnumb>
        <drugadministrationroute>040</drugadministrationroute>
        <drugindication>RENAL FAILURE CHRONIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041127</drugstartdate>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN ACTRAPID HUMAN</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DREISAVIT</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SODIUM POLYSTYRENE SULFONATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARVEDILOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM GLUCONATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DESFERAL</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060624</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050296-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060630</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-US184905</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ATRIAL FIBRILLATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE MARROW FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERKALAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERPLASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EPOGEN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DIALYSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMIODARONE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RENAGEL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMITRIPTYLINE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REGLAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DARVOCET</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEPHROCAPS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZINC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>QUININE SULFATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROTONIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEGACE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050297-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060601</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-US178081</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANTI-ERYTHROPOIETIN ANTIBODY POSITIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEUKOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THERAPEUTIC RESPONSE DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARANESP</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RENAL FAILURE CHRONIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060401</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMURAN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19890101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYCLOSPORINE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19890101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE TAB</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19890101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IRON</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050298-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060627</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006-DE-02855GD</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>92</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ATRIAL FIBRILLATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRADYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENTRICULAR FIBRILLATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIGOXIN</medicinalproduct>
        <drugauthorizationnumb>21648</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050299-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060626</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006-DE-03254GD</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>INSULIN-REQUIRING TYPE II DIABETES MELLITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METABOLIC SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
        <drugauthorizationnumb>88587</drugauthorizationnumb>
        <drugindication>HYPERTENSION</drugindication>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050300-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060627</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006-DE-02846GD</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>76</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MYOCLONUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LITHIUM CARBONATE</medicinalproduct>
        <drugauthorizationnumb>17812</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050301-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060627</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006-DE-02849GD</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>47</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CEREBRAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COORDINATION ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOXIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LITHIUM CARBONATE</medicinalproduct>
        <drugauthorizationnumb>17812</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050302-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060627</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006-DE-02848GD</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>64</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PANCYTOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STOMATITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugauthorizationnumb>40054</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050303-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060704</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006CG01154</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>17</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD IRON DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD IRON INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDE ATTEMPT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMIG</medicinalproduct>
        <drugauthorizationnumb>20768</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TARDYFERON</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MAGNE B6</medicinalproduct>
        <drugdosagetext>THREE BLISTERS ONCE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PERIDYS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050304-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060706</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006UW14191</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <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>DIABETIC COMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIABETIC KETOACIDOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCREATITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugauthorizationnumb>020639</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050305-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060605</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006CG01201</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>32</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD CHROMOGRANIN A INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LABILE HYPERTENSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MOPRAL</medicinalproduct>
        <drugauthorizationnumb>19810</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DUODENAL ULCER</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MOPRAL</medicinalproduct>
        <drugauthorizationnumb>019810</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ABDOMINAL PAIN UPPER</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MOPRAL</medicinalproduct>
        <drugauthorizationnumb>019810</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DYSPEPSIA</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LANSOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DUODENAL ULCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040501</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LANSOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ABDOMINAL PAIN UPPER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040501</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LANSOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DYSPEPSIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040501</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050306-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060626</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>007892</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>50</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BREAST CANCER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MEDROXYPROGESTERONE ACETATE</medicinalproduct>
        <drugauthorizationnumb>40159</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19940101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMPRO</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19940101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19940101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROVERA</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19940101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050307-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060619</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006PV015874</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>82</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>90.7194</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCORRECT DOSE ADMINISTERED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BYETTA</medicinalproduct>
        <drugauthorizationnumb>21773</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE, SC</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>DIABETES MELLITUS NON-INSULIN-DEPENDENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060611</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BYETTA</medicinalproduct>
        <drugauthorizationnumb>21773</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE, SC</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>DIABETES MELLITUS NON-INSULIN-DEPENDENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060612</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INSULIN</medicinalproduct>
        <drugdosagetext>SEE IMAGE,</drugdosagetext>
        <drugindication>DIABETES MELLITUS NON-INSULIN-DEPENDENT</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INSULIN</medicinalproduct>
        <drugdosagetext>SEE IMAGE,</drugdosagetext>
        <drugindication>DIABETES MELLITUS NON-INSULIN-DEPENDENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACTOS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMARYL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050309-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060619</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006PV015468</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>60</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BYETTA</medicinalproduct>
        <drugauthorizationnumb>21773</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE, SC</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>DIABETES MELLITUS NON-INSULIN-DEPENDENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050610</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050711</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BYETTA</medicinalproduct>
        <drugauthorizationnumb>21773</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE, SC</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>DIABETES MELLITUS NON-INSULIN-DEPENDENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050711</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BYETTA</medicinalproduct>
        <drugauthorizationnumb>21773</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE, SC</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>DIABETES MELLITUS NON-INSULIN-DEPENDENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060406</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050311-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060619</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006PV014908</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>78</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>77.1115</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BYETTA</medicinalproduct>
        <drugbatchnumb>9RY71M</drugbatchnumb>
        <drugauthorizationnumb>21773</drugauthorizationnumb>
        <drugdosagetext>5 MCG; BID; SC</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>DIABETES MELLITUS NON-INSULIN-DEPENDENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060601</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMULIN N</medicinalproduct>
        <drugdosagetext>35 IU; PRN; SC</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>DIABETES MELLITUS NON-INSULIN-DEPENDENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMALOG</medicinalproduct>
        <drugdosagetext>6 IU; TID; SC</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>DIABETES MELLITUS NON-INSULIN-DEPENDENT</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060531</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENALAPRIL MALEATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZETIA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPAMAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050312-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060619</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006PV012588</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>54</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>121.1104</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY OCCLUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY STENOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DILATATION ATRIAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EJECTION FRACTION DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EPIGASTRIC DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BYETTA</medicinalproduct>
        <drugauthorizationnumb>21773</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE, SC</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>DIABETES MELLITUS NON-INSULIN-DEPENDENT</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOPHAGE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACTOPLUS MET</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTIVITAMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRICOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VIAGRA</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050314-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060621</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006PV015586</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>60</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>89.8122</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BACTERIAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CELLULITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COAGULOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DECREASED APPETITE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLUENZA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STAPHYLOCOCCAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BYETTA</medicinalproduct>
        <drugauthorizationnumb>21773</drugauthorizationnumb>
        <drugdosagetext>5 MCG; BID; SC</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>DIABETES MELLITUS NON-INSULIN-DEPENDENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051125</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060315</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BYETTA</medicinalproduct>
        <drugauthorizationnumb>21773</drugauthorizationnumb>
        <drugdosagetext>5 MCG; BID; SC</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>DIABETES MELLITUS NON-INSULIN-DEPENDENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060605</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOPHAGE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMARYL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANTOPRAZOLE SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>K-DUR 10</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EZETIMIBE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050316-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060620</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006PV016056</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>42</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>88.4514</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE URTICARIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYSTEMIC LUPUS ERYTHEMATOSUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BYETTA</medicinalproduct>
        <drugauthorizationnumb>21773</drugauthorizationnumb>
        <drugdosagetext>5 MCG; BID; SC</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>DIABETES MELLITUS NON-INSULIN-DEPENDENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060411</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050317-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060620</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006PV015973</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>66</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>86.1834</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD POTASSIUM DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EXCORIATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENTRICULAR TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BYETTA</medicinalproduct>
        <drugauthorizationnumb>21773</drugauthorizationnumb>
        <drugdosagetext>5 MCG; BID; SC</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>DIABETES MELLITUS NON-INSULIN-DEPENDENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLIMEPIRIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMIODARONE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRICOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ISOSORBIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOCLOPRAMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050318-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060621</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>R301632-315-USA</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>62</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>84</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ARTERIAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTERIAL STENOSIS LIMB</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISEASE PROGRESSION</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>DYSPEPSIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060406</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060420</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROXYZINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BUPROPION (BUPROPION)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GARLIC (GARLIC)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEGA 3 (FISH OIL)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN A</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN B COMPLEX (B-KOMPLEX  LECIVA)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASCORBIC ACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN E</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TUMS (CALCIUM CARBONATE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NIACIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050319-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060623</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>060109</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>56</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>71.6683</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NULYTELY</medicinalproduct>
        <drugauthorizationnumb>19797</drugauthorizationnumb>
        <drugdosagetext>APPROX. 2L, 1X, PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>COLONOSCOPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060514</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROTONIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THYROID TAB</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050320-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060705</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ZA-AVENTIS-200617103GDDC</companynumb>
    <primarysource>
      <reportercountry>SOUTH AFRICA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>COLLAPSE OF LUNG</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALIGNANT PLEURAL EFFUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLEURAL EFFUSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOCETAXEL</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>20449</drugauthorizationnumb>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050321-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060621</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AVENTIS-200616669GDDC</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>53</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>50.8</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CELLULITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISEASE PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPONATRAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SQUAMOUS CELL CARCINOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOCETAXEL</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>20449</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>SQUAMOUS CELL CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060607</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060607</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PLACEBO</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SQUAMOUS CELL CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060510</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060615</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PERCOCET-5</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugdosagetext>DOSE: FOUR TIMES DAILY PRN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050322-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060515</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-AVENTIS-200615228GDDC</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>67</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CATHETER SEPSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ENDOCARDITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GLOMERULONEPHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMODYNAMIC INSTABILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STAPHYLOCOCCAL SEPSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOCETAXEL</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>20449</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>GASTROOESOPHAGEAL CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060502</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060502</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CISPLATIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>GASTROOESOPHAGEAL CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060502</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060502</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUOROURACIL</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>GASTROOESOPHAGEAL CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060502</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORAZEPAM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE TAB</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050323-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060627</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006BH011490</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MORPHINE</medicinalproduct>
        <drugdosagetext>INTH</drugdosagetext>
        <drugadministrationroute>037</drugadministrationroute>
        <drugindication>PAIN</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050324-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060630</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>HQWYE575005JUL06</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>51</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>118.04</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG EFFECT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRIMATENE MIST</medicinalproduct>
        <drugauthorizationnumb>16126</drugauthorizationnumb>
        <drugdosagetext>1-2 PUFFS AS NEEDED, INHALATION  YEARS AGO</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRIMATENE MIST</medicinalproduct>
        <drugdosagetext>1 TABLET AS NEEDED, ORAL  YEARS AGO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050325-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060623</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>MC200600339</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>86</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY PERFORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROCEDURAL COMPLICATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ANGIOMAX</medicinalproduct>
        <drugauthorizationnumb>20873</drugauthorizationnumb>
        <drugdosagetext>0.75 MG/KG, BOLUS, IV BOLUS; 1.75 MG/KG, HR, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>040</drugadministrationroute>
        <drugindication>CORONARY ANGIOPLASTY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060525</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060525</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ANGIOMAX</medicinalproduct>
        <drugauthorizationnumb>20873</drugauthorizationnumb>
        <drugdosagetext>0.75 MG/KG, BOLUS, IV BOLUS; 1.75 MG/KG, HR, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>040</drugadministrationroute>
        <drugindication>CORONARY ANGIOPLASTY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060525</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060525</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050326-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060621</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>06-000569</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>18</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>68</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ODYNOPHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OESOPHAGEAL ULCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DORYX</medicinalproduct>
        <drugauthorizationnumb>50795</drugauthorizationnumb>
        <drugdosagetext>100 MG, TWICE DAILY, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ACNE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060515</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060619</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050327-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>007894</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BREAST CANCER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MEDROXYPROGESTERONE ACETATE</medicinalproduct>
        <drugauthorizationnumb>40159</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19890101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19991201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19890101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19991201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMPRO</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19890101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19991201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROVERA</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19890101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19991201</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050330-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060703</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CG-MERCK-0607USA00760</companynumb>
    <primarysource>
      <reportercountry>CONGO</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>23</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ADVERSE EVENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>STROMECTOL</medicinalproduct>
        <drugauthorizationnumb>050742</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060518</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060518</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050331-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060703</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0607USA00091</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>59</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VYTORIN</medicinalproduct>
        <drugauthorizationnumb>021687</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060501</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDRODIURIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050332-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060606</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-MERCK-0606USA02215</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>71</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD CREATINE PHOSPHOKINASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC FUNCTION ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLEURAL EFFUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEPCID</medicinalproduct>
        <drugauthorizationnumb>19510</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>GASTRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060526</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060530</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>JUVELA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CEREBRAL INFARCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEPCID RPD</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HOKUNALIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUTIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050333-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060703</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CG-MERCK-0607USA00743</companynumb>
    <primarysource>
      <reportercountry>CONGO</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>33</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ADVERSE EVENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>STROMECTOL</medicinalproduct>
        <drugauthorizationnumb>050742</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060520</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060520</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050334-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>007893</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BREAST CANCER FEMALE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MEDROXYPROGESTERONE ACETATE</medicinalproduct>
        <drugauthorizationnumb>40159</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19870101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20000401</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19870101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20000401</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMPHASE (PREMARIN;CYCRIN 14/14)</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19870101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20000401</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROVERA</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19870101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20000401</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050337-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060622</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>224091</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>64</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIABETES MELLITUS NON-INSULIN-DEPENDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIPLOPIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSSTASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GUILLAIN-BARRE SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NERVE ROOT LESION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEURITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUROPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARALYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAPARESIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSORIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUPRAVENTRICULAR EXTRASYSTOLES</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RAPTIVA</medicinalproduct>
        <drugdosagetext>0.9 , 1/WEEK</drugdosagetext>
        <drugindication>PSORIASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041221</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060313</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLIMEPIRIDE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050338-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200614367BWH</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>51</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANAPHYLACTIC REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ELECTROMECHANICAL DISSOCIATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POST PROCEDURAL COMPLICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VASCULAR BYPASS GRAFT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRASYLOL</medicinalproduct>
        <drugauthorizationnumb>20304</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>AORTIC VALVE REPAIR</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060629</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VANCOMYCIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CEFTRIAXONE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050339-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060626</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>163-20785-06040127</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>73</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ACUTE RESPIRATORY FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CHLORIDE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD FIBRINOGEN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRAIN MASS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARBON DIOXIDE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIOMEGALY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISEASE PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOPTYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HERPES ZOSTER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERCALCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERVERTEBRAL DISC PROTRUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LETHARGY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALIGNANT NEOPLASM PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METASTASES TO BONE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MONOCLONAL IMMUNOGLOBULIN PRESENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE MYELOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULAR WEAKNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NUCLEAR MAGNETIC RESONANCE IMAGING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OROPHARYNGEAL CANDIDIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLASMACYTOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLEURAL EFFUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROTHROMBIN TIME PROLONGED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE CHRONIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUS DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPINAL CORD COMPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPINAL CORD HERNIATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPINAL CORD OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STAPHYLOCOCCAL SEPSIS</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>THALOMID</medicinalproduct>
        <drugbatchnumb>0288X</drugbatchnumb>
        <drugauthorizationnumb>20785</drugauthorizationnumb>
        <drugdosagetext>200 - 300 MG, QD, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020208</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>THALOMID</medicinalproduct>
        <drugbatchnumb>0288X</drugbatchnumb>
        <drugauthorizationnumb>20785</drugauthorizationnumb>
        <drugdosagetext>200 - 300 MG, QD, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060307</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOXIL</medicinalproduct>
        <drugdosagetext>70 MG, DAILY, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060321</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060321</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VELCADE</medicinalproduct>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYCLOPHOSPHAMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUCONAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FENTANYL CITRATE (POULTICE OR PATCH)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SENNA (SENNA) (TABLETS)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANTOPRAZOLE SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HUMALOG</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL XL (TABLETS)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACTOPLUS MET</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CEFEPIME (CEFEPIME)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VANCOMYCIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOSYN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050341-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200612314GDS</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>56</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ACUTE RESPIRATORY DISTRESS SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ATRIAL FIBRILLATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE CONGESTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH GENERALISED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVELOX</medicinalproduct>
        <drugauthorizationnumb>21085</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SINUSITIS</drugindication>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
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    </patient>
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  <safetyreport>
    <safetyreportid>5050342-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060626</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
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      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <patientonsetage>50</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>50</patientweight>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
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      <reaction>
        <reactionmeddrapt>DISEASE PROGRESSION</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>THALOMID</medicinalproduct>
        <drugbatchnumb>0176A</drugbatchnumb>
        <drugauthorizationnumb>20785</drugauthorizationnumb>
        <drugdosagetext>1 IN 1 D, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030108</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060328</drugenddate>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugdosagetext>25 MG, DAILY, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060526</drugstartdate>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DECADRON</medicinalproduct>
        <drugdosagetext>[V.9.0]</drugdosagetext>
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    </patient>
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  <safetyreport>
    <safetyreportid>5050343-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060621</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
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    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
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    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <patientonsetage>9</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CHROMOSOME ABNORMALITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL CELL CARCINOMA STAGE UNSPECIFIED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARBOPLATIN</medicinalproduct>
        <drugauthorizationnumb>77269</drugauthorizationnumb>
        <drugindication>NEPHROBLASTOMA</drugindication>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ETOPOSIDE</medicinalproduct>
        <drugindication>NEPHROBLASTOMA</drugindication>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOPHOSPHAMIDE</medicinalproduct>
        <drugindication>NEPHROBLASTOMA</drugindication>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VINCRISTINE</medicinalproduct>
        <drugindication>NEPHROBLASTOMA</drugindication>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DACTINOMYCIN</medicinalproduct>
        <drugindication>NEPHROBLASTOMA</drugindication>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOXORUBICIN HCL</medicinalproduct>
        <drugindication>NEPHROBLASTOMA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050344-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060621</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
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    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
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    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <patientonsetage>39</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>120</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BILIARY DILATATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG TOXICITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FOOD POISONING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LORTAB</medicinalproduct>
        <drugauthorizationnumb>40100</drugauthorizationnumb>
        <drugdosagetext>30 MG 4/D PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN MANAGEMENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060119</drugenddate>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALVIMOPAN</medicinalproduct>
        <drugdosagetext>0.5 MG 1/D PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INTESTINAL FUNCTIONAL DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051026</drugstartdate>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
        <drugdosagetext>500 MG PRN PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19960101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060128</drugenddate>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SETRALINE HCL</medicinalproduct>
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    </patient>
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  <safetyreport>
    <safetyreportid>5050346-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
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    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>163-21880-06060902</companynumb>
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      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <patientonsetage>57</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
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        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
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      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugbatchnumb>0014A</drugbatchnumb>
        <drugauthorizationnumb>21880</drugauthorizationnumb>
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        <drugindication>MYELODYSPLASTIC SYNDROME</drugindication>
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        <drugstartdate>20060101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060201</drugenddate>
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  <safetyreport>
    <safetyreportid>5050347-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
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      <reportercountry>GERMANY</reportercountry>
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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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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CIPROFLOXACIN</medicinalproduct>
        <drugauthorizationnumb>19847</drugauthorizationnumb>
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  <safetyreport>
    <safetyreportid>5050348-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
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    <receivedateformat>102</receivedateformat>
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    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060623</receiptdate>
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      <reportercountry>UNITED STATES</reportercountry>
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    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <patientonsetage>66</patientonsetage>
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        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
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      <reaction>
        <reactionmeddrapt>DISEASE PROGRESSION</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>MYELODYSPLASTIC SYNDROME</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
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  <safetyreport>
    <safetyreportid>5050350-3</safetyreportid>
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      <reportercountry>UNITED STATES</reportercountry>
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    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
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        <patientdeathdate></patientdeathdate>
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      <reaction>
        <reactionmeddrapt>MALIGNANT NEOPLASM PROGRESSION</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>MULTIPLE MYELOMA</reactionmeddrapt>
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      <drug>
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        <drugindication>MULTIPLE MYELOMA</drugindication>
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        <drugstartdate>20030108</drugstartdate>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DECADRON</medicinalproduct>
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    <safetyreportid>5050352-7</safetyreportid>
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      <reportercountry>JAPAN</reportercountry>
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      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <patientonsetage>51</patientonsetage>
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        <reactionmeddrapt>RHABDOMYOLYSIS</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
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    <safetyreportid>5050354-0</safetyreportid>
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      <reportercountry>UNITED STATES</reportercountry>
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    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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      <reaction>
        <reactionmeddrapt>LYMPHOEDEMA</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>NERVE INJURY</reactionmeddrapt>
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        <drugstartdate>19961101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19970401</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ESTRADERM</medicinalproduct>
        <drugdosagetext>TRANSDERMAL</drugdosagetext>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19850101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19970501</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MEDROXYPROGESTERONE ACETATE</medicinalproduct>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19850101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19970401</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMPRO</medicinalproduct>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19970501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20011201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROVERA</medicinalproduct>
        <drugdosagetext>TRANSDERMAL</drugdosagetext>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19850101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19970401</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRILOSEC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLARITIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLONASE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DUONEB (IPRATROPIUM BROMIDE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL SPIROS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIAZEPAM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050356-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060622</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-2006-012017</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>60</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>79.4</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANGINA PECTORIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CYSTITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FACIAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>KIDNEY INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE SCLEROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NECK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEPHROLITHIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BETASERON</medicinalproduct>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>SECONDARY PROGRESSIVE MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060701</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BETASERON</medicinalproduct>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>SECONDARY PROGRESSIVE MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLTX (PYRIDOXINE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BETAPACE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EFEXOR /USA/ (VENLAFAXINE HYDROCHLORIDE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KLONOPIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMANTADINE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DITROPAN XL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RESTASIS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MOBITZ</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CADUET</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BACLOFEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACTONEL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PYRIDOXINE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYANOCOBALAMIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050358-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060622</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-2006-005412</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>67</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>93</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BONE MARROW FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CANDIDA SEPSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHRONIC LYMPHOCYTIC LEUKAEMIA TRANSFORMATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COOMBS POSITIVE HAEMOLYTIC ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CYTOMEGALOVIRUS INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EOSINOPHILIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOLYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MARROW HYPERPLASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYELODYSPLASTIC SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CAMPATH</medicinalproduct>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>CHRONIC LYMPHOCYTIC LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050801</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CAMPATH</medicinalproduct>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>CHRONIC LYMPHOCYTIC LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050803</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050803</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CAMPATH</medicinalproduct>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>CHRONIC LYMPHOCYTIC LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050812</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051215</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUDARA</medicinalproduct>
        <drugdosagetext>25 MG/M2 D1,2,3 Q4WEEKS, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CHRONIC LYMPHOCYTIC LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051003</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051110</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEUKINE</medicinalproduct>
        <drugdosagetext>500 UG X 7 DAYS/EACH MONTH, SUBCUTANEOUS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>COLONY STIMULATING FACTOR PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050922</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060301</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RITUXIMAB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYCLOPHOSPHAMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEUPOGEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENADRYL ^ACHE^ (AMMONIUM CHLORIDE, DIPHENHYDRAMINE HYDROCHLORIDE, MEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMARYL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOXYL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR /NET/ (ATORVASTATIN CALCIUM)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SINGULAIR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPROL-XL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACYCLOVIR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUCONAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SULFAMETHOXAZOLE + TRIMETHOPRIM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANXEMET (DOLASETRON MESILATE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DRIXORAL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LAMISIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROVENTIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDRALAZINE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYZAAR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEGACE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALTREX (VALCICLOVIR HYDROCHLORIDE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREVACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLARITIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NASACORT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZYRTEC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZYVOX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050359-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060626</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-2006-004351</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>49</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL TENDERNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC FUNCTION ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATOMEGALY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BETASERON</medicinalproduct>
        <drugbatchnumb>UA4527A</drugbatchnumb>
        <drugdosagetext>8 MIU, EVERY 2D, SUBCUTANEOUS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051123</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060301</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060301</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FIBERCON (POLYCARBOPHIL CALCIUM)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VIVELLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RHINOCORT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM GLUCONATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ONE-A-DAY (RETINOL)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZETIA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHADONE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREVACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYMBYAX (FLUOXETINE, OLANZAPINE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SINEMET</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HCL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050361-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060626</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-2006-003889</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>58</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEATH</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>19940629</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050362-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060623</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-2006-016716</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>50</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <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>RELAPSING-REMITTING MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19931130</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050363-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CLOF-10266</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </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>ARRHYTHMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD POTASSIUM INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NECROTISING FASCIITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POST PROCEDURAL COMPLICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPTIC SHOCK</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOFARABINE</medicinalproduct>
        <drugauthorizationnumb>21673</drugauthorizationnumb>
        <drugdosagetext>10 MG/M2 IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MYELODYSPLASTIC SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060612</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060616</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050365-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060620</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-2006-012301</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>29</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL DISTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ADDISON'S DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTERIOSCLEROSIS CORONARY ARTERY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE CONGESTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BETASERON</medicinalproduct>
        <drugbatchnumb>UA4758A</drugbatchnumb>
        <drugdosagetext>8 MIU, EVERY 2D, SUBCUTANEOUS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051108</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060318</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050366-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060621</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DSA_28369_2006</companynumb>
    <primarysource>
      <reportercountry>SPAIN</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>33</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ALVEOLITIS ALLERGIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMANGIOMA OF LIVER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERSTITIAL LUNG DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPHOHISTIOCYTOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEPHROLITHIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY GRANULOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRAMADOL HCL</medicinalproduct>
        <drugauthorizationnumb>21693</drugauthorizationnumb>
        <drugdosagetext>50 MG Q8HR/A FEW WEEKS</drugdosagetext>
        <drugindication>FIBROMYALGIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRAMADOL HCL</medicinalproduct>
        <drugauthorizationnumb>21693</drugauthorizationnumb>
        <drugdosagetext>50 MG Q8HR/A FEW WEEKS</drugdosagetext>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PAROXETINE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMIPRAMINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050367-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060621</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IMP_2345_2006</companynumb>
    <primarysource>
      <reportercountry>SPAIN</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>47</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ATRIOVENTRICULAR BLOCK THIRD DEGREE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BREATH SOUNDS ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CYANOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE ROLLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALLOR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHLOROQUINE PHOSPHATE</medicinalproduct>
        <drugauthorizationnumb>80880</drugauthorizationnumb>
        <drugdosagetext>250 MG QDAY</drugdosagetext>
        <drugindication>SYSTEMIC LUPUS ERYTHEMATOSUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19960101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HYDROXYCHLOROQUINE SULFATE</medicinalproduct>
        <drugdosagetext>200 MG QDAY</drugdosagetext>
        <drugindication>SYSTEMIC LUPUS ERYTHEMATOSUS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050368-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060621</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DSA_28381_2006</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>79</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>60</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANGIONEUROTIC OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSED LEVEL OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSARTHRIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LABORATORY TEST ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OROPHARYNGEAL SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARYNGEAL STENOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARYNGOLARYNGEAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY ARREST</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RENIVACE</medicinalproduct>
        <drugauthorizationnumb>18998</drugauthorizationnumb>
        <drugdosagetext>5 MG QAM PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050618</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNIPHYL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORAZEPAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SEPAMIT-R</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ONION/PRANKULAST HYDRATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GASTER D</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZYRTEC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUTIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HOKUNALIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRAVIT</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050369-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060619</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006BL003572</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>78</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>NON-HODGKIN'S LYMPHOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE SODIUM PHOSPHATE</medicinalproduct>
        <drugauthorizationnumb>40069</drugauthorizationnumb>
        <drugdosagetext>4 MILLIGRAMS, DAILY; ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AQUEOUS CREAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LACTULOSE</medicinalproduct>
        <drugdosagetext>DAILY; ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LANSOPRAZOLE</medicinalproduct>
        <drugdosagetext>15 MILLIGRAMS; DAILY; ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
        <drugdosagetext>DAILY; ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>QUININE SULFATE</medicinalproduct>
        <drugdosagetext>300 MILLIGRAMS; DAILY; ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALBUTEROL SPIROS</medicinalproduct>
        <drugdosagetext>OROPHARYNGEAL</drugdosagetext>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SENNA</medicinalproduct>
        <drugdosagetext>DAILY; ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SERETIDE</medicinalproduct>
        <drugdosagetext>DAILY; OROPHARYNGEAL</drugdosagetext>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
        <drugdosagetext>DAILY; OROPHARYNGEAL</drugdosagetext>
        <drugadministrationroute>049</drugadministrationroute>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050370-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060626</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>060626-0000568</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>35</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABNORMAL BEHAVIOUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENTAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCREATITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRANXENE</medicinalproduct>
        <drugauthorizationnumb>17105</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEPAKENE</medicinalproduct>
        <drugdosagetext>500 MG; QD; PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>EPILEPSY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060512</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METRONIDAZOLE</medicinalproduct>
        <drugdosagetext>500 MG; TID; PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060507</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060512</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ROXITHROMYCIN (ROXITHROMYCIN)</medicinalproduct>
        <drugdosagetext>150 MG; BID; PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060507</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060512</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN</medicinalproduct>
        <drugdosagetext>5000 IU; QD; SC</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060512</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SERTRALINE</medicinalproduct>
        <drugdosagetext>50  MG; BID; PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060512</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OLANZAPINE</medicinalproduct>
        <drugdosagetext>20 MG; QD; PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MENTAL DISORDER</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060512</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BACLOFEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>POTASSIUM CHLORIDE</medicinalproduct>
        <drugdosagetext>600 MG; QD; PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOMPERIDONE (DOMPERIDONE)</medicinalproduct>
        <drugdosagetext>PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050371-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060626</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006072644</companynumb>
    <primarysource>
      <reportercountry>SPAIN</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>40</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD CHOLESTEROL INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD TRIGLYCERIDES INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LISTERINE  (MENTHOL, METHYL SALICYLATE, EUCALYPTOL, THYMOL)</medicinalproduct>
        <drugdosagetext>1 CAP BID, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DENTAL DISORDER PROPHYLAXIS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050701</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050372-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060622</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006-06-1680</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>34</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>AGITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA FACIAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEMORY IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLARITIN REDITABS</medicinalproduct>
        <drugauthorizationnumb>20704</drugauthorizationnumb>
        <drugdosagetext>10 MG QD ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERSENSITIVITY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060621</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060622</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATIVAN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050373-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060622</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006RR-02762</companynumb>
    <primarysource>
      <reportercountry>ITALY</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>NEONATAL HYPOXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY HYPERTENSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
        <drugauthorizationnumb>70469</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugindication>PATENT DUCTUS ARTERIOSUS REPAIR</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050374-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060531</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-AVENTIS-200616230GDDC</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>64</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>21081</drugauthorizationnumb>
        <drugadministrationroute>058</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATACAND</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DILATREND</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050375-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060607</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AVENTIS-200615068US</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>ASCITES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEDICAL DEVICE COMPLICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLEURAL EFFUSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
        <drugbatchnumb>E054</drugbatchnumb>
        <drugauthorizationnumb>021081</drugauthorizationnumb>
        <drugdosagetext>DOSE UNIT: UNITS</drugdosagetext>
        <drugindication>DIABETES MELLITUS NON-INSULIN-DEPENDENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050901</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OPTICLIK (INSULIN INJECTION PEN)</medicinalproduct>
        <drugbatchnumb>D041</drugbatchnumb>
        <drugauthorizationnumb>021081</drugauthorizationnumb>
        <drugdosagetext>DOSE: UNKNOWN</drugdosagetext>
        <drugindication>DIABETES MELLITUS NON-INSULIN-DEPENDENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050901</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NOVOLOG</medicinalproduct>
        <drugdosagetext>DOSE: UNKNOWN</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SLO-MAG</medicinalproduct>
        <drugdosagetext>DOSE: UNKNOWN</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROGRAF</medicinalproduct>
        <drugdosagetext>DOSE: UNKNOWN</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRILOSEC</medicinalproduct>
        <drugdosagetext>DOSE: UNKNOWN</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugdosagetext>DOSE: UNKNOWN</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugdosagetext>DOSE: UNKNOWN</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NASAL PREPARATIONS</medicinalproduct>
        <drugdosagetext>DOSE: UNKNOWN</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050376-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060526</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AVENTIS-200614736US</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HYPERGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREATMENT NONCOMPLIANCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
        <drugbatchnumb>40N010</drugbatchnumb>
        <drugauthorizationnumb>021081</drugauthorizationnumb>
        <drugdosagetext>DOSE UNIT: UNITS</drugdosagetext>
        <drugindication>DIABETES MELLITUS NON-INSULIN-DEPENDENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060525</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OPTICLIK (INSULIN INJECTION PEN)</medicinalproduct>
        <drugbatchnumb>E018</drugbatchnumb>
        <drugauthorizationnumb>021081</drugauthorizationnumb>
        <drugindication>DIABETES MELLITUS NON-INSULIN-DEPENDENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060525</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060528</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>APIDRA</medicinalproduct>
        <drugbatchnumb>40N010</drugbatchnumb>
        <drugauthorizationnumb>021629</drugauthorizationnumb>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
        <drugindication>DIABETES MELLITUS NON-INSULIN-DEPENDENT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONIDINE</medicinalproduct>
        <drugdosagetext>DOSE: UNKNOWN</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
        <drugdosagetext>DOSE: UNKNOWN</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugdosagetext>DOSE: UNKNOWN</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
        <drugdosagetext>DOSE: UNKNOWN</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PERCOCET</medicinalproduct>
        <drugdosagetext>DOSE: UNKNOWN</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SOMA</medicinalproduct>
        <drugdosagetext>DOSE: UNKNOWN</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
        <drugdosagetext>DOSE: UNKNOWN</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HUMULIN N</medicinalproduct>
        <drugdosagetext>DOSE: ^30 UNITS QID (?)^  AS PER PHYSICIAN REPORT</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HUMULIN 70/30</medicinalproduct>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050381-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060621</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>8017575</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>80</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</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>DEPAKENE</medicinalproduct>
        <drugdosagetext>PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>EPILEPSY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050382-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060510</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>8013080</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>7</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>32</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABNORMAL BEHAVIOUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STATUS EPILEPTICUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KEPPRA</medicinalproduct>
        <drugauthorizationnumb>21035</drugauthorizationnumb>
        <drugindication>CONVULSION</drugindication>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EPILIM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONAZEPAM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050383-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060627</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200610825BYL</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>89</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>54.5</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>EOSINOPHILIC PNEUMONIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVELOX</medicinalproduct>
        <drugauthorizationnumb>21085</drugauthorizationnumb>
        <drugdosagetext>400 MG, QD, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BRONCHITIS ACUTE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060223</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060227</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KLARICID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIART</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZESTROMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AIROCOOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIBELANT SANKEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHYCOOL CHEMIPHAR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEIACT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAO-BUSHI-SAISHIN-TO</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRAVIT</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050385-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060622</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DSA_81632_2006</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</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>XYREM</medicinalproduct>
        <drugauthorizationnumb>21196</drugauthorizationnumb>
        <drugdosagetext>DF UNK PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VIGIL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050386-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesscongenitalanomali>1</seriousnesscongenitalanomali>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2002-10-4000</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>1</patientonsetage>
      <patientonsetageunit>804</patientonsetageunit>
      <reaction>
        <reactionmeddrapt>CAESAREAN SECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PREGNANCY OF PARTNER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRANSMISSION OF DRUG VIA SEMEN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENTRICULAR SEPTAL DEFECT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBETOL</medicinalproduct>
        <drugauthorizationnumb>20903</drugauthorizationnumb>
        <drugdosagetext>800 MG QD ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020128</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020712</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>20020128</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>20020128</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>20020211</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EUGLUCAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ROHYPNOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HALCION</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050388-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060627</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006-06-1946</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <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>NASONEX</medicinalproduct>
        <drugauthorizationnumb>20762</drugauthorizationnumb>
        <drugdosagetext>NASAL SPRAY</drugdosagetext>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DRUG NAME UNKNOWN (CATEGORY ONLY - NOT A DRUG ENTRY)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050389-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060623</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200610578BFR</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>64</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>45</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DISEASE PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERAL PHYSICAL HEALTH DETERIORATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SORAFENIB</medicinalproduct>
        <drugauthorizationnumb>21923</drugauthorizationnumb>
        <drugdosagetext>400 MG, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RENAL CELL CARCINOMA STAGE UNSPECIFIED</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060420</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEXOMIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMOVANE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATHYMIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOPHAGE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FERROUS SULFATE TAB</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050391-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060627</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>T200600584</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>88</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>26</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HOT FLUSH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SHOCK</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OPTIRAY 320</medicinalproduct>
        <drugauthorizationnumb>19710</drugauthorizationnumb>
        <drugdosagetext>50 MI, SINGLE, IV DRIP</drugdosagetext>
        <drugindication>COMPUTERISED TOMOGRAM ABDOMEN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060524</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060524</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NITRAZEPAM (NITRAZEPAM) TABLET</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIAZEPAM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050393-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006-05-1128</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>42</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>72</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>GASTRIC ULCER HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEG-INTRON                (PEGINTERFERON ALFA-2B)</medicinalproduct>
        <drugdosagetext>100 MCG QW SUBCUTANEOUS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050428</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050715</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBETOL</medicinalproduct>
        <drugdosagetext>800 MG ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050425</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050715</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HALCION</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BERIZYM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LAC G GRANULES</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050395-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060626</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CERZ-10592</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>20</patientonsetage>
      <patientonsetageunit>802</patientonsetageunit>
      <patientweight>10</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BACTERIAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRONCHITIS ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIFFICULT TO WEAN FROM VENTILATOR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EPILEPSY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER FUNCTION TEST ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OPISTHOTONUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SLEEP DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VIRAL INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CEREZYME</medicinalproduct>
        <drugbatchnumb>996713B</drugbatchnumb>
        <drugauthorizationnumb>20367</drugauthorizationnumb>
        <drugdosagetext>120 U/KG Q2WKS IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>GAUCHER'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050930</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CEREZYME</medicinalproduct>
        <drugbatchnumb>996713C</drugbatchnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CEREZYME</medicinalproduct>
        <drugbatchnumb>996713E</drugbatchnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CEREZYME</medicinalproduct>
        <drugbatchnumb>3463073B</drugbatchnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CEREZYME</medicinalproduct>
        <drugbatchnumb>3463073D</drugbatchnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CEREZYME</medicinalproduct>
        <drugbatchnumb>3463073E</drugbatchnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CEREZYME</medicinalproduct>
        <drugdosagetext>1000 UNITS Q2WKS IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>GAUCHER'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040908</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050915</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CEREZYME</medicinalproduct>
        <drugdosagetext>800 UNITS Q2WKS IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>GAUCHER'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030813</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040824</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLOBAZAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMBROXOL HYDROCHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARBOCYSTEINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TPN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050397-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060626</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006-144593-NL</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
    </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>
      <reaction>
        <reactionmeddrapt>SLEEP DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIRTAZAPINE</medicinalproduct>
        <drugauthorizationnumb>21208</drugauthorizationnumb>
        <drugdosagetext>30 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050398-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060626</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006-144766-NL</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
    </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>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULAR WEAKNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OBSTRUCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SENSORY DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEROTONIN SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUS TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VERTIGO</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL DISTURBANCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIRTAZAPINE</medicinalproduct>
        <drugauthorizationnumb>21208</drugauthorizationnumb>
        <drugdosagetext>15 MG/30 MG/45 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051018</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051130</drugenddate>
        <drugtreatmentduration>44</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIRTAZAPINE</medicinalproduct>
        <drugauthorizationnumb>21208</drugauthorizationnumb>
        <drugdosagetext>15 MG/30 MG/45 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051017</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIRTAZAPINE</medicinalproduct>
        <drugauthorizationnumb>21208</drugauthorizationnumb>
        <drugdosagetext>15 MG/30 MG/45 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SETRALINE HCL</medicinalproduct>
        <drugdosagetext>50 MG/100 MG/150 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051025</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051121</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SETRALINE HCL</medicinalproduct>
        <drugdosagetext>50 MG/100 MG/150 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051122</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051123</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SETRALINE HCL</medicinalproduct>
        <drugdosagetext>50 MG/100 MG/150 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051124</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060116</drugenddate>
        <drugtreatmentduration>54</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VENLAFAXINE HCL</medicinalproduct>
        <drugdosagetext>75 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050117</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROMETHAZINE</medicinalproduct>
        <drugdosagetext>100 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060116</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060117</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETYLSALICYLIC ACID SRT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMUSULPRIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORAZEPAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLURAZEPAM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050399-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060627</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006-144804-NL</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>28</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>EPILEPSY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIRTAZAPINE</medicinalproduct>
        <drugauthorizationnumb>21208</drugauthorizationnumb>
        <drugdosagetext>45 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANXIETY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060321</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060407</drugenddate>
        <drugtreatmentduration>17</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIRTAZAPINE</medicinalproduct>
        <drugauthorizationnumb>21208</drugauthorizationnumb>
        <drugdosagetext>45 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060321</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060407</drugenddate>
        <drugtreatmentduration>17</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACAMPROSATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DISULPIRAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CHLORDIAZEPOXIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ESCITALOPRAM OXALATE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050400-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060626</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006-144650-NL</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>63</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ATRIAL FIBRILLATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ATRIAL FLUTTER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA EXERTIONAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIRTAZAPINE</medicinalproduct>
        <drugauthorizationnumb>21208</drugauthorizationnumb>
        <drugdosagetext>7.5 MG/30 MG/45 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060415</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060416</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIRTAZAPINE</medicinalproduct>
        <drugauthorizationnumb>21208</drugauthorizationnumb>
        <drugdosagetext>7.5 MG/30 MG/45 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060417</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060420</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIRTAZAPINE</medicinalproduct>
        <drugauthorizationnumb>21208</drugauthorizationnumb>
        <drugdosagetext>7.5 MG/30 MG/45 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060421</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLPIDEM TARTRATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIAZEPAM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050402-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060623</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>510#6#2006-00004</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>54</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PULMONARY CONGESTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALPROSTADIL</medicinalproduct>
        <drugauthorizationnumb>18484</drugauthorizationnumb>
        <drugdosagetext>80 MCG (40 MCG 2 IN 1 DAY(S))</drugdosagetext>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>PERIPHERAL ISCHAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060606</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060614</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DICLOFENAC SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAMADOL HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMOXICILLIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VERAPAMIL HYDROCHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALSARTAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANTOPRAZOLE SODIUM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050403-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060704</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200610411BNE</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>61</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>LETHARGY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SORAFENIB</medicinalproduct>
        <drugauthorizationnumb>21923</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RENAL CELL CARCINOMA STAGE UNSPECIFIED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050603</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050615</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SORAFENIB</medicinalproduct>
        <drugauthorizationnumb>21923</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RENAL CELL CARCINOMA STAGE UNSPECIFIED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050628</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENDROFLUAZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VENLAFAXINE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMOXICILLIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CETIRIZINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACYCLOVIR</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050404-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>530#5#2006-00031</companynumb>
    <primarysource>
      <reportercountry>POLAND</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>77</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BRONCHOPNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATEMESIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFECTED SKIN ULCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEG AMPUTATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NECROSIS ISCHAEMIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN ULCER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALPROSTADIL</medicinalproduct>
        <drugauthorizationnumb>18484</drugauthorizationnumb>
        <drugdosagetext>2 X 40 MCG PER DAY</drugdosagetext>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>PERIPHERAL ISCHAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060516</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060612</drugenddate>
        <drugtreatmentduration>28</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KETOPROFEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PETHIDINE HYDROCHLORIDE 50MG, AMPOULES (PETHIDINE HYDROCHLORIDE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PETHIDINE HYDROCLORIDE 100 MG, AMPOULES (PETHIDINE HYDROCHLORIDE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE 5MG, TABLETS (AMLODIPINE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TICLOPIDINE 250MG, TABLETS (TICLOPIDINE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM CHLORIDE 750MG, TABLETS (POTASSIUM CHLORIDE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RANITIDINE HYDROCHLORIDE 150MG, TABLETS (RANITIDINE HYDROCHLORIDE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM 24000IU, AMPOULES (HEPARIN SODIUM)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RANITIDINE 100MG, AMPOULES (RANITIDINE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE 40 MG, AMPOULES (OMEPRAZOLE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SODIUM CHLORIDE 0.9% SOLUTION (SODIUM CHLORIDE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENOXAPARIN SODIUM 40MG, AMPOULES (HEPARIN-FRACTION, SODIUM SALT)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDDE 40MG, AMPOULES (FUROSEMIDE)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050405-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060707</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20060503172</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLINDNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GLAUCOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTRAOCULAR PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOPIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISION BLURRED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOPAMAX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MIGRAINE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOPAMAX</medicinalproduct>
        <drugauthorizationnumb>020505</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONVULSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050407-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060626</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006-144479-NL</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>34</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CRYING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NUVARING</medicinalproduct>
        <drugauthorizationnumb>21187</drugauthorizationnumb>
        <drugdosagetext>DF</drugdosagetext>
        <drugtreatmentduration>48</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROPRANOLOL HYDROCHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SUMATRIPTAN SUCCINATE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050408-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060626</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006-144533-NL</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>78</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY GAS EXCHANGE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DANAPAROID SODIUM</medicinalproduct>
        <drugauthorizationnumb>20430</drugauthorizationnumb>
        <drugdosagetext>2000 ANTI_XA Q1HR</drugdosagetext>
        <drugadministrationroute>051</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050409-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060703</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200610364GDS</companynumb>
    <primarysource>
      <reportercountry>POLAND</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>69</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>65</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METABOLIC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTI-ORGAN FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SORAFENIB</medicinalproduct>
        <drugbatchnumb>CT2084/2</drugbatchnumb>
        <drugauthorizationnumb>21923</drugauthorizationnumb>
        <drugdosagetext>400 MG, BID, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>METASTATIC RENAL CELL CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051202</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051215</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ISOSORBID MONONITRANS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETYLSALICYLIC ACID SRT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KETOPROFEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAMADOL HCL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050410-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060627</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006US001371</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FOAMING AT MOUTH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SALIVARY HYPERSECRETION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMBISOME</medicinalproduct>
        <drugauthorizationnumb>50740</drugauthorizationnumb>
        <drugdosagetext>3 MG/KG</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUCONAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TEICOPLANIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CEFTRIAXONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METRONIDAZOLE (METRONIDAZOLE SODIUM)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050411-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060626</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006JP001905</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>17</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>LYMPHOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROTOPIC</medicinalproduct>
        <drugauthorizationnumb>50777</drugauthorizationnumb>
        <drugdosagetext>TOPICAL</drugdosagetext>
        <drugadministrationroute>061</drugadministrationroute>
        <drugindication>DERMATITIS ATOPIC</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050412-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060621</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006EU001759</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>15</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>55</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>APPLICATION SITE PAPULES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>APPLICATION SITE REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GRANULOMA SKIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAPSORIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSEUDOCYST</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROTOPIC</medicinalproduct>
        <drugauthorizationnumb>50777</drugauthorizationnumb>
        <drugdosagetext>0.1 %, BID, TOPICAL</drugdosagetext>
        <drugadministrationroute>061</drugadministrationroute>
        <drugindication>DERMATITIS ATOPIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050415</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060505</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXERYL (WHITE SOFT PARAFFIN, PARAFFIN, LIQUID)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050413-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060705</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20060404099</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>18.5</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIOMYOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERICARDIAL EFFUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOXIC EPIDERMAL NECROLYSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHILDREN'S MOTRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHILDREN'S MOTRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHILDREN'S MOTRIN</medicinalproduct>
        <drugauthorizationnumb>020516</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHILDREN'S MOTRIN</medicinalproduct>
        <drugauthorizationnumb>020516</drugauthorizationnumb>
        <drugindication>PYREXIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CEFZIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CEFZIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CEFZIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CEFZIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PHARYNGITIS STREPTOCOCCAL</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CEFUROXIME</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CEFUROXIME</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PHARYNGITIS STREPTOCOCCAL</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CEFAZOLIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PHARYNGITIS STREPTOCOCCAL</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CEFOXITIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PHARYNGITIS STREPTOCOCCAL</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM CHLORIDE</medicinalproduct>
        <drugdosagetext>30 MEQ 8 HOUR; Q 12 H PRN</drugdosagetext>
        <drugindication>MINERAL SUPPLEMENTATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCORTISONE</medicinalproduct>
        <drugdosagetext>AS NECESSARY</drugdosagetext>
        <drugadministrationroute>061</drugadministrationroute>
        <drugindication>ECZEMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYLENOL (CAPLET)</medicinalproduct>
        <drugdosagetext>AS NECESSARY</drugdosagetext>
        <drugindication>PYREXIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUCONAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUCONAZOLE</medicinalproduct>
        <drugdosagetext>ORAL AND IV</drugdosagetext>
        <drugindication>FUNGAEMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATIVAN</medicinalproduct>
        <drugadministrationroute>050</drugadministrationroute>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATIVAN</medicinalproduct>
        <drugadministrationroute>050</drugadministrationroute>
        <drugindication>ANXIETY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANSOPRAZOLE</medicinalproduct>
        <drugadministrationroute>050</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALDACTONE</medicinalproduct>
        <drugadministrationroute>050</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
        <drugdosagetext>0.25 MG/KG/HR CONTINUOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FENTANYL TRANSDERMAL SYSTEM</medicinalproduct>
        <drugdosagetext>50 MCH/HR CONTINUOUS VIA J-TUBE/BOLUS 25-50 MECG IV Q 1 HOUR PRN</drugdosagetext>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CIPROFLOXACIN</medicinalproduct>
        <drugdosagetext>EACH EYE</drugdosagetext>
        <drugadministrationroute>047</drugadministrationroute>
        <drugindication>INFECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LACRI-LUBE</medicinalproduct>
        <drugindication>PROPHYLAXIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050414-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060622</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006JP001880</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>69</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL DISTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HOT FLUSH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VESICARE</medicinalproduct>
        <drugauthorizationnumb>21518</drugauthorizationnumb>
        <drugdosagetext>5 MG, D, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060613</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060614</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLARITHROMYCIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE BESYLATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DASEN (SERRAPEPTASE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CHOREITOU (HERBAL EXTRACT NOS)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TINELAC (SENNOSIDE A+B)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050415-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060627</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2005JP001764</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>9</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>39</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLEPHAROSPASM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSED LEVEL OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ENCEPHALOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE MOVEMENT DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEARING IMPAIRED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEMORY IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NYSTAGMUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THERAPY NON-RESPONDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROGRAF</medicinalproduct>
        <drugauthorizationnumb>50709</drugauthorizationnumb>
        <drugdosagetext>1 MG, D, IV DRIP</drugdosagetext>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>BONE MARROW TRANSPLANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050807</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050820</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUNGUARD (MICAFUNGIN)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VICCLOX (ACICLOVIR)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAXIPIME</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SOLU-MEDROL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FRAGMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOPAMINE HYDROCHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>URSO 250</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ITRACONAZOLE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050416-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>S06-FRA-02576-01</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>54</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CLONUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HOT FLUSH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SALIVARY HYPERSECRETION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPEECH DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROPLEX (ESCITALOPRAM)</medicinalproduct>
        <drugauthorizationnumb>21323</drugauthorizationnumb>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060516</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060516</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050417-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060626</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006US001372</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>17</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CHRONIC ALLOGRAFT NEPHROPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIALYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>KIDNEY TRANSPLANT REJECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POLYOMAVIRUS-ASSOCIATED NEPHROPATHY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROGRAF</medicinalproduct>
        <drugauthorizationnumb>50708</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS AGAINST TRANSPLANT REJECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE TAB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DACLIXIMAB (DACLIZUMAB)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AZATIOPRIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050418-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060626</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006US001369</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>14</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>KIDNEY TRANSPLANT REJECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POLYOMAVIRUS-ASSOCIATED NEPHROPATHY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROGRAF</medicinalproduct>
        <drugauthorizationnumb>50708</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS AGAINST TRANSPLANT REJECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MYCOPHENOLATE MOFETIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE TAB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMULECT</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050419-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>S06-FRA-01380-01</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>38</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ACUTE RESPIRATORY DISTRESS SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CALCIUM DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CHLORIDE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIO-RESPIRATORY ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIOGENIC SHOCK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIOMYOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBRAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIALYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EJECTION FRACTION DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOKALAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METABOLIC ACIDOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTI-ORGAN FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NOSOCOMIAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROTEIN TOTAL DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL TUBULAR NECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STATUS EPILEPTICUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TORSADE DE POINTES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENTRICULAR FIBRILLATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENTRICULAR TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROPLEX (ESCITALOPRAM)</medicinalproduct>
        <drugauthorizationnumb>21323</drugauthorizationnumb>
        <drugdosagetext>5 MG QD PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050630</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051214</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAXATIVES</medicinalproduct>
        <drugindication>CONSTIPATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050420-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060623</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006EU001922</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>64</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PERITONEAL EFFUSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TACROLIMUS CAPSULES</medicinalproduct>
        <drugauthorizationnumb>50708</drugauthorizationnumb>
        <drugdosagetext>5 MG, UID/QD, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>LIVER TRANSPLANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050403</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060323</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZENAPAX</medicinalproduct>
        <drugdosagetext>120 MG, UID/QD, IV NOS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>LIVER TRANSPLANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050329</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050405</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MYCOPHENOLATE MOFETIL</medicinalproduct>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>LIVER TRANSPLANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050329</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050402</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MYCOPHENOLATE MOFETIL</medicinalproduct>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>LIVER TRANSPLANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050403</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060323</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHYLPREDNISOLONE</medicinalproduct>
        <drugdosagetext>50 MG, UID/QD</drugdosagetext>
        <drugindication>LIVER TRANSPLANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050329</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050403</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISONE TAB</medicinalproduct>
        <drugdosagetext>1 MG, UID/QD</drugdosagetext>
        <drugindication>LIVER TRANSPLANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050404</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060323</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOVIRAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALACYCLOVIR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BACTRIM (TRIMETHOPRIM)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HEPARIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FRAXIPARINE (NADROPARIN CALCIUM)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050421-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060620</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>S06-AUT-02401-01</companynumb>
    <primarysource>
      <reportercountry>AUSTRIA</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>74</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEGACOLON</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUBILEUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ESCITALOPRAM OXALATE</medicinalproduct>
        <drugauthorizationnumb>21323</drugauthorizationnumb>
        <drugdosagetext>5 MG QD PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DYSTHYMIC DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060328</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060505</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050422-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060622</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006RR-02760</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>26</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ARRHYTHMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMODYNAMIC INSTABILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METABOLIC ACIDOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
        <drugauthorizationnumb>70469</drugauthorizationnumb>
        <drugdosagetext>90 30 CAPSULES, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OVERDOSE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050423-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200610618BFR</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>APHASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEMIPLEGIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugauthorizationnumb>21317</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050424-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060621</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006RR-02766</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>60</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>0</patientsex>
      <reaction>
        <reactionmeddrapt>ANGIONEUROTIC OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URTICARIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENALAPRIL MALEATE</medicinalproduct>
        <drugauthorizationnumb>75556</drugauthorizationnumb>
        <drugdosagetext>5 MG, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD PRESSURE INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050728</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060512</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATORVASTATIN CALCIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CODEINE PHOSPHATE (CODEINE PHOSPHATE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN W/ CODEINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>QUININE SULFATE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050426-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060623</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>RENA-11810</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL ABSCESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LARGE INTESTINE PERFORATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RENAGEL</medicinalproduct>
        <drugauthorizationnumb>21179</drugauthorizationnumb>
        <drugindication>HYPERPHOSPHATAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050427-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060621</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>8017672</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
    </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>AMNESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMPLEX REGIONAL PAIN SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISEASE PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STATUS EPILEPTICUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KEPPRA</medicinalproduct>
        <drugauthorizationnumb>21035</drugauthorizationnumb>
        <drugdosagetext>1500 MG /D PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060428</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARBAMAZEPINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYGESIC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELECOXIB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALPROATE SODIUM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050429-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060704</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200610864BYL</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugauthorizationnumb>21317</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CEREBRAL INFARCTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SERMION</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THYRADIN S</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050430-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060630</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DEU-2006-0002312</companynumb>
    <primarysource>
      <reportercountry>SLOVAKIA (Slovak Republic)</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>54</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PALLADONE-SR 8 MG(HYDROMORPHONE HYDROCHLORIDE) PROLONGED-RELEASE CAPSU</medicinalproduct>
        <drugauthorizationnumb>21044</drugauthorizationnumb>
        <drugdosagetext>8 MG, TWICE, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060623</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060624</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050432-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060703</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>USA-2006-0024542</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>17</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>OCULOMUCOCUTANEOUS SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CEFDITOREN PIVOXIL (SIMILAR TO NDA 21-222)(CEFDITOREN PIVOXIL) UNKNOWN</medicinalproduct>
        <drugauthorizationnumb>21222</drugauthorizationnumb>
        <drugdosagetext>MG</drugdosagetext>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030501</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050434-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006US001243</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>60</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLD SWEAT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CYANOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEFT VENTRICULAR FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY ARREST</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ADENOSCAN</medicinalproduct>
        <drugauthorizationnumb>20059</drugauthorizationnumb>
        <drugdosagetext>30 MG, IV DRIP</drugdosagetext>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>SCAN MYOCARDIAL PERFUSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060529</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060529</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050435-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060626</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006BH011407</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG TOXICITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
        <drugauthorizationnumb>87702</drugauthorizationnumb>
        <drugdosagetext>8 MG; 2X A DAY</drugdosagetext>
        <drugindication>OVARIAN CANCER</drugindication>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CISPLATIN</medicinalproduct>
        <drugdosagetext>75 MG/M**2</drugdosagetext>
        <drugindication>OVARIAN CANCER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAXOTERE</medicinalproduct>
        <drugdosagetext>75 MG/M**2 ; 85 MG/M**2</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050437-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060627</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006US001284</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>61</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>54</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANGINA PECTORIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ATRIOVENTRICULAR BLOCK FIRST DEGREE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY STENOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL ISCHAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ADENOSCAN</medicinalproduct>
        <drugauthorizationnumb>20059</drugauthorizationnumb>
        <drugdosagetext>38.9 MG, IV NOS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>SCAN MYOCARDIAL PERFUSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060614</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060614</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THALLIUM CHLORIDE (THALLOUS CHLORIDE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAPIDIL (TRAPIDIL)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NIFEDIPINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TEMOCAPRIL HYDROCHLORIDE (TEMOCAPRIL HYDROCHLORIDE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VOGLIBOSE (VOGLIBOSE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TEPRENONE (TEPRENONE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN HUMAN (INSULIN HUMAN)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050438-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060509</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006PK01000</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>3559</patientonsetage>
      <patientonsetageunit>804</patientonsetageunit>
      <patientweight>30</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLISTER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DERMATITIS BULLOUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EMLA</medicinalproduct>
        <drugauthorizationnumb>19941</drugauthorizationnumb>
        <drugadministrationroute>061</drugadministrationroute>
        <drugindication>LOCAL ANAESTHESIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060504</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADVANTAN</medicinalproduct>
        <drugindication>ECZEMA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050440-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060626</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006BH011408</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
        <drugauthorizationnumb>87702</drugauthorizationnumb>
        <drugdosagetext>8 MG; 2X A DAY; UNK</drugdosagetext>
        <drugindication>OVARIAN CANCER</drugindication>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CISPLATIN</medicinalproduct>
        <drugdosagetext>75 MG/M**2</drugdosagetext>
        <drugindication>OVARIAN CANCER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAXOTERE</medicinalproduct>
        <drugdosagetext>75 MG/M**2 ; 85 MG/M**2</drugdosagetext>
        <drugindication>OVARIAN CANCER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050441-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060621</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DSA_26546_2005</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>53</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ALANINE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANGIONEUROTIC OEDEMA</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>DISEASE RECURRENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPHONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EOSINOPHIL PERCENTAGE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FACE OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAMMA-GLUTAMYLTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC FUNCTION ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LARYNGEAL OEDEMA</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>TONGUE OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RENIVACE</medicinalproduct>
        <drugauthorizationnumb>18998</drugauthorizationnumb>
        <drugdosagetext>5 MG QD PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050315</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050503</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MARZULENE S</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DILTIAZEM HCL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050442-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>MEDI-0004708</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>4</patientonsetage>
      <patientonsetageunit>802</patientonsetageunit>
      <patientsex>0</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHINOLARYNGITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SYNAGIS</medicinalproduct>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>ANTIVIRAL PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051025</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051025</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SYNAGIS</medicinalproduct>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>ANTIVIRAL PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051122</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SYNAGIS</medicinalproduct>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>ANTIVIRAL PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060103</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SYNAGIS</medicinalproduct>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>ANTIVIRAL PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060131</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SYNAGIS</medicinalproduct>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>ANTIVIRAL PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060228</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050443-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060623</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>226642</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>44</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ERYSIPELAS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIMB INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WOUND</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RAPTIVA</medicinalproduct>
        <drugindication>PSORIASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050444-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060623</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>060626-0000562</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>31</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>LYMPHADENITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ETHOTOIN (ETHOTOIN)</medicinalproduct>
        <drugauthorizationnumb>10841</drugauthorizationnumb>
        <drugdosagetext>1000 MG;QD;PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>EPILEPSY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060519</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060531</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLORAZEPATE DIPOTASSIUM</medicinalproduct>
        <drugdosagetext>22.5 MG;QD;PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>EPILEPSY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020801</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PHENYTOIN SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADENINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIAZEPAM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050445-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060622</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>8017446</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>45</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>83</patientweight>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>AGGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBRAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMPAIRED SELF-CARE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL ISCHAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KEPPRA</medicinalproduct>
        <drugauthorizationnumb>21035</drugauthorizationnumb>
        <drugdosagetext>2000 MG /D</drugdosagetext>
        <drugindication>EPILEPSY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KEPPRA</medicinalproduct>
        <drugdosagetext>3000 MG /D PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>EPILEPSY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060610</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TEGRETOL</medicinalproduct>
        <drugdosagetext>300 MG 2/D PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>EPILEPSY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19920101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060610</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ABILIFY</medicinalproduct>
        <drugdosagetext>30 MG /D PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PSYCHOTIC DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060610</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CIPRAMIL</medicinalproduct>
        <drugdosagetext>20 MG /D PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060610</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KEMADRIN</medicinalproduct>
        <drugdosagetext>5 MG 2/D PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060610</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050446-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060621</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>8015330</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>54</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GLOMERULAR FILTRATION RATE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEUKOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PH URINE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VIRAL INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KEPPRA</medicinalproduct>
        <drugauthorizationnumb>21035</drugauthorizationnumb>
        <drugdosagetext>500 MG 3/D</drugdosagetext>
        <drugindication>EPILEPSY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KEPPRA</medicinalproduct>
        <drugdosagetext>1.25 G /D</drugdosagetext>
        <drugindication>EPILEPSY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KEPPRA</medicinalproduct>
        <drugdosagetext>1 G /D</drugdosagetext>
        <drugindication>EPILEPSY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KEPPRA</medicinalproduct>
        <drugdosagetext>625 MG /D</drugdosagetext>
        <drugindication>EPILEPSY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050447-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060622</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>8010012</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CONVERSION DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GRAND MAL CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCORRECT DOSE ADMINISTERED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE TWITCHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KEPPRA</medicinalproduct>
        <drugauthorizationnumb>21035</drugauthorizationnumb>
        <drugdosagetext>2000 MG /D PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>TEMPORAL LOBE EPILEPSY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KEPPRA</medicinalproduct>
        <drugdosagetext>3000 MG /D PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>TEMPORAL LOBE EPILEPSY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KEPPRA</medicinalproduct>
        <drugdosagetext>PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>TEMPORAL LOBE EPILEPSY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030130</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KEPPRA</medicinalproduct>
        <drugdosagetext>3000 MG /D PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>TEMPORAL LOBE EPILEPSY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030228</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPIRAMATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SEROXAT</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050448-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060623</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>8017579</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>82</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>STATUS EPILEPTICUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THERAPY NON-RESPONDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KEPPRA</medicinalproduct>
        <drugauthorizationnumb>21035</drugauthorizationnumb>
        <drugdosagetext>2 G ONCE IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>STATUS EPILEPTICUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OTHER ANTICONVULSANT DRUGS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SEDATIVES</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050450-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060606</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-MERCK-0606USA02216</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>74</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>LIVER DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BUFFERIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANGINA PECTORIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060410</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEPCID RPD</medicinalproduct>
        <drugauthorizationnumb>020752</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>STOMACH DISCOMFORT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060512</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060524</drugenddate>
        <drugtreatmentduration>13</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PANALDINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANGINA PECTORIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060511</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060522</drugenddate>
        <drugtreatmentduration>12</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NITOROL-R</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANGINA PECTORIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060510</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060526</drugenddate>
        <drugtreatmentduration>17</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ISOSORBIDE MONONITRATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANGINA PECTORIS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060510</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050451-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060703</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CG-MERCK-0607USA00703</companynumb>
    <primarysource>
      <reportercountry>CONGO</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>45</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ADVERSE EVENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>STROMECTOL</medicinalproduct>
        <drugauthorizationnumb>050742</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060519</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060519</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit></drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050452-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060627</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>MX-MERCK-0607MEX00009</companynumb>
    <primarysource>
      <reportercountry>MEXICO</reportercountry>
      <qualification>5</qualification>
    </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>CARDIAC ARREST</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INVANZ</medicinalproduct>
        <drugauthorizationnumb>021337</drugauthorizationnumb>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>ABDOMINAL INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060504</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060510</drugenddate>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050453-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060120</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-MERCK-0601USA02671</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>95</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ALANINE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASPARTATE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CALCIUM DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD LACTATE DEHYDROGENASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOKALAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LONG QT SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TORSADE DE POINTES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENTRICULAR TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEPCID RPD</medicinalproduct>
        <drugauthorizationnumb>20752</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051015</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060118</drugenddate>
        <drugtreatmentduration>96</drugtreatmentduration>
        <drugtreatmentdurationunit></drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040724</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BLOPRESS</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060107</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATARAX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040724</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060118</drugenddate>
        <drugtreatmentduration>544</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LENDORMIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040724</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060118</drugenddate>
        <drugtreatmentduration>544</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORAZEPAM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040724</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060118</drugenddate>
        <drugtreatmentduration>544</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMOBAN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040724</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060118</drugenddate>
        <drugtreatmentduration>544</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COLDRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040724</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060118</drugenddate>
        <drugtreatmentduration>544</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KAKKON-TO</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLOMOX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060114</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060118</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SODIUM PICOSULFATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000426</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060118</drugenddate>
        <drugtreatmentduration>2094</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THYRADIN-S</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000426</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SENNA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060107</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060118</drugenddate>
        <drugtreatmentduration>12</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PL-GRANULES</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060114</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060118</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050454-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060622</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>8017577</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <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>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STATUS EPILEPTICUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KEPPRA</medicinalproduct>
        <drugauthorizationnumb>21035</drugauthorizationnumb>
        <drugdosagetext>1500 MG IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>EPILEPSY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KEPPRA</medicinalproduct>
        <drugdosagetext>1500 MG</drugdosagetext>
        <drugindication>EPILEPSY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIAZEPAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROPOFOL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050457-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060531</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006-143464-NL</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>70</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGIC DIATHESIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DANAPAROID SODIUM</medicinalproduct>
        <drugauthorizationnumb>20430</drugauthorizationnumb>
        <drugdosagetext>INTRAVENOUS (NOS)</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>DISSEMINATED INTRAVASCULAR COAGULATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060311</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060313</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CEFPIROME SULFATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ISEPAMICIN SULFATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MINOPHAGEN C</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUTATHIONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MIDAZOLAM HYDROCHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VECURONIUM BROMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOPAMINE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VERAPAMIL HYDROCHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GABEXATE MESILATE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050459-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>TCI2006A02225</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>74</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLADDER NEOPLASM</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>20051018</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NATEGLINIDE</medicinalproduct>
        <drugdosagetext>60 MG, 90 MG, 120 MG, OR PLACEBO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS NON-INSULIN-DEPENDENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051115</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HALCION</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MICARDIS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LENDORMIN D (BROTIZOLAM)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050461-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060630</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>TCI2006A02637</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
    </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 BILIRUBIN 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>REFUSAL OF TREATMENT BY PATIENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACTOS</medicinalproduct>
        <drugauthorizationnumb>21073</drugauthorizationnumb>
        <drugdosagetext>30 MG (30 MG, 1 D) PER ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS NON-INSULIN-DEPENDENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060406</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060622</drugenddate>
        <drugtreatmentduration>77</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050463-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>LTI2006A00150</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>67</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CHOLANGITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACTOS</medicinalproduct>
        <drugauthorizationnumb>21073</drugauthorizationnumb>
        <drugdosagetext>30 MG (30 MG, 1 IN 1 D), ORAL  MORE THAN 1 YEAR</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS NON-INSULIN-DEPENDENT</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050464-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060703</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CG-MERCK-0607USA00750</companynumb>
    <primarysource>
      <reportercountry>CONGO</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>31</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ADVERSE EVENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>STROMECTOL</medicinalproduct>
        <drugauthorizationnumb>050742</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060519</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060519</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit></drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050465-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0611871A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>AGRANULOCYTOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEXXAR</medicinalproduct>
        <drugbatchnumb>061041</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050466-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20020724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-318122</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>22</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>95.7</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ALOPECIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AMNESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANGER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BALANCE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHILLS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHRONIC SINUSITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSED MOOD</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION SUICIDAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIPLOPIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EAR PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ENCEPHALOMALACIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GINGIVITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GRAND MAL CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GUN SHOT WOUND</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEAD INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IRRITABILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LACERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NECK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARYNGOLARYNGEAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHINITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ROAD TRAFFIC ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEXUALLY TRANSMITTED DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN PAPILLOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDE ATTEMPT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TONSILLITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTHACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRAUMATIC BRAIN INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TYMPANIC MEMBRANE PERFORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL ACUITY REDUCED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>18662</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ACNE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990602</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20001010</drugenddate>
        <drugtreatmentduration>497</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ROBAXIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000510</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INDOCIN SR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000510</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMITRIPTYLINE HCL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN B6</medicinalproduct>
        <drugdosagetext>DOSE STATED AS 1 QHS</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>VITAMIN SUPPLEMENTATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050467-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-409415</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>23</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>73.5</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL ABSCESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL ADHESIONS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAEMIA VITAMIN B12 DEFICIENCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANASTOMOTIC LEAK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANHEDONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BILIARY FIBROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD POTASSIUM DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHOLELITHIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CROHN'S DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISEASE RECURRENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DUODENITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPEPSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EAR PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EOSINOPHIL COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FIBROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRITIS EROSIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL ANASTOMOTIC LEAK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROOESOPHAGEAL REFLUX DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHOIDS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEMIPLEGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HERNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERCHLORHYDRIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTHYROIDISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLAMMATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLAMMATORY BOWEL DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTESTINAL OBSTRUCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IRRITABLE BOWEL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LARGE INTESTINAL ULCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPHADENOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTI-ORGAN DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE HYPERTROPHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEPHROLITHIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OESOPHAGEAL STENOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARYNGOLARYNGEAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POLYARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROSTATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYLOROSPASM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RECTAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RED BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SCAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SCOLIOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN PAPILLOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SMALL INTESTINAL OBSTRUCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPONDYLOARTHROPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREATMENT NONCOMPLIANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UPPER RESPIRATORY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>18662</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19890223</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19890615</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050468-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060703</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>THQ2006A00213</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>83</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ACUTE CORONARY SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CLEAR CELL CARCINOMA OF THE KIDNEY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL NEOPLASM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PIOGLITAZONE HCL</medicinalproduct>
        <drugauthorizationnumb>21073</drugauthorizationnumb>
        <drugdosagetext>8 MG</drugdosagetext>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031216</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040301</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CIPRO (CIPROFLOXACIN)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050469-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20051109</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-ROCHE-424552</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>CAESAREAN SECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NO ADVERSE EFFECT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NORMAL NEWBORN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ROACUTAN</medicinalproduct>
        <drugauthorizationnumb>18662</drugauthorizationnumb>
        <drugindication>ACNE</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050515</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050470-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040818</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-378079</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>34</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>88.5</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ADRENAL INSUFFICIENCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ALANINE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AMENORRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASPARTATE AMINOTRANSFERASE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLEPHARITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLEPHAROSPASM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CHOLESTEROL INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD TRIGLYCERIDES INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRONCHITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CAESAREAN SECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHRONIC FATIGUE SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLITIS ULCERATIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONTUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CYSTITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE BEFORE PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPEPSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EAR CONGESTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ELECTROCARDIOGRAM T WAVE ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EPSTEIN-BARR VIRUS ANTIBODY POSITIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLATULENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FOOD INTOLERANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FURUNCLE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL CANDIDIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HERPES ZOSTER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HORMONE LEVEL ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HUMAN HERPESVIRUS 6 INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERCOAGULATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMMUNE SYSTEM DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLAMMATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLAMMATORY BOWEL DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLUENZA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LACERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPHADENITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METAL POISONING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE ALLERGIES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OESOPHAGITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN JAW</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARYNGOLARYNGEAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PITTING OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RECTAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHINITIS ALLERGIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUS TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUSITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STRESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TONGUE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTH INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTHACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOTAL CHOLESTEROL/HDL RATIO INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TWIN PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UPPER RESPIRATORY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VAGINAL DISCHARGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VITAMIN B COMPLEX DEFICIENCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VULVOVAGINAL MYCOTIC INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>18662</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ACNE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19930515</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19930615</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050472-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060623</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>TUK2006A00042</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MACULAR OEDEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACTOS</medicinalproduct>
        <drugauthorizationnumb>21073</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050474-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060706</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>THQ2006A00581</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>8</patientonsetage>
      <patientonsetageunit>800</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PERICARDIAL EFFUSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACTOS</medicinalproduct>
        <drugauthorizationnumb>21073</drugauthorizationnumb>
        <drugdosagetext>30 MG  APPROX. ONE OR TWO YEARS AGO</drugdosagetext>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050475-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060627</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>TCI2006A01992</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>75</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE CONGESTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUID RETENTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERIPHERAL ARTERIAL OCCLUSIVE DISEASE</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>20051012</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060225</drugenddate>
        <drugtreatmentduration>136</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BUFFERIN (ACETYLSALICYLIC ACID, ALUMINIUM GLYCINATE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EBRANTIL (URAPIDIL)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HERBRESSOR R (DILTIAZEM HYDROCHLORIDE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050476-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060705</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006S1000134</companynumb>
    <primarysource>
      <reportercountry>BELGIUM</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>7</patientonsetage>
      <patientonsetageunit>804</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIOVASCULAR DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTESTINAL PERFORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PATENT DUCTUS ARTERIOSUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY DISORDER NEONATAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INOMAX</medicinalproduct>
        <drugbatchnumb>02888</drugbatchnumb>
        <drugauthorizationnumb>20845</drugauthorizationnumb>
        <drugdosagetext>5 PPM; INH GAS; CONT</drugdosagetext>
        <drugindication>LUNG DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060626</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INOMAX</medicinalproduct>
        <drugbatchnumb>02888</drugbatchnumb>
        <drugauthorizationnumb>20845</drugauthorizationnumb>
        <drugdosagetext>5 PPM; INH GAS; CONT</drugdosagetext>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060626</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CAFEINE (CAFEINE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MICONAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VANCOMYCIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CEFOTAXIME SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METRONIDAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FENTANYL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATROPINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMPICILLIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050478-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060621</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>111135ISR</companynumb>
    <primarysource>
      <reportercountry>COLOMBIA</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>41</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>AMERICAN TRYPANOSOMIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CREATININE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>KIDNEY FIBROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPHOCYTIC INFILTRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEPHRITIS INTERSTITIAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL TUBULAR ATROPHY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHYLPREDNISOLONE</medicinalproduct>
        <drugauthorizationnumb>40664</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYCLOSPORINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MYCOPHENOLATE MOFETIL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050479-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20051103</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-423642</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>46</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>81.6</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>COLITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLITIS ULCERATIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CROHN'S DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLAMMATORY BOWEL DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY RETENTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>18662</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ACNE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19970615</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19980615</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COZAAR</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLARITIN-D</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FIORICET</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050480-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-433886</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>165</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MASS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NIGHT BLINDNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEGENER'S GRANULOMATOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>18662</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ACNE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19940315</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19940715</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050481-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060502</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-446716</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>84</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BONIVA</medicinalproduct>
        <drugauthorizationnumb>21455</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050482-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060301</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-438839</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>18</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>68.9</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CELLULITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CROHN'S DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRY SKIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLAMMATORY BOWEL DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IRRITABLE BOWEL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIP DRY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE SCLEROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>18662</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980223</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19980317</drugenddate>
        <drugtreatmentduration>23</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>018662</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980318</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19980719</drugenddate>
        <drugtreatmentduration>124</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ORTHO TRI-CYCLEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORDETTE-21</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050483-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060406</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-443745</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>3.2</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>APGAR SCORE LOW</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BREECH PRESENTATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CAESAREAN SECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE BEFORE PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NO ADVERSE EFFECT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NORMAL NEWBORN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PREGNANCY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>18662</drugauthorizationnumb>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19860615</drugstartdate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>018662</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980714</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19981215</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>018662</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000915</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ORTHO CYCLEN-28</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050484-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20051215</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AR-ROCHE-428642</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>57</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>MUCOSAL INFLAMMATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY OEDEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CAPECITABINE</medicinalproduct>
        <drugauthorizationnumb>20896</drugauthorizationnumb>
        <drugdosagetext>DOSE REPORTED AS 4000 (NO UNITS PROVIDED).</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051123</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051201</drugenddate>
        <drugtreatmentduration>9</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALPRAZOLAM</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050515</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051209</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE TAB</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050515</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050615</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TELMISARTAN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030615</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051209</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050485-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060301</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-438833</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>24</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>81.6</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRITIS REACTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ATTENTION DEFICIT/HYPERACTIVITY DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CROHN'S DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERALISED ANXIETY DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLAMMATORY BOWEL DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IRRITABLE BOWEL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOPOROSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>18662</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ACNE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19940615</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19940615</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>018662</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19970615</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19971215</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>018662</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020715</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030115</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050487-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060615</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006-143965-NL</companynumb>
    <primarysource>
      <reportercountry>SWEDEN</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DESOLETT</medicinalproduct>
        <drugauthorizationnumb>20071</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050488-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060621</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>111199ISR</companynumb>
    <primarysource>
      <reportercountry>NETHERLANDS</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>48</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PERICARDIAL EFFUSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMOTRIGINE</medicinalproduct>
        <drugauthorizationnumb>20241</drugauthorizationnumb>
        <drugdosagetext>175 MILLIGRAM ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>EPILEPSY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060309</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060621</drugenddate>
        <drugtreatmentduration>15</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALPROATE SODIUM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050489-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060630</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>HQWYE926605JUN06</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>11</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD CREATININE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPONATRAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELLCEPT, CONTROL FOR SIROLIMUS</medicinalproduct>
        <drugauthorizationnumb>50722</drugauthorizationnumb>
        <drugdosagetext>750 MG 1X PER 1 DAY ORAL; 1250 MG 1X PER 1 DAY ORAL; 1000 MG 1X PER 1 DAY ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS AGAINST TRANSPLANT REJECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051020</drugenddate>
        <drugtreatmentduration>324</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELLCEPT, CONTROL FOR SIROLIMUS</medicinalproduct>
        <drugauthorizationnumb>50722</drugauthorizationnumb>
        <drugdosagetext>750 MG 1X PER 1 DAY ORAL; 1250 MG 1X PER 1 DAY ORAL; 1000 MG 1X PER 1 DAY ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS AGAINST TRANSPLANT REJECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051021</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060115</drugenddate>
        <drugtreatmentduration>87</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELLCEPT, CONTROL FOR SIROLIMUS</medicinalproduct>
        <drugauthorizationnumb>50722</drugauthorizationnumb>
        <drugdosagetext>750 MG 1X PER 1 DAY ORAL; 1250 MG 1X PER 1 DAY ORAL; 1000 MG 1X PER 1 DAY ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS AGAINST TRANSPLANT REJECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060116</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE TAB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TACROLIMUS (TACROLIMUS)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCITRIOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOCUSATE SODIUM (DOCUSATE SODIUM)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENALAPRIL MALEATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050491-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FRWYE006331JAN03</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>51</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CYTOMEGALOVIRUS INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG TOXICITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>KIDNEY FIBROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>KIDNEY TRANSPLANT REJECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROGRAF</medicinalproduct>
        <drugauthorizationnumb>50708</drugauthorizationnumb>
        <drugdosagetext>2 MG 1X PER 1 DAY ORAL; 3 MG 1X PER 1 DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS AGAINST TRANSPLANT REJECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020719</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20021101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROGRAF</medicinalproduct>
        <drugauthorizationnumb>50708</drugauthorizationnumb>
        <drugdosagetext>2 MG 1X PER 1 DAY ORAL; 3 MG 1X PER 1 DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS AGAINST TRANSPLANT REJECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELLCEPT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE TAB</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050492-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesscongenitalanomali>1</seriousnesscongenitalanomali>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060621</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>6023656</companynumb>
    <primarysource>
      <reportercountry>ITALY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CAESAREAN SECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONGENITAL ANOMALY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEVELOPMENTAL DELAY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EXOMPHALOS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PREMATURE SEPARATION OF PLACENTA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKULL MALFORMATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREATMENT NONCOMPLIANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TWIN PREGNANCY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHIMAZOLE</medicinalproduct>
        <drugauthorizationnumb>40547</drugauthorizationnumb>
        <drugdosagetext>40,000 MG (40 MG, 1 IN 1 D); 20,000 MG (20  MG, 1 IN 1 D) TRANSPLACENTAL    MATERNAL USE</drugdosagetext>
        <drugadministrationroute>064</drugadministrationroute>
        <drugindication>BASEDOW'S DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROPRANOLOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HALOPERINDOL (HALOPERINDOL)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050493-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesscongenitalanomali>1</seriousnesscongenitalanomali>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060621</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>6023615</companynumb>
    <primarysource>
      <reportercountry>ITALY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>APLASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHOANAL ATRESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONGENITAL GENITOURINARY ABNORMALITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYELID DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTONIA NEONATAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PILONIDAL CYST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PREMATURE BABY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKULL MALFORMATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UMBILICAL HERNIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHIMAZOLE</medicinalproduct>
        <drugauthorizationnumb>40547</drugauthorizationnumb>
        <drugdosagetext>10,000 MG (10 MG, 1 IN 1 D) TRANSPLACENTAL      MATERNAL USE</drugdosagetext>
        <drugadministrationroute>064</drugadministrationroute>
        <drugindication>BASEDOW'S DISEASE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050495-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060621</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>6023580</companynumb>
    <primarysource>
      <reportercountry>HUNGARY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>1</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ALOPECIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>APLASIA CUTIS CONGENITA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE SCAN ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSMORPHISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PREMATURE BABY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SCAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKULL MALFORMATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHIMAZOLE</medicinalproduct>
        <drugauthorizationnumb>40547</drugauthorizationnumb>
        <drugdosagetext>40,000 MG (40 MG, 1 IN 1 D) TRANSPLACENTAL   MATERNAL USE</drugdosagetext>
        <drugadministrationroute>064</drugadministrationroute>
        <drugindication>HYPERTHYROIDISM</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050496-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060621</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>6023561</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>53</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>APLASTIC ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CALCIUM DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE MARROW FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE MARROW PLASMACYTE COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GOITRE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOKALAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMMUNODEFICIENCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARYNGOLARYNGEAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA STREPTOCOCCAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROTHROMBIN TIME PROLONGED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHIMAZOLE</medicinalproduct>
        <drugauthorizationnumb>40547</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050497-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060705</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-454422</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>44</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PULMONARY OEDEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEGASYS</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060412</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COPEGUS</medicinalproduct>
        <drugauthorizationnumb>021511</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060412</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050498-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060609</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>SE-ROCHE-454279</companynumb>
    <primarysource>
      <reportercountry>SWEDEN</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>18</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANGIONEUROTIC OEDEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ROACCUTAN</medicinalproduct>
        <drugauthorizationnumb>18662</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ACNE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051124</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060321</drugenddate>
        <drugtreatmentduration>118</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050499-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060627</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-453646</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>23</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE BEFORE PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NO ADVERSE EFFECT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PREGNANCY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>18662</drugauthorizationnumb>
        <drugdosagetext>DOSAGE REGIMEN REPORTED: DAILY.</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060109</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060514</drugenddate>
        <drugtreatmentduration>126</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMNESTEEM</medicinalproduct>
        <drugindication>ACNE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050500-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060703</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>MX-ROCHE-454139</companynumb>
    <primarysource>
      <reportercountry>MEXICO</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>71</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>43</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BONE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROENTERITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BONIVA</medicinalproduct>
        <drugbatchnumb>RJ0003</drugbatchnumb>
        <drugauthorizationnumb>021455</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS POSTMENOPAUSAL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060424</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060613</drugenddate>
        <drugtreatmentduration>51</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060608</drugenddate>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050501-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060607</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-451125</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>58</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>70.3</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>EPISTAXIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOUTH HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NASAL DRYNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BONIVA</medicinalproduct>
        <drugbatchnumb>B1011</drugbatchnumb>
        <drugauthorizationnumb>21455</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051227</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060527</drugenddate>
        <drugtreatmentduration>152</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTIVITAMIN NOS</medicinalproduct>
        <drugdosagetext>TDD REPORTED AS 1</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050502-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060602</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-450381</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>52</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>90.7</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>APPENDICITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCISION SITE ABSCESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEG-INTERFERON A-2A (RO 25-8310)</medicinalproduct>
        <drugbatchnumb>82408018</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050414</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060311</drugenddate>
        <drugtreatmentduration>332</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RIBAVIRIN</medicinalproduct>
        <drugbatchnumb>KH06215</drugbatchnumb>
        <drugauthorizationnumb>021511</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050414</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060311</drugenddate>
        <drugtreatmentduration>332</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050503-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060703</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-ROCHE-454134</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BONIVA</medicinalproduct>
        <drugauthorizationnumb>021455</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060615</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060615</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050504-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060706</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-454434</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>47</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>CARDIAC ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ILL-DEFINED DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEGASYS</medicinalproduct>
        <drugdosagetext>ROUTE REPORTED AS INJECTABLE.</drugdosagetext>
        <drugadministrationroute>050</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050506-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060221</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-ROCHE-438240</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>40</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>63</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>GINGIVAL RECESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SENSITIVITY OF TEETH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>18662</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PYODERMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051018</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIANETTE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ACNE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051017</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TETRALYSAL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ACNE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051013</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051018</drugenddate>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050507-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060103</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-430587</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>52</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ALOPECIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD THYROID STIMULATING HORMONE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CYSTITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EXOSTOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYELID OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTHYROIDISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MIGRAINE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POST PROCEDURAL COMPLICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUSITIS</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>058</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051114</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051229</drugenddate>
        <drugtreatmentduration>46</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEGASYS</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060114</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060621</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEGASYS</medicinalproduct>
        <drugdosagetext>DOSAGE WAS REDUCED.</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060621</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COPEGUS</medicinalproduct>
        <drugauthorizationnumb>021511</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051114</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051215</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COPEGUS</medicinalproduct>
        <drugauthorizationnumb>021511</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051215</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051229</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COPEGUS</medicinalproduct>
        <drugauthorizationnumb>021511</drugauthorizationnumb>
        <drugdosagetext>REDUCED FROM 800 MG DAILY TO 400 MG DAILY AS A RESULT OF THE PATIENT'S LABWORK.</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060114</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEUPOGEN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060327</drugenddate>
        <drugtreatmentduration>86</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEUPOGEN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CITALOPRAM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATIVAN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SOMNOLENCE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RESTORIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SOMNOLENCE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050509-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060619</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>S02-FRA-02174-01</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>34</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ALANINE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASCITES</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 FIBRINOGEN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COAGULATION FACTOR V LEVEL DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COAGULOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CYANOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC TRAUMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTHERMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERITONEAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROTHROMBIN LEVEL DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SHOCK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SHOCK HAEMORRHAGIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENTRICULAR HYPERKINESIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CITALOPRAM HYDROBROMIDE</medicinalproduct>
        <drugauthorizationnumb>20822</drugauthorizationnumb>
        <drugdosagetext>40 MG QD PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020902</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN</medicinalproduct>
        <drugdosagetext>37000 UNITS ONCE IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PULMONARY EMBOLISM</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020902</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020902</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN</medicinalproduct>
        <drugindication>PULMONARY EMBOLISM</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020906</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREVISCAN (FLUINDIONE)</medicinalproduct>
        <drugdosagetext>20 MG ONCE PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020902</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020902</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050510-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060619</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>S06-SWI-02005-01</companynumb>
    <primarysource>
      <reportercountry>SWITZERLAND</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>76</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSED LEVEL OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISTURBANCE IN ATTENTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLIGHT OF IDEAS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERAL PHYSICAL HEALTH DETERIORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERREFLEXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METABOLIC ACIDOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MIOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY ACIDOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHABDOMYOLYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEROTONIN SYNDROME</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>20060222</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MORPHINE</medicinalproduct>
        <drugdosagetext>8 MG BID SC</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060220</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060221</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRAMADOL HCL</medicinalproduct>
        <drugdosagetext>400 MG QD PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060220</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060222</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CIBACIN (BENAZEPRIL HYDROCHLORIDE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLPIDEM TARTRATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HEPARIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050511-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060630</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006P1000354</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>70</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY STENOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RETEPLASE (RETEPLASE)</medicinalproduct>
        <drugdosagetext>IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ACUTE MYOCARDIAL INFARCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060131</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060131</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REOPRO</medicinalproduct>
        <drugdosagetext>IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ACUTE MYOCARDIAL INFARCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060131</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060131</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETYLSALICYLIC ACID SRT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLOPIDOGREL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACEBUTOLOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RAMIPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATROVASTATIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050512-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060616</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>S06-SWE-02611-01</companynumb>
    <primarysource>
      <reportercountry>SWEDEN</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>85</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSED LEVEL OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY DEPRESSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MEMANTINE HCL</medicinalproduct>
        <drugauthorizationnumb>21487</drugauthorizationnumb>
        <drugdosagetext>10 MG BID PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEMENTIA ALZHEIMER'S TYPE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051220</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060414</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALVEDON (PARACETAMOL)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PEVARYL (ECONAZOLE NITRATE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENALAPRIL ACTAVIS (ENALAPRIL)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLACIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BEHEPAN (CYANOCOBALAMIN)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIGOXIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KALUM RETARD</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NITROMEX (GLYCERYL TRINITRATE)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050513-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060524</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>S06-UKI-02610-01</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>70</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>GAZE PALSY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE RIGIDITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL STIFFNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MEMANTINE HCL</medicinalproduct>
        <drugauthorizationnumb>21487</drugauthorizationnumb>
        <drugdosagetext>5 MG BID PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEMENTIA ALZHEIMER'S TYPE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060510</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FENTANYL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050514-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060619</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>S06-FRA-02605-01</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>53</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DELIRIUM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC STEATOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATOMEGALY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JAUNDICE CHOLESTATIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE DRUG OVERDOSE INTENTIONAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROTHROMBIN TIME PROLONGED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY DISTRESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROPLEX (ESCITALOPRAM)</medicinalproduct>
        <drugauthorizationnumb>21323</drugauthorizationnumb>
        <drugdosagetext>20 TABLET ONCE PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060504</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060504</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROPLEX (ESCITALOPRAM)</medicinalproduct>
        <drugdosagetext>1 TABLET QD PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060504</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060504</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXAZEPAM</medicinalproduct>
        <drugdosagetext>60 TABLET ONCE PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060504</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060504</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXAZEPAM</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060504</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060504</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050515-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060619</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>S06-FRA-02604-01</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>69</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>COMPLETED SUICIDE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJURY ASPHYXIATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL SELF-INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARANOIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROPLEX (ESCITALOPRAM)</medicinalproduct>
        <drugauthorizationnumb>21323</drugauthorizationnumb>
        <drugdosagetext>10 MG QD PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANTIDEPRESSANT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060222</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060515</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GLUCOPHAGE</medicinalproduct>
        <drugdosagetext>1700 MG QD PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060523</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TERCIAN (CYAMEMAZINE)</medicinalproduct>
        <drugdosagetext>0.5 UNITS BID PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060516</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060523</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ATORVASTATIN CALCIUM</medicinalproduct>
        <drugdosagetext>40 MG QD PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060523</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INEXIUM (ESOMEPRAZOLE)</medicinalproduct>
        <drugdosagetext>20 MG QD PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060222</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060523</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RAMIPRIL</medicinalproduct>
        <drugdosagetext>1.25 MG BID PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060523</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>75 MG QD PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060523</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugdosagetext>40 MG QD PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060523</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050516-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060621</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>226259</companynumb>
    <primarysource>
      <reportercountry>GREECE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>59</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>92</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE DENSITY DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEBRILE NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATOCRIT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOWER RESPIRATORY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OESOPHAGITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCREATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLEURAL EFFUSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVASTIN</medicinalproduct>
        <drugdosagetext>460 MG, Q2W, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLON CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051213</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060321</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXALIPLATIN(OXALIPLATIN)</medicinalproduct>
        <drugdosagetext>178 MG, Q2W, INTRAVENOUS; 157.5 MG</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLON CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051213</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXALIPLATIN(OXALIPLATIN)</medicinalproduct>
        <drugdosagetext>178 MG, Q2W, INTRAVENOUS; 157.5 MG</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLON CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060321</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUOROURACIL</medicinalproduct>
        <drugdosagetext>840 MG, INTRAVENOUS; 630 MG, IV BOLUS; 1050 MG</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLON CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051213</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUOROURACIL</medicinalproduct>
        <drugdosagetext>840 MG, INTRAVENOUS; 630 MG, IV BOLUS; 1050 MG</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLON CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060321</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEUCOVORIN CALCIUM</medicinalproduct>
        <drugdosagetext>420 MG, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLON CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051213</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEORECORMON (EPOETIN BETA)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050517-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060620</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>S06-FRA-02186-01</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>68</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD CHLORIDE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERALISED OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPONATRAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROPLEX (ESCITALOPRAM)</medicinalproduct>
        <drugauthorizationnumb>21323</drugauthorizationnumb>
        <drugdosagetext>10 MG QD PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060503</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060511</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GAVISCON</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PSEUDOPHAGE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IPERTEN (MANIDIPINE HYDROCHLORIDE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SERETIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOZITEC (FOSINOPRIL)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYPERIUM (RILMENIDINE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANTOPRAZOLE SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XALATAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PERMIXON (SERENOA REPENS)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050518-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060621</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>224658</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>49</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLUENZA LIKE ILLNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HERCEPTIN</medicinalproduct>
        <drugdosagetext>8  MG/KG, INTRAVENOUS; 6 MG/KG, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PHENERGAN (PROMETHAZINE HYDROCHLORIDE)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050519-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060619</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>226889</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD CREATINE PHOSPHOKINASE MB INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOSITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HERCEPTIN</medicinalproduct>
        <drugdosagetext>INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050520-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>430007E06ITA</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>70</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>BLOOD CULTURE POSITIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHILLS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTI-ORGAN FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSEUDOMONAS INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY DISTRESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPTIC SHOCK</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NOVANTRONE (MITOXANTRONE HYDROCHLORIDE)</medicinalproduct>
        <drugauthorizationnumb>19297</drugauthorizationnumb>
        <drugdosagetext>10 MG</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060605</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYTARABINE</medicinalproduct>
        <drugdosagetext>180 MG</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060607</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ETOPOSIDE</medicinalproduct>
        <drugdosagetext>180  MG</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060603</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050521-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060627</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>430002E06DEU</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>75</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>APLASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRONCHOPULMONARY ASPERGILLOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NOVANTRONE</medicinalproduct>
        <drugauthorizationnumb>19297</drugauthorizationnumb>
        <drugdosagetext>14 MG, 1 IN 1 DAYS</drugdosagetext>
        <drugindication>ACUTE MYELOID LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040811</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040815</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYTARABINE</medicinalproduct>
        <drugdosagetext>194 MG, 1 IN 1 DAYS</drugdosagetext>
        <drugindication>ACUTE MYELOID LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040811</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040817</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ETOPOSIDE</medicinalproduct>
        <drugdosagetext>194 MG, 1 IN 1 DAYS</drugdosagetext>
        <drugindication>ACUTE MYELOID LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040811</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040813</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VANCOMYCIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEROPENEM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050522-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060622</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>S06-FRA-02185-01</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>55</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>GAMMA-GLUTAMYLTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROPLEX (ESCITALOPRAM)</medicinalproduct>
        <drugauthorizationnumb>21323</drugauthorizationnumb>
        <drugdosagetext>10 MG QD PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060314</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EFFEXOR</medicinalproduct>
        <drugdosagetext>75 MG QD</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050523-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060622</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>S06-ITA-00438-01</companynumb>
    <primarysource>
      <reportercountry>ITALY</reportercountry>
    </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>BLOOD POTASSIUM DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONTUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEAD INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPONATRAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POVERTY OF SPEECH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPEECH DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ESCITALOPRAM OXALATE</medicinalproduct>
        <drugauthorizationnumb>21323</drugauthorizationnumb>
        <drugdosagetext>5 MG QD PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MAJOR DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051119</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051204</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FELODIPINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IRBESARTAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROPAFENONE HYDROCHLORIDE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050524-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060627</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>230019M06CAN</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>32</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HEPATIC FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBIF</medicinalproduct>
        <drugtreatmentduration>14</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050525-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060621</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>S06-GER-02617-01</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>40</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>NEUTROPHIL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ESCITALOPRAM OXALATE</medicinalproduct>
        <drugauthorizationnumb>21323</drugauthorizationnumb>
        <drugdosagetext>10 MG QD PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIRTAZAPINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENZODIAZEPINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050526-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060623</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>S06-IRL-01956-01</companynumb>
    <primarysource>
      <reportercountry>IRELAND</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>3.385</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEONATAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEXAPRO</medicinalproduct>
        <drugauthorizationnumb>21323</drugauthorizationnumb>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060220</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050527-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060623</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>S06-AUT-02401-01</companynumb>
    <primarysource>
      <reportercountry>AUSTRIA</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>74</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>66</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BENIGN PROSTATIC HYPERPLASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD LACTATE DEHYDROGENASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLONIC POLYP</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERURICAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEGACOLON</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCREATIC ATROPHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUBILEUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUPRAVENTRICULAR TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ESCITALOPRAM OXALATE</medicinalproduct>
        <drugauthorizationnumb>21323</drugauthorizationnumb>
        <drugdosagetext>5 MG QD PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DYSTHYMIC DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060328</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060505</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050528-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060626</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CERZ-11268</companynumb>
    <primarysource>
      <reportercountry>ITALY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>0</patientsex>
      <reaction>
        <reactionmeddrapt>SPLENIC RUPTURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CEREZYME</medicinalproduct>
        <drugauthorizationnumb>20367</drugauthorizationnumb>
        <drugindication>GAUCHER'S DISEASE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050529-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060622</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>S06-BRA-02000-01</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>45</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>65</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>COMPLETED SUICIDE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJURY ASPHYXIATION</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>20060425</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060513</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONAZEPAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALPROATE SODIUM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050530-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060621</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>S06-GER-02616-01</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>22</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>120</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ESCITALOPRAM OXALATE</medicinalproduct>
        <drugauthorizationnumb>21323</drugauthorizationnumb>
        <drugdosagetext>20 MG QD PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SUICIDE ATTEMPT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050801</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOPAMAX</medicinalproduct>
        <drugindication>WEIGHT CONTROL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050531-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060621</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2202</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>63</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>57</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ALANINE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASPARTATE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONJUNCTIVAL HYPERAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EOSINOPHILIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EPIDERMAL NECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FACE OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL MUCOSA EROSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALMAR-PLANTAR ERYTHRODYSAESTHESIA SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN EXFOLIATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOXIC SKIN ERUPTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TARGRETIN</medicinalproduct>
        <drugauthorizationnumb>21055</drugauthorizationnumb>
        <drugdosagetext>300 MG QD PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MYCOSIS FUNGOIDES</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060327</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060409</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAHOR (ATORVASTATIN)</medicinalproduct>
        <drugdosagetext>20 MG QD PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DYSLIPIDAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060327</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATORVASTATIN CALCIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DESLORATADINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROXYZINE HYDROCHLORIDE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050532-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060622</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DSA_28382_2006</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>47</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDE ATTEMPT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAVOR</medicinalproduct>
        <drugauthorizationnumb>17794</drugauthorizationnumb>
        <drugdosagetext>80 MG ONCE PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060622</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060622</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DRAIN PIPE CLEANER</medicinalproduct>
        <drugdosagetext>5 ML ONCE</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060622</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060622</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050533-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>HQWYE490629JUN06</companynumb>
    <primarysource>
      <reportercountry>SPAIN</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>70</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TORSADE DE POINTES</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRANGOREX                            (AMIODARONE)</medicinalproduct>
        <drugauthorizationnumb>18972</drugauthorizationnumb>
        <drugdosagetext>200 MG 1X PER 1 DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050202</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060412</drugenddate>
        <drugtreatmentduration>435</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRANGOREX                            (AMIODARONE)</medicinalproduct>
        <drugauthorizationnumb>18972</drugauthorizationnumb>
        <drugdosagetext>200 MG 1X PER 1 DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATRIAL FLUTTER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050202</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060412</drugenddate>
        <drugtreatmentduration>435</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050534-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060630</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>HQWYE514130JUN06</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>45</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DIABETES MELLITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RAPAMUNE</medicinalproduct>
        <drugauthorizationnumb>21110</drugauthorizationnumb>
        <drugdosagetext>3 MG 1X PER 1 DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS AGAINST TRANSPLANT REJECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050922</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOSPORINE</medicinalproduct>
        <drugindication>PROPHYLAXIS AGAINST TRANSPLANT REJECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050611</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051003</drugenddate>
        <drugtreatmentduration>115</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MYCOPHENOLATE MOFETIL</medicinalproduct>
        <drugdosagetext>1 G 2X PER 1 DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS AGAINST TRANSPLANT REJECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050611</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISONE TAB</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS AGAINST TRANSPLANT REJECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060112</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060120</drugenddate>
        <drugtreatmentduration>9</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZENAPAX</medicinalproduct>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PROPHYLAXIS AGAINST TRANSPLANT REJECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050610</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050610</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZENAPAX</medicinalproduct>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PROPHYLAXIS AGAINST TRANSPLANT REJECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050623</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050623</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TENORMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INEXIUM (ESOMEPRAZOLE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050535-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GBWYE894829JUN06</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>54</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>AMNESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HALLUCINATIONS, MIXED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISION BLURRED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BENZHEXOL (TRIHEXYPHENIDYL)</medicinalproduct>
        <drugauthorizationnumb>6773</drugauthorizationnumb>
        <drugdosagetext>1 MG 1X PER 1 DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DYSTONIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060425</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BENZHEXOL (TRIHEXYPHENIDYL)</medicinalproduct>
        <drugauthorizationnumb>6773</drugauthorizationnumb>
        <drugdosagetext>1 MG 1X PER 1 DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>TREMOR</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060425</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ASPIRIN TAB</medicinalproduct>
        <drugdosagetext>75 MG</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LAMOTRIGINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRAVASTATIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROPRANOLOL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050536-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-NOVOPROD-254623</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>53</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>72</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HYPOGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDE ATTEMPT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NOVORAPID 30 MIX CHU FLEXPEN</medicinalproduct>
        <drugauthorizationnumb>21172</drugauthorizationnumb>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLICLAZIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIGOXIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SENNOSIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FAMOTIDINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050537-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FRWYE134716MAY03</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>53</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CHRONIC ALLOGRAFT NEPHROPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMODIALYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>KIDNEY TRANSPLANT REJECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RAPAMUNE</medicinalproduct>
        <drugauthorizationnumb>21083</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS AGAINST TRANSPLANT REJECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030109</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030127</drugenddate>
        <drugtreatmentduration>19</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RAPAMUNE</medicinalproduct>
        <drugauthorizationnumb>21083</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS AGAINST TRANSPLANT REJECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030128</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ANTITHYMOCYTE IMMUNOGLOBULIN (ANTITHYMOCYTE IMMUNOGLOBULIN, , 0)</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PROPHYLAXIS AGAINST TRANSPLANT REJECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030109</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030115</drugenddate>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MYCOPHENOLATE MOFETIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS AGAINST TRANSPLANT REJECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030109</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SOLU-MEDROL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030109</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050538-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FRWYE859028JUN06</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMPLETED SUICIDE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EFFEXOR</medicinalproduct>
        <drugauthorizationnumb>20151</drugauthorizationnumb>
        <drugdosagetext>75 MG TOTAL DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GENERALISED ANXIETY DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ANXIOLYTICS                           (ANXIOLYTICS, , 0)</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GENERALISED ANXIETY DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050539-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DEWYE657929MAY06</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>45</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>COMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE DRUG OVERDOSE INTENTIONAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDE ATTEMPT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VENLAFAXINE HCL</medicinalproduct>
        <drugauthorizationnumb>20699</drugauthorizationnumb>
        <drugdosagetext>50 CAPSULES (OVERDOSE AMOUNT 3750 MG)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060528</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060528</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOXEPIN HCL</medicinalproduct>
        <drugdosagetext>90 TABLETS (OVERDOSE AMOUNT 4500 MG)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060528</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060528</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KLOSTERFRAU MELISSENGEIST           (ETHANOL/HERBAL EXTRACTS NOS, , 0)</medicinalproduct>
        <drugdosagetext>1 BOTTLE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060528</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060528</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOLPIDEM TARTRATE</medicinalproduct>
        <drugdosagetext>20 TABLETS (OVERDOSE AMOUNT 200 MG)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060528</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060528</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050540-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>6023926</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>67</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>NIGHTMARE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSYCHOTIC DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CONCOR COR           (BISOPROLOL FUMARATE)</medicinalproduct>
        <drugauthorizationnumb>19982</drugauthorizationnumb>
        <drugdosagetext>1 DOSAGE FORMS (1 DOSAGE FORMS,1 IN 1 D)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERKINETIC HEART SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060401</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050541-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006-142849-NL</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>60</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>AIRWAY COMPLICATION OF ANAESTHESIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VECURONIUM BROMIDE</medicinalproduct>
        <drugauthorizationnumb>18776</drugauthorizationnumb>
        <drugdosagetext>0.1 MG/KG ONCE</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>INDUCTION OF ANAESTHESIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEVOFLURANE</medicinalproduct>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>MAINTENANCE OF ANAESTHESIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROPOFOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NITROUS OXIDE W/ OXYGEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EPHEDRINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEOSTIGMINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATROPINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050542-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040719</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0519857A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>71.4</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DISABILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG DEPENDENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG WITHDRAWAL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HALLUCINATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERFORMANCE STATUS DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSYCHOTIC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TINNITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VERTIGO</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
        <drugauthorizationnumb>20031</drugauthorizationnumb>
        <drugdosagetext>20MG AT NIGHT</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PANIC ATTACK</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19950101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BUSPAR</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050543-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050503</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0558201A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>43</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>AMNESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANGER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISTURBANCE IN ATTENTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG WITHDRAWAL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IRRITABILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANIC ATTACK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOCIAL PROBLEM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THINKING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISION BLURRED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAXIL CR</medicinalproduct>
        <drugauthorizationnumb>20936</drugauthorizationnumb>
        <drugdosagetext>25MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANXIETY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040601</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050544-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050503</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0558210A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>43</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>103.2</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>AGGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANGER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CRYING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG WITHDRAWAL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING JITTERY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HOMICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HOT FLUSH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MIGRAINE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NERVOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NIGHTMARE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDE ATTEMPT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISION BLURRED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
        <drugauthorizationnumb>20031</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANXIETY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19971201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAROXETINE HYDROCHLORIDE</medicinalproduct>
        <drugauthorizationnumb>020031</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030929</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROPRANOLOL</medicinalproduct>
        <drugdosagetext>55TAB SINGLE DOSE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020709</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020709</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WELLBUTRIN SR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATIVAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KLONOPIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCAGON</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMITREX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050545-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050509</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0558613A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>53</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>AGGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ALOPECIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG WITHDRAWAL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING OF DESPAIR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOOD ALTERED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NIGHTMARE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDE ATTEMPT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
        <drugauthorizationnumb>20031</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PANIC DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020904</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SINGULAIR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREVACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WELLBUTRIN SR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CATAPRES-TTS-1</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050546-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050509</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0558621A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>47</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>AGGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AGORAPHOBIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANGER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISORIENTATION</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>HOSTILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOOD ALTERED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
        <drugauthorizationnumb>20031</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19970101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONAZEPAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WELLBUTRIN SR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDROXYPROGESTERONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050547-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050531</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0560480A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>131.8</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABNORMAL BEHAVIOUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AGITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AMNESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANGER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COGNITIVE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CRYING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPENDENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISABILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG DEPENDENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG WITHDRAWAL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FOOD CRAVING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIBIDO DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOOD SWINGS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NIGHT SWEATS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANIC ATTACK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERFORMANCE STATUS DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
        <drugauthorizationnumb>20031</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANXIETY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19970801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040501</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VIAGRA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RITALIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DYAZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN SUPPLEMENTS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HERBAL SUPPLEMENTS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WELLBUTRIN XL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLEXERIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALEVE (CAPLET)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050548-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0591323A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>40</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>71.4</patientweight>
      <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>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISABILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG WITHDRAWAL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLAT AFFECT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MANIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENTAL STATUS CHANGES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OBSESSIVE THOUGHTS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSYCHOMOTOR HYPERACTIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSYCHOTIC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TENSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>WELLBUTRIN XL</medicinalproduct>
        <drugauthorizationnumb>21515</drugauthorizationnumb>
        <drugdosagetext>150MG IN THE MORNING</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040122</drugstartdate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
        <drugauthorizationnumb>020031</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RESTLESS LEGS SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROZAC</medicinalproduct>
        <drugdosagetext>20MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
        <drugdosagetext>15MG AT NIGHT</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MANIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030501</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMBIEN</medicinalproduct>
        <drugindication>SLEEP DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050549-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060206</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0592526A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>13</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING OF DESPAIR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLAT AFFECT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HOMICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL SELF-INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OBSESSIVE THOUGHTS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARANOIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SELF MUTILATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEXUAL DYSFUNCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDE ATTEMPT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THINKING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
        <drugauthorizationnumb>020031</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OBSESSIVE-COMPULSIVE DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAXIL CR</medicinalproduct>
        <drugauthorizationnumb>020936</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OBSESSIVE-COMPULSIVE DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020901</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAROXETINE HYDROCHLORIDE</medicinalproduct>
        <drugauthorizationnumb>020031</drugauthorizationnumb>
        <drugdosagetext>20MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OBSESSIVE-COMPULSIVE DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROZAC</medicinalproduct>
        <drugindication>OBSESSIVE-COMPULSIVE DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19970701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19980601</drugenddate>
        <drugtreatmentduration>11</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BUSPAR</medicinalproduct>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020901</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ISONIAZID</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>TUBERCULOSIS SKIN TEST POSITIVE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GEODON</medicinalproduct>
        <drugdosagetext>20MG TWICE PER DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>STRATTERA</medicinalproduct>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030201</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050550-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060313</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0597662A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>32</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ALPHA 1 FOETOPROTEIN ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NORMAL NEWBORN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRISOMY 21</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EPIVIR</medicinalproduct>
        <drugauthorizationnumb>20564</drugauthorizationnumb>
        <drugdosagetext>300MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZIDOVUDINE</medicinalproduct>
        <drugauthorizationnumb>019655</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ANTIVIRAL PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIDANOSINE</medicinalproduct>
        <drugdosagetext>400MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEVIRAPINE</medicinalproduct>
        <drugdosagetext>400MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KALETRA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051208</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051219</drugenddate>
        <drugtreatmentduration>12</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050551-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060623</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>226994</companynumb>
    <primarysource>
      <reportercountry>THAILAND</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>60</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVASTIN</medicinalproduct>
        <drugdosagetext>10 MG/KG, Q2W, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLON CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060619</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUSPECTED DRUG(GENERIC COMPONENT(S) NOT KNOWN)</medicinalproduct>
        <drugindication>COLON CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060619</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEUCOVORIN CALCIUM</medicinalproduct>
        <drugindication>COLON CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060619</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUOROURACIL</medicinalproduct>
        <drugindication>COLON CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060619</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXALIPLATIN (OXALIPLATIN)</medicinalproduct>
        <drugindication>COLON CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060619</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTIBIOTICS NOS (ANTIBIOTICS NOS)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050552-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060707</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0611458A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>74</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSYCHOTIC DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAROXETINE HCL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>20031</drugauthorizationnumb>
        <drugdosagetext>40MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BIPOLAR DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
        <drugauthorizationnumb>020031</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BIPOLAR DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>STEROIDS (UNKNOWN)</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VICODIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM GLUCONATE</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>ISOSORBIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPROL-XL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLONASE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALPHAGAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NITROGLYCERIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADVAIR DISKUS 100/50</medicinalproduct>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050553-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060711</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0611806A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>61</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CRYING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NIGHT SWEATS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEROTONIN SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
        <drugbatchnumb>UNKOWN</drugbatchnumb>
        <drugauthorizationnumb>020031</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060529</drugstartdate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL SPIROS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050554-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060707</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-GLAXOSMITHKLINE-A0611994A</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>24</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG TOXICITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDE ATTEMPT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYBAN</medicinalproduct>
        <drugauthorizationnumb>020711</drugauthorizationnumb>
        <drugdosagetext>6TAB SINGLE DOSE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060707</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060707</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050555-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060712</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0612047A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>LEUKAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VALTREX</medicinalproduct>
        <drugauthorizationnumb>020487</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NO CONCURRENT MEDICATIONS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050556-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060111</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-JPN-A200600054</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>24</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>53</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEPRESSED LEVEL OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GRAND MAL CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY RATE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDE ATTEMPT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
        <drugauthorizationnumb>20031</drugauthorizationnumb>
        <drugdosagetext>10MG VARIABLE DOSE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030122</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060108</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ANEXATE TAB</medicinalproduct>
        <drugdosagetext>.5MG PER DAY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060108</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060108</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VASOLAN</medicinalproduct>
        <drugdosagetext>120MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>TACHYCARDIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021003</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060108</drugenddate>
        <drugtreatmentduration>171</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRYPTANOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERVENTILATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021003</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060108</drugenddate>
        <drugtreatmentduration>110</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GASMOTIN</medicinalproduct>
        <drugdosagetext>15MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030618</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031213</drugenddate>
        <drugtreatmentduration>179</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VOLTAREN</medicinalproduct>
        <drugdosagetext>50MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEADACHE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030709</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060108</drugenddate>
        <drugtreatmentduration>915</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SOLANAX</medicinalproduct>
        <drugdosagetext>1.2MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERVENTILATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031022</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060108</drugenddate>
        <drugtreatmentduration>810</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NAUZELIN</medicinalproduct>
        <drugdosagetext>15MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>VOMITING</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031213</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060108</drugenddate>
        <drugtreatmentduration>758</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOGMATYL</medicinalproduct>
        <drugdosagetext>100MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040526</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060108</drugenddate>
        <drugtreatmentduration>593</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ROHYPNOL</medicinalproduct>
        <drugdosagetext>4MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INSOMNIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040621</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060108</drugenddate>
        <drugtreatmentduration>567</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RIVOTRIL</medicinalproduct>
        <drugdosagetext>1MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041027</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060108</drugenddate>
        <drugtreatmentduration>439</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HIRNAMIN</medicinalproduct>
        <drugdosagetext>75MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041222</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060108</drugenddate>
        <drugtreatmentduration>383</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>20050105</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060108</drugenddate>
        <drugtreatmentduration>369</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TEGRETOL</medicinalproduct>
        <drugdosagetext>400MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ESSENTIAL TREMOR</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050720</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060108</drugenddate>
        <drugtreatmentduration>173</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMIGRAN</medicinalproduct>
        <drugdosagetext>100MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEADACHE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030709</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060108</drugenddate>
        <drugtreatmentduration>915</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050557-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060112</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>J200600007</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>47</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANOREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRIC ULCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC FUNCTION ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JAUNDICE CHOLESTATIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCREATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN DISCOLOURATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SAWACILLIN</medicinalproduct>
        <drugauthorizationnumb>50754</drugauthorizationnumb>
        <drugdosagetext>750MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HELICOBACTER INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051205</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051212</drugenddate>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAKEPRON</medicinalproduct>
        <drugdosagetext>30MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HELICOBACTER INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051205</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051212</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLARITHROMYCIN</medicinalproduct>
        <drugdosagetext>400MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HELICOBACTER INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051205</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051212</drugenddate>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050558-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-GLAXOSMITHKLINE-B0409613A</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>66</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ADRENAL INSUFFICIENCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AMYOTROPHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CENTRAL OBESITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CUSHING'S SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIPOHYPERTROPHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOPOROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPINAL COMPRESSION FRACTURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SERETIDE DISKUS</medicinalproduct>
        <drugauthorizationnumb>21077</drugauthorizationnumb>
        <drugdosagetext>1PUFF TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>BRONCHIAL HYPERREACTIVITY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051201</drugenddate>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NORVIR</medicinalproduct>
        <drugdosagetext>100MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EPIVIR</medicinalproduct>
        <drugdosagetext>300MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REYATAZ</medicinalproduct>
        <drugdosagetext>300MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VIDEX</medicinalproduct>
        <drugdosagetext>400MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050701</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050559-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060412</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IT-GLAXOSMITHKLINE-B0421029A</companynumb>
    <primarysource>
      <reportercountry>ITALY</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>31</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DERMATITIS ALLERGIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH MACULO-PAPULAR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AUGMENTIN '125'</medicinalproduct>
        <drugauthorizationnumb>50564</drugauthorizationnumb>
        <drugdosagetext>1G TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>COUGH</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060324</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060327</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050560-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060424</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-JPN-A200601345</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>73</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>58</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE DIASTOLIC DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE SYSTOLIC INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAZE PALSY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMODIALYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERACUSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULAR WEAKNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NERVE INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SENSORY DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPEECH DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VALTREX</medicinalproduct>
        <drugauthorizationnumb>20487</drugauthorizationnumb>
        <drugdosagetext>1000MG THREE TIMES PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HERPES ZOSTER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060423</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060423</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANDEL</medicinalproduct>
        <drugdosagetext>40MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990428</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NU-LOTAN</medicinalproduct>
        <drugdosagetext>50MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000412</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugdosagetext>20MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030124</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>JUVELA N</medicinalproduct>
        <drugdosagetext>200MG THREE TIMES PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NEUROPATHY PERIPHERAL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19840705</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NITOROL R</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANGINA PECTORIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19991006</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FERROMIA</medicinalproduct>
        <drugdosagetext>50MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19970929</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THYRADIN S</medicinalproduct>
        <drugdosagetext>25MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPOTHYROIDISM</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041110</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOXONIN</medicinalproduct>
        <drugdosagetext>60MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PHARYNGOLARYNGEAL PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050922</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARDENALIN</medicinalproduct>
        <drugdosagetext>.5MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060322</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NOVORAPID</medicinalproduct>
        <drugdosagetext>12IU THREE TIMES PER DAY</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020426</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN</medicinalproduct>
        <drugdosagetext>10IU PER DAY</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19941104</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARASENA-A</medicinalproduct>
        <drugdosagetext>300MG PER DAY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>HERPES ZOSTER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060420</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ISOTONIC SODIUM CHLORIDE SOLUTION</medicinalproduct>
        <drugdosagetext>250ML PER DAY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060420</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060422</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYANOCOBALAMIN</medicinalproduct>
        <drugdosagetext>500MCG THREE TIMES PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NEUROPATHY PERIPHERAL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060420</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060423</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANDERM</medicinalproduct>
        <drugadministrationroute>003</drugadministrationroute>
        <drugindication>HERPES ZOSTER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060420</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060423</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050561-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060621</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>221141</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>65</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD ALBUMIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD BICARBONATE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD SODIUM DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NECK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROTEIN TOTAL INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVASTIN</medicinalproduct>
        <drugbatchnumb>B1766</drugbatchnumb>
        <drugdosagetext>470 MG, Q3W, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLON CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050913</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060626</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVASTIN</medicinalproduct>
        <drugbatchnumb>M50309</drugbatchnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CAPECITABINE (CAPECITABINE)</medicinalproduct>
        <drugdosagetext>1650 MG, BID, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>COLON CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050913</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060626</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXALIPLATIN (OXALIPLATIN)</medicinalproduct>
        <drugdosagetext>130 MG, Q3W, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLON CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050913</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060626</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXALIPLATIN (OXALIPLATIN)</medicinalproduct>
        <drugbatchnumb>U0029</drugbatchnumb>
        <drugdosagetext>150 MG</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAXOLON</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANADOL (ACETAMINOPHEN)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>QUINAPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IRBESARTAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE BESYLATE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050562-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060508</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-JPN-A200601479</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>62</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ASCITES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC CIRRHOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC FUNCTION ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JAUNDICE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLEURAL EFFUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SHOCK</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZIAGEN</medicinalproduct>
        <drugauthorizationnumb>20977</drugauthorizationnumb>
        <drugdosagetext>300MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050927</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060329</drugenddate>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RETROVIR</medicinalproduct>
        <drugauthorizationnumb>019655</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19961126</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060329</drugenddate>
        <drugtreatmentduration>10</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EPIVIR</medicinalproduct>
        <drugauthorizationnumb>020564</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19961126</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050926</drugenddate>
        <drugtreatmentduration>9</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KALETRA</medicinalproduct>
        <drugdosagetext>6U PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050927</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060329</drugenddate>
        <drugtreatmentduration>26</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMARYL</medicinalproduct>
        <drugdosagetext>1 PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060329</drugenddate>
        <drugtreatmentduration>52</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>FACTOR VIII DEFICIENCY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060329</drugenddate>
        <drugtreatmentduration>52</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050563-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060510</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>J200600007</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>47</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ALANINE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANOREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASPARTATE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BILIRUBIN CONJUGATED INCREASED</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 GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD LACTATE DEHYDROGENASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARCINOEMBRYONIC ANTIGEN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAMMA-GLUTAMYLTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC FUNCTION ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JAUNDICE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JAUNDICE CHOLESTATIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN DISCOLOURATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMOXICILLIN</medicinalproduct>
        <drugauthorizationnumb>50754</drugauthorizationnumb>
        <drugdosagetext>750MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HELICOBACTER INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051205</drugstartdate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLARITHROMYCIN</medicinalproduct>
        <drugdosagetext>400MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HELICOBACTER INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051205</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051212</drugenddate>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAKEPRON</medicinalproduct>
        <drugdosagetext>30MG VARIABLE DOSE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HELICOBACTER INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051128</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051212</drugenddate>
        <drugtreatmentduration>15</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050564-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060524</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-GLAXOSMITHKLINE-B0425316A</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>51</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>CEREBRAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG RASH WITH EOSINOPHILIA AND SYSTEMIC SYMPTOMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERNATIONAL NORMALISED RATIO INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL SOFT TISSUE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROTHROMBIN LEVEL DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PURPURA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH MACULO-PAPULAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SHOCK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOXIC SKIN ERUPTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMICTAL</medicinalproduct>
        <drugauthorizationnumb>20241</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060209</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060328</drugenddate>
        <drugtreatmentduration>48</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CIBLOR</medicinalproduct>
        <drugauthorizationnumb>050564</drugauthorizationnumb>
        <drugdosagetext>250MG UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ORCHITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060321</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREVISCAN</medicinalproduct>
        <drugdosagetext>10MG AT NIGHT</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PHLEBITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060328</drugenddate>
        <drugtreatmentduration>87</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CIFLOX</medicinalproduct>
        <drugdosagetext>500MG UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ORCHITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060321</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050565-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060530</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-JPN-A200601807</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>75</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>45</patientweight>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ANOREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLISTER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSED LEVEL OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULAR WEAKNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALLOR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SCAB</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUDDEN DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VIRAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VIRAL MYOCARDITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VALTREX</medicinalproduct>
        <drugauthorizationnumb>20487</drugauthorizationnumb>
        <drugdosagetext>1000MG VARIABLE DOSE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HERPES ZOSTER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060518</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060525</drugenddate>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DECADRON</medicinalproduct>
        <drugdosagetext>.25MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUTIDE</medicinalproduct>
        <drugdosagetext>200MCG PER DAY</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLEANAL</medicinalproduct>
        <drugdosagetext>1200MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNIPHYL</medicinalproduct>
        <drugdosagetext>400MCG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MICARDIS</medicinalproduct>
        <drugdosagetext>20MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031110</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOGMATYL</medicinalproduct>
        <drugdosagetext>150MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031006</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRIMPERAN TAB</medicinalproduct>
        <drugdosagetext>3U PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050409</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050566-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060602</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-GLAXOSMITHKLINE-B0426428B</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>1.9</patientweight>
      <reaction>
        <reactionmeddrapt>APNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONGENITAL ANOMALY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IRRITABILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE TWITCHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUROMYOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYPNOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
        <drugauthorizationnumb>20031</drugauthorizationnumb>
        <drugdosagetext>120MG PER DAY</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060531</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060531</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEPAS</medicinalproduct>
        <drugdosagetext>1MG PER DAY</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060601</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RIZE</medicinalproduct>
        <drugdosagetext>6U PER DAY</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060601</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050567-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060605</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-JPN-A200601873</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>72</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>44</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>APNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSED LEVEL OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EXTENSOR PLANTAR RESPONSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MIOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYPNOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VALTREX</medicinalproduct>
        <drugauthorizationnumb>020487</drugauthorizationnumb>
        <drugdosagetext>1000MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HERPES ZOSTER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060531</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060601</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THEO-DUR</medicinalproduct>
        <drugdosagetext>200MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060602</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KIPRES</medicinalproduct>
        <drugdosagetext>5MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060602</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EBASTEL</medicinalproduct>
        <drugdosagetext>10MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060602</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PERSANTIN</medicinalproduct>
        <drugdosagetext>300MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060602</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ISOSORBIDE MONONITRATE</medicinalproduct>
        <drugdosagetext>40MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANGINA PECTORIS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060602</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
        <drugdosagetext>200MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060602</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TERNELIN</medicinalproduct>
        <drugdosagetext>2MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CERVICOBRACHIAL SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060602</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VASOLAN</medicinalproduct>
        <drugdosagetext>120MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANGINA PECTORIS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060602</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MUCOSOLVAN</medicinalproduct>
        <drugdosagetext>45MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060602</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FRANDOL S</medicinalproduct>
        <drugdosagetext>40MG PER DAY</drugdosagetext>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>ANGINA PECTORIS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060602</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>20060602</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BIOFERMIN R</medicinalproduct>
        <drugdosagetext>3MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060602</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEROPEN</medicinalproduct>
        <drugdosagetext>.5MG PER DAY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060425</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060515</drugenddate>
        <drugtreatmentduration>21</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUNGUARD</medicinalproduct>
        <drugdosagetext>100MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>FUNGAL INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060428</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060515</drugenddate>
        <drugtreatmentduration>18</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EPOGEN</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060422</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEUTROGIN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060425</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060501</drugenddate>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLOBULIN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060426</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060430</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050568-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060607</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-JPN-A200601905</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>66</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>54</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COORDINATION ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DELUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIPLOPIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSARTHRIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HALLUCINATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULAR WEAKNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPEECH DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOXIC INDUCED ENCEPHALOPATHY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VALTREX</medicinalproduct>
        <drugauthorizationnumb>20487</drugauthorizationnumb>
        <drugdosagetext>500MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HERPES ZOSTER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060603</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYANOCOBALAMIN</medicinalproduct>
        <drugdosagetext>1.5MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HERPES ZOSTER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060605</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRAVIT</medicinalproduct>
        <drugdosagetext>100MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RENAL FAILURE CHRONIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060530</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060603</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NAPROXEN</medicinalproduct>
        <drugdosagetext>600MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HERPES ZOSTER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060605</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALINAMIN-F</medicinalproduct>
        <drugdosagetext>75MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HERPES ZOSTER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060605</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROMAC</medicinalproduct>
        <drugdosagetext>1G PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RENAL FAILURE CHRONIC</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAKEPRON</medicinalproduct>
        <drugdosagetext>15MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RENAL FAILURE CHRONIC</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>100MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RENAL FAILURE CHRONIC</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ISOSORBIDE MONONITRATE</medicinalproduct>
        <drugdosagetext>40MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RENAL FAILURE CHRONIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060330</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIGMART</medicinalproduct>
        <drugdosagetext>15MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060330</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>URSO</medicinalproduct>
        <drugdosagetext>300MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BIO THREE</medicinalproduct>
        <drugdosagetext>3U PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALTAN</medicinalproduct>
        <drugdosagetext>3G PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GOSHA-JINKI-GAN</medicinalproduct>
        <drugdosagetext>7.5G PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEXITIL</medicinalproduct>
        <drugdosagetext>150MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060514</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANALDINE</medicinalproduct>
        <drugdosagetext>200MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CAROTID ARTERY STENOSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060227</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050569-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060614</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-JPN-A200602054</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>64</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>COMPLETED SUICIDE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
        <drugauthorizationnumb>20031</drugauthorizationnumb>
        <drugdosagetext>10MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION POSTMENOPAUSAL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030205</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060527</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEPROMEL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION POSTMENOPAUSAL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030205</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060527</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIMAS</medicinalproduct>
        <drugdosagetext>400MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION POSTMENOPAUSAL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030122</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030205</drugenddate>
        <drugtreatmentduration>15</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METLIGINE</medicinalproduct>
        <drugdosagetext>4MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030205</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060527</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GRAMALIL</medicinalproduct>
        <drugdosagetext>50MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION POSTMENOPAUSAL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030205</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060527</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORAZEPAM</medicinalproduct>
        <drugdosagetext>2MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION POSTMENOPAUSAL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030205</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060527</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEPAS</medicinalproduct>
        <drugdosagetext>1MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION POSTMENOPAUSAL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030205</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060527</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FORSENID</medicinalproduct>
        <drugdosagetext>2U PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONSTIPATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030205</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060527</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LENDORMIN</medicinalproduct>
        <drugdosagetext>.25MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030122</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030205</drugenddate>
        <drugtreatmentduration>15</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050570-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060615</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>NL-GLAXOSMITHKLINE-B0428165A</companynumb>
    <primarysource>
      <reportercountry>NETHERLANDS</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABORTION SPONTANEOUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUMATRIPTAN SUCCINATE</medicinalproduct>
        <drugauthorizationnumb>20080</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAXALT</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050571-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060623</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>226385</companynumb>
    <primarysource>
      <reportercountry>NETHERLANDS</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>70</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PANCREATITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVASTIN</medicinalproduct>
        <drugdosagetext>7.5 MG/KG, Q3W, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLORECTAL CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060526</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CAPECITABINE (CAPECITABINE)</medicinalproduct>
        <drugdosagetext>1000 MG/M2, BID, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>COLORECTAL CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060526</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXALIPLATIN (OXALIPLATIN)</medicinalproduct>
        <drugdosagetext>130 MG/M2, Q3W, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLORECTAL CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOCLOPRAMIDE (METOCLOPRAMIDE HYDROCHLORIDE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SLOW-K</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOPERAMIDE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050572-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060619</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-JPN-A200602148</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>38</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>59</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEPRESSED LEVEL OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG TOXICITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IRRITABILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDE ATTEMPT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
        <drugauthorizationnumb>20031</drugauthorizationnumb>
        <drugdosagetext>10MG SEE DOSAGE TEXT</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060529</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060617</drugenddate>
        <drugtreatmentduration>20</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN DRUG</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEILAX</medicinalproduct>
        <drugdosagetext>1MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060529</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060611</drugenddate>
        <drugtreatmentduration>14</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GASMOTIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEILAX</medicinalproduct>
        <drugdosagetext>2MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060612</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060617</drugenddate>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050573-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060626</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-JPN-A200602285</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>83</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VALTREX</medicinalproduct>
        <drugauthorizationnumb>20487</drugauthorizationnumb>
        <drugdosagetext>1000MG THREE TIMES PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HERPES ZOSTER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060621</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060626</drugenddate>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYANOCOBALAMIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NAPROXEN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRICOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPIDIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MUCOSTA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050574-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-JPN-A200602387</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <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>PAXIL</medicinalproduct>
        <drugauthorizationnumb>20031</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OBSESSIVE-COMPULSIVE DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060516</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEPAS</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060601</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050575-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060627</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DK-GLAXOSMITHKLINE-B0429501A</companynumb>
    <primarysource>
      <reportercountry>DENMARK</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>28</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CONCUSSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SERETIDE</medicinalproduct>
        <drugauthorizationnumb>21077</drugauthorizationnumb>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060103</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050576-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060630</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-GLAXOSMITHKLINE-B0429515A</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>71</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANAPHYLACTIC SHOCK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CREATININE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS GENERALISED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TINNITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL DISTURBANCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLAMOXYL</medicinalproduct>
        <drugauthorizationnumb>50754</drugauthorizationnumb>
        <drugdosagetext>1G SINGLE DOSE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NASAL POLYPS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060617</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060617</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RHINOCORT</medicinalproduct>
        <drugdosagetext>1PUFF SINGLE DOSE</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>NASAL POLYPS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060617</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060617</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVLOCARDYL</medicinalproduct>
        <drugdosagetext>160MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLOR</medicinalproduct>
        <drugdosagetext>5MG PER DAY</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PAROXETINE HCL</medicinalproduct>
        <drugdosagetext>20MG PER DAY</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRANXENE 10</medicinalproduct>
        <drugdosagetext>10MG PER DAY</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050577-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060630</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-JPN-A200602401</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>EPISTAXIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGE SUBCUTANEOUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC FUNCTION ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
        <drugauthorizationnumb>20031</drugauthorizationnumb>
        <drugdosagetext>20MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060530</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060629</drugenddate>
        <drugtreatmentduration>30</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDONINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARTIST</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>URALYT</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEVALOTIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SELBEX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEPAS</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEILAX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGNESIUM OXIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050578-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060704</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-GLAXOSMITHKLINE-B0429711A</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>47</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REQUIP</medicinalproduct>
        <drugauthorizationnumb>20658</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050208</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SINEMET</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050426</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060530</drugenddate>
        <drugtreatmentduration>13</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROPRAM</medicinalproduct>
        <drugdosagetext>1UNIT PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040115</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>STILNOX</medicinalproduct>
        <drugdosagetext>10MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040115</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050579-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060703</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>NL-GLAXOSMITHKLINE-B0430106A</companynumb>
    <primarysource>
      <reportercountry>NETHERLANDS</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>64</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>EYE DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAROXETINE HCL</medicinalproduct>
        <drugauthorizationnumb>020031</drugauthorizationnumb>
        <drugdosagetext>20MG UNKNOWN</drugdosagetext>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060404</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060430</drugenddate>
        <drugtreatmentduration>27</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLORAZEPATE</medicinalproduct>
        <drugdosagetext>5MG THREE TIMES PER DAY</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050580-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060703</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-JPN-A200602471</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CORNEAL EPITHELIUM DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IRIS DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOVIRAX</medicinalproduct>
        <drugauthorizationnumb>18603</drugauthorizationnumb>
        <drugadministrationroute>047</drugadministrationroute>
        <drugindication>KERATITIS HERPETIC</drugindication>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050581-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060630</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-JPN-A200602483</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>24</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HEMIPLEGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMIGRAN</medicinalproduct>
        <drugauthorizationnumb>20132</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050582-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060707</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>NL-GLAXOSMITHKLINE-B0430275A</companynumb>
    <primarysource>
      <reportercountry>NETHERLANDS</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>MICROCYTIC ANAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ROSIGLITAZONE MALEATE</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050583-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060710</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-GLAXOSMITHKLINE-B0430313A</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>62</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZELITREX</medicinalproduct>
        <drugauthorizationnumb>20487</drugauthorizationnumb>
        <drugdosagetext>500MG SIX TIMES PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HERPES ZOSTER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060610</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060615</drugenddate>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMIODARONE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARDENSIEL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRIATEC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREVISCAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KALEORID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPANTHYL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EQUANIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIMETANE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050584-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060706</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-JPN-A200602516</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>22</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANAPHYLACTIC SHOCK</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
        <drugauthorizationnumb>20031</drugauthorizationnumb>
        <drugdosagetext>20MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PANIC DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060703</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NAUZELIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEILAX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050585-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060710</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-GLAXOSMITHKLINE-B0430384A</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>9</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERNATIONAL NORMALISED RATIO INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLAMOXYL</medicinalproduct>
        <drugauthorizationnumb>50754</drugauthorizationnumb>
        <drugdosagetext>1G THREE TIMES PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060613</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060619</drugenddate>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACENOCOUMAROL</medicinalproduct>
        <drugdosagetext>1TAB SEE DOSAGE TEXT</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060618</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEROXAT</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060619</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXEOL</medicinalproduct>
        <drugdosagetext>1UNIT PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060619</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOLIPRANE</medicinalproduct>
        <drugdosagetext>6UNIT PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060619</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HEMIGOXINE NATIVELLE</medicinalproduct>
        <drugdosagetext>.125MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060619</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANTOPRAZOLE SODIUM</medicinalproduct>
        <drugdosagetext>40MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060619</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TEMESTA</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRIATEC</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIFFU K</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060619</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASILIX</medicinalproduct>
        <drugdosagetext>500MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASILIX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060620</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060623</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050586-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060623</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>226480</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>68</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>45.4</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CHEST DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EFFECT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUROPATHY PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STOMATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUPRAVENTRICULAR EXTRASYSTOLES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENTRICULAR EXTRASYSTOLES</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVASTIN</medicinalproduct>
        <drugdosagetext>7.5 MG/KG, Q3W, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLORECTAL CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060511</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060531</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CAPECITABINE (CAPECITABINE)</medicinalproduct>
        <drugdosagetext>2000 MG/M2, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>COLORECTAL CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060511</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060606</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXALIPLATIN(OXALIPLATIN)</medicinalproduct>
        <drugdosagetext>130 MG/M2, Q3W, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLORECTAL CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060511</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060531</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050587-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060706</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BE-GLAXOSMITHKLINE-B0430392A</companynumb>
    <primarysource>
      <reportercountry>BELGIUM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>45</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MALARONE</medicinalproduct>
        <drugauthorizationnumb>021078</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MALARIA PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANXIOLYTIC</medicinalproduct>
        <drugindication>STRESS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050588-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060704</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-GLAXOSMITHKLINE-B0430406A</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>84</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>70</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>EPISTAXIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEROXAT</medicinalproduct>
        <drugauthorizationnumb>20031</drugauthorizationnumb>
        <drugdosagetext>20MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060503</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>STALEVO 100</medicinalproduct>
        <drugdosagetext>300MG THREE TIMES PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PARKINSON'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060214</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060603</drugenddate>
        <drugtreatmentduration>110</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LAROXYL</medicinalproduct>
        <drugdosagetext>50MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DYSTHYMIC DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPANTHYL</medicinalproduct>
        <drugdosagetext>160MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERCHOLESTEROLAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SERESTA</medicinalproduct>
        <drugdosagetext>10MG FOUR TIMES PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DYSTHYMIC DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DAFALGAN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GENITAL PAIN FEMALE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NOVONORM</medicinalproduct>
        <drugdosagetext>1MG PER DAY</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VASTAREL</medicinalproduct>
        <drugdosagetext>2UNIT PER DAY</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050589-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060706</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-JPN-A200602521</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>81</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>URINARY RETENTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOVIRAX</medicinalproduct>
        <drugauthorizationnumb>018603</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ONEALFA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>JUVELA</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050590-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060704</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-GLAXOSMITHKLINE-B0430539A</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ATTENTION DEFICIT/HYPERACTIVITY DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GUILLAIN-BARRE SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HALLUCINATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATOTOXICITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUROTOXICITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARALYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>506U78</medicinalproduct>
        <drugauthorizationnumb>21877</drugauthorizationnumb>
        <drugdosagetext>2.7G UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>NON-HODGKIN'S LYMPHOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060621</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060623</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAZOBAC</medicinalproduct>
        <drugdosagetext>4.5G THREE TIMES PER DAY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060620</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugdosagetext>20MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060620</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
        <drugdosagetext>100MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060620</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COTRIM DS</medicinalproduct>
        <drugdosagetext>960MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060602</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAMADOL HCL</medicinalproduct>
        <drugdosagetext>50MG FOUR TIMES PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060620</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DICLOFENAC</medicinalproduct>
        <drugdosagetext>25MG THREE TIMES PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BLEMAREN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FENISTIL</medicinalproduct>
        <drugdosagetext>4MG THREE TIMES PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060620</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMPHOMORONAL</medicinalproduct>
        <drugdosagetext>400MG FOUR TIMES PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060620</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050591-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060704</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-GLAXOSMITHKLINE-B0430569A</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>4</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>12</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CRYOGLOBULINAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CUTANEOUS VASCULITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ECCHYMOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOE AMPUTATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VENTOLIN</medicinalproduct>
        <drugauthorizationnumb>018473</drugauthorizationnumb>
        <drugindication>ASTHMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060301</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLIXOTIDE</medicinalproduct>
        <drugauthorizationnumb>020121</drugauthorizationnumb>
        <drugdosagetext>50MCG PER DAY</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060301</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MOTILIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VFEND</medicinalproduct>
        <drugdosagetext>50MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040501</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BACTRIM</medicinalproduct>
        <drugdosagetext>5ML THREE TIMES PER WEEK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INFECTION PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020501</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GRANOCYTE</medicinalproduct>
        <drugdosagetext>13.4IU6 THREE TIMES PER WEEK</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GAVISCON</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050592-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060704</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-GLAXOSMITHKLINE-B0430655A</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>82</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARIXTRA</medicinalproduct>
        <drugauthorizationnumb>021345</drugauthorizationnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PHLEBITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050593-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060706</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IT-GLAXOSMITHKLINE-B0430681A</companynumb>
    <primarysource>
      <reportercountry>ITALY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>POLYCYTHAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMICTAL</medicinalproduct>
        <drugauthorizationnumb>20241</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BIPOLAR DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTIHYPERTENSIVE</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050594-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnesscongenitalanomali>1</seriousnesscongenitalanomali>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060710</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>NL-GLAXOSMITHKLINE-B0430707A</companynumb>
    <primarysource>
      <reportercountry>NETHERLANDS</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>0</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>3</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY HYPERTENSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAROXETINE HCL</medicinalproduct>
        <drugauthorizationnumb>020031</drugauthorizationnumb>
        <drugdosagetext>20MG PER DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEPAKENE</medicinalproduct>
        <drugdosagetext>500MG PER DAY</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050595-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-GLAXOSMITHKLINE-D0050171A</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>55</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>APTYALISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BURNING SENSATION MUCOSAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRY MOUTH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPEPSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GLOSSODYNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC ENZYME INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AUGMENTIN '125'</medicinalproduct>
        <drugauthorizationnumb>50564</drugauthorizationnumb>
        <drugdosagetext>1TAB THREE TIMES PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060511</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060515</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ESTRADOT</medicinalproduct>
        <drugdosagetext>37.5UG PER DAY</drugdosagetext>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060615</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HORMONE</medicinalproduct>
        <drugadministrationroute>045</drugadministrationroute>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060616</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050596-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060707</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-GLAXOSMITHKLINE-D0050246A</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PREMATURE LABOUR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RETROVIR</medicinalproduct>
        <drugauthorizationnumb>19655</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050597-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060707</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-GLAXOSMITHKLINE-D0050246B</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>7</patientonsetage>
      <patientonsetageunit>804</patientonsetageunit>
      <patientweight>19.8</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>NECROTISING COLITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RETROVIR</medicinalproduct>
        <drugauthorizationnumb>19655</drugauthorizationnumb>
        <drugdosagetext>3MG FOUR TIMES PER DAY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ANTIVIRAL PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030614</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030623</drugenddate>
        <drugtreatmentduration>10</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RETROVIR</medicinalproduct>
        <drugindication>HIV INFECTION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030614</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050598-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060622</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>226990</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>60</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BRONCHOSPASM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSARTHRIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVASTIN</medicinalproduct>
        <drugdosagetext>687.5 MG, Q3W, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLON CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060117</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060117</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CAPECITABINE (CAPECITABINE)</medicinalproduct>
        <drugdosagetext>4300 MG, QD, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>COLON CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060117</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXALIPLATIN (OXALIPLATIN)</medicinalproduct>
        <drugdosagetext>275 MG, Q3W, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLON CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060117</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060117</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CITALOPRAM HYDROBROMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FERROUS SULFATE TAB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GRANISETRON (GRANISETRON HYDROCHLORIDE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOCLOPRAMIDE (METOCLOPRAMIDE HYDROCHLORIDE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050599-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060711</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-GLAXOSMITHKLINE-D0050285A</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>16</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CIRCULATORY COLLAPSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARIXTRA</medicinalproduct>
        <drugauthorizationnumb>021345</drugauthorizationnumb>
        <drugdosagetext>2.5MG UNKNOWN</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>THROMBOSIS PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060101</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050600-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060703</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-KINGPHARMUSA00001-K200600864</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>64</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CHEST DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERICARDITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALTACE</medicinalproduct>
        <drugauthorizationnumb>019901</drugauthorizationnumb>
        <drugdosagetext>10 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060120</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BISOPROLOL FUMARATE</medicinalproduct>
        <drugdosagetext>1 U, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050404</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugdosagetext>1 U, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERCHOLESTEROLAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050405</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>75 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANTIPLATELET THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050405</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050601-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060615</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-ABBOTT-06P-167-0336606-00</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HAEMATOLOGY TEST ABNORMAL</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>20040417</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051031</drugenddate>
        <drugtreatmentduration>562</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060330</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060609</drugenddate>
        <drugtreatmentduration>70</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROXYCHLOROQUINE</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLURBIPROFEN</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORETHISTERONE</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050602-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060621</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>226886</companynumb>
    <primarysource>
      <reportercountry>NETHERLANDS</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>61</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVASTIN</medicinalproduct>
        <drugdosagetext>7.5 MG/KG, Q3W, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLORECTAL CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060524</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CAPECITABINE (CAPECITABINE)</medicinalproduct>
        <drugdosagetext>1000 MG/M2, BID, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>COLORECTAL CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060524</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXALIPLATIN (OXALIPLATIN)</medicinalproduct>
        <drugdosagetext>130 MG/M2, Q3W, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLORECTAL CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060524</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050603-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060621</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>226613</companynumb>
    <primarysource>
      <reportercountry>GREECE</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>59</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>92</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD UREA DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATOCRIT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OESOPHAGITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVASTIN</medicinalproduct>
        <drugdosagetext>460 MG, Q2W, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLON CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051213</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060321</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXALIPLATIN (OXALIPLATIN)</medicinalproduct>
        <drugdosagetext>178 MG, Q2W, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLON CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051213</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUOROURACIL</medicinalproduct>
        <drugdosagetext>840 MG, 2/WEEK/Q2W, INTRAVENOUS; SEE IMAGE</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLON CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051213</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUOROURACIL</medicinalproduct>
        <drugdosagetext>840 MG, 2/WEEK/Q2W, INTRAVENOUS; SEE IMAGE</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLON CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051213</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUOROURACIL</medicinalproduct>
        <drugbatchnumb>B1919</drugbatchnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEUCOVORIN CALCIUM</medicinalproduct>
        <drugdosagetext>420 MG, Q2W, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLON CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051213</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EPOETIN BETA (EPOETIN BETA)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050604-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060622</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>226333</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>48</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>56</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANKLE FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISEASE PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TENDON RUPTURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVASTIN</medicinalproduct>
        <drugdosagetext>280 MG, Q2W, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLORECTAL CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051115</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060115</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NOVALGIN (DIPYRONE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAMADOL HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AQUAPHOR (CERESIN, MINERAL OIL, PETROLATUM, WOOL ALCOHOL)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CIPROFLOXACIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHYLPREDNISOLONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MIRTAZAPINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050605-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060706</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-ABBOTT-06P-167-0337832-00</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>22</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEPRESSION</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>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050606-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060630</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200610308BVD</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>61</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>94</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERAL PHYSICAL HEALTH DETERIORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SORAFENIB</medicinalproduct>
        <drugauthorizationnumb>21923</drugauthorizationnumb>
        <drugdosagetext>400  MG, BID, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATIC NEOPLASM MALIGNANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060130</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060306</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MARCUMAR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLEXANE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANTOZOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XANEF [ENALAPRIL MALEATE]</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BELOC ZOK</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050607-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060627</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200612707GDS</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>66</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVELOX</medicinalproduct>
        <drugauthorizationnumb>21085</drugauthorizationnumb>
        <drugdosagetext>400 MG, TOTAL DAILY, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050608-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060623</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>RS006060-J</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>89</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>CARDIO-RESPIRATORY ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATEMESIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERSTITIAL LUNG DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OXYGEN SATURATION DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</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>REFLUX OESOPHAGITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060423</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060430</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugdosagetext>20 MG, 1 IN 1 D, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>REFLUX OESOPHAGITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060420</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060422</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SELBEX                 (TEPRENONE)</medicinalproduct>
        <drugdosagetext>150 MG, 3 IN 1 D, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060423</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MAGMITT               (MAGNESIUM OXIDE)</medicinalproduct>
        <drugdosagetext>750 MG, 3 IN 1 D, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONSTIPATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060423</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HALTHROW                     (TAMSULOSIN HYDROCHLORIDE)</medicinalproduct>
        <drugdosagetext>0.2 MG, 1 IN 1 D, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BENIGN PROSTATIC HYPERPLASIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060425</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUMARIN                    (FLOMOXEF SODIUM)</medicinalproduct>
        <drugdosagetext>2 GM, 2 IN 1 D, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>C-REACTIVE PROTEIN INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060420</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060421</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADONA (CARBAZOCHROME SODIUM SULFONATE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALESION (EPINASTINE HYDROCHLORIDE)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050609-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060626</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-2006-017221</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>27</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>64</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOGLYCAEMIA</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>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NOVORAPID (INSULIN ASPART)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050610-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060706</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-ABBOTT-06P-167-0337856-00</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>66</patientweight>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>AORTIC DISSECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERICARDIAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041124</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050415</drugenddate>
        <drugtreatmentduration>141</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>AMLODIPINE</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>DIDRONEL</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>ISOSORBIDE MONONITRATE</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>TEMAZEPAM</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>5050611-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060706</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-ABBOTT-06P-028-0337859-00</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>95.34</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050803</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FERROUS GLUCONATE</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CODEINE CONTIN</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>ISOPHANE INSULIN</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>DOMPERIDONE</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>PREDNISONE TAB</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYANOCOBALAMIN</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>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>MULTIVITAMIN</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM GLUCONATE</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RISEDRONATE SODIUM</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050928</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050612-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>NO-2005-026286</companynumb>
    <primarysource>
      <reportercountry>NORWAY</reportercountry>
      <qualification>3</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>BRAIN DAMAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRAIN DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRAIN OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YASMIN</medicinalproduct>
        <drugauthorizationnumb>21098</drugauthorizationnumb>
        <drugdosagetext>1 TAB(S), 21D/28D, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONTRACEPTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040801</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050613-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-2006-017326</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>27</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>GOITRE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METRORRHAGIA</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>20060521</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050614-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060623</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IE-2006-017522</companynumb>
    <primarysource>
      <reportercountry>IRELAND</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>37</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANGIOTENSIN CONVERTING ENZYME INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA NODOSUM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLUENZA LIKE ILLNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE ATROPHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE CELLULITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANNICULITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THERAPY NON-RESPONDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BETASERON</medicinalproduct>
        <drugdosagetext>SUBCUTANEOUS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RELAPSING-REMITTING MULTIPLE SCLEROSIS</drugindication>
        <drugtreatmentduration>120</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BETASERON</medicinalproduct>
        <drugdosagetext>SUBCUTANEOUS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RELAPSING-REMITTING MULTIPLE SCLEROSIS</drugindication>
        <drugtreatmentduration>823</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SUMATRIPTAN SUCCINATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DICLOFENAC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLATIRAMER ACETATE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050615-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060621</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PL-2005-005527</companynumb>
    <primarysource>
      <reportercountry>POLAND</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>49</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEEP VEIN THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DELUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENTAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>REFUSAL OF TREATMENT BY PATIENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPASTIC PARAPLEGIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BETAFERON</medicinalproduct>
        <drugdosagetext>250 OR 500 UG EVERY 2D, SUBCUTANEOUS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040715</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050411</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BETAFERON</medicinalproduct>
        <drugdosagetext>250 OR 500 UG EVERY 2D, SUBCUTANEOUS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050827</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PALIN (PIPEMIDIC ACID)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GUTRON (MIDODRINE HYDROCHLORIDE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SOLU-MEDROL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMIPRAMINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CITALOPRAM HYDROBROMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MIANSERIN       (MIANSERIN)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VINPOCETINE            (VINPOCETINE)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050616-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060329</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ES-SANOFI-SYNTHELABO-F01200600920</companynumb>
    <primarysource>
      <reportercountry>SPAIN</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>75</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>INTESTINAL PERFORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPTIC SHOCK</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CAPECITABINE</medicinalproduct>
        <drugdosagetext>1000 MG/M2 TWICE DAILY FROM DAY 1 TO DAY 15, Q3W</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>COLORECTAL CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040113</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040123</drugenddate>
        <drugtreatmentduration>11</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXALIPLATIN</medicinalproduct>
        <drugauthorizationnumb>021492</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLORECTAL CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040113</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040113</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>805</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050617-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060623</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006RR-02791</companynumb>
    <primarysource>
      <reportercountry>NETHERLANDS</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>77</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASCITES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMODIALYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEPHRITIS INTERSTITIAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CIPROFLOXACIN</medicinalproduct>
        <drugauthorizationnumb>75747</drugauthorizationnumb>
        <drugdosagetext>750 MG BID ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEVICE RELATED INFECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIPYRADIMAL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FENOTEROL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IPRATROPRIUM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050618-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060622</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006RR-02778</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ALANINE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVERDOSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CODEINE PHOSPHATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PARACETAMOL FAMILY (PARACETAMOL) TABLET</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRAMADOL HCL</medicinalproduct>
        <drugdosagetext>50 MG QID ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050619-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006-06-0185</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>68</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>60</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>CARDIO-RESPIRATORY ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBRAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTRACRANIAL HAEMATOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCYTOPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEG-INTRON</medicinalproduct>
        <drugdosagetext>80 MCG QW SUBCUTANEOUS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060203</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060505</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBETOL</medicinalproduct>
        <drugdosagetext>600-400*MG ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060203</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060509</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>URSO</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DAI-KENCHU-TO GRANULES</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLOSTRIDIUM BUTYRICUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TSUMURA JUZEN-TAIHO-TO</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050620-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060705</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006-05-0060</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>64</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>94</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CHILLS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TEMODAL</medicinalproduct>
        <drugauthorizationnumb>21029</drugauthorizationnumb>
        <drugdosagetext>400-300 MG ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GLIOBLASTOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060227</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060322</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CHEMOTHERAPY REGIMENS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RADIATION THERAPY</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATORVASTATIN CALCIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMOVANE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANTOPRAZOLE SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREVISCAN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050621-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060630</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-SANOFI-SYNTHELABO-A04200600671</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>68</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>GASTRIC ULCER HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugauthorizationnumb>020839</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CORONARY ARTERY DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041201</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050622-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060703</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-SANOFI-SYNTHELABO-A02200601732</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>61</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL ANGIODYSPLASIA HAEMORRHAGIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATEMESIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MELAENA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NORMOCHROMIC NORMOCYTIC ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RECTAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BRONCHODUAL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BROMAZEPAM</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TARDYFERON</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NASACORT</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>045</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BUFLOMEDIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAHOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DYSLIPIDAEMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VASTAREL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugauthorizationnumb>020839</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060531</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050623-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060630</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006-06-2091</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>65</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ACUTE RESPIRATORY FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG INFILTRATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INTRON A</medicinalproduct>
        <drugdosagetext>9 MIU QWK SUBCUTANEOUS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040920</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051105</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050624-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20051123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-426618</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>16</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>68</patientweight>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>AFFECTIVE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAL FISTULA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANOGENITAL WARTS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>APPENDICITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AUTOIMMUNE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AUTOIMMUNE HEPATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD URINE PRESENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BODY TEMPERATURE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BUNDLE BRANCH BLOCK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIOLIPIN ANTIBODY POSITIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CELLULITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHOLECYSTITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLITIS ULCERATIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMPLEMENT FACTOR C3 DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMPLEMENT FACTOR C4 DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CROHN'S DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEEP VEIN THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIABETES MELLITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG DEPENDENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ENDOMETRIOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLANK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FUNGAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GALLBLADDER DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRIC VARICES HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGIC OVARIAN CYST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHOIDS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC CIRRHOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC NECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATITIS CHRONIC ACTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMPAIRED HEALING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFECTED CYST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLAMMATORY BOWEL DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IRRITABLE BOWEL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LABORATORY TEST ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEUKOCYTOCLASTIC VASCULITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOWER EXTREMITY MASS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENSTRUATION IRREGULAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTI-ORGAN DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NECK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEPHROLITHIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OBSESSIVE-COMPULSIVE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVARIAN CYST RUPTURED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCYTOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PELVIC INFLAMMATORY DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PELVIC PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERIRECTAL ABSCESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PILONIDAL CYST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PORTAL HYPERTENSIVE GASTROPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRECANCEROUS CELLS PRESENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROTHROMBIN TIME PROLONGED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYELONEPHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RAYNAUD'S PHENOMENON</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RED BLOOD CELL SEDIMENTATION RATE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SALPINGITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SJOGREN'S SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN PAPILLOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN ULCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPLENOMEGALY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STAPHYLOCOCCAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYSTEMIC LUPUS ERYTHEMATOSUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TIBIA FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UMBILICAL HERNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>18662</drugauthorizationnumb>
        <drugdosagetext>ACCUTANE 40 - 80 ALTERNATING.</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ACNE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19930716</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>018662</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19930815</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19931130</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASACOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMURAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE TAB</medicinalproduct>
        <drugindication>AUTOIMMUNE HEPATITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PHENERGAN HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CIPRO</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TEGRETOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEMEROL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHADONE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CORTISOL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050625-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006-06-1647</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>COMPLETED SUICIDE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GUN SHOT WOUND</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INTERFERON ALFA-2A</medicinalproduct>
        <drugauthorizationnumb>20903</drugauthorizationnumb>
        <drugindication>HEPATITIS C</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COPEGUS CAPSULES                    (RIBAVIRIN)</medicinalproduct>
        <drugindication>HEPATITIS C</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050626-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060704</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>OMPQ-UK-0607S-0837</companynumb>
    <primarysource>
      <reportercountry>NORWAY</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>39</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>COMPARTMENT SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EXTRAVASATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OMNIPAQUE 140</medicinalproduct>
        <drugauthorizationnumb>18956</drugauthorizationnumb>
        <drugdosagetext>100 ML SINGLE DOSE IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BILE DUCT OBSTRUCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051117</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051117</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050627-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>T200600728</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>30</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANAPHYLACTIC SHOCK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONTRAST MEDIA REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPHORIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEXABRIX</medicinalproduct>
        <drugauthorizationnumb>18905</drugauthorizationnumb>
        <drugdosagetext>2 ML SINGLE INTRA-ARTERIAL</drugdosagetext>
        <drugadministrationroute>013</drugadministrationroute>
        <drugindication>ANGIOGRAM CEREBRAL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060621</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060621</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SENNOSIDE A+B</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050629-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060627</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>14317</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>73</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FASCIITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL STIFFNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POLYARTHRITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARBOPLATIN</medicinalproduct>
        <drugauthorizationnumb>76517</drugauthorizationnumb>
        <drugindication>OVARIAN EPITHELIAL CANCER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NICARDIPINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRAZEPAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MOCLOBEMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRAZEPAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENZAFIBRATE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050630-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US017857</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
    </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>PROVIGIL</medicinalproduct>
        <drugauthorizationnumb>20717</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050631-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060530</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-SANOFI-SYNTHELABO-A03200603672</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>AMNESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EATING DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HALLUCINATION, AUDITORY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAND FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEAD DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEAD INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENTAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NECK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ROAD TRAFFIC ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ROTATOR CUFF SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SLEEP WALKING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPINAL FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THYROID DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INDERAL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ESKALITH</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENZTROPINE MESYLATE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XENICAL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMBIEN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>019908</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040501</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SERZONE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19970101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HALCION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIAZEPAM</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050632-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060705</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-SANOFI-SYNTHELABO-A03200604270</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DRUG LEVEL INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMPAIRED DRIVING ABILITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMBIEN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050633-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060626</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>430001L06FRA</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>59</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>AGRANULOCYTOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRONCHIAL OBSTRUCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEUKAEMIA RECURRENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY DISTRESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STENOTROPHOMONAS INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MITOXANTRONE</medicinalproduct>
        <drugauthorizationnumb>19297</drugauthorizationnumb>
        <drugindication>ACUTE MYELOID LEUKAEMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYTARABINE</medicinalproduct>
        <drugindication>ACUTE MYELOID LEUKAEMIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050634-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060705</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-SANOFI-SYNTHELABO-A03200604261</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>35</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BRADYPHRENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HOMICIDE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMPAIRED DRIVING ABILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ROAD TRAFFIC ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMBIEN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021774</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060630</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060701</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050635-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060704</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-SANOFI-SYNTHELABO-A02200601769</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>47</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REQUIP</medicinalproduct>
        <drugdosagetext>DOSE INCREASED UNTIL 4 MG X 3 DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PARKINSON'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050208</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050425</drugenddate>
        <drugtreatmentduration>77</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REQUIP</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050426</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060108</drugenddate>
        <drugtreatmentduration>258</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REQUIP</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060109</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060531</drugenddate>
        <drugtreatmentduration>143</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REQUIP</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060531</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REQUIP</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060531</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROPRAM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040115</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SINEMET</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PARKINSON'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050426</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051026</drugenddate>
        <drugtreatmentduration>184</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SINEMET</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051027</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060530</drugenddate>
        <drugtreatmentduration>216</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>STILNOX</medicinalproduct>
        <drugauthorizationnumb>019908</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040115</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050636-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060703</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-SANOFI-SYNTHELABO-A02200601733</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>63</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANAL FISSURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL ANGIODYSPLASIA HAEMORRHAGIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHOIDS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MELAENA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RECTAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAHOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DYSLIPIDAEMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugauthorizationnumb>020839</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PERIPHERAL ARTERIAL OCCLUSIVE DISEASE</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060530</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RAMIPRIL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060530</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050638-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060622</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2006FR09414</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>20</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DIABETES MELLITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOSPORINE</medicinalproduct>
        <drugauthorizationnumb>80336</drugauthorizationnumb>
        <drugindication>MYOSITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19910101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19980101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugindication>MYOSITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMMUNOGLOBULINS (IMMUNOGLOBULINS)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLASMAPHERESIS (NO INGREDIENTS/SUBSTANCES)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYCLOPHOSPHAMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MYCOPHENOLATE MOFETIL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050639-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060630</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006RL000245</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>80</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DYSARTHRIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSGEUSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FACIAL PALSY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL DISTURBANCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RYTHMOL</medicinalproduct>
        <drugauthorizationnumb>19151</drugauthorizationnumb>
        <drugdosagetext>600 MG; QD; PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060505</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060603</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASCORBIC ACID/CACLIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NAFTIDROFURYL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUINDIONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050640-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060623</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>NL-2006-017511</companynumb>
    <primarysource>
      <reportercountry>NETHERLANDS</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>13</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD TRIGLYCERIDES INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CYTOMEGALOVIRUS INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HISTIOCYTOSIS HAEMATOPHAGIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SERUM FERRITIN INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUDARA</medicinalproduct>
        <drugauthorizationnumb>20038</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugindication>BONE MARROW CONDITIONING REGIMEN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTITHYMCYTE IMMUNOGLOBULIN (ANTITHYMOCYTE IMMUNOGLOBULIN)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYCLOPHOSHAMIDE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050641-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060627</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-2006-016554</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>61</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>62</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CSF TEST ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DELIRIUM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MAGNEVIST</medicinalproduct>
        <drugauthorizationnumb>19596</drugauthorizationnumb>
        <drugdosagetext>10 ML, 0.67 ML/SEC, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NUCLEAR MAGNETIC RESONANCE IMAGING</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060405</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060405</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMARYL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050643-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060704</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006-07-0049</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>39</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HYPERPARATHYROIDISM PRIMARY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MINERAL DEFICIENCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPINAL FRACTURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TEMODAL</medicinalproduct>
        <drugauthorizationnumb>21029</drugauthorizationnumb>
        <drugindication>GLIOBLASTOMA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050644-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060704</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GXKR2006DE03812</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>28</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>AFFECT LABILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ALCOHOLISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG DEPENDENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PARACETAMOL (NGX)(PARACETAMOL) TABLET</medicinalproduct>
        <drugauthorizationnumb>89959</drugauthorizationnumb>
        <drugdosagetext>500 MG, 9QD, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050646-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060624</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GXKR2006DE01624</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>42</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>55</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ACTIVATED PARTIAL THROMBOPLASTIN TIME PROLONGED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BODY TEMPERATURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COAGULOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSGEUSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EOSINOPHILIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA ORAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JARISCH-HERXHEIMER REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEUKOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEURALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PETECHIAE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESTLESSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SENSATION OF FOREIGN BODY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VAGINAL CANDIDIASIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CEFTRIAXONE</medicinalproduct>
        <drugauthorizationnumb>65204</drugauthorizationnumb>
        <drugdosagetext>2 G, QD, INFUSION</drugdosagetext>
        <drugindication>NEUROBORRELIOSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060203</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060221</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050647-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060626</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004238693CA</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>67</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>74</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ACUTE CORONARY SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AMNESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIOMYOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHOLECYSTITIS ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DILATATION ATRIAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EAR PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EMBOLISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FACIAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GALLBLADDER DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC LESION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MITRAL VALVE INCOMPETENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE TWITCHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUTENT</medicinalproduct>
        <drugbatchnumb>L-0671</drugbatchnumb>
        <drugauthorizationnumb>21938</drugauthorizationnumb>
        <drugdosagetext>37.5 MG (CYCLIC), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTROINTESTINAL STROMAL TUMOUR</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041006</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041008</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOSEC (OMEPRAZOLE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LENOLTECH NO 3 (CAFFEINE, CODEINE, PARACETAMOL)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NITROLINGUAL (GLYCERYL TRINITRATE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALPRAZOLAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALTACE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050649-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060623</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>226991</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>42</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PURPURA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HERCEPTIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050650-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>012341</companynumb>
    <primarysource>
      <reportercountry>AUSTRIA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>70</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MONOPARESIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRIALT</medicinalproduct>
        <drugauthorizationnumb>21060</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>037</drugadministrationroute>
        <drugindication>PAIN</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050651-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060622</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006073174</companynumb>
    <primarysource>
      <reportercountry>FINLAND</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>40</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>64</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DECOMPRESSION SICKNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISORIENTATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG ABUSER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG DEPENDENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUROLOGICAL SYMPTOM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TUNNEL VISION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL ACUITY REDUCED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NICORETTE</medicinalproduct>
        <drugauthorizationnumb>20714</drugauthorizationnumb>
        <drugdosagetext>12 -18 CAPS (120-180 MG) DAILY AS NEEDED, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SMOKING CESSATION THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000801</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050652-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060626</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>14326</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BONE MARROW FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARBOPLATIN</medicinalproduct>
        <drugauthorizationnumb>76517</drugauthorizationnumb>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GEMCITABINE</medicinalproduct>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050654-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2005-12-1151</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>64</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ALANINE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASPARTATE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CREATINE PHOSPHOKINASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GRIP STRENGTH DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE NECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POLYMYOSITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEG-INTRON</medicinalproduct>
        <drugdosagetext>100 MCG QW SUBCUTANEOUS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050425</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051107</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBETOL</medicinalproduct>
        <drugdosagetext>800 MG ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050425</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051113</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050656-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060630</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006-06-2180</companynumb>
    <primarysource>
      <reportercountry>CZECH REPUBLIC</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>55</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIPLOPIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYASTHENIA GRAVIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INTRON A</medicinalproduct>
        <drugindication>METASTATIC RENAL CELL CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROLEUKIN</medicinalproduct>
        <drugindication>METASTATIC RENAL CELL CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030701</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050658-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060630</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006-06-2165</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD CREATININE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD UREA INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOVOLAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ISOSORBIDE MONONITRATE</medicinalproduct>
        <drugauthorizationnumb>20225</drugauthorizationnumb>
        <drugdosagetext>60 MG QD ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANGINA PECTORIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
        <drugdosagetext>40 MG QD ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>FLUID RETENTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMITRIPTYLINE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BETAMETHASONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CHLORDIAZEPOXIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EZETROL (EZETIMIBE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NICORANDIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RANITIDINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XALATAN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050659-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060630</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006-06-2087</companynumb>
    <primarysource>
      <reportercountry>NORWAY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>55</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CHOLESTASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC ENZYME INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AERIUS (DESLORATADINE) TABLETS</medicinalproduct>
        <drugauthorizationnumb>21165</drugauthorizationnumb>
        <drugindication>URTICARIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050661-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-INTERMUNE-2003IM000829</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>66</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>42.8</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANOREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DECREASED APPETITE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROENTERITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLUENZA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYELONEPHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INTERFERON ALFACON-1 (INTERFERON ALFACON-1)</medicinalproduct>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020726</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020805</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INTERFERON ALFACON-1 (INTERFERON ALFACON-1)</medicinalproduct>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020806</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020808</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FAMOTIDINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOSARTAN POTASSIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EPINASTINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLORIDE TEPRENONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LACTOBACILLUS BIFIDUS, LYOPHILIZED</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SULPIRIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEFENAMIC ACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>URSODEOXYCHOLIC ACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KETOTIFEN FUMARATE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050662-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060626</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006VX000646</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>65</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>63</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ALANINE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASPARTATE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD ALKALINE PHOSPHATASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD BILIRUBIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THERAPY NON-RESPONDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TASMAR</medicinalproduct>
        <drugauthorizationnumb>20697</drugauthorizationnumb>
        <drugdosagetext>300 MG;QD;PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PARKINSON'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060313</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060619</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMITRIPTYLINE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>APOMORPHINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MADOPAR</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050664-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060626</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>MC200600428</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>68</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIAC ARREST</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ANGIOMAX</medicinalproduct>
        <drugauthorizationnumb>20873</drugauthorizationnumb>
        <drugdosagetext>60 MG, BOLUS, INTRACORONARY</drugdosagetext>
        <drugadministrationroute>022</drugadministrationroute>
        <drugindication>PERCUTANEOUS CORONARY INTERVENTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060623</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060623</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050665-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060626</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006RR-02785</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>43</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLARITHROMYCIN</medicinalproduct>
        <drugauthorizationnumb>65174</drugauthorizationnumb>
        <drugdosagetext>500 MG</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LANSOPRAZOLE</medicinalproduct>
        <drugdosagetext>30 MG, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HELICOBACTER INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060520</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060522</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METRONIDAZOLE</medicinalproduct>
        <drugdosagetext>400 MG</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RANITIDINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050666-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060622</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006RR-02779</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>51</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ERYTHEMA MULTIFORME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
        <drugauthorizationnumb>70469</drugauthorizationnumb>
        <drugdosagetext>400MG, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRALGIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060523</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060525</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENDROFLUAZIDE (BENDROFLUMETHIAZIDE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ERYTHROMYCIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050667-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060627</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006064046</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>12</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>41</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URTICARIA GENERALISED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AZITHROMYCIN</medicinalproduct>
        <drugauthorizationnumb>50710</drugauthorizationnumb>
        <drugdosagetext>500 MG (500 MG, 1 IN 1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>COUGH</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060506</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060508</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MEDICON (DEXTROMETHORPHAN HYDROBROMIDE)</medicinalproduct>
        <drugdosagetext>45 MG, (15 MG, 3 IN 1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>COUGH</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060506</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060508</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARBOCISTEINE (CARBOCISTEINE)</medicinalproduct>
        <drugdosagetext>750 MG (250 MG, 3 IN 1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCTIVE COUGH</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060506</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060508</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MUCOSOLVAN (AMBROXOL HYDROCHLORIDE)</medicinalproduct>
        <drugdosagetext>45 MG (15 MG, 3 IN 1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCTIVE COUGH</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060506</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060508</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050668-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060627</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006068739</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>68</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CHOLELITHIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG DEPENDENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EPELIN KAPSEALS  (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>19960101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARDENALE (PHENOBARBITAL SODIUM)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050669-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060626</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006068086</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>61</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CHEILITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONJUNCTIVITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FACE OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALATAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PURPURA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH MACULO-PAPULAR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MEDROL</medicinalproduct>
        <drugauthorizationnumb>11153</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060310</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060329</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PANTOPRAZOLE SODIUM</medicinalproduct>
        <drugdosagetext>40 MG (1 IN 1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060310</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060328</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060310</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060329</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>URABNYL (CLOBAZAM)</medicinalproduct>
        <drugdosagetext>5 MG (1 IN 1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060310</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060329</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOLPIDEM TARTRATE</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060310</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060328</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMICTAL</medicinalproduct>
        <drugdosagetext>50 MG (1 IN 1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060310</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060329</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050670-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060627</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006067876</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>82</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HEPATIC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>UNASYN</medicinalproduct>
        <drugauthorizationnumb>50608</drugauthorizationnumb>
        <drugdosagetext>3 GRAM, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060512</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060516</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050671-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060627</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006065400</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>39</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>72.5755</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCREASED APPETITE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugauthorizationnumb>21446</drugauthorizationnumb>
        <drugdosagetext>150 MG (75 MG, 2 IN 1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NEURALGIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060411</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060501</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CITALOPRAM HYDROBROMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONAZEPAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMITRIPTYLINE (AMITRIPTYLINE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GABAPENTIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050672-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060627</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006071765</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>73</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>67</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE CONGESTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EAR INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL ISCHAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUTENT</medicinalproduct>
        <drugauthorizationnumb>21938</drugauthorizationnumb>
        <drugdosagetext>50 MG (50 MG, CYCLIC), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTROINTESTINAL STROMAL TUMOUR</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060421</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060519</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CODEINE PHOSPHATE (CODEINE PHOSPHATE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BECLOMETHASONE (BECLOMETHASONE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SALAMOL (SALBUTAMOL SULFATE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUMETASONE PIVALATE (FLUMETASONE PIVALATE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GENTAMICIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLYCERYL TRINITRATE (GLYCERLY TRINITRATE)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050673-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060622</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>VER_0016_2006</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEVICE FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TWINJECT</medicinalproduct>
        <drugbatchnumb>T0509035C</drugbatchnumb>
        <drugauthorizationnumb>20800</drugauthorizationnumb>
        <drugdosagetext>1 U ONCE SC</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>ANAPHYLACTIC REACTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060619</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060619</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050674-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060630</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006-07-0009</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>67</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRY MOUTH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JAUNDICE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRANSAMINASES INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TEMODAL</medicinalproduct>
        <drugauthorizationnumb>21029</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GLIOBLASTOMA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050675-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060621</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>6023565</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>APLASIA CUTIS CONGENITA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE DEVELOPMENT ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN LESION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHIMAZOLE</medicinalproduct>
        <drugauthorizationnumb>40547</drugauthorizationnumb>
        <drugdosagetext>1 IN 1 D TRANSPLACENTAL  DURING FIRST 3 MONTHS AS FOETUS</drugdosagetext>
        <drugadministrationroute>064</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050676-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060703</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006-07-0017</companynumb>
    <primarysource>
      <reportercountry>ITALY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>RETINITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RIBAVIRIN</medicinalproduct>
        <drugauthorizationnumb>20903</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050677-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060630</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ST-2006-009103</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>53</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>STEVENS-JOHNSON SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OLMETEC</medicinalproduct>
        <drugauthorizationnumb>21286</drugauthorizationnumb>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051107</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LOXONIN</medicinalproduct>
        <drugindication>ARTHRALGIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051107</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PABRON COLD</medicinalproduct>
        <drugindication>PYREXIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051118</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PABRON</medicinalproduct>
        <drugindication>PYREXIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051118</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PL GRAN.</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051120</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MUCOSTA</medicinalproduct>
        <drugindication>ARTHRALGIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051107</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RIMATIL</medicinalproduct>
        <drugindication>ARTHRALGIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051107</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLOMOX</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051120</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050678-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060630</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006-07-0003</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>75</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>RETINITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUTAMIDE</medicinalproduct>
        <drugauthorizationnumb>18554</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050679-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060621</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>6023607</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>APLASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CAESAREAN SECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONGENITAL INTESTINAL MALFORMATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FOETAL GROWTH RETARDATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GALLBLADDER ANOMALY CONGENITAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IRIS COLOBOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MICROCORNEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NIPPLE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLACENTA PRAEVIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RETINAL COLOBOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SHOCK HAEMORRHAGIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UMBILICAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHIMAZOLE</medicinalproduct>
        <drugauthorizationnumb>40547</drugauthorizationnumb>
        <drugdosagetext>MATERNAL USE</drugdosagetext>
        <drugadministrationroute>064</drugadministrationroute>
        <drugindication>BASEDOW'S DISEASE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050680-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GXKR2006BE02600</companynumb>
    <primarysource>
      <reportercountry>BELGIUM</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>73</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>33.5</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CHOLESTASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATITIS ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATOCELLULAR DAMAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
        <drugauthorizationnumb>75985</drugauthorizationnumb>
        <drugdosagetext>250 MG, BID, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugtreatmentduration>21</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>STARLIX</medicinalproduct>
        <drugdosagetext>90 MG, TID, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugtreatmentduration>183</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PIOGLITAZONE HCL</medicinalproduct>
        <drugdosagetext>15 MG, QD, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugtreatmentduration>183</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050681-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060121</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GXKR2006FR00591</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>12</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG ABUSER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEXUAL ASSAULT VICTIM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VICTIM OF CHILD ABUSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALPRAZOLAM (NGX)(ALPRAZOLAM) 0.5MG</medicinalproduct>
        <drugauthorizationnumb>74112</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050682-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>6023733</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>79</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HYPOKALAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPONATRAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVOTHYROX (TABLET) (LEVOTHYROXINE)</medicinalproduct>
        <drugauthorizationnumb>21301</drugauthorizationnumb>
        <drugdosagetext>150 MCG (150 MCG, 1 D) ORAL; 75 MCG (75 MCG, 1D)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPOTHYROIDISM</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19890615</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060517</drugenddate>
        <drugtreatmentduration>17</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYANOCOBALAMINE (CYANOCOBALAMIN)</medicinalproduct>
        <drugdosagetext>1 AMPULE EVERY 15 DAYS (2 IN 1 M)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010615</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRACTAZIN (TABLET) (SPIRONOLACTONE, ALTIZIDE)</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060516</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugdosagetext>20 MG (20 MG, 1D) ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RIVOTRIL (ORAL SOLUTION) (CLONAZEPAM)</medicinalproduct>
        <drugdosagetext>20 DROPS/DAY (1D) ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990615</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TIAPRIDAL (TABLET) (TIAPRIDE)</medicinalproduct>
        <drugdosagetext>100 MG (100 MG, 1 D) ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060516</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050683-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060121</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GXKR2006FR00590</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>16</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>AMNESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG ABUSER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEDATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEXUAL ASSAULT VICTIM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALPRAZOLAM</medicinalproduct>
        <drugauthorizationnumb>74112</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050684-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060627</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GXKR2006DE02149</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>64</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERLIPIDAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHABDOMYOLYSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugauthorizationnumb>65017</drugauthorizationnumb>
        <drugdosagetext>80 MG</drugdosagetext>
        <drugindication>HYPERLIPIDAEMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOSPORINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050685-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060630</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GXKR2006JP03722</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>74</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ALANINE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASPARTATE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE FLUCTUATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISORIENTATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EXTRAPYRAMIDAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE RIGIDITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUROLEPTIC MALIGNANT SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSYCHOMOTOR RETARDATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAROXETINE HCL</medicinalproduct>
        <drugauthorizationnumb>75566</drugauthorizationnumb>
        <drugdosagetext>20 MG</drugdosagetext>
        <drugindication>MAJOR DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALPRAZOLAM</medicinalproduct>
        <drugdosagetext>1.2 MG</drugdosagetext>
        <drugindication>MAJOR DEPRESSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050686-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060630</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>HQWYE804112APR06</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>19</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GRAFT DYSFUNCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>KIDNEY TRANSPLANT REJECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL TUBULAR DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RAPAMUNE</medicinalproduct>
        <drugauthorizationnumb>21083</drugauthorizationnumb>
        <drugdosagetext>SEE ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS AGAINST TRANSPLANT REJECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041108</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050211</drugenddate>
        <drugtreatmentduration>96</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RAPAMUNE</medicinalproduct>
        <drugauthorizationnumb>21083</drugauthorizationnumb>
        <drugdosagetext>SEE ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS AGAINST TRANSPLANT REJECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050211</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050216</drugenddate>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RAPAMUNE</medicinalproduct>
        <drugauthorizationnumb>21083</drugauthorizationnumb>
        <drugdosagetext>SEE ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS AGAINST TRANSPLANT REJECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050216</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050902</drugenddate>
        <drugtreatmentduration>198</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RAPAMUNE</medicinalproduct>
        <drugauthorizationnumb>21083</drugauthorizationnumb>
        <drugdosagetext>SEE ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS AGAINST TRANSPLANT REJECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050902</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051104</drugenddate>
        <drugtreatmentduration>64</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RAPAMUNE</medicinalproduct>
        <drugauthorizationnumb>21083</drugauthorizationnumb>
        <drugdosagetext>SEE ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS AGAINST TRANSPLANT REJECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051104</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060215</drugenddate>
        <drugtreatmentduration>104</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RAPAMUNE</medicinalproduct>
        <drugauthorizationnumb>21083</drugauthorizationnumb>
        <drugdosagetext>SEE ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS AGAINST TRANSPLANT REJECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060215</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060418</drugenddate>
        <drugtreatmentduration>62</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE TAB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TACROLIMUS (TACROLIMUS)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCITRIOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RANITIDINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENALAPRIL MALEATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARANESP</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IRON (IRON)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LABETALOL HCL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050687-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006081725</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>25</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIOLIPIN ANTIBODY POSITIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG TOXICITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FIBRIN D DIMER INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PO2 DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALPRAZOLAM</medicinalproduct>
        <drugauthorizationnumb>18276</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RIZE (CLOTIAZEPAM)</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMITRIPTYLINE HCL</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PZC (PERPHENAZINE MALEATE)</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MEILAX (ETHYL LOFLAZEPATE)</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050688-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060630</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BEWYE708909JUN06</companynumb>
    <primarysource>
      <reportercountry>BELGIUM</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DISEASE RECURRENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FOCAL GLOMERULOSCLEROSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SIROLIMUS (SIROLIMUS, UNSPEC)</medicinalproduct>
        <drugauthorizationnumb>21083</drugauthorizationnumb>
        <drugdosagetext>15 MG 1X PER 1 DAY ORAL; 4 MG 1X PER 1 DAY ORAL; 5 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>20041018</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041018</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SIROLIMUS (SIROLIMUS, UNSPEC)</medicinalproduct>
        <drugauthorizationnumb>21083</drugauthorizationnumb>
        <drugdosagetext>15 MG 1X PER 1 DAY ORAL; 4 MG 1X PER 1 DAY ORAL; 5 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>20041019</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041027</drugenddate>
        <drugtreatmentduration>9</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SIROLIMUS (SIROLIMUS, UNSPEC)</medicinalproduct>
        <drugauthorizationnumb>21083</drugauthorizationnumb>
        <drugdosagetext>15 MG 1X PER 1 DAY ORAL; 4 MG 1X PER 1 DAY ORAL; 5 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>20041029</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041112</drugenddate>
        <drugtreatmentduration>15</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SIROLIMUS (SIROLIMUS, UNSPEC)</medicinalproduct>
        <drugauthorizationnumb>21083</drugauthorizationnumb>
        <drugdosagetext>15 MG 1X PER 1 DAY ORAL; 4 MG 1X PER 1 DAY ORAL; 5 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>20041113</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041129</drugenddate>
        <drugtreatmentduration>17</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TACROLIMUS (TACROLIMUS)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZENAPAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CORTICOSTEROIDS (CORTICOSTEROIDS)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050689-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060627</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006081808</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD CREATINE PHOSPHOKINASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>REBOUND EFFECT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAHOR (ATORVASTATIN)</medicinalproduct>
        <drugauthorizationnumb>20702</drugauthorizationnumb>
        <drugdosagetext>(20 MG)</drugdosagetext>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060619</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050690-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060517</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006081775</companynumb>
    <primarysource>
      <reportercountry>BELGIUM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>73</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>76</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCREASED VISCOSITY OF BRONCHIAL SECRETION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>YELLOW SKIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUTENT</medicinalproduct>
        <drugbatchnumb>N0401490</drugbatchnumb>
        <drugauthorizationnumb>21968</drugauthorizationnumb>
        <drugdosagetext>50 MG (50 MG, OD - INTERVAL:  4W/2W), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>METASTATIC RENAL CELL CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060505</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060517</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050691-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060627</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006082170</companynumb>
    <primarysource>
      <reportercountry>KOREA, REPUBLIC OF</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLISTER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EPISTAXIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GINGIVAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HERPES ZOSTER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMMUNOSUPPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL INTAKE REDUCED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN EXFOLIATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TONGUE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUTENT</medicinalproduct>
        <drugauthorizationnumb>21938</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050692-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006082193</companynumb>
    <primarysource>
      <reportercountry>DENMARK</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>59</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>92</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BUNDLE BRANCH BLOCK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC ARREST</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELECOXIB (CELECOXIB)</medicinalproduct>
        <drugauthorizationnumb>20998</drugauthorizationnumb>
        <drugdosagetext>200 MG 200 MG, 1 IN 1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MUSCULOSKELETAL PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20001101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050693-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006082186</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <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>BLOOD CREATINE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERKALAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SPIRONOLACTONE</medicinalproduct>
        <drugauthorizationnumb>12151</drugauthorizationnumb>
        <drugdosagetext>25 MG (25 MG, DAILY), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MYOCARDIAL ISCHAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060523</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060523</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PERINDOPRIL ERBUMINE</medicinalproduct>
        <drugdosagetext>2 MG (2 MG, DAILY), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MYOCARDIAL ISCHAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060523</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060523</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUOXETINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ISOSORBIDE MONONITRATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTIVITAMIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050694-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>HQWYE473129JUN06</companynumb>
    <primarysource>
      <reportercountry>ARGENTINA</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>24</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>KIDNEY TRANSPLANT REJECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL TUBULAR NECROSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEORAL</medicinalproduct>
        <drugauthorizationnumb>50738</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS AGAINST TRANSPLANT REJECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060317</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060621</drugenddate>
        <drugtreatmentduration>97</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SULFAMETHOXAZOLE + TRIMETHOPRIM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050695-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2005035615</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>65</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>100</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOXIC EPIDERMAL NECROLYSIS</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>20050123</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050129</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FORTECORTIN (DEXAMETHASONE)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050696-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060630</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2005015691</companynumb>
    <primarysource>
      <reportercountry>SWEDEN</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>30</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DIABETES MELLITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OBSESSIVE THOUGHTS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVERWEIGHT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
        <drugauthorizationnumb>19839</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUOXETINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050697-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060703</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-SANOFI-SYNTHELABO-A02200601730</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>76</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ERYTHEMA MULTIFORME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOXIC SKIN ERUPTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060405</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIAMICRON</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060429</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAREG</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060429</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KERLONE</medicinalproduct>
        <drugauthorizationnumb>019507</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060429</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060429</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMISIL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060310</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060311</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050698-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FRWYE180420JUN03</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>50</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ARTERIOVENOUS FISTULA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMPLICATIONS OF TRANSPLANTED KIDNEY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEVICE MIGRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL INFARCT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STAPHYLOCOCCAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUPERINFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VASCULAR GRAFT COMPLICATION</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>20020818</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELLCEPT</medicinalproduct>
        <drugdosagetext>1.5 G 1X PER 1 DAY ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020818</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050699-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060630</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CAWYE980804JUL06</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>11</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>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS AGAINST TRANSPLANT REJECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041005</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041015</drugenddate>
        <drugtreatmentduration>11</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RAPAMUNE</medicinalproduct>
        <drugauthorizationnumb>21083</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS AGAINST TRANSPLANT REJECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041015</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041029</drugenddate>
        <drugtreatmentduration>15</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RAPAMUNE</medicinalproduct>
        <drugauthorizationnumb>21083</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS AGAINST TRANSPLANT REJECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041029</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041105</drugenddate>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RAPAMUNE</medicinalproduct>
        <drugauthorizationnumb>21083</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS AGAINST TRANSPLANT REJECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041105</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041211</drugenddate>
        <drugtreatmentduration>37</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RAPAMUNE</medicinalproduct>
        <drugauthorizationnumb>21083</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS AGAINST TRANSPLANT REJECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041211</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050211</drugenddate>
        <drugtreatmentduration>63</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RAPAMUNE</medicinalproduct>
        <drugauthorizationnumb>21083</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS AGAINST TRANSPLANT REJECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050211</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050225</drugenddate>
        <drugtreatmentduration>15</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RAPAMUNE</medicinalproduct>
        <drugauthorizationnumb>21083</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS AGAINST TRANSPLANT REJECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050225</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050506</drugenddate>
        <drugtreatmentduration>70</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RAPAMUNE</medicinalproduct>
        <drugauthorizationnumb>21083</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS AGAINST TRANSPLANT REJECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050506</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060131</drugenddate>
        <drugtreatmentduration>271</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RAPAMUNE</medicinalproduct>
        <drugauthorizationnumb>21083</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS AGAINST TRANSPLANT REJECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060131</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE TAB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TACROLIMUS (TACROLIMUS)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLOBAZAM (CLOBAZAM)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SODIUM CHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOSEC (OMEPRAZOLE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARANESP</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SODIUM BICARBONATE IN PLASTIC CONTAINER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZINC SULFATE (ZINC SULFATE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOSARTAN POTASSIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCITROL (CALCIUM CARBONATE/ERGOCALCIFEROL/RETINOL)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050705-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-ROCHE-453566</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ACNE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AGEUSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANOSMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRY EYE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRY SKIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NASAL DRYNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SENSORY DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VIRAL INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>18662</drugauthorizationnumb>
        <drugdosagetext>THE PATIENT RECEIVED ONE 40MG CAPSULE ONCE PER DAY, AND TWO 10MG CAPSULES ONCE PER DAY.</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ACNE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030613</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030702</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>018662</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030702</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031115</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050711-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060327</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-BRISTOL-MYERS SQUIBB COMPANY-13326921</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>77</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>45</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD IRON DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ESCHERICHIA INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERAL PHYSICAL HEALTH DETERIORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOUTH ULCERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL INTAKE REDUCED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARKINSON'S DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARKINSONISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SINEMET</medicinalproduct>
        <drugauthorizationnumb>17555</drugauthorizationnumb>
        <drugindication>PARKINSON'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040301</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>FERROUS SULFATE TAB</medicinalproduct>
        <drugindication>BLOOD IRON DECREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CITALOPRAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUDROCORTISONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUROSAMIDE</medicinalproduct>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060301</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050712-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060703</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-BRISTOL-MYERS SQUIBB COMPANY-13432539</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>45</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>72</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD LACTATE DEHYDROGENASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD LACTIC ACID INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LACTIC ACIDOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRANSAMINASES INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REYATAZ</medicinalproduct>
        <drugauthorizationnumb>021567</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZERIT</medicinalproduct>
        <drugauthorizationnumb>020412</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIDEX</medicinalproduct>
        <drugauthorizationnumb>020154</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVIR</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050713-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060607</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-BRISTOL-MYERS SQUIBB COMPANY-13406103</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>76</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CANDIDA SEPSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CATHETER RELATED INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERAL PHYSICAL HEALTH DETERIORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RECTAL PROLAPSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPTIC SHOCK</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAXOL</medicinalproduct>
        <drugauthorizationnumb>20262</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>OVARIAN CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031208</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040105</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PARAPLATIN</medicinalproduct>
        <drugauthorizationnumb>019880</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>OVARIAN CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031208</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040105</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050714-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060703</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-BRISTOL-MYERS SQUIBB COMPANY-13431895</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>55</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ARTHRITIS INFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEVICE RELATED INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ORENCIA</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020604</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050715-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060703</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-BRISTOL-MYERS SQUIBB COMPANY-13437660</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSYCHIATRIC SYMPTOM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARIPIPRAZOLE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
        <drugtreatmentduration>10</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050716-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060407</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-BRISTOL-MYERS SQUIBB COMPANY-13343181</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>80</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANOREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CREATINE PHOSPHOKINASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CYTOLYTIC HEPATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERAL PHYSICAL HEALTH DETERIORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATITIS CHOLESTATIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VASTEN TABS 20 MG</medicinalproduct>
        <drugauthorizationnumb>19898</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERCHOLESTEROLAEMIA</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060218</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANTOPRAZOLE SODIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BUFLOMEDIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NITRODERM</medicinalproduct>
        <drugdosagetext>DOSAGE FORM = PATCH</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREVISCAN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOPRESSOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050717-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20051116</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PT-BRISTOL-MYERS SQUIBB COMPANY-13186044</companynumb>
    <primarysource>
      <reportercountry>PORTUGAL</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>23</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FOETAL MOVEMENTS DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NORMAL NEWBORN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PREGNANCY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ABILIFY</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051212</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050718-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060703</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>TH-BRISTOL-MYERS SQUIBB COMPANY-13432372</companynumb>
    <primarysource>
      <reportercountry>THAILAND</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD BILIRUBIN UNCONJUGATED INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OCULAR ICTERUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RED BLOOD CELL SCHISTOCYTES PRESENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>YELLOW SKIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REYATAZ</medicinalproduct>
        <drugauthorizationnumb>21567</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050303</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050313</drugenddate>
        <drugtreatmentduration>9</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVIR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEVIRAPINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ABACAVIR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LAMIVUDINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050719-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060704</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-BRISTOL-MYERS SQUIBB COMPANY-13434352</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>50</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMIKIN</medicinalproduct>
        <drugauthorizationnumb>062311</drugauthorizationnumb>
        <drugdosagetext>DRUG WITHDRAWN ON AN UPSPECIFIED DATE.</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060331</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TARGOCID</medicinalproduct>
        <drugdosagetext>DRUG WITHDRAWN ON AN UPSPECIFIED DATE.</drugdosagetext>
        <drugindication>BACK PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060331</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COLCHICINE</medicinalproduct>
        <drugindication>GOUT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060404</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060407</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050720-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060703</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-BRISTOL-MYERS SQUIBB COMPANY-13432208</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>76</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>96</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPEPSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEMORAL HERNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRIC ULCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MONOPLEGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PREPYLORIC STENOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYLORIC STENOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WOUND EVISCERATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ELISOR TABS 20 MG</medicinalproduct>
        <drugauthorizationnumb>19898</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000801</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VERCYTE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>POLYCYTHAEMIA</drugindication>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19961201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OMIX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MONO-TILDIEM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>UN-ALFA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NITRODERM</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19970101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050721-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060606</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-BRISTOL-MYERS SQUIBB COMPANY-13402235</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>76</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>56</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HAEMATURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOLYTIC ANAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ELISOR TABS 20 MG</medicinalproduct>
        <drugauthorizationnumb>19898</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>LIPID METABOLISM DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVOTHYROX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SINTROM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMIODARONE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIGOXIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NOROXIN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060413</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060416</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEPAMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CITALOPRAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SERESTA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OLMIFON</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATARAX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050722-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060704</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-BRISTOL-MYERS SQUIBB COMPANY-13432182</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>35</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>71</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ABILIFY</medicinalproduct>
        <drugbatchnumb>5M05780</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PSYCHOTIC DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060327</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060328</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERDAL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PSYCHOTIC DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050723-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060706</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-13434733</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>6</patientonsetage>
      <patientonsetageunit>800</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CHEST DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ELECTROCARDIOGRAM CHANGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY ARREST</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ERBITUX</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLORECTAL CANCER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVASTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYLENOL (CAPLET)</medicinalproduct>
        <drugindication>PREMEDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAGAMET</medicinalproduct>
        <drugindication>PREMEDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENADRYL</medicinalproduct>
        <drugindication>PREMEDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DECADRON</medicinalproduct>
        <drugindication>PREMEDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050724-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060703</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PL-BRISTOL-MYERS SQUIBB COMPANY-13431523</companynumb>
    <primarysource>
      <reportercountry>POLAND</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>27</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>67</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BASEDOW'S DISEASE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>STAVUDINE</medicinalproduct>
        <drugauthorizationnumb>20412</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMIVUDINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMPRENAVIR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RITONAVIR</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050725-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060710</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-13438213</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ERBITUX</medicinalproduct>
        <drugindication>NEOPLASM MALIGNANT</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050726-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060710</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-BRISTOL-MYERS SQUIBB COMPANY-13436712</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABORTION SPONTANEOUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTRA-UTERINE DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PREGNANCY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BLEOMYCIN SULFATE</medicinalproduct>
        <drugauthorizationnumb>50443</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>HODGKIN'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000211</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20000615</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VELBE</medicinalproduct>
        <drugindication>HODGKIN'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000211</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20000615</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FARMORUBICIN</medicinalproduct>
        <drugindication>HODGKIN'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000211</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20000615</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE TAB</medicinalproduct>
        <drugindication>HODGKIN'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000211</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20000615</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050727-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050927</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-BRISTOL-MYERS SQUIBB COMPANY-13123591</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>25</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>70</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PREMATURE LABOUR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUSTIVA</medicinalproduct>
        <drugauthorizationnumb>020972</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050112</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TENOFOVIR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050112</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LAMIVUDINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050112</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050728-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060703</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-BRISTOL-MYERS SQUIBB COMPANY-13435862</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>93</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DYSARTHRIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCORRECT DOSE ADMINISTERED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEDICATION ERROR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRANSIENT ISCHAEMIC ATTACK</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CAPTEA TABS</medicinalproduct>
        <drugauthorizationnumb>18709</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ESSENTIAL HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060522</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060526</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LAMALINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACTONEL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CACIT D3</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYBUTYNIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>URINARY INCONTINENCE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KALEORID</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050729-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050712</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>HK-BRISTOL-MYERS SQUIBB COMPANY-13033758</companynumb>
    <primarysource>
      <reportercountry>HONG KONG</reportercountry>
      <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>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG INFILTRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALIGNANT NEOPLASM PROGRESSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ERBITUX</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLORECTAL CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050628</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050628</drugenddate>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IRINOTECAN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLORECTAL CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050628</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050628</drugenddate>
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  <safetyreport>
    <safetyreportid>5050730-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060619</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PT-BRISTOL-MYERS SQUIBB COMPANY-13416409</companynumb>
    <primarysource>
      <reportercountry>PORTUGAL</reportercountry>
      <qualification>1</qualification>
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    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>65</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <reaction>
        <reactionmeddrapt>MALIGNANT PALATE NEOPLASM</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>STAVUDINE</medicinalproduct>
        <drugauthorizationnumb>20412</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050601</drugstartdate>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZIDOVUDINE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050601</drugstartdate>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KALETRA</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050601</drugstartdate>
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    </patient>
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  <safetyreport>
    <safetyreportid>5050731-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060410</receiptdate>
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    <companynumb>GB-BRISTOL-MYERS SQUIBB COMPANY-13341672</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>46</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANAPHYLACTIC REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SINEMET</medicinalproduct>
        <drugauthorizationnumb>17555</drugauthorizationnumb>
        <drugdosagetext>TABS</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PARKINSON'S DISEASE</drugindication>
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        <drugstartdate>20060101</drugstartdate>
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      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>AMOXICILLIN</medicinalproduct>
        <drugauthorizationnumb>061885</drugauthorizationnumb>
        <drugindication>INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRAMIPEXOLE HCL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PARKINSON'S DISEASE</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060406</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SERTRALINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ROSUVASTATIN CALCIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>QUININE SULFATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MUSCLE SPASMS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050732-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060703</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-BRISTOL-MYERS SQUIBB COMPANY-13437009</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>69</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LACTIC ACIDOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METFORMIN HCL</medicinalproduct>
        <drugauthorizationnumb>20357</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS NON-INSULIN-DEPENDENT</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060208</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PERINDOPRIL ERBUMINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETIC NEPHROPATHY</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060208</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACARBOSE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCICHEW</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FERROUS SULFATE TAB</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MYELODYSPLASTIC SYNDROME</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MYELODYSPLASTIC SYNDROME</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLICLAZIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS NON-INSULIN-DEPENDENT</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050733-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060707</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-13436183</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>69</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>77</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ALOPECIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEPHROLITHIASIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GLUCOVANCE</medicinalproduct>
        <drugauthorizationnumb>21178</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS MANAGEMENT</drugindication>
        <drugtreatmentduration>10</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRAVACHOL</medicinalproduct>
        <drugauthorizationnumb>019898</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CEREBROVASCULAR ACCIDENT</drugindication>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALTACE</medicinalproduct>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050734-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060630</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-BRISTOL-MYERS SQUIBB COMPANY-13432539</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>45</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>72</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD LACTATE DEHYDROGENASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD LACTIC ACID INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LACTIC ACIDOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRANSAMINASES INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZERIT</medicinalproduct>
        <drugauthorizationnumb>20412</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIDEX</medicinalproduct>
        <drugauthorizationnumb>020154</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REYATAZ</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVIR</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050735-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060525</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CZ-BRISTOL-MYERS SQUIBB COMPANY-13392006</companynumb>
    <primarysource>
      <reportercountry>CZECH REPUBLIC</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MEGACE</medicinalproduct>
        <drugauthorizationnumb>016979</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CACHEXIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040107</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050736-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060510</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-BRISTOL-MYERS SQUIBB COMPANY-13373386</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>62</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>67</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PANCREATITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIDEX</medicinalproduct>
        <drugauthorizationnumb>020154</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060331</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060406</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATAZANAVIR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050704</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060406</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LAMIVUDINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050704</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060406</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RITONAVIR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050704</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060406</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MICARDIS</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050737-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060627</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006-DE-02852GD</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>52</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BRADYPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MORPHINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050738-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060622</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>S06-AUS-02626-01</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>35</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG HYPERSENSITIVITY</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>20060601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALIUM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050739-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060621</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>S06-FRA-02620-01</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>21</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANOREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>C-REACTIVE PROTEIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIOMYOPATHY ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ELECTROCARDIOGRAM QRS COMPLEX PROLONGED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATITIS ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERKALAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPONATRAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LACTIC ACIDOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MIOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE DRUG OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA ASPIRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CITALOPRAM HYDROBROMIDE</medicinalproduct>
        <drugauthorizationnumb>20822</drugauthorizationnumb>
        <drugdosagetext>10 MG QD PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060315</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERDAL</medicinalproduct>
        <drugdosagetext>1 MG BID PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060315</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LOXAPINE SUCCINATE</medicinalproduct>
        <drugdosagetext>110 MG QD PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060315</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ATARAX</medicinalproduct>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060315</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXAZEPAM</medicinalproduct>
        <drugdosagetext>50 MG QD PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060315</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMICTAL</medicinalproduct>
        <drugdosagetext>100 MG QD PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060315</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CERAZETTE (DESOGESTREL)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MOTILIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEPRONIZINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DUPHALAC</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050740-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060626</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>S06-UKI-01577-01</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>46</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANIC ATTACK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHOTOPHOBIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPEECH DISORDER</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>19991021</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19990101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CHLORDIAZEPOXIDE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050741-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060623</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>S06-UKI-02647-01</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>62</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>COMPLETED SUICIDE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CITALOPRAM HYDROBROMIDE</medicinalproduct>
        <drugauthorizationnumb>20822</drugauthorizationnumb>
        <drugdosagetext>20 MG QD PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSED MOOD</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060117</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CETOMACROGOL 1000</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CODEINE PHOSPHATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CODEINE PHOSPHATE HEMIHYDRATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PARACETAMOL DC</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050742-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060623</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>S06-UKI-02644-01</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CITALOPRAM HYDROBROMIDE</medicinalproduct>
        <drugauthorizationnumb>20822</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LOSARTAN POTASSIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MOMETASONE FUROATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NYSTATIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXYGEN (OXYGEN)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PHOLCODINE TAB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMBIVENT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMBIVENT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SALBUTAMOL (SALBUTAMOL)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SERETIDE (FLUTICASONE PROPIONATE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SERETIDE (SALMETEROL XINAFOATE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TIOTROPIUM BROMIDE ^SPIRIVA^ (TIOTROPIUM BROMIDE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XALATAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOPICLONE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050743-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060621</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006BI009310</companynumb>
    <primarysource>
      <reportercountry>BELGIUM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>39</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>56</patientweight>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>CEREBRAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COGNITIVE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</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>5050744-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060621</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>S06-FRA-02618-01</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>64</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROPLEX (ESCITALOPRAM)</medicinalproduct>
        <drugauthorizationnumb>21323</drugauthorizationnumb>
        <drugdosagetext>20 MG QD PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060620</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060620</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BUSPAR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALACYCLOVIR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLPIDEM TARTRATE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050754-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060707</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IT-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2006-IT-00177IT</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PETECHIAE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH VESICULAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STOMATITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIRAMUNE</medicinalproduct>
        <drugauthorizationnumb>020636</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ACUTE HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060513</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060607</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IRON SULFATETHIAMIN COMPOUND TAB</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060513</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060607</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COMBIVIR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060513</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060607</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050755-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060711</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2006-BP-07869BR</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>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
        <drugbatchnumb>601797</drugbatchnumb>
        <drugauthorizationnumb>021395</drugauthorizationnumb>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>BRONCHITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FORASEQ</medicinalproduct>
        <drugindication>BRONCHITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANCORON</medicinalproduct>
        <drugindication>ARRHYTHMIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050756-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060710</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2006-FF-00601FF</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>74</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FACE OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERALISED ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH MACULAR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
        <drugauthorizationnumb>021395</drugauthorizationnumb>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060629</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060706</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYMBICORT</medicinalproduct>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060706</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATACAND</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060501</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAHOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060629</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NASONEX</medicinalproduct>
        <drugadministrationroute>045</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060629</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050757-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060523</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2006-BP-05942NB</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>66.5</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>INTERSTITIAL LUNG DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPHOCYTE STIMULATION TEST POSITIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MICARDIS</medicinalproduct>
        <drugauthorizationnumb>20850</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060424</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060430</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZITHROMAC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLOMOX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PHARYNGITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060411</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060413</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVELOX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PHARYNGITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060417</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060421</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050758-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060710</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2006-DE-03529GD</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLONIDINE</medicinalproduct>
        <drugauthorizationnumb>017407</drugauthorizationnumb>
        <drugdosagetext>0.15 TO 0.3 MG (0.15 MG/ME2)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ENDOCRINE TEST</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050759-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060704</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BE-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2006-BL-00159BL</companynumb>
    <primarysource>
      <reportercountry>BELGIUM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>83</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>OESOPHAGITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TPV/RTV CO-ADMIN</medicinalproduct>
        <drugdosagetext>250/100 MG X 4</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060328</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VIREAD</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060328</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EPIVIR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060328</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BACTRIM DS</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PNEUMOCYSTIS JIROVECI PNEUMONIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060321</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050760-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060626</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2006-BP-07267NB</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>63.6</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>RENAL IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MICARDIS</medicinalproduct>
        <drugauthorizationnumb>020850</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031015</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031128</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PATYUNA (TICLOPIDINE HYDROCHLORIDE)</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021022</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TANATRIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021022</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031112</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021022</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031112</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATELEC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030311</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050761-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060704</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BE-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2006-BL-00158BL</companynumb>
    <primarysource>
      <reportercountry>BELGIUM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>55</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>LIVER FUNCTION TEST ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SHOCK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TPV/RTV CO-ADMIN</medicinalproduct>
        <drugdosagetext>250/100 MG X 4</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060413</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060421</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRIZIVIR</medicinalproduct>
        <drugdosagetext>300/150/300 MG X 2</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060413</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060421</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VIREAD</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060413</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060421</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUZEON</medicinalproduct>
        <drugdosagetext>90 MG/ML X 2</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060413</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060421</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050762-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060321</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2006-BP-03217BP</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>140.61</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DIVERTICULITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MICARDIS HCT</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060228</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060320</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISONE TAB</medicinalproduct>
        <drugauthorizationnumb>080352</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BRONCHITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060303</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060307</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADVAIR DISKUS 100/50</medicinalproduct>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>BRONCHITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060228</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060315</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050763-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060630</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2006-BP-07523NB</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>76</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MICARDIS</medicinalproduct>
        <drugauthorizationnumb>20850</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060629</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050765-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060621</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006CL000683</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>53</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>73.4827</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SYMLIN</medicinalproduct>
        <drugauthorizationnumb>21332</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>DIABETES MELLITUS INSULIN-DEPENDENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060403</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060406</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SYMLIN</medicinalproduct>
        <drugauthorizationnumb>21332</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>DIABETES MELLITUS INSULIN-DEPENDENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060406</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060409</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SYMLIN</medicinalproduct>
        <drugauthorizationnumb>21332</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>DIABETES MELLITUS INSULIN-DEPENDENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060409</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060505</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SYMLIN</medicinalproduct>
        <drugauthorizationnumb>21332</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>DIABETES MELLITUS INSULIN-DEPENDENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060506</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060614</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SYMLIN</medicinalproduct>
        <drugauthorizationnumb>21332</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>DIABETES MELLITUS INSULIN-DEPENDENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060614</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMALOG</medicinalproduct>
        <drugdosagetext>PRN;SC</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>DIABETES MELLITUS INSULIN-DEPENDENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REGLAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050766-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060623</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006041940</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </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>CAROTID ARTERY OCCLUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HIGH DENSITY LIPOPROTEIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYSTERECTOMY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOW DENSITY LIPOPROTEIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</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>VITAMINS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM GLUCONATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALL OTHER THERAPEUTIC PRODUCTS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COLACE (DOCUSATE SODIUM)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050767-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060623</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006059086</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>61</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>69.8539</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY STENOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HERNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREATMENT NONCOMPLIANCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugauthorizationnumb>20998</drugauthorizationnumb>
        <drugindication>ARTHRALGIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050768-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060623</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006067810</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </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>ATRIAL FIBRILLATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CHOLESTEROL INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRAIN STEM ISCHAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIOMYOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBRAL ATROPHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBRAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FRUSTRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTRACARDIAC THROMBUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MITRAL VALVE INCOMPETENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARTNER STRESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SELF ESTEEM DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUSITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRICUSPID VALVE INCOMPETENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENTRICULAR DYSFUNCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEXTRA</medicinalproduct>
        <drugauthorizationnumb>21341</drugauthorizationnumb>
        <drugdosagetext>20 MG (20 MG, 1 IN 1 D)</drugdosagetext>
        <drugindication>MONARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041112</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041231</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050769-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060626</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A126777</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>45</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DECUBITUS ULCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ENTEROCOCCAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POSTOPERATIVE ABSCESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEROTONIN SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SERTRALINE</medicinalproduct>
        <drugauthorizationnumb>19839</drugauthorizationnumb>
        <drugdosagetext>200 MG (200 MG, 1 IN 1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LINEZOLID</medicinalproduct>
        <drugdosagetext>1200 MG (600 MG, 2 IN 1 D), INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PATHOGEN RESISTANCE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLAGYL</medicinalproduct>
        <drugdosagetext>2000 MG (500 MG, 4 IN 1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INFECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERIDONE</medicinalproduct>
        <drugdosagetext>2 MG (1MG,2 IN 1 D)</drugdosagetext>
        <drugindication>PSYCHOTIC DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BUPROPION HCL</medicinalproduct>
        <drugdosagetext>150 MG (75 MG, 2 IN 1 D)</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LITHIUM CARBONATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAZODONE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BACLOFEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOCUSATE SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BISCODYL (BISACODYL)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEGESTROL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANSOPRAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROMETHAZINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYPROHEPTADINE HCL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050770-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006082258</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEXTRA</medicinalproduct>
        <drugauthorizationnumb>21341</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041001</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050771-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060630</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006081979</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>89</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD CREATINE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HIP FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPONATRAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POST PROCEDURAL COMPLICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POSTOPERATIVE INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
        <drugauthorizationnumb>19787</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALDACTONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISONE TAB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRO-BANTHINE (PROPANTHELINE BROMIDE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ULTRAM</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEPCID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMERON</medicinalproduct>
        <drugdosagetext>15 MG (15 MG, 1 IN 1 D)</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EFFEXOR XR</medicinalproduct>
        <drugdosagetext>225 MG (225 MG, 1 IN 1 D)</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ADVAIR DISKUS 100/50</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOCUSATE SODIUM (DOCUSATE SODIUM)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LOVENOX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ANCEF</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRAZODONE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KEFLEX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SLO-MAG (MAGNESIUM CHLORIDE ANHYDROUS)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BUCINDOLOL HYDROCHLORIDE (BUCINDOLOL HYDROCHLORIDE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COZAR (LOSARTAN POTASSIUM)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DARVOCET-N 100</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DUONEB</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050772-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060623</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2005141755</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>69</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>113.3993</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NERVOUS SYSTEM DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POLYTRAUMATISM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugauthorizationnumb>20998</drugauthorizationnumb>
        <drugdosagetext>400 MG (200 MG, 2 IN 1 D)</drugdosagetext>
        <drugindication>ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050122</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugauthorizationnumb>20998</drugauthorizationnumb>
        <drugdosagetext>400 MG (200 MG, 2 IN 1 D)</drugdosagetext>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050122</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050773-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2005142159</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>29</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ALOPECIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BITE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRY THROAT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLATULENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRIC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL SELF-INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOVEMENT DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE RIGIDITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAIL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NERVOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SLEEP DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDE ATTEMPT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALPRAZOLAM</medicinalproduct>
        <drugauthorizationnumb>18276</drugauthorizationnumb>
        <drugdosagetext>0.5 MG (0.5 MG, 1 IN 1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANXIETY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060501</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALPRAZOLAM</medicinalproduct>
        <drugauthorizationnumb>18276</drugauthorizationnumb>
        <drugdosagetext>0.5 MG (0.5 MG, 1 IN 1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060501</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUOXETINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVONORGESTREL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PAROXETIN (PAROXETIN)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVONORGESTREL W/ETHINYLESTRADIOL (ETHINYLESTRADIOL, LEVONORGESTREL)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ETHINYL ESTRADIOL TAB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEPAKENE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050774-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006039264</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>62</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>52</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CYTOLYTIC HEPATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG TOXICITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC NECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC STEATOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATOCELLULAR DAMAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATOTOXICITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AROMASIN</medicinalproduct>
        <drugauthorizationnumb>20753</drugauthorizationnumb>
        <drugindication>BREAST CANCER FEMALE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060313</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COZAAR</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050775-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060630</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006014158</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>47</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>91.6</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN LOWER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE FLUCTUATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC TAMPONADE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ELECTROCARDIOGRAM QT PROLONGED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTRACRANIAL PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARTIAL SEIZURES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERICARDIAL EFFUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PUPILS UNEQUAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TORSADE DE POINTES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENTRICULAR TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUTENT</medicinalproduct>
        <drugauthorizationnumb>21938</drugauthorizationnumb>
        <drugdosagetext>50 MG (50 MG, DAILY INTERVAL:  EVERYDAY), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RENAL CELL CARCINOMA STAGE UNSPECIFIED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060113</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060125</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GABAPENTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ORAMORPH SR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROZAC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOPICLONE (ZOPICLONE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MORPHINE SULFATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROPRANOLOL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050776-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060623</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006052176</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>65</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>67.3</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ALANINE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD ALKALINE PHOSPHATASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHROMATURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAMMA-GLUTAMYLTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG NEOPLASM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARYNGOLARYNGEAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN DISCOLOURATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TONSILLITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TUMOUR LYSIS SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TUMOUR NECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUTENT</medicinalproduct>
        <drugauthorizationnumb>21968</drugauthorizationnumb>
        <drugdosagetext>50 MG (50 MG, DAILY INTERVAL:  CYCLIC), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RENAL CELL CARCINOMA STAGE UNSPECIFIED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060328</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENDROFLUAZIDE (BENDROFLUMETHIAZIDE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LACTULOSE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SENOKOT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FYBOGEL (ISPAGHULA)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050777-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060622</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006063976</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
    </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>ALCOHOL USE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCORRECT DOSE ADMINISTERED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPEECH DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDE ATTEMPT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYRTEC</medicinalproduct>
        <drugauthorizationnumb>19835</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALCOHOL (ALCOHOL)</medicinalproduct>
        <drugdosagetext>ONE HALF BOTTLE, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050778-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060627</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006063774</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>52</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>AUTOIMMUNE THYROIDITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIABETES MELLITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTHYROIDISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugauthorizationnumb>20702</drugauthorizationnumb>
        <drugdosagetext>5-10 MG (1 IN 1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERCHOLESTEROLAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021120</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060506</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050779-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060703</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20060700429</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>62.6</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BASAL CELL CARCINOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugbatchnumb>05G054P1</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugbatchnumb>05G054P1</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugbatchnumb>05G054P1</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugbatchnumb>05G054P1</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugbatchnumb>05G054P1</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugbatchnumb>05G054P1</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugbatchnumb>05G054P1</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugbatchnumb>05G054P1</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugbatchnumb>05G054P1</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugbatchnumb>05G054P1</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugbatchnumb>05G054P1</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugbatchnumb>05G054P1</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugbatchnumb>05G054P1</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugbatchnumb>05G054P1</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugbatchnumb>05G054P1</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugbatchnumb>05G054P1</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugbatchnumb>05G054P1</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugbatchnumb>05G054P1</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugbatchnumb>05G054P1</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugbatchnumb>05G054P1</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugbatchnumb>05G054P1</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugbatchnumb>05G054P1</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugbatchnumb>05G054P1</drugbatchnumb>
        <drugdosagetext>4 INFUSIONS PRIOR TO BASELINE</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CROHN'S DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MERCAPTOPURINE</medicinalproduct>
        <drugindication>CROHN'S DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MESALAMINE</medicinalproduct>
        <drugindication>CROHN'S DISEASE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050780-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060703</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-JNJFOC-20060700444</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>38</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFUSION RELATED REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPINAL FRACTURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugdosagetext>3 INFUSIONS ON UNKNOWN DATES</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ANKYLOSING SPONDYLITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYLENOL (CAPLET)</medicinalproduct>
        <drugindication>PREMEDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENADRYL</medicinalproduct>
        <drugindication>PREMEDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050781-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006065226</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>66</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CHOLESTASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CYTOLYTIC HEPATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
        <drugauthorizationnumb>20235</drugauthorizationnumb>
        <drugdosagetext>600 MG (100 MG, 6 IN 1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060322</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMOVANE (ZOPICLONE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROZAC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULATARD NPH HUMAN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050782-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060627</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006064893</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>80</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEMIPARESIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
        <drugauthorizationnumb>20235</drugauthorizationnumb>
        <drugdosagetext>(300 MG, ONCE), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCIATICA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENDEP</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050783-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FRWYE881229JUN06</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>49</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DIALYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SIROLIMUS (SIROLIMUS, SOLUTION)</medicinalproduct>
        <drugauthorizationnumb>21083</drugauthorizationnumb>
        <drugdosagetext>5 MG 1X PER 1 DAY; 15 MG 1X PER 1 DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RENAL TRANSPLANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020830</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020830</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SIROLIMUS (SIROLIMUS, SOLUTION)</medicinalproduct>
        <drugauthorizationnumb>21083</drugauthorizationnumb>
        <drugdosagetext>5 MG 1X PER 1 DAY; 15 MG 1X PER 1 DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RENAL TRANSPLANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020831</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SOLU-MEDROL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THYMOGLOBULIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MYCOPHENOLATE MOFETIL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050784-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FRWYE207207JUL03</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>64</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>REMOVAL OF RENAL TRANSPLANT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RAPAMUNE</medicinalproduct>
        <drugauthorizationnumb>21083</drugauthorizationnumb>
        <drugdosagetext>15 MG DAILY THEN 12 MG DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS AGAINST TRANSPLANT REJECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030404</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030604</drugenddate>
        <drugtreatmentduration>62</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE TAB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MYCOPHENOLATE MOFETIL (MYCOPHENOLATE MOFETIL, 0)</medicinalproduct>
        <drugdosagetext>1500 MG 1X PER 1 DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS AGAINST TRANSPLANT REJECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030502</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030603</drugenddate>
        <drugtreatmentduration>33</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050785-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060703</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>HQWYE356023JUN06</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
    </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>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPONATRAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CORDARONE</medicinalproduct>
        <drugauthorizationnumb>18972</drugauthorizationnumb>
        <drugdosagetext>200 MG 1X PER 1 DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EUPRESSYL (URAPIDIL)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEXOMIL (URAPIDIL)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN W/ PROPOXYPHENE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALDACTONE</medicinalproduct>
        <drugdosagetext>25 MG 1X PER 1 DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060127</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060527</drugenddate>
        <drugtreatmentduration>121</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COAPROVEL (IRBESARTAN/HYDROCHLOROTHIAZIDE,)</medicinalproduct>
        <drugdosagetext>300 MG 1X PER 1 DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060527</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugdosagetext>20 MG 1X PER 1 DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050786-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060627</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>HQWYE722810APR06</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>69</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ACTIVATED PARTIAL THROMBOPLASTIN TIME SHORTENED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ALANINE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASPARTATE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CALCIUM DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CREATININE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CREATININE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD LACTATE DEHYDROGENASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD POTASSIUM DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD SODIUM DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD SODIUM INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD UREA INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHILLS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHABDOMYOLYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TUMOUR LYSIS SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHEEZING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MYLOTARG</medicinalproduct>
        <drugauthorizationnumb>21174</drugauthorizationnumb>
        <drugdosagetext>A SINGLE 9 MG/M^2 DOSE</drugdosagetext>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>ACUTE MYELOID LEUKAEMIA RECURRENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060405</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060405</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MYLOTARG</medicinalproduct>
        <drugauthorizationnumb>21174</drugauthorizationnumb>
        <drugdosagetext>A SINGLE 9 MG/M^2 DOSE</drugdosagetext>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>ACUTE MYELOID LEUKAEMIA RECURRENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060517</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060517</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CEFTAZIDIME</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTITHROMBIN III (ANTITHROMBIN III)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORMAL HUMAN IMMUNOGLOBULIN (NORMAL HUMAN IMMUNOGLOBULIN)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMIKACIN SULFATE</medicinalproduct>
        <drugdosagetext>400 MG 1X PER 1 DAY; 200 MG 1X PER 1 DAY</drugdosagetext>
        <drugadministrationroute>041</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060330</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060407</drugenddate>
        <drugtreatmentduration>9</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMIKACIN SULFATE</medicinalproduct>
        <drugdosagetext>400 MG 1X PER 1 DAY; 200 MG 1X PER 1 DAY</drugdosagetext>
        <drugadministrationroute>041</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060408</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060421</drugenddate>
        <drugtreatmentduration>14</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MEROPEN (MEROPENEM,)</medicinalproduct>
        <drugdosagetext>1 G 1X  PER 1 DAY; 2 G 1X PER 1 DAY</drugdosagetext>
        <drugadministrationroute>041</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060404</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060407</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MEROPEN (MEROPENEM,)</medicinalproduct>
        <drugdosagetext>1 G 1X  PER 1 DAY; 2 G 1X PER 1 DAY</drugdosagetext>
        <drugadministrationroute>041</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060408</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060421</drugenddate>
        <drugtreatmentduration>14</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FRAGMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VFEND (VORINCONAZOLE)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050787-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060626</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>HQWYE391826JUN06</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
    </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>CUTANEOUS LUPUS ERYTHEMATOSUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA MULTIFORME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS GENERALISED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PANTOPRAZOLE SODIUM</medicinalproduct>
        <drugauthorizationnumb>20987</drugauthorizationnumb>
        <drugdosagetext>40 MG 1X PER 1 DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050801</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GABAPENTIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050788-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060706</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FRWYE001427JAN03</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>65</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CHOLESTASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATOTOXICITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEORAL</medicinalproduct>
        <drugauthorizationnumb>50738</drugauthorizationnumb>
        <drugdosagetext>100 MG DAILY AT THE TIME OF THE EVENT ONSET</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS AGAINST TRANSPLANT REJECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021030</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELLCEPT</medicinalproduct>
        <drugdosagetext>2 G 1X PER 1 DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS AGAINST TRANSPLANT REJECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021024</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CORTANCYL (PREDNISONE, 0)</medicinalproduct>
        <drugdosagetext>12.5 MG AT THE TIME OF THE EVENT ONSET</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS AGAINST TRANSPLANT REJECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20011024</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050789-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060630</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>HQWYE017614APR05</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>64</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD IMMUNOGLOBULIN E INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PEMPHIGOID</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EUPANTOL (PANTOPRZAZOLE, TABLET, DELAYED RELEASE)</medicinalproduct>
        <drugauthorizationnumb>20987</drugauthorizationnumb>
        <drugdosagetext>40 MG 1X PER 1 DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BACK PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050114</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050124</drugenddate>
        <drugtreatmentduration>11</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLOR (AMLODIINE BESILATE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FRACTAL (FLUVASTATIN,)</medicinalproduct>
        <drugdosagetext>1 DOSAGE FORM 1X PER 1 DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXEN (NIMESULIDE,)</medicinalproduct>
        <drugdosagetext>100 MG ^SOME TIME (S) SOME DF^</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BACK PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050114</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050124</drugenddate>
        <drugtreatmentduration>11</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>THIOCOLCHICOSIDE (THIOCOLCHICOSIDE)</medicinalproduct>
        <drugdosagetext>^SOME TIME (S) SOME DF^</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BACK PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050114</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050124</drugenddate>
        <drugtreatmentduration>11</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZAMADOL (TRAMADOL,)</medicinalproduct>
        <drugdosagetext>^SOME TIME (S) SOME DF^</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BACK PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050114</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050124</drugenddate>
        <drugtreatmentduration>11</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050790-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060703</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GBWYE633117MAY06</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>ACUTE CORONARY SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EFFEXOR XR</medicinalproduct>
        <drugauthorizationnumb>20699</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SERTRALINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050791-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006082419</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>37</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE NECROSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ATARAX</medicinalproduct>
        <drugauthorizationnumb>11111</drugauthorizationnumb>
        <drugdosagetext>50 MG, INTRAMUSCULAR</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060622</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060622</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PENTAZOCINE LACTATE</medicinalproduct>
        <drugdosagetext>INTRAMUSCULAR</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060622</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060622</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ATROPINE</medicinalproduct>
        <drugdosagetext>INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050792-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060627</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006082490</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>13</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANTICONVULSANT DRUG LEVEL BELOW THERAPEUTIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAMMA-GLUTAMYLTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DILANTIN</medicinalproduct>
        <drugauthorizationnumb>8762</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VFEND</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050793-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060627</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006082430</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>NEPHROLITHIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINE ANALYSIS ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EPELIN KAPSEALS (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>19960101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GARDENAL ^AVENTIS^ (PHENOBARBITAL)</medicinalproduct>
        <drugdosagetext>200 MG (100 MG, 2 IN 1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050794-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060630</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006082534</companynumb>
    <primarysource>
      <reportercountry>CHILE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>85</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANOREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSED LEVEL OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOKALAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPONATRAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY OEDEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SERTRALINE</medicinalproduct>
        <drugauthorizationnumb>19839</drugauthorizationnumb>
        <drugdosagetext>25 MG</drugdosagetext>
        <drugindication>MAJOR DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALPRAZOLAM EXTENDED-RELEASE</medicinalproduct>
        <drugdosagetext>0.5 MG</drugdosagetext>
        <drugindication>MAJOR DEPRESSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050795-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060627</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006082606</companynumb>
    <primarysource>
      <reportercountry>IRELAND</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DEPRESSED LEVEL OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEDATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugauthorizationnumb>21446</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CANCER PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENZODIAZEPINE DERIVATIVES (BENZODIAZEPINE DERIVATIVES)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050796-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060627</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006082604</companynumb>
    <primarysource>
      <reportercountry>IRELAND</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>SEDATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugauthorizationnumb>21446</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CANCER PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENZODIAZEPINE DERIVATIVES (BENZODIAZEPINE DERIVATIVES)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050797-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060627</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006082567</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>58</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>62</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISTURBANCE IN ATTENTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE ATROPHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULAR WEAKNESS</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>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060425</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060607</drugenddate>
      </drug>
      <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>LOW DENSITY LIPOPROTEIN INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060425</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060607</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050798-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006082811</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>53</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ALANINE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASPARTATE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CHOLESTEROL INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CREATINE PHOSPHOKINASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD LACTATE DEHYDROGENASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD TRIGLYCERIDES INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GOITRE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRIMARY HYPOTHYROIDISM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ATORVASTATIN CALCIUM</medicinalproduct>
        <drugauthorizationnumb>20702</drugauthorizationnumb>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050799-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GXKR2006JP03595</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>67</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>LIVER DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RIFAMPICIN</medicinalproduct>
        <drugauthorizationnumb>64150</drugauthorizationnumb>
        <drugindication>TUBERCULOSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ISONIAZID</medicinalproduct>
        <drugindication>TUBERCULOSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ETHAMBUTOL (NGX) (ETHAMBUTOL)</medicinalproduct>
        <drugindication>TUBERCULOSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PYRAZINAMIDE</medicinalproduct>
        <drugindication>TUBERCULOSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050800-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060627</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GXKR2006IL03709</companynumb>
    <primarysource>
      <reportercountry>ISRAEL</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>38</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ACTIVATED PARTIAL THROMBOPLASTIN TIME PROLONGED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASCITES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DILATATION VENTRICULAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATOMEGALY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTHYROIDISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JUGULAR VEIN DISTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEUKOCYTOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPHILIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA ASPIRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROTHROMBIN TIME PROLONGED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY ARTERIAL PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY CONGESTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RALES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRICUSPID VALVE INCOMPETENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENTRICULAR DYSFUNCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMIODARONE (NGX) (AMIODARONE)</medicinalproduct>
        <drugauthorizationnumb>75315</drugauthorizationnumb>
        <drugdosagetext>ONCE/SINGLE, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050801-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GXKR2006BR03796</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>12</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>47</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABNORMAL BEHAVIOUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CRYING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSED MOOD</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SCHOOL REFUSAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMOXICILLIN</medicinalproduct>
        <drugbatchnumb>Z0001</drugbatchnumb>
        <drugauthorizationnumb>64076</drugauthorizationnumb>
        <drugdosagetext>500 MG, TID, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PHARYNGITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060606</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060616</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050802-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060703</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GXKR2006DE03760</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>3</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>12</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CRYING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISORIENTATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HALLUCINATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL STIFFNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NIGHTMARE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESTLESSNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CEFUROXIME</medicinalproduct>
        <drugauthorizationnumb>65126</drugauthorizationnumb>
        <drugdosagetext>5 ML, BID, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>EAR INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060404</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060405</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OTOBACID (CALCIUM PANTOTHENATE, CHLORAMPHENICOL, DEXAMETHASONE, PROPYP</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050803-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060707</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-13435912</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>61</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
        <drugauthorizationnumb>009218</drugauthorizationnumb>
        <drugindication>CORONARY ARTERY DISEASE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050804-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060626</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GXKR2006GB03699</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>54</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>90</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIPLEGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLONIDINE</medicinalproduct>
        <drugauthorizationnumb>70886</drugauthorizationnumb>
        <drugdosagetext>0.3 MG, TID, ORAL; SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>FLUSHING</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060522</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060525</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BETAMETHASONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIHYDROCODONE (DIHYDROCODEINE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GABAPENTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VERAPAMIL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050805-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060623</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GXKR2006TW03572</companynumb>
    <primarysource>
      <reportercountry>TAIWAN, PROVINCE OF CHINA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>57</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLINDNESS TRANSIENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RETINOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISION BLURRED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL ACUITY REDUCED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FAMOTIDINE</medicinalproduct>
        <drugauthorizationnumb>75302</drugauthorizationnumb>
        <drugdosagetext>20 MG, BID</drugdosagetext>
        <drugindication>GASTRIC ULCER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050806-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060626</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GXKR2006GB03698</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>29</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SENSORY LOSS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THERMAL BURN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GABAPENTIN</medicinalproduct>
        <drugauthorizationnumb>75539</drugauthorizationnumb>
        <drugdosagetext>800 MG, TID, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONAZEPAM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050807-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060623</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GXKR2006TN03580</companynumb>
    <primarysource>
      <reportercountry>TUNISIA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>71</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HYPOCALCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCREATITIS NECROTISING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INDOMETHACIN</medicinalproduct>
        <drugauthorizationnumb>70673</drugauthorizationnumb>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugtreatmentduration>30</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CAPTOPRIL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050808-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060703</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CG-MERCK-0607USA00735</companynumb>
    <primarysource>
      <reportercountry>CONGO</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>38</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ADVERSE EVENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>STROMECTOL</medicinalproduct>
        <drugauthorizationnumb>050742</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060519</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060519</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050809-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060207</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-MERCK-0602DEU00036</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>83</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ANOREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ATRIAL FIBRILLATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRONCHITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIOVASCULAR INSUFFICIENCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONCUSSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONTUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG ADMINISTRATION ERROR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FUNGAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL INFLAMMATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMARTHROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HUMERUS FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEUKOCYTOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OESOPHAGITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA BACTERIAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RADIUS FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL CYST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESORPTION BONE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESTLESSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN LACERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY RETENTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL DISTURBANCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>20560</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030823</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060121</drugenddate>
        <drugtreatmentduration>883</drugtreatmentduration>
        <drugtreatmentdurationunit></drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021209</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060122</drugenddate>
        <drugtreatmentduration>1141</drugtreatmentduration>
        <drugtreatmentdurationunit></drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021209</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060122</drugenddate>
        <drugtreatmentduration>1141</drugtreatmentduration>
        <drugtreatmentdurationunit></drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM (UNSPECIFIED) AND VITAMIN D (UNSPECIFIED)</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030823</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060122</drugenddate>
        <drugtreatmentduration>884</drugtreatmentduration>
        <drugtreatmentdurationunit></drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050810-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060703</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CG-MERCK-0607USA00733</companynumb>
    <primarysource>
      <reportercountry>CONGO</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>42</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ADVERSE EVENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>STROMECTOL</medicinalproduct>
        <drugauthorizationnumb>050742</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060512</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060512</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050811-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060710</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0607USA01652</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>58</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VYTORIN</medicinalproduct>
        <drugauthorizationnumb>021687</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060705</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060705</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPROL-XL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050812-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060615</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0606USA04347</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>83</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>86</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HEPATOTOXICITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHABDOMYOLYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WRONG TECHNIQUE IN DRUG USAGE PROCESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugauthorizationnumb>19766</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>LIPIDS INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060301</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPROL-XL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRINZIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVATOL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRILOSEC</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050813-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060703</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CG-MERCK-0607USA00726</companynumb>
    <primarysource>
      <reportercountry>CONGO</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>40</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ADVERSE EVENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>STROMECTOL</medicinalproduct>
        <drugauthorizationnumb>050742</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060518</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060518</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050814-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060703</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CG-MERCK-0607USA00715</companynumb>
    <primarysource>
      <reportercountry>CONGO</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>42</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ADVERSE EVENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>STROMECTOL</medicinalproduct>
        <drugauthorizationnumb>050742</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060518</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060518</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050815-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060703</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CG-MERCK-0607USA00738</companynumb>
    <primarysource>
      <reportercountry>CONGO</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>60</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ADVERSE EVENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>STROMECTOL</medicinalproduct>
        <drugauthorizationnumb>050742</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060519</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060519</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050816-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>214221</companynumb>
    <primarysource>
      <reportercountry>MEXICO</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>72</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSORIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</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>20050406</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050420</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050817-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>219160</companynumb>
    <primarysource>
      <reportercountry>SWITZERLAND</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>46</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BASOPHIL COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD POTASSIUM INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EOSINOPHIL COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOCHROMIC ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPHADENOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPHOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSORIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TUBERCULOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EFALIZUMAB (EFALIZUMAB) PWDR + SOLVENT, INJECTION SOLN, 125MG</medicinalproduct>
        <drugdosagetext>0.142 MG/KG, 1/WEEK, SUBCUTANEOUS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PSORIASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050317</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050901</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050818-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060706</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>225337</companynumb>
    <primarysource>
      <reportercountry>SWEDEN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>OPTIC NERVE INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAPILLOEDEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MABTHERA (RITUXIMAB) CONC FOR SOLUTION FOR INFUSION</medicinalproduct>
        <drugdosagetext>700 MG,</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051102</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYCLOPHOSPHAMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ONCOVIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE TAB</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050819-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060706</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>215514</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>69</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>56</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HAEMATURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOLYSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MABTHERA (RITUXIMAB) CONC FOR SOLUTION FOR INFUSION</medicinalproduct>
        <drugdosagetext>850 MG, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CHRONIC LYMPHOCYTIC LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050423</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050501</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUDARABINE</medicinalproduct>
        <drugdosagetext>25 MG/M2, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CHRONIC LYMPHOCYTIC LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050429</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050501</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOPHOSPHAMIDE</medicinalproduct>
        <drugdosagetext>250 MG/M2, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CHRONIC LYMPHOCYTIC LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050429</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050501</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VORICONAZOLE (VORICONAZOLE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ESOMEPRAZOLE (ESOMEPRAZOLE MAGNESIUM)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050820-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060706</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>215262</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MABTHERA (RITUXIMAB) CONC FOR SOLUTION FOR INFUSION</medicinalproduct>
        <drugdosagetext>250 MG/M2, SINGLE, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041209</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041209</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MABTHERA (RITUXIMAB) CONC FOR SOLUTION FOR INFUSION</medicinalproduct>
        <drugdosagetext>250 MG/M2, SINGLE, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041216</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041216</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZEVALIN</medicinalproduct>
        <drugdosagetext>0.4 MCI/KG, SINGLE, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NON-HODGKIN'S LYMPHOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041216</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041216</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050821-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>225499</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>61</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>DISSEMINATED INTRAVASCULAR COAGULATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMODIALYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC ENCEPHALOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATITIS B</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATITIS FULMINANT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RITUXAN</medicinalproduct>
        <drugdosagetext>650 MG, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NON-HODGKIN'S LYMPHOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050119</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050627</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOPHOSPHAMIDE</medicinalproduct>
        <drugindication>NON-HODGKIN'S LYMPHOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050120</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOXORUBICIN HCL</medicinalproduct>
        <drugindication>NON-HODGKIN'S LYMPHOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050120</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VINCRISTINE</medicinalproduct>
        <drugindication>NON-HODGKIN'S LYMPHOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050120</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISONE TAB</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050120</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050822-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060626</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>226673</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>68</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MABTHERA (RITUXIMAB) CONC FOR SOLUTION FOR INFUSION</medicinalproduct>
        <drugindication>MANTLE CELL LYMPHOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CHEMOTHERAPY (ANTINEOPLASTIC AGENT NOS)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050823-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060626</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>226673</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>68</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MABTHERA (RITUXIMAB) CONC FOR SOLUTION FOR INFUSION</medicinalproduct>
        <drugindication>MANTLE CELL LYMPHOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CHEMOTHERAPY (ANTINEOPLASTIC AGENT NOS)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050824-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060621</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GXKR2006JP03596</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>72</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>AZOTAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIALYSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RIFAMPICIN</medicinalproduct>
        <drugauthorizationnumb>8678</drugauthorizationnumb>
        <drugindication>GRANULOMA SKIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ETHAMBUTOL (NGX) (ETHAMBUTOL)</medicinalproduct>
        <drugindication>GRANULOMA SKIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ISONIAZID</medicinalproduct>
        <drugindication>GRANULOMA SKIN</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050825-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060627</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GXKR2006JP02313</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>66</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>HAEMODIALYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATITIS FULMINANT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RIMACTANE</medicinalproduct>
        <drugauthorizationnumb>64150</drugauthorizationnumb>
        <drugdosagetext>300 MG, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY TUBERCULOSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060302</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060420</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ISONIAZID</medicinalproduct>
        <drugdosagetext>400 MG, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY TUBERCULOSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060302</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060420</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PYRAZINAMIDE</medicinalproduct>
        <drugdosagetext>1 G, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY TUBERCULOSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060302</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060420</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ETHAMBUTOL HCL</medicinalproduct>
        <drugdosagetext>500 MG, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY TUBERCULOSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060302</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060420</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADEROXAL (PYRIDOXAL PHOSPHATE)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050826-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GXKR2006PL03742</companynumb>
    <primarysource>
      <reportercountry>POLAND</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>18</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOODY DISCHARGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EPISTAXIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PETECHIAE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLONIDAN (NGX) (LORATADINE) TABLET</medicinalproduct>
        <drugauthorizationnumb>75209</drugauthorizationnumb>
        <drugdosagetext>10 MG, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHINITIS ALLERGIC</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050827-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060622</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2006PL09404</companynumb>
    <primarysource>
      <reportercountry>POLAND</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>35</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>GINGIVAL HYPERPLASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMANGIOMA OF SKIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN DEPIGMENTATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN NODULE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VASCULAR SKIN DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOSPORINE</medicinalproduct>
        <drugauthorizationnumb>40194</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugindication>PSORIATIC ARTHROPATHY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugindication>PSORIATIC ARTHROPATHY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHYLPREDNISOLONE</medicinalproduct>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugindication>PSORIATIC ARTHROPATHY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050828-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060626</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GXKR2006GB03694</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>29</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ERECTILE DYSFUNCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugauthorizationnumb>75757</drugauthorizationnumb>
        <drugdosagetext>40 MG, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ABDOMINAL PAIN UPPER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060508</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060601</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ERYTHROMYCIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050829-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060627</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2006TR09735</companynumb>
    <primarysource>
      <reportercountry>TURKEY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>52</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CHOLECYSTITIS CHRONIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHOLELITHIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCISION SITE COMPLICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METASTASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERITONEAL CARCINOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOSPORINE</medicinalproduct>
        <drugauthorizationnumb>80339</drugauthorizationnumb>
        <drugdosagetext>100 MG, BID</drugdosagetext>
        <drugindication>RENAL TRANSPLANT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AZATHIOPRINE</medicinalproduct>
        <drugdosagetext>100 MG/D</drugdosagetext>
        <drugindication>RENAL TRANSPLANT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugdosagetext>5 MG/D</drugdosagetext>
        <drugindication>RENAL TRANSPLANT</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050830-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060627</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006081087</companynumb>
    <primarysource>
      <reportercountry>ISRAEL</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUTENT</medicinalproduct>
        <drugauthorizationnumb>21968</drugauthorizationnumb>
        <drugdosagetext>37.5 MG (37.5 MG, 1 IN 1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>METASTATIC RENAL CELL CARCINOMA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050831-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060626</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006081178</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>68</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>AGGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AGITATION</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>20060106</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060510</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>URAPIDIL (URAPIDIL)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NAFTIDROFURYL OXALATE (NAFTIDROFURYL OXALATE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NICARDIPINE HYDROCHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOPICLONE (ZOPICLONE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONAZEPAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TIAPRIDE HYDROCHLORIDE (TIAPRIDE HYDROCHLORIDE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MORPHINE SULFATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MACROGOL (MACROGOL)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050832-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060627</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006080930</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>35</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANOREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG TOXICITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FACE OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLEURAL EFFUSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUTENT</medicinalproduct>
        <drugauthorizationnumb>21968</drugauthorizationnumb>
        <drugdosagetext>50 MG (50 MG, DAILY - INTERVAL: EVERY DAY), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RENAL CELL CARCINOMA STAGE UNSPECIFIED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060519</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050833-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060627</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006081314</companynumb>
    <primarysource>
      <reportercountry>POLAND</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>52</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>70</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUTENT</medicinalproduct>
        <drugauthorizationnumb>21968</drugauthorizationnumb>
        <drugdosagetext>37.5 MG, INTERVAL: EVERY DAY, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RENAL CELL CARCINOMA STAGE UNSPECIFIED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060614</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050834-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060626</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006081245</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>63</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>75</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SOLU-MEDROL</medicinalproduct>
        <drugauthorizationnumb>11856</drugauthorizationnumb>
        <drugdosagetext>120 MG, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060407</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060407</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PACLITAXEL</medicinalproduct>
        <drugdosagetext>300 MG (300 MG), INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060407</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060407</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RANITIDINE</medicinalproduct>
        <drugdosagetext>50 MG (50 MG), INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060407</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060407</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEXCHLORPHENIRAMINE MALEATE</medicinalproduct>
        <drugdosagetext>5 MG (5 MG), INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060407</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060407</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GEMCITABINE</medicinalproduct>
        <drugdosagetext>2300 MG (2300 MG), INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060407</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060407</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KYTRIL</medicinalproduct>
        <drugdosagetext>3 MG (3 MG), INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060407</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060407</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050835-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060627</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006081600</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>78</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>72</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CHILLS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LETHARGY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUTENT</medicinalproduct>
        <drugauthorizationnumb>21968</drugauthorizationnumb>
        <drugdosagetext>50 MG (50 MG, 1 IN 1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RENAL CELL CARCINOMA STAGE UNSPECIFIED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060609</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUDROCORTISONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCORTISONE TAB</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>ATORVASTATIN CALCIUM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050836-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060627</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006081468</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>78</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CSF LYMPHOCYTE COUNT ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CSF PROTEIN INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugauthorizationnumb>20998</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050837-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060627</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006081323</companynumb>
    <primarysource>
      <reportercountry>NETHERLANDS</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>45</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>67</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTHYROIDISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUTENT</medicinalproduct>
        <drugauthorizationnumb>21968</drugauthorizationnumb>
        <drugdosagetext>50 MG (50 MG, 1 IN 1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RENAL CELL CARCINOMA STAGE UNSPECIFIED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060529</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAMADOL HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXAZEPAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALPROIC ACID</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050838-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200612455GDS</companynumb>
    <primarysource>
      <reportercountry>VENEZUELA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>22</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ENCEPHALITIC INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVELOX</medicinalproduct>
        <drugauthorizationnumb>21085</drugauthorizationnumb>
        <drugdosagetext>400 MG, QD, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SINUSITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060511</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060518</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCORT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SINGULAIR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ROCEPHIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050839-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200612733GDS</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>61</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EPISTAXIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVELOX</medicinalproduct>
        <drugauthorizationnumb>21085</drugauthorizationnumb>
        <drugdosagetext>400 MG, ONCE,</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALTACE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLOVENT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MODURET</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SALBUTAMOL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050840-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200612761GDS</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>POISONING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVELOX</medicinalproduct>
        <drugauthorizationnumb>21085</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THEOPHYLLINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050841-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200612762GDS</companynumb>
    <primarysource>
      <reportercountry>VENEZUELA</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>80</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>50</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ARRHYTHMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSARTHRIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STUPOR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UNEVALUABLE EVENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</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>20060627</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050842-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060529</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CHNY2006DE01659</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>45</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>100</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CHEST DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NICOTINELL KAUGUMMI            CHEWABLE GUM</medicinalproduct>
        <drugauthorizationnumb>20076</drugauthorizationnumb>
        <drugdosagetext>16-20 MG DAILY, CHEWED</drugdosagetext>
        <drugadministrationroute>002</drugadministrationroute>
        <drugindication>STOMATITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050313</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060515</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050843-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060623</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CHNY2006JP01932</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>64</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD CREATINE PHOSPHOKINASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH GENERALISED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH VESICULAR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NICOTINELL</medicinalproduct>
        <drugauthorizationnumb>20076</drugauthorizationnumb>
        <drugdosagetext>QD, TRANSDERMAL</drugdosagetext>
        <drugadministrationroute>062</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060601</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050844-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060626</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CHNY2006AU01940</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>59</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL DISTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CAROTID PULSE ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREATMENT NONCOMPLIANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALPHAPHARM QUITX   (NICOTINE)</medicinalproduct>
        <drugauthorizationnumb>20076</drugauthorizationnumb>
        <drugdosagetext>21 MG, QD, TRANSDERMAL</drugdosagetext>
        <drugadministrationroute>062</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060618</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060620</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADALAT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MINAX         (METOPROLOL TARTRATE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZANTAC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MORPINE (MORPHINE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIORESAL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DUCENE          (DIAZEPAM)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEPTRAN (DOXEPIN HYDROCHLORIDE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIAMICRON (GLICLAZIDE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050845-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0429994A</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>41</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDE ATTEMPT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
        <drugauthorizationnumb>20031</drugauthorizationnumb>
        <drugdosagetext>PER DAY/ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugtreatmentduration>136</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIAZEPAM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050846-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060627</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0429646A</companynumb>
    <primarysource>
      <reportercountry>SPAIN</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>7</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ENANTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EPSTEIN-BARR VIRUS ANTIBODY POSITIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA MULTIFORME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MONONUCLEOSIS SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN HYPERPIGMENTATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN TEST POSITIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AUGMENTIN '250'</medicinalproduct>
        <drugauthorizationnumb>50564</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050847-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060626</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0429577A</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>58</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>53.8873</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD CREATINE PHOSPHOKINASE MB INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CREATININE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD MAGNESIUM DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPONATRAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORTHOSTATIC HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYARRHYTHMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THERAPEUTIC AGENT TOXICITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TROPONIN I INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LANOXIN</medicinalproduct>
        <drugauthorizationnumb>20405</drugauthorizationnumb>
        <drugdosagetext>YEARS</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TELITHROMYCIN (TELITHROMYCIN)</medicinalproduct>
        <drugindication>BRONCHITIS ACUTE</drugindication>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOSINOPRIL SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROGESTERONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PAROXETINE HYDROCHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BUDESONIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TERBUTALINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BISOPROLOL FUMARATE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050848-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0429888A</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>12</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>GASTRIC VARICES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATOTOXICITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPLENOMEGALY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VARICES OESOPHAGEAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>THIOGUANINE</medicinalproduct>
        <drugauthorizationnumb>12429</drugauthorizationnumb>
        <drugindication>ACUTE LYMPHOCYTIC LEUKAEMIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050849-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0429886A</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>11</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DUODENAL VARICES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRIC VARICES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATOSPLENOMEGALY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATOTOXICITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>THIOGUANINE</medicinalproduct>
        <drugauthorizationnumb>12429</drugauthorizationnumb>
        <drugindication>ACUTE LYMPHOCYTIC LEUKAEMIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050850-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0429884A</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>12</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>GASTRIC VARICES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATOSPLENOMEGALY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATOTOXICITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OESOPHAGEAL VARICES HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ULTRASOUND SCAN ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>THIOGUANINE</medicinalproduct>
        <drugauthorizationnumb>12429</drugauthorizationnumb>
        <drugindication>ACUTE LYMPHOCYTIC LEUKAEMIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050851-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0429879A</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>6</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CLUBBING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATOSPLENOMEGALY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATOTOXICITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TELANGIECTASIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>THIOGUANINE</medicinalproduct>
        <drugauthorizationnumb>12429</drugauthorizationnumb>
        <drugindication>ACUTE LYMPHOCYTIC LEUKAEMIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050852-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060630</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200612658GDS</companynumb>
    <primarysource>
      <reportercountry>NETHERLANDS</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>45</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>IRITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVELOX</medicinalproduct>
        <drugauthorizationnumb>21085</drugauthorizationnumb>
        <drugindication>BRONCHITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050853-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006077332</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>75</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>68</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARTROTEC (DICLOFENAC SODIUM, MISOPROSTOL)</medicinalproduct>
        <drugauthorizationnumb>20607</drugauthorizationnumb>
        <drugdosagetext>50 MG (FREQUENCY: DAILY), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BACK PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060617</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050854-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060627</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006076795</companynumb>
    <primarysource>
      <reportercountry>VENEZUELA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>84</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>46.4</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE CONGESTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHOLECYSTECTOMY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEPHROLITHIASIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugauthorizationnumb>21446</drugauthorizationnumb>
        <drugdosagetext>75 MG (75 MG, 1 IN 1 D)</drugdosagetext>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugauthorizationnumb>21446</drugauthorizationnumb>
        <drugdosagetext>75 MG (75 MG, 1 IN 1 D)</drugdosagetext>
        <drugindication>POST HERPETIC NEURALGIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENALAPRIL MALEATE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050855-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006076086</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SULFASALAZINE</medicinalproduct>
        <drugauthorizationnumb>7073</drugauthorizationnumb>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050856-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060622</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006079349</companynumb>
    <primarysource>
      <reportercountry>LATVIA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>48</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>50</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugauthorizationnumb>21446</drugauthorizationnumb>
        <drugdosagetext>75 MG (75 MG, 1 IN 1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BACK PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060625</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060625</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugauthorizationnumb>21446</drugauthorizationnumb>
        <drugdosagetext>75 MG (75 MG, 1 IN 1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NEURALGIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060625</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060625</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAVANCE (ALENDRONIC ACID, COLECALCIFEROL)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENAP (ENALAPRIL)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050857-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006078945</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>81</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
        <drugauthorizationnumb>19787</drugauthorizationnumb>
        <drugdosagetext>5 MG, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALDACTONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BUFFERIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIART (AZOSEMIDE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FAMOTIDINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PURSENNID (SENNA LEAF)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ISOSORBIDE DINITRATE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050858-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060626</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006078704</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CIRCULATORY COLLAPSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugauthorizationnumb>21446</drugauthorizationnumb>
        <drugdosagetext>300 MG (75 MG, 4 IN 1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RESTLESSNESS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050859-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006078187</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>14</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>41</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEPRESSED LEVEL OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVERDOSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALPRAZOLAM</medicinalproduct>
        <drugauthorizationnumb>18276</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050860-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060627</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006079479</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>68</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>101</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUTENT</medicinalproduct>
        <drugauthorizationnumb>21968</drugauthorizationnumb>
        <drugdosagetext>50 MG (50 MG, DAILY - INTERVAL: CYCLIC), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RENAL CELL CARCINOMA STAGE UNSPECIFIED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060607</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GABAPENTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALPROIC ACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMITRIPTYLINE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCORTISONE TAB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUDROCORTISONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAMADOL HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COD-LIVER OIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTIVITAMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IRON</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIPROBASE CREAM (CETOMACROGOL, CETOSTEARYL ALCOHOL, PARAFFIN, LIQUID, </medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050861-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060626</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006082695</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CREATININE RENAL CLEARANCE DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugauthorizationnumb>20702</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050862-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006082624</companynumb>
    <primarysource>
      <reportercountry>NETHERLANDS</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>0</patientsex>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugauthorizationnumb>21446</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050863-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060626</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006083178</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>81</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>AGRANULOCYTOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAHOR (ATORVASTATIN)</medicinalproduct>
        <drugauthorizationnumb>20702</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PANTOPRAZOLE SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugdosagetext>75 MG, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060506</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060510</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OFLOXACIN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060427</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060508</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIRTAZAPINE</medicinalproduct>
        <drugdosagetext>15 MG, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060323</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060510</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060402</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060504</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INDAPAMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CITALOPRAM HYDROBROMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RAMIPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIGOXIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM CHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIPARINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVENOX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050864-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060627</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006082980</companynumb>
    <primarysource>
      <reportercountry>SOUTH AFRICA</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EPILEPSY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VERTIGO</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL DISTURBANCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EPANUTIN (PHENYTOIN SODIUM)</medicinalproduct>
        <drugauthorizationnumb>84349</drugauthorizationnumb>
        <drugdosagetext>400 MG (1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>EPILEPSY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DILANTIN</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>EPILEPSY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050865-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060623</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006083593</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>3</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HALLUCINATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NIGHTMARE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARASOMNIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CETIRIZINE HCL</medicinalproduct>
        <drugauthorizationnumb>20346</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KETOTIFEN (KETOTIFEN)</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060606</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050866-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060623</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006083543</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>GAMMA-GLUTAMYLTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRANSAMINASES INCREASED</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>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUOXETINE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060501</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050868-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060622</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006083263</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>LARYNGEAL OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA MOUTH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugauthorizationnumb>21446</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050870-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060627</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006074497</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>37</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ACUTE TONSILLITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AGRANULOCYTOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUDDEN DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOXORUBICIN HCL</medicinalproduct>
        <drugauthorizationnumb>50467</drugauthorizationnumb>
        <drugdosagetext>50 MG/25 ML, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060215</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060418</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VINCRISTINE SULFATE</medicinalproduct>
        <drugdosagetext>INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060215</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060218</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BORTEZOMIB (BORTEZOMIB)</medicinalproduct>
        <drugdosagetext>INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060418</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060421</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE SODIUM PHOSPHATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CIFLOX (CIPROFLOXACIN)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CEFTAZIDIME PENTAHYDRATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AUGMENTIN '125'</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARANESP</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050873-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060626</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006080337</companynumb>
    <primarysource>
      <reportercountry>POLAND</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>79</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>74</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HYPOTONIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUTENT</medicinalproduct>
        <drugbatchnumb>N0401490</drugbatchnumb>
        <drugauthorizationnumb>21968</drugauthorizationnumb>
        <drugdosagetext>50  MG (50 MG, QD - INTERVAL:  EVERY DAY), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>METASTATIC RENAL CELL CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060520</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EFFOX LONG (ISOSORBIDE MONONITRATE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MOLSIDOMINE (MOLSIDOMINE)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050879-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060626</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006080267</companynumb>
    <primarysource>
      <reportercountry>POLAND</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>60</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>79</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>SUBARACHNOID HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUTENT</medicinalproduct>
        <drugbatchnumb>N0401490</drugbatchnumb>
        <drugauthorizationnumb>21968</drugauthorizationnumb>
        <drugdosagetext>50 MG (50 MG, QD - INTERVAL:  EVERY DAY), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>METASTATIC RENAL CELL CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060531</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050881-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060626</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006080833</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>IMPAIRED HEALING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN NECROSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUTENT</medicinalproduct>
        <drugauthorizationnumb>21968</drugauthorizationnumb>
        <drugindication>METASTASIS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUTENT</medicinalproduct>
        <drugauthorizationnumb>21968</drugauthorizationnumb>
        <drugindication>RENAL CELL CARCINOMA STAGE UNSPECIFIED</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050883-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060627</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006080548</companynumb>
    <primarysource>
      <reportercountry>POLAND</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>52</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>90</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>BLISTER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA EXERTIONAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EMBOLISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOXIC EPIDERMAL NECROLYSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUTENT</medicinalproduct>
        <drugauthorizationnumb>21968</drugauthorizationnumb>
        <drugdosagetext>50 MG (50 MG, 1 IN 1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CLEAR CELL CARCINOMA OF THE KIDNEY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060504</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060601</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050885-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060627</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006080923</companynumb>
    <primarysource>
      <reportercountry>ITALY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>79</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>HYPONATRAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYVOX</medicinalproduct>
        <drugauthorizationnumb>21131</drugauthorizationnumb>
        <drugdosagetext>1200 MG (1200 MG, DAILY), INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MENINGITIS TUBERCULOUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060608</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060612</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PIRALDINA (PYRAZINAMIDE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RIFADIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NICOZID (ISONIAZID)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ETAPIAM (ETHAMBUTOL DIHYDROCHLORIDE)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050889-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060627</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006080909</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>32</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD COPPER INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>C-REACTIVE PROTEIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RED BLOOD CELL SEDIMENTATION RATE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRANSAMINASES INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZITHROMAX</medicinalproduct>
        <drugauthorizationnumb>50670</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PHARYNGOLARYNGEAL PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060526</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060528</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050892-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060626</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006080880</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>49</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>96</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BONE MARROW FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CANDIDA SEPSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBRAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ENTEROBACTER SEPSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTHERMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLAMMATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOXORUBICIN HCL</medicinalproduct>
        <drugauthorizationnumb>50467</drugauthorizationnumb>
        <drugdosagetext>INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060119</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060328</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYTARABINE</medicinalproduct>
        <drugdosagetext>INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060118</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060503</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYTARABINE</medicinalproduct>
        <drugdosagetext>INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060118</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060503</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ETOPOSIDE</medicinalproduct>
        <drugdosagetext>INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060429</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060503</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RITUXIMAB (RITUXIMAB)</medicinalproduct>
        <drugdosagetext>INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060119</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060428</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugdosagetext>INTRATHECAL</drugdosagetext>
        <drugadministrationroute>037</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060118</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060329</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VINCRISTINE SULFATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OFLOXACIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMOXYCILLINE/CLAVULANIC ACID (AMOXYCILLINE, CLAVULANIC ACID)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE TAB</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050894-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060627</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006080932</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>INTRACRANIAL VENOUS SINUS THROMBOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SULFASALAZINE</medicinalproduct>
        <drugauthorizationnumb>7073</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050897-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060630</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006-DE-03046GD</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>33</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>66</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTHERMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POST PROCEDURAL COMPLICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MORPHINE</medicinalproduct>
        <drugdosagetext>100 MG, IT</drugdosagetext>
        <drugadministrationroute>037</drugadministrationroute>
        <drugindication>SPINAL ANAESTHESIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BUPIVACAINE</medicinalproduct>
        <drugdosagetext>10 MG (SEE TEXT), IT</drugdosagetext>
        <drugadministrationroute>037</drugadministrationroute>
        <drugindication>SPINAL ANAESTHESIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RINGER LACTATE (RINGER-LACTATE /01126301/)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EPHEDRINE SUL CAP</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OCYTOCINE (OXYTOCIN)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CEFAZOLINE (CEFAZOLIN)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050899-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060630</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006-DE-03347GD</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>7</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>44</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ELECTROMYOGRAM ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INVESTIGATION ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOTOR DYSFUNCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NERVE ROOT COMPRESSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MORPHINE</medicinalproduct>
        <drugdosagetext>2.5 MG (SEE TEXT, SINGLE CAUDAL INJECTION OF 2.5 MG MORPHINE/100 ML SALINE OVER ABOUT 20 S), ED</drugdosagetext>
        <drugadministrationroute>008</drugadministrationroute>
        <drugindication>POSTOPERATIVE ANALGESIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MIDAZOLAM HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SEVOFLURANE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NITROUS OXIDE W/ OXYGEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYGEN (OXYGEN)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REMIFENTANIL (REMIFENTANIL)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050900-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060627</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006-BP-07413RO</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>43</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>102</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ACCIDENTAL OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG ADMINISTRATION ERROR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INADEQUATE ANALGESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCORRECT DRUG ADMINISTRATION RATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEDICAL DEVICE COMPLICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MORPHINE</medicinalproduct>
        <drugdosagetext>5 MG LOADING DOSE, UP TO 15 MG, MORPHINE 5 MG/ML, 2 MG PCA DOSE, 10-MIN LOCKOUT, NO 4 HR MAXIMUM, IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PAIN</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050901-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060627</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006-BP-07403RO</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>52</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD ARSENIC INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COGNITIVE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GLIOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEUKOENCEPHALOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEMORY IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugauthorizationnumb>40054</drugauthorizationnumb>
        <drugdosagetext>12 MG/DOSE, TR</drugdosagetext>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>ACUTE PROMYELOCYTIC LEUKAEMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARSENIC TRIOXIDE (ARSENIC TRIOXIDE)</medicinalproduct>
        <drugdosagetext>10 MG/DAY , PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ACUTE PROMYELOCYTIC LEUKAEMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRETINOIN</medicinalproduct>
        <drugdosagetext>70 MG/DAY, PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ACUTE PROMYELOCYTIC LEUKAEMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ASCORBIC ACID</medicinalproduct>
        <drugdosagetext>1 G/DAY, PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ACUTE PROMYELOCYTIC LEUKAEMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYTARABINE</medicinalproduct>
        <drugdosagetext>50 MG/DOSE, TR</drugdosagetext>
        <drugindication>ACUTE PROMYELOCYTIC LEUKAEMIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050902-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006-DE-03300GD</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>AORTIC ANEURYSM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AORTIC ARTERIOSCLEROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AORTIC NECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AORTITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOLLUSCUM CONTAGIOSUM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISONE TAB</medicinalproduct>
        <drugauthorizationnumb>80352</drugauthorizationnumb>
        <drugindication>ECZEMA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050903-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006-DE-03320GD</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>62</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHEUMATOID ARTHRITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LANSOPRAZOLE</medicinalproduct>
        <drugauthorizationnumb>20406</drugauthorizationnumb>
        <drugdosagetext>30 MG</drugdosagetext>
        <drugindication>HELICOBACTER INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19991112</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLARITHROMYCIN</medicinalproduct>
        <drugdosagetext>600 MG</drugdosagetext>
        <drugindication>HELICOBACTER INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19991112</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugdosagetext>7.5 MG PER WEEK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMOXICILLIN</medicinalproduct>
        <drugdosagetext>1500 MG</drugdosagetext>
        <drugindication>HELICOBACTER INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19991112</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>D-PENICILLAMINE (PENICILLAMINE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GOLD SALT (GOLD)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>STEROIDS (CORTICOSTEROIDS)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050904-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060627</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006-BP-07398RO</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>58</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>54</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ATRIAL FIBRILLATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CREATINE PHOSPHOKINASE MB INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CREATININE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD POTASSIUM DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIOACTIVE DRUG LEVEL INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ELECTROCARDIOGRAM REPOLARISATION ABNORMALITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOMAGNESAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPONATRAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORTHOSTATIC HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYARRHYTHMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THERAPEUTIC AGENT TOXICITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TROPONIN I INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIGOXIN</medicinalproduct>
        <drugauthorizationnumb>21648</drugauthorizationnumb>
        <drugdosagetext>0.25 MG/DAY (0.25 MG)</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
        <drugdosagetext>25 MG/DAY (1 IN 1 D)</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TELITHROMYCIN (TELITHROMYCIN)</medicinalproduct>
        <drugdosagetext>800 MG/DAY</drugdosagetext>
        <drugindication>BRONCHITIS ACUTE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BUDESONIDE</medicinalproduct>
        <drugdosagetext>IH</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>BRONCHITIS ACUTE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TERBUTALINE SULFATE</medicinalproduct>
        <drugdosagetext>10 MG/DAY (10 MG)</drugdosagetext>
        <drugindication>BRONCHITIS ACUTE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROGESTERONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PAROXETINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050905-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060627</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GXKR2006JP03495</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>61</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>50</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>C-REACTIVE PROTEIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC ENZYME INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG CONSOLIDATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ISONIAZID</medicinalproduct>
        <drugauthorizationnumb>8678</drugauthorizationnumb>
        <drugdosagetext>400 MG</drugdosagetext>
        <drugindication>MYCOBACTERIUM KANSASII INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLARITHROMYCIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ETHAMBUTOL HYDROCHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RIFAMPICIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050907-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060630</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-2006-002285</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>43</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>88</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN LOWER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AMENORRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLADDER DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEIOMYOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POST PROCEDURAL PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</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>20050401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CO-DIOVAN (VALSARTAN)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NOVALGIN /SCH/ (METAMIZOLE SODIUM MONOHYDRATE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PASPERTIN (METOCLOPRAMIDE HYDROCHLORIDE)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050908-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060626</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>TN-2006-009780</companynumb>
    <primarysource>
      <reportercountry>TUNISIA</reportercountry>
      <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>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EOSINOPHIL COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYDROCELE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFERTILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL COLIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RETROPERITONEAL FIBROSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SOTALOL HYDROCHLORIDE</medicinalproduct>
        <drugauthorizationnumb>19865</drugauthorizationnumb>
        <drugdosagetext>2 TAB(S), 1X/DAY, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARRHYTHMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060420</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050910-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060623</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>NL-2006-017537</companynumb>
    <primarysource>
      <reportercountry>NETHERLANDS</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>10</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ADENOVIRUS INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD TRIGLYCERIDES INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMPLICATIONS OF BONE MARROW TRANSPLANT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATOMEGALY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HISTIOCYTOSIS HAEMATOPHAGIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HUMAN POLYOMAVIRUS INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCYTOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY SYNCYTIAL VIRUS INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SERUM FERRITIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPLENOMEGALY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VIRAL INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUDARA</medicinalproduct>
        <drugauthorizationnumb>20038</drugauthorizationnumb>
        <drugdosagetext>150 MG, MG/M2</drugdosagetext>
        <drugindication>BONE MARROW CONDITIONING REGIMEN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTITHYMOCYTE IMMUNOGLOBULIN (ANTITHYMOCYTE IMMUNOGLOBULIN)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYCLOPHOSPHAMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>G-CSF (GRANULOCYTE COLONY STIMULATING FACTOR)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050911-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060623</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>NL-2006-017521</companynumb>
    <primarysource>
      <reportercountry>NETHERLANDS</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>11</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CYTOMEGALOVIRUS INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HISTIOCYTOSIS HAEMATOPHAGIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUDARA</medicinalproduct>
        <drugauthorizationnumb>20038</drugauthorizationnumb>
        <drugdosagetext>150 MG/M2</drugdosagetext>
        <drugindication>BONE MARROW CONDITIONING REGIMEN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTITHYMOCYTE IMMUNOGLOBULIN (ANTITHYMOCYTE IMMUNOGLOBULIN)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYCLOPHOSPHAMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>G-CSF (GRANULOCYTE COLONY STIMULATING FACTOR)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050913-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060623</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>NL-2006-017511</companynumb>
    <primarysource>
      <reportercountry>NETHERLANDS</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>13</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CYTOMEGALOVIRUS INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HISTIOCYTOSIS HAEMATOPHAGIC</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUDARA</medicinalproduct>
        <drugauthorizationnumb>20038</drugauthorizationnumb>
        <drugdosagetext>150 MG/M2</drugdosagetext>
        <drugindication>BONE MARROW CONDITIONING REGIMEN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTITHYMOCYTE IMMUNOGLOBULIN (ANTITHYMOCYTE IMMUNOGLOBULIN)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYCLOPHOSPHAMIDE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050916-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060630</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-2006-017795</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>36</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ENDOMETRIAL CANCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENOPAUSAL SYMPTOMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METRORRHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OESTROGEN RECEPTOR ASSAY POSITIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROGESTERONE RECEPTOR ASSAY POSITIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UTERINE ENLARGEMENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIRENA</medicinalproduct>
        <drugauthorizationnumb>21225</drugauthorizationnumb>
        <drugdosagetext>20 UG, CONT, INTRA-UTERINE</drugdosagetext>
        <drugadministrationroute>015</drugadministrationroute>
        <drugindication>CONTRACEPTION</drugindication>
        <drugtreatmentduration>365</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050918-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060626</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>223152</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>47</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BONE MARROW FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EPISTAXIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EPSTEIN-BARR VIRUS INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC STEATOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLAMMATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCYTOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>T-CELL LYMPHOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RAPTIVA</medicinalproduct>
        <drugdosagetext>0.8 ML, 1/WEEK, SUBCUTANEOUS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PSORIASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030514</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031021</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050919-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>215054</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>3</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>ABNORMAL BEHAVIOUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ACUTE PRERENAL FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AUTOIMMUNE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIALYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HALLUCINATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLUENZA LIKE ILLNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEUKOCYTOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOBAR PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPHADENOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENINGITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENINGOENCEPHALITIS BACTERIAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOTOR DYSFUNCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NERVOUS SYSTEM DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROTEINURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSYCHOMOTOR HYPERACTIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTH ABSCESS</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>20050419</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050526</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENALAPRIL MALEATE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050923-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060619</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>226989</companynumb>
    <primarysource>
      <reportercountry>NETHERLANDS</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>51</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>BLOOD LACTIC ACID INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>C-REACTIVE PROTEIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC VENTRICULAR DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIOGENIC SHOCK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVASTIN</medicinalproduct>
        <drugdosagetext>500 MG, Q3W, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLORECTAL CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060519</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CAPECITABINE (CAPECITABINE)</medicinalproduct>
        <drugdosagetext>4000 MG, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>COLORECTAL CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060519</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXALIPLATIN (OXALIPLATIN)</medicinalproduct>
        <drugdosagetext>260 MG, Q3W, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLORECTAL CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060519</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MICROLAX (DODECYL SULFOACETIC ACID, GLYCERIN, LAURETH 9, SODIUM CITRAT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SLEEPING MEDICATION NOS (HYPNOTIC NOS)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050924-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060622</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>226331</companynumb>
    <primarysource>
      <reportercountry>NETHERLANDS</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>73</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DUODENAL ULCER HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATEMESIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUCOSAL INFLAMMATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STOMATITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVASTIN</medicinalproduct>
        <drugdosagetext>7.5 MG/KG, Q3W, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLORECTAL CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060310</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060331</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CAPECITABINE (CAPECITABINE)</medicinalproduct>
        <drugdosagetext>1000 MG/M2, BID, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>COLORECTAL CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060309</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060330</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXALIPLATIN (OXALIPLATIN)</medicinalproduct>
        <drugdosagetext>130 MG/M2, Q3W, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLORECTAL CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060309</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060330</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ERBITUX</medicinalproduct>
        <drugdosagetext>400 MG/M2, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLORECTAL CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060309</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NSAID (NON-STEROIDAL ANTI-INFLAMMATORY DRUG NOS)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASCAL (CARBASPIRIN CALCIUM)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050925-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060705</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>S06-FRA-00445-01</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>21</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HYPOKALAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRESCRIBED OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ESCITALOPRAM OXALATE</medicinalproduct>
        <drugauthorizationnumb>21323</drugauthorizationnumb>
        <drugdosagetext>20 MG QD PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ESCITALOPRAM OXALATE</medicinalproduct>
        <drugdosagetext>40 MG QD PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ESCITALOPRAM OXALATE</medicinalproduct>
        <drugdosagetext>20 MG QD PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARIPIPRAZOLE</medicinalproduct>
        <drugdosagetext>20 MG QD PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PSYCHOTIC DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HEPTAMINOL HYDROCHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMOVANE (ZOPICLONE)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050926-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060622</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>S06-CAN-02625-01</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>81</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DUODENAL ULCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ESCITALOPRAM OXALATE</medicinalproduct>
        <drugauthorizationnumb>21323</drugauthorizationnumb>
        <drugdosagetext>10 MG QD PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PMS-MELOXICAM (MELOXICAM)</medicinalproduct>
        <drugdosagetext>15 MG QD PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALPRAZOLAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLOVENT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORAZEPAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PHENYTOIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL SPIROS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050927-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060704</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IE-ABBOTT-06P-229-0337496-00</companynumb>
    <primarysource>
      <reportercountry>IRELAND</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>COMPLETED SUICIDE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HALLUCINATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KLACID</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>50662</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050928-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060614</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BE-ABBOTT-06P-013-0336854-00</companynumb>
    <primarysource>
      <reportercountry>BELGIUM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>OOPHORECTOMY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SMALL INTESTINAL PERFORATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SIBUTRAMINE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>20632</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OBESITY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051216</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
        <drugindication>HYPERTHYROIDISM</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNSPECIFIED CONTRACEPTIVES</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050929-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060411</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AT-ABBOTT-06P-009-0330577-00</companynumb>
    <primarysource>
      <reportercountry>AUSTRIA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>74</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>91</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOMYELITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN ULCER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZEMPLAR</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>20819</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>HYPERPARATHYROIDISM SECONDARY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060126</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060330</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZEMPLAR</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020819</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051114</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060125</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZEMPLAR</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020819</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060331</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTIPHOSPHATE</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050926</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051221</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTIPHOSPHATE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051221</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCITRIOL</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050930-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060703</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-ABBOTT-06P-167-0337587-00</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>61</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ALOPECIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH MACULO-PAPULAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH PRURITIC</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050119</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051001</drugenddate>
        <drugtreatmentduration>373</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060501</drugenddate>
        <drugtreatmentduration>373</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RISEDRONATE SODIUM</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE</medicinalproduct>
        <drugindication>BLOOD PRESSURE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM GLUCONATE</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLOPIDOGREL</medicinalproduct>
        <drugindication>BLOOD PRESSURE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DICLOFENAC</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ERGOCALCIFEROL</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANSOPRAZOLE</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050931-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060627</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ABBOTT-06P-087-0336923-00</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>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CEFZON</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>50739</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060616</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060617</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OSELTAMIVIR</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060616</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060617</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOSFOMYCIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>050</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060616</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060616</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COCARL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060616</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060619</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TIPEPIDINE HIBENZATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060616</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060619</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PARACETA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060617</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060619</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SG GRANULE</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060617</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060619</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TIPEPIDINE HIBENZATE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060616</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060617</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050932-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesscongenitalanomali>1</seriousnesscongenitalanomali>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060703</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-ABBOTT-06P-056-0337580-00</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ARNOLD-CHIARI MALFORMATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HORSESHOE KIDNEY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENINGOCELE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MICROCEPHALY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERICARDIAL EFFUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLEURAL EFFUSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEPAKENE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>018081</drugauthorizationnumb>
        <drugindication>DRUG EXPOSURE DURING PREGNANCY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050933-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060607</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-ABBOTT-06P-167-0335539-00</companynumb>
    <primarysource>
      <reportercountry>IRELAND</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HODGKIN'S DISEASE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040201</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050934-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060703</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-ABBOTT-06P-056-0337582-00</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>33</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABORTION INDUCED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEPAKENE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>018081</drugauthorizationnumb>
        <drugindication>EPILEPSY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19950901</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031001</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050935-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060601</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-ABBOTT-06P-020-0335178-00</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>APPLICATION SITE IRRITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BREAST MASS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLUENZA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE HAEMATOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060411</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>FIBROMYALGIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE TAB</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DICLOFENAC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIAZEPAM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANXIETY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050936-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060403</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-ABBOTT-06P-056-0330175-00</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>52</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>85</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DYSAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUROPATHY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHIROCAINE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>ANALGESIC EFFECT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051122</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051122</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</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>CITALOPRAM</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXAZEPAM</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>DICLOFENAC</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>CLONIDINE</medicinalproduct>
        <drugdosagetext>75 GAMMA</drugdosagetext>
        <drugindication>ANAESTHESIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANAESTHETICS, GENERAL</medicinalproduct>
        <drugindication>ANAESTHESIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050937-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060703</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-ABBOTT-06P-056-0337404-00</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>76</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>96</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL STRANGULATED HERNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPEPSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRIC ULCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERAL PHYSICAL HEALTH DETERIORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PREPYLORIC STENOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SCAR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VERCYTE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>16245</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>POLYCYTHAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010215</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060215</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DILTIAZEM HCL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAMSULOSINE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALPHACALCIDOL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACETYLSALICYLIC ACID SRT</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000801</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRAVASTATIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000801</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GLYCERYL TRINITRATE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050938-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060623</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>S06-AUT-02641-01</companynumb>
    <primarysource>
      <reportercountry>AUSTRIA</reportercountry>
    </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>HALLUCINATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ILLUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESTLESSNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ESCITALOPRAM OXALATE</medicinalproduct>
        <drugauthorizationnumb>21323</drugauthorizationnumb>
        <drugdosagetext>10 MG QD PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051003</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050939-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060620</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>S06-CAN-02522-01</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>58</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TIAZAC</medicinalproduct>
        <drugauthorizationnumb>20401</drugauthorizationnumb>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TELMISARTAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RANITIDINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COMBIVENT (ALBUTEROL/IPRATROPIUM)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SALMETEROL XINAFOATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUTICASONE PROPIONATE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050940-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060623</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>S06-UKI-02638-01</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>71</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPONATRAEMIA</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>20060511</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060525</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PENICILLAMINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050941-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060622</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>S06-CAN-02624-01</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>28</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG ABUSER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL OVERDOSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELEXA</medicinalproduct>
        <drugauthorizationnumb>20822</drugauthorizationnumb>
        <drugdosagetext>200 MG ONCE</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELEXA</medicinalproduct>
        <drugdosagetext>20 MG QD PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>WELLBUTRIN SR</medicinalproduct>
        <drugdosagetext>1500 MG ONCE</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050942-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2005134722</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>57</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIOVASCULAR DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBRAL THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugauthorizationnumb>20998</drugauthorizationnumb>
        <drugdosagetext>400 MG (200 MG, 2 IN 1 D),</drugdosagetext>
        <drugindication>SYSTEMIC LUPUS ERYTHEMATOSUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030716</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEXTRA</medicinalproduct>
        <drugdosagetext>20 MG (20 MG, 1 IN 1 D),</drugdosagetext>
        <drugindication>SYSTEMIC LUPUS ERYTHEMATOSUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030411</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030716</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050943-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2005134615</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>83.9154</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CEREBRAL THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NECK PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugauthorizationnumb>20998</drugauthorizationnumb>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEXTRA</medicinalproduct>
        <drugdosagetext>20 MG (20 MG, 1 IN 1 D),</drugdosagetext>
        <drugindication>MUSCULOSKELETAL PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEXTRA</medicinalproduct>
        <drugdosagetext>20 MG (20 MG, 1 IN 1 D),</drugdosagetext>
        <drugindication>NECK PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050944-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060612</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006002229</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>58</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>90.7194</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CYANOPSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIAGRA</medicinalproduct>
        <drugauthorizationnumb>20895</drugauthorizationnumb>
        <drugdosagetext>(50 MG,), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>LIBIDO DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050945-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060627</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2005172578</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>35</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEPRESSION</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>
        <drugdosagetext>(300 MG)</drugdosagetext>
        <drugindication>DIABETIC NEUROPATHY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
        <drugauthorizationnumb>20235</drugauthorizationnumb>
        <drugdosagetext>(300 MG)</drugdosagetext>
        <drugindication>NEUROPATHY PERIPHERAL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050946-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2005171160</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>69</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>56.6996</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE CONGESTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUTENT</medicinalproduct>
        <drugauthorizationnumb>21968</drugauthorizationnumb>
        <drugdosagetext>50 MG (50 MG, INTERVAL:  X 28 DAYS), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>METASTATIC RENAL CELL CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051209</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALTACE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTIVITAMIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050947-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006034879</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>61</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>90.7194</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>CARDIAC ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUDDEN CARDIAC DEATH</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>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040413</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041116</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADVIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BEXTRA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DARVOCET</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050948-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006030588</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>55</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>90.7194</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ACTIVITIES OF DAILY LIVING IMPAIRED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FOOT DEFORMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAND DEFORMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEMIPLEGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugauthorizationnumb>20998</drugauthorizationnumb>
        <drugdosagetext>400 MG (200 MG, 2 IN 1 D),</drugdosagetext>
        <drugindication>ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050949-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060626</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006058692</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>52</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD CHOLESTEROL INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROOESOPHAGEAL REFLUX DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL STONE REMOVAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPINAL FUSION SURGERY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ULCER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugauthorizationnumb>20998</drugauthorizationnumb>
        <drugdosagetext>200 MG (100 MG, 2 IN 1 D),</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000324</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050950-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060626</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>226773</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>53</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MYOPATHY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVASTIN</medicinalproduct>
        <drugdosagetext>10 MG/KG,</drugdosagetext>
        <drugindication>METASTATIC RENAL CELL CARCINOMA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050951-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060626</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>226768</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>66</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>83.8</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ARTERIOSCLEROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISSEMINATED INTRAVASCULAR COAGULATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ECCHYMOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMODIALYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEAD INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOVOLAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL TUBULAR NECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOTIC MICROANGIOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TUMOUR LYSIS SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEVACIZUMAB OR PLACEBO (BEVACIZUMAB) PWDR + SOLVENT, INFUSION SOLN, 10</medicinalproduct>
        <drugdosagetext>15 MG/KG, Q3W, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PROSTATE CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060419</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOCETAXEL (DOCETAXEL)</medicinalproduct>
        <drugdosagetext>75 MG/M2, Q3W, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PROSTATE CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060419</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISONE TAB</medicinalproduct>
        <drugdosagetext>5 MG, BID, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLEDRONIC ACID (ZOLEDRONIC ACID)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COZAAR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IBURPOFEN (IBUPROFEN)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LUPRON</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OS-CAL (CALCIUM CARBONATE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050952-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060621</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>226815</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>81</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>64.5</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DECREASED APPETITE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STOMATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVASTIN</medicinalproduct>
        <drugbatchnumb>206101</drugbatchnumb>
        <drugdosagetext>325 MG, Q2W, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLORECTAL CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060524</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXALIPLATIN (OXALIPLATIN)</medicinalproduct>
        <drugbatchnumb>059704</drugbatchnumb>
        <drugdosagetext>145 MG, Q2W, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLORECTAL CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060524</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CAPECITABINE (CAPECITABINE)</medicinalproduct>
        <drugbatchnumb>U5086</drugbatchnumb>
        <drugdosagetext>5000 MG, QD, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>COLORECTAL CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060524</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE TAB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NABUMETONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM (CALCIUM NOS)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTIVITAMIN (MULTIVITAMINS NOS)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050953-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060626</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>226702</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>51</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD UREA DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOKALAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVASTIN</medicinalproduct>
        <drugdosagetext>5 MG/KG, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLORECTAL CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060124</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ERBITUX</medicinalproduct>
        <drugdosagetext>250 MG/M2, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLORECTAL CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060124</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUOROURACIL</medicinalproduct>
        <drugdosagetext>400 MG/M2, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLORECTAL CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060124</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXALIPLATIN (OXALIPLATIN)</medicinalproduct>
        <drugdosagetext>85 MG/M2, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLORECTAL CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060124</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENADRYL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMBIEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COMPAZINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENTYL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTIVITAMIN (MULTIVITAMINS NOS)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROTONIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOMOTIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLAGYL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PHENERGAN (PROMETHAZINE HYDROCHLORIDE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROMETHEZINE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OCTREOTIDE ACETATE (OCTREOTIDE ACETATE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOFLOXACIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050954-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>225612</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>81</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>63</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ATRIAL THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTRACARDIAC THROMBUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL ARTERY THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVASTIN</medicinalproduct>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugindication>COLON CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060316</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060427</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVASTIN</medicinalproduct>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugindication>COLON CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060216</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUOROURACIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEUCOVORIN CALCIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANOXIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KLONOPIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORTAB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROTONIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DECADRON</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANZEMET</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>B12 COMPLEX (CYANOCOBALAMIN, VITAMIN B COMPLEX)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050955-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060626</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>225783</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>AGNOSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEMYELINATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE SCLEROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NUCLEAR MAGNETIC RESONANCE IMAGING BRAIN ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>REFUSAL OF TREATMENT BY PATIENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPEECH DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HERCEPTIN</medicinalproduct>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051106</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060524</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EFFEXOR XR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADRIAMYCIN PFS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYTOXAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RADIATION (RADIATION THERAPY)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAMOXIFEN CITRATE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050956-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060703</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CG-MERCK-0607USA00731</companynumb>
    <primarysource>
      <reportercountry>CONGO</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>52</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ADVERSE EVENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>STROMECTOL</medicinalproduct>
        <drugauthorizationnumb>050742</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060512</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060512</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050957-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060626</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006SS000058</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>30</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANOREXIA NERVOSA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CREATINE PHOSPHOKINASE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MYOBLOC</medicinalproduct>
        <drugbatchnumb>K95003A</drugbatchnumb>
        <drugdosagetext>30000 U; IM</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>TORTICOLLIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060217</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060217</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050958-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060703</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CG-MERCK-0607USA00722</companynumb>
    <primarysource>
      <reportercountry>CONGO</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>36</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ADVERSE EVENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>STROMECTOL</medicinalproduct>
        <drugauthorizationnumb>050742</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060518</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060518</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050959-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060703</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CG-MERCK-0607USA00713</companynumb>
    <primarysource>
      <reportercountry>CONGO</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>47</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ADVERSE EVENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>STROMECTOL</medicinalproduct>
        <drugauthorizationnumb>050742</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060518</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060518</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050960-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060614</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-MERCK-0606GBR00052</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>59</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>80</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRY THROAT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROAT TIGHTNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugauthorizationnumb>19766</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060308</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060503</drugenddate>
        <drugtreatmentduration>57</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CARDIOVASCULAR EVENT PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD PRESSURE INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENDROFLUMETHIAZIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD PRESSURE INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050222</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IRBESARTAN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD PRESSURE INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050222</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050961-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060703</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CG-MERCK-0607USA00737</companynumb>
    <primarysource>
      <reportercountry>CONGO</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>53</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ADVERSE EVENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>STROMECTOL</medicinalproduct>
        <drugauthorizationnumb>050742</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060518</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060518</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050962-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060710</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ES-MERCK-0607ESP00012</companynumb>
    <primarysource>
      <reportercountry>SPAIN</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>80</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>74</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG LEVEL DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INVANZ</medicinalproduct>
        <drugauthorizationnumb>21337</drugauthorizationnumb>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>PNEUMONIA BACTERIAL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051231</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060109</drugenddate>
        <drugtreatmentduration>10</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VALPROATE SODIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>EPILEPSY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19950101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060103</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VALPROATE SODIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060104</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060105</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VALPROATE SODIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060106</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060109</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VALPROATE SODIUM</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060110</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060110</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VALPROATE SODIUM</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060111</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060120</drugenddate>
        <drugtreatmentduration>10</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALPROATE SODIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060121</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050963-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006082426</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BEDRIDDEN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TETANUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugauthorizationnumb>21446</drugauthorizationnumb>
        <drugindication>BACK PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALL OTHER THERAPEUTIC PRODUCTS (ALL OTHER THERAPEUTIC PRODUCTS)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050964-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060630</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006082547</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>NEOPLASM MALIGNANT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
        <drugauthorizationnumb>19839</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050965-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060627</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006082529</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>RHABDOMYOLYSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GEODON</medicinalproduct>
        <drugauthorizationnumb>20825</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALL OTHER THERAPEUTIC PRODUCTS (ALL OTHER THERAPEUTIC PRODUCTS)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050966-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060703</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AT-ABBOTT-06P-009-0337408-00</companynumb>
    <primarysource>
      <reportercountry>AUSTRIA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>71</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STAPHYLOCOCCAL SEPSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>POLYARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DICLOFENAC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EBETREXAT</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RABEPRAZOLE SODIUM</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050967-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006082517</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </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>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugauthorizationnumb>21446</drugauthorizationnumb>
        <drugdosagetext>200 MG (100 MG, 2 IN 1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060501</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COPAXONE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050968-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006082591</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZARONTIN</medicinalproduct>
        <drugauthorizationnumb>12380</drugauthorizationnumb>
        <drugdosagetext>50 MG (50 MG, 1 IN 1 D),</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060623</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEPAKOTE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050969-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006082773</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>58</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>102.0593</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CEREBRAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISTURBANCE IN ATTENTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugauthorizationnumb>20998</drugauthorizationnumb>
        <drugdosagetext>400 MG (200 MG, 2 IN 1 D),</drugdosagetext>
        <drugindication>KNEE OPERATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050970-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060627</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006082926</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>82</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ACUTE GRAFT VERSUS HOST DISEASE IN SKIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ACUTE MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BILIARY TRACT DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE MARROW FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CANDIDA SEPSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHOLESTASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GRAFT VERSUS HOST DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERBILIRUBINAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL CANDIDIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STEVENS-JOHNSON SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STREPTOCOCCAL SEPSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYSTEMIC CANDIDA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THERAPY NON-RESPONDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRANSFUSION REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
        <drugauthorizationnumb>20235</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PANTOPRAZOLE SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METOPROLOL (METOPROLOL)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMIODARONE (AMIODARONE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASCRIPTIN (ACETYLSALICYLIC ACID, ALUMINIUM HYDROXIDE, MAGNESIUM HYDROX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM CHLORIDE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050971-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060627</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006082884</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>68.0396</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CREATININE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC ENZYME INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WRONG TECHNIQUE IN DRUG USAGE PROCESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugauthorizationnumb>20702</drugauthorizationnumb>
        <drugdosagetext>5 MG (5 MG, 1 IN 1 D),</drugdosagetext>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060626</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LAMICTAL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMBIEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM (CALCIUM)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTIVITAMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NADOLOL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050972-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060705</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BE-ABBOTT-06P-013-0337690-00</companynumb>
    <primarysource>
      <reportercountry>BELGIUM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>WRIST FRACTURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050714</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INDOMETHACIN</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050973-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060706</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHO2006CL11002</companynumb>
    <primarysource>
      <reportercountry>CHILE</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>57</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>APPENDICITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZELMAC / HTF 919A</medicinalproduct>
        <drugauthorizationnumb>21200</drugauthorizationnumb>
        <drugdosagetext>6 MG, TID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>IRRITABLE BOWEL SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060627</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTIBIOTICS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050974-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060712</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2006HR10358</companynumb>
    <primarysource>
      <reportercountry>CROATIA (local name: Hrvatska)</reportercountry>
    </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>EYELID OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYELIDS PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL ACUITY REDUCED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
        <drugauthorizationnumb>020665</drugauthorizationnumb>
        <drugdosagetext>80 MG/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060603</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060628</drugenddate>
        <drugtreatmentduration>37440</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CONCOR</medicinalproduct>
        <drugdosagetext>2.5 MG, UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050975-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060614</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2006JP09097</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INTESTINAL OPERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LARGE INTESTINAL ULCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MELAENA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SHOCK HAEMORRHAGIC</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LOXOPROFEN SODIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>WOUND COMPLICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050801</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VOLTAREN</medicinalproduct>
        <drugauthorizationnumb>019201</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>WOUND COMPLICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050801</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050976-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060615</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2006VE09128</companynumb>
    <primarysource>
      <reportercountry>VENEZUELA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>44</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>OOPHORECTOMY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POLYNEUROPATHY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugauthorizationnumb>21223</drugauthorizationnumb>
        <drugdosagetext>4 MG, EVERY 28 DAYS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>METASTASES TO BONE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051123</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060627</drugenddate>
        <drugtreatmentduration>217</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FEMARA</medicinalproduct>
        <drugdosagetext>2.5 MG/D</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060208</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050977-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060530</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2006JP07840</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>57</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>55</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ALANINE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANURIA</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 LACTATE DEHYDROGENASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD UREA INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAMMA-GLUTAMYLTRANSFERASE ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATOCRIT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMODIALYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC FUNCTION ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYDRONEPHROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POSTRENAL FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RED BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL TUBULAR NECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URETERAL CATHETERISATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGMITT KENEI</medicinalproduct>
        <drugdosagetext>1500 MG/D</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060523</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MARZULENE S</medicinalproduct>
        <drugdosagetext>1.5 G/D</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060523</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SOLANAX</medicinalproduct>
        <drugdosagetext>0.4 MG/D</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060523</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMOBAN</medicinalproduct>
        <drugdosagetext>7.5 MG/D</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060523</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOXONIN</medicinalproduct>
        <drugdosagetext>1 DF/D</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060523</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCONTIN</medicinalproduct>
        <drugdosagetext>10 MG/D</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060524</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugauthorizationnumb>021223</drugauthorizationnumb>
        <drugdosagetext>4 MG, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>METASTASES TO BONE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060529</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060529</drugenddate>
        <drugtreatmentduration>1440</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050978-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060704</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHO2006AR10855</companynumb>
    <primarysource>
      <reportercountry>ARGENTINA</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>74</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABNORMAL FAECES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL SURGERY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOMYELITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZELMAC / HTF 919A</medicinalproduct>
        <drugauthorizationnumb>21200</drugauthorizationnumb>
        <drugdosagetext>UNK, BID</drugdosagetext>
        <drugindication>IRRITABLE BOWEL SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050979-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2006TR09674</companynumb>
    <primarysource>
      <reportercountry>TURKEY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>POISONING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TEGASEROD</medicinalproduct>
        <drugauthorizationnumb>21200</drugauthorizationnumb>
        <drugdosagetext>24 MG/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>IRRITABLE BOWEL SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060627</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050980-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060616</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2006JP09093</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>47</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>77</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BODY TEMPERATURE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOVENTILATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALLOR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY ARREST</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VOLTAREN</medicinalproduct>
        <drugauthorizationnumb>19201</drugauthorizationnumb>
        <drugdosagetext>100 MG, ONCE/SINGLE</drugdosagetext>
        <drugadministrationroute>054</drugadministrationroute>
        <drugindication>PROCEDURAL PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050215</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050215</drugenddate>
        <drugtreatmentduration>1440</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050981-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2006JP09831</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>41</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD CREATININE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENOVASCULAR HYPERTENSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
        <drugauthorizationnumb>20665</drugauthorizationnumb>
        <drugdosagetext>40 MG/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060610</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060612</drugenddate>
        <drugtreatmentduration>4320</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
        <drugdosagetext>5 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060610</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050982-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060302</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHO2006JP03680</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>75</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRIC CANCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATEMESIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC CANCER METASTATIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MELAENA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERITONITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SURGERY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
        <drugauthorizationnumb>21283</drugauthorizationnumb>
        <drugdosagetext>80 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030710</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050404</drugenddate>
        <drugtreatmentduration>635</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIGOSIN</medicinalproduct>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050422</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050422</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIART</medicinalproduct>
        <drugindication>CARDIAC FAILURE</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050422</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARTIST</medicinalproduct>
        <drugindication>CARDIAC FAILURE</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050422</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050983-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060630</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2006JP09950</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>74</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANAPHYLACTOID SHOCK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSED LEVEL OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOXIC ENCEPHALOPATHY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VOLTAREN</medicinalproduct>
        <drugauthorizationnumb>19201</drugauthorizationnumb>
        <drugdosagetext>25 MG/DAY</drugdosagetext>
        <drugadministrationroute>054</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050301</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050984-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060707</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2006US08707</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>78</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CALCULUS URINARY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRY MOUTH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLATULENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH MACULAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISION BLURRED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
        <drugauthorizationnumb>020665</drugauthorizationnumb>
        <drugdosagetext>160MG</drugdosagetext>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19960101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
        <drugauthorizationnumb>020665</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARDURA</medicinalproduct>
        <drugdosagetext>4MG</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050985-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060127</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2006TW01638</companynumb>
    <primarysource>
      <reportercountry>NETHERLANDS</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>21</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 BILIRUBIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD OSMOLARITY INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DERMATITIS EXFOLIATIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIABETES MELLITUS INSULIN-DEPENDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIABETIC KETOACIDOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG RASH WITH EOSINOPHILIA AND SYSTEMIC SYMPTOMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EOSINOPHILIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FACE OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HUMAN HERPESVIRUS 6 INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSULIN C-PEPTIDE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEUKOCYTOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LICHENOID KERATOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIP EROSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPHOCYTOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METABOLIC ACIDOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NORMOCHROMIC NORMOCYTIC ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCREATIC ENZYMES INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROTHROMBIN TIME PROLONGED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH MACULO-PAPULAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TONSILLITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DICLOFENAC</medicinalproduct>
        <drugauthorizationnumb>19201</drugauthorizationnumb>
        <drugindication>PHARYNGOLARYNGEAL PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IBUPROFEN (NGX)</medicinalproduct>
        <drugindication>PHARYNGOLARYNGEAL PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PENICILLIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050986-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060609</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2006JP08779</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>83</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>AGRANULOCYTOSIS</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>C-REACTIVE PROTEIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CIRCULATORY COLLAPSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GRANULOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLAMMATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPHOCYTE COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <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>DIOVAN</medicinalproduct>
        <drugauthorizationnumb>20665</drugauthorizationnumb>
        <drugdosagetext>20 MG/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060425</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060527</drugenddate>
        <drugtreatmentduration>47520</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAKEPRON</medicinalproduct>
        <drugdosagetext>30 MG/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060422</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060527</drugenddate>
        <drugtreatmentduration>51840</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ONEALFA</medicinalproduct>
        <drugdosagetext>1.0 UG/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>COMPRESSION FRACTURE</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060528</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050987-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060707</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2006JP10287</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>HYPONATRAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLEANAL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GASCON</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
        <drugauthorizationnumb>020665</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050988-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060701</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2006US08673</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </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>ABORTION SPONTANEOUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRILEPTAL</medicinalproduct>
        <drugauthorizationnumb>21014</drugauthorizationnumb>
        <drugdosagetext>750 MG, QD</drugdosagetext>
        <drugindication>CONVULSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050989-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060609</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2006JP08863</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>80</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ATRIOVENTRICULAR BLOCK</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CALBLOCK</medicinalproduct>
        <drugdosagetext>16 MG/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060609</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAKEPRON</medicinalproduct>
        <drugdosagetext>15 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060417</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MOBIC</medicinalproduct>
        <drugdosagetext>10 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050801</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
        <drugauthorizationnumb>020665</drugauthorizationnumb>
        <drugdosagetext>80 MG/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060609</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALPRAZOLAM</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050801</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050990-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060627</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2006US08358</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>48</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>87.074</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPINAL OSTEOARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WALKING AID USER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZELNORM</medicinalproduct>
        <drugauthorizationnumb>21200</drugauthorizationnumb>
        <drugdosagetext>6 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONSTIPATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051213</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060113</drugenddate>
        <drugtreatmentduration>46080</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050991-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060601</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHFR2006MT01881</companynumb>
    <primarysource>
      <reportercountry>MALTA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>55</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>60</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANGIONEUROTIC OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPHADENOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEOPLASM MALIGNANT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
        <drugauthorizationnumb>021283</drugauthorizationnumb>
        <drugdosagetext>160 MG/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CORONARY ARTERY BYPASS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060602</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
        <drugauthorizationnumb>021283</drugauthorizationnumb>
        <drugdosagetext>80 MG/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060603</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BURINEX</medicinalproduct>
        <drugdosagetext>1 MG, BID</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
        <drugdosagetext>50 MG, BID</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050992-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060704</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHO2006CL10874</companynumb>
    <primarysource>
      <reportercountry>CHILE</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>27</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CYST REMOVAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OOPHORECTOMY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVARIAN ABSCESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SALPINGECTOMY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZELMAC / HTF 919A</medicinalproduct>
        <drugauthorizationnumb>21200</drugauthorizationnumb>
        <drugdosagetext>6 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLINDAMYCIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050993-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060418</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2006US05523</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>NEOPLASM MALIGNANT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENABLEX</medicinalproduct>
        <drugauthorizationnumb>21513</drugauthorizationnumb>
        <drugindication>HYPERTONIC BLADDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050994-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2006JP09829</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>69</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL DISTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ACUTE RESPIRATORY DISTRESS SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASPERGILLOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST X-RAY ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSED LEVEL OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DILATATION ATRIAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ENTEROCOCCAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ILEAL PERFORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ILEAL STENOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ILEECTOMY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LARGE INTESTINE PERFORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MORGANELLA INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERITONITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PURULENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SMALL INTESTINAL PERFORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STAPHYLOCOCCAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUBCUTANEOUS ABSCESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUBILEUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SURGERY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYSTEMIC INFLAMMATORY RESPONSE SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LOXOPROFEN SODIUM</medicinalproduct>
        <drugdosagetext>180 MG/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20000101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DICLOFENAC SODIUM</medicinalproduct>
        <drugauthorizationnumb>019201</drugauthorizationnumb>
        <drugdosagetext>75 MG/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20000101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050995-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060706</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-SANOFI-SYNTHELABO-A01200605350</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>55</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>65</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>EYE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LARYNGOSPASM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXALIPLATIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>21492</drugauthorizationnumb>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>COLORECTAL CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060302</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060302</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>805</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050996-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060705</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IE-JNJFOC-20060404214</companynumb>
    <primarysource>
      <reportercountry>IRELAND</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>96</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BREAST CANCER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugdosagetext>20TH INFUSION</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050997-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060706</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-JNJFOC-20060305522</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>35</patientweight>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>BRONCHOPNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ANKYLOSING SPONDYLITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>B12</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMITRIPTYLINE HCL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BUPRENORPHINE HCL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCICHEW D3 FORTE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PARACETAMOL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THYROXINE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOPERAMIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5050998-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060706</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-JNJFOC-20060305522</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>35</patientweight>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>BRONCHOPNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ANKYLOSING SPONDYLITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>B12</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMITRIPTYLINE HCL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BUPRENORPHINE HCL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCICHEW D3 FORTE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PARACETAMOL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THYROXINE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOPERAMIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051003-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060705</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-BRACCO-BRO-010313</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>45</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANAPHYLACTIC REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC ARREST</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIOPAM</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>18735</drugauthorizationnumb>
        <drugadministrationroute>050</drugadministrationroute>
        <drugindication>PERCUTANEOUS CORONARY INTERVENTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060522</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060522</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IOHEXOL</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugadministrationroute>050</drugadministrationroute>
        <drugindication>PERCUTANEOUS CORONARY INTERVENTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060522</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060522</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BIVALIRUDIN</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PERCUTANEOUS CORONARY INTERVENTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060522</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060522</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BIVALIRUDIN</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060522</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060522</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051004-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060705</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20060700637</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>71.22</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugbatchnumb>05K023P1</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugbatchnumb>05K023P1</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugbatchnumb>05K023P1</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugbatchnumb>05K023P1</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugbatchnumb>05K023P1</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugbatchnumb>05K023P1</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugbatchnumb>05K023P1</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugbatchnumb>05K023P1</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugbatchnumb>05K023P1</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugbatchnumb>05K023P1</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugbatchnumb>05K023P1</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugbatchnumb>05K023P1</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugbatchnumb>05K023P1</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugbatchnumb>05K023P1</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugbatchnumb>05K023P1</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugbatchnumb>05K023P1</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugbatchnumb>05K023P1</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugbatchnumb>05K023P1</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugbatchnumb>05K023P1</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugbatchnumb>05K023P1</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugbatchnumb>05K023P1</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugbatchnumb>05K023P1</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugbatchnumb>05K023P1</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugbatchnumb>05K023P1</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugbatchnumb>05K023P1</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugbatchnumb>05K023P1</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugbatchnumb>05K023P1</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugbatchnumb>05K023P1</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugbatchnumb>05K023P1</drugbatchnumb>
        <drugdosagetext>2 INFUSIONS PRIOR TO BASELINE</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CROHN'S DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROTONIX</medicinalproduct>
        <drugindication>CROHN'S DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
        <drugindication>PREMEDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTIHISTAMINES</medicinalproduct>
        <drugindication>PREMEDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051005-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060705</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20060700729</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>68.04</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MULTIPLE MYELOMA</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>5051006-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060705</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20060700764</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD CORTISOL DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLITIS ULCERATIVE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051007-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060705</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-JNJFOC-20060701704</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANAL FISSURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG RESISTANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ECZEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ANKYLOSING SPONDYLITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051009-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060706</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006AP03115</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>26783</patientonsetage>
      <patientonsetageunit>804</patientonsetageunit>
      <reaction>
        <reactionmeddrapt>DYSPHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCONTINENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOBILITY DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSYCHOMOTOR SKILLS IMPAIRED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugauthorizationnumb>20639</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INTERMITTENT EXPLOSIVE DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050926</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060502</drugenddate>
        <drugtreatmentduration>219</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHLOMIPRAMINE HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051118</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060502</drugenddate>
        <drugtreatmentduration>166</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OGEN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060316</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060502</drugenddate>
        <drugtreatmentduration>48</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050926</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060502</drugenddate>
        <drugtreatmentduration>219</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OLANZAPINE</medicinalproduct>
        <drugindication>INTERMITTENT EXPLOSIVE DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050926</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060502</drugenddate>
        <drugtreatmentduration>219</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EPILIM</medicinalproduct>
        <drugindication>INTERMITTENT EXPLOSIVE DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050626</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060502</drugenddate>
        <drugtreatmentduration>311</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugindication>OEDEMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050926</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060502</drugenddate>
        <drugtreatmentduration>219</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050926</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060502</drugenddate>
        <drugtreatmentduration>219</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALDACTONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OEDEMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050926</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060502</drugenddate>
        <drugtreatmentduration>219</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALDACTONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050926</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060502</drugenddate>
        <drugtreatmentduration>219</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051010-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060630</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006SE03710</companynumb>
    <primarysource>
      <reportercountry>SWEDEN</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INADEQUATELY CONTROLLED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TENORMIN</medicinalproduct>
        <drugauthorizationnumb>018240</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TENORMIN</medicinalproduct>
        <drugauthorizationnumb>018240</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051011-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060711</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006PK01480</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>20066</patientonsetage>
      <patientonsetageunit>804</patientonsetageunit>
      <patientweight>75</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLITIS ISCHAEMIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VASOCONSTRICTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ASCOTOP</medicinalproduct>
        <drugauthorizationnumb>20768</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MIGRAINE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060215</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060218</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>ASCOTOP</medicinalproduct>
        <drugauthorizationnumb>020768</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060514</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>ARCOXIA</medicinalproduct>
        <drugindication>OSTEOARTHRITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051012-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060615</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006SE03417</companynumb>
    <primarysource>
      <reportercountry>ITALY</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>21624</patientonsetage>
      <patientonsetageunit>804</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANAPHYLACTIC SHOCK</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugauthorizationnumb>019810</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>REFLUX OESOPHAGITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060511</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060511</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugauthorizationnumb>019810</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>EROSIVE DUODENITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060511</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060511</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENTELAN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051013-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060602</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006UW10697</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>15981</patientonsetage>
      <patientonsetageunit>804</patientonsetageunit>
      <patientweight>83.6</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ALANINE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASPARTATE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD ALKALINE PHOSPHATASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD BILIRUBIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD LACTATE DEHYDROGENASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD TRIGLYCERIDES INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAMMA-GLUTAMYLTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC ENZYME INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPHOCYTE COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPHIL COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugauthorizationnumb>21366</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050208</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060602</drugenddate>
        <drugtreatmentduration>480</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRICOR</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051014-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060705</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006UW13861</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>GRANULOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugauthorizationnumb>021153</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTROOESOPHAGEAL REFLUX DISEASE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051015-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060705</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006UW14118</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>23796</patientonsetage>
      <patientonsetageunit>804</patientonsetageunit>
      <patientweight>72.7</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANOREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IRESSA</medicinalproduct>
        <drugauthorizationnumb>21399</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IRINOTECAN</medicinalproduct>
        <drugauthorizationnumb>021399</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NEOPLASM MALIGNANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060503</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060510</drugenddate>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GEMCITABINE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NEOPLASM MALIGNANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060503</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060510</drugenddate>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VYTORIN</medicinalproduct>
        <drugindication>HYPERLIPIDAEMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PERCOCET</medicinalproduct>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCONTIN</medicinalproduct>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AUGMENTIN '125'</medicinalproduct>
        <drugindication>URINARY TRACT INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060517</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060523</drugenddate>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEGACE ES</medicinalproduct>
        <drugindication>ANOREXIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060517</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060523</drugenddate>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051016-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060705</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006UW14031</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>62</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>RETINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARIMIDEX</medicinalproduct>
        <drugauthorizationnumb>020541</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PEPCID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPROL-XL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051018-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060705</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>TR-JNJFOC-20060701539</companynumb>
    <primarysource>
      <reportercountry>TURKEY</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>THYROIDITIS SUBACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEGENER'S GRANULOMATOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOPHOSPHAMIDE</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CORTICOSTEROIDS</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051019-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060705</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20060306351</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>85.73</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BREAST CANCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BREAST CANCER STAGE I</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>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugindication>GASTROOESOPHAGEAL REFLUX DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALEGRA</medicinalproduct>
        <drugindication>RHINITIS ALLERGIC</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051030-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060707</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CN-JNJFOC-20060701791</companynumb>
    <primarysource>
      <reportercountry>CHINA</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>52</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HEPATIC FUNCTION ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYLENOL EXTENDED RELEASE</medicinalproduct>
        <drugauthorizationnumb>19872</drugauthorizationnumb>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYLENOL EXTENDED RELEASE</medicinalproduct>
        <drugauthorizationnumb>019872</drugauthorizationnumb>
        <drugindication>PYREXIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051031-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060705</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20060701954</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG TOXICITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYLENOL (CAPLET)</medicinalproduct>
        <drugauthorizationnumb>019872</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYLENOL (CAPLET)</medicinalproduct>
        <drugauthorizationnumb>019872</drugauthorizationnumb>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051032-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060705</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2006JP10232</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>67</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>IMPLANTABLE DEFIBRILLATOR MALFUNCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENTRICULAR TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
        <drugauthorizationnumb>017963</drugauthorizationnumb>
        <drugdosagetext>UNK, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051033-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060706</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2006US08696</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LETHARGY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZELNORM</medicinalproduct>
        <drugauthorizationnumb>021200</drugauthorizationnumb>
        <drugtreatmentduration>43200</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051034-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060704</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2006US08563</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </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>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZELNORM</medicinalproduct>
        <drugauthorizationnumb>021200</drugauthorizationnumb>
        <drugdosagetext>6 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONSTIPATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060706</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051035-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060710</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2006US08790</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>83</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD CREATININE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD UREA INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CREATININE RENAL CLEARANCE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZELNORM</medicinalproduct>
        <drugauthorizationnumb>021200</drugauthorizationnumb>
        <drugdosagetext>6 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVENOX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ESTROGEN NOS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLORINEF</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROTONIX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051037-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060704</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHRM2006FR02013</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>AGEUSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DUODENAL ULCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMISIL</medicinalproduct>
        <drugauthorizationnumb>020539</drugauthorizationnumb>
        <drugdosagetext>250 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NAIL TINEA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060601</drugenddate>
        <drugtreatmentduration>87840</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051041-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060705</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHNU2006DE02456</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>C-REACTIVE PROTEIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCREATITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMISIL</medicinalproduct>
        <drugauthorizationnumb>020539</drugauthorizationnumb>
        <drugdosagetext>1 DF, ONCE/SINGLE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060705</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060705</drugenddate>
        <drugtreatmentduration>1440</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051042-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060704</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHFR2006GB02149</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>AMNESIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FEMARA</medicinalproduct>
        <drugauthorizationnumb>020726</drugauthorizationnumb>
        <drugdosagetext>2.5 MG/DAY</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051044-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060705</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20060405142</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>42.46</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>AGRANULOCYTOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>URSODIOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM GLUCONATE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051054-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060705</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHNU2006DE02453</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COORDINATION ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRILEPTAL</medicinalproduct>
        <drugdosagetext>DOSAGE CHANGED</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRILEPTAL</medicinalproduct>
        <drugdosagetext>300 MG, BID</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060704</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060704</drugenddate>
        <drugtreatmentduration>1440</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRILEPTAL</medicinalproduct>
        <drugdosagetext>1200 MG/D</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060705</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRILEPTAL</medicinalproduct>
        <drugdosagetext>300 MG, BID</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARBAMAZEPINE</medicinalproduct>
        <drugauthorizationnumb>016608</drugauthorizationnumb>
        <drugdosagetext>DOSAGE CHANGED</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARBAMAZEPINE</medicinalproduct>
        <drugauthorizationnumb>016608</drugauthorizationnumb>
        <drugdosagetext>2400 MG/D (1000-0-1400)</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060704</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060704</drugenddate>
        <drugtreatmentduration>1440</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARBAMAZEPINE</medicinalproduct>
        <drugauthorizationnumb>016608</drugauthorizationnumb>
        <drugdosagetext>1200 MG/D</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060705</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARBAMAZEPINE</medicinalproduct>
        <drugauthorizationnumb>016608</drugauthorizationnumb>
        <drugdosagetext>2400 MG/D (1000-0-1400)</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051055-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060703</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHRM2006FR02040</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>52</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SENSE OF OPPRESSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COTAREG</medicinalproduct>
        <drugauthorizationnumb>020818</drugauthorizationnumb>
        <drugdosagetext>1 DF, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060308</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060601</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXEN</medicinalproduct>
        <drugdosagetext>UNK, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BACK PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060620</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060601</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051056-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060705</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2006GB10365</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>44</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>COGNITIVE DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARBAMAZEPINE</medicinalproduct>
        <drugauthorizationnumb>016608</drugauthorizationnumb>
        <drugdosagetext>500 MG/DAY</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>FACIAL NEURALGIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051063-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060710</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2006US08810</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>62</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INADEQUATELY CONTROLLED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CYSTITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY RETENTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIOVAN HCT</medicinalproduct>
        <drugauthorizationnumb>020818</drugauthorizationnumb>
        <drugdosagetext>160MG VAL/12.5MG HCT, QD</drugdosagetext>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060601</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIOVAN HCT</medicinalproduct>
        <drugauthorizationnumb>020818</drugauthorizationnumb>
        <drugdosagetext>320MG VAL/25MG HCT, QD</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060601</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051064-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060524</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2006AT07842</companynumb>
    <primarysource>
      <reportercountry>AUSTRIA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>59</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>EAR PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOACUSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OTITIS MEDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OTOSCLEROSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ISOPTIN</medicinalproduct>
        <drugdosagetext>80 MG, TID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060116</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>URBASON</medicinalproduct>
        <drugdosagetext>10 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANTOPRAZOLE SODIUM</medicinalproduct>
        <drugdosagetext>40 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060116</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TEGRETOL</medicinalproduct>
        <drugauthorizationnumb>016608</drugauthorizationnumb>
        <drugdosagetext>200 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NEURALGIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060227</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060301</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TEGRETOL</medicinalproduct>
        <drugauthorizationnumb>016608</drugauthorizationnumb>
        <drugdosagetext>200 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060301</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051065-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060704</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2006DK10162</companynumb>
    <primarysource>
      <reportercountry>DENMARK</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>18</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPERM COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TESTIS CANCER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TEGRETOL</medicinalproduct>
        <drugauthorizationnumb>016608</drugauthorizationnumb>
        <drugadministrationroute>064</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051066-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060710</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHRM2006FR02017</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>71</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACTERIA URINE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BETA 2 MICROGLOBULIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERAL PHYSICAL HEALTH DETERIORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GRANULOCYTE COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLAMMATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEUKOCYTOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NIGHT SWEATS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYELONEPHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RED BLOOD CELL SEDIMENTATION RATE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SERUM FERRITIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TEGRETOL</medicinalproduct>
        <drugauthorizationnumb>016608</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>FACIAL NEURALGIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041102</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050401</drugenddate>
        <drugtreatmentduration>151</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051067-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060615</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2006JP09145</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>56</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ARRHYTHMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTERIOSCLEROSIS</reactionmeddrapt>
      </reaction>
      <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>BRONCHITIS CHRONIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>C-REACTIVE PROTEIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG ERUPTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EJECTION FRACTION DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYELID OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAMMA-GLUTAMYLTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRITIS ATROPHIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGE SUBCUTANEOUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HIATUS HERNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HICCUPS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPHOCYTE STIMULATION TEST POSITIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUROGENIC BLADDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLEURAL FIBROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH PUSTULAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL CYST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TEGRETOL</medicinalproduct>
        <drugauthorizationnumb>16608</drugauthorizationnumb>
        <drugdosagetext>200 MG/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETIC NEUROPATHY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060329</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060329</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACTOS</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060329</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EUGLUCON</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060329</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRAVASTATIN SODIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060329</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051068-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060704</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHFR2006GB02150</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>6</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ACCIDENTAL EXPOSURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TEGRETOL</medicinalproduct>
        <drugauthorizationnumb>016608</drugauthorizationnumb>
        <drugdosagetext>UNK, UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051069-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060710</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2006CN10305</companynumb>
    <primarysource>
      <reportercountry>CHINA</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>CAESAREAN SECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CRYING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IRRITABILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEONATAL DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TEGRETOL</medicinalproduct>
        <drugauthorizationnumb>016608</drugauthorizationnumb>
        <drugadministrationroute>064</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051070-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2006JP09836</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>68</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG TOXICITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GLASGOW COMA SCALE ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VARICELLA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TEGRETOL</medicinalproduct>
        <drugauthorizationnumb>16608</drugauthorizationnumb>
        <drugdosagetext>1400 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>TRIGEMINAL NEURALGIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051071-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060710</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2006CN10304</companynumb>
    <primarysource>
      <reportercountry>CHINA</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>28</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CAESAREAN SECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NORMAL NEWBORN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TEGRETOL</medicinalproduct>
        <drugauthorizationnumb>016608</drugauthorizationnumb>
        <drugdosagetext>400 MG/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>EPILEPSY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051072-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060626</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHMT2006CA01462</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>66</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>COORDINATION ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETYLSALICYLIC ACID SRT</medicinalproduct>
        <drugdosagetext>81MG QD</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PMS-CARBAMAZEPINE</medicinalproduct>
        <drugauthorizationnumb>016608</drugauthorizationnumb>
        <drugdosagetext>1200MG QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>EPILEPSY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050301</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051073-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060411</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2006US04751</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANGER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FRUSTRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEAN CELL HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEAN CELL VOLUME ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OBSESSIVE-COMPULSIVE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RED BLOOD CELL COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDE ATTEMPT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
        <drugindication>HYPOTHYROIDISM</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEXAPRO</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KLONOPIN</medicinalproduct>
        <drugdosagetext>0.5MG BID, PRN</drugdosagetext>
        <drugindication>ANXIETY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LUNESTA</medicinalproduct>
        <drugindication>INSOMNIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TEGRETOL</medicinalproduct>
        <drugauthorizationnumb>016608</drugauthorizationnumb>
        <drugdosagetext>200 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BIPOLAR DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051117</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TEGRETOL</medicinalproduct>
        <drugauthorizationnumb>016608</drugauthorizationnumb>
        <drugdosagetext>400 MG, QHS</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060415</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMBIEN</medicinalproduct>
        <drugdosagetext>10 MG, QHS</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELEXA</medicinalproduct>
        <drugdosagetext>20 MG, QD</drugdosagetext>
        <drugindication>ANXIETY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051079-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060710</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHRM2006FR02018</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>38</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>GENITAL PRURITUS FEMALE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENITAL ULCERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LACTOBACILLUS INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOUTH ULCERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH ERYTHEMATOUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH MACULOVESICULAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOXIC SKIN ERUPTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TEGRETOL</medicinalproduct>
        <drugauthorizationnumb>016608</drugauthorizationnumb>
        <drugdosagetext>500 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060414</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060504</drugenddate>
        <drugtreatmentduration>30240</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051080-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060627</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006081363</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BREAST CANCER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROVERA TABLET (MEDROXYPROGESTERONE ACETATE)</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>PREMARIN</medicinalproduct>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMPRO</medicinalproduct>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051083-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060627</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006081227</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING PROJECTILE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugauthorizationnumb>21446</drugauthorizationnumb>
        <drugdosagetext>300 MG (100 MG, 3 IN 1 D)</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VICODIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARBOPLATIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051085-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060515</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ES-BRISTOL-MYERS SQUIBB COMPANY-13384904</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>69</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GRANULOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUCOSAL INFLAMMATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ERBITUX</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050816</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050816</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IRINOTECAN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050816</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050816</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051086-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060706</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-BRISTOL-MYERS SQUIBB COMPANY-13440623</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>60</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INTESTINAL ISCHAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTESTINAL PERFORATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ERBITUX</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>COLORECTAL CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060301</drugenddate>
        <drugtreatmentduration>120</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051087-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060704</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-JNJFOC-20060700576</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>53</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ACUTE PULMONARY OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ADHESIOLYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CELLULITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NECROTISING FASCIITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEPHROLITHIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMOCYSTIS JIROVECI PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA BACTERIAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SMALL INTESTINAL OBSTRUCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CROHN'S DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>STEROIDS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051088-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060705</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20060700814</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>67.13</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BREAST CANCER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZETIA</medicinalproduct>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRICOR</medicinalproduct>
        <drugindication>BLOOD TRIGLYCERIDES INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugindication>GASTROOESOPHAGEAL REFLUX DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OGEN</medicinalproduct>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EFFEXOR XR</medicinalproduct>
        <drugindication>ANTIDEPRESSANT THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RESTORIL</medicinalproduct>
        <drugindication>SLEEP DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIAZIDE</medicinalproduct>
        <drugdosagetext>3.5/25 MG</drugdosagetext>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARDIZEM CD</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM GLUCONATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROVIGIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMMUNE GLOBULIN INTRAVENOUS (HUMAN)</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>HYPOGAMMAGLOBULINAEMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOPHAGE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZELNORM</medicinalproduct>
        <drugindication>INFLAMMATORY BOWEL DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FEMRING</medicinalproduct>
        <drugindication>HORMONE THERAPY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051089-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060705</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20060503856</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>64</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>112.49</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MULTIPLE MYELOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROSTATE CANCER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051090-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060705</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20060503128</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>SKIN CANCER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>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>PREDNISONE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051091-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060619</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PT-BRISTOL-MYERS SQUIBB COMPANY-13416409</companynumb>
    <primarysource>
      <reportercountry>PORTUGAL</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>65</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <reaction>
        <reactionmeddrapt>MALIGNANT PALATE NEOPLASM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>STAVUDINE</medicinalproduct>
        <drugauthorizationnumb>20412</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZIDOVUDINE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KALETRA</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050601</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051092-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060704</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PE-BRISTOL-MYERS SQUIBB COMPANY-13432562</companynumb>
    <primarysource>
      <reportercountry>PERU</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>45</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ESCHERICHIA INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATOMA INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DASATINIB</medicinalproduct>
        <drugdosagetext>INTERRUPT: 30JUN06 RESTART: 10JUL06</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CHRONIC MYELOID LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050613</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051096-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060627</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006081114</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>46</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>77.1115</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COORDINATION ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEMORY IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISION BLURRED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugauthorizationnumb>21446</drugauthorizationnumb>
        <drugdosagetext>150 MG, (75 MG, 2 IN 1 D)</drugdosagetext>
        <drugindication>NEURALGIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WELLBUTRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENICAR</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051097-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060627</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006081287</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>74</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>58.9676</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IATROGENIC INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>KNEE ARTHROPLASTY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL STIFFNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NERVE INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROCEDURAL COMPLICATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugauthorizationnumb>20702</drugauthorizationnumb>
        <drugdosagetext>10 MG (10 MG DAILY) ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VERAPAMIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENAZEPRIL HYDROCHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051099-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060626</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006081238</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>59</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>71.6683</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>AGITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE DISORDER</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>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NERVOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSYCHOMOTOR HYPERACTIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TENSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GEODON</medicinalproduct>
        <drugauthorizationnumb>20825</drugauthorizationnumb>
        <drugdosagetext>20 MG (20 MG, 1 IN 1 D)</drugdosagetext>
        <drugindication>ASTHENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060623</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060623</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEXAPRO</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051101-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060627</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006081316</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>50</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>519.3686</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>AMNESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISORIENTATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROOESOPHAGEAL REFLUX DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCOHERENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENTAL IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULAR WEAKNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugauthorizationnumb>20702</drugauthorizationnumb>
        <drugdosagetext>10 MG (10 MG, 1 IN 1 D)</drugdosagetext>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060601</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREVACID</medicinalproduct>
        <drugindication>GASTROOESOPHAGEAL REFLUX DISEASE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051102-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006081709</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>38</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLINDNESS TRANSIENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIAGRA</medicinalproduct>
        <drugauthorizationnumb>20895</drugauthorizationnumb>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051104-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060707</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-JNJFOC-20041006284</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>45</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEOPLASM MALIGNANT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DURAGESIC-100</medicinalproduct>
        <drugbatchnumb>4EB4V00</drugbatchnumb>
        <drugauthorizationnumb>19813</drugauthorizationnumb>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>CANCER PAIN</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051105-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060705</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-JNJFOC-20060402069</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>DELIRIUM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GALLBLADDER CANCER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DUROTEP</medicinalproduct>
        <drugauthorizationnumb>19813</drugauthorizationnumb>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>CANCER PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ISOSORBIDE DINITRATE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>CARDIAC FAILURE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>URSODESOXYCHOLIC ACID</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CHOLECYSTITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CARDIAC FAILURE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE BESYLATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERURICAEMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRONOLACTONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CARDIAC FAILURE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ISOSORBIDE MONONITRATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CARDIAC FAILURE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METILDIGOXIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CARDIAC FAILURE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DICLOFENAC SODIUM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>GALLBLADDER CANCER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051106-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060710</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20040704013</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>CARDIO-RESPIRATORY ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSED LEVEL OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DURAGESIC-100</medicinalproduct>
        <drugadministrationroute>062</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DURAGESIC-100</medicinalproduct>
        <drugauthorizationnumb>019813</drugauthorizationnumb>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SILVADENE</medicinalproduct>
        <drugadministrationroute>061</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEPAKOTE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THIAMINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RISPERDAL</medicinalproduct>
        <drugdosagetext>EVERY 4-6 HRS AS NEEDED.</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>AGITATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTIVITAMIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN E</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REMERON</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NICODERM</medicinalproduct>
        <drugadministrationroute>062</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PERCOCET</medicinalproduct>
        <drugdosagetext>5 MG ONE TO TWO EVERY 4 HRS</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORTAB</medicinalproduct>
        <drugdosagetext>ONE TO TWO TABS EVERY 4-6 HRS</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MORPHINE</medicinalproduct>
        <drugdosagetext>2-4 MG INTRAVENOUS EVERY 3 HRS AS NEEDED.</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PAIN</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051107-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060630</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006081734</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>OPTIC ISCHAEMIC NEUROPATHY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIAGRA</medicinalproduct>
        <drugauthorizationnumb>20895</drugauthorizationnumb>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051112-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060703</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-JNJFOC-20060604949</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>70</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDE ATTEMPT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CONCERTA</medicinalproduct>
        <drugauthorizationnumb>21121</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUOXETINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051113-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060704</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-JNJFOC-20060702074</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>30</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PANCREATITIS ACUTE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CONTRAMAL</medicinalproduct>
        <drugauthorizationnumb>20281</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>ANALGESIC THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EFFERALGAN CODEINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DAFALGAN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>ANALGESIC THERAPY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051114-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060705</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20060206297</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>53.52</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HYPERGAMMAGLOBULINAEMIA BENIGN MONOCLONAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ELMIRON</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ELMIRON</medicinalproduct>
        <drugauthorizationnumb>020193</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CYSTITIS INTERSTITIAL</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMIPRAMINE</medicinalproduct>
        <drugindication>CYSTITIS INTERSTITIAL</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugindication>OSTEOPOROSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051115-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060704</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-JNJFOC-20060404450</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>52</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DEPRESSED LEVEL OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOVOLAEMIC SHOCK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYDRIASIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERDAL</medicinalproduct>
        <drugauthorizationnumb>20272</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PSYCHOTIC DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRAZEPAM</medicinalproduct>
        <drugindication>ANXIETY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RIVOTRIL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051116-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-JNJFOC-20060700488</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>70</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BRADYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERDAL</medicinalproduct>
        <drugauthorizationnumb>020588</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INSOMNIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>QUETIAPINE FUMARATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMIODARONE HCL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051117-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060704</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-JNJFOC-20060401801</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>CANDIDA SEPSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIABETES MELLITUS INSULIN-DEPENDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIABETIC KETOACIDOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARYNGOLARYNGEAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERDAL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANXIETY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERDAL</medicinalproduct>
        <drugauthorizationnumb>020272</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ASPERGER'S DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARBAMAZEPINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>AGITATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORAZEPAM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>AGITATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051118-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060705</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-JNJFOC-20060700973</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>81</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>50</patientweight>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>BLOOD POTASSIUM INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRADYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CIRCULATORY COLLAPSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEMENTIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSED LEVEL OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG LEVEL INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EXTRAPYRAMIDAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FAECAL INCONTINENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERDAL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SLEEP DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERDAL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RESTLESSNESS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERDAL</medicinalproduct>
        <drugauthorizationnumb>020272</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONFUSIONAL STATE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CAPTROPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ISDN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TURFA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VIGANTOLELTEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NAFLOURID</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051119-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060705</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>NL-JNJFOC-20060700988</companynumb>
    <primarysource>
      <reportercountry>NETHERLANDS</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MOVEMENT DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERDAL</medicinalproduct>
        <drugauthorizationnumb>020272</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LITHIUM CARBONATE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051120-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060705</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-JNJFOC-20060701256</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>5</patientonsetage>
      <patientonsetageunit>800</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>AMENORRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PROLACTIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERDAL</medicinalproduct>
        <drugauthorizationnumb>020272</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051121-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060704</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-JNJFOC-20060701515</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>70</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>RESTLESSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERDAL</medicinalproduct>
        <drugauthorizationnumb>20272</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOPICIONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOLPIDEM TARTRATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NIFEDIPINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TIAPRIDE HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SENNOSIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051122-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060704</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-JNJFOC-20060701529</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>17</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAZE PALSY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERPHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL SELF-INJURY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERDAL</medicinalproduct>
        <drugauthorizationnumb>20272</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HALLUCINATION, AUDITORY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051123-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060703</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-JNJFOC-20060403610</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MELAENA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STOMACH DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOXIC EPIDERMAL NECROLYSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ITRACONAZOLE</medicinalproduct>
        <drugauthorizationnumb>20083</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NAIL TINEA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060320</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060320</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051125-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006082194</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>74.8435</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CEREBRAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MITRAL VALVE DISEASE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugauthorizationnumb>20998</drugauthorizationnumb>
        <drugdosagetext>200 MG (200 MG, 1 IN 1 D), UNKNOWN</drugdosagetext>
        <drugindication>ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLIPIZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIURETICS (DIURETICS)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051126-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006082174</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>62</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>69.8539</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE SYSTOLIC INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRONCHITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
        <drugauthorizationnumb>19787</drugauthorizationnumb>
        <drugdosagetext>5 MG (5 MG, 1 IN 1 D), UNKNOWN</drugdosagetext>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPROL-XL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051127-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006082312</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEXTRA</medicinalproduct>
        <drugauthorizationnumb>21341</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030725</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051129-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060705</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ES-JNJFOC-20060604270</companynumb>
    <primarysource>
      <reportercountry>SPAIN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>66</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ACUTE MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugdosagetext>5 MG/KG</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CROHN'S DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMUREL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>CROHN'S DISEASE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051130-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060703</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-STX185216</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMPRESSION FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CYSTOPEXY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OOPHORECTOMY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UTERINE CANCER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>D066256</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000501</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051131-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006082384</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>TRICHOTILLOMANIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
        <drugauthorizationnumb>19839</drugauthorizationnumb>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051133-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060529</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006082304</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>72</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugauthorizationnumb>20702</drugauthorizationnumb>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KETEK</medicinalproduct>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051135-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060630</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006082261</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>93.8946</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLINDNESS TRANSIENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COORDINATION ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GLAUCOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LARGE INTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RECTAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TONGUE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISION BLURRED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL DISTURBANCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugauthorizationnumb>20998</drugauthorizationnumb>
        <drugdosagetext>(200 MG, UNKNOWN)</drugdosagetext>
        <drugindication>POLYP COLORECTAL</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RESTORIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIAZEPAM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051136-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006082211</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>GASTRIC CANCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROOESOPHAGEAL REFLUX DISEASE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugauthorizationnumb>20998</drugauthorizationnumb>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEXTRA</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051138-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060702</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-STX184982</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DIVERTICULITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCREASED TENDENCY TO BRUISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OPTIC NERVE DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>P059028</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PSORIASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>P059028</drugbatchnumb>
        <drugindication>PSORIATIC ARTHROPATHY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051139-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006082439</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>44</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD CREATINE PHOSPHOKINASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL STIFFNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GEODON</medicinalproduct>
        <drugauthorizationnumb>20825</drugauthorizationnumb>
        <drugindication>SCHIZOAFFECTIVE DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051140-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060627</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006081690</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD TRIGLYCERIDES INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugauthorizationnumb>20702</drugauthorizationnumb>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051141-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GBWYE472215MAR06</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABORTION SPONTANEOUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PREGNANCY</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>20031101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SOLPADOL</medicinalproduct>
        <drugdosagetext>1-2 TABLETS FREQUENCY UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060301</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNSPECIFIED CONTRACEPTIVE</medicinalproduct>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060301</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051142-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040531</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ES-AMGEN-US079787</companynumb>
    <primarysource>
      <reportercountry>SPAIN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LARYNGOSPASM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040121</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040308</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACECLOFENAC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ISONIAZID</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>URBASON</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19950101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051146-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060627</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006081616</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>47</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANOREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUID INTAKE REDUCED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OXYGEN SATURATION DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUTENT</medicinalproduct>
        <drugauthorizationnumb>21968</drugauthorizationnumb>
        <drugdosagetext>(50 MG, DAILY), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RENAL CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060622</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VALIUM</medicinalproduct>
        <drugdosagetext>(AS NECESSARY), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPOTONIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060501</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENDOCEST (OXYCODONE HYDROCHLORIDE, PARACETAMOL)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051147-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060228</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-NOVOPROD-251200</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>41</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>160</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENOUS THROMBOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NOVOSEVEN</medicinalproduct>
        <drugdosagetext>480 KIU, SINGLE</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>THORACIC HAEMORRHAGE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060219</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060219</drugenddate>
        <drugtreatmentduration>1440</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARGATROBAN</medicinalproduct>
        <drugdosagetext>2.4-72</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060110</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060131</drugenddate>
        <drugtreatmentduration>30240</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARGATROBAN</medicinalproduct>
        <drugdosagetext>UNK MG, QD</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060207</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060216</drugenddate>
        <drugtreatmentduration>12960</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DESMOPRESSIN</medicinalproduct>
        <drugdosagetext>24 UG, QD</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060218</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060218</drugenddate>
        <drugtreatmentduration>1440</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FIBRINOGEN</medicinalproduct>
        <drugdosagetext>2 G, QD</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060218</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060218</drugenddate>
        <drugtreatmentduration>1440</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FRESH FROZEN PLASMA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLATELETS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051148-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060323</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-NOVOPROD-251924</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>26</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>78</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIAC ENZYMES INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NOVOSEVEN</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugdosagetext>40 UG/KG, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>POST PROCEDURAL HAEMORRHAGE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010528</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NITROGLYCERIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOPAMIN                            /00000101/</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051149-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060421</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-NOVOPROD-252618</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>73</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>83</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIAC ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIABETES MELLITUS INADEQUATE CONTROL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTESTINAL OBSTRUCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVEMIR</medicinalproduct>
        <drugauthorizationnumb>21536</drugauthorizationnumb>
        <drugdosagetext>38 IU, QD</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>INSULIN-REQUIRING TYPE II DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050628</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVEMIR</medicinalproduct>
        <drugauthorizationnumb>021536</drugauthorizationnumb>
        <drugdosagetext>44 IU, QD</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050706</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVEMIR</medicinalproduct>
        <drugauthorizationnumb>021536</drugauthorizationnumb>
        <drugdosagetext>30 IU, QD</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050713</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050721</drugenddate>
        <drugtreatmentduration>11520</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TARIVID                            /00731801/</medicinalproduct>
        <drugdosagetext>400 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050620</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050620</drugenddate>
        <drugtreatmentduration>1440</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugdosagetext>20 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050628</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050705</drugenddate>
        <drugtreatmentduration>10080</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRAVASTATIN</medicinalproduct>
        <drugdosagetext>10 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050623</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050705</drugenddate>
        <drugtreatmentduration>17280</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUOXETINE</medicinalproduct>
        <drugdosagetext>20 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050620</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050705</drugenddate>
        <drugtreatmentduration>21600</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZIMOVANE</medicinalproduct>
        <drugdosagetext>7.5 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050620</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050705</drugenddate>
        <drugtreatmentduration>21600</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACTRAPID</medicinalproduct>
        <drugindication>INSULIN-REQUIRING TYPE II DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050620</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULATARD NPH HUMAN</medicinalproduct>
        <drugindication>INSULIN-REQUIRING TYPE II DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050620</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
        <drugdosagetext>100 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050620</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050705</drugenddate>
        <drugtreatmentduration>21600</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BUMETANIDE</medicinalproduct>
        <drugdosagetext>1 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050627</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050704</drugenddate>
        <drugtreatmentduration>10080</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KLACID                             /00984601/</medicinalproduct>
        <drugdosagetext>1000 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050713</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050721</drugenddate>
        <drugtreatmentduration>11520</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AUGMENTIN                          /00756801/</medicinalproduct>
        <drugdosagetext>1250 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050717</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050721</drugenddate>
        <drugtreatmentduration>5760</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TEICOPLANIN</medicinalproduct>
        <drugdosagetext>600 MG, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050720</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050721</drugenddate>
        <drugtreatmentduration>1440</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SLOW-K</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NOVORAPID PENFILL</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>INSULIN-REQUIRING TYPE II DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050628</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050706</drugenddate>
        <drugtreatmentduration>11520</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOPICLONE</medicinalproduct>
        <drugdosagetext>75 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050620</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050705</drugenddate>
        <drugtreatmentduration>21600</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ROSUVASTATIN</medicinalproduct>
        <drugdosagetext>10 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050623</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050705</drugenddate>
        <drugtreatmentduration>17280</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MICROLAX                           /00285401/</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAZOCIN</medicinalproduct>
        <drugdosagetext>4.5 G, QD</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050706</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050718</drugenddate>
        <drugtreatmentduration>17280</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METRONIDAZOLE</medicinalproduct>
        <drugdosagetext>500 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050706</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050718</drugenddate>
        <drugtreatmentduration>17280</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIGOXIN</medicinalproduct>
        <drugdosagetext>125 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050709</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050721</drugenddate>
        <drugtreatmentduration>17280</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051150-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060703</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-NOVOPROD-254639</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>50</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>91</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HYPOGLYCAEMIC COMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WRONG DRUG ADMINISTERED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NOVOLOG</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020986</drugauthorizationnumb>
        <drugdosagetext>55 IU, BID</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>INSULIN-REQUIRING TYPE II DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060702</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NOVOLOG MIX 70/30</medicinalproduct>
        <drugdosagetext>55 IU, UNK</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>INSULIN-REQUIRING TYPE II DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060601</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051151-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060529</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-NOVOPROD-253699</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>77</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>50</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANTI-INSULIN ANTIBODY POSITIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BASEN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>.9 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051203</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INNOLET 30R CHU</medicinalproduct>
        <drugauthorizationnumb>019991</drugauthorizationnumb>
        <drugdosagetext>26 IU, QD</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>INSULIN-REQUIRING TYPE II DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050921</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051030</drugenddate>
        <drugtreatmentduration>56160</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NOVORAPID 30 MIX CHU FLEXPEN</medicinalproduct>
        <drugdosagetext>26 IU, QD</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>INSULIN-REQUIRING TYPE II DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040909</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050920</drugenddate>
        <drugtreatmentduration>376</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NOVOLIN R</medicinalproduct>
        <drugdosagetext>28 IU, PRN</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>INSULIN-REQUIRING TYPE II DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051031</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>URSO</medicinalproduct>
        <drugdosagetext>300 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041225</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADALAT</medicinalproduct>
        <drugdosagetext>40 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040820</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BLOPRESS</medicinalproduct>
        <drugdosagetext>8 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>100 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030103</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGNESIUM                          /00552801/</medicinalproduct>
        <drugdosagetext>1 G, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050622</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MYSLEE</medicinalproduct>
        <drugdosagetext>5 MG, UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041215</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC                            /00972402/</medicinalproduct>
        <drugdosagetext>5 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030103</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMARYL</medicinalproduct>
        <drugdosagetext>6 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041224</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACTOS                              /01460202/</medicinalproduct>
        <drugdosagetext>15 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040824</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugdosagetext>30 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051014</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051152-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060703</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-NOVOPROD-254707</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>67</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ENDOCRINE TEST ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NOVORAPID CHU FLEXPEN</medicinalproduct>
        <drugauthorizationnumb>20986</drugauthorizationnumb>
        <drugdosagetext>52 IU, QD</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060327</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060403</drugenddate>
        <drugtreatmentduration>10080</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NOVOLIN R</medicinalproduct>
        <drugdosagetext>32 IU, QD</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060324</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060326</drugenddate>
        <drugtreatmentduration>2880</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NOVOLIN N</medicinalproduct>
        <drugdosagetext>44 IU, QD</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060327</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060403</drugenddate>
        <drugtreatmentduration>10080</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HUMALOG                            /01293501/</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051153-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060703</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CN-NOVOPROD-254705</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>68</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>55</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>LIPOATROPHY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NOVOLIN R</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>19991</drugauthorizationnumb>
        <drugdosagetext>30-40IU MORNING AND EVENING</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>INSULIN-REQUIRING TYPE II DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040807</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NOVOLIN 50R PENFILL</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugdosagetext>30-40 IU MORNING AND EVENING</drugdosagetext>
        <drugindication>INSULIN-REQUIRING TYPE II DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050801</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051154-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060703</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-NOVOPROD-254641</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>50</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>91</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG DISPENSING ERROR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOGLYCAEMIC COMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WRONG DRUG ADMINISTERED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NOVOLOG</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020986</drugauthorizationnumb>
        <drugdosagetext>55 IU, BID</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>INSULIN-REQUIRING TYPE II DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060702</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NOVOLOG MIX 70/30</medicinalproduct>
        <drugdosagetext>55 IU, BID</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>INSULIN-REQUIRING TYPE II DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060601</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051155-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060703</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-NOVOPROD-254665</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>56</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BREAST CANCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BREAST CANCER FEMALE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VAGIFEM</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020908</drugauthorizationnumb>
        <drugdosagetext>1 TAB, QD</drugdosagetext>
        <drugadministrationroute>067</drugadministrationroute>
        <drugindication>VULVOVAGINAL DRYNESS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060601</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MENEST                             /00073001/</medicinalproduct>
        <drugdosagetext>.5 TAB, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MENOPAUSAL SYMPTOMS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROMETRIUM</medicinalproduct>
        <drugdosagetext>1 TAB, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MENOPAUSAL SYMPTOMS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051156-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060703</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-NOVOPROD-254709</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>65</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ENDOCRINE TEST ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMARYL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BASEN</medicinalproduct>
        <drugdosagetext>UNK, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NOVORAPID 30 MIX CHU FLEXPEN</medicinalproduct>
        <drugauthorizationnumb>021172</drugauthorizationnumb>
        <drugdosagetext>28 IU, UNK</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060522</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NOVORAPID CHU FLEXPEN</medicinalproduct>
        <drugdosagetext>20 IU, UNK</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060523</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060603</drugenddate>
        <drugtreatmentduration>15840</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NOVOLIN N</medicinalproduct>
        <drugdosagetext>6 IU, UNK</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060523</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060603</drugenddate>
        <drugtreatmentduration>15840</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HUMALOG                            /00030501/</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060604</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060601</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051157-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060627</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006081881</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ARRHYTHMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUDDEN DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEXTRA</medicinalproduct>
        <drugauthorizationnumb>21341</drugauthorizationnumb>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051158-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006081738</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>43</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>86.1834</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLINDNESS UNILATERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEAFNESS UNILATERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</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>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEXTRA</medicinalproduct>
        <drugdosagetext>(2 IN 1 D)</drugdosagetext>
        <drugindication>ARTHRITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051161-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060627</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006081950</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEXTRA</medicinalproduct>
        <drugauthorizationnumb>21341</drugauthorizationnumb>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020201</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051163-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006082095</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CYSTITIS RADIATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NECROTISING FASCIITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VAGINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TIKOSYN</medicinalproduct>
        <drugauthorizationnumb>20931</drugauthorizationnumb>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051165-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060704</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-KINGPHARMUSA00001-K200600867</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>OPHTHALMOPLEGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POLYNEUROPATHY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALTACE</medicinalproduct>
        <drugauthorizationnumb>019901</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050301</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051166-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20030129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-AMGEN-US184225</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ACUTE RESPIRATORY FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FUNGAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERAL PHYSICAL HEALTH DETERIORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEGIONELLA INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTI-ORGAN FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMOCYSTIS JIROVECI PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY FIBROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY ACIDOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TUBERCULOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010117</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20021019</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010301</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREMIQUE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RANITIDINE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19910201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PARACETAMOL</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020807</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUOXETINE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020208</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETYLSALICYLIC ACID SRT</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980301</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19971001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYANOCOBALAMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYPROMELLOSE</medicinalproduct>
        <drugadministrationroute>047</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010515</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CEPHALEXIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLACEBO</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INDOMETHACIN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990501</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051167-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060703</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-NOVOPROD-254640</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>50</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>91</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG DISPENSING ERROR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOGLYCAEMIC COMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WRONG DRUG ADMINISTERED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NOVOLOG</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020986</drugauthorizationnumb>
        <drugdosagetext>55 IU, BID</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>INSULIN-REQUIRING TYPE II DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060702</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NOVOLOG MIX 70/30</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>55 IU, BID</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>INSULIN-REQUIRING TYPE II DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060601</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051168-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060529</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-AMGEN-US178316</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD BILIRUBIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATOCRIT INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>ANKYLOSING SPONDYLITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050620</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060501</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INDOCID</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051169-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060702</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-US185015</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BALANCE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FORMICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NECK PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040428</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051171-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060627</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006081906</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</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>20030714</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030920</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021202</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030714</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051174-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060627</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006081900</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRANSIENT ISCHAEMIC ATTACK</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEXTRA</medicinalproduct>
        <drugauthorizationnumb>21341</drugauthorizationnumb>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990501</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051176-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060630</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GBWYE928030JUN06</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>88</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOCALISED INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NODULE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040818</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>QUININE SULFATE</medicinalproduct>
        <drugdosagetext>UNKNOWN</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
        <drugdosagetext>UNKNOWN</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INDOMETHACIN</medicinalproduct>
        <drugdosagetext>UNKNOWN</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
        <drugdosagetext>UNKNOWN</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIHYDROCODEINE</medicinalproduct>
        <drugdosagetext>UNKNOWN</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051177-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060626</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>HQWYE552723JAN04</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>61</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BREAST CANCER METASTATIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC LESION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METASTASES TO LYMPH NODES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OESTROGEN RECEPTOR ASSAY POSITIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROGESTERONE RECEPTOR ASSAY POSITIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPLENIC GRANULOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMPRO</medicinalproduct>
        <drugauthorizationnumb>20527</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051178-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060626</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>HQWYE935404AUG04</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>50</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>67.19</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BREAST CANCER METASTATIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EMOTIONAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METRORRHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NERVE INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OESTROGEN RECEPTOR ASSAY POSITIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEITIS DEFORMANS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROGESTERONE RECEPTOR ASSAY POSITIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RETRACTED NIPPLE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMPHASE 14/14</medicinalproduct>
        <drugauthorizationnumb>20527</drugauthorizationnumb>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051179-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060608</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ZA-ROCHE-451621</companynumb>
    <primarysource>
      <reportercountry>SOUTH AFRICA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>69</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>96</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CEREBRAL ATROPHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COGNITIVE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEMORY IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUBDURAL HAEMATOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEGASYS</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060320</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEGASYS</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060520</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COZAAR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051180-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060621</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-ROCHE-452732</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>60</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>BLOOD DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CITROBACTER INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GRAFT VERSUS HOST DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTHERMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTI-ORGAN FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCYTOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PATHOGEN RESISTANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOXIC EPIDERMAL NECROLYSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELLCEPT</medicinalproduct>
        <drugauthorizationnumb>50722</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060512</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060515</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROGRAF</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060503</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060522</drugenddate>
        <drugtreatmentduration>20</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SOLU-MEDROL</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060503</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051181-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060706</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-ROCHE-454207</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>35</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>144</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XENICAL</medicinalproduct>
        <drugauthorizationnumb>020766</drugauthorizationnumb>
        <drugdosagetext>3 DOSE FORM UNSPECIFIED DAILY.</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OBESITY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060315</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060320</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051182-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060706</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-ROCHE-454177</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>33</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FRUSTRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VALIUM</medicinalproduct>
        <drugauthorizationnumb>13263</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LITHIUM CARBONATE</medicinalproduct>
        <drugdosagetext>LONG TERM THERAPY.</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERDAL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HALOPERIDOL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROZAC</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LARGACTIL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051183-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060705</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-454023</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>75</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>61.2</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DISEASE PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OESOPHAGITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XELODA</medicinalproduct>
        <drugauthorizationnumb>20896</drugauthorizationnumb>
        <drugdosagetext>GIVEN EVERY TWELVE HOURS ON DAYS ONE TO FIVE (MONDAY-FRIDAY) FOR 5.5 WEEKS ON RADIATION THERAPY DAY+</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060110</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060214</drugenddate>
        <drugtreatmentduration>36</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVASTIN</medicinalproduct>
        <drugauthorizationnumb>020896</drugauthorizationnumb>
        <drugdosagetext>GIVEN OVER 30-90 MINUTES ON DAYS ONE, FIFTEEN AND TWENTY-NINE OF CHEMORADIATION DAYS.</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060110</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060214</drugenddate>
        <drugtreatmentduration>36</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051184-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CZ-ROCHE-411791</companynumb>
    <primarysource>
      <reportercountry>CZECH REPUBLIC</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>21</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>68</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AUTOIMMUNE THYROIDITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC TAMPONADE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIOMEGALY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISEASE RECURRENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERICARDIAL EFFUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERICARDITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLEURAL EFFUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLEURISY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POLYSEROSITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEG-INTERFERON A-2A (RO 25-8310)</medicinalproduct>
        <drugdosagetext>FORMULATION: SYRINGE</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040930</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050526</drugenddate>
        <drugtreatmentduration>239</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RIBAVIRIN</medicinalproduct>
        <drugauthorizationnumb>021511</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040930</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050602</drugenddate>
        <drugtreatmentduration>246</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040527</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIANE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030615</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051185-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060221</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PT-RB-2850-2006</companynumb>
    <primarysource>
      <reportercountry>PORTUGAL</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>30</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UNEVALUABLE EVENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BUPRENORPHINE HYDROCHLORIDE</medicinalproduct>
        <drugauthorizationnumb>020732</drugauthorizationnumb>
        <drugadministrationroute>060</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041114</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050301</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BUPRENORPHINE HYDROCHLORIDE</medicinalproduct>
        <drugauthorizationnumb>020732</drugauthorizationnumb>
        <drugadministrationroute>060</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050801</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BUPRENORPHINE HYDROCHLORIDE</medicinalproduct>
        <drugauthorizationnumb>020732</drugauthorizationnumb>
        <drugadministrationroute>060</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051186-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060531</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-RB-3390-2006</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>77.18</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ALCOHOL WITHDRAWAL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRAIN OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE CONGESTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIOMEGALY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG TOXICITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC CONGESTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY CONGESTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPLEEN CONGESTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BUPRENORPHINE HYDROCHLORIDE</medicinalproduct>
        <drugauthorizationnumb>20732</drugauthorizationnumb>
        <drugadministrationroute>060</drugadministrationroute>
        <drugindication>DRUG DEPENDENCE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060130</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060130</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BUPRENORPHINE HYDROCHLORIDE</medicinalproduct>
        <drugauthorizationnumb>020732</drugauthorizationnumb>
        <drugadministrationroute>060</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060131</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060131</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CHLORDIAZEPOXIDE HCL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>ALCOHOL WITHDRAWAL SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060131</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060131</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CHLORDIAZEPOXIDE HCL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060131</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060131</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONIDINE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>ALCOHOL WITHDRAWAL SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060131</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060131</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROMETHAZINE HCL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>NAUSEA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060131</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060131</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060131</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060131</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PARACETAMOL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060131</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060131</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROXYZINE EMBONATE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>ANXIETY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060131</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060131</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051187-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20051219</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-RB-2480-2005</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>33</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>64</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>BRONCHITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CYANOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY ARREST</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BUPRENORPHINE HYDROCHLORIDE</medicinalproduct>
        <drugauthorizationnumb>20732</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050919</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIAZEPAM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANXIETY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050914</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050914</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LORAZEPAM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANXIETY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050905</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LOXAPINE SUCCINATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050905</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYAMEMAZINE</medicinalproduct>
        <drugdosagetext>DOSAGE UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALIMEMAZINE TARTRATE</medicinalproduct>
        <drugdosagetext>DOSAGE UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050905</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMOXICILLIN</medicinalproduct>
        <drugdosagetext>2-3 G QD</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050914</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugdosagetext>DOSAGE UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OROPIVALONE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050919</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANTOPRAZOLE SODIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050905</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HELICIDINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>COUGH</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050905</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRISTINAMYCIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050919</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMBROXOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050919</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUOXETINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050905</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051188-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060705</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-454041</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>68</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <reaction>
        <reactionmeddrapt>ANOREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSED LEVEL OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERIPHERAL MOTOR NEUROPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPEECH DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NAPROXEN</medicinalproduct>
        <drugauthorizationnumb>17581</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVASTIN</medicinalproduct>
        <drugauthorizationnumb>017581</drugauthorizationnumb>
        <drugdosagetext>GIVEN ON DAYS ONE AND FIFTEEN OF EACH CYCLE; REPEATED EVERY TWENTYEIGHT DAYS.</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060512</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CCI-779</medicinalproduct>
        <drugdosagetext>GIVEN ON DAYS ONE, EIGHT, FIFTEEN AND TWENTYTWO OF EACH CYCLE; REPEATED EVERY TWENTYEIGHT DAYS.</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060512</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MORPHINE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FENTANYL TRANSDERMAL SYSTEM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051189-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-ROCHE-434410</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>50</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD COUNT ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BREAST DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOTHORAX</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HERPES SIMPLEX</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JOINT EFFUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NIGHT SWEATS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERICARDIAL EFFUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLEURAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POLYSEROSITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SENSATION OF PRESSURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEGASYS</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040715</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050615</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RIBAVIRIN</medicinalproduct>
        <drugauthorizationnumb>021511</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040715</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050615</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051190-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060704</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-ROCHE-454290</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>43</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>60</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CHORIOMENINGITIS LYMPHOCYTIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOACUSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEUKOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RETINAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYPHILIS TEST POSITIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TINNITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL ACUITY REDUCED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEGASYS</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051212</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060515</drugenddate>
        <drugtreatmentduration>155</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBETOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051212</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060601</drugenddate>
        <drugtreatmentduration>172</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KIVEXA</medicinalproduct>
        <drugindication>HIV INFECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VIREAD</medicinalproduct>
        <drugindication>HIV INFECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KALETRA</medicinalproduct>
        <drugindication>HIV INFECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEROXAT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>STILNOX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051191-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060706</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>SE-ROCHE-454283</companynumb>
    <primarysource>
      <reportercountry>SWEDEN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PREGNANCY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ROACCUTAN</medicinalproduct>
        <drugauthorizationnumb>18662</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051192-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060706</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GR-ROCHE-454498</companynumb>
    <primarysource>
      <reportercountry>GREECE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BREAST OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BREAST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BONIVA</medicinalproduct>
        <drugauthorizationnumb>021455</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051193-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060707</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PE-ROCHE-454746</companynumb>
    <primarysource>
      <reportercountry>PERU</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>78</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL MUCOSAL PETECHIAE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARYNGOLARYNGEAL PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BONIVA</medicinalproduct>
        <drugauthorizationnumb>021455</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060706</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CALCIUM GLUCONATE</medicinalproduct>
        <drugauthorizationnumb>021455</drugauthorizationnumb>
        <drugdosagetext>DOSAGE REGIMEN REPORTED AS DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060706</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060707</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IRRIGOR</medicinalproduct>
        <drugdosagetext>DAILY</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051194-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060704</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ROCHE-454440</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>65</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HEPATIC NEOPLASM MALIGNANT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEG-INTERFERON A-2A (RO 25-8310)</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040202</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040531</drugenddate>
        <drugtreatmentduration>120</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>20040802</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041012</drugenddate>
        <drugtreatmentduration>72</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>20041129</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041206</drugenddate>
        <drugtreatmentduration>8</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>20041213</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050214</drugenddate>
        <drugtreatmentduration>64</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>20050221</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050404</drugenddate>
        <drugtreatmentduration>43</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>20050411</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050912</drugenddate>
        <drugtreatmentduration>155</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>20051102</drugstartdate>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>URSO</medicinalproduct>
        <drugdosagetext>DOSE FORM: ORAL FORMULATION (NOT OTHERWISE SPECIFIED)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GASTER</medicinalproduct>
        <drugdosagetext>DOSE FORM: ORAL FORMULATION (NOT OTHERWISE SPECIFIED)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALTAT</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041025</drugstartdate>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FERROMIA</medicinalproduct>
        <drugdosagetext>DOSE FORM: ORAL FORMULATION (NOT OTHERWISE SPECIFIED)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051102</drugstartdate>
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  <safetyreport>
    <safetyreportid>5051195-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060614</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHO2006JP09828</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
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    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <patientonsetage>81</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
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      <reaction>
        <reactionmeddrapt>ACUTE MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENTRICULAR FIBRILLATION</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LOCHOL</medicinalproduct>
        <drugauthorizationnumb>20261</drugauthorizationnumb>
        <drugdosagetext>20 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERCHOLESTEROLAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010904</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030701</drugenddate>
        <drugtreatmentduration>666</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LOCHOL</medicinalproduct>
        <drugauthorizationnumb>020261</drugauthorizationnumb>
        <drugdosagetext>30 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030702</drugstartdate>
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        <drugenddate>20051104</drugenddate>
        <drugtreatmentduration>857</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LANDEL</medicinalproduct>
        <drugdosagetext>20 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ESSENTIAL HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980611</drugstartdate>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LANDEL</medicinalproduct>
        <drugdosagetext>40 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LANDEL</medicinalproduct>
        <drugdosagetext>20 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051104</drugenddate>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BLOPRESS</medicinalproduct>
        <drugindication>ESSENTIAL HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THEOLONG</medicinalproduct>
        <drugindication>ASTHMA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051196-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060705</receiptdate>
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    <companynumb>GB-JNJFOC-20060605136</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>14</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PRESCRIBED OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSYCHOTIC DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CONCERTA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CONCERTA</medicinalproduct>
        <drugauthorizationnumb>021121</drugauthorizationnumb>
        <drugdosagetext>EXPERIMENTAL OVERDOSE PRESCRIBED BY DOCTOR</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051197-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060705</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20050905877</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CREATININE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD POTASSIUM DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD SODIUM INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CLOSTRIDIUM DIFFICILE COLITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLITIS ISCHAEMIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CUTANEOUS ANTHRAX</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEMENTIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATOCHEZIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATOCRIT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LARGE INTESTINAL ULCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL INTAKE REDUCED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSEUDOMEMBRANOUS COLITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RECTAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVAQUIN</medicinalproduct>
        <drugauthorizationnumb>20634</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INFECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVOFLOXACIN</medicinalproduct>
        <drugauthorizationnumb>020635</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>WOUND INFECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>STOOL SOFTNER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METRONIDAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VANCOMYCIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051198-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060705</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20060701583</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>96.16</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CEREBRAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEAD INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ROAD TRAFFIC ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN LACERATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DURAGESIC-100</medicinalproduct>
        <drugauthorizationnumb>019813</drugauthorizationnumb>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PERCOCET</medicinalproduct>
        <drugdosagetext>10 MG / 650 MG, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLEXERIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MUSCLE SPASMS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051199-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060707</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20060701863</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEVICE LEAKAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DURAGESIC-100</medicinalproduct>
        <drugauthorizationnumb>019813</drugauthorizationnumb>
        <drugindication>PAIN</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051200-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060428</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHO2006US07039</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>74</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>103</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CREATININE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRADYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BURSITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISEASE PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA AT REST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA EXERTIONAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOBAR PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG INFILTRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE ATROPHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL INTAKE REDUCED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORTHOSTATIC HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRODUCTIVE COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPUTUM DISCOLOURED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TENDONITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHEEZING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXYCONTIN</medicinalproduct>
        <drugdosagetext>15 MG,Q4-6H</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060602</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EPOGEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXJADE</medicinalproduct>
        <drugauthorizationnumb>021882</drugauthorizationnumb>
        <drugdosagetext>2000 MG DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD IRON INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051207</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060423</drugenddate>
        <drugtreatmentduration>138</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTIVITAMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CORAL CALCIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PAROXETINE HYDROCHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FISH OIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COMBIVENT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADVAIR DISKUS 100/50</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AZITHROMYCIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANTOPRAZOLE SODIUM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051201-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060630</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ES-BRISTOL-MYERS SQUIBB COMPANY-13430293</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>59</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEBRILE NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IRINOTECAN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060425</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060425</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ERBITUX</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060607</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060607</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TEGAFUR</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060607</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060607</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CPT-11</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060607</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060607</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051202-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060608</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BE-BRISTOL-MYERS SQUIBB COMPANY-13405089</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>65</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>98</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CISPLATIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>SMALL CELL LUNG CANCER STAGE UNSPECIFIED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060508</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060508</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IRINOTECAN HCL</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>SMALL CELL LUNG CANCER STAGE UNSPECIFIED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060508</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060516</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZURCAL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HALDOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENTUMINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DURAGESIC-100</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MORPHINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COMBIVENT</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051203-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20051228</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-BRISTOL-MYERS SQUIBB COMPANY-13230529</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>72</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>47</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HAEMATEMESIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ERBITUX</medicinalproduct>
        <drugdosagetext>440 MG/M2 12DEC05 (DAY 1) 250 MG/M2 16JAN06</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLORECTAL CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051226</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051226</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IRINOTECAN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLORECTAL CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051212</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051226</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OPSO</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051226</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060105</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGNESIUM OXIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051226</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060102</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GASMOTIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051226</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060102</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LINTON</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051226</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060102</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NOVAMIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051226</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060102</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PURSENNIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051226</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060102</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORAZEPAM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051226</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060102</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAKEPRON</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051226</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060102</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCONTIN</medicinalproduct>
        <drugdosagetext>20-40 MG 2 TABS PER DAY ; 1 EVERY 12 HOURS, ORALLY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051226</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060102</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051204-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>19980623</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-BRISTOL-MYERS SQUIBB COMPANY-13432653</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>73</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>LEUKOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PACKED RED BLOOD CELL TRANSFUSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAXOL</medicinalproduct>
        <drugauthorizationnumb>20262</drugauthorizationnumb>
        <drugindication>OESOPHAGEAL CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980326</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CISPLATIN</medicinalproduct>
        <drugauthorizationnumb>018057</drugauthorizationnumb>
        <drugindication>OESOPHAGEAL CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19970501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19970601</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ETOPOSIDE</medicinalproduct>
        <drugauthorizationnumb>018768</drugauthorizationnumb>
        <drugindication>OESOPHAGEAL CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19970501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19970601</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
        <drugindication>OESOPHAGEAL CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19970501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19970601</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUOROURACIL</medicinalproduct>
        <drugindication>OESOPHAGEAL CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19970501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19970601</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051205-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20051026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-13159017</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>66</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BACTERAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACTERIAL SEPSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD URINE PRESENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ESCHERICHIA INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ERBITUX</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050721</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050721</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARBOPLATIN</medicinalproduct>
        <drugdosagetext>AUC 3. PT HAD REC'D 5 COURSES PRIOR TO EVENT.</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>LUNG CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051012</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051012</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GEMCITABINE</medicinalproduct>
        <drugdosagetext>PT HAD REC'D 5 COURSES PRIOR TO EVENT</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>LUNG CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051021</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051021</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOXYL</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19850101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19850101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VERAPAMIL</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051206-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060705</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-JNJFOC-20060700713</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051207-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060704</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-JNJFOC-20060604720</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>46</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ALANINE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASPARTATE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD LACTATE DEHYDROGENASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATOCRIT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC FUNCTION ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NECROTISING FASCIITIS STREPTOCOCCAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROTHROMBIN TIME PROLONGED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN ULCER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VOLTAREN</medicinalproduct>
        <drugadministrationroute>054</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VOLTAREN</medicinalproduct>
        <drugadministrationroute>054</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACTONEL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZANTAC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KETOPROFEN</medicinalproduct>
        <drugdosagetext>DOSE 7CM X 10 CM</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOLIAMIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOLIAMIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RHEUMATREX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RHEUMATREX</medicinalproduct>
        <drugdosagetext>TEMPORARILY, 4 MG/WEEK AND 8 MG/WEEK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RHEUMATREX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RHEUMATREX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RHEUMATREX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KENACORT</medicinalproduct>
        <drugdosagetext>ROUTE: ^IR^</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugdosagetext>START DATE: LATE APR-2005</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDROL</medicinalproduct>
        <drugdosagetext>DOSE ^6-5 MG^</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDROL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDROL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METALCAPTASE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BONALON</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYANOCOBALAMIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALFAROL</medicinalproduct>
        <drugdosagetext>DOSE: 0.5 RG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MUCOSTA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PYDOXAL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CINAL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN RHEUMATOID ARTHRITIS MEDICATION</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADRENAL HORMONE PREPARATION</medicinalproduct>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051208-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060707</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-13436050</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>54</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>57</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DERMATITIS ACNEIFORM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUCOSAL INFLAMMATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEISSERIA INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STOMATITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ERBITUX</medicinalproduct>
        <drugdosagetext>1ST DOSE: 17MAY06</drugdosagetext>
        <drugindication>NEOPLASM MALIGNANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060621</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060621</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOCETAXEL</medicinalproduct>
        <drugindication>NEOPLASM MALIGNANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060621</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060621</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RADIOTHERAPY</medicinalproduct>
        <drugindication>NEOPLASM MALIGNANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060706</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060706</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051209-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060626</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>HQWYE817904AUG04</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>50</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>136.2</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BREAST CANCER FEMALE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BREAST CANCER METASTATIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BREAST MICROCALCIFICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CELLULITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHILLS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG NEOPLASM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPHOEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METASTASES TO LYMPH NODES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERIODONTAL DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY CALCIFICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPINAL OSTEOARTHRITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMPRO</medicinalproduct>
        <drugauthorizationnumb>20527</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE   ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19970101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19960101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19970101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROVERA</medicinalproduct>
        <drugdosagetext>2.5MG, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19960101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19970101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051210-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060626</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>HQWYE618629JUL04</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>56</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>50.85</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BREAST CANCER FEMALE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BREAST CANCER RECURRENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CYST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERVERTEBRAL DISC DEGENERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERVERTEBRAL DISC PROTRUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OESTROGEN RECEPTOR ASSAY POSITIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PELVIC MASS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROGESTERONE RECEPTOR ASSAY POSITIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SCOLIOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UTERINE POLYP</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMPRO</medicinalproduct>
        <drugauthorizationnumb>20527</drugauthorizationnumb>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010901</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051211-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060707</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AVENTIS-200615692US</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ALANINE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASPARTATE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD BILIRUBIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOMID</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>016131</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOMID</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>016131</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROGESTERONE</medicinalproduct>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ESTROGENS SOL/INJ</medicinalproduct>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051213-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060626</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>HQWYE964211OCT05</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>52</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BREAST CANCER METASTATIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METASTASES TO LYMPH NODES</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMPRO</medicinalproduct>
        <drugauthorizationnumb>20527</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19970101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19990101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051216-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060627</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>SU-2006-004988</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>52</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>122.4712</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>AGGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSSTASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAINFUL ERECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PENILE HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SURGERY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BENICAR</medicinalproduct>
        <drugauthorizationnumb>21286</drugauthorizationnumb>
        <drugdosagetext>40 MG QD PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020822</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060526</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SULAR</medicinalproduct>
        <drugdosagetext>20 MG QM PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD PRESSURE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050613</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050615</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCODONE BITARTRATE + ACETAMINOPHEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADVIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051217-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060707</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2006US08736</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>82</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
        <drugauthorizationnumb>021283</drugauthorizationnumb>
        <drugdosagetext>40MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060411</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060501</drugenddate>
        <drugtreatmentduration>30240</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIGOXIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYLENOL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051218-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060703</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2006JP09918</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>56</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>MULTI-ORGAN FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POST PROCEDURAL COMPLICATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEORAL</medicinalproduct>
        <drugauthorizationnumb>050715</drugauthorizationnumb>
        <drugdosagetext>500 MG/D</drugdosagetext>
        <drugindication>LIVER TRANSPLANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060617</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060622</drugenddate>
        <drugtreatmentduration>8640</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051219-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060703</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2006JP10030</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>79</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>AORTIC DISSECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GINGIVAL HYPERTROPHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEORAL</medicinalproduct>
        <drugauthorizationnumb>050737</drugauthorizationnumb>
        <drugdosagetext>125 MG/D</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PSORIASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060322</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060325</drugenddate>
        <drugtreatmentduration>5760</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TALION</medicinalproduct>
        <drugdosagetext>20 MG/D</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051108</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060325</drugenddate>
        <drugtreatmentduration>138</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTIHYPERTENSIVES</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051220-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060707</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2006JP10353</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>68</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>60</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>EOSINOPHIL COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA MULTIFORME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPHOCYTE STIMULATION TEST POSITIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
        <drugauthorizationnumb>020665</drugauthorizationnumb>
        <drugdosagetext>80 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050127</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060530</drugenddate>
        <drugtreatmentduration>489</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PEGASYS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051221-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060627</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GXKR2006US03656</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>71</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATOCHEZIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOPTYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERNATIONAL NORMALISED RATIO INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROTHROMBIN TIME PROLONGED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
        <drugauthorizationnumb>40196</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugindication>CARDIOVASCULAR EVENT PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NUTRITION SUPPLEMENTS(NUTRITION SUPPLEMENTS)</medicinalproduct>
        <drugdosagetext>24 OUNCES</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051226-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060330</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-AVENTIS-200613646GDDC</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>58</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>80</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANGINA PECTORIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD POTASSIUM INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLD SWEAT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEAFNESS UNILATERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIABETES MELLITUS INADEQUATE CONTROL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE IRREGULAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSULIN RESISTANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NERVOUS SYSTEM DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>21081</drugauthorizationnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>DIABETES MELLITUS INSULIN-DEPENDENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051209</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AUTOPEN INSULIN INJECTION PEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NOVORAPID</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugindication>DIABETES MELLITUS INSULIN-DEPENDENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051212</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN SOLUTION</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATORVASTATIN CALCIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUSIDIC ACID 2% CREAM</medicinalproduct>
        <drugadministrationroute>061</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCORTISONE ACETATE CREAM 1%</medicinalproduct>
        <drugadministrationroute>061</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FYBOGEL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN LISPRO</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORMETAZEPAM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HCL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NITROLINGUAL PUMPSPRAY</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PARACETAMOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SOTALOL HCL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051227-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20051022</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AVENTIS-200518407US</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>49.9</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
        <drugbatchnumb>40D023</drugbatchnumb>
        <drugauthorizationnumb>021081</drugauthorizationnumb>
        <drugdosagetext>DOSE UNIT: UNITS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>DIABETES MELLITUS NON-INSULIN-DEPENDENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050922</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051024</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OPTICLIK (INSULIN INJECTION PEN)</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021081</drugauthorizationnumb>
        <drugindication>DIABETES MELLITUS NON-INSULIN-DEPENDENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050929</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051024</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALTACE</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALTACE</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051002</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051013</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALTACE</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051014</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051021</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALTACE</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051022</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051228-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060607</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHO2006FR09341</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>56</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>78</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>DISEASE PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPTIC SHOCK</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HEPARIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BACTRIM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ROVALCYTE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CERTICAN</medicinalproduct>
        <drugdosagetext>1.5 MG / DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RENAL TRANSPLANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060503</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060621</drugenddate>
        <drugtreatmentduration>72000</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEORAL</medicinalproduct>
        <drugauthorizationnumb>050715</drugauthorizationnumb>
        <drugdosagetext>100 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RENAL TRANSPLANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060502</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060528</drugenddate>
        <drugtreatmentduration>38880</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugdosagetext>17.5 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RENAL TRANSPLANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060502</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051229-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060707</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHRM2006FR02015</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>87</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPONATRAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COVERSYL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAHOR</medicinalproduct>
        <drugdosagetext>80 MG/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEXOMIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TANAKAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TARDYFERON</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAREG</medicinalproduct>
        <drugauthorizationnumb>021283</drugauthorizationnumb>
        <drugdosagetext>80 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060401</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051230-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060704</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHNU2006DE02454</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>9</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>AGITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG LEVEL DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG LEVEL INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRILEPTAL</medicinalproduct>
        <drugindication>CONVULSION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060601</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRILEPTAL</medicinalproduct>
        <drugdosagetext>25 MG/KG/D</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060602</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRILEPTAL</medicinalproduct>
        <drugdosagetext>10 MG/KG/D</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SANDIMMUNE</medicinalproduct>
        <drugauthorizationnumb>050574</drugauthorizationnumb>
        <drugdosagetext>120 MG, BID</drugdosagetext>
        <drugindication>STEM CELL TRANSPLANT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTIHYPERTENSIVE DRUGS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051231-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060704</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHFR2006GB02137</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>33</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>INFERTILITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEORAL</medicinalproduct>
        <drugauthorizationnumb>50715</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>RENAL TRANSPLANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MYCOPHENOLATE MOFETIL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051235-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060627</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GXKR2006US03633</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>31</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GLYCOSYLATED HAEMOGLOBIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STEVENS-JOHNSON SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GLIPIZIDE</medicinalproduct>
        <drugauthorizationnumb>74305</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugindication>DIABETES MELLITUS NON-INSULIN-DEPENDENT</drugindication>
        <drugtreatmentduration>365</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051236-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060708</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHO2006MX11095</companynumb>
    <primarysource>
      <reportercountry>MEXICO</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATEMESIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERKALAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METABOLIC ACIDOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
        <drugauthorizationnumb>021283</drugauthorizationnumb>
        <drugdosagetext>320 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051205</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060511</drugenddate>
        <drugtreatmentduration>158</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ERYTHROPOIETIN HUMAN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051237-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2006JP09853</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DELIRIUM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RITALIN</medicinalproduct>
        <drugauthorizationnumb>10187</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MALAISE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051238-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2006JP09852</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DELIRIUM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RITALIN</medicinalproduct>
        <drugauthorizationnumb>10187</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MALAISE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051239-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060702</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006-07-0189</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>50</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD COUNT ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENORRHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL INTAKE REDUCED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCREATIC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWELLING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEG-INTRON</medicinalproduct>
        <drugdosagetext>SUBCUTANEOUS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060526</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBETOL</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060526</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DARVOCET-N 100</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KLONOPIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051240-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2006JP09850</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DELIRIUM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RITALIN</medicinalproduct>
        <drugauthorizationnumb>10187</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MALAISE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051241-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060608</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHMT2006CA01338</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>77</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMPLANTABLE DEFIBRILLATOR MALFUNCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENTRICULAR TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMTAN</medicinalproduct>
        <drugauthorizationnumb>20796</drugauthorizationnumb>
        <drugdosagetext>200 MG, TID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PARKINSON'S DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMERON</medicinalproduct>
        <drugdosagetext>30 MG QD</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVAPRO</medicinalproduct>
        <drugdosagetext>300 MG QD</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugdosagetext>25 MG, BID</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugdosagetext>20 MG QD</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALDACTONE</medicinalproduct>
        <drugdosagetext>12.5 MG QD</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>81 MG QD</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugdosagetext>75 MG QD</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATORVASTATIN CALCIUM</medicinalproduct>
        <drugdosagetext>20 MG QD</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SINEMET</medicinalproduct>
        <drugdosagetext>200/50 TID</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051242-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060609</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2006JP08798</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>15</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <reaction>
        <reactionmeddrapt>ATRIAL HYPERTROPHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ECG SIGNS OF VENTRICULAR HYPERTROPHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HALLUCINATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RITALIN</medicinalproduct>
        <drugauthorizationnumb>10187</drugauthorizationnumb>
        <drugdosagetext>15 MG/D</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATTENTION DEFICIT/HYPERACTIVITY DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051243-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060703</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHMT2006CA01463</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>79</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DELUSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMTAN</medicinalproduct>
        <drugauthorizationnumb>020796</drugauthorizationnumb>
        <drugdosagetext>100 MG, QID</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060623</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SINEMET CR</medicinalproduct>
        <drugdosagetext>100/25 MG QHS</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVODOPA</medicinalproduct>
        <drugdosagetext>100 MG, TID</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051244-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060705</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2006JP10236</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>24</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CIRCULATORY COLLAPSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSED LEVEL OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG SCREEN POSITIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJURY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RITALIN</medicinalproduct>
        <drugauthorizationnumb>010187</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOGMATYL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEPAS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051245-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060705</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2006NO10004</companynumb>
    <primarysource>
      <reportercountry>NORWAY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>9</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>29.7</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DYSARTHRIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPHEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPRAXIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RITALIN</medicinalproduct>
        <drugauthorizationnumb>010187</drugauthorizationnumb>
        <drugdosagetext>35 MG/D</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATTENTION DEFICIT/HYPERACTIVITY DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050801</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOSEC</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>STRATTERA</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051246-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2006JP09851</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DELIRIUM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RITALIN</medicinalproduct>
        <drugauthorizationnumb>10187</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MALAISE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051247-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060701</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006-07-0145</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>52</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>117.4816</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ALOPECIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>APPENDICITIS PERFORATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHOLELITHIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG DOSE OMISSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRY SKIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GANGRENE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POSTOPERATIVE WOUND INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RED BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEG-INTRON</medicinalproduct>
        <drugdosagetext>SUBCUTANEOUS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051217</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RIBAVIRIN</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051217</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACTONEL (RISEDRONATE SODIUM) TABLETS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMPERAZOLE CAPSULES</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051249-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060701</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006-07-0194</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>54</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRY SKIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRODUCTIVE COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROSTATIC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN EXFOLIATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEG-INTRON</medicinalproduct>
        <drugdosagetext>SUBCUTANEOUS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060526</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RIBAVIRIN</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060525</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KLONOPIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051251-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060706</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2006US08630</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CHEST DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISEASE RECURRENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMTAN</medicinalproduct>
        <drugauthorizationnumb>20796</drugauthorizationnumb>
        <drugdosagetext>200 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PARKINSON'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060607</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060618</drugenddate>
        <drugtreatmentduration>17280</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMTAN</medicinalproduct>
        <drugauthorizationnumb>020796</drugauthorizationnumb>
        <drugdosagetext>200 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060620</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARBIDOPA W/LEVODOPA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIRAPEX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMANTADINE HCL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051252-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060320</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006UW10437</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>11109</patientonsetage>
      <patientonsetageunit>804</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BIPOLAR DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugauthorizationnumb>20639</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BIPOLAR I DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051228</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060219</drugenddate>
        <drugtreatmentduration>54</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>STUDY PROCEDURE</medicinalproduct>
        <drugindication>BIPOLAR I DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATIVAN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANXIETY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060105</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060118</drugenddate>
        <drugtreatmentduration>14</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051253-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060626</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>HQWYE446528JUN06</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>52</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>65.83</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROTONIX</medicinalproduct>
        <drugauthorizationnumb>20987</drugauthorizationnumb>
        <drugdosagetext>40 MG 1X PER 1 DAY, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTROOESOPHAGEAL REFLUX DISEASE</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060601</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMBIEN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051254-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20051004</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-GILEAD-2005-0008776</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD ALKALINE PHOSPHATASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CREATININE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PHOSPHORUS DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD POTASSIUM DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULAR WEAKNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPSERA</medicinalproduct>
        <drugauthorizationnumb>21449</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS B</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050323</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050928</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPSERA</medicinalproduct>
        <drugauthorizationnumb>021449</drugauthorizationnumb>
        <drugindication>HEPATIC CIRRHOSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZEFFIX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATIC CIRRHOSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020516</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051116</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THYRADIN S</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PYDOXAL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>URSO</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAURINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYANOCOBALAMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGNESIUM OXIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALDACTONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAKEPRON</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051255-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060626</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>HQWYE242610MAY06I</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>46</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>62.65</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ACTIVITIES OF DAILY LIVING IMPAIRED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANOREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CHOLESTEROL INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHILLS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG DEPENDENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EFFECT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRY MOUTH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERAL PHYSICAL HEALTH DETERIORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HOT FLUSH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMPAIRED SELF-CARE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMPAIRED WORK ABILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEDICATION RESIDUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENTAL IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANIC ATTACK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RETCHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SELF-INJURIOUS IDEATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STRESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EFFEXOR XR</medicinalproduct>
        <drugauthorizationnumb>20699</drugauthorizationnumb>
        <drugdosagetext>150 MG 2X PER 1 DAY, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060415</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EFFEXOR</medicinalproduct>
        <drugdosagetext>75 MG FREQUENCY UNSPECIFIED</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060416</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CENESTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLEXERIL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051256-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060626</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>HQWYE414126JUL04</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>50</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>68.55</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BREAST CANCER IN SITU</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BREAST CANCER METASTATIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BREAST MICROCALCIFICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CELLULITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METASTASES TO LYMPH NODES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OESTROGEN RECEPTOR ASSAY POSITIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POST PROCEDURAL HAEMATOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEROMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMPRO</medicinalproduct>
        <drugauthorizationnumb>20527</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MENOPAUSAL SYMPTOMS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19961001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20000801</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051259-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060626</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>HQWYE408827JUN06</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>50</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMPRO</medicinalproduct>
        <drugauthorizationnumb>20527</drugauthorizationnumb>
        <drugdosagetext>0.45 MG/ 1.5 ONCE DAILY, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NIGHT SWEATS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060501</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAMADOL HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONAPIN (CLONAZEPAM)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051263-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060626</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>HQWYE430127JUN06</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BREAST CANCER FEMALE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
        <drugauthorizationnumb>4782</drugauthorizationnumb>
        <drugindication>OESTROGEN REPLACEMENT THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCRIN</medicinalproduct>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROVERA</medicinalproduct>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051267-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060627</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AUWYE848828JUN06</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>21</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BEDRIDDEN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EFFECT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG WITHDRAWAL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</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>19980101</drugstartdate>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051268-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060706</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20060702055</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>89.36</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE RUPTURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DURAGESIC-100</medicinalproduct>
        <drugauthorizationnumb>019813</drugauthorizationnumb>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VICODIN</medicinalproduct>
        <drugdosagetext>7.5 MG/750 MG, 1 IN 12 HOURS, AS NEEDED, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BREAKTHROUGH PAIN</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051269-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>HQWYE576831MAY06</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>39</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABORTION INDUCED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLIGHTED OVUM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PREGNANCY ON ORAL CONTRACEPTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UNINTENDED PREGNANCY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRIQUILAR-28 (LEVONORGESTREL/ETHINYL ESTRADIOL/INERT, TABLET)</medicinalproduct>
        <drugauthorizationnumb>19190</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ORAL CONTRACEPTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051270-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060704</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-JNJFOC-20060701399</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>44</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>60</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>AGGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HOMICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOPAMAX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOPAMAX</medicinalproduct>
        <drugauthorizationnumb>020505</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MOOD ALTERED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PAROXETINE HCL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MOOD ALTERED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RIVOTRIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INSOMNIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RIVOTRIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANXIETY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOFRANIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOFRANIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MOOD ALTERED</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051271-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>HQWYE446728JUN06</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>36</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BIPOLAR I DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INAPPROPRIATE SCHEDULE OF DRUG ADMINISTRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METRORRHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OLIGOMENORRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WITHDRAWAL BLEEDING IRREGULAR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVONORGESTREL + ETHINYL ESTRADIOL</medicinalproduct>
        <drugauthorizationnumb>19192</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ORAL CONTRACEPTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19890101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060301</drugenddate>
        <drugtreatmentduration>17</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVONORGESTREL + ETHINYL ESTRADIOL</medicinalproduct>
        <drugauthorizationnumb>19192</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ORAL CONTRACEPTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060501</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051272-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060706</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FRWYE074027MAR03</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>70</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>INTESTINAL OBSTRUCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROCEDURAL COMPLICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RETROPERITONEAL HAEMATOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RAPAMUNE</medicinalproduct>
        <drugauthorizationnumb>21110</drugauthorizationnumb>
        <drugindication>PROPHYLAXIS AGAINST TRANSPLANT REJECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021212</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20021220</drugenddate>
        <drugtreatmentduration>9</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELLCEPT</medicinalproduct>
        <drugdosagetext>2 G 1X PER 1 DAY</drugdosagetext>
        <drugindication>PROPHYLAXIS AGAINST TRANSPLANT REJECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021211</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CORTANCYL (PREDNISONE, ,0)</medicinalproduct>
        <drugdosagetext>40 MG 1X PER 1 DAY</drugdosagetext>
        <drugindication>PROPHYLAXIS AGAINST TRANSPLANT REJECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021217</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051273-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060626</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DEWYE799626JUN06</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>45</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG LEVEL INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HALLUCINATION, VISUAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUS TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VERTIGO</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VENLAFAXINE HCL</medicinalproduct>
        <drugauthorizationnumb>20699</drugauthorizationnumb>
        <drugdosagetext>75 MG ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060117</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060117</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROMETHAZINE</medicinalproduct>
        <drugdosagetext>100 MG ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060116</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060117</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIRTAZAPINE</medicinalproduct>
        <drugdosagetext> SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051017</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051017</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIRTAZAPINE</medicinalproduct>
        <drugdosagetext> SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051018</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051130</drugenddate>
        <drugtreatmentduration>44</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIRTAZAPINE</medicinalproduct>
        <drugdosagetext> SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051025</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051121</drugenddate>
        <drugtreatmentduration>28</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051122</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051123</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051124</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060116</drugenddate>
        <drugtreatmentduration>54</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SOLIAN (AMISULPRIDE), 300 + 150 MG</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAVOR (LORAZEPAM) 1.5 MG + 1 ML + 0.5</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>STAURODORM NEU (FLURAZEPAM)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETYLSALICYLIC ACID SRT</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051274-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060703</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>HQWYE247518JUL05</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>30</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD CREATININE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIABETES MELLITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RAPAMUNE</medicinalproduct>
        <drugauthorizationnumb>21110</drugauthorizationnumb>
        <drugdosagetext>6 + 4 + 2 MG 1X PER 1 DAY ORAL - SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS AGAINST TRANSPLANT REJECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050614</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051025</drugenddate>
        <drugtreatmentduration>134</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RAPAMUNE</medicinalproduct>
        <drugauthorizationnumb>21110</drugauthorizationnumb>
        <drugdosagetext>6 + 4 + 2 MG 1X PER 1 DAY ORAL - SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS AGAINST TRANSPLANT REJECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051026</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060523</drugenddate>
        <drugtreatmentduration>210</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RAPAMUNE</medicinalproduct>
        <drugauthorizationnumb>21110</drugauthorizationnumb>
        <drugdosagetext>6 + 4 + 2 MG 1X PER 1 DAY ORAL - SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS AGAINST TRANSPLANT REJECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060524</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060628</drugenddate>
        <drugtreatmentduration>36</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE TAB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NYSTATIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SULFAMETHOXAZOLE + TRIMETHOPRIM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORFLOXACIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYCLOSPORINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051275-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060706</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-AVENTIS-200612435FR</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>POSTOPERATIVE WOUND COMPLICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPINAL HAEMATOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LOVENOX</medicinalproduct>
        <drugauthorizationnumb>020164</drugauthorizationnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>THROMBOSIS PROPHYLAXIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051276-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060710</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AVENTIS-200615717US</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>HEPATIC CIRRHOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATOCELLULAR DAMAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARAVA</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>020905</drugauthorizationnumb>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031001</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051277-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060707</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-AVENTIS-200617119GDDC</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>53</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>120</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARAVA</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>020905</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041227</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KARVEZIDE</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENDONE</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALIUM</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVAPRO</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051278-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060710</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-AVENTIS-200612448FR</companynumb>
    <primarysource></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>CARDIAC ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ELECTROCARDIOGRAM QRS COMPLEX PROLONGED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERAL PHYSICAL HEALTH DETERIORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERKALAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SHOCK</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LASILIX</medicinalproduct>
        <drugauthorizationnumb>16273</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060616</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALDACTONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060427</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060616</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COVERSYL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060616</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADANCOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANGINA PECTORIS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060616</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAHOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060616</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DISCOTRINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANGINA PECTORIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060616</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051279-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060706</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AVENTIS-200615765US</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ALPHA 1 FOETOPROTEIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LABORATORY TEST ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEURAL TUBE DEFECT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OESTRIOL ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARAVA</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>020905</drugauthorizationnumb>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051280-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20030115</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CH-AVENTIS-200310133EU</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>74</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERKALAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE CHRONIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugauthorizationnumb>16273</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20021116</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LASILACTON</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20021116</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VALSARTAN AND HYDROCHLOROTHIAZIDE</medicinalproduct>
        <drugdosagetext>DOSE: 80 + 12.5</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20021116</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMIODARONE HCL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NITROGLYCERIN</medicinalproduct>
        <drugadministrationroute>062</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051281-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060522</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-AVENTIS-200615795GDDC</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>41</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ALANINE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD ALKALINE PHOSPHATASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD BILIRUBIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAMMA-GLUTAMYLTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC ENZYME INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARAVA</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060405</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060427</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060427</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OROXINE</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051282-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060518</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-AVENTIS-200611818FR</companynumb>
    <primarysource></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>CELLULITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG WITHDRAWAL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ECCHYMOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOSITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NECROTISING FASCIITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RECTAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TENDON RUPTURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOPALGIC</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060410</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060411</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROFENID</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060410</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060411</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LOVENOX</medicinalproduct>
        <drugauthorizationnumb>020164</drugauthorizationnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060410</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060411</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACUPAN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060410</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060411</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MOPRAL</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060410</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060411</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060410</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060411</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MORPHINE SULFATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060411</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MYOLASTAN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060412</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRANXENE</medicinalproduct>
        <drugindication>DRUG WITHDRAWAL SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060412</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN B1 AND B6</medicinalproduct>
        <drugindication>DRUG WITHDRAWAL SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060412</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NICOTINE</medicinalproduct>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>DRUG WITHDRAWAL SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060412</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051283-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20051212</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-AVENTIS-200521109GDDC</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>57</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PLEURAL EFFUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA BACTERIAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHEUMATOID NODULE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREATMENT NONCOMPLIANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TUBERCULOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARAVA</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>20905</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010126</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030701</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARAVA</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>020905</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051123</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARAVA</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>020905</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MELOXICAM</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010306</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMITRIPTYLINE HCL</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010306</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010126</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COMBINATIONS OF ANTIHYPERTENSIVES IN ATC-GR.</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugdosagetext>DOSE: 50/125</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051284-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20051123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-AVENTIS-200513851FR</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>60</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>65</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ALANINE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ALDOLASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASPARTATE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AUTOIMMUNE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CREATINE PHOSPHOKINASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD LACTATE DEHYDROGENASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRY SKIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ELECTROMYOGRAM ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAMMOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERGAMMAGLOBULINAEMIA BENIGN MONOCLONAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOREFLEXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ICHTHYOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLAMMATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPHOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOTOR DYSFUNCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE ENZYME INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE HYPERTROPHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULAR WEAKNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PITTING OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POLYMYOSITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROTEINURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSORIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RED BLOOD CELL SEDIMENTATION RATE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHEUMATOID FACTOR POSITIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN DISCOLOURATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN LESION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VASCULITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARAVA</medicinalproduct>
        <drugauthorizationnumb>20905</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050515</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050722</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SOLUPRED</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MOPRAL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DAFALGAN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRALGIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OROCAL VITAMINE D3</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CALCIUM DECREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051285-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040722</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR9369810DEC2002</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>56</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>KIDNEY TRANSPLANT REJECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPHOCELE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RAPAMUNE</medicinalproduct>
        <drugauthorizationnumb>21083</drugauthorizationnumb>
        <drugdosagetext>10 MG 1X PER 1 DAY ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RENAL TRANSPLANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021110</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE TAB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELLCEPT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE BESYLATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAHOR (ATORVASTATIN)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EPOETIN BETA (EPOETIN BETA)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051286-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060530</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-AVENTIS-200611590DE</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>36</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABORTION INDUCED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLEXANE</medicinalproduct>
        <drugauthorizationnumb>20164</drugauthorizationnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PELVIC VENOUS THROMBOSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060501</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051287-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-AVENTIS-200612426FR</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>58</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>55</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CYTOLYTIC HEPATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MELAENA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LOVENOX</medicinalproduct>
        <drugauthorizationnumb>20164</drugauthorizationnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060513</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060523</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RAPIFEN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ANAESTHESIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060513</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060523</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLAVENTIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060515</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060523</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FUNGIZONE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ASPERGILLOSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060512</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060517</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CATAPRES</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060513</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060515</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRAVASTATIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLOR</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DI-ANTALVIC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FERROGRAD</medicinalproduct>
        <drugindication>IRON DEFICIENCY ANAEMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTIFUNGALS FOR SYSTEMIC USE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060518</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051288-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060704</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DEWYE853328JUN06</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>75</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>VITH NERVE PARALYSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VENLAFAXINE HCL</medicinalproduct>
        <drugauthorizationnumb>20699</drugauthorizationnumb>
        <drugdosagetext>75 MG 1X PER 1 DAY ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANXIETY</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VENLAFAXINE HCL</medicinalproduct>
        <drugauthorizationnumb>20699</drugauthorizationnumb>
        <drugdosagetext>75 MG 1X PER 1 DAY ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051289-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060626</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>HQWYE554305MAY05</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>47</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE SYSTOLIC INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PANTOPRAZOLE SODIUM</medicinalproduct>
        <drugauthorizationnumb>20987</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMISULPRIDE</medicinalproduct>
        <drugdosagetext>SOME TIME(S) SOME DF^ ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
        <drugdosagetext>^SOME TIME(S) SOME DF^ ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOXAZOSIN MESYLATE</medicinalproduct>
        <drugdosagetext>^SOME TIME(S) SOME DF^ ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FENTANYL</medicinalproduct>
        <drugdosagetext>^SOME TIME(S) SOME DF^ INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FENTANYL</medicinalproduct>
        <drugdosagetext>^DF^ TOPICAL</drugdosagetext>
        <drugadministrationroute>061</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HALOPERIDOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCYCLIDINE HYDROCHLORIDE 2MG TAB</medicinalproduct>
        <drugdosagetext>^SOME TIME(S) SOME DF^ ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RIFAMPICIN</medicinalproduct>
        <drugdosagetext>^SOME TIME(S) SOME DF^ INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOPICLONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYVOX</medicinalproduct>
        <drugdosagetext>600 MG 2X PER 1 DAY INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>STAPHYLOCOCCAL INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041017</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041020</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051290-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060515</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>145795USA</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>24</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</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>20050201</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051291-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060524</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>TCI2006A01252</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>9</patientonsetage>
      <patientonsetageunit>800</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>INTERSTITIAL LUNG DISEASE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEUPLIN SR</medicinalproduct>
        <drugauthorizationnumb>19010</drugauthorizationnumb>
        <drugdosagetext>11.25 MG (11.25 MG, 1 IN 12 WK) PER ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROSTATE CANCER</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051215</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CASODEX</medicinalproduct>
        <drugdosagetext>PER ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051292-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060626</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006-144491-NL</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>29</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEEP VEIN THROMBOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NUVARING</medicinalproduct>
        <drugauthorizationnumb>21187</drugauthorizationnumb>
        <drugdosagetext>DF</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ORTHO EVRA</medicinalproduct>
        <drugdosagetext>DF</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051293-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060705</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006UW14123</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>74</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BALANCE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEMORY IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugauthorizationnumb>020639</drugauthorizationnumb>
        <drugdosagetext>7 PM</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MENTAL DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060301</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMERON</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONAZEPAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALTACE</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051294-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060711</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006UW14263</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>50</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>142</patientweight>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>COMPLETED SUICIDE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVERDOSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugauthorizationnumb>020639</drugauthorizationnumb>
        <drugindication>HALLUCINATION, AUDITORY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugauthorizationnumb>020639</drugauthorizationnumb>
        <drugindication>MAJOR DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugauthorizationnumb>020639</drugauthorizationnumb>
        <drugindication>PSYCHOTIC DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KLONOPIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051295-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006-141543-NL</companynumb>
    <primarysource>
      <reportercountry>SWITZERLAND</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>44</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HEPATOCELLULAR DAMAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ULTRASOUND BILIARY TRACT ABNORMAL</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>20030301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051120</drugenddate>
        <drugtreatmentduration>32</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ESCITALOPRAM</medicinalproduct>
        <drugdosagetext>DF ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051120</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLPIDEM TARTRATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CODEINE/PHENYLTOLOXAMINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051296-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060704</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006-144907-NL</companynumb>
    <primarysource>
      <reportercountry>NETHERLANDS</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>43</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DIABETIC HYPERGLYCAEMIC COMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE TAB</medicinalproduct>
        <drugauthorizationnumb>14694</drugauthorizationnumb>
        <drugdosagetext>8 MG</drugdosagetext>
        <drugindication>NAUSEA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050501</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CISPLATIN</medicinalproduct>
        <drugdosagetext>100 MG/M2</drugdosagetext>
        <drugindication>NASOPHARYNGEAL CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050501</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051297-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060704</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006-144979-NL</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>69</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ACTIVATED PARTIAL THROMBOPLASTIN TIME PROLONGED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGIC DIATHESIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HENOCH-SCHONLEIN PURPURA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STAPHYLOCOCCAL INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DANAPAROID SODIUM</medicinalproduct>
        <drugauthorizationnumb>20430</drugauthorizationnumb>
        <drugdosagetext>INTRAVENOUS (NOS)</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>DISSEMINATED INTRAVASCULAR COAGULATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060510</drugenddate>
        <drugtreatmentduration>10</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HEPARIN-FRACTION, SODIUM SALT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXPANTHENOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALPROSTADIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEROPENEM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MINOPHAGEN C</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VANCOMYCIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051298-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060703</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006-144962-NL</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>64</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DEPRESSED LEVEL OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGIC DIATHESIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCYTOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUBARACHNOID HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DANAPAROID SODIUM</medicinalproduct>
        <drugauthorizationnumb>20430</drugauthorizationnumb>
        <drugdosagetext>INTRAVENOUS (NOS)</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>DISSEMINATED INTRAVASCULAR COAGULATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051116</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051128</drugenddate>
        <drugtreatmentduration>13</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOPAMINE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEROPENEM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUCONAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMMUNE GLOBULIN INTRAVENOUS (HUMAN)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEUPOGEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHYLPREDNISOLONE SODIUM SUCCINATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOBRAMYCIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NAFAMOSTAT MESILATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TEICOPLANIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051299-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060622</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006-143464-NL</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>70</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GALLBLADDER DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGIC DIATHESIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC ISCHAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DANAPAROID SODIUM</medicinalproduct>
        <drugauthorizationnumb>20430</drugauthorizationnumb>
        <drugdosagetext>INTRAVENOUS DRIP</drugdosagetext>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>DISSEMINATED INTRAVASCULAR COAGULATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060311</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060314</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CEFEPIROME SULFATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ISEPAMICIN SULFATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MINOPHAGEN C</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUTATHIONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MIDAZOLAM HYDROCHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VECURONIUM BROMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOPAMINE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VERAPAMIL HYDROCHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GABEXATE MESILATE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051300-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060622</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0429254A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RELAFEN</medicinalproduct>
        <drugauthorizationnumb>19583</drugauthorizationnumb>
        <drugdosagetext>500 MG / TWICE PER DAY</drugdosagetext>
        <drugindication>OSTEOARTHRITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051301-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0430068A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CHILLS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG TOXICITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
        <drugauthorizationnumb>20031</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LINEZOLID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRAMADOL HCL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051302-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0430059A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG TOXICITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
        <drugauthorizationnumb>20031</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LINEZOLID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRAZODONE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMITRIPTYLINE (AMITRIPTYLINE)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051303-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0430047A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG TOXICITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
        <drugauthorizationnumb>20031</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LINEZOLID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CITALOPRAM HYDROBROMIDE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051304-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060706</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-BRACCO-BRO-010310</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANGIONEUROTIC OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URTICARIA GENERALISED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MULTIHANCE</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021357</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050725</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050725</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051305-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0430112A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>39</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE TWITCHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEROTONIN SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
        <drugauthorizationnumb>20031</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LINEZOLID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIRTAZAPINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051306-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0430036A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEROTONIN SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
        <drugauthorizationnumb>20031</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LINEZOLID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CITALOPRAM HYDROBROMIDE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051307-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0430031A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>45</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CLONUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEROTONIN SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BUPROPION HCL</medicinalproduct>
        <drugauthorizationnumb>18644</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LINEZOLID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERIDONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SERTRALINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRAZODONE HCL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051308-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060703</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ES-JNJFOC-20060600745</companynumb>
    <primarysource>
      <reportercountry>SPAIN</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>65</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CHEST INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMOTHORAX</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RIB FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUBCUTANEOUS EMPHYSEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TENDON RUPTURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVOFLOXACIN</medicinalproduct>
        <drugauthorizationnumb>20634</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYGEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHYLPREDNISOLONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SALBUTAMOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IPRATROPIUM BROMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PAROXETINE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETYLCYSTEINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THEOPHYLLINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENALAPRIL MALEATE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051309-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060113</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CHPA2006US00900</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>53</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>49</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG WITHDRAWAL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOTION SICKNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>REBOUND EFFECT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRANSDERM SCOP</medicinalproduct>
        <drugbatchnumb>0525155</drugbatchnumb>
        <drugauthorizationnumb>17874</drugauthorizationnumb>
        <drugdosagetext>1.5 MG FROM 29 - 31 JAN, TRANSDERMAL</drugdosagetext>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>PROPHYLAXIS AGAINST MOTION SICKNESS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051229</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051231</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>QVAR (BECLOMETASONE DIPROPIONATE)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051313-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060612</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006AC01128</companynumb>
    <primarysource>
      <reportercountry>NETHERLANDS</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>754</patientonsetage>
      <patientonsetageunit>802</patientonsetageunit>
      <patientweight>73</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>POLYMYALGIA RHEUMATICA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugauthorizationnumb>21366</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERCHOLESTEROLAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031217</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050322</drugenddate>
        <drugtreatmentduration>462</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COZAAR</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030703</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051314-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060314</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006UW05055</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>31</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GESTATIONAL DIABETES</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugauthorizationnumb>020639</drugauthorizationnumb>
        <drugdosagetext>100-900 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INSOMNIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060131</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugauthorizationnumb>020639</drugauthorizationnumb>
        <drugdosagetext>100-900 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>AFFECTIVE DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060131</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugauthorizationnumb>020639</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060506</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugauthorizationnumb>020639</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060506</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051316-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060706</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006CG01173</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GRANULOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLAMMATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARIMIDEX</medicinalproduct>
        <drugauthorizationnumb>020541</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051317-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060705</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006UW13941</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>92</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DEEP VEIN THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOLADEX</medicinalproduct>
        <drugauthorizationnumb>020578</drugauthorizationnumb>
        <drugadministrationroute>058</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MEGACE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRIAZOLAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACIPHEX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CITRACAL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051318-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060703</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006AP03029</companynumb>
    <primarysource>
      <reportercountry>INDONESIA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>25257</patientonsetage>
      <patientonsetageunit>804</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MELAENA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IRESSA</medicinalproduct>
        <drugauthorizationnumb>21399</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060623</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060630</drugenddate>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PARACETAMOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CANCER PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060615</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CODEINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CANCER PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060615</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CEFOTAXIME</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060620</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACTRAPID HM</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060621</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051325-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060710</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>LB-BRISTOL-MYERS SQUIBB COMPANY-13437140</companynumb>
    <primarysource>
      <reportercountry>LEBANON</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>56</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>80</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>CARDIAC ARREST</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COAPROVEL TABS 300MG/12.5MG</medicinalproduct>
        <drugauthorizationnumb>20758</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051207</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051326-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060419</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-13351143</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>67</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>52</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPENDENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOKINESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STOMACH DISCOMFORT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARBIDOPA + LEVODOPA</medicinalproduct>
        <drugauthorizationnumb>17555</drugauthorizationnumb>
        <drugindication>PARKINSON'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19950501</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REQUIP</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EVISTA</medicinalproduct>
        <drugindication>ARTHRALGIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCODONE</medicinalproduct>
        <drugindication>ARTHRALGIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051327-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>19980708</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-BRISTOL-MYERS SQUIBB COMPANY-13432679</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>59</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HAEMOPTYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALIGNANT NEOPLASM PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAPROTEINAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAXOL</medicinalproduct>
        <drugauthorizationnumb>20262</drugauthorizationnumb>
        <drugindication>BRONCHIAL CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PLATINEX</medicinalproduct>
        <drugauthorizationnumb>018057</drugauthorizationnumb>
        <drugindication>BRONCHIAL CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19971201</drugstartdate>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VEPESID</medicinalproduct>
        <drugauthorizationnumb>018768</drugauthorizationnumb>
        <drugindication>BRONCHIAL CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19971201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GEMCITABINE</medicinalproduct>
        <drugindication>BRONCHIAL CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORZAAR PLUS</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CONCOR</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CORANGIN RETARD</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>L-THYROXINE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>STANGYL</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRAVASIN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980701</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051328-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060712</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ZA-BRISTOL-MYERS SQUIBB COMPANY-13439351</companynumb>
    <primarysource>
      <reportercountry>SOUTH AFRICA</reportercountry>
      <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>
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      <reaction>
        <reactionmeddrapt>GASTROENTERITIS</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DASATINIB</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060315</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060710</drugenddate>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMOXICILLIN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060705</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060701</drugenddate>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PHARMATON</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060530</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060701</drugenddate>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PARACETAMOL</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060701</drugenddate>
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    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051329-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060713</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PR-BRISTOL-MYERS SQUIBB COMPANY-13441415</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>56</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ENDOPHTHALMITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOPYON</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL ACUITY REDUCED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VITRITIS</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KENALOG-40</medicinalproduct>
        <drugbatchnumb>6B21109</drugbatchnumb>
        <drugauthorizationnumb>014901</drugauthorizationnumb>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN</medicinalproduct>
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        <drugindication>DIABETES MELLITUS</drugindication>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZYMAR</medicinalproduct>
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    </patient>
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  <safetyreport>
    <safetyreportid>5051330-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
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    <receivedate>20060714</receivedate>
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    <companynumb>PR-BRISTOL-MYERS SQUIBB COMPANY-13441456</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>ENDOPHTHALMITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOPYON</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL ACUITY REDUCED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VITRITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KENALOG-40</medicinalproduct>
        <drugbatchnumb>6C15315</drugbatchnumb>
        <drugauthorizationnumb>014901</drugauthorizationnumb>
        <drugadministrationroute>031</drugadministrationroute>
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        <drugstartdate>20060607</drugstartdate>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZYMAR</medicinalproduct>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
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    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051331-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006-06-1806</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <patientonsetage>51</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>95.709</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>APPLICATION SITE PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRY SKIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN LESION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEG-INTRON</medicinalproduct>
        <drugdosagetext>SUBCUTANEOUS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060331</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RIBAVIRIN</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060331</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLIPIZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOPHAGE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IBUPROFEN TABLETS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRINIVIL TABLETS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROTONIX (PANTOPRAZOLE SODIUM) TABLETS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VISTARIL CAP</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051332-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060630</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PAR_0648_2006</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>71</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>84.369</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANGINA PECTORIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BENIGN PROSTATIC HYPERPLASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EMPHYSEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALLOR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POLLAKIURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SCAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MEGESTROL ACETATE</medicinalproduct>
        <drugauthorizationnumb>72423</drugauthorizationnumb>
        <drugdosagetext>40 MG QID PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROSTATE CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060213</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060620</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LUPRON</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051333-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060703</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-JNJFOC-20060700397</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>T-CELL LYMPHOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CROHN'S DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AZATHIOPRINE</medicinalproduct>
        <drugindication>CROHN'S DISEASE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051334-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060705</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20060701124</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>117.94</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL DISTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CYSTITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFUSION RELATED REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH MACULAR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>POLYARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugdosagetext>4 VIALS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>SARCOIDOSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LOVENOX</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051335-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060705</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20060503909</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>133.81</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL MASS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPHOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NON-HODGKIN'S LYMPHOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugdosagetext>TOTAL OF 17 INFUSIONS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugtreatmentduration>36</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051336-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060703</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-GILEAD-2006-0009842</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CATARACT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPSERA</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051337-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060519</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GILEAD-2006-0009606</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </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 BEFORE PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRUVADA</medicinalproduct>
        <drugauthorizationnumb>21752</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEXIVA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RITONAVIR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COMBIVIR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060412</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KALETRA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060412</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051340-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006BI009362</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>29</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>78.0187</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ARRESTED LABOUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CAESAREAN SECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</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>
      </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>20041201</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051341-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006BI009385</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>54</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>LUNG ADENOCARCINOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugdosagetext>30 UG QW IM</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980501</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051342-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060706</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0607USA01188</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>COMPLETED SUICIDE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISTURBANCE IN ATTENTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NIGHTMARE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MEVACOR</medicinalproduct>
        <drugauthorizationnumb>019643</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051343-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060711</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0607USA01859</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>39</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BRAIN ABSCESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SINGULAIR</medicinalproduct>
        <drugauthorizationnumb>020829</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERSENSITIVITY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051344-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060515</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BE-MERCK-0605BEL00015</companynumb>
    <primarysource>
      <reportercountry>BELGIUM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>60</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ARTERIOSCLEROSIS CORONARY ARTERY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL ISCHAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>QUINAPRIL HCL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugauthorizationnumb>019766</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERCHOLESTEROLAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLYBURIDE AND METFORMIN HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLOPIDOGREL BISULFATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANGIOPATHY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN HUMAN ZINC, EXTENDED</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060123</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VENLAFAXINE HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE BESYLATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051345-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060711</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AT-MERCK-0607AUT00007</companynumb>
    <primarysource>
      <reportercountry>AUSTRIA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>67</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CIRCULATORY COLLAPSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUDDEN DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZETIA</medicinalproduct>
        <drugauthorizationnumb>021445</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>LIPID METABOLISM DISORDER</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060612</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051346-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060614</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0606USA02748</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>50</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>83</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ALANINE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AMNESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASPARTATE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CREATINE PHOSPHOKINASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PHOSPHORUS DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISORIENTATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VYTORIN</medicinalproduct>
        <drugauthorizationnumb>021687</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051011</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060601</drugenddate>
        <drugtreatmentduration>234</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VYTORIN</medicinalproduct>
        <drugauthorizationnumb>021687</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>METABOLIC SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051011</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060601</drugenddate>
        <drugtreatmentduration>234</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANTIPLATELET THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051011</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060301</drugenddate>
        <drugtreatmentduration>168</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060327</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051011</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051021</drugenddate>
        <drugtreatmentduration>11</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051347-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060612</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0606USA02355</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>37</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ALLERGIC GRANULOMATOUS ANGIITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SINGULAIR</medicinalproduct>
        <drugauthorizationnumb>20829</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051348-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006BI009414</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>46</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>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>19970301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050801</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051349-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006BI009416</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>72</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</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>20030201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030801</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugbatchnumb>P35080</drugbatchnumb>
        <drugdosagetext>30 UG QW IM</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030901</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051350-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060622</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006078751</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FOAMING AT MOUTH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COOL MINT LISTERINE (MENTHOL, METHYL SALICYLATE, EUCALYPTOL, THYMOL)</medicinalproduct>
        <drugdosagetext>THREE 500 ML BOTTLES ONCE, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060622</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060622</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051351-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060627</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006068676</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>17</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>63.05</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD POTASSIUM INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LETHARGY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE TWITCHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARYNGEAL OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUDAFED NON-DRYING SINUS (PSEUDOEPHEDRINE, GUAIFENESIN)</medicinalproduct>
        <drugbatchnumb>A15728</drugbatchnumb>
        <drugdosagetext>2 LIQUIDCAPS 1 TIME, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SINUS DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060524</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060524</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051352-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060221</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0603USA00969</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>48</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRONCHITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIOVASCULAR DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRY SKIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIMB INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POLYMYOSITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugauthorizationnumb>019766</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051130</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LITHIUM ACETATE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051353-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060619</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-MERCK-0607USA00875</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>66</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>40</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CONJUNCTIVAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugauthorizationnumb>19766</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERLIPIDAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010919</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020513</drugenddate>
        <drugtreatmentduration>237</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CERIVASTATIN SODIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000419</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010718</drugenddate>
        <drugtreatmentduration>456</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VITAMIN E NICOTINATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020729</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031120</drugenddate>
        <drugtreatmentduration>480</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRAVASTATIN SODIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031120</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040117</drugenddate>
        <drugtreatmentduration>59</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROBUCOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040812</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051019</drugenddate>
        <drugtreatmentduration>434</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROBUCOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051020</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060529</drugenddate>
        <drugtreatmentduration>222</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051354-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060701</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006082541</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HALLUCINATION, AUDITORY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCORRECT DOSE ADMINISTERED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DRAMAMINE</medicinalproduct>
        <drugdosagetext>12 TABLETS, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051355-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006-06-2215</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>86.1834</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEG-INTRON</medicinalproduct>
        <drugindication>HEPATITIS C</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RIBAVIRIN</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugindication>HEPATITIS C</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051356-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060627</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-US184525</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>91.7</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RECTAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PALIFERMIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>STOMATITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060623</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060630</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VICODIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060519</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORAZEPAM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060613</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VIBRAMYCIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060616</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SUDAFED 12 HOUR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060616</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EQUATE</medicinalproduct>
        <drugadministrationroute>045</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060616</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORTAB</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEULASTA</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060628</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CISPLATIN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060627</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RADIATION THERAPY</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060626</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATIVAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COMPAZINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060626</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REGLAN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060626</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051357-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>SU-2006-005113</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>68</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>108.8633</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ALOPECIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TONGUE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UNEVALUABLE EVENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BENICAR HCT</medicinalproduct>
        <drugauthorizationnumb>21532</drugauthorizationnumb>
        <drugdosagetext>MG QD PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HUMALOG MIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HUMULIN N</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051358-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060626</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>007819</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>21</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>52.2</patientweight>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ABDOMINAL DISTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARRHYTHMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG USE FOR UNKNOWN INDICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLUENZA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENORRHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PELVIC INFLAMMATORY DISEASE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PLAN B</medicinalproduct>
        <drugauthorizationnumb>21045</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONTRACEPTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060228</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PLAN B</medicinalproduct>
        <drugauthorizationnumb>21045</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONTRACEPTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060329</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ORTHO TRI-CYCLEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTIBIOTICS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYLENOL COLD MEDICATION (CHLORPHENAMINE MALEATE, PSEUDOEPHEDRINE HYDRO</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMPHETAMINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051359-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060618</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>HQWYE771011JUL06</companynumb>
    <primarysource>
      <reportercountry>ISRAEL</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>28</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>POLYARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PURPURA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHEUMATOID ARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THERAPEUTIC RESPONSE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VASCULITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>POLYARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060601</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CORTICOSTEROID NOS</medicinalproduct>
        <drugdosagetext>VARIABLE DOSAGE</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>POLYARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYCLOPHOSPHAMIDE</medicinalproduct>
        <drugdosagetext>1 G</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>POLYARTHRITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051360-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060711</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006UW14237</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>35</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY DISTRESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugauthorizationnumb>020639</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLONAZEPAM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051361-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060427</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2006BR08614</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>40</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LARYNGEAL OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XOLAIR</medicinalproduct>
        <drugdosagetext>150 MG, ONCE/SINGLE</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060528</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugdosagetext>600MG/DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SALBUTAMOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORASEQ</medicinalproduct>
        <drugauthorizationnumb>020831</drugauthorizationnumb>
        <drugdosagetext>3 DF/DAY</drugdosagetext>
        <drugindication>ASTHMA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051362-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060530</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL181389</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>102</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANTI-ERYTHROPOIETIN ANTIBODY POSITIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOLYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARATHYROIDECTOMY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THERAPEUTIC RESPONSE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EPOGEN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>RENAL FAILURE CHRONIC</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051363-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060630</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006055185</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>81.6475</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BALANCE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOW DENSITY LIPOPROTEIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugbatchnumb>0647035</drugbatchnumb>
        <drugauthorizationnumb>20702</drugauthorizationnumb>
        <drugdosagetext>10 MG (10 MG, 1 IN 1 D)</drugdosagetext>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020501</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARDURA</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051364-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006-04-0702</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>38</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ALOPECIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EAR PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUID INTAKE REDUCED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MIGRAINE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN JAW</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAINFUL DEFAECATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SELF-INJURIOUS IDEATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROAT IRRITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THYROID DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHEEZING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEG-INTRON</medicinalproduct>
        <drugdosagetext>SUBCUTANEOUS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050509</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060403</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RIBAVIRIN</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050509</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060403</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARDIZEM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAXALT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VICODIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LITHIUM CARBONATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PAROXETINE HYDROCHLORIDE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051365-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060630</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006051255</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>8</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>AGGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CRYING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG DISPENSING ERROR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCORRECT DOSE ADMINISTERED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
        <drugauthorizationnumb>19839</drugauthorizationnumb>
        <drugdosagetext>50 MG, 1 IN 1 D, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANXIETY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
        <drugauthorizationnumb>19839</drugauthorizationnumb>
        <drugdosagetext>50 MG, 1 IN 1 D, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OBSESSIVE-COMPULSIVE DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ADDERALL 10</medicinalproduct>
        <drugindication>ATTENTION DEFICIT/HYPERACTIVITY DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ADDERALL 10</medicinalproduct>
        <drugindication>PSYCHOMOTOR HYPERACTIVITY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051366-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060627</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006061755</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>0</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG LEVEL INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DETROL LA</medicinalproduct>
        <drugauthorizationnumb>21228</drugauthorizationnumb>
        <drugdosagetext>2 MG (2 MG), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEPAKOTE</medicinalproduct>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051367-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006058795</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>71</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>86.1834</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISTURBANCE IN ATTENTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRANSIENT ISCHAEMIC ATTACK</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEXTRA</medicinalproduct>
        <drugauthorizationnumb>21341</drugauthorizationnumb>
        <drugdosagetext>20 MG (20 MG, 1 IN 1 D)</drugdosagetext>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051368-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060626</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006065368</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>64</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>58.9676</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ATROPHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRANSIENT ISCHAEMIC ATTACK</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEXTRA</medicinalproduct>
        <drugauthorizationnumb>21341</drugauthorizationnumb>
        <drugdosagetext>20 MG</drugdosagetext>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugdosagetext>400 MG (200 MG, 2 IN 1 D)</drugdosagetext>
        <drugindication>OSTEOARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040419</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051369-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060626</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006066533</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>43</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>82.5547</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIAC DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GEODON</medicinalproduct>
        <drugauthorizationnumb>20825</drugauthorizationnumb>
        <drugdosagetext>160 MG (80 MG, 2 IN 1 D)</drugdosagetext>
        <drugindication>BIPOLAR I DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051001</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051370-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060626</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006073252</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>69</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>80.7403</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ARRHYTHMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ATRIAL FIBRILLATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLADDER OPERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIOMEGALY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DILATATION ATRIAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STRESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEXTRA</medicinalproduct>
        <drugauthorizationnumb>21341</drugauthorizationnumb>
        <drugindication>ARTHRALGIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE TAB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTIBIOTICS (ANTIBIOTICS)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETYLSALICYLIC ACID ENTERIC COATED (ACETYLSALICYLIC ACID)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051371-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060627</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006072695</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BACK DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIO-RESPIRATORY ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSED LEVEL OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIALYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LACTIC ACIDOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEURALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESUSCITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISONE TAB</medicinalproduct>
        <drugauthorizationnumb>9986</drugauthorizationnumb>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060410</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugdosagetext>150 MG (50 MG, 3 IN 1 D)</drugdosagetext>
        <drugindication>NEURALGIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060410</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060401</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060414</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOPHAGE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VICODIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</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>LISINOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASCORBIC ACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTIVITAMIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051374-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006RL000244</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>46</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>126.1</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OMACOR</medicinalproduct>
        <drugauthorizationnumb>21654</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060625</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OMACOR</medicinalproduct>
        <drugauthorizationnumb>21654</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060626</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060628</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLARITIN-D</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NICOTINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051375-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-2006-015467</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>88</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>RETINAL ARTERY OCCLUSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIRENA</medicinalproduct>
        <drugbatchnumb>53496C</drugbatchnumb>
        <drugauthorizationnumb>21225</drugauthorizationnumb>
        <drugdosagetext>20 UG/DAY, CONT, INTRA-UTERINE</drugdosagetext>
        <drugadministrationroute>015</drugadministrationroute>
        <drugindication>CONTRACEPTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060510</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060607</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051376-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060624</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-2006-002624</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>46</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>51</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BODY TEMPERATURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRONCHITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CLOSTRIDIUM DIFFICILE COLITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONJUNCTIVITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EFFECT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE ABSCESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE SCLEROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUSITIS</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>20011001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060602</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLINDAMYCIN</medicinalproduct>
        <drugindication>INJECTION SITE ABSCESS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DETROL - SLOW RELEASE (TOLTERODINE L-TARTRATE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CONTRAST MEDIA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DETROL - SLOW RELEASE (TOLTERODINE L-TARTRATE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051377-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050406</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-401254</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>6</patientonsetage>
      <patientonsetageunit>802</patientonsetageunit>
      <patientweight>3.1</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLACENTA PRAEVIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PREMATURE RUPTURE OF MEMBRANES</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COPEGUS</medicinalproduct>
        <drugauthorizationnumb>21511</drugauthorizationnumb>
        <drugadministrationroute>064</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040323</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040828</drugenddate>
        <drugtreatmentduration>159</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEGASYS</medicinalproduct>
        <drugadministrationroute>064</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040323</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040828</drugenddate>
        <drugtreatmentduration>159</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041011</drugenddate>
        <drugtreatmentduration>11</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ABILIFY</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041012</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041018</drugenddate>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KLONOPIN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041012</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041018</drugenddate>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCODONE HCL</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040926</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041004</drugenddate>
        <drugtreatmentduration>9</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040926</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041004</drugenddate>
        <drugtreatmentduration>9</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADVAIR DISKUS 100/50</medicinalproduct>
        <drugindication>ASTHMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040822</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL SPIROS</medicinalproduct>
        <drugindication>ASTHMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040822</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051379-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050331</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-400579</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>24</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>93.9</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAL SKIN TAGS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTERIOSCLEROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTERIOSCLEROSIS CORONARY ARTERY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHONDROMALACIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLON ADENOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLONIC POLYP</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CROHN'S DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DECREASED APPETITE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLANK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GROIN PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ILEITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLAMMATORY BOWEL DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IRRITABLE BOWEL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JOINT EFFUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LARGE INTESTINAL ULCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIGAMENT SPRAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MELANOCYTIC NAEVUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTI-ORGAN DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NIGHT BLINDNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SCAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNOVIAL CYST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL DISTURBANCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>18662</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ACNE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19890615</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19890615</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>018662</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19930315</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19930816</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>018662</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19931103</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19940415</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>018662</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19960109</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>018662</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19961015</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>018662</drugauthorizationnumb>
        <drugdosagetext>3RD COURSE.</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19970115</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19970415</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>018662</drugauthorizationnumb>
        <drugdosagetext>DAILY FOR ONE MONTH [EST. JUL1997],</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19970616</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19970715</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>018662</drugauthorizationnumb>
        <drugdosagetext>40 MG/D ON MONDAY, WEDNESDAY AND FRIDAY.</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19970715</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19971215</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>018662</drugauthorizationnumb>
        <drugdosagetext>40 MG ONCE DAILY ON MONDAY, WEDNESDAY AND FRIDAY.</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010102</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>018662</drugauthorizationnumb>
        <drugdosagetext>DOSE IS INCREASED TO ACCUTANE 40 MG ONCE DAILY FOR 3 MONTHS [EST. END APR2001].</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010102</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010415</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>018662</drugauthorizationnumb>
        <drugdosagetext>TAKEN ONCE EVERY THREE TO FIVE DAYS AS NECESSARY.</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010423</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>018662</drugauthorizationnumb>
        <drugdosagetext>ACCUTANE 40 MG/DAY ON MONDAY, WEDNESDAY AND FRIDAY.</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020408</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>018662</drugauthorizationnumb>
        <drugdosagetext>EVERY OTHER DAY FOR 1-2 WEEKS AS NEEDED.</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020611</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>018662</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040419</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>018662</drugauthorizationnumb>
        <drugdosagetext>STRENGTH. 40 MG.</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051031</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BACTRIM DS</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19930119</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RETIN-A</medicinalproduct>
        <drugadministrationroute>061</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19930119</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANOXYL</medicinalproduct>
        <drugadministrationroute>061</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19930119</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BACTROBAN</medicinalproduct>
        <drugadministrationroute>061</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19940520</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENZAC 5</medicinalproduct>
        <drugadministrationroute>061</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19940520</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KENALOG-10</medicinalproduct>
        <drugdosagetext>IN JUL-92: PATIENT RECEIVED KENALOG IN ORABASE FOR APHTHOUS ULCERS.</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19940526</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19940526</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METROGEL</medicinalproduct>
        <drugadministrationroute>061</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19941123</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPECTAZOLE</medicinalproduct>
        <drugadministrationroute>061</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19941123</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIFLUCAN</medicinalproduct>
        <drugdosagetext>DOSAGE REGIMEN REPORTED AS: 200MG.</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19950814</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ERYTHROMYCIN</medicinalproduct>
        <drugindication>ACNE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19920728</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLEOCIN T</medicinalproduct>
        <drugindication>ACNE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19920728</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NIZORAL CREAM</medicinalproduct>
        <drugadministrationroute>061</drugadministrationroute>
        <drugindication>ACNE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19920728</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIDEX</medicinalproduct>
        <drugindication>ULCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19920728</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CIPRO</medicinalproduct>
        <drugdosagetext>RESTARTED ON 28 JUL 2004 FOR OTITIS EXTERNA.</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19960109</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BROMFED</medicinalproduct>
        <drugindication>EUSTACHIAN TUBE DYSFUNCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990218</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METAMUCIL</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19991008</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GAS-X</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19991008</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MYLANTA PLUS</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19991008</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GENERIC UNKNOWN</medicinalproduct>
        <drugdosagetext>TRADE NAME GIVEN AS: SITZ BATHS.</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010531</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KEFLEX</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010531</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTIBIOTICS NOS</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010621</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVAQUIN</medicinalproduct>
        <drugdosagetext>TAKEN PRIOR TO SURGERY ON 22 AUG-01.</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010817</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DURATUSS</medicinalproduct>
        <drugdosagetext>STOPPED AND RESTARTED IN 04 APR 2002.</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20011004</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZITHROMAX</medicinalproduct>
        <drugdosagetext>STOPPED AND RESTARTED IN 04 APR 2002 AND 18 AUG 2003.</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20011004</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENADRYL</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20011004</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TUSSIONEX</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020404</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOXYCYCLINE</medicinalproduct>
        <drugindication>SINUSITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020605</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORTAB</medicinalproduct>
        <drugindication>SINUSITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020605</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLEGRA</medicinalproduct>
        <drugindication>ALLERGIC SINUSITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030818</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
        <drugdosagetext>STOPPED AND RETAKEN ON 3 MAR 2005.</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041005</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SUDAFED 12 HOUR</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050504</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NIACIN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050105</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SEPTRA DS</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19890407</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19910919</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MOTRIN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19890407</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DESOWEN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19911125</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOPROX</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19911125</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACNE MEDICATION</medicinalproduct>
        <drugdosagetext>TRADE NAME: IL TAC.</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19971105</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CEPHALEXIN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030527</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030607</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051380-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041115</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-386394</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>20</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>88.5</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ALANINE AMINOTRANSFERASE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLINDNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CHOLESTEROL DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CHOLESTEROL INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIVERTICULITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIVERTICULUM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLANK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FOLLICULITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATOCHEZIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATOCRIT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHOIDS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HIGH DENSITY LIPOPROTEIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLAMMATORY BOWEL DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLUENZA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JOINT SPRAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOW DENSITY LIPOPROTEIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEAN CELL HAEMOGLOBIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENTAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEPHROLITHIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NERVE COMPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NIGHT BLINDNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OLIGURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARYNGITIS STREPTOCOCCAL</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 NODULE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISION BLURRED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL DISTURBANCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>18662</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ACNE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030210</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030325</drugenddate>
        <drugtreatmentduration>44</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>018662</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030325</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030422</drugenddate>
        <drugtreatmentduration>29</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>018662</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030422</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030610</drugenddate>
        <drugtreatmentduration>50</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTIBIOTIC</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CEPHALEXIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ACNE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030210</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051381-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050623</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-408899</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>18</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>77.1</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL DISTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ALOPECIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRUXISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COAGULOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLITIS ULCERATIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CROHN'S DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRY SKIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPEPSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EAR INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERUCTATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRIC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL MOTILITY DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROOESOPHAGEAL REFLUX DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATOCHEZIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHOIDS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ILEITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ILL-DEFINED DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLAMMATORY BOWEL DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTESTINAL OBSTRUCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IRON DEFICIENCY ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IRRITABLE BOWEL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIP DRY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTI-ORGAN DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NECK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OESOPHAGEAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RECTAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUSITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISION BLURRED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>18662</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ACNE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990803</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19990907</drugenddate>
        <drugtreatmentduration>36</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>018662</drugauthorizationnumb>
        <drugdosagetext>40MG AND 40MG BID ADMINISTERED ALTERNATE DAYS</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990907</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19991005</drugenddate>
        <drugtreatmentduration>29</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>018662</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19991005</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19991102</drugenddate>
        <drugtreatmentduration>29</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>018662</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19991102</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20000215</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051382-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060705</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>SE-ABBOTT-06P-150-0337867-00</companynumb>
    <primarysource>
      <reportercountry>SWEDEN</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>STATUS EPILEPTICUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VALPROIC ACID</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>018081</drugauthorizationnumb>
        <drugdosagetext>NOT REPORTED</drugdosagetext>
        <drugindication>CONVULSION PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VALPROIC ACID</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>018081</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051383-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060706</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>NL-ABBOTT-06P-114-0337664-00</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD CREATININE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD OSMOLARITY DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD SODIUM DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INAPPROPRIATE ANTIDIURETIC HORMONE SECRETION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEPAKENE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>018081</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>EPILEPSY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060317</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASASANTIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FENOBARBITAL PCH</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXAZEPAM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THYRAX DUOTAB</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOSARTAN POTASSIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RABEPRAZOLE SODIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SERETIDE</medicinalproduct>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051384-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060705</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>SE-ABBOTT-06P-150-0337869-00</companynumb>
    <primarysource>
      <reportercountry>SWEDEN</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>STATUS EPILEPTICUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VALPROIC ACID</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>018081</drugauthorizationnumb>
        <drugdosagetext>NOT REPORTED</drugdosagetext>
        <drugindication>CONVULSION PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VALPROIC ACID</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>018081</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051385-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060705</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>SE-ABBOTT-06P-150-0337870-00</companynumb>
    <primarysource>
      <reportercountry>SWEDEN</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>STATUS EPILEPTICUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VALPROIC ACID</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>018081</drugauthorizationnumb>
        <drugdosagetext>NOT REPORTED</drugdosagetext>
        <drugindication>CONVULSION PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VALPROIC ACID</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>018081</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051386-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060301</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-438849</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>18</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>60.8</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ATELECTASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE CONGESTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CROHN'S DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROOESOPHAGEAL REFLUX DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLAMMATORY BOWEL DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IRON DEFICIENCY ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLEURAL EFFUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUBCUTANEOUS ABSCESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>18662</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ACNE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19950911</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19960215</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051387-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060705</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-ABBOTT-06P-056-0337414-00</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>74</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH MACULO-PAPULAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWELLING FACE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZECLAR</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>50662</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PNEUMOCOCCAL INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060610</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060613</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051388-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060515</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-ABBOTT-06P-020-0333403-00</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>43</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>63</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROAT TIGHTNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KLARICID UD</medicinalproduct>
        <drugbatchnumb>35049QP</drugbatchnumb>
        <drugauthorizationnumb>50775</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ACUTE TONSILLITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060510</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060512</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>QUETIAPINE FUMARATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>AFFECTIVE DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051389-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060705</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>SE-ABBOTT-06P-150-0337865-00</companynumb>
    <primarysource>
      <reportercountry>SWEDEN</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>STATUS EPILEPTICUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VALPROIC ACID</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>018081</drugauthorizationnumb>
        <drugdosagetext>NOT REPORTED</drugdosagetext>
        <drugindication>CONVULSION PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VALPROIC ACID</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>018081</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051390-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060705</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-ABBOTT-06P-008-0337658-00</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>PNEUMONIA FUNGAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOSPORINE</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>065003</drugauthorizationnumb>
        <drugindication>PROPHYLAXIS AGAINST TRANSPLANT REJECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PROPHYLAXIS AGAINST TRANSPLANT REJECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>ON DAYS 3, 6, +/- 11</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MYCOPHENOLATE MOFETIL</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugindication>PROPHYLAXIS AGAINST TRANSPLANT REJECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MYCOPHENOLATE MOFETIL</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>REDUCING TO 0 OVER 30 DAYS</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BACTRIM</medicinalproduct>
        <drugindication>ANTIBIOTIC PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUCONAZOLE</medicinalproduct>
        <drugdosagetext>EITHER INTRAVENOUSLY OR ORALLY</drugdosagetext>
        <drugindication>ANTIFUNGAL PROPHYLAXIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051391-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060705</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ES-ABBOTT-06P-144-0337442-00</companynumb>
    <primarysource>
      <reportercountry>SPAIN</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>48</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BACTERIAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ENDOPHTHALMITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROCEDURAL COMPLICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROPIONIBACTERIUM INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>NOT REPORTED</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEFLUNOMIDE</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>NOT REPORTED</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugdosagetext>NOT REPORTED</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051392-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060706</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-ABBOTT-06P-056-0337678-00</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>2</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>TARKA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020591</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19960101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051393-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060706</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006AP03109</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>15920</patientonsetage>
      <patientonsetageunit>804</patientonsetageunit>
      <patientweight>98</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>EYE ROLLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POST PROCEDURAL COMPLICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROPOFOL</medicinalproduct>
        <drugauthorizationnumb>019627</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>GENERAL ANAESTHESIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060321</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIDAZOLAM HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>GENERAL ANAESTHESIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALFENTANIL</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>GENERAL ANAESTHESIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060321</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MORPHINE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060321</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYRTEC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CO-PHENYLCAINE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060321</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SEVOFLURANE</medicinalproduct>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>GENERAL ANAESTHESIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060321</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LAMISIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051394-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060705</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>SE-ABBOTT-06P-150-0337871-00</companynumb>
    <primarysource>
      <reportercountry>SWEDEN</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STATUS EPILEPTICUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VALPROIC ACID</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>018081</drugauthorizationnumb>
        <drugdosagetext>NOT REPORTED</drugdosagetext>
        <drugindication>CONVULSION PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VALPROIC ACID</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>018081</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051395-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060619</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006AP02846</companynumb>
    <primarysource>
      <reportercountry>THAILAND</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>42</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>58</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BRADYARRHYTHMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EXTRASYSTOLES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROCEDURAL COMPLICATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MARCAINE</medicinalproduct>
        <drugbatchnumb>G12358</drugbatchnumb>
        <drugauthorizationnumb>70553</drugauthorizationnumb>
        <drugadministrationroute>037</drugadministrationroute>
        <drugindication>HYSTERECTOMY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060605</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060605</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MARCAINE</medicinalproduct>
        <drugbatchnumb>G12358</drugbatchnumb>
        <drugauthorizationnumb>070553</drugauthorizationnumb>
        <drugadministrationroute>037</drugadministrationroute>
        <drugindication>APPENDICECTOMY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060605</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060605</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MARCAINE</medicinalproduct>
        <drugbatchnumb>G12358</drugbatchnumb>
        <drugauthorizationnumb>070553</drugauthorizationnumb>
        <drugadministrationroute>037</drugadministrationroute>
        <drugindication>CAESAREAN SECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060605</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060605</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MORPHINE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ANALGESIC EFFECT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060605</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060605</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051396-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060705</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-ABBOTT-06P-008-0337657-00</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>BACTERIAL SEPSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOSPORINE</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>065003</drugauthorizationnumb>
        <drugindication>PROPHYLAXIS AGAINST TRANSPLANT REJECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PROPHYLAXIS AGAINST TRANSPLANT REJECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>ON DAYS 3, 6, +/- 11</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MYCOPHENOLATE MOFETIL</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugindication>PROPHYLAXIS AGAINST TRANSPLANT REJECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MYCOPHENOLATE MOFETIL</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>REDUCING TO 0 OVER 30 DAYS</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BACTRIM</medicinalproduct>
        <drugindication>ANTIBIOTIC PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUCONAZOLE</medicinalproduct>
        <drugdosagetext>EITHER INTRAVENOUSLY OR ORALLY</drugdosagetext>
        <drugindication>ANTIFUNGAL PROPHYLAXIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051397-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060705</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-ABBOTT-06P-008-0337458-00</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>BACTERIAL SEPSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOSPORINE</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>065003</drugauthorizationnumb>
        <drugindication>PROPHYLAXIS AGAINST TRANSPLANT REJECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PROPHYLAXIS AGAINST TRANSPLANT REJECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>ON DAYS 3, 6, +/- 11</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MYCOPHENOLATE MOFETIL</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugindication>PROPHYLAXIS AGAINST TRANSPLANT REJECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MYCOPHENOLATE MOFETIL</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>REDUCING TO 0 OVER 30 DAYS</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BACTRIM</medicinalproduct>
        <drugindication>ANTIBIOTIC PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUCONAZOLE</medicinalproduct>
        <drugdosagetext>EITHER INTRAVENOUSLY OR ORALLY</drugdosagetext>
        <drugindication>ANTIFUNGAL PROPHYLAXIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051398-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060531</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006AP02516</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>79</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANGINA PECTORIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY STENOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MARCAINE</medicinalproduct>
        <drugauthorizationnumb>71202</drugauthorizationnumb>
        <drugadministrationroute>037</drugadministrationroute>
        <drugindication>SPINAL ANAESTHESIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FENTANYL CITRATE</medicinalproduct>
        <drugdosagetext>GIVEN AFTER MARCAIN STARTED BEFORE EVENT DEVELOPED</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>STARTED 20 YEARS AGO, STOPPED 7 DAYS BEFORE TRANSURETHRAL URETERO LITHTRIPSY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CALCULUS URETERIC</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051399-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060712</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006CG01222</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>25</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>SUDDEN DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TENORMIN</medicinalproduct>
        <drugauthorizationnumb>018240</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTROPHIC CARDIOMYOPATHY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060706</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CORGARD</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTROPHIC CARDIOMYOPATHY</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060701</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051400-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060619</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006UW13874</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>803</patientonsetage>
      <patientonsetageunit>802</patientonsetageunit>
      <patientweight>84.5</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD CREATINE PHOSPHOKINASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHOKING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GINGIVAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GLOSSODYNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugbatchnumb>1226</drugbatchnumb>
        <drugauthorizationnumb>21366</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060201</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALTACE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADVIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051401-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060706</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006UW14189</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>758</patientonsetage>
      <patientonsetageunit>802</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD BILIRUBIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EFFECT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FASLODEX</medicinalproduct>
        <drugbatchnumb>CW793</drugbatchnumb>
        <drugauthorizationnumb>21344</drugauthorizationnumb>
        <drugdosagetext>250 MG X 2</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060510</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060614</drugenddate>
        <drugtreatmentduration>36</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GABAPENTIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RANITIDINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051402-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060705</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-454427</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>61</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD ELECTROLYTES DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD THYROID STIMULATING HORMONE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSGEUSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIP DRY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEGASYS</medicinalproduct>
        <drugdosagetext>ROUTE REPORTED AS INJECTABLE. PATIENT WAS OFF THERAPY FOR TEN DAYS.</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060426</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEGASYS</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RIBAVIRIN</medicinalproduct>
        <drugauthorizationnumb>021511</drugauthorizationnumb>
        <drugdosagetext>PATIENT WAS OFF THERAPY FOR TEN DAYS.</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060426</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RIBAVIRIN</medicinalproduct>
        <drugauthorizationnumb>021511</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPOTHYROIDISM</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALDACTONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060615</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051403-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060705</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-454396</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>RESORPTION BONE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BONIVA</medicinalproduct>
        <drugauthorizationnumb>021455</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051404-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060706</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-454548</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BONIVA</medicinalproduct>
        <drugauthorizationnumb>021455</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051405-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20051103</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-423644</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>16</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>86.2</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANHEDONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANKLE FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ATROPHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CAPILLARY DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CLAVICLE FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CROHN'S DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EXOSTOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FAECES DISCOLOURED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLAMMATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLAMMATORY BOWEL DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUCOUS MEMBRANE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NASAL SEPTUM DEVIATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RECTAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WRIST FRACTURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>18662</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19850615</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19850615</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051406-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060706</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-2006-005106</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>45</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TEMPOROMANDIBULAR JOINT SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLIMARA</medicinalproduct>
        <drugauthorizationnumb>20375</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>MENOPAUSAL SYMPTOMS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060222</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ESTROGEN NOS (MYLAN PHARMACEUTICALS)(ESTROGEN NOS) PATCH</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051407-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060623</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-2006-016706</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>51</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>EYE HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA FACIAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISION BLURRED</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>20060109</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051409-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060626</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006AP000478</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>54</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE SYSTOLIC INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHROPSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE OPERATION COMPLICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SCAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREATMENT NONCOMPLIANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISION BLURRED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VITREOUS FLOATERS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TERAZOSIN HCL CAPSULES (1 MG)</medicinalproduct>
        <drugauthorizationnumb>75498</drugauthorizationnumb>
        <drugdosagetext>1 MG;HS;PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060623</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060626</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GUANFACINE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVAPRO</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051410-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050829</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-416080</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>21</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>95.3</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABSCESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANHEDONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ATELECTASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ATRIOVENTRICULAR BLOCK FIRST DEGREE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLINDNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CHOLESTEROL INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD TRIGLYCERIDES INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRONCHITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLITIS ULCERATIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CUSHINGOID</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ECONOMIC PROBLEM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRIC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GRANULOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAND FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC STEATOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOVENTILATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ILEUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ILIOTIBIAL BAND SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLAMMATORY BOWEL DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IRRITABLE BOWEL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LABYRINTHITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MELANOCYTIC NAEVUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTI-ORGAN DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEPHROLITHIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NOCTURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCREATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PILONIDAL CYST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLEURITIC PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUSITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STRESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TONSILLECTOMY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRAUMATIC FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UPPER RESPIRATORY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VERTIGO</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WOUND</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>18662</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ACNE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19860715</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19861115</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ASACOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19940609</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051411-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040115</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-356278</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>12</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>65.8</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL DISTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABSCESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AGITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AGNOSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ALOPECIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAEMIA MEGALOBLASTIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAL FISSURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AORTIC VALVE INCOMPETENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRITIS BACTERIAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AUTOIMMUNE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BENIGN INTRACRANIAL HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CHOLESTEROL INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD URIC ACID INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CELLULITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBELLAR INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CERVICOBRACHIAL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHROMATURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CITROBACTER INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLITIS ULCERATIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CUSHING'S SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CUSHINGOID</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CYST RUPTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CYSTITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CYSTITIS HAEMORRHAGIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DERMAL CYST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DERMOID CYST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISEASE RECURRENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSMENORRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSTHYMIC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ELECTROENCEPHALOGRAM ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ENCOPRESIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ENDOMETRIOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GLUCOSE URINE PRESENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOLYTIC ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HALLUCINATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HERPES SIMPLEX</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ILL-DEFINED DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLAMMATORY BOWEL DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERVERTEBRAL DISC DEGENERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IRRITABLE BOWEL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JOINT SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVEDO RETICULARIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUPUS NEPHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MASS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEGACOLON</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEMORY IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENTAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MITRAL VALVE INCOMPETENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOUTH ULCERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOPIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NASAL DRYNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEPHROPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NERVOUS SYSTEM DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NITRITE URINE PRESENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORTHOPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOMYELITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCREATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCYTOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERICARDIAL EFFUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARYNGOLARYNGEAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POLYP</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROTEIN URINE PRESENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSEUDOMENINGOCELE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RECTAL TENESMUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUSITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STAPHYLOCOCCAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYSTEMIC LUPUS ERYTHEMATOSUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TEMPERATURE INTOLERANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TENDERNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THINKING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRICUSPID VALVE INCOMPETENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UPPER RESPIRATORY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URETHRAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URETHRAL POLYP</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINE KETONE BODY PRESENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINE LEUKOCYTE ESTERASE POSITIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UROBILIN URINE PRESENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UROGENITAL PROLAPSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VAGINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VASCULITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VIRAL PHARYNGITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VULVOVAGINAL MYCOTIC INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEGENER'S GRANULOMATOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>18662</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19961229</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19970221</drugenddate>
        <drugtreatmentduration>55</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051412-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050928</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-419570</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>21</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>101.2</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABSCESS INTESTINAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANHEDONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLITIS ULCERATIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLONIC POLYP</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EFFECT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATOCRIT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HERPES SIMPLEX</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOKALAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLAMMATORY BOWEL DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IRRITABLE BOWEL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEUKOCYTOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUCOSAL ULCERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERSONALITY DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARYNGITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROCTITIS ULCERATIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RECTAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RED BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUSITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPONDYLOLYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STRESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNOVIAL CYST</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>18662</drugauthorizationnumb>
        <drugdosagetext>ADMINISTERED IN THE EVENINGS.</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ACNE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19960312</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19960815</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ERYTHROMYCIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ACNE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19960507</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19960703</drugenddate>
        <drugtreatmentduration>58</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051413-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060705</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>SE-ABBOTT-06P-150-0337868-00</companynumb>
    <primarysource>
      <reportercountry>SWEDEN</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>STATUS EPILEPTICUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VALPROIC ACID</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>018081</drugauthorizationnumb>
        <drugdosagetext>NOT REPORTED</drugdosagetext>
        <drugindication>CONVULSION PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VALPROIC ACID</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>018081</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051414-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060705</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-ABBOTT-06P-008-0337656-00</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>BACTERIAL SEPSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOSPORINE</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>065003</drugauthorizationnumb>
        <drugindication>PROPHYLAXIS AGAINST TRANSPLANT REJECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PROPHYLAXIS AGAINST TRANSPLANT REJECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>ON DAYS 3, 6, +/- 11</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MYCOPHENOLATE MOFETIL</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugindication>PROPHYLAXIS AGAINST TRANSPLANT REJECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MYCOPHENOLATE MOFETIL</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>REDUCING TO 0 OVER 30 DAYS</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BACTRIM</medicinalproduct>
        <drugindication>ANTIBIOTIC PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUCONAZOLE</medicinalproduct>
        <drugdosagetext>EITHER INTRAVENOUSLY OR ORALLY</drugdosagetext>
        <drugindication>ANTIFUNGAL PROPHYLAXIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051415-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060706</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CO-ABBOTT-06P-036-0337740-00</companynumb>
    <primarysource>
      <reportercountry>COLOMBIA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>74</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>47.8</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZEMPLAR</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020819</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>HYPERPARATHYROIDISM SECONDARY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060522</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZEMPLAR</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020819</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060406</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060522</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRAZOSIN HCL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060606</drugenddate>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060606</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060606</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
        <drugindication>CORONARY ARTERY DISEASE</drugindication>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENALAPRIL MALEATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19970101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060606</drugenddate>
        <drugtreatmentduration>9</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENALAPRIL MALEATE</medicinalproduct>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugtreatmentduration>9</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM CARBONATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERPARATHYROIDISM SECONDARY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060606</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EPOGEN</medicinalproduct>
        <drugdosagetext>8000 UNITS PER WEEK</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>ANAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060606</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANAEMIA PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060606</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NIFEDIPINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060606</drugenddate>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RENAL FAILURE CHRONIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060606</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVASTATIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DYSLIPIDAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060606</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051416-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060705</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>SE-ABBOTT-06P-150-0337459-00</companynumb>
    <primarysource>
      <reportercountry>SWEDEN</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>STATUS EPILEPTICUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STILLBIRTH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VALPROIC ACID</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>018081</drugauthorizationnumb>
        <drugdosagetext>DECREASED DOSE</drugdosagetext>
        <drugindication>CONVULSION PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VALPROIC ACID</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>018081</drugauthorizationnumb>
        <drugdosagetext>NOT REPORTED</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051417-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060707</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006SE03826</companynumb>
    <primarysource>
      <reportercountry>SOUTH AFRICA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MYOCLONIC EPILEPSY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARALYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRANSIENT ISCHAEMIC ATTACK</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIPRIVAN</medicinalproduct>
        <drugauthorizationnumb>019627</drugauthorizationnumb>
        <drugindication>SEDATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051418-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnesscongenitalanomali>1</seriousnesscongenitalanomali>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060705</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006UW13922</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>23631</patientonsetage>
      <patientonsetageunit>804</patientonsetageunit>
      <patientweight>82.5</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JAUNDICE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCREATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IRESSA</medicinalproduct>
        <drugauthorizationnumb>021399</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>METASTATIC NEOPLASM</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060517</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060602</drugenddate>
        <drugtreatmentduration>17</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREVACID</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTROOESOPHAGEAL REFLUX DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051419-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060113</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-432363</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>15</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>52.2</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRONCHITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEILITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CLOSTRIDIUM DIFFICILE TOXIN TEST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CLOSTRIDIUM DIFFICILE TOXIN TEST POSITIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLITIS ULCERATIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONJUNCTIVITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CROHN'S DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRY EYE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPEPSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ECZEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EPISTAXIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALSE POSITIVE LABORATORY RESULT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GRANULOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMANGIOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HERPES SIMPLEX</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLAMMATORY BOWEL DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFUSION RELATED REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIP DRY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIPOMA EXCISION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MASS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MELANOCYTIC NAEVUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NASAL CONGESTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OCULAR HYPERAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PEPTIC ULCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARYNGOLARYNGEAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN LACERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN PAPILLOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN STRIAE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOFT TISSUE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINE KETONE BODY PRESENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINE LEUKOCYTE ESTERASE POSITIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>18662</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19970113</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19970408</drugenddate>
        <drugtreatmentduration>86</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>018662</drugauthorizationnumb>
        <drugdosagetext>ACCUTANE INCREASED TO 80MG EVERY THIRD DAY.</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19970408</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19970509</drugenddate>
        <drugtreatmentduration>32</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>018662</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19970711</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19970810</drugenddate>
        <drugtreatmentduration>31</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>018662</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980223</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19980325</drugenddate>
        <drugtreatmentduration>31</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>018662</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980727</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19980923</drugenddate>
        <drugtreatmentduration>59</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>018662</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20001211</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010215</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>018662</drugauthorizationnumb>
        <drugdosagetext>05 FEBRUARY 2001: NOTED PATIENT IS ON ACCUTANE.</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>018662</drugauthorizationnumb>
        <drugdosagetext>40MG ONCE DAILY ALTERNATING WITH 80MG EVERY THIRD DAY.</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030902</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030930</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>018662</drugauthorizationnumb>
        <drugdosagetext>40MG ONCE DAILY ALTERNATING WITH 80MG EVERY THIRD DAY.</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040107</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLARAVIS</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPECTAZOLE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20001226</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DERMATOP</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20001226</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051420-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050928</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-419573</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>13</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>52.2</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANOREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BREAST MASS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLITIS ULCERATIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CROHN'S DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EMOTIONAL DISTRESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FAECAL FAT INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRIC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GYNAECOMASTIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATOCRIT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC ENZYME INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMPAIRED WORK ABILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLAMMATORY BOWEL DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IRRITABLE BOWEL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MONOCYTE PERCENTAGE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NASOPHARYNGITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OCCULT BLOOD POSITIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALLOR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANIC ATTACK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARYNGEAL ULCERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARYNGITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARYNGOLARYNGEAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRODUCTIVE COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSEUDOPOLYP</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RECTAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RED BLOOD CELL SEDIMENTATION RATE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUSITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN LESION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROAT LESION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTH ABSCESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ULCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URTICARIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHEEZING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>18662</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19940815</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19940915</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>018662</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980115</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19980615</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>018662</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980815</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19990915</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>018662</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021115</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030415</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051421-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20051121</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-425888</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>54</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN LOWER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CATARACT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHROMATURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DECREASED APPETITE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG WITHDRAWAL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HOMICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IRRITABILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENTAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVARIAN DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSYCHIATRIC SYMPTOM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEGASYS</medicinalproduct>
        <drugdosagetext>ROUTE REPORTD AS INJECTABLE.</drugdosagetext>
        <drugadministrationroute>050</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050424</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060615</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COPEGUS</medicinalproduct>
        <drugauthorizationnumb>021511</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050424</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060615</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051422-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060707</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-454873</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>64</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>113.4</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>NEOPLASM MALIGNANT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SALIVARY GLAND CANCER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XENICAL</medicinalproduct>
        <drugauthorizationnumb>020766</drugauthorizationnumb>
        <drugdosagetext>OTHER INDICATION WEIGHT LOSS</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OBESITY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010615</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010615</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051423-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060614</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHFR2006GB01983</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>39</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALLOR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZARIL</medicinalproduct>
        <drugauthorizationnumb>19758</drugauthorizationnumb>
        <drugdosagetext>225MG/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060524</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060629</drugenddate>
        <drugtreatmentduration>53280</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CHLORPROMAZINE</medicinalproduct>
        <drugdosagetext>100MG/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALPROATE SODIUM</medicinalproduct>
        <drugdosagetext>1000MG/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugdosagetext>20MG/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROCYCLIDINE HYDROCHLORIDE 2MG TAB</medicinalproduct>
        <drugdosagetext>5MG/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>EXTRAPYRAMIDAL DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051424-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041027</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-384554</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>20</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>65.8</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABORTION THREATENED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAESTHETIC COMPLICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLISTER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CHOLESTEROL INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD TRIGLYCERIDES INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BREAST MASS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BREAST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CAESAREAN SECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COAGULOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLITIS ULCERATIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CROHN'S DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CYST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DERMATITIS CONTACT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRY SKIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ECZEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FORAMEN MAGNUM STENOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROENTERITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGIC CYST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEAD INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERLIPIDAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCISION SITE COMPLICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCISION SITE OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLAMMATORY BOWEL DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERNAL INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERVERTEBRAL DISC DEGENERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IRRITABLE BOWEL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JOINT INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOW DENSITY LIPOPROTEIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENOMETRORRHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MIGRAINE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTI-ORGAN DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL STIFFNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NASOPHARYNGITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVARIAN CYST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHOTOPHOBIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLANTAR FASCIITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PREGNANCY ON ORAL CONTRACEPTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RECTAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SCAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SCOLIOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE VASOVAGAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TENDERNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VAGINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISION BLURRED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>18662</drugauthorizationnumb>
        <drugdosagetext>DOSAGE REGIMEN: EVERY DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19991206</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20000515</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MINOCYCLINE HCL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19991206</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ORTHO CYCLEN-28</medicinalproduct>
        <drugdosagetext>DRUG NAME REPORTED AS ORTHO TRI-CYCLEN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051425-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060504</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2006US05861</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>22</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>67.12</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABNORMAL BEHAVIOUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AMNESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANOREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INAPPROPRIATE AFFECT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCOHERENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERSONALITY CHANGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXJADE</medicinalproduct>
        <drugauthorizationnumb>21882</drugauthorizationnumb>
        <drugdosagetext>1500 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD IRON INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060202</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060401</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXJADE</medicinalproduct>
        <drugauthorizationnumb>021882</drugauthorizationnumb>
        <drugdosagetext>UNK, UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060502</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060601</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051426-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060630</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2006BR09973</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>42</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>77</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ILLUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SURGERY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEPONEX</medicinalproduct>
        <drugauthorizationnumb>19758</drugauthorizationnumb>
        <drugdosagetext>250 MG/D</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051201</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051427-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060517</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHFR2006GB01767</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>38</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOWER RESPIRATORY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE SCLEROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERICARDITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLEURAL EFFUSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZARIL</medicinalproduct>
        <drugauthorizationnumb>19758</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030812</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051428-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060608</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHNU2006DE02250</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>42</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>74</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ELECTROENCEPHALOGRAM ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPHIL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SALIVARY HYPERSECRETION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LAMOTRIGINE</medicinalproduct>
        <drugdosagetext>UNK, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SOLIAN</medicinalproduct>
        <drugdosagetext>200 MG/DAY</drugdosagetext>
        <drugindication>SCHIZOPHRENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020216</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060531</drugenddate>
        <drugtreatmentduration>1566</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRUXAL</medicinalproduct>
        <drugdosagetext>150 MG/DAY</drugdosagetext>
        <drugindication>SCHIZOPHRENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060608</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIPIPERON</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIAZEPAM</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BELLADONNYSAT</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19930101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060618</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEPONEX</medicinalproduct>
        <drugauthorizationnumb>019758</drugauthorizationnumb>
        <drugdosagetext>UP TO 500 MG/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA, PARANOID TYPE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19930101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060618</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051429-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060704</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2006TH09911</companynumb>
    <primarysource>
      <reportercountry>THAILAND</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>66</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD SODIUM DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATOCRIT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPONATRAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRILEPTAL</medicinalproduct>
        <drugauthorizationnumb>021014</drugauthorizationnumb>
        <drugdosagetext>150 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NEURALGIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060621</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060624</drugenddate>
        <drugtreatmentduration>5760</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRILEPTAL</medicinalproduct>
        <drugauthorizationnumb>021014</drugauthorizationnumb>
        <drugdosagetext>300 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060625</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060702</drugenddate>
        <drugtreatmentduration>11520</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM GLUCONATE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>N.A</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CEFTRIAXONE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLIBENCLAMIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PARIET</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLOXACILLIN SODIUM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PARAFOR-FORTE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051430-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060630</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006-07-0141</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>87.0906</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANOREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHILLS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPEPSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MIGRAINE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ONYCHOMADESIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PIGMENTATION DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEG-INTRON</medicinalproduct>
        <drugdosagetext>SUBCUTANEOUS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060218</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBETOL</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060218</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051431-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060630</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006-06-0907</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>52</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>71.2147</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARRHYTHMIA</reactionmeddrapt>
      </reaction>
      <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>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HUNGER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL INTAKE REDUCED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEG-INTRON</medicinalproduct>
        <drugdosagetext>SUBCUTANEOUS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060407</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RIBAVIRIN</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060407</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL AND HYDROCHLOROTHIAZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACTONEL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMBIEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPROL-XL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIGOXIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KLOR-CON</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051432-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060630</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006-07-0139</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>40</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>108.8633</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>KIDNEY INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MIDDLE INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEPHROLITHIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEG-INTRON</medicinalproduct>
        <drugdosagetext>SUBCUTANEOUS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RIBAVIRIN</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060401</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051433-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>06H-163-0308581-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>23</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEPRESSED LEVEL OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALLOR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MAGNESIUM SULFATE</medicinalproduct>
        <drugbatchnumb>37837</drugbatchnumb>
        <drugauthorizationnumb>20309</drugauthorizationnumb>
        <drugdosagetext>4 GM BOLUS THEN 3 GM/HR, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PRE-ECLAMPSIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060629</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060629</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051434-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>225576</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>14</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>59.1</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BRAIN NEOPLASM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEOPLASM RECURRENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRIMITIVE NEUROECTODERMAL TUMOUR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NUTROPIN</medicinalproduct>
        <drugauthorizationnumb>19676</drugauthorizationnumb>
        <drugdosagetext>0.67 ML, QDX6D/WK, SUBCUTANEOUS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>GROWTH HORMONE DEFICIENCY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19970103</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LUPRON</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COZAAR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROCARDIA</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051435-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060622</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>35693</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>CORNEAL OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ENDOPHTHALMITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POST PROCEDURAL COMPLICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PUPIL FIXED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WRONG TECHNIQUE IN DRUG USAGE PROCESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BSS PLUS</medicinalproduct>
        <drugauthorizationnumb>18469</drugauthorizationnumb>
        <drugindication>SURGERY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060614</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060614</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051436-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060614</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHRM2006FR01780</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>69</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD CHLORIDE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUID INTAKE RESTRICTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPONATRAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PELVIC PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRILEPTAL</medicinalproduct>
        <drugauthorizationnumb>21014</drugauthorizationnumb>
        <drugdosagetext>3 DF/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060505</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUDEX</medicinalproduct>
        <drugdosagetext>1 DF/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060505</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRIMETAZIDINE</medicinalproduct>
        <drugdosagetext>2 DF/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugdosagetext>1 DF/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LAROXYL</medicinalproduct>
        <drugdosagetext>50 MG/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRAVASTATIN</medicinalproduct>
        <drugdosagetext>20 MG/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
        <drugdosagetext>50 MG, QD</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MOTILIUM</medicinalproduct>
        <drugdosagetext>PRN</drugdosagetext>
        <drugindication>NAUSEA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051437-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060207</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2006US01763</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>52</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>56.235</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ACUTE SINUSITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ALANINE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAL DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASPARTATE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLISTER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD ALKALINE PHOSPHATASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD ALKALINE PHOSPHATASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CALCIUM DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD GASES ABNORMAL</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 SODIUM DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BODY TEMPERATURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CACHEXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLONOSCOPY ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DERMAL CYST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FACIAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL TUBE INSERTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATOCRIT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIFE SUPPORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG CARCINOMA CELL TYPE UNSPECIFIED RECURRENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPH NODE PALPABLE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALIGNANT NEOPLASM PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METASTASES TO CENTRAL NERVOUS SYSTEM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METASTASES TO LARGE INTESTINE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOUTH ULCERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NUCLEAR MAGNETIC RESONANCE IMAGING BRAIN ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PCO2 INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERIORBITAL OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROCTALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH ERYTHEMATOUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH PRURITIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>REFUSAL OF TREATMENT BY PATIENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEBACEOUS CYST EXCISION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUSITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN EXFOLIATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPUTUM PURULENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STOMATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TONGUE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOXIC EPIDERMAL NECROLYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VAGINAL DISCHARGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VULVAL ULCERATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRILEPTAL</medicinalproduct>
        <drugauthorizationnumb>21014</drugauthorizationnumb>
        <drugindication>CONVULSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030129</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030131</drugenddate>
        <drugtreatmentduration>4320</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DILANTIN</medicinalproduct>
        <drugindication>CONVULSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACYCLOVIR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NYSTATIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRIAMCINOLONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PEPCID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOCUSATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CEFTRIAXONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUCONAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GYNE-LOTRIMIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051438-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060622</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>35695</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>CORNEAL OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ENDOPHTHALMITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POST PROCEDURAL COMPLICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PUPIL FIXED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WRONG TECHNIQUE IN DRUG USAGE PROCESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BSS PLUS</medicinalproduct>
        <drugauthorizationnumb>18469</drugauthorizationnumb>
        <drugindication>SURGERY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060614</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060614</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051439-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060704</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2006TH09912</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>
      <reaction>
        <reactionmeddrapt>SKIN LESION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXJADE</medicinalproduct>
        <drugauthorizationnumb>021882</drugauthorizationnumb>
        <drugdosagetext>20 MG/KG/D</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD IRON INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060418</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INDERAL</medicinalproduct>
        <drugdosagetext>1 X 3</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051441-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060625</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006-144584-NL</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>72</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CLOSTRIDIUM DIFFICILE COLITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DELIRIUM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPONATRAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIRTAZAPINE</medicinalproduct>
        <drugauthorizationnumb>20415</drugauthorizationnumb>
        <drugdosagetext>7.5 MG DAILY ORAL, USED FOR 5 DAYS</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MAJOR DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CHOLESTYRAMINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROCHLORPERAZINE TAB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL SPIROS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VANCOMYCIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051442-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060627</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>226828</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>RECTAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RAPTIVA</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051443-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>225546</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>61</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>103.4</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PULMONARY FIBROSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RAPTIVA</medicinalproduct>
        <drugdosagetext>125 MG 1/WEEK INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PSORIASIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051444-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>226861</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>69</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PLEURAL EFFUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY CONGESTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RITUXAN</medicinalproduct>
        <drugdosagetext>INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MANTLE CELL LYMPHOMA</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060515</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051445-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060626</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>225176</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>81</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>59</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN LOWER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AORTIC STENOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AORTIC VALVE INCOMPETENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ATRIAL FIBRILLATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD LACTATE DEHYDROGENASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE DIASTOLIC INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ELECTROCARDIOGRAM T WAVE ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLANK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTRACARDIAC THROMBUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LETHARGY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MITRAL VALVE INCOMPETENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL ISCHAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLEURAL EFFUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROTHROMBIN TIME PROLONGED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL ARTERY THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVASTIN</medicinalproduct>
        <drugdosagetext>5 MG/KG, Q2W, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLON CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060216</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUOROURACIL</medicinalproduct>
        <drugdosagetext>500 MG/M2, 1/WEEK, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLON CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060202</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEUCOVORIN CALCIUM</medicinalproduct>
        <drugdosagetext>500 MG/M2, 1/WEEK, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLON CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060202</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DECADRON</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANZEMET</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>B12 COMPLEX (CYANOCOBALAMIN, VITAMIN B COMPLEX)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANOXIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PACERONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PEPCID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KLONOPIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIAZEPAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMPICILLIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CENTRUM SILVER (MINERALS NOS, MULTIVITAMINS NOS)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IRON (IRON NOS)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORTAB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROTONIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTIBIOTIC</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051446-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060705</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>226138</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>48</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ENTEROVESICAL FISTULA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY ANASTOMOTIC LEAK</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVASTIN</medicinalproduct>
        <drugdosagetext>15 MG/KG, Q3W, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BLADDER CANCER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GEMCITABINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CISPLATIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051447-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060626</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>226149</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>74</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INAPPROPRIATE ANTIDIURETIC HORMONE SECRETION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVASTIN</medicinalproduct>
        <drugdosagetext>15 MG/KG, Q3W, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060302</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060419</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAXOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARBOPLATIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASTATIN CALCIUM)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SINGULAIR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XALATAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAZODONE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COMBIVENT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MINESTRIN (ETHINYL ESTRADIOL, NORETHINDRONE ACETATE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATIVAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALDACTONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARDIZEM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051449-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060626</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>225820</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>66</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>83.8</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIOVASCULAR DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISSEMINATED INTRAVASCULAR COAGULATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ECCHYMOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EMBOLISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMODIALYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOCALCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPONATRAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORBITAL OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL CYST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL TUBULAR NECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOTIC MICROANGIOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEVACIZUMAB OR PLACEBO(BEVACIZUMAB) PWDR + SOLVENT, INFUSION SOLN, 100</medicinalproduct>
        <drugdosagetext>15 MG/KG, Q3W, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PROSTATE CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060419</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060419</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOCETAXEL (DOCETAXEL)</medicinalproduct>
        <drugdosagetext>75 MG/M2, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PROSTATE CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060419</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060419</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISONE TAB</medicinalproduct>
        <drugdosagetext>5 MG, BID, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROSTATE CANCER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COZAAR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LUPRON</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OS-CAL (CALCIUM CARBONATE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051450-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060627</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>226555</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>68</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>63.9</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HAEMOPTYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OXYGEN SATURATION DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVASTIN</medicinalproduct>
        <drugbatchnumb>M58984</drugbatchnumb>
        <drugdosagetext>1009 MG, Q3W, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ELOXATIN</medicinalproduct>
        <drugbatchnumb>0580936</drugbatchnumb>
        <drugdosagetext>197 MG, Q3W, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALIMTA</medicinalproduct>
        <drugbatchnumb>ET000767</drugbatchnumb>
        <drugdosagetext>820 MG, Q3W, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVAPRO</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROTONIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRAVACHOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL INHALER (ALBUTEROL/ALBUTEROL SULFATE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NITROGLYCERIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XALATAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SONATA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYANOCOBALAMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051453-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060627</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006083445</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>69</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>63.5036</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROSTATIC OPERATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugauthorizationnumb>20702</drugauthorizationnumb>
        <drugdosagetext>20 MG (20 MG, 1 IN 1 D); UNKNOWN</drugdosagetext>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALL OTHER THERAPEUTIC PRODUCTS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOTREL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETYLSALICYLIC ACID SRT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ROXICET</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051454-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A021138</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>48</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ABDOMINAL INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AORTIC INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONTUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG TOXICITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOPNEUMOTHORAX</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEAD INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC TRAUMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ROAD TRAFFIC ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEDATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKULL FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUBARACHNOID HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THORACIC VERTEBRAL FRACTURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
        <drugauthorizationnumb>19839</drugauthorizationnumb>
        <drugdosagetext>150 MG (50 MG, 3 IN 1 D) ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SKELAN (CARISOPRODOL, PHENYLBUTAZONE CALCIUM)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VICODIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051455-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060627</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006070251</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>58</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>73.0291</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BALANCE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BREAST OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING DRUNK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROENTERITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ILL-DEFINED DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCREASED APPETITE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEURALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POLLAKIURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ROSACEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TENDON DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
        <drugauthorizationnumb>20235</drugauthorizationnumb>
        <drugdosagetext>UNKNOWN (100 MG, UNKNOWN) UNKN</drugdosagetext>
        <drugindication>NECK PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19980101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugdosagetext>25 MG (25 MG, 1 IN 1 D) UNKNOWN</drugdosagetext>
        <drugindication>NEURALGIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060503</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugindication>NEURALGIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROZAC</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PERCOCET</medicinalproduct>
        <drugindication>NEURALGIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROTONIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRINIVIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WELLBUTRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCITONIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VICODIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALL OTHER THERAPEUTIC PRODUCTS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051456-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006075890</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>57</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLEPHAROSPASM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OPTIC ISCHAEMIC NEUROPATHY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIAGRA</medicinalproduct>
        <drugauthorizationnumb>20895</drugauthorizationnumb>
        <drugdosagetext>UNKNOWN (100MG, UNKNOWN),</drugdosagetext>
        <drugindication>ERECTILE DYSFUNCTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVANDAMET</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZETIA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMBIEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACCUPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NASONEX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051457-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060627</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006074924</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>78</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>103.4201</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GROIN PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NECK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUSITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugauthorizationnumb>20702</drugauthorizationnumb>
        <drugdosagetext>10 MG (DAILY),</drugdosagetext>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060301</drugenddate>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETYLSALICYLIC ACID SRT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLEGRA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTIVITAMIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051458-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060608</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006073970</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>54</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>86.1834</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLISTER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMPAIRED WORK ABILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOCAL SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugauthorizationnumb>20998</drugauthorizationnumb>
        <drugdosagetext>200 MG (200 MG, 1 IN 1 D)</drugdosagetext>
        <drugindication>INTERVERTEBRAL DISC DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060603</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BISOPROLOL FUMARATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051459-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060626</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006076462</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>73</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>49.8957</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPEPSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROAT IRRITATION</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>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060606</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EVISTA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051460-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060626</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006080246</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </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>AMNESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSED LEVEL OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HANGOVER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVATIO</medicinalproduct>
        <drugauthorizationnumb>21845</drugauthorizationnumb>
        <drugdosagetext>60 MG (20 MG, 3 IN  1 D);</drugdosagetext>
        <drugindication>PULMONARY HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060620</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MONTELUKAST</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WELLBUTRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TERIPARATIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHADONE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BACLOFEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MOMETASONE FUROATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>STOOL SOFTENER (DOCUSATE SODIUM)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051462-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060706</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20060702219</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>COMPLETED SUICIDE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL OVERDOSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXTRA STRENGTH TYLENOL</medicinalproduct>
        <drugindication>SUICIDE ATTEMPT</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051463-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060710</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006AC01269</companynumb>
    <primarysource>
      <reportercountry>NETHERLANDS</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>22524</patientonsetage>
      <patientonsetageunit>804</patientonsetageunit>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUDDEN DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugauthorizationnumb>021366</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060302</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRAVASTATIN</medicinalproduct>
        <drugindication>ANGINA PECTORIS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060302</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TILDIEM</medicinalproduct>
        <drugindication>ANGINA PECTORIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19940101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETYL CARDIO</medicinalproduct>
        <drugindication>ANGINA PECTORIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19940101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051464-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060706</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006CG01170</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>CAUDA EQUINA SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NAROPIN</medicinalproduct>
        <drugauthorizationnumb>020533</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>ANAESTHESIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051465-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060418</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006AP01886</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>22947</patientonsetage>
      <patientonsetageunit>804</patientonsetageunit>
      <patientweight>61</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ALCOHOLISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISEASE RECURRENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugauthorizationnumb>21366</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERCHOLESTEROLAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060111</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060411</drugenddate>
        <drugtreatmentduration>91</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYANAMIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ALCOHOL POISONING</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CERCINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ALCOHOL POISONING</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051466-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060711</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006CG01209</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>26</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>COMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMIGORO</medicinalproduct>
        <drugauthorizationnumb>21231</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MIGRAINE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060625</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060625</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>JASMINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
        <drugindication>MIGRAINE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PARACETAMOL</medicinalproduct>
        <drugindication>MIGRAINE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051467-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060711</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006CG01210</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>71</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>76</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHOLESTASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CYTOLYTIC HEPATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH ERYTHEMATOUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugauthorizationnumb>021366</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERLIPIDAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060429</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060613</drugenddate>
        <drugtreatmentduration>46</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ESIDRIX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060429</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060613</drugenddate>
        <drugtreatmentduration>46</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COZAAR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060429</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060613</drugenddate>
        <drugtreatmentduration>46</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TEMERIT</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060613</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TEMERIT</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060614</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051468-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060707</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006GB01169</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>84</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EXERCISE TOLERANCE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEFT VENTRICULAR FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BICALUTAMIDE</medicinalproduct>
        <drugauthorizationnumb>20498</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROSTATE CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060527</drugenddate>
        <drugtreatmentduration>1242</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYPROTERONE ACETATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROSTATE CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060527</drugenddate>
        <drugtreatmentduration>1242</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BISOPROLOL FUMARATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FERROUS SULFATE TAB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OLMESARTAN MEDOXOMIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRONOLACTONE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051469-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060710</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006GB01183</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>70</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMODIALYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LACTIC ACIDOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugauthorizationnumb>019777</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060416</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS NON-INSULIN-DEPENDENT</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060416</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GOUT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000617</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060416</drugenddate>
        <drugtreatmentduration>2130</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060416</drugenddate>
        <drugtreatmentduration>1751</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATORVASTATIN CALCIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20011001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060416</drugenddate>
        <drugtreatmentduration>1659</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BISOPROLOL FUMARATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060416</drugenddate>
        <drugtreatmentduration>746</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BISOPROLOL FUMARATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>TACHYARRHYTHMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060416</drugenddate>
        <drugtreatmentduration>746</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOXAZOSIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060416</drugenddate>
        <drugtreatmentduration>563</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SILDENAFIL CITRATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ERECTILE DYSFUNCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060416</drugenddate>
        <drugtreatmentduration>320</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051470-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060705</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006UW14199</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>56</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>131.5</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CATHETER RELATED COMPLICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTRAVENOUS CATHETER MANAGEMENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MERREM</medicinalproduct>
        <drugbatchnumb>LK0118</drugbatchnumb>
        <drugauthorizationnumb>050706</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>POSTOPERATIVE WOUND INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060704</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VANCOMYCIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>POSTOPERATIVE WOUND INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060704</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GENTAMICIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>POSTOPERATIVE WOUND INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050624</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051471-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060712</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006UW14344</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugauthorizationnumb>020639</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051473-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060620</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US200606004631</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugbatchnumb>FF5X10A</drugbatchnumb>
        <drugauthorizationnumb>21318</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051474-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060620</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US200606004667</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>71</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CONTUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY OCCLUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugauthorizationnumb>21318</drugauthorizationnumb>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARDIZEM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NITROGLYCERIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>QUININE SULFATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NITROSTAT</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051476-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060620</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US200606004666</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLINDNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARCINOMA IN SITU OF EYE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MACULAR DEGENERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RETINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugauthorizationnumb>21318</drugauthorizationnumb>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051477-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060620</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US200606004644</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>DIALYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EMBOLISM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugauthorizationnumb>21318</drugauthorizationnumb>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051479-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060620</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US200606005019</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>77</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugbatchnumb>FF5X21A</drugbatchnumb>
        <drugauthorizationnumb>21318</drugauthorizationnumb>
        <drugindication>OSTEOPOROSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051480-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060620</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US200606005039</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>73</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugauthorizationnumb>21318</drugauthorizationnumb>
        <drugdosagetext>20 UG</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060612</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENICAR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENADRYL    (AMMONIUM CHLORIDE, DIPHENHYDRAMINE HYDROCHLORIDE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM GLUCONATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIAZEPAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KEFLEX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051481-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060620</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US200606004674</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUROPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESTLESS LEGS SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STENT PLACEMENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugauthorizationnumb>21318</drugauthorizationnumb>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREGABALIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051482-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060620</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US200605004095</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>89.3</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE CONGESTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIABETES MELLITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL ISCHAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
        <drugauthorizationnumb>20592</drugauthorizationnumb>
        <drugdosagetext>10 MG ; 20MG</drugdosagetext>
        <drugindication>ANXIETY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040601</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
        <drugauthorizationnumb>20592</drugauthorizationnumb>
        <drugdosagetext>10 MG ; 20MG</drugdosagetext>
        <drugindication>ANXIETY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040501</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051483-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060701</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006-05-1546</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>51</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CELLULITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JAUNDICE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RED BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEG-INTRON</medicinalproduct>
        <drugdosagetext>SUBCUTANEOUS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060429</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060501</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RIBAVIRIN</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060429</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060501</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
        <drugdosagetext>10 MG ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEORAL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM/VITAMIN D TABLETS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELLCEPT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGNESIUM OXIDE TABLETS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>URSODEOXYCHOLIC ACID CAPSULES</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROTONIX (PANTOPRAZOLE SODIUM) EXTENDED RELEASE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051484-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060706</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>S06-USA-02080-01</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>74</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCISIONAL HERNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPHOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEOPLASM RECURRENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERIPHERAL ARTERY ANEURYSM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY RETENTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NAMENDA</medicinalproduct>
        <drugauthorizationnumb>21487</drugauthorizationnumb>
        <drugdosagetext>10 MG BID; PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>AMNESIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NAMENDA</medicinalproduct>
        <drugdosagetext>5 MG QD; PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>AMNESIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NAMENDA</medicinalproduct>
        <drugdosagetext>5 MG BID; PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>AMNESIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NAMENDA</medicinalproduct>
        <drugdosagetext>15 MG QD; PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>AMNESIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051485-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060630</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>S06-USA-02125-01</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>83</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANOREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORTHOSTATIC HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THERAPEUTIC AGENT TOXICITY</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>20060518</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIGOXIN</medicinalproduct>
        <drugdosagetext>0.25 MG; QD</drugdosagetext>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIGOXIN</medicinalproduct>
        <drugdosagetext>0.125 MG, TIW</drugdosagetext>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX (FUROSEMEIDE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAMOXIFEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051486-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>163-21880-06050167</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>76</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>CARDIAC DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugauthorizationnumb>21880</drugauthorizationnumb>
        <drugdosagetext>10 MG DAILY ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MYELODYSPLASTIC SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060407</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060401</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051487-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060630</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>S06-USA-02488-01</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>69</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DIABETES MELLITUS NON-INSULIN-DEPENDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EXTRASYSTOLES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>THYROID TAB</medicinalproduct>
        <drugbatchnumb>110501</drugbatchnumb>
        <drugdosagetext>75 MG QD; PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPOTHYROIDISM</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENAZEPRIL HYDROCHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DYAZIDE (TRIAMTERENE/HYDROCHLOROTHIAZIDE)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051488-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060707</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>S06-USA-02081-01</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>46</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>136.0791</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GUN SHOT WOUND</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HALLUCINATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCREASED INSULIN REQUIREMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSYCHOTIC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDE ATTEMPT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY RETENTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEXAPRO</medicinalproduct>
        <drugauthorizationnumb>21323</drugauthorizationnumb>
        <drugdosagetext>10 MG QD; PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MAJOR DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050901</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEXAPRO</medicinalproduct>
        <drugdosagetext>10 MG QD; PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MAJOR DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060515</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060522</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEXAPRO</medicinalproduct>
        <drugdosagetext>20 MG QD; PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MAJOR DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060514</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN ANTIHYPERTENSIVE MEDICATION</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051489-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060630</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>S06-USA-01901-01</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>42</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ALANINE AMINOTRANSFERASE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD UREA NITROGEN/CREATININE RATIO DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIVORCED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HOMICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEGAL PROBLEM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF EMPLOYMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STRESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDAL BEHAVIOUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TEARFULNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREATMENT NONCOMPLIANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEXAPRO</medicinalproduct>
        <drugauthorizationnumb>21323</drugauthorizationnumb>
        <drugdosagetext>30 MG QD; PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060203</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEXAPRO</medicinalproduct>
        <drugdosagetext>20 MG QD; PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060202</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugdosagetext>200 MG QHS</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MARIJUANA</medicinalproduct>
        <drugindication>MIGRAINE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZONEGRAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WELLBUTRIN XL (BUPROPION)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051490-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060627</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>163-21880-06020197</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>49</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>73.0291</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>INTERNATIONAL NORMALISED RATIO INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugauthorizationnumb>21880</drugauthorizationnumb>
        <drugdosagetext>DAILY ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060501</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMOXICILLIN</medicinalproduct>
        <drugdosagetext>500 MG</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060204</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PERCOCET</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMBIEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DECADRON</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VELCADE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DURAGESIC (FENTANYL) (POULTICE OR PATCH)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MORPHINE SULFATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KYTRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RESTORIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VICODIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROTONIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COMPAZINE (PROCHLORPERAZINE EDISYLATE) (SUPPOSITORY)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCODONE HCL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051491-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060706</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>S06-USA-01617-01</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>72</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HYPOTHYROIDISM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEXAPRO</medicinalproduct>
        <drugauthorizationnumb>21323</drugauthorizationnumb>
        <drugdosagetext>5 MG QD; PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANXIETY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060623</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EVISTA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACTONEL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051492-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060706</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>S06-USA-01505-01</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>46</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>71.6683</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CATARACT</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>20050301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALTREX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051493-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>163-20785-06060925</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>68</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>MULTI-ORGAN DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>THALOMID</medicinalproduct>
        <drugbatchnumb>0014A</drugbatchnumb>
        <drugauthorizationnumb>20785</drugauthorizationnumb>
        <drugdosagetext>1 IN 1 D ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050801</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051494-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060706</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>S06-USA-02525-01</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>43</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE FLUCTUATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEXAPRO</medicinalproduct>
        <drugauthorizationnumb>21323</drugauthorizationnumb>
        <drugdosagetext>10 MG QD; PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>STRESS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060606</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HUMALOG</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FEXOFENADINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IRON</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASCORBIC ACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051495-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060630</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>163-20785-06070036</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY DISEASE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>THALOMID</medicinalproduct>
        <drugauthorizationnumb>20785</drugauthorizationnumb>
        <drugdosagetext>200 MG, 1 IN 1 D, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040707</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051496-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006PV015791</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>54</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL DISTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AORTIC VALVE CALCIFICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ATRIAL FIBRILLATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ATRIAL FLUTTER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIOMYOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DECREASED APPETITE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DILATATION ATRIAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EJECTION FRACTION DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GLYCOSYLATED HAEMOGLOBIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MITRAL VALVE CALCIFICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENTRICULAR HYPERTROPHY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BYETTA</medicinalproduct>
        <drugbatchnumb>9SF13M</drugbatchnumb>
        <drugauthorizationnumb>21773</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>DIABETES MELLITUS NON-INSULIN-DEPENDENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BYETTA</medicinalproduct>
        <drugbatchnumb>9SF13M</drugbatchnumb>
        <drugauthorizationnumb>21773</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>DIABETES MELLITUS NON-INSULIN-DEPENDENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>STARLIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACTOS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HUMALOG</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMIODARONE HCL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051497-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006PV016650</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>63</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>136.0791</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANOREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY OCCLUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THERAPEUTIC RESPONSE UNEXPECTED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BYETTA</medicinalproduct>
        <drugauthorizationnumb>21773</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>DIABETES MELLITUS NON-INSULIN-DEPENDENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050801</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BYETTA</medicinalproduct>
        <drugauthorizationnumb>21773</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>DIABETES MELLITUS NON-INSULIN-DEPENDENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HUMULIN N</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HUMALOG</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051499-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006PV016618</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUDDEN DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BYETTA</medicinalproduct>
        <drugauthorizationnumb>21773</drugauthorizationnumb>
        <drugdosagetext>5 MCG;BID;SC</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>DIABETES MELLITUS NON-INSULIN-DEPENDENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060629</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051500-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060627</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006PV016492</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>58</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>123.3784</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HYPOGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LETHARGY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SLUGGISHNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREATMENT NONCOMPLIANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISION BLURRED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BYETTA</medicinalproduct>
        <drugauthorizationnumb>21773</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>DIABETES MELLITUS NON-INSULIN-DEPENDENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060301</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BYETTA</medicinalproduct>
        <drugauthorizationnumb>21773</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>DIABETES MELLITUS NON-INSULIN-DEPENDENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060301</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMALOG</medicinalproduct>
        <drugdosagetext>100 BID; SC</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>DIABETES MELLITUS NON-INSULIN-DEPENDENT</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051501-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040714</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2004US07674</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>2</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>13.6</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>AGRANULOCYTOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DECREASED APPETITE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPHONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EAR INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EPSTEIN-BARR VIRUS INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GINGIVAL BLEEDING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPONATRAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEPHROLITHIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUROPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NON-HODGKIN'S LYMPHOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL CANDIDIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCYTOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHONOLOGICAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY DISTRESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STAPHYLOCOCCAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STOMATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOCAL CORD DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WOUND INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ELIDEL</medicinalproduct>
        <drugauthorizationnumb>21302</drugauthorizationnumb>
        <drugdosagetext>1 G, BID</drugdosagetext>
        <drugadministrationroute>061</drugadministrationroute>
        <drugindication>DERMATITIS ATOPIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030410</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030401</drugenddate>
        <drugtreatmentduration>20160</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ELIDEL</medicinalproduct>
        <drugauthorizationnumb>021302</drugauthorizationnumb>
        <drugdosagetext>UNK, PRN</drugdosagetext>
        <drugadministrationroute>061</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031013</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZITHROMAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BIAXIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMNICEF</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EUCERIN CREME</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051502-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060704</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHFR2006GB02145</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>MENINGIOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GLEEVEC</medicinalproduct>
        <drugauthorizationnumb>021588</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>CHRONIC MYELOID LEUKAEMIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051503-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060607</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHO2006FR09341</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>56</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>78</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>DISEASE PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPTIC SHOCK</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HEPARIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BACTRIM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ROVALCYTE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CERTICAN</medicinalproduct>
        <drugdosagetext>1.5 MG / DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RENAL TRANSPLANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060503</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060621</drugenddate>
        <drugtreatmentduration>72000</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEORAL</medicinalproduct>
        <drugauthorizationnumb>050715</drugauthorizationnumb>
        <drugdosagetext>100 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RENAL TRANSPLANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060502</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060528</drugenddate>
        <drugtreatmentduration>38880</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugdosagetext>17.5 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RENAL TRANSPLANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060502</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051504-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060627</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006PV016468</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>68</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>84.8226</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BYETTA</medicinalproduct>
        <drugbatchnumb>A189476</drugbatchnumb>
        <drugauthorizationnumb>21773</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>DIABETES MELLITUS NON-INSULIN-DEPENDENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060501</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BYETTA</medicinalproduct>
        <drugbatchnumb>A189476</drugbatchnumb>
        <drugauthorizationnumb>21773</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>DIABETES MELLITUS NON-INSULIN-DEPENDENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060501</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACTOS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMARYL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051505-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060705</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006PV016918</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>59</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>140.0254</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAPHYLACTIC REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OXYGEN SATURATION DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URTICARIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BYETTA</medicinalproduct>
        <drugauthorizationnumb>21773</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>DIABETES MELLITUS NON-INSULIN-DEPENDENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060524</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060622</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BYETTA</medicinalproduct>
        <drugauthorizationnumb>21773</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>DIABETES MELLITUS NON-INSULIN-DEPENDENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060623</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060702</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051506-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060627</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>163-20785-06050153</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>45</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>AUTOIMMUNE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROENTERITIS CRYPTOSPORIDIAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>THALOMID</medicinalproduct>
        <drugbatchnumb>0254X</drugbatchnumb>
        <drugauthorizationnumb>20785</drugauthorizationnumb>
        <drugdosagetext>100-400MG DAILY ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NEURODERMATITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060301</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051507-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060627</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>8016846</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>42</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>AGGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AGITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSSTASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LETHARGY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEMORY IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEDATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STATUS EPILEPTICUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRAUMATIC BRAIN INJURY</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>20030101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ABILIFY</medicinalproduct>
        <drugdosagetext>10 MG /D PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>AGITATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEXAPRO</medicinalproduct>
        <drugdosagetext>D PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARBATROL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051508-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>8017601</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>40</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>61.5</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>LOWER LIMB FRACTURE</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>20030101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DILANTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CENTRUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM MAGNESIUM ZINC</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051509-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060627</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006-BP-07412RO</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DIARRHOEA HAEMORRHAGIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTI-ORGAN FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugauthorizationnumb>40054</drugauthorizationnumb>
        <drugdosagetext>20 MG/M2 X 1 DOSE (NR, ONCE) IM</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>ECTOPIC PREGNANCY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051510-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006BI009287</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>47</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>58.9676</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CLOSTRIDIAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DECUBITUS ULCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFECTED SKIN ULCER</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>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>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051511-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>8017574</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>15</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GRAND MAL CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THERAPEUTIC RESPONSE DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KEPPRA</medicinalproduct>
        <drugauthorizationnumb>21035</drugauthorizationnumb>
        <drugdosagetext>2000 MG/D PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONVULSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LAMICTAL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRANXENE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051512-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060622</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ABILS-06-0013</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>63</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>75</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANOREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FACIAL PALSY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUROPATHY PERIPHERAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ABRAXANE</medicinalproduct>
        <drugauthorizationnumb>21660</drugauthorizationnumb>
        <drugdosagetext>440 MG DAY/EVERY 3 WEEKS/11 DOSES (440 MG, EVERY 3 WEEKS), INTRAVENOUS DRIP</drugdosagetext>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>BREAST CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050511</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060118</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREVACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM CHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COZAAR</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051513-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060627</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006BI008356</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>69</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</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>LASIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MERREM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VESICARE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AZACTAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMIPROMINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TIMOLOL MALEATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENZONATATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM CHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FELODIPINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ONEPRAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COZAAR</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051514-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060623</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ABILS-06-0281</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>66</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>115.2136</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE CONGESTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY CONGESTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUS TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUPRAVENTRICULAR TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ABRAXANE</medicinalproduct>
        <drugauthorizationnumb>21660</drugauthorizationnumb>
        <drugdosagetext>LAST DOSE 28-APR-2006 (175 MG/M2, EVERY 3 WEEKS), INTRAVENOUS DRIP</drugdosagetext>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>BREAST CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060407</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugdosagetext>(80000 IU, WEEKLY), SUBCUTANEOUS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>ANAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060417</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060528</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYTOXAN</medicinalproduct>
        <drugdosagetext>LAST DOSE 25-APR-2006 (500 MG/M2, 1 IN 3 WEEKS), INTRAVENOUS DRIP</drugdosagetext>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>BREAST CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060405</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOXORUBICIN HCL</medicinalproduct>
        <drugdosagetext>LAST DOSE 25-APR-2006 (50 MG/M2, EVERY 3 WEEKS), INTRAVENOUS DRIP</drugdosagetext>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>BREAST CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060405</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEUPOGEN</medicinalproduct>
        <drugdosagetext>480 MG, SUBCUTANEOUS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>NEUTROPENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060503</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060508</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORTAB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FEMARA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZESTRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VERAPAMIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GEMFIBROZIL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051515-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060630</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006S1000050</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>50</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CHILLS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EOSINOPHILIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERALISED OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEUKOCYTOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEPHRITIS INTERSTITIAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN EXFOLIATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THERAPEUTIC AGENT TOXICITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CUBICIN</medicinalproduct>
        <drugauthorizationnumb>21572</drugauthorizationnumb>
        <drugdosagetext>320 MG; Q24H; IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>OSTEOMYELITIS</drugindication>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RIFAMPIN</medicinalproduct>
        <drugindication>OSTEOMYELITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060309</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VANCOMYCIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RIFAMPIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ROCEPHIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CAPTOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATORVASTATIN CALCIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOCLOPRAMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALPROATE SEMISDOIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN TAB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOSAMINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PSEUDOEPHEDRINE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ESTROGENS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM CITRATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051516-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006BI006909</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>47</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HYSTERECTOMY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugbatchnumb>P35057</drugbatchnumb>
        <drugdosagetext>30 UG;QW;IM</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060401</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAZODONE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IRON</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051517-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060627</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006S1000118</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>52</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>64</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANGIONEUROTIC OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG ERUPTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EOSINOPHILIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERNATIONAL NORMALISED RATIO INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEUKOCYTOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL INTAKE REDUCED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CUBICIN</medicinalproduct>
        <drugauthorizationnumb>21572</drugauthorizationnumb>
        <drugdosagetext>6 MG/KG;Q24H;IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ENTEROCOCCAL INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060518</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060520</drugenddate>
      </drug>
      <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>20060518</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060520</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VANCOMYCIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOFLOXACIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROMETHAZINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HERBAL SUPPLEMENT</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051518-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060613</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2556</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>21</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PREGNANCY ON ORAL CONTRACEPTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMNESTEEM</medicinalproduct>
        <drugauthorizationnumb>75945</drugauthorizationnumb>
        <drugdosagetext>40 MG, BID, PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060321</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060420</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051519-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006BI006781</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>56</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CATARACT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DENTAL CARIES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GINGIVAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GINGIVAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOOSE TOOTH</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>19970301</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051520-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060626</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2730</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PREGNANCY OF PARTNER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMNESTEEM</medicinalproduct>
        <drugauthorizationnumb>75945</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051521-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060627</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2752</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PREGNANCY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMNESTEEM</medicinalproduct>
        <drugbatchnumb>0378661493</drugbatchnumb>
        <drugauthorizationnumb>75945</drugauthorizationnumb>
        <drugadministrationroute>064</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051522-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006BI006379</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>51</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>72.5755</patientweight>
      <patientsex>2</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>19980901</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>20060201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRICOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALTACE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRILOSEC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NO6 [NITRATE]</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051523-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006BI008469</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>68</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSSTASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERVERTEBRAL DISC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MONOPARESIS</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>19960902</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>5051524-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>163-21880-06020575</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>84</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>CANDIDIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA EXERTIONAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATITIS C</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLEURAL EFFUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RED BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugauthorizationnumb>21880</drugauthorizationnumb>
        <drugdosagetext>1 IN 1 D, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MYELODYSPLASTIC SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060130</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060301</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051525-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060630</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>163-21880-06050516</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>69</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ACUTE MYELOID LEUKAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISEASE PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugauthorizationnumb>21880</drugauthorizationnumb>
        <drugdosagetext>EVERY OTHER DAY, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MYELODYSPLASTIC SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060417</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTIBIOTICS           (ANTIBIOTICS)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051526-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006BI009493</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>38</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEEP VEIN THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HALLUCINATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LETHARGY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEMORY IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MONOPLEGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOVEMENT DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NATALIZUMAB</medicinalproduct>
        <drugdosagetext>300 MG;QM;IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050201</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051527-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060630</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006-01679</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>44</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>59.9</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CHEST DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERCALCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</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>20060619</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060626</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMIPRAMINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051528-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060703</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-2006-017751</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>24</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>74.4</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PAPILLOEDEMA</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>20050201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060619</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051529-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006BI009394</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>75</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>88.905</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLINDNESS UNILATERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPHOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OCULAR HYPERAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZEVALIN</medicinalproduct>
        <drugdosagetext>1X, IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MANTLE CELL LYMPHOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060307</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060307</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZEVALIN</medicinalproduct>
        <drugdosagetext>1X;IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MANTLE CELL LYMPHOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060314</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060314</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RITUXAN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051530-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-2006-014810</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>10</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>38.6</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLADDER DISTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMPUTERISED TOMOGRAM ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG TOXICITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DUODENAL ULCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRIC ULCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATOCRIT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ILEUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPHADENOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OTITIS EXTERNA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEUKINE</medicinalproduct>
        <drugbatchnumb>B08900</drugbatchnumb>
        <drugdosagetext>0.5ML (231.6 MCG) 1X/DAY, SUBCUTANEOUS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>CROHN'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060425</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PENTASA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL SPIROS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLOVENT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MIRALAX (MARCROGOL)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DAILY MULTIVITAMIN (VITAMINS NOS)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROBIOTICA (LACTOBACILLUS REUTER)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRILOSEC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOFRAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PHENERGAN                              (PROMETHAZINE HYDROCHLORIDE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZANTAC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CORTISPORIN OTIC DROPS (POLYMYXIN B SULFATE)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051531-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>HQWYE092201MAR06</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>65</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>DISEASE PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER FUNCTION TEST ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MYLOTARG</medicinalproduct>
        <drugauthorizationnumb>21174</drugauthorizationnumb>
        <drugdosagetext>12 MG 1X PER 1 DAY, INTRAVNEOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ACUTE MYELOID LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060119</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060119</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051532-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>226554</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>18</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>61</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>STAPHYLOCOCCAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUBCUTANEOUS ABSCESS</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>20051010</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NASONEX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADVAIR DISKUS 100/50</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL            (ALBUTEROL/ALBUTEROL SULFATE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SINGULAIR        (MONTELUKAS SODIUM)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ELOCON</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051533-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060705</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GBWYE012505JUL06</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLINDNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EPISCLERITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugdosagetext>UNKNOWN</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugindication>VASCULITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051534-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060616</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHNU2006DE02290</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>40</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <reaction>
        <reactionmeddrapt>ACCIDENTAL EXPOSURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTHERMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEDICATION ERROR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULAR WEAKNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIORESAL</medicinalproduct>
        <drugauthorizationnumb>17851</drugauthorizationnumb>
        <drugdosagetext>UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MEDICATION ERROR</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060616</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060616</drugenddate>
        <drugtreatmentduration>1440</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051536-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-2006-017458</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>72</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FOAMING AT MOUTH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY DISTRESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN DISCOLOURATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URTICARIA LOCALISED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ULTRAVIST 300</medicinalproduct>
        <drugauthorizationnumb>20220</drugauthorizationnumb>
        <drugdosagetext>100 ML, 1 DOSE, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COMPUTERISED TOMOGRAM ABDOMEN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060621</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060621</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051538-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-2006-017461</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>63</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>84.8</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLISTER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POST PROCEDURAL COMPLICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SCAR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ULTRAVIST (PHARMACY BULK)</medicinalproduct>
        <drugauthorizationnumb>21425</drugauthorizationnumb>
        <drugdosagetext>100 MI, 1 DOSE; INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COMPUTERISED TOMOGRAM ABDOMEN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060621</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060621</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DONADOL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051540-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-2006-017396</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>65</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>113.4</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CONTRAST MEDIA REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPHONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTUBATION COMPLICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWOLLEN TONGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URTICARIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ULTRAVIST (PHARMACY BULK)</medicinalproduct>
        <drugbatchnumb>53508A</drugbatchnumb>
        <drugauthorizationnumb>21425</drugauthorizationnumb>
        <drugdosagetext>20 MI, 1 DOSE; INTRAVENOUS, 90 MI, 1 DOSE; INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ARTERIOGRAM CORONARY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060615</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060615</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051541-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060627</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-2006-003953</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>28</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>AFFECTIVE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ALCOHOL USE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG ABUSER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HALLUCINATION, VISUAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE SCLEROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARANOIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRANSAMINASES INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BETASERON</medicinalproduct>
        <drugdosagetext>0.25 MI, EVERY 2D, SUBCUTANEOUS; SEE IMAGINE</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RELAPSING-REMITTING MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050513</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050525</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BETASERON</medicinalproduct>
        <drugdosagetext>0.25 MI, EVERY 2D, SUBCUTANEOUS; SEE IMAGINE</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RELAPSING-REMITTING MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050527</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050608</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BETASERON</medicinalproduct>
        <drugdosagetext>0.25 MI, EVERY 2D, SUBCUTANEOUS; SEE IMAGINE</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RELAPSING-REMITTING MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050610</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050701</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BETASERON</medicinalproduct>
        <drugdosagetext>0.25 MI, EVERY 2D, SUBCUTANEOUS; SEE IMAGINE</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RELAPSING-REMITTING MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BETASERON</medicinalproduct>
        <drugdosagetext>0.25 MI, EVERY 2D, SUBCUTANEOUS; SEE IMAGINE</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RELAPSING-REMITTING MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060323</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060331</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BETASERON</medicinalproduct>
        <drugdosagetext>0.25 MI, EVERY 2D, SUBCUTANEOUS; SEE IMAGINE</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RELAPSING-REMITTING MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BETASERON</medicinalproduct>
        <drugdosagetext>20 MG, 1X/DAY; SUBCUTANEOUS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RELAPSING-REMITTING MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040923</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050414</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EFFEXOR XR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORTRIPTYLINE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAZODONE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MIRTAZAPINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCORTISONE CREAM, 1%</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORAZEPAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMBIEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ORTHO TRI-CYCLEN LO (NORGESTIMATE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMITRIPTYLINE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VICODIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMOCIXILLIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDROL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CEPHALEXIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EFEXOR XR (VENLAFAXINE)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051542-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060626</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-2006-010284</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>45</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>COMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE SCLEROSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BETASERON</medicinalproduct>
        <drugbatchnumb>VA7949A</drugbatchnumb>
        <drugdosagetext>8 MIU, EVERY 2D, SUBCUTANEOUS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RELAPSING-REMITTING MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19941031</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051544-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060706</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-2005-018617</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE NECROSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BETASERON</medicinalproduct>
        <drugdosagetext>SUBCUTANEOUS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19990101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051545-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060703</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2006SE09891</companynumb>
    <primarysource>
      <reportercountry>SWEDEN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>64</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugauthorizationnumb>021223</drugauthorizationnumb>
        <drugdosagetext>4 MG, QMO</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HYPERCALCAEMIA</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060601</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BETAPRED</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOLCONTIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051546-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050822</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2005CZ12482</companynumb>
    <primarysource>
      <reportercountry>CZECH REPUBLIC</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>41</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BONE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE TRIMMING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DENTAL DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GINGIVAL SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMPAIRED HEALING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYELOMA RECURRENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERIOSTITIS HYPERTROPHIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRIMARY SEQUESTRUM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEQUESTRECTOMY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SURGERY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTH EXTRACTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLODRONATE DISODIUM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CHEMOTHERAPEUTICS,OTHER</medicinalproduct>
        <drugdosagetext>HIGH-DOSAGE</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugauthorizationnumb>021223</drugauthorizationnumb>
        <drugdosagetext>4 MG, 4-WEEK INTERVAL</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050701</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugauthorizationnumb>021223</drugauthorizationnumb>
        <drugdosagetext>4 MG, 4 WEEK INTERVALS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALTRATE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEGACE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANALGESICS</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051547-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060220</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2006JP02908</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>72</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>54</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD CREATININE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD UREA INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSED LEVEL OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG LEVEL ABOVE THERAPEUTIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMODIALYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HALLUCINATION, VISUAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NERVOUS SYSTEM DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINE OUTPUT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VOLTAREN</medicinalproduct>
        <drugauthorizationnumb>19201</drugauthorizationnumb>
        <drugdosagetext>112.5 MG/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060215</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060216</drugenddate>
        <drugtreatmentduration>2880</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VALTREX</medicinalproduct>
        <drugdosagetext>3000 MG/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HERPES ZOSTER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060215</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060216</drugenddate>
        <drugtreatmentduration>2880</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SELBEX</medicinalproduct>
        <drugdosagetext>150 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060215</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060216</drugenddate>
        <drugtreatmentduration>2880</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MUCOSTA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEVALOTIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051548-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20051103</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHFR2005GB03677</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>52</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ENDODONTIC PROCEDURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugauthorizationnumb>21223</drugauthorizationnumb>
        <drugdosagetext>UNK, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>METASTASES TO BONE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051549-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060427</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2006NO06512</companynumb>
    <primarysource>
      <reportercountry>NORWAY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>61</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HYPERBARIC OXYGEN THERAPY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMPAIRED HEALING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SURGERY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTH EXTRACTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugauthorizationnumb>21223</drugauthorizationnumb>
        <drugdosagetext>4 MG</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020612</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060105</drugenddate>
        <drugtreatmentduration>1304</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SELO-ZOK</medicinalproduct>
        <drugdosagetext>50 MG, QD</drugdosagetext>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugdosagetext>20 MG/D</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANTACID THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
        <drugdosagetext>100 MG, QD</drugdosagetext>
        <drugindication>ANTIDEPRESSANT THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYNORM</medicinalproduct>
        <drugdosagetext>20 MG, MAXIMUM 6 TABLETS/D</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANALGESIC THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMOVANE</medicinalproduct>
        <drugdosagetext>7.5 MG/D</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INSOMNIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DURAGESIC-100</medicinalproduct>
        <drugdosagetext>EACH THIRD DAY</drugdosagetext>
        <drugadministrationroute>003</drugadministrationroute>
        <drugindication>ANALGESIC THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
        <drugdosagetext>80 MG, QD</drugdosagetext>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051550-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060614</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHFR2006GB02006</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugauthorizationnumb>21223</drugauthorizationnumb>
        <drugdosagetext>4MG/DAY</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>METASTASES TO BONE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051551-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060516</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHO2006US08004</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>73</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>73.6</patientweight>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ACIDOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ACUTE MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTERIOSCLEROSIS CORONARY ARTERY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ATRIOVENTRICULAR BLOCK FIRST DEGREE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CREATININE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CULTURE POSITIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRAIN NATRIURETIC PEPTIDE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE CONGESTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIOMYOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CATHETER PLACEMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CENTRAL LINE INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DILATATION ATRIAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EJECTION FRACTION DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC ENZYME INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOKALAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALIGNANT NEOPLASM PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MITRAL VALVE DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MITRAL VALVE INCOMPETENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL CANDIDIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RALES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE CHRONIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPTIC SHOCK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUS TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STAPHYLOCOCCAL SEPSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENTRICULAR HYPERTROPHY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOLEDRONIC ACID</medicinalproduct>
        <drugauthorizationnumb>21223</drugauthorizationnumb>
        <drugdosagetext>4 MG, QMO</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>METASTASES TO BONE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060117</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060508</drugenddate>
        <drugtreatmentduration>112</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM GLUCONATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRICOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLTX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDRALAZINE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VISTARIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ISOSORBIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLARITIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COZAAR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEGESTROL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOPRESSOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATARAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRILOSEC</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051552-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060627</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-2006-017295</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>75</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>MULTIPLE SCLEROSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BETASERON</medicinalproduct>
        <drugdosagetext>SUBCUTANEOUS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051553-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060630</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-2006-017491</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>48</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</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>20050424</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060623</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051555-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060627</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-2006-016884</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>48</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE NECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</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>19981201</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051557-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060619</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US200606005332</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>92</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>50.8</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>COMPRESSION FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATOCRIT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPONATRAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RIB FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TENDERNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugauthorizationnumb>21318</drugauthorizationnumb>
        <drugdosagetext>20 UG, DAILY (1/D)</drugdosagetext>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060301</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FORTEO PEN                (FORTEO PEN)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIGOXIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARDIZEM CD</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DETROL - SLOW RELEASE                  (TOLTERODINE L-TARTRATE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMBIEN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051558-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060619</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US200606004397</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>72</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>APPENDICITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHILLS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MIGRAINE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugbatchnumb>9RY23P</drugbatchnumb>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>60 MG</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENICAR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPAMAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORAZEPAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REQUIP</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COMBIVENT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DETROL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZYRTEC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTIBIOTICS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DUONEB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN TAB</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051560-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060619</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US200606004404</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>66.7</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>INCORRECT DOSE ADMINISTERED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WRONG TECHNIQUE IN DRUG USAGE PROCESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>10 MG, DAILY, (1/D); 20 MG, DAILY (1/D)</drugdosagetext>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060217</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060223</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>10 MG, DAILY, (1/D); 20 MG, DAILY (1/D)</drugdosagetext>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060224</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060324</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLPIDEM TARTRATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RIZATRIPTAN (RIZATRIPTAN)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CETIRIZINE (CETIRIZINE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BLACK COHOSH                      (CIMICIFUGA RACEMOSA ROOT)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CITRACAL + D (CALCIUM CITRATE, ERGOCALCIFEROL)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FAMOTIDINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PSEUDOEPHEDRINE (PSEUDOEPHEDRINE)</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>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051561-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060516</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHNU2006DE01991</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BONE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DENTAL TREATMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTH INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRENANTONE</medicinalproduct>
        <drugdosagetext>1 DF, Q3MO</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PROSTATE CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050309</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RADIOTHERAPY</medicinalproduct>
        <drugdosagetext>3 GY</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>RADIOTHERAPY TO BONE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060330</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060412</drugenddate>
        <drugtreatmentduration>20160</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugauthorizationnumb>021223</drugauthorizationnumb>
        <drugdosagetext>4 MG, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>METASTASES TO BONE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050321</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051562-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060703</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHO2006IT10945</companynumb>
    <primarysource>
      <reportercountry>ITALY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>68</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>OSTEITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOLEDRONATE VS PLACEBO</medicinalproduct>
        <drugdosagetext>TREATMENT PERIOD</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>METASTASES TO BONE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugauthorizationnumb>021223</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>METASTASES TO BONE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LHRH FERRING</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTIANDROGENS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ESTRAMUSTINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DELTACORTENE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAXOTERE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051563-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060704</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHNU2006DE02437</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MANDIBULECTOMY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugauthorizationnumb>021223</drugauthorizationnumb>
        <drugdosagetext>4 MG, QMO</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051564-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2006NO00455</companynumb>
    <primarysource>
      <reportercountry>NORWAY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>61</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BONE DEBRIDEMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERBARIC OXYGEN THERAPY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMPAIRED HEALING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SURGERY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTH EXTRACTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SELO-ZOK</medicinalproduct>
        <drugdosagetext>50 MG, QD</drugdosagetext>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYNORM</medicinalproduct>
        <drugdosagetext>20 MG, PRN, MAXIMUM 6 TABLETS/D</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANALGESIC THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMOVANE</medicinalproduct>
        <drugdosagetext>7.5 MG/D</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INSOMNIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugauthorizationnumb>021223</drugauthorizationnumb>
        <drugdosagetext>4 MG, QMO</drugdosagetext>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020612</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060105</drugenddate>
        <drugtreatmentduration>1304</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
        <drugdosagetext>50 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANTIDEPRESSANT THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugdosagetext>20 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANTACID THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
        <drugdosagetext>80 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DURAGESIC-100</medicinalproduct>
        <drugdosagetext>UNK, EACH THIRD DAY</drugdosagetext>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>ANALGESIC THERAPY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051565-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060619</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US200606004339</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>82</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>AMMONIA INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DELIRIUM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>30 MG</drugdosagetext>
        <drugindication>NEURALGIA</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051567-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060619</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US200606004312</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HOMICIDE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREATMENT NONCOMPLIANCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugindication>DEPRESSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051568-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060619</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US200606004311</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>51</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>GASTRIC BYPASS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051569-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060616</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US200606004129</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>61</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLINDNESS UNILATERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>REFUSAL OF TREATMENT BY PATIENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL ACUITY REDUCED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugbatchnumb>9RX41P</drugbatchnumb>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>30 MEQ, DAILY (1/D)</drugdosagetext>
        <drugindication>NEUROPATHY PERIPHERAL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060613</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051571-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060616</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US200606004082</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>73</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ATRIAL FIBRILLATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC ENZYME INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>30 MG, DAILY (1/D), ORAL; 20 MG, DAILY, (1/D)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>POST-TRAUMATIC STRESS DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DYNACIRC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COENZYME Q10</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLOMAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UROXATRAL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM W/MAGNESIUM/ZINC                (CALCIUM, MAGNESIUM, ZINC)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>B-COMPLEX             (VITAMIN B NOS)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CENTRUM SILVER (ASCORBIC ACID, CALCIUM, MINERALS NOS, RETINOL, TOCOPHE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SELENIUM (SELENIUM)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYANOCOBALAMIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051573-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060705</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>S06-USA-02524-01</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>26</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</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>20060601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060601</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051574-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060626</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006UW13376</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>70</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE CONGESTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIOVASCULAR DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIABETES MELLITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
        <drugauthorizationnumb>18240</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMDUR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051575-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>S06-USA-02484-01</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>53</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEXAPRO</medicinalproduct>
        <drugauthorizationnumb>21323</drugauthorizationnumb>
        <drugdosagetext>20 MG QD PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRAMADOL HCL</medicinalproduct>
        <drugdosagetext>50 MG PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BACK PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORTAB (HYDROCODONE/ECETAMINOPHEN)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLARITIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RELAFEN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051576-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>APP200600182</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>33</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ALVEOLITIS ALLERGIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EOSINOPHILIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEUKOCYTOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLEURAL EFFUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>REACTION TO DRUG EXCIPIENTS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY ACIDOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY DISTRESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TYPE IV HYPERSENSITIVITY REACTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROGESTERONE INJ</medicinalproduct>
        <drugauthorizationnumb>75906</drugauthorizationnumb>
        <drugdosagetext>50 MG (50 MG, 1 IN 1 D), INTRAMUSCULAR</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>ASSISTED FERTILISATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ESTRADIOL INJ</medicinalproduct>
        <drugdosagetext>4 MG, 2 IN 1 WK, INTRAMUSCULAR</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>ASSISTED FERTILISATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051577-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>163-21880-06070111</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>83</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugauthorizationnumb>21880</drugauthorizationnumb>
        <drugdosagetext>5  MG, 1 IN 1 D, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>LYMPHOPROLIFERATIVE DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060607</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060628</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051578-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060627</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>163-21880-06070022</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>63</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugauthorizationnumb>21880</drugauthorizationnumb>
        <drugdosagetext>5 MG, QD, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MYELODYSPLASTIC SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060513</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060626</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051579-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060627</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>163-21880-06040790</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>62</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERNATIONAL NORMALISED RATIO INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG INFILTRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUROPATHY PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPHIL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROTHROMBIN TIME PROLONGED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VIRAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugbatchnumb>427709</drugbatchnumb>
        <drugauthorizationnumb>21880</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060127</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060131</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugbatchnumb>427709</drugbatchnumb>
        <drugauthorizationnumb>21880</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060421</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060501</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugbatchnumb>427709</drugbatchnumb>
        <drugauthorizationnumb>21880</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060518</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060601</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugbatchnumb>427709</drugbatchnumb>
        <drugauthorizationnumb>21880</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051580-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>163-21880-06060959</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>75</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LETHARGY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugbatchnumb>V0365705700-001001</drugbatchnumb>
        <drugauthorizationnumb>21880</drugauthorizationnumb>
        <drugdosagetext>10 MG, 1 IN 1 D, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MYELODYSPLASTIC SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060512</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060619</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051582-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060627</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>163-21880-06040809</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>71</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ACUTE MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE CONGESTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISEASE PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIVERTICULUM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FULL BLOOD COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHOIDS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERCHOLESTEROLAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCYTOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRANSIENT ISCHAEMIC ATTACK</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugbatchnumb>427924</drugbatchnumb>
        <drugauthorizationnumb>21880</drugauthorizationnumb>
        <drugdosagetext>5 MG, QD, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MYELODYSPLASTIC SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060419</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>THALOMID</medicinalproduct>
        <drugdosagetext>100 MG, QHS, ORAL; QHS, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MYELODYSPLASTIC SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060428</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060501</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>THALOMID</medicinalproduct>
        <drugdosagetext>100 MG, QHS, ORAL; QHS, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MYELODYSPLASTIC SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040520</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DILAUDID</medicinalproduct>
        <drugdosagetext>2 MG, Q 4HRS, PRN, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BACK PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIDAZA</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZESTRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EPOGEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEUPOGEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051584-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060623</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US200601001087</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</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>DIABETES MELLITUS NON-INSULIN-DEPENDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EFFECT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENORRHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METABOLIC SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OBESITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
        <drugauthorizationnumb>20592</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BIPOLAR DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030714</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030728</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
        <drugauthorizationnumb>20592</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BIPOLAR DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030728</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051017</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROZAC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BUSPAR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ORTHO-NOVUM 1/35</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051585-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060623</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US200601002949</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>41</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>120.2</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIABETES MELLITUS INADEQUATE CONTROL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIABETES MELLITUS NON-INSULIN-DEPENDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GLYCOSYLATED HAEMOGLOBIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC STEATOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOKALAEMIC SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IRRITABLE BOWEL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MICROALBUMINURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUROPATHY PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POLLAKIURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRESCRIBED OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RECTAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>REFUSAL OF TREATMENT BY PATIENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE CHRONIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISION BLURRED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
        <drugauthorizationnumb>20592</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BIPOLAR DISORDER</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020501</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
        <drugauthorizationnumb>20592</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BIPOLAR DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990804</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REMERON</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BUSPIRONE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BUMETANIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROCHLORPERAZINE TAB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMBIEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALTACE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROTONIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ETODOLAC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIAZEPAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GEODON</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCODONE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TEMAZEPAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALPRAZOLAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LITHIUM CARBONATE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051586-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060623</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US200602001654</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>54</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>59</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DIABETES MELLITUS NON-INSULIN-DEPENDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GLYCOSYLATED HAEMOGLOBIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATOCHEZIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSULIN C-PEPTIDE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUROPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
        <drugauthorizationnumb>20592</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BIPOLAR DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021119</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030812</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
        <drugauthorizationnumb>20592</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BIPOLAR DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
        <drugauthorizationnumb>20592</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BIPOLAR DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020821</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
        <drugauthorizationnumb>20592</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BIPOLAR DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030812</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONAZEPAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FENOFIBRATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LITHIUM CARBONATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAZODONE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BUPROPION HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIAZEPAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROGESTERONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>QUININE SULFATE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051588-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060623</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US200602002462</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>37</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>90.7</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DIABETES MELLITUS NON-INSULIN-DEPENDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPEPSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ELECTROCARDIOGRAM QT PROLONGED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRESCRIBED OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
        <drugauthorizationnumb>20592</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BIPOLAR DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010609</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010728</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
        <drugauthorizationnumb>20592</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BIPOLAR DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010729</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20011210</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
        <drugauthorizationnumb>20592</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BIPOLAR DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20011211</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020215</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
        <drugauthorizationnumb>20592</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BIPOLAR DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020216</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020416</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
        <drugauthorizationnumb>20592</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BIPOLAR DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020417</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020428</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
        <drugauthorizationnumb>20592</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BIPOLAR DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020429</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020505</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
        <drugauthorizationnumb>20592</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BIPOLAR DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020506</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020512</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
        <drugauthorizationnumb>20592</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BIPOLAR DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020513</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020823</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RISPERDAL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ELAVIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051589-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060622</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US200604002386</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>54</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>AMENORRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLINDNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIALYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOCAL SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENOPAUSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN LACERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
        <drugauthorizationnumb>20592</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BIPOLAR DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051590-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060620</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US200605003925</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>20</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>63.4</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BACTERAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG LEVEL BELOW THERAPEUTIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HALLUCINATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOMANIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NO THERAPEUTIC RESPONSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STEVENS-JOHNSON SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
        <drugauthorizationnumb>20592</drugauthorizationnumb>
        <drugdosagetext>5 MG, DAILY (1/D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HALLUCINATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051117</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060427</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LAMICTAL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LITHIUM CARBONATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WELLBUTRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEPAKOTE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051592-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060621</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US200606003330</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>69</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>71.7</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>AORTIC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BALANCE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CALCINOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CANDIDIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FUNCTION TEST ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRY MOUTH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRESCRIBED OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
        <drugbatchnumb>8EJ08P</drugbatchnumb>
        <drugauthorizationnumb>20592</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BIPOLAR DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LITHIUM CARBONATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALPROIC ACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM CARBONATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACTONEL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZYRTEC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MOBIC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>C-VITAMIN (ASCORBIC ACID)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAMADOL HCL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051593-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060619</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US200606004306</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugauthorizationnumb>21318</drugauthorizationnumb>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050501</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051594-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060703</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-STX185000</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLAMMATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>KNEE ARTHROPLASTY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUROPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESTLESSNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>P063744</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000801</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060501</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051595-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060703</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>HQWYE596506JUL06</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>SYSTEMIC LUPUS ERYTHEMATOSUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060403</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060414</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060512</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ISCOTIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051599-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060526</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GBWYE667430MAY06</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051600-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060704</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GBWYE971204JUL06</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>69</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>78</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWELLING FACE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugdosagetext>25MG</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060606</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
        <drugdosagetext>25MG, FREQUENCY UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
        <drugdosagetext>5MG TWICE WEEKLY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOPICLONE</medicinalproduct>
        <drugdosagetext>7MG, FREQUENCY UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MELOXICAM</medicinalproduct>
        <drugdosagetext>UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugdosagetext>15MG ONE TIMES A WEEK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PARACETAMOL</medicinalproduct>
        <drugdosagetext>500MG, FREQUENCY UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETYLSALICYLIC ACID SRT</medicinalproduct>
        <drugdosagetext>75MG, FREQUENCY UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLYCERYL TRINITRATE</medicinalproduct>
        <drugdosagetext>AS NECESSARY</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051601-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060703</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>HQWYE536703JUL06</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <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>20050624</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060428</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugdosagetext>UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051603-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060619</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US200606004363</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>RESPIRATORY SYNCYTIAL VIRUS INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugbatchnumb>FF5Z26A</drugbatchnumb>
        <drugauthorizationnumb>21318</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040801</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051604-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060619</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US200606004360</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>99</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ATRIAL FIBRILLATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugbatchnumb>FF5D52A</drugbatchnumb>
        <drugauthorizationnumb>21318</drugauthorizationnumb>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051605-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060619</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US200606004337</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>84</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugauthorizationnumb>21318</drugauthorizationnumb>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051607-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060619</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US200606004308</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugauthorizationnumb>21318</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051608-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060619</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US200606004307</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>77</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>46.3</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DIVERTICULITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL CELL CARCINOMA STAGE UNSPECIFIED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugauthorizationnumb>21318</drugauthorizationnumb>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEVACOR</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051609-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060619</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US200606004835</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>81</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BALANCE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BEDRIDDEN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSSTASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYDROCEPHALUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VERTIGO</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHEELCHAIR USER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugbatchnumb>FF5Z43A</drugbatchnumb>
        <drugauthorizationnumb>21318</drugauthorizationnumb>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040501</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM (CALCIUM)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM W/MAGNESIUM (CALCIUM, MAGNESIUM)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NUTRILYTE  (CALCIUM GLUCONATE, MAGNESIUM CHLORIDE ANHYDROUS, POTASSIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MIACALCIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051611-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060619</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US200606004412</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ILL-DEFINED DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugauthorizationnumb>21318</drugauthorizationnumb>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051009</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051612-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060619</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US200606004401</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>AGORAPHOBIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANIC ATTACK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugbatchnumb>FF5J49A</drugbatchnumb>
        <drugauthorizationnumb>21318</drugauthorizationnumb>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FORTEO PEN (250MCG/ML) (FORTEO PEN 250MCG/MG (3ML)) PEN,DISPOSABLE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051613-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060606</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AVENTIS-200615131US</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>31</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD BILIRUBIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHILLS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATITIS ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERNATIONAL NORMALISED RATIO INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRANSAMINASES INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KETEK</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>21144</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>UPPER RESPIRATORY TRACT INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050928</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051002</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KETEK</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021144</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051007</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051011</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KETEK</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021144</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SINUS DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050928</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051002</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KETEK</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021144</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051007</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051011</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KETEK</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021144</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PHARYNGOLARYNGEAL PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050928</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051002</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KETEK</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021144</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051007</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051011</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051614-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060622</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-AVENTIS-200612278FR</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>75</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA HAEMORRHAGIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERAL PHYSICAL CONDITION ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE VASOVAGAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KETEK</medicinalproduct>
        <drugauthorizationnumb>021144</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BRONCHITIS ACUTE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060519</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TARDYFERON</medicinalproduct>
        <drugindication>ANAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060519</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051615-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060706</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-AVENTIS-200617152GDDC</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>64</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>JAUNDICE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER FUNCTION TEST ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS GENERALISED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METRONIDAZOLE</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>20743</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ABSCESS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060511</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060518</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CO-AMOXICLAV</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ABSCESS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060510</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060517</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051616-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060711</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-AVENTIS-200612461FR</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>14</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PANCREATITIS ACUTE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLAGYL</medicinalproduct>
        <drugauthorizationnumb>20743</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060603</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060612</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PENTASA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060608</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060612</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PENTASA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060612</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060621</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PENTASA</medicinalproduct>
        <drugadministrationroute>054</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060612</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060621</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051617-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060626</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006CL000684</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>50</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>69.4003</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HYPOGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SYMLIN</medicinalproduct>
        <drugauthorizationnumb>21332</drugauthorizationnumb>
        <drugdosagetext>15 MCG; TID; SC</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>DIABETES MELLITUS INSULIN-DEPENDENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060315</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060329</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMALOG</medicinalproduct>
        <drugdosagetext>2 UNITS; PRN; SC</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>DIABETES MELLITUS INSULIN-DEPENDENT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051618-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040719</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0519689A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG WITHDRAWAL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL SELF-INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAXIL CR</medicinalproduct>
        <drugauthorizationnumb>20936</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VICODIN</medicinalproduct>
        <drugdosagetext>10TAB SINGLE DOSE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041023</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041023</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051619-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050503</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0558206A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>45</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BALANCE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISTURBANCE IN ATTENTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG WITHDRAWAL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE IRRITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HALLUCINATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOOD SWINGS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NIGHTMARE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANIC ATTACK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOCIAL PHOBIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TINNITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
        <drugauthorizationnumb>20031</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANXIETY DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19960918</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONAZEPAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SINGULAIR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPAMAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEPAKOTE ER</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051620-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060707</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-GLAXOSMITHKLINE-A0611660A</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>57</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HEPATIC CIRRHOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>21071</drugauthorizationnumb>
        <drugdosagetext>4MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DIABETES MELLITUS NON-INSULIN-DEPENDENT</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051621-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060706</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0611694A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>38</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UMBILICAL CORD ABNORMALITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMICTAL</medicinalproduct>
        <drugauthorizationnumb>020241</drugauthorizationnumb>
        <drugdosagetext>200MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BIPOLAR DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORAZEPAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXEDRINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELEXA</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051622-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060711</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0611796A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>17</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>COMPLETED SUICIDE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY ARREST</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>WELLBUTRIN XL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021515</drugauthorizationnumb>
        <drugdosagetext>300MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NO CONCURRENT MEDICATION</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051623-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060710</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0611880A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>39</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABORTION SPONTANEOUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMICTAL</medicinalproduct>
        <drugauthorizationnumb>020241</drugauthorizationnumb>
        <drugdosagetext>250MG UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BIPOLAR DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050801</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHYLDOPA</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTIBIOTICS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051624-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060711</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0611893A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>32</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABORTION SPONTANEOUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHORIOAMNIONITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FUNISITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMIVUDINE</medicinalproduct>
        <drugauthorizationnumb>020564</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060509</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NELFINAVIR</medicinalproduct>
        <drugdosagetext>1250MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060509</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051625-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060710</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0612048A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ALPHA 1 FOETOPROTEIN ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AMNIOTIC FLUID VOLUME DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GESTATIONAL DIABETES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PREMATURE RUPTURE OF MEMBRANES</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BUPROPION HYDROCHLORIDE</medicinalproduct>
        <drugauthorizationnumb>018644</drugauthorizationnumb>
        <drugdosagetext>300MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060130</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060228</drugenddate>
        <drugtreatmentduration>30</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VICODIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051626-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060710</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0612048B</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>3.2</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>COLOSTOMY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ILEAL PERFORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIFE SUPPORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NECROTISING COLITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA NEONATAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BUPROPION HYDROCHLORIDE</medicinalproduct>
        <drugauthorizationnumb>018644</drugauthorizationnumb>
        <drugdosagetext>300MG PER DAY</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060130</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060228</drugenddate>
        <drugtreatmentduration>30</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VICODIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051627-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060711</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0612052A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>26</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABORTION SPONTANEOUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMBIVIR</medicinalproduct>
        <drugauthorizationnumb>020857</drugauthorizationnumb>
        <drugdosagetext>2TAB PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ASYMPTOMATIC HIV INFECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIRAMUNE</medicinalproduct>
        <drugdosagetext>400MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ASYMPTOMATIC HIV INFECTION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051628-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060711</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-GLAXOSMITHKLINE-A0612082A</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLEEDING TIME PROLONGED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONTUSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VALTREX</medicinalproduct>
        <drugauthorizationnumb>020487</drugauthorizationnumb>
        <drugdosagetext>500MG UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANTIVIRAL PROPHYLAXIS</drugindication>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051629-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060710</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0612106A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CHILLS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAIL GROWTH ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL MUCOSAL BLISTERING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SCAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN HYPERPIGMENTATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STEVENS-JOHNSON SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROAT TIGHTNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOXIC EPIDERMAL NECROLYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY TRACT DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMICTAL</medicinalproduct>
        <drugauthorizationnumb>020241</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BIPOLAR DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040304</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
        <drugindication>BIPOLAR DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040302</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYLENOL (CAPLET)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NYQUIL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051630-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060711</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>447</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>75</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>87</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OXYGEN SATURATION DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY OEDEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLOLAN</medicinalproduct>
        <drugauthorizationnumb>20444</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060630</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060630</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051631-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060609</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-GLAXOSMITHKLINE-B0427471A</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>58</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>60</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COORDINATION ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMPAIRED DRIVING ABILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYBAN</medicinalproduct>
        <drugauthorizationnumb>020711</drugauthorizationnumb>
        <drugdosagetext>150MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SMOKING CESSATION THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060423</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060429</drugenddate>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>100MG PER DAY</drugdosagetext>
        <drugindication>THROMBOSIS PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugdosagetext>40MG PER DAY</drugdosagetext>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980512</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRITACE</medicinalproduct>
        <drugdosagetext>5MG PER DAY</drugdosagetext>
        <drugindication>BLOOD PRESSURE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20011001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugdosagetext>20MG PER DAY</drugdosagetext>
        <drugindication>GASTROOESOPHAGEAL REFLUX DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DILTIAZEM HCL</medicinalproduct>
        <drugdosagetext>180MG PER DAY</drugdosagetext>
        <drugindication>BLOOD PRESSURE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALCOHOL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051632-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060704</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-GLAXOSMITHKLINE-B0429839A</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>25</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACTERIAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CULTURE STOOL POSITIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FACE OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERAL PHYSICAL HEALTH DETERIORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLAMMATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NORMOCHROMIC NORMOCYTIC ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH MACULO-PAPULAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOXIC SKIN ERUPTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VIRAL INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMICTAL</medicinalproduct>
        <drugauthorizationnumb>20241</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>EPILEPSY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060404</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060529</drugenddate>
        <drugtreatmentduration>56</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEPAKENE</medicinalproduct>
        <drugdosagetext>500MG THREE TIMES PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>EPILEPSY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060601</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>EPILEPSY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051633-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060707</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-GLAXOSMITHKLINE-B0430514A</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>64</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CEREBRAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULAR WEAKNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EPIVIR</medicinalproduct>
        <drugauthorizationnumb>20564</drugauthorizationnumb>
        <drugdosagetext>300MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20001213</drugenddate>
        <drugtreatmentduration>67</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EPIVIR</medicinalproduct>
        <drugauthorizationnumb>020564</drugauthorizationnumb>
        <drugdosagetext>300MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010213</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051206</drugenddate>
        <drugtreatmentduration>59</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EPIVIR</medicinalproduct>
        <drugauthorizationnumb>020564</drugauthorizationnumb>
        <drugdosagetext>150MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060112</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RETROVIR</medicinalproduct>
        <drugauthorizationnumb>019655</drugauthorizationnumb>
        <drugdosagetext>400MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000106</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20000117</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RETROVIR</medicinalproduct>
        <drugauthorizationnumb>019655</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010213</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051206</drugenddate>
        <drugtreatmentduration>251</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RETROVIR</medicinalproduct>
        <drugauthorizationnumb>019655</drugauthorizationnumb>
        <drugdosagetext>400MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060112</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>20010213</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050405</drugenddate>
        <drugtreatmentduration>216</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>STOCRIN</medicinalproduct>
        <drugdosagetext>400MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050406</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VIREAD</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051207</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060111</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051634-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060710</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>13430020</companynumb>
    <primarysource>
      <reportercountry>BOTSWANA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>46</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROENTERITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMBIVIR</medicinalproduct>
        <drugauthorizationnumb>020857</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050509</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060614</drugenddate>
        <drugtreatmentduration>402</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>STAVUDINE</medicinalproduct>
        <drugdosagetext>60MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060614</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>20060509</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051635-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060707</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-GLAXOSMITHKLINE-B0430859A</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>45</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INTOLERANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRANSAMINASES INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYBAN</medicinalproduct>
        <drugauthorizationnumb>020711</drugauthorizationnumb>
        <drugdosagetext>150MG VARIABLE DOSE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHADONE HCL</medicinalproduct>
        <drugdosagetext>140MG PER DAY</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051636-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060710</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BE-GLAXOSMITHKLINE-B0430893A</companynumb>
    <primarysource>
      <reportercountry>BELGIUM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>68</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ATRIOVENTRICULAR BLOCK FIRST DEGREE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRADYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMOTRIGINE</medicinalproduct>
        <drugauthorizationnumb>20241</drugauthorizationnumb>
        <drugindication>BIPOLAR DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LORMETAZEPAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BISOPROLOL FUMARATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MIRTAZAPINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUOXETINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CANDESARTAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATORVASTATIN CALCIUM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051637-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060703</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006012177</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>37</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>64</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG ABUSER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMICTAL</medicinalproduct>
        <drugauthorizationnumb>020241</drugauthorizationnumb>
        <drugdosagetext>700MG SINGLE DOSE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060703</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060703</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051638-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006PV015746</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>63</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>136.0791</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IRON DEFICIENCY ANAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BYETTA</medicinalproduct>
        <drugbatchnumb>9SC15M</drugbatchnumb>
        <drugauthorizationnumb>21773</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS NON-INSULIN-DEPENDENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050701</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BYETTA</medicinalproduct>
        <drugbatchnumb>9SC15M</drugbatchnumb>
        <drugauthorizationnumb>21773</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS NON-INSULIN-DEPENDENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLIPIZIDE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051639-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060630</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>226937</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>45</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>INTERSTITIAL LUNG DISEASE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XOLAIR</medicinalproduct>
        <drugdosagetext>Q2W,</drugdosagetext>
        <drugindication>ASTHMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060501</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>STEROID (STEROID NOS)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051640-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060626</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>8017563</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>18.18</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABNORMAL BEHAVIOUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AGGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG DISPENSING ERROR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCORRECT DOSE ADMINISTERED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KEPPRA</medicinalproduct>
        <drugauthorizationnumb>21505</drugauthorizationnumb>
        <drugdosagetext>1000 MG 2/D PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PETIT MAL EPILEPSY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060625</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KEPPRA</medicinalproduct>
        <drugdosagetext>1000 MG ONCE PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PETIT MAL EPILEPSY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060626</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060626</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RITALIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051641-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>8017381</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>6</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HENOCH-SCHONLEIN PURPURA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTUSSUSCEPTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METADATE CD</medicinalproduct>
        <drugauthorizationnumb>21259</drugauthorizationnumb>
        <drugdosagetext>10 MG 1/D PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATTENTION DEFICIT/HYPERACTIVITY DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060515</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060523</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ISONIAZID</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051642-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060627</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006-144681-NL</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>24</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METRORRHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UTERINE SPASM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NUVARING</medicinalproduct>
        <drugauthorizationnumb>21187</drugauthorizationnumb>
        <drugindication>CONTRACEPTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEG-INTRON</medicinalproduct>
        <drugindication>HEPATITIS C</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RIBAVIRIN</medicinalproduct>
        <drugindication>HEPATITIS C</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVAQUIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEXAPRO</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051643-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060626</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006PV015677</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>57</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ATRIAL FIBRILLATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPEPSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROOESOPHAGEAL REFLUX DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THYROID FUNCTION TEST ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENTRICULAR ARRHYTHMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BYETTA</medicinalproduct>
        <drugauthorizationnumb>21773</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>DIABETES MELLITUS NON-INSULIN-DEPENDENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060502</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060531</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BYETTA</medicinalproduct>
        <drugauthorizationnumb>21773</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>DIABETES MELLITUS NON-INSULIN-DEPENDENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOVANCE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SINGULAIR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WELLBUTRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAVIK</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051644-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060625</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006-144584-NL</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>72</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CLOSTRIDIUM DIFFICILE COLITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DELIRIUM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPONATRAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIRTAZAPINE</medicinalproduct>
        <drugauthorizationnumb>20415</drugauthorizationnumb>
        <drugdosagetext>7.5 MG DAILY ORAL, USED FOR 5 DAYS</drugdosagetext>
        <drugindication>MAJOR DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CHOLESTYRAMINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROCHLORPERAZINE TAB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL SPIROS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VANCOMYCIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051645-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060620</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US200605000686</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>3</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>FEEDING TUBE COMPLICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL NECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL TUBE INSERTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTI-ORGAN FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMATROPE</medicinalproduct>
        <drugauthorizationnumb>19640</drugauthorizationnumb>
        <drugdosagetext>0.2 MG</drugdosagetext>
        <drugindication>PROGERIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060301</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051646-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060609</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AVENTIS-200615158US</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>46</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIAC TAMPONADE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHRONIC MYELOMONOCYTIC LEUKAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERICARDIAL EFFUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLEURAL EFFUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREATMENT NONCOMPLIANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAXOTERE</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>20449</drugauthorizationnumb>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
        <drugindication>BREAST CANCER</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060401</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOXORUBICIN HCL</medicinalproduct>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
        <drugindication>BREAST CANCER</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060401</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYTOXAN</medicinalproduct>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
        <drugindication>BREAST CANCER</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060401</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE TAB</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
        <drugindication>PREMEDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051647-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060516</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AVENTIS-200615302GDDC</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>60</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>39</patientweight>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>LARYNGEAL CANCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OBSTRUCTIVE AIRWAYS DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>REFUSAL OF TREATMENT BY PATIENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUDDEN DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRACHEOSTOMY MALFUNCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOCETAXEL</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>20449</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>SQUAMOUS CELL CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060508</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060508</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CODE UNBROKEN</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SQUAMOUS CELL CARCINOMA</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060514</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051648-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060703</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2006US08574</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>64</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>OPEN WOUND</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN JAW</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN EXFOLIATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugauthorizationnumb>021223</drugauthorizationnumb>
        <drugdosagetext>EVERY 2 MONTHS</drugdosagetext>
        <drugindication>MULTIPLE MYELOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugauthorizationnumb>021223</drugauthorizationnumb>
        <drugdosagetext>EVERY 3 MONTHS</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugauthorizationnumb>021223</drugauthorizationnumb>
        <drugdosagetext>EVERY MONTH</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060601</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THALIDOMIDE</medicinalproduct>
        <drugdosagetext>REPORTED AS INTERMITTENT</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050801</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE TAB</medicinalproduct>
        <drugdosagetext>REPORTED AS INTERMITTENT</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050801</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051649-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006PV015657</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>60</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>96.1626</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BYETTA</medicinalproduct>
        <drugbatchnumb>A187964</drugbatchnumb>
        <drugauthorizationnumb>21773</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>DIABETES MELLITUS NON-INSULIN-DEPENDENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060430</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BYETTA</medicinalproduct>
        <drugbatchnumb>A187964</drugbatchnumb>
        <drugauthorizationnumb>21773</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>DIABETES MELLITUS NON-INSULIN-DEPENDENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060501</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMARYL</medicinalproduct>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS NON-INSULIN-DEPENDENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060501</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMARYL</medicinalproduct>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS NON-INSULIN-DEPENDENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060501</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051650-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060620</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US200606003335</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>72</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTOLERANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEMUR FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HOT FLUSH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EVISTA</medicinalproduct>
        <drugauthorizationnumb>20815</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051651-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060620</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US200604002526</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>44</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>DRUG TOXICITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUDDEN DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugbatchnumb>9RU70T</drugbatchnumb>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060221</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060227</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugbatchnumb>9RU70T</drugbatchnumb>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060228</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051652-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060627</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006PV015043</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>65</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>97.977</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIVERTICULITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCREATITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BYETTA</medicinalproduct>
        <drugauthorizationnumb>21773</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>DIABETES MELLITUS NON-INSULIN-DEPENDENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060518</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060616</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BYETTA</medicinalproduct>
        <drugauthorizationnumb>21773</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>DIABETES MELLITUS NON-INSULIN-DEPENDENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060619</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060620</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BYETTA</medicinalproduct>
        <drugauthorizationnumb>21773</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>DIABETES MELLITUS NON-INSULIN-DEPENDENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060621</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOVANCE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPROL-XL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051653-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060626</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006PV016389</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>46</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>163.2949</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ABNORMAL BEHAVIOUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>APNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHILLS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CYANOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DECREASED APPETITE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERAL PHYSICAL HEALTH DETERIORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMMOBILE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULSE ABSENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>REFUSAL OF TREATMENT BY PATIENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BYETTA</medicinalproduct>
        <drugauthorizationnumb>21773</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>DIABETES MELLITUS NON-INSULIN-DEPENDENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060120</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060217</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BYETTA</medicinalproduct>
        <drugauthorizationnumb>21773</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>DIABETES MELLITUS NON-INSULIN-DEPENDENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060217</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060612</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOPHAGE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COLACE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVASTATIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051654-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060620</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US200604002659</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANGER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISTURBANCE IN ATTENTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC STEATOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEROTONIN SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPEECH DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THINKING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WALKING AID USER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060401</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROZAC</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20000101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAZODONE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADVIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLEGRA-D/01367401/ (FEXOFENADINE HYDROCHLORIDE, PSEUDOEPHEDRINE HYDRO</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051655-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060626</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006PV016301</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>75</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>110.6777</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG DOSE OMISSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SCREAMING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BYETTA</medicinalproduct>
        <drugbatchnumb>9RY66M</drugbatchnumb>
        <drugauthorizationnumb>21773</drugauthorizationnumb>
        <drugdosagetext>5 MCG; BID; SC</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>DIABETES MELLITUS NON-INSULIN-DEPENDENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060313</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMULIN N</medicinalproduct>
        <drugdosagetext>68 UNITS; QD;</drugdosagetext>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19890101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMALOG</medicinalproduct>
        <drugdosagetext>20 UNITS; QD;</drugdosagetext>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19890101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HUMULIN N</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HUMULIN N</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HUMULIN N</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HUMALOG</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HUMALOG</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051656-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060620</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US200605004825</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>49</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>79.8</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD BILIRUBIN INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060501</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060417</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051657-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060620</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US200603000783</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>12</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BRAIN SCAN ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>STRATTERA</medicinalproduct>
        <drugauthorizationnumb>21411</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051658-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060517</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2006IE07270</companynumb>
    <primarysource>
      <reportercountry>IRELAND</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>61</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABSCESS JAW</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DENTAL TREATMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCISIONAL DRAINAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLAMMATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESORPTION BONE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTH EXTRACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTHACHE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LUSTRAL</medicinalproduct>
        <drugdosagetext>50 MG, QD</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIFENE</medicinalproduct>
        <drugdosagetext>UNK, PRN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARIMIDEX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CHEMOTHERAPEUTICS,OTHER</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugauthorizationnumb>021223</drugauthorizationnumb>
        <drugdosagetext>4 MG, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>METASTASES TO BONE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051659-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>8017584</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>60</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>63.63</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANOREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRONCHITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUID RETENTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THERAPY NON-RESPONDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZAROXOLYN</medicinalproduct>
        <drugauthorizationnumb>17386</drugauthorizationnumb>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XOPENEX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IPRATROPIUM BROMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLOVENT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACTONEL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYGEN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051660-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060703</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-KINGPHARMUSA00001-K200600874</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>68</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>88</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE SYSTOLIC INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWOLLEN TONGUE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALTACE</medicinalproduct>
        <drugauthorizationnumb>19901</drugauthorizationnumb>
        <drugdosagetext>5 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060612</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
        <drugdosagetext>300 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GOUT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19960101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugdosagetext>75 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>81 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMBIEN</medicinalproduct>
        <drugdosagetext>15 MG, QHS</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INSOMNIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACTOS</medicinalproduct>
        <drugdosagetext>30 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EFFEXOR</medicinalproduct>
        <drugdosagetext>^LOW DOSE^, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VYTORIN</medicinalproduct>
        <drugdosagetext>UNK, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRILOSEC</medicinalproduct>
        <drugdosagetext>UNK, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTROOESOPHAGEAL REFLUX DISEASE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051661-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060627</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006PV015874</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>82</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>90.7194</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DIABETES MELLITUS INADEQUATE CONTROL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCORRECT DOSE ADMINISTERED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BYETTA</medicinalproduct>
        <drugauthorizationnumb>21773</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>DIABETES MELLITUS NON-INSULIN-DEPENDENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060420</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060611</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BYETTA</medicinalproduct>
        <drugauthorizationnumb>21773</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>DIABETES MELLITUS NON-INSULIN-DEPENDENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060612</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INSULIN</medicinalproduct>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugindication>DIABETES MELLITUS NON-INSULIN-DEPENDENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060420</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060507</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INSULIN</medicinalproduct>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugindication>DIABETES MELLITUS NON-INSULIN-DEPENDENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060508</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060611</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INSULIN</medicinalproduct>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugindication>DIABETES MELLITUS NON-INSULIN-DEPENDENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060612</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACTOS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMARYL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CITRACAL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051662-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060705</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200612802BCC</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>52</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ARTERY DISSECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UNEVALUABLE EVENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALKA SELTZER PLUS COLD AND SINUS</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051663-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060626</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200612700BCC</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>86.1834</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>EPISTAXIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROOESOPHAGEAL REFLUX DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALEVE (CAPLET)</medicinalproduct>
        <drugbatchnumb>284294B</drugbatchnumb>
        <drugauthorizationnumb>20204</drugauthorizationnumb>
        <drugdosagetext>220 MG, PRN, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRALGIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>PRN, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEADACHE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>PRN, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051664-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060626</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200612621BCC</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>79</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>86.1834</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALEVE (CAPLET)</medicinalproduct>
        <drugbatchnumb>223736C</drugbatchnumb>
        <drugauthorizationnumb>20204</drugauthorizationnumb>
        <drugdosagetext>220 MG, ONCE, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRALGIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060619</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BLOOD PRESSURE MEDICATION</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051665-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060630</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200612591BCC</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>61</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>68.4932</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BREAST ENLARGEMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VAGINAL DISCHARGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GENUINE BAYER TABLETS (ACETYLSALICYLIC ACID)</medicinalproduct>
        <drugdosagetext>325 MG, QD, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANTICOAGULANT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060124</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GENUINE BAYER TABLETS (ACETYLSALICYLIC ACID)</medicinalproduct>
        <drugdosagetext>325 MG, QD, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CORONARY ARTERY BYPASS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060124</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GENUINE BAYER TABLETS (ACETYLSALICYLIC ACID)</medicinalproduct>
        <drugdosagetext>325 MG, QD, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ISCHAEMIC HEART DISEASE PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060124</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060626</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYZAAR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOVANCE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALTACE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051666-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006BI009421</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>40</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>LYMPHOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugbatchnumb>P35068</drugbatchnumb>
        <drugdosagetext>30 UG;QW;IM</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051667-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006BI009424</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>62</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>KNEE ARTHROPLASTY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOWER LIMB FRACTURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugdosagetext>30 UG;QW;IM</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19960901</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>20031001</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051668-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060619</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US200606003016</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HYPERCALCAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugauthorizationnumb>21318</drugauthorizationnumb>
        <drugdosagetext>LIQUID</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051669-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060505</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>TH-GILEAD-2006-0009561</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>40</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANOREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ATRIAL TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ATRIOVENTRICULAR BLOCK SECOND DEGREE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CREATININE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA EXERTIONAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ELECTROCARDIOGRAM T WAVE INVERSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOKALAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPONATRAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEPHROPATHY TOXIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALLOR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLEURAL EFFUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROTEINURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL TUBULAR DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EMTRICITABINE/TENOFOVIR DISOPROXIL FUMARATE</medicinalproduct>
        <drugbatchnumb>72913</drugbatchnumb>
        <drugauthorizationnumb>21752</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060408</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EMTRICITABINE/TENOFOVIR DISOPROXIL FUMARATE</medicinalproduct>
        <drugbatchnumb>72913</drugbatchnumb>
        <drugauthorizationnumb>021752</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050919</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060407</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SAQUINAVIR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050919</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RITONAVIR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050919</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COTRIMOXAZOLE</medicinalproduct>
        <drugdosagetext>400/80 MG</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060124</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060405</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COTRIMOXAZOLE</medicinalproduct>
        <drugdosagetext>800/160 MG</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050820</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051221</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUCONAZOLE</medicinalproduct>
        <drugindication>INFECTION PROPHYLAXIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051670-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesscongenitalanomali>1</seriousnesscongenitalanomali>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060519</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GILEAD-2006-0009607</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>3</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>APNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION NEONATAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEVELOPMENTAL DELAY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE MOVEMENT DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEEDING DISORDER NEONATAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERREFLEXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOPITUITARISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTONIA NEONATAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFANTILE APNOEIC ATTACK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METABOLIC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NERVOUS SYSTEM DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OXYGEN SATURATION DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY DISORDER NEONATAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS NEONATAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRISOMY 15</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRUVADA</medicinalproduct>
        <drugauthorizationnumb>21752</drugauthorizationnumb>
        <drugadministrationroute>064</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040316</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050330</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVIR</medicinalproduct>
        <drugadministrationroute>064</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040316</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050330</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REYATAZ</medicinalproduct>
        <drugadministrationroute>064</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040316</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050330</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KALETRA</medicinalproduct>
        <drugadministrationroute>064</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050330</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050525</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRIZIVIR</medicinalproduct>
        <drugadministrationroute>064</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050330</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050525</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VIRACEPT</medicinalproduct>
        <drugadministrationroute>064</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050603</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051227</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COMBIVIR</medicinalproduct>
        <drugadministrationroute>064</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050603</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051227</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZIDOVUDINE</medicinalproduct>
        <drugadministrationroute>064</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051103</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051103</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZIDOVUDINE</medicinalproduct>
        <drugadministrationroute>064</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051103</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051103</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRIMETHOPRIM + SULFAMETHOXAZOLE</medicinalproduct>
        <drugadministrationroute>064</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLATE SUPPLEMENT</medicinalproduct>
        <drugadministrationroute>064</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051671-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060712</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>80</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>68</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COORDINATION ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NYSTAGMUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WRONG DRUG ADMINISTERED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PHENYTOIN</medicinalproduct>
        <drugdosagetext>400 MG DAILY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONVULSION</drugindication>
        <drugtreatmentduration>10</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051672-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060619</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US200602005246</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>7</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>22.2</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PETIT MAL EPILEPSY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>STRATTERA</medicinalproduct>
        <drugauthorizationnumb>21411</drugauthorizationnumb>
        <drugdosagetext>25 MG</drugdosagetext>
        <drugindication>ATTENTION DEFICIT/HYPERACTIVITY DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050803</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060214</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051673-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060619</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US200603005278</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>34</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>66.7</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ALANINE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASPARTATE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CRYING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG WITHDRAWAL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ENDOMETRIOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HOT FLUSH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENTAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MIGRAINE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULAR WEAKNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY RATE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SENSORY DISTURBANCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>F1J-MC-HMEF DULOXETINE 60/120MG VS PLB I(DULOXETINE HYDROCHLORIDE) CAP</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>FIBROMYALGIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060313</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTIVITAMINS (ASCORBIC ACID, ERGOCALCIFEROL, FOLIC ACID, NICOTINAMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DARVOCET-N 100</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051674-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060712</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>107</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ACUTE PRERENAL FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD ALBUMIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIALYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAMIDRONATE DISODIUM</medicinalproduct>
        <drugdosagetext>60 MG DAILY IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>OSTEITIS DEFORMANS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060428</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060501</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INDOMETHACIN</medicinalproduct>
        <drugdosagetext>`25 MG Q8H PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GOUT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060430</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060501</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INDOMETHACIN</medicinalproduct>
        <drugdosagetext>`25 MG Q8H PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060430</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060501</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INDOMETHACIN</medicinalproduct>
        <drugdosagetext>`25 MG Q8H PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060430</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060501</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051675-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060616</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US200605005732</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>50</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>GASTRIC CANCER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugindication>PAIN</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051676-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060630</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006BI009485</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>47</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOSITIS</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>20051201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051230</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>20060502</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051677-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060619</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US200603004899</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>43</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>99.8</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FEELING JITTERY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FORMICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESTLESSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugindication>SEASONAL AFFECTIVE DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060131</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060206</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugindication>SEASONAL AFFECTIVE DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060207</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060219</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LAMISIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NAPROXEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ULTRAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DETROL - SLOW RELEASE (TOLTERODINE L-TARTRATE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASA (ASPIRIN (ACETYLSALICYLIC ACID)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051678-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060712</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>84.8226</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ACIDOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ATRIAL FIBRILLATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CLOSTRIDIAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VANCOMYCIN</medicinalproduct>
        <drugdosagetext>1 G BY LEVEL IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>LOCALISED INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060528</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOSYN</medicinalproduct>
        <drugdosagetext>2.25 GM Q6 IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>LOCALISED INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060520</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060526</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLINDAMYCIN</medicinalproduct>
        <drugdosagetext>300 MG D8</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060428</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060501</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051679-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060619</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US200605004817</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>38</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>117.9</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>TRANSIENT ISCHAEMIC ATTACK</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>60 MG, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANXIETY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060210</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060507</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRILOSEC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEGA 3 (FISH OIL)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051680-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060630</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006BI009487</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>52</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040710</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051681-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060620</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>USA0510111758</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>43</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>80.7</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ALANINE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD BILIRUBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERNATIONAL NORMALISED RATIO DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050719</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EXCEDRIN (ACETYLSALICYLIC ACID, CAFFEINE, PARACETAMOL)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051682-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060619</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US200606000461</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>92</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>50.8</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DIVERTICULUM INTESTINAL HAEMORRHAGIC</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugauthorizationnumb>21318</drugauthorizationnumb>
        <drugdosagetext>20 UG, DAILY (1/D)</drugdosagetext>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060301</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIGOXIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DILTIAZEM HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DETROL - SLOW RELEASE (TOLTERODINE L-TARTRATE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMBIEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051683-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060712</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>64</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN LOWER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTESTINAL OBSTRUCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RECTAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENOXAPARIN SODIUM</medicinalproduct>
        <drugdosagetext>SQ</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PULMONARY OEDEMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060509</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051684-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060630</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006BI009488</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>39</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DYSSTASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugdosagetext>30 UG;QW;IM</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050228</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051685-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060705</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-BRISTOL-MYERS SQUIBB COMPANY-13435813</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>47</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>87</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>C-REACTIVE PROTEIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CISPLATIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CERVIX CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060523</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060523</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051686-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060704</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IT-BRISTOL-MYERS SQUIBB COMPANY-13432067</companynumb>
    <primarysource>
      <reportercountry>ITALY</reportercountry>
      <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>COMPLETED SUICIDE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ABILIFY</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA, PARANOID TYPE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060616</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060628</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
        <drugindication>SCHIZOPHRENIA, PARANOID TYPE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040520</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060629</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMARYL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD GLUCOSE</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060630</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALIUM</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060629</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040618</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051687-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060712</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>56</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>SWELLING FACE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugdosagetext>20 MG DAILY</drugdosagetext>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060428</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051688-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060419</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-13351630</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>16</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>82</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>AMNESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CIRCULATORY COLLAPSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCREASED APPETITE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIBIDO INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAINFUL ERECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ABILIFY</medicinalproduct>
        <drugdosagetext>DOSE VALUE:  15 OR 20 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONDUCT DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
        <drugtreatmentduration>9</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRAZODONE HCL</medicinalproduct>
        <drugauthorizationnumb>018207</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SLEEP DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050603</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050715</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRILEPTAL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>AFFECTIVE DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXEDRINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051689-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060406</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-BRISTOL-MYERS SQUIBB COMPANY-13341102</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>AGGRESSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ABILIFY</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051690-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060713</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PR-BRISTOL-MYERS SQUIBB COMPANY-13441472</companynumb>
    <primarysource>
      <reportercountry>PUERTO RICO</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>82</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HYPOPYON</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL ACUITY REDUCED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VITRITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KENALOG-40</medicinalproduct>
        <drugbatchnumb>6C15315</drugbatchnumb>
        <drugauthorizationnumb>014901</drugauthorizationnumb>
        <drugadministrationroute>031</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060530</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VIGAMOX</medicinalproduct>
        <drugdosagetext>DOSE VALUE: 10 DEGREE</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COZAAR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACTOS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COSOPT</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051691-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060712</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>59</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>SWELLING FACE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREATMENT NONCOMPLIANCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugdosagetext>40 MG DAILY</drugdosagetext>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060201</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051692-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060616</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US200606004026</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>47</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABNORMAL SENSATION IN EYE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIPLOPIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMPAIRED DRIVING ABILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHOTOPHOBIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISION BLURRED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL DISTURBANCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>60 MG, DAILY (1/D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEPAKOTE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EFFEXOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WELLBUTRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051693-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060712</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>49</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG THERAPY CHANGED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWELLING FACE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugdosagetext>20 MG [1 DOSE]</drugdosagetext>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060510</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051694-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060615</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US200606003805</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>25</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULAR WEAKNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SCREAMING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugbatchnumb>9RY23P</drugbatchnumb>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>60 MG</drugdosagetext>
        <drugindication>FIBROMYALGIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPAMAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARDCAL (DILTIAZEM HYDROCHLORIDE)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051695-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006BI003963</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>57</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>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>20041008</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060210</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051696-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060616</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US200606004167</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>67</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIAC OPERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NERVOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMALOG</medicinalproduct>
        <drugauthorizationnumb>20563</drugauthorizationnumb>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMULIN N</medicinalproduct>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051697-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060712</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>57</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SIMILAR REACTION ON PREVIOUS EXPOSURE TO DRUG</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IOHEXOL (CONTRAST DYE)</medicinalproduct>
        <drugdosagetext>50 ML (X1)</drugdosagetext>
        <drugindication>ANGIOGRAM</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060502</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051698-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060619</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US200606004256</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE BRUISING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERVERTEBRAL DISC PROTRUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPINAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STAPHYLOCOCCAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL ACUITY REDUCED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMALOG PEN</medicinalproduct>
        <drugbatchnumb>0RC83M</drugbatchnumb>
        <drugauthorizationnumb>20563</drugauthorizationnumb>
        <drugdosagetext>50 U, 3/D</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMALOG</medicinalproduct>
        <drugdosagetext>50 U, 3/D</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19960101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051699-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060619</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US200606004302</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>56</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY OCCLUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GALLBLADDER DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROCEDURAL PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMALOG</medicinalproduct>
        <drugauthorizationnumb>20563</drugauthorizationnumb>
        <drugdosagetext>AS NEEDED, SUB. PUMP</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051700-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060712</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>56</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CEREBRAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEAD INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENTAL STATUS CHANGES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORTHOSTATIC HYPOTENSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHLORDIAZEPOXIDE</medicinalproduct>
        <drugdosagetext>TAPER-SEE TEXT</drugdosagetext>
        <drugindication>ALCOHOL WITHDRAWAL SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060527</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060529</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLONIDINE</medicinalproduct>
        <drugdosagetext>X1</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060527</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LORAZEPAM</medicinalproduct>
        <drugdosagetext>X1</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060527</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051701-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060627</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006BI003540</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>47</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>85.2762</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>OVERDOSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugdosagetext>30 UG;QW;IM</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060207</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051702-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060619</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US200606004386</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>68</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>61.2</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE FLUCTUATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEDICAL DEVICE COMPLICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SCIATICA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WRONG TECHNIQUE IN DRUG USAGE PROCESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMALOG MIX 75/25</medicinalproduct>
        <drugbatchnumb>FF5AT3A</drugbatchnumb>
        <drugauthorizationnumb>20563</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HUMALOG MIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIURETICS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPROL-XL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051703-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060713</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2006US09031</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>63</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ABNORMAL BEHAVIOUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JAUNDICE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL INTAKE REDUCED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMISIL</medicinalproduct>
        <drugauthorizationnumb>020539</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051704-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060706</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2006BE10148</companynumb>
    <primarysource>
      <reportercountry>BELGIUM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MENTAL DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FEMARA</medicinalproduct>
        <drugauthorizationnumb>020726</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BREAST CANCER METASTATIC</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051705-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060705</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHFR2006GB02151</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BREAST CANCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BREAST CANCER METASTATIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TUMOUR HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FEMARA</medicinalproduct>
        <drugauthorizationnumb>020726</drugauthorizationnumb>
        <drugindication>BREAST CANCER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051706-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060609</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2006IE08696</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>DYSMENORRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENSTRUAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VAGINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOSEC</medicinalproduct>
        <drugdosagetext>20 MG, QD</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCICHEW-D3 MITE</medicinalproduct>
        <drugdosagetext>1 DF, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SOLPADOL</medicinalproduct>
        <drugdosagetext>UNK, PRN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZIMOVANE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FEMARA</medicinalproduct>
        <drugauthorizationnumb>020726</drugauthorizationnumb>
        <drugdosagetext>2.5 MG/D</drugdosagetext>
        <drugindication>BREAST CANCER FEMALE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050505</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051708-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060712</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>62</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>COAGULOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XIGRIS</medicinalproduct>
        <drugdosagetext>24 MCG/KG/HR</drugdosagetext>
        <drugindication>SEPSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060415</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060418</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051709-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060616</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US200606004144</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPINAL FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STOMACH DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STRESS FRACTURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugauthorizationnumb>21318</drugauthorizationnumb>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051710-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2005BI003682</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>53</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HIP DYSPLASIA</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>19960501</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>5051711-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060712</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>59</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ORAL INTAKE REDUCED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCREATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ABACAVIR</medicinalproduct>
        <drugdosagetext>300 BID</drugdosagetext>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060301</drugstartdate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct> ATAZANAVIR</medicinalproduct>
        <drugdosagetext> 400 MG DAILY</drugdosagetext>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060301</drugstartdate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RITONAVIR</medicinalproduct>
        <drugdosagetext>100 MG DAILY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMIVUDINE</medicinalproduct>
        <drugdosagetext>150 MG BID</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051712-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060712</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>53</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>79</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CLOSTRIDIAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CLOSTRIDIUM DIFFICILE COLITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOSYN</medicinalproduct>
        <drugdosagetext>Q6H IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>GASTROINTESTINAL INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060303</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060406</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOSYN</medicinalproduct>
        <drugdosagetext>Q6H IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PNEUMONIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060303</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060406</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VANCOMYCIN</medicinalproduct>
        <drugdosagetext>Q12 H IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PNEUMONIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060314</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060319</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VANCOMYCIN</medicinalproduct>
        <drugdosagetext>Q12 H IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PNEUMONIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060403</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060413</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CEFEPIME</medicinalproduct>
        <drugindication>GASTROINTESTINAL INFECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CEFEPIME</medicinalproduct>
        <drugindication>PNEUMONIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051713-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060705</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006BI009616</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>53</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DIABETES MELLITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIMB INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THERAPY NON-RESPONDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOE AMPUTATION</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>20060402</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051714-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060712</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>63</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATOCRIT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN</medicinalproduct>
        <drugdosagetext>CONTINUOUS INFUSION</drugdosagetext>
        <drugindication>PULMONARY EMBOLISM</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060412</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060424</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051715-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060705</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006BI009618</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BREAST CANCER FEMALE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>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>5051716-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060705</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006BI009620</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>21</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA FACIAL</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>20030131</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>5051717-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060712</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>65.7716</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY RETENTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXYCODONE 40 MG (PT GOT @ CVS PHARMACY 865-525-4533) RX#697779</medicinalproduct>
        <drugdosagetext>40 MG Q8H PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060630</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060714</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXYCODONE 40 MG (PT GOT @ CVS PHARMACY 865-525-4533) RX#697779</medicinalproduct>
        <drugdosagetext>40 MG Q8H PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SURGERY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060630</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060714</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051718-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060705</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006BI009621</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>66</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugdosagetext>30 UG; QW; IM</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051719-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060705</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>USA-2005-0020345</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>43</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ACUTE MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANGINA PECTORIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD TESTOSTERONE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE CONGESTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIOMEGALY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARPAL TUNNEL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLD SWEAT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSED LEVEL OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISEASE PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG DEPENDENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPHONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EMOTIONAL DISTRESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ESSENTIAL HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FACE INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INADEQUATE ANALGESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERVERTEBRAL DISC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERVERTEBRAL DISC PROTRUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JOINT HYPEREXTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LACERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL STIFFNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NASAL CONGESTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ODYNOPHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN JAW</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALLOR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PELVIC PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHINORRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ROAD TRAFFIC ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEDATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPINAL HAEMANGIOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TESTICULAR PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXYCONTIN</medicinalproduct>
        <drugauthorizationnumb>20553</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORTAB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENADRYL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SOMA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOPRESSOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRINIVIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRAVACHOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NITROGLYCERIN SUBLINGUAL SPRAY</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 C AND E (ASCORBIC ACID, TOCOPHEROL)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051720-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060705</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006BI009624</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>43</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</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>20040608</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051721-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060712</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>59</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>49.8957</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ENDOPHTHALMITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL ACUITY REDUCED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KENALOG-40</medicinalproduct>
        <drugbatchnumb>6C13553</drugbatchnumb>
        <drugdosagetext>4 MG ONCE INTRAVITREAL</drugdosagetext>
        <drugindication>MACULAR OEDEMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060706</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KENALOG-40</medicinalproduct>
        <drugbatchnumb>6B21109</drugbatchnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051722-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060706</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006BI005194</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>47</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>KNEE 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>20010801</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>5051723-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060705</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006BI003793</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>57</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BACTERIAL SEPSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CATHETER RELATED INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHILLS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLUENZA LIKE ILLNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POSTOPERATIVE FEVER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSEUDOMONAS INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUPRAVENTRICULAR TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WOUND COMPLICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WOUND DRAINAGE</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>20040917</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051724-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060714</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>60</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CEFEPIME</medicinalproduct>
        <drugdosagetext>2 G IV Q8 H</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BONE DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060711</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051725-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060705</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006BI000954</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>43</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>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>19960901</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOTREL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ESTRADIOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BACLOFEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZANAFLEX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANOXIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DITROPAN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051726-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006062364</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>46</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEG-INTRON</medicinalproduct>
        <drugdosagetext>SUBCUTANEOUS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBETOL</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELEXA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHADONE HYDROCHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051727-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060712</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>69</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>55.7924</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugindication>SPINAL COLUMN STENOSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051728-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060703</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200612136BCC</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>69.8539</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>OCULAR VASCULAR DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL DISTURBANCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>QD, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051729-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060630</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006-04-0929</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>58</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DELIRIUM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATEMESIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLUENZA LIKE ILLNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LACTIC ACIDOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENTAL STATUS CHANGES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA STAPHYLOCOCCAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPTIC SHOCK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STOMACH DISCOMFORT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEG-INTRON</medicinalproduct>
        <drugtreatmentduration>20</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RIBAVIRIN</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugtreatmentduration>20</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROZAC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN BABY</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALIUM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051730-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060712</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>51</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>122.4712</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH PRURITIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN LESION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVELOX</medicinalproduct>
        <drugdosagetext>ONE QD</drugdosagetext>
        <drugindication>SINUSITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060623</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060627</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRILOSEC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLARITIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NASONEX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051731-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060703</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200612022BCC</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>64</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>75.7507</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>KNEE ARTHROPLASTY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRALGIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19760101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRALGIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19900101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DARVOCET</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KLONOPIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RELAFEN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051732-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060706</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200611487BCC</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>RECTAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MILK OF MAGNESIA TAB</medicinalproduct>
        <drugbatchnumb>217025N</drugbatchnumb>
        <drugdosagetext>ONCE, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONSTIPATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051733-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnesscongenitalanomali>1</seriousnesscongenitalanomali>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060712</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>54.4316</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERDAL</medicinalproduct>
        <drugdosagetext>50 MG SHOTS 3X IN 3 WEEKS</drugdosagetext>
        <drugindication>PSYCHOTIC DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060525</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060621</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051734-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060626</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006S1000133</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>14</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEDICAL DEVICE COMPLICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OXYGEN SATURATION DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INOMAX</medicinalproduct>
        <drugauthorizationnumb>20845</drugauthorizationnumb>
        <drugdosagetext>CONT;INH</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060617</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051735-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060630</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200610281BWH</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>47</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>60</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ENTERITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ODYNOPHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SORAFENIB</medicinalproduct>
        <drugauthorizationnumb>21923</drugauthorizationnumb>
        <drugdosagetext>200 MG, BID, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>METASTATIC RENAL CELL CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051208</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051230</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COLACE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROMORPHONE HYDROCHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHADONE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FENTANYL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051736-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060712</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>41</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>97.977</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANOREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRY MOUTH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEXAPRO</medicinalproduct>
        <drugdosagetext>10 MG Q DAY ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GENERALISED ANXIETY DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060611</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060614</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051737-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060703</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200610847BWH</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>64</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>63.5036</patientweight>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>CLOSTRIDIUM DIFFICILE COLITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METASTASES TO GASTROINTESTINAL TRACT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METASTASES TO STOMACH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METASTATIC RENAL CELL CARCINOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SMALL INTESTINAL OBSTRUCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXAVAR</medicinalproduct>
        <drugauthorizationnumb>21923</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RENAL CELL CARCINOMA STAGE UNSPECIFIED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060209</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060212</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXAVAR</medicinalproduct>
        <drugauthorizationnumb>21923</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RENAL CELL CARCINOMA STAGE UNSPECIFIED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLEXERIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PERCOCET</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMINS NOS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COLACE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LYSINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REJUVEX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COQ10</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MARINOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COLACE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051738-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060712</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>78</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>66.2252</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>COMPLETED SUICIDE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEXEVA</medicinalproduct>
        <drugdosagetext>ONCE EVERY 2 WEEKS</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROMETHAZINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051739-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060705</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>14174</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>45</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>75.2971</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLEURISY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY TOXICITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PACLITAXEL</medicinalproduct>
        <drugauthorizationnumb>76131</drugauthorizationnumb>
        <drugdosagetext>312 MG FORTNIGHTLY IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050811</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050825</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PACLITAXEL</medicinalproduct>
        <drugdosagetext>250 MG FORTNIGHTLY IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050825</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050908</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051740-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060707</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200612768BWH</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>61</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ATELECTASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD ALBUMIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD LACTATE DEHYDROGENASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE CONGESTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBRAL ISCHAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSGEUSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EJECTION FRACTION DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING COLD</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERSTITIAL LUNG DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERVERTEBRAL DISC DEGENERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPHANGIOSIS CARCINOMATOSA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERICARDIAL EFFUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERICARDIAL FIBROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY FIBROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTHAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOPHLEBITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>YELLOW SKIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXAVAR</medicinalproduct>
        <drugauthorizationnumb>21923</drugauthorizationnumb>
        <drugdosagetext>400 MG, BID, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>METASTATIC RENAL CELL CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051017</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060207</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXAVAR</medicinalproduct>
        <drugauthorizationnumb>21923</drugauthorizationnumb>
        <drugdosagetext>400 MG, BID, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>METASTATIC RENAL CELL CARCINOMA</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060303</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COLACE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCONTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PERCOCET</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SENNA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MIRALAX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051741-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060630</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200614412BWH</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>ANURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIALYSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRASYLOL</medicinalproduct>
        <drugauthorizationnumb>20304</drugauthorizationnumb>
        <drugdosagetext>INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CORONARY ARTERY BYPASS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRASYLOL</medicinalproduct>
        <drugauthorizationnumb>20304</drugauthorizationnumb>
        <drugdosagetext>INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>HEART VALVE REPLACEMENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FACTOR VII</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051742-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060712</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>60</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>99.7913</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COZAAR</medicinalproduct>
        <drugbatchnumb>F4669</drugbatchnumb>
        <drugdosagetext>100 MG QD PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060623</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060625</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051743-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060627</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>14182</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>55</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>111.5849</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PULMONARY FIBROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY TOXICITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PACLITAXEL</medicinalproduct>
        <drugauthorizationnumb>76131</drugauthorizationnumb>
        <drugdosagetext>315 MG ONCE IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060408</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060506</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051744-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060705</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200613941BWH</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>89</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>79.7</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ARRHYTHMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXAVAR</medicinalproduct>
        <drugauthorizationnumb>21923</drugauthorizationnumb>
        <drugdosagetext>400 MG, QD, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RENAL CELL CARCINOMA STAGE UNSPECIFIED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060501</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEGA 3 [FISH OIL]</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NITROSTAT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN B COMPLEX CAP</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TEMAZEPAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRILOSEC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COLACE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CORDARONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARANESP</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLOMAX [MORNIFLUMATE]</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZETIA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COZAAR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BISACODYL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051745-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060712</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>68.9467</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREATMENT NONCOMPLIANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LUNESTA</medicinalproduct>
        <drugdosagetext>2 MG Q HS PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INSOMNIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060615</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060620</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051746-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060626</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006-06-1098</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>50</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>86</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CHILLS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEEP VEIN THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEBRILE NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FUNGAL RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STOMATITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TEMODAR</medicinalproduct>
        <drugauthorizationnumb>21029</drugauthorizationnumb>
        <drugdosagetext>150 MG DAY ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GLIOBLASTOMA MULTIFORME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060417</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060528</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DILANTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEPRON</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DECADRON</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRILOSEC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COLACE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RADIATION THERAPY</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051747-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060712</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>52</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>POSTMENOPAUSAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>25 MG TWICE WEEKLY SUBQ</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051748-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060616</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US200604001967</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>47</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>60.5</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD CREATININE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPHIL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALIMTA</medicinalproduct>
        <drugauthorizationnumb>21462</drugauthorizationnumb>
        <drugdosagetext>795 MG, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060329</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYANOCOBALAMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACIPHEX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VERAPAMIL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051749-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060713</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DECREASED APPETITE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL INTAKE REDUCED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH ERYTHEMATOUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH PRURITIC</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXCARBAZEPINE</medicinalproduct>
        <drugindication>NEUTROPENIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIPHENHYDRAMINE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATARAX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051750-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060704</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>DE-JNJFOC-20060602579</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIPASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMINYL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMINYL</medicinalproduct>
        <drugauthorizationnumb>021169</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEMENTIA ALZHEIMER'S TYPE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051751-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060703</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>ID-JNJFOC-20060603431</companynumb>
    <primarysource>
      <reportercountry>INDONESIA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>54</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>50</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENTRICULAR FIBRILLATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NESIRITIDE</medicinalproduct>
        <drugbatchnumb>R0020A</drugbatchnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NESIRITIDE</medicinalproduct>
        <drugbatchnumb>R0020A</drugbatchnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NESIRITIDE</medicinalproduct>
        <drugbatchnumb>R0020A</drugbatchnumb>
        <drugauthorizationnumb>020920</drugauthorizationnumb>
        <drugdosagetext>BOLUS</drugdosagetext>
        <drugindication>CARDIAC FAILURE ACUTE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOBUTAMINE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPILET</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ISDN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIGOXIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051752-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060619</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US200606004387</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>46</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MEMORY IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ROAD TRAFFIC ACCIDENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMULIN R</medicinalproduct>
        <drugauthorizationnumb>18780</drugauthorizationnumb>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMULIN L</medicinalproduct>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051753-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060713</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FLUID INTAKE REDUCED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROENTERITIS VIRAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENTAL STATUS CHANGES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCREATITIS ACUTE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TACROLIMUS</medicinalproduct>
        <drugdosagetext>8 MG 2 X/D PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TACROLIMUS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALGANCICLOVIR HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MYCOPHENOLATE MOFETIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COTRIMOXAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LUNESTA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NIZANTIDINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VICODIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051754-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060713</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DYSURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEAD INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMOTHORAX</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RIB FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY RETENTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXANDRIN</medicinalproduct>
        <drugbatchnumb>A11329</drugbatchnumb>
        <drugdosagetext>20 MG BID X 12 WKS ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>WEIGHT DECREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060510</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051755-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060702</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006-07-0173</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>54</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEG-INTRON</medicinalproduct>
        <drugdosagetext>SUBCUTANEOUS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060428</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RIBAVIRIN</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060428</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMARYL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOPHAGE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NAPROXEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROTONIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRIAMTERENE AND HYDROCHLOROTHIAZIDE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051756-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060619</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US200606004381</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMULIN R</medicinalproduct>
        <drugauthorizationnumb>18780</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051757-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060713</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>97.977</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>NOCTURIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GABAPENTIN</medicinalproduct>
        <drugdosagetext>2 CAPSULES TID ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NEUROPATHY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060331</drugenddate>
      </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>5051758-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060616</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US200606005417</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>71</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANGINA PECTORIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLISTER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE FLUCTUATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONTUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GANGRENE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERKERATOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OPEN WOUND</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERIPHERAL VASCULAR DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WOUND</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMULIN N</medicinalproduct>
        <drugbatchnumb>9RR88M</drugbatchnumb>
        <drugauthorizationnumb>18780</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMALOG PEN</medicinalproduct>
        <drugbatchnumb>8RY13M</drugbatchnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060608</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMALOG PEN</medicinalproduct>
        <drugbatchnumb>8RY13M</drugbatchnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060608</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051759-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060626</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2005S1012098</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </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>INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZAPINE</medicinalproduct>
        <drugauthorizationnumb>75417</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZAPINE</medicinalproduct>
        <drugauthorizationnumb>75417</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOFLOXACIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZIPRASIDONE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SETRALINE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051760-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060713</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>16</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>50</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARYNGEAL ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH MORBILLIFORM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMOTRIGINE</medicinalproduct>
        <drugdosagetext>25 MG QOD</drugdosagetext>
        <drugindication>CONVULSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060609</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060620</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VALPROIC ACID</medicinalproduct>
        <drugdosagetext>1500 MG QHS</drugdosagetext>
        <drugindication>CONVULSION</drugindication>
        <drugtreatmentduration>11</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051761-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060626</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006S1004684</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>24</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>81.1939</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>APALLIC SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SELF-MEDICATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FENTANYL TRANSDERMAL SYSTEM</medicinalproduct>
        <drugauthorizationnumb>76258</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060224</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060225</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051762-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060713</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>52.8</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CULTURE WOUND POSITIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALIGNANT NEOPLASM PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POST PROCEDURAL COMPLICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SERRATIA INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IRINOTECAN HCL</medicinalproduct>
        <drugdosagetext>325MG/M2 DAY 1,8,22,29 IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>GLIOBLASTOMA MULTIFORME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060614</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IRINOTECAN HCL</medicinalproduct>
        <drugdosagetext>325MG/M2 DAY 1,8,22,29 IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>GLIOBLASTOMA MULTIFORME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060621</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IRINOTECAN HCL</medicinalproduct>
        <drugdosagetext>325MG/M2 DAY 1,8,22,29 IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>GLIOBLASTOMA MULTIFORME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060707</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TEMODAR</medicinalproduct>
        <drugdosagetext>200MG/M2 DAYS 1-5 PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GLIOBLASTOMA MULTIFORME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050614</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060618</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DILANTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE TAB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SENOKOT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENDOCET</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051763-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060626</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006S1005421</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>37</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>117.9352</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>AGGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AGITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HOSTILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IRRITABILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMITRIPTYLINE HCL</medicinalproduct>
        <drugauthorizationnumb>86009</drugauthorizationnumb>
        <drugdosagetext>200 MG; QD; ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BIPOLAR I DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060528</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060608</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONAZEPAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARBAMAZEPINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RISPERIDONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PAROXETINE HCL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051764-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060713</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>63</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>76.2043</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA EXERTIONAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OXYGEN SATURATION DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOCETAXEL</medicinalproduct>
        <drugdosagetext>75MG/M2 IV EVERY 2 WEEK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060523</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOCETAXEL</medicinalproduct>
        <drugdosagetext>75MG/M2 IV EVERY 2 WEEK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060606</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOCETAXEL</medicinalproduct>
        <drugdosagetext>75MG/M2 IV EVERY 2 WEEK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060620</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOCETAXEL</medicinalproduct>
        <drugdosagetext>75MG/M2 IV EVERY 2 WEEK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060711</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEULASTA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE TAB</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051765-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060626</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006S1005839</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>78</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>75.7507</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXTENDED PHENYTOIN SODIUM</medicinalproduct>
        <drugbatchnumb>1N3267</drugbatchnumb>
        <drugauthorizationnumb>40298</drugauthorizationnumb>
        <drugdosagetext>300 MG; QHS; PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONVULSION PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060516</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060622</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXTENDED PHENYTOIN SODIUM</medicinalproduct>
        <drugbatchnumb>1N3267</drugbatchnumb>
        <drugauthorizationnumb>40298</drugauthorizationnumb>
        <drugdosagetext>300 MG; QHS; PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONVULSION PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060624</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060625</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVODART</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOSAMAX ONCE WEEKLY</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UROCEF</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UROCIT-K</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051766-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060713</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>130.6359</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>IMPAIRED HEALING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JAW DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN ULCER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TARCEVA</medicinalproduct>
        <drugdosagetext>100 MG, QD, PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NEOPLASM MALIGNANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060114</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVASTIN</medicinalproduct>
        <drugdosagetext>10 MG/M2 Q 14 DAYS IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NEOPLASM MALIGNANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051114</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060109</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051769-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060713</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>82</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>63.9</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051770-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060713</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>93</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>72.2</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051771-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060713</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>93</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>72.2</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051772-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060713</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>72</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>108</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051773-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060713</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>93</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>72.2</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051774-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060712</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>70</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>106.6</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VARDENAFIL HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL SPIROS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUOXETINE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CETIRIZINE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUTICASONE PROP</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLOTRIMAZOLE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051775-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060712</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>59</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>81.6</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FENTANYL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYPROMELLOSE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GABAPENTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIDOCAINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HYDROCHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MECLIZINE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCODONE 5/ACETAMINOPHEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MISOPROSTOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DILANTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONAZEPAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CETYLPYRDINIUM 0.07%/MENTHOL 2MG LOZ</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN B COMPLEX/VITAMIN C</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLOTRIMAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOCUSATE NA 50MG/SENNOSIDES</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051776-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060712</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>76</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>87.5</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TERAZOSIN HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FINASTERIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLOPIDOGREL BISULFATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RAMIPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SULINDAC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CILOSTAZOL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051777-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060714</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>10</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG ERUPTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMOXICILLIN</medicinalproduct>
        <drugdosagetext>1/2 TEASPOON  TID PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OTITIS MEDIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060708</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060711</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051778-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060714</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FEXOFENADINE</medicinalproduct>
        <drugdosagetext>180 MG ONCE DAILY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SEASONAL ALLERGY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060501</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FEXOFENADINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREMPRO</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOSINOPRIL SODIUM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051779-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060714</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>51</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>70</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BRADYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC ENZYMES INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ELECTROCARDIOGRAM T WAVE INVERSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ENCEPHALOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTHERMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENTAL STATUS CHANGES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL ISCHAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY RETENTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEPODUR</medicinalproduct>
        <drugdosagetext>10MG X1 EPIDURAL</drugdosagetext>
        <drugadministrationroute>008</drugadministrationroute>
        <drugindication>JOINT ARTHROPLASTY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060710</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060712</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051780-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060714</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>56</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>70.3075</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IRRITABILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugdosagetext>20 MG ONCE/DAILY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>LOW DENSITY LIPOPROTEIN INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060703</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060707</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051781-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060714</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>63</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>83.9154</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOKINESIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EVISTA</medicinalproduct>
        <drugbatchnumb>MRI</drugbatchnumb>
        <drugdosagetext>60MG ONCE A DAY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030331</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060707</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051782-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060714</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>48</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>42</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE CONTRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEPHROGENIC FIBROSING DERMOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN ULCER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GADILENIUM</medicinalproduct>
        <drugindication>DIAGNOSTIC PROCEDURE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041016</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041120</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051783-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060714</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>46</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>58.9676</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>AGEUSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSGEUSIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMISIL</medicinalproduct>
        <drugdosagetext>250MG ONCE A DAY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ONYCHOMYCOSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060708</drugenddate>
        <drugtreatmentduration>9</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051784-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060714</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD POTASSIUM DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARBON DIOXIDE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CITROBACTER INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CULTURE URINE POSITIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ENTEROCOCCAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ESCHERICHIA INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATOCRIT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCREASED UPPER AIRWAY SECRETION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPHIL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POST PROCEDURAL COMPLICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPUTUM CULTURE POSITIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STAPHYLOCOCCAL INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAXOTERE</medicinalproduct>
        <drugdosagetext>60.00</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXALIPLATIN</medicinalproduct>
        <drugdosagetext>100.00</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051785-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060713</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>56</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>88.3</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ETODOLAC</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051786-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060713</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>72</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>74.3</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>RENAL IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DYAZIDE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051787-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060713</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>60</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>82.6</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051788-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060713</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>54</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>85.3</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>SKIN DISCOLOURATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HIBICLENS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051789-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060713</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>54</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>79.4</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>QUININE SULFATE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051790-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060713</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>58</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>86.2</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051791-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060713</receiptdate>
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    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>57</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>75.3</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ROSUVASTATIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051792-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
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    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060713</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>51</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>87.8</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INTERFERON ALFA-2B</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RIBAVIRIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051793-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060712</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
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      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <patientonsetage>64</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>105.2</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANGIONEUROTIC OEDEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugdosagetext>20 MG, 20MG QD, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060412</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060413</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051794-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
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    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
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    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060712</receiptdate>
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      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
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    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <patientonsetage>49</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>99.8</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CEFTRIAXONE</medicinalproduct>
        <drugdosagetext>2G . 2G Q24H , INTRAVEN</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>STAPHYLOCOCCAL BACTERAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060327</drugstartdate>
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        <drugenddate>20060419</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051795-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060712</receiptdate>
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      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>42</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>89</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD CREATININE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GENTAMICIN</medicinalproduct>
        <drugdosagetext>2.7G, 90 MG Q8H , INTRAVEN</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BACTERAEMIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051796-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060712</receiptdate>
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    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
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    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <patientonsetage>68</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
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      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD CREATINE PHOSPHOKINASE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugdosagetext>40 MG, 40 MG HS, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERLIPIDAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051128</drugstartdate>
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        <drugenddate>20060425</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051797-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
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    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060712</receiptdate>
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      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
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    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>66</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>92.5</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TERAZOSIN HCL</medicinalproduct>
        <drugdosagetext>5 MG . 5 MG HS, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BENIGN PROSTATIC HYPERPLASIA</drugindication>
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        <drugstartdate>20060512</drugstartdate>
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        <drugenddate>20060519</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051798-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060712</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>84</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
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      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANGIONEUROTIC OEDEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSINOPRIL SODIUM</medicinalproduct>
        <drugdosagetext>40 MG , 40 MG QD, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050516</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060510</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051799-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
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    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
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    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060712</receiptdate>
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    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>49</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>50.6</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VANCOMYCIN</medicinalproduct>
        <drugdosagetext>1G, 1G Q24 H , INTRAVEN</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CATHETER SEPSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060505</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060507</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051800-9</safetyreportid>
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    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060712</receiptdate>
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      <reportercountry>UNITED STATES</reportercountry>
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    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>49</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
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      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXYCODONE HCL</medicinalproduct>
        <drugdosagetext>5-10Q4HP,5-10Q4 HP, ORAL</drugdosagetext>
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        <drugindication>PROCEDURAL PAIN</drugindication>
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        <drugstartdate>20060502</drugstartdate>
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        <drugenddate>20060504</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051801-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
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    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060713</receiptdate>
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    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>80</patientonsetage>
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      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HYPERKALAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALDACTONE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051802-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
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    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060713</receiptdate>
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    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
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    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <patientonsetage>69</patientonsetage>
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      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MORPHINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051803-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
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    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060713</receiptdate>
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    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
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    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <patientonsetage>45</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
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      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MORPHINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051804-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
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    <seriousnessother>1</seriousnessother>
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    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060713</receiptdate>
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    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <patientonsetage>79</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
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      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>GYNAECOMASTIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
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    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051805-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
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    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
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    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
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    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <patientonsetage>39</patientonsetage>
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      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PENICILLIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051806-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
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    <receiptdate>20060713</receiptdate>
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    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
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    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <patientonsetage>65</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
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      <reaction>
        <reactionmeddrapt>DELIRIUM</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ATIVAN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051807-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
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    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060713</receiptdate>
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    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>62</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>103.9</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
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    </patient>
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  <safetyreport>
    <safetyreportid>5051808-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060713</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>54</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>64</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URTICARIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CIPROFLOXACIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051809-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060712</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>60</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>61.2356</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH PAPULAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VANOS</medicinalproduct>
        <drugdosagetext>75 GR ONCE DERMAL</drugdosagetext>
        <drugindication>MALIGNANT TUMOUR EXCISION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060522</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051810-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060713</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>98.4</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ELECTROCARDIOGRAM T WAVE ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORTHOSTATIC HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE VASOVAGAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARBOPLATIN</medicinalproduct>
        <drugdosagetext>524 MG</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060629</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAXOL</medicinalproduct>
        <drugdosagetext>355 MG</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060629</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051811-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060712</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>68.9467</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HEPATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UPPER RESPIRATORY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMOTRIGINE</medicinalproduct>
        <drugdosagetext>100 MG BID PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MOOD ALTERED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051207</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051231</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVOFLOXACIN</medicinalproduct>
        <drugdosagetext>500 MG QD PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>UPPER RESPIRATORY TRACT INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051230</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051231</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIPHENHYDRAMINE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PSYLLIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOCUSATE SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RISPERIDONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONAZEPAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENZTROPINE MESYLATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM CHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOLNAFTATE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051812-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060712</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>86.1834</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MENTAL STATUS CHANGES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TONIC CLONIC MOVEMENTS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
        <drugdosagetext>5-25MG QDAY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>AGITATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051216</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051217</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIVALPROEX SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM CARBONATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DONEPEZIL HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVASTATIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORAZEPAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051813-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060713</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>22.7</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD CULTURE POSITIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BODY TEMPERATURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LACERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIMB INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSEUDOMONAS INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY RATE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPTIC SHOCK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOPHOSPHAMIDE</medicinalproduct>
        <drugdosagetext>800 MG</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYTARABINE</medicinalproduct>
        <drugdosagetext>480 MG</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE TAB</medicinalproduct>
        <drugdosagetext>168 MG</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugdosagetext>24 MG</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEG-L-ASPARAGINASE (K-H)</medicinalproduct>
        <drugdosagetext>4000 MILLION IU</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>THIOGUANINE</medicinalproduct>
        <drugdosagetext>700 MG</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VINCRISTINE SULFATE</medicinalproduct>
        <drugdosagetext>4.8 MG</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051814-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060712</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>68</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HALLUCINATIONS, MIXED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BACLOFEN</medicinalproduct>
        <drugdosagetext>10 MG TID PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COZAAR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051815-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060623</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>COT_0621_2006</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>87</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>68.0396</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROSTATE EXAMINATION ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VENTAVIS</medicinalproduct>
        <drugbatchnumb>54143A</drugbatchnumb>
        <drugauthorizationnumb>21779</drugauthorizationnumb>
        <drugdosagetext>5 MCG 6XD IH</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>PULMONARY HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050915</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSPIRA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLOMAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEXAPRO</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051816-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060712</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>27</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEPTRA DS</medicinalproduct>
        <drugdosagetext>1 TAB BID PO  FEW DAYS</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RIFAMPIN</medicinalproduct>
        <drugdosagetext>600 MG DAILY PO  FEW DAYS</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051817-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060712</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>65</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISORIENTATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TEQUIN</medicinalproduct>
        <drugdosagetext>400 MG DAILY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADVAIR INHALER</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051818-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060626</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>1-14003093</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>32</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>AUTOIMMUNE THYROIDITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRY EYE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DYNACIN</medicinalproduct>
        <drugauthorizationnumb>65131</drugauthorizationnumb>
        <drugdosagetext>BID</drugdosagetext>
        <drugindication>ACNE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTIVITAMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WELLBUTRIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051819-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060712</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>90.7194</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABNORMAL BEHAVIOUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AMNESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMBIEN CR</medicinalproduct>
        <drugdosagetext>12.5 MIL 1 AT P.M.</drugdosagetext>
        <drugindication>SOMNOLENCE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060410</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060610</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051820-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060626</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006RL000231</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>ANGIONEUROTIC OEDEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FENOFIBRATE</medicinalproduct>
        <drugauthorizationnumb>21695</drugauthorizationnumb>
        <drugdosagetext>160 MG; QD;</drugdosagetext>
        <drugindication>MIXED HYPERLIPIDAEMIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051821-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060712</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>72</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>65.5</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANGIONEUROTIC OEDEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ESOMEPRAZOLE MAGNESIUM</medicinalproduct>
        <drugbatchnumb>F5006</drugbatchnumb>
        <drugdosagetext>20 MG ONCE DAILY ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTROOESOPHAGEAL REFLUX DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060608</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060609</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOCUSATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENTERIC ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENOXAPARIN SODIUM</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALENDRONATE SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RANITIDINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051822-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060626</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006RL000236</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>CHOLECYSTECTOMY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FENOFIBRATE</medicinalproduct>
        <drugauthorizationnumb>21695</drugauthorizationnumb>
        <drugdosagetext>160 MG; QD;</drugdosagetext>
        <drugindication>MIXED HYPERLIPIDAEMIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051823-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060626</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006RL000237</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>CEREBRAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FENOFIBRATE</medicinalproduct>
        <drugauthorizationnumb>21695</drugauthorizationnumb>
        <drugdosagetext>160 MG; QD;</drugdosagetext>
        <drugindication>MIXED HYPERLIPIDAEMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EZETIMIBE (EZETIMIBE)</medicinalproduct>
        <drugdosagetext>10 MG; QD;</drugdosagetext>
        <drugindication>MIXED HYPERLIPIDAEMIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051824-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060712</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>94</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>65.7716</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugbatchnumb>MB 5005</drugbatchnumb>
        <drugdosagetext>5 MG QD PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERLIPIDAEMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051825-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060626</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006RL000234</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>CHOLANGITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FENOFIBRATE</medicinalproduct>
        <drugauthorizationnumb>21695</drugauthorizationnumb>
        <drugdosagetext>160 MG; QD;</drugdosagetext>
        <drugindication>MIXED HYPERLIPIDAEMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EZETIMIBE (EZETIMIBE)</medicinalproduct>
        <drugdosagetext>10 MG; QD;</drugdosagetext>
        <drugindication>MIXED HYPERLIPIDAEMIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051826-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060712</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>53</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HOSPITALISATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CEFTRIAXONE</medicinalproduct>
        <drugdosagetext>2 GRAM EVERY 24 IVPB</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>SEPSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060626</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060706</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051827-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-2006-017297</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>43</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANAPHYLACTIC SHOCK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSED LEVEL OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ULTRAVIST 370</medicinalproduct>
        <drugbatchnumb>53513A</drugbatchnumb>
        <drugauthorizationnumb>20220</drugauthorizationnumb>
        <drugdosagetext>100 ML, 1 DOSE, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ANGIOGRAM</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060626</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060626</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051828-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060712</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051830-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060712</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>64.184</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH ERYTHEMATOUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH PAPULAR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMIFOSTINE</medicinalproduct>
        <drugdosagetext>SQ 500 MG M-F [11 DOSES SINCE 6/11/06]</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>SQUAMOUS CELL CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060611</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REGLAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COMPAZINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051831-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060630</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2005BI008206</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>64</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BREAST CANCER FEMALE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugdosagetext>IM</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990801</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugdosagetext>IM</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051832-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060712</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>71.2147</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>GINGIVAL INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JAW DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN ULCER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugdosagetext>4 MG IV Q28 DAYS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050408</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugdosagetext>4 MG IV Q28 DAYS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050509</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugdosagetext>4 MG IV Q28 DAYS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050607</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugdosagetext>4 MG IV Q28 DAYS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050705</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugdosagetext>4 MG IV Q28 DAYS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050802</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugdosagetext>4 MG IV Q28 DAYS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050830</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugdosagetext>4 MG IV Q28 DAYS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050923</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugdosagetext>4 MG IV Q28 DAYS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051025</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugdosagetext>4 MG IV Q28 DAYS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051121</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugdosagetext>4 MG IV Q28 DAYS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051219</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugdosagetext>4 MG IV Q28 DAYS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060116</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THALIDOMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DECADRON</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051833-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060705</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006BI007653</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>50</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INTESTINAL OBSTRUCTION</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>20010101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugbatchnumb>P35053</drugbatchnumb>
        <drugdosagetext>30 UG;QW;IM</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060401</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051834-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060712</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>62</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN JAW</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugdosagetext>4 MG MONTHLY INFUSION</drugdosagetext>
        <drugindication>PROSTATE CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041104</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051229</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOPID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMDUR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOPRESSOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MICRO-K</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KLONOPIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRILOSEC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCONTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACTOPLUS MET</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRENTAL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LUPRON</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DARBEPOETIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ELAVIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MORPHINE SULFATE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051835-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060705</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006BI007044</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>46</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>NEOPLASM MALIGNANT</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>20031231</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051836-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060712</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>54</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NECK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ODYNOPHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OESOPHAGITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RETCHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAXOL</medicinalproduct>
        <drugdosagetext>45 MG/M2</drugdosagetext>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060710</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARBOPLATIN</medicinalproduct>
        <drugdosagetext>AUC 2</drugdosagetext>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060710</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVASTIN</medicinalproduct>
        <drugdosagetext>10 MG/KG</drugdosagetext>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060710</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RADIATION THERAPY</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051837-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060705</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006BI006755</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>45</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>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>20040421</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051838-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060705</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006BI008267</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>47</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE SCLEROSIS RELAPSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPINAL CORD 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>19990701</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>5051839-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060712</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>102.5129</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROOESOPHAGEAL REFLUX DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPONATRAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOVOLAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEUKOCYTOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OBESITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLEURITIC PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugdosagetext>80000 IU SQ WKLY</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>ANAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060417</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060619</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYTOXAN</medicinalproduct>
        <drugdosagetext>500 MG/M2 IV Q 3 WKS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BREAST CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060405</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060612</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ADRIAMYCIN PFS</medicinalproduct>
        <drugdosagetext>50 MG /M2 IV Q3 WKS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BREAST CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060405</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060612</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ABRAXANE</medicinalproduct>
        <drugdosagetext>175 MG/M2 IV Q3 WKS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BREAST CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060407</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060615</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DILAUDID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BETA EXROTINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VIT B12</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEGACE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOFRAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COLACE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FEMARA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GEMFIBROZIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VERAPAMIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVAQUIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMBIEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORTAB</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051840-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060705</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006BI008227</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>59</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>LIGAMENT RUPTURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19970101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030801</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030801</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051841-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060713</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugdosagetext>IV  FOR LAST 2 YRS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BREAST CANCER METASTATIC</drugindication>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugdosagetext>PO  FOR 2 YRS PRIOR TO ZOMETA</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051842-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060706</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BE-ABBOTT-06P-013-0337672-00</companynumb>
    <primarysource>
      <reportercountry>BELGIUM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>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>20050714</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051843-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060210</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>VE-ABBOTT-06P-178-0324723-00</companynumb>
    <primarysource>
      <reportercountry>VENEZUELA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>59</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>GASTRIC ULCER HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UPPER GASTROINTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZEMPLAR</medicinalproduct>
        <drugbatchnumb>28182DK</drugbatchnumb>
        <drugauthorizationnumb>20819</drugauthorizationnumb>
        <drugdosagetext>15MCG/3ML</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>HYPERPARATHYROIDISM SECONDARY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050801</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOSARTAN POTASSIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>VITAMIN SUPPLEMENTATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTIVITAMIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>VITAMIN SUPPLEMENTATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EPOGEN</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>ANAEMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETYLSALICYLIC ACID SRT</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANTIPLATELET THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ISOPHANE INSULIN</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051844-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060705</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006BI007743</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>56</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>COAGULOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POST PROCEDURAL COMPLICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SALPINGITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugdosagetext>30 UG;QW;IM</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980501</drugstartdate>
        <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>20050901</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051845-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060420</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-ABBOTT-06P-167-0331328-03</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>22.7</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>C-REACTIVE PROTEIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CAROTID ARTERY ATHEROMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DECREASED APPETITE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOBILITY DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA ASPIRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRANSIENT ISCHAEMIC ATTACK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VERTIGO</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040525</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060320</drugenddate>
        <drugtreatmentduration>664</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NULYTELY</medicinalproduct>
        <drugindication>CONSTIPATION PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SENNA</medicinalproduct>
        <drugindication>CONSTIPATION PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051019</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060320</drugenddate>
        <drugtreatmentduration>152</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
        <drugindication>VITAMIN SUPPLEMENTATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051019</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060320</drugenddate>
        <drugtreatmentduration>152</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN W/ CODEINE</medicinalproduct>
        <drugdosagetext>1-2 TABLETS 30/500</drugdosagetext>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040819</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEKOVIT CA</medicinalproduct>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ESCITALOPRAM OXALATE</medicinalproduct>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COMMERCIAL HUMIRA</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031208</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051846-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060323</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-ABBOTT-06P-056-0329562-00</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>56</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>CROHN'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051847-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060705</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-ABBOTT-06P-020-0337699-00</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>50</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ALANINE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASPARTATE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JAUNDICE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CORTISONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DICLOFENAC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ISONIAZID</medicinalproduct>
        <drugindication>ANTIBIOTIC PROPHYLAXIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051848-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060706</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IE-ABBOTT-06P-229-0337817-00</companynumb>
    <primarysource>
      <reportercountry>IRELAND</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>POUCHITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>ANKYLOSING SPONDYLITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>COLITIS ULCERATIVE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051849-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060704</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-ABBOTT-06P-028-0337772-00</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>70.37</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>SKIN DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYSTEMIC LUPUS ERYTHEMATOSUS</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>20060628</drugenddate>
        <drugtreatmentduration>848</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugindication>RHEUMATOID ARTHRITIS</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>FLURBIPROFEN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RABEPRAZOLE SODIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MOMETASONE FUROATE</medicinalproduct>
        <drugadministrationroute>061</drugadministrationroute>
        <drugindication>RASH</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SOLAIR CREAM</medicinalproduct>
        <drugadministrationroute>061</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROXYCHLOROQUINE PHOSPHATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051850-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060524</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IE-ABBOTT-06P-229-0334201-00</companynumb>
    <primarysource>
      <reportercountry>IRELAND</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HODGKIN'S DISEASE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NORVIR</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>20945</drugauthorizationnumb>
        <drugindication>HIV INFECTION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051851-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060706</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>NL-ABBOTT-06P-114-0337714-00</companynumb>
    <primarysource>
      <reportercountry>NETHERLANDS</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>95</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DIVERTICULITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIVERTICULUM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTESTINAL PERFORATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040421</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060213</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060227</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040213</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051852-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20021024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-ABBOTT-02P-062-0202920-02</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>82</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIAC TAMPONADE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERICARDIAL EFFUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERICARDIAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERICARDITIS INFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SALMONELLA SEPSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugdosagetext>40 MG</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20001128</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20021114</drugenddate>
        <drugtreatmentduration>716</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELECOXIB</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020719</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETYLSALICYLIC ACID SRT</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>THROMBOSIS PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20011215</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARDACE</medicinalproduct>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20011030</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANSOPRAZOLE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS AGAINST GASTROINTESTINAL ULCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990211</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIDROKIT</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19950201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COLOXYL WITH DANTHRON</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19981209</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051853-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060705</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>NL-ABBOTT-06P-114-0337684-00</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEONATAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PREMATURE BABY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TIPRANAVIR+RITONAVIR</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>20945</drugauthorizationnumb>
        <drugindication>DRUG EXPOSURE DURING PREGNANCY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TIPRANAVIR+RITONAVIR</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020945</drugauthorizationnumb>
        <drugindication>PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BOOSTED LOPINAVIR</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021251</drugauthorizationnumb>
        <drugindication>PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEVIRAPINE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>DRUG EXPOSURE DURING PREGNANCY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZIDOVUDINE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>DRUG EXPOSURE DURING PREGNANCY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZIDOVUDINE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMIVUDINE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMIVUDINE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ABACAVIR</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>DRUG EXPOSURE DURING PREGNANCY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ABACAVIR</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TENOFOVIR</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>DRUG EXPOSURE DURING PREGNANCY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TENOFOVIR</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENFUVIRTIDE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>DRUG EXPOSURE DURING PREGNANCY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENFUVIRTIDE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>STAVUDINE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>DRUG EXPOSURE DURING PREGNANCY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEVIRAPINE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEVIRAPINE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051854-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060712</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>44</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>92.0802</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ERECTILE DYSFUNCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRIAPISM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRAZODONE 50MG/100MG</medicinalproduct>
        <drugdosagetext>50MG, PRN, PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INSOMNIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060214</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060310</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NICOTINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RANITIDINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ETODOLAC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYCLOBENZAPRINE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051855-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060707</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-06P-163-0337735-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>RAYNAUD'S PHENOMENON</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEPAKOTE ER</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021168</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>EPILEPSY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051856-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060704</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>NO-ABBOTT-06P-122-0337805-00</companynumb>
    <primarysource>
      <reportercountry>NORWAY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>67</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ATRIAL FIBRILLATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENTRICULAR TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060113</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060520</drugenddate>
        <drugtreatmentduration>126</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>METHOTREXATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLSYRE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</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>CALCIGRAN FORTE</medicinalproduct>
        <drugdosagetext>CALC</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051857-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060705</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-06P-163-0337522-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HEPATIC CIRRHOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER FUNCTION TEST ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BIAXIN XL</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>050775</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PNEUMONIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051858-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060706</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ABBOTT-06P-087-0337742-00</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>EOSINOPHIL COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KLARICID</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>50662</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BRONCHITIS ACUTE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060621</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060624</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HOKUNALIN TAPE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>BRONCHITIS ACUTE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060621</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060624</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SALICYLAMIDE/ACETAMINOPHEN/ANHYDROUSCAFFEINE/PROMETHAZIN METHYLENEDISA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BRONCHITIS ACUTE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060619</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060624</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MOXIFLOXACIN HYDROCHLORIDE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BRONCHITIS ACUTE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060621</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060624</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMBROXOL HYDROCHLORIDE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BRONCHITIS ACUTE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060621</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060624</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEXTROMETHORPHAN HYDROBROMIDE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BRONCHITIS ACUTE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060621</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060624</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051859-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060705</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006BI008303</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>46</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POST PROCEDURAL COMPLICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugdosagetext>30 UG;QW;IM</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19960806</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugdosagetext>30 UG;QW;IM</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TEGRETOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREVACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ESTRATEST</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>TOPROL-XL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTIVERT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOMPERIDONE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051860-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060712</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>92</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>51.7101</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE CONGESTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TERAZOSIN 2MG</medicinalproduct>
        <drugdosagetext>2MG, QHS, PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060114</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060301</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCODONE BITARTRATE + ACETAMINOPHEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VERAPAMIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOPERAMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RISEDROMATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SALSALATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VIT A</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051861-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060627</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CHPA2006US06350</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>59</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>63.5</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRANSDERM SCOP</medicinalproduct>
        <drugbatchnumb>11651001</drugbatchnumb>
        <drugauthorizationnumb>17874</drugauthorizationnumb>
        <drugdosagetext>1.5 MG, Q72H, TRANSDERMAL</drugdosagetext>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>MOTION SICKNESS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060618</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060625</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051862-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060712</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>79</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BRADYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIO-RESPIRATORY ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FERRLECIT</medicinalproduct>
        <drugdosagetext>500MG IV INFUSION (1 INFUSION)</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>IRON DEFICIENCY ANAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060209</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FELODIPINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOCLOPRAMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SUCRALFATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TERAZOSIN HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FERROUS SULFATE TAB</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051863-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060707</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200612709BCC</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>74</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>81.6475</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPEPSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRIC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HIATUS HERNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ULCER HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALEVE</medicinalproduct>
        <drugbatchnumb>208015E</drugbatchnumb>
        <drugauthorizationnumb>20204</drugauthorizationnumb>
        <drugdosagetext>440 MG, BID, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ABDOMINAL PAIN UPPER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALEVE COLD AND SINUS</medicinalproduct>
        <drugbatchnumb>299884P</drugbatchnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEADACHE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugbatchnumb>259322P</drugbatchnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALKA-SELTZER</medicinalproduct>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALKA-SELTZER PLUS</medicinalproduct>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MYLANTA [ALUMINIUM HYDROXIDE,MAGNESIUM HYDROXIDE, SIMETICONE]</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIPHENHYDRAMINE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICATION FOR HIGH BLOOD PRESSURE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICATION FOR DIABETES</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051864-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060712</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>69</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>111.1313</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LOVASTATIN</medicinalproduct>
        <drugbatchnumb>W050802</drugbatchnumb>
        <drugdosagetext>80 MG, QDAY, PO GRADUALLY INCREASING DOSE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERLIPIDAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060203</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051865-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060712</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXYCODONE ER</medicinalproduct>
        <drugdosagetext>40 MG ONE Q 12 HOURS PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BACK PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060201</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051866-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060703</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200614108BWH</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>49</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>45.2</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG TOXICITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ENTEROCOCCAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSIVE CRISIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTESTINAL OBSTRUCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER ABSCESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POST PROCEDURAL COMPLICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>REVERSIBLE POSTERIOR LEUKOENCEPHALOPATHY SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SORAFENIB</medicinalproduct>
        <drugauthorizationnumb>21923</drugauthorizationnumb>
        <drugdosagetext>400 MG, BID, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BILE DUCT CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060112</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060524</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MICRO-K</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MS CONTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MORPHINE SULFATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COLACE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PHENERGAN HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGNESIUM SULPHATE [MAGNESIUM SULFATE]</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051867-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060712</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>53.978</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GLUCOPHAGE</medicinalproduct>
        <drugdosagetext>750MG BID</drugdosagetext>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051868-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060712</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>79</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHABDOMYOLYSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051869-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060713</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>54</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN</medicinalproduct>
        <drugdosagetext>GTT PER PROTOCOL</drugdosagetext>
        <drugindication>THROMBOSIS PROPHYLAXIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051870-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060713</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>92</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CLOSTRIDIUM DIFFICILE COLITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VANCOMYCIN</medicinalproduct>
        <drugdosagetext>1 G IV Q 12 H</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PLEURAL EFFUSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MOXIFLOXACIN HCL</medicinalproduct>
        <drugdosagetext>400 MG IV QD</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PLEURAL EFFUSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051871-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060713</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>67</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>RASH GENERALISED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AUGMENTIN '500'</medicinalproduct>
        <drugdosagetext>500 MG PO TID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DISEASE RECURRENCE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AUGMENTIN '500'</medicinalproduct>
        <drugdosagetext>500 MG PO TID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SKIN INFECTION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051872-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060713</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>49</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>AGITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BUPROPION HCL</medicinalproduct>
        <drugdosagetext>150 MG BID</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051873-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060713</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>46</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>76.1136</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ETOPOSIDE</medicinalproduct>
        <drugbatchnumb>828343</drugbatchnumb>
        <drugdosagetext>IV (525 ML/HR) ONCE DAILY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>TESTIS CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060703</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ETOPOSIDE</medicinalproduct>
        <drugbatchnumb>828343</drugbatchnumb>
        <drugdosagetext>IV (525 ML/HR) ONCE DAILY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>TESTIS CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060704</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANZEMET</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DECADRON</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051874-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060713</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>101.6057</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUID OVERLOAD</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugdosagetext>80,000 IU SQ WEEKLY</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>ANAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060417</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060707</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYTOXAN</medicinalproduct>
        <drugdosagetext>500 MG/M2 IV Q 3 WKS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BREAST CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060405</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060612</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ADRIAMYCIN PFS</medicinalproduct>
        <drugdosagetext>50 MG/M2 IV Q 3 WKS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BREAST CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060405</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060612</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ABRAXANE</medicinalproduct>
        <drugdosagetext>175 MG/M2 IV Q 3 WKS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BREAST CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060407</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060615</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051875-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060713</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>70</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>55.3388</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSED LEVEL OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLUENZA LIKE ILLNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MASS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUS CONGESTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN ODOUR ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DETROL</medicinalproduct>
        <drugdosagetext>2 MG BID</drugdosagetext>
        <drugindication>HYPERTONIC BLADDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060516</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060702</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIAZEPAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CIPRODEX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIDODERM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ES TYLENOL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051876-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060713</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>56</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>65.1</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BRADYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIOMYOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFUSION RELATED REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENTRICULAR FIBRILLATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ERBITUX</medicinalproduct>
        <drugbatchnumb>06C00139B</drugbatchnumb>
        <drugdosagetext>430 MG IV X 1 (DOSED 250MG/M2)</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>LUNG NEOPLASM MALIGNANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060711</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051877-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060712</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2006-BP-08064NB</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>92</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <reaction>
        <reactionmeddrapt>DRUG ERUPTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
        <drugauthorizationnumb>021395</drugauthorizationnumb>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060703</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060710</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051878-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060607</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2006-BP-06468NB</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ATRIAL FIBRILLATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSED LEVEL OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SHOCK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SLEEP ATTACKS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BI-SIFROL TABLETS</medicinalproduct>
        <drugauthorizationnumb>20667</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PARKINSON'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060511</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060511</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051879-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060711</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2006-BP-08002NB</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>72</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PULMONARY ALVEOLAR HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MICARDIS</medicinalproduct>
        <drugauthorizationnumb>20850</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ATELEC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051880-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2006-BP-07524AU</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>65</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ASASANTIN CAPSULES</medicinalproduct>
        <drugbatchnumb>NR</drugbatchnumb>
        <drugauthorizationnumb>20884</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIABEX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051881-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060606</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2006-BP-06520BP</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>47</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>63.96</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL INTAKE REDUCED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>REFUSAL OF TREATMENT BY PATIENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREATMENT NONCOMPLIANCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>APTIVUS/RITONAVIR CAPSULES</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>21814</drugauthorizationnumb>
        <drugdosagetext>TPV 1000MG / RTV ?</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050622</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050714</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>APTIVUS/RITONAVIR CAPSULES</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>021814</drugauthorizationnumb>
        <drugindication>ACQUIRED IMMUNODEFICIENCY SYNDROME</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLINDAMYCIN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050714</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DARAPRIM</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050714</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DAPSONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050714</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPORANOX</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050507</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050714</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZITHROMAX</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050309</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050714</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEUCOVORIN CALCIUM</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050714</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRUVADA</medicinalproduct>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050714</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051882-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060228</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2006-BP-02755NB</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>51</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
        <drugauthorizationnumb>21395</drugauthorizationnumb>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>EMPHYSEMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051214</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060103</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIROPENT</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19900101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNIPHYL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19900101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SINGULAIR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19900101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUTIDE</medicinalproduct>
        <drugadministrationroute>055</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19900101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROCATEROL HCL</medicinalproduct>
        <drugadministrationroute>055</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19900101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROCATEROL HCL</medicinalproduct>
        <drugadministrationroute>055</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19900101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INTAL</medicinalproduct>
        <drugadministrationroute>055</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19900101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PENMALIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051212</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051231</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZITHROMAC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051230</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051231</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051883-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060711</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2006-BP-08006AU</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GOUT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MICARDIS</medicinalproduct>
        <drugbatchnumb>NR</drugbatchnumb>
        <drugauthorizationnumb>020850</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051884-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060711</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2006-BP-07912AU</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>65</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CIRCULATORY COLLAPSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LACTIC ACIDOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MICARDIS HCT</medicinalproduct>
        <drugbatchnumb>NR</drugbatchnumb>
        <drugauthorizationnumb>21162</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ESSENTIAL HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIABEX</medicinalproduct>
        <drugbatchnumb>NR</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GLIMEL</medicinalproduct>
        <drugbatchnumb>NR</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
        <drugindication>ESSENTIAL HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051885-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20051220</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2005-BP-21953NB</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>52.5</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>VISUAL FIELD DEFECT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MICARDIS</medicinalproduct>
        <drugauthorizationnumb>20850</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051112</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051213</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEVALOTIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERLIPIDAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19970714</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CEREBRAL INFARCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030509</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NE-SOFT (TOCOPHEROL NICOTINATE)</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERLIPIDAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19960805</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALFASULY (ALFACALCIDOL)</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19960805</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MOBIC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050216</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZESTROMIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INSOMNIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000912</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SENNOSIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONSTIPATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050216</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051886-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060502</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2006-BP-05011BP</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLINDNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE INFECTION STAPHYLOCOCCAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROCEDURAL COMPLICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RETINAL DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLOMAX</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>20579</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROSTATITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051887-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060620</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200613954BWH</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>69</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HYPOGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVELOX</medicinalproduct>
        <drugauthorizationnumb>21277</drugauthorizationnumb>
        <drugdosagetext>400 MG, TOTAL DAILY, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>LUNG INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060422</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060604</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TEQUIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMIODARONE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYLENOL REGULAR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASCORBIC ACID</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051888-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060627</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200613611BWH</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>54</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>67.2</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA EXERTIONAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLANK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEPHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLEURITIC PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RIB FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEGENER'S GRANULOMATOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SORAFENIB</medicinalproduct>
        <drugauthorizationnumb>21923</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>METASTATIC NEOPLASM</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060513</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060517</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SORAFENIB</medicinalproduct>
        <drugauthorizationnumb>21923</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>TRANSITIONAL CELL CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060513</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060517</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SORAFENIB</medicinalproduct>
        <drugauthorizationnumb>21923</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>METASTATIC NEOPLASM</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060530</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060610</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SORAFENIB</medicinalproduct>
        <drugauthorizationnumb>21923</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>TRANSITIONAL CELL CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060530</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060610</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MOXIFLOXACIN HCL</medicinalproduct>
        <drugdosagetext>400 MG, TOTAL DAILY, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060511</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCODONE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COMBIVENT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOCLOPRAMIDE HYDROCHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCONTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MOTRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZITHROMAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLOMAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEGACE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051889-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060619</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US200606002538</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>65</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ACTIVATED PARTIAL THROMBOPLASTIN TIME PROLONGED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISSEMINATED INTRAVASCULAR COAGULATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XIGRIS</medicinalproduct>
        <drugdosagetext>INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>DISSEMINATED INTRAVASCULAR COAGULATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060609</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051890-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060616</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US200606004559</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>17</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>VISION BLURRED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
        <drugauthorizationnumb>20592</drugauthorizationnumb>
        <drugdosagetext>20 MG</drugdosagetext>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060401</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051891-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060616</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US200606003864</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PULMONARY HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XIGRIS</medicinalproduct>
        <drugdosagetext>INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ACUTE RESPIRATORY DISTRESS SYNDROME</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051892-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060616</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US200606003879</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>28</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XIGRIS</medicinalproduct>
        <drugdosagetext>INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ACUTE RESPIRATORY DISTRESS SYNDROME</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051893-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060613</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CZ-MERCK-0606CZE00011</companynumb>
    <primarysource>
      <reportercountry>CZECH REPUBLIC</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>33</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABORTION SPONTANEOUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SINGULAIR</medicinalproduct>
        <drugauthorizationnumb>20829</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CORTICOSTEROIDS (UNSPECIFIED)</medicinalproduct>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051894-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesscongenitalanomali>1</seriousnesscongenitalanomali>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060612</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0606USA02727</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</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>SINGULAIR</medicinalproduct>
        <drugauthorizationnumb>20829</drugauthorizationnumb>
        <drugindication>ASTHMA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051895-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040929</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0410USA00021</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>68</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>58</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ORAL CAVITY FISTULA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>20560</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040901</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DEEP VEIN THROMBOSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KLONOPIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>ANXIETY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HYPERLIPIDAEMIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051896-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060703</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-MERCK-0607GBR00031</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ARRHYTHMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOKALAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOMAGNESAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CANCIDAS</medicinalproduct>
        <drugauthorizationnumb>021227</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>SYSTEMIC CANDIDA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VANCOMYCIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEROPENEM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051897-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060605</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0606USA00751</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>48</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>91</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ARRHYTHMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOKALAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HYZAAR</medicinalproduct>
        <drugauthorizationnumb>20387</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060119</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060301</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HYZAAR</medicinalproduct>
        <drugauthorizationnumb>020387</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060530</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPROL-XL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD PRESSURE INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ECOTRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANTICOAGULANT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051898-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050707</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-MERCK-0507USA01317</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>82</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>40</patientweight>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>DEPRESSED LEVEL OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENINGITIS BACTERIAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>STROMECTOL</medicinalproduct>
        <drugauthorizationnumb>50742</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>STRONGYLOIDIASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050705</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050705</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051899-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060616</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US200606004092</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>50</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>GRANULOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
        <drugauthorizationnumb>20592</drugauthorizationnumb>
        <drugdosagetext>10 MG</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLOZAPINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEPAKOTE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LITHOBID</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051900-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060616</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US200606004116</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>84</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BRADYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERICARDIAL EFFUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENTRICULAR HYPERTROPHY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
        <drugauthorizationnumb>20592</drugauthorizationnumb>
        <drugdosagetext>5 MG, DAILY (1/D)</drugdosagetext>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060613</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAZODONE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX (FUROSEMIDE, FUROSEMIDE SODIUM)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NOVOLIN 70/30</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NOVOLIN R</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENALAPRIL MALEATE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051901-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060619</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US200606004260</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>56</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE CONGESTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTHYROIDISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ILETIN</medicinalproduct>
        <drugauthorizationnumb>17931</drugauthorizationnumb>
        <drugindication>DIABETES MELLITUS NON-INSULIN-DEPENDENT</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051902-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060619</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US200605006838</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>9</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>GENERAL PHYSICAL HEALTH DETERIORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GLIOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMATROPE</medicinalproduct>
        <drugauthorizationnumb>19640</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030901</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMATROPE</medicinalproduct>
        <drugauthorizationnumb>19640</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HUMATROPEN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051903-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060713</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>131.5431</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY RETENTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEPODUR</medicinalproduct>
        <drugbatchnumb>05-400S</drugbatchnumb>
        <drugdosagetext>15 MG X1 EPIDURAL</drugdosagetext>
        <drugadministrationroute>008</drugadministrationroute>
        <drugindication>KNEE ARTHROPLASTY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060619</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051904-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060613</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CZ-MERCK-0606USA04996</companynumb>
    <primarysource>
      <reportercountry>CZECH REPUBLIC</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABORTION SPONTANEOUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SINGULAIR</medicinalproduct>
        <drugauthorizationnumb>20829</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INHALED CORTICOSTEROID (UNSPECIFIED)</medicinalproduct>
        <drugadministrationroute>055</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051905-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060712</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AT-MERCK-0607AUT00009</companynumb>
    <primarysource>
      <reportercountry>AUSTRIA</reportercountry>
      <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>GLOSSITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STOMATITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRIMAXIN</medicinalproduct>
        <drugauthorizationnumb>050587</drugauthorizationnumb>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>COLECTOMY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060415</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060422</drugenddate>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NIFEDIPINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CANDESARTAN CILEXETIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MOLSIDOMINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051906-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060515</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0605USA02706</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>57</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ADVERSE DRUG REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLISTER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OESOPHAGEAL ULCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARYNGEAL OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN EXFOLIATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VYTORIN</medicinalproduct>
        <drugauthorizationnumb>021687</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060302</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060426</drugenddate>
        <drugtreatmentduration>56</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVALIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD PRESSURE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060502</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FORTAMET EXTENDED RELEASE TABLETS</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051907-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060511</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0605USA02073</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>56</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SINGULAIR</medicinalproduct>
        <drugbatchnumb>F4995</drugbatchnumb>
        <drugauthorizationnumb>20829</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHINITIS ALLERGIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060425</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060425</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SINGULAIR</medicinalproduct>
        <drugbatchnumb>F4995</drugbatchnumb>
        <drugauthorizationnumb>020829</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERSENSITIVITY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060425</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060425</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLARITIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NASONEX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NULEV</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALAN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ESGIC-PLUS TABLETS</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMITREX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>MIGRAINE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051908-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060612</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0606USA02316</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABORTION SPONTANEOUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SINGULAIR</medicinalproduct>
        <drugauthorizationnumb>20829</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051909-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060712</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-MERCK-0607FRA00033</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>71</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>76</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>C-REACTIVE PROTEIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHOLESTASIS</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>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COZAAR</medicinalproduct>
        <drugauthorizationnumb>20386</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060429</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060613</drugenddate>
        <drugtreatmentduration>46</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060429</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060613</drugenddate>
        <drugtreatmentduration>46</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ROSUVASTATIN CALCIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DYSLIPIDAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060429</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060613</drugenddate>
        <drugtreatmentduration>46</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEBIVOLOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060613</drugenddate>
        <drugtreatmentduration>529</drugtreatmentduration>
        <drugtreatmentdurationunit></drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEBIVOLOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060615</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE AND VALSARTAN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060428</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALSARTAN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060619</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051910-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060621</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-MERCK-0606USA05688</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>35</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ADVERSE EVENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOLYTIC ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALDOMET</medicinalproduct>
        <drugauthorizationnumb>13400</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051911-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060710</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-MERCK-0607FRA00027</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>64</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CANCIDAS</medicinalproduct>
        <drugauthorizationnumb>21227</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>FUNGAL INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060528</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060612</drugenddate>
        <drugtreatmentduration>16</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYTARABINE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ACUTE MYELOID LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060607</drugenddate>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PIPERACILLIN SODIUM AND TAZOBACTAM SODIUM</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060524</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060610</drugenddate>
        <drugtreatmentduration>18</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOMUSTINE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ACUTE MYELOID LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060601</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DAUNORUBICIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ACUTE MYELOID LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060605</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IDARUBICIN HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ACUTE MYELOID LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060605</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051912-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060710</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ES-MERCK-0607ESP00014</companynumb>
    <primarysource>
      <reportercountry>SPAIN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>68</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CHOLESTASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATOTOXICITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CANCIDAS</medicinalproduct>
        <drugauthorizationnumb>021227</drugauthorizationnumb>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>SYSTEMIC CANDIDA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060627</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060702</drugenddate>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CANCIDAS</medicinalproduct>
        <drugauthorizationnumb>021227</drugauthorizationnumb>
        <drugadministrationroute>041</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060703</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060703</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMIODARONE HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIPYRONE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRONOLACTONE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DALTEPARIN SODIUM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROPOFOL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NOREPINEPHRINE HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TEICOPLANIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIGOXIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUCONAZOLE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051913-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060710</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-MERCK-0607FRA00020</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>60</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>74</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>EOSINOPHILIC CELLULITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URTICARIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZETIA</medicinalproduct>
        <drugauthorizationnumb>021445</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060501</drugenddate>
        <drugtreatmentduration>152</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NIFUROXAZIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALPRAZOLAM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051914-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060614</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-MERCK-0606FRA00027</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>53</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>EOSINOPHIL COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPHADENOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH SCARLATINIFORM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NOROXIN</medicinalproduct>
        <drugauthorizationnumb>19384</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CYSTITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060304</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060312</drugenddate>
        <drugtreatmentduration>9</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ERYTHROMYCIN STEARATE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060309</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060310</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOPRAZOLAM MESYLATE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONAZEPAM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INDORAMIN HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GABAPENTIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANETHOLE TRITHIONE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TETRAZEPAM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060601</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051915-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060524</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>MY-MERCK-0605MYS00007</companynumb>
    <primarysource>
      <reportercountry>MALAYSIA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>15</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>50</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>PRESCRIBED OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CANCIDAS</medicinalproduct>
        <drugauthorizationnumb>21227</drugauthorizationnumb>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>FUNGAL INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060519</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060523</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051916-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060705</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-MERCK-0607USA00878</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>21</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROPECIA</medicinalproduct>
        <drugauthorizationnumb>020788</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060630</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060701</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051917-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060713</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LORATADINE</medicinalproduct>
        <drugdosagetext>2TSP PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ALLERGY TO ANIMAL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060707</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LORATADINE</medicinalproduct>
        <drugdosagetext>2TSP PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ECZEMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060707</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LORATADINE</medicinalproduct>
        <drugdosagetext>2TSP PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>FOOD ALLERGY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060707</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051918-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060713</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>114.76</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VYTORIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051919-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060713</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>72</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>57.7883</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GEMCITABINE</medicinalproduct>
        <drugdosagetext>800 MG/M2 IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>OROPHARYNGEAL CANCER RECURRENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GEMCITABINE</medicinalproduct>
        <drugdosagetext>800 MG/M2 IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>OROPHARYNGEAL CANCER RECURRENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060608</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GEMCITABINE</medicinalproduct>
        <drugdosagetext>800 MG/M2 IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>OROPHARYNGEAL CANCER RECURRENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060622</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GEMCITABINE</medicinalproduct>
        <drugdosagetext>800 MG/M2 IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>OROPHARYNGEAL CANCER RECURRENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060630</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOXORUBICIN HCL</medicinalproduct>
        <drugdosagetext>25 MG /M2 IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>OROPHARYNGEAL CANCER RECURRENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOXORUBICIN HCL</medicinalproduct>
        <drugdosagetext>25 MG /M2 IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>OROPHARYNGEAL CANCER RECURRENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060608</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOXORUBICIN HCL</medicinalproduct>
        <drugdosagetext>25 MG /M2 IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>OROPHARYNGEAL CANCER RECURRENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060622</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOXORUBICIN HCL</medicinalproduct>
        <drugdosagetext>25 MG /M2 IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>OROPHARYNGEAL CANCER RECURRENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060630</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051920-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060713</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>48</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SULINDAC</medicinalproduct>
        <drugdosagetext>150 MG PO BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRALGIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SULINDAC</medicinalproduct>
        <drugdosagetext>150 MG PO BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051921-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006BI009415</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>58</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FEMUR FRACTURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugbatchnumb>P01080</drugbatchnumb>
        <drugdosagetext>30 UG; QW; IM</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010201</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051922-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006BI009422</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>41</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugbatchnumb>P35072</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>5051923-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060713</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>49</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HALLUCINATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROPRANOLOL</medicinalproduct>
        <drugdosagetext>60 MG PO QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD PRESSURE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051924-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060630</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006BI009434</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>49</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>NEPHROLITHIASIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugbatchnumb>P35069</drugbatchnumb>
        <drugdosagetext>30 U G; QW; IM</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051001</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051925-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060713</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>63</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TERAZOSIN HCL</medicinalproduct>
        <drugdosagetext>1 MG @ HS</drugdosagetext>
        <drugindication>BENIGN PROSTATIC HYPERPLASIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051926-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060630</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006BI009490</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>63</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20011001</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>5051927-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060713</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>56</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE 4MG TAB</medicinalproduct>
        <drugdosagetext>6 MG PO Q D</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BRAIN NEOPLASM</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051928-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060703</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006BI009564</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>26</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>UTERINE LEIOMYOMA</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>20021117</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051929-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060705</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006BI009615</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>38</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CEREBRAL 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>20051001</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051930-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060703</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006BI009560</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>54</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CHILLS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLUENZA LIKE ILLNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugdosagetext>30 U; QW; IM</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060510</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051931-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006BI009351</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>62</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>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>5051932-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060620</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US200606004604</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>20</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CHOLESTASIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>20 MG,</drugdosagetext>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060607</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONIDINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ERYTHROPOIETIN (ERYTHROPOIETIN)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANSOPRAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FENTANYL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCODONE (OXYCODONE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OLANZAPINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SEVELAMER (SEVELAMER)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ORTHO EVRA /USA/ (ETHINYLESTRADIOL, NORELGESTROMIN)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CEFEPIME (CEFEPIME)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VANCOMYCIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SODIUM THIOSULFATE (SODIUM THIOSULFATE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051933-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060620</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US200606004377</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>71</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE IRREGULAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEOPLASM MALIGNANT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN LESION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMALOG MIX 75/25</medicinalproduct>
        <drugauthorizationnumb>20563</drugauthorizationnumb>
        <drugdosagetext>2/D,</drugdosagetext>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HUMALOG MIX 25L / 75NPL PEN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051934-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060620</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US200606004673</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>EYE SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOE AMPUTATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URTICARIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMALOG</medicinalproduct>
        <drugauthorizationnumb>20563</drugauthorizationnumb>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20011210</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLYBURIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRECOSE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOPRESSOR</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051935-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060620</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US200606005936</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>90</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE FLUCTUATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSED LEVEL OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE NODULE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL ACUITY REDUCED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMALOG</medicinalproduct>
        <drugauthorizationnumb>20563</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMULIN N</medicinalproduct>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMULIN R</medicinalproduct>
        <drugdosagetext>SUB. PUMP</drugdosagetext>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ILETIN</medicinalproduct>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMALOG PEN</medicinalproduct>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060619</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060620</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HUMALOG PEN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051936-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060620</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US200606004613</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>61</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSED LEVEL OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMULIN R</medicinalproduct>
        <drugbatchnumb>8SG67M</drugbatchnumb>
        <drugauthorizationnumb>18780</drugauthorizationnumb>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19880101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMULIN N</medicinalproduct>
        <drugbatchnumb>9SC38M</drugbatchnumb>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19880101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051937-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060620</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US200606004672</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMULIN N</medicinalproduct>
        <drugauthorizationnumb>18780</drugauthorizationnumb>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMALOG</medicinalproduct>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL (METOPROLOL)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN TAB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOPHAGE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051938-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060620</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US200606004742</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMULIN N</medicinalproduct>
        <drugauthorizationnumb>18780</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051939-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060620</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US200606004876</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>111.1</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD CHOLESTEROL INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIABETES MELLITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METABOLIC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISION BLURRED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
        <drugauthorizationnumb>20592</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040301</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051940-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060623</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0606USA04565</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>58</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>43</patientweight>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHABDOMYOLYSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VYTORIN</medicinalproduct>
        <drugauthorizationnumb>021687</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL</drugindication>
        <drugtreatmentduration>10</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>[THERAPY UNSPECIFIED]</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRAVACHOL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051941-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060623</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US200606002512</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>96.6</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANGIOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CHOLESTEROL ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD TRIGLYCERIDES INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIABETES MELLITUS NON-INSULIN-DEPENDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIBIDO DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL ACUITY REDUCED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
        <drugauthorizationnumb>20592</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19971208</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYMBYAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GEODON</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HALDOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRILAFON</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEPAKOTE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WELLBUTRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOLAZAMIDE (TOLAZAMIDE)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051942-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060620</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US200606002788</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>35</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>104.3</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ACTIVITIES OF DAILY LIVING IMPAIRED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CHOLESTEROL ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD TRIGLYCERIDES INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIABETES MELLITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL ISCHAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRESCRIBED OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
        <drugauthorizationnumb>20592</drugauthorizationnumb>
        <drugdosagetext>40 MG, DAILY (1/D),</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19970101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010701</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WELLBUTRIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051943-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060620</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US200606004506</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>75</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugauthorizationnumb>21318</drugauthorizationnumb>
        <drugindication>OSTEOPOROSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051945-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060620</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US200606004592</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENTRICULAR DYSFUNCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugbatchnumb>FF5J49A</drugbatchnumb>
        <drugauthorizationnumb>21318</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051946-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060620</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US200606004591</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>CARDIAC ARREST</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugauthorizationnumb>21318</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051947-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060620</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US200606004589</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugauthorizationnumb>21318</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051948-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060620</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US200606004617</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugauthorizationnumb>21318</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051949-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060627</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006-144661-NL</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>25</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CEREBRAL THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</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>20060101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060601</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051950-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060627</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006-144676-NL</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>29</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>65.8</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANIC ATTACK</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NUVARING</medicinalproduct>
        <drugauthorizationnumb>21187</drugauthorizationnumb>
        <drugdosagetext>VAGINAL, 3 WEEKS IN. 1 WEEK OUT</drugdosagetext>
        <drugadministrationroute>067</drugadministrationroute>
        <drugindication>CONTRACEPTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060615</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051951-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060630</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006-06-2363</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>59</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>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>5051952-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060622</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006US001341</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>55</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>98</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BRONCHITIS ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CELLULITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THERAPY NON-RESPONDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMEVIVE</medicinalproduct>
        <drugdosagetext>15 MG, WEEKLY, INTRAMUSCULAR</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>PSORIASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040510</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051953-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060630</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US017748</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>43</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>89.8122</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG ABUSER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MANIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROVIGIL</medicinalproduct>
        <drugauthorizationnumb>20717</drugauthorizationnumb>
        <drugindication>DRUG DEPENDENCE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060526</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060602</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PLACEBO</medicinalproduct>
        <drugindication>DRUG DEPENDENCE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060526</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060602</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051954-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060630</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2002-09-0653</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>42</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>65.7716</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ACTIVITIES OF DAILY LIVING IMPAIRED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ALOPECIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AUTOIMMUNE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BALANCE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CALCIUM DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD IMMUNOGLOBULIN G INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRONCHITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COGNITIVE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONNECTIVE TISSUE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEAFNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIPLOPIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRY MOUTH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPEPSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSSTASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EAR PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EPISTAXIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EXTENSOR PLANTAR RESPONSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FIBROMYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOPTYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMMOBILE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCORRECT DOSE ADMINISTERED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLUENZA LIKE ILLNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JOINT CREPITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JOINT RANGE OF MOTION DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JOINT SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METRORRHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOVEMENT DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL STIFFNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOSITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUROPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NIGHT SWEATS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCYTOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHOTOSENSITIVITY REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POLYNEUROPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POOR QUALITY SLEEP</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROTEIN TOTAL INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RAYNAUD'S PHENOMENON</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RED BLOOD CELL SEDIMENTATION RATE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SCIATICA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUS DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUSITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN DISCOLOURATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STAPHYLOCOCCAL ABSCESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STAPHYLOCOCCAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYSTEMIC LUPUS ERYTHEMATOSUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TEMPOROMANDIBULAR JOINT SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TENDON DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TENDON RUPTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TENDONITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VASCULITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISION BLURRED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL ACUITY REDUCED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WALKING AID USER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEG-INTRON</medicinalproduct>
        <drugbatchnumb>2CO32</drugbatchnumb>
        <drugdosagetext>96 MCG QWK SUBCUTANEOUS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020614</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBETOL</medicinalproduct>
        <drugdosagetext>800 MG QD ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020614</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VICODIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELEXA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DALAMANE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORFLEX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051955-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060630</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006-07-0137</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>68</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEAD INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLUENZA LIKE ILLNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEG-INTRON</medicinalproduct>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060619</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060620</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBETOL</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060619</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060620</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051956-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060630</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006-06-0369</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>42</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>64.4108</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DECREASED APPETITE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATOCRIT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIP DRY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MIGRAINE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEG-INTRON</medicinalproduct>
        <drugdosagetext>120 MGC QWK SUBCUTANEOUS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060130</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBETOL</medicinalproduct>
        <drugdosagetext>1000 MG QWK ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060130</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIDRIN</medicinalproduct>
        <drugindication>MIGRAINE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELEXA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCODONE HYDROCHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PHENERGAN HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL SPIROS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051957-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060627</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004065552</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>49</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABSCESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COAGULOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMPLETED SUICIDE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEMUR FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FOOT FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GUN SHOT WOUND</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOTHORAX</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MAJOR DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEDIASTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE DRUG OVERDOSE INTENTIONAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE FRACTURES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PELVIC FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RADIUS FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPINAL COMPRESSION FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPLENIC INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STAPHYLOCOCCAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDE ATTEMPT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ULNA FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UPPER LIMB FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
        <drugauthorizationnumb>20235</drugauthorizationnumb>
        <drugdosagetext>900 MG (300 MG, 3 IN 1 D)</drugdosagetext>
        <drugindication>NEURALGIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000727</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
        <drugauthorizationnumb>20235</drugauthorizationnumb>
        <drugdosagetext>900 MG (300 MG, 3 IN 1 D)</drugdosagetext>
        <drugindication>NEUROPATHY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000727</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
        <drugauthorizationnumb>20235</drugauthorizationnumb>
        <drugdosagetext>900 MG (300 MG, 3 IN 1 D)</drugdosagetext>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000727</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KLONOPIN</medicinalproduct>
        <drugdosagetext>1 MG (0.5 MG, 2 IN 1 D)</drugdosagetext>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PERCOCET</medicinalproduct>
        <drugdosagetext>3 TABLETS (3 IN 1 D)</drugdosagetext>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LORCET-HD</medicinalproduct>
        <drugdosagetext>60 MG (10 MG, AS NEEDED)</drugdosagetext>
        <drugindication>NEURALGIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020727</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LORCET-HD</medicinalproduct>
        <drugdosagetext>60 MG (10 MG, AS NEEDED)</drugdosagetext>
        <drugindication>NEUROPATHY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020727</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LORCET-HD</medicinalproduct>
        <drugdosagetext>60 MG (10 MG, AS NEEDED)</drugdosagetext>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020727</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROTONIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XALATAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GEMFIBROZIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRAVACHOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLONASE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GAVISCON</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALTERNAGEL (ALUMINIUM HYDROXIDE GEL, DRIED)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051958-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2005130952</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>68</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>120.2032</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MICROANGIOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRANSIENT ISCHAEMIC ATTACK</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>20040301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041129</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIAZEPAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCONTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIGOXIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLEGRA-D 12 HOUR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLYNASE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DILTIAZEM HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOSINOPRIL SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN B6</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOSAMINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051959-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060630</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2005062678</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>66</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANKYLOSING SPONDYLITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BURSITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARPAL TUNNEL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSORIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RED BLOOD CELL SEDIMENTATION RATE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
        <drugauthorizationnumb>19787</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNSPECIFIED ACE INHIBITOR (ACE INHIBITOR)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNSPECIFIED BETA-BLOCKER (BETA BLOCKING AGENTS)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051960-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060622</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>06071803</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>85</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMIODARONE HYDROCHLORIDE</medicinalproduct>
        <drugauthorizationnumb>75424</drugauthorizationnumb>
        <drugdosagetext>200MG, QD, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051010</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060315</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPROL-XL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIGITEK (DIGIXON)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051961-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2005072670</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>13</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>54.4316</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CONVERSION DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSKINESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BENADRYL</medicinalproduct>
        <drugbatchnumb>12704V</drugbatchnumb>
        <drugauthorizationnumb>5845</drugauthorizationnumb>
        <drugdosagetext>1 ULTRATAB PRN, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE ALLERGIES</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050507</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LORATADINE</medicinalproduct>
        <drugdosagetext>ONE TABLET, PRAN (10 MG), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050507</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051962-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060627</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006081202</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>69</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>58.9676</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>VAGINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZANTAC 150</medicinalproduct>
        <drugbatchnumb>A17878</drugbatchnumb>
        <drugauthorizationnumb>21698</drugauthorizationnumb>
        <drugdosagetext>1 TABLET ONCE DAILY AT BEDTIME, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTROOESOPHAGEAL REFLUX DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060613</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060625</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THEOPHYLLINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANTOPRAZOLE SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALPRAZOLAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRIAMCINOLONE ACETONIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COMBIVENT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTI-ASTHMATICS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051963-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060627</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006081193</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>47</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>58.9676</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>GLOSSODYNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERIORBITAL OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS GENERALISED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URTICARIA GENERALISED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ROLAIDS</medicinalproduct>
        <drugbatchnumb>51096V</drugbatchnumb>
        <drugdosagetext>1 TABLET ONCE, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DYSPEPSIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060626</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060626</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051964-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006082429</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POLLAKIURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RECTAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUDAFED PE SINUS HEADACHE CAPLET (ACETMINOPHEN, PHENYLEPHRINE HYDROCHL</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060628</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051965-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060619</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US200604003659</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>63</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL ADHESIONS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE IRRITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEIOMYOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PELVIC MASS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERITONEAL CYST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WOUND DEHISCENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugauthorizationnumb>21318</drugauthorizationnumb>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040512</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051966-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060616</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US200601005414</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>53</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>81.2</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIABETES MELLITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL ISCHAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OBESITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
        <drugauthorizationnumb>20592</drugauthorizationnumb>
        <drugdosagetext>ORAL; 2.7 MG, ORAL; 5 MG, ORAL; 10 MG, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL                (METOPROLOL)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051967-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060615</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US200601000322</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>31</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>66.2</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL DISTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD ALBUMIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRITIS EROSIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATOCHEZIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOPROTEINAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEUKOCYTOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METABOLIC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVARIAN CYST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCREATITIS ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCREATITIS CHRONIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROTEIN URINE PRESENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RED BLOOD CELLS URINE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINE KETONE BODY PRESENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINE LEUKOCYTE ESTERASE POSITIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
        <drugauthorizationnumb>20592</drugauthorizationnumb>
        <drugdosagetext>2.5 MG, AS NEEDED, ORAL; 2.5 MEQ, DAILY (1/D), ORAL; 5 MG, EACH EVENING, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040510</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
        <drugauthorizationnumb>20592</drugauthorizationnumb>
        <drugdosagetext>2.5 MG, AS NEEDED, ORAL; 2.5 MEQ, DAILY (1/D), ORAL; 5 MG, EACH EVENING, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040510</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
        <drugauthorizationnumb>20592</drugauthorizationnumb>
        <drugdosagetext>2.5 MG, AS NEEDED, ORAL; 2.5 MEQ, DAILY (1/D), ORAL; 5 MG, EACH EVENING, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051968-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060619</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US200605004195</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>55</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>COLITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DECREASED APPETITE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALIGNANT NEOPLASM PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METASTASES TO LIVER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUCOUS STOOLS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GEMZAR</medicinalproduct>
        <drugauthorizationnumb>20509</drugauthorizationnumb>
        <drugdosagetext>1250 MG, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BREAST CANCER STAGE IV</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050919</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060505</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAXOTERE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EFFEXOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PERCOCET</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORAZEPAM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051969-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060619</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US200606004333</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>55</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BREAST CANCER FEMALE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EVISTA</medicinalproduct>
        <drugauthorizationnumb>20815</drugauthorizationnumb>
        <drugindication>OSTEOPOROSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051970-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060616</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US200606004081</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HALLUCINATION, AUDITORY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TINNITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CIALIS</medicinalproduct>
        <drugauthorizationnumb>21368</drugauthorizationnumb>
        <drugdosagetext>5 MG</drugdosagetext>
        <drugindication>ERECTILE DYSFUNCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060615</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RANITIDINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KLONOPIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TEGRETOL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051971-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060616</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US_0509122476</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>50</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIABETES MELLITUS NON-INSULIN-DEPENDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA FACIAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POLYURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THYROID DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
        <drugauthorizationnumb>20592</drugauthorizationnumb>
        <drugdosagetext>5 MG, ORAL; 10  MG, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BIPOLAR DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19970301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040525</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
        <drugauthorizationnumb>20592</drugauthorizationnumb>
        <drugdosagetext>5 MG, ORAL; 10  MG, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BIPOLAR DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19970301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040525</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RISPERIDONE  JANSSEN   (RISPERIDONE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EFFEXOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONAZEPAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROTONIX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051972-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060616</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US200606004146</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>85</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BREAST CANCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THIRST</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EVISTA</medicinalproduct>
        <drugauthorizationnumb>20815</drugauthorizationnumb>
        <drugdosagetext>60 MG, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051973-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060627</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006080227</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>89</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HIP FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPONATRAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POSTOPERATIVE INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALDACTONE</medicinalproduct>
        <drugauthorizationnumb>12151</drugauthorizationnumb>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CEFAZOLIN</medicinalproduct>
        <drugdosagetext>PARENTERAL</drugdosagetext>
        <drugadministrationroute>051</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ADVAIR DISKUS 100/50</medicinalproduct>
        <drugdosagetext>INHALATION</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMERON</medicinalproduct>
        <drugdosagetext>15 MG, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050301</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ULTRAM</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOCUSATE SODIUM (DOCUSATE 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>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEPCID</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LOVENOX</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISONE TAB</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KEFLEX</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SLOW-MAG (MAGNESIUM CHLORIDE ANHYDROUS)</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRO-BANTHINE (PROPANTHELINE BROMIDE)</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEXTRA</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COZAAR</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DARVOCET-N 100</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DUONEB</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EFFEXOR XR</medicinalproduct>
        <drugdosagetext>225 MG</drugdosagetext>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050301</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRAZODONE HCL</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051974-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060625</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006079812</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>77.1115</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CATARACT OPERATION COMPLICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMPAIRED HEALING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTRAOCULAR PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHOTOSENSITIVITY REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISION BLURRED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIAGRA</medicinalproduct>
        <drugauthorizationnumb>20895</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MOTRIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051975-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060626</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006080448</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>76</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INADEQUATE ANALGESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROCEDURAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SHOULDER OPERATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
        <drugauthorizationnumb>20235</drugauthorizationnumb>
        <drugindication>PARAESTHESIA ORAL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060622</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALL OTHER THERAPEUTIC PRODUCTS (ALL OTHER THERAPEUTIC PRODUCTS)</medicinalproduct>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTIHYPERTENSIVES</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALL OTHER THERAPEUTIC PRODUCTS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051976-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060626</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006080253</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </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>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GEODON</medicinalproduct>
        <drugauthorizationnumb>20825</drugauthorizationnumb>
        <drugdosagetext>120 MG (60 MG, 2 IN 1 D)</drugdosagetext>
        <drugindication>BIPOLAR DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MOTRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PERCOCET</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051977-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060626</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006080509</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>48</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>JAW DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METASTASES TO CENTRAL NERVOUS SYSTEM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUTENT</medicinalproduct>
        <drugauthorizationnumb>21968</drugauthorizationnumb>
        <drugdosagetext>CYCLIC</drugdosagetext>
        <drugindication>RENAL CELL CARCINOMA STAGE UNSPECIFIED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060623</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugdosagetext>INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>HYPERCALCAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060228</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060601</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCONTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PERCOCET</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DECADRON</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WELLBUTRIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051978-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060626</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006080488</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </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>ABASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISORIENTATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATOCHEZIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LETHARGY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WALKING AID USER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUTENT</medicinalproduct>
        <drugauthorizationnumb>21968</drugauthorizationnumb>
        <drugdosagetext>50 MG (50 MG, FREQUENCY: DAILY INTERVAL: EVERY DAY), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RENAL CELL CARCINOMA STAGE UNSPECIFIED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060529</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060601</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051979-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2005134755</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>59</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>89.3586</patientweight>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</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>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010323</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030924</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEXTRA</medicinalproduct>
        <drugdosagetext>30 MG (10 MG, 3 IN 1 D)</drugdosagetext>
        <drugindication>ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020828</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050314</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051980-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2005134745</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CEREBRAL THROMBOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugauthorizationnumb>20998</drugauthorizationnumb>
        <drugdosagetext>200 MG (200 MG, 1 IN 1 D)</drugdosagetext>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEXTRA</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051981-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060623</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US200606002355</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>77</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>88</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CREATININE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FAILURE TO THRIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LETHARGY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GEMZAR</medicinalproduct>
        <drugauthorizationnumb>20509</drugauthorizationnumb>
        <drugdosagetext>750 MG/M2</drugdosagetext>
        <drugindication>BLADDER CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060116</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060403</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX (FUROSEMIDE, FUROSEMIDE SODIUM)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOPRESSOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051982-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060620</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US200606001697</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>77</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugbatchnumb>FF5X32A</drugbatchnumb>
        <drugauthorizationnumb>21318</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051983-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060620</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>USA020312149</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>61</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>101.4</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BODY HEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE INDURATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROSTATE CANCER METASTATIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RADIATION SKIN INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMALOG</medicinalproduct>
        <drugbatchnumb>8RP76M</drugbatchnumb>
        <drugauthorizationnumb>20563</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DITROPAN XL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARTIA XT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLADEX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LUPRON</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOSAMINE CHONDROITIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HERBAL PREPARATION</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051984-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060620</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US200605006629</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>72</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISORIENTATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NON-SMALL CELL LUNG CANCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PATHOGEN RESISTANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STAPHYLOCOCCAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMALOG</medicinalproduct>
        <drugbatchnumb>9RT33M</drugbatchnumb>
        <drugauthorizationnumb>20563</drugauthorizationnumb>
        <drugdosagetext>AS NEEDED</drugdosagetext>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMULIN U</medicinalproduct>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051985-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060620</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>USA041285901</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>66</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PANCREATECTOMY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCREATIC CARCINOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMALOG</medicinalproduct>
        <drugauthorizationnumb>20563</drugauthorizationnumb>
        <drugindication>DIABETES MELLITUS INSULIN-DEPENDENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010501</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HUMALOG PEN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051986-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060620</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>USA021022980</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>89</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>45.5</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL DISTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ACOUSTIC NEUROMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AUTONOMIC NEUROPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLEPHARITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLINDNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLINDNESS UNILATERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CHOLESTEROL INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CYSTITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRY EYE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPEPSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPHONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE IRRITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FUNGAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GLYCOSYLATED HAEMOGLOBIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERKERATOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMPAIRED GASTRIC EMPTYING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCONTINENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE CALCIFICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MACULAR DEGENERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALABSORPTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSEUDOPHAKIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH PRURITIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SCOTOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREATMENT NONCOMPLIANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VEIN DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL ACUITY REDUCED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INSULIN(INSULIN, ANIMAL) VIAL</medicinalproduct>
        <drugauthorizationnumb>17931</drugauthorizationnumb>
        <drugdosagetext>SUBCUTANEOUS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMULIN N</medicinalproduct>
        <drugbatchnumb>7SH73M</drugbatchnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMALOG</medicinalproduct>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19960101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMALOG</medicinalproduct>
        <drugbatchnumb>8RJ21M</drugbatchnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMALOG</medicinalproduct>
        <drugbatchnumb>8RP79M</drugbatchnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMULIN R</medicinalproduct>
        <drugdosagetext>SUBCUTANEOUS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LACTULOSE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ESTRADIOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMINS NOS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN B-12</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NOVOLOG</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRAVACHOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLENDIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATACAND</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMULIN</medicinalproduct>
        <drugbatchnumb>7SG68M</drugbatchnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051987-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060620</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US_0501110545</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>68</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>117.9</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CHOLESTEROL ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD TRIGLYCERIDES INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CALCINOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIABETES MELLITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
        <drugauthorizationnumb>20592</drugauthorizationnumb>
        <drugdosagetext>15 MG</drugdosagetext>
        <drugindication>BIPOLAR DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051988-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060623</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US200601000813</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>43</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>72.6</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DIABETES MELLITUS NON-INSULIN-DEPENDENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
        <drugauthorizationnumb>20592</drugauthorizationnumb>
        <drugindication>SCHIZOPHRENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051989-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DEU-2006-0002315</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>47</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CATHETER RELATED COMPLICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CAUDA EQUINA SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE NODULE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEURALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RADICULAR PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MORPHINE SULFATE</medicinalproduct>
        <drugdosagetext>25 MG, DAILY, INTRATHECAL</drugdosagetext>
        <drugadministrationroute>037</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OPIOIDS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANALGESICS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051990-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>146375USA</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>31</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GLYCOSYLATED HAEMOGLOBIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIP HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN OF SKIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SCAB</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STEVENS-JOHNSON SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GLIPIZIDE</medicinalproduct>
        <drugauthorizationnumb>74497</drugauthorizationnumb>
        <drugdosagetext>10 MILLIGRAM QD ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS NON-INSULIN-DEPENDENT</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051991-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>146411USA</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>56</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ADRUCIL</medicinalproduct>
        <drugauthorizationnumb>40023</drugauthorizationnumb>
        <drugindication>COLON CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041116</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041116</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOLINIC ACID</medicinalproduct>
        <drugindication>COLON CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041116</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041116</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ERBITUX</medicinalproduct>
        <drugindication>COLON CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041116</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041116</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IRINOTECAN</medicinalproduct>
        <drugindication>COLON CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041116</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041116</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LESCOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLIMARA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCONTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PHENERGAN HCL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051992-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060630</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>0602088US</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>41</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ARTERIOSPASM CORONARY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BOTOX</medicinalproduct>
        <drugauthorizationnumb>1145</drugauthorizationnumb>
        <drugdosagetext>SINGLE, INTRAMUSCULAR</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051993-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060622</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>432356</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>14</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>79.4</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL DISTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABSCESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABSCESS INTESTINAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ACNE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ACTIVITIES OF DAILY LIVING IMPAIRED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AGEUSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ALLERGY TEST POSITIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANOGENITAL WARTS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANOSMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHROPOD BITE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BIOPSY COLON ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLISTER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CHOLESTEROL INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRONCHITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CALCINOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CELLULITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLITIS ULCERATIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COXSACKIE VIRAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CREPITATIONS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CROHN'S DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DERMAL CYST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DUODENITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPLASTIC NAEVUS SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EPSTEIN-BARR VIRUS ANTIGEN POSITIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EXOSTOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE MOVEMENT DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEAR OF DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROOESOPHAGEAL REFLUX DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GROIN PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATEMESIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATOCHEZIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERKERATOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLAMMATORY BOWEL DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERNATIONAL NORMALISED RATIO DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTESTINAL OBSTRUCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IRRITABLE BOWEL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JOINT INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LACRIMATION INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIP DRY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOW DENSITY LIPOPROTEIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALIGNANT MELANOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MELANOCYTIC NAEVUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MICROCYTIC ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULAR WEAKNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NASAL CONGESTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NECK INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NECK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OCULAR HYPERAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL INTAKE REDUCED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARYNGITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POLLAKIURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POLYP</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRODUCTIVE COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROSTATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROTHROMBIN TIME PROLONGED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH PAPULAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH PUSTULAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RECTAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RECTAL TENESMUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RED CELL DISTRIBUTION WIDTH DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>REFLUX GASTRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHINITIS ALLERGIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ROAD TRAFFIC ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SCAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN PAPILLOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STRESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TENDERNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TESTICULAR PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UPPER RESPIRATORY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELLS STOOL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>XEROSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>18662</drugauthorizationnumb>
        <drugdosagetext>40 MG 2 PER 1 DAY ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ACNE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19960106</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19970625</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GENERIC DRUGS (GENERIC DRUG NOS)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTIBIOTIC NOS (ANTIBIOTIC NOS)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051994-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060626</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>WAES 0606USA04331</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>65</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ASPERGILLOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD SODIUM DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DECREASED APPETITE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA PRIMARY ATYPICAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DECADRON</medicinalproduct>
        <drugauthorizationnumb>11664</drugauthorizationnumb>
        <drugdosagetext>PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VORINOSTAT</medicinalproduct>
        <drugdosagetext>200 MG/BID/PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GLIOBLASTOMA MULTIFORME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060519</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060531</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051995-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060622</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2736</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>25</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYSTEMIC LUPUS ERYTHEMATOSUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMNESTEEM (ISOTRETINOIN), 40MG CAPSULESM MYLAN</medicinalproduct>
        <drugauthorizationnumb>75945</drugauthorizationnumb>
        <drugdosagetext>40MG, QD, PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ACNE</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060418</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051996-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060627</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2668</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>14</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMNESTEEM</medicinalproduct>
        <drugauthorizationnumb>75945</drugauthorizationnumb>
        <drugdosagetext>40 MG, QD, PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ACNE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060401</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051997-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060623</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2694</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>16</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE BEFORE PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PREGNANCY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMNESTEEM</medicinalproduct>
        <drugauthorizationnumb>75945</drugauthorizationnumb>
        <drugdosagetext>40MG, QD, PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ACNE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060130</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060210</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMNESTEEM</medicinalproduct>
        <drugdosagetext>40MG, QOD, PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060130</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060210</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5051998-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060623</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>13422951</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSIVE CRISIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EMSAM</medicinalproduct>
        <drugauthorizationnumb>21336</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060501</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052000-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060622</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ABILP-06-0225</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>63</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>77.5</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BREAST CANCER METASTATIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYELID PTOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FACIAL PALSY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HERPES SIMPLEX</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUROPATHY PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TONGUE DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ABRAXANE</medicinalproduct>
        <drugauthorizationnumb>21660</drugauthorizationnumb>
        <drugdosagetext>400 MG DAY/EVERY 3 WEEKS 8 DOSES (220 MG/M2, EVERY 3 WEEKS), INTRAVENOUS DRIP</drugdosagetext>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>BREAST CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051122</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060421</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HORMONAL AGENTS (OTHER HORMONES)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FENTANYL CITRATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRILOSEC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACCUPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOPHAGE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLYBURIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FERROUS SULFATE TAB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REGLAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EFFEXOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KYTRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DECADRON</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COMPAZINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052002-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>S06-USA-02485-01</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>73</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>RECTAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NAMENDA</medicinalproduct>
        <drugauthorizationnumb>21487</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060501</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052003-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060622</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US200606005035</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>21</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PRESCRIBED OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSYCHOTIC DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYPREXA ZYDIS</medicinalproduct>
        <drugbatchnumb>9RS99M</drugbatchnumb>
        <drugauthorizationnumb>20592</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugindication>BIPOLAR DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060528</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060601</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYPREXA ZYDIS</medicinalproduct>
        <drugbatchnumb>9RS99M</drugbatchnumb>
        <drugauthorizationnumb>20592</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugindication>BIPOLAR DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYPREXA ZYDIS</medicinalproduct>
        <drugbatchnumb>9RS99M</drugbatchnumb>
        <drugauthorizationnumb>20592</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugindication>BIPOLAR DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060528</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYPREXA ZYDIS</medicinalproduct>
        <drugbatchnumb>9RS99M</drugbatchnumb>
        <drugauthorizationnumb>20592</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugindication>BIPOLAR DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYPREXA ZYDIS</medicinalproduct>
        <drugbatchnumb>9SA70M</drugbatchnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052004-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060620</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US200606004472</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>20</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BOWEL SOUNDS ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSED LEVEL OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE MOVEMENT DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GLASGOW COMA SCALE ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUCOUS MEMBRANE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA ASPIRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PUPILLARY LIGHT REFLEX TESTS ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUS TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDE ATTEMPT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UNRESPONSIVE TO STIMULI</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
        <drugauthorizationnumb>20592</drugauthorizationnumb>
        <drugdosagetext>600 MG, OTHER, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052005-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060620</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US200606004641</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>44</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIABETES MELLITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG DOSE OMISSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IRRITABILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NIGHT SWEATS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugbatchnumb>9RW75M</drugbatchnumb>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugbatchnumb>9RW75M</drugbatchnumb>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060525</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugbatchnumb>9RG96U</drugbatchnumb>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HORMONES AND RELATED AGENTS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052006-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060620</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US200606002255</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>LANGERHANS' CELL GRANULOMATOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACE INHIBITOR NOS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052007-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060620</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US200606004618</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSKINESIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPAMAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORAZEPAM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052008-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060620</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US200605006664</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>64</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>30 MG</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060509</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLOVENT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROPANOLOL        (PROPANOLOL)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE  (HYDROCHOROTHIAZIDE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>QUINAPRIL HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VIAGRA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052009-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060626</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006-133</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>21</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>APALLIC SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD ALKALINE PHOSPHATASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD BILIRUBIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRADYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBRAL ATROPHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CORYNEBACTERIUM INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ENCEPHALOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAMMA-GLUTAMYLTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYDROCEPHALUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUCOSAL INFLAMMATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEOPLASM RECURRENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERICARDIAL EFFUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLEURAL EFFUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN TOXICITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STEM CELL TRANSPLANT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARBOPLATIN</medicinalproduct>
        <drugauthorizationnumb>76602</drugauthorizationnumb>
        <drugdosagetext>500MG/M2</drugdosagetext>
        <drugindication>BRAIN NEOPLASM MALIGNANT</drugindication>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ETOPOSIDE</medicinalproduct>
        <drugdosagetext>100MG/M2</drugdosagetext>
        <drugindication>BRAIN NEOPLASM MALIGNANT</drugindication>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>THIOTEPA</medicinalproduct>
        <drugdosagetext>300MG/M2</drugdosagetext>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052010-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060613</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006BH010018</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>34</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>134.2647</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>BODY TEMPERATURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROCEDURAL COMPLICATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ANTICOAGULANT SODIUM CITRATE SOLUTION</medicinalproduct>
        <drugbatchnumb>C674978</drugbatchnumb>
        <drugauthorizationnumb>77923</drugauthorizationnumb>
        <drugdosagetext>ONCE; IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PLASMAPHERESIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060506</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060506</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SODIUM CHLORIDE 0.9%</medicinalproduct>
        <drugbatchnumb>C675579</drugbatchnumb>
        <drugdosagetext>ONCE; IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PLASMAPHERESIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060506</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060506</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTIDEPRESSANTS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTI-ANXIETY</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MOOD-BRIGHTENING MEDICATIONS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROVIGIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEXAPRO</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KLONOPIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PHENERGAN HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RELPAX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052011-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060626</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006S1005865</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE/TRIAMTERENE  (37.5 MG)</medicinalproduct>
        <drugauthorizationnumb>74701</drugauthorizationnumb>
        <drugdosagetext>37.5 MG; PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DILTIAZEM TABLETS (120 MG)</medicinalproduct>
        <drugdosagetext>120 MG; PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052012-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060626</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006S1005886</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>35</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZAPINE</medicinalproduct>
        <drugauthorizationnumb>75417</drugauthorizationnumb>
        <drugdosagetext>300 MG; HS; PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20001001</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052013-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060626</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006S1006064</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>56</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>83.9154</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>OTOSCLEROSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugauthorizationnumb>76071</drugauthorizationnumb>
        <drugdosagetext>20 MG; QD; PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051201</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052014-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>28623</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>58</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEUCOVORIN CALCIUM</medicinalproduct>
        <drugauthorizationnumb>89384</drugauthorizationnumb>
        <drugdosagetext>400MG/M2/ DAY 1 OF WKS 1, 3, 5</drugdosagetext>
        <drugindication>ADENOCARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041116</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEUCOVORIN CALCIUM</medicinalproduct>
        <drugauthorizationnumb>89384</drugauthorizationnumb>
        <drugdosagetext>400MG/M2/ DAY 1 OF WKS 1, 3, 5</drugdosagetext>
        <drugindication>METASTASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041116</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEUCOVORIN CALCIUM</medicinalproduct>
        <drugauthorizationnumb>89384</drugauthorizationnumb>
        <drugdosagetext>400MG/M2/ DAY 1 OF WKS 1, 3, 5</drugdosagetext>
        <drugindication>ADENOCARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041214</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEUCOVORIN CALCIUM</medicinalproduct>
        <drugauthorizationnumb>89384</drugauthorizationnumb>
        <drugdosagetext>400MG/M2/ DAY 1 OF WKS 1, 3, 5</drugdosagetext>
        <drugindication>METASTASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041214</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052015-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060627</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>226826</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD IMMUNOGLOBULIN M INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EXTREMITY NECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POST PROCEDURAL NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>REBOUND EFFECT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOE AMPUTATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RITUXAN</medicinalproduct>
        <drugindication>WALDENSTROM'S MACROGLOBULINAEMIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052016-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060627</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A-US2006-12517</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>20</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>80</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>COXSACKIE VIRAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FULL BLOOD COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HERPES SIMPLEX</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERNATIONAL NORMALISED RATIO INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL FUNGAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARVOVIRUS INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VIRAL INFECTION</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>20041201</drugstartdate>
      </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>TOPAMAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PERIACTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSPRA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOVIRAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYGEN (OXYGEN)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052017-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060630</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A-US2005-10403</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>64</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANAPHYLACTIC REACTION</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>20050612</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050613</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052018-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006BI009353</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>17</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HEMIPARESIS</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>5052019-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060619</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE200605002828</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>50</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BENIGN PROSTATIC HYPERPLASIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>60 MG</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060223</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060418</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052020-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060616</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FI200606004242</companynumb>
    <primarysource>
      <reportercountry>FINLAND</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>67</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HEPATIC ENZYME INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>60 MG DAILY (1/D) ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060324</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060523</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052021-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060619</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR200606004037</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>66</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>POLYNEUROPATHY IDIOPATHIC PROGRESSIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMALOG</medicinalproduct>
        <drugauthorizationnumb>20563</drugauthorizationnumb>
        <drugdosagetext>3 IU, 3/D, SUBCUTANEOUS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>DIABETES MELLITUS INSULIN-DEPENDENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052022-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060626</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>8015291</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>3</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>12</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEBRILE INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC ENZYME INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY RETENTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KEPPRA</medicinalproduct>
        <drugauthorizationnumb>21035</drugauthorizationnumb>
        <drugdosagetext>300 MG 2/D</drugdosagetext>
        <drugindication>PARTIAL SEIZURES</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXCARBAZEPINE</medicinalproduct>
        <drugdosagetext>480 MG/D</drugdosagetext>
        <drugindication>PARTIAL SEIZURES</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052023-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060621</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR200606000480</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>44</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EFFECT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PITUITARY TUMOUR RECURRENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SOMATROPIN (SOMATROPIN) VIAL</medicinalproduct>
        <drugauthorizationnumb>19640</drugauthorizationnumb>
        <drugdosagetext>0.4 MG DAILY (1/D), SUBCUTANEOUS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>GROWTH HORMONE DEFICIENCY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050223</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANDROTARDYL (TESTOSTERONE ENANTATE)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052024-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060620</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP200604001304</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>13</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>56</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>EPIPHYSIOLYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMATROPE</medicinalproduct>
        <drugauthorizationnumb>19640</drugauthorizationnumb>
        <drugdosagetext>1.6 MG 6/W SUBCUTANEOUS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051014</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051210</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMATROPE</medicinalproduct>
        <drugauthorizationnumb>19640</drugauthorizationnumb>
        <drugdosagetext>1.6 MG 6/W SUBCUTANEOUS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051211</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060407</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMATROPE</medicinalproduct>
        <drugauthorizationnumb>19640</drugauthorizationnumb>
        <drugdosagetext>1.6 MG 6/W SUBCUTANEOUS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060612</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CORTRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEPAKENE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DESMOPRESSIN ACETATE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052025-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060620</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE200606003991</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>75</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>63</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>COLON CANCER METASTATIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METASTASES TO ABDOMINAL WALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVARIAN CANCER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YENTREVE (DULOXETINE HYDROCHLORIDE) CAPSULE</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>20 MG DAILY (1/D) ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>URINARY INCONTINENCE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040928</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041008</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYBUTYNIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052026-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060626</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-2006-007813</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>65</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BETASERON</medicinalproduct>
        <drugdosagetext>SUBCUTANEOUS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BEZAFIBRATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VERAPAMIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATORVASTATIN CALCIUM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052027-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060626</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-2006-017282</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>53</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HEPATIC FUNCTION ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BETASERON</medicinalproduct>
        <drugdosagetext>SUBCUTANEOUS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060327</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060401</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052028-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060630</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-2006-014525</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>36</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>50</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>AXILLARY MASS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENSTRUAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOSITIS</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>20031201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052029-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060706</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-2006-004161</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>46</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD TRIGLYCERIDES INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PETIBELLE 30 (21) (DROSPIRENONE, ETHINYLESTRADIOL) FILM TABLET</medicinalproduct>
        <drugauthorizationnumb>21098</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052030-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060703</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-2006-016411</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>45</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>85</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>19980101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIRENA</medicinalproduct>
        <drugdosagetext>20 UG/DAY, CONT, INTRA-UTERINE</drugdosagetext>
        <drugadministrationroute>015</drugadministrationroute>
        <drugindication>CONTRACEPTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052031-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060703</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-2006-016412</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>40</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>82</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>MENORRHAGIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010126</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052032-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060619</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>UA-2006-014311</companynumb>
    <primarysource>
      <reportercountry>UKRAINE</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ACUTE ABDOMEN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AFFECT LABILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AMENORRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>APPENDICITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BODY TEMPERATURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HOT FLUSH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTRA-ABDOMINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVARIAN CYST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVARIAN NECROSIS</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>20041201</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052033-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060620</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>NL200605004067</companynumb>
    <primarysource>
      <reportercountry>NETHERLANDS</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>20</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>70</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>AGGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARANOIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>STRATTERA</medicinalproduct>
        <drugauthorizationnumb>21411</drugauthorizationnumb>
        <drugdosagetext>60 MG, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATTENTION DEFICIT/HYPERACTIVITY DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060113</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060403</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RISPERDAL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052034-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060621</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR200603006968</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>73</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>71</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>EATING DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE CONTRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GEMZAR</medicinalproduct>
        <drugauthorizationnumb>20509</drugauthorizationnumb>
        <drugdosagetext>1000 MG/M2, OTHER, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ADENOCARCINOMA PANCREAS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060208</drugstartdate>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOFRAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SOLU-MEDROL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052035-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060621</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP200606000925</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>62</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ERYTHEMA MULTIFORME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEUKOCYTOCLASTIC VASCULITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GEMZAR</medicinalproduct>
        <drugauthorizationnumb>20509</drugauthorizationnumb>
        <drugdosagetext>1400 MG, OTHER, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PANCREATIC CARCINOMA STAGE IV</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060515</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060522</drugenddate>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GEMZAR</medicinalproduct>
        <drugauthorizationnumb>20509</drugauthorizationnumb>
        <drugdosagetext>1400 MG, OTHER, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PANCREATIC CARCINOMA STAGE IV</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060619</drugstartdate>
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    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052036-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060626</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>S06-DEN-02659-01</companynumb>
    <primarysource>
      <reportercountry>DENMARK</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>39</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>64</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ORAL MUCOSAL BLISTERING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VAGINAL MUCOSAL BLISTERING</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>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CITALOPRAM HYDROBROMIDE</medicinalproduct>
        <drugindication>DEPRESSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052037-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060627</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>S06-CAN-01345-01</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>26</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>63.5036</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>COMPLETED SUICIDE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJURY ASPHYXIATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELEXA</medicinalproduct>
        <drugauthorizationnumb>20822</drugauthorizationnumb>
        <drugdosagetext>40 MG QD, PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELEXA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VENLAFAXINE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONAZEPAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OLANZAPINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052038-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060626</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>T06-SWI-02396-01</companynumb>
    <primarysource>
      <reportercountry>SWITZERLAND</reportercountry>
      <qualification>3</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>PARKINSONISM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ESCITALOPRAM OXALATE</medicinalproduct>
        <drugauthorizationnumb>21323</drugauthorizationnumb>
        <drugdosagetext>10 MG QD; PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060326</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060328</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ESCITALOPRAM OXALATE</medicinalproduct>
        <drugdosagetext>5 MG QD; PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060320</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060325</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARICEPT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MARCUMAR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALDACTONE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052039-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060626</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>T06-SWI-02397-01</companynumb>
    <primarysource>
      <reportercountry>SWITZERLAND</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>22</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD SODIUM INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GRAND MAL CONVULSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ESCITALOPRAM OXALATE</medicinalproduct>
        <drugauthorizationnumb>21323</drugauthorizationnumb>
        <drugdosagetext>10 MG QD; PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSED MOOD</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugdosagetext>600 MG QD; PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TEGRETOL</medicinalproduct>
        <drugdosagetext>400 MG QD; PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>EPILEPSY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052040-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060626</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>151-20785-06070095</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>76</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>DISEASE PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</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>20031208</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZELMAC (TEGASEROD)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052041-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060429</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006-01704</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DISEASE PROGRESSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VELCADE</medicinalproduct>
        <drugauthorizationnumb>21602</drugauthorizationnumb>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052042-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060407</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006-01632</companynumb>
    <primarysource>
      <reportercountry>SOUTH AFRICA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>61</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>81</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CAUDA EQUINA SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERAL PHYSICAL HEALTH DETERIORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HERPES ZOSTER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</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>20060303</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CHLORTHALIDONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMOVANE (ZOPICLONE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KYTRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAXOLON</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN B6</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CENTRUM (VITAMINS NOS, MINERALS NOS) TABLET</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOPERAMIDE HYDROCHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TARGOCID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMIKACIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CEFEPIME</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAMADOL HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CIPROFLOXACIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052043-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060626</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2005-01764</companynumb>
    <primarysource>
      <reportercountry>NETHERLANDS</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>71</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>71</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD ALBUMIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CALCIUM DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CAECITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIOMEGALY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ECZEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLATULENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERAL PHYSICAL HEALTH DETERIORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ILEUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERNATIONAL NORMALISED RATIO INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTESTINAL OBSTRUCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLEURAL EFFUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH ERYTHEMATOUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH PAPULAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RED BLOOD CELL SEDIMENTATION RATE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TONGUE DRY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VELCADE</medicinalproduct>
        <drugauthorizationnumb>21602</drugauthorizationnumb>
        <drugdosagetext>2.50 MG, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050517</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOXIL</medicinalproduct>
        <drugdosagetext>57.00 MG, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050517</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACENOCOUMAROL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASCORBIC ACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>APD (PAMIDRONATE DISODIUM)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOFRAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COZAAR PLUS (HYDROCHLOROTHIAZIDE, LOSARTAN  POTASSIUM)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COZAAR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RYTMONORM (PROPAFENONE HYDROCHLORIDE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XATRAL (ALFUZOSIN)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052044-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060620</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR200604004085</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>68</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>55</patientweight>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>SUDDEN DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugauthorizationnumb>21318</drugauthorizationnumb>
        <drugdosagetext>20 UG DAILY (1/D), SUBCUTANEOUS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041018</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FIXICAL VITAMINE D3 (CALCIUM CARBONATE, COLECALCIFEROL)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052045-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060621</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA200606003538</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>2</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>ZYPREXA</medicinalproduct>
        <drugauthorizationnumb>20592</drugauthorizationnumb>
        <drugdosagetext>2/D, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VENOFER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARANESP</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TUMS (CALCIUM CARBONATE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORAZEPAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052046-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060621</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CZ200605003671</companynumb>
    <primarysource>
      <reportercountry>CZECH REPUBLIC</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>44</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ALCOHOLISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASPIRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
        <drugauthorizationnumb>20592</drugauthorizationnumb>
        <drugdosagetext>15 MG DAILY (1/D) ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BIPOLAR DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050317</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LAMOTRIGINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROMETHAZINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLEGOMAZIN              (CHLORPROMAZINE HYDROCHLORIDE)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052047-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060621</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>TR200606002715</companynumb>
    <primarysource>
      <reportercountry>TURKEY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>23</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>80</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>INTENTIONAL OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDE ATTEMPT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
        <drugauthorizationnumb>20592</drugauthorizationnumb>
        <drugdosagetext>5 MG DAILY (1/D) ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PSYCHOTIC DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052048-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006-00980</companynumb>
    <primarysource>
      <reportercountry>NEW ZEALAND</reportercountry>
      <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>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUROPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STRESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VELCADE</medicinalproduct>
        <drugauthorizationnumb>21602</drugauthorizationnumb>
        <drugdosagetext>2.30 MG</drugdosagetext>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060109</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052049-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060630</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006-01629</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>66</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>BRONCHIOLITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VIRAL INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VELCADE</medicinalproduct>
        <drugauthorizationnumb>21602</drugauthorizationnumb>
        <drugindication>MULTIPLE MYELOMA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052050-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060626</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006-01609</companynumb>
    <primarysource>
      <reportercountry>ITALY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>75</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>METASTASES TO SKIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VELCADE</medicinalproduct>
        <drugauthorizationnumb>21602</drugauthorizationnumb>
        <drugdosagetext>1.30 MG/M2</drugdosagetext>
        <drugindication>MULTIPLE MYELOMA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052051-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060627</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006-00629</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>84</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>51</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EJECTION FRACTION DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TROPONIN I INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VELCADE</medicinalproduct>
        <drugauthorizationnumb>21602</drugauthorizationnumb>
        <drugdosagetext>1.80 MG, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060308</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060320</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORON        (CLODRONATE SODIUM)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CIPROFLOXACIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CHLORHEXIDINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUCONAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACYCLOVIR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SODIUM CHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GRANISETRON  HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EPOETIN ALFA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MANEVAC (SENNA, ISPAGHULA)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052052-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060626</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006-01608</companynumb>
    <primarysource>
      <reportercountry>ITALY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>PANCYTOPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VELCADE</medicinalproduct>
        <drugauthorizationnumb>21602</drugauthorizationnumb>
        <drugdosagetext>INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052053-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060627</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-2006-015407</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ALVEOLITIS ALLERGIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERAL PHYSICAL HEALTH DETERIORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOWER RESPIRATORY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CAMPATH</medicinalproduct>
        <drugindication>CHRONIC LYMPHOCYTIC LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060508</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060526</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUDARABINE</medicinalproduct>
        <drugindication>CHRONIC LYMPHOCYTIC LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOPHOSPHAMIDE</medicinalproduct>
        <drugindication>CHRONIC LYMPHOCYTIC LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051201</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052054-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060705</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-2006-017860</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>MYELITIS TRANSVERSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUDARABINE</medicinalproduct>
        <drugauthorizationnumb>20038</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052055-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-2006-010449</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
    </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>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEUKINE</medicinalproduct>
        <drugdosagetext>6 UG/KG, 1X/DAY; SUBCUTANEOUS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>CROHN'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060417</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060421</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM CARBONATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOSAMINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D3</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMITRIPTYLINE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052056-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>225827</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>44</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>53</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>JOINT INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENISCUS LESION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XOLAIR</medicinalproduct>
        <drugdosagetext>150 MG, SUBCUTANEOUS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050815</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYMBICORT (BUDESONIDE, FORMOTEROL FUMARATE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SINGULAIR</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052057-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060626</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>224795</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>12</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>42.7</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ARRHYTHMIA SUPRAVENTRICULAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ATRIAL CONDUCTION TIME PROLONGATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ELECTROCARDIOGRAM P WAVE ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ELECTROLYTE IMBALANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NASAL CONGESTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NASOPHARYNGITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUS TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XOLAIR</medicinalproduct>
        <drugdosagetext>SUBCUTANEOUS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060315</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADVAIR DISKUS 100/50</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SINGULAIR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FERRITIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VENTOLIN (ALBUTEROL/ALBUTEROL SULFATE)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052058-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060626</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-2006-017324</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>24</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HEPATIC FUNCTION ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BETASERON</medicinalproduct>
        <drugdosagetext>MIU, SUBCUTANEOUS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052059-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060703</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>S06-FRA-01780-01</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>81</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>68</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>NEPHROTIC SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MEMANTINE HCL</medicinalproduct>
        <drugauthorizationnumb>21487</drugauthorizationnumb>
        <drugdosagetext>20 MG QD, PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEMENTIA ALZHEIMER'S TYPE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060126</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PERINDOPRIL ERBUMINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SECTRAL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052060-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060630</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006-01388</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>66</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRONCHIOLITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORTHOSTATIC HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VIRAL INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VELCADE</medicinalproduct>
        <drugauthorizationnumb>21602</drugauthorizationnumb>
        <drugdosagetext>1.40 MG/M2</drugdosagetext>
        <drugindication>MULTIPLE MYELOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052061-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060627</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>226154</companynumb>
    <primarysource>
      <reportercountry>POLAND</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>49</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>76</patientweight>
      <patientsex>0</patientsex>
      <reaction>
        <reactionmeddrapt>AGRANULOCYTOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHILLS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARYNGOLARYNGEAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RITUXIMAB (RITUXIMAB) CONC FOR SOLUTION FOR INFUSION</medicinalproduct>
        <drugdosagetext>95 MG, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CHRONIC LYMPHOCYTIC LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060510</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060510</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>20060510</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060512</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUDARABINE</medicinalproduct>
        <drugdosagetext>47.5 MG, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CHRONIC LYMPHOCYTIC LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060510</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060512</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANSOPRAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KETOPROFEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METESCULETOL SODIUM (METESCULETOL)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052062-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060627</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>8012160</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>41</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>70.5</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>AGGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASTICITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA</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>20050301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050901</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KEPPRA</medicinalproduct>
        <drugauthorizationnumb>21035</drugauthorizationnumb>
        <drugdosagetext>1000 MG 2/D PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>EPILEPSY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050901</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KEPPRA</medicinalproduct>
        <drugauthorizationnumb>21035</drugauthorizationnumb>
        <drugdosagetext>1000 MG 2/D PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PARTIAL SEIZURES</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050901</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KEPPRA</medicinalproduct>
        <drugdosagetext>2250 MG 2/D PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONVULSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050901</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KEPPRA</medicinalproduct>
        <drugdosagetext>2250 MG 2/D PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>EPILEPSY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050901</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KEPPRA</medicinalproduct>
        <drugdosagetext>2250 MG 2/D PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PARTIAL SEIZURES</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050901</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ERGENYL CHRONO</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ERGENYL CHRONO</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052063-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060623</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ALMO2006067</companynumb>
    <primarysource>
      <reportercountry>SPAIN</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>28</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>63</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>AGRANULOCYTOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALMOGRAN 12.5 MG 4 COMPRIMIDOS RECU</medicinalproduct>
        <drugauthorizationnumb>21001</drugauthorizationnumb>
        <drugdosagetext>25 MG PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MIGRAINE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060404</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060504</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOPAMAX</medicinalproduct>
        <drugindication>MIGRAINE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060404</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060504</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NAPROXEN</medicinalproduct>
        <drugdosagetext>550 MG PRN PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MIGRAINE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060501</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IBUPROFENO</medicinalproduct>
        <drugdosagetext>400 MG PRN PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MIGRAINE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060501</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052064-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>E2090-00014-SPO-JP</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>72</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>AGRANULOCYTOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZONISAMIDE</medicinalproduct>
        <drugauthorizationnumb>20789</drugauthorizationnumb>
        <drugdosagetext>400 MG, 2 IN 1 D, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONVULSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060416</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060511</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TICLOPIDINE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LONGES (LISINOPRIL)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052065-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060704</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>E2090-00040-SPO-JP</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>76</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH PUSTULAR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZONISAMIDE</medicinalproduct>
        <drugauthorizationnumb>20789</drugauthorizationnumb>
        <drugdosagetext>200 MG, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>EPILEPSY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEPAKENE</medicinalproduct>
        <drugdosagetext>400 MG, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TICLOPIDINE HCL</medicinalproduct>
        <drugdosagetext>200 MG, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLONAZEPAM</medicinalproduct>
        <drugdosagetext>0.5 MG, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRAVASTATIN</medicinalproduct>
        <drugdosagetext>5 MG, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052066-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060704</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>E2020-00203-SPO-JP</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>83</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>48</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>LARYNGEAL OEDEMA</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>20060223</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060309</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>20060310</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060626</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARTEOLOL HYDROCHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PERDIPINE LA (NICARDIPINE HYDROCHLORIDE) (NICARDIPINE HYDROCHLORIDE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOUGHMAC E (DIASTASE COMBINATION DRUG) (TOUGHMAC E)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MARZULENE S (SODIUM AZULENE SULFONATE L-GLUTAMINE) (MARZULENE S)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MYONAL (EPERISONE HYDROCHLORIDE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>JUVELA N (TOCOPHEROL NICOTINATE) (TOCOPHERYL NICOTINATE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MIYA BM (CLOSTRIDIUM BUTYRICUM)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NIZATIDINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GASMOTIN (MOSAPRIDE CITRATE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MUCOSTA (REBAMIPIDE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BLOPRESS (CANDESARTAN CILEXETIL)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052067-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>E2020-00169-SPO-JP</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>83</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ATRIOVENTRICULAR BLOCK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRADYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCONTINENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</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 ALZHEIMER'S TYPE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060517</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060614</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARVEDILOL</medicinalproduct>
        <drugdosagetext>10 MG, 1 IN 1 D, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060614</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BLOPRESS (CANDESARTAN CILEXETIL)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CONIEL (BENIDIPINE HYDROCHLORIDE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ITOROL (ISOSORBIDE HYDROCHLORIDE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SINLESTAL (PROBUCOL)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052068-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060630</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>E2020-00066-SPO-JP</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>84</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>46</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBELLAR HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSSTASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEMORY IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</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>20060511</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060517</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>20060518</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060518</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GASMOTIN (MOSAPRIDE CITRATE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>URSO 250</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052069-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>E044-318-3803</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>70</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>81.9</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ARRHYTHMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBRAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERCAPNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA ASPIRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SICK SINUS 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>DEMENTIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040817</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050622</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DONEPEZIL HCL</medicinalproduct>
        <drugauthorizationnumb>20690</drugauthorizationnumb>
        <drugdosagetext>5 MG, 1 IN 1 D, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEMENTIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050624</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050715</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DONEPEZIL HCL</medicinalproduct>
        <drugdosagetext>DOUBLEBLIND, 1 IN 1, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEMENTIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040204</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040816</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVODOPA (LEVODOPA)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RAMIPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CAVERJET (ALPROSTADIL)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEBRISINOL (TOLTERODINE L-TARTRATE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMBROXOL (AMBROXOL)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PIPERACILLIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COMBACTIM (SULBACTAM SODIUM)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FRAXIPARIN (HEPARIN-FRACTION, CALCIUM SALT)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COPYRKAL (COPYRKAL)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL (METOPROLOL)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARMEN (LERCANIDIPINE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MOTILIUM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052070-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A-CH2006-12523</companynumb>
    <primarysource>
      <reportercountry>BELGIUM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>69</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>44</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HEPATITIS TOXIC</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>20051010</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060612</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REMODULIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RYTMONORM (PROPAFENONE HYDROCHLORIDE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CITALOPRAM HYDROBROMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BUMETANIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KALIUM DURETTES (POTASSIUM CHLORIDE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MOTILIUM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052071-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A-JP2005-10177</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>57</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>35</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATOMEGALY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RIGHT VENTRICULAR FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRACLEER</medicinalproduct>
        <drugauthorizationnumb>21290</drugauthorizationnumb>
        <drugdosagetext>31.25 MG BID ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050627</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050628</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EPOPROSTENOL SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DILTIAZEM HYDROCHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLPIDEM TARTRATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SODIUM AZULENE SULFONATE AND L-GLUTAMINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BETAMETHASONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>URSODEOXYCHOLIC ACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENALAPRIL MALEATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REBAMIPIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYALURONATE SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYANOCOBALAMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRANILAST</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOBUTAMINE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYGEN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052072-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060627</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A-CH2006-12522</companynumb>
    <primarysource>
      <reportercountry>BELGIUM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>7</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>20.5</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIAC DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRACLEER</medicinalproduct>
        <drugauthorizationnumb>21290</drugauthorizationnumb>
        <drugdosagetext>40 MG BID ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CAVOPULMONARY ANASTOMOSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060613</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIURETICS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NILSTAT (NYSTATIN)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VIAGRA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARVEDILOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALDACTONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENOXAPARIN SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZESTRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN B1 TAB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZANTAC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGNESIUM SULFATE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052073-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060630</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A-CH2006-12542</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>77</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANAEMIA</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>20060401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060628</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETYLSALICYLIC ACID SRT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIURETICS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052074-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006BI009469</companynumb>
    <primarysource>
      <reportercountry>ITALY</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>46</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HEPATITIS FULMINANT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER 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>20030901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052075-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060703</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006BI009510</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>27</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CHORIOMENINGITIS LYMPHOCYTIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CSF PROTEIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugdosagetext>30 UG QW IM</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060601</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052076-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060703</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006BI009592</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>DEHYDRATION</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>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060629</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052077-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060703</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006BI009466</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <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>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugdosagetext>30 UG QW</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>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060401</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EFFEXOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RIVOTRIL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052078-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060630</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200610634BFR</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>79</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIVERTICULUM INTESTINAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROTHROMBIN TIME SHORTENED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RECTAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SHOCK</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CIFLOX (CIPROFLOXACIN)</medicinalproduct>
        <drugauthorizationnumb>19847</drugauthorizationnumb>
        <drugdosagetext>INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>GASTROENTERITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060609</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060610</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CIFLOX (CIPROFLOXACIN)</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTROENTERITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060611</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060614</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
        <drugdosagetext>2 MG, QD, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060612</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052079-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060626</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006EN000137</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
    </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>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ABELCET</medicinalproduct>
        <drugauthorizationnumb>50724</drugauthorizationnumb>
        <drugdosagetext>QD;IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MUCORMYCOSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052080-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060619</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AT200606004219</companynumb>
    <primarysource>
      <reportercountry>AUSTRIA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>82</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANKLE FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEMORAL NECK FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ULNA FRACTURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TERIPARATIDE (TERIPARATIDE)PEN, DISPOSABLE</medicinalproduct>
        <drugauthorizationnumb>21318</drugauthorizationnumb>
        <drugdosagetext>20 UG, DAILY (1/D), SUBCUTANEOUS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FORTEO PEN (FORTEO PEN)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052081-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060619</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IT200605003582</companynumb>
    <primarysource>
      <reportercountry>ITALY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HAEMODIALYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XIGRIS</medicinalproduct>
        <drugbatchnumb>A137985</drugbatchnumb>
        <drugdosagetext>24 MG/KG, OTHER</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060515</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060518</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052082-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060619</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU200606005619</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>76</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CAROTID ARTERY STENOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugauthorizationnumb>21318</drugauthorizationnumb>
        <drugdosagetext>20 UG, DAILY (1/D)</drugdosagetext>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060614</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FORTEO PEN (FORTEO PEN)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KARVEZIDE (HYDROCHLOROTHIAZIDE, IRBESARTAN)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FELODIPINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MELOXICAM (MELOXICAM)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052083-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060619</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AT200606004218</companynumb>
    <primarysource>
      <reportercountry>AUSTRIA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>82</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>LARGE INTESTINE PERFORATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugauthorizationnumb>21318</drugauthorizationnumb>
        <drugdosagetext>20 UG, DAILY (1/D), SUBCUTANEOUS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FORTEO PEN (FORTEO PEN)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052084-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060619</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA200606004513</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>67</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTESTINAL OBSTRUCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugbatchnumb>FF5S35E</drugbatchnumb>
        <drugauthorizationnumb>21318</drugauthorizationnumb>
        <drugdosagetext>20 MG, OTHER</drugdosagetext>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051213</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FORTEO PEN (FORTEO PEN)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052085-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060619</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BE200606004528</companynumb>
    <primarysource>
      <reportercountry>BELGIUM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>76</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>COMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEAD INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUBDURAL HAEMATOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugauthorizationnumb>21318</drugauthorizationnumb>
        <drugdosagetext>20 UG, DAILY (1/D), SUBCUTANEOUS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FORTEO PEN (FORTEO PEN)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM (CALCIUM)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LONARID (AMOBARBITAL, CAFFEINE, CODEINE PHOSPHATE, OCTIBENZONIUM BROMI</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052086-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060704</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ATWYE967004JUL06</companynumb>
    <primarysource>
      <reportercountry>AUSTRIA</reportercountry>
    </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>EFECTIN (VENLAFAXINE HYDROCHLORIDE, UNSPEC, 0)</medicinalproduct>
        <drugauthorizationnumb>20151</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052087-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060706</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FRWYE056107JUL06</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>61</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>SCIATICA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RAPAMUNE</medicinalproduct>
        <drugauthorizationnumb>21083</drugauthorizationnumb>
        <drugdosagetext>4 MG TOTAL DAILY AT THE TIME OF THE EVENT ONSET ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS AGAINST TRANSPLANT REJECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020816</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052088-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060425</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006-141715-NL</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>60</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANAPHYLACTIC SHOCK</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VECURONIUM BROMIDE</medicinalproduct>
        <drugauthorizationnumb>18776</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>INDUCTION OF ANAESTHESIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050512</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050512</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052089-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060626</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>29347</companynumb>
    <primarysource>
      <reportercountry>SPAIN</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>70</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PLEURAL EFFUSION</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>
        <drugindication>TACHYARRHYTHMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060606</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIURETICS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052090-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060626</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GXKR2006FR03597</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>68</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ARTERIOSCLEROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CAROTID ARTERY STENOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CAROTID ARTERY THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLAMMATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRANSIENT ISCHAEMIC ATTACK</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugauthorizationnumb>80336</drugauthorizationnumb>
        <drugindication>ARTERITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOPIDOGREL</medicinalproduct>
        <drugindication>TRANSIENT ISCHAEMIC ATTACK</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AZATHIOPRINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052091-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060626</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GXKR2006FR03598</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMODIALYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYDRONEPHROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OBSTRUCTIVE UROPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SULFADIAZINE</medicinalproduct>
        <drugauthorizationnumb>40091</drugauthorizationnumb>
        <drugindication>TOXOPLASMOSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052092-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060320</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006BH006374</companynumb>
    <primarysource>
      <reportercountry>CHINA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY RETENTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIDAZOLAM HYDROCHLORIDE</medicinalproduct>
        <drugauthorizationnumb>75324</drugauthorizationnumb>
        <drugdosagetext>4.0 UG/KG;/MIN; UNKNOWN</drugdosagetext>
        <drugindication>CONVULSION NEONATAL</drugindication>
        <drugtreatmentduration>65</drugtreatmentduration>
        <drugtreatmentdurationunit>805</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052093-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GXKR2006GB03822</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>39</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>61</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DYSKINESIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRAMADOL HCL</medicinalproduct>
        <drugbatchnumb>447H02</drugbatchnumb>
        <drugauthorizationnumb>75968</drugauthorizationnumb>
        <drugdosagetext>100 MG, UNK, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060531</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060531</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HUMALOG</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052094-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DEU-2006-0002318</companynumb>
    <primarysource>
      <reportercountry>CHINA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>18</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ACCIDENTAL OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG TOXICITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EXTRAPYRAMIDAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MIOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OCULOGYRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESTLESSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TORTICOLLIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MORPHINE SULFATE</medicinalproduct>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugindication>CANCER PAIN</drugindication>
        <drugtreatmentduration>61</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NALOXONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HALOPERIDOL</medicinalproduct>
        <drugdosagetext>2 MG, BID, INTRAMUSCULAR</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052095-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060630</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DEU-2006-0002129</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>80</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>90.2</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HUMERUS FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMPINGEMENT SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXY CR TAB 20 MG(OXY CR TAB 20 MG)(OXYCODONE HYDROCHLORIDE) PROLONGED-</medicinalproduct>
        <drugauthorizationnumb>20553</drugauthorizationnumb>
        <drugdosagetext>40 MG, DAILY, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BACK PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060327</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060405</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GABAPENTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MOVICOL (SODIUM CHLORIDE, SODIUM BICARBONATE, POTASSIUM CHLORIDE, MACR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACTONEL (RIEDRONATE SODIUM)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COLECALCIFEROL (COLECALCIFEROL)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLYBURIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORATADINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052096-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060623</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR200606005232</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>70</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CYTOLYTIC HEPATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATOCELLULAR DAMAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RIGHT VENTRICULAR FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALIMTA</medicinalproduct>
        <drugauthorizationnumb>21462</drugauthorizationnumb>
        <drugdosagetext>INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052097-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060621</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GR200606004764</companynumb>
    <primarysource>
      <reportercountry>GREECE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>10</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>25</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL ACUITY REDUCED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CECLOR</medicinalproduct>
        <drugauthorizationnumb>50521</drugauthorizationnumb>
        <drugdosagetext>15 ML, DAILY (1/D), ONLY 2 DOSES GIVEN, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PHARYNGITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060603</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060603</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052098-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060620</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA200605003439</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>3.3</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPEPSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEEDING DISORDER NEONATAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEONATAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PREMATURE BABY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMALOG</medicinalproduct>
        <drugauthorizationnumb>20563</drugauthorizationnumb>
        <drugdosagetext>TRANSPLACENTAL</drugdosagetext>
        <drugadministrationroute>064</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052099-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060627</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>SGB1-2006-00238</companynumb>
    <primarysource>
      <reportercountry>ITALY</reportercountry>
      <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>
      <reaction>
        <reactionmeddrapt>HAEMODIALYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCREATITIS ACUTE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOZNOL               (LANTHANUM CARBONATE)</medicinalproduct>
        <drugbatchnumb>1C03/2007</drugbatchnumb>
        <drugdosagetext>750MG, 1X/DAY;QD, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060415</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060423</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FEROGRAD                             (ASCORBIC ACID, FERROUS SULFATE)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052100-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060620</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE200606004477</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>11</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>VENTRICULAR EXTRASYSTOLES</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>STRATTERA</medicinalproduct>
        <drugauthorizationnumb>21411</drugauthorizationnumb>
        <drugdosagetext>60 MG, DAILY (1/D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATTENTION DEFICIT/HYPERACTIVITY DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060610</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052101-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060621</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR200606004456</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>47</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>STATUS EPILEPTICUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROZAC</medicinalproduct>
        <drugauthorizationnumb>18936</drugauthorizationnumb>
        <drugdosagetext>20 MG, DAILY (1/D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060516</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEPTIUR              (TRIPATEPINE HYDROCHLORIDE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KALETRA              (LOPINAVIRM RITONAVIR)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ABACAVIR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEXOMIL (BROMAZEPAM)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DITROPAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRAXILENE (NAFTIDROFURYL OXALATE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MOPRAL        (OMEPRZOLE)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052102-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060623</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IT200606005013</companynumb>
    <primarysource>
      <reportercountry>ITALY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>74</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ENCEPHALOPATHY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GEMCITABINE HYDROCHLORIDE</medicinalproduct>
        <drugauthorizationnumb>20509</drugauthorizationnumb>
        <drugdosagetext>1000 MG/M2, OTHER, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NON-HODGKIN'S LYMPHOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RITUXIMAB (RITUXIMAB)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CHLORPHENAMINE (CHLORPHENAMINE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXALIPLATIN (OXALIPLATIN)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXTROS INFUSIO FLUID 5% (GLUCOSE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IFOSFAMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MESNA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GRANULOCYTE COLONY STIMULATING FACTOR (GRANULOCYTE COLONY STIMULATING </medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052103-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060622</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB200606004855</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BRONCHOSPASM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GEMZAR</medicinalproduct>
        <drugbatchnumb>C6052422</drugbatchnumb>
        <drugauthorizationnumb>20509</drugauthorizationnumb>
        <drugdosagetext>1250 MG</drugdosagetext>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060403</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052104-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GXKR2006GB03825</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>64</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ALANINE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD ALBUMIN 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 FUNCTION TEST ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS GENERALISED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CO-AMOXICLAV</medicinalproduct>
        <drugauthorizationnumb>18740</drugauthorizationnumb>
        <drugdosagetext>625 MG, TID, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ABSCESS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060510</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060517</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METRONIDAZOLE</medicinalproduct>
        <drugdosagetext>200 MG, TID, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ABSCESS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060511</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060518</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052105-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GXKR2006GR03680</companynumb>
    <primarysource>
      <reportercountry>GREECE</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>70</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANTIPSYCHOTIC DRUG LEVEL INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION INHIBITION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ELECTROCARDIOGRAM QT PROLONGED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENTRICULAR EXTRASYSTOLES</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CIPROFLOXACIN</medicinalproduct>
        <drugauthorizationnumb>75939</drugauthorizationnumb>
        <drugdosagetext>800 MG, QD, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PNEUMONIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OLANZAPINE</medicinalproduct>
        <drugdosagetext>10 MG, QD, UNKNOWN</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AZATHIOPRINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALSARTAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052106-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060410</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ES200607000172</companynumb>
    <primarysource>
      <reportercountry>SPAIN</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>80</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABNORMAL FAECES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBRAL THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COORDINATION ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSED MOOD</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugbatchnumb>FF5K73C</drugbatchnumb>
        <drugauthorizationnumb>21318</drugauthorizationnumb>
        <drugdosagetext>20 UG, DAILY (1/D), SUBCUTANEOUS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060407</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FORTEO PEN 9250MCG/ML) (FORTEO PEN 250MCG/ML (3ML)) PEN, DISPOSABLE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052107-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060623</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DK200606004951</companynumb>
    <primarysource>
      <reportercountry>DENMARK</reportercountry>
      <qualification>5</qualification>
    </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>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OLANZAPINE</medicinalproduct>
        <drugauthorizationnumb>20592</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANXIETY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OLANZAPINE</medicinalproduct>
        <drugauthorizationnumb>20592</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANXIETY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CITALOPRAM HYDROBROMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUPENTIXOL DIHYDROCHLORIDE (FLUPENTIXOL DIHYDROCHLORIDE)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052108-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060620</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR200606004449</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>47</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PROTHROMBIN LEVEL INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
        <drugauthorizationnumb>20592</drugauthorizationnumb>
        <drugdosagetext>10 MG, DAILY (1/D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ABNORMAL BEHAVIOUR</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060607</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SINTROM             /NET/(ACENOCOUMAROL)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CIRKAN (ASCORBIC ACID, HERBAL EXTRACTS NOS, HESPERIDIN METHYL CHALCONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGNE-B6 (MEGNESIUM LACTATE, PYRIDOXINE HYDROCHLORIDE)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052109-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060623</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR200606004937</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>84</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>45</patientweight>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>AGGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CYTOMEGALOVIRUS GASTROENTERITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LACRIMATION INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOGORRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NECROSIS ISCHAEMIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROCTITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RECTAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
        <drugauthorizationnumb>20592</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MANIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060306</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060317</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEPAKOTE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELLCEPT     /USA/(MYCOPHENOLATE MOFETIL)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CORTANCYL    /FRA/(PREDNISONE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMOVANE       /UNK/ (ZOPICLONE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEXOMIL (BROMAZEPAM)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIGOXIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPEGIC 1000</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIDOSE VITAMINE D (CALCIUM CARBONATE, COLECALCIFEROL)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOSAMAX   /ITA/(ALENDRONATE SODIUM)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAMADOL HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BISOPROLOL FUMARATE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052110-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060622</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR200606005447</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>49</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>EXTRADURAL HAEMATOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEAD INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INAPPROPRIATE ANTIDIURETIC HORMONE SECRETION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERICARDIAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSYCHIATRIC SYMPTOM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUPRAVENTRICULAR TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
        <drugauthorizationnumb>20592</drugauthorizationnumb>
        <drugdosagetext>10 MG, DAILY (1/D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIHYDANTOIN (PHENYTOIN)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAMADOL HCL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052111-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060621</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB200606004728</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>27</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONGESTIVE CARDIOMYOPATHY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
        <drugauthorizationnumb>20592</drugauthorizationnumb>
        <drugdosagetext>10 MG, DAILY (1/D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050801</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BECLOMETHASONE DIPROPIONATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SALBUTAMOL (SALBUTAMOL)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052112-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060623</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP200606005884</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>32</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
        <drugauthorizationnumb>20592</drugauthorizationnumb>
        <drugdosagetext>20 MG, DAILY (1/D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LAXATIVES</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYPNOTICS AND SEDATIVES</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052113-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060616</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR200605003816</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
    </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 ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOLYTIC ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAPTOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEAD INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CEFACLOR</medicinalproduct>
        <drugauthorizationnumb>50521</drugauthorizationnumb>
        <drugdosagetext>500 MG, 2/D ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BRONCHITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060123</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060127</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENGERIX-B</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEORECORMON (EPOETIN BETA)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE BESYLATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIDIA (CALCIUM CARBONATE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BISOPROLOL FUMARATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPEGIC 1000</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EUPRESSYL (URAPIDIL)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EXACYL (TRANEXAMIC ACID)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052114-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060619</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA200602004365</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>34</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MARITAL PROBLEM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>STRATTERA</medicinalproduct>
        <drugbatchnumb>A097114</drugbatchnumb>
        <drugauthorizationnumb>21411</drugauthorizationnumb>
        <drugdosagetext>10 MG DAILY (1/D) ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATTENTION DEFICIT/HYPERACTIVITY DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051201</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052115-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060619</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ES200606000940</companynumb>
    <primarysource>
      <reportercountry>SPAIN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>52</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>75</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRAIN DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBRAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIABETES INSIPIDUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTHERMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTI-ORGAN FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XIGRIS</medicinalproduct>
        <drugdosagetext>INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>SEPSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060329</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MIDAZOLAM HYDROCHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTIBIOTICS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CORTICOSTEROIDS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOPAMINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORADRENALINE (NOREPINEPHRINE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANTOPRAZOLE SODIUM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052116-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060620</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GR200605002281</companynumb>
    <primarysource>
      <reportercountry>GREECE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>22</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>57</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INFLAMMATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SALPINGITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VAGINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUOXETINE HYDROCHLORIDE</medicinalproduct>
        <drugauthorizationnumb>18936</drugauthorizationnumb>
        <drugdosagetext>10 MG DAILY 1/D, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060502</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060501</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052117-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060620</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU200606002095</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>44</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BEDRIDDEN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERAL PHYSICAL HEALTH DETERIORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HOT FLUSH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOVENTILATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE TWITCHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL INTAKE REDUCED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANIC ATTACK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUOXETINE</medicinalproduct>
        <drugauthorizationnumb>18936</drugauthorizationnumb>
        <drugdosagetext>40 MG DAILY (1/D)</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060413</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060501</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PONSTAN/CAN/(MEFENAMIC ACID)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVLEN (ETHINYLESTRADIOL, LEVONORGESTREL)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052118-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200610201BFR</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>38</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>96</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISEASE RECURRENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROSTATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH GENERALISED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TENDON DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TENDONITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VASCULAR PURPURA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CIFLOX (CIPROFLOXACIN)</medicinalproduct>
        <drugauthorizationnumb>19537</drugauthorizationnumb>
        <drugdosagetext>500 MG ORAL ; 500 MG ORAL ; BID ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROSTATECTOMY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060207</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060214</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CIFLOX (CIPROFLOXACIN)</medicinalproduct>
        <drugauthorizationnumb>19537</drugauthorizationnumb>
        <drugdosagetext>500 MG ORAL ; 500 MG ORAL ; BID ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROSTATECTOMY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CIFLOX (CIPROFLOXACIN)</medicinalproduct>
        <drugauthorizationnumb>19537</drugauthorizationnumb>
        <drugdosagetext>500 MG ORAL ; 500 MG ORAL ; BID ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROSTATECTOMY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TENSTATEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANTOPRAZOLE SODIUM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052119-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060705</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200610610BFR</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>65</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALIGNANT NEOPLASM PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL CELL CARCINOMA STAGE UNSPECIFIED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SORAFENIB</medicinalproduct>
        <drugauthorizationnumb>21923</drugauthorizationnumb>
        <drugdosagetext>400 MG BID ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RENAL CELL CARCINOMA STAGE UNSPECIFIED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060103</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060504</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SORAFENIB</medicinalproduct>
        <drugauthorizationnumb>21923</drugauthorizationnumb>
        <drugdosagetext>400 MG BID ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RENAL CELL CARCINOMA STAGE UNSPECIFIED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060519</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060614</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TIORFAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOPERAMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLAMOXYL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPALGIC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RIVOTRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRIMPERAN TAB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HALDOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NON STEROID ANTI-INFLAMMATORY</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CORTICOSTEROIDS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052120-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060703</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200610611BVD</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>66</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>82</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PETECHIAE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVELOX</medicinalproduct>
        <drugauthorizationnumb>21085</drugauthorizationnumb>
        <drugdosagetext>400 MG QD</drugdosagetext>
        <drugindication>BRONCHITIS ACUTE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060424</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060429</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOCOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052131-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060712</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>40</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HYPERPROLACTINAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERIDONE</medicinalproduct>
        <drugdosagetext>1 MG BID</drugdosagetext>
        <drugindication>POST-TRAUMATIC STRESS DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060619</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060626</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052132-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060712</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>44</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TIGECYCLINE 50MG</medicinalproduct>
        <drugdosagetext>50MG   Q12H   IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060620</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060628</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052133-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060712</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>71</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>SWELLING FACE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugdosagetext>20 MG DAILY</drugdosagetext>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060606</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052134-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060712</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>46</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>SWELLING FACE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROAT TIGHTNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LISINOPRIL AND HYDROCHLOROTHIAZIDE</medicinalproduct>
        <drugdosagetext>10 MG/12.5 MG DAILY</drugdosagetext>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060329</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060602</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052135-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060712</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>101.6965</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHABDOMYOLYSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugdosagetext>40MG  DAILY  PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DYSLIPIDAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060522</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060623</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GEMFIBROZIL</medicinalproduct>
        <drugdosagetext>600MG  BID  PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DYSLIPIDAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060522</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060623</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052136-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060712</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>80</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>75</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGIC STROKE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERIDONE</medicinalproduct>
        <drugdosagetext>0.5 MG PO DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEMENTIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060601</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052137-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060712</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>66</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSARTHRIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENTAL STATUS CHANGES</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROMETHAZINE</medicinalproduct>
        <drugdosagetext>12.5 MG IV X 1</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NAUSEA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060622</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROMETHAZINE</medicinalproduct>
        <drugdosagetext>12.5 MG IV X 1</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>VOMITING</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060622</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052138-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060712</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>76</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPONATRAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULAR WEAKNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXCARBAZEPINE</medicinalproduct>
        <drugdosagetext>600 MG Q AM /900 MG QPM [DOSE INCREASE START 5/16]</drugdosagetext>
        <drugindication>BIPOLAR DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060516</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052139-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060712</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>90.7194</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRIMIDONE</medicinalproduct>
        <drugdosagetext>100 MG X 2 TWICE A DAY</drugdosagetext>
        <drugindication>TREMOR</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060506</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052140-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060712</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>57</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>72.5755</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>TINNITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMITRIPTYLINE HCL</medicinalproduct>
        <drugdosagetext>1/2 TAB AT BED TIME ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NEURALGIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050826</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050828</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052141-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060712</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>82</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HYPERGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TEQUIN</medicinalproduct>
        <drugdosagetext>400 MG DAILY X14 DAYS IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>FOOT FRACTURE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060124</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060210</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TEQUIN</medicinalproduct>
        <drugdosagetext>400 MG DAILY X14 DAYS IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>STRESS FRACTURE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060124</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060210</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TEQUIN</medicinalproduct>
        <drugdosagetext>400 MG DAILY X 40 DAYS PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>STRESS FRACTURE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060211</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060410</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052142-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060712</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>31</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG LEVEL CHANGED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEAD INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THERAPEUTIC RESPONSE UNEXPECTED WITH DRUG SUBSTITUTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PHENYTOIN</medicinalproduct>
        <drugdosagetext>200 MG Q AM, 130 MG QHS [A LONG TIME]</drugdosagetext>
        <drugindication>CONVULSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LAMICTAL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052143-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060712</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THERAPEUTIC RESPONSE UNEXPECTED WITH DRUG SUBSTITUTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRIAMTERENE AND HYDROCHLOROTHIAZIDE</medicinalproduct>
        <drugdosagetext>ONE PO QD EVERYDAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052144-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060712</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>47</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ALANINE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASPARTATE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASPERGILLOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BILIRUBIN CONJUGATED INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BIOPSY LYMPH GLAND ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EOSINOPHILIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER FUNCTION TEST ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYSTEMIC CANDIDA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PHENYTOIN</medicinalproduct>
        <drugdosagetext>100 MG Q8H PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060425</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060610</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PHENYTOIN</medicinalproduct>
        <drugdosagetext>100 MG Q8H PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SUBARACHNOID HAEMORRHAGE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060425</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060610</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052145-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060712</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>82</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>49.4421</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUID RETENTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DYAZIDE</medicinalproduct>
        <drugdosagetext>1 QD</drugdosagetext>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052146-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060712</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>35</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>68.0396</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABNORMAL BEHAVIOUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BIPOLAR DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MANIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE INJURY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KEPPRA</medicinalproduct>
        <drugdosagetext>3000 MG DAY</drugdosagetext>
        <drugindication>EPILEPSY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052147-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060712</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>77</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>101.7</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BACTRIM DS</medicinalproduct>
        <drugdosagetext>Q12H X 3, Q12H X 3,ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INDWELLING CATHETER MANAGEMENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060428</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060429</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052148-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060712</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>49</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>71.2</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>NEUROLEPTIC MALIGNANT SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERIDONE</medicinalproduct>
        <drugdosagetext>3 MG 1AM + 2HS ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060420</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060522</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052149-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060712</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>81</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>66</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD CREATININE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>POLYMIXIN B</medicinalproduct>
        <drugdosagetext>1750K U, 875K Q12, INTRAVEN</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>KLEBSIELLA INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060511</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060530</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>POLYMIXIN B</medicinalproduct>
        <drugdosagetext>1750K U, 875K Q12, INTRAVEN</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>URINARY TRACT INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060511</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060530</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052150-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060712</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>67</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>90.7</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUDARABINE</medicinalproduct>
        <drugdosagetext>50 MG, 50 MG QD, INTRAVEN</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>B-CELL LYMPHOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060605</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060608</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052151-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060712</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>65</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>67</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TERAZOSIN HCL</medicinalproduct>
        <drugdosagetext>5 MG, 5 MG HS,ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BENIGN PROSTATIC HYPERPLASIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060505</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060607</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052152-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060712</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>59</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>84.8</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CEFEPIME</medicinalproduct>
        <drugdosagetext>2-6G, 208; 1012, INTRAVEN</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CATHETER RELATED INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060525</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060608</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VANCOMYCIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052153-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060712</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>85</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>61.1</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ATRIOVENTRICULAR BLOCK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRADYCARDIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
        <drugdosagetext>100MG, 100 MG QD, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050421</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060602</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052154-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060712</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>52</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>86.5</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HYPERGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARIPIPRAZOLE</medicinalproduct>
        <drugdosagetext>5MG, 5MG HS, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050726</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060613</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052155-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060714</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>42</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>AGGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AMNESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE SYSTOLIC INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRAIN DAMAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHOTOPSIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
        <drugdosagetext>40 MG   DAILY   ORAL  1-2 YEARS</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NORTRIPTYLINE HCL</medicinalproduct>
        <drugdosagetext>75 MG   DAILY   ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN BLOOD PRESSURE MEDICATION</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052156-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060714</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>45</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OMNIPAQUE 350</medicinalproduct>
        <drugbatchnumb>10376948</drugbatchnumb>
        <drugdosagetext>350 MG ONE TIME IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ABDOMINAL PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060621</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060621</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052157-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060714</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>90</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>56.7</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFUSION SITE REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVAQUIN</medicinalproduct>
        <drugdosagetext>250 MG Q 24 HOURS IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CELLULITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060624</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060624</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPROL-XL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052158-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060714</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>26</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>56.6996</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ARRHYTHMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEAFNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUROPATHY PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SENSATION OF PRESSURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISION BLURRED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NOROXIN</medicinalproduct>
        <drugbatchnumb>0843-816</drugbatchnumb>
        <drugdosagetext>400 MG TWICE DAILY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>URINARY TRACT INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060619</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060622</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052159-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060714</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>36</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>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>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD IMMUNOGLOBULIN E INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>C-REACTIVE PROTEIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROTHROMBIN TIME PROLONGED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMISIL</medicinalproduct>
        <drugindication>ONYCHOMYCOSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060419</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060427</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052160-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060714</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>68.0396</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>AMNESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSED LEVEL OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EXCORIATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SLEEP WALKING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMBIEN CR</medicinalproduct>
        <drugbatchnumb>XC10</drugbatchnumb>
        <drugdosagetext> 1 TABLET AT BEDTIME PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INSOMNIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060710</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060711</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052161-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060714</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>93</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MENTAL STATUS CHANGES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE TWITCHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugindication>CONVULSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052162-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060714</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>59</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URTICARIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OMNIPAQUE 350</medicinalproduct>
        <drugbatchnumb>10376948</drugbatchnumb>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060629</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060629</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052163-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060713</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>49</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>84.369</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD CREATINE PHOSPHOKINASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DAPTOMYCIN 500 MG CUBIST PHARMACEUTICALS</medicinalproduct>
        <drugbatchnumb>351453F</drugbatchnumb>
        <drugdosagetext>500 MG DAILY IV BOLUS</drugdosagetext>
        <drugadministrationroute>040</drugadministrationroute>
        <drugindication>STAPHYLOCOCCAL BACTERAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060616</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060619</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRONOLACTONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLPIDEM TARTRATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPRIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARVEDILOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANOXIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATORVASTATIN CALCIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANTOPRAZOLE SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MIRTAZAPINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OLANZAPINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LINEZOLID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VANCOMYCIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052164-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060713</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>79</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>80.7403</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GEMCITABINE</medicinalproduct>
        <drugdosagetext>1500 MG/M2 Q2 WEEKS IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060428</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060526</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEMETREXED</medicinalproduct>
        <drugdosagetext>500 MG/M2 Q2 WEEKS IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060428</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060526</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052165-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060713</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>79.8331</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>OSTEOPOROSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugdosagetext>300 MG PER NIGHT PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BIPOLAR DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugdosagetext>75 MG PER DAY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SEREQUEL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052166-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060713</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>56</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>70.7611</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IRRITABILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POLLAKIURIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugdosagetext>10 MG DAILY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>LOW DENSITY LIPOPROTEIN INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060615</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060622</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052167-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060713</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>54</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>74.8435</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWELLING FACE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVELOX</medicinalproduct>
        <drugdosagetext>400 MG QD PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SINUSITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060418</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060418</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RANITIDINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NASONEX AS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052168-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060712</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>52</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>60.3284</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DYSKINESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSTONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOVEMENT DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
        <drugdosagetext>20MG ONCE DAILY ORALLY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PANIC DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050501</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052169-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060712</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>68</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>74.8435</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>RECTAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SULAR</medicinalproduct>
        <drugdosagetext>ONE TABLET DAILY</drugdosagetext>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060509</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRICOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZINC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ECHINACEA</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052170-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060712</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>53</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>47.6277</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BONIVA</medicinalproduct>
        <drugdosagetext>150 MG MONTHLY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060601</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugdosagetext>WEEKLY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051201</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052171-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060712</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>81</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>53.5</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>INTERNATIONAL NORMALISED RATIO INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
        <drugdosagetext>7.5MG QD BY MOUTH</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050310</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050915</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRILOSEC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SENNOSIDES</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOCLOPRAMIDE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCODONE AND ACETAMINOPHEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATORVASTATIN CALCIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DILTIAZEM (INWOOD)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052172-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060712</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>56</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>63.5</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENOXAPARIN SODIUM</medicinalproduct>
        <drugdosagetext>60MG,Q12H, SUBCUTAN</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051003</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051005</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENOXAPARIN SODIUM</medicinalproduct>
        <drugdosagetext>80MG, Q12H, SUBCUTANEOUS</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051005</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051009</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARFARIN NA (COUMADIN)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FELODIPINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIPHENHYDRAMINE ELIXIR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THIAMINE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTIVITAMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PAROXETINE HCL (PAXIL)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FERROUS SULFATE TAB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASCORBIC ACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRILOSEC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NICOTINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SODIUM BICARBONATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052173-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060712</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>62</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>59</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMIPENEM</medicinalproduct>
        <drugdosagetext>1500MG,  500MGQ8H, INTRAVEN</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PNEUMONIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060327</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060403</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052174-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060712</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>43</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>82.4</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HYPERKALAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugdosagetext>20MG, 20MG, QD, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060209</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060404</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EMTRICITABINE / TENOFOVIR</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052175-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060712</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>86</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>40.6</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMIPENEM</medicinalproduct>
        <drugdosagetext>1000MG, 250MGQ6H, INTRAVEN</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>URINARY TRACT INFECTION PSEUDOMONAL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060330</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060407</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052176-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060712</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>59</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>87.1</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugdosagetext>20MG,  20MG QD, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050509</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060410</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052177-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060712</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>86</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>74.8</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VANCOMYCIN</medicinalproduct>
        <drugdosagetext>1000MG, ONCE, INTRAVEN</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>POSTOPERATIVE CARE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060408</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060408</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052178-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060712</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>76</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>83.2</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HYPERKALAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COZAAR</medicinalproduct>
        <drugdosagetext>25MG, 25MG QD, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060411</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052179-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060712</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>70</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>68</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HAEMOPTYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REOPRO</medicinalproduct>
        <drugindication>PERCUTANEOUS CORONARY INTERVENTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050505</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050505</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN</medicinalproduct>
        <drugindication>PERCUTANEOUS CORONARY INTERVENTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050705</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050705</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052180-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060712</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>78.4723</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HEPATIC FUNCTION ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KETEK</medicinalproduct>
        <drugindication>SINUSITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060525</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060531</drugenddate>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052181-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060712</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>44</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>TARDIVE DYSKINESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREATMENT NONCOMPLIANCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERDAL</medicinalproduct>
        <drugdosagetext>PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052182-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060712</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>59</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>95</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GEMZAR</medicinalproduct>
        <drugdosagetext>WEEKLY X 3   IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PANCREATIC CARCINOMA METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060620</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IV PAIN MEDS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DILAUDID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TORADOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYLENOL ATC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCONTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BUMEX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SOLU-MEDROL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORAZEPAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HALDOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANTOPRAZOLE SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEGESTROL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TARCEVA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LACTULOSE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REGLAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BACTRIM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CEFIPIME</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VANCOMYCIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROVIGIL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052183-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060712</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>61</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>62.5964</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NECK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BONIVA</medicinalproduct>
        <drugdosagetext>1 TABLET   ONCE A MONTH   PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RESORPTION BONE INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060708</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060708</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052184-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060714</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>37</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>80.9</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS GENERALISED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NAPROXEN SODIUM</medicinalproduct>
        <drugbatchnumb>1836</drugbatchnumb>
        <drugindication>CAESAREAN SECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060712</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060712</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NAPROXEN SODIUM</medicinalproduct>
        <drugbatchnumb>1836</drugbatchnumb>
        <drugindication>PROCEDURAL PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060712</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060712</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052185-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060714</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>48</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URTICARIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OMNIPAQUE 350</medicinalproduct>
        <drugbatchnumb>10376948</drugbatchnumb>
        <drugdosagetext>350 MG   ONE TIME   IV BOLUS</drugdosagetext>
        <drugadministrationroute>040</drugadministrationroute>
        <drugindication>ABDOMINAL PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060703</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060703</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052186-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060714</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>35</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>45</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HAEMODIALYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LACTIC ACIDOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LINEZOLID</medicinalproduct>
        <drugdosagetext>600MG   TWICE DAILY   PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MYCOBACTERIUM AVIUM COMPLEX INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060108</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060212</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TENOFOVIR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EMTRICITABINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EFAVIRENZ</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PYRIDOXINE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ETHAMBUTOL HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLARITHROMYCIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATOVAQUONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALACYCLOVIR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EPOGEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEUKINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEUCOVORIN CALCIUM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052187-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060714</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>39</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>90.7194</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENTAL STATUS CHANGES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUBDURAL HAEMATOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KALETRA</medicinalproduct>
        <drugdosagetext>3 TABS BID PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ACQUIRED IMMUNODEFICIENCY SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040817</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052188-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060714</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>64</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>58.9676</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MELANOCYTIC NAEVUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN CANCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SQUAMOUS CELL CARCINOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACTONEL</medicinalproduct>
        <drugdosagetext>35 MG  1/WEEK  PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040904</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060304</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052189-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060714</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>9</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>RASH MACULO-PAPULAR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZITHROMAX</medicinalproduct>
        <drugdosagetext>ONCE DAILY   PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OTITIS MEDIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060710</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060713</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052190-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060714</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>73</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>61.7</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>RASH GENERALISED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN AND CODEINE PHOSPHATE #3</medicinalproduct>
        <drugdosagetext>ONE TABLET  Q6H   BUCCAL</drugdosagetext>
        <drugadministrationroute>002</drugadministrationroute>
        <drugindication>CHEST INJURY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060709</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060709</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052191-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060714</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>70</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>83.9154</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>RASH ERYTHEMATOUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH GENERALISED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE TAB</medicinalproduct>
        <drugindication>OSTEOARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060711</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060711</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIDOCAINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MARCAINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052192-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060714</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DISEASE RECURRENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>KIDNEY INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEPHROLITHIASIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>PO63741</drugbatchnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugindication>PSORIATIC ARTHROPATHY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060410</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060610</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>PO63741</drugbatchnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugindication>PSORIATIC ARTHROPATHY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060611</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060710</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>PO68344</drugbatchnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052193-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060714</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>69</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>57.1532</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BONE PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugdosagetext>70MG  ONCE PER WEEK  PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060409</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060509</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052194-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060714</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>35</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>72.5755</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLINDNESS TRANSIENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERMETROPIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LENS DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISION BLURRED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL ACUITY REDUCED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOPAMAX</medicinalproduct>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEADACHE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060618</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060627</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOPAMAX</medicinalproduct>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MIGRAINE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060618</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060627</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAZODONE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MOTRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ULTRAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FIORICET</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052195-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060705</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20060700733</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>104.33</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PERONEAL NERVE PALSY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052196-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060704</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-JNJFOC-20060601896</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>77</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PNEUMONIA LEGIONELLA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RHEUMATREX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RHEUMATREX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MEDROL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VOLTAREN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTRIC ULCER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052197-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060706</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-JNJFOC-20060701055</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>82</patientweight>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DICLOFENAC</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VENTOLIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZANTAC</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052198-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060705</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20060602928</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>99.34</patientweight>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ARTERIOSCLEROSIS CORONARY ARTERY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIFFUSE ALVEOLAR DAMAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DILATATION VENTRICULAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC CONGESTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC STEATOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OBESITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLEURAL EFFUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA LEGIONELLA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugbatchnumb>6CM03031</drugbatchnumb>
        <drugdosagetext>6 VIALS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugbatchnumb>6CM03031</drugbatchnumb>
        <drugdosagetext>MAINTENANCE TREATMENT FOR APPROXIMATELY 2 YEARS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PSORIATIC ARTHROPATHY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TREXALL</medicinalproduct>
        <drugindication>PSORIATIC ARTHROPATHY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052199-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060705</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20060504331</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>75.52</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA OF EYELID</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER FUNCTION TEST ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POLYARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PSORIATIC ARTHROPATHY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INH</medicinalproduct>
        <drugindication>TUBERCULOSIS SKIN TEST POSITIVE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALCOHOL</medicinalproduct>
        <drugindication>ALCOHOL USE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOTREL</medicinalproduct>
        <drugindication>BLOOD PRESSURE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOXAZOSIN</medicinalproduct>
        <drugindication>BLOOD PRESSURE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZYRTEC-D 12 HOUR</medicinalproduct>
        <drugindication>HYPERSENSITIVITY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugindication>PSORIATIC ARTHROPATHY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>B6</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052217-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060710</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PL-JNJFOC-20060701634</companynumb>
    <primarysource>
      <reportercountry>POLAND</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>80</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BLINDED; ABCIXIMA</medicinalproduct>
        <drugauthorizationnumb>8135</drugauthorizationnumb>
        <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>ATROPINE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BRADYCARDIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CORDARONE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>VENTRICULAR FIBRILLATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MORPHINE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ANALGESIC EFFECT</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052218-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060706</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DK-JNJFOC-20060700947</companynumb>
    <primarysource>
      <reportercountry>DENMARK</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>74</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>65</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>TUBERCULOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAREVAN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMUREL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SALAZOPYRIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>ARTHRITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052219-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060706</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>NL-JNJFOC-20060700953</companynumb>
    <primarysource>
      <reportercountry>NETHERLANDS</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>21</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARYNGOLARYNGEAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugdosagetext>RE-STARTED FOLLOWING TREATMENT IN 2005.</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugdosagetext>3 INFUSIONS.</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CROHN'S DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PENTASA</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CORTICOSTEROIDS</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052243-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2006BE09744</companynumb>
    <primarysource>
      <reportercountry>BELGIUM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HEPATIC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATITIS TOXIC</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZADITEN</medicinalproduct>
        <drugauthorizationnumb>21066</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052244-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060710</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHRM2006FR02012</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>6</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>NIGHTMARE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZADITEN</medicinalproduct>
        <drugauthorizationnumb>021066</drugauthorizationnumb>
        <drugdosagetext>UNK, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060606</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060606</drugenddate>
        <drugtreatmentduration>1440</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052245-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060705</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHO2006JP11073</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>77</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>47</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BILE DUCT STONE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEUKOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCYTOPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SANDOSTATIN LAR</medicinalproduct>
        <drugauthorizationnumb>021008</drugauthorizationnumb>
        <drugdosagetext>30MG EVERY 4 WEEKS</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>CARCINOID TUMOUR</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050827</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060316</drugenddate>
        <drugtreatmentduration>202</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SANDOSTATIN LAR</medicinalproduct>
        <drugauthorizationnumb>021008</drugauthorizationnumb>
        <drugdosagetext>20MG EVERY 4 WEEKS</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050729</drugenddate>
        <drugtreatmentduration>41760</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CISPLATIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TS 1</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADALAT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NU-LOTAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NITRODERM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TINELAC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEPAS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAKEPRON</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLETAL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KREMEZIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BONALON</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ONEALFA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALDACTONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACTOS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052288-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060704</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-KINGPHARMUSA00001-K200600887</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <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>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OESOPHAGEAL OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SALIVARY HYPERSECRETION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALTACE</medicinalproduct>
        <drugauthorizationnumb>019901</drugauthorizationnumb>
        <drugtreatmentduration>14400</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052289-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060616</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-KINGPHARMUSA00001-K200600779</companynumb>
    <primarysource>
      <reportercountry>ITALY</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>33</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DYSPHONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYELID OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LARYNGOSPASM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ODYNOPHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URTICARIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALTACE</medicinalproduct>
        <drugauthorizationnumb>19901</drugauthorizationnumb>
        <drugdosagetext>5 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CORONARY ANGIOPLASTY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060516</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060529</drugenddate>
        <drugtreatmentduration>20160</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugdosagetext>20 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060516</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TICLID</medicinalproduct>
        <drugdosagetext>500 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060516</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SELOKEN</medicinalproduct>
        <drugdosagetext>200 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060516</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARDIRENE</medicinalproduct>
        <drugdosagetext>160 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060516</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TORVAST</medicinalproduct>
        <drugdosagetext>20 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060516</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METBAY</medicinalproduct>
        <drugdosagetext>1000 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060516</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060529</drugenddate>
        <drugtreatmentduration>20160</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052290-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060710</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-BRISTOL-MYERS SQUIBB COMPANY-13438486</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>66</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OESOPHAGITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUBCUTANEOUS HAEMATOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
        <drugauthorizationnumb>009218</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>EMBOLISM</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060115</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060408</drugenddate>
        <drugtreatmentduration>84</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
        <drugauthorizationnumb>009218</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>THROMBOSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060115</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060408</drugenddate>
        <drugtreatmentduration>84</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMOVANE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SLEEP DISORDER</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060411</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>EPILEPSY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051115</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ODRIK</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060408</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEPAMIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060411</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TERCIAN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOXEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATHYMIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDIATENSYL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AKINETON</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052291-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060707</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-KINGPHARMUSA00001-K200600883</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>40</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BODY TEMPERATURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OXYGEN SATURATION DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEPTRA</medicinalproduct>
        <drugauthorizationnumb>17376</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060601</drugstartdate>
        <drugtreatmentduration>20160</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EFAVIRENZ</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KIVEXA</medicinalproduct>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060601</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052293-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040707</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ABBOTT-04P-087-0266466-00</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>COLON OPERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL PERFORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERLIPIDAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KALETRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>21226</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040226</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LAMIVUDINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040226</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>STAVUDINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040226</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GANCICLOVIR</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CYTOMEGALOVIRUS TEST</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040210</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040224</drugenddate>
        <drugtreatmentduration>14</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AZITHROMYCIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANTIBIOTIC PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040226</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BACTRIM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANTIBIOTIC PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041226</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050523</drugenddate>
        <drugtreatmentduration>147</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052294-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060705</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-06P-163-0338023-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>36</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>COMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDE ATTEMPT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEPAKOTE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>018723</drugauthorizationnumb>
        <drugindication>SUICIDE ATTEMPT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060611</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060611</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OLANZAPINE</medicinalproduct>
        <drugindication>SUICIDE ATTEMPT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060611</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060611</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLONAZEPAM</medicinalproduct>
        <drugindication>SUICIDE ATTEMPT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060611</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060611</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052295-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060627</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-ABBOTT-06P-062-0337051-00</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CHILLS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ENCEPHALITIS VIRAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BIAXIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>50662</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HELICOBACTER INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060622</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060626</drugenddate>
        <drugtreatmentduration>4</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>20060622</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060626</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PANTOPRAZOLE SODIUM</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HELICOBACTER INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060622</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060627</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052296-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060508</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ABBOTT-06P-087-0332853-00</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ASCITES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC CIRRHOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC FUNCTION ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JAUNDICE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SHOCK</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KALETRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>21226</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050927</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060329</drugenddate>
        <drugtreatmentduration>183</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZIDOVUDINE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050926</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZIDOVUDINE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050927</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060329</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ABACAVIR</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050927</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060329</drugenddate>
        <drugtreatmentduration>183</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LAMIVUDINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050926</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLIMEPIRIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060329</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COAGULATION FACTOR VIII</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>FACTOR VIII DEFICIENCY</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060329</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052297-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060705</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>NL-ABBOTT-06P-114-0337687-00</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>33</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MEDICAL OBSERVATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PREMATURE RUPTURE OF MEMBRANES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THERAPY NON-RESPONDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TIPRANAVIR+RITONAVIR</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>20945</drugauthorizationnumb>
        <drugindication>SYSTEMIC ANTIVIRAL TREATMENT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEVIRAPINE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>SYSTEMIC ANTIVIRAL TREATMENT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZIDOVUDINE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>SYSTEMIC ANTIVIRAL TREATMENT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZIDOVUDINE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMIVUDINE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>SYSTEMIC ANTIVIRAL TREATMENT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ABACAVIR</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>SYSTEMIC ANTIVIRAL TREATMENT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TENOFOVIR</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>SYSTEMIC ANTIVIRAL TREATMENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19960101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENFUVIRTIDE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>SYSTEMIC ANTIVIRAL TREATMENT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIDANOSINE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>SYSTEMIC ANTIVIRAL TREATMENT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>STAVUDINE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19960101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KALETRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021226</drugauthorizationnumb>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19960101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052298-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060705</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ABBOTT-06P-087-0337761-00</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>69</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ELECTROCARDIOGRAM QT PROLONGED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TORSADE DE POINTES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENTRICULAR FIBRILLATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLARITHROMYCIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>50662</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NASOPHARYNGITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051031</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EPINASTINE HYDROCHLORIDE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NASOPHARYNGITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051031</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052299-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060706</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-ABBOTT-06P-062-0337666-00</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG LEVEL INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATEMESIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEUKOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ERGENYL CHRONO TABLETS</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>18081</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>EPILEPSY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060206</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060210</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ERGENYL CHRONO TABLETS</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>018081</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060211</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060516</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ERGENYL CHRONO TABLETS</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>018081</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060517</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060609</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ERGENYL CHRONO TABLETS</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>018081</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060610</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052300-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060609</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-06P-163-0335667-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>56</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ACQUIRED IMMUNODEFICIENCY SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLINDNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEAFNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERAL PHYSICAL HEALTH DETERIORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENINGITIS CRYPTOCOCCAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RITONAVIR SOFT GELATIN CAPSULES</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>20945</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050701</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>APTIVUS</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050701</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUZEON</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050701</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LAMIVUDINE + ZIDOVUDINE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050701</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052307-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-US165808</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>APLASTIC ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BIOPSY BONE MARROW ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD BILIRUBIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATOCELLULAR DAMAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050429</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDROL</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050102</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INDOCIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052308-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060704</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-AMGEN-KDL185172</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010629</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052309-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060420</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>NLWYE570421APR06</companynumb>
    <primarysource>
      <reportercountry>NETHERLANDS</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PSOAS ABSCESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUBACUTE ENDOCARDITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOE OPERATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMURAN</medicinalproduct>
        <drugdosagetext>UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052310-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060705</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>HQWYE668507JUL06</companynumb>
    <primarysource>
      <reportercountry>ARGENTINA</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>60</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DECREASED IMMUNE RESPONSIVENESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GALLBLADDER DISORDER</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>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050202</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DICLOFENAC</medicinalproduct>
        <drugindication>PAIN</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052311-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060704</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-JNJFOC-20060604811</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INFUSION RELATED REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUPUS-LIKE SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CROHN'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052312-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060704</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-JNJFOC-20060605449</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>40</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>LUPUS-LIKE SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052313-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060704</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-JNJFOC-20060604868</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>25</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ALLERGIC KERATITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PSORIATIC ARTHROPATHY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugindication>PSORIATIC ARTHROPATHY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052314-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060704</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-JNJFOC-20060605000</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>35</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ALLERGIC KERATITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052318-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060706</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-JNJFOC-20060701301</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>62</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CYTOMEGALOVIRUS INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugdosagetext>4-5 INFUSIONS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CROHN'S DISEASE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052335-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060710</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHFR2006GB02192</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD SODIUM DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BENDROFLUMETHIAZIDE</medicinalproduct>
        <drugdosagetext>2.5MG / DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD PRESSURE INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060512</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060526</drugenddate>
        <drugtreatmentduration>21600</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LETROZOLE</medicinalproduct>
        <drugauthorizationnumb>020726</drugauthorizationnumb>
        <drugdosagetext>2.5MG / DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060526</drugenddate>
        <drugtreatmentduration>87</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052340-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060707</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-JNJFOC-20060605512</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCORRECT DOSE ADMINISTERED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INDUCED LABOUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PREMATURE LABOUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYLENOL (CAPLET)</medicinalproduct>
        <drugauthorizationnumb>19872</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INFLUENZA</drugindication>
        <drugtreatmentduration>10</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYLENOL (CAPLET)</medicinalproduct>
        <drugauthorizationnumb>019872</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PYREXIA</drugindication>
        <drugtreatmentduration>10</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052347-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060705</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20060402203</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>74.84</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ULCER HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VASCULITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REGRANEX</medicinalproduct>
        <drugbatchnumb>12/06</drugbatchnumb>
        <drugadministrationroute>061</drugadministrationroute>
        <drugindication>SKIN ULCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060315</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060330</drugenddate>
        <drugtreatmentduration>16</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEXAPRO</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MOTRIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VIACTIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052348-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060706</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-JNJFOC-20060701299</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DELIRIUM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HALDOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HALDOL</medicinalproduct>
        <drugauthorizationnumb>015923</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SAROTEN</medicinalproduct>
        <drugdosagetext>GIVEN ORALLY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SAROTEN</medicinalproduct>
        <drugdosagetext>GIVEN INTRAVENOUSLY</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VENLAFAXINE HCL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VENLAFAXINE HCL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIRTAZAPINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAVOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>QUINOLUM RETARD</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>QUINOLUM RETARD</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOCITON</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRAVASIN</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>THYROXIN</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AZATHIOPRINE</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRUXAL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052349-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060706</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ES-JNJFOC-20060202941</companynumb>
    <primarysource>
      <reportercountry>SPAIN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>33</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ALVEOLITIS ALLERGIC</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRAMADOL HCL</medicinalproduct>
        <drugauthorizationnumb>20281</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>FIBROMYALGIA</drugindication>
        <drugtreatmentduration>35</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PAROXETINE HCL</medicinalproduct>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PARACETAMOL</medicinalproduct>
        <drugindication>FIBROMYALGIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMIPRAMINE</medicinalproduct>
        <drugindication>DEPRESSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052351-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060706</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-JNJFOC-20060701398</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>27</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG ABUSER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG WITHDRAWAL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVERDOSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMODIUM</medicinalproduct>
        <drugauthorizationnumb>019487</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052352-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060706</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-JNJFOC-20060701419</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>41</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ELECTROCARDIOGRAM QT PROLONGED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ITRACONAZOLE</medicinalproduct>
        <drugauthorizationnumb>020083</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANTIFUNGAL PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RABEPRAZOLE SODIUM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>URSODESOXYCHOLIC ACID</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTIBIOTICS RESISTANT LACTIC ACID BACTERIAE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUITRAZEPAM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGNESIUM OXIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052353-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060706</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20060701861</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>NEOPLASM MALIGNANT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DURAGESIC-100</medicinalproduct>
        <drugauthorizationnumb>019813</drugauthorizationnumb>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052354-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060706</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20060702080</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>81.65</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PELVIC MASS</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>FENTANYL TRANSDERMAL SYSTEM</medicinalproduct>
        <drugadministrationroute>062</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FENTANYL TRANSDERMAL SYSTEM</medicinalproduct>
        <drugadministrationroute>062</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FENTANYL TRANSDERMAL SYSTEM</medicinalproduct>
        <drugauthorizationnumb>019813</drugauthorizationnumb>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENAPRIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052355-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060707</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20060702449</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>CARDIAC ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCORRECT ROUTE OF DRUG ADMINISTRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY ARREST</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FENTANYL TRANSDERMAL SYSTEM</medicinalproduct>
        <drugauthorizationnumb>019813</drugauthorizationnumb>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>PAIN</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052356-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060707</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-JNJFOC-20060701874</companynumb>
    <primarysource>
      <reportercountry>IRELAND</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>58</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPINAL FRACTURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERDAL CONSTA</medicinalproduct>
        <drugauthorizationnumb>021346</drugauthorizationnumb>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052357-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060707</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-JNJFOC-20060701908</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>6</patientonsetage>
      <patientonsetageunit>800</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DYSTONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREATMENT NONCOMPLIANCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERDAL</medicinalproduct>
        <drugauthorizationnumb>020272</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052358-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20060702697</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>BLINDNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOPAMAX</medicinalproduct>
        <drugauthorizationnumb>020505</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052361-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060704</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006AC01239</companynumb>
    <primarysource>
      <reportercountry>BELGIUM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>15</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugauthorizationnumb>020639</drugauthorizationnumb>
        <drugdosagetext>PATIENT TREATED WITH 300 TO 400 MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ABNORMAL BEHAVIOUR</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052362-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060424</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006AP01917</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>12948</patientonsetage>
      <patientonsetageunit>804</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>AGGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HOMICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugauthorizationnumb>20639</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030526</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060314</drugenddate>
        <drugtreatmentduration>1024</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LOSIZOPILON</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060221</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060314</drugenddate>
        <drugtreatmentduration>22</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARTANE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060314</drugenddate>
        <drugtreatmentduration>988</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VEGETAMIN A</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19970512</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060314</drugenddate>
        <drugtreatmentduration>3229</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ROHYPNOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19970512</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060314</drugenddate>
        <drugtreatmentduration>3229</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMOBAN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031021</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060314</drugenddate>
        <drugtreatmentduration>876</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SOMELIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040326</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060314</drugenddate>
        <drugtreatmentduration>719</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGNESIUM OXIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040326</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060314</drugenddate>
        <drugtreatmentduration>719</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052363-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060624</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006AP02920</companynumb>
    <primarysource>
      <reportercountry>TAIWAN, PROVINCE OF CHINA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>59</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>61</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIAC ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENTRICULAR FIBRILLATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARIMIDEX</medicinalproduct>
        <drugauthorizationnumb>20541</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041013</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060609</drugenddate>
        <drugtreatmentduration>605</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUOROURACIL</medicinalproduct>
        <drugdosagetext>GIVEN AS 6 CYCLES</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19930617</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19930930</drugenddate>
        <drugtreatmentduration>106</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EPIRUBICIN</medicinalproduct>
        <drugdosagetext>GIVEN AS 6 CYCLES</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19930617</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19930930</drugenddate>
        <drugtreatmentduration>106</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYCLOPHOSPHAMIDE</medicinalproduct>
        <drugdosagetext>GIVEN AS 6 CYCLES</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19930617</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19930930</drugenddate>
        <drugtreatmentduration>106</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RADIOTHERAPY</medicinalproduct>
        <drugdosagetext>500CGY/25 FRACTIONS/33 ELAPSED DAYS</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052364-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060523</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006AP02351</companynumb>
    <primarysource>
      <reportercountry>BELGIUM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>21116</patientonsetage>
      <patientonsetageunit>804</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>GASTRIC ULCER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAMOXIFEN CITRATE</medicinalproduct>
        <drugauthorizationnumb>17970</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040908</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAMOXIFEN CITRATE</medicinalproduct>
        <drugauthorizationnumb>017970</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052365-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060224</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006AP00960</companynumb>
    <primarysource>
      <reportercountry>CHINA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>LEUKOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugauthorizationnumb>20639</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060221</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060224</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HALOPERIDOL</medicinalproduct>
        <drugindication>SCHIZOPHRENIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052367-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060706</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006AP03119</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>5416</patientonsetage>
      <patientonsetageunit>804</patientonsetageunit>
      <patientweight>57</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugauthorizationnumb>020639</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HALLUCINATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060123</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060326</drugenddate>
        <drugtreatmentduration>63</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugauthorizationnumb>020639</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060327</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060329</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VALPROATE SODIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060125</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUVOXAMINE MALEATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060124</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052368-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060510</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006AP02207</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>61</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ACUTE MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD TRIGLYCERIDES INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METASTASES TO LYMPH NODES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METASTASES TO SKIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NOLVADEX</medicinalproduct>
        <drugauthorizationnumb>17970</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MALIGNANT MELANOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CISPLATIN</medicinalproduct>
        <drugindication>MALIGNANT MELANOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DACARBAZINE</medicinalproduct>
        <drugindication>MALIGNANT MELANOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NIMUSTINE HYDROCHLORIDE</medicinalproduct>
        <drugindication>MALIGNANT MELANOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030701</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052369-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060706</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006PK01488</companynumb>
    <primarysource>
      <reportercountry>SWITZERLAND</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>54</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD CREATINE PHOSPHOKINASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG TOXICITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEDICATION ERROR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE RIGIDITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCLONUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEROTONIN SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugauthorizationnumb>20639</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ACUTE PSYCHOSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060405</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060421</drugenddate>
        <drugtreatmentduration>17</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SOLIAN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ACUTE PSYCHOSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060121</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060422</drugenddate>
        <drugtreatmentduration>92</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ESCITALOPRAM OXALATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ACUTE PSYCHOSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060422</drugenddate>
        <drugtreatmentduration>81</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EDRONAX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ACUTE PSYCHOSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060302</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060422</drugenddate>
        <drugtreatmentduration>52</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052370-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060601</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006UW10377</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>26882</patientonsetage>
      <patientonsetageunit>804</patientonsetageunit>
      <patientweight>77</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTERIOVENOUS MALFORMATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERCALCAEMIA OF MALIGNANCY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOLADEX</medicinalproduct>
        <drugauthorizationnumb>19726</drugauthorizationnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PROSTATE CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>HYPERCALCAEMIA OF MALIGNANCY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060202</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060502</drugenddate>
        <drugtreatmentduration>90</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CARDIAC VALVE PROSTHESIS USER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19960102</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060519</drugenddate>
        <drugtreatmentduration>3791</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLENDIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19960102</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052371-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060711</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006UW14235</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>53</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>81.6</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BIPOLAR DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BUNDLE BRANCH BLOCK BILATERAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugauthorizationnumb>020639</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BIPOLAR DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ABILIFY</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONAZEPAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRICOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VASOTEC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LITHIUM CARBONATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052377-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20030908</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2003AP03222</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>23900</patientonsetage>
      <patientonsetageunit>804</patientonsetageunit>
      <patientweight>45</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>GAMMA-GLUTAMYLTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC FUNCTION ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LABORATORY TEST ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ANAPEINE</medicinalproduct>
        <drugauthorizationnumb>20533</drugauthorizationnumb>
        <drugdosagetext>2 ML/H, 3 ML/TIME, VIA PCA</drugdosagetext>
        <drugadministrationroute>008</drugadministrationroute>
        <drugindication>EPIDURAL ANAESTHESIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030730</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030829</drugenddate>
        <drugtreatmentduration>31</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARBOCAIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>NERVE BLOCK</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030723</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARBOCAIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>EPIDURAL ANAESTHESIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030723</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARBOCAIN</medicinalproduct>
        <drugadministrationroute>008</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030730</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030730</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARBOCAIN</medicinalproduct>
        <drugadministrationroute>008</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030730</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030730</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOFRANIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030723</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOFRANIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030814</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMOBAN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030723</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGNESIUM OXIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030804</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEUROTROPIN</medicinalproduct>
        <drugdosagetext>16UT/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SELBEX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030808</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOXONIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MUCOSTA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030807</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052379-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060707</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006AC01254</companynumb>
    <primarysource>
      <reportercountry>NETHERLANDS</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>19137</patientonsetage>
      <patientonsetageunit>804</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE IRREGULAR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SELOKEEN ZOC</medicinalproduct>
        <drugauthorizationnumb>19962</drugauthorizationnumb>
        <drugdosagetext>DRUG TEMPORARILY STOPPED FOR A CAG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARRHYTHMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SELOKEEN ZOC</medicinalproduct>
        <drugauthorizationnumb>019962</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060703</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SELOKEEN ZOC</medicinalproduct>
        <drugauthorizationnumb>019962</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060704</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060704</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPRO CARDIO</medicinalproduct>
        <drugdosagetext>USED FOR A SHORT TIME</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATORVASTATIN CALCIUM</medicinalproduct>
        <drugdosagetext>USED FOR A SHORT TIME</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052380-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060706</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-JNJFOC-20060701240</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>72</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BREAST CANCER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugdosagetext>15TH INFUSION</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugdosagetext>12TH INFUSION</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugdosagetext>11 INFUSIONS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052396-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040618</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>WW FILE # 2181</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>15</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DELIRIUM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSYCHOTIC DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHLOROQUINE PHOSPHATE</medicinalproduct>
        <drugauthorizationnumb>40516</drugauthorizationnumb>
        <drugdosagetext>500MG PER DAY ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ADORAL 10MG</medicinalproduct>
        <drugdosagetext>10MG 1 X DAY ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADORAL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052397-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060619</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-SP-2006-01722</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>66</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMMUCYST</medicinalproduct>
        <drugbatchnumb>LOT NOT REP</drugbatchnumb>
        <drugadministrationroute>043</drugadministrationroute>
        <drugindication>BLADDER CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060508</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060613</drugenddate>
        <drugtreatmentduration>36</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROPIVERINE HYDROCHLORIDE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060501</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052398-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060710</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-SP-2006-01730</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>65</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>POLYARTHRITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMMUCYST</medicinalproduct>
        <drugbatchnumb>LOT NOT REP</drugbatchnumb>
        <drugdosagetext>6 WEEKS OF TREATMENT</drugdosagetext>
        <drugadministrationroute>043</drugadministrationroute>
        <drugindication>BLADDER CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000901</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CORTICOID THERAPY</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052400-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060705</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHRM2006FR02010</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>86</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPHIL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RED BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BLOOD CELLS, PACKED HUMAN</medicinalproduct>
        <drugdosagetext>2 UNITS/DAY FOR 2 DAYS EVERY 3 WEEKS</drugdosagetext>
        <drugindication>BONE MARROW FAILURE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DESFERAL</medicinalproduct>
        <drugauthorizationnumb>016267</drugauthorizationnumb>
        <drugindication>SERUM FERRITIN INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060628</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052401-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060706</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHNU2006DE02469</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>42</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRILEPTAL</medicinalproduct>
        <drugauthorizationnumb>021014</drugauthorizationnumb>
        <drugdosagetext>150 MG, BID</drugdosagetext>
        <drugindication>BIPOLAR DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060630</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUANXOL - SLOW RELEASE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SOLIAN</medicinalproduct>
        <drugdosagetext>400 MG/D</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052402-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060627</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2006BR09884</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>51</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>54</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>AMNESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANGINA PECTORIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISTURBANCE IN ATTENTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMANGIOMA OF LIVER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEMORY IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENOPAUSAL SYMPTOMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METRORRHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSYCHOMOTOR SKILLS IMPAIRED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ROAD TRAFFIC ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TEGRETOL</medicinalproduct>
        <drugauthorizationnumb>20234</drugauthorizationnumb>
        <drugdosagetext>200 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>EPILEPSY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19960131</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TEGRETOL</medicinalproduct>
        <drugauthorizationnumb>020234</drugauthorizationnumb>
        <drugdosagetext>200 MG/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TEGRETOL</medicinalproduct>
        <drugauthorizationnumb>020234</drugauthorizationnumb>
        <drugdosagetext>200 MG, TID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051001</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052403-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060710</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2006JP10426</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABSCESS NECK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AGRANULOCYTOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TONSILLITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TEGRETOL</medicinalproduct>
        <drugauthorizationnumb>016608</drugauthorizationnumb>
        <drugdosagetext>600 MG/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>TRIGEMINAL NEURALGIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052404-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060622</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2006US08219</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>76</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>80.725</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ORAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOMYELITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugdosagetext>4 MG Q4WK</drugdosagetext>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AREDIA</medicinalproduct>
        <drugauthorizationnumb>020036</drugauthorizationnumb>
        <drugdosagetext>90MG Q3WKS</drugdosagetext>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20021201</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052405-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060421</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2006US05279</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>16</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AGGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AGITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIBIDO INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MANIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAINFUL ERECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SLEEP DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRILEPTAL</medicinalproduct>
        <drugauthorizationnumb>21014</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONDUCT DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050701</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ABILIFY</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONDUCT DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050701</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRAZODONE HCL</medicinalproduct>
        <drugdosagetext>50 MG, QHS</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SLEEP DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050603</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050715</drugenddate>
        <drugtreatmentduration>61920</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXEDRINE</medicinalproduct>
        <drugdosagetext>UNK, UNK</drugdosagetext>
        <drugindication>CONVULSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19970101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052406-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060706</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHFR2006GB02172</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>32</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABORTION SPONTANEOUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD ALKALINE PHOSPHATASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GINGIVAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAINFUL RESPIRATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAMIDRONATE DISODIUM</medicinalproduct>
        <drugauthorizationnumb>020036</drugauthorizationnumb>
        <drugdosagetext>90 MG, ONCE</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COMPLEX REGIONAL PAIN SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060410</drugstartdate>
        <drugtreatmentduration>56160</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugdosagetext>20 MG, QD</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DYSPEPSIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PAROXETINE HCL</medicinalproduct>
        <drugdosagetext>40 MG, QD</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PANIC ATTACK</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19970101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052407-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060704</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHO2006BR11024</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>34</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>104</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIMB DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULAR WEAKNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIOVAN HCT</medicinalproduct>
        <drugauthorizationnumb>020818</drugauthorizationnumb>
        <drugdosagetext>80/12.5MG DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052408-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060607</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2006US07472</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>52</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BONE DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AREDIA</medicinalproduct>
        <drugauthorizationnumb>20036</drugauthorizationnumb>
        <drugdosagetext>90 MG, QMO</drugdosagetext>
        <drugindication>METASTASES TO BONE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990513</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040518</drugenddate>
        <drugtreatmentduration>1833</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052409-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060710</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2006JP10425</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DIPLOPIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL ACUITY REDUCED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VEGETAMIN A</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RISPERDAL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEXOTAN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CONTOMIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HIRNAMIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARTANE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADALAT</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TEGRETOL</medicinalproduct>
        <drugauthorizationnumb>016608</drugauthorizationnumb>
        <drugdosagetext>1200 MG/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052410-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060526</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHNU2006DE02107</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>80</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>RETINAL DEGENERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RETINITIS PIGMENTOSA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISION BLURRED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL ACUITY REDUCED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL FIELD DEFECT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BLOOD TRANSFUSION, AUXILIARY PRODUCTS</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DESFERAL</medicinalproduct>
        <drugauthorizationnumb>016267</drugauthorizationnumb>
        <drugdosagetext>1 G, BID</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>HAEMOCHROMATOSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060524</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MARCUMAR</medicinalproduct>
        <drugdosagetext>UNK, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052411-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060531</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2006US07169</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>123.81</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONCOMITANT DISEASE AGGRAVATED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMDUR</medicinalproduct>
        <drugdosagetext>30 MG, QD</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR                                 /NET/</medicinalproduct>
        <drugdosagetext>20 MG, QD</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CAPTOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LUNESTA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZANTAC</medicinalproduct>
        <drugdosagetext>150 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATIVAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENABLEX</medicinalproduct>
        <drugauthorizationnumb>021513</drugauthorizationnumb>
        <drugdosagetext>15 MG, QD</drugdosagetext>
        <drugindication>HYPERTONIC BLADDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060515</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060516</drugenddate>
        <drugtreatmentduration>2880</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052412-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060620</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2006FR09389</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>28</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>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>1</drugcharacterization>
        <medicinalproduct>CARBAMAZEPINE</medicinalproduct>
        <drugauthorizationnumb>16608</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>MALIGNANT OLIGODENDROGLIOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugdosagetext>60 MG</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugdosagetext>80 MG</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052415-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060714</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>70</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLUENZA LIKE ILLNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PHOSPHOSODA GINGER LEMON</medicinalproduct>
        <drugdosagetext>45 ML: X1; PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>COLONOSCOPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040606</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040607</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052417-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060714</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>58</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PHOSPHOSODA UNFLAVORED</medicinalproduct>
        <drugdosagetext>45ML; X1; PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SIGMOIDOSCOPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040120</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040120</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052418-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060714</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>50</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEMON LIME PHOSPHOSODA</medicinalproduct>
        <drugdosagetext>45ML BID PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>COLOSTOMY CLOSURE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040613</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEMON LIME PHOSPHOSODA</medicinalproduct>
        <drugdosagetext>45ML BID PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>COLOSTOMY CLOSURE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040620</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052419-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060714</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>67.1324</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OXYGEN SATURATION DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAXOL</medicinalproduct>
        <drugdosagetext>172.0 MG IV WEEKLY X3</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060609</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAXOL</medicinalproduct>
        <drugdosagetext>172.0 MG IV WEEKLY X3</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060616</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAXOL</medicinalproduct>
        <drugdosagetext>172.0 MG IV WEEKLY X3</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060623</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARBOPLATIN</medicinalproduct>
        <drugdosagetext>466.0 MG EVERY 3 WEEKS</drugdosagetext>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060609</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052420-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060531</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-13397203</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>62</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CANDIDIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONTUSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CEENU</medicinalproduct>
        <drugauthorizationnumb>017588</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BRAIN NEOPLASM</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052421-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060704</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2006IT10005</companynumb>
    <primarysource>
      <reportercountry>ITALY</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>43</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANTIBODY TEST POSITIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD BILIRUBIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD LACTATE DEHYDROGENASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CYTOMEGALOVIRUS INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GRAFT COMPLICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMODIALYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOLYTIC URAEMIC SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>KIDNEY TRANSPLANT REJECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEUKOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEPHRECTOMY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RED BLOOD CELL ABNORMALITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOSPORINE</medicinalproduct>
        <drugindication>RENAL TRANSPLANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19960101</drugstartdate>
        <drugtreatmentduration>30240</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIROLIMUS</medicinalproduct>
        <drugindication>RENAL TRANSPLANT</drugindication>
        <drugtreatmentduration>30240</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SIMULECT</medicinalproduct>
        <drugindication>RENAL TRANSPLANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TACROLIMUS</medicinalproduct>
        <drugindication>RENAL TRANSPLANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MYCOPHENOLATE MOFETIL</medicinalproduct>
        <drugindication>RENAL TRANSPLANT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>STEROIDS NOS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052422-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060714</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>46</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>73.0291</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TARCEVA</medicinalproduct>
        <drugbatchnumb>P424101</drugbatchnumb>
        <drugdosagetext>150 MG PO QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>TONGUE NEOPLASM MALIGNANT STAGE UNSPECIFIED</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060710</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CISPLATIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RADIATION THERAPY</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052423-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060714</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>BELGIUM</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>33</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DYSPNOEA EXERTIONAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugdosagetext>ORAL 0,0</drugdosagetext>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050822</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060207</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052424-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060713</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>80</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>67.9</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BRADYCARDIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LABETALOL HCL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052425-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060713</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>64</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>46.7</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HYPOKALAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052426-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060714</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>49.5</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBRAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBRAL ISCHAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULAR WEAKNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugdosagetext>45 MG</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEG-L-ASPARGINASE (K-H)</medicinalproduct>
        <drugdosagetext>3750 IU</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VINCRISTINE SULFATE</medicinalproduct>
        <drugdosagetext>6 MG</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYTARABINE</medicinalproduct>
        <drugdosagetext>880 MG</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOXORUBICIN HYDROCHLORIDE</medicinalproduct>
        <drugdosagetext>112.5 MG</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052427-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060714</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>83</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERIPHERAL ARTERIAL OCCLUSIVE DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERIPHERAL ISCHAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>L-ASPARGINASE</medicinalproduct>
        <drugdosagetext>60000 MG</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VINCRISTINE SULFATE</medicinalproduct>
        <drugdosagetext>8 MG</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
        <drugdosagetext>7500 MG</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOPHOSPHAMIDE</medicinalproduct>
        <drugdosagetext>2390 MG</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DAUNORUBICIN HCL</medicinalproduct>
        <drugdosagetext>480 MG</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE TAB</medicinalproduct>
        <drugdosagetext>270 MG</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>G-CSF (FILGRASTIM, AMGEN)</medicinalproduct>
        <drugdosagetext>2880 MG</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052428-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060714</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>77.5</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASCITES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD BILIRUBIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC TAMPONADE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CENTRAL LINE INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMPUTERISED TOMOGRAM ABDOMEN ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSED LEVEL OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIALYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISSEMINATED TUBERCULOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTI-ORGAN FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OXYGEN SATURATION DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERITONEAL EFFUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLEURAL EFFUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY DISTRESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPLEEN DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STAPHYLOCOCCAL INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOPHOSPHAMIDE</medicinalproduct>
        <drugdosagetext>1860 MG</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYTARABINE</medicinalproduct>
        <drugdosagetext>560 MG</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DAUNORUBICIN HCL</medicinalproduct>
        <drugdosagetext>188 MG</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MERCAPTOPURINE</medicinalproduct>
        <drugdosagetext>0 MG</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugdosagetext>45 MG</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEG-L-ASPARAGINASE (K-H)</medicinalproduct>
        <drugdosagetext>4675 IU</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugdosagetext>3080 MG</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VINCRISTINE SULFATE</medicinalproduct>
        <drugdosagetext>8 MG</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052430-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060706</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20060203396</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>70.9</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>B-CELL 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>METHOTREXATE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052431-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060707</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-JNJFOC-20060606514</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>37</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>70</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>C-REACTIVE PROTEIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLAMMATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POLYARTHRITIS</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>ANKYLOSING SPONDYLITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052437-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060706</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2006JP10101</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>BLOOD UREA INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugauthorizationnumb>021223</drugauthorizationnumb>
        <drugdosagetext>DRIP INFUSION</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>METASTASES TO BONE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052438-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060706</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2006BR10311</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugauthorizationnumb>021223</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052439-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060630</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2006BE10001</companynumb>
    <primarysource>
      <reportercountry>BELGIUM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>50</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>OSTEITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugauthorizationnumb>21223</drugauthorizationnumb>
        <drugdosagetext>UNK, UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060301</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CHEMOTHERAPEUTICS,OTHER</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CORTICOSTEROIDS</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052440-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050712</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-13034467</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>58</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ESTRACE</medicinalproduct>
        <drugauthorizationnumb>084499</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ROGAINE</medicinalproduct>
        <drugindication>ALOPECIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050508</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052441-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050715</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-13039417</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>58</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>73</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ESTRACE</medicinalproduct>
        <drugauthorizationnumb>084499</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19950101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROVERA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19950101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052442-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050722</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-13048616</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN LOWER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OESTRONE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ESTRADIOL</medicinalproduct>
        <drugauthorizationnumb>084499</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052443-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050907</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-13103221</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DYSPAREUNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VAGINAL PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ESTRACE</medicinalproduct>
        <drugauthorizationnumb>084499</drugauthorizationnumb>
        <drugindication>HYSTERECTOMY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FEMRING</medicinalproduct>
        <drugadministrationroute>067</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052444-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050915</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-13112479</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>46</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>73</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DYSPAREUNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VAGINAL PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ESTRACE</medicinalproduct>
        <drugauthorizationnumb>084499</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040901</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPAMAX</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052445-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20051019</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-13149323</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ALOPECIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ESTRACE</medicinalproduct>
        <drugauthorizationnumb>084499</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052446-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20051111</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-13178371</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ESTRACE</medicinalproduct>
        <drugauthorizationnumb>084499</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052447-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20051222</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-13227954</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ESTRACE</medicinalproduct>
        <drugauthorizationnumb>084499</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052448-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060109</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-13240536</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ESTRADIOL</medicinalproduct>
        <drugauthorizationnumb>084499</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052449-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060109</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-13240791</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FLUID RETENTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ESTRACE</medicinalproduct>
        <drugauthorizationnumb>084499</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052450-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060118</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-13251269</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>BREAST CYST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BREAST DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ESTRACE</medicinalproduct>
        <drugauthorizationnumb>084499</drugauthorizationnumb>
        <drugtreatmentduration>11</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052451-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060131</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-13265384</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>59</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD OESTROGEN INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ESTRADIOL</medicinalproduct>
        <drugauthorizationnumb>084499</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLIMARA</medicinalproduct>
        <drugauthorizationnumb>084499</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052452-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060202</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-13271259</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>59</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>98</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GALLBLADDER DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METRORRHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ESTRACE</medicinalproduct>
        <drugauthorizationnumb>084499</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MENOPAUSAL SYMPTOMS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZESTRIL</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19890101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROGESTERONE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052453-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060215</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-13285267</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BREAST TENDERNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG ADMINISTRATION ERROR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ESTRACE</medicinalproduct>
        <drugauthorizationnumb>084499</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MENOPAUSE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19960101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052454-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060307</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-13305941</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DISTURBANCE IN ATTENTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HOT FLUSH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MIGRAINE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ESTRACE</medicinalproduct>
        <drugauthorizationnumb>084499</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052455-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060405</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-13338314</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>67</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>109</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ESTRACE</medicinalproduct>
        <drugauthorizationnumb>084499</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAXZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONIDINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PAMELOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPROL-XL</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052456-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060412</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-13344924</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>50</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>54</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HOT FLUSH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ESTRACE</medicinalproduct>
        <drugauthorizationnumb>084499</drugauthorizationnumb>
        <drugindication>HOT FLUSH</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLAXSEED</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052457-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060417</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-13348610</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INFLUENZA LIKE ILLNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ESTRACE</medicinalproduct>
        <drugauthorizationnumb>084499</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052458-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060425</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-13356522</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DRY MOUTH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERALISED OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LETHARGY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERFORMANCE STATUS DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THINKING ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ESTRACE</medicinalproduct>
        <drugauthorizationnumb>084499</drugauthorizationnumb>
        <drugdosagetext>DOSAGE FORM = 1-2 MG A DAY</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19930101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052459-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060503</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-13364906</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DYSARTHRIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSKINESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPHONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ESTRACE</medicinalproduct>
        <drugauthorizationnumb>084499</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052460-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060518</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-13381579</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BREAST TENDERNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ESTRACE</medicinalproduct>
        <drugauthorizationnumb>084499</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052461-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060523</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-13387188</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>49</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISION BLURRED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ESTRADIOL</medicinalproduct>
        <drugauthorizationnumb>084499</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052462-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060530</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-13394457</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>39</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ESTRACE</medicinalproduct>
        <drugauthorizationnumb>084499</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052468-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060627</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2006US08352</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>70</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DEAFNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugauthorizationnumb>21223</drugauthorizationnumb>
        <drugdosagetext>4MG Q3WKS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PROSTATE CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060425</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060628</drugenddate>
        <drugtreatmentduration>93600</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LUPRON</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORTAB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMITRIPTYLINE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CASODEX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PAPAVERIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATIVAN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052469-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060705</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2006SE09922</companynumb>
    <primarysource>
      <reportercountry>SWEDEN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ABSCESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FISTULA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALIGNANT NEOPLASM PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTH DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTH EXTRACTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugauthorizationnumb>021223</drugauthorizationnumb>
        <drugdosagetext>4 MG, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>METASTASES TO BONE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOLCONTIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CHOP</medicinalproduct>
        <drugdosagetext>UNK, UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RADIOTHERAPY</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052470-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060705</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2006NO10088</companynumb>
    <primarysource>
      <reportercountry>NORWAY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DENTAL TREATMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugauthorizationnumb>021223</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052471-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060705</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2006US08609</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>60</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABSCESS JAW</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PURULENT DISCHARGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN DISCOLOURATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugauthorizationnumb>021223</drugauthorizationnumb>
        <drugdosagetext>EVERY MONTH</drugdosagetext>
        <drugindication>METASTASES TO BONE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060401</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052472-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060705</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHRM2006FR02047</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>67</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>GENERAL PHYSICAL HEALTH DETERIORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METASTASES TO CENTRAL NERVOUS SYSTEM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOLYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN JAW</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRISMUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugauthorizationnumb>021223</drugauthorizationnumb>
        <drugdosagetext>4 MG, QMO</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>METASTASES TO BONE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052477-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060712</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>66</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>89.8122</patientweight>
      <reaction>
        <reactionmeddrapt>CYTOMEGALOVIRUS ANTIGEN POSITIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CYTOMEGALOVIRUS INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA EXERTIONAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA PRIMARY ATYPICAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugdosagetext>75MG   BID   PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETIC NEUROPATHY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060303</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060707</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUTICASONE INHALER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL SPIROS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CINACACET</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOCUSATE SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EPO</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GANCICLOVIR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GUAIFENESIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANSOPRAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGNESIUM SULFATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>M.V.I.</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEPHROCAPS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SENNA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TACROLIMUS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KAYEXALATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SODIUM BICARBONATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HEPARIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052478-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060706</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GXKR2006TR03846</companynumb>
    <primarysource>
      <reportercountry>TURKEY</reportercountry>
    </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>PALMAR-PLANTAR ERYTHRODYSAESTHESIA SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCYTOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPTIC SHOCK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN LESION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CAPECITABINE</medicinalproduct>
        <drugindication>METASTASES TO LUNG</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOCETAXEL (NGX)</medicinalproduct>
        <drugindication>METASTASES TO LUNG</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOLEDRONIC ACID</medicinalproduct>
        <drugauthorizationnumb>021223</drugauthorizationnumb>
        <drugdosagetext>UNK, UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>METASTASES TO BONE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041201</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052479-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060712</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>38</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>108.8633</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL STIFFNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SENSORY DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LUPRON</medicinalproduct>
        <drugdosagetext>MONTHLY INJECTION    IM</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>ABDOMINAL PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051210</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060210</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LUPRON</medicinalproduct>
        <drugdosagetext>MONTHLY INJECTION    IM</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>DYSMENORRHOEA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051210</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060210</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LUPRON</medicinalproduct>
        <drugdosagetext>MONTHLY INJECTION    IM</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>ENDOMETRIOSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051210</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060210</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LUPRON</medicinalproduct>
        <drugdosagetext>MONTHLY INJECTION    IM</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>OVULATION PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051210</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060210</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052480-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060712</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>38</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>101.2</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CONJUNCTIVAL HYPERAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONJUNCTIVAL OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUCOSAL ULCERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH ERYTHEMATOUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH PAPULAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TONGUE COATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TONGUE OEDEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EQUETRO</medicinalproduct>
        <drugdosagetext>400MG  BID   PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BIPOLAR DISORDER</drugindication>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052481-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060712</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>18</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>49</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>RASH GENERALISED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXJADE</medicinalproduct>
        <drugdosagetext>100MG  DAILY  PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CHELATION THERAPY</drugindication>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052483-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060615</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHO2006TW09978</companynumb>
    <primarysource>
      <reportercountry>TAIWAN, PROVINCE OF CHINA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>66</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>121</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD CREATININE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DECREASED APPETITE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPEPSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLANK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYDRONEPHROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERKALAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERLIPIDAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALIGNANT NEOPLASM PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOLEDRONIC ACID</medicinalproduct>
        <drugauthorizationnumb>21223</drugauthorizationnumb>
        <drugdosagetext>4 MG EVERY 3-4 WEEKS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>METASTASES TO BONE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060412</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM GLUCONATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEPERIDINE HCL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052485-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060712</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ATRIOVENTRICULAR BLOCK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUS BRADYCARDIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARICEPT</medicinalproduct>
        <drugdosagetext>5MG  DAILY  PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEMENTIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060518</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052487-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060712</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>46</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>COORDINATION ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIFEDIPINE</medicinalproduct>
        <drugdosagetext>1 TABLET   DAILY  PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052488-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060712</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>52</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>68.0396</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BODY MASS INDEX INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugbatchnumb>01366V</drugbatchnumb>
        <drugdosagetext>150 MG   BID   PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NEURALGIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060305</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060711</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COPAXONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EFFEXOR XR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BACLOFEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORATDINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUOXETINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYTROL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BONIVA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IRON</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GINKO BILOBA</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052489-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060712</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>53</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYRTEC</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052490-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060713</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>175.9956</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DYSPHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUCOSAL INFLAMMATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TARCEVA</medicinalproduct>
        <drugdosagetext>100 MG, QD, PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NEOPLASM MALIGNANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060114</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVASTIN</medicinalproduct>
        <drugdosagetext>10 MG/M2. Q 14 DAYS , IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NEOPLASM MALIGNANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051114</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060109</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CISPLATIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RADIATION THERAPY</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052491-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060713</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>INTERCEPTED MEDICATION ERROR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEDICATION ERROR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOPENTOLATE HYDROCHLORIDE</medicinalproduct>
        <drugbatchnumb>90414F</drugbatchnumb>
        <drugdosagetext>OPHTHALMIC</drugdosagetext>
        <drugadministrationroute>047</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TROPICAMIDE</medicinalproduct>
        <drugbatchnumb>56696F</drugbatchnumb>
        <drugdosagetext>OPHTHALMIC</drugdosagetext>
        <drugadministrationroute>047</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052492-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060317</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AVENTIS-200612719US</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>97</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ATRIAL FIBRILLATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIABETES MELLITUS INADEQUATE CONTROL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ELECTROENCEPHALOGRAM ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EPILEPSY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>APIDRA</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021629</drugauthorizationnumb>
        <drugdosagetext>DOSE UNIT: UNITS</drugdosagetext>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060313</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060313</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HUMALOG</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugdosagetext>DOSE: 5 UNITS QAC AND SLIDING SCALE</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HUMALOG</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugdosagetext>DOSE UNIT: UNITS</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugdosagetext>DOSE: UNKNOWN</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOTENSIN</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVENOX</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARDIZEM</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NOVOLOG</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052493-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060608</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-AVENTIS-200612089FR</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>35</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PANCREATITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLAGYL</medicinalproduct>
        <drugauthorizationnumb>20743</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060507</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060512</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RULID</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060507</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060512</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEPAKENE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>EPILEPSY</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060512</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FRAGMIN</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060512</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060512</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MENTAL DISORDER</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060512</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ABNORMAL BEHAVIOUR</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060512</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIORESAL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRANXENE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIFFU K</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MOTILIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052494-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060116</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-AVENTIS-200610169FR</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>48</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PERIPHERAL MOTOR NEUROPATHY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLAGYL</medicinalproduct>
        <drugauthorizationnumb>20743</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CLOSTRIDIAL INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051111</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051123</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLAGYL</medicinalproduct>
        <drugauthorizationnumb>020743</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051124</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051220</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMBISOME</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ABELCET</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEORAL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTIFUNGALS FOR SYSTEMIC USE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051210</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051223</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTIFUNGALS FOR SYSTEMIC USE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051224</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052495-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060703</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-AVENTIS-200612058JP</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>38</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>72</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ALOPECIA AREATA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALLEGRA</medicinalproduct>
        <drugauthorizationnumb>20872</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>URTICARIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060626</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060630</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052496-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>19980629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-AVENTIS-199811314RHF</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 BILIRUBIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ENCEPHALOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOLYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RIFATER</medicinalproduct>
        <drugauthorizationnumb>50705</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980323</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19980511</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIAMICRON</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19980511</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LOVENOX</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19980511</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MYAMBUTOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980323</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19980511</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COZAAR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19980511</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052497-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060217</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AVENTIS-200611652US</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ALANINE AMINOTRANSFERASE INCREASED</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 BILIRUBIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CALCIUM DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD SODIUM DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHROMATURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DECREASED APPETITE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ENTEROCOLITIS INFECTIOUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EOSINOPHIL COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATOCRIT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC ENZYME INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC LESION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATOCELLULAR DAMAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATOMEGALY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERNATIONAL NORMALISED RATIO DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RED BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL CYST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL INJURY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KETEK</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>21144</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SINUSITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060112</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SINGULAIR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADVAIR DISKUS 100/50</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLONASE</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NASACORT</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HERBAL PREPARATION</medicinalproduct>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACTIVELLA</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugdosagetext>DOSE: 1MG/.5MG</drugdosagetext>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060206</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN E</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060206</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SINGULAIR</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060206</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROZAC</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060206</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLOVENT</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060206</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052498-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060606</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AVENTIS-200615140US</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>59</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>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>HEPATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JAUNDICE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KETEK</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>21144</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051126</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051128</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052499-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060711</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-AVENTIS-200612467FR</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>78</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CLOSTRIDIUM DIFFICILE COLITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSEUDOMEMBRANOUS COLITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLAGYL</medicinalproduct>
        <drugauthorizationnumb>20743</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060323</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060329</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AUGMENTIN '125'</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060323</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060329</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NORFLOXACIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060414</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060414</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARICEPT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PAROXETINE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TANAKAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TIORFAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPANTHYL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANZOR</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052500-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnesscongenitalanomali>1</seriousnesscongenitalanomali>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060706</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20060701081</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>IMMATURE RESPIRATORY SYSTEM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PREMATURE BABY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRANSMISSION OF DRUG VIA SEMEN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugbatchnumb>5LMU4011P1;5KM42011P1</drugbatchnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugbatchnumb>5LMU4011P1;5KM42011P1</drugbatchnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugbatchnumb>5LMU4011P1;5KM42011P1</drugbatchnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugbatchnumb>5LMU4011P1;5KM42011P1</drugbatchnumb>
        <drugdosagetext>5 MG/KG TOTAL OF SIX DOSES 07-JAN-05 THROUGH 14-NOV-05</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugbatchnumb>5LMU4011P1;5KM42011P1</drugbatchnumb>
        <drugdosagetext>5MG/KG TOTAL OF SIX DOSES 23-JAN-04 THROUGH 05-NOV-04</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugbatchnumb>5LMU4011P1;5KM42011P1</drugbatchnumb>
        <drugdosagetext>5 MG/KG ON 12-DEC-03 AND 26-DEC-03</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugbatchnumb>5LMU4011P1;5KM42011P1</drugbatchnumb>
        <drugdosagetext>5 MG/KG RECEIVED FOUR DOSES 04-SEP-02 THROUGH 13-DEC-02</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugbatchnumb>5LMU4011P1;5KM42011P1</drugbatchnumb>
        <drugdosagetext>UNKNOWN NUMBER OF INFUSIONS IN YEAR PRIOR TO BASELINE</drugdosagetext>
        <drugindication>TRANSMISSION OF DRUG VIA SEMEN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTIHISTAMINES</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>STEROIDS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052501-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060706</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-JNJFOC-20060503658</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABSCESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMPLANT SITE INFLAMMATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEGENER'S GRANULOMATOSIS</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>DOSE 200 MG / TWO INFUSIONS GIVEN ON UNKNOWN DATES</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>WEGENER'S GRANULOMATOSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052502-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050809</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-AVENTIS-200512324JP</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>76</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</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>
      <reaction>
        <reactionmeddrapt>PNEUMONIA ASPIRATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RILUTEK</medicinalproduct>
        <drugauthorizationnumb>020599</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>AMYOTROPHIC LATERAL SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000207</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20011121</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RILUTEK</medicinalproduct>
        <drugauthorizationnumb>020599</drugauthorizationnumb>
        <drugdosagetext>ROUTE: GASTROSTOMY TUBE</drugdosagetext>
        <drugadministrationroute>050</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20011122</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020227</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PURSENNID</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONSTIPATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000228</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020103</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SENNOSIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONSTIPATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000228</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020103</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CEROCRAL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CEREBRAL INFARCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000821</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020227</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GASTER</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTRIC ULCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20011030</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEPAS</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANXIETY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020131</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020228</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEPROMEL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020208</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020228</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEOPHYLLIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020217</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020228</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SAWACILLIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PNEUMONIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020217</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020228</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MINOCYCLINE HCL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PNEUMONIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020212</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020228</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MUCOSOLVAN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCTIVE COUGH</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020217</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020228</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLINDAMYCIN HCL</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>PNEUMONIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20011214</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20011221</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052503-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060713</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>50</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>83.0083</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANAPHYLACTIC SHOCK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANGINA PECTORIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG IMPLANT REJECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMMUNE SYSTEM DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POSTOPERATIVE FEVER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URTICARIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CORDIS CYPHER STENT   JOHNSON AND JOHNSON</medicinalproduct>
        <drugdosagetext>INTRACARDIA</drugdosagetext>
        <drugadministrationroute>016</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040505</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060711</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CORDIS CYPHER STENT   JOHNSON AND JOHNSON</medicinalproduct>
        <drugdosagetext>INTRACARDIA</drugdosagetext>
        <drugadministrationroute>016</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050128</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060711</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052504-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-AVENTIS-200612021JP</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>56</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PURPURA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ULCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VASCULITIS NECROTISING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARAVA</medicinalproduct>
        <drugauthorizationnumb>020905</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060412</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060629</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RHEUMATREX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050729</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050905</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RHEUMATREX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050906</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051003</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RHEUMATREX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051004</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060409</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIAMIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050729</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060409</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050729</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SALIGREN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050729</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAKEPRON</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050729</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SELBEX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050729</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOBU</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050729</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051205</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051205</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051219</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051219</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060117</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060117</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060313</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060313</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052505-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AVENTIS-200610962US</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC MURMUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBRAL VENTRICLE DILATATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSED LEVEL OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUROGLYCOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PURPURA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMARYL</medicinalproduct>
        <drugauthorizationnumb>20496</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS NON-INSULIN-DEPENDENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMARYL</medicinalproduct>
        <drugauthorizationnumb>020496</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051118</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMARYL</medicinalproduct>
        <drugauthorizationnumb>020496</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051118</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DRUG USED IN DIABETES</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>DIABETES MELLITUS NON-INSULIN-DEPENDENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050701</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DRUG USED IN DIABETES</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051116</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DRUG USED IN DIABETES</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACTOS</medicinalproduct>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051117</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACTOS</medicinalproduct>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051118</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOPHAGE</medicinalproduct>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOPHAGE</medicinalproduct>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051118</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL W/HYDROCHLOROTHIAZIDE</medicinalproduct>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHROID</medicinalproduct>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052506-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060619</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-AVENTIS-200611887JP</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>70</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD CREATINE PHOSPHOKINASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FACE OEDEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMARYL</medicinalproduct>
        <drugauthorizationnumb>20496</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYANOCOBALAMIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052507-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060712</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>34</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>66.6788</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRINESSA</medicinalproduct>
        <drugdosagetext>1 PILL EVERY DAY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONTRACEPTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060611</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060708</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052508-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060712</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>37</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>55</patientweight>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ABASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC TAMPONADE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRIC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERAL PHYSICAL HEALTH DETERIORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLEURAL EFFUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SENSATION OF PRESSURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMODULIN</medicinalproduct>
        <drugbatchnumb>902539</drugbatchnumb>
        <drugdosagetext>16 NGR PER 48 HOURS 48 HOURS INTRAVESICA</drugdosagetext>
        <drugadministrationroute>043</drugadministrationroute>
        <drugindication>PULMONARY HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060528</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060622</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052509-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060713</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>81</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>BLOOD CREATINE PHOSPHOKINASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHOLECYSTECTOMY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLOSTOMY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIVERTICULAR PERFORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FAECAL INCONTINENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMODIALYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OXYGEN SATURATION DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugdosagetext>15 MILLIGRAMS QWEEKLY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052510-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060703</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2006US09898</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>62</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ACUTE MYELOID LEUKAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GRAFT VERSUS HOST DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALIGNANT NEOPLASM PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN NEOPLASM EXCISION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SQUAMOUS CELL CARCINOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOSPORINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>STEM CELL TRANSPLANT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISONE (NGX)</medicinalproduct>
        <drugindication>STEM CELL TRANSPLANT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYCLOPHOSPHAMIDE</medicinalproduct>
        <drugdosagetext>120 MG/KG/D</drugdosagetext>
        <drugindication>STEM CELL TRANSPLANT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUDARABINE</medicinalproduct>
        <drugindication>STEM CELL TRANSPLANT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOSPORINE</medicinalproduct>
        <drugauthorizationnumb>050573</drugauthorizationnumb>
        <drugdosagetext>3 MG/KG/D</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052511-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060704</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2006HK09987</companynumb>
    <primarysource>
      <reportercountry>HONG KONG</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>47</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD GASES ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIOVASCULAR DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMPUTERISED TOMOGRAM THORAX ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIABETES MELLITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERLIPIDAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTUBATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIFE SUPPORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERCUTANEOUS CORONARY INTERVENTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE CHRONIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENTRICULAR DYSFUNCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOSPORINE</medicinalproduct>
        <drugauthorizationnumb>50574</drugauthorizationnumb>
        <drugdosagetext>75 MG, BID</drugdosagetext>
        <drugindication>HEART TRANSPLANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990901</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugdosagetext>5 MG, BID</drugdosagetext>
        <drugindication>HEART TRANSPLANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990901</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MYCOPHENOLATE MOFETIL</medicinalproduct>
        <drugdosagetext>1 G, BID</drugdosagetext>
        <drugindication>HEART TRANSPLANT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SIROLIMUS</medicinalproduct>
        <drugdosagetext>6 MG/D</drugdosagetext>
        <drugindication>HEART TRANSPLANT</drugindication>
        <drugtreatmentduration>1440</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SIROLIMUS</medicinalproduct>
        <drugdosagetext>2 MG, QD</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052512-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060703</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2006ES09908</companynumb>
    <primarysource>
      <reportercountry>SPAIN</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>52</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ATRIAL FIBRILLATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIOVERSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHOLECYSTECTOMY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHOLECYSTITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHRONIC ALLOGRAFT NEPHROPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GINGIVAL HYPERPLASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERCHOLESTEROLAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTRACARDIAC THROMBUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENTRICULAR DYSKINESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENTRICULAR FIBRILLATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOSPORINE</medicinalproduct>
        <drugauthorizationnumb>50574</drugauthorizationnumb>
        <drugdosagetext>4 MG/KG, BID</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>RENAL TRANSPLANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19930101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20011101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TACROLIMUS</medicinalproduct>
        <drugindication>RENAL TRANSPLANT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATORVASTATIN CALCIUM</medicinalproduct>
        <drugdosagetext>20 MG/D</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TELMISARTAN</medicinalproduct>
        <drugdosagetext>80 MG/D</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISONE (NGX)</medicinalproduct>
        <drugdosagetext>0.5 MG/D</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>RENAL TRANSPLANT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUVASTATIN</medicinalproduct>
        <drugdosagetext>20 MG/D</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HYPERCHOLESTEROLAEMIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052513-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060713</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>81.6475</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANAPHYLACTIC REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TYPE I HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URTICARIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ORTHO TRI-CYCLEN</medicinalproduct>
        <drugdosagetext>1 DAY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONTRACEPTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980829</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19980830</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052514-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060713</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>67</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANGIONEUROTIC OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BIOPSY SKIN ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DERMATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLAMMATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN OF SKIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POST PROCEDURAL COMPLICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH ERYTHEMATOUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH VESICULAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TYPE IV HYPERSENSITIVITY REACTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IOHEXOL</medicinalproduct>
        <drugdosagetext>105 ML IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CATHETERISATION CARDIAC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060111</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060122</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>805</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052515-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060711</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AVENTIS-200615768US</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>50</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEVICE FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GALLBLADDER OPERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
        <drugbatchnumb>E067</drugbatchnumb>
        <drugauthorizationnumb>021081</drugauthorizationnumb>
        <drugdosagetext>DOSE UNIT: UNITS</drugdosagetext>
        <drugindication>DIABETES MELLITUS INSULIN-DEPENDENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OPTICLIK (INSULIN INJECTION PEN)</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021081</drugauthorizationnumb>
        <drugindication>PHARMACEUTICAL PRODUCT COMPLAINT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RAPAMUNE</medicinalproduct>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SERUMLIPIDREDUCING AGENTS</medicinalproduct>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SENSIPAR</medicinalproduct>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZANTAC</medicinalproduct>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMURAN</medicinalproduct>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOPRESSOR</medicinalproduct>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NOVOLOG</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052516-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060404</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-AVENTIS-200611117JP</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>26</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>59.3</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DYSARTHRIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUDDEN HEARING LOSS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
        <drugauthorizationnumb>021081</drugauthorizationnumb>
        <drugdosagetext>DOSE UNIT: UNITS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>DIABETES MELLITUS INSULIN-DEPENDENT</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060403</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
        <drugauthorizationnumb>021081</drugauthorizationnumb>
        <drugdosagetext>DOSE UNIT: UNITS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060403</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
        <drugauthorizationnumb>021081</drugauthorizationnumb>
        <drugdosagetext>DOSE UNIT: UNITS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060601</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OPTICLIK (INSULIN INJECTION PEN)</medicinalproduct>
        <drugauthorizationnumb>021081</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NU-LOTAN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETIC NEPHROPATHY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NOVORAPID</medicinalproduct>
        <drugdosagetext>DOSE: 8-8-9-0; DOSE UNIT: UNITS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060403</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NOVORAPID</medicinalproduct>
        <drugdosagetext>DOSE: 6-0-8-0; DOSE UNIT: UNITS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060403</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052517-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060420</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AVENTIS-200613699US</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>21081</drugauthorizationnumb>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HUMALOG</medicinalproduct>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THYROID PREPARATIONS</medicinalproduct>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
        <drugindication>THYROID DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052518-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060630</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IE-AVENTIS-200616904GDDC</companynumb>
    <primarysource>
      <reportercountry>IRELAND</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>77</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>86.06</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANIMAL SCRATCH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CELLULITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>21081</drugauthorizationnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060424</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052519-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060703</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHNU2006DE02423</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DEAFNESS UNILATERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENINGEAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENTAL DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SANDIMMUNE</medicinalproduct>
        <drugauthorizationnumb>050574</drugauthorizationnumb>
        <drugdosagetext>100MG/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RENAL FAILURE CHRONIC</drugindication>
        <drugtreatmentduration>1825</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INEGY</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETYLSALICYLIC ACID SRT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COAPROVEL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VENLAFAXINE HCL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052520-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060613</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHNU2006DE02302</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>APPLICATION SITE IRRITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>APPLICATION SITE PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POISONING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMBIPATCH</medicinalproduct>
        <drugbatchnumb>S0031</drugbatchnumb>
        <drugauthorizationnumb>020870</drugauthorizationnumb>
        <drugdosagetext>2 DF, QW</drugdosagetext>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060517</drugstartdate>
        <drugtreatmentduration>20160</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>L-THYROXINE</medicinalproduct>
        <drugdosagetext>100MG/DAY</drugdosagetext>
        <drugindication>HYPOTHYROIDISM</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SINUSITIS N</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052521-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060220</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2006JP02907</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>68</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>65</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 PRESSURE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>C-REACTIVE PROTEIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EATING DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EOSINOPHILIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHABDOMYOLYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINE OUTPUT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDONINE</medicinalproduct>
        <drugdosagetext>5 MG/D</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040903</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEORAL</medicinalproduct>
        <drugauthorizationnumb>050715</drugauthorizationnumb>
        <drugdosagetext>300 MG/D</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>EOSINOPHILIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050704</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060216</drugenddate>
        <drugtreatmentduration>228</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NU LOTAN</medicinalproduct>
        <drugdosagetext>50 MG/D</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041216</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060216</drugenddate>
        <drugtreatmentduration>428</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BONALON</medicinalproduct>
        <drugdosagetext>5 MG/D</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAKEPRON</medicinalproduct>
        <drugdosagetext>15 MG/D</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041208</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALESION</medicinalproduct>
        <drugdosagetext>40 MG/D</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050405</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052522-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060703</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2006US09900</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>59</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>GRAFT VERSUS HOST DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OBLITERATIVE BRONCHIOLITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN NEOPLASM EXCISION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUPERFICIAL SPREADING MELANOMA STAGE II</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOSPORINE</medicinalproduct>
        <drugauthorizationnumb>50573</drugauthorizationnumb>
        <drugdosagetext>3 MG/KG/D</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>STEM CELL TRANSPLANT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOSPORINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISONE (NGX)</medicinalproduct>
        <drugindication>STEM CELL TRANSPLANT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MYCOPHENOLATE MOFETIL</medicinalproduct>
        <drugindication>STEM CELL TRANSPLANT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PUVA</medicinalproduct>
        <drugindication>STEM CELL TRANSPLANT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOCORTICOSTEROIDS</medicinalproduct>
        <drugadministrationroute>061</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYCLOPHOSPHAMIDE</medicinalproduct>
        <drugdosagetext>120 MG/KG/D</drugdosagetext>
        <drugindication>STEM CELL TRANSPLANT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUDARABINE</medicinalproduct>
        <drugdosagetext>125 MG/M2</drugdosagetext>
        <drugindication>STEM CELL TRANSPLANT</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052523-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060704</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2006JP10017</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>16</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>CARDIO-RESPIRATORY ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIFE SUPPORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SANDIMMUNE</medicinalproduct>
        <drugauthorizationnumb>050573</drugauthorizationnumb>
        <drugdosagetext>180 MG/D</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLITIS ULCERATIVE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060630</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060701</drugenddate>
        <drugtreatmentduration>2880</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052524-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060703</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2006US09902</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>61</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GRAFT VERSUS HOST DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OBLITERATIVE BRONCHIOLITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN NEOPLASM EXCISION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SQUAMOUS CELL CARCINOMA OF SKIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOSPORINE</medicinalproduct>
        <drugauthorizationnumb>50573</drugauthorizationnumb>
        <drugdosagetext>3 MG/KG/D</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>STEM CELL TRANSPLANT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISONE (NGX)</medicinalproduct>
        <drugindication>STEM CELL TRANSPLANT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugindication>STEM CELL TRANSPLANT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MYCOPHENOLATE MOFETIL</medicinalproduct>
        <drugindication>STEM CELL TRANSPLANT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PUVA</medicinalproduct>
        <drugindication>STEM CELL TRANSPLANT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOCORTICOSTEROIDS</medicinalproduct>
        <drugadministrationroute>061</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYCLOPHOSPHAMIDE</medicinalproduct>
        <drugdosagetext>120 MG/KG/D</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUDARABINE</medicinalproduct>
        <drugdosagetext>125 MG/M2</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOSPORINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052525-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060622</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHO2006JP10326</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>54</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ACUTE MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY BYPASS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ELECTROCARDIOGRAM ST SEGMENT ELEVATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
        <drugauthorizationnumb>21283</drugauthorizationnumb>
        <drugdosagetext>80 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIVALO KOWA</medicinalproduct>
        <drugindication>HYPERCHOLESTEROLAEMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SEDIEL</medicinalproduct>
        <drugindication>NEUROSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052526-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060619</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR200605003821</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>80</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEMORAL NECK FRACTURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugauthorizationnumb>21318</drugauthorizationnumb>
        <drugdosagetext>20 UG, DAILY (1/D), SUBCUTANEOUS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORAZEPAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATACAND</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OROCAL D(3)             (CALCIUM CARBONATE, COLECALCIFEROL)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052527-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesscongenitalanomali>1</seriousnesscongenitalanomali>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060616</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>EWC041141570</companynumb>
    <primarysource>
      <reportercountry>GREECE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>12</patientonsetage>
      <patientonsetageunit>803</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CAESAREAN SECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HIP DYSPLASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UNINTENDED PREGNANCY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
        <drugauthorizationnumb>20592</drugauthorizationnumb>
        <drugdosagetext>TRANSPLACENTAL</drugdosagetext>
        <drugadministrationroute>064</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040525</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEGOFER (FERRIPROTINATE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FERRUM (FERROUS FUMARATE)</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 GLUCONATE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052528-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060712</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2006JP10463</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>92</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIOVASCULAR INSUFFICIENCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG ADMINISTRATION ERROR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VALSARTAN</medicinalproduct>
        <drugauthorizationnumb>20665</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIGOXIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AROTINOLOL HYDROCHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ISOSORBIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IFENPRODIL TARTRATE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052529-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060308</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHO2006DE04144</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>26</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>COMPLICATIONS OF TRANSPLANTED KIDNEY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMPLICATIONS OF TRANSPLANTED LIVER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOVOLAEMIC SHOCK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER TRANSPLANT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTI-ORGAN FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POST PROCEDURAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYSTEMIC INFLAMMATORY RESPONSE SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SANDIMMUNE</medicinalproduct>
        <drugdosagetext>NOT REPORTED</drugdosagetext>
        <drugindication>RENAL TRANSPLANT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugdosagetext>NOT REPORTED</drugdosagetext>
        <drugindication>RENAL TRANSPLANT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MYFORTIC</medicinalproduct>
        <drugauthorizationnumb>050791</drugauthorizationnumb>
        <drugindication>RENAL TRANSPLANT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CERTICAN</medicinalproduct>
        <drugdosagetext>NO TREATMENT</drugdosagetext>
        <drugindication>RENAL TRANSPLANT</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052530-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060427</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2006BR08614</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>40</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LARYNGEAL OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XOLAIR</medicinalproduct>
        <drugdosagetext>150 MG, ONCE/SINGLE</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060528</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugdosagetext>600MG/DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SALBUTAMOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORASEQ</medicinalproduct>
        <drugauthorizationnumb>020831</drugauthorizationnumb>
        <drugdosagetext>3 DF/DAY</drugdosagetext>
        <drugindication>ASTHMA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052531-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060706</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2006TR10116</companynumb>
    <primarysource>
      <reportercountry>TURKEY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>INTRAOCULAR PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OPEN ANGLE GLAUCOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORASEQ</medicinalproduct>
        <drugauthorizationnumb>20831</drugauthorizationnumb>
        <drugindication>ASTHMA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052532-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060619</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ES200604000859</companynumb>
    <primarysource>
      <reportercountry>SPAIN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>48</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>GRANULOCYTOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEUKOCYTURIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>20592</drugauthorizationnumb>
        <drugdosagetext>60 MG; 120 MG; 60 MG</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060302</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060316</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>20592</drugauthorizationnumb>
        <drugdosagetext>60 MG; 120 MG; 60 MG</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060316</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060327</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>20592</drugauthorizationnumb>
        <drugdosagetext>60 MG; 120 MG; 60 MG</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060327</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
        <drugindication>PSYCHOTIC DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VENLAFAXINE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAZODONE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LUDIOMIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIAZEPAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHROID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLATELET AGGREGATION INHIBITORS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052536-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060706</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2006US08730</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DEEP VEIN THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXJADE</medicinalproduct>
        <drugauthorizationnumb>021882</drugauthorizationnumb>
        <drugdosagetext>UNK, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052537-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060703</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2006FR09848</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>55</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>AMYOTROPHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULAR WEAKNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERIPHERAL COLDNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARTEOLOL HYDROCHLORIDE</medicinalproduct>
        <drugauthorizationnumb>019972</drugauthorizationnumb>
        <drugdosagetext>1 DRP/DAY</drugdosagetext>
        <drugindication>GLAUCOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARTEOLOL HYDROCHLORIDE</medicinalproduct>
        <drugauthorizationnumb>019972</drugauthorizationnumb>
        <drugdosagetext>1 DRP/DAY</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052538-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060602</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2006US07270</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>75</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANAPHYLACTIC REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EOSINOPHIL PERCENTAGE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEUKOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPHOCYTE PERCENTAGE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPHIL PERCENTAGE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>81 MG, QD</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MIRAPEX</medicinalproduct>
        <drugdosagetext>125 MG, TID</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugdosagetext>10 MG, QD</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARTHROTEC</medicinalproduct>
        <drugdosagetext>75 MG, BID</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYLENOL (CAPLET)</medicinalproduct>
        <drugdosagetext>UNK, PRN</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYLENOL SINUS</medicinalproduct>
        <drugdosagetext>UNK, PRN</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXJADE</medicinalproduct>
        <drugauthorizationnumb>021882</drugauthorizationnumb>
        <drugdosagetext>UNK MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MYELODYSPLASTIC SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060226</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060304</drugenddate>
        <drugtreatmentduration>10080</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052539-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060627</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2006CL09616</companynumb>
    <primarysource>
      <reportercountry>CHILE</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG DISPENSING ERROR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEPONEX</medicinalproduct>
        <drugauthorizationnumb>19758</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052540-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060707</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2006US08763</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>77</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MACULAR DEGENERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL ACUITY REDUCED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXJADE</medicinalproduct>
        <drugauthorizationnumb>021882</drugauthorizationnumb>
        <drugdosagetext>1250 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MYELODYSPLASTIC SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060501</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052542-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060626</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006080861</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>91</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>74.8435</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
        <drugauthorizationnumb>20235</drugauthorizationnumb>
        <drugdosagetext>300 MG DAILY</drugdosagetext>
        <drugindication>NEUROPATHY</drugindication>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARDURA</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052544-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060621</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2006JP09425</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>65</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>NEOPLASM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNOVIAL CYST</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOSPORINE</medicinalproduct>
        <drugauthorizationnumb>050574</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>SYSTEMIC LUPUS ERYTHEMATOSUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SYSTEMIC LUPUS ERYTHEMATOSUS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052545-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20020425</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0367026A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>42</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>54.1</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANOREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FAECES DISCOLOURED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTESTINAL OBSTRUCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LETHARGY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LOTRONEX</medicinalproduct>
        <drugauthorizationnumb>21107</drugauthorizationnumb>
        <drugdosagetext>1MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>IRRITABLE BOWEL SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20000901</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KLONOPIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RESTORIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HUMULIN N</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRILOSEC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EXLAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MORPHINE</medicinalproduct>
        <drugdosagetext>30MG TWICE PER DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HALCION</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARDIZEM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACTOS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052546-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040719</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0519846A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG WITHDRAWAL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOOD SWINGS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANIC ATTACK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
        <drugauthorizationnumb>20031</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021201</drugstartdate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAXIL CR</medicinalproduct>
        <drugauthorizationnumb>020936</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040901</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052547-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050302</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0548238A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>48</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>77.7</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ARTERIOSPASM CORONARY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD POTASSIUM DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRADYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC ENZYMES INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERICARDITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMITREX</medicinalproduct>
        <drugauthorizationnumb>20132</drugauthorizationnumb>
        <drugdosagetext>50MG AS REQUIRED</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020226</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052548-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050516</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0559053A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>AGGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANGER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BIPOLAR DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISORIENTATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EFFECT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG WITHDRAWAL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESTLESSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TINNITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
        <drugauthorizationnumb>20031</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANXIETY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000501</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYZAAR</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052549-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060310</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0597159A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>64</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HEART RATE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SENSORY DISTURBANCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REQUIP</medicinalproduct>
        <drugauthorizationnumb>20658</drugauthorizationnumb>
        <drugdosagetext>.25MG SINGLE DOSE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RESTLESS LEGS SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060303</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060303</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM GLUCONATE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052550-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060328</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0599379A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>52</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISEASE PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIPASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METASTASES TO PANCREAS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCREATITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HYCAMTIN</medicinalproduct>
        <drugauthorizationnumb>20671</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060327</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NO CONCURRENT MEDICATION</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052551-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060325</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0599987A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ADVAIR DISKUS 100/50</medicinalproduct>
        <drugauthorizationnumb>21077</drugauthorizationnumb>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
        <drugtreatmentduration>9</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL SPIROS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052552-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060420</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0602623A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>68</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEPRESSED MOOD</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISSOCIATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EMOTIONAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOOD ALTERED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
        <drugauthorizationnumb>020031</drugauthorizationnumb>
        <drugdosagetext>20MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN MEDICATION</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPAMAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KLONOPIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052553-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060504</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0604727A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>50</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD CATECHOLAMINES INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY BYPASS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT AND COLD</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>WELLBUTRIN</medicinalproduct>
        <drugauthorizationnumb>18644</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060224</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBIF</medicinalproduct>
        <drugdosagetext>44MCG THREE TIMES PER WEEK</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040322</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052554-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060526</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0607084A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>79</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG ADMINISTRATION ERROR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POOR QUALITY DRUG ADMINISTERED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRANSIENT ISCHAEMIC ATTACK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ADVAIR DISKUS 100/50</medicinalproduct>
        <drugbatchnumb>5ZP3678</drugbatchnumb>
        <drugauthorizationnumb>21077</drugauthorizationnumb>
        <drugdosagetext>1PUFF TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL SPIROS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IPRATROPIUM BROMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NADOLOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REQUIP</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONAZEPAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHADOSE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052555-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060613</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0608831A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>50</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>79.5</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BALANCE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COORDINATION ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISORIENTATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HALLUCINATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEMORY IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN EXFOLIATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMICTAL</medicinalproduct>
        <drugauthorizationnumb>20241</drugauthorizationnumb>
        <drugdosagetext>200MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BIPOLAR DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060109</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060308</drugenddate>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHYLPHENIDATE HCL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052556-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0609218C</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL DISTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOPOTECAN</medicinalproduct>
        <drugauthorizationnumb>20671</drugauthorizationnumb>
        <drugdosagetext>3.5MGM2 CYCLIC</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>OVARIAN CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060511</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAXOTERE</medicinalproduct>
        <drugdosagetext>30MGM2 CYCLIC</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>OVARIAN CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060511</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
        <drugdosagetext>5MG AT NIGHT</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
        <drugdosagetext>50MG PER DAY</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052557-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060619</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-GLAXOSMITHKLINE-A0609613A</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>62</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREATMENT NONCOMPLIANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VASCULAR BYPASS GRAFT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>21071</drugauthorizationnumb>
        <drugdosagetext>4MG AT NIGHT</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADALAT</medicinalproduct>
        <drugdosagetext>60MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
        <drugdosagetext>100MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugdosagetext>20MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>81MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLICLAZIDE</medicinalproduct>
        <drugdosagetext>80MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
        <drugdosagetext>850MG THREE TIMES PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052558-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060622</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0610045A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>39</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>72.7</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD IRON INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAXIL CR</medicinalproduct>
        <drugauthorizationnumb>020936</drugauthorizationnumb>
        <drugdosagetext>25MG UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KLONOPIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IRON</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052559-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060626</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0610527A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>58</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugauthorizationnumb>20297</drugauthorizationnumb>
        <drugdosagetext>6.25MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050801</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052560-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060707</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0611450A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>12</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCREASED UPPER AIRWAY SECRETION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARYNGOLARYNGEAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ADVAIR DISKUS 100/50</medicinalproduct>
        <drugbatchnumb>6ZP9710</drugbatchnumb>
        <drugauthorizationnumb>21077</drugauthorizationnumb>
        <drugdosagetext>1PUFF TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL SPIROS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052561-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060707</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0611494A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>32</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OLIGOHYDRAMNIOS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PREGNANCY INDUCED HYPERTENSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMICTAL</medicinalproduct>
        <drugauthorizationnumb>20241</drugauthorizationnumb>
        <drugdosagetext>50MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PANIC ATTACK</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRENATAL VITAMINS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052562-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060707</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0611494B</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>3.3</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CAESAREAN SECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOGLYCAEMIA NEONATAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PREMATURE BABY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMICTAL</medicinalproduct>
        <drugauthorizationnumb>20241</drugauthorizationnumb>
        <drugdosagetext>50MG PER DAY</drugdosagetext>
        <drugindication>EPILEPSY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRENATAL VITAMINS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052563-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060707</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0611557A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DENTAL CARIES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FAECES DISCOLOURED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRIC HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATOCHEZIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HERNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NICOTINE DEPENDENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STOMACH DISCOMFORT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6E01</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugadministrationroute>002</drugadministrationroute>
        <drugindication>SMOKING CESSATION THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THYROID TAB</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052564-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060710</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0611631A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>79</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CATARACT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GLOSSITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GLOSSODYNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TONGUE DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugauthorizationnumb>20297</drugauthorizationnumb>
        <drugdosagetext>6.25MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORAZEPAM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052565-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060710</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0611656A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>41</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ILL-DEFINED DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUS CONGESTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROAT IRRITATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ADVAIR DISKUS 100/50</medicinalproduct>
        <drugbatchnumb>R221819</drugbatchnumb>
        <drugauthorizationnumb>021077</drugauthorizationnumb>
        <drugdosagetext>1PUFF TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060424</drugstartdate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NASACORT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENADRYL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNSPECIFIED MEDICATION</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLERGY SHOT</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052566-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060706</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0611685A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>22</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>COMPLETED SUICIDE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>WELLBUTRIN</medicinalproduct>
        <drugauthorizationnumb>18644</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050610</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050601</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052567-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060710</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006-05-1546</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>51</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EMOTIONAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
        <drugauthorizationnumb>20031</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEORAL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM + VITAMIN D</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELLCEPT</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGNESIUM OXIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>URSODEOXYCHOLIC ACID</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROTONIX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052568-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060710</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0611711A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAXIL CR</medicinalproduct>
        <drugauthorizationnumb>20936</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052569-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060708</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0611734A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>52</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>COAGULOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EXTRAVASATION BLOOD</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PIGMENTATION DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ECOTRIN</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052570-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060710</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0611770A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>47</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRIC PERFORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATEMESIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEAD INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOUTH HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RECTAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ULCER HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WOUND</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GOODY'S</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugindication>TENSION HEADACHE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19760101</drugstartdate>
        <drugtreatmentduration>30</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052571-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060713</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>1-27414249</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>35</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE CONGESTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUS TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE VASOVAGAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROAT TIGHTNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URTICARIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VESTIBULITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAGAMET</medicinalproduct>
        <drugauthorizationnumb>017920</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051030</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REBIF</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052572-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060710</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006-004847</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>ADVERSE EVENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLOLAN</medicinalproduct>
        <drugbatchnumb>A121</drugbatchnumb>
        <drugauthorizationnumb>020444</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052573-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060711</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0612342A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PREMATURE LABOUR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BUPROPION HYDROCHLORIDE</medicinalproduct>
        <drugauthorizationnumb>018644</drugauthorizationnumb>
        <drugdosagetext>600MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MAJOR DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050909</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALTREX</medicinalproduct>
        <drugdosagetext>500MG PER DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZELNORM</medicinalproduct>
        <drugdosagetext>6MG PER DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOPHAGE</medicinalproduct>
        <drugdosagetext>500MG PER DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL SPIROS</medicinalproduct>
        <drugadministrationroute>055</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LITHIUM CARBONATE</medicinalproduct>
        <drugdosagetext>900MG PER DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPAMAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAZORAC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADVAIR DISKUS 100/50</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREVACID</medicinalproduct>
        <drugdosagetext>30MG PER DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SINGULAIR</medicinalproduct>
        <drugdosagetext>10MG PER DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FISH OIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLAXSEED</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGNESIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEGA B</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CA++</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052574-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060717</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0612348A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>AGGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AGITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>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>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEMORY IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOOD ALTERED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
        <drugauthorizationnumb>020031</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052575-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060712</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-GLAXOSMITHKLINE-A0612350A</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>69</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>66</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FACE OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MACULAR OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RETINAL EXUDATES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RETINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL ACUITY REDUCED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060601</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
        <drugdosagetext>850MG THREE TIMES PER DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MONOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>L-LYSINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOSEC</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052576-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060206</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2005JP002169</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>79</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ILL-DEFINED DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STAPHYLOCOCCAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOXIC EPIDERMAL NECROLYSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CEFAZOLIN</medicinalproduct>
        <drugdosagetext>1G TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>INFECTION PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050708</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050710</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PHENOBAL</medicinalproduct>
        <drugdosagetext>45MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONVULSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050612</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050714</drugenddate>
        <drugtreatmentduration>33</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADALAT</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050705</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050718</drugenddate>
        <drugtreatmentduration>14</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HERBESSER</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050705</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050718</drugenddate>
        <drugtreatmentduration>14</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ISOSORBIDE MONONITRATE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050705</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050718</drugenddate>
        <drugtreatmentduration>14</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDONINE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060714</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VANCOMYCIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FERROMIA</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050624</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050714</drugenddate>
        <drugtreatmentduration>21</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CINAL</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050624</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050714</drugenddate>
        <drugtreatmentduration>21</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARTIST</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050610</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050705</drugenddate>
        <drugtreatmentduration>26</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GASTER</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050610</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050718</drugenddate>
        <drugtreatmentduration>39</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050610</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050718</drugenddate>
        <drugtreatmentduration>39</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIGMART</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050610</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050718</drugenddate>
        <drugtreatmentduration>39</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLYCERYL TRINITRATE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050610</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050714</drugenddate>
        <drugtreatmentduration>35</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGLAX</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050610</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050714</drugenddate>
        <drugtreatmentduration>35</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050705</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050718</drugenddate>
        <drugtreatmentduration>14</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052577-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060303</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IE-GLAXOSMITHKLINE-B0415081A</companynumb>
    <primarysource>
      <reportercountry>IRELAND</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>PSYCHOTIC DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SERETIDE</medicinalproduct>
        <drugauthorizationnumb>21254</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052578-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060403</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-JPN-A200601127</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>33</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>41</patientweight>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BUPROPION HCL</medicinalproduct>
        <drugauthorizationnumb>21515</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050906</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060220</drugenddate>
        <drugtreatmentduration>168</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052579-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060412</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IT-GLAXOSMITHKLINE-B0421029A</companynumb>
    <primarysource>
      <reportercountry>ITALY</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>31</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DERMATITIS ALLERGIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH MACULO-PAPULAR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AUGMENTIN '125'</medicinalproduct>
        <drugauthorizationnumb>50564</drugauthorizationnumb>
        <drugdosagetext>1G TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>COUGH</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060324</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060327</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052580-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060510</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-GLAXOSMITHKLINE-B0423238A</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>63</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOKINESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPINAL MANIPULATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REQUIP</medicinalproduct>
        <drugauthorizationnumb>20658</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PARKINSON'S DISEASE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052581-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060626</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IN-GLAXOSMITHKLINE-B0423601B</companynumb>
    <primarysource>
      <reportercountry>INDIA</reportercountry>
      <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>CARDIAC ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GRAND MAL CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA ASPIRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMOTRIGINE</medicinalproduct>
        <drugauthorizationnumb>20241</drugauthorizationnumb>
        <drugdosagetext>50MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PARTIAL SEIZURES</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051019</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIAZEPAM</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060624</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060624</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RANTAC</medicinalproduct>
        <drugdosagetext>150MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>GASTRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060624</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060624</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUIDS</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060624</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060625</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARBAMAZEPINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052582-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060523</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006JP001462</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>30</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSED LEVEL OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SHOCK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE VASOVAGAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CEFAMEZIN</medicinalproduct>
        <drugdosagetext>.5G FOUR TIMES PER DAY</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>APPENDICITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060509</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060509</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADALAT</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052583-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060529</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006JP001547</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>62</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CEREBRAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSED LEVEL OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGIC DIATHESIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERNATIONAL NORMALISED RATIO INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTRACRANIAL ANEURYSM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POST PROCEDURAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VITAMIN K DEFICIENCY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CEFAMEZIN</medicinalproduct>
        <drugdosagetext>1G TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>POSTOPERATIVE CARE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060411</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060522</drugenddate>
        <drugtreatmentduration>42</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLYCEOL</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060411</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060414</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HEPARIN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060411</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060413</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RADICUT</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060412</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060423</drugenddate>
        <drugtreatmentduration>12</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXTRAN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060412</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060419</drugenddate>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MANNITOL</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060415</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060523</drugenddate>
        <drugtreatmentduration>39</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>P N TWIN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060415</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060518</drugenddate>
        <drugtreatmentduration>34</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>P N TWIN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060417</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060522</drugenddate>
        <drugtreatmentduration>36</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>M.V.I.</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060415</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060522</drugenddate>
        <drugtreatmentduration>38</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>M.V.I.</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060415</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060522</drugenddate>
        <drugtreatmentduration>38</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ELEMENMIC</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060415</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060522</drugenddate>
        <drugtreatmentduration>38</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRANSAMIN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060513</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060515</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FAMOTIDINE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060513</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060515</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GENERAL ANAESTHESIA</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060411</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060411</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TPN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CEPHEM ANTIBIOTICS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052584-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060525</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-GLAXOSMITHKLINE-B0425967A</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>68</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL DISTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ILEUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOPOTECAN</medicinalproduct>
        <drugauthorizationnumb>20671</drugauthorizationnumb>
        <drugdosagetext>1.2MGM2 PER DAY</drugdosagetext>
        <drugindication>OVARIAN CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060417</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060421</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLPIDEM TARTRATE</medicinalproduct>
        <drugindication>INSOMNIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052585-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060601</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>J200601489</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>53</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>LARYNGOTRACHEO BRONCHITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SAWACILLIN</medicinalproduct>
        <drugauthorizationnumb>62216</drugauthorizationnumb>
        <drugdosagetext>250MG THREE TIMES PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060417</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060420</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AZELASTINE HCL</medicinalproduct>
        <drugdosagetext>1MG THREE TIMES PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060308</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060415</drugenddate>
        <drugtreatmentduration>39</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HISPORAN</medicinalproduct>
        <drugdosagetext>3MG THREE TIMES PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060308</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060415</drugenddate>
        <drugtreatmentduration>39</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLARITHROMYCIN</medicinalproduct>
        <drugdosagetext>200MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>LARYNGOTRACHEO BRONCHITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060420</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060424</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PONTAL</medicinalproduct>
        <drugdosagetext>750MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060417</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060420</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LYSOZYME HYDROCHLORIDE</medicinalproduct>
        <drugdosagetext>90MG THREE TIMES PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>TONSILLITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060417</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060420</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALESION</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NIPOLAZIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
        <drugdosagetext>.625MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060524</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MUCODYNE</medicinalproduct>
        <drugdosagetext>500MG THREE TIMES PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>LARYNGOTRACHEO BRONCHITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060420</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060424</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASVERIN</medicinalproduct>
        <drugdosagetext>20MG THREE TIMES PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>LARYNGOTRACHEO BRONCHITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060420</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060424</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLORIAMIN</medicinalproduct>
        <drugdosagetext>.5G THREE TIMES PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>LARYNGOTRACHEO BRONCHITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060420</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060424</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052586-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060601</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>NZ-GLAXOSMITHKLINE-B0427403A</companynumb>
    <primarysource>
      <reportercountry>NEW ZEALAND</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>28</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABORTION SPONTANEOUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTRA-UTERINE DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMICTAL</medicinalproduct>
        <drugauthorizationnumb>20241</drugauthorizationnumb>
        <drugdosagetext>400MG PER DAY</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>EPILEPSY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EPILIM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>EPILEPSY</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19980101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOBAZAM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>EPILEPSY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010901</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
        <drugdosagetext>5MG UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052587-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060601</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>NZ-GLAXOSMITHKLINE-B0427403B</companynumb>
    <primarysource>
      <reportercountry>NEW ZEALAND</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRISOMY 21</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMICTAL</medicinalproduct>
        <drugauthorizationnumb>20241</drugauthorizationnumb>
        <drugdosagetext>400MG PER DAY</drugdosagetext>
        <drugindication>EPILEPSY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EPILIM</medicinalproduct>
        <drugindication>EPILEPSY</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19980101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOBAZAM</medicinalproduct>
        <drugindication>EPILEPSY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010901</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
        <drugdosagetext>5MG UNKNOWN</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052588-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060608</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IN-GLAXOSMITHKLINE-B0427598A</companynumb>
    <primarysource>
      <reportercountry>INDIA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>32</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMMUNE RECONSTITUTION SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEPROSY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEURITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERONEAL NERVE PALSY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN LESION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZIDOVUDINE</medicinalproduct>
        <drugauthorizationnumb>019655</drugauthorizationnumb>
        <drugdosagetext>600MG PER DAY</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMIVUDINE</medicinalproduct>
        <drugauthorizationnumb>020564</drugauthorizationnumb>
        <drugdosagetext>300MG PER DAY</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEVIRAPINE</medicinalproduct>
        <drugdosagetext>400MG PER DAY</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RIFAMPICIN</medicinalproduct>
        <drugdosagetext>600MG MONTHLY</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>LEPROSY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLOFAZIMINE</medicinalproduct>
        <drugdosagetext>100MG THREE TIMES PER DAY</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>LEPROSY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COTRIMOXAZOLE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>INFECTION PROPHYLAXIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052589-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060614</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-JPN-A200602069</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>6</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>25</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLAVAMOX</medicinalproduct>
        <drugauthorizationnumb>50575</drugauthorizationnumb>
        <drugdosagetext>1.9G TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OTITIS MEDIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060612</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060612</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SAWACILLIN</medicinalproduct>
        <drugauthorizationnumb>062216</drugauthorizationnumb>
        <drugdosagetext>250MG THREE TIMES PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>STREPTOCOCCAL INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060525</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060603</drugenddate>
        <drugtreatmentduration>10</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZADITEN</medicinalproduct>
        <drugdosagetext>1.5G PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060606</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060612</drugenddate>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLOMOX</medicinalproduct>
        <drugdosagetext>249MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>STREPTOCOCCAL INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060606</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060612</drugenddate>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BIOFERMIN R</medicinalproduct>
        <drugdosagetext>3G PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>STREPTOCOCCAL INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060606</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060612</drugenddate>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ONON</medicinalproduct>
        <drugdosagetext>100MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030415</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THEO-DUR</medicinalproduct>
        <drugdosagetext>120MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BISOLVON</medicinalproduct>
        <drugdosagetext>8MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PERIACTIN</medicinalproduct>
        <drugdosagetext>6MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUTIDE DISKUS</medicinalproduct>
        <drugdosagetext>200MCG PER DAY</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030501</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KETOTIFEN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052590-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060612</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-JPN-A200602072</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>23</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>49</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANOREXIA AND BULIMIA SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EATING DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NIGHTMARE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OBSESSIVE-COMPULSIVE DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
        <drugauthorizationnumb>020031</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SOCIAL PHOBIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060427</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060630</drugenddate>
        <drugtreatmentduration>65</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALPRAZOLAM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANXIETY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060530</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060630</drugenddate>
        <drugtreatmentduration>32</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERDAL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060609</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GASMOTIN</medicinalproduct>
        <drugdosagetext>10MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060428</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060609</drugenddate>
        <drugtreatmentduration>43</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOXONIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEADACHE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060616</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052591-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060613</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BE-GLAXOSMITHKLINE-B0427745A</companynumb>
    <primarysource>
      <reportercountry>BELGIUM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>61</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>85</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ANAPHYLACTIC SHOCK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRONCHOSPASM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHILLS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CIRCULATORY COLLAPSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPTIC SHOCK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENTRICULAR FIBRILLATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AUGMENTIN '125'</medicinalproduct>
        <drugauthorizationnumb>50564</drugauthorizationnumb>
        <drugdosagetext>1G FOUR TIMES PER DAY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060603</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060603</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NOVORAPID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
        <drugdosagetext>54IU24 PER DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOPHAGE</medicinalproduct>
        <drugdosagetext>850MG TWICE PER DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>APROVEL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYTRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EMCONCOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DAKAR</medicinalproduct>
        <drugdosagetext>15MG PER DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
        <drugdosagetext>.25MG SEE DOSAGE TEXT</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052592-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060616</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006/01210</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>6</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>20</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG ERUPTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA MULTIFORME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SAWACILLIN</medicinalproduct>
        <drugauthorizationnumb>50542</drugauthorizationnumb>
        <drugdosagetext>2G THREE TIMES PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>STREPTOCOCCAL INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060407</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060418</drugenddate>
        <drugtreatmentduration>12</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEFTOSE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PHARYNGITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060407</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060410</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MUCOSOLVAN</medicinalproduct>
        <drugdosagetext>2ML THREE TIMES PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PHARYNGITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060407</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060410</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICON</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PHARYNGITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060418</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060422</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENTERONON-R</medicinalproduct>
        <drugdosagetext>.66G THREE TIMES PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060407</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060418</drugenddate>
        <drugtreatmentduration>12</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POLARAMINE</medicinalproduct>
        <drugdosagetext>5ML THREE TIMES PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PHARYNGITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060418</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060422</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052593-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060619</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-JPN-A200602147</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>45</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>41</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ENTEROCOLITIS HAEMORRHAGIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATOCHEZIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MELAENA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AUGMENTIN '125'</medicinalproduct>
        <drugauthorizationnumb>050564</drugauthorizationnumb>
        <drugdosagetext>1U THREE TIMES PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CYSTITIS NONINFECTIVE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060612</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060615</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN DRUG</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GOSHA-JINKI-GAN</medicinalproduct>
        <drugdosagetext>2.5G THREE TIMES PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052594-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060620</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>J200601539</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>29</patientonsetage>
      <patientonsetageunit>802</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EOSINOPHIL COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC FUNCTION ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMOXICILLIN</medicinalproduct>
        <drugauthorizationnumb>50542</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>STREPTOCOCCAL INFECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060301</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FROBEN</medicinalproduct>
        <drugindication>KAWASAKI'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060301</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLARITHROMYCIN</medicinalproduct>
        <drugindication>UPPER RESPIRATORY TRACT INFLAMMATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMMUNE GLOBULIN INTRAVENOUS (HUMAN)</medicinalproduct>
        <drugindication>KAWASAKI'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060301</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052595-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesscongenitalanomali>1</seriousnesscongenitalanomali>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060630</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-JPN-A200602391</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>37</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>68</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STILLBIRTH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
        <drugauthorizationnumb>20031</drugauthorizationnumb>
        <drugdosagetext>2.5MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PANIC DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060403</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060404</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RIZE</medicinalproduct>
        <drugdosagetext>5MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PANIC DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060410</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SEPAZON</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PANIC DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051125</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HANGE-KOBOKU-TO</medicinalproduct>
        <drugdosagetext>7.5G PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PANIC DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060206</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060401</drugenddate>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052596-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060626</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-JPN-A200602275</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>52</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>76</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HALLUCINATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NERVOUS SYSTEM DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOVIRAX</medicinalproduct>
        <drugauthorizationnumb>20089</drugauthorizationnumb>
        <drugdosagetext>400MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HERPES ZOSTER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060623</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060625</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WYTENS</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADALAT</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARTIST</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRECIPITATED CALCIUM CARBONATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARDENALIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RENAGEL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALFAROL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRAVIT</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052597-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060704</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-JPN-A200602472</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BONE MARROW FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOVIRAX</medicinalproduct>
        <drugauthorizationnumb>18603</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052598-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060707</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IT-GLAXOSMITHKLINE-B0430310A</companynumb>
    <primarysource>
      <reportercountry>ITALY</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>64</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ANAPHYLACTIC REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CIRCUMORAL OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AUGMENTIN '125'</medicinalproduct>
        <drugauthorizationnumb>050564</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060629</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060629</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOFENOPRIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052599-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060706</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-JPN-A200602511</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>50</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD CREATINE PHOSPHOKINASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE RIGIDITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUROLEPTIC MALIGNANT SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
        <drugauthorizationnumb>020031</drugauthorizationnumb>
        <drugdosagetext>20MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MAJOR DEPRESSION</drugindication>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RISPERIDONE</medicinalproduct>
        <drugdosagetext>6MG PER DAY</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OLANZAPINE</medicinalproduct>
        <drugdosagetext>25MG PER DAY</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CHLORPROMAZINE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SULPIRIDE</medicinalproduct>
        <drugdosagetext>150MG PER DAY</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMOXAPINE</medicinalproduct>
        <drugdosagetext>225MG PER DAY</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMIPRAMINE HCL</medicinalproduct>
        <drugdosagetext>150MG PER DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUVOXAMINE MALEATE</medicinalproduct>
        <drugdosagetext>50MG PER DAY</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052600-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060705</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-GLAXOSMITHKLINE-B0430396A</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>65</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ACNE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AMYOTROPHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CORTISOL DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CENTRAL OBESITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CUSHING'S SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CUSHINGOID</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOPOROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN STRIAE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SERETIDE DISKUS</medicinalproduct>
        <drugauthorizationnumb>21077</drugauthorizationnumb>
        <drugdosagetext>1PUFF TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051201</drugenddate>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </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>20031001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TELZIR</medicinalproduct>
        <drugdosagetext>1400MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EPIVIR</medicinalproduct>
        <drugdosagetext>300MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VIDEX</medicinalproduct>
        <drugdosagetext>200MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050701</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052601-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060705</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-GLAXOSMITHKLINE-B0430398A</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>66</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ADRENAL INSUFFICIENCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AMYOTROPHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CENTRAL OBESITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CUSHING'S SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIABETES MELLITUS INSULIN-DEPENDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERLACTACIDAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTRIGLYCERIDAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METABOLIC SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MITOCHONDRIAL CYTOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOPOROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PURPURA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN FRAGILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPINAL COMPRESSION FRACTURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SERETIDE DISKUS</medicinalproduct>
        <drugauthorizationnumb>21077</drugauthorizationnumb>
        <drugdosagetext>1PUFF TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060101</drugenddate>
        <drugtreatmentduration>22</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </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>20020601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOPINAVIR</medicinalproduct>
        <drugdosagetext>400MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INVIRASE</medicinalproduct>
        <drugdosagetext>1000MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050201</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052602-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060704</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-GLAXOSMITHKLINE-B0430447A</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>9</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>EPISTAXIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGE URINARY TRACT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIC PURPURA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SERETIDE DISKUS</medicinalproduct>
        <drugauthorizationnumb>21077</drugauthorizationnumb>
        <drugdosagetext>1UNIT TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VENTOLIN DOS AER</medicinalproduct>
        <drugdosagetext>100MCG AS REQUIRED</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060201</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052603-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060707</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-JPN-A200602535</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HYPOMANIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOGORRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOOD ALTERED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
        <drugauthorizationnumb>020031</drugauthorizationnumb>
        <drugdosagetext>10MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060707</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTOMIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052604-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060710</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>13422415</companynumb>
    <primarysource>
      <reportercountry>BOTSWANA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>33</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY TUBERCULOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMBIVIR</medicinalproduct>
        <drugauthorizationnumb>020857</drugauthorizationnumb>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041117</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EFAVIRENZ</medicinalproduct>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041117</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052605-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060710</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-JPN-A200602563</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>AGGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOROSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
        <drugauthorizationnumb>020031</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PANIC ATTACK</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050702</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051227</drugenddate>
        <drugtreatmentduration>179</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052606-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060704</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-GLAXOSMITHKLINE-B0430680A</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>73</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>45</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ACID BASE BALANCE ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANION GAP</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CYANOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAMMA-GLUTAMYLTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VERTIGO</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEROXAT</medicinalproduct>
        <drugauthorizationnumb>20031</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060309</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060408</drugenddate>
        <drugtreatmentduration>31</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYVOXID</medicinalproduct>
        <drugdosagetext>600MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060403</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060414</drugenddate>
        <drugtreatmentduration>12</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VANCOMYCIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RIFADIN</medicinalproduct>
        <drugdosagetext>1200MG PER DAY</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060403</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060406</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HEPARIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MOTILIUM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEXOMIL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARDENSIEL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASILIX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIAMOX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATARAX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SINTROM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIALYSIS</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060327</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052607-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060711</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-JPN-A200602579</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>43</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD CREATINE PHOSPHOKINASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DECREASED APPETITE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG WITHDRAWAL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EXTRAPYRAMIDAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MASKED FACIES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL STIFFNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
        <drugauthorizationnumb>020031</drugauthorizationnumb>
        <drugdosagetext>50MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060124</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060608</drugenddate>
        <drugtreatmentduration>136</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052608-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060707</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>453721</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>65</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARVEDILOL</medicinalproduct>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>1.25MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONGESTIVE CARDIOMYOPATHY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040805</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050420</drugenddate>
        <drugtreatmentduration>259</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALDACTONE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040810</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050426</drugenddate>
        <drugtreatmentduration>260</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052609-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060711</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ES-GLAXOSMITHKLINE-B0430945A</companynumb>
    <primarysource>
      <reportercountry>SPAIN</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>36</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMBIVIR</medicinalproduct>
        <drugauthorizationnumb>020857</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051215</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KALETRA</medicinalproduct>
        <drugdosagetext>3CAP TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051215</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052610-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060707</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006-00066</companynumb>
    <primarysource>
      <reportercountry>SWITZERLAND</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>32</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>62</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD OSMOLARITY DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOKALAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPONATRAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESTLESSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STATUS EPILEPTICUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAROXETINE HCL</medicinalproduct>
        <drugauthorizationnumb>20031</drugauthorizationnumb>
        <drugdosagetext>20MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060505</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMERON</medicinalproduct>
        <drugdosagetext>30MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060505</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
        <drugdosagetext>25MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugdosagetext>20MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NOZINAN</medicinalproduct>
        <drugdosagetext>1U AS REQUIRED</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>STESOLID</medicinalproduct>
        <drugdosagetext>10MG AS REQUIRED</drugdosagetext>
        <drugadministrationroute>054</drugadministrationroute>
        <drugindication>STATUS EPILEPTICUS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052611-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060711</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>RU-GLAXOSMITHKLINE-B0431061A</companynumb>
    <primarysource>
      <reportercountry>RUSSIAN FEDERATION</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>67</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>99</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EATON-LAMBERT SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYARRHYTHMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SERETIDE</medicinalproduct>
        <drugbatchnumb>L01002</drugbatchnumb>
        <drugauthorizationnumb>21077</drugauthorizationnumb>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060704</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARIFON</medicinalproduct>
        <drugdosagetext>1.5MG PER DAY</drugdosagetext>
        <drugindication>CARDIAC FAILURE CHRONIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYGEN THERAPY</medicinalproduct>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>RESPIRATORY FAILURE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SEREVENT</medicinalproduct>
        <drugadministrationroute>055</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060501</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VERAPAMIL</medicinalproduct>
        <drugdosagetext>80MG PER DAY</drugdosagetext>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052612-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060713</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0431145A</companynumb>
    <primarysource>
      <reportercountry>BANGLADESH</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>CHOKING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJURY ASPHYXIATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALBENDAZOLE</medicinalproduct>
        <drugauthorizationnumb>20666</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIETHYLCARBAMAZINE CITRATE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052613-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060712</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>453724</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>84</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUS ARREST</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARVEDILOL</medicinalproduct>
        <drugauthorizationnumb>20297</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MYOCARDIAL INFARCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031118</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031224</drugenddate>
        <drugtreatmentduration>37</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METILDIGOXIN</medicinalproduct>
        <drugdosagetext>.1MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031109</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031223</drugenddate>
        <drugtreatmentduration>45</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031106</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031223</drugenddate>
        <drugtreatmentduration>48</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIGMART</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031106</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031223</drugenddate>
        <drugtreatmentduration>48</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIART</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031111</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031223</drugenddate>
        <drugtreatmentduration>43</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALDACTONE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031111</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031223</drugenddate>
        <drugtreatmentduration>43</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052614-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060711</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IT-GLAXOSMITHKLINE-B0431217A</companynumb>
    <primarysource>
      <reportercountry>ITALY</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONJUNCTIVITIS VIRAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL CANDIDIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHOTOPHOBIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POLYNEUROPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUSITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL ACUITY REDUCED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZIAGEN</medicinalproduct>
        <drugauthorizationnumb>020977</drugauthorizationnumb>
        <drugdosagetext>1TAB PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050719</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050726</drugenddate>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052615-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060522</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-GLAXOSMITHKLINE-D0049804A</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <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>HEPATIC ENZYME INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VIRAL INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AUGMENTIN '125'</medicinalproduct>
        <drugauthorizationnumb>50575</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060201</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052616-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060707</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006012414</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>75</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LACTIC ACIDOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>WELLVONE</medicinalproduct>
        <drugauthorizationnumb>20500</drugauthorizationnumb>
        <drugdosagetext>750MG THREE TIMES PER WEEK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANTIBIOTIC PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYVOXID</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052617-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060710</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006012772</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>73</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>100</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDE ATTEMPT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>QUILONUM RETARD</medicinalproduct>
        <drugauthorizationnumb>18152</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AGOPTON</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMITRIPTYLIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BERODUAL</medicinalproduct>
        <drugadministrationroute>055</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DECORTIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>THEOPHYLLINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KERLONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METOCLOPRAMID</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PANCREATIN TRIPLE STRENGTH CAP</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TURFA</medicinalproduct>
        <drugauthorizationnumb>016042</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VERAPAMIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052618-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060711</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-GLAXOSMITHKLINE-D0050283A</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>SUBILEUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HYCAMTIN</medicinalproduct>
        <drugauthorizationnumb>020671</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052619-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060712</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-GLAXOSMITHKLINE-D0050308A</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>67</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>72</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLEURAL EFFUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDAMET</medicinalproduct>
        <drugauthorizationnumb>021410</drugauthorizationnumb>
        <drugdosagetext>1004MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060523</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CHOLESTEROL REDUCING AGENT</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052620-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060713</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-GLAXOSMITHKLINE-D0050328A</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>53</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>45</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HYPOKALAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPONATRAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL SALT-WASTING SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HYCAMTIN</medicinalproduct>
        <drugauthorizationnumb>020671</drugauthorizationnumb>
        <drugdosagetext>2.5MGM2 PER DAY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060501</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KALINOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SODIUM CHLORIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ELECTROLYTES</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052624-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060619</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR200604004320</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>64</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>64</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DERMATITIS PSORIASIFORM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOXIC SKIN ERUPTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EVISTA</medicinalproduct>
        <drugauthorizationnumb>20815</drugauthorizationnumb>
        <drugdosagetext>60 MG, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060515</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INDAPAMIDE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052628-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060705</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200612762GDS</companynumb>
    <primarysource>
      <reportercountry>VENEZUELA</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>80</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>50</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ARRHYTHMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSARTHRIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULAR WEAKNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STUPOR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</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>20060627</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052634-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060704</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200612822GDS</companynumb>
    <primarysource>
      <reportercountry>ITALY</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>60</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MOUTH HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH MORBILLIFORM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STOMATITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CIPROFLOXACIN</medicinalproduct>
        <drugauthorizationnumb>19537</drugauthorizationnumb>
        <drugdosagetext>500 MG, TOTAL DAILY, ORAL; 250 MG, TOTAL DAILY, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PYREXIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060529</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060603</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CIPROFLOXACIN</medicinalproduct>
        <drugauthorizationnumb>19537</drugauthorizationnumb>
        <drugdosagetext>500 MG, TOTAL DAILY, ORAL; 250 MG, TOTAL DAILY, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PYREXIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060628</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PARACETAMOLUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAALOX [ALUMINIUM HYDROXIDE, MAGNESIUM HYDROXIDE]</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ROCEPHIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ROCALTROL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAVOR [LORAZEPAM]</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052638-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060706</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200612874GDS</companynumb>
    <primarysource>
      <reportercountry>AUSTRIA</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>76</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>URTICARIA GENERALISED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VASCULITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXAVAR</medicinalproduct>
        <drugauthorizationnumb>21923</drugauthorizationnumb>
        <drugdosagetext>400-0-400 MG, BID, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RENAL CELL CARCINOMA STAGE UNSPECIFIED</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052641-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060626</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006EN000136</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>15</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ABELCET</medicinalproduct>
        <drugauthorizationnumb>50724</drugauthorizationnumb>
        <drugdosagetext>QD; IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MUCORMYCOSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052642-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060712</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>57</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>75.8</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TESTOSTERONE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052646-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060712</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>80</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>75.1</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TERAZOSIN HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TERAZOSIN HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PHENYTOIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOCUSATE/SENNOSIDES</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MILK OF MAGNESIA TAB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIDOCAINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIAZEPAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PHENOBARBITAL TAB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUTICASONE PROP</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LUBRICATING</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IPRATROPIUM BROMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUOXETINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL SPIROS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052649-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060712</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>39</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>129.7</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIDODERM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLOTRIMAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROXYZINE PAMOATE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052652-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060712</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>85</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>80.7</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN AND HYDROCODONE BITARTRATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ETODOLAC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BICALUTAMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LUBRICATING (PF) OPH OINT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYPROMELLOSE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052655-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060712</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>56</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>68</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXYCODONE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BETAMETHASONE DIPROPIONATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL SPIROS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TERAZOSIN HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENZONATATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MELOXICAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUNISOLIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IPRATROPIUM BROMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052658-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060712</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>75</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>77.1</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CIPROFLOXACIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HYDROCHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATORVASTATIN CALCIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NIACIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CITALOPRAM HYDROBROMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FISH OIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOCUSATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PSYLLIUM SF</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYBUTYNIN CHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUTICASONE PROP</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HEMORRHOIDAL RTL OINT</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052662-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060712</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>83</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>104.4</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HEPATIC ENZYME ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RIFAMPIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DICLOXACILLIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RIFAMPIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PAPAIN 830000U / UREA 10% (ACCUZYME) OINT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM CHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OLANZAPINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NITROGLYCERIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL SUCCINATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUOXETINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NITROGLYCERIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MILK OF MAGNESIA TAB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052664-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060706</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DK-KINGPHARMUSA00001-K200600884</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ACCIDENTAL EXPOSURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VASOCONSTRICTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EPIPEN</medicinalproduct>
        <drugbatchnumb>0000091053;92576;PCR60511B</drugbatchnumb>
        <drugauthorizationnumb>019430</drugauthorizationnumb>
        <drugdosagetext>.3 MG, SINGLE</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060511</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060511</drugenddate>
        <drugtreatmentduration>1440</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052665-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060712</receiptdate>
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    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>78</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>86</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLINDAMYCIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL SUCCINATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM / VITAMIN D</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM CHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OLANZAPINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL SUCCINATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IPRATROPIUM BROMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL SPIROS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TIMOLOL MALEATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM CHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORAZEPAM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052670-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060714</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>61</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>48</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE DIASTOLIC INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXALIPLATIN</medicinalproduct>
        <drugdosagetext>192 MG QD IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>SALIVARY GLAND CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060712</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CAPECITABINE</medicinalproduct>
        <drugdosagetext>1300 MG PO BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SALIVARY GLAND CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060713</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060726</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOFRAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHADONE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DILAUDID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALTRATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATIVAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COLACE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENOXAPARIN SODIUM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052672-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060714</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>96.4</patientweight>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVASTIN</medicinalproduct>
        <drugdosagetext>Q2 WEEKS IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>GLIOBLASTOMA MULTIFORME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060707</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052675-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060714</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>51</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>73.4827</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DIABETES MELLITUS INADEQUATE CONTROL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SENSORY DISTURBANCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOXYCYCLINE</medicinalproduct>
        <drugbatchnumb>61571A</drugbatchnumb>
        <drugdosagetext>100 MG CAP;  1 CAP PO BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SINUSITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060623</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060628</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HUMALOG</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052678-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060714</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>56</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>61.6892</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INADEQUATE ANALGESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THERAPEUTIC RESPONSE UNEXPECTED WITH DRUG SUBSTITUTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FENTANYL</medicinalproduct>
        <drugdosagetext>100 MG Q 2-3 DAY  TOPICAL</drugdosagetext>
        <drugadministrationroute>061</drugadministrationroute>
        <drugindication>BACK PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060501</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FENTANYL</medicinalproduct>
        <drugdosagetext>100 MG Q 2-3 DAY  TOPICAL</drugdosagetext>
        <drugadministrationroute>061</drugadministrationroute>
        <drugindication>INTERVERTEBRAL DISC DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060501</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052682-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060705</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2006US08591</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>66</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>81.632</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHILLS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISEASE RECURRENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATOCHEZIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUCOUS STOOLS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NORMOCHROMIC NORMOCYTIC ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RECTAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZELNORM</medicinalproduct>
        <drugauthorizationnumb>021200</drugauthorizationnumb>
        <drugdosagetext>6 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONSTIPATION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051210</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051208</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLIPIZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREVACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ELAVIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ESTRACE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TIAZAC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYLENOL (CAPLET)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL SPIROS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADVAIR DISKUS 100/50</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOTROL XL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VICODIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052683-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060706</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20060701151</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>77.11</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BREAST CANCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFUSION RELATED REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CROHN'S DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SULFASALAZINE</medicinalproduct>
        <drugindication>CROHN'S DISEASE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052684-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060706</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-JNJFOC-20060701753</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>77.7</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>TONGUE NEOPLASM MALIGNANT STAGE UNSPECIFIED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INFLIXIMAB, RECOMBINANT</medicinalproduct>
        <drugdosagetext>BLINDED DOSAGE OF 3, 6 OR 10 MG/KG</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INFLIXIMAB, RECOMBINANT</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INFLIXIMAB, RECOMBINANT</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INFLIXIMAB, RECOMBINANT</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RHEUMATREX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RHEUMATREX</medicinalproduct>
        <drugdosagetext>STARTED PRIOR TO 25-JAN-2006</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RHEUMATREX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIAMIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugdosagetext>INITIATED BEFORE 25-JAN-2006</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AZULFIDINE EN-TABS</medicinalproduct>
        <drugdosagetext>INITIATED BEFORE 25-JAN-2006</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOXONIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SELEBEX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTROINTESTINAL DISORDER THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACINON</medicinalproduct>
        <drugdosagetext>INITIATED BEFORE 25-JAN-2006</drugdosagetext>
        <drugindication>GASTROINTESTINAL DISORDER THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GASLON N</medicinalproduct>
        <drugdosagetext>INITIATED BEFORE 25-JAN-2006</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTROINTESTINAL DISORDER THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ISCONTIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANTIBIOTIC PROPHYLAXIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052685-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060714</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>80</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>91.8</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>RESPIRATION ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOSYN</medicinalproduct>
        <drugbatchnumb>LN053298</drugbatchnumb>
        <drugdosagetext>3.375 G/IV/X1</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PNEUMONIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060611</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052686-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060704</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHO2006BR11019</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>51</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>60</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZELMAC / HTF 919A</medicinalproduct>
        <drugauthorizationnumb>21200</drugauthorizationnumb>
        <drugdosagetext>3 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>IRRITABLE BOWEL SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060601</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZELMAC / HTF 919A</medicinalproduct>
        <drugbatchnumb>Z0026</drugbatchnumb>
        <drugauthorizationnumb>021200</drugauthorizationnumb>
        <drugdosagetext>6 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060601</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052687-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20051207</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2005US13300</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>41</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>111</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>DRUG HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EOSINOPHIL PERCENTAGE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JAUNDICE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER FUNCTION TEST ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OCULAR ICTERUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZELNORM</medicinalproduct>
        <drugauthorizationnumb>21200</drugauthorizationnumb>
        <drugdosagetext>6 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>IRRITABLE BOWEL SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051102</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051128</drugenddate>
        <drugtreatmentduration>38880</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052688-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060627</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHO2006GB10483</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>38</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>97.8</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABSCESS DRAINAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CELLULITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERIANAL ABSCESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TEGASEROD</medicinalproduct>
        <drugauthorizationnumb>21200</drugauthorizationnumb>
        <drugdosagetext>4MG DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>IRRITABLE BOWEL SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19991115</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020314</drugenddate>
        <drugtreatmentduration>851</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052689-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060710</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20060605623</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>CARDIAC ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYLENOL (CAPLET)</medicinalproduct>
        <drugauthorizationnumb>19872</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYLENOL (CAPLET)</medicinalproduct>
        <drugauthorizationnumb>019872</drugauthorizationnumb>
        <drugdosagetext>2600-2925 MG PER DAY FOR 1 WEEK</drugdosagetext>
        <drugindication>HEADACHE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052690-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060706</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20060701392</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>50</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>64.86</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOPAMAX</medicinalproduct>
        <drugauthorizationnumb>020505</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MIGRAINE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052691-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060706</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-JNJFOC-20050805469</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>30</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>VENTRICULAR EXTRASYSTOLES</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ITRACONAZOLE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ITRACONAZOLE</medicinalproduct>
        <drugauthorizationnumb>020083</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NAIL TINEA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052692-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060711</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FI-JNJFOC-20060702520</companynumb>
    <primarysource>
      <reportercountry>FINLAND</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>68</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>SUDDEN HEARING LOSS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOXORUBICIN HCL</medicinalproduct>
        <drugdosagetext>DOSE, FREQENCY UNSPECIFIED</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOXORUBICIN HCL</medicinalproduct>
        <drugdosagetext>DOSE, FREQENCY UNSPECIFIED</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOXORUBICIN HCL</medicinalproduct>
        <drugauthorizationnumb>050718</drugauthorizationnumb>
        <drugdosagetext>DOSE, FREQUENCY UNSPECIFIED</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>OVARIAN CANCER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052693-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060706</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20060701105</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>SACROILIITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CROHN'S DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FEMARA</medicinalproduct>
        <drugindication>BREAST CANCER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENTOCORT</medicinalproduct>
        <drugindication>CROHN'S DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XIFAXAN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052694-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060706</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20060701112</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>64</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>106.6</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MALIGNANT MELANOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROSTATE CANCER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052695-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060704</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2006BR09980</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>CARDIOMEGALY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EMBOLISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HALLUCINATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CODATEN</medicinalproduct>
        <drugauthorizationnumb>19201</drugauthorizationnumb>
        <drugdosagetext>100 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051114</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051114</drugenddate>
        <drugtreatmentduration>1440</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CODATEN</medicinalproduct>
        <drugauthorizationnumb>019201</drugauthorizationnumb>
        <drugdosagetext>1 TAB/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051115</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051115</drugenddate>
        <drugtreatmentduration>1440</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052696-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060517</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2006JP07531</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>66</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CREATININE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>C-REACTIVE PROTEIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATOCRIT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLAMMATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MONONEUROPATHY MULTIPLEX</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEPHRITIS INTERSTITIAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OCCULT BLOOD POSITIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROTEIN URINE PRESENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RED BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VASCULITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DICLOFENAC SODIUM</medicinalproduct>
        <drugauthorizationnumb>019201</drugauthorizationnumb>
        <drugindication>PYREXIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SULTAMICILLIN TOSILATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PYREXIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CEFTAZIDIME</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PYREXIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOXOPROFEN SODIUM</medicinalproduct>
        <drugindication>PYREXIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOXAZOSIN MESYLATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugdosagetext>30 MG/DAY</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040301</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052697-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060712</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>7</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>APLASTIC ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENE MUTATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IDIOPATHIC THROMBOCYTOPENIC PURPURA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RED BLOOD CELL ABNORMALITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RITALIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052699-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060703</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2006US09903</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>53</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BASAL CELL CARCINOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GRAFT VERSUS HOST DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALIGNANT MELANOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN NEOPLASM EXCISION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOSPORINE</medicinalproduct>
        <drugdosagetext>3 MG/KG/D</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>STEM CELL TRANSPLANT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOSPORINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISONE (NGX)</medicinalproduct>
        <drugindication>STEM CELL TRANSPLANT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
        <drugauthorizationnumb>080399</drugauthorizationnumb>
        <drugindication>STEM CELL TRANSPLANT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MYCOPHENOLATE MOFETIL</medicinalproduct>
        <drugindication>STEM CELL TRANSPLANT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYCLOPHOSPHAMIDE</medicinalproduct>
        <drugdosagetext>120 MG/KG/D</drugdosagetext>
        <drugindication>STEM CELL TRANSPLANT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUDARABINE</medicinalproduct>
        <drugdosagetext>125 MG/M2</drugdosagetext>
        <drugindication>STEM CELL TRANSPLANT</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052701-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060714</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERECTILE DYSFUNCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRAZODONE HCL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052703-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060707</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-06P-163-0337707-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>20</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>29.873</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>APNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCOHERENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREATMENT NONCOMPLIANCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VICODIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>088058</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>TOOTH EXTRACTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060614</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060614</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NICOTINE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>EX-SMOKER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060614</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060614</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052704-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060526</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-ABBOTT-06P-167-0334625-00</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>68</patientweight>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ARTERIOSCLEROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRAIN STEM SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL ISCHAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050715</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060115</drugenddate>
        <drugtreatmentduration>184</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENDROFLUMETHIAZIDE</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>IRBESARTAN</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ROFECOXIB</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052705-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060517</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-ABBOTT-06P-062-0333436-00</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ASPARTATE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CREATINE PHOSPHOKINASE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ERGENYL CHRONO TABLETS</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>18081</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOAFFECTIVE DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>QUETIAPINE FUMARATE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052706-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060608</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-ABBOTT-06P-020-0335590-00</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>60</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>CEREBRAL ISCHAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EAR INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MASTOIDITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENINGOENCEPHALITIS BACTERIAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CORTICOID</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052707-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060608</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-ABBOTT-06P-020-0335594-00</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HEPATITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KALETRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>21226</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMIVUDINE</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>STAVUDINE</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EFAVIRENZ</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LAMIVUDINE + ZIDOVUDINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052708-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060706</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20060701080</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>26</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PREMATURE LABOUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PREMATURE SEPARATION OF PLACENTA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugbatchnumb>5LMU4011P1;5KM42011P1</drugbatchnumb>
        <drugadministrationroute>050</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugbatchnumb>5LMU4011P1;5KM42011P1</drugbatchnumb>
        <drugadministrationroute>050</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugbatchnumb>5LMU4011P1;5KM42011P1</drugbatchnumb>
        <drugadministrationroute>050</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugbatchnumb>5LMU4011P1;5KM42011P1</drugbatchnumb>
        <drugdosagetext>5MG/KG TOTAL OF SIX DOSES 07-JAN-05 THROUGH 14-NOV-05</drugdosagetext>
        <drugadministrationroute>050</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugbatchnumb>5LMU4011P1;5KM42011P1</drugbatchnumb>
        <drugdosagetext>5 MG/KG TOTAL OF SIX DOSES 23-JAN-04 THROUGH 05-NOV-04</drugdosagetext>
        <drugadministrationroute>050</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugbatchnumb>5LMU4011P1;5KM42011P1</drugbatchnumb>
        <drugdosagetext>5MG/KG 12-DEC-03 AND 26-DEC-03</drugdosagetext>
        <drugadministrationroute>050</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugbatchnumb>5LMU4011P1;5KM42011P1</drugbatchnumb>
        <drugdosagetext>5 MG/KG RECEIVED FOUR DOSES 04-SEP-02 THROUGH 13-DEC-02</drugdosagetext>
        <drugadministrationroute>050</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugbatchnumb>5LMU4011P1;5KM42011P1</drugbatchnumb>
        <drugdosagetext>UNKNOWN NUMBER OF INFUSIONS IN YEAR PRIOR TO BASELINE</drugdosagetext>
        <drugadministrationroute>050</drugadministrationroute>
        <drugindication>TRANSMISSION OF DRUG VIA SEMEN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
        <drugindication>PREMEDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTIHISTAMINES</medicinalproduct>
        <drugindication>PREMEDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>STEROIDS</medicinalproduct>
        <drugindication>PREMEDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052710-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060714</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>100.9</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAXOL</medicinalproduct>
        <drugdosagetext>150 MG</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATIVAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARDIZEM CD</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE TAB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PHENERGAN HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREVACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPROL-XL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052716-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060714</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>91.3</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BACTERAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSED LEVEL OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPTIC SHOCK</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GEMCITABINE HYDROCHLORIDE</medicinalproduct>
        <drugdosagetext>3150 MG</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060707</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052719-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060714</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>135</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>AIR EMBOLISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHILLS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROCEDURAL COMPLICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CISPLATIN</medicinalproduct>
        <drugdosagetext>100 MG</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAXOL</medicinalproduct>
        <drugdosagetext>270 MG</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052723-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060712</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0607USA02317</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLINDNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE IRRITATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COSOPT</medicinalproduct>
        <drugauthorizationnumb>020869</drugauthorizationnumb>
        <drugadministrationroute>047</drugadministrationroute>
        <drugindication>GLAUCOMA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052724-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060601</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-MERCK-0606USA00795</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>62</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHABDOMYOLYSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugauthorizationnumb>19766</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERLIPIDAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060404</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060412</drugenddate>
        <drugtreatmentduration>9</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NARCARICIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERURICAEMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TANATRIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>JUVELA N</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERLIPIDAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060413</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052725-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060208</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-MERCK-0602GBR00063</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>80</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>75</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugauthorizationnumb>19766</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERCHOLESTEROLAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19890101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20000201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugauthorizationnumb>019766</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugauthorizationnumb>019766</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugauthorizationnumb>019766</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050901</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIPYRIDAMOLE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CEREBROVASCULAR ACCIDENT PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010523</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010531</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>ASPIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CEREBROVASCULAR ACCIDENT PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052726-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060608</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0606USA01656</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>40</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>155</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE CONGESTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</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>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULAR WEAKNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL STIFFNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HYZAAR</medicinalproduct>
        <drugbatchnumb>R6187</drugbatchnumb>
        <drugauthorizationnumb>020387</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060504</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060605</drugenddate>
        <drugtreatmentduration>33</drugtreatmentduration>
        <drugtreatmentdurationunit></drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLEXERIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MYALGIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050901</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RELAFEN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLEGRA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERSENSITIVITY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052727-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060630</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BE-MERCK-0607BEL00004</companynumb>
    <primarysource>
      <reportercountry>BELGIUM</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>33</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>77</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULAR WEAKNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NERVOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSYCHOMOTOR HYPERACTIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SINGULAIR</medicinalproduct>
        <drugauthorizationnumb>020829</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060629</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060629</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SINGULAIR</medicinalproduct>
        <drugauthorizationnumb>020829</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BRONCHITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060629</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060629</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CETIRIZINE HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SEASONAL ALLERGY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052728-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060711</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0607USA01764</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ARRHYTHMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HYZAAR</medicinalproduct>
        <drugauthorizationnumb>20387</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SOTALOL HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM (UNSPECIFIED)</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052729-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AT-ROCHE-433466</companynumb>
    <primarysource>
      <reportercountry>AUSTRIA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>34</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>65</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>RENAL TRANSPLANT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRANSPLANT REJECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEG-INTERFERON ALFA 2A (RO 25-8310)</medicinalproduct>
        <drugdosagetext>FORMULATION REPORTED AS SYRINGE. DATE OF LAST DOSE PRIOR TO SAE WAS 28 DEC 2005</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050914</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060104</drugenddate>
        <drugtreatmentduration>113</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEG-INTERFERON ALFA 2A (RO 25-8310)</medicinalproduct>
        <drugdosagetext>FORMULATION REPORTED AS SYRINGE. PATIENT REPORTED AS A NON-RESPONDER IN WEEK 24.</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060118</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RIBAVIRIN</medicinalproduct>
        <drugauthorizationnumb>021511</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALUMINUM HYDROXIDE GEL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANCREATIN TRIPLE STRENGTH CAP</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SEVELAMER HYDROCHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOW MOLECULAR WEIGHT HEPARINS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EPOGEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GANCICLOVIR</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060607</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MYCOPHENOLATE MOFETIL</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060607</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCITRIOL</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060607</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ESOMEPRAZOLE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SULFAMETHOXAZOLE + TRIMETHOPRIM</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060607</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NADROPARIN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060607</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARVEDILOL</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060601</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052730-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>NL-ROCHE-430293</companynumb>
    <primarysource>
      <reportercountry>NETHERLANDS</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>70</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERCALCAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CAPECITABINE</medicinalproduct>
        <drugauthorizationnumb>20896</drugauthorizationnumb>
        <drugdosagetext>GIVEN FROM DAYS ONE TO FOURTEEN OF A THREE WEEK CYCLE.</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVASTIN</medicinalproduct>
        <drugauthorizationnumb>020896</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXALIPLATIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRIMPERAN TAB</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052731-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-384417</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>28</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>66.2</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANGINA PECTORIS</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>BLOOD CHOLESTEROL INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD TRIGLYCERIDES INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC MURMUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CLOSTRIDIAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLITIS ULCERATIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EAR OPERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FOREIGN BODY IN EYE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROOESOPHAGEAL REFLUX DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATOCRIT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHOIDS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLAMMATORY BOWEL DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INGROWING NAIL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERNAL INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIGAMENT RUPTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIP DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MELANOCYTIC NAEVUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOFASCITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NASAL OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NECK INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NECK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANIC ATTACK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PECTUS EXCAVATUM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLEURISY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POLYTRAUMATISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSEUDOMEMBRANOUS COLITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RECTAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>REFUSAL OF TREATMENT BY PATIENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ROAD TRAFFIC ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ROTATOR CUFF SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STRESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUPERFICIAL INJURY OF EYE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TENDON INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TENDONITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UMBILICAL HERNIA REPAIR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>18662</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ACNE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19940516</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19941213</drugenddate>
        <drugtreatmentduration>212</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>018662</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19960708</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19960907</drugenddate>
        <drugtreatmentduration>62</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052733-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060714</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>81</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATOCRIT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOPHOSPHAMIDE</medicinalproduct>
        <drugdosagetext>1760 MG</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060622</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYTARABINE</medicinalproduct>
        <drugdosagetext>10560 MG</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060624</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>G-CSF (FILGRASTIM, AMGEN)</medicinalproduct>
        <drugdosagetext>4800 MG</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060704</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052736-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060713</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>77</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG TOXICITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUOROURACIL</medicinalproduct>
        <drugdosagetext>10200 MG</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEVACIZUMAB (RHUMAB VEGF)</medicinalproduct>
        <drugdosagetext>780 MG</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060530</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEUCOVORIN CALCIUM</medicinalproduct>
        <drugdosagetext>1560 MG</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060530</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ELOXATIN</medicinalproduct>
        <drugdosagetext>310 MG</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060530</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052737-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-412370</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>20</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>68</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>AFFECTIVE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAL FISSURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD ALKALINE PHOSPHATASE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRONCHITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CANDIDIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLITIS ULCERATIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRY THROAT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPHORIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ECZEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FRUSTRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHOIDS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC ENZYME INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLAMMATORY BOWEL DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IRON DEFICIENCY ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IRRITABLE BOWEL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG NEOPLASM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MICROCYTIC ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTI-ORGAN DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NASAL CONGESTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NECK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PILONIDAL CYST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POSTNASAL DRIP</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTHAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>18662</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ACNE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990715</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19990915</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052738-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050621</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-408637</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>21</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>99.8</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANHEDONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASCITES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CLOSTRIDIAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLITIS ULCERATIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DECREASED APPETITE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG LEVEL BELOW THERAPEUTIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRY SKIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLATULENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROOESOPHAGEAL REFLUX DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GIARDIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHOIDS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HUNGER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOALBUMINAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLAMMATORY BOWEL DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IRON DEFICIENCY ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IRRITABLE BOWEL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPHOCYTE COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAPILLOEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROCTITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSEUDOPOLYP</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RADIUS FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RECTAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RETINAL DEGENERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ROAD TRAFFIC ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEASONAL ALLERGY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUS HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THERAPY NON-RESPONDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ULNA FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UPPER RESPIRATORY TRACT INFECTION</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>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>18662</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ACNE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19950130</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19950615</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>018662</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980915</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19981115</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>018662</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980831</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19981215</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>018662</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19981215</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19990104</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>018662</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990104</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19990215</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052739-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041215</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ROCHE-389475</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>64</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEG-INTERFERON A-2A (RO 25-8310)</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040920</drugenddate>
        <drugtreatmentduration>204</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RIBAVIRIN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020312</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040826</drugenddate>
        <drugtreatmentduration>899</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052740-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050224</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-396709</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>19</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>54.4</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABORTION SPONTANEOUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ACNE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANHEDONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BILIARY DILATATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CHOLESTEROL INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CELLULITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLITIS</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>DRUG HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRY SKIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSMENORRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EAR PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EATING DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EMOTIONAL DISTRESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYSIPELAS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FACIAL BONES FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRIC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL STOMA COMPLICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROOESOPHAGEAL REFLUX DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGIC OVARIAN CYST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLAMMATORY BOWEL DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTESTINAL OBSTRUCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IRRITABLE BOWEL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIP DRY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MAJOR DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOOD ALTERED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTI-ORGAN DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEPHROLITHIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA MOUTH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVARIAN CYST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POUCHITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROCTITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RECTAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SCOLIOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUS DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPLENIC CYST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STRESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTH ABSCESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UPPER RESPIRATORY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UTERINE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VAGINITIS BACTERIAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VICTIM OF ABUSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>18662</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ACNE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990730</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19990915</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>018662</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19991029</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20000526</drugenddate>
        <drugtreatmentduration>211</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052741-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060619</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GILEAD-2006-0009758</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>46.308</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ABDOMINAL DISTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERAL PHYSICAL HEALTH DETERIORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LACTIC ACIDOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRUVADA</medicinalproduct>
        <drugauthorizationnumb>021752</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060119</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060616</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REYATAZ</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060119</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060616</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVIR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060119</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060616</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BACTRIM DS</medicinalproduct>
        <drugindication>ANTIBIOTIC PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060119</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZITHROMAX</medicinalproduct>
        <drugindication>MYCOBACTERIUM AVIUM COMPLEX INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060119</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ETHAMBUTOL HCL</medicinalproduct>
        <drugindication>MYCOBACTERIUM AVIUM COMPLEX INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060215</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060617</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BIAXIN</medicinalproduct>
        <drugindication>MYCOBACTERIUM AVIUM COMPLEX INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060307</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052742-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060113</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-432352</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>17</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>72.6</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>APPENDICITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CHOLESTEROL ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHAPPED LIPS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEILITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CROHN'S DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CRYING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE BEFORE PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROENTERITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHOIDS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ILEAL STENOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLAMMATORY BOWEL DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IRON DEFICIENCY ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IRRITABLE BOWEL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JOINT STIFFNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENTAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOOD SWINGS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL STIFFNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVARIAN CYST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEROSITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SMALL INTESTINAL OBSTRUCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>XEROSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>18662</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ACNE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980925</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19990316</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>018662</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990316</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19990405</drugenddate>
        <drugtreatmentduration>21</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ORTHO TRI-CYCLEN</medicinalproduct>
        <drugdosagetext>FREQUENCY REPORTED AS DAILY.</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19981015</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052743-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050812</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-414262</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>17</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>45.8</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANKYLOSING SPONDYLITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANOREXIA</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>BACTERIURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CHOLESTEROL INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD URINE PRESENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRACHIAL PLEXOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BUNION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CERVICITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CERVICITIS HUMAN PAPILLOMA VIRUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEILITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLITIS ULCERATIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DACRYOSTENOSIS ACQUIRED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRY SKIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE IRRITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FUNGAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROOESOPHAGEAL REFLUX DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHOIDS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERMOBILITY SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERVERTEBRAL DISC DEGENERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTI-ORGAN DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NECK INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POUCHITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROCEDURAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYLORIC STENOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYLOROSPASM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RADICULOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RECTAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ROAD TRAFFIC ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SCOLIOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPONDYLOARTHROPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STRESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE VASOVAGAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINE LEUKOCYTE ESTERASE POSITIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>18662</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ACNE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980713</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19990126</drugenddate>
        <drugtreatmentduration>198</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>018662</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000519</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20000622</drugenddate>
        <drugtreatmentduration>35</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>018662</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010523</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BACTRIM DS</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SINUSITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19981124</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DRYSOL</medicinalproduct>
        <drugindication>HYPERHIDROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980713</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052744-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050621</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-408667</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>22</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>64.9</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABORTION SPONTANEOUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ADHESION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANHEDONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANOREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLINDNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BREAST DISCHARGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CANDIDIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHRONIC FATIGUE SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLITIS ULCERATIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DERMATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRY SKIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ECZEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ENDOMETRIOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALLOPIAN TUBE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FIBROCYSTIC BREAST DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FUNGAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GALACTORRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROOESOPHAGEAL REFLUX DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATEMESIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHOIDS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HELICOBACTER INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYDRONEPHROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCISION SITE COMPLICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLAMMATORY BOWEL DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IRRITABLE BOWEL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIP DRY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENORRHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METRORRHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NERVOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PELVIC INFLAMMATORY DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PELVIC PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PEPTIC ULCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POLLAKIURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RECTAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RETCHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEDATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPINAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THIRST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UMBILICAL HERNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UPPER RESPIRATORY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URGE INCONTINENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINE ODOUR ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UTERINE LEIOMYOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UTERINE PROLAPSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VAGINAL BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VAGINAL DISCHARGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>18662</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19920708</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19921115</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>018662</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000126</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20000622</drugenddate>
        <drugtreatmentduration>149</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BIRTH CONTROL PILLS</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ORAL CONTRACEPTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ORTHO TRI-CYCLEN</medicinalproduct>
        <drugindication>CONTRACEPTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19991012</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PHENERGAN HCL</medicinalproduct>
        <drugdosagetext>TAKEN EVERY 4-6 HOURS PRN.</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19991012</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYLENOL (CAPLET)</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000107</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZANTAC</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000107</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052745-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060711</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PL-MERCK-0607POL00006</companynumb>
    <primarysource>
      <reportercountry>POLAND</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>56</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SINGULAIR</medicinalproduct>
        <drugauthorizationnumb>020829</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060501</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SALMETEROL XINAFOATE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060501</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUTICASONE PROPIONATE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060501</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052746-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060706</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-MERCK-0607CAN00031</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>70</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHABDOMYOLYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZETIA</medicinalproduct>
        <drugauthorizationnumb>21445</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060401</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZETIA</medicinalproduct>
        <drugauthorizationnumb>021445</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ROSUVASTATIN CALCIUM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060401</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ROSUVASTATIN CALCIUM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050701</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALSARTAN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIMENHYDRINATE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN AND CAFFEINE, CITRATED AND CODEINE PHOSPHATE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>MYALGIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN AND CAFFEINE, CITRATED AND CODEINE PHOSPHATE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052747-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060613</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ROCHE-451993</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>71</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>51</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ANOREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASCITES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISSEMINATED INTRAVASCULAR COAGULATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATITIS FULMINANT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPHOCYTE STIMULATION TEST POSITIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTI-ORGAN FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OLIGURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY ARREST</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAMIFLU</medicinalproduct>
        <drugauthorizationnumb>21087</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060219</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060220</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980717</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060220</drugenddate>
        <drugtreatmentduration>2776</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NITOROL R</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980717</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060220</drugenddate>
        <drugtreatmentduration>2776</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLETAL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980717</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060220</drugenddate>
        <drugtreatmentduration>2776</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KINEDAK</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040607</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060220</drugenddate>
        <drugtreatmentduration>624</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HALCION</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990625</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060220</drugenddate>
        <drugtreatmentduration>2433</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052748-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060706</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20060701060</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>5</patientonsetage>
      <patientonsetageunit>800</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MYCOSIS FUNGOIDES</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugindication>PSORIATIC ARTHROPATHY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052749-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060706</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-ROCHE-454213</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>40</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>86</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ERYTHEMA MULTIFORME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CEFTRIAXONE SODIUM</medicinalproduct>
        <drugauthorizationnumb>050585</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060308</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060310</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052750-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060530</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-ROCHE-450157</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>43</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>90</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERICARDITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUS TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUPRAVENTRICULAR EXTRASYSTOLES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENTRICULAR EXTRASYSTOLES</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LARIAM</medicinalproduct>
        <drugauthorizationnumb>19591</drugauthorizationnumb>
        <drugdosagetext>REPORTED AS 250 MG AS TOTAL.</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060403</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060403</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MEDIATOR 150</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OVERWEIGHT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040415</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060410</drugenddate>
        <drugtreatmentduration>726</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HAVRIX</medicinalproduct>
        <drugdosagetext>FORM: INJECTABLE SOLUTION.</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060403</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060403</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RABIPUR</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060404</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060404</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052751-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060713</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>88</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CAECITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COAGULOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GRAND MAL CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCREATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUPERIOR SAGITTAL SINUS THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRANSVERSE SINUS THROMBOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEG-L-ASPARAGINASE (K-H)</medicinalproduct>
        <drugdosagetext>5140 IU</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052752-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0430084A</companynumb>
    <primarysource>
      <reportercountry>SPAIN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>23</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANGIONEUROTIC OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RADIOALLERGOSORBENT TEST POSITIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH MACULO-PAPULAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN TEST POSITIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AUGMENTIN '125'</medicinalproduct>
        <drugauthorizationnumb>50564</drugauthorizationnumb>
        <drugdosagetext>500 MG / SINGLE DOSE / ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052754-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060524</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-ROCHE-449702</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>69</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>64</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANGIONEUROTIC OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XENICAL</medicinalproduct>
        <drugauthorizationnumb>20766</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDIATOR 150</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MIANSERINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>REPORTED AS KARDEGIC 75.</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRIATEC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CODOLIPRANE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugdosagetext>REPORTED AS OMEPRAZOLE 20.</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052755-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060208</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ROCHE-435209</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>81</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANAPHYLACTOID SHOCK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOXIC ENCEPHALOPATHY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ANEXATE TAB</medicinalproduct>
        <drugauthorizationnumb>20073</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020115</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020115</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052756-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060706</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-ROCHE-454216</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>66</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ANAPHYLACTIC REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANGIONEUROTIC OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWOLLEN TONGUE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CEFTRIAXONE SODIUM</medicinalproduct>
        <drugauthorizationnumb>050585</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060327</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060327</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052757-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060415</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-ROCHE-445280</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>22</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAROXYSMAL NOCTURNAL HAEMOGLOBINURIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>18662</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>ACNE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050615</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052758-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060303</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IE-ROCHE-438894</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>21</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>79.9</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BUDD-CHIARI SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC VEIN THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAROXYSMAL NOCTURNAL HAEMOGLOBINURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PORTAL VEIN THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL VEIN THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENA CAVA THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>18662</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ACNE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040815</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050215</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052759-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060703</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>HK-ROCHE-453789</companynumb>
    <primarysource>
      <reportercountry>HONG KONG</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>41</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>68</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD CREATININE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CAPECITABINE</medicinalproduct>
        <drugbatchnumb>47126</drugbatchnumb>
        <drugauthorizationnumb>20896</drugauthorizationnumb>
        <drugdosagetext>ADMINSTERED ON DAYS 1-14 OF 21 DAY CYCLE.</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060516</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060627</drugenddate>
        <drugtreatmentduration>43</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVASTIN</medicinalproduct>
        <drugbatchnumb>B1837</drugbatchnumb>
        <drugauthorizationnumb>020896</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060516</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060627</drugenddate>
        <drugtreatmentduration>43</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LAMIVUDINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIROLIMUS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM CHLORIDE</medicinalproduct>
        <drugdosagetext>DRUG REPORTED AS ^POTASSIUM CHLORIDE SR^.</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADEFOVIR DIPIVOXIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NIFEDIPINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PYRIDOXINE HCL</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060517</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOCLOPRAMIDE HCL</medicinalproduct>
        <drugdosagetext>UP TO THREE TIMES DAILY.</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060606</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052760-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060410</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-444043</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>68</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GRAND MAL CONVULSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XELODA</medicinalproduct>
        <drugauthorizationnumb>20896</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060406</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060409</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XELODA</medicinalproduct>
        <drugauthorizationnumb>020896</drugauthorizationnumb>
        <drugdosagetext>REINTRODUCED.</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052761-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060517</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-448694</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>65</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ALOPECIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSGRAPHIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RECTAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEGASYS</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060303</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060310</drugenddate>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEGASYS</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060312</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COPEGUS</medicinalproduct>
        <drugauthorizationnumb>021511</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060303</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060310</drugenddate>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COPEGUS</medicinalproduct>
        <drugauthorizationnumb>021511</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060312</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052762-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060509</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-447406</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>53</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>PNEUMOCOCCAL SEPSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPTIC SHOCK</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEGASYS</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060326</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COPEGUS</medicinalproduct>
        <drugauthorizationnumb>021511</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060326</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052763-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060522</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ES-ROCHE-449070</companynumb>
    <primarysource>
      <reportercountry>SPAIN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>38</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HYPERSOMNIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INVIRASE</medicinalproduct>
        <drugauthorizationnumb>20628</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060212</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052764-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060630</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0428158A</companynumb>
    <primarysource>
      <reportercountry>KOREA, REPUBLIC OF</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>29</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH ERYTHEMATOUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH MACULAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMICTAL</medicinalproduct>
        <drugauthorizationnumb>20241</drugauthorizationnumb>
        <drugindication>EPILEPSY</drugindication>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEPAKINE CHRONO (DEPAKINE CHRONO)</medicinalproduct>
        <drugdosagetext>YEARS</drugdosagetext>
        <drugindication>EPILEPSY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052765-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0430086A</companynumb>
    <primarysource>
      <reportercountry>SPAIN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>21</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PRURITUS GENERALISED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN TEST POSITIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URTICARIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMOXIL</medicinalproduct>
        <drugauthorizationnumb>50542</drugauthorizationnumb>
        <drugdosagetext>500 MG / SINGLE DOSE / ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052766-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060704</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ROCHE-453977</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>12</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>CARDIO-RESPIRATORY ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOWER LIMB FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PELVIC FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SELF-MEDICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UPPER LIMB FRACTURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAMIFLU</medicinalproduct>
        <drugauthorizationnumb>021087</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060703</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060703</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALONAL</medicinalproduct>
        <drugdosagetext>FORMULATION: ORAL FORMULATION (NOT OTHERWISE SPECIFIED).</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060703</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060703</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052767-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ROCHE-453545</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>68</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>GRANULOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PANALDINE</medicinalproduct>
        <drugauthorizationnumb>19979</drugauthorizationnumb>
        <drugdosagetext>ADDITIONAL INDICATION: STENT PLACEMENT, ACUTE MYOCARDIAL INFARCTION</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>THROMBOSIS PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060513</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060609</drugenddate>
        <drugtreatmentduration>28</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060513</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GASTER</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060513</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060609</drugenddate>
        <drugtreatmentduration>28</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CERCINE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060512</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060609</drugenddate>
        <drugtreatmentduration>29</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYTOTEC</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060514</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOXONIN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060514</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060517</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALDACTONE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060517</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SLOW-K</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060517</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060620</drugenddate>
        <drugtreatmentduration>35</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MICARDIS</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060518</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060604</drugenddate>
        <drugtreatmentduration>18</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BISOLVON</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060518</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060523</drugenddate>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VENETLIN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060518</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060519</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RHYTHMY</medicinalproduct>
        <drugdosagetext>TAKEN PRN</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060518</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
        <drugdosagetext>TAKEN PRN</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060514</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HALCION</medicinalproduct>
        <drugdosagetext>TAKEN AS PRN.</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060522</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060609</drugenddate>
        <drugtreatmentduration>19</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060523</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060609</drugenddate>
        <drugtreatmentduration>18</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMARYL</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060527</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060609</drugenddate>
        <drugtreatmentduration>14</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGNESIUM OXIDE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060513</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060529</drugenddate>
        <drugtreatmentduration>17</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GRAMALIL</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060513</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060529</drugenddate>
        <drugtreatmentduration>17</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060513</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060529</drugenddate>
        <drugtreatmentduration>17</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SOLITA</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060513</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060525</drugenddate>
        <drugtreatmentduration>13</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HEPARIN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060513</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060525</drugenddate>
        <drugtreatmentduration>13</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIGMART</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060513</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060516</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SODIUM CHLORIDE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060513</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060521</drugenddate>
        <drugtreatmentduration>9</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CEFAMEZIN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060513</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060513</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOSE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060513</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060523</drugenddate>
        <drugtreatmentduration>11</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMEDIN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060513</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060516</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VISCORIN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060513</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060513</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUMIN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060415</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060516</drugenddate>
        <drugtreatmentduration>32</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INOVAN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060514</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060516</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEROPEN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060514</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060523</drugenddate>
        <drugtreatmentduration>10</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VENOGLOBULIN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060515</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060517</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SOLU-MEDROL</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060515</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060517</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>1 CONCOMITANT DRUG</medicinalproduct>
        <drugdosagetext>DOPUTAMIN (DOBUTAMINE HYDROCHLORIDE).  600MCG/200ML</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060515</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060519</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ELASPOL</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060516</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060521</drugenddate>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLINDAMYCIN HCL</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060519</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060523</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052768-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060707</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IT-ROCHE-454325</companynumb>
    <primarysource>
      <reportercountry>ITALY</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>88</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRIC ULCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATEMESIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KETOROLAC TROMETHAMINE</medicinalproduct>
        <drugauthorizationnumb>19645</drugauthorizationnumb>
        <drugdosagetext>AS NEEDED</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060614</drugenddate>
        <drugtreatmentduration>14</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FRAXIPARINA</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>THROMBOSIS PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060614</drugenddate>
        <drugtreatmentduration>14</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NAPRILENE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIVASTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UROTRACTIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052769-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060707</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CH-ROCHE-454504</companynumb>
    <primarysource>
      <reportercountry>SWITZERLAND</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>73</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>80.5</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>AGITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</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>DRUG TOXICITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HALLUCINATION, VISUAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCLONUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCREATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPTIC SHOCK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TORSEMIDE</medicinalproduct>
        <drugauthorizationnumb>20136</drugauthorizationnumb>
        <drugdosagetext>INDICATION AS REPORTED: HYPERTENSIVE HEART DISEASE WITH (CONGESTIVE) HEART FAILURE.</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSIVE HEART DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060321</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060330</drugenddate>
        <drugtreatmentduration>10</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>FOSITENS</medicinalproduct>
        <drugdosagetext>INDICATION REPORTED AS HYPERTENSIVE HEART DISEASE WITH (CONGESTIVE) HEART FAILURE.</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSIVE HEART DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060316</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060331</drugenddate>
        <drugtreatmentduration>16</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>ALDOZONE FORTE</medicinalproduct>
        <drugdosagetext>INDICATION REPORTED AS HYPERTENSION HEART DISEASE WITH (CONGESTIVE) HEART FAILURE. STRENGTH REPORTE+</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSIVE HEART DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060316</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060321</drugenddate>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
        <drugdosagetext>INDICATION REPORTED AS HYPERTENSIVE HEART DISEASE WITH (CONGESTIVE) HEART FAILURE.</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSIVE HEART DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060316</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060330</drugenddate>
        <drugtreatmentduration>15</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
        <drugdosagetext>DOSAGE REGIMEN WAS CHANGED TO EVERY OTHER DAY.</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060330</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060331</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>COAPROVEL 150 MG/12.5 MG COMPRIMES</medicinalproduct>
        <drugdosagetext>INDICATION REPORTED AS HYPERTENSIVE HEART DISEASE WITH (CONGESTIVE) HEART FAILURE. STRENGTH REPORTE+</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSIVE HEART DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060316</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060330</drugenddate>
        <drugtreatmentduration>15</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>COAPROVEL 150 MG/12.5 MG COMPRIMES</medicinalproduct>
        <drugdosagetext>DOSAGE REGIMEN WAS CHANGED TO EVERY OTHER DAY.</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060330</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060331</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MS CONTIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060330</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060331</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VIBRAMYCIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060316</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060321</drugenddate>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZINAT</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060321</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052770-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060706</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-ROCHE-454656</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>38</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOCALCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHABDOMYOLYSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEGASYS</medicinalproduct>
        <drugdosagetext>DOSE FORM: PRE-FILLED SYRINGE</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051018</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060318</drugenddate>
        <drugtreatmentduration>152</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COPEGUS</medicinalproduct>
        <drugauthorizationnumb>021511</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051018</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060318</drugenddate>
        <drugtreatmentduration>152</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHADONE HCL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG DETOXIFICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052771-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060706</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-454539</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NO ADVERSE EFFECT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NORMAL NEWBORN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>018662</drugauthorizationnumb>
        <drugindication>ACNE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19940713</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>018662</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>018662</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19940824</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19950615</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>018662</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19870615</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052772-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060706</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20060701041</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DOUBLE STRANDED DNA ANTIBODY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUPUS-LIKE SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052773-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060706</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20060701075</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>70.31</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BASAL CELL CARCINOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SQUAMOUS CELL CARCINOMA OF SKIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugbatchnumb>SJM59011P1</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugbatchnumb>SJM59011P1</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugbatchnumb>SJM59011P1</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugbatchnumb>SJM59011P1</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugbatchnumb>SJM59011P1</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugbatchnumb>SJM59011P1</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugbatchnumb>SJM59011P1</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugbatchnumb>SJM59011P1</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugbatchnumb>SJM59011P1</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugbatchnumb>SJM59011P1</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugbatchnumb>SJM59011P1</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugbatchnumb>SJM59011P1</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugbatchnumb>SJM59011P1</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugbatchnumb>SJM59011P1</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugbatchnumb>SJM59011P1</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugbatchnumb>SJM59011P1</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugbatchnumb>SJM59011P1</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugbatchnumb>SJM59011P1</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugbatchnumb>SJM59011P1</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugbatchnumb>SJM59011P1</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugbatchnumb>SJM59011P1</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugbatchnumb>SJM59011P1</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugbatchnumb>SJM59011P1</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugbatchnumb>SJM59011P1</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugbatchnumb>SJM59011P1</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugbatchnumb>SJM59011P1</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugbatchnumb>SJM59011P1</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugbatchnumb>SJM59011P1</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugbatchnumb>SJM59011P1</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugbatchnumb>SJM59011P1</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugbatchnumb>SJM59011P1</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugbatchnumb>SJM59011P1</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugbatchnumb>SJM59011P1</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugbatchnumb>SJM59011P1</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugbatchnumb>SJM59011P1</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugbatchnumb>SJM59011P1</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugbatchnumb>SJM59011P1</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugbatchnumb>SJM59011P1</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugbatchnumb>SJM59011P1</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugbatchnumb>SJM59011P1</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugbatchnumb>SJM59011P1</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugbatchnumb>SJM59011P1</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugbatchnumb>SJM59011P1</drugbatchnumb>
        <drugdosagetext>7 INFUSIONS ON UNSPECIFIED DATES PRIOR TO BASELINE</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CROHN'S DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugindication>CROHN'S DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MESALAMINE</medicinalproduct>
        <drugindication>CROHN'S DISEASE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052774-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060711</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2006TW10296</companynumb>
    <primarysource>
      <reportercountry>TAIWAN, PROVINCE OF CHINA</reportercountry>
      <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>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GLEEVEC</medicinalproduct>
        <drugauthorizationnumb>021588</drugauthorizationnumb>
        <drugdosagetext>400 MG/D</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060128</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060623</drugenddate>
        <drugtreatmentduration>147</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052775-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060712</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>50</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>64.5</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HYPERKALAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugdosagetext>80MG, 40MG BID, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060508</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060613</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052776-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060712</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>84</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>68</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ATRIOVENTRICULAR BLOCK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRADYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZIPRASIDONE HCL</medicinalproduct>
        <drugdosagetext>160MG,  80MG BID,  ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060109</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060604</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052777-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060712</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>84</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>76.1</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HYPERKALAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugdosagetext>10MG,  10 MG  QD, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060331</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060615</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052778-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060705</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-454361</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>41</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>45.4</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CELLULITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE CELLULITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE HAEMATOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BONIVA</medicinalproduct>
        <drugauthorizationnumb>021858</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>OSTEOPENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060629</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060629</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE MAGNESIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052779-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060706</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-ROCHE-454234</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</reportercountry>
      <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>PANCREATITIS ACUTE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XENICAL</medicinalproduct>
        <drugauthorizationnumb>020766</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052780-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060706</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-454540</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE BEFORE PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NO ADVERSE EFFECT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NORMAL NEWBORN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>018662</drugauthorizationnumb>
        <drugindication>ACNE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19870615</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052781-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060706</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DK-ROCHE-454316</companynumb>
    <primarysource>
      <reportercountry>DENMARK</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>54</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>113</patientweight>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>SUDDEN DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XENICAL</medicinalproduct>
        <drugauthorizationnumb>020766</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OBESITY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050412</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ESCITALOPRAM OXALATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051129</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052782-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060706</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-ROCHE-454224</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>3</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>15</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>RASH ERYTHEMATOUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWELLING FACE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ROCEPHIN</medicinalproduct>
        <drugauthorizationnumb>050585</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060329</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060329</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RULIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VENTOLIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATROVENT</medicinalproduct>
        <drugdosagetext>DDRUG REPORTED AS: ATROVENT NEBULISING SOLUTION.</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMOXYCILLIN SODIUM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052783-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060706</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-454532</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>40</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>IRRITABLE BOWEL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEGASYS</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060415</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060629</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RIBAVIRIN</medicinalproduct>
        <drugauthorizationnumb>021511</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060415</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060629</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>IRRITABILITY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOXYCYCLINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052784-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060712</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>54</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>59.5</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZIDOVUDINE</medicinalproduct>
        <drugdosagetext>600MG,  300MG BID, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060515</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060619</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052785-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060705</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHNR2006AU00873</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DYSLIPIDAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FACE OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PIGMENTATION DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSORIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GLEEVEC</medicinalproduct>
        <drugauthorizationnumb>021588</drugauthorizationnumb>
        <drugdosagetext>UNK, UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052786-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060706</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20060201915</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>68</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DISSEMINATED TUBERCULOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC CIRRHOSIS</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>TUBERCULOSIS MEDICATIONS</medicinalproduct>
        <drugindication>TUBERCULOSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052787-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060706</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-JNJFOC-20060701771</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>48</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST X-RAY ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OXYGEN SATURATION DECREASED</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>1</drugcharacterization>
        <medicinalproduct>RHEUMATREX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052788-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060711</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IT-JNJFOC-20060701789</companynumb>
    <primarysource>
      <reportercountry>ITALY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>57</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOXORUBICIN HCL</medicinalproduct>
        <drugauthorizationnumb>050718</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>OVARIAN CANCER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARBOPLATIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>OVARIAN CANCER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052789-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060330</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHRM2006FR01193</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>39</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>50</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BREAST CANCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BREAST OPERATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GLEEVEC</medicinalproduct>
        <drugauthorizationnumb>21588</drugauthorizationnumb>
        <drugdosagetext>400 MG DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CHRONIC MYELOID LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEUPOGEN</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>CHRONIC MYELOID LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052790-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060712</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>64</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>59.4</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PIPERACILLIN AND TAZOBACTAM</medicinalproduct>
        <drugdosagetext>13.5G, 3.375GQ6, INTRAVEN</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>WOUND INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060619</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060626</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052791-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060712</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>72</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>95.3</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CONJUNCTIVAL OEDEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRAVOPROST</medicinalproduct>
        <drugdosagetext>ONE DROP,  RT EYE H, OPHTHALM</drugdosagetext>
        <drugadministrationroute>047</drugadministrationroute>
        <drugindication>GLAUCOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060626</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060629</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052792-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060712</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>55</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>88</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugdosagetext>20MG, 20MG  QD, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060414</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060623</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052793-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060714</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>68</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>91.8534</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MEDICATION ERROR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WRONG DRUG ADMINISTERED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MORPHINE SULFATE</medicinalproduct>
        <drugbatchnumb>457259B</drugbatchnumb>
        <drugdosagetext>30 MG  TWICE DAILY  PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060711</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060712</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052794-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060630</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2006DK09998</companynumb>
    <primarysource>
      <reportercountry>DENMARK</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>72</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE ENZYME INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULAR WEAKNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOSITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHABDOMYOLYSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GLEEVEC</medicinalproduct>
        <drugauthorizationnumb>21588</drugauthorizationnumb>
        <drugdosagetext>200 MG/D</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CHRONIC MYELOID LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060522</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060628</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052795-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060519</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2006JP07579</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>50</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <reaction>
        <reactionmeddrapt>CHRONIC MYELOID LEUKAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NON-HODGKIN'S LYMPHOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GLEEVEC</medicinalproduct>
        <drugauthorizationnumb>21588</drugauthorizationnumb>
        <drugdosagetext>400 MG/D</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CHRONIC MYELOID LEUKAEMIA</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GLEEVEC</medicinalproduct>
        <drugauthorizationnumb>021588</drugauthorizationnumb>
        <drugdosagetext>600 MG/D</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052796-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060531</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-BRISTOL-MYERS SQUIBB COMPANY-13400189</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>AGEUSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANOREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC NEOPLASM MALIGNANT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KARVEA</medicinalproduct>
        <drugauthorizationnumb>20757</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052797-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060710</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-BRISTOL-MYERS SQUIBB COMPANY-13438601</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>41</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUSTIVA</medicinalproduct>
        <drugauthorizationnumb>020972</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020204</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRIZIVIR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020204</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052798-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060713</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>77</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>78.0187</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CAROTID ARTERY DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBRAL ATROPHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBRAL ISCHAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EJECTION FRACTION DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EMBOLIC CEREBRAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRANSIENT ISCHAEMIC ATTACK</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ERBITUX</medicinalproduct>
        <drugdosagetext>458 MG WEKLY X 4 IV DRIP</drugdosagetext>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>LUNG NEOPLASM MALIGNANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060531</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060614</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052799-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060713</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>55.3</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PATHOGEN RESISTANCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XIFAXAN</medicinalproduct>
        <drugbatchnumb>C4G03571</drugbatchnumb>
        <drugdosagetext>400 MG  Q8 H PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>COLITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060710</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SOTALOL HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OCTREOTIDE ACETATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUTAMINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RIFAXIMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOCLOPRAMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENOXAPARIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ESOMEPRAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VANCOMYCIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMIPENEM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052800-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060621</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CH-BRISTOL-MYERS SQUIBB COMPANY-13428024</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>42</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>57</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>REVERSIBLE POSTERIOR LEUKOENCEPHALOPATHY SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ERBITUX</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLORECTAL CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060308</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060523</drugenddate>
        <drugtreatmentduration>76</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CPT-11</medicinalproduct>
        <drugdosagetext>100-200MG UTIL 03MAY06</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLORECTAL CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040728</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060503</drugenddate>
        <drugtreatmentduration>644</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MIRTAZAPINE</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VENLAFAXINE HCL</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BROMAZEPAM</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052801-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060710</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-13437454</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DERMATITIS ACNEIFORM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREATMENT NONCOMPLIANCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ERBITUX</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NEOPLASM MALIGNANT</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052802-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050310</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-12894028</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>67</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FUNGAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ERBITUX</medicinalproduct>
        <drugdosagetext>INITIAL TX DATE: 04-OCT-04. DRUG DISCONTINUED</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLORECTAL CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050209</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050209</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXALIPLATIN</medicinalproduct>
        <drugdosagetext>INITIAL TX DATE: 04-OCT-04. DRUG DISCONTINUED</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLORECTAL CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050207</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050207</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUOROURACIL</medicinalproduct>
        <drugdosagetext>INITIAL TX DATE: 04-OCT-04. DRUG DISCONTINUED</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLORECTAL CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050207</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050207</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEUCOVORIN CALCIUM</medicinalproduct>
        <drugdosagetext>INITIAL TX DATE: 04-OCT-04. DRUG DISCONTINUED</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLORECTAL CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050207</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050207</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052803-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060609</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-BRISTOL-MYERS SQUIBB COMPANY-13407127</companynumb>
    <primarysource>
      <reportercountry>BELGIUM</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>65</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PACLITAXEL</medicinalproduct>
        <drugindication>ENDOMETRIAL CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060523</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060523</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOXORUBICIN HCL</medicinalproduct>
        <drugindication>ENDOMETRIAL CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060523</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060523</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CIPROFLOXACIN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060530</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052804-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060131</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-13266747</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>40</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CISPLATIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>GASTRIC CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051118</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051118</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TS-1</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTRIC CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050121</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMBIEN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INSOMNIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENICAR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACIPHEX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTROOESOPHAGEAL REFLUX DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROMORPHONE HCL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NAUSEA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANXIETY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOFRAN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NAUSEA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050121</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COMPAZINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NAUSEA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050121</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SENOKOT</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONSTIPATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050122</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADVIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050127</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GAS-X</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>FLATULENCE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050411</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMODIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIARRHOEA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050411</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EXCEDRIN (MIGRAINE)</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050328</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DYSPEPSIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050402</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EMEND</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS OF NAUSEA AND VOMITING</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050324</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYLENOL (CAPLET)</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050910</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DECADRON</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PREMEDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050318</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOFRAN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PREMEDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050121</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052805-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060706</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-13435110</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>30</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>87</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CHILLS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ORENCIA</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADDERALL 10</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRILOSEC</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052806-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060515</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-BRISTOL-MYERS SQUIBB COMPANY-13383583</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>35</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>58</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BALANCE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLINDNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CYTOMEGALOVIRUS INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG LEVEL INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERAL PHYSICAL HEALTH DETERIORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>KAPOSI'S SARCOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NERVOUS SYSTEM DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NYSTAGMUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OPTIC ATROPHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OPTIC NERVE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORGAN FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POLYNEUROPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SCOTOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VASCULITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL ACUITY REDUCED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUSTIVA</medicinalproduct>
        <drugauthorizationnumb>21360</drugauthorizationnumb>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031127</drugenddate>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VIREAD</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060301</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EPIVIR</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060301</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COTRIM</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040701</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052807-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060516</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-13378583</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIOVASCULAR DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
        <drugauthorizationnumb>9218</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052808-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060712</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ZA-BRISTOL-MYERS SQUIBB COMPANY-13439351</companynumb>
    <primarysource>
      <reportercountry>SOUTH AFRICA</reportercountry>
      <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>GASTROENTERITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DASATINIB</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060315</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060710</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMOXICILLIN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060705</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060701</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PHARMATON</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060530</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060701</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PARACETAMOL</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060701</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052809-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060207</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-13273883</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>70</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALIGNANT NEOPLASM PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTI-ORGAN FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CISPLATIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060106</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060106</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TS-1</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060106</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060127</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060127</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GOUT</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060127</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060127</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060127</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZETIA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CORONARY ARTERY DISEASE</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060127</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CORONARY ARTERY BYPASS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060127</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DECADRON</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS OF NAUSEA AND VOMITING</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060107</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060127</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EMEND</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS OF NAUSEA AND VOMITING</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060106</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060127</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRILOSEC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTROOESOPHAGEAL REFLUX DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060104</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060127</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYCODAN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>COUGH</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060104</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060127</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMBIEN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INSOMNIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060104</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060127</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYLENOL W/ CODEINE NO. 3</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060104</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060127</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052810-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060705</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-BRISTOL-MYERS SQUIBB COMPANY-13433461</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>53</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>70</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>AKATHISIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOVEMENT DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TARDIVE DYSKINESIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ABILIFY</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOAFFECTIVE DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060307</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ISOSORBIDE MONONITRATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NICORANDIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOPICLONE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052811-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060706</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006AC01247</companynumb>
    <primarysource>
      <reportercountry>NETHERLANDS</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>17523</patientonsetage>
      <patientonsetageunit>804</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RHINOCORT</medicinalproduct>
        <drugauthorizationnumb>020746</drugauthorizationnumb>
        <drugadministrationroute>045</drugadministrationroute>
        <drugindication>EAR INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060628</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060629</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugdosagetext>DOSE INCREASED FROM 10 MG TO 20 MG ON UNKNOWN DATE</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COVERSYL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052812-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060707</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006AC01278</companynumb>
    <primarysource>
      <reportercountry>SWEDEN</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>81</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MUSCULAR WEAKNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOSITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugauthorizationnumb>019810</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ATORVASTATIN CALCIUM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052813-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060706</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006AP03124</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>60</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANAESTHETIC COMPLICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROCEDURAL COMPLICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPINAL HAEMATOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BUPIVACAINE HYDROCHLORIDE</medicinalproduct>
        <drugauthorizationnumb>18304</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ROPIVACAINE HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIGNOCAINE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FENTANYL TRANSDERMAL SYSTEM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PETHIDINE HYDROCHLORIDE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052814-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060713</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>63</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ACUTE MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIO-RESPIRATORY ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENTRICULAR TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052815-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060713</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>62</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>75.7507</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>AMNESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCOHERENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STUPOR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMBIEN CR</medicinalproduct>
        <drugdosagetext>12.5 MG TWICE A WEEK PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INITIAL INSOMNIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060628</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060629</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZESTRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EVISTA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATARAXM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052816-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060713</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>52.1637</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG DEPENDENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG WITHDRAWAL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VERTIGO</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
        <drugdosagetext>150 ,G 1/DAY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANXIETY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040815</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060712</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052817-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060316</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006GB00476</companynumb>
    <primarysource>
      <reportercountry>IRELAND</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>46</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>72.3</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESTLESS LEGS SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugauthorizationnumb>020639</drugauthorizationnumb>
        <drugdosagetext>DOSE REDUCED TO 100MG BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PSYCHOTIC DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051019</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugauthorizationnumb>020639</drugauthorizationnumb>
        <drugdosagetext>DOSE REDUCED FROM 400MG BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060406</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PSYCHOTIC DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030306</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>AGITATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060126</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRIADEL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BIPOLAR DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040309</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052818-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060712</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006AP03225</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>72</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HEPATIC NEOPLASM MALIGNANT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CASODEX</medicinalproduct>
        <drugauthorizationnumb>020498</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROSTATE CANCER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052819-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060706</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006AP03146</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</reportercountry>
      <qualification>3</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>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URTICARIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROPOFOL</medicinalproduct>
        <drugauthorizationnumb>19627</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050826</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050826</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GLYCERYL TRINITRATE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIDAZOLAM HYDROCHLORIDE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050826</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050826</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FENTANYL TRANSDERMAL SYSTEM</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050826</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050826</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PANCURONIUM BROMIDE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050826</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050826</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VANCOMYCIN HYDROCHLORIDE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050826</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050826</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SERETIDE ACCUHALER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLYCERYL TRINITRATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENOXAPARIN SODIUM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052820-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060619</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006AP02825</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>71</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>69.4</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION POTENTIATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERNATIONAL NORMALISED RATIO FLUCTUATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYCOBACTERIUM AVIUM COMPLEX INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MEROPEN</medicinalproduct>
        <drugauthorizationnumb>50706</drugauthorizationnumb>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>PNEUMONIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050831</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050910</drugenddate>
        <drugtreatmentduration>11</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MEROPEN</medicinalproduct>
        <drugauthorizationnumb>050706</drugauthorizationnumb>
        <drugadministrationroute>041</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050915</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050928</drugenddate>
        <drugtreatmentduration>14</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTERIAL THROMBOSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050828</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050902</drugenddate>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050903</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050904</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050905</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050905</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050914</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050917</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050918</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050923</drugenddate>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MINOPEN</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>PNEUMONIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050902</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050906</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SULBACTAM SODIUM-AMPICILLIN SODIUM</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>PNEUMONIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050830</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050830</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMMUNE GLOBULIN INTRAVENOUS (HUMAN)</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>PNEUMONIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050831</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050902</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VANCOMYCIN</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>PNEUMONIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050901</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RIMACTANE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATYPICAL MYCOBACTERIAL INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050923</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052821-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060713</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOKALAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SARGRAMOSTIM 250 MICROGRAMS BERLEX</medicinalproduct>
        <drugbatchnumb>B08458</drugbatchnumb>
        <drugdosagetext>250 MICROGRAMS 2 SINGLE DOSES IM</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>DRUG THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050819</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050919</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KALETRA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TENOFOVIR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REYATAZ</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DILANTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROPRANOLOL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052822-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060713</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>57.6068</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CRYING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISTURBANCE IN ATTENTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG WITHDRAWAL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EAR DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMPAIRED WORK ABILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEMORY IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EFFEXOR</medicinalproduct>
        <drugdosagetext>1 DAY PO  6-8 MONTHS</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060701</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EFFEXOR</medicinalproduct>
        <drugdosagetext>1 DAY PO  6-8 MONTHS</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060701</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052823-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060706</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20060203724</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHOLECYSTITIS ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIVERTICULAR PERFORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCISION SITE ABSCESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCREATIC CARCINOMA METASTATIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERITONITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugbatchnumb>01H125AP1</drugbatchnumb>
        <drugdosagetext>4 DOSES RECEIVED</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugbatchnumb>01H125AP1</drugbatchnumb>
        <drugdosagetext>4 DOSES RECEIVED</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugbatchnumb>01H125AP1</drugbatchnumb>
        <drugdosagetext>19 DOSES RECEIVED</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
        <drugindication>HYPOTHYROIDISM</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMINS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL SPIROS</medicinalproduct>
        <drugadministrationroute>055</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATROVENT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROTONIX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052824-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060706</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20060701040</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>INTESTINAL OPERATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugindication>CROHN'S DISEASE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052825-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060706</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20060701122</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>74.84</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>DEATH</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>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CROHN'S DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMDUR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOPRESSOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CIPRO</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PEPCID</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052826-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060706</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-JNJFOC-20060306514</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>80</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PUSTULAR PSORIASIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugindication>CROHN'S DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PENTASA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CROHN'S DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEUKERIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CROHN'S DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GASTROM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MUCOSTA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052827-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2005134690</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIOVASCULAR DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBRAL THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugauthorizationnumb>20998</drugauthorizationnumb>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEXTRA</medicinalproduct>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052828-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2005134688</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>63</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>INTRACARDIAC THROMBUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugauthorizationnumb>20998</drugauthorizationnumb>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEXTRA</medicinalproduct>
        <drugdosagetext>(20 MG)</drugdosagetext>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052829-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2005134682</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>55</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>93.8946</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIOVASCULAR DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DERMATITIS ALLERGIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugauthorizationnumb>20998</drugauthorizationnumb>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEXTRA</medicinalproduct>
        <drugdosagetext>(20 MG)</drugdosagetext>
        <drugindication>ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052830-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2005134666</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>45</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>145.151</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIOVASCULAR DISORDER</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>ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugindication>ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052831-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2005134739</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>63</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIOVASCULAR DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBRAL THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugauthorizationnumb>20998</drugauthorizationnumb>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEXTRA</medicinalproduct>
        <drugdosagetext>20 MG (20 MG, 1 IN 1 D)</drugdosagetext>
        <drugindication>OSTEOARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040813</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050311</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052832-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2005134733</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>52</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>70.3075</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIOVASCULAR DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBRAL THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugauthorizationnumb>20998</drugauthorizationnumb>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEXTRA</medicinalproduct>
        <drugdosagetext>20 MG (20 MG, 1 IN 1 D)</drugdosagetext>
        <drugindication>ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050301</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052833-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2005134732</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>76</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>96.1626</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIOVASCULAR DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugauthorizationnumb>20998</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEXTRA</medicinalproduct>
        <drugdosagetext>(1 IN 1 D)</drugdosagetext>
        <drugindication>ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052834-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060703</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200613775BWH</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>62</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>78.9259</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>APHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CREATINE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD POTASSIUM INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISORIENTATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCREASED UPPER AIRWAY SECRETION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OLIGODIPSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXAVAR</medicinalproduct>
        <drugauthorizationnumb>21923</drugauthorizationnumb>
        <drugdosagetext>400 MG, BID, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>METASTATIC RENAL CELL CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060509</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060525</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORA TAB</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052835-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060623</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>HQWYE373426JUN06</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>61</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEUMEGA</medicinalproduct>
        <drugindication>PLATELET COUNT DECREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060608</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAXOL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052836-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060626</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200610186BBE</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>LUNG INJURY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GAMUNEX</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060625</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052837-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060706</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-JNJFOC-20060701387</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</reportercountry>
      <qualification>1</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>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052838-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060622</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006BH010487</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>53</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>78</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PNEUMOPERITONEUM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FIBRIN SEALANT TISSEL VH KIT</medicinalproduct>
        <drugindication>SURGERY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060523</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052839-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060620</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006BH011276</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HEPATITIS C VIRUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEMOFIL</medicinalproduct>
        <drugindication>HAEMOPHILIA CARRIER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROPLEX T</medicinalproduct>
        <drugindication>HAEMOPHILIA CARRIER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052840-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060620</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>THYM-10981</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>23</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JOINT SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEUKOCYTOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG CONSOLIDATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>THYMOGLOBULIN</medicinalproduct>
        <drugindication>RENAL TRANSPLANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060603</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060610</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROGRAF</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELLCEPT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BACTRIM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALCYTE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROTONIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEMADEX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SODIUM CARBONATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REGLAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BUMEX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052845-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060630</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200613952BWH</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>71</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>95.2554</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ACQUIRED DIAPHRAGMATIC EVENTRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ACTIVITIES OF DAILY LIVING IMPAIRED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLINDNESS UNILATERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTRAOCULAR PRESSURE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NASOPHARYNGITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OPTIC ATROPHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OPTIC ISCHAEMIC NEUROPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PUPILLARY REFLEX IMPAIRED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RED BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UPPER RESPIRATORY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISION BLURRED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVITRA</medicinalproduct>
        <drugauthorizationnumb>21400</drugauthorizationnumb>
        <drugdosagetext>ONCE, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ERECTILE DYSFUNCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060421</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AZOPT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XALATAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TIMOPTIC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEVANAC</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052846-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060630</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200612770BCC</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>67</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>75.2971</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANAPHYLACTIC REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FOAMING AT MOUTH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY ARREST</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALEVE (CAPLET)</medicinalproduct>
        <drugbatchnumb>216645L</drugbatchnumb>
        <drugauthorizationnumb>20204</drugauthorizationnumb>
        <drugdosagetext>220 MG, ONCE, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BACK PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060625</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRAVACHOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052847-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060626</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200612700BCC</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>86.1834</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>EPISTAXIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROOESOPHAGEAL REFLUX DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JOINT SWELLING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALEVE (CAPLET)</medicinalproduct>
        <drugbatchnumb>284294B</drugbatchnumb>
        <drugauthorizationnumb>20204</drugauthorizationnumb>
        <drugdosagetext>220 MG, PRN, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRALGIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>PRN, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEADACHE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>PRN, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052848-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060703</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200611659BCC</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>83</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>47.6277</patientweight>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALEVE (CAPLET)</medicinalproduct>
        <drugauthorizationnumb>20204</drugauthorizationnumb>
        <drugdosagetext>440 MG, TOTAL DAILY, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRALGIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROXYZINE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPROL-XL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANOXICAPS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IRON</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052849-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060630</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CHPA2006US06352</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>40</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>56.7</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG TOXICITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOTOR DYSFUNCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NICOTINE</medicinalproduct>
        <drugbatchnumb>21173301</drugbatchnumb>
        <drugauthorizationnumb>20076</drugauthorizationnumb>
        <drugdosagetext>21 MG, QD, TRANSDERMAL</drugdosagetext>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>SMOKING CESSATION THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060618</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060620</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NICOTINE</medicinalproduct>
        <drugbatchnumb>21173301</drugbatchnumb>
        <drugauthorizationnumb>20076</drugauthorizationnumb>
        <drugdosagetext>21 MG, QD, TRANSDERMAL</drugdosagetext>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>SMOKING CESSATION THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060626</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060626</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TIAZAC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEMULEN (ETHINYLESTRADIOL, ETYNODIOL DIACETATE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENTOCORT (BUDESONIDE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HALCION</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FIORICET</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMERGE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052850-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CHPA2006US06345</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>62</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>83</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NICOTINE</medicinalproduct>
        <drugauthorizationnumb>20076</drugauthorizationnumb>
        <drugdosagetext>21 MG, QD, TRANSDERMAL</drugdosagetext>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>SMOKING CESSATION THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060627</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060627</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052851-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060630</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200614410BWH</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>78</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CLOSTRIDIUM DIFFICILE TOXIN TEST POSITIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENTAL STATUS CHANGES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RED BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CIPRO</medicinalproduct>
        <drugauthorizationnumb>19537</drugauthorizationnumb>
        <drugindication>PSEUDOMONAS INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060520</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LINEZOLID</medicinalproduct>
        <drugindication>PSEUDOMONAS INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060520</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPROL-XL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROTONIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYLENOL REGULAR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XALATAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>STUDY DRUG</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052852-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060705</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200614411BWH</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>61</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>EJECTION FRACTION DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOACUSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OTOTOXICITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POST PROCEDURAL COMPLICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROCEDURAL HYPERTENSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRASYLOL</medicinalproduct>
        <drugauthorizationnumb>20304</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060622</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRASYLOL</medicinalproduct>
        <drugauthorizationnumb>20304</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060622</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VANCOMYCIN</medicinalproduct>
        <drugdosagetext>1 G, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ANTIBIOTIC PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060622</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052853-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060705</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200614426BWH</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>76</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>60</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD UREA INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOACUSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OTOTOXICITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POST PROCEDURAL COMPLICATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRASYLOL</medicinalproduct>
        <drugauthorizationnumb>20304</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060613</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VANCOMYCIN</medicinalproduct>
        <drugdosagetext>1 G, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>INFECTION PROPHYLAXIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052854-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060705</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200614427BWH</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>OTOTOXICITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRASYLOL</medicinalproduct>
        <drugauthorizationnumb>20304</drugauthorizationnumb>
        <drugdosagetext>200 ML, ONCE, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CARDIAC OPERATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VANCOMYCIN</medicinalproduct>
        <drugdosagetext>INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052855-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060705</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200614428BWH</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>OTOTOXICITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POST PROCEDURAL COMPLICATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRASYLOL</medicinalproduct>
        <drugauthorizationnumb>20304</drugauthorizationnumb>
        <drugdosagetext>200 ML, ONCE, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CARDIAC OPERATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VANCOMYCIN</medicinalproduct>
        <drugdosagetext>INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052856-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200614441BWH</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXAVAR</medicinalproduct>
        <drugauthorizationnumb>21923</drugauthorizationnumb>
        <drugdosagetext>400 MG, BID, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RENAL CELL CARCINOMA STAGE UNSPECIFIED</drugindication>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052857-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060713</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>76.2</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANOREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY TUBERCULOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INFLIXIMAB 100 MG CENTOCOR</medicinalproduct>
        <drugdosagetext>5 MG/KG EVERY 8 WEEKS IV DRIP</drugdosagetext>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060528</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARVEDILOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OLMESARTAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GABAPENTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VERAPAMIL ER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EPOETIN ALFA</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052858-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>HQWYE800912APR06</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>70</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>90</patientweight>
      <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 ALKALINE PHOSPHATASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD BILIRUBIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD LACTATE DEHYDROGENASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE MARROW TRANSPLANT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHILLS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISEASE PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEBRILE NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GRAFT VERSUS HOST DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMODIALYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFUSION RELATED REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG CONSOLIDATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYELOID LEUKAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STAPHYLOCOCCAL SEPSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOTIC THROMBOCYTOPENIC PURPURA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MYLOTARG</medicinalproduct>
        <drugauthorizationnumb>21174</drugauthorizationnumb>
        <drugdosagetext>18.9 MG 1X PER 1 DAY, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ACUTE MYELOID LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051027</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051027</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052859-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FABR-11544</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>51</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>67</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROCEDURAL COMPLICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</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>20041229</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052860-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A-US2006-12532</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>48</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>AORTIC THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTERIAL THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUBCLAVIAN ARTERY THROMBOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRACLEER</medicinalproduct>
        <drugauthorizationnumb>21290</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052862-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060703</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006BI009459</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>104.3273</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BREAST CANCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLUENZA LIKE ILLNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG NEOPLASM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugdosagetext>30 U G; QW; IM</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052863-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060703</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006BI009498</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>45</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>91.173</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACTERIA STOOL IDENTIFIED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL INFECTION</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>19960101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052864-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060630</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006BI009448</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>53</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>63.5036</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INTERVERTEBRAL DISC PROTRUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE SCLEROSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugdosagetext>30 U G; 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>20040101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052865-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060706</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20060701104</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>82</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>UTERINE CANCER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052866-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060706</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>JP-JNJFOC-20060604218</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>69</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PNEUMOCYSTIS JIROVECI PNEUMONIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NSAIDS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DMARDS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052867-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060706</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>JP-JNJFOC-20060603889</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>PNEUMOCYSTIS JIROVECI PNEUMONIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052868-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060706</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-JNJFOC-20060604215</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>66</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANOREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GRANULOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPHADENOPATHY MEDIASTINAL</reactionmeddrapt>
      </reaction>
      <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>
      </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>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NSAIDS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CORTICOSTEROIDS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052869-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060630</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006BI009432</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>59</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>58.9676</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CEREBRAL HAEMATOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UPPER LIMB FRACTURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugdosagetext>30 UG; QW; IM</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>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>5052870-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060707</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006UW14278</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>TIC</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZESTRIL</medicinalproduct>
        <drugauthorizationnumb>019777</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052871-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006BI009378</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>39</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VERTIGO</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>20011120</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>5052873-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006BI009533</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>41</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANAESTHETIC COMPLICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STOMACH DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THYROID DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugdosagetext>30 UG; QW; IM</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052874-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060705</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006BI009643</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>52</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INFLUENZA LIKE ILLNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOARTHRITIS</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>20060328</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052875-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060703</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006BI009653</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugdosagetext>IM</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031213</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052876-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060706</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006BI009661</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>48</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLINDNESS UNILATERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</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>19960101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020101</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>20030806</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052877-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060706</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006BI009666</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>63</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>LUNG NEOPLASM MALIGNANT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugdosagetext>IM</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980901</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052878-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060706</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006BI009668</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>66</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>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>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugdosagetext>30 UG; QW; IM</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052879-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060705</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006BI009685</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>67</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIAC ARREST</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>20051101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052880-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060703</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006BI003730</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>48</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>49.8957</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLADDER DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BREAST CANCER FEMALE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</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>20060328</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FEMARA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAMOXIFEN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052882-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PR-2005-026668</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>38</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRY SKIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HALLUCINATION, VISUAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE IRRITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE REACTION</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>20040717</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALEVE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052883-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060623</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US200606005306</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY STENOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIALYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL TRANSPLANT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMULIN N</medicinalproduct>
        <drugauthorizationnumb>18780</drugauthorizationnumb>
        <drugdosagetext>SLIDING SCALE</drugdosagetext>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMULIN R</medicinalproduct>
        <drugdosagetext>SLIDING SCALE</drugdosagetext>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052884-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060627</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006S1005909</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>56</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXALIPLATIN (85 MG/M**2)</medicinalproduct>
        <drugauthorizationnumb>71591</drugauthorizationnumb>
        <drugdosagetext>170 MCG; Q2W; IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PANCREATIC NEOPLASM</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060530</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060530</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEVACIZUMAB (5 MG/KG)</medicinalproduct>
        <drugdosagetext>400 MG; Q2W; IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PANCREATIC NEOPLASM</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060530</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060530</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUOROURACIL</medicinalproduct>
        <drugdosagetext>800 MG; Q2W; IV;  2400 MG; Q2W; IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PANCREATIC NEOPLASM</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060530</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060530</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUOROURACIL</medicinalproduct>
        <drugdosagetext>800 MG; Q2W; IV;  2400 MG; Q2W; IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PANCREATIC NEOPLASM</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060530</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060530</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEUCOVORIN CALCIUM</medicinalproduct>
        <drugdosagetext>400 MG; Q2W; IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PANCREATIC NEOPLASM</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060530</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060530</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE TAB</medicinalproduct>
        <drugdosagetext>20 MG; Q2W; IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PANCREATIC NEOPLASM</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060530</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060530</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LORAZEPAM</medicinalproduct>
        <drugdosagetext>1 MG; Q2W; PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PANCREATIC NEOPLASM</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060530</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060530</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GRANISETRON (10 UG/KG)</medicinalproduct>
        <drugdosagetext>800 UG; Q2W; IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PANCREATIC NEOPLASM</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060530</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060530</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN (CON.)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOPERAMIDE HCL (CON.)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORAZEPAM (CON.)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052885-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006S1006051</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>59</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZAPINE</medicinalproduct>
        <drugauthorizationnumb>75417</drugauthorizationnumb>
        <drugdosagetext>100 MG; QAM; PO;   700 MG; HS; PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050914</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060601</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZAPINE</medicinalproduct>
        <drugauthorizationnumb>75417</drugauthorizationnumb>
        <drugdosagetext>100 MG; QAM; PO;   700 MG; HS; PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050914</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060601</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREVACID (CON.)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANTUS (CON.)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XENADERM (CON.)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL (CON.)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARICEPT (CON.)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NAMENDA (CON.)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KCL (CON.)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLYBURIDE (CON.)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONAZEPAM (CON.)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLBEE (CON.)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052886-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060627</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2005S1011736</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>49</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>70.3075</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>DRUG LEVEL INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG TOXICITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOVENTILATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SNORING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FENTANYL TRANSDERMAL SYSTEM</medicinalproduct>
        <drugauthorizationnumb>76258</drugauthorizationnumb>
        <drugdosagetext>100 MCG/HR; 1X; TDER</drugdosagetext>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>BACK PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050705</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FENTANYL TRANSDERMAL SYSTEM</medicinalproduct>
        <drugauthorizationnumb>76258</drugauthorizationnumb>
        <drugdosagetext>100 MCG/HR; 1X; TDER</drugdosagetext>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>NECK PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050705</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FENTANYL TRANSDERMAL SYSTEM</medicinalproduct>
        <drugauthorizationnumb>76258</drugauthorizationnumb>
        <drugdosagetext>100 MCG/HR; 1X; TDER</drugdosagetext>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050705</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CHLORDIAZEPOXIDE (CON.)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCODONE (CON.)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GABAPENTIN (CON.)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IBUPROFEN (CON.)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PARACETAMOL (CON.)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PERCOCET (CON.)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052887-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060703</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006-07-0255</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>39</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ALOPECIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEG-INTRON</medicinalproduct>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060428</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RIBASPHERE</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060428</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMITRIPTYLINE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENZOTROPINE MESYLATE TABLETS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GABITRIL FILMTAB TABLETS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LITHIUM CARBONATE EXTENDED RELEASE TABLET</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PERPHENAZINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM CHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROMETHAZINE HYDROCHLORIDE TABLETS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROPRANOLOL HYDROCHLORIDE TABLETS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPAMAX TABLETS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPROL-XL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAZODONE HYDROCHLORIDE TABLETS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052888-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060627</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>007709</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>27</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABORTION INDUCED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PREGNANCY ON ORAL CONTRACEPTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PREGNANCY WITH CONTRACEPTIVE DEVICE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UNINTENDED PREGNANCY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLARAVIS</medicinalproduct>
        <drugauthorizationnumb>76135</drugauthorizationnumb>
        <drugdosagetext>40 MG,  BID, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051109</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060607</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ORAL CONTRACEPTIVE NOS (ORAL CONTRACEPTIVE NOS)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052889-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060707</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>007938</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BREAST CANCER FEMALE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MEDROXYPROGESTERONE ACETATE</medicinalproduct>
        <drugauthorizationnumb>40159</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19920101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CENESTIN</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19920101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19920101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROVERA</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19920101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052891-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060707</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006S1000133</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>15</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>49.2</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEVICE LEAKAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OXYGEN SATURATION DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMOTHORAX</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INOMAX</medicinalproduct>
        <drugbatchnumb>5LP056-03</drugbatchnumb>
        <drugauthorizationnumb>20845</drugauthorizationnumb>
        <drugdosagetext>3.3 PPM;CONT;INH</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>HYPOXIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060603</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060621</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052892-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060712</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>72</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>80.5</patientweight>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISSEMINATED INTRAVASCULAR COAGULATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLANK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFUSION RELATED REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>WINRHO SDF</medicinalproduct>
        <drugdosagetext>6000MCG   X1   IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ANAEMIA HAEMOLYTIC AUTOIMMUNE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052893-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060626</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>TRP_0803_2006</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>56</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>64.8644</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ALOPECIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANGER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MADAROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYSTEMIC LUPUS ERYTHEMATOSUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RIBASPHERE</medicinalproduct>
        <drugauthorizationnumb>76203</drugauthorizationnumb>
        <drugdosagetext>DF PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060613</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEG-INTRON</medicinalproduct>
        <drugdosagetext>DF SC</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060104</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060613</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052894-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060630</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006-07-0274</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>COLON CANCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBETOL</medicinalproduct>
        <drugauthorizationnumb>20903</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INTRON A</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052895-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060630</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006-07-0323</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>BURSITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CATARACT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DUPUYTREN'S CONTRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRIGGER FINGER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VITREOUS FLOATERS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INTRON A</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19950501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19970630</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052897-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060630</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006-07-0335</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>AMNESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISTURBANCE IN ATTENTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATOMEGALY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UVEITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RIBAVIRIN</medicinalproduct>
        <drugauthorizationnumb>20903</drugauthorizationnumb>
        <drugindication>HEPATITIS C</drugindication>
        <drugtreatmentduration>48</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INTERFERON INJECTABLE</medicinalproduct>
        <drugindication>HEPATITIS C</drugindication>
        <drugtreatmentduration>48</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052898-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060630</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006-07-0324</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BONE MARROW DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEG-INTRON</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RIBAVIRIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052899-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060630</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>HQWYE102825AUG05</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>67</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>72.4</patientweight>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>BRAIN OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BREAST CANCER FEMALE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBELLAR HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEBRILE NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GINGIVAL BLEEDING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYELODYSPLASTIC SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MYLOTARG</medicinalproduct>
        <drugauthorizationnumb>21174</drugauthorizationnumb>
        <drugdosagetext>14 MG 1X PER 1 DAY, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ACUTE MYELOID LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050816</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050816</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANASTROZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052900-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060712</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>45.3597</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HEAD TITUBATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THERAPEUTIC RESPONSE UNEXPECTED WITH DRUG SUBSTITUTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLONAZEPAM</medicinalproduct>
        <drugbatchnumb>B51-07-C-4</drugbatchnumb>
        <drugdosagetext>0.5 MG, 5/DAY, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ESSENTIAL TREMOR</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLONAZEPAM</medicinalproduct>
        <drugbatchnumb>B51-07-C-4</drugbatchnumb>
        <drugdosagetext>0.5 MG, 5/DAY, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>TORTICOLLIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052901-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060709</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-JNJFOC-20060702317</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>23</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>55</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDE ATTEMPT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMOSEC</medicinalproduct>
        <drugauthorizationnumb>19487</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
        <drugauthorizationnumb>019872</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
        <drugauthorizationnumb>019872</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIMENHYDRINATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PENICILLIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SUICIDE ATTEMPT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PYRIDOXINE HCL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052902-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060630</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>HQWYE337009JUN05</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>48</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>69</patientweight>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ASPARTATE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISEASE PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEBRILE NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFUSION RELATED REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRANSAMINASES INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MYLOTARG</medicinalproduct>
        <drugauthorizationnumb>21174</drugauthorizationnumb>
        <drugdosagetext>9 MG 1X PER 1 DAY, INTRAVENOUS; SEE IMAGE</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ACUTE MYELOID LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050425</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050425</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MYLOTARG</medicinalproduct>
        <drugauthorizationnumb>21174</drugauthorizationnumb>
        <drugdosagetext>9 MG 1X PER 1 DAY, INTRAVENOUS; SEE IMAGE</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ACUTE MYELOID LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050512</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050512</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MYLOTARG</medicinalproduct>
        <drugauthorizationnumb>21174</drugauthorizationnumb>
        <drugdosagetext>9 MG 1X PER 1 DAY, INTRAVENOUS; SEE IMAGE</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ACUTE MYELOID LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050530</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050530</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDREA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYTARABINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MITOXANTRONE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052904-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060705</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>HQWYE642405APR06</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>57</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>88.53</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>KIDNEY TRANSPLANT REJECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOSPORINE</medicinalproduct>
        <drugdosagetext>100 MG 2X PER 1 DAY</drugdosagetext>
        <drugindication>PROPHYLAXIS AGAINST TRANSPLANT REJECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051206</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MYCOPHENOLATE MOFETIL</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>HYDROCHLOROTHIAZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VYTORIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ULTRAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BACTRIM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMBIEN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052905-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060704</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006082745</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>48</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>79.3795</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ARTHROPOD BITE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POOR QUALITY DRUG ADMINISTERED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ROCKY MOUNTAIN SPOTTED FEVER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KAOPECTATE (BISMUTH SUBSALICYLATE)</medicinalproduct>
        <drugbatchnumb>12KKT</drugbatchnumb>
        <drugdosagetext>2 TABLESPOONS 2-3 TIMES IN 1 DAY, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIARRHOEA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060702</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060702</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BUPROPION HYDROCHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ESCITALOPRAM (ESCITALOPRAM)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052906-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060702</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006082906</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>17</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DRAMAMINE</medicinalproduct>
        <drugbatchnumb>68518</drugbatchnumb>
        <drugdosagetext>12 TABLETS ONCE, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>EUPHORIC MOOD</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060702</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060702</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052907-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060712</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CHILLS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ERBITUX</medicinalproduct>
        <drugdosagetext>432 MG IV EVERY WEEK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NEOPLASM MALIGNANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060613</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALIMTA</medicinalproduct>
        <drugdosagetext>346 MG EVERY 3 WEEKS IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060620</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052908-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060630</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006083734</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>77</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>63.05</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POISONING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEOSPORIN</medicinalproduct>
        <drugbatchnumb>256N5L</drugbatchnumb>
        <drugdosagetext>QUARTER SIZE TWICE A DAY, TOPICAL</drugdosagetext>
        <drugadministrationroute>061</drugadministrationroute>
        <drugindication>SKIN LACERATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060628</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052909-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060712</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>62</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MUSCLE STRAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugdosagetext>10 MG DAILY PO [FEW DAYS]</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAZODONE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MTFORMIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052910-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>TRP_0804_2006</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>41</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FRUSTRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RIBASPHERE</medicinalproduct>
        <drugauthorizationnumb>76203</drugauthorizationnumb>
        <drugdosagetext>DF PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060128</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEG-INTRON</medicinalproduct>
        <drugdosagetext>DF SC</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060128</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELEXA</medicinalproduct>
        <drugdosagetext>40 MG PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052911-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>TRP_0806_2006</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>57</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHOIDS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE URTICARIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RED BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URTICARIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RIBASPHERE</medicinalproduct>
        <drugauthorizationnumb>76203</drugauthorizationnumb>
        <drugdosagetext>1200 MG QDAY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060130</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEGASYS</medicinalproduct>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060130</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060525</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RIBASPHERE</medicinalproduct>
        <drugdosagetext>1000 MG QDAY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEGASYS</medicinalproduct>
        <drugdosagetext>135 MCG QWK SC</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEXAPRO</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052912-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060712</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>101.1521</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ORTHO EVRA</medicinalproduct>
        <drugbatchnumb>0432428</drugbatchnumb>
        <drugdosagetext>3 PACKS 1 EVERY WEEKS 3 WEEKS</drugdosagetext>
        <drugindication>CONTRACEPTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060402</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060408</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ORTHO EVRA</medicinalproduct>
        <drugbatchnumb>0432428</drugbatchnumb>
        <drugdosagetext>3 PACKS 1 EVERY WEEKS 3 WEEKS</drugdosagetext>
        <drugindication>CONTRACEPTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060416</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052913-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060705</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>0104-2828</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>UNEVALUABLE EVENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ADVICOR</medicinalproduct>
        <drugauthorizationnumb>21249</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052914-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060615</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006S1005563</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>54</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DEVICE FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG WITHDRAWAL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCORRECT DOSE ADMINISTERED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THERAPEUTIC RESPONSE UNEXPECTED WITH DRUG SUBSTITUTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FENTANYL TRANSDERMAL SYSTEM</medicinalproduct>
        <drugbatchnumb>6N0121</drugbatchnumb>
        <drugauthorizationnumb>76258</drugauthorizationnumb>
        <drugdosagetext>75 UG/HR; Q3D; TRANS</drugdosagetext>
        <drugindication>PANCREATITIS CHRONIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050601</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052915-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060712</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>70.3075</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WALKING AID USER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19960101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052916-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060627</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006S1005879</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>63</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEBRILE NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL INTAKE REDUCED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN DISCOLOURATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STOMATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VINFLUNINE (280 MG/M**2)</medicinalproduct>
        <drugauthorizationnumb>75597</drugauthorizationnumb>
        <drugdosagetext>280 MG/M**2; IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NEOPLASM MALIGNANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060323</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060329</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KETOCONAZOLE TABLETS (400 MG)</medicinalproduct>
        <drugdosagetext>400 MG; PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NEOPLASM MALIGNANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060322</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060328</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DYAZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZYRTEC</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052917-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060627</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006S1005907</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>40</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>APPLICATION SITE DERMATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EFFECT INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCORRECT DOSE ADMINISTERED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WRONG TECHNIQUE IN DRUG USAGE PROCESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FENTANYL TRANSDERMAL SYSTEM</medicinalproduct>
        <drugbatchnumb>6N0148</drugbatchnumb>
        <drugauthorizationnumb>76258</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>062</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060621</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060621</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FENTANYL TRANSDERMAL SYSTEM</medicinalproduct>
        <drugbatchnumb>6N0148</drugbatchnumb>
        <drugauthorizationnumb>76258</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>062</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASMANEX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052918-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060712</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>66</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ALANINE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASPARTATE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEUKOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEPAKOTE</medicinalproduct>
        <drugdosagetext>500 MG BID PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>AFFECTIVE DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060310</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060427</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRILEPTAL</medicinalproduct>
        <drugdosagetext>300 MG BID PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>AFFECTIVE DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060310</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060427</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052919-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060712</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>76</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>83.9154</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGIC STROKE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugdosagetext>1 TAB BY MOUTH /DAY</drugdosagetext>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050601</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugdosagetext>1 TAB BY MOUTH /DAY</drugdosagetext>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050601</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugdosagetext>1 TAB BY MOUTH /DAY</drugdosagetext>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060408</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugdosagetext>1 TAB BY MOUTH /DAY</drugdosagetext>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060408</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052920-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060707</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>007941</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BREAST CANCER FEMALE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MEDROXYPROGESTERONE ACETATE</medicinalproduct>
        <drugauthorizationnumb>40159</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19940101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19940101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMPRO</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19940101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROVERA</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19940101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052921-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060710</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-AVENTIS-200612468FR</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>62</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>73</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERVENTILATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAXOTERE</medicinalproduct>
        <drugauthorizationnumb>20449</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060505</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060505</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAXOTERE</medicinalproduct>
        <drugauthorizationnumb>020449</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060529</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060529</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAXOTERE</medicinalproduct>
        <drugauthorizationnumb>020449</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060623</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060623</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SOLU-MEDROL</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CHEMOTHERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060623</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060623</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SOLU-MEDROL</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PREMEDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060623</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060623</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SOLUPRED</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CHEMOTHERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060622</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060622</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SOLUPRED</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PREMEDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060622</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060622</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOPHREN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CHEMOTHERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060623</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060623</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOPHREN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PREMEDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060623</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060623</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052922-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060621</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-AVENTIS-200611916JP</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>58</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>57</patientweight>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC FUNCTION ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTI-ORGAN FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPHIL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLEURISY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAXOTERE</medicinalproduct>
        <drugauthorizationnumb>20449</drugauthorizationnumb>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>LIP AND/OR ORAL CAVITY CANCER STAGE III</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060605</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060605</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BRIPLATIN</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>LIP AND/OR ORAL CAVITY CANCER STAGE III</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060605</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060605</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTINEOPLASTIC AND IMMUNOSUPPRESSIVE AGENTS</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>LIP AND/OR ORAL CAVITY CANCER STAGE III</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060117</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060522</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052923-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060710</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AVENTIS-200617154GDDC</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>60</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>91</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL DISTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CREATININE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD UREA INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BODY TEMPERATURE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPENIC INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPHIL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL INTAKE REDUCED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STAPHYLOCOCCAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINE OUTPUT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAXOTERE</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>020449</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060626</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060626</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENOXAPARIN SODIUM</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060703</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IRINOTECAN</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060626</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060626</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052924-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060707</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>007942</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BREAST CANCER FEMALE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MEDROXYPROGESTERONE ACETATE</medicinalproduct>
        <drugauthorizationnumb>40159</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19950101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19950101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMPRO</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19950101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROVERA</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19950101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052925-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060516</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>06061797</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>87</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HAEMATURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERNATIONAL NORMALISED RATIO INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
        <drugauthorizationnumb>40301</drugauthorizationnumb>
        <drugdosagetext>2.5MG, QD, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ROYAL JELLY</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FELODIPINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCODONE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DILTIAZEM HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM (POTASSIUM CHLORIDE)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052926-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060627</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006-135</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>68</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL TENDERNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ACTIVITIES OF DAILY LIVING IMPAIRED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ALANINE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASPARTATE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHABDOMYOLYSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARBOPLATIN</medicinalproduct>
        <drugauthorizationnumb>76602</drugauthorizationnumb>
        <drugindication>PLEURAL MESOTHELIOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEMETREXED</medicinalproduct>
        <drugdosagetext>500 MG/M2</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PLEURAL MESOTHELIOMA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052927-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060627</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006-136</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>19</patientonsetage>
      <patientonsetageunit>802</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL DISTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ACTIVATED PARTIAL THROMBOPLASTIN TIME PROLONGED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANTITHROMBIN III DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD ALBUMIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD FIBRINOGEN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COAGULOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC VEIN THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATOMEGALY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IRRITABILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG INFILTRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPHOCYTE COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MONOCYTE PERCENTAGE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUCOSAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUCOSAL ULCERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROTEIN C DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROTEIN S DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROTEIN TOTAL DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROTHROMBIN TIME PROLONGED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RECTAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY DISTRESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARBOPLATIN</medicinalproduct>
        <drugauthorizationnumb>76602</drugauthorizationnumb>
        <drugdosagetext>400 MG/M2</drugdosagetext>
        <drugindication>BRAIN NEOPLASM MALIGNANT</drugindication>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LOMUSTINE</medicinalproduct>
        <drugdosagetext>75 MG/M2</drugdosagetext>
        <drugindication>BRAIN NEOPLASM MALIGNANT</drugindication>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052928-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060701</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006082549</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>54</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABNORMAL BEHAVIOUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DELIRIUM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIABETES MELLITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BENADRYL</medicinalproduct>
        <drugauthorizationnumb>5845</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060701</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052929-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060702</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006082554</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>60</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>86.1834</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DIABETES MELLITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BENADRYL</medicinalproduct>
        <drugbatchnumb>06096V</drugbatchnumb>
        <drugauthorizationnumb>5845</drugauthorizationnumb>
        <drugdosagetext>2 KAPSEALS ONCE, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERSENSITIVITY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060701</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052930-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060627</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006076174</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>79</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>APHONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LARYNGEAL DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LISTERINE MOUTHWASH ADVANCED ARCTIC MINT (MENTHOL, METHYL SALICYLATE, </medicinalproduct>
        <drugdosagetext>ONCE, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060301</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052931-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060712</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200613776EU</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DEPENDENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NICORETTE</medicinalproduct>
        <drugauthorizationnumb>018612</drugauthorizationnumb>
        <drugadministrationroute>002</drugadministrationroute>
        <drugindication>SMOKING CESSATION THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052932-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060712</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200613760EU</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DEPENDENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NICORETTE</medicinalproduct>
        <drugauthorizationnumb>018612</drugauthorizationnumb>
        <drugadministrationroute>002</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052933-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060712</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0612112A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASPIRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHOKING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARYNGOLARYNGEAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SENSATION OF FOREIGN BODY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AQUAFRESH EXTREME CLEAN WHITENING MINT EXPERIENCE TOOTHPASTE</medicinalproduct>
        <drugbatchnumb>6C20B</drugbatchnumb>
        <drugindication>DENTAL CLEANING</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052934-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060705</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-GLAXOSMITHKLINE-B0430182A</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PIRITON</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052935-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060619</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>RO200606003868</companynumb>
    <primarysource>
      <reportercountry>ROMANIA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>74</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>80</patientweight>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METASTASES TO LIVER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCREATIC CARCINOMA METASTATIC</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMULIN 70/30</medicinalproduct>
        <drugauthorizationnumb>18780</drugauthorizationnumb>
        <drugdosagetext> SEE IMAGE</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>DIABETES MELLITUS NON-INSULIN-DEPENDENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051004</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INDAPAMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PERINDOPRIL ERBUMINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052936-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060630</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>226211</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>56</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>79.8</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ENTERITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEBRILE NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SMALL INTESTINAL OBSTRUCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVASTIN</medicinalproduct>
        <drugbatchnumb>M822720</drugbatchnumb>
        <drugdosagetext>5 MG/KG, Q2W, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PANCREATIC NEOPLASM</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060502</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060530</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
        <drugdosagetext>20 MG, Q2W, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PANCREATIC NEOPLASM</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060502</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060530</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LORAZEPAM</medicinalproduct>
        <drugdosagetext>1 MG, Q2W, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PANCREATIC NEOPLASM</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060502</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060530</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GRANISETRON (GRANISETRON HYDROCHLORIDE)</medicinalproduct>
        <drugdosagetext>10 AUG/KG, Q2W, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PANCREATIC NEOPLASM</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060502</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060530</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXALIPLATIN (OXALIPLATIN)</medicinalproduct>
        <drugdosagetext>85 MG/M2, Q2W, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PANCREATIC NEOPLASM</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060502</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060530</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEUCOVORIN CALCIUM</medicinalproduct>
        <drugdosagetext>200 MG/M2, Q2W, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PANCREATIC NEOPLASM</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060502</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060530</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUOROURACIL</medicinalproduct>
        <drugdosagetext>Q2W</drugdosagetext>
        <drugindication>PANCREATIC NEOPLASM</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060502</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060530</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORAZEPAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VICODIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATIVAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLEGRA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRILOSEC</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052937-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060630</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006-02654</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>74</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL HYPOMOTILITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DILACOR XR</medicinalproduct>
        <drugauthorizationnumb>20092</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMIODARONE HCL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052938-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>MC200600442</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>73</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>93.4</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIAC ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COAGULATION TIME ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THERAPEUTIC RESPONSE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENTRICULAR FIBRILLATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ANGIOMAX</medicinalproduct>
        <drugauthorizationnumb>20873</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>040</drugadministrationroute>
        <drugindication>PERCUTANEOUS CORONARY INTERVENTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060626</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060626</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052939-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060701</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>SPV1-2006-00174</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>31</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRESCRIBED OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RECTAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ADDERALL 10</medicinalproduct>
        <drugauthorizationnumb>21303</drugauthorizationnumb>
        <drugdosagetext>30 MG DAILY</drugdosagetext>
        <drugindication>ATTENTION DEFICIT/HYPERACTIVITY DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060610</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060630</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052940-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>225671</companynumb>
    <primarysource>
      <reportercountry>SPAIN</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>65</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>72</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FEBRILE NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MABTHERA (RITUXIMAB) CONC FOR SOLUTION FOR INFUSION</medicinalproduct>
        <drugdosagetext>375 MG/M2, Q4W, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>LYMPHOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041222</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050519</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUDARABINE</medicinalproduct>
        <drugdosagetext>25 MG/M2, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>LYMPHOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041220</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050519</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOPHOSPHAMIDE</medicinalproduct>
        <drugdosagetext>1000 MG/M2, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>LYMPHOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041220</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050519</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052941-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060627</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-2006-017913</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>53</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>EPISTAXIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOPTYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYSTEMIC LUPUS ERYTHEMATOSUS</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>19960601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060215</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052942-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060627</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-2005-025992</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>72</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>DIABETES MELLITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BETASERON</medicinalproduct>
        <drugdosagetext>SUBCUTANEOUS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19940408</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052943-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060627</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-2005-006143</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>54</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>81.6</patientweight>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>BLEPHAROSPASM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISEASE PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLUENZA LIKE ILLNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE SCLEROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY TRACT 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>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041223</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050214</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAMADOL HCL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052944-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060627</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-2006-017256</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>63</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HEPATOMEGALY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER FUNCTION TEST ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOBILITY DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BETASERON</medicinalproduct>
        <drugbatchnumb>VA8406B</drugbatchnumb>
        <drugdosagetext>8 MIU, EVERY 2D, SUBCUTANEOUS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RELAPSING-REMITTING MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021016</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BACLOFEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLIPIZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOPHAGE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NITROFURANTOIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052945-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>225662</companynumb>
    <primarysource>
      <reportercountry>SPAIN</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>67</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>72</patientweight>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ASPERGILLOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACTERAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CYTOMEGALOVIRUS INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERAL PHYSICAL HEALTH DETERIORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OBLITERATIVE BRONCHIOLITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STAPHYLOCOCCAL INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MABTHERA (RITUXIMAB) CONC FOR SOLUTION FOR INFUSION</medicinalproduct>
        <drugdosagetext>875 MG/M2, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NON-HODGKIN'S LYMPHOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041222</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050316</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUDARABINE</medicinalproduct>
        <drugdosagetext>25 MG/M2, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NON-HODGKIN'S LYMPHOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041220</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050316</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOPHOSPHAMIDE</medicinalproduct>
        <drugdosagetext>1000 MG/M2, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NON-HODGKIN'S LYMPHOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041220</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050316</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IDALPREM (LORAZEPAM)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VANOBID (CANDICIDIN)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CIPROFLOX (CIPROFLOXACIN)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SEPTRIN FORTE (SULFAMETHOXAZOLE, TRIMETHOPRIM)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACYCLOVIR SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VENTOLIN (ALBUTEROL/ALBUTEROL SULFATE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PULMICORT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GANCICLOVIR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ITRACONAZOL (ITRACONAZOLE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TEICOPLANIN (TEICOPLANIN)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NUBAIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CIPRALEX (ESCITALOPRAM OXALATE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHYLPREDNISOLONE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052946-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006068506</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>23</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GALLBLADDER OPERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</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>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20000801</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugauthorizationnumb>20998</drugauthorizationnumb>
        <drugdosagetext>200 MG (200 MG, 1 IN 1 D)</drugdosagetext>
        <drugindication>NECK INJURY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20000801</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugauthorizationnumb>20998</drugauthorizationnumb>
        <drugdosagetext>200 MG (200 MG, 1 IN 1 D)</drugdosagetext>
        <drugindication>TORTICOLLIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20000801</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052947-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060701</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006073358</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>61</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>90.7194</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLADDER DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLINDNESS UNILATERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL DISORDER</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>BLOOD CHOLESTEROL</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALL OTHER THERAPEUTIC PRODUCTS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052948-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060619</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DK200606002305</companynumb>
    <primarysource>
      <reportercountry>DENMARK</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>73</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ELECTROCARDIOGRAM QT PROLONGED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DULOXETINE HYDROCHLORIDE (DULOXETINE HYDROCHLORIDE) CAPSULE</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>60 MG, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060131</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REMERON</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM /UNK/(ESOMEPRAZOLE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALOPAM (OXAZEPAM)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>STILNOCT (ZOLPIDEM TARTRATE)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052949-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006081368</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLINDNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYVOX</medicinalproduct>
        <drugauthorizationnumb>21131</drugauthorizationnumb>
        <drugindication>ENTEROCOCCAL INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052950-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006081707</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>50</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG ABUSER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
        <drugauthorizationnumb>20235</drugauthorizationnumb>
        <drugdosagetext>1200 MG (400 MG, 3 IN 1 D)</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORAZEPAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVITRA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052951-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060619</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ES200604000859</companynumb>
    <primarysource>
      <reportercountry>SPAIN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>48</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>GRANULOCYTOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELLS URINE POSITIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>60 MG; SEE IMAGE</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060302</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060316</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>60 MG; SEE IMAGE</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060316</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060327</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>60 MG; SEE IMAGE</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060327</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
        <drugindication>PSYCHOTIC DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VENLAFAXINE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAZODONE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LUDIOMIL /SCH/ (MAPROTILINE HYDROCHLORIDE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIAZEPAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHROID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLATELET AGGREGATION INHIBITORS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052952-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060705</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-2006-017905</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>36</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>73</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DYSPHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SNEEZING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHEEZING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MAGNEVIST</medicinalproduct>
        <drugbatchnumb>53010D</drugbatchnumb>
        <drugauthorizationnumb>19596</drugauthorizationnumb>
        <drugdosagetext>15 ML, 1 DOSE, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NUCLEAR MAGNETIC RESONANCE IMAGING</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060705</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060705</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052953-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060706</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-2006-001853</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>55</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>71.2</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ATRIAL FIBRILLATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BREAST CANCER FEMALE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BREAST CANCER IN SITU</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC VALVE DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EJECTION FRACTION DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG ADENOCARCINOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPHOEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OESTROGEN RECEPTOR ASSAY POSITIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POST PROCEDURAL COMPLICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROGESTERONE RECEPTOR ASSAY POSITIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SCAR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLIMARA</medicinalproduct>
        <drugauthorizationnumb>20375</drugauthorizationnumb>
        <drugdosagetext>0.5 MG/D, CONT, TRANSDERMAL</drugdosagetext>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>MENOPAUSAL SYMPTOMS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19960624</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19970717</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ESTRADERM</medicinalproduct>
        <drugdosagetext>0.5 MG, CONT, TRANSDERMAL</drugdosagetext>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>MENOPAUSAL SYMPTOMS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19910502</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19960624</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROVERA</medicinalproduct>
        <drugdosagetext>2.5 MG,</drugdosagetext>
        <drugindication>MENOPAUSAL SYMPTOMS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19910710</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19970717</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMPRO</medicinalproduct>
        <drugindication>MENOPAUSAL SYMPTOMS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19970717</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19990801</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CEPHALEXIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052954-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060626</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-2006-016917</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>59</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>PULMONARY THROMBOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BETASERON</medicinalproduct>
        <drugdosagetext>SUBCUTANEOUS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060108</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052955-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060626</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-2006-012157</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>51</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRAIN NEOPLASM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STATUS EPILEPTICUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT DECREASED</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>19960201</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052956-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060626</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-2006-016906</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>45</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>COMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DELUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HALLUCINATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENTAL STATUS CHANGES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POST PROCEDURAL COMPLICATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BETASERON</medicinalproduct>
        <drugbatchnumb>VA4527A</drugbatchnumb>
        <drugdosagetext>8 MIU, EVERY 2D, SUBCUTANEOUS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060210</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052957-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060619</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE200606001540</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>65</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ALANINE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASPARTATE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BILE DUCT STENOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BILIARY DILATATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAMMA-GLUTAMYLTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCREATIC DUCT OBSTRUCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GEMCITABINE</medicinalproduct>
        <drugauthorizationnumb>20509</drugauthorizationnumb>
        <drugdosagetext>1700 MG, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060531</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060531</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOCETAXEL (*DOCETAXEL) UNKNOWN</medicinalproduct>
        <drugdosagetext>127.5 MG, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060531</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060531</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GRANOCYTE (LENOGRASTIM)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NAVOBAN /SCH/ (TROPISETRON HYDROCHLORIDE)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052958-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-2005-019898</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>52</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ARTERIOSCLEROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIOVASCULAR 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>20010730</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAZODONE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BACLOFEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MIRAPEX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUOXETINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RANITIDINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYLENOL PM (DIPHENHYDRAMINE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENADRYL ^WARNER-LAMBERT^ /USA/ (DIPHENHYDRAMINE HYDROCHLORIDE)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052959-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060627</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-2006-017264</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>58</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DYSPEPSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GINGIVAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMMUNOSUPPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFECTION IN AN IMMUNOCOMPROMISED HOST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLUENZA LIKE ILLNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JAW DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOMYELITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BETASERON</medicinalproduct>
        <drugbatchnumb>VA6811A</drugbatchnumb>
        <drugdosagetext>8 MIU, EVERY 2D, SUBCUTANEOUS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060315</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ANTINEOPLASTIC AGENTS ()</medicinalproduct>
        <drugdosagetext>FIVE TREATMENTS,</drugdosagetext>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060301</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052960-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060627</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-2006-016885</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BETASERON</medicinalproduct>
        <drugdosagetext>SUBCUTANEOUS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052961-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060616</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP200606001514</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>68</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>56</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ELECTROCARDIOGRAM ST-T CHANGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SENSATION OF HEAVINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VARICOSE VEIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENOUS THROMBOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EVISTA</medicinalproduct>
        <drugauthorizationnumb>20815</drugauthorizationnumb>
        <drugdosagetext>60 MG, DAILY (1/D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS POSTMENOPAUSAL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060509</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALFACALCIDOL (ALFACALCIDOL) TABLET</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOXONIN (LOXOPROFEN SODIUM)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EPENARD (EPERISONE HYDROCHLORIDE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MUCOSTA (REBAMIPIDE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HALCION /NET/(TRIAZOLAM) TABLET</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOVAN ^NOVARTIS^ (VALSARTAN) TABLET, 80 MG</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>JUVELA /JPN/ (TOCOPHERYL NICOTINATE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MECOBALAMIN (MECOBALAMIN)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052962-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006081318</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>61</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>56.6996</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANOREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHROMATOPSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISORIENTATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MIDDLE INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN DISCOLOURATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VFEND</medicinalproduct>
        <drugauthorizationnumb>21266</drugauthorizationnumb>
        <drugdosagetext>400 MG (200 MG, 2 IN 1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ASPERGILLOSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060531</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALPHA HYDROXY ACID (ALPHA HYDROXY ACID)</medicinalproduct>
        <drugdosagetext>TOPICAL</drugdosagetext>
        <drugadministrationroute>061</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADVAIR DISKUS 100/50</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DYAZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VASOTEC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052963-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2005134681</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>85</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>72.5755</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CEREBRAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBRAL THROMBOSIS</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>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031217</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050418</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052964-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060630</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2005134645</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>68.0396</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBRAL THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DILATATION VENTRICULAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTRACARDIAC THROMBUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENTRICULAR HYPOKINESIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugauthorizationnumb>20998</drugauthorizationnumb>
        <drugdosagetext>(200 MG)</drugdosagetext>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEXTRA</medicinalproduct>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052965-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006081828</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BREAST CANCER FEMALE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROVERA</medicinalproduct>
        <drugauthorizationnumb>11839</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ESTRATEST</medicinalproduct>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052966-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006018740</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>40</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>50.6</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUTENT</medicinalproduct>
        <drugauthorizationnumb>21938</drugauthorizationnumb>
        <drugdosagetext>50 MG (25 MG, TWICE A DAY FOR 4 WKS WITH 2 WK WASHOUT), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTROINTESTINAL STROMAL TUMOUR</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050517</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATIVAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENADRYL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MS CONTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCODONE (OXYCODONE)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052967-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2005153164</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>46</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>106.5953</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FEAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STRESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEXTRA</medicinalproduct>
        <drugauthorizationnumb>21341</drugauthorizationnumb>
        <drugdosagetext>(20 MG)</drugdosagetext>
        <drugindication>BACK PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031114</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052968-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060619</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR200603006231</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>71</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PULMONARY FIBROSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugauthorizationnumb>21318</drugauthorizationnumb>
        <drugdosagetext>20 UG, DAILY (1/D), SUBCUTANEOUS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050513</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052969-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006082121</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BREAST CANCER FEMALE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROVERA</medicinalproduct>
        <drugauthorizationnumb>11839</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMPRO</medicinalproduct>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052970-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006054750</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>43</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PERSECUTORY DELUSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AZITHROMYCIN</medicinalproduct>
        <drugauthorizationnumb>50670</drugauthorizationnumb>
        <drugdosagetext>500 MG, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>URETHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060403</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CIPRO</medicinalproduct>
        <drugdosagetext>1000 MG, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>URETHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060403</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZANTAC</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052971-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006040636</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>55</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>85</patientweight>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>DIALYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUTENT</medicinalproduct>
        <drugauthorizationnumb>21968</drugauthorizationnumb>
        <drugdosagetext>50 MG (50 MG, 1 IN 1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RENAL CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060118</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060208</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELLCEPT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROGRAF</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLYBURIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZAROXOLYN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE TAB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARDURA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KEFLEX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PERCOCET</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMBIEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTIVITAMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORAZEPAM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052972-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006081919</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BREAST CANCER FEMALE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROVERA</medicinalproduct>
        <drugauthorizationnumb>11839</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCRIN</medicinalproduct>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052973-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006060392</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>26</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>113.3993</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG SCREEN FALSE POSITIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LOMOTIL</medicinalproduct>
        <drugauthorizationnumb>12462</drugauthorizationnumb>
        <drugdosagetext>1 CAPSULE (4 IN 1 D),</drugdosagetext>
        <drugindication>DIARRHOEA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PENICILLIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MECLIZINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052975-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060616</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>SE200606004454</companynumb>
    <primarysource>
      <reportercountry>SWEDEN</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>71</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>VITREOUS DETACHMENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EVISTA</medicinalproduct>
        <drugauthorizationnumb>20815</drugauthorizationnumb>
        <drugdosagetext>60 MG DAILY (1/D) ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050629</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060320</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052976-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060616</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR200606004016</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>45</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CAUSTIC INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GLOSSODYNIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROZAC</medicinalproduct>
        <drugauthorizationnumb>18936</drugauthorizationnumb>
        <drugdosagetext>20 MG DAILY (1/D) ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060616</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060616</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052977-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060630</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006065306</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GLUCOTROL</medicinalproduct>
        <drugauthorizationnumb>17783</drugauthorizationnumb>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GLUCOPHAGE</medicinalproduct>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052978-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006063590</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DISEASE PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugauthorizationnumb>21446</drugauthorizationnumb>
        <drugdosagetext>300 MG (150 MG, 2 IN 1 D)</drugdosagetext>
        <drugindication>COMPLEX REGIONAL PAIN SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugauthorizationnumb>21446</drugauthorizationnumb>
        <drugdosagetext>300 MG (150 MG, 2 IN 1 D)</drugdosagetext>
        <drugindication>RADICULOPATHY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REVLIMID (UK-14,275)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EFFEXOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHADONE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCODONE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NITROFURANTOIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052979-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006082855</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>90.7194</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIOVASCULAR DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugauthorizationnumb>20998</drugauthorizationnumb>
        <drugdosagetext>100 MG (100 MG, 1 IN 1 D)</drugdosagetext>
        <drugindication>ARTHRALGIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020820</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052980-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006071826</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREATMENT NONCOMPLIANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL ACUITY REDUCED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GLUCOTROL XL</medicinalproduct>
        <drugauthorizationnumb>20329</drugauthorizationnumb>
        <drugdosagetext>2.5 MG (2.5 MG,1 IN 1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GLIPIZIDE</medicinalproduct>
        <drugdosagetext>10 MG (5 MG, 2 IN 1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052981-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006080733</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>69.8539</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLADDER DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYSTERECTOMY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POOR PERIPHERAL CIRCULATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENOUS OPERATION</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>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CAMPRAL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROMETRIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NITROFURAN (NITROFURANTOIN)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052982-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060619</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR200606004255</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>33</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>AGGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISORIENTATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG WITHDRAWAL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ENCEPHALITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HALLUCINATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTHERMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENINGITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCLONUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROZAC</medicinalproduct>
        <drugauthorizationnumb>18936</drugauthorizationnumb>
        <drugdosagetext>20 MG DAILY (1/D) ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060501</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PAROXETINE HYDROCHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATARAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RAMIPRIL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052983-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006082831</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>78</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BRONCHOSPASM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCORRECT DOSE ADMINISTERED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCREASED BRONCHIAL SECRETION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XALATAN</medicinalproduct>
        <drugauthorizationnumb>20597</drugauthorizationnumb>
        <drugdosagetext>2 DROP (EVERY DAY)</drugdosagetext>
        <drugindication>GLAUCOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060105</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVAPRO</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZANTAC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CENTRUM (MINERALS NOS, VITAMINS NOS)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM GLUCONATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGNESIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052984-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006082053</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>5</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>31.7518</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHEEZING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZITHROMAX</medicinalproduct>
        <drugauthorizationnumb>50670</drugauthorizationnumb>
        <drugindication>CYSTITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052985-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060619</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR200606004453</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>78</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HAEMODIALYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOLYTIC URAEMIC SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOTIC MICROANGIOPATHY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROZAC</medicinalproduct>
        <drugauthorizationnumb>18936</drugauthorizationnumb>
        <drugdosagetext>20 MG DAILY (1/D) ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060418</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARTOTEC   (DICLOFENAC SODIUM, MISOPROSTOL)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BECONASE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COZAAR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OROCAL      (CALCIUM CARBONATE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FENOFIBRATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRAXILENE      (NAFTIDROFORYL OXALATE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VENTOLIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DI-ANTALVIC    (DEXTROPROPOXYPHENE HYDROCHLORIDE)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052986-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006082199</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>68.0396</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANTINUCLEAR ANTIBODY POSITIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FIBROMYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOFASCIAL PAIN SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY FIBROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THERAPY NON-RESPONDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugauthorizationnumb>20998</drugauthorizationnumb>
        <drugdosagetext>200 MG (200 MG, 1 IN 1 D)</drugdosagetext>
        <drugindication>MUSCULOSKELETAL PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THEO-DUR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROTONIX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052987-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006082819</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>61</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>97.5234</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugauthorizationnumb>20998</drugauthorizationnumb>
        <drugdosagetext>400 MG (200 MG, 2 IN 1 D)</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990625</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040411</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052988-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006082248</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>50</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>73.0291</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PAIN OF SKIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH PRURITIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SCAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEXTRA</medicinalproduct>
        <drugauthorizationnumb>21341</drugauthorizationnumb>
        <drugdosagetext>20 MG (20 MG, 1 IN 1 D)</drugdosagetext>
        <drugindication>ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052990-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060630</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006083343</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>51</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>82.5547</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DIABETIC NEUROPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIALYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC ENZYME INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROTEIN TOTAL DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VASCULAR BYPASS GRAFT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>YELLOW SKIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugauthorizationnumb>20702</drugauthorizationnumb>
        <drugdosagetext>80 MG (80 MG, DAILY)</drugdosagetext>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRICOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALL OTHER THERAPEUTIC PRODUCTS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMDUR</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052991-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060616</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB200606004512</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGE INTRACRANIAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XIGRIS</medicinalproduct>
        <drugindication>MENINGITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052992-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006082886</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>64</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PROSTATE CANCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROSTATE EXAMINATION ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugauthorizationnumb>20998</drugauthorizationnumb>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052993-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006083650</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>LOW DENSITY LIPOPROTEIN INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugauthorizationnumb>20702</drugauthorizationnumb>
        <drugdosagetext>20 MG</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052994-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060616</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>NL200606003867</companynumb>
    <primarysource>
      <reportercountry>NETHERLANDS</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>10</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>34.0198</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANOREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FOOD POISONING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTHERMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SHOCK</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>STRATTERA</medicinalproduct>
        <drugauthorizationnumb>21411</drugauthorizationnumb>
        <drugindication>ATTENTION DEFICIT/HYPERACTIVITY DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052995-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060705</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>TAP2006Q01147</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>96</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>72.6</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPEPSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRIC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRIC ULCER PERFORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HOT FLUSH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLUENZA LIKE ILLNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LUPRON DEPOT-4</medicinalproduct>
        <drugauthorizationnumb>20517</drugauthorizationnumb>
        <drugdosagetext>30 MG, EVERY 4 TO 6 MONTHS, INTRAMUSCULAR</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>PROSTATE CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060605</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IRON</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIURETICS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TART CHERRY EXTRACT</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052996-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060706</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>TAP2006Q01156</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>66</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISION BLURRED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREVACID</medicinalproduct>
        <drugauthorizationnumb>20406</drugauthorizationnumb>
        <drugdosagetext>30 MG, 1 IN 1 D, PER ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052997-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060626</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-CVT-061395</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DISORIENTATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RANEXA</medicinalproduct>
        <drugauthorizationnumb>21526</drugauthorizationnumb>
        <drugdosagetext>500 MG, BID, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANGINA PECTORIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060601</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052998-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060619</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE200511000181</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>15</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>59.013</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>AGGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AGITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOOD ALTERED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NO THERAPEUTIC RESPONSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>STRATTERA</medicinalproduct>
        <drugauthorizationnumb>21411</drugauthorizationnumb>
        <drugdosagetext>25 MG DAILY (1/D) ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATTENTION DEFICIT/HYPERACTIVITY DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050824</drugstartdate>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5052999-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060626</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GP022506</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>61.2356</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>COMPLEX PARTIAL SEIZURES</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GRIS-PEG 250MG TABLET, PEDINOL PHARMACAL INC.</medicinalproduct>
        <drugauthorizationnumb>50475</drugauthorizationnumb>
        <drugdosagetext>250 MG TID, ORALLY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ONYCHOMYCOSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TEGRETOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEPAKOTE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053000-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2005134706</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </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>CEREBRAL THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTRACARDIAC THROMBUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugauthorizationnumb>20998</drugauthorizationnumb>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEXTRA</medicinalproduct>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053001-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040712</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>HP20041134</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HEART RATE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PANAFIL OINTMENT (HEALTHPOINT, LTD.)</medicinalproduct>
        <drugdosagetext>1X DAILY (060)</drugdosagetext>
        <drugindication>PROMOTION OF WOUND HEALING</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040621</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040724</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REGRANEX</medicinalproduct>
        <drugdosagetext>(060)</drugdosagetext>
        <drugindication>PROMOTION OF WOUND HEALING</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040621</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040724</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053002-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060703</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006-07-0241</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>47</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CHILLS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ILL-DEFINED DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLUENZA LIKE ILLNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RIBAVIRIN</medicinalproduct>
        <drugauthorizationnumb>20903</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060301</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEGASYS</medicinalproduct>
        <drugdosagetext>SUBCUTANEOUS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060301</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053003-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060626</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006RR-02818</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>51</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHABDOMYOLYSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugauthorizationnumb>76285</drugauthorizationnumb>
        <drugdosagetext>20 MG, BID, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERCHOLESTEROLAEMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RITONAVIR (RITONAVIR)</medicinalproduct>
        <drugdosagetext>100 MG, BID, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERCHOLESTEROLAEMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZIDOVUDINE TABLETS (ZIDOVUDINE) TABLET</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMIVUDINE (LAMIVUDINE) TABLET</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INDINIVIR SULFATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</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>MECLIZINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053004-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060228</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IT200601001751</companynumb>
    <primarysource>
      <reportercountry>ITALY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>67</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>73.5</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>CARDIAC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERICARDIAL EFFUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEMETREXED</medicinalproduct>
        <drugauthorizationnumb>21462</drugauthorizationnumb>
        <drugdosagetext>910 MG OTHER INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MESOTHELIOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050812</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CISPLATIN</medicinalproduct>
        <drugdosagetext>136 MG OTHER INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MESOTHELIOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050812</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN B12( CYANCOBALAMIN)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RADIATION (RADIATION)</medicinalproduct>
        <drugdosagetext>DAILY (1/D)</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051109</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051221</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VERAPAMIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMIODARONE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ISOPTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN W/ CODEINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053005-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>225778</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>81</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANTERIOR CHAMBER FLARE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONJUNCTIVAL HYPERAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CORNEAL OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CORNEAL STRIAE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE OPERATION COMPLICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LATEX ALLERGY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVASTIN</medicinalproduct>
        <drugbatchnumb>20061705</drugbatchnumb>
        <drugdosagetext>1 MG, SINGLE, INTRAVITREAL</drugdosagetext>
        <drugindication>MACULAR DEGENERATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVASTIN</medicinalproduct>
        <drugbatchnumb>M66781</drugbatchnumb>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GENTAMICIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053006-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060627</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006BI002679</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>56</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>97.5234</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEBRILE CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</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>20040714</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMITREX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MOTRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MYSOLINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPAMAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEPAKOTE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053007-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>225779</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>78</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CORNEAL OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LATEX ALLERGY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVASTIN</medicinalproduct>
        <drugbatchnumb>20061705</drugbatchnumb>
        <drugdosagetext>1 MG, SINGLE, INTRAVITREAL</drugdosagetext>
        <drugindication>MACULAR DEGENERATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVASTIN</medicinalproduct>
        <drugbatchnumb>M66781</drugbatchnumb>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GENTAMICIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053008-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060519</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GILEAD-2006-0009608</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>30</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ALPHA 1 FOETOPROTEIN ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PREGNANCY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRUVADA</medicinalproduct>
        <drugauthorizationnumb>21752</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040316</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050330</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVIR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040316</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040330</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REYATAZ</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040316</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040330</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KALETRA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050330</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050525</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRIZIVIR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050330</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050525</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VIRACEPT</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050603</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051227</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COMBIVIR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050603</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051227</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZIDOVUDINE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051103</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051103</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZIDOVUDINE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051103</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051103</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLATE SUPPLEMENT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRIMETHOPRIM + SULFAMETHOXAZOLE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053009-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060706</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006BI009667</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>71</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ARRHYTHMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRONCHIECTASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RIGHT VENTRICULAR FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SCAR</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>19960901</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>20060526</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053010-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006056922</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>46</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>63.5036</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEXTRA</medicinalproduct>
        <drugauthorizationnumb>21341</drugauthorizationnumb>
        <drugdosagetext>20 MG (20 MG, 1 IN 1 D)</drugdosagetext>
        <drugindication>TENDON INJURY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040614</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugdosagetext>50 MG (25 MG, 2 IN 1 D)</drugdosagetext>
        <drugindication>MUSCULOSKELETAL DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040611</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040815</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADVIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEMEROL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MORPHINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053011-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060703</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006BI009502</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>64</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>77.1115</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY OCCLUSION</reactionmeddrapt>
      </reaction>
      <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>20010420</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>5053012-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006056473</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIOVASCULAR DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEXTRA</medicinalproduct>
        <drugauthorizationnumb>21341</drugauthorizationnumb>
        <drugdosagetext>1 IN 1 D</drugdosagetext>
        <drugindication>APPENDIX DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEXTRA</medicinalproduct>
        <drugauthorizationnumb>21341</drugauthorizationnumb>
        <drugdosagetext>1 IN 1 D</drugdosagetext>
        <drugindication>BACK PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053013-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006054685</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>62</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>90.7194</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ANGIOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTERIAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIOVASCULAR DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBRAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugauthorizationnumb>20998</drugauthorizationnumb>
        <drugdosagetext>400 MG (200 MG, 2 IN 1 D)</drugdosagetext>
        <drugindication>HEADACHE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000706</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040919</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053014-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060705</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006BI007367</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>41</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>RENAL CELL CARCINOMA STAGE UNSPECIFIED</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>20050401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050601</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053015-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060525</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006058796</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>69</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>99.7913</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ARRHYTHMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ATRIAL FIBRILLATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ATRIOVENTRICULAR BLOCK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STRESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENTRICULAR DYSFUNCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugauthorizationnumb>20998</drugauthorizationnumb>
        <drugdosagetext>400 MG (200 MG, 2 IN 1 D)</drugdosagetext>
        <drugindication>ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19981010</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053016-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060705</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006BI007600</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>63</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLADDER PROLAPSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CYSTITIS</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>20060106</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060619</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053017-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060525</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006058779</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>68</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>73.9363</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ACUTE MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIOMEGALY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MITRAL VALVE INCOMPETENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUS BRADYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRICUSPID VALVE INCOMPETENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENTRICULAR EXTRASYSTOLES</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugauthorizationnumb>20998</drugauthorizationnumb>
        <drugdosagetext>400 MG (200 MG, 2 IN 1 D)</drugdosagetext>
        <drugindication>ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20011101</drugstartdate>
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    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053018-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006058391</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>51</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>86.1834</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ACUTE MYOCARDIAL INFARCTION</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>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053019-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060705</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006BI007303</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>59</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIAC ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MITRAL VALVE DISEASE</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>20060329</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053020-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060526</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006057870</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>54</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>65.7716</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBRAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG HYPERSENSITIVITY</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>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020612</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041008</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053021-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006068712</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>59</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>65.7716</patientweight>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>CARDIO-RESPIRATORY ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugauthorizationnumb>20998</drugauthorizationnumb>
        <drugdosagetext>200 MG (100 MG, 2 IN 1 D)</drugdosagetext>
        <drugindication>OSTEOARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19991219</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030513</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053022-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060706</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006BI006983</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CYSTITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERVERTEBRAL DISC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>KIDNEY INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NERVE COMPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SCIATIC NERVE 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>20020220</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>5053023-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006081901</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BREAST CANCER FEMALE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>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>PREMARIN</medicinalproduct>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053024-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006082134</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BREAST CANCER FEMALE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>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>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053025-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006BI006369</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>59</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE SCLEROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERONEAL NERVE PALSY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VASCULAR INSUFFICIENCY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugbatchnumb>P35056</drugbatchnumb>
        <drugdosagetext>30 UG;QW;IM</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19971007</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>5053026-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2005134637</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>61</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIOVASCULAR DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBRAL THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEMIPARESIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MITRAL VALVE REPLACEMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRANSIENT ISCHAEMIC ATTACK</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugauthorizationnumb>20998</drugauthorizationnumb>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEXTRA</medicinalproduct>
        <drugdosagetext>10 MG (10 MG, 1 IN 1 D)</drugdosagetext>
        <drugindication>OSTEOARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030617</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053027-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2005071963</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>117.9352</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STEVENS-JOHNSON SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEXTRA</medicinalproduct>
        <drugauthorizationnumb>21341</drugauthorizationnumb>
        <drugindication>ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050401</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053028-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004121728</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>53</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>98.2</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL STROMAL TUMOUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATEMESIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TUMOUR HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TUMOUR PERFORATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUTENT</medicinalproduct>
        <drugauthorizationnumb>21938</drugauthorizationnumb>
        <drugdosagetext>50 MG (50 MG, CYCLIC INTERVAL: DAY 1-28 OF 6 WEEKS0, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTROINTESTINAL STROMAL TUMOUR</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041013</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041221</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLOBETASOL (CLOBETASOL)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COLACE (DOCUSATE SODIUM)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FENTANYL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOFRAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REGLAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM CHLORIDE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053029-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060630</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2005105632</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>48</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>83.9154</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABNORMAL BEHAVIOUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTERIOSCLEROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BOREDOM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COGNITIVE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSARTHRIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSLEXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPHASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEMORY IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE ATROPHY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEXTRA</medicinalproduct>
        <drugauthorizationnumb>21341</drugauthorizationnumb>
        <drugdosagetext>10 MG</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030701</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053030-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060630</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2005134716</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>46</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>77.1115</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE CONGESTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIOVASCULAR DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBRAL THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTRACARDIAC THROMBUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugauthorizationnumb>20998</drugauthorizationnumb>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEXTRA</medicinalproduct>
        <drugdosagetext>2-3 PER DAY (20 MG)</drugdosagetext>
        <drugindication>MUSCULOSKELETAL STIFFNESS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEXTRA</medicinalproduct>
        <drugdosagetext>2-3 PER DAY (20 MG)</drugdosagetext>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053031-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060707</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20060701363</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIAC FIBRILLATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONTUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIPOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAXZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053032-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006082124</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BREAST CANCER FEMALE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEMOTHERAPY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RADIOTHERAPY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SURGERY</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>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053033-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006012785</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>68</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOACUSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL ACUITY REDUCED</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>PAIN IN EXTREMITY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053034-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2005163001</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>59.8748</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ALOPECIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DERMATITIS ALLERGIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHOTOSENSITIVITY REACTION</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>ARTHRITIS</drugindication>
      </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>SYSTEMIC LUPUS ERYTHEMATOSUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAQUENIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARAVA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SULFASALAZINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053035-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2005155002</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>43</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>82.5547</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANGINA PECTORIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY STENOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSLIPIDAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOBACCO ABUSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugauthorizationnumb>20998</drugauthorizationnumb>
        <drugdosagetext>400 MG (200 MG, 2 IN 1 D)</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040915</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050112</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRILOSEC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORTAB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROTONIX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053036-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006030200</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIAGRA</medicinalproduct>
        <drugauthorizationnumb>20895</drugauthorizationnumb>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053037-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006082141</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BREAST CANCER FEMALE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>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>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053038-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060525</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006053258</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>67</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG ERUPTION</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>BACK PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BACTRIM</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053039-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060701</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006050132</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>89</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>58.0604</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLATULENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUS HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TEMPORAL ARTERITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CADUET</medicinalproduct>
        <drugauthorizationnumb>21540</drugauthorizationnumb>
        <drugdosagetext>10/5 MG    ALMOST 2 YEARS AGO -ONGOING</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAXZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IBANDRONATE SODIUM (IBANDRONATE SODIUM)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPROL-XL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM (CALCIUM)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARICEPT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CENTRUM SILVER (ASCORBIC ACID, CALCIUM, MINERALS NOS, RETINOL, TOCOPHE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LUMIGAN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053040-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006082140</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </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>PREMARIN</medicinalproduct>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CENESTIN</medicinalproduct>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053041-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060526</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006048539</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>66</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>93.8946</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ACUTE MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIO-RESPIRATORY ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERLIPIDAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEXTRA</medicinalproduct>
        <drugauthorizationnumb>21341</drugauthorizationnumb>
        <drugdosagetext>20 MG (10 MG, 2 IN 1 D)</drugdosagetext>
        <drugindication>PAIN MANAGEMENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030628</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040729</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053042-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060526</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006057530</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>48</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>121.564</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY STENOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugauthorizationnumb>20998</drugauthorizationnumb>
        <drugdosagetext>200 MG (100 MG, 2 IN 1 D)</drugdosagetext>
        <drugindication>ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053043-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006082139</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BREAST CANCER FEMALE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>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>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053044-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006082148</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>OVARIAN CANCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SURGERY</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>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053045-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006082152</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </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>PREMARIN</medicinalproduct>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053046-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006082155</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BREAST CANCER FEMALE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROVERA</medicinalproduct>
        <drugauthorizationnumb>11839</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMPRO</medicinalproduct>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053047-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060609</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006UW12435</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>42</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>86.8</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD CREATINE PHOSPHOKINASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD URINE PRESENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FACIAL PALSY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugauthorizationnumb>21366</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DYSLIPIDAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060606</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060608</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053048-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006082157</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BREAST CANCER FEMALE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROVERA</medicinalproduct>
        <drugauthorizationnumb>11839</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMPRO</medicinalproduct>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ESTRATAB</medicinalproduct>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053049-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006082145</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BREAST CANCER FEMALE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POLYTRAUMATISM</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>COMBIPATCH</medicinalproduct>
        <drugdosagetext>250 MCG, TRANSDERMAL</drugdosagetext>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053050-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060502</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-BRISTOL-MYERS SQUIBB COMPANY-13364153</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>60</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>71</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ATRIAL FIBRILLATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARBOPLATIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>LUNG NEOPLASM MALIGNANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060321</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060321</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAXOL</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>LUNG NEOPLASM MALIGNANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060321</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060321</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROMORPHONE HCL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060310</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATIVAN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060320</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MILK OF MAGNESIA TAB</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051208</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EMTEC-30</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060119</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOCUSATE SODIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060301</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SENOKOT</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LACTULOSE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051129</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060410</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROCHLORPERAZINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060321</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060424</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EX-LAX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053051-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060710</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-13437728</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BREAST CANCER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ESTRACE</medicinalproduct>
        <drugauthorizationnumb>084499</drugauthorizationnumb>
        <drugindication>HORMONE THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ESTRADIOL</medicinalproduct>
        <drugauthorizationnumb>084499</drugauthorizationnumb>
        <drugindication>HORMONE THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROVERA</medicinalproduct>
        <drugindication>HORMONE THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
        <drugindication>HORMONE THERAPY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053052-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060523</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-13386255</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>39</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>CHRONIC MYELOID LEUKAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL ULCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLEURAL EFFUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESTRICTIVE PULMONARY DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DASATINIB</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CHRONIC MYELOID LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060316</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060608</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053053-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060607</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-BRISTOL-MYERS SQUIBB COMPANY-13407036</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>74</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>123</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ACUTE MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ERBITUX</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>COLORECTAL CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050831</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IRINOTECAN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLORECTAL CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050831</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOLINIC ACID</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLORECTAL CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050831</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUOROURACIL</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLORECTAL CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050831</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugindication>GASTROOESOPHAGEAL REFLUX DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NIFEDIPINE</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NITRAZEPAM</medicinalproduct>
        <drugindication>INSOMNIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVAPRO HCT</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROPANOL</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MINOCYCLINE HCL</medicinalproduct>
        <drugindication>RASH</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BETAMETHASONE</medicinalproduct>
        <drugindication>PARONYCHIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCORTISONE</medicinalproduct>
        <drugindication>RASH</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BETADINE</medicinalproduct>
        <drugindication>PARONYCHIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNEFRIN</medicinalproduct>
        <drugindication>OCULAR HYPERAEMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PHENERGAN HCL</medicinalproduct>
        <drugindication>PREMEDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ONDANSETRON HCL</medicinalproduct>
        <drugindication>NAUSEA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE TAB</medicinalproduct>
        <drugindication>PREMEDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALAMINE</medicinalproduct>
        <drugindication>RASH</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANOLIN</medicinalproduct>
        <drugindication>RASH</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053054-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060710</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-13437769</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BREAST CANCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BREAST CANCER FEMALE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ESTRACE</medicinalproduct>
        <drugauthorizationnumb>084499</drugauthorizationnumb>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROVERA</medicinalproduct>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MEDROXYPROGESTERONE ACETATE</medicinalproduct>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053055-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060706</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-13439450</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>INFLAMMATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL ACUITY REDUCED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KENALOG-40</medicinalproduct>
        <drugbatchnumb>6C15315, 6C18416</drugbatchnumb>
        <drugauthorizationnumb>014901</drugauthorizationnumb>
        <drugadministrationroute>031</drugadministrationroute>
        <drugindication>MACULAR OEDEMA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053056-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060706</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-13435839</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>INFLAMMATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL ACUITY REDUCED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KENALOG-40</medicinalproduct>
        <drugbatchnumb>6C15315, 6C18416</drugbatchnumb>
        <drugauthorizationnumb>014901</drugauthorizationnumb>
        <drugadministrationroute>031</drugadministrationroute>
        <drugindication>MACULAR OEDEMA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053057-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060706</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-13439476</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>INFLAMMATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL ACUITY REDUCED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KENALOG-40</medicinalproduct>
        <drugbatchnumb>6C15315, 6C18416</drugbatchnumb>
        <drugauthorizationnumb>014901</drugauthorizationnumb>
        <drugadministrationroute>031</drugadministrationroute>
        <drugindication>MACULAR OEDEMA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053058-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060710</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-13437744</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>65</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>98</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ALANINE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASPARTATE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ATRIAL FIBRILLATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CREATINE PHOSPHOKINASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OESOPHAGITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ERBITUX</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>SQUAMOUS CELL CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060522</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060522</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOCETAXEL</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>SQUAMOUS CELL CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060626</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060626</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RADIATION THERAPY</medicinalproduct>
        <drugindication>SQUAMOUS CELL CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060629</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060629</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CIALIS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYZAAR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCODONE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PILOCARPINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053059-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006082162</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BREAST CANCER FEMALE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>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>PREMARIN</medicinalproduct>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19920101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19980101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053060-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060630</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006082179</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE SYSTOLIC INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
        <drugauthorizationnumb>19787</drugauthorizationnumb>
        <drugdosagetext>5 MG (5 MG, FREQUENCY: QD INTERVAL: EVERYDAY), ORAL; 8 YRS AGO - ONGOING</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053061-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006082165</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BREAST CANCER FEMALE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROVERA</medicinalproduct>
        <drugauthorizationnumb>11839</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMPRO</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053062-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006082160</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>59</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>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>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19950101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19950101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ESTRATEST</medicinalproduct>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19950101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACTIVELLA</medicinalproduct>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19950101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053063-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060707</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-ABBOTT-06P-167-0337816-00</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABSCESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060201</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053064-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060623</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-ABBOTT-06P-167-0336957-00</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>50</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060120</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</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>UNSPECIFIED INHALERS</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>CYCLOSPORINE</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053065-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060708</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-ABBOTT-06P-028-0337894-00</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>54.48</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FACIAL PALSY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LACRIMATION INCREASED</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>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</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>PYRIDOXINE HYDROCHLORIDE INJ</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYANOCOBALAMIN</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053066-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060707</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CZ-ABBOTT-06P-217-0337773-00</companynumb>
    <primarysource>
      <reportercountry>CZECH REPUBLIC</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPEPSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>JUVENILE ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030903</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHYLPREDNISOLONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>JUVENILE ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19900101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS AGAINST GASTROINTESTINAL ULCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COXTRAL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>JUVENILE ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053067-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060706</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ABBOTT-06P-087-0337662-00</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
    </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>RHEUMATOID ARTHRITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLARITHROMYCIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>050662</drugauthorizationnumb>
        <drugindication>HELICOBACTER INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19991112</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LANSOPRAZOLE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>HELICOBACTER INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19991112</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMOXICILLIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>HELICOBACTER INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19991112</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PENICILLAMINE</medicinalproduct>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GOLD SALT</medicinalproduct>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>STEROIDS</medicinalproduct>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053068-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060706</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20051101871</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>67</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>B-CELL LYMPHOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHEUMATOID ARTHRITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugdosagetext>RECEIVED 22 INFUSIONS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAQUENIL</medicinalproduct>
        <drugdosagetext>STARTED PRE-2002</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugdosagetext>STARTED PRE-2002, DOSE 7.5-10MG/WEEK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DISALCID</medicinalproduct>
        <drugdosagetext>STARTED PRE-2002</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IRON</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>M.V.I.</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VERELAN</medicinalproduct>
        <drugdosagetext>STARTED PRE-2002</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREVACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COLACE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SULFASALAZINE</medicinalproduct>
        <drugdosagetext>STARTED PRE-2002</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DYAZIDE</medicinalproduct>
        <drugdosagetext>STARTED PRE-2002</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053069-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060706</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20060203421</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>LYMPHOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053070-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006082577</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>45</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>54.4316</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CHEST DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL MUCOSAL BLISTERING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHOTOSENSITIVITY REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUNBURN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
        <drugauthorizationnumb>20235</drugauthorizationnumb>
        <drugdosagetext>300 MG  (100 MG, 3 IN 1 D)</drugdosagetext>
        <drugindication>NEURALGIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugdosagetext>300 MG (100 MG, 3 IN 1 D)</drugdosagetext>
        <drugindication>NEURALGIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEXAPRO</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCODONE BITARTRATE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053071-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006082471</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>0</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>AGITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVERDOSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GEODON</medicinalproduct>
        <drugauthorizationnumb>20919</drugauthorizationnumb>
        <drugdosagetext>20 MG, INTRAMUSCULAR</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053072-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006082317</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FIBROMYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC STEATOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTHYROIDISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IRRITABLE BOWEL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METABOLIC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUROPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCREATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugauthorizationnumb>20702</drugauthorizationnumb>
        <drugdosagetext>20 MG</drugdosagetext>
        <drugindication>BLOOD CHOLESTEROL</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugauthorizationnumb>20702</drugauthorizationnumb>
        <drugdosagetext>20 MG</drugdosagetext>
        <drugindication>BLOOD TRIGLYCERIDES</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugauthorizationnumb>20702</drugauthorizationnumb>
        <drugdosagetext>20 MG</drugdosagetext>
        <drugindication>HEPATIC STEATOSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
        <drugdosagetext>1800 MG (600 MG, 3 IN 1 D)</drugdosagetext>
        <drugindication>FIBROMYALGIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HYDROCODONE BITARTRATE</medicinalproduct>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SANDOSTATIN (OCTREOTIDE ACETATE)</medicinalproduct>
        <drugindication>DIARRHOEA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRONOLACTONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMBIEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALL OTHER THERAPEUTIC PRODUCTS (ALL OTHER THERAPEUTIC PRODUCTS)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZANAFLEX</medicinalproduct>
        <drugindication>FIBROMYALGIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053073-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006082878</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>29</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>97.977</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEXTRA</medicinalproduct>
        <drugauthorizationnumb>21341</drugauthorizationnumb>
        <drugdosagetext>20 MG (20 MG, 1 IN 1 D)</drugdosagetext>
        <drugindication>ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020923</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053074-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060707</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-ABBOTT-06P-167-0337898-00</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>84</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ARTERIOSCLEROSIS CORONARY ARTERY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY THROMBOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031115</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEFLUNOMIDE</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>AMITRIPTYLINE HCL</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETYLSALICYLIC ACID SRT</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BUPRENORPHINE HCL</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELECOXIB</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DF 118</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENALAPRIL MALEATE</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUCLOXACILLIN</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>PARACETAMOL</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053075-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060707</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-ABBOTT-06P-028-0337827-00</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>LENTIGO MALIGNA STAGE UNSPECIFIED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050704</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053076-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060707</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-ABBOTT-06P-028-0337726-00</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>21</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>LEUKOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MERIDIA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020632</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>WEIGHT DECREASED</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053077-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050708</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IT-ABBOTT-05P-083-0305385-00</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>24</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG LEVEL DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYELID OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCORRECT DOSE ADMINISTERED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OCULAR ICTERUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STEVENS-JOHNSON SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THERAPY REGIMEN CHANGED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VALPROATE SODIUM</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>018081</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GRAND MAL CONVULSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VALPROATE SODIUM</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>018081</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>LAMOTRIGINE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GRAND MAL CONVULSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>LAMOTRIGINE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>LAMOTRIGINE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053078-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060519</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-06P-163-0334110-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>30</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABORTION SPONTANEOUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KALETRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>21906</drugauthorizationnumb>
        <drugdosagetext>798 MG/198 MG DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060412</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NORVIR</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020945</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060201</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMPRENAVIR CALCIUM</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060201</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TENOFOVIR DISOPROXIL FULMARATE/EMTRICITABINE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>200 MG/300 MG DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060201</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMIVUDINE + ZIDOVUDINE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>600 MG/ 300 MG DAILY</drugdosagetext>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060412</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053079-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060619</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-ABBOTT-06P-062-0336375-00</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>77</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>KNEE ARTHROPLASTY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060315</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060510</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NSAR</medicinalproduct>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOCORTICOIDS</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053080-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050307</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-ABBOTT-05P-167-0293539-00</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>76</patientweight>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>FASCIITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030630</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050301</drugenddate>
        <drugtreatmentduration>610</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KETOPROFEN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TIBOLONE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM CARBONATE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PARACETAMOL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053081-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060608</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-ABBOTT-06P-020-0335590-00</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>60</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>EAR INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ISCHAEMIC STROKE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MASTOIDITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENINGOENCEPHALITIS BACTERIAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CORTICOID</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053082-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060707</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BE-ABBOTT-06P-013-0337825-00</companynumb>
    <primarysource>
      <reportercountry>BELGIUM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INTERVERTEBRAL DISC PROTRUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WOUND INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041209</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060601</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053083-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060707</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GR-ABBOTT-06P-066-0337685-00</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>23</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INTENTIONAL OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPHOCYTOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDE ATTEMPT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEPAKENE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>018081</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>EPILEPSY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19920101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEPAKENE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>018081</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INTENTIONAL OVERDOSE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060625</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060625</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEPAKENE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>018081</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LAMOTRIGINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>EPILEPSY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053084-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060410</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2006-BP-04513AU</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DEVICE FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY RETENTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
        <drugbatchnumb>NR</drugbatchnumb>
        <drugauthorizationnumb>021395</drugauthorizationnumb>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>QVAR 40</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BRICANYL (TERBUTALINE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RHINOCORT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VIBRA-TABS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX (FRUSEMIDE)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053085-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060606</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2006-BP-06520BP</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>47</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>63.96</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ENCEPHALOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOXOPLASMOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>APTIVUS/RITONAVIR CAPSULES</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>21814</drugauthorizationnumb>
        <drugdosagetext>TPV 1000MG / RTV ?</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050622</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050714</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>APTIVUS/RITONAVIR CAPSULES</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>021814</drugauthorizationnumb>
        <drugindication>ACQUIRED IMMUNODEFICIENCY SYNDROME</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLINDAMYCIN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050714</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DARAPRIM</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050714</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DAPSONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050714</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPORANOX</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050507</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050714</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZITHROMAX</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050309</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050714</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEUCOVORIN CALCIUM</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050714</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRUVADA</medicinalproduct>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050714</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053086-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060710</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2006-BP-07897AU</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>94</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOWER RESPIRATORY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MICARDIS</medicinalproduct>
        <drugbatchnumb>NR</drugbatchnumb>
        <drugauthorizationnumb>020850</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053087-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060517</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2006-BP-05578BP</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>73</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>49.09</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BRONCHOSPASM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CYANOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LARYNGOSPASM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ATROVENT</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>19085</drugauthorizationnumb>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20000101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>QVAR 80</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ELAVIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACCOLATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALDACTONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>QUININE SULFATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHROID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMINS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053088-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060713</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2006-BP-08087BP</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>83</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTRACRANIAL HAEMATOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLOMAX</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>020579</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060325</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060325</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053089-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060711</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2006-BP-07900AU</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>90</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FACE OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIP EXFOLIATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA ORAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MOBIC</medicinalproduct>
        <drugbatchnumb>NR</drugbatchnumb>
        <drugauthorizationnumb>020938</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051205</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051206</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DITHIAZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EPILIM EC (SODIUM VALPROATE)</medicinalproduct>
        <drugindication>EPILEPSY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OROXINE</medicinalproduct>
        <drugindication>HYPOTHYROIDISM</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053090-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050329</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>MX-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2005-BP-05239MX</companynumb>
    <primarysource>
      <reportercountry>MEXICO</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>53</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MOBICOX 15.0 MG TABLETS</medicinalproduct>
        <drugbatchnumb>NR</drugbatchnumb>
        <drugauthorizationnumb>20938</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NEUROPATHY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050107</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050127</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053091-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060707</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006BI008473</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>53</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>OSTEOARTHRITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030801</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030801</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053092-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060703</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006BI008221</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>52</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEMIPARESIS</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>20010501</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>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053093-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060706</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006BI007960</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053094-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060705</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006BI007640</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>44</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugdosagetext>30 UG;QW;IM</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053095-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060707</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006BI008477</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>67</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CELLULITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugdosagetext>30 UG;QW; IM</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030523</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>5053096-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040405</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>7747</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>17</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>69</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CHEMICAL BURN OF SKIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG CLEARANCE DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugauthorizationnumb>11719</drugauthorizationnumb>
        <drugdosagetext>20 G ONCE IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BONE SARCOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040224</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040224</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugdosagetext>20 G ONCE IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BONE SARCOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040331</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040331</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SODIUM BICARBONATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KYTRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENADRYL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DECADRON SRC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PHENERGAN HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATIVAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZANTAC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM CARBONATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FERRIC GLUCONATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COLACE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LACTOBACILLUS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIFFLUCAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PENTAMIDINE ISETHIONATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEUCOVORIN CALCIUM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053097-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060622</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US200606005054</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>47</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>IMPAIRED WORK ABILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERVERTEBRAL DISC PROTRUSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>60 MG, DAILY (1/D), UNK</drugdosagetext>
        <drugindication>FIBROMYALGIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ULTRACET</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VICODIN (HYDROCODONE BITRATRATE, PARACETAMOL)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZELNORM   /CAN/(TEGASEROD MALEATE)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053098-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060621</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US200606004804</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>44</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CHILLS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CRYING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FAECALOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FOOD INTOLERANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROOESOPHAGEAL REFLUX DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ILL-DEFINED DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLUENZA LIKE ILLNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OESOPHAGOGASTRIC FUNDOPLASTY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROCEDURAL COMPLICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINE COLOUR ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINE ODOUR ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>30 MG, 3/D, UNK</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060524</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VICODIN (HYDROCODONE BITARTRATE, PARACETAMOL0</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIAZEPAM</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>DUONEB</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053099-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060623</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US200603000200</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>76</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIAC FLUTTER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE BRUISING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STENT PLACEMENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugbatchnumb>FF5L26A</drugbatchnumb>
        <drugauthorizationnumb>21318</drugauthorizationnumb>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060131</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060306</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugbatchnumb>FF5X11C</drugbatchnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060323</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060415</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053100-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060623</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US200602003875</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>78</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ACCIDENTAL OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ATRIAL FIBRILLATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONTUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCORRECT DOSE ADMINISTERED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE BRUISING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEDICATION ERROR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SLEEP DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STRESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugbatchnumb>FF5M45B</drugbatchnumb>
        <drugauthorizationnumb>21318</drugauthorizationnumb>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060215</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060401</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugbatchnumb>FF5H77A</drugbatchnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060607</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060601</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FEMARA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYLENOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM GLUCONATE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053101-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060623</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US200606005340</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>79</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ARTERIOSCLEROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugauthorizationnumb>21318</drugauthorizationnumb>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060402</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053102-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060623</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US200606005372</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>55</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE BRUISING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESTRICTIVE PULMONARY DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugbatchnumb>FF5T50A</drugbatchnumb>
        <drugauthorizationnumb>21318</drugauthorizationnumb>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE TAB</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053103-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060623</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US200606005341</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>76</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>LARYNGEAL CANCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugauthorizationnumb>21318</drugauthorizationnumb>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053104-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060623</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US200606005392</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>71</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BONE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugbatchnumb>FF4G16C</drugbatchnumb>
        <drugauthorizationnumb>21318</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053105-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ES-SANOFI-SYNTHELABO-A01200605125</companynumb>
    <primarysource>
      <reportercountry>SPAIN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ISCOVER</medicinalproduct>
        <drugauthorizationnumb>20839</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053106-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060616</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>KR-SANOFI-SYNTHELABO-A01200604590</companynumb>
    <primarysource>
      <reportercountry>KOREA, REPUBLIC OF</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>61</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>GASTRIC CANCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATOCHEZIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ISOSORBIDE MONONITRATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANGINA PECTORIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041014</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATORVASTATIN CALCIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERLIPIDAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041217</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BETAXOLOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041115</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALSARTAN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041029</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NIFEDIPINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041012</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>THROMBOSIS PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041012</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050422</drugenddate>
        <drugtreatmentduration>193</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugauthorizationnumb>020839</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>THROMBOSIS PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041020</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053107-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060705</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-SANOFI-SYNTHELABO-A01200605093</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>STILNOX</medicinalproduct>
        <drugauthorizationnumb>19908</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SSRI</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053108-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060712</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IT-SANOFI-SYNTHELABO-A06200600236</companynumb>
    <primarysource>
      <reportercountry>ITALY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>57</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CHOLINERGIC SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROENTERITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TATIONIL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRIMETON</medicinalproduct>
        <drugadministrationroute>050</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SOLDESAM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOFRAN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SOLFATO DI MAGNESIO</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIO GLUCONATO</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ELOXATIN</medicinalproduct>
        <drugauthorizationnumb>021492</drugauthorizationnumb>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>COLON CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060420</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060420</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053109-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060706</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-SANOFI-SYNTHELABO-A03200604351</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG ABUSER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EATING DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ILL-DEFINED DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ROAD TRAFFIC ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SLEEP TALKING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SLEEP WALKING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMBIEN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>019908</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INSOMNIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053110-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060706</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-SANOFI-SYNTHELABO-A03200604340</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>AMNESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EATING DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NIGHTMARE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ROAD TRAFFIC ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SLEEP WALKING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARBATROL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOPID</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SINGULAIR</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KLONOPIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMBIEN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>019908</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INSOMNIA</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053111-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-SANOFI-SYNTHELABO-A03200600432</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG ADMINISTERED AT INAPPROPRIATE SITE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE NECROSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ELIGARD</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>21379</drugauthorizationnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PROSTATE CANCER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053112-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060711</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>KR-SANOFI-SYNTHELABO-A01200605386</companynumb>
    <primarysource>
      <reportercountry>KOREA, REPUBLIC OF</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>75</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DIFFUSE ALVEOLAR DAMAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEUCOVORIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>GASTRIC CANCER</drugindication>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>805</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXALIPLATIN</medicinalproduct>
        <drugauthorizationnumb>021492</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>GASTRIC CANCER</drugindication>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>805</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUOROURACIL</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>GASTRIC CANCER</drugindication>
        <drugtreatmentduration>22</drugtreatmentduration>
        <drugtreatmentdurationunit>805</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053113-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060623</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US200606005382</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>97</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HIP ARTHROPLASTY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugbatchnumb>FF5Z44A</drugbatchnumb>
        <drugauthorizationnumb>21318</drugauthorizationnumb>
        <drugindication>OSTEOPOROSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugbatchnumb>FF5B90A</drugbatchnumb>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053114-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060622</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US200604002230</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>73</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPHONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG NEOPLASM MALIGNANT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugbatchnumb>FF5M44A</drugbatchnumb>
        <drugauthorizationnumb>21318</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050910</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060412</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugbatchnumb>FF5M44A</drugbatchnumb>
        <drugauthorizationnumb>21318</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050506</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053115-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060704</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-SANOFI-SYNTHELABO-A02200601763</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>65</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ALANINE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD ALKALINE PHOSPHATASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG RASH WITH EOSINOPHILIA AND SYSTEMIC SYMPTOMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EOSINOPHILIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FACE OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAMMA-GLUTAMYLTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROTHROMBIN TIME SHORTENED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH PRURITIC</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TEGRETOL</medicinalproduct>
        <drugdosagetext>800 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060422</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060514</drugenddate>
        <drugtreatmentduration>23</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060422</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060514</drugenddate>
        <drugtreatmentduration>23</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRAVASTATIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERCHOLESTEROLAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060422</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060514</drugenddate>
        <drugtreatmentduration>23</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIAMICRON</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060422</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060514</drugenddate>
        <drugtreatmentduration>23</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugauthorizationnumb>020839</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CEREBROVASCULAR ACCIDENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060422</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060514</drugenddate>
        <drugtreatmentduration>23</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053116-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060707</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-SANOFI-SYNTHELABO-A01200605329</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEUKOCYTOCLASTIC VASCULITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ELIGARD</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021343</drugauthorizationnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PROSTATE CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060515</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060515</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053117-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060330</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-SANOFI-SYNTHELABO-A03200601950</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEUPRORELIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>21343</drugauthorizationnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>CONVULSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053118-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060705</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-SANOFI-SYNTHELABO-A03200604358</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020839</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053119-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060711</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-SANOFI-SYNTHELABO-F01200601633</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PHLEBITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GEMZAR</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060524</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060525</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ERBITUX</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060531</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060531</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RAMIPRIL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VERAPAMIL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060524</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROPRANOLOL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXALIPLATIN</medicinalproduct>
        <drugauthorizationnumb>021492</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLORECTAL CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060525</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060525</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053120-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060711</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-SANOFI-SYNTHELABO-F01200601640</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>VARICES OESOPHAGEAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMIKACIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060621</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXACILLIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060620</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NADROPARIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060607</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRIMEBUTINE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060607</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RAMIPRIL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VERAPAMIL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060524</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GEMZAR</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060622</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060622</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROPRANOLOL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ERBITUX</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060621</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060621</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXALIPLATIN</medicinalproduct>
        <drugauthorizationnumb>021492</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLORECTAL CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060622</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060622</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053121-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20051216</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IT-SANOFI-SYNTHELABO-F01200502807</companynumb>
    <primarysource>
      <reportercountry>ITALY</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>54</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERAL PHYSICAL HEALTH DETERIORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STOMATITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051117</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BUSCOPAN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051104</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE TAB</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051013</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051116</drugenddate>
        <drugtreatmentduration>35</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOBETIN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051004</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLINIC ACID</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051004</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051128</drugenddate>
        <drugtreatmentduration>56</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEMETREXED</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>GASTRIC CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051014</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXALIPLATIN</medicinalproduct>
        <drugauthorizationnumb>021492</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>GASTRIC CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051014</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053122-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060711</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-SANOFI-SYNTHELABO-F01200601648</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ARRHYTHMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE CONGESTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISEASE PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEBRILE NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERAL PHYSICAL HEALTH DETERIORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALNUTRITION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXALIPLATIN</medicinalproduct>
        <drugauthorizationnumb>21492</drugauthorizationnumb>
        <drugdosagetext>188 MG</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLORECTAL CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051226</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051226</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>805</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEUCOVORIN</medicinalproduct>
        <drugdosagetext>400 MG/M2</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLORECTAL CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051226</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051226</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>805</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUOROURACIL</medicinalproduct>
        <drugdosagetext>1ST/2ND LINE:400 MG/M2 BOLUS + 1200 MG/M2 OVER 46 HOURS, Q2W</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLORECTAL CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051226</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051227</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053123-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006BI006765</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>70</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>65</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ELECTROCARDIOGRAM POOR R-WAVE PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASTICITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEURALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOPOROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POST PROCEDURAL COMPLICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPINAL COMPRESSION FRACTURE</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>19990601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugdosagetext>30 UG;QW</drugdosagetext>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIORESAL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EMSELEX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALORON</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DURAGESIC-100</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SAROTEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLEXANE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOSOMAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAMADOL HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZANTAC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LACRISIC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OSTEOPLUS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANTOZOL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053124-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060626</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006BI007739</companynumb>
    <primarysource>
      <reportercountry>NETHERLANDS</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>66</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>INFLUENZA LIKE ILLNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARALYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</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>20041005</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060521</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCONTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONAZEPAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053125-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060621</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE200606004724</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>37</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD CHOLESTEROL INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HIGH DENSITY LIPOPROTEIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIPASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOW DENSITY LIPOPROTEIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METABOLIC SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
        <drugauthorizationnumb>20592</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DELUSIONAL DISORDER, PERSECUTORY TYPE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060703</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>JOHANNISKRAUT-KAPSELN                   (HYPERICUM EXTRACT)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053126-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060620</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CO200606004754</companynumb>
    <primarysource>
      <reportercountry>COLOMBIA</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>69</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugauthorizationnumb>21318</drugauthorizationnumb>
        <drugdosagetext>20 UG, DAILY (1/D), SUBCUTANEOUS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060321</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060616</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053127-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060620</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB200604003479</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>83</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>EMPHYSEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRESCRIBED OVERDOSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugauthorizationnumb>21318</drugauthorizationnumb>
        <drugdosagetext>25 UG, DAILY (1/D), SUBCUTANEOUS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060601</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCICHEW D3 (CALCIUM CARBONATE, COLECALCIFEROL)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALENDRONIC ACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRONOLACTONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RANITIDINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053128-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060619</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>SE200605002973</companynumb>
    <primarysource>
      <reportercountry>SWEDEN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>46</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>80</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CEREBRAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBRAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEMIANOPIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL DISTURBANCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
        <drugauthorizationnumb>20592</drugauthorizationnumb>
        <drugdosagetext>5 MG, DAILY (1/D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BIPOLAR DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030901</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LITHIUM CARBONATE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053129-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060616</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA200606004310</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PERIPHERAL ISCHAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GEMZAR</medicinalproduct>
        <drugauthorizationnumb>20509</drugauthorizationnumb>
        <drugdosagetext>INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>LUNG NEOPLASM MALIGNANT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARBOPLATIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KYTRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DECADRON</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROCHLORPERAZINE TAB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATIVAN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053130-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060616</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR200606004265</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>72</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BREAST CANCER FEMALE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EVISTA</medicinalproduct>
        <drugauthorizationnumb>20815</drugauthorizationnumb>
        <drugdosagetext>60 MG, DAILY (1/D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060401</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053131-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>111292ISR</companynumb>
    <primarysource>
      <reportercountry>CHILE</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>56</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ACQUIRED PIGMENTED RETINOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLINDNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RETINAL DEGENERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISION BLURRED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHLOROQUINE PHOSPHATE</medicinalproduct>
        <drugauthorizationnumb>6002</drugauthorizationnumb>
        <drugdosagetext>250 MILLIGRAM ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050901</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAMADOL HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053132-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060706</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>146443USA</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>39</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL ULCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STOMACH DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MERCAPTOPURINE</medicinalproduct>
        <drugauthorizationnumb>9053</drugauthorizationnumb>
        <drugdosagetext>50 MILLIGRAM ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CROHN'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040901</drugenddate>
        <drugtreatmentduration>11</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053133-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>HQWYE358516MAR06</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>56</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLAST CELL COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD ALKALINE PHOSPHATASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD LACTATE DEHYDROGENASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>C-REACTIVE PROTEIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COAGULATION FACTOR XIII LEVEL DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISEASE PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEBRILE NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FIBRIN DEGRADATION PRODUCTS INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAMMA-GLUTAMYLTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERFORMANCE STATUS DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MYLOTARG</medicinalproduct>
        <drugauthorizationnumb>21174</drugauthorizationnumb>
        <drugdosagetext>A SINGLE 7 MG/M^2 DOSE INTRAVENOUS DRIP</drugdosagetext>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>ACUTE MYELOID LEUKAEMIA RECURRENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060124</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060124</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ROXATIDINE ACETATE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAG-LAX (MAGNESIUM HYDROXIDE/PARAFFIN, LIQUID)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOFRAN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053134-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060703</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BEWYE708909JUN06</companynumb>
    <primarysource>
      <reportercountry>BELGIUM</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD CREATININE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISEASE RECURRENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FOCAL GLOMERULOSCLEROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROTEINURIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SIROLIMUS</medicinalproduct>
        <drugauthorizationnumb>21083</drugauthorizationnumb>
        <drugdosagetext>15 + 4 + 5MG 1X PER 1 DAY ORAL - SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS AGAINST TRANSPLANT REJECTION</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</medicinalproduct>
        <drugauthorizationnumb>21083</drugauthorizationnumb>
        <drugdosagetext>15 + 4 + 5MG 1X PER 1 DAY ORAL - SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS AGAINST TRANSPLANT REJECTION</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</medicinalproduct>
        <drugauthorizationnumb>21083</drugauthorizationnumb>
        <drugdosagetext>15 + 4 + 5MG 1X PER 1 DAY ORAL - SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS AGAINST TRANSPLANT REJECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041029</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041112</drugenddate>
        <drugtreatmentduration>15</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SIROLIMUS</medicinalproduct>
        <drugauthorizationnumb>21083</drugauthorizationnumb>
        <drugdosagetext>15 + 4 + 5MG 1X PER 1 DAY ORAL - SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS AGAINST TRANSPLANT REJECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041113</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041124</drugenddate>
        <drugtreatmentduration>12</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TACROLIMUS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZENAPAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CORTICOSTEROIDS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053135-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060704</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BEWYE000305JUL06</companynumb>
    <primarysource>
      <reportercountry>BELGIUM</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>49</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>STEVENS-JOHNSON SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VASCULITIS NECROTISING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EFFEXOR</medicinalproduct>
        <drugauthorizationnumb>20699</drugauthorizationnumb>
        <drugdosagetext>150 + 225MG 1X PER 1 DAY ORAL - SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060601</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EFFEXOR</medicinalproduct>
        <drugauthorizationnumb>20699</drugauthorizationnumb>
        <drugdosagetext>150 + 225MG 1X PER 1 DAY ORAL - SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060701</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XANAX (ALPRAZLAM)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053136-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060630</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DEWYE922830JUN06</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PATHOGEN RESISTANCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYGACIL</medicinalproduct>
        <drugauthorizationnumb>21821</drugauthorizationnumb>
        <drugindication>BACTERIAL INFECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYCLOSPORINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053137-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060420</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>HQWYE510030JUN06</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>53</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>EOSINOPHILIC PNEUMONIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
        <drugauthorizationnumb>4782</drugauthorizationnumb>
        <drugdosagetext>0.625 MG 1X PER 1 DAY ORAL - SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>METRORRHAGIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060531</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
        <drugauthorizationnumb>4782</drugauthorizationnumb>
        <drugdosagetext>0.625 MG 1X PER 1 DAY ORAL - SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>METRORRHAGIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060612</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060601</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RASPJINE            (AZELASTINE HYDROCHLORIDE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLARITHROMYCIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MUCODYNE (CARBOCISTEINE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADVERIN (TIPEPIDINE HIBENZATE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLORIAMIN   (AZULENE SODIUM SULFONATE/LEVOGLUTAMIDE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEQUITAZINE     (MEQUITAZINE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMOXICILLIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEFENAMIC ACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LYSOZYME HYDROCHLORIDE                  (LYSOZYME HYDROCHLORIDE)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053138-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060630</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>HQWYE513530JUN06</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>8</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CHEILITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONJUNCTIVAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DERMATITIS BULLOUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHOTOSENSITIVITY REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PURPURA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OROKEN</medicinalproduct>
        <drugauthorizationnumb>50622</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ABDOMINAL PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060502</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060515</drugenddate>
        <drugtreatmentduration>14</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OROKEN</medicinalproduct>
        <drugauthorizationnumb>50622</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PYREXIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060502</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060515</drugenddate>
        <drugtreatmentduration>14</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BACTRIM</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ABDOMINAL PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060502</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060515</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BACTRIM</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PYREXIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060502</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060515</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053139-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060621</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US200606002430</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
        <drugauthorizationnumb>20592</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053140-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060622</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US200606005052</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DIALYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVING IN RESIDENTIAL INSTITUTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE CHRONIC</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROZAC</medicinalproduct>
        <drugauthorizationnumb>18936</drugauthorizationnumb>
        <drugdosagetext>10 MG, 3/D, UNK</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053141-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060621</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US200606004659</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>13</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>MYOCARDITIS BACTERIAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARYNGITIS STREPTOCOCCAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUDDEN DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THERAPY NON-RESPONDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROZAC</medicinalproduct>
        <drugauthorizationnumb>18936</drugauthorizationnumb>
        <drugdosagetext>20 MG, DAILY (1/D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060301</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ELSPAR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONIDINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053142-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060622</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US200606005025</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>64</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE FLUCTUATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GANGRENE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POSTOPERATIVE WOUND INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOE AMPUTATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMULIN 70/30</medicinalproduct>
        <drugbatchnumb>9RL98M</drugbatchnumb>
        <drugauthorizationnumb>18780</drugauthorizationnumb>
        <drugdosagetext>AS NEEDED</drugdosagetext>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060501</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053143-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060621</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US200606004812</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>16</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVERDOSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>STRATTERA</medicinalproduct>
        <drugauthorizationnumb>21411</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053144-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060621</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US200606004848</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>11</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE DIASTOLIC DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSED LEVEL OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PUPIL FIXED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>STRATTERA</medicinalproduct>
        <drugauthorizationnumb>21411</drugauthorizationnumb>
        <drugdosagetext>180 MG, OTHER, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053145-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060621</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US200606004782</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>6</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <reaction>
        <reactionmeddrapt>ACCIDENTAL EXPOSURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AGITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE SYSTOLIC INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>STRATTERA</medicinalproduct>
        <drugauthorizationnumb>21411</drugauthorizationnumb>
        <drugdosagetext>25 MG, OTHER, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053146-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060621</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US200606004817</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>11</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SELF INJURIOUS BEHAVIOUR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>STRATTERA</medicinalproduct>
        <drugauthorizationnumb>21411</drugauthorizationnumb>
        <drugdosagetext>200 MG. OTHER, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053147-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060630</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2005134645</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>68.0396</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIOVASCULAR DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBRAL THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DILATATION VENTRICULAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EJECTION FRACTION DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTRACARDIAC THROMBUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NUCLEAR MAGNETIC RESONANCE IMAGING BRAIN ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARESIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENTRICULAR HYPOKINESIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugauthorizationnumb>20998</drugauthorizationnumb>
        <drugdosagetext>200 MG</drugdosagetext>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEXTRA</medicinalproduct>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053148-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2005134637</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>61</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIOVASCULAR DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBRAL THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTRACARDIAC THROMBUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MITRAL VALVE REPLACEMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULAR WEAKNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRANSIENT ISCHAEMIC ATTACK</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugauthorizationnumb>20998</drugauthorizationnumb>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEXTRA</medicinalproduct>
        <drugdosagetext>10 MG (10 MG, 1 IN 1 D)</drugdosagetext>
        <drugindication>OSTEOARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030617</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053149-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2005071963</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>117.9352</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STEVENS-JOHNSON SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEXTRA</medicinalproduct>
        <drugauthorizationnumb>21341</drugauthorizationnumb>
        <drugindication>ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050401</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053150-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060630</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2005105632</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>48</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>83.9154</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABNORMAL BEHAVIOUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTERIOSCLEROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BOREDOM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE ATROPHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SLEEP DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEXTRA</medicinalproduct>
        <drugauthorizationnumb>21341</drugauthorizationnumb>
        <drugdosagetext>10 MG</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030701</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053151-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060630</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2005134716</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>46</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>77.1115</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE CONGESTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIOVASCULAR DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBRAL THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTRACARDIAC THROMBUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugauthorizationnumb>20998</drugauthorizationnumb>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEXTRA</medicinalproduct>
        <drugdosagetext>2-3 PER DAY (20 MG</drugdosagetext>
        <drugindication>MUSCULOSKELETAL STIFFNESS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEXTRA</medicinalproduct>
        <drugdosagetext>2-3 PER DAY (20 MG</drugdosagetext>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053152-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2005134681</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>85</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>72.5755</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIOVASCULAR DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBRAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBRAL THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NUCLEAR MAGNETIC RESONANCE IMAGING BRAIN ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOSIS</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>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031217</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050418</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053153-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006018740</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>40</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>50.6</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLUENZA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUTENT</medicinalproduct>
        <drugauthorizationnumb>21938</drugauthorizationnumb>
        <drugdosagetext>50 MG (25 MG, TWICE A DAY FOR 4 WKS WITH 2 WK WASHOUT), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTROINTESTINAL STROMAL TUMOUR</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050517</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATIVAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENADRYL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MS CONTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCODONE (OXYCODONE)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053154-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2005153164</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>46</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>106.5953</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ACUTE MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EMOTIONAL DISTRESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEXTRA</medicinalproduct>
        <drugauthorizationnumb>21341</drugauthorizationnumb>
        <drugdosagetext>20 MG</drugdosagetext>
        <drugindication>BACK PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031114</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053155-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060621</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US200606004755</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>21</patientonsetage>
      <patientonsetageunit>802</patientonsetageunit>
      <patientweight>11.4</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>OVERDOSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>STRATTERA</medicinalproduct>
        <drugauthorizationnumb>21411</drugauthorizationnumb>
        <drugdosagetext>7.04 MG/KG, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053156-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060621</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US200606004774</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>3</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>13.6</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>OVERDOSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>STRATTERA</medicinalproduct>
        <drugauthorizationnumb>21411</drugauthorizationnumb>
        <drugdosagetext>5.88 MG/KG, OTHER, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053157-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060623</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US200606005000</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>78</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>56.3</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ABASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL DISTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLADDER CANCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CREATINE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD POTASSIUM INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD SODIUM DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD UREA INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE CONGESTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CATHETER SITE ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CELLULITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHILLS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CORYNEBACTERIUM INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DECUBITUS ULCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYDRONEPHROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALIGNANT NEOPLASM PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALNUTRITION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULAR WEAKNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL INTAKE REDUCED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLEURAL EFFUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROTHROMBIN TIME PROLONGED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RED BLOOD CELLS URINE POSITIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY DISTRESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GEMCITABINE</medicinalproduct>
        <drugauthorizationnumb>20509</drugauthorizationnumb>
        <drugdosagetext>1770 MG, OTHER, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BLADDER CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050110</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050208</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PACLITAXEL</medicinalproduct>
        <drugdosagetext>216 MG, OTHER, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BLADDER CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050110</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVAQUIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ROCEPHIN            /GFR/ (CEFTRIAXONE SODIUM)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053158-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060623</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US200606005317</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>32</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>STRATTERA</medicinalproduct>
        <drugauthorizationnumb>21411</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugindication>ATTENTION DEFICIT/HYPERACTIVITY DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060617</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060623</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LITHIUM (LITHIUM)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053159-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060622</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US200606005031</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>50</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLISTER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOCALISED INFECTION</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>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053160-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060623</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US200606005295</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEDICAL DEVICE COMPLICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMALOG</medicinalproduct>
        <drugbatchnumb>FF4AB2A</drugbatchnumb>
        <drugauthorizationnumb>20563</drugauthorizationnumb>
        <drugdosagetext>6 U, 3/D</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HUMALOG PEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053161-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060622</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US200606005165</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>58</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HIP ARTHROPLASTY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL TRANSPLANT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMALOG MIX 75/25</medicinalproduct>
        <drugauthorizationnumb>20563</drugauthorizationnumb>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL SUCCINATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROGRAF   /USA/ (TACROLIMUS)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VICODIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053162-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060621</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US200606004886</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>65</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>65.8</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BONE DENSITY DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEAFNESS UNILATERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EVISTA</medicinalproduct>
        <drugbatchnumb>A118393</drugbatchnumb>
        <drugauthorizationnumb>20815</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM WITH VITAMIN D (CALCIUM PHOSPHATE, CALCIUM SODIUM LACTATE, ERG</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTIVITAMIN ^LAPPE^ (VITAMINS NOS)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HISTORY OF DIAZIDE (GLICLAZIDE)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053163-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060705</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>USA-2006-0024563</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ROAD TRAFFIC ACCIDENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXYCONTIN</medicinalproduct>
        <drugauthorizationnumb>20553</drugauthorizationnumb>
        <drugdosagetext>MG,</drugdosagetext>
        <drugindication>BACK DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053164-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060623</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US200606002660</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>46</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>112.5</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DIABETES MELLITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIABETIC COMPLICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSULIN RESISTANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>KETONURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL ISCHAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
        <drugauthorizationnumb>20592</drugauthorizationnumb>
        <drugdosagetext>20 MG,</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20001228</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053165-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060712</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-MERCK-0607FRA00035</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>65</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>TENDONITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugauthorizationnumb>019766</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DYSLIPIDAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IRBESARTAN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053166-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060707</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-MERCK-0607AUS00044</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>70</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BONE DENSITY DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BREAST CANCER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMINS (UNSPECIFIED)</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM CARBONATE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D (UNSPECIFIED)</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053167-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060712</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0607USA02510</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULAR WEAKNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZETIA</medicinalproduct>
        <drugauthorizationnumb>021445</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053168-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060713</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BE-MERCK-0607BEL00012</companynumb>
    <primarysource>
      <reportercountry>BELGIUM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>83</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BRONCHIAL ULCERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRONCHOPNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRACHEAL ULCER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053169-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20051024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-MERCK-0510USA08727</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>84</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>46</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MYELODYSPLASTIC SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>20560</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050622</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051017</drugenddate>
        <drugtreatmentduration>118</drugtreatmentduration>
        <drugtreatmentdurationunit></drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIDRONEL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACTONEL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053170-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060710</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-MERCK-0607FRA00015</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>70</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BRONCHOSPASM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MEFOXIN</medicinalproduct>
        <drugauthorizationnumb>50517</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>INFECTION PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051011</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051011</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUCCINYLCHOLINE IODIDE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>GENERAL ANAESTHESIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051011</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051011</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROPOFOL</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>GENERAL ANAESTHESIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051011</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051011</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CISATRACURIUM BESYLATE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>GENERAL ANAESTHESIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051011</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051011</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUFENTANIL CITRATE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>GENERAL ANAESTHESIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051011</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051011</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEFOPAM HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>051</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051011</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051011</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053171-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>HQWYE265725NOV03</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>44</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>69.2</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CENTRAL LINE INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEBRILE NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MYLOTARG</medicinalproduct>
        <drugauthorizationnumb>21174</drugauthorizationnumb>
        <drugdosagetext>17.8 MG 1X PER 1 DAY; INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ACUTE MYELOID LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021126</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20021126</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053172-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>HQWYE456629APR05</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>56</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ATELECTASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRADYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRAIN OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBRAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONCOMITANT DISEASE PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CULTURE URINE POSITIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISSEMINATED INTRAVASCULAR COAGULATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ENTEROCOCCAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ISCHAEMIC STROKE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROSTATE CANCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MYLOTARG</medicinalproduct>
        <drugauthorizationnumb>21174</drugauthorizationnumb>
        <drugdosagetext>18.9 MG 1X PER 1 DAY; INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ACUTE MYELOID LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050421</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050421</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMPICILLIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOFLOXACIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE TAB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CEFEPIME</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRETINOIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>........................</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VANCOMYCIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANTOPRAZOLE SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>.........................</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053173-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060630</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>HQWYE387126JUN06</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>67</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>107.05</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>KIDNEY TRANSPLANT REJECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RAPAMUNE</medicinalproduct>
        <drugbatchnumb>2005P0792, 10981</drugbatchnumb>
        <drugauthorizationnumb>21110</drugauthorizationnumb>
        <drugdosagetext>89 MG ONCE DAILY, STUDY SUPPLY; ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS AGAINST TRANSPLANT REJECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050405</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060609</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RAPAMUNE</medicinalproduct>
        <drugdosagetext>UNKNOWN DOSE, COMMERCIAL SUPPLY, ORAL (SEE IMAGE)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS AGAINST TRANSPLANT REJECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060621</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060601</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RAPAMUNE</medicinalproduct>
        <drugdosagetext>UNKNOWN DOSE, COMMERCIAL SUPPLY, ORAL (SEE IMAGE)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS AGAINST TRANSPLANT REJECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060610</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060615</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RAPAMUNE</medicinalproduct>
        <drugdosagetext>UNKNOWN DOSE, COMMERCIAL SUPPLY, ORAL (SEE IMAGE)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS AGAINST TRANSPLANT REJECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060623</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELLCEPT</medicinalproduct>
        <drugdosagetext>UNSPECIFIED; ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS AGAINST TRANSPLANT REJECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZENAPAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CORTICOSTEROID NOS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053174-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060707</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-MERCK-0607GBR00047</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>10</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VASCULITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SINGULAIR</medicinalproduct>
        <drugauthorizationnumb>020830</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060604</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060609</drugenddate>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053175-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060713</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-MERCK-0607AUS00048</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>20560</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BONE DENSITY DECREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MELOXICAM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANTOPRAZOLE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SULFASALAZINE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ERGOCALCIFEROL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIGOXIN</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>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SERTRALINE HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053176-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20051209</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0512USA01717</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>56</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>90</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BONE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DENTAL DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTH DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTHACHE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>20560</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPOTHYROIDISM</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990301</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERLIPIDAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ESTRATEST</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRICOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTRIGLYCERIDAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN E</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SINGULAIR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERSENSITIVITY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050525</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053177-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>HQWYE666507JUL06</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>55</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENOOCCLUSIVE LIVER DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MYLOTARG</medicinalproduct>
        <drugauthorizationnumb>21174</drugauthorizationnumb>
        <drugdosagetext>9.3 MG 1X PER 1 DAY; INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ACUTE MYELOID LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040908</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040908</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053178-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>HQWYE630507JUL06</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>55</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>88.2</patientweight>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ACUTE MYELOID LEUKAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ALANINE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASPARTATE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD ALKALINE PHOSPHATASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD LACTATE DEHYDROGENASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALIGNANT NEOPLASM PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MYLOTARG</medicinalproduct>
        <drugauthorizationnumb>21174</drugauthorizationnumb>
        <drugdosagetext>14.85 MG 1X PER 1 DAY; INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ACUTE MYELOID LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051004</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051004</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053179-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060623</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US200606002566</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>44</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>127</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD CHOLESTEROL ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIABETES MELLITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATITIS VIRAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OBESITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISION BLURRED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
        <drugauthorizationnumb>20592</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000315</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053180-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060711</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>HQWYE766311MAR04</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>60</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>118.49</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ACUTE MYELOID LEUKAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACTERIA STOOL IDENTIFIED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEBRILE NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPONATRAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALIGNANT NEOPLASM PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RETCHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STAPHYLOCOCCAL INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MYLOTARG</medicinalproduct>
        <drugauthorizationnumb>21174</drugauthorizationnumb>
        <drugdosagetext>INTRAVENOUS, 18MG 1X PER 1 DAY; INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ACUTE MYELOID LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040128</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040128</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MYLOTARG</medicinalproduct>
        <drugauthorizationnumb>21174</drugauthorizationnumb>
        <drugdosagetext>INTRAVENOUS, 18MG 1X PER 1 DAY; INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ACUTE MYELOID LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040211</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040211</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROTONIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COMBIVENT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVAQUIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUCONAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HUMULIN 70/30</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DILTIAZEM HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM CHLORIDE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053181-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060623</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US200606001468</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BREAST CANCER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugauthorizationnumb>21318</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053182-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060622</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US200606005097</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIAC DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugauthorizationnumb>21318</drugauthorizationnumb>
        <drugtreatmentduration>549</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053183-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US200512002320</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>72</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ARRHYTHMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD ALKALINE PHOSPHATASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRAIN OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLLAPSE OF LUNG</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HILAR LYMPHADENOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG CANCER METASTATIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG NEOPLASM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METASTASES TO BONE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NECK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOSARCOMA METASTATIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLEURAL EFFUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POSITRON EMISSION TOMOGRAM ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugauthorizationnumb>21318</drugauthorizationnumb>
        <drugindication>BACK PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GABAPENTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUTICASONE PROPIONATE W/SALMETEROL (FLUTICASONE PROPIONATE, SALMETERO</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SULCRATE (SUCRALFATE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYBUTYNIN (OXYBUTYNIN)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASA (ASPIRIN (ACETYLSALICYLIC ACID) CAPSULE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORAZEPAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMITRIPTYLINE (AMITRIPTYLINE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOSAMINE (GLUCOSAMINE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CHONDROITIN SULFATE 9CHONDROITIN SULFATE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTIVITAMINS, PLAIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM (CALCIUM)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ERGOCALCIFEROL (VITAMIN D) (ERGOCALCIFEROL (VITAMIN D) UNKNOWN FORMULA</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053184-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060622</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US200606005041</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL WALL NEOPLASM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALIGNANT MELANOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugauthorizationnumb>21318</drugauthorizationnumb>
        <drugindication>OSTEOPOROSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053185-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060621</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US200604002898</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>76</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>72.6</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEVICE FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HIP FRACTURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugauthorizationnumb>21318</drugauthorizationnumb>
        <drugdosagetext>20 UG, DAILY (1/D), UNK</drugdosagetext>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040922</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugdosagetext>20 UG, DAILY (1/D), UNK</drugdosagetext>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040922</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053186-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060622</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US200606005766</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HIP FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PELVIC FRACTURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugauthorizationnumb>21318</drugauthorizationnumb>
        <drugdosagetext>20 UG</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053187-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060622</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US200606005569</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>75</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HIP FRACTURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugauthorizationnumb>21318</drugauthorizationnumb>
        <drugdosagetext>20 UG</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050901</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053188-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060622</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US200606005040</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>82</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CONTUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HIP FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MONOPLEGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugauthorizationnumb>21318</drugauthorizationnumb>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053189-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060621</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US200602000403</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>77</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ATRIAL FIBRILLATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG ADMINISTRATION ERROR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JOINT SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugbatchnumb>FF5H40A</drugbatchnumb>
        <drugauthorizationnumb>21318</drugauthorizationnumb>
        <drugdosagetext>20 UG, DAILY (1/D), UNK</drugdosagetext>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051106</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060110</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053190-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060621</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US200606005316</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>85</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRANSIENT ISCHAEMIC ATTACK</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>20 MG</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
        <drugdosagetext>7.5 MG</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053191-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060621</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US200606005053</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>36</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>TRANSAMINASES INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>30 MG; 30 MG</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
        <drugtreatmentduration>30</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>30 MG; 30 MG</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
        <drugtreatmentduration>61</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053192-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006082129</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BREAST CANCER FEMALE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>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>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053193-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006082126</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BREAST CANCER</reactionmeddrapt>
      </reaction>
      <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>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053194-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060623</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US200606001198</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>12</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>42.2</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 ALKALINE PHOSPHATASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD BILIRUBIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD BILIRUBIN UNCONJUGATED INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>STRATTERA</medicinalproduct>
        <drugauthorizationnumb>21411</drugauthorizationnumb>
        <drugdosagetext>25 MG, DAILY (1/D)</drugdosagetext>
        <drugindication>ATTENTION DEFICIT/HYPERACTIVITY DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060531</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMINS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053195-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006082144</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BREAST CANCER</reactionmeddrapt>
      </reaction>
      <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>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053196-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006040636</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>55</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>85</patientweight>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>DIALYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUTENT</medicinalproduct>
        <drugauthorizationnumb>21968</drugauthorizationnumb>
        <drugdosagetext>50 MG (50 MG, 1 IN 1 D),ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RENAL CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060118</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060208</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELLCEPT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROGRAF</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLYBURIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZAROXOLYN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDISONE (PREDISONE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARDURA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KEFLEX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PERCOCET</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMBIEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTIVITAMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORAZEPAM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053197-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006054750</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>43</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CHLAMYDIAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GONORRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERSECUTORY DELUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URETHRAL DISCHARGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AZITHROMYCIN</medicinalproduct>
        <drugauthorizationnumb>50670</drugauthorizationnumb>
        <drugdosagetext>500 MG, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>URETHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060403</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CIRPO ^BAYER^ (CIPROFLOXACIN)</medicinalproduct>
        <drugdosagetext>1000 MG, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>URETHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060403</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZANTAC</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053198-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006063590</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugauthorizationnumb>21446</drugauthorizationnumb>
        <drugdosagetext>300 MG (1500 MG, 2 IN 1 D)</drugdosagetext>
        <drugindication>RADICULOPATHY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REVLIMID (UK-14, 275)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EFFEXOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHADONE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCODONE (OXYCODONE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NITROFURANTOIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ECOTRIN (ACETYLSALIYCLIC ACID)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053199-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060627</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-MERCK-0606USA05694</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>30</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <reaction>
        <reactionmeddrapt>ALANINE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANTINUCLEAR ANTIBODY INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASPARTATE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SINGULAIR</medicinalproduct>
        <drugauthorizationnumb>20829</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050824</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060301</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUTIDE</medicinalproduct>
        <drugadministrationroute>055</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEPTIN</medicinalproduct>
        <drugadministrationroute>055</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNIPHYL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NOSCAPINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050926</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ONON</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050926</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053200-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006060392</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>26</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>113.3993</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>LABORATORY TEST ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LOMOTIL</medicinalproduct>
        <drugauthorizationnumb>12462</drugauthorizationnumb>
        <drugdosagetext>1 CAPSULE (4 IN 1 D)</drugdosagetext>
        <drugindication>DIARRHOEA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PENICILLIN NOS (PENICILIN NOS)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MECLIZINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053201-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060630</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006065306</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ADVERSE DRUG REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GLUCOTROL</medicinalproduct>
        <drugauthorizationnumb>17783</drugauthorizationnumb>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GLUCOPHAGE</medicinalproduct>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053202-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesscongenitalanomali>1</seriousnesscongenitalanomali>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060522</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-06P-163-0333996-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>FOETAL HEART RATE ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PREMATURE BABY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRISOMY 18</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KALETRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>21906</drugauthorizationnumb>
        <drugindication>DRUG EXPOSURE DURING PREGNANCY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRIZIVIR</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>DRUG EXPOSURE DURING PREGNANCY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BARACLUDE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>DRUG EXPOSURE DURING PREGNANCY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZIDOVUDINE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>DRUG EXPOSURE DURING PREGNANCY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053203-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006071826</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLITIS ULCERATIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREATMENT NONCOMPLIANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL ACUITY REDUCED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GLUCOTROL XL</medicinalproduct>
        <drugauthorizationnumb>20329</drugauthorizationnumb>
        <drugdosagetext>2.5 MG (2.5 MG, 1 IN 1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GLIPIZIDE</medicinalproduct>
        <drugdosagetext>10 MG (5 MG, 2 IN 1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053204-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006080733</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>69.8539</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLADDER DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EFFECT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYSTERECTOMY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OLIGURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POOR PERIPHERAL CIRCULATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
        <drugauthorizationnumb>20235</drugauthorizationnumb>
        <drugdosagetext>1600 MG (800 MG, 2 IN 1D)</drugdosagetext>
        <drugindication>NEUROPATHY PERIPHERAL</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CAMPRAL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROMETRIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NITROFURAN (NITROFURANTOIN)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053205-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006082053</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>5</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>31.7518</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CYSTITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHEEZING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZITHROMAX</medicinalproduct>
        <drugauthorizationnumb>50670</drugauthorizationnumb>
        <drugindication>CYSTITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053206-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006082248</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>50</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>73.0291</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN OF SKIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH PRURITIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SCAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEXTRA</medicinalproduct>
        <drugauthorizationnumb>21341</drugauthorizationnumb>
        <drugdosagetext>20 MG (20 MG, 1 IN 1 D),</drugdosagetext>
        <drugindication>ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053207-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006082199</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>68.0396</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANTINUCLEAR ANTIBODY INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FIBROMYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMPAIRED WORK ABILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY FIBROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugauthorizationnumb>20998</drugauthorizationnumb>
        <drugdosagetext>200 MG (200 MG, 1 IN 1 D),</drugdosagetext>
        <drugindication>MUSCULOSKELETAL PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THEO-DUR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROTONIX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053208-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006082511</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>32</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DECREASED APPETITE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL INTAKE REDUCED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT GAIN POOR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SERTRALINE</medicinalproduct>
        <drugauthorizationnumb>19839</drugauthorizationnumb>
        <drugdosagetext>50 MG</drugdosagetext>
        <drugindication>MAJOR DEPRESSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053209-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2005134664</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>108.8633</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIOVASCULAR DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBRAL THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugauthorizationnumb>20998</drugauthorizationnumb>
        <drugdosagetext>400 MG (400 MG, 1 IN 1 D),</drugdosagetext>
        <drugindication>OSTEOARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000106</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEXTRA</medicinalproduct>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053210-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2005134656</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>111.1313</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIOVASCULAR DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBRAL THROMBOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugauthorizationnumb>20998</drugauthorizationnumb>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEXTRA</medicinalproduct>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053211-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2005134639</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>86.1834</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANKLE FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRAIN STEM THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIOVASCULAR DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugauthorizationnumb>20998</drugauthorizationnumb>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053212-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2005134601</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>52</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>111.5849</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIOVASCULAR DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBRAL THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugauthorizationnumb>20998</drugauthorizationnumb>
        <drugdosagetext>(50 MG, AS NECESSARY),</drugdosagetext>
        <drugindication>ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030801</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEXTRA</medicinalproduct>
        <drugdosagetext>(20 MG, AS NECESSARY),</drugdosagetext>
        <drugindication>ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030226</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053213-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041221</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-ABBOTT-04P-056-0284340-00</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>77</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG LEVEL DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EXTRAPYRAMIDAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARKINSONISM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEPAKENE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>18081</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>EPILEPSY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041018</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEPAKENE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>018081</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041102</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041114</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEPAKENE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>018081</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041115</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041115</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEPAKENE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>018081</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041116</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041217</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEPAKENE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>018081</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041218</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEPAKINE CHRONO POWDER</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020593</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>EPILEPSY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041014</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041017</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMIODARONE HYDROCHLORIDE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041109</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041109</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMIODARONE HYDROCHLORIDE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041110</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041110</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMIODARONE HYDROCHLORIDE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041111</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041111</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMIODARONE HYDROCHLORIDE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041112</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PARACETAMOL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041018</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PARACETAMOL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041010</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041013</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAROXETINE HYDROCHLORIDE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041018</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAROXETINE HYDROCHLORIDE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041130</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041202</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041018</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BUFLOMEDIL HYDROCHLORIDE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041018</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BUFLOMEDIL HYDROCHLORIDE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041010</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BUFLOMEDIL HYDROCHLORIDE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041018</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BUFLOMEDIL HYDROCHLORIDE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041018</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BUFLOMEDIL HYDROCHLORIDE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041018</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLOPIDOGREL BISULFATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041013</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLOPIDOGREL BISULFATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041018</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>QUINAPRIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041013</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>QUINAPRIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041018</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LACTULOSE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041013</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LACTULOSE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041018</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN</medicinalproduct>
        <drugdosagetext>DAILY DOSE ADAPTED TO GLYCEMIA</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>DIABETES MELLITUS NON-INSULIN-DEPENDENT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GABAPENTIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041013</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CITALOPRAM</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041130</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053214-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesscongenitalanomali>1</seriousnesscongenitalanomali>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060626</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-ABBOTT-06P-167-0337013-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>0.13</patientweight>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>DOUBLE OUTLET RIGHT VENTRICLE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STILLBIRTH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENTRICULAR SEPTAL DEFECT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KALETRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>21226</drugauthorizationnumb>
        <drugindication>DRUG EXPOSURE DURING PREGNANCY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMIVUDINE AND ZIDOVUDINE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>DRUG EXPOSURE DURING PREGNANCY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053215-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060707</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-ABBOTT-06P-167-0337753-00</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>EXTRAVASATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KLARICID IV</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>50662</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053216-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060505</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-06P-163-0332827-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABNORMAL DREAMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ACTIVITIES OF DAILY LIVING IMPAIRED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANGER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANOREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANTISOCIAL BEHAVIOUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONSTRICTED AFFECT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CRYING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPERSONALISATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEREALISATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISORIENTATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISTURBANCE IN ATTENTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EMOTIONAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING OF DESPAIR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FRUSTRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IRRITABILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JUDGEMENT IMPAIRED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENTAL IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENTAL STATUS CHANGES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOOD SWINGS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOTOR DYSFUNCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANIC REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARANOIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSYCHOTIC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STRESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THINKING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VITAL FUNCTIONS ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BIAXIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>50662</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>STAPHYLOCOCCAL INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060301</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BACTRIM</medicinalproduct>
        <drugindication>STAPHYLOCOCCAL INFECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MUPIROCIN</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053217-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060707</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-ABBOTT-06P-056-0337680-00</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>20</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PHOTODERMATOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEPAKOTE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>18723</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYAMEMAZINE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060518</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYAMEMAZINE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>50-50-50-100=250 DROPS DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060519</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALPRAZOLAM</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HYDROXYZINE HYDROCHLORIDE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARIPIPRAZOLE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060415</drugstartdate>
        <drugtreatmentduration>30</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OLANZAPINE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060512</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060517</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OLANZAPINE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060519</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053218-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20031027</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-03P-163-0238797-00</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>34</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE SYSTOLIC INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION POTENTIATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EOSINOPHILIC PNEUMONIA ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERICARDIAL EFFUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLEURAL EFFUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH MACULAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY RATE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUS TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>VALPROIC ACID</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>018081</drugauthorizationnumb>
        <drugindication>PSYCHOTIC DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HALOPERIDOL</medicinalproduct>
        <drugindication>PSYCHOTIC DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIPHENHYDRAMINE HCL</medicinalproduct>
        <drugindication>PSYCHOTIC DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLOZAPINE</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENZATROPINE</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OLANZAPINE</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053219-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060707</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ES-ABBOTT-06P-144-0337741-00</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>73</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>RASH PUSTULAR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SECALIP</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>19304</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060301</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZUCLOPENTHIXOL DECANOATE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051019</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060418</drugenddate>
        <drugtreatmentduration>181</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETYLSALICYLIC ACID SRT</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060301</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060301</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053220-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060707</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-06P-163-0337642-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>18</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PREMATURE LABOUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PREMATURE RUPTURE OF MEMBRANES</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KALETRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021906</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SYSTEMIC ANTIVIRAL TREATMENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060131</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BARACLUDE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SYSTEMIC ANTIVIRAL TREATMENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060131</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZIDOVUDINE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>SYSTEMIC ANTIVIRAL TREATMENT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRIZIVIR</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SYSTEMIC ANTIVIRAL TREATMENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060131</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053221-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060630</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>163-21880-06070123</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>73</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugbatchnumb>427424</drugbatchnumb>
        <drugauthorizationnumb>21880</drugauthorizationnumb>
        <drugdosagetext>10 MG, QD, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060512</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060616</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053222-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060707</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-ABBOTT-06P-020-0337679-00</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VALPAKINE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>18081</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONVULSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060502</drugenddate>
        <drugtreatmentduration>30</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053223-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060621</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>163-21880-06040858</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>0</patientsex>
      <reaction>
        <reactionmeddrapt>NO ADVERSE EFFECT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugauthorizationnumb>21880</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053224-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060630</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>163-21880-06040337</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>56</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ACUTE MYELOID LEUKAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISEASE PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugauthorizationnumb>21880</drugauthorizationnumb>
        <drugdosagetext>10 MG, 3 WEEKS ON AND 1 WEEK OFF, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>5Q-SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060314</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugauthorizationnumb>21880</drugauthorizationnumb>
        <drugdosagetext>10 MG, 3 WEEKS ON AND 1 WEEK OFF, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MYELODYSPLASTIC SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060314</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMICAR (AMINOCAPROPIC ACID)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEUPOGEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARANESP</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053225-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060630</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>163-21880-06060002</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>56</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>DISEASE PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>REFUSAL OF TREATMENT BY PATIENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THERAPY NON-RESPONDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugauthorizationnumb>21880</drugauthorizationnumb>
        <drugdosagetext>1 IN 1 D, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MYELODYSPLASTIC SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060428</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060504</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARANESP</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053226-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060627</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>163-21880-06040809</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>71</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ACUTE MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE MARROW FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE CONGESTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBRAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISEASE PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHOIDS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENINGORRHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYELODYSPLASTIC SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCYTOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRANSIENT ISCHAEMIC ATTACK</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugauthorizationnumb>21880</drugauthorizationnumb>
        <drugdosagetext>5 MG, QD, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MYELODYSPLASTIC SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060419</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>THALOMID</medicinalproduct>
        <drugdosagetext>100 MG, QHS, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MYELODYSPLASTIC SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060428</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060501</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>THALOMID</medicinalproduct>
        <drugdosagetext>100 MG, QHS, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MYELODYSPLASTIC SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040520</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DILAUDID</medicinalproduct>
        <drugdosagetext>2 MG, Q 4HRS PRN, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BACK PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIDAZA</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZESTRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EPOGEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEUPOGEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053227-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060623</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US200601002048</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>34</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>81.6</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD ALKALINE PHOSPHATASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CHOLESTEROL INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD TRIGLYCERIDES INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIABETES MELLITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIABETIC COMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIABETIC NEUROPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERLIPIDAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LETHARGY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
        <drugauthorizationnumb>20592</drugauthorizationnumb>
        <drugdosagetext> SEE IMAGE</drugdosagetext>
        <drugindication>BIPOLAR DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030512</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030702</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
        <drugauthorizationnumb>20592</drugauthorizationnumb>
        <drugdosagetext> SEE IMAGE</drugdosagetext>
        <drugindication>BIPOLAR DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030702</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030801</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALTREX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL SULFATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SINGULAIR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELEXA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLEGRA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORTAB</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053228-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060623</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US200601001099</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>52</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>117.9</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ALANINE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASPARTATE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CATARACT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHOLELITHIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CREATININE RENAL CLEARANCE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIABETES MELLITUS NON-INSULIN-DEPENDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GLYCOSYLATED HAEMOGLOBIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC STEATOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERCHOLESTEROLAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTRIGLYCERIDAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POLYCYTHAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
        <drugauthorizationnumb>20592</drugauthorizationnumb>
        <drugdosagetext>10 MG, ORAL; SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19971015</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
        <drugauthorizationnumb>20592</drugauthorizationnumb>
        <drugdosagetext>10 MG, ORAL; SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BUSPAR /AUS/ (BUSPIRONE HYDROCHLORIDE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EFFEXOR XR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOPHAGE ^UNS^ (METFORMIN HYDROCHLORIDE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYZAAR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEXAPRO /USA/ (ESCITALOPRAM)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VENTOLIN /00139501/ (SALBUTAMOL)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZESTRIL /USA/ (LISINOPRIL)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SINGULAIR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DETROL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COMBIVENT /GFR/ (IPRATROPIUM BROMIDE, SALBUTAMOL SULFATE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZYRTEC</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053229-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060623</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US200601003513</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>51</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>111.1</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD BICARBONATE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE CONGESTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COR PULMONALE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIABETES MELLITUS NON-INSULIN-DEPENDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIASTOLIC DYSFUNCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EMBOLISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FOOD POISONING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HIGH DENSITY LIPOPROTEIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERCAPNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERCHOLESTEROLAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERLIPIDAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IRON DEFICIENCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENOMETRORRHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENSTRUATION IRREGULAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENTAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERICARDIAL EFFUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERICARDITIS CONSTRICTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRESCRIBED OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>QRS AXIS ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWELLING FACE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UPPER RESPIRATORY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UTERINE LEIOMYOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
        <drugauthorizationnumb>20592</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19971001</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053230-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060622</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US200604001234</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>50</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>78.9</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>CHOLELITHIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JAUNDICE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL CYST</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>60 MG, DAILY (1/D)</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050418</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060308</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ESTRADIOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTIVITAMINS (ASCORBIC ACID, ERGOCALCIFEROL, FOLIC ACID, NICOTINAMIDE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053231-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060623</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US200606005418</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugauthorizationnumb>21318</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FORTEO PEN (FORTEO PEN)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053232-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>R301639-PAP-USA</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>82</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>70</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ACUTE RESPIRATORY FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASPIRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</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>20050301</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COMBIVENT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYANOCOBALAMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARICEPT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NAMENDA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WELLBUTRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LESCOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NITROGLYCERIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053233-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>R301638-PAP-USA</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>67</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>71</patientweight>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ACUTE RESPIRATORY FAILURE</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>20030101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOPHAGE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CONEQ</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZYRTEC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053234-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060627</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>R301636-315-USA</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>67</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>119</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACIPHEX</medicinalproduct>
        <drugauthorizationnumb>20973</drugauthorizationnumb>
        <drugdosagetext>1 TABLET, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DYSPEPSIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060527</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOVAN HCT (CO-DIOVAN)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROZAC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTIVITAMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN E</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM (CALCIUM)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053235-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060626</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>163-20785-06060506</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>18</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>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>300 MG, 3 IN 1 D, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BRAIN NEOPLASM MALIGNANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060301</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053236-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060630</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>163-20785-06060022</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>83</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>91.6266</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LETHARGY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENTAL STATUS CHANGES</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>THALOMID</medicinalproduct>
        <drugauthorizationnumb>20785</drugauthorizationnumb>
        <drugdosagetext>100 MG TO 200 MG DAILY, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MYELODYSPLASTIC SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060414</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060522</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIDAZA</medicinalproduct>
        <drugdosagetext>75 MG/M2, SUBCUTANEOUS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RENAL CELL CARCINOMA STAGE UNSPECIFIED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREVACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COMPAZINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEUKINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VIDAZA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIFLUCAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MECLIZINE HYDROCHLORIDE (MECLOZINE HYDROCHLORIDE) (TABLETS)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIPHENHYDRAMINE HYDROCHLORIDE (DIPHENHYDRAMINE HYDROCHLORIDE) (CAPSULE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CODICLEAR (CODICLEAR) (SYRUP)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MILK OF MAGNESIA (MAGNESIUM HYDROXIDE) (SUSPENSION)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOPERAMIDE HYDROCHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYLENOL W/ CODEINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NITROGLYCERIN (GLYCERYL TRINITRATE) (CAPSULES)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NITROLINGUAL (GLYCERYL TRINITRATE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COMBIVENT (COMBIVENT) (AEROSOL FOR INHALATION)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VICODIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROSOM (ESTAZOLAM)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMDUR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OCUVITE (OCUVITE) (TABLETS)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NYSTATIN (NYSTATIN) (SUSPENSION)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEGACE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LAXATIVES (LAXATIVES)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053237-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060622</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>163-21880-06070131</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>65</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>NEOPLASM MALIGNANT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugauthorizationnumb>21880</drugauthorizationnumb>
        <drugdosagetext>10 MG, DAILY, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MYELODYSPLASTIC SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060106</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053238-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060623</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US200606002932</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>LIVER DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMALOG</medicinalproduct>
        <drugauthorizationnumb>20563</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053239-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060623</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US200605006401</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>51</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UTERINE LEIOMYOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMALOG</medicinalproduct>
        <drugbatchnumb>FF5AV4A</drugbatchnumb>
        <drugauthorizationnumb>20563</drugauthorizationnumb>
        <drugdosagetext>AS NEEDED,</drugdosagetext>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMALOG</medicinalproduct>
        <drugbatchnumb>FF5AV4A</drugbatchnumb>
        <drugauthorizationnumb>20563</drugauthorizationnumb>
        <drugdosagetext>AS NEEDED,</drugdosagetext>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053240-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060623</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>USA0510110219</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMALOG</medicinalproduct>
        <drugauthorizationnumb>20563</drugauthorizationnumb>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053241-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060621</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US200605001446</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>18</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ALANINE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASPARTATE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>STRATTERA</medicinalproduct>
        <drugauthorizationnumb>21411</drugauthorizationnumb>
        <drugdosagetext>60 MG,</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040421</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060301</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEXAPRO</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADDERALL XR 10</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053242-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060621</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US200606002081</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>76</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugauthorizationnumb>21318</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053243-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060621</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US200605005097</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugauthorizationnumb>21318</drugauthorizationnumb>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060209</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053244-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060621</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US200606000208</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>90</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugauthorizationnumb>21318</drugauthorizationnumb>
        <drugdosagetext>20 UG, DAILY (1/D),</drugdosagetext>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051129</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060121</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FORTEO PEN (250MCG/ML)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053245-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060621</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US200606004972</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>90</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HIP FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS GENERALISED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugbatchnumb>FF5Z44A</drugbatchnumb>
        <drugauthorizationnumb>21318</drugauthorizationnumb>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugbatchnumb>FF5Z44A</drugbatchnumb>
        <drugauthorizationnumb>21318</drugauthorizationnumb>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060619</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FORTEO PEN (250MCG/ML)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM CARBONATE                          (CALCIUM CARBONATE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMINS WITH MINERALS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>................................</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053246-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060623</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US200606001605</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMALOG</medicinalproduct>
        <drugauthorizationnumb>20563</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053247-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060623</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US200606005051</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>52</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOWER LIMB FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOBILITY DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>60 MG,</drugdosagetext>
        <drugindication>DIABETIC NEUROPATHY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EFFEXOR</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053248-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060622</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>USA050598518</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>91</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>AORTIC DISSECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEMORY IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugbatchnumb>FF4BJ3A</drugbatchnumb>
        <drugauthorizationnumb>21318</drugauthorizationnumb>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050301</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX (FUROSEMIDE /00032601/)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FORTEO PEN, 250MCG/ML (3ML) (FORTEO PEN 250MCG/ML (3ML)) PEN, DISPOSAB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053249-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060622</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US200606000736</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>50</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <reaction>
        <reactionmeddrapt>NO ADVERSE DRUG EFFECT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugauthorizationnumb>21318</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060501</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053250-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060621</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US200606001168</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>43</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>99.3</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BACTERIA STOOL IDENTIFIED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLITIS ULCERATIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugindication>CHRONIC FATIGUE SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060502</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060621</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugindication>CHRONIC FATIGUE SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060611</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053251-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060622</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US200603005184</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>66</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CATARACT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIABETIC RETINOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OPEN ANGLE GLAUCOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL ACUITY REDUCED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMULIN N</medicinalproduct>
        <drugauthorizationnumb>18780</drugauthorizationnumb>
        <drugdosagetext>35 U, 2/D,</drugdosagetext>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMULIN R</medicinalproduct>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOPHAGE ^UNS^ (METFORMIN HYDROCHLORIDE)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053252-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060623</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US200602004107</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>62</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HEART TRANSPLANT REJECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMALOG PEN</medicinalproduct>
        <drugbatchnumb>9RR92M</drugbatchnumb>
        <drugauthorizationnumb>20563</drugauthorizationnumb>
        <drugdosagetext>SUBCUTANEOUS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HUMALOG PEN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053253-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060622</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US97091981A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>49</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>181.4</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BALANCE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARPAL TUNNEL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIABETES MELLITUS INADEQUATE CONTROL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIABETIC NEPHROPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEG AMPUTATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOMYELITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STOMACH DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STRESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMULIN N</medicinalproduct>
        <drugauthorizationnumb>18780</drugauthorizationnumb>
        <drugdosagetext>90 U, DAILY (1/D), SUBCUTANEOUS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19890101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19980101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMALOG MIX 75/25</medicinalproduct>
        <drugbatchnumb>FF2BV6A</drugbatchnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050520</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMALOG MIX 75/25</medicinalproduct>
        <drugbatchnumb>FF2BV6A</drugbatchnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050520</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMALOG MIX 75/25</medicinalproduct>
        <drugbatchnumb>FF2BV6A</drugbatchnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMALOG MIX 75/25</medicinalproduct>
        <drugbatchnumb>FF2BV6A</drugbatchnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMALOG PEN</medicinalproduct>
        <drugbatchnumb>9RP06M</drugbatchnumb>
        <drugdosagetext>AS NEEDED,</drugdosagetext>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050520</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HUMALOG MIX75/25 PEN (HUMALOG MIX 25L / 75NPL PEN) PEN, DISPOSABLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ELAVIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN TAB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRENTAL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NIACIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOPHAGE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACTOS /CAN/ (PIOGLITAZONE HYDROCHLORIDE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053254-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060630</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>HQWYE308712JAN06</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>80</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>83.26</patientweight>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>FEBRILE NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPTIC SHOCK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUPRAVENTRICULAR TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MYLOTARG</medicinalproduct>
        <drugauthorizationnumb>21174</drugauthorizationnumb>
        <drugdosagetext>17 MG 1X PER 1 DAY, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ACUTE MYELOID LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051229</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051229</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053255-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesscongenitalanomali>1</seriousnesscongenitalanomali>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>8016576</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>2.6</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ACROCHORDON</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMPLEX PARTIAL SEIZURES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSMORPHISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GESTATIONAL DIABETES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GRAND MAL CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GYNAECOLOGICAL CHLAMYDIA INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMANGIOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HIGH ARCHED PALATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTELORISM OF ORBIT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTH DEVELOPMENT DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KEPPRA</medicinalproduct>
        <drugauthorizationnumb>21035</drugauthorizationnumb>
        <drugdosagetext>750 MG TRP</drugdosagetext>
        <drugadministrationroute>064</drugadministrationroute>
        <drugindication>EPILEPSY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050831</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PHENOBARBITAL TAB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRENATAL VITAMINS /01549301/</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZITHROMAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZANTAC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN K</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053256-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>8017588</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>3</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ENCEPHALITIS VIRAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EPISTAXIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KEPPRA</medicinalproduct>
        <drugauthorizationnumb>21505</drugauthorizationnumb>
        <drugdosagetext>225 MG 2/D PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>EPILEPSY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060515</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060611</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KEPPRA</medicinalproduct>
        <drugdosagetext>850 MG PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>EPILEPSY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060612</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060615</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KEPPRA</medicinalproduct>
        <drugdosagetext>500 MG 2/D PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>EPILEPSY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060616</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060628</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KEPPRA</medicinalproduct>
        <drugdosagetext>950 MG PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>EPILEPSY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060629</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PHENOBARBITAL TAB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PHENOBARBITAL TAB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZONISAMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEPAKOTE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053257-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>14268</companynumb>
    <primarysource>
      <reportercountry>SERBIA AND MONTENEGRO</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>37</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>NEUTROPENIC COLITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYTARABINE</medicinalproduct>
        <drugauthorizationnumb>71868</drugauthorizationnumb>
        <drugdosagetext>200 MG BID IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ACUTE MYELOID LEUKAEMIA</drugindication>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VEPESID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADRIBLASTINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053258-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>226918</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>52</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLITIS ISCHAEMIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISEASE PROGRESSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RITUXAN</medicinalproduct>
        <drugdosagetext>1000 MG, SINGLE, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053259-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060626</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>224722</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>46</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>142</patientweight>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ANGINA PECTORIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CHOLESTEROL INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD POTASSIUM DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIOVASCULAR DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ECONOMIC PROBLEM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROOESOPHAGEAL REFLUX DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOKALAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLUENZA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL ISCHAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUROPATHY PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYSTEMIC LUPUS ERYTHEMATOSUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREATMENT NONCOMPLIANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>X-RAY OF PELVIS AND HIP ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RITUXIMAB (RITUXIMAB) CONC FOR SOLUTION FOR INFUSION</medicinalproduct>
        <drugbatchnumb>10152</drugbatchnumb>
        <drugdosagetext>1000 MG, DAYS 1+15, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>SYSTEMIC LUPUS ERYTHEMATOSUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060406</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060420</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELLCEPT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE TAB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAQUENIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PERCOCET</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MUPIROCIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLOBETASOL PROPIONATE (CLOBETASOL PROPIONATE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE TAB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NITROGLYCERIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENADRYL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SOLU-MEDROL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053260-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060623</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US200606005421</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>77</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPEECH DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugauthorizationnumb>21318</drugauthorizationnumb>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053261-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060622</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US200606000665</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>66</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>EYE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EVISTA</medicinalproduct>
        <drugbatchnumb>A163377</drugbatchnumb>
        <drugauthorizationnumb>20815</drugauthorizationnumb>
        <drugindication>OSTEOPOROSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugbatchnumb>FF5X21A</drugbatchnumb>
        <drugdosagetext>DAILY (1/D),</drugdosagetext>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMINS, OTHER COMBINATIONS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BELLAMINE S (BELLADONNA ALKALOIDS, ERGOTAMINE TARTRATE, PHENOBARBITAL)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053262-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060704</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>USA-2006-0024402</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>59</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE IMMEASURABLE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALLOR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARYNGEAL ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARYNGOLARYNGEAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRODUCTIVE COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH GENERALISED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SENSORY DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URTICARIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CEFDITOREN PIVOXIL</medicinalproduct>
        <drugauthorizationnumb>21222</drugauthorizationnumb>
        <drugdosagetext>100 MG, DAILY, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BRONCHITIS ACUTE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060501</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RADEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEPAS                  (ETIZOLAM)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>URINORM (BENZBROMARONE)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053263-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060623</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PL200512003387</companynumb>
    <primarysource>
      <reportercountry>POLAND</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>72</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CATARACT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GLAUCOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMAN INSULIN         (RDNA ORIGIN) NPH</medicinalproduct>
        <drugauthorizationnumb>18780</drugauthorizationnumb>
        <drugdosagetext>14 U, 2/D, SUBCUTANEOUS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031020</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INHIBACE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BISOPROLOL       (BISPROLOL)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACARD       (ACETYLSALICYLIC ACID)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CHLORAMPHENICOL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053264-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060627</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2006KR09901</companynumb>
    <primarysource>
      <reportercountry>KOREA, REPUBLIC OF</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>43</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG LEVEL INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HERPES SIMPLEX</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>KIDNEY TRANSPLANT REJECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYELONEPHRITIS ACUTE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOSPORINE</medicinalproduct>
        <drugauthorizationnumb>80339</drugauthorizationnumb>
        <drugindication>RENAL TRANSPLANT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugindication>RENAL TRANSPLANT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHYLPREDNISOLONE</medicinalproduct>
        <drugdosagetext>INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>KIDNEY TRANSPLANT REJECTION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053265-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>13792</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>55</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>IMPAIRED HEALING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JAW DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL CAVITY FISTULA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SURGICAL PROCEDURE REPEATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTH EXTRACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WOUND DEHISCENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAMIDRONATE DISODIUM</medicinalproduct>
        <drugauthorizationnumb>75841</drugauthorizationnumb>
        <drugindication>DRUG THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040407</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CHEMOTHERAPY</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INTERFERON</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053266-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>13436</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>64</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>65</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAPHYLACTOID REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HOT FLUSH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARBOPLATIN</medicinalproduct>
        <drugbatchnumb>R041686</drugbatchnumb>
        <drugauthorizationnumb>76517</drugauthorizationnumb>
        <drugdosagetext>490 MG IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>OVARIAN CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051229</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051229</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARBOPLATIN</medicinalproduct>
        <drugbatchnumb>R031666</drugbatchnumb>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRAZEPAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMOVANE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053267-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060622</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA200606005586</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>90</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>CEREBRAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugauthorizationnumb>21318</drugauthorizationnumb>
        <drugdosagetext>20 UG, DAILY (1/D),</drugdosagetext>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060309</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060429</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FORTEO PEN (250MCG/ML)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053268-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060623</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BE200606005023</companynumb>
    <primarysource>
      <reportercountry>BELGIUM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>39</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BRONCHOSPASM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORTHOSTATIC HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>60 MG, DAILY (1/D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>FIBROMYALGIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060325</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060325</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EFFEXOR</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053269-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060623</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE200606005230</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>48</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BRAIN OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSED LEVEL OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUROLEPTIC MALIGNANT SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHABDOMYOLYSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
        <drugauthorizationnumb>20592</drugauthorizationnumb>
        <drugdosagetext>7.5 MG, 2/D, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PSYCHOTIC DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060327</drugenddate>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
      </drug>
    </patient>
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  <safetyreport>
    <safetyreportid>5053270-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060621</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP200606005237</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CEREBRAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENOUS THROMBOSIS LIMB</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EVISTA</medicinalproduct>
        <drugauthorizationnumb>20815</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053271-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060710</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>MX-2006-006557</companynumb>
    <primarysource>
      <reportercountry>MEXICO</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>21</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BREAST NEOPLASM</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>20060117</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060317</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053272-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060626</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-2006-001818</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>30</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>EPILEPSY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEAD INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROCEDURAL COMPLICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE VASOVAGAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BETAFERON 250 UG, 500 UG AND COPAXONE (BETAFERON (SH Y0367A)) INJECTIO</medicinalproduct>
        <drugdosagetext>8 OR 16 MIU, EVERY 2D, SUBCUTANEOUS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RELAPSING-REMITTING MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040603</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>YOHIMBINE (YOHIMBINE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GURANA (PAULLINIA CUPANA)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LYCOPODIUM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053273-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060626</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DSA_28386_2006</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>38</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEEP VEIN THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEDATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAVOR</medicinalproduct>
        <drugauthorizationnumb>17794</drugauthorizationnumb>
        <drugdosagetext>7.5 MG Q DAY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060220</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060402</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HALDOL</medicinalproduct>
        <drugdosagetext>20 MG Q DAY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060220</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060407</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AKINETON</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>JODTHYROX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053274-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060630</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>THYR-10328</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>50</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ANION GAP INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRADYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIO-RESPIRATORY ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERKALAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LETHARGY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METABOLIC ACIDOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL ISCHAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL INTAKE REDUCED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUS TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>THYROGEN</medicinalproduct>
        <drugauthorizationnumb>20898</drugauthorizationnumb>
        <drugdosagetext>0.9 MG ONCE IM</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>DIAGNOSTIC PROCEDURE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060619</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060619</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANTOPRAZOLE SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DILTIAZERN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATACAND</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053275-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060704</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006-07-0093</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>59</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PULMONARY FIBROSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEG-INTRON</medicinalproduct>
        <drugdosagetext>100 MCG QW SUBCUTANEOUS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060420</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060630</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBETOL</medicinalproduct>
        <drugdosagetext>600 MG ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060420</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060630</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053276-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006RR-02826</companynumb>
    <primarysource>
      <reportercountry>ISRAEL</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>59</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIOGENIC SHOCK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LETHARGY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METABOLIC ACIDOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NODAL RHYTHM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLEURAL EFFUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY CONGESTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VERAPAMIL</medicinalproduct>
        <drugauthorizationnumb>75556</drugauthorizationnumb>
        <drugdosagetext>3 G, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENALAPRIL MALEATE</medicinalproduct>
        <drugdosagetext>6 PILLS, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DISOTHIAZIDE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053277-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060627</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006BL003726</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>MESOTHELIOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
        <drugauthorizationnumb>40069</drugauthorizationnumb>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATORVASTATIN (ATORASVASTATIN)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BECLOMETHASONE DIPROPIONATE (BECLOMEHTASONE DIPROPIONATE)</medicinalproduct>
        <drugdosagetext>DAILY; OROPHARYNGEAL</drugdosagetext>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DILTIAZEM</medicinalproduct>
        <drugdosagetext>DAILY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOSULEPIN (DOSULEPIN)</medicinalproduct>
        <drugdosagetext>DAILY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FRUMIL (FRUMIL)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
        <drugdosagetext>DAILY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GAVISCON</medicinalproduct>
        <drugdosagetext>DAILY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LACTULOSE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LANSOPRAZOLE</medicinalproduct>
        <drugdosagetext>DAILY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METOCLOPRAMIDE</medicinalproduct>
        <drugdosagetext>DAILY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NITROLINGUAL (GLYCERYL TRINITRATE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NOZINAN (LEVOMEPROMAZINE MALEATE)</medicinalproduct>
        <drugdosagetext>DAILY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXYCODONE (OXYCODONE)</medicinalproduct>
        <drugdosagetext>DAILY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXYGEN (OXYGEN)</medicinalproduct>
        <drugdosagetext>OROPHARYNGEAL</drugdosagetext>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMBIVENT</medicinalproduct>
        <drugdosagetext>OROPHARYNGEAL</drugdosagetext>
        <drugadministrationroute>049</drugadministrationroute>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030617</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040513</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SALBUTAMOL (SALBUMATOL)</medicinalproduct>
        <drugdosagetext>DAILY; OROPHARYNGEAL</drugdosagetext>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
        <drugdosagetext>18 MICROGRAMS; DAILY; OROPHARYNEAL</drugdosagetext>
        <drugadministrationroute>049</drugadministrationroute>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030617</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040701</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SPIRONOLACTONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SYMBICORT TURBUHALER ^ASTRAZENECA^ (SYMBICORT TURBUHALER ^DRACO^)</medicinalproduct>
        <drugdosagetext>OROPHARYNGEAL</drugdosagetext>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TEMAZEPAM</medicinalproduct>
        <drugdosagetext>DAILY</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053278-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060626</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DSA_28226_2006</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>69</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CHOLECYSTITIS ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHOLELITHIASIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ATIVAN</medicinalproduct>
        <drugauthorizationnumb>17794</drugauthorizationnumb>
        <drugdosagetext>1 MG 5XD PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANXIETY</drugindication>
        <drugtreatmentduration>30</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ATIVAN</medicinalproduct>
        <drugdosagetext>10 MG Q DAY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANXIETY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19760101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROPRANOLOL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053279-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060626</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006RR-02828</companynumb>
    <primarysource>
      <reportercountry>GREECE</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>58</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRODUODENITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCREATITIS ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ULCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugauthorizationnumb>76285</drugauthorizationnumb>
        <drugdosagetext>40 MG, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERCHOLESTEROLAEMIA</drugindication>
        <drugtreatmentduration>61</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>100 MG, QD</drugdosagetext>
        <drugtreatmentduration>2190</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053280-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060623</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006RR-02815</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>26</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ARRHYTHMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE SYSTOLIC DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMODYNAMIC INSTABILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METABOLIC ACIDOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
        <drugauthorizationnumb>70469</drugauthorizationnumb>
        <drugdosagetext>SUSTAINED RELEASE TABLETS, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053281-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060622</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>226713</companynumb>
    <primarysource>
      <reportercountry>SPAIN</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>56</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>60</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CACHEXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG TOXICITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERCATABOLISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ILEUS PARALYTIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALNUTRITION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVASTIN</medicinalproduct>
        <drugdosagetext>INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLON CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060420</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060420</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ELOXATIN</medicinalproduct>
        <drugdosagetext>INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060419</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060420</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUOROURACIL</medicinalproduct>
        <drugdosagetext>INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060419</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060420</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BUSCAPINA (SCOPOLAMINE BUTYLBROMIDE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OCTREOTIDE ACETATE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053282-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060627</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AZAUK200600229</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>52</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>83.1</patientweight>
      <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>MYELODYSPLASTIC SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPENIC SEPSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AZACITIDINE (AZACITIDINE) (INJECTION)</medicinalproduct>
        <drugauthorizationnumb>50794</drugauthorizationnumb>
        <drugdosagetext>75 MG/M2, SUBCUTANEOUS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>ACUTE MYELOID LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060614</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060620</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053283-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060626</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>224341</companynumb>
    <primarysource>
      <reportercountry>SPAIN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>57</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>NEUROTOXICITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OPTIC NEUROPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL ACUITY REDUCED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HERCEPTIN</medicinalproduct>
        <drugdosagetext>INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041115</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051215</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOCETAXEL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAXOTERE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EPIRUBICIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOREMIFENE (TOREMIFENE CITRATE)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053284-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060630</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006-02664</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLISTER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN INFLAMMATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN REACTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ANDRODERM</medicinalproduct>
        <drugauthorizationnumb>20489</drugauthorizationnumb>
        <drugdosagetext>5 MG, TRANSDERMAL</drugdosagetext>
        <drugadministrationroute>062</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060406</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TESTOSTERONE                      (TESTOSTERONE) GEL</medicinalproduct>
        <drugdosagetext>TOPICAL</drugdosagetext>
        <drugadministrationroute>061</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060413</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060414</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENDROFLUAZIDE (BENDROFLUMETHIAZIDE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANSOPRAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LATANOPROST</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOSARTAN POTASSIUM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053285-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060626</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>225648</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>48</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CHILLS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISEASE RECURRENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISSEMINATED INTRAVASCULAR COAGULATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLUENZA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHINOLARYNGITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RAPTIVA</medicinalproduct>
        <drugdosagetext>0.9 ML, 1/WEEK, SUBCUTANEOUS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PSORIASIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053286-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>226913</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>68</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>75</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CHOLESTASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPLENOMEGALY</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>20060210</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060421</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROXYZINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BETAMETHASONE DIPROPIONATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SALICYLIC ACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DESLORATADINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053287-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060630</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>14346</companynumb>
    <primarysource>
      <reportercountry>HUNGARY</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>56</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>78</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEURALGIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PACLITAXEL</medicinalproduct>
        <drugbatchnumb>R036866</drugbatchnumb>
        <drugauthorizationnumb>76131</drugauthorizationnumb>
        <drugdosagetext>175 MG/M2</drugdosagetext>
        <drugindication>OVARIAN CANCER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SOLU-MEDROL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIMUSC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOLARGAN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053288-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060615</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>5253</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>50</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>COELIAC DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOWER RESPIRATORY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MASS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METABOLIC ACIDOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STEM CELL TRANSPLANT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CISPLATIN</medicinalproduct>
        <drugauthorizationnumb>71868</drugauthorizationnumb>
        <drugdosagetext>33 MG/M2 TID IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>LYMPHADENOPATHY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20000101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYTARABINE</medicinalproduct>
        <drugdosagetext>2 G/M2 BID</drugdosagetext>
        <drugindication>LYMPHADENOPATHY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE TAB</medicinalproduct>
        <drugdosagetext>160 MG PER_CYCLE PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>LYMPHADENOPATHY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20000101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ETOPOSIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYCLOPHOSPHAMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CCNU</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053289-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>14332</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>32</patientonsetage>
      <patientonsetageunit>802</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>AKINESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ALANINE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASPARTATE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIOMYOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG WITHDRAWAL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ECHOCARDIOGRAM ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ELECTROCARDIOGRAM ST SEGMENT ELEVATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ELECTROCARDIOGRAM T WAVE INVERSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENTRICULAR TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIDAZOLAM HYDROCHLORIDE</medicinalproduct>
        <drugauthorizationnumb>75396</drugauthorizationnumb>
        <drugindication>RESPIRATORY FAILURE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BUPRENORPHINE HCL</medicinalproduct>
        <drugindication>RESPIRATORY FAILURE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VECURONIUM BROMIDE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053290-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060627</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2006IT10027</companynumb>
    <primarysource>
      <reportercountry>ITALY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>58</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CONJUNCTIVAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CYTOMEGALOVIRUS INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATOCRIT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATOTOXICITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HERPES VIRUS INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HERPES ZOSTER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEPHROPATHY TOXIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RED BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL LYMPHOCELE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SCEDOSPORIUM INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOFT TISSUE INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUBCUTANEOUS ABSCESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TENDON RUPTURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOSPORINE</medicinalproduct>
        <drugauthorizationnumb>80336</drugauthorizationnumb>
        <drugdosagetext>3 MG/KG/D</drugdosagetext>
        <drugindication>RENAL TRANSPLANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19950201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugdosagetext>8 MG/D</drugdosagetext>
        <drugindication>RENAL TRANSPLANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19950201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ANTITHYMOCYTE IMMUNOGLOBULIN (RABBIT)(ANTITHYMOCYTE IMMUNOGLOBULIN (RA</medicinalproduct>
        <drugindication>RENAL TRANSPLANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19950201</drugstartdate>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VORICONAZOLE (VORICONAZOLE)</medicinalproduct>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugtreatmentduration>91</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VORICONAZOLE (VORICONAZOLE)</medicinalproduct>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugtreatmentduration>91</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VORICONAZOLE (VORICONAZOLE)</medicinalproduct>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugtreatmentduration>91</drugtreatmentduration>
        <drugtreatmentdurationunit>805</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053291-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060704</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GXKR2006TR03785</companynumb>
    <primarysource>
      <reportercountry>TURKEY</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>7</patientonsetage>
      <patientonsetageunit>805</patientonsetageunit>
      <patientweight>3.7</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD ALDOSTERONE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRADYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERKALAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEONATAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUPRAVENTRICULAR TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMIODARONE HCL</medicinalproduct>
        <drugauthorizationnumb>75315</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugindication>SUPRAVENTRICULAR TACHYCARDIA</drugindication>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMIODARONE HCL</medicinalproduct>
        <drugauthorizationnumb>75315</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugindication>SUPRAVENTRICULAR TACHYCARDIA</drugindication>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>805</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMIODARONE HCL</medicinalproduct>
        <drugauthorizationnumb>75315</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugindication>SUPRAVENTRICULAR TACHYCARDIA</drugindication>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>807</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053292-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060630</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A-CH2006-12494</companynumb>
    <primarysource>
      <reportercountry>NETHERLANDS</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>76</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>73</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>BLOOD BILIRUBIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRAIN NATRIURETIC PEPTIDE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CYANOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL FIBROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENTRICULAR ARRHYTHMIA</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>20060518</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060608</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>20060609</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060619</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANOXIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ISOSORBIDE DINITRATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETYLSALICYLIC ACID SRT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACENOCOUMAROL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BUMETANIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANTOZOL (PANTOPRAZOLE SODIUM)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCICHEW (CALCIUM CARBONATE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SERETIDE (SALMETEROL, FLUTICASONE PROPIONATE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATROVENT</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053293-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060630</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>14340</companynumb>
    <primarysource>
      <reportercountry>ITALY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>56</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ADRENOCORTICAL INSUFFICIENCY ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ELECTROLYTE IMBALANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FUSARIUM INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYCOBACTERIUM AVIUM COMPLEX INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA FUNGAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STOMACH DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUCONAZOLE</medicinalproduct>
        <drugauthorizationnumb>76617</drugauthorizationnumb>
        <drugindication>SYSTEMIC CANDIDA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COTRIM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GANCICLOVIR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZIDOVUDINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LAMIVUDINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOPINAVIR/RITONAVIR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EFAVIRENZ</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LINEZOLID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PIPERACILLIN AND TAZOBACTAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CORTISONE ACETATE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053294-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060630</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>14336</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>74</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>LOWER RESPIRATORY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPENIC SEPSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUOROURACIL</medicinalproduct>
        <drugauthorizationnumb>11719</drugauthorizationnumb>
        <drugdosagetext>950 MG FREQ IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060330</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060330</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHOTREXATE SODIUM</medicinalproduct>
        <drugdosagetext>80 MG FREQ IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060330</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060330</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOPHOSPHAMIDE</medicinalproduct>
        <drugdosagetext>950 MG FREQ IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060330</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060330</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIAZEPAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROXOCOBALAMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANSOPRAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053295-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060622</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>RU200603006346</companynumb>
    <primarysource>
      <reportercountry>RUSSIAN FEDERATION</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>38</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>75</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>CIRCULATORY COLLAPSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
        <drugauthorizationnumb>20592</drugauthorizationnumb>
        <drugdosagetext>10 MG, DAILY (1/D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060201</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053296-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060623</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ES200606005760</companynumb>
    <primarysource>
      <reportercountry>SPAIN</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>87</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugbatchnumb>FF5534J</drugbatchnumb>
        <drugauthorizationnumb>21318</drugauthorizationnumb>
        <drugdosagetext>20 UG, DAILY (1/D), SUBCUTANEOUS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060616</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053297-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060623</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR200606005262</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>70</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HOT FLUSH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPONATRAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE VASOVAGAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VERTIGO</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugauthorizationnumb>21318</drugauthorizationnumb>
        <drugdosagetext>20 UG, DAILY (1/D), SUBCUTANEOUS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050718</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053298-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060623</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BE200606004528</companynumb>
    <primarysource>
      <reportercountry>BELGIUM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>76</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>COMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEAD INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUBDURAL HAEMATOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugauthorizationnumb>21318</drugauthorizationnumb>
        <drugdosagetext>20 UG, DAILY (1/D), SUBCUTANEOUS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM (CALCIUM)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LONARID (AMOBARBITAL, CAFFEINE, CODEINE PHOSPHATE, OCTIBENZONIUM BROMI</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOFTYL (BUFLOMEDIL HYDROCHLORIDE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN+CAFFEINE (ACETYLSALICYLIC ACID, CAFFEINE)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053299-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060622</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE200606005620</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>56</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ALANINE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASPARTATE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAMMA-GLUTAMYLTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>60 MG, DAILY (1/D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060518</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060620</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMITRIPTYLINE HYDROCHLORIDE (AMITRIPTYLINE HYDROCHLORIDE) SLOW RELEASE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053300-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060626</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DSA_28391_2006</companynumb>
    <primarysource>
      <reportercountry>SWEDEN</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>76</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD CREATININE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERKALAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENALAPRIL MALEATE</medicinalproduct>
        <drugauthorizationnumb>18998</drugauthorizationnumb>
        <drugdosagetext>10 MG QD PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CARDIAC DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GLYBURIDE</medicinalproduct>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL SUCCINATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053301-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060626</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DSA_28385_2006</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>39</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ARRHYTHMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC VALVE DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEEP VEIN THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAVOR</medicinalproduct>
        <drugauthorizationnumb>17794</drugauthorizationnumb>
        <drugdosagetext>3 MG QD PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060319</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060411</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
        <drugdosagetext>20 MG QD PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060319</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060411</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POLAMIDON</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANITOP</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ISOKET</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HCT</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053302-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060626</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DSA_28334_2006</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>65</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>COMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CYANOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE DRUG OVERDOSE INTENTIONAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDE ATTEMPT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAVOR</medicinalproduct>
        <drugauthorizationnumb>17794</drugauthorizationnumb>
        <drugdosagetext>DR ONCE PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060608</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060608</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DALMADORM</medicinalproduct>
        <drugdosagetext>DF ONCE PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060608</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060608</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRICYCLIC ANTIDEPRESSANTS</medicinalproduct>
        <drugdosagetext>DF ONCE PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060608</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060608</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PERAZINE</medicinalproduct>
        <drugdosagetext>DF ONCE PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060608</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060608</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALCOHOL</medicinalproduct>
        <drugdosagetext>500 ML ONCE PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060608</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060608</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053303-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060627</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PAR_0689_2006</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>51</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ERYTHEMA MULTIFORME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
        <drugauthorizationnumb>70481</drugauthorizationnumb>
        <drugdosagetext>DF UNK PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRALGIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060523</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060525</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENDROFLUAZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ERYTHROMYCIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053304-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060704</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006-07-0094</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>27</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HEPATIC ENCEPHALOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JAUNDICE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEG-INTRON</medicinalproduct>
        <drugdosagetext>SUBCUTANEOUS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060131</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBETOL</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060131</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053305-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006054537</companynumb>
    <primarysource>
      <reportercountry>TURKEY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>21</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>66</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ARTERIOSPASM CORONARY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BETA HAEMOLYTIC STREPTOCOCCAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC PROCEDURE COMPLICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARYNGITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUSITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TONSILLITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUDAFED 12 HOUR</medicinalproduct>
        <drugdosagetext>60 MG 3 TIMES IN 1 DAY, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>UPPER RESPIRATORY TRACT INFECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CEFAZOLIN SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SULFAMETHOXAZOLE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053306-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060626</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DSA_28393_2006</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>LIVER DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPHOCYTE STIMULATION TEST POSITIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RENIVACE</medicinalproduct>
        <drugauthorizationnumb>18998</drugauthorizationnumb>
        <drugdosagetext>5 MG QD PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CARDIAC FAILURE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060501</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>DF UNK PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PANALDINE</medicinalproduct>
        <drugdosagetext>DF UNK PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIVALO</medicinalproduct>
        <drugdosagetext>DF UNK PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SIGMART</medicinalproduct>
        <drugdosagetext>DF</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053307-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060626</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DSA_28387_2006</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>50</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABNORMAL BEHAVIOUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DELIRIUM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DELUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISORIENTATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISTURBANCE IN ATTENTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG WITHDRAWAL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEMORY IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SLEEP DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THINKING ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAVOR</medicinalproduct>
        <drugauthorizationnumb>17794</drugauthorizationnumb>
        <drugdosagetext>0.5 MG PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050129</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050131</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAVOR</medicinalproduct>
        <drugdosagetext>1 MG PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050128</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050128</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAVOR</medicinalproduct>
        <drugdosagetext>2 MG PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050119</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050127</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VENLAFAXINE HCL</medicinalproduct>
        <drugdosagetext>VAR PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050119</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050124</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VENLAFAXINE HCL</medicinalproduct>
        <drugdosagetext>225 MG PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050125</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VENLAFAXINE HCL</medicinalproduct>
        <drugdosagetext>300 MG PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050206</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050208</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VENLAFAXINE HCL</medicinalproduct>
        <drugdosagetext>150 MG PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050209</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050213</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VENLAFAXINE HCL</medicinalproduct>
        <drugdosagetext>75 MG PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050214</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050214</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053318-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060223</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-SP-2006-00458</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>59</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANAPHYLACTIC SHOCK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONJUNCTIVITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CYSTITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JOINT SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>KERATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER FUNCTION TEST ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS GENERALISED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>REITER'S SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URETHRAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URETHRITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMMUCYST</medicinalproduct>
        <drugbatchnumb>LOT NOT REP</drugbatchnumb>
        <drugadministrationroute>043</drugadministrationroute>
        <drugindication>CARCINOMA IN SITU OF BLADDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060117</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060221</drugenddate>
        <drugtreatmentduration>35</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENOXACIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060124</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060131</drugenddate>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CERNITIN POLLEN EXTRACT</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060124</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060131</drugenddate>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FAMOTIDINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060124</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060131</drugenddate>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAMSULOSIN HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060124</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060220</drugenddate>
        <drugtreatmentduration>27</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOXOPROFEN SODIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060124</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060220</drugenddate>
        <drugtreatmentduration>27</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DICLOFENAC SODIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060131</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060220</drugenddate>
        <drugtreatmentduration>20</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053319-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060712</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>HU-SP-2006-01742</companynumb>
    <primarysource>
      <reportercountry>HUNGARY</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>68</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>EPIDIDYMITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SCROTAL PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMMUCYST</medicinalproduct>
        <drugbatchnumb>LOT NOT REP</drugbatchnumb>
        <drugadministrationroute>043</drugadministrationroute>
        <drugindication>BLADDER CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051213</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051213</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMMUCYST</medicinalproduct>
        <drugbatchnumb>LOT NOT REP</drugbatchnumb>
        <drugadministrationroute>043</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051220</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051220</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMMUCYST</medicinalproduct>
        <drugbatchnumb>LOT NOT REP</drugbatchnumb>
        <drugadministrationroute>043</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051227</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051227</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMMUCYST</medicinalproduct>
        <drugbatchnumb>LOT NOT REP</drugbatchnumb>
        <drugadministrationroute>043</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060103</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060103</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMMUCYST</medicinalproduct>
        <drugbatchnumb>LOT NOT REP</drugbatchnumb>
        <drugadministrationroute>043</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060110</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060110</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMMUCYST</medicinalproduct>
        <drugbatchnumb>LOT NOT REP</drugbatchnumb>
        <drugadministrationroute>043</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060117</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060117</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMMUCYST</medicinalproduct>
        <drugbatchnumb>LOT NOT REP</drugbatchnumb>
        <drugadministrationroute>043</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060307</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060307</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMMUCYST</medicinalproduct>
        <drugbatchnumb>LOT NOT REP</drugbatchnumb>
        <drugadministrationroute>043</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060314</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060314</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMMUCYST</medicinalproduct>
        <drugbatchnumb>LOT NOT REP</drugbatchnumb>
        <drugadministrationroute>043</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060321</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060321</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMMUCYST</medicinalproduct>
        <drugbatchnumb>LOT NOT REP</drugbatchnumb>
        <drugadministrationroute>043</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060606</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060606</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMMUCYST</medicinalproduct>
        <drugbatchnumb>LOT NOT REP</drugbatchnumb>
        <drugadministrationroute>043</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060613</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060613</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMMUCYST</medicinalproduct>
        <drugbatchnumb>LOT NOT REP</drugbatchnumb>
        <drugadministrationroute>043</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060620</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060620</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BETALOC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NITROMINT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EDNYT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIAPREL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053320-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060707</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-JNJFOC-20060604274</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>76</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DISSEMINATED TUBERCULOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>SPONDYLOARTHROPATHY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053321-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060710</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PL-JNJFOC-20060701688</companynumb>
    <primarysource>
      <reportercountry>POLAND</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>30</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>56</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIOGENIC SHOCK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REOPRO</medicinalproduct>
        <drugindication>PERCUTANEOUS CORONARY INTERVENTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETYLSALICYLIC ACID SRT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNFRACTIONATED HEPARIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLOPIDOGREL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053322-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060710</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AT-JNJFOC-20060604665</companynumb>
    <primarysource>
      <reportercountry>AUSTRIA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>77</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HEPATIC NEOPLASM MALIGNANT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugbatchnumb>5RMKA703</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PSORIASIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XEFO</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XEFO</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053323-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060425</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006BH010647</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>31</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>80</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HYPERLIPIDAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VASCULAR STENOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENTRICULAR FIBRILLATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ADVATE (OCTOCOG ALFA)</medicinalproduct>
        <drugbatchnumb>LE01D015AG</drugbatchnumb>
        <drugdosagetext>2000 IU; AS NEEDED</drugdosagetext>
        <drugindication>HAEMARTHROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051215</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051215</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HUMAN FACTOR VIII</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053324-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060707</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060608</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006BH011579</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>28</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>90</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>INFLUENZA LIKE ILLNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ADVATE (OCTOCOG ALFA)</medicinalproduct>
        <drugdosagetext>20 IU/KG; 3X A WEEK;  10 IU/KG; 2X A WEEK</drugdosagetext>
        <drugindication>FACTOR VIII DEFICIENCY</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050401</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ADVATE (OCTOCOG ALFA)</medicinalproduct>
        <drugdosagetext>20 IU/KG; 3X A WEEK;  10 IU/KG; 2X A WEEK</drugdosagetext>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050401</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ADVATE (OCTOCOG ALFA)</medicinalproduct>
        <drugdosagetext>20 IU/KG; 3X A WEEK;  10 IU/KG; 2X A WEEK</drugdosagetext>
        <drugindication>FACTOR VIII DEFICIENCY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050417</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ADVATE (OCTOCOG ALFA)</medicinalproduct>
        <drugdosagetext>20 IU/KG; 3X A WEEK;  10 IU/KG; 2X A WEEK</drugdosagetext>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050417</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HUMAN FACTOR VIII</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INFLUENZA VACCINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053325-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060623</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200410297BYL</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>22</patientonsetage>
      <patientonsetageunit>802</patientonsetageunit>
      <patientweight>11.4</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BRONCHITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOLYTIC ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOVITAMINOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IRON DEFICIENCY ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GAMIMUNE N 5%</medicinalproduct>
        <drugbatchnumb>26N2C71</drugbatchnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>KAWASAKI'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040210</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040211</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GAMIMUNE N 5%</medicinalproduct>
        <drugbatchnumb>26N2C71</drugbatchnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>KAWASAKI'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040211</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040212</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GAMIMUNE N 5%</medicinalproduct>
        <drugbatchnumb>26N2C71</drugbatchnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>KAWASAKI'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040213</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040217</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GAMIMUNE N 5%</medicinalproduct>
        <drugbatchnumb>26N2C71</drugbatchnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>KAWASAKI'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040217</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040221</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GAMIMUNE N 5%</medicinalproduct>
        <drugbatchnumb>26N2C71</drugbatchnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>KAWASAKI'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040211</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARBENIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HOKUNALIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUMARIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEO-MINOPHAGEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BROACT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MIRACLID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOSMICIN S</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANVITAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FROBEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INCREMIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053327-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20051114</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2005BH002955</companynumb>
    <primarysource>
      <reportercountry>ITALY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>16</patientonsetage>
      <patientonsetageunit>802</patientonsetageunit>
      <patientweight>15.2</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ADVATE (OCTOCOG ALFA)</medicinalproduct>
        <drugbatchnumb>LE01D005AE</drugbatchnumb>
        <drugdosagetext>934 IU; ONCE; IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>HAEMORRHAGE</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050904</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053328-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060620</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>THYM-10921</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>47</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>72</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HEART TRANSPLANT REJECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEUKOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>THYMOGLOBULIN</medicinalproduct>
        <drugdosagetext>125 MG QD IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>HEART TRANSPLANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060224</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060227</drugenddate>
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    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053331-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060620</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>THYM-10920</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>18</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>55</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HEART TRANSPLANT REJECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPARIN-INDUCED THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEUKOPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>THYMOGLOBULIN</medicinalproduct>
        <drugdosagetext>125 MG QD IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>HEART TRANSPLANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060227</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060303</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>THYMOGLOBULIN</medicinalproduct>
        <drugdosagetext>100 MG QD IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>HEART TRANSPLANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060304</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060305</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>THYMOGLOBULIN</medicinalproduct>
        <drugdosagetext>50 MG QD IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>HEART TRANSPLANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060306</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060308</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MYCOPHENOLATE MOFETIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DILANTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BLOOD PLATELET</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FRESH FROZEN PLASMA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RED BLOOD CELLS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053338-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060705</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060627</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>HQ1095616FEB2000</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>25</patientonsetage>
      <patientonsetageunit>802</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANAPHYLACTOID REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG SPECIFIC ANTIBODY PRESENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BENEFIX</medicinalproduct>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>FACTOR IX DEFICIENCY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980509</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19981223</drugenddate>
        <drugtreatmentduration>229</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BENEFIX</medicinalproduct>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>FACTOR IX DEFICIENCY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990107</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19990107</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BENEFIX</medicinalproduct>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>FACTOR IX DEFICIENCY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19981201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19990107</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053341-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006082168</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>CELLULITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUTENT</medicinalproduct>
        <drugauthorizationnumb>21968</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>METASTATIC RENAL CELL CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051011</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051220</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUTENT</medicinalproduct>
        <drugauthorizationnumb>21968</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>METASTATIC RENAL CELL CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060103</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060626</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053342-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006082502</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>71</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DELIRIUM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugbatchnumb>0039125</drugbatchnumb>
        <drugauthorizationnumb>21446</drugauthorizationnumb>
        <drugdosagetext>150 MG (75 MG, 2 IN 1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NEURALGIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060622</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060624</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZANAFLEX</medicinalproduct>
        <drugbatchnumb>4K192</drugbatchnumb>
        <drugdosagetext>16 MG (8 MG), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NEURALGIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060613</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060622</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACTONEL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CILAZAPRIL (CILAZAPRIL)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANTOLOC (PANTOPRAZOLE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COMTAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DETROL LA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONAZEPAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EZETROL (EZETIMIBE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SINEMET CR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SEROQUET (QUETIAPINE FUMARATE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCODONE AND ACETAMINOPHEN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053343-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006082303</companynumb>
    <primarysource>
      <reportercountry>MEXICO</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>65</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>66</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HEPATIC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UPPER GASTROINTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUTENT</medicinalproduct>
        <drugauthorizationnumb>21968</drugauthorizationnumb>
        <drugdosagetext>50 MG 50 MG, 1 IN 1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>METASTATIC RENAL CELL CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060531</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060625</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENSURE (AMINO ACIDS NOS, MINERALS NOS, VITAMINS NOS)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053345-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006081170</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>2</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>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHROPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHEUMATOID ARTHRITIS</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>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060221</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VASOTEC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARVEDILOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INDOMETHACIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NITRO-SPRAY (ISOSORBIDE DINITRATE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>APO-FUROSEMIDE (FUROSEMIDE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053349-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060703</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006080650</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>61</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>GLOMERULONEPHRITIS RAPIDLY PROGRESSIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEPHRITIS INTERSTITIAL</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>1</drugcharacterization>
        <medicinalproduct>CARDENALIN (DOXAZOSIN)</medicinalproduct>
        <drugdosagetext>4 MG (1 IN 1 D, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
        <drugdosagetext>10 MG (1 IN 1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BLOPRESS (CANDESARTAN CILEXETIL)</medicinalproduct>
        <drugdosagetext>8 MG (1 IN 1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
        <drugdosagetext>100 MG (1 IN 1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENALAPRIL MALEATE</medicinalproduct>
        <drugdosagetext>5 MG (1 IN 1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060422</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060505</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053351-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060711</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2006US08965</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>41</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>66.666</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INTENTIONAL SELF-INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDE ATTEMPT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMISIL</medicinalproduct>
        <drugauthorizationnumb>020539</drugauthorizationnumb>
        <drugdosagetext>250 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NAIL TINEA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060601</drugenddate>
        <drugtreatmentduration>93</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053352-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060707</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2006US08744</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANOREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD BILIRUBIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHOLECYSTECTOMY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHROMATURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS GENERALISED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMISIL</medicinalproduct>
        <drugauthorizationnumb>020539</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053353-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060630</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006080183</companynumb>
    <primarysource>
      <reportercountry>IRELAND</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>65</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>EPISTAXIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugauthorizationnumb>21446</drugauthorizationnumb>
        <drugdosagetext>100 MG (50 MG, 2 IN 1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NEURALGIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053354-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2006JP09846</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ALANINE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASPARTATE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BILIARY DILATATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD ALKALINE PHOSPHATASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHOLEDOCHOENTEROSTOMY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMISIL</medicinalproduct>
        <drugauthorizationnumb>20539</drugauthorizationnumb>
        <drugdosagetext>125 MG/D</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NAIL TINEA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060530</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060621</drugenddate>
        <drugtreatmentduration>33120</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>URSO</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053355-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060707</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHRM2006FR02020</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>35</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DYSAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GRANULOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH MACULO-PAPULAR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMISIL</medicinalproduct>
        <drugauthorizationnumb>020539</drugauthorizationnumb>
        <drugdosagetext>250 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NAIL TINEA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050301</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053357-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006081837</companynumb>
    <primarysource>
      <reportercountry>PHILIPPINES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZMAX (AZITHROMCYN)</medicinalproduct>
        <drugauthorizationnumb>50797</drugauthorizationnumb>
        <drugdosagetext>(500 MG), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053358-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060630</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006081869</companynumb>
    <primarysource>
      <reportercountry>TAIWAN, PROVINCE OF CHINA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>66</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HEPATITIS ACUTE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUTENT</medicinalproduct>
        <drugauthorizationnumb>21968</drugauthorizationnumb>
        <drugdosagetext>25 MG (25 MG, 1 IN 1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>METASTATIC RENAL CELL CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060109</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADALAT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMOVANE (ZOPICLONE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RAMIPRIL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053359-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060623</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR200606005245</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>56</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>POLYNEUROPATHY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CIALIS</medicinalproduct>
        <drugauthorizationnumb>21368</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ERECTILE DYSFUNCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053360-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060613</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2006JP08946</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>41</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>68</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HAEMATOCRIT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IRON DEFICIENCY ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RED BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UTERINE LEIOMYOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMISIL</medicinalproduct>
        <drugauthorizationnumb>20539</drugauthorizationnumb>
        <drugdosagetext>125 MG/D</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NAIL TINEA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060628</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMISIL</medicinalproduct>
        <drugauthorizationnumb>020539</drugauthorizationnumb>
        <drugdosagetext>125 MG/D</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060513</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060613</drugenddate>
        <drugtreatmentduration>46080</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053361-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060710</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2006JP10380</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>52</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD CREATINE PHOSPHOKINASE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMISIL</medicinalproduct>
        <drugauthorizationnumb>020539</drugauthorizationnumb>
        <drugdosagetext>125 MG/D</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053362-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060621</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP200606005276</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>49</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ASCITES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARBOHYDRATE ANTIGEN 19-9 INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARCINOEMBRYONIC ANTIGEN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DECREASED APPETITE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HICCUPS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JAUNDICE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER FUNCTION TEST ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GEMZAR</medicinalproduct>
        <drugauthorizationnumb>20509</drugauthorizationnumb>
        <drugindication>PANCREATIC CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050518</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050615</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053364-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060626</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE200607000173</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>60</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ENTEROCOLITIS HAEMORRHAGIC</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GEMCITABINE HYDROCHLORIDE (GEMCITABINE HYDROCHLORIDE)</medicinalproduct>
        <drugauthorizationnumb>20509</drugauthorizationnumb>
        <drugdosagetext>1500 MG, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060605</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060605</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>^*DOCETAXEL (*DOCETAXEL)</medicinalproduct>
        <drugdosagetext>125 MG, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060605</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060605</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE TAB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAVEGIL (CLEMASTINE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CIMETIDINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053365-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060621</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA200606005022</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>57</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOSCLEROSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugauthorizationnumb>21318</drugauthorizationnumb>
        <drugdosagetext>20 UG, DAILY (1/D)</drugdosagetext>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051118</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060519</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM GLUCONATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLEXERIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTIVIT (VITAMINS NOS)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IRON</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053366-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2006JP09837</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>53</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CEREBRAL ATROPHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMPUTERISED TOMOGRAM ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NUCLEAR MAGNETIC RESONANCE IMAGING ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TEGRETOL</medicinalproduct>
        <drugauthorizationnumb>16608</drugauthorizationnumb>
        <drugdosagetext>300 MG/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>TEMPORAL LOBE EPILEPSY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020930</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060711</drugenddate>
        <drugtreatmentduration>1381</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053367-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060328</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2006JP04884</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>11</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>34</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD CREATINE PHOSPHOKINASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TEGRETOL</medicinalproduct>
        <drugauthorizationnumb>16608</drugauthorizationnumb>
        <drugdosagetext>100 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>EPILEPSY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040330</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TEGRETOL</medicinalproduct>
        <drugauthorizationnumb>016608</drugauthorizationnumb>
        <drugdosagetext>125 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050208</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TEGRETOL</medicinalproduct>
        <drugauthorizationnumb>016608</drugauthorizationnumb>
        <drugdosagetext>175 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050510</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TEGRETOL</medicinalproduct>
        <drugauthorizationnumb>016608</drugauthorizationnumb>
        <drugdosagetext>200 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050906</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TEGRETOL</medicinalproduct>
        <drugauthorizationnumb>016608</drugauthorizationnumb>
        <drugdosagetext>250 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051011</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TEGRETOL</medicinalproduct>
        <drugauthorizationnumb>016608</drugauthorizationnumb>
        <drugdosagetext>200 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060328</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TEGRETOL</medicinalproduct>
        <drugauthorizationnumb>016608</drugauthorizationnumb>
        <drugdosagetext>125 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060411</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TEGRETOL</medicinalproduct>
        <drugauthorizationnumb>016608</drugauthorizationnumb>
        <drugdosagetext>50 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060425</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TEGRETOL</medicinalproduct>
        <drugauthorizationnumb>016608</drugauthorizationnumb>
        <drugdosagetext>175 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060508</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TEGRETOL</medicinalproduct>
        <drugauthorizationnumb>016608</drugauthorizationnumb>
        <drugdosagetext>150 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060523</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TEGRETOL</medicinalproduct>
        <drugauthorizationnumb>016608</drugauthorizationnumb>
        <drugdosagetext>125 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060620</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TEGRETOL</medicinalproduct>
        <drugauthorizationnumb>016608</drugauthorizationnumb>
        <drugdosagetext>100 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060704</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TEGRETOL</medicinalproduct>
        <drugauthorizationnumb>016608</drugauthorizationnumb>
        <drugdosagetext>150 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050405</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TEGRETOL</medicinalproduct>
        <drugauthorizationnumb>016608</drugauthorizationnumb>
        <drugdosagetext>70 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031224</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZONISAMIDE</medicinalproduct>
        <drugdosagetext>120 MG/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>EPILEPSY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060328</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZONISAMIDE</medicinalproduct>
        <drugdosagetext>160 MG/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZONISAMIDE</medicinalproduct>
        <drugdosagetext>200 MG/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZONISAMIDE</medicinalproduct>
        <drugdosagetext>280 MG/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZONISAMIDE</medicinalproduct>
        <drugdosagetext>320 MG/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053368-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060712</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2006JP10480</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>57</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DISSEMINATED INTRAVASCULAR COAGULATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG ERUPTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TEGRETOL</medicinalproduct>
        <drugauthorizationnumb>016608</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053371-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060621</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA200606004869</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>82</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugbatchnumb>FF5S35E</drugbatchnumb>
        <drugauthorizationnumb>21318</drugauthorizationnumb>
        <drugdosagetext>20 UG, DAILY (1/D)</drugdosagetext>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060609</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALTACE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRONOLACTONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANOXIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM GLUCONATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053373-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060621</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR200606005294</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>66</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>50</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DIABETES MELLITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugauthorizationnumb>21318</drugauthorizationnumb>
        <drugdosagetext>20 UG, (DAILY) 1/D, SUBCUTANEOUS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060519</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMIODARONE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM GLUCONATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PURAN T4 (LEVOTHYROXINE SODIUM)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMINS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053376-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060706</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IE-2006-018087</companynumb>
    <primarysource>
      <reportercountry>IRELAND</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>40</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>66</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN LOWER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BETA HAEMOLYTIC STREPTOCOCCAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STREPTOCOCCAL INFECTION</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>20060530</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060626</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053377-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060621</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR200606005345</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>69</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLINDNESS UNILATERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COAGULOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOPTYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugauthorizationnumb>21318</drugauthorizationnumb>
        <drugdosagetext>20 UG, DAILY (1/D), SUBCUTANEOUS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050923</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIDOSE (CALCIUM CARBONATE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM CHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEXOMIL (BROMAZEPAM)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MOTILIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MUCOMYST</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYMBICORT (BUDESONIDE, FORMOTEROL FUMARATE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DURAGESIC-100</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRAXILENE (NAFTIDROFURYL OXALATE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPECIAFOLDINE (FOLIC ACID)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TANGANIL (ETHANOLAMINE ACETYLLEUCINATE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053380-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006MP000225</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>57</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIOGENIC SHOCK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY STENOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AGGRASTAT</medicinalproduct>
        <drugauthorizationnumb>20912</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ANGINA UNSTABLE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060211</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060211</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AGGRASTAT</medicinalproduct>
        <drugauthorizationnumb>20912</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ANGINA UNSTABLE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060211</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060213</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HEPARIN LOW MOLECULAR WEIGHT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053381-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060704</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A-CH2006-12544</companynumb>
    <primarysource>
      <reportercountry>BELGIUM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>68</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>77.2</patientweight>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ACUTE ABDOMEN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ACUTE RESPIRATORY DISTRESS SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASPARTATE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RETROPERITONEAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRACLEER</medicinalproduct>
        <drugauthorizationnumb>21290</drugauthorizationnumb>
        <drugdosagetext>125 MG, BID, ORAL; SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040123</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANOXIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EMCONCOR (BISOPROLOL)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MARCUMAR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALPRAZOLAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOPHAGE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EFFEXOR</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053382-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A-CH2006-12539</companynumb>
    <primarysource>
      <reportercountry>TURKEY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>15</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>53</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ACTIVATED PARTIAL THROMBOPLASTIN TIME PROLONGED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRADYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROTHROMBIN TIME PROLONGED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDE ATTEMPT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISION BLURRED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</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>5053383-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060705</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A-CH2006-12495</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>64</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD CREATINE PHOSPHOKINASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD THYROID STIMULATING HORMONE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTHYROIDISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER FUNCTION TEST ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULAR WEAKNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUROPATHY PERIPHERAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRACLEER</medicinalproduct>
        <drugauthorizationnumb>21290</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053384-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060531</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2006US07089</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>51</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWELLING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CALCITRIOL</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AREDIA</medicinalproduct>
        <drugauthorizationnumb>020036</drugauthorizationnumb>
        <drugdosagetext>30MG Q3MOS</drugdosagetext>
        <drugindication>OSTEOPENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060601</drugenddate>
        <drugtreatmentduration>730</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053385-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060707</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHNU2006DE02467</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>LEUKOCYTOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DESFERAL</medicinalproduct>
        <drugauthorizationnumb>016267</drugauthorizationnumb>
        <drugdosagetext>2 G, QW5</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>HAEMOSIDEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053386-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060711</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2006US08863</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DECREASED INTEREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERAL PHYSICAL HEALTH DETERIORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AREDIA</medicinalproduct>
        <drugauthorizationnumb>020036</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053387-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060206</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHNU2006DE00843</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>50</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ACTINOMYCOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BIOPSY SITE UNSPECIFIED ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BIOPSY SKIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMPUTERISED TOMOGRAM ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DENTAL TREATMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRIC ULCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GINGIVAL ULCERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMPAIRED HEALING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTUBATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYELOFIBROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OESOPHAGOGASTRODUODENOSCOPY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL SURGERY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOMYELITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOMYELITIS CHRONIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOSCLEROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN JAW</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRIMARY SEQUESTRUM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SCINTIGRAPHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEQUESTRECTOMY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTH EXTRACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WOUND DEBRIDEMENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XELODA</medicinalproduct>
        <drugdosagetext>1700 MG, BID FOR 2 WEEKS</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VINORELBINE</medicinalproduct>
        <drugdosagetext>42 MG, QW</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEGESTROL ACETATE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050801</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NSAID'S</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugdosagetext>4 MG, QMO</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>METASTASES TO BONE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AREDIA</medicinalproduct>
        <drugauthorizationnumb>020036</drugauthorizationnumb>
        <drugdosagetext>UNK, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>METASTASES TO BONE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19950101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053388-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060711</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2006US08869</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DECREASED INTEREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERAL PHYSICAL HEALTH DETERIORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AREDIA</medicinalproduct>
        <drugauthorizationnumb>020036</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053389-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FABR-11563</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>63</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>60</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>PNEUMONIA ASPIRATION</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>20050308</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060530</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053390-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060706</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2006US08730</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>85</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>98.412</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ATELECTASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLINDNESS UNILATERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBRAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBRAL ISCHAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEEP VEIN THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NECK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NUCLEAR MAGNETIC RESONANCE IMAGING BRAIN ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESTLESSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRANSIENT ISCHAEMIC ATTACK</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTIVITAMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYCLOSPORINE</medicinalproduct>
        <drugdosagetext>50 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051121</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXJADE</medicinalproduct>
        <drugauthorizationnumb>021882</drugauthorizationnumb>
        <drugdosagetext>2000 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HAEMOSIDEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060428</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARANESP</medicinalproduct>
        <drugdosagetext>400 MG, QW</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>ANAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060301</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVAQUIN</medicinalproduct>
        <drugdosagetext>500 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060704</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
        <drugdosagetext>325 MG, PRN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEADACHE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
        <drugdosagetext>5 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19100211</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREVACID</medicinalproduct>
        <drugdosagetext>30 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051027</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TERAZOSIN HCL</medicinalproduct>
        <drugdosagetext>5 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BENIGN PROSTATIC HYPERPLASIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051027</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SODIUM BICARBONATE</medicinalproduct>
        <drugdosagetext>650 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053391-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHFR2006GB02116</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>35</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTESTINAL FUNCTIONAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IRRITABLE BOWEL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>REBOUND EFFECT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZARIL</medicinalproduct>
        <drugauthorizationnumb>019758</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050906</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060616</drugenddate>
        <drugtreatmentduration>284</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMISULPRIDE</medicinalproduct>
        <drugdosagetext>400MG/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PIRENZEPINE</medicinalproduct>
        <drugdosagetext>25MG/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALPROATE SODIUM</medicinalproduct>
        <drugdosagetext>1.5G/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LAMOTRIGINE</medicinalproduct>
        <drugdosagetext>100MG/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053392-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060616</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>6662</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>53</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BURSITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>C-REACTIVE PROTEIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JOINT EFFUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYCOBACTERIAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPHIL COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNOVIAL CYST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNOVIAL DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugauthorizationnumb>11719</drugauthorizationnumb>
        <drugdosagetext>10 MG DAILY IM</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOSPORINE</medicinalproduct>
        <drugdosagetext>100 MG DAILY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MYOSITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugdosagetext>5 MG DAILY</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053393-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006BH011613</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>73</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>TOXIC EPIDERMAL NECROLYSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXTRANEAL</medicinalproduct>
        <drugauthorizationnumb>21321</drugauthorizationnumb>
        <drugdosagetext>IP</drugdosagetext>
        <drugadministrationroute>033</drugadministrationroute>
        <drugindication>DIALYSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053394-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060709</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2006US08928</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXJADE</medicinalproduct>
        <drugauthorizationnumb>021882</drugauthorizationnumb>
        <drugdosagetext>UNK, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060613</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053395-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060703</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006-06-0633</companynumb>
    <primarysource>
      <reportercountry>LUXEMBOURG</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>71</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIABETES MELLITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERSTITIAL LUNG DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY FIBROSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEG-INTRON</medicinalproduct>
        <drugdosagetext>80 UG QWK SUBCUTANEOUS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050628</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050930</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBETOL</medicinalproduct>
        <drugdosagetext>800 MG QD ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050628</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050930</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARVEDILOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UTROGESTAN (MICRONIZED ORAL PROGESTERONE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACTONEL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM CARBONATE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053401-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006071858</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>45</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>70</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTHERMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLEURAL EFFUSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUTENT</medicinalproduct>
        <drugauthorizationnumb>21968</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RENAL CELL CARCINOMA STAGE UNSPECIFIED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051226</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060122</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUTENT</medicinalproduct>
        <drugauthorizationnumb>21968</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RENAL CELL CARCINOMA STAGE UNSPECIFIED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060206</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060305</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUTENT</medicinalproduct>
        <drugauthorizationnumb>21968</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RENAL CELL CARCINOMA STAGE UNSPECIFIED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060424</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060521</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053402-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060630</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006069987</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>66</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CATARACT OPERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MACULAR OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UVEITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL ACUITY REDUCED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VITREOUS FLOATERS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XALATAN</medicinalproduct>
        <drugauthorizationnumb>20597</drugauthorizationnumb>
        <drugdosagetext>ONE DROP (DAILY)</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CORTICOSTEROIDS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DORZOLAMIDE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053403-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006069018</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>35</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ATROPHIC VULVOVAGINITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPAREUNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LABORATORY TEST INTERFERENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VAGINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VULVOVAGINAL DRYNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEPO-PROVERA</medicinalproduct>
        <drugauthorizationnumb>20246</drugauthorizationnumb>
        <drugdosagetext>150 MG (150 MG, FIRST INJECTION/ TRIMESTRAL)</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>UTERINE LEIOMYOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060422</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060422</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053405-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060630</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006077879</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>76</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMLODIPINE</medicinalproduct>
        <drugauthorizationnumb>19787</drugauthorizationnumb>
        <drugdosagetext>5 MG</drugdosagetext>
        <drugindication>ANGINA PECTORIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19930101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050601</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053406-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060707</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-JNJFOC-20060701642</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>23</patientonsetage>
      <patientonsetageunit>802</patientonsetageunit>
      <patientweight>12</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEDICATION ERROR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
        <drugauthorizationnumb>019872</drugauthorizationnumb>
        <drugdosagetext>19 DROPS, 3 HOURS LATER</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
        <drugauthorizationnumb>019872</drugauthorizationnumb>
        <drugdosagetext>12 DROPS</drugdosagetext>
        <drugindication>PYREXIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053407-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060707</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20060702222</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE CHRONIC</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
        <drugauthorizationnumb>019872</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
        <drugauthorizationnumb>019872</drugauthorizationnumb>
        <drugdosagetext>^EXTRA^</drugdosagetext>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053408-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060707</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20060702224</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG DEPENDENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
        <drugauthorizationnumb>019872</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
        <drugauthorizationnumb>019872</drugauthorizationnumb>
        <drugdosagetext>12 A DAY</drugdosagetext>
        <drugindication>BACK PAIN</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053409-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060707</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-JNJFOC-20060605536</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PREMATURE BABY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYLENOL (CAPLET)</medicinalproduct>
        <drugauthorizationnumb>19872</drugauthorizationnumb>
        <drugadministrationroute>064</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYLENOL (CAPLET)</medicinalproduct>
        <drugauthorizationnumb>019872</drugauthorizationnumb>
        <drugadministrationroute>064</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053410-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006074301</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>47</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD SODIUM DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CORTEF</medicinalproduct>
        <drugauthorizationnumb>8697</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ADDISON'S DISEASE</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060615</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CORTEF</medicinalproduct>
        <drugauthorizationnumb>8697</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ADDISON'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLORINEF</medicinalproduct>
        <drugindication>ADDISON'S DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISONE TAB</medicinalproduct>
        <drugindication>ADDISON'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROVERA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THYROID TAB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053413-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006073819</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>36</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>60.2</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>EPSTEIN-BARR VIRUS INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOLYTIC ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SULPERAZON             (SULBACTAM, CEFOPERAZONE)</medicinalproduct>
        <drugauthorizationnumb>50551</drugauthorizationnumb>
        <drugdosagetext>2 GRAM (1 GRAM, 2 IN 1 D), INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BILIARY TRACT INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060519</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060522</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LOXONIN                (LOXOPROFEN SODIUM)</medicinalproduct>
        <drugdosagetext>60 MG (60MG, AS NEEDED), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PYREXIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060519</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VOLTAREN</medicinalproduct>
        <drugdosagetext>25 MG (25 MG, AS NEEDED), RECTAL</drugdosagetext>
        <drugadministrationroute>054</drugadministrationroute>
        <drugindication>PYREXIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060519</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053415-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060619</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006078407</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>50</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CATARACT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL DISTURBANCE</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</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030401</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053417-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060630</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006079820</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>0</patientsex>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
        <drugauthorizationnumb>19787</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053418-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2006NL09725</companynumb>
    <primarysource>
      <reportercountry>NETHERLANDS</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>79</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ILLUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOBILITY DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE RIGIDITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXELON</medicinalproduct>
        <drugauthorizationnumb>20823</drugauthorizationnumb>
        <drugdosagetext>1.5 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEMENTIA ALZHEIMER'S TYPE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060222</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXELON</medicinalproduct>
        <drugauthorizationnumb>020823</drugauthorizationnumb>
        <drugdosagetext>3 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXELON</medicinalproduct>
        <drugauthorizationnumb>020823</drugauthorizationnumb>
        <drugdosagetext>1.5 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060306</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COZAAR</medicinalproduct>
        <drugdosagetext>50 MG, QD</drugdosagetext>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRAVASTATIN</medicinalproduct>
        <drugdosagetext>20 MG, QD</drugdosagetext>
        <drugindication>HYPERCHOLESTEROLAEMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>80 MG, QD</drugdosagetext>
        <drugindication>ANGIOPATHY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053426-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060710</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ES-JNJFOC-20060503928</companynumb>
    <primarysource>
      <reportercountry>SPAIN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ATELECTASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE MARROW FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLANK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYCLOSPORINE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053427-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060707</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20060701719</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>73.94</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>NEOPLASM MALIGNANT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053434-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>226895</companynumb>
    <primarysource>
      <reportercountry>SPAIN</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>56</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>85</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ACUTE CORONARY SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MABTHERA (RITUXIMAB) CONC FOR SOLUTION FOR INFUSION</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053436-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060703</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>226981</companynumb>
    <primarysource>
      <reportercountry>SWITZERLAND</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>31</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>INFUSION RELATED REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MABTHERA (RITUXIMAB) CONC FOR SOLUTION FOR INFUSION</medicinalproduct>
        <drugdosagetext>1000 MG, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BEHCET'S SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060501</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053438-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>14330</companynumb>
    <primarysource>
      <reportercountry>AUSTRIA</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>33</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>IMMUNODEFICIENCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPHOPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugauthorizationnumb>11719</drugauthorizationnumb>
        <drugdosagetext>25 MG WEEKLY INJ</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AKTIFERRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYCLACOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DICLOFENAC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KEPPRA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEXALEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARBAMAZEPINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAMADOLOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COLECALCIFEROL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANTOPRAZOLE SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SULFASALAZINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053439-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>223596</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>70</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>66</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANGIOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMPLEMENT FACTOR C3 DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMPLEMENT FACTOR C4 DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIVERTICULAR HERNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIVERTICULITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIVERTICULUM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EFFUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYDROCELE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERPLASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ILL-DEFINED DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTESTINAL DILATATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LARGE INTESTINE PERFORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUCOSAL INFLAMMATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUCOUS MEMBRANE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERITONITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLEURAL EFFUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POST PROCEDURAL COMPLICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SIGMOIDITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WOUND SECRETION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RITUXIMAB (RITUXIMAB) CONC FOR SOLUTION FOR INFUSION</medicinalproduct>
        <drugdosagetext>1000 MG, DAYS 1+15, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060106</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060120</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISONE TAB</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060107</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060119</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>20060106</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060120</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACIDE FOLIQUE (FOLIC ACID)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NAPROXEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RISEDRONIC ACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CACIT D3 (CALCIUM CARBONATE, CHOLECALCIFEROL)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DAFALGAN CODEINE (ACETAMINOPHEN, CODEINE PHOSPHATE)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053440-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>14328</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANAPHYLACTIC SHOCK</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHYLENE BLUE</medicinalproduct>
        <drugindication>SURGERY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053441-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060707</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BE-JNJFOC-20060604633</companynumb>
    <primarysource>
      <reportercountry>BELGIUM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>38</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>C-REACTIVE PROTEIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIGAMENT DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PSORIASIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053443-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>14331</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>74</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>LOWER RESPIRATORY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPENIC SEPSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugauthorizationnumb>11719</drugauthorizationnumb>
        <drugdosagetext>80 MG ONCE IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060330</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060330</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUOROURACIL</medicinalproduct>
        <drugdosagetext>950 MG ONCE IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060330</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060330</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOPHOSPHAMIDE</medicinalproduct>
        <drugdosagetext>950 MG ONCE IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060330</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060330</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIAZEPAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROXOCOBALAMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANSOPRAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053445-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060630</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>14338</companynumb>
    <primarysource>
      <reportercountry>HUNGARY</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>48</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>64</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GROIN PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARYNGOLARYNGEAL PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PACLITAXEL</medicinalproduct>
        <drugbatchnumb>R036866</drugbatchnumb>
        <drugauthorizationnumb>76131</drugauthorizationnumb>
        <drugdosagetext>175 MG/M2</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SALSOL A</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SOLU-MEDROL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZANTAC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SUPRASTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ORADEXON TAB</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053449-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060706</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>USA-2006-0024567</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>1</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>AGRANULOCYTOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CEFDITOREN PIVOXIL (SIMILAR TO NDA 21-222)(CELDITOREN PIVOXIL) OTHER</medicinalproduct>
        <drugauthorizationnumb>21222</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PHARYNGITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060626</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060630</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BIOFERMIN R (STREPTOCOCCUS FAECALIS)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053450-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060619</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-STX183518</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>129.8</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEPHROLITHIASIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>P059022</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19970101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HUMABID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM CHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COZAAR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DETROL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053451-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060707</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHO2006PL11042</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>73</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LETROZOLE</medicinalproduct>
        <drugauthorizationnumb>020726</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BREAST CANCER METASTATIC</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053457-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060619</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006083435</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>72</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ALANINE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASPARTATE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC FUNCTION ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ESTRACYT (ESTRAMUSTINE PHOSPHATE SODIUM)</medicinalproduct>
        <drugauthorizationnumb>18045</drugauthorizationnumb>
        <drugdosagetext>626.8 MG, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROSTATE CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060421</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060612</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEUPROLIDE ACETATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053460-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060706</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-AMGEN-KDL185624</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>5</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>ENBREL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PSORIATIC ARTHROPATHY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060111</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053461-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060620</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GBWYE756120JUN06</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>98</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWELLING FACE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWOLLEN TONGUE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060608</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060618</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </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>METHOTREXATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053462-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060706</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AR-JNJFOC-20060702011</companynumb>
    <primarysource>
      <reportercountry>ARGENTINA</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>12</patientonsetage>
      <patientonsetageunit>802</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>KAWASAKI'S DISEASE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IBUPIRAC</medicinalproduct>
        <drugdosagetext>UNKNOWN DOSE GIVEN IN DOSE CUP</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IBUPIRAC</medicinalproduct>
        <drugauthorizationnumb>019842</drugauthorizationnumb>
        <drugindication>PYREXIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053463-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060706</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-US185388</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>29</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC STEATOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER FUNCTION TEST ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSORIATIC ARTHROPATHY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>PSORIATIC ARTHROPATHY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KEPPRA</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053464-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BEWYE902829JUN06</companynumb>
    <primarysource>
      <reportercountry>BELGIUM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>46</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>RETINAL DETACHMENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>NOT PROVIDED</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PSORIATIC ARTHROPATHY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060301</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053465-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060703</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006080907</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>73</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DEAFNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STRESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALDACTONE</medicinalproduct>
        <drugauthorizationnumb>12151</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060529</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060608</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALDACTONE</medicinalproduct>
        <drugauthorizationnumb>12151</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060609</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060615</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALDACTONE</medicinalproduct>
        <drugauthorizationnumb>12151</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060616</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060623</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053466-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006080629</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>68</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>INTERSTITIAL LUNG DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STOMACH DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>X-RAY ABNORMAL</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>20060301</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIAZEPAM</medicinalproduct>
        <drugdosagetext>5 MG (AS NEEDED), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INSOMNIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060620</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEPRICOR (BEPRIDIL)</medicinalproduct>
        <drugdosagetext>50 MG (2 IN 1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARRHYTHMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060601</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053467-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006081913</companynumb>
    <primarysource>
      <reportercountry>KOREA, REPUBLIC OF</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>52</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEBRILE NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPHADENOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALIGNANT NEOPLASM PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUROPATHY PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA STREPTOCOCCAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SMALL CELL CARCINOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IRINOTECAN HCL</medicinalproduct>
        <drugauthorizationnumb>20571</drugauthorizationnumb>
        <drugindication>GASTRIC CANCER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CISPLATIN</medicinalproduct>
        <drugindication>GASTRIC CANCER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MESNA</medicinalproduct>
        <drugindication>GASTRIC CANCER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ETOPOSIDE</medicinalproduct>
        <drugindication>GASTRIC CANCER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PACLITAXEL</medicinalproduct>
        <drugindication>GASTRIC CANCER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053470-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006080202</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>34</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>55</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE NECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE ULCER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ATARAX</medicinalproduct>
        <drugauthorizationnumb>11111</drugauthorizationnumb>
        <drugdosagetext>50 MG (ONCE), INTRAMUSCULAR</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>PREOPERATIVE CARE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060619</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060619</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PURSENNID (SENNA LEAF)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGCOROL (MAGNESIUM CITRATE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LAXOBERON (SODIUM PICOSULFATE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLYCERIN (GLYCERIN)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CEFAZOLIN SODIUM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053471-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060215</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DEWYE395515FEB06</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>77</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DERMATITIS ALLERGIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ENCEPHALITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC STEATOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>ANKYLOSING SPONDYLITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050923</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040801</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053472-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060705</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-JNJFOC-20060606590</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>60</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC FUNCTION ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ITRACONAZOLE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ITRACONAZOLE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ITRACONAZOLE</medicinalproduct>
        <drugauthorizationnumb>020083</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NAIL TINEA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>BENIDIPINE HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CANDESARTAN CILEXETIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053473-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006081727</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>40</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLISTER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRAIN OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRONCHOPNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG TOXICITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGE SUBCUTANEOUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTRACARDIAC THROMBUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN EXFOLIATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRIAZOLAM</medicinalproduct>
        <drugauthorizationnumb>17892</drugauthorizationnumb>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053475-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006081583</companynumb>
    <primarysource>
      <reportercountry>SWEDEN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>64</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>112.5</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BREAST CANCER FEMALE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GENOTROPIN</medicinalproduct>
        <drugauthorizationnumb>20280</drugauthorizationnumb>
        <drugdosagetext>0.4 MG (5 MG, DAILY), SUBCUTANEOUS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>GROWTH HORMONE DEFICIENCY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031208</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053476-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006081825</companynumb>
    <primarysource>
      <reportercountry>PHILIPPINES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>32</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZMAX</medicinalproduct>
        <drugauthorizationnumb>50797</drugauthorizationnumb>
        <drugdosagetext>2 GRAM (2 GRAM, 1 IN 1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BRONCHITIS CHRONIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060627</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060627</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZMAX</medicinalproduct>
        <drugauthorizationnumb>50797</drugauthorizationnumb>
        <drugdosagetext>2 GRAM (2 GRAM, 1 IN 1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONDITION AGGRAVATED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060627</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060627</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEOZEP (ASCORBIC ACID, CHLORPHENAMINE MALEATE, PARACETAMOL, PHENYLPROP</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053477-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060707</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-JNJFOC-20060701622</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>13</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>RENAL IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LOPEMIN</medicinalproduct>
        <drugauthorizationnumb>17694</drugauthorizationnumb>
        <drugdosagetext>IN THREE DIVIDED DOSES</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIARRHOEA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053478-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060707</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-JNJFOC-20060701314</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG ADMINISTRATION ERROR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UNINTENDED PREGNANCY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ORTHO EVRA</medicinalproduct>
        <drugauthorizationnumb>021180</drugauthorizationnumb>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>CONTRACEPTION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053479-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060706</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20051104569</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>91.63</patientweight>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ALPHA-1 ANTI-TRYPSIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANION GAP INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASCITES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD AMYLASE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BUDD-CHIARI SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEEP VEIN THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ESCHERICHIA INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FACTOR V LEIDEN MUTATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPARIN-INDUCED THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERNATIONAL NORMALISED RATIO DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTESTINAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER FUNCTION TEST ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERITONITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENOUS THROMBOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ORTHO EVRA</medicinalproduct>
        <drugauthorizationnumb>21180</drugauthorizationnumb>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>ACNE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ORTHO TRI-CYCLEN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ORTHO TRI-CYCLEN</medicinalproduct>
        <drugauthorizationnumb>019697</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ACNE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053480-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060707</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20060702053</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>60.78</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ALOPECIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COELIAC DISEASE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ELMIRON</medicinalproduct>
        <drugauthorizationnumb>020193</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CYSTITIS INTERSTITIAL</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROPRANOLOL</medicinalproduct>
        <drugindication>HEADACHE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
        <drugdosagetext>100 MG, ONCE DAILY IN THE MORNING</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASACOL</medicinalproduct>
        <drugindication>ABDOMINAL PAIN UPPER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASACOL</medicinalproduct>
        <drugdosagetext>400 MG TABLET, TWO TABLETS, THREE IN ONE DAY</drugdosagetext>
        <drugindication>DIARRHOEA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053481-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060706</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-JNJFOC-20060701437</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>84</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>AGRANULOCYTOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERDAL</medicinalproduct>
        <drugauthorizationnumb>020272</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NIFEDIPINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RAMIPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MELPERON</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053482-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060707</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-JNJFOC-20060403942</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>29</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>73.8</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABNORMAL BEHAVIOUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AGGRESSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERDAL CONSTA</medicinalproduct>
        <drugauthorizationnumb>21346</drugauthorizationnumb>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>PSYCHOTIC DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053483-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006082049</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>37</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ASPARTATE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD ALBUMIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD ALKALINE PHOSPHATASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD BILIRUBIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CREATINE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAMMA-GLUTAMYLTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIFLUCAN</medicinalproduct>
        <drugauthorizationnumb>19949</drugauthorizationnumb>
        <drugdosagetext>800 MG (400 MG, 2 IN 1 D);</drugdosagetext>
        <drugindication>MENINGITIS CRYPTOCOCCAL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060622</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PHENYTOIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053484-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060707</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-JNJFOC-20060701705</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DELUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERVOLAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERDAL CONSTA</medicinalproduct>
        <drugauthorizationnumb>021346</drugauthorizationnumb>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053485-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060706</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-JNJFOC-20060700492</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>4</patientonsetage>
      <patientonsetageunit>802</patientonsetageunit>
      <patientweight>4.7</patientweight>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ASPIRATION BRONCHIAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOPAMAX</medicinalproduct>
        <drugbatchnumb>05HS103/U</drugbatchnumb>
        <drugauthorizationnumb>20505</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONVULSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PHENOBARBITAL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONVULSION</drugindication>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EPELIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONVULSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMETHICONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ABDOMINAL PAIN</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053486-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060707</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-JNJFOC-20060700019</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>95</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIAC ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOPAMAX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOPAMAX</medicinalproduct>
        <drugauthorizationnumb>020505</drugauthorizationnumb>
        <drugdosagetext>125MG AM 100MG PM</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>EPILEPSY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARBAMAZEPINE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>EPILEPSY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CITALOPRAM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053487-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006081637</companynumb>
    <primarysource>
      <reportercountry>THAILAND</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>50</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISORDER OF ORBIT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTRAOCULAR PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OPEN ANGLE GLAUCOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OPTIC ATROPHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RETINAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SCOTOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISION BLURRED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIAGRA</medicinalproduct>
        <drugauthorizationnumb>20895</drugauthorizationnumb>
        <drugdosagetext>50 MG (50 MG, EVERY 3 TO 4 DAYS), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ERECTILE DYSFUNCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053488-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006082136</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>59</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUTENT</medicinalproduct>
        <drugauthorizationnumb>21968</drugauthorizationnumb>
        <drugdosagetext>50 MG (50 MG, CYCLIC); ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RENAL CELL CARCINOMA STAGE UNSPECIFIED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050701</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053490-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006082164</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>55</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>52</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERCALCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METASTASES TO BONE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUTENT</medicinalproduct>
        <drugauthorizationnumb>21968</drugauthorizationnumb>
        <drugdosagetext>37.5 MG (37.5 MG, 1 IN 1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RENAL CELL CARCINOMA STAGE UNSPECIFIED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060405</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060613</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053491-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060621</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP200606005250</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CEREBRAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EVISTA</medicinalproduct>
        <drugauthorizationnumb>20815</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053492-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060624</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PH200606005259</companynumb>
    <primarysource>
      <reportercountry>PHILIPPINES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>71</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>60 MG, DAILY (1/D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060619</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053493-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006082005</companynumb>
    <primarysource>
      <reportercountry>PHILIPPINES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>52</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>HEPATITIS FULMINANT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SULPERAZONE</medicinalproduct>
        <drugauthorizationnumb>50551</drugauthorizationnumb>
        <drugdosagetext>INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PNEUMONIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIFLUCAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RIFAMPICIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ISONIAZID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PYRAZINAMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMIKACIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COTRIM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053494-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060704</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-SANOFI-SYNTHELABO-A04200600700</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>75</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DEEP VEIN THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NUCLEAR MAGNETIC RESONANCE IMAGING BRAIN ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STENT OCCLUSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>ARTERIAL STENT INSERTION</drugindication>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOPIDOGREL</medicinalproduct>
        <drugauthorizationnumb>020839</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTERIAL STENT INSERTION</drugindication>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOPIDOGREL</medicinalproduct>
        <drugauthorizationnumb>020839</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM INJECTION</medicinalproduct>
        <drugauthorizationnumb>018237</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053495-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-SANOFI-SYNTHELABO-A03200604229</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>73</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD ALKALINE PHOSPHATASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METASTASES TO BONE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROSTATIC SPECIFIC ANTIGEN INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ELIGARD</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>21343</drugauthorizationnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053496-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060510</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-SANOFI-SYNTHELABO-A04200600508</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>90</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OESOPHAGITIS ULCERATIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOXIC EPIDERMAL NECROLYSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALCOHOL</medicinalproduct>
        <drugdosagetext>1 BOTTLE OF SCHNAPPS</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BIPOLAR I DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060316</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060316</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BIPOLAR I DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060316</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060316</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAVOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BIPOLAR I DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060316</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060316</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>STILNOX</medicinalproduct>
        <drugauthorizationnumb>019908</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BIPOLAR I DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060316</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060316</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053497-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060706</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-SANOFI-SYNTHELABO-A03200604360</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>78.91</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MACULAR DEGENERATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTIHYPERTENSIVE NOS</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020839</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTERIAL OCCLUSIVE DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060317</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060505</drugenddate>
        <drugtreatmentduration>50</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053498-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060622</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP200603000651</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>30</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>EPILEPSY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRESCRIBED OVERDOSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
        <drugauthorizationnumb>20592</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053500-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060621</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB200604001385</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>33</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CAROTID ARTERY DISSECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
        <drugauthorizationnumb>20592</drugauthorizationnumb>
        <drugdosagetext>2.5 MG, DAILY (1/D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PARANOIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060405</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060420</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUOXETINE</medicinalproduct>
        <drugdosagetext>20 MG</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051019</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VENLAFAXINE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RISPERIDONE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053501-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060622</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR200606004940</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>78</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD IMMUNOGLOBULIN E INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD LACTATE DEHYDROGENASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG RESISTANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ECZEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAMMA-GLUTAMYLTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOPROTEINAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IRON DEFICIENCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYCOSIS FUNGOIDES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUROPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NORMOCHROMIC NORMOCYTIC ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROZAC</medicinalproduct>
        <drugauthorizationnumb>18936</drugauthorizationnumb>
        <drugdosagetext>20 MG, 2/D, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TEMESTA (LORAZEPAM) TABLET, ENTERIC COATED</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053503-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060706</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-JNJFOC-20060701351</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>37</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MENINGITIS LISTERIA</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>AZATHIOPRINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CORTICOSTERIODS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053504-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060706</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-JNJFOC-20041206675</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>46</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFUSION RELATED REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMOCYSTIS JIROVECI PNEUMONIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RHEUMATREX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RHEUMATREX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RHEUMATREX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RHEUMATREX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDONINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VOLTAREN</medicinalproduct>
        <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>ZYRTEC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZANTAC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NSAIDS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DMARDS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN</medicinalproduct>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053510-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060710</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2006US08833</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>LEUKAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ELIDEL</medicinalproduct>
        <drugauthorizationnumb>021302</drugauthorizationnumb>
        <drugadministrationroute>061</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053511-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060622</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2006US08126</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>67</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>81.632</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BIOPSY SKIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALIGNANT MELANOMA IN SITU</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ELIDEL</medicinalproduct>
        <drugauthorizationnumb>21302</drugauthorizationnumb>
        <drugdosagetext>UNK, BID</drugdosagetext>
        <drugadministrationroute>061</drugadministrationroute>
        <drugindication>ECZEMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050609</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050801</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053517-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060131</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHO2006KR01910</companynumb>
    <primarysource>
      <reportercountry>KOREA, REPUBLIC OF</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>64</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>61</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIABETES MELLITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIABETES MELLITUS INADEQUATE CONTROL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL INTAKE REDUCED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MYFORTIC</medicinalproduct>
        <drugauthorizationnumb>50791</drugauthorizationnumb>
        <drugdosagetext>360 MG, TID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RENAL TRANSPLANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060105</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MYFORTIC</medicinalproduct>
        <drugauthorizationnumb>050791</drugauthorizationnumb>
        <drugdosagetext>1440 MG /DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051031</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060104</drugenddate>
        <drugtreatmentduration>95040</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053523-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060622</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GR200606004844</companynumb>
    <primarysource>
      <reportercountry>GREECE</reportercountry>
      <qualification>2</qualification>
    </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>DIABETIC KETOACIDOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEDICAL DEVICE COMPLICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMULIN 70/30</medicinalproduct>
        <drugbatchnumb>FF5C26B</drugbatchnumb>
        <drugauthorizationnumb>18780</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE, SUBCUTANEOUS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>DIABETES MELLITUS INSULIN-DEPENDENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053526-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060622</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ES200606005909</companynumb>
    <primarysource>
      <reportercountry>SPAIN</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>82</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC CYST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugauthorizationnumb>21318</drugauthorizationnumb>
        <drugdosagetext>20 UG, DAILY (1/D), SUBCUTANEOUS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060501</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FORTEO PEN (FORTEO PEN) PEN, DISPOSABLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHROID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORAZEPAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIGOXIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BOI K (POTASSIUM ASCORBATE)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053531-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060711</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CN-JNJFOC-20060701817</companynumb>
    <primarysource>
      <reportercountry>CHINA</reportercountry>
      <qualification>5</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>CHEST DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POOR QUALITY DRUG ADMINISTERED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>019872</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>019872</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PYREXIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053532-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060707</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-JNJFOC-20060702330</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>37</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CHOLESTASIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CRAVIT</medicinalproduct>
        <drugauthorizationnumb>20634</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040801</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053533-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>SPV1-2006-00145</companynumb>
    <primarysource>
      <reportercountry>NEW ZEALAND</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>0</patientsex>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DAYTRANA    (METHYLPHENIDATE)</medicinalproduct>
        <drugauthorizationnumb>21514</drugauthorizationnumb>
        <drugdosagetext>TRANSDERMAL</drugdosagetext>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>ATTENTION DEFICIT/HYPERACTIVITY DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053534-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060621</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IE200606004719</companynumb>
    <primarysource>
      <reportercountry>IRELAND</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>30</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>STRATTERA</medicinalproduct>
        <drugauthorizationnumb>21411</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugindication>LEARNING DISABILITY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SULFADINE (SULFADIMIDINE)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053535-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060704</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200612535GDS</companynumb>
    <primarysource>
      <reportercountry>KOREA, DEMOCRATIC PEOPLE'S REPUBLIC OF</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>49</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>52.4</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SORAFENIB</medicinalproduct>
        <drugauthorizationnumb>21923</drugauthorizationnumb>
        <drugdosagetext>400 MG BIDO RAL; 400 MG QD ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATIC NEOPLASM MALIGNANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060315</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060416</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SORAFENIB</medicinalproduct>
        <drugauthorizationnumb>21923</drugauthorizationnumb>
        <drugdosagetext>400 MG BIDO RAL; 400 MG QD ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATIC NEOPLASM MALIGNANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060426</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060525</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MUCALGEL                          (MAG., CAL., ALUMINIUM, SILICATE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GASTREG GRAN           (ECABET SODIUM)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>K-40            (POTASSIUM CHLORIDE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MUCOSTA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MACPERAN      (METOCLOPRAMIDE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RESPILENE                        [ZIPEPROL DIHYDROCHLORIDE]</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CODEIN PHOSPHATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ERDOS   (ERDOSTEINE)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053536-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060626</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE200606005471</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>74</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEEP VEIN THROMBOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
        <drugauthorizationnumb>20592</drugauthorizationnumb>
        <drugdosagetext>5 MG, DAILY (1/D) ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BIPOLAR I DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060403</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060406</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORTRILEN (NORTRIPTYLINE HYDROCHLORIDE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EUNERPAN (MELPERONE HYDROCHLORIDE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BLOPRESS(CANDESARTAN CILEXETIL)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DISALUNIL (HYDROCHLOROTHIAZIDE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>L-THYROXIN (LEVOTHRYOXINE SODIUM)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053537-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060707</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200610495BVD</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>53</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>70</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>EPILEPSY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METASTASES TO CENTRAL NERVOUS SYSTEM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SORAFENIB</medicinalproduct>
        <drugauthorizationnumb>21923</drugauthorizationnumb>
        <drugdosagetext>800 MG TOTAL DAILY ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RENAL CELL CARCINOMA STAGE UNSPECIFIED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050323</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETYLSALICYLIC ACID SRT</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053538-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060623</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ES200602002928</companynumb>
    <primarysource>
      <reportercountry>SPAIN</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>84</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RED BLOOD CELL SEDIMENTATION RATE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugauthorizationnumb>21318</drugauthorizationnumb>
        <drugdosagetext>20 U DAILY (1/D) SUBCUTANEOUS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060124</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FORTEO PEN (FORTEO PEN)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CORTISONE ACETATE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053539-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060623</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ES200603000045</companynumb>
    <primarysource>
      <reportercountry>SPAIN</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>62</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HEPATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL COLIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THERAPY NON-RESPONDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>YELLOW SKIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugauthorizationnumb>21318</drugauthorizationnumb>
        <drugindication>OSTEOPOROSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FORTEO PEN (FORTEO PEN)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EUTIROX (LEVOTHYROXINE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLYBURIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARDURAN (DOXAZOSIN MESILATE)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053540-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060704</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200610638BFR</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>50</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>GOUT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEUKOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPHOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CIFLOX           (CIPROFLOXACIN)</medicinalproduct>
        <drugauthorizationnumb>19537</drugauthorizationnumb>
        <drugindication>BACK PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060224</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060331</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CIFLOX           (CIPROFLOXACIN)</medicinalproduct>
        <drugauthorizationnumb>19537</drugauthorizationnumb>
        <drugindication>PYREXIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060224</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060331</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RIFADIN</medicinalproduct>
        <drugindication>BACK PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060224</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060331</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RIFADIN</medicinalproduct>
        <drugindication>PYREXIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060224</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060331</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COLCHICINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LOVENOX</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060224</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060331</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053541-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200610640BFR</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>76</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>90</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG ERUPTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EOSINOPHILIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUCOSAL EROSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URTICARIA PAPULAR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXAVAR</medicinalproduct>
        <drugauthorizationnumb>21923</drugauthorizationnumb>
        <drugdosagetext>200 MG BID ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>METASTATIC RENAL CELL CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060609</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060701</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXAVAR</medicinalproduct>
        <drugauthorizationnumb>21923</drugauthorizationnumb>
        <drugdosagetext>200 MG BID ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>METASTATIC RENAL CELL CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060701</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053542-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060707</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200610721BVD</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>62</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>CARDIAC ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL ULCER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SORAFENIB</medicinalproduct>
        <drugauthorizationnumb>21923</drugauthorizationnumb>
        <drugdosagetext>400 MG BID ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RENAL CELL CARCINOMA STAGE UNSPECIFIED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051215</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060522</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053544-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060626</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CO200606002969</companynumb>
    <primarysource>
      <reportercountry>COLOMBIA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>77</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>65</patientweight>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTESTINAL OBSTRUCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUMBAR VERTEBRAL FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METABOLIC ACIDOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRESCRIBED OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROCEDURAL COMPLICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugauthorizationnumb>21318</drugauthorizationnumb>
        <drugdosagetext>20 UG DAILY (1/D) SUBCUTANEOUS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060322</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060423</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FORTEO PEN(FORTEO PEN)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DRAMAMINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NIMOTOP</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL (METOPROLOL)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM (CALCIUM)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIPYRONE (METAMIZOLE SODIUM)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCITRIOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAMADOL HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CIPROFLOXACIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONAZEPAM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053546-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060630</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CHNY2006AR01931</companynumb>
    <primarysource>
      <reportercountry>ARGENTINA</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG TOXICITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERAL PHYSICAL HEALTH DETERIORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERIORBITAL HAEMATOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH GENERALISED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WRONG TECHNIQUE IN DRUG USAGE PROCESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NICOTINELL TTS</medicinalproduct>
        <drugauthorizationnumb>20076</drugauthorizationnumb>
        <drugdosagetext>21 MG QD TRANSDERMAL</drugdosagetext>
        <drugadministrationroute>062</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060616</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060621</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053547-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060622</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AT200606001755</companynumb>
    <primarysource>
      <reportercountry>AUSTRIA</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>82</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>INTESTINAL PERFORATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GEMZAR</medicinalproduct>
        <drugauthorizationnumb>20509</drugauthorizationnumb>
        <drugindication>NON-HODGKIN'S LYMPHOMA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053548-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060703</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200610858BVD</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>58</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>RESUSCITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENTRICULAR FIBRILLATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VARDENAFIL</medicinalproduct>
        <drugauthorizationnumb>21400</drugauthorizationnumb>
        <drugdosagetext>20 MG TOTAL DAILY ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ERECTILE DYSFUNCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060702</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMANTADINE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MADOPAR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CABASERIL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053549-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060622</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA200604003791</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>54</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVARIAN CANCER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugbatchnumb>FF5D18B</drugbatchnumb>
        <drugauthorizationnumb>21318</drugauthorizationnumb>
        <drugdosagetext>20 UG DAILY (1/D)</drugdosagetext>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051118</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051219</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FORTEO PEN (FORTEO PEN)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONAZEPAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTIVIT (VITAMINS NOS)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN A</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM (CALCIUM)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053551-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060623</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB200604003117</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>0</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STILLBIRTH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>STRATTERA</medicinalproduct>
        <drugauthorizationnumb>21411</drugauthorizationnumb>
        <drugdosagetext>TRANSPLACENTAL</drugdosagetext>
        <drugadministrationroute>064</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050901</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053553-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060627</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PL200606002998</companynumb>
    <primarysource>
      <reportercountry>POLAND</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>66</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>86</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ERYSIPELAS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VARICOSE VEIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMULIN 70/30</medicinalproduct>
        <drugauthorizationnumb>18780</drugauthorizationnumb>
        <drugdosagetext>30 U DAILY (1/D)SUBCUTANEOUS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030708</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EFFOX (ISOSORBIDE MONINITRATE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACARD (ACETYLSALICYLIC ACID)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BISCARD (BISOPROLOL)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NAPROXEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLOPIN (AMLODIPINE BESILATE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENALAPRIL MALEATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RUTAVIT (RUTOSIDE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TULIP (FLURBIFPROFEN)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRIMETAZIDINE DIHYDROCHLORIDE(TRIMETAZIDINE HYDROCHLORIDE)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053558-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060623</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB200603006756</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>3.7</patientweight>
      <patientsex>0</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ANOXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LABOUR COMPLICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STILLBIRTH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>STRATTERA</medicinalproduct>
        <drugauthorizationnumb>21411</drugauthorizationnumb>
        <drugdosagetext>TRANSPLACENTAL</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050708</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050729</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053560-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>RS006139-F</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HALLUCINATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RABEPRAZOLE SODIUM</medicinalproduct>
        <drugauthorizationnumb>20973</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053562-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060626</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>028-20785-06040423</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>71</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>RECTAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>THALOMID</medicinalproduct>
        <drugbatchnumb>0009A</drugbatchnumb>
        <drugauthorizationnumb>20785</drugauthorizationnumb>
        <drugdosagetext>50 MG, 1 IN 1 D, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MYELOFIBROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060301</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>THALOMID</medicinalproduct>
        <drugbatchnumb>0015A</drugbatchnumb>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NITRO PATCH (GLYCERYL TRINITRATE) (POULTICE OF PATCH)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROPRANOLOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>URSODIOL (URSODEOXYCHOLIC ACID)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATORVASTATIN CALCIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HUMALOG</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE TAB</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053563-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesscongenitalanomali>1</seriousnesscongenitalanomali>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060518</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-13383690</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>3</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEVELOPMENTAL DELAY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRISOMY 15</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REYATAZ</medicinalproduct>
        <drugauthorizationnumb>21567</drugauthorizationnumb>
        <drugdosagetext>ONGOING AT CONCEPTION</drugdosagetext>
        <drugadministrationroute>064</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050330</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NORVIR</medicinalproduct>
        <drugdosagetext>ONGOING AT CONCEPTION</drugdosagetext>
        <drugadministrationroute>064</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050330</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRUVADA</medicinalproduct>
        <drugdosagetext>ONGOING AT CONCEPTION</drugdosagetext>
        <drugadministrationroute>064</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040316</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050330</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KALETRA</medicinalproduct>
        <drugadministrationroute>064</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050330</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050525</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRIZIVIR</medicinalproduct>
        <drugadministrationroute>064</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050330</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050525</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIRACEPT</medicinalproduct>
        <drugadministrationroute>064</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050603</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051103</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMBIVIR</medicinalproduct>
        <drugadministrationroute>064</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050603</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051103</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RETROVIR</medicinalproduct>
        <drugdosagetext>INCREASED AFTER 200 MG/DAY LOADING DOSE TO 400 MG/DAY</drugdosagetext>
        <drugadministrationroute>064</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051103</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051103</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLATE</medicinalproduct>
        <drugadministrationroute>064</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRIMETHOPRIM + SULFAMETHOXAZOLE</medicinalproduct>
        <drugadministrationroute>064</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053564-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060705</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-13439898</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL DISTURBANCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KENALOG-40</medicinalproduct>
        <drugauthorizationnumb>014901</drugauthorizationnumb>
        <drugadministrationroute>031</drugadministrationroute>
        <drugindication>MACULAR OEDEMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060628</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KENALOG-40</medicinalproduct>
        <drugauthorizationnumb>014901</drugauthorizationnumb>
        <drugadministrationroute>031</drugadministrationroute>
        <drugindication>RETINAL VEIN OCCLUSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060628</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053566-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060620</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>076-20785-06070078</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>50</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>COMPRESSION FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAPARESIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPINAL CORD DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>THALIDOMIDE (THALIDOMIDE) (CAPSULES)</medicinalproduct>
        <drugauthorizationnumb>20785</drugauthorizationnumb>
        <drugdosagetext>100 MG, 1 IN 1 D, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RIBAVIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BISPHOSPHONATES (BISPHOSPHONATES)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHYLPREDNISOLONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYTOXANE (CYCLOPHOSPHAMIDE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PEG-INTRON</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053567-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060505</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>447694</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ARTHRITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BONIVA</medicinalproduct>
        <drugauthorizationnumb>21455</drugauthorizationnumb>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060315</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053568-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060627</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP200603004036</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>77</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>39.9</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ACUTE RESPIRATORY DISTRESS SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE MARROW FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIOMEGALY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DECREASED APPETITE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERAL PHYSICAL HEALTH DETERIORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERALISED OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOALBUMINAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY CONGESTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SHOCK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYSTEMIC INFLAMMATORY RESPONSE SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GEMZAR</medicinalproduct>
        <drugauthorizationnumb>20509</drugauthorizationnumb>
        <drugdosagetext>1200 MG, OTHER, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PANCREATIC CARCINOMA STAGE IV</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060222</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060222</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OPSO (MORPHINE HYDROCHLORIDE) LIQUID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DUROTEP (FENTANYL)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIFLUCAN (FLUCONAZOLE) CAPSULE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANSOPRAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RINDERON (BETAMETHASONE) TABLET</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053570-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060505</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>447699</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL DISTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG ADMINISTRATION ERROR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BONIVA</medicinalproduct>
        <drugauthorizationnumb>21455</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053571-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060705</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-BRISTOL-MYERS SQUIBB COMPANY-13433776</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>73</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>65</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARBOPLATIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060412</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060412</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PACLITAXEL</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060412</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060412</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SERETIDE</medicinalproduct>
        <drugadministrationroute>055</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THYROXINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIGOXIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RAMIPRIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VENTOLIN</medicinalproduct>
        <drugadministrationroute>055</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FELODIPINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053572-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060529</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ES-BRISTOL-MYERS SQUIBB COMPANY-13392402</companynumb>
    <primarysource>
      <reportercountry>SPAIN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>64</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>82</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KARVEA</medicinalproduct>
        <drugauthorizationnumb>20757</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051210</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KARVEA</medicinalproduct>
        <drugauthorizationnumb>020757</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051210</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PARACETAMOL</medicinalproduct>
        <drugindication>PAIN</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053573-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060705</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-BRISTOL-MYERS SQUIBB COMPANY-13440342</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>7</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>EMPHYSEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCREATITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENDOXAN</medicinalproduct>
        <drugauthorizationnumb>12142</drugauthorizationnumb>
        <drugindication>ACUTE LYMPHOCYTIC LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VINCREX SULFATE</medicinalproduct>
        <drugauthorizationnumb>070867</drugauthorizationnumb>
        <drugindication>ACUTE LYMPHOCYTIC LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugindication>ACUTE LYMPHOCYTIC LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE TAB</medicinalproduct>
        <drugindication>ACUTE LYMPHOCYTIC LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PIRARUBICIN HCL</medicinalproduct>
        <drugindication>ACUTE LYMPHOCYTIC LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053575-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060207</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-13275250</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>67</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>72</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>UPPER RESPIRATORY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ERBITUX</medicinalproduct>
        <drugindication>BREAST CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060130</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060130</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARBOPLATIN</medicinalproduct>
        <drugindication>BREAST CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060124</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060124</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IRINOTECAN</medicinalproduct>
        <drugindication>BREAST CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060124</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060124</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VERAPAMIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19900101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OS-CAL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MINERAL SUPPLEMENTATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLEOCIN GEL</medicinalproduct>
        <drugadministrationroute>061</drugadministrationroute>
        <drugindication>DERMATITIS ACNEIFORM</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060123</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMODIUM</medicinalproduct>
        <drugindication>DIARRHOEA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050131</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OPIUM TINCTURE</medicinalproduct>
        <drugindication>DIARRHOEA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060131</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COMPAZINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NAUSEA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060131</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVAQUIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>UPPER RESPIRATORY TRACT INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060202</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VERAPAMIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19900101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053576-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060523</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>MX-BRISTOL-MYERS SQUIBB COMPANY-13387220</companynumb>
    <primarysource>
      <reportercountry>MEXICO</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>66</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HYPOGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CAPTOPRIL</medicinalproduct>
        <drugauthorizationnumb>74472</drugauthorizationnumb>
        <drugdosagetext>DURATION: 6 YEARS</drugdosagetext>
        <drugindication>ESSENTIAL HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RAMIPRIL</medicinalproduct>
        <drugindication>BLOOD PRESSURE INCREASED</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053581-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060710</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-AVENTIS-200612454FR</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>60</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MUCOSAL EROSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHOTOSENSITIVITY REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHABDOMYOLYSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARAVA</medicinalproduct>
        <drugauthorizationnumb>020905</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARAVA</medicinalproduct>
        <drugauthorizationnumb>020905</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHYLPREDNISONE</medicinalproduct>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053582-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060710</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-AVENTIS-200612457FR</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>72</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIVERTICULUM INTESTINAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOVOLAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RECTAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LOVENOX</medicinalproduct>
        <drugauthorizationnumb>20164</drugauthorizationnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>THROMBOSIS PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060522</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060606</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LOVENOX</medicinalproduct>
        <drugauthorizationnumb>020164</drugauthorizationnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>HIP ARTHROPLASTY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060522</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060606</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>AORTIC ARTERIOSCLEROSIS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060606</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DI-ANTALVIC</medicinalproduct>
        <drugdosagetext>DOSE UNIT: UNITS</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOPHAGE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060606</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOPHAGE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060608</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRAVASTATIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERCHOLESTEROLAEMIA</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060606</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRAVASTATIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060607</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BISOPROLOL FUMARATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060606</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COVERSYL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060606</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COVERSYL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060609</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HUMALOG MIX</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HUMALOG MIX 25</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MORPHINE SULFATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053583-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060711</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IT-AVENTIS-200613831EU</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>82</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URTICARIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLEXANE</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>20164</drugauthorizationnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>DEEP VEIN THROMBOSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060520</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060525</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DAFLON</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEEP VEIN THROMBOSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060520</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060525</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALSARTAN W/ HYDROCHLOROTHIAZIDE</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugdosagetext>DOSE: UNKNOWN DOSE</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053584-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>19980624</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-AVENTIS-FR02-09124</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>BLOOD BILIRUBIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ENCEPHALOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOLYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LOVENOX</medicinalproduct>
        <drugauthorizationnumb>20164</drugauthorizationnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>THROMBOSIS PROPHYLAXIS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19980511</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIAMICRON</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19980511</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RIFATER</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MYCOBACTERIA URINE TEST POSITIVE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980323</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19980511</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MYAMBUTOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MYCOBACTERIA URINE TEST POSITIVE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980323</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19980511</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COZAAR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19980511</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053585-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-AVENTIS-200616870GDDC</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>56</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CELLULITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SJOGREN'S SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN ULCER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARAVA</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>20905</drugauthorizationnumb>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053586-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060420</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AVENTIS-200613709US</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL DISTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ATELECTASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BREATH SOUNDS ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONTUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ECCHYMOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPARIN-INDUCED THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC ENZYME INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LETHARGY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG INFILTRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCREAS INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHONCHI</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPTIC SHOCK</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LOVENOX</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>20164</drugauthorizationnumb>
        <drugindication>THROMBOSIS PROPHYLAXIS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DILTIAZEM HCL</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>HYDROCORTISONE</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REGLAN</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOPRESSOR</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROTONIX</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CIPRO</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIFLUCAN</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZYVOX</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053587-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060626</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ES200602000333</companynumb>
    <primarysource>
      <reportercountry>SPAIN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>18</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PULMONARY HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XIGRIS</medicinalproduct>
        <drugdosagetext>20 MG, OTHER, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MENINGOCOCCAL SEPSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060111</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060113</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CORTICOSTEROIDS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053588-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060517</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AVENTIS-200614448US</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>79.99</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DYSFUNCTIONAL UTERINE BLEEDING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NON-HODGKIN'S LYMPHOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UTERINE CANCER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARAVA</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>20905</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19970101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060508</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHATREXATE</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060508</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAQUENIL</medicinalproduct>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19930101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NSAID'S</medicinalproduct>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19970101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RELAFEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZIAC</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053589-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060630</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-AVENTIS-200611920DE</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>88</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>95</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RETROPERITONEAL HAEMATOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SHOCK HAEMORRHAGIC</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLEXANE</medicinalproduct>
        <drugauthorizationnumb>20164</drugauthorizationnumb>
        <drugdosagetext>DOSE: 0.8 - 0 - 0.8</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>BRONCHOSCOPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060613</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060617</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLEXANE</medicinalproduct>
        <drugauthorizationnumb>020164</drugauthorizationnumb>
        <drugdosagetext>DOSE: 0.8 - 0 - 0.8</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>THROMBOSIS PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060613</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060617</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MARCUMAR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DECORTIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060604</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060619</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060604</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060619</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SORTIS</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CARDIAC FAILURE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ROCEPHIN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060618</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GENTAMICIN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060618</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KLACID</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060618</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
        <drugdosagetext>DOSE: 0-0-1</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYMBICORT</medicinalproduct>
        <drugdosagetext>DOSE: 1-0-1</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SALMETEROL</medicinalproduct>
        <drugdosagetext>DOSE: 1-0-1</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053590-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060502</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AVENTIS-200614008US</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>54.54</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTRACRANIAL HYPOTENSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LOVENOX</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>20164</drugauthorizationnumb>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LOVENOX</medicinalproduct>
        <drugbatchnumb>89494</drugbatchnumb>
        <drugauthorizationnumb>020164</drugauthorizationnumb>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060502</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MORPHINE</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>EPIDURAL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053591-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060705</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ENTC2006-0187</companynumb>
    <primarysource>
      <reportercountry>FINLAND</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>66</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG ADMINISTRATION ERROR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GRUNTING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTESTINAL STOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OBSTRUCTIVE AIRWAYS DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARKINSON'S DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UNDERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOCAL CORD DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>STALEVO 100</medicinalproduct>
        <drugauthorizationnumb>21485</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PARKINSON'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050727</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060213</drugenddate>
        <drugtreatmentduration>201</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>STALEVO 100</medicinalproduct>
        <drugauthorizationnumb>21485</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PARKINSON'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050213</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060310</drugenddate>
        <drugtreatmentduration>390</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>STALEVO 100</medicinalproduct>
        <drugauthorizationnumb>21485</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PARKINSON'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060310</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>STALEVO 100</medicinalproduct>
        <drugauthorizationnumb>21485</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PARKINSON'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060615</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>STALEVO 100</medicinalproduct>
        <drugauthorizationnumb>21485</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PARKINSON'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060617</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053593-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>HQWYE753830SEP03</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>23</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>NEPHROPATHY TOXIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY TRACT INFECTION ENTEROCOCCAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RAPAMUNE</medicinalproduct>
        <drugbatchnumb>29114</drugbatchnumb>
        <drugauthorizationnumb>21110</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS AGAINST TRANSPLANT REJECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050630</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050630</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RAPAMUNE</medicinalproduct>
        <drugbatchnumb>29114</drugbatchnumb>
        <drugauthorizationnumb>21110</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS AGAINST TRANSPLANT REJECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050707</drugenddate>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RAPAMUNE</medicinalproduct>
        <drugbatchnumb>29114</drugbatchnumb>
        <drugauthorizationnumb>21110</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS AGAINST TRANSPLANT REJECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050708</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050720</drugenddate>
        <drugtreatmentduration>13</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RAPAMUNE</medicinalproduct>
        <drugbatchnumb>29114</drugbatchnumb>
        <drugauthorizationnumb>21110</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS AGAINST TRANSPLANT REJECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050721</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050801</drugenddate>
        <drugtreatmentduration>12</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RAPAMUNE</medicinalproduct>
        <drugbatchnumb>29114</drugbatchnumb>
        <drugauthorizationnumb>21110</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS AGAINST TRANSPLANT REJECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050802</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051006</drugenddate>
        <drugtreatmentduration>66</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RAPAMUNE</medicinalproduct>
        <drugbatchnumb>29114</drugbatchnumb>
        <drugauthorizationnumb>21110</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS AGAINST TRANSPLANT REJECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051007</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOSPORINE</medicinalproduct>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050628</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050701</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOSPORINE</medicinalproduct>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050702</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050705</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOSPORINE</medicinalproduct>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050706</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050707</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOSPORINE</medicinalproduct>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050708</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050720</drugenddate>
        <drugtreatmentduration>13</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOSPORINE</medicinalproduct>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050721</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050801</drugenddate>
        <drugtreatmentduration>12</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOSPORINE</medicinalproduct>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050802</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050914</drugenddate>
        <drugtreatmentduration>44</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOSPORINE</medicinalproduct>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050915</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051004</drugenddate>
        <drugtreatmentduration>20</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOSPORINE</medicinalproduct>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051005</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GANCICLOVIR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SODIUM BICARBONATE IN PLASTIC CONTAINER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BACTRIM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE TAB</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053594-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060623</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP200606000016</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>58</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>59</patientweight>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>CEREBELLAR INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBRAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBRAL ISCHAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATEMESIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALIGNANT NEOPLASM PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MELAENA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METASTASES TO LIVER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCREATIC CARCINOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GEMZAR</medicinalproduct>
        <drugauthorizationnumb>20509</drugauthorizationnumb>
        <drugdosagetext>1000 MG, OTHER, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PANCREATIC CARCINOMA STAGE IV</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060403</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060403</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CISPLATIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDONINE-1 (PREDNISOLONE ACETATE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KYTRIL - FOR INFUSION (GRANISETRON HYDROCHLORIDE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCONTIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053595-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006082154</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>71</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>84</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ILL-DEFINED DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUTENT</medicinalproduct>
        <drugauthorizationnumb>21968</drugauthorizationnumb>
        <drugdosagetext>50 MG (50 MG, CYCLIC), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RENAL CELL CARCINOMA STAGE UNSPECIFIED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060531</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053596-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>HQWYE489329JUN06</companynumb>
    <primarysource>
      <reportercountry>ITALY</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>55</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFUSION RELATED REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SENSE OF OPPRESSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMIODARONE HCL</medicinalproduct>
        <drugauthorizationnumb>20377</drugauthorizationnumb>
        <drugdosagetext>150 MG ONCE INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060614</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060614</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENOXAPARIN SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALSARTAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LAROXYL (AMTRIPTYLINE HYDROCHLORIDE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TACHIPIRINA (PARACEMTAMOL)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053597-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060627</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>863#1#2006-00007</companynumb>
    <primarysource>
      <reportercountry>BELGIUM</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>71</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ACTIVATED PARTIAL THROMBOPLASTIN TIME PROLONGED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERNATIONAL NORMALISED RATIO DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IDROLAX (MACROGOL)</medicinalproduct>
        <drugauthorizationnumb>76652</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONSTIPATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060303</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PHENPROCOUMON (PHENPROCOUMON)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE BESYLATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053598-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060707</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2006US08821</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>PANCREATITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugauthorizationnumb>021223</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053599-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060706</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHMT2006CA01485</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>70</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BONE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTH DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTH EXTRACTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugauthorizationnumb>021223</drugauthorizationnumb>
        <drugdosagetext>4 MG, QMO</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BREAST CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060426</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PAMIDRONATE DISODIUM</medicinalproduct>
        <drugdosagetext>90 MG, QMO</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030701</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053601-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20051004</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>805#9#2005-00062</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>13</patientonsetage>
      <patientonsetageunit>804</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYPNOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALPROSTADIL</medicinalproduct>
        <drugauthorizationnumb>18484</drugauthorizationnumb>
        <drugdosagetext>INTRAVENOUS DRIP</drugdosagetext>
        <drugindication>HEART DISEASE CONGENITAL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050806</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050823</drugenddate>
        <drugtreatmentduration>18</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMPICILLIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053603-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040722</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FRWYE059707JUL06</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>53</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HYDROCELE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RAPAMUNE</medicinalproduct>
        <drugauthorizationnumb>21083</drugauthorizationnumb>
        <drugdosagetext>4 MG TOTAL DAILY AT THE TIME OF THE EVENT, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS AGAINST TRANSPLANT REJECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030413</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030730</drugenddate>
        <drugtreatmentduration>109</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053604-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060705</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2006JP10195</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>4</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD ALKALINE PHOSPHATASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERPHOSPHATASAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOSPORINE</medicinalproduct>
        <drugauthorizationnumb>050574</drugauthorizationnumb>
        <drugindication>NEPHROTIC SYNDROME</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040301</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053605-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060224</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHNU2006DE01122</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>74</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>50</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DENTAL PROSTHESIS USER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DENTAL TREATMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FEMARA</medicinalproduct>
        <drugdosagetext>2.5 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010801</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RADIOTHERAPY</medicinalproduct>
        <drugdosagetext>50 GY</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>RADIOTHERAPY TO BREAST</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugauthorizationnumb>021223</drugauthorizationnumb>
        <drugdosagetext>4 MG, QMO</drugdosagetext>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051201</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053606-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHNU2006DE00601</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>72</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DENTAL TREATMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTH EXTRACTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOLADEX</medicinalproduct>
        <drugdosagetext>10.8 MG, Q3MO</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PROSTATE CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CASODEX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOCETAXEL</medicinalproduct>
        <drugdosagetext>135 MG, SOME CYCLES</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PROSTATE CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040501</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MULTOSIN</medicinalproduct>
        <drugdosagetext>TEMPORARILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugauthorizationnumb>021223</drugauthorizationnumb>
        <drugdosagetext>4 MG, QMO</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>METASTASES TO BONE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030605</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053607-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060606</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHNU2006DE02171</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>4</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>DENTAL DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MANDIBULECTOMY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL INTAKE REDUCED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL SURGERY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOMYELITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOSYNTHESIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN JAW</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PURULENT DISCHARGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOFT TISSUE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTH EXTRACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTH LOSS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugauthorizationnumb>21223</drugauthorizationnumb>
        <drugdosagetext>4 MG, QMO</drugdosagetext>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053608-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060706</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHNU2006DE02464</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>79</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>OSTEITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STOMATITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugauthorizationnumb>021223</drugauthorizationnumb>
        <drugdosagetext>UNK, QMO</drugdosagetext>
        <drugindication>PROSTATE CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040719</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060407</drugenddate>
        <drugtreatmentduration>628</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053609-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060706</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2006JP10317</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEORAL</medicinalproduct>
        <drugauthorizationnumb>050715</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>LIVER TRANSPLANT</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053611-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DEWYE886829JUN06</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>21</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BRADYPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG ABUSER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MIOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE DRUG OVERDOSE INTENTIONAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOPOR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VENLAFAXINE HCL</medicinalproduct>
        <drugauthorizationnumb>20151</drugauthorizationnumb>
        <drugdosagetext>OVERDOSE AMOUNT UNKNOWN, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060529</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060529</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEROIN (DIAMORPHINE, , 0_</medicinalproduct>
        <drugdosagetext>OVERDOSE AMOUNT UNKNOWN</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060529</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060529</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ROHYPNOL (FLUNITRAZEPAM, , 0)</medicinalproduct>
        <drugdosagetext>OVERDOSE UNKNOWN, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060529</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060529</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053614-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060703</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>HQWYE561105JUL06</companynumb>
    <primarysource>
      <reportercountry>SPAIN</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>44</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL HERNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POST PROCEDURAL COMPLICATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SIROLIMUS (SIROLIMUS, TABLET)</medicinalproduct>
        <drugauthorizationnumb>21110</drugauthorizationnumb>
        <drugindication>PROPHYLAXIS AGAINST TRANSPLANT REJECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051121</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060620</drugenddate>
        <drugtreatmentduration>212</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053615-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050909</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHRM2005FR02449</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>32</patientonsetage>
      <patientonsetageunit>802</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENSIVE CARE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTUBATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIFE SUPPORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUROTOXICITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUNGIZONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050903</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SOLUPRED</medicinalproduct>
        <drugdosagetext>15 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050903</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMUREL</medicinalproduct>
        <drugdosagetext>25 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050831</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>50 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050903</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BACTRIM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050903</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SODIUM BICARBONATE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050903</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEORAL</medicinalproduct>
        <drugdosagetext>110 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RENAL TRANSPLANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050819</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050909</drugenddate>
        <drugtreatmentduration>31680</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SANDIMMUNE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RENAL TRANSPLANT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SIMULECT</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RENAL TRANSPLANT</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053616-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060706</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2006JP10280</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>PLEURISY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LUDIOMIL</medicinalproduct>
        <drugauthorizationnumb>017543</drugauthorizationnumb>
        <drugdosagetext>UNK, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053617-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060710</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHNU2006DE02488</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>IMPAIRED HEALING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTH EXTRACTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugauthorizationnumb>021223</drugauthorizationnumb>
        <drugdosagetext>4 MG, QMO</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040901</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053618-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060705</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHRM2006FR01979</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>44</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CSF TEST ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CYTOMEGALOVIRUS ANTIGEN POSITIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTRACRANIAL PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NODULE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAPILLOEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL ACUITY REDUCED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SANDIMMUNE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060308</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060315</drugenddate>
        <drugtreatmentduration>11520</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEORAL</medicinalproduct>
        <drugauthorizationnumb>050715</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060315</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060322</drugenddate>
        <drugtreatmentduration>11520</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053619-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060627</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2006JP09774</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>84</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <reaction>
        <reactionmeddrapt>BLADDER INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPINAL COMPRESSION FRACTURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LUDIOMIL</medicinalproduct>
        <drugauthorizationnumb>017543</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053620-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20051118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2005JP17027</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
    </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>BLOOD ALKALINE PHOSPHATASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISEASE RECURRENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERPHOSPHATASAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEPHROTIC SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROTEINURIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEORAL</medicinalproduct>
        <drugauthorizationnumb>50716</drugauthorizationnumb>
        <drugdosagetext>90 MG/D</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NEPHROTIC SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041017</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050711</drugenddate>
        <drugtreatmentduration>268</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEORAL</medicinalproduct>
        <drugauthorizationnumb>050716</drugauthorizationnumb>
        <drugdosagetext>40 MG/D</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050712</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050920</drugenddate>
        <drugtreatmentduration>71</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEORAL</medicinalproduct>
        <drugauthorizationnumb>050716</drugauthorizationnumb>
        <drugdosagetext>40 MG/D</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050929</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LONGES</medicinalproduct>
        <drugdosagetext>3 MG/D</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041126</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050614</drugenddate>
        <drugtreatmentduration>201</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDONINE</medicinalproduct>
        <drugdosagetext>30-7.5 MG/D</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050920</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051114</drugenddate>
        <drugtreatmentduration>80640</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053621-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050114</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHNU2005DE00548</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>62</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>53</patientweight>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>FISTULA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOCAL ANAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALIGNANT NEOPLASM PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PURULENT DISCHARGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WOUND DEBRIDEMENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MITOXANTRONE</medicinalproduct>
        <drugdosagetext>19.7 MG, UNK</drugdosagetext>
        <drugindication>BREAST CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030731</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031222</drugenddate>
        <drugtreatmentduration>145</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NAVELBINE</medicinalproduct>
        <drugdosagetext>41 MG, UNK</drugdosagetext>
        <drugindication>BREAST CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030731</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031222</drugenddate>
        <drugtreatmentduration>145</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MITOMYCIN</medicinalproduct>
        <drugdosagetext>16 MG, UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>BREAST CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040602</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041012</drugenddate>
        <drugtreatmentduration>133</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SOLU-DECORTIN-H</medicinalproduct>
        <drugdosagetext>100 MG, UNK</drugdosagetext>
        <drugindication>BREAST CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040602</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041012</drugenddate>
        <drugtreatmentduration>133</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XELODA</medicinalproduct>
        <drugdosagetext>3000 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040602</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041012</drugenddate>
        <drugtreatmentduration>133</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FORTECORTIN</medicinalproduct>
        <drugdosagetext>8 MG, UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030731</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031222</drugenddate>
        <drugtreatmentduration>145</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AROMASIN</medicinalproduct>
        <drugdosagetext>1 DF, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040123</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040416</drugenddate>
        <drugtreatmentduration>85</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugauthorizationnumb>021223</drugauthorizationnumb>
        <drugdosagetext>4 MG, QMO</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>METASTASES TO BONE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030718</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050103</drugenddate>
        <drugtreatmentduration>536</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053625-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060707</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-AVENTIS-200617265GDDC</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>38</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>50</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ACTIVITIES OF DAILY LIVING IMPAIRED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISORIENTATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG WITHDRAWAL SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RIFAMPICIN</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>50420</drugauthorizationnumb>
        <drugindication>MENINGITIS MENINGOCOCCAL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060602</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060604</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHADONE HCL</medicinalproduct>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PAROXETINE HCL</medicinalproduct>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SALBUTAMOL</medicinalproduct>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SALMETEROL</medicinalproduct>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053626-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060505</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IT-AVENTIS-200614893GDDC</companynumb>
    <primarysource>
      <reportercountry>ITALY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>18</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANAPHYLACTIC SHOCK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONGENITAL HYPEREXTENSION OF SPINE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVERSION DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIPLOPIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEUKOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NERVOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NUCHAL RIGIDITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STARING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URTICARIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VERTIGO</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KETEK</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>21144</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SINUSITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060413</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060419</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053627-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060331</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BE-AVENTIS-200613412GDDC</companynumb>
    <primarysource>
      <reportercountry>BELGIUM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>70</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ATRIOVENTRICULAR BLOCK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CHOLESTEROL INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HIGH DENSITY LIPOPROTEIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOW DENSITY LIPOPROTEIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KETEK</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>21144</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RESPIRATORY TRACT INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060320</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060301</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACTONEL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051213</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20011024</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060208</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SOTALOL HCL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060222</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATACAND</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041111</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRADONAL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040915</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053628-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060622</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AVENTIS-200615425US</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER FUNCTION TEST ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCREATIC ENZYMES INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KETEK</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>21144</drugauthorizationnumb>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
        <drugindication>PHARYNGITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060605</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060607</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053629-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060706</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-AVENTIS-200617057GDDC</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>58</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>54</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIAC ENZYMES INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIOACTIVE DRUG LEVEL INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ELECTROCARDIOGRAM REPOLARISATION ABNORMALITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOMAGNESAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYARRHYTHMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THERAPEUTIC AGENT TOXICITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KETEK</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021144</drugauthorizationnumb>
        <drugindication>BRONCHITIS ACUTE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIGOXIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOSINOPRIL SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROGESTERONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PAROXETINE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BUDESONIDE</medicinalproduct>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TERBUTALINE</medicinalproduct>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053632-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006082173</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>61</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANAL INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUTENT</medicinalproduct>
        <drugauthorizationnumb>21968</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>METASTATIC RENAL CELL CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051011</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051220</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUTENT</medicinalproduct>
        <drugauthorizationnumb>21968</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>METASTATIC RENAL CELL CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060103</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060510</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053644-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006082502</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>71</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DELIRIUM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAND DEFORMITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugbatchnumb>0039125</drugbatchnumb>
        <drugauthorizationnumb>21446</drugauthorizationnumb>
        <drugdosagetext>150 MG (75 MG,2 IN 1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NEURALGIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060622</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060624</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZANAFLEX</medicinalproduct>
        <drugbatchnumb>4K192</drugbatchnumb>
        <drugdosagetext>16 MG (8 MG), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NEURALGIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060613</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060622</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACTONEL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CILAZAPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANTOLOC ^BYK MADAUS^ (PANTOPRAZOLE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COMTAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DETROL LA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONAZEPAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EZETROL (EZETIMIBE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SINEMET CR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCODONE AND ACETAMINOPHEN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053645-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006082303</companynumb>
    <primarysource>
      <reportercountry>MEXICO</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>65</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>66</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HEPATIC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UPPER GASTROINTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUTENT</medicinalproduct>
        <drugauthorizationnumb>21968</drugauthorizationnumb>
        <drugdosagetext>50 MG (50 MG, 1 IN 1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>METASTATIC RENAL CELL CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060531</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060625</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENSURE (AMINO ACID NOS, MINERALS NOS, VITAMINS NOS)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053651-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006019056</companynumb>
    <primarysource>
      <reportercountry>KOREA, REPUBLIC OF</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>30</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>44</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ASCITES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>KETOACIDOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENTAL STATUS CHANGES</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUTENT</medicinalproduct>
        <drugauthorizationnumb>21938</drugauthorizationnumb>
        <drugdosagetext>50 MG (50 MG, 1 IN 1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTROINTESTINAL STROMAL TUMOUR</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051104</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM POLYSTYRENE SULFONATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MORPHINE SULFATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LACTULOSE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGNESIUM OXIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PHENIRAMINE MALEATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOCLOPRAMIDE HYDROCHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAMADOL HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUMIN (HUMAN)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RABEPRAZOLE SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOMPERIDONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KETOPROFEN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053653-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006040834</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>57</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JOINT SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL STIFFNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TENDON DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TENDONITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugauthorizationnumb>20702</drugauthorizationnumb>
        <drugdosagetext>40 MG (40 MG, DAILY), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERLIPIDAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040325</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040511</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FELODIPINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SECTRAL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATACAND</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053655-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006037839</companynumb>
    <primarysource>
      <reportercountry>NETHERLANDS</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>57</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>65</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL DISTENSION</reactionmeddrapt>
      </reaction>
      <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 ALKALINE PHOSPHATASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD BILIRUBIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD LACTATE DEHYDROGENASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE DIASTOLIC INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BODY TEMPERATURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CACHEXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISEASE PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EAR INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAMMA-GLUTAMYLTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERAL PHYSICAL HEALTH DETERIORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATOMEGALY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE VASOVAGAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WOUND</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUTENT</medicinalproduct>
        <drugauthorizationnumb>21938</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTROINTESTINAL STROMAL TUMOUR</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050901</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUTENT</medicinalproduct>
        <drugauthorizationnumb>21938</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTROINTESTINAL STROMAL TUMOUR</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060317</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DURAGESIC-100</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMILORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARANESP</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053656-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060117</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHNU2006DE00576</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BIOPSY MUSCLE ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EOSINOPHILIC FASCIITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOCALCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLUENZA LIKE ILLNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACLASTA</medicinalproduct>
        <drugauthorizationnumb>021223</drugauthorizationnumb>
        <drugdosagetext>5 MG, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>OSTEITIS DEFORMANS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050901</drugenddate>
        <drugtreatmentduration>1440</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053663-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060608</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2006US07517</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>50</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLINDNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE IRRITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYELID DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RESTASIS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GENTEAL GEL (NVO)</medicinalproduct>
        <drugbatchnumb>955321</drugbatchnumb>
        <drugindication>DRY EYE</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060601</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GENTEAL MODERATE LUBRICANT EYE DROPS (NVO)</medicinalproduct>
        <drugbatchnumb>361393</drugbatchnumb>
        <drugdosagetext>1 GTT, PRN</drugdosagetext>
        <drugindication>DRY EYE</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060601</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053664-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006037240</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>78</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>71.3</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 GASES ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD POTASSIUM DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BODY TEMPERATURE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERAMYLASAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERBILIRUBINAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERSTITIAL LUNG DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METABOLIC ACIDOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLEURAL EFFUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLEURAL FIBROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL TUBULAR DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>YELLOW SKIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUTENT</medicinalproduct>
        <drugauthorizationnumb>21968</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RENAL CELL CARCINOMA STAGE UNSPECIFIED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060313</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUTENT</medicinalproduct>
        <drugauthorizationnumb>21968</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RENAL CELL CARCINOMA STAGE UNSPECIFIED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060412</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060420</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CANDESARTAN CILEXETIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>I.V. SOLUTIONS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOSE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FAMOTIDINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIFLUCORTOLONE VALERATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIDOCAINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE BESILATE (AMLODIPINE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SENNOSIDE A+B</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053665-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060608</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2006US07518</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>50</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLINDNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE IRRITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYELID DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYELID PTOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RESTASIS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GENTEAL MODERATE LUBRICANT EYE DROPS (NVO)</medicinalproduct>
        <drugindication>DRY EYE</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060601</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GENTEAL GEL (NVO)</medicinalproduct>
        <drugbatchnumb>955321</drugbatchnumb>
        <drugindication>DRY EYE</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060601</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053666-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006081837</companynumb>
    <primarysource>
      <reportercountry>PHILIPPINES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZMAX</medicinalproduct>
        <drugauthorizationnumb>50797</drugauthorizationnumb>
        <drugdosagetext>500 MG, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053667-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006062236</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>61</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>67.2</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>CACHEXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIALYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEMIPARESIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATOTOXICITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTUBATION COMPLICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METABOLIC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METASTASES TO CENTRAL NERVOUS SYSTEM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OPPORTUNISTIC INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TUMOUR LYSIS SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUTENT</medicinalproduct>
        <drugbatchnumb>505160</drugbatchnumb>
        <drugauthorizationnumb>21968</drugauthorizationnumb>
        <drugdosagetext>50 MG (50 MG, 1 IN 1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>METASTATIC RENAL CELL CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060505</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060619</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLYBURIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MINOXIDIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM ACETATE (CALCIUM ACETATE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENALAPRIL MALEATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IRBESARTAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FERROUS SULFATE TAB</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053668-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060213</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-ROCHE-436986</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>35</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>95</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSED MOOD</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROTEINURIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>18662</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051215</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>018662</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051215</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>018662</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060113</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PHENELZINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053669-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050121</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-393478</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>16</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>58.1</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ACNE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANOREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARRHYTHMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BULIMIA NERVOSA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONTUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COSTOCHONDRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CROHN'S DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSKINESIA OESOPHAGEAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ELECTROCARDIOGRAM PR SHORTENED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING GUILTY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROOESOPHAGEAL REFLUX DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERALISED ANXIETY DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HIATUS HERNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLAMMATORY BOWEL DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MAJOR DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MITRAL VALVE PROLAPSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTI-ORGAN DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OESOPHAGEAL STENOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RECTAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SCAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDE ATTEMPT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROAT TIGHTNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL ACUITY REDUCED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>18662</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19991006</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19991108</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>018662</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19991108</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20000228</drugenddate>
        <drugtreatmentduration>113</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>018662</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000228</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ORTHO TRI-CYCLEN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053670-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050928</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-419592</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>33</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>61.2</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ALLERGIC COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ALLERGY TO ARTHROPOD BITE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANHEDONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHMA</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>CYSTITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRY SKIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ECZEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EXOSTOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FOOD ALLERGY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FUNGAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROOESOPHAGEAL REFLUX DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHOIDAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HOUSE DUST ALLERGY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLAMMATORY BOWEL DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JOINT SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MELANOCYTIC NAEVUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENSTRUATION IRREGULAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERIPHERAL COLDNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHINITIS ALLERGIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SCOLIOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SELF-MEDICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUSITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN PAPILLOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SLEEP APNOEA SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UPPER RESPIRATORY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>18662</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19970922</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19971115</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ORTHO TRI-CYCLEN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053671-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060704</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-AMGEN-UK185029</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>80</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>40</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</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>20060325</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CORTANCYL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060325</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060517</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VASTAREL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060506</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FUMAFER</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060325</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALKERAN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060325</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060517</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053673-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050812</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-414410</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>20</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>69.9</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ALOPECIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CROHN'S DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRY SKIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ENDOMETRIOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EPISTAXIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FIBROADENOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLAMMATORY BOWEL DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IRRITABLE BOWEL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIP DRY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OESOPHAGITIS ULCERATIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVARIAN CYST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAPILLOMA VIRAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAROVARIAN CYST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UTERINE POLYP</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>18662</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ACNE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990721</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19990824</drugenddate>
        <drugtreatmentduration>35</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>018662</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990825</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20000110</drugenddate>
        <drugtreatmentduration>139</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053674-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006057226</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>73</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>45</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD LACTIC ACID INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CYANOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG TOXICITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAMMA-GLUTAMYLTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCYTOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VERTIGO</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYVOX</medicinalproduct>
        <drugauthorizationnumb>21131</drugauthorizationnumb>
        <drugdosagetext>1200 MG (600 MG, 2 IN 1 D), INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060403</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060414</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAROXETINE</medicinalproduct>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060309</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060403</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAROXETINE</medicinalproduct>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060404</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060405</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAROXETINE</medicinalproduct>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060406</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060408</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HEPARIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOMPERIDONE (DOMPERIDONE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BISOPROLOL FUMARATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEXOMIL (BROMAZEPAM)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RIFADIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIAMOX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATARAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SINTROM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053681-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050316</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-ROCHE-398986</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>3</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG DOSE OMISSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE BEFORE PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NO ADVERSE EFFECT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NORMAL NEWBORN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>018662</drugauthorizationnumb>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CONTRACEPTIVE PILL</medicinalproduct>
        <drugindication>CONTRACEPTION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053682-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20030825</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-345207</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>24</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>73.5</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANGER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASCITES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CHOLESTEROL INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD URINE PRESENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CAT SCRATCH DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CELLULITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHAPPED LIPS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHILLS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHOLELITHIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLITIS ULCERATIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DECREASED APPETITE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ENCEPHALOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLATULENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROENTERITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAND FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HIATUS HERNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ILEUS PARALYTIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLAMMATORY BOWEL DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>KETONURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEGIONELLA INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPHADENITIS BACTERIAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPHADENOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NIGHT SWEATS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OCULAR HYPERAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PENICILLIOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POUCHITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROTEINURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSEUDOPOLYPOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ROSAI-DORFMAN SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEROMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUBCUTANEOUS ABSCESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THERAPY NON-RESPONDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>18662</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ACNE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19950622</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19951019</drugenddate>
        <drugtreatmentduration>120</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053683-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060703</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2005150682</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>58</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>52</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANAPHYLACTIC SHOCK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRADYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIOACTIVE DRUG LEVEL INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHOLECYSTITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHOLELITHIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSED LEVEL OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISEASE PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EFFECT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ELECTROMECHANICAL DISSOCIATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GALLBLADDER ENLARGEMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPONATRAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOUTH BREATHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHLEBITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POST PROCEDURAL COMPLICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE CHRONIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESTLESSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARDENALIN (DOXAZOSIN )</medicinalproduct>
        <drugauthorizationnumb>19668</drugauthorizationnumb>
        <drugdosagetext>8 MG (4 MG, BID), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051021</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051031</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DILTIAZEM HYDROCHLORIDE</medicinalproduct>
        <drugdosagetext>36 MG, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051031</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051031</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMLODIPINE</medicinalproduct>
        <drugdosagetext>10 MG (5 MG, BID), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051017</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051031</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PERDIPINE (NICARDIPINE HYDROCHLORIDE)</medicinalproduct>
        <drugdosagetext>500 MG (500 MG, QD), INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051017</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051031</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CALSLOT (MANIDIPINE HYDROCHLORIDE)</medicinalproduct>
        <drugdosagetext>40 MG (20 MG, BID), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051021</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051031</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIFEDIPINE</medicinalproduct>
        <drugdosagetext>60 MG, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051018</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051031</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARVEDILOL</medicinalproduct>
        <drugdosagetext>20 MG, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051018</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051031</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053684-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060309</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ROCHE-439839</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>52</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE ATROPHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOPOROSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELLCEPT</medicinalproduct>
        <drugauthorizationnumb>50722</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020715</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELLCEPT</medicinalproduct>
        <drugauthorizationnumb>050722</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELLCEPT</medicinalproduct>
        <drugauthorizationnumb>050722</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041215</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050331</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELLCEPT</medicinalproduct>
        <drugauthorizationnumb>050722</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050621</drugenddate>
        <drugtreatmentduration>82</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELLCEPT</medicinalproduct>
        <drugauthorizationnumb>050722</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050622</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050720</drugenddate>
        <drugtreatmentduration>29</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROGRAF</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020515</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051206</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROGRAF</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051207</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060221</drugenddate>
        <drugtreatmentduration>77</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROGRAF</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060222</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDONINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020615</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDONINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050817</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDONINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050818</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050914</drugenddate>
        <drugtreatmentduration>28</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZEFFIX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000115</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041215</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HEPSERA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020315</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOVIRAX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020515</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040415</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PARIET</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020515</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020615</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MUCOSTA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020515</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>URSO</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020515</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PERSANTIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020515</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020615</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DAONIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020715</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040715</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053685-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060224</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ROCHE-438557</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>59</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>50</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HEAD DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAMIFLU</medicinalproduct>
        <drugauthorizationnumb>21087</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060217</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060219</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALONAL</medicinalproduct>
        <drugdosagetext>TAKEN AS NEEDED.</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060217</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060218</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053686-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050525</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-405864</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>22</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>52.2</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ACNE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>APPENDICITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AUTOIMMUNE THYROIDITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHAPPED LIPS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLITIS ULCERATIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRY SKIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPEPSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EPISTAXIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ILL-DEFINED DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLAMMATORY BOWEL DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERVERTEBRAL DISC DEGENERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTI-ORGAN DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NIGHT BLINDNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PREMENSTRUAL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROCTITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RADICULOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RECTAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPONDYLITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STRESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VITREOUS FLOATERS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>18662</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19960610</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19960702</drugenddate>
        <drugtreatmentduration>23</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>018662</drugauthorizationnumb>
        <drugdosagetext>REPORTED AS '40MG A/W 80MG' AND CLARIFIED AS 'ALTERNATING 40 MG AND 80 MG EVERY OTHER DAY'</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19960702</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19960716</drugenddate>
        <drugtreatmentduration>15</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>018662</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19960716</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19961114</drugenddate>
        <drugtreatmentduration>122</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>018662</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19981209</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19990212</drugenddate>
        <drugtreatmentduration>66</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053687-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060622</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-AMGEN-UK184235</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>96</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLISTER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSGEUSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TONGUE DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KEPIVANCE</medicinalproduct>
        <drugbatchnumb>N1131AF</drugbatchnumb>
        <drugadministrationroute>040</drugadministrationroute>
        <drugindication>MUCOSAL INFLAMMATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060613</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VINCRISTINE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060614</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IFOSFAMIDE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060614</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060618</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ETOPOSIDE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060617</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060618</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARA-C</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060614</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060618</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CORTISONE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RITUXIMAB</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060616</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060614</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060615</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053688-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>KR-ROCHE-372240</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>56</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>METABOLIC ACIDOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA STAPHYLOCOCCAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPTIC SHOCK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CAPECITABINE</medicinalproduct>
        <drugauthorizationnumb>20896</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040428</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040430</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IXABEPILONE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BREAST CANCER</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>MEFENAMIC ACID</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040413</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040507</drugenddate>
        <drugtreatmentduration>25</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PETHIDINE HYDROCHLORIDE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040413</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040503</drugenddate>
        <drugtreatmentduration>21</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIPHENHYDRAMINE HCL</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040407</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040429</drugenddate>
        <drugtreatmentduration>23</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CIMETIDINE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040407</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040429</drugenddate>
        <drugtreatmentduration>23</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053689-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060113</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-432383</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>22</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>86.2</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CHAPPED LIPS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHOLELITHIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLITIS ULCERATIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRY EYE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRY SKIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EPISTAXIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLAMMATORY BOWEL DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NASAL DRYNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROCTITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>018662</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ACNE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19870615</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>018662</drugauthorizationnumb>
        <drugdosagetext>40 MG DAILY, THEN ADD 40 MG MORE EVERY OTHER DAY.</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19940713</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19940823</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>018662</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19940824</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19950615</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>018662</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20000215</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>018662</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000217</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20000615</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053691-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060622</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CN-ROCHE-452638</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>64</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTI-ORGAN FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PURPURA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CAPECITABINE</medicinalproduct>
        <drugauthorizationnumb>20896</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTRIC CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050117</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050523</drugenddate>
        <drugtreatmentduration>127</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ELOXATIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>GASTRIC CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050206</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050523</drugenddate>
        <drugtreatmentduration>107</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ELOXATIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050117</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050206</drugenddate>
        <drugtreatmentduration>21</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053692-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060412</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PA-ROCHE-445259</companynumb>
    <primarysource>
      <reportercountry>PANAMA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>28</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>57</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABORTION INDUCED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE BEFORE PREGNANCY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>18662</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ACNE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050915</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060215</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053693-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060706</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-454534</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>16</patientonsetage>
      <patientonsetageunit>802</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BONE MARROW TRANSPLANT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>018662</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053697-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006021945</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>49</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL DISTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLISTER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMPAIRED WORK ABILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAROSMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUSITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN DISCOLOURATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GENOTROPIN</medicinalproduct>
        <drugauthorizationnumb>20280</drugauthorizationnumb>
        <drugdosagetext>0.4 MG (0.6 MG, 6 IN 1 WK), SUBCUTANEOUS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>BLOOD GROWTH HORMONE DECREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060103</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060401</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GENOTROPIN</medicinalproduct>
        <drugauthorizationnumb>20280</drugauthorizationnumb>
        <drugdosagetext>0.4 MG (0.6 MG, 6 IN 1 WK), SUBCUTANEOUS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>OFF LABEL USE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060103</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060401</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053699-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060327</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-442351</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>50</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ALOPECIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRY SKIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOOD SWINGS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARANOIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHINITIS ALLERGIC</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>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051004</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COPEGUS</medicinalproduct>
        <drugauthorizationnumb>021511</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051004</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053700-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060704</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-US185232</companynumb>
    <primarysource>
      <reportercountry>TAIWAN, PROVINCE OF CHINA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARANESP</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RENAL FAILURE CHRONIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051215</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RECORMON</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19991115</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARBAMAZEPINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM ACETATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BROMAZEPAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GEMFIBROZIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASCORBIC ACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONAZEPAM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053701-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060706</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-ROCHE-454526</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>78</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>70</patientweight>
      <reaction>
        <reactionmeddrapt>BRAIN OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEAD INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METASTASES TO CENTRAL NERVOUS SYSTEM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CAPECITABINE</medicinalproduct>
        <drugauthorizationnumb>20896</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051026</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060221</drugenddate>
        <drugtreatmentduration>119</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXALIPLATIN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051026</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051102</drugenddate>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BISOPROLOL FUMARATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRONOLACTONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ISCOVER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>1 CONCOMITANT DRUG</medicinalproduct>
        <drugdosagetext>DRUG REPORTED AS AMISULPRID.</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VENLAFAXINE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MIRTAZAPINE</medicinalproduct>
        <drugdosagetext>DRUG REPORTED AS MIRTAZEPIN.</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AQUAPHOR</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053702-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060706</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>SE-ROCHE-454148</companynumb>
    <primarysource>
      <reportercountry>SWEDEN</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>24</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANGIONEUROTIC OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LARIAM</medicinalproduct>
        <drugauthorizationnumb>019591</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MALARIA PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060613</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060620</drugenddate>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053703-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060620</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-ROCHE-452493</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>42</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>98</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLISTER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PEMPHIGOID</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH GENERALISED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XENICAL</medicinalproduct>
        <drugauthorizationnumb>020766</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>WEIGHT CONTROL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20001110</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060525</drugenddate>
        <drugtreatmentduration>2023</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIOFOR</medicinalproduct>
        <drugdosagetext>DOSAGE REGIMEN REPORTED AS 3 PER DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NOVONORM</medicinalproduct>
        <drugdosagetext>DOSAGE REGIMEN REPORTED AS 2 PER DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EFEROX</medicinalproduct>
        <drugdosagetext>DOSAGE REGIMEN REPORTED AS 1 PER DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
        <drugdosagetext>ALLOPURINOL 100. DOSAGE REGIMEN REPORTED AS 2 PER DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HCT</medicinalproduct>
        <drugdosagetext>DOSAGE REGIMEN REPORTED AS 3 PER DAY</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053704-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060523</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-ROCHE-449034</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>71</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>68</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>GLIOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RADIATION INJURY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INTERFERON ALFA-2A</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>METASTATIC RENAL CELL CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051006</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060522</drugenddate>
        <drugtreatmentduration>229</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVASTIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>METASTATIC RENAL CELL CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051006</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060522</drugenddate>
        <drugtreatmentduration>229</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051006</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060515</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATACAND</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060115</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050808</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060418</drugenddate>
        <drugtreatmentduration>254</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MOVICOL</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060508</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053705-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060706</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-ROCHE-454557</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOOD SWINGS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>018662</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060615</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060615</drugenddate>
        <drugtreatmentduration>10</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053706-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060509</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>NL-ROCHE-448090</companynumb>
    <primarysource>
      <reportercountry>NETHERLANDS</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>40</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DEAFNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TINNITUS</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>20060210</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COPEGUS</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060210</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNSPECIFIED DRUG</medicinalproduct>
        <drugdosagetext>THE PATIENT PARTICIPATES IN A TRIAL CALLED POPS AND RECEIVES EITHER A PLACEBO OR AN ANTIDEPRESSANT +</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053707-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060612</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-AMGEN-US183027</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARANESP</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RENAL FAILURE CHRONIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050412</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060609</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053708-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060615</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-452159</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>68</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DECREASED APPETITE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POLLAKIURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEGASYS</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060324</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060707</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEGASYS</medicinalproduct>
        <drugdosagetext>IN WEEK 16 DOSE WAS REDUCED TO 135 MCG.</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060707</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COPEGUS</medicinalproduct>
        <drugauthorizationnumb>021511</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060324</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053709-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060609</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-451556</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>72</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>62.6</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLUENZA LIKE ILLNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THERAPY NON-RESPONDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BONIVA</medicinalproduct>
        <drugauthorizationnumb>21455</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060303</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060603</drugenddate>
        <drugtreatmentduration>93</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040615</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053710-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060330</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CN-ROCHE-442590</companynumb>
    <primarysource>
      <reportercountry>CHINA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>64</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XELODA</medicinalproduct>
        <drugauthorizationnumb>20896</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTRIC CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050117</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050523</drugenddate>
        <drugtreatmentduration>127</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XELODA</medicinalproduct>
        <drugauthorizationnumb>020896</drugauthorizationnumb>
        <drugdosagetext>FOR 14 DAYS.</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041221</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XELODA</medicinalproduct>
        <drugauthorizationnumb>020896</drugauthorizationnumb>
        <drugdosagetext>THE DOSE WAS DECREASED FOR THE FOLLOWING 21 DAYS.</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXALIPLATIN</medicinalproduct>
        <drugdosagetext>200 MG PER DAY FOR 7 DAYS AND THE DOSE WAS CHANGED TO 150 MG PER DAY FOR THE FOLLOWING 28 DAYS.  FR+</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>GASTRIC CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041221</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050523</drugenddate>
        <drugtreatmentduration>154</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053715-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006082232</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREATMENT NONCOMPLIANCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MEDROXYPROGESTERONE ACETATE</medicinalproduct>
        <drugauthorizationnumb>20246</drugauthorizationnumb>
        <drugdosagetext>INTRAMUSCULAR</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>CONTRACEPTION</drugindication>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053716-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060426</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-ROCHE-446082</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>71</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>84.8</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>COLONIC POLYP</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XENICAL</medicinalproduct>
        <drugauthorizationnumb>020766</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OBESITY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051026</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060415</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XENICAL</medicinalproduct>
        <drugauthorizationnumb>020766</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060417</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XENICAL</medicinalproduct>
        <drugauthorizationnumb>020766</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060702</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053717-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060706</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CH-ROCHE-454240</companynumb>
    <primarysource>
      <reportercountry>SWITZERLAND</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>70</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CHOLANGITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CAPECITABINE</medicinalproduct>
        <drugauthorizationnumb>20896</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BILIARY CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060621</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060623</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GEMCITABINE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BILIARY CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060621</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060621</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DUPHALAC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TEMESTA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAMADOL HCL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053718-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060706</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-454615</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>55</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD CREATININE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLUENZA LIKE ILLNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RIBAVIRIN</medicinalproduct>
        <drugauthorizationnumb>21511</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060515</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060526</drugenddate>
        <drugtreatmentduration>12</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INTERFERON ALFACON-1</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060515</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060526</drugenddate>
        <drugtreatmentduration>12</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053719-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006082173</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>61</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANAL INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUTENT</medicinalproduct>
        <drugauthorizationnumb>21968</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>METASTATIC RENAL CELL CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051011</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051220</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUTENT</medicinalproduct>
        <drugauthorizationnumb>21968</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>METASTATIC RENAL CELL CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060103</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060510</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053720-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060705</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-AMGEN-UK185043</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>68</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>OPTIC NEURITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL ACUITY REDUCED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEULASTA</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>CHEMOTHERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060203</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060428</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARACYTINE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050211</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060511</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMIODARONE HCL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060615</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ETOPOSIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050620</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060208</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BISOPROLOL FUMARATE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASILIX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053727-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006079347</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>56</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugauthorizationnumb>21446</drugauthorizationnumb>
        <drugdosagetext>150 MG (75 MG, 2 IN 1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NEURALGIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060524</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMITRIPTYLINE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BACLOFEN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053728-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060228</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-AMGEN-UK170660</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>32</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>44</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GRAND MAL CONVULSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KINERET</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCORTISONE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IDEOS</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOLIPRANE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TERCIAN (ADVENTIS PHARMA)</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACTONEL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053729-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060623</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IT-AMGEN-UK184232</companynumb>
    <primarysource>
      <reportercountry>ITALY</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>37</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEUPOGEN</medicinalproduct>
        <drugbatchnumb>N1093AC</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>CHEMOTHERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060428</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060608</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EPIRUBICIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060427</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060608</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053730-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006079336</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>43</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DYSGEUSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POST PROCEDURAL COMPLICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TONSILLITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HALCION</medicinalproduct>
        <drugauthorizationnumb>17892</drugauthorizationnumb>
        <drugdosagetext>AS NECESSARY, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SLEEP DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HALCION</medicinalproduct>
        <drugauthorizationnumb>17892</drugauthorizationnumb>
        <drugdosagetext>AS NECESSARY, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>STRESS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NITRAZEPAM</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEPAS (ETIZOLAM)</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053731-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006081365</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>44</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD LACTATE DEHYDROGENASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEPHROLITHIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCYTOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SERUM FERRITIN INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLINDAMYCIN HYDROCHLORIDE</medicinalproduct>
        <drugauthorizationnumb>50162</drugauthorizationnumb>
        <drugdosagetext>1.2 GRAM (EVERY DAY), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CEREBRAL TOXOPLASMOSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050822</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060505</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PYRIMETHAMINE TAB</medicinalproduct>
        <drugdosagetext>1 DOSE FORM (EVERY DAY), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CEREBRAL TOXOPLASMOSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050822</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060505</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SUSTIVA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRUVADA</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053734-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006081170</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>2</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>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHEUMATOID ARTHRITIS</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>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060221</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VASOTEC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARVEDILOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INDOMETHACIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NITRO-SPRAY (ISOSORBIDE DINITRATE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>APO-FUROSEMIDE (FUROSEMIDE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053736-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060515</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-US179578</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>25</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HERPES ZOSTER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYELODYSPLASTIC SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCYTOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THERAPEUTIC RESPONSE DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARANESP</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>014</drugadministrationroute>
        <drugindication>RENAL FAILURE CHRONIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050217</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EPOGEN</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>DIALYSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040718</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050217</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONIDINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AZACITIDINE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050830</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060521</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053737-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060405</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-US175756</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>52.2</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MYELODYSPLASTIC SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THERAPEUTIC RESPONSE DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>RENAL FAILURE CHRONIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040309</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THYROID TAB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HALDOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACTONEL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DARVOCET</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053738-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060712</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20060702738</companynumb>
    <primarysource>
      <reportercountry>IRELAND</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REOPRO</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053741-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060703</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006080650</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>61</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DIALYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GLOMERULONEPHRITIS RAPIDLY PROGRESSIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEPHRITIS INTERSTITIAL</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>1</drugcharacterization>
        <medicinalproduct>CARDENALIN (DOXAZOSIN)</medicinalproduct>
        <drugdosagetext>4 MG (1 IN 1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
        <drugdosagetext>10 MG (1 IN 1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BLOPRESS (CANDESARTAN CILEXETIL)</medicinalproduct>
        <drugdosagetext>8 MG (1 IN 1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
        <drugdosagetext>100 MG (1 IN 1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENALAPRIL MALEATE</medicinalproduct>
        <drugdosagetext>5 MG (1 IN 1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060422</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060505</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053743-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060630</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006014158</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>47</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>91.6</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE FLUCTUATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC ENZYMES INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC TAMPONADE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTRACRANIAL PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARTIAL SEIZURES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERICARDIAL EFFUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PUPILS UNEQUAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TORSADE DE POINTES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENTRICULAR TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUTENT</medicinalproduct>
        <drugauthorizationnumb>21938</drugauthorizationnumb>
        <drugdosagetext>50 MG (50 MG, DAILY INTERVAL: EVERYDAY), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RENAL CELL CARCINOMA STAGE UNSPECIFIED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060113</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060125</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GABAPENTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ORAMORPH SR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROZAC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOPICLONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MST (MORPHINE SULFATE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROPRANOLOL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053744-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060707</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006AC01279</companynumb>
    <primarysource>
      <reportercountry>NEW ZEALAND</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>70</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MUSCLE ATROPHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOPATHY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ESOMEPRAZOLE</medicinalproduct>
        <drugauthorizationnumb>21153</drugauthorizationnumb>
        <drugdosagetext>STOPPED DUE TO ADVERSE EVENT</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053745-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060705</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006AP03074</companynumb>
    <primarysource>
      <reportercountry>HONG KONG</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>18022</patientonsetage>
      <patientonsetageunit>804</patientonsetageunit>
      <patientweight>52.8</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DECREASED APPETITE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IRESSA</medicinalproduct>
        <drugauthorizationnumb>021399</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NASOPHARYNGEAL CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060509</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060608</drugenddate>
        <drugtreatmentduration>31</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THYMOL GARGLE</medicinalproduct>
        <drugadministrationroute>061</drugadministrationroute>
        <drugindication>MUCOSAL INFLAMMATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060523</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060606</drugenddate>
        <drugtreatmentduration>15</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MORPHINE SULFATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BACK PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060523</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROXYGINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRURITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060523</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060606</drugenddate>
        <drugtreatmentduration>15</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLINDAMYCIN</medicinalproduct>
        <drugadministrationroute>061</drugadministrationroute>
        <drugindication>RASH</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060523</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060606</drugenddate>
        <drugtreatmentduration>15</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AQUEOUS CREAM</medicinalproduct>
        <drugadministrationroute>061</drugadministrationroute>
        <drugindication>DRY SKIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060523</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060606</drugenddate>
        <drugtreatmentduration>15</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SENNA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONSTIPATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060606</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060610</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MEDICAL DIET</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060606</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060624</drugenddate>
        <drugtreatmentduration>19</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053746-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006AP03050</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>68</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>71</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROCEDURAL COMPLICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROCEDURAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>REACTION TO DRUG EXCIPIENTS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XYLOCAINE TOPICAL FILM</medicinalproduct>
        <drugauthorizationnumb>8816</drugauthorizationnumb>
        <drugadministrationroute>045</drugadministrationroute>
        <drugindication>LOCAL ANAESTHESIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060627</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060627</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRIVINA</medicinalproduct>
        <drugadministrationroute>045</drugadministrationroute>
        <drugindication>ENDOSCOPY UPPER GASTROINTESTINAL TRACT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060627</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060627</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>JELLIED LUBRICANT</medicinalproduct>
        <drugadministrationroute>045</drugadministrationroute>
        <drugindication>ENDOSCOPY UPPER GASTROINTESTINAL TRACT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060627</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060627</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XYLOCAINE</medicinalproduct>
        <drugadministrationroute>045</drugadministrationroute>
        <drugindication>LOCAL ANAESTHESIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060627</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060627</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XYLOCAINE</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060628</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060628</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053747-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006082150</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>78</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>72</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LETHARGY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUTENT</medicinalproduct>
        <drugauthorizationnumb>21968</drugauthorizationnumb>
        <drugdosagetext>50 MG (50 MG, CYCLIC), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RENAL CELL CARCINOMA STAGE UNSPECIFIED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060609</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053748-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006051403</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>65</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>80</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugauthorizationnumb>21446</drugauthorizationnumb>
        <drugdosagetext>150 MG (75 MG, 2 IN 1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NEURALGIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060206</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCODONE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALL OTHER THERAPEUTIC PRODUCTS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053754-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006056673</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>71</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>0</patientsex>
      <reaction>
        <reactionmeddrapt>DYSKINESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</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>20060324</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060424</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053757-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060705</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006AP03168</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>28708</patientonsetage>
      <patientonsetageunit>804</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CHOLELITHIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EXOCRINE PANCREATIC FUNCTION TEST ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC FUNCTION ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CASODEX</medicinalproduct>
        <drugauthorizationnumb>020498</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROSTATE CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060308</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060617</drugenddate>
        <drugtreatmentduration>102</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEUPLIN</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060324</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ESTROGENIC SUBSTANCE</medicinalproduct>
        <drugdosagetext>LARGE VOLUME</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060201</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053758-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060508</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006GB00811</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>69</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ARRHYTHMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugauthorizationnumb>21153</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053759-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060710</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006CG01195</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>53</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>65</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ATRIAL SEPTAL DEFECT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ISCHAEMIC STROKE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NOLVADEX</medicinalproduct>
        <drugauthorizationnumb>017970</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060603</drugenddate>
        <drugtreatmentduration>11</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEXOMIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060603</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROZAC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060603</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HAVLANE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060603</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEPAMIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060603</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LAROXYL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NEURALGIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NEURALGIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053760-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060711</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006UW14264</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugauthorizationnumb>020639</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053761-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060714</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006UW14455</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOLADEX</medicinalproduct>
        <drugauthorizationnumb>019726</drugauthorizationnumb>
        <drugadministrationroute>058</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053762-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060714</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006UW14493</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>CLOSTRIDIAL INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugauthorizationnumb>021153</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARAFATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REGLAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIDOCAINE HCL VISCOUS</medicinalproduct>
        <drugadministrationroute>002</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAALOX FAST BLOCKER</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053763-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060705</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2006US08571</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>83</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BALANCE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONTUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEAD INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWELLING FACE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
        <drugauthorizationnumb>021283</drugauthorizationnumb>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEXAPRO</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARDIZEM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053764-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060504</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2006US05868</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>62</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>120.18</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANGIONEUROTIC OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIOMEGALY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMPUTERISED TOMOGRAM ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWOLLEN TONGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URTICARIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPROL-XL</medicinalproduct>
        <drugdosagetext>50 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugdosagetext>10 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MOBIC</medicinalproduct>
        <drugdosagetext>15 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>81 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
        <drugauthorizationnumb>020665</drugauthorizationnumb>
        <drugdosagetext>160 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060125</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060424</drugenddate>
        <drugtreatmentduration>90</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053766-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060630</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006082299</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>PANCYTOPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALDACTONE</medicinalproduct>
        <drugauthorizationnumb>12151</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053769-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060711</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006UW14314</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>67</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CHILLS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HOT FLUSH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IRESSA</medicinalproduct>
        <drugauthorizationnumb>021399</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BRONCHIOLOALVEOLAR CARCINOMA</drugindication>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053773-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060630</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006082340</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>54</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG ERUPTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHOTOSENSITIVITY REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
        <drugauthorizationnumb>19787</drugauthorizationnumb>
        <drugdosagetext>ORAL/A FEW DAYS</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053775-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060710</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-JNJFOC-20060701876</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>57</patientweight>
      <patientsex>2</patientsex>
      <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>2</drugcharacterization>
        <medicinalproduct>SULFASALAZINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCICHEW</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLOPIDOGREL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FELODIPINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROXYCHLOROQUINE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MELOXICAM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RISEDRONATE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053777-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006079766</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>59</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>APHASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COORDINATION ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOVEMENT DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NERVOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THERAPEUTIC RESPONSE UNEXPECTED WITH DRUG SUBSTITUTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VIRAL INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZARONTIN</medicinalproduct>
        <drugauthorizationnumb>12380</drugauthorizationnumb>
        <drugdosagetext>250 MG (250 MG, 1 IN 1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>EPILEPSY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ETHOSUXIMIDE</medicinalproduct>
        <drugindication>CONVULSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PHENOBARBITAL TAB</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053778-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006079575</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>44</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>88</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ACUTE MYOCARDIAL INFARCTION</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>CATHETER RELATED COMPLICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CELLULITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHROMATURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY OCCLUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLAMMATION OF WOUND</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NECROTISING FASCIITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PURULENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL IMPAIRMENT</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>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030203</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060619</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARVEDILOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BLOPRESS (CANDESARTAN CILEXETIL)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIGMART (NICORANDIL)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMARYL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053779-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006079530</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>95</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HYPOPROTHROMBINAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SULPERAZON (SULBACTAM, CEFOPERAZONE)</medicinalproduct>
        <drugauthorizationnumb>50551</drugauthorizationnumb>
        <drugdosagetext>2 GRAM (1 GRAM, 2 IN 1 D), INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BILIARY TRACT DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060503</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060508</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOPAMINE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDIUM (BELLADONNA EXTRACT, ERGOTAMINE TARTRATE, MEPROBAMATE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HUMULIN R</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053781-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006082232</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREATMENT NONCOMPLIANCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MEDROXYPROGESTERONE ACETATE</medicinalproduct>
        <drugauthorizationnumb>20246</drugauthorizationnumb>
        <drugdosagetext>INTRAMUSCULAR</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>CONTRACEPTION</drugindication>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053783-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006081194</companynumb>
    <primarysource>
      <reportercountry>HONDURAS</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>49</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DECEREBRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DELUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HALLUCINATION, AUDITORY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCORRECT DOSE ADMINISTERED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY ARREST</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GEODON</medicinalproduct>
        <drugauthorizationnumb>20825</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060627</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALPRAZOLAM</medicinalproduct>
        <drugindication>INSOMNIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLONAZEPAM</medicinalproduct>
        <drugindication>INSOMNIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALL OTHER THERAPEUTIC PRODUCTS (ALL OTHER THERAPEUTIC PRODUCTS)</medicinalproduct>
        <drugindication>INSOMNIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053784-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006050546</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>59</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>70.8</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ATRIOVENTRICULAR BLOCK FIRST DEGREE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>C-REACTIVE PROTEIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUCOSAL INFLAMMATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL ISCHAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL INTAKE REDUCED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>QRS AXIS ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUS BRADYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHEEZING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUTENT</medicinalproduct>
        <drugauthorizationnumb>21968</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RENAL CELL CARCINOMA STAGE UNSPECIFIED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060324</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060406</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUTENT</medicinalproduct>
        <drugauthorizationnumb>21968</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RENAL CELL CARCINOMA STAGE UNSPECIFIED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060407</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060411</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUTENT</medicinalproduct>
        <drugauthorizationnumb>21968</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RENAL CELL CARCINOMA STAGE UNSPECIFIED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060505</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CINNARIZINE (CINNARIZINE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENDROFLUAZIDE (BENDROFLUMETHIAZIDE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUOXETINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CO-CODAMOL (CODEINE PHOSPHATE, PARACETAMOL)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SERC</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053786-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060710</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006066805</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>31</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ABDOMINAL TENDERNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARRHYTHMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ATRIAL FIBRILLATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BALANCE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BODY TEMPERATURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISORIENTATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE RIGIDITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYDRIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ATARAX</medicinalproduct>
        <drugauthorizationnumb>10392</drugauthorizationnumb>
        <drugdosagetext>200 MG (1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060207</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060212</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHADONE HCL</medicinalproduct>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHADONE HCL</medicinalproduct>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060209</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060209</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHADONE HCL</medicinalproduct>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060210</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060210</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHADONE HCL</medicinalproduct>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060211</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060211</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHADONE HCL</medicinalproduct>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060207</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060212</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHADONE HCL</medicinalproduct>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060212</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060212</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLONAZEPAM</medicinalproduct>
        <drugdosagetext>6 MG (2 MG, 3 IN 1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060206</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060212</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BACTRIM</medicinalproduct>
        <drugdosagetext>2 DF (1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060210</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060212</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN W/ PROPOXYPHENE HCL</medicinalproduct>
        <drugdosagetext>6 DF (1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060210</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060211</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TERCIAN (CYAMEMAZINE)</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060206</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060212</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SMECTITE (SMECTITE)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053788-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060627</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>TR-AVENTIS-200617242GDDC</companynumb>
    <primarysource>
      <reportercountry>TURKEY</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>17</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>62</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DIABETIC KETOACIDOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INSULIN GLARGINE</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>21081</drugauthorizationnumb>
        <drugindication>DIABETES MELLITUS INSULIN-DEPENDENT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OPTIPEN (INSULIN PUMP)</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugindication>DIABETES MELLITUS INSULIN-DEPENDENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040617</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HUMALOG</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>DIABETES MELLITUS INSULIN-DEPENDENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20001208</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053789-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060627</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>TR-AVENTIS-200617245GDDC</companynumb>
    <primarysource>
      <reportercountry>TURKEY</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>22</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>69.1</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DIABETIC KETOACIDOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INSULIN GLARGINE</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021081</drugauthorizationnumb>
        <drugdosagetext>DOSE UNIT: UNITS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>DIABETES MELLITUS INSULIN-DEPENDENT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OPTIPEN (INSULIN PUMP)</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugindication>DIABETES MELLITUS INSULIN-DEPENDENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040405</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HUMALOG</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>DIABETES MELLITUS INSULIN-DEPENDENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20011004</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053790-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060526</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AVENTIS-200614842US</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLINDNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OBESITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021081</drugauthorizationnumb>
        <drugdosagetext>DOSE UNIT: UNITS</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OPTICLIK (INSULIN INJECTION PEN)</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021081</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HUMALOG</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugdosagetext>DOSE: AT MEALTIME</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053791-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060411</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-AVENTIS-200613973GDDC</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>75</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HYPOGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VIRAL INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>21081</drugauthorizationnumb>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053792-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060308</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>KR-AVENTIS-200612254GDDC</companynumb>
    <primarysource>
      <reportercountry>KOREA, REPUBLIC OF</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>72</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ATRIAL FIBRILLATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE FLUCTUATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRAIN DAMAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST X-RAY ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSKINESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EMBOLIC CEREBRAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOGLYCAEMIC COMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOGLYCAEMIC ENCEPHALOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA ASPIRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRODUCTIVE COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STUPOR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>21081</drugauthorizationnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060202</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021081</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060203</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060214</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021081</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060215</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HYDROCHLORIDE</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060202</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060305</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053793-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060328</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AVENTIS-200613098US</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEVICE MALFUNCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>KETOACIDOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>21081</drugauthorizationnumb>
        <drugdosagetext>DOSE: UNKNOWN</drugdosagetext>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OPTICLIK (INSULIN INJECTION PEN)</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021081</drugauthorizationnumb>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053794-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060501</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AVENTIS-200614062US</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>80</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>80.5</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLINDNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG DOSE OMISSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MACULAR DEGENERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEDICAL DEVICE COMPLICATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
        <drugbatchnumb>D011</drugbatchnumb>
        <drugauthorizationnumb>21081</drugauthorizationnumb>
        <drugdosagetext>DOSE: 15-19; DOSE UNIT: UNITS</drugdosagetext>
        <drugindication>DIABETES MELLITUS NON-INSULIN-DEPENDENT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OPTICLIK (INSULIN INJECTION PEN)</medicinalproduct>
        <drugbatchnumb>D040</drugbatchnumb>
        <drugauthorizationnumb>021081</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HUMALOG</medicinalproduct>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TEVETEN</medicinalproduct>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VASOTEC</medicinalproduct>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOPRESSOR</medicinalproduct>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM GLUCONATE</medicinalproduct>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EFFEXOR XR</medicinalproduct>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMBIEN</medicinalproduct>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COLACE</medicinalproduct>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLARITIN</medicinalproduct>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FORTEO                                  /USA/</medicinalproduct>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ULTRACET</medicinalproduct>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMDUR</medicinalproduct>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053795-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060423</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AVENTIS-200614125US</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANGINA PECTORIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREATMENT NONCOMPLIANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WRONG TECHNIQUE IN DRUG USAGE PROCESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021081</drugauthorizationnumb>
        <drugdosagetext>DOSE UNIT: UNITS</drugdosagetext>
        <drugindication>DIABETES MELLITUS NON-INSULIN-DEPENDENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060423</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OPTICLIK (INSULIN INJECTION PEN)</medicinalproduct>
        <drugbatchnumb>E060</drugbatchnumb>
        <drugauthorizationnumb>021081</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NOVOLOG</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SINGULAIR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XOPENEX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN DRUG</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053796-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060508</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHFR2006GB01650</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>71</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugauthorizationnumb>021223</drugauthorizationnumb>
        <drugdosagetext>MONTHLY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>METASTATIC PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060201</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053797-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006059137</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>47</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ALANINE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAMMA-GLUTAMYLTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATOCRIT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCREATIC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCREATITIS ACUTE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ATORVASTATIN CALCIUM</medicinalproduct>
        <drugauthorizationnumb>20702</drugauthorizationnumb>
        <drugdosagetext>10 MG (10 MG, 1 IN 1 D)</drugdosagetext>
        <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>5053798-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006069920</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>87</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>60.782</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABNORMAL DREAMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHROPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BALANCE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DROOLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSKINESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugauthorizationnumb>21446</drugauthorizationnumb>
        <drugdosagetext>75 MG, (75 MG, 1 IN 1 D),ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NEURALGIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060512</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060602</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CAFFEINE/CODEINE PHOSPHATE/PARACETAMOL (CAFFEINE, CODEINE PHOSPHATE, P</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYLENOL W/ CODEINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOPICLONE (ZOPICLONE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TELMISARTAN (TELMISARTAN)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COMBIVENT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANTOPRAZOLE SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INDAPAMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYMBICORT (BUDESONIDE, FORMOTEROL FUMARATE)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053799-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006073167</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>60</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INTERSTITIAL LUNG DISEASE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EPIRUBICIN</medicinalproduct>
        <drugauthorizationnumb>50778</drugauthorizationnumb>
        <drugdosagetext>60 MG/M*2, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060118</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060308</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUOROURACIL</medicinalproduct>
        <drugdosagetext>500 MG/M*2, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060118</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060308</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOPHOSPHAMIDE</medicinalproduct>
        <drugdosagetext>500 MG/M*2, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060118</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060308</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DRUG (DRUG)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053800-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050503</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0558196A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>19</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANGER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CRYING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG WITHDRAWAL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EMOTIONAL DISTRESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IRRITABILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOOD SWINGS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANIC ATTACK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SMOKER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
        <drugauthorizationnumb>20031</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20001001</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053801-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050509</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0558614A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>32</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG WITHDRAWAL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHYSICAL DISABILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISION BLURRED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
        <drugauthorizationnumb>20031</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OBSESSIVE-COMPULSIVE DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000131</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELEXA</medicinalproduct>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20000131</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WELLBUTRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KLONOPIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053802-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050714</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0566542A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>26</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPENDENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG WITHDRAWAL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOOD SWINGS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NERVOUSNESS</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>
        <drugauthorizationnumb>20031</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20011001</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053803-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20051014</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0579229A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>12</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABNORMAL BEHAVIOUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AGGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EMOTIONAL DISTRESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
        <drugauthorizationnumb>20031</drugauthorizationnumb>
        <drugdosagetext>20MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020308</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020829</drugenddate>
        <drugtreatmentduration>175</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATIVAN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053804-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060131</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0591941A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL MUCOSAL BLISTERING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPLENECTOMY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDE ATTEMPT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMICTAL</medicinalproduct>
        <drugbatchnumb>UNAVAILABLE</drugbatchnumb>
        <drugauthorizationnumb>20241</drugauthorizationnumb>
        <drugdosagetext>50MG UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BIPOLAR DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050101</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>WELLBUTRIN</medicinalproduct>
        <drugauthorizationnumb>020358</drugauthorizationnumb>
        <drugdosagetext>150MG THREE TIMES PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RITALIN</medicinalproduct>
        <drugdosagetext>20MG THREE TIMES PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATTENTION DEFICIT/HYPERACTIVITY DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KLONOPIN</medicinalproduct>
        <drugdosagetext>1MG THREE TIMES PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPRAM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRILOSEC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GEODON</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053805-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060302</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0596359A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>AFFECTIVE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AGGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENTAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESTLESSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
        <drugauthorizationnumb>20031</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053806-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060325</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0599987A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ADVAIR DISKUS 100/50</medicinalproduct>
        <drugauthorizationnumb>21077</drugauthorizationnumb>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
        <drugtreatmentduration>9</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL SPIROS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053807-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060328</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>S2006US02300</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>34</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>97.7</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HELLP SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANIC ATTACK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRE-ECLAMPSIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACYCLOVIR</medicinalproduct>
        <drugauthorizationnumb>18603</drugauthorizationnumb>
        <drugdosagetext>400MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANTIVIRAL PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060222</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060320</drugenddate>
        <drugtreatmentduration>27</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
        <drugauthorizationnumb>020031</drugauthorizationnumb>
        <drugdosagetext>10MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
        <drugindication>HYPOTHYROIDISM</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONAZEPAM</medicinalproduct>
        <drugdosagetext>.5MG THREE TIMES PER DAY</drugdosagetext>
        <drugindication>PANIC ATTACK</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051219</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051222</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FAMCICLOVIR</medicinalproduct>
        <drugdosagetext>250MG TWICE PER DAY</drugdosagetext>
        <drugindication>ANTIVIRAL PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060208</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060222</drugenddate>
        <drugtreatmentduration>15</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTIVITAMIN W/OUT IRON</medicinalproduct>
        <drugdosagetext>1TAB PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CHINESE HERBS</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HERBAL TEA</medicinalproduct>
        <drugdosagetext>2CUP PER DAY</drugdosagetext>
        <drugindication>PREGNANCY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050601</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053808-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060512</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>S2006US02300</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>3.4</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACYCLOVIR</medicinalproduct>
        <drugauthorizationnumb>18603</drugauthorizationnumb>
        <drugdosagetext>400MG TWICE PER DAY</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060222</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060320</drugenddate>
        <drugtreatmentduration>27</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
        <drugauthorizationnumb>020031</drugauthorizationnumb>
        <drugdosagetext>10MG PER DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONAZEPAM</medicinalproduct>
        <drugdosagetext>.5MG THREE TIMES PER DAY</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051219</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051222</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FAMCICLOVIR</medicinalproduct>
        <drugdosagetext>250MG TWICE PER DAY</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060208</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060222</drugenddate>
        <drugtreatmentduration>15</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTIVITAMIN W/OUT IRON</medicinalproduct>
        <drugdosagetext>1TAB PER DAY</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CHINESE HERBS</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HERBAL TEA</medicinalproduct>
        <drugdosagetext>2CUP PER DAY</drugdosagetext>
        <drugindication>PREGNANCY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050601</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053809-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesscongenitalanomali>1</seriousnesscongenitalanomali>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060331</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0600379A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>33</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ALPHA 1 FOETOPROTEIN ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRIZIVIR</medicinalproduct>
        <drugauthorizationnumb>021205</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060228</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053810-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060425</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0603622A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>11</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>50</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABNORMAL BEHAVIOUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AGGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AMNESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANGER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CRYING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IRRITABILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ADVAIR DISKUS 100/50</medicinalproduct>
        <drugauthorizationnumb>21077</drugauthorizationnumb>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050912</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060101</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053811-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060428</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0603644A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>30</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMICTAL</medicinalproduct>
        <drugauthorizationnumb>20241</drugauthorizationnumb>
        <drugdosagetext>25MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BIPOLAR DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060401</drugenddate>
        <drugtreatmentduration>10</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GEODON</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BIPOLAR DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060401</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053812-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060609</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-GLAXOSMITHKLINE-A0608528A</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>80</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>63.5</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE CONGESTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DECREASED APPETITE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA EXERTIONAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUID OVERLOAD</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOBAR PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLEURAL EFFUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE CHRONIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UPPER GASTROINTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>21071</drugauthorizationnumb>
        <drugdosagetext>4MG PER DAY</drugdosagetext>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060606</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugdosagetext>20MG PER DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADALAT</medicinalproduct>
        <drugdosagetext>60MG PER DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FERROUS GLUCONATE</medicinalproduct>
        <drugdosagetext>900MG PER DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN MEDICATION</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053813-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060612</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AR-GLAXOSMITHKLINE-A0609048A</companynumb>
    <primarysource>
      <reportercountry>ARGENTINA</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>56</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HYPERTHERMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH ERYTHEMATOUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMICTAL</medicinalproduct>
        <drugauthorizationnumb>20241</drugauthorizationnumb>
        <drugdosagetext>100MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BIPOLAR DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060330</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060423</drugenddate>
        <drugtreatmentduration>25</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PENICILLIN</medicinalproduct>
        <drugauthorizationnumb>062273</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060415</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053814-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060630</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0611013A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>13</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>30</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ATRIOVENTRICULAR BLOCK FIRST DEGREE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ELECTROCARDIOGRAM PR PROLONGATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMICTAL</medicinalproduct>
        <drugauthorizationnumb>20241</drugauthorizationnumb>
        <drugdosagetext>450MG PER DAY</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053815-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060627</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0611135A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>71.4</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABNORMAL DREAMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</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>DRUG WITHDRAWAL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERACUSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MANIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OBSESSIVE-COMPULSIVE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHOTOSENSITIVITY REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SLEEP DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
        <drugauthorizationnumb>20031</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANXIETY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
        <drugindication>PANIC DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INDERAL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FIORICET</medicinalproduct>
        <drugindication>HEADACHE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPAMAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BUSPAR</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053816-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060712</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006A200151</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>9</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD BILIRUBIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JAUNDICE NEONATAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZIDOVUDINE</medicinalproduct>
        <drugauthorizationnumb>19910</drugauthorizationnumb>
        <drugdosagetext>8MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS AGAINST HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060619</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEVIRAPINE</medicinalproduct>
        <drugdosagetext>8MG AS DIRECTED</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS AGAINST HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060619</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060625</drugenddate>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053817-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060713</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0612175A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>75</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NIGHT SWEATS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH MACULAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN ATROPHY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMICTAL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020241</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BIPOLAR DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KLONOPIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DILTIAZEM HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RANITIDINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN B-12</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053818-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060714</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0612330A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HALLUCINATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OBSESSIVE-COMPULSIVE DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REQUIP</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020658</drugauthorizationnumb>
        <drugdosagetext>1MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RESTLESS LEGS SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050701</drugstartdate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NO CONCURRENT MEDICATION</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053819-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060711</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-GLAXOSMITHKLINE-A0612355A</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>2</patientonsetage>
      <patientonsetageunit>802</patientonsetageunit>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEDICATION ERROR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSYCHOMOTOR HYPERACTIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIGOXIN</medicinalproduct>
        <drugbatchnumb>B00659</drugbatchnumb>
        <drugauthorizationnumb>021755</drugauthorizationnumb>
        <drugdosagetext>.3ML THREE TIMES PER DAY</drugdosagetext>
        <drugindication>HEART DISEASE CONGENITAL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060210</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060215</drugenddate>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNSPECIFIED MEDICATION</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053820-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060713</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0612361A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>20</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>COMPLETED SUICIDE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMICTAL</medicinalproduct>
        <drugauthorizationnumb>020241</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BIPOLAR DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053821-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060713</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0612369A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANGER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL SELF-INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JOB DISSATISFACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LACERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERSONALITY CHANGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>WELLBUTRIN</medicinalproduct>
        <drugauthorizationnumb>020358</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SMOKING CESSATION THERAPY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053822-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060711</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0612384A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>NOCTURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY RETENTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVODART</medicinalproduct>
        <drugauthorizationnumb>021319</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROSTATE EXAMINATION ABNORMAL</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053823-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060713</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BPC-SR-06-060</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>OVERDOSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>WELLBUTRIN SR</medicinalproduct>
        <drugauthorizationnumb>020358</drugauthorizationnumb>
        <drugdosagetext>150MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053824-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060714</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-GLAXOSMITHKLINE-A0612530A</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>18</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDE ATTEMPT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AEROLIN</medicinalproduct>
        <drugauthorizationnumb>18473</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>SUICIDE ATTEMPT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060714</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060714</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMOXICILLIN</medicinalproduct>
        <drugauthorizationnumb>050754</drugauthorizationnumb>
        <drugdosagetext>10TAB SINGLE DOSE</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>SUICIDE ATTEMPT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060714</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060714</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053825-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060428</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-GLAXOSMITHKLINE-B0421887A</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>74</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>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>JAUNDICE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>21071</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERIDONE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053826-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060510</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-JPN-A200601506</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>81</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>73</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DYSLALIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMODIALYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULAR WEAKNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OLIGURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL INTAKE REDUCED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VALTREX</medicinalproduct>
        <drugauthorizationnumb>20487</drugauthorizationnumb>
        <drugdosagetext>1000MG THREE TIMES PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HERPES ZOSTER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060506</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060510</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LOXONIN</medicinalproduct>
        <drugdosagetext>60MG THREE TIMES PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HERPES ZOSTER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060506</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060510</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MUCOSTA</medicinalproduct>
        <drugdosagetext>300MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060506</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060510</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </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>MICARDIS</medicinalproduct>
        <drugdosagetext>40MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EPADEL</medicinalproduct>
        <drugdosagetext>900MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERLIPIDAEMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>URINORM</medicinalproduct>
        <drugdosagetext>25MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERURICAEMIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053827-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060511</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006JP001295</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>61</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANAPHYLACTIC REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AURICULAR SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OXYGEN SATURATION DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH ERYTHEMATOUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CEFAZOLIN</medicinalproduct>
        <drugdosagetext>1G PER DAY</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIDAZOLAM HCL</medicinalproduct>
        <drugdosagetext>2MG PER DAY</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FENTANYL CITRATE</medicinalproduct>
        <drugdosagetext>100MCG PER DAY</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROPOFOL</medicinalproduct>
        <drugdosagetext>150MG PER DAY</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ROCURONIUM BROMIDE</medicinalproduct>
        <drugdosagetext>50MG PER DAY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053828-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060511</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-GLAXOSMITHKLINE-B0423998A</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>7</patientonsetage>
      <patientonsetageunit>804</patientonsetageunit>
      <patientweight>4.2</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CHOLESTASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONJUNCTIVAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CYTOLYTIC HEPATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSED LEVEL OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERAL PHYSICAL HEALTH DETERIORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATITIS FULMINANT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HERPES VIRUS INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYLORIC STENOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOVIRAX</medicinalproduct>
        <drugauthorizationnumb>18603</drugauthorizationnumb>
        <drugdosagetext>20MGK THREE TIMES PER DAY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060405</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060512</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTIBIOTICS (UNSPECIFIED)</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060404</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053829-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060519</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-GLAXOSMITHKLINE-B0424730A</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>41</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIAC ARREST</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOPHREN</medicinalproduct>
        <drugauthorizationnumb>20103</drugauthorizationnumb>
        <drugdosagetext>16MG CYCLIC</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060418</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GRANOCYTE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VOGALENE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOCLOPRAMIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CHEMOTHERAPY</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DURAGESIC-100</medicinalproduct>
        <drugdosagetext>50UGH SEE DOSAGE TEXT</drugdosagetext>
        <drugadministrationroute>062</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CONTRAMAL</medicinalproduct>
        <drugdosagetext>150MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OLICLINOMEL</medicinalproduct>
        <drugdosagetext>1INJ PER DAY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053830-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060615</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-JPN-A200602067</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>73</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>COMPLETED SUICIDE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
        <drugauthorizationnumb>20031</drugauthorizationnumb>
        <drugdosagetext>20MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051229</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060401</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053831-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060615</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BE-GLAXOSMITHKLINE-B0428322A</companynumb>
    <primarysource>
      <reportercountry>BELGIUM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>48</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>73.2</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANAPHYLACTIC REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLD SWEAT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AUGMENTIN '125'</medicinalproduct>
        <drugauthorizationnumb>050564</drugauthorizationnumb>
        <drugdosagetext>2G THREE TIMES PER DAY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>LIVER ABSCESS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060310</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060310</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOPHAGE</medicinalproduct>
        <drugdosagetext>500MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIAMICRON</medicinalproduct>
        <drugdosagetext>30MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORMETAZEPAM</medicinalproduct>
        <drugdosagetext>1MG THREE TIMES PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CACIT VITAMINE D3</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTABUSE</medicinalproduct>
        <drugdosagetext>400UG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ALCOHOLISM</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060401</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053832-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060623</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-JPN-A200602249</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>82</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DELIRIUM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSED LEVEL OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MANIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VALTREX</medicinalproduct>
        <drugauthorizationnumb>20487</drugauthorizationnumb>
        <drugdosagetext>1000MG THREE TIMES PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HERPES ZOSTER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060617</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060622</drugenddate>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SG</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053833-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesscongenitalanomali>1</seriousnesscongenitalanomali>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060630</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-JPN-A200602391</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>37</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>68</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANIC ATTACK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STILLBIRTH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
        <drugauthorizationnumb>20031</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PANIC DISORDER</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060404</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RIZE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PANIC DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060410</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SEPAZON</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PANIC DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051125</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HANGE-KOBOKU-TO</medicinalproduct>
        <drugdosagetext>7.5G PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PANIC DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060206</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060401</drugenddate>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053834-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060703</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-JPN-A200602471</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CORNEAL EPITHELIUM DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IRIS DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOVIRAX</medicinalproduct>
        <drugauthorizationnumb>18603</drugauthorizationnumb>
        <drugadministrationroute>047</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060630</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060703</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VALTREX</medicinalproduct>
        <drugauthorizationnumb>020487</drugauthorizationnumb>
        <drugdosagetext>500MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053835-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060710</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-GLAXOSMITHKLINE-B0430527A</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>58</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUFFOCATION FEELING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZANTAC</medicinalproduct>
        <drugauthorizationnumb>19090</drugauthorizationnumb>
        <drugdosagetext>50MG SINGLE DOSE</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060420</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060420</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOPHREN</medicinalproduct>
        <drugauthorizationnumb>020103</drugauthorizationnumb>
        <drugdosagetext>8MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060420</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060420</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>POLARAMINE</medicinalproduct>
        <drugdosagetext>5MG SINGLE DOSE</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060420</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060420</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAXOL</medicinalproduct>
        <drugdosagetext>175MG SINGLE DOSE</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060420</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060420</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARBOPLATIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060420</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060420</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053836-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060711</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-GLAXOSMITHKLINE-B0430564A</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>60</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>EYELID OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERALISED ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URTICARIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZINNAT 250 MG</medicinalproduct>
        <drugauthorizationnumb>50605</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051222</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051225</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053837-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060710</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>13397815</companynumb>
    <primarysource>
      <reportercountry>SOUTH AFRICA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>11</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD BILIRUBIN UNCONJUGATED INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ELECTROCARDIOGRAM QT CORRECTED INTERVAL PROLONGED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERBILIRUBINAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMIVUDINE</medicinalproduct>
        <drugauthorizationnumb>20564</drugauthorizationnumb>
        <drugdosagetext>11ML TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060503</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ATAZANAVIR</medicinalproduct>
        <drugdosagetext>200MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060503</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>STAVUDINE</medicinalproduct>
        <drugdosagetext>50MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060503</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RITONAVIR</medicinalproduct>
        <drugdosagetext>100MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060503</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BACTRIM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTIVITAMIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053838-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060712</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-GLAXOSMITHKLINE-B0430778A</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HALLUCINATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SLEEP DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMBIVIR</medicinalproduct>
        <drugauthorizationnumb>020857</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053839-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060711</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-GLAXOSMITHKLINE-B0430950A</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>68</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARVEDILOL</medicinalproduct>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>1.25MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CARDIAC FAILURE CHRONIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041206</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050129</drugenddate>
        <drugtreatmentduration>55</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041122</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050129</drugenddate>
        <drugtreatmentduration>69</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANALDINE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041122</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050129</drugenddate>
        <drugtreatmentduration>69</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIGMART</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041122</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050129</drugenddate>
        <drugtreatmentduration>69</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEVALOTIN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041122</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050129</drugenddate>
        <drugtreatmentduration>69</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAGAMET</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACARDI</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041122</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050129</drugenddate>
        <drugtreatmentduration>69</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALDACTONE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041122</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050129</drugenddate>
        <drugtreatmentduration>69</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041122</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050129</drugenddate>
        <drugtreatmentduration>69</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BASEN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041122</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050129</drugenddate>
        <drugtreatmentduration>69</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMARYL</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041122</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050129</drugenddate>
        <drugtreatmentduration>69</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053840-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060711</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-JPN-A200602570</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>COMPLETED SUICIDE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
        <drugauthorizationnumb>020031</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053841-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060711</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-JPN-A200602576</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>57</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>LIVER DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VALTREX</medicinalproduct>
        <drugauthorizationnumb>020487</drugauthorizationnumb>
        <drugdosagetext>1000MG THREE TIMES PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HERPES ZOSTER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060531</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060606</drugenddate>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOXONIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MUCOSTA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053842-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060711</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-JPN-A200602589</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>31</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLOLAN</medicinalproduct>
        <drugauthorizationnumb>020444</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>EISENMENGER'S SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050905</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRONOLACTONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRACLEER</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051007</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053843-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060712</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-JPN-A200602605</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>69</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>40</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ENCEPHALOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TUBULOINTERSTITIAL NEPHRITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOVIRAX</medicinalproduct>
        <drugauthorizationnumb>018603</drugauthorizationnumb>
        <drugdosagetext>200MG PER DAY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>HERPES ZOSTER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060628</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060704</drugenddate>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN DRUG</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALFAROL</medicinalproduct>
        <drugdosagetext>.25MCG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN DRUG</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIN</medicinalproduct>
        <drugdosagetext>5MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
        <drugdosagetext>80MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053844-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060712</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-JPN-A200602606</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>92</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <reaction>
        <reactionmeddrapt>RENAL DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VALTREX</medicinalproduct>
        <drugauthorizationnumb>020487</drugauthorizationnumb>
        <drugdosagetext>1000MG THREE TIMES PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HERPES ZOSTER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053845-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060712</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-JPN-A200602609</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>38</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>TOXIC INDUCED ENCEPHALOPATHY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VALTREX</medicinalproduct>
        <drugauthorizationnumb>020487</drugauthorizationnumb>
        <drugdosagetext>1000MG THREE TIMES PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HERPES ZOSTER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060707</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060709</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053846-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060713</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-JPN-A200602623</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>25</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>IMPULSIVE BEHAVIOUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INAPPROPRIATE SCHEDULE OF DRUG ADMINISTRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IRRITABILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
        <drugauthorizationnumb>020031</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060525</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEILAX</medicinalproduct>
        <drugdosagetext>1MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060525</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060602</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOLEDOMIN</medicinalproduct>
        <drugdosagetext>.25MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060525</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060602</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORAZEPAM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060525</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060602</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORAZEPAM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060620</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060626</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORAZEPAM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060627</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060711</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RHYTHMY</medicinalproduct>
        <drugdosagetext>2MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060603</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060612</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RHYTHMY</medicinalproduct>
        <drugdosagetext>2MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060710</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DESYREL</medicinalproduct>
        <drugdosagetext>25MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060603</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060612</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEPAS</medicinalproduct>
        <drugdosagetext>.5MG THREE TIMES PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060603</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060612</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEPAS</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060603</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060619</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEPAS</medicinalproduct>
        <drugdosagetext>.5MG THREE TIMES PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060620</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060626</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOGMATYL</medicinalproduct>
        <drugdosagetext>50MG THREE TIMES PER DAY</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060603</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060612</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HOCHU-EKKI-TO</medicinalproduct>
        <drugdosagetext>2.5G THREE TIMES PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060603</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060619</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMOBAN</medicinalproduct>
        <drugdosagetext>7.5MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060613</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CERCINE</medicinalproduct>
        <drugdosagetext>2MG PER DAY</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060613</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060619</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CERCINE</medicinalproduct>
        <drugdosagetext>2MG PER DAY</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060710</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060711</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LULLAN</medicinalproduct>
        <drugdosagetext>4MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060627</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060711</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053847-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060713</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ZA-GLAXOSMITHKLINE-B0431041A</companynumb>
    <primarysource>
      <reportercountry>SOUTH AFRICA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>WELLBUTRIN</medicinalproduct>
        <drugauthorizationnumb>018644</drugauthorizationnumb>
        <drugindication>DEPRESSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053848-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060713</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ZA-GLAXOSMITHKLINE-B0431045A</companynumb>
    <primarysource>
      <reportercountry>SOUTH AFRICA</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>LOCAL SWELLING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYBAN</medicinalproduct>
        <drugauthorizationnumb>018644</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060709</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053849-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060711</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>453719</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>67</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLEURAL EFFUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARVEDILOL</medicinalproduct>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>1.25MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030716</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030922</drugenddate>
        <drugtreatmentduration>69</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FRANDOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MICARDIS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIART</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053850-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060712</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>453722</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>57</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARVEDILOL</medicinalproduct>
        <drugauthorizationnumb>20297</drugauthorizationnumb>
        <drugdosagetext>1.25MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONGESTIVE CARDIOMYOPATHY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040117</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040401</drugenddate>
        <drugtreatmentduration>76</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031208</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031208</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIART</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031208</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACARDI</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031208</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GASTER D</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031208</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053851-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060713</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>454695</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>82</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PLEURAL EFFUSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARVEDILOL</medicinalproduct>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>1.25MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MYOCARDIAL INFARCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041217</drugstartdate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041206</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MICARDIS</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041206</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053852-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060713</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>454524</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>82</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARVEDILOL</medicinalproduct>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>1.25MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040127</drugstartdate>
        <drugtreatmentduration>154</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TEMOCAPRIL HYDROCHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GASTER D</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACARDI</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053853-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060713</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>453788</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>65</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CEREBRAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIPLOPIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARVEDILOL</medicinalproduct>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>2.5MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031017</drugstartdate>
        <drugtreatmentduration>19</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030917</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALDACTONE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030917</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BLOPRESS</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030917</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030917</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SALOBEL</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031020</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053854-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060711</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CH-GLAXOSMITHKLINE-B0431394A</companynumb>
    <primarysource>
      <reportercountry>SWITZERLAND</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>53</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MENORRHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POSTMENOPAUSAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDAMET</medicinalproduct>
        <drugauthorizationnumb>021410</drugauthorizationnumb>
        <drugdosagetext>1TAB PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KLIOGEST</medicinalproduct>
        <drugdosagetext>1TAB PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugtreatmentduration>10</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENALAPRIL MALEATE</medicinalproduct>
        <drugdosagetext>20MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053855-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20031006</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>142712</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>52</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>87</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL ADHESIONS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>C-REACTIVE PROTEIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MESENTERIC ARTERY STENOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MIGRAINE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMIGRAN NASAL SPRAY</medicinalproduct>
        <drugauthorizationnumb>20626</drugauthorizationnumb>
        <drugdosagetext>1UNIT SINGLE DOSE</drugdosagetext>
        <drugadministrationroute>045</drugadministrationroute>
        <drugindication>MIGRAINE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030924</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ASCO TOP</medicinalproduct>
        <drugdosagetext>2.5MG UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>MIGRAINE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030924</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugdosagetext>50MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030921</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030929</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOLMITRIPTAN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>MIGRAINE</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030901</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPASMO CIBALGIN SUPP</medicinalproduct>
        <drugdosagetext>1SUP SINGLE DOSE</drugdosagetext>
        <drugadministrationroute>054</drugadministrationroute>
        <drugindication>MIGRAINE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030924</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030923</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROPRANOLOL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>MIGRAINE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030701</drugstartdate>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053856-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060710</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>142825</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>APNOEIC ATTACK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SLEEP APNOEA SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SNORING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAROXETINE HYDROCHLORIDE</medicinalproduct>
        <drugauthorizationnumb>020031</drugauthorizationnumb>
        <drugdosagetext>20MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MAJOR DEPRESSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053857-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060717</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-GLAXOSMITHKLINE-D0050346A</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEDICATION ERROR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARIXTRA</medicinalproduct>
        <drugauthorizationnumb>021345</drugauthorizationnumb>
        <drugdosagetext>2.5MG UNKNOWN</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>KNEE OPERATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053858-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060622</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DK200604004657</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>10</patientonsetage>
      <patientonsetageunit>805</patientonsetageunit>
      <patientweight>3</patientweight>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>CARDIOPULMONARY FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STREPTOCOCCAL INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUOXETINE HCL</medicinalproduct>
        <drugauthorizationnumb>18936</drugauthorizationnumb>
        <drugdosagetext>20 MG, DAILY (1/D), TRANSPLACENTAL</drugdosagetext>
        <drugadministrationroute>064</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050915</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060529</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRANDATE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053860-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006068395</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>83</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HAEMOPTYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY ALVEOLAR HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ESTRAMUSTINE PHOSPHATE SODIUM</medicinalproduct>
        <drugauthorizationnumb>18045</drugauthorizationnumb>
        <drugdosagetext>280 MG, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROSTATE CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051125</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060512</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BENEXATE HYDROCHLORIDE                    (BENEXATE HYDROCHLORIDE)</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTRIC ULCER</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060512</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAROXETINE HCL</medicinalproduct>
        <drugdosagetext>20 MG, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060512</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRIMEBUTINE MALEATE            (TRIMEBUTINE MALEATE)</medicinalproduct>
        <drugdosagetext>300 MG, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTRITIS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060512</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>100 MG, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANGINA PECTORIS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060512</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DILTIAZEM HYDROCHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ISOSORIDE DINITRATE (ISOSORIDE DINITRATE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NICORANDIL (NICORANDIL)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NITROGLYCERIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053862-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006078761</companynumb>
    <primarysource>
      <reportercountry>SWITZERLAND</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>61</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugauthorizationnumb>21446</drugauthorizationnumb>
        <drugdosagetext>150 MG (75 MG, 2 IN  1 D),ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NEURALGIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060313</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAMBOCOR</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053863-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060707</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2006KR10221</companynumb>
    <primarysource>
      <reportercountry>KOREA, REPUBLIC OF</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>43</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BIOPSY BREAST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BREAST CANCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BREAST MASS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MASTECTOMY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GLEEVEC</medicinalproduct>
        <drugauthorizationnumb>021588</drugauthorizationnumb>
        <drugdosagetext>400 MG/D</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CHRONIC MYELOID LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020815</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053865-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060623</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU200606000916</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ALPHA-1 ANTI-TRYPSIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD TRIGLYCERIDES INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARBOHYDRATE ANTIGEN 15-3 INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARBOHYDRATE ANTIGEN 19-9 INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHOLELITHIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIPASE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUOXETINE</medicinalproduct>
        <drugauthorizationnumb>18936</drugauthorizationnumb>
        <drugdosagetext>30 MG, DAILY (1/D)</drugdosagetext>
        <drugindication>POST-TRAUMATIC STRESS DISORDER</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060603</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053868-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060630</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006078706</companynumb>
    <primarysource>
      <reportercountry>FINLAND</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>53</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARYNGEAL OEDEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugauthorizationnumb>21446</drugauthorizationnumb>
        <drugdosagetext>225 MG (85 MG, 3 IN 1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>POLYNEUROPATHY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060601</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053870-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060622</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>EWC980400286</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>39</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>55</patientweight>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>AGITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG DEPENDENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE DRUG OVERDOSE INTENTIONAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDE ATTEMPT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THERAPY NON-RESPONDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROZAC</medicinalproduct>
        <drugauthorizationnumb>18936</drugauthorizationnumb>
        <drugdosagetext>20 MG, DAILY (1/D), ORAL; SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19970101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19970619</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROZAC</medicinalproduct>
        <drugauthorizationnumb>18936</drugauthorizationnumb>
        <drugdosagetext>20 MG, DAILY (1/D), ORAL; SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19970609</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19970619</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONAZEPAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIPIPERON (PIPAMPERONE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALPROATE SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEPRONIZINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THERALENE (ALIMEMAZINE TARTRATE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PHENERGAN (PROMETHAZINE HYDROCHLORIDE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANAFRANIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMITRIPTYLINE HCL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053871-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060705</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006077310</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>57</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD BILIRUBIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE SYSTOLIC INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ELECTROCARDIOGRAM Q WAVE ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOKALAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREATMENT NONCOMPLIANCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugauthorizationnumb>20702</drugauthorizationnumb>
        <drugdosagetext>10 MG, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060604</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>JUVELA (TOCOPHEROL)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTIHYPERTENSIVES (ANTIHYPERTENSIVES)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053872-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060706</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHNU2006DE02466</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>APHTHOUS STOMATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATITIS C</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GLEEVEC</medicinalproduct>
        <drugauthorizationnumb>021588</drugauthorizationnumb>
        <drugdosagetext>ALTERNATING BETWEEN 200 TO 300 MG/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040901</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CHOLESTEROL- AND TRIGLYCERIDE REDUCERS</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053873-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060707</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-454537</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <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>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>018662</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ACNE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053874-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060706</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-454541</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DISEASE RECURRENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NO ADVERSE EFFECT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NORMAL NEWBORN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROCTITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RECTAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>018662</drugauthorizationnumb>
        <drugindication>ACNE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19870615</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>018662</drugauthorizationnumb>
        <drugdosagetext>BEGIN OF ISOTRETINOIN 40 MG PER DAY, AND THEN ADD 40 MG MORE EVERY OTHER DAY.</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19940713</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19940823</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>018662</drugauthorizationnumb>
        <drugdosagetext>INCREASE TO 40 MG BID ON 24 AUGUST 1994. ON 28 NOVEMBER 1994 STILL ONGOING WITH SAME DOSING REGIMEN.</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19940824</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19950615</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>018662</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20000215</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>018662</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000217</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20000615</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053875-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060301</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-438831</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>24</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>63.5</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL DISTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ADENOMYOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>APHTHOUS STOMATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ATROPHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CHOLESTEROL INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD TRIGLYCERIDES INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRADYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BREAST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRONCHITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BURSITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC MURMUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC VALVE DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CERVICAL CYST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CERVICITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHANGE OF BOWEL HABIT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHRONIC FATIGUE SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CLOSTRIDIUM DIFFICILE COLITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLITIS ULCERATIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLON ADENOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLONIC POLYP</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CROHN'S DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA HAEMORRHAGIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSGEUSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSMENORRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPEPSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPHONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ENDOMETRIOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ESSENTIAL HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FACIAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FIBROMYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLATULENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROENTERITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROOESOPHAGEAL REFLUX DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATOCHEZIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC ENZYME INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HERPES SIMPLEX</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HODGKIN'S DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYSTERECTOMY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFERTILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLAMMATORY BOWEL DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTESTINAL OBSTRUCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LACERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LARGE INTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIBIDO DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOW DENSITY LIPOPROTEIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENSTRUATION IRREGULAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MIGRAINE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MITRAL VALVE INCOMPETENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MITRAL VALVE PROLAPSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUCOUS STOOLS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE TIGHTNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL ISCHAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NASAL SEPTUM DEVIATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEOPLASM MALIGNANT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NIGHT BLINDNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NON-HODGKIN'S LYMPHOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCREATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANIC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAKERATOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARYNGOLARYNGEAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PITTING OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POLLAKIURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROCTALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSYCHOMOTOR HYPERACTIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY VALVE INCOMPETENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULSE PRESSURE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RECTAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SALIVARY GLAND MASS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SALPINGO-OOPHORECTOMY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SCAB</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUS DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUSITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SLEEP APNOEA SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STOMATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STRESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWELLING FACE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE VASOVAGAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYSTEMIC LUPUS ERYTHEMATOSUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOTAL CHOLESTEROL/HDL RATIO INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRANSIENT ISCHAEMIC ATTACK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRICUSPID VALVE INCOMPETENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UTERINE CERVICAL SQUAMOUS METAPLASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENTRICULAR EXTRASYSTOLES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISION BLURRED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VULVOVAGINAL DRYNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>18662</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ACNE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19830615</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19830615</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>018662</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19840813</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>018662</drugauthorizationnumb>
        <drugdosagetext>ACCUTANE DECREASED TO 1 DAILY OR ONE ONCE DAILY OR ONE TWICE WEEKLY.</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19850114</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19850314</drugenddate>
        <drugtreatmentduration>60</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>018662</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19870115</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19870615</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>1 CONCOMITANT DRUG</medicinalproduct>
        <drugdosagetext>DRUG REPORTED AS ASPIRIN/TYLENOL.</drugdosagetext>
        <drugindication>HEADACHE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053876-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060707</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20060702215</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>76.2</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERVERTEBRAL DISC PROTRUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THERAPEUTIC RESPONSE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTH FRACTURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DURAGESIC-100</medicinalproduct>
        <drugbatchnumb>0541854</drugbatchnumb>
        <drugadministrationroute>062</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DURAGESIC-100</medicinalproduct>
        <drugbatchnumb>0541854</drugbatchnumb>
        <drugauthorizationnumb>019813</drugauthorizationnumb>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TIZANIDINE HCL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MUSCLE RELAXANT THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACIPHEX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTRIC DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PEROAZEPAM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INSOMNIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIDOCAINE</medicinalproduct>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>PAIN MANAGEMENT</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053877-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060707</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20060702448</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>86.18</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BIPOLAR DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEPHROLITHIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FENTANYL TRANSDERMAL SYSTEM</medicinalproduct>
        <drugauthorizationnumb>019813</drugauthorizationnumb>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>PAIN</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053878-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060711</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20060702747</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>54.43</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DECREASED APPETITE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPEPSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DURAGESIC-100</medicinalproduct>
        <drugauthorizationnumb>019813</drugauthorizationnumb>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053879-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060710</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20060702754</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CROHN'S DISEASE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FENTANYL TRANSDERMAL SYSTEM</medicinalproduct>
        <drugauthorizationnumb>019813</drugauthorizationnumb>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CROHN'S DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIURETIC THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTRIC DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053880-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060710</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20060702755</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>56.7</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>APPLICATION SITE PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>APPLICATION SITE SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>APPLICATION SITE VESICLES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC NEOPLASM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOWER GASTROINTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FENTANYL TRANSDERMAL SYSTEM</medicinalproduct>
        <drugauthorizationnumb>019813</drugauthorizationnumb>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PERCODAN</medicinalproduct>
        <drugdosagetext>7.5 MG, 1 EVERY 6 TO 8 HOURS, AS NEEDED, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPROL-XL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMIODARONE HCL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053881-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060623</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE200606003709</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>60</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC ENZYME ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FUNCTION TEST ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>30 MG, DAILY (1/D), ORAL; SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060501</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>30 MG, DAILY (1/D), ORAL; SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060523</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>STANGYL/GFR/ (TRIMIPRAMINE MALEATE)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053882-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060630</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006080183</companynumb>
    <primarysource>
      <reportercountry>IRELAND</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>65</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>EPISTAXIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugauthorizationnumb>21446</drugauthorizationnumb>
        <drugdosagetext>100 MG (50 MG, 2 IN 1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NEURALGIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053883-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060622</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR200601005294</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>39</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>COMPLETED SUICIDE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG DEPENDENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE DRUG OVERDOSE INTENTIONAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROZAC</medicinalproduct>
        <drugauthorizationnumb>18936</drugauthorizationnumb>
        <drugdosagetext>20 MG, DAILY (1/D), ORAL; SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19970101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROZAC</medicinalproduct>
        <drugauthorizationnumb>18936</drugauthorizationnumb>
        <drugdosagetext>20 MG, DAILY (1/D), ORAL; SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19970101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PIPAMPERONE (PIPAMPERONE)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053884-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060626</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DK200606002971</companynumb>
    <primarysource>
      <reportercountry>DENMARK</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>56</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>112</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>PULMONARY OEDEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEMETREXED (PEMETREXED) VIAL</medicinalproduct>
        <drugauthorizationnumb>21462</drugauthorizationnumb>
        <drugdosagetext>1200 MG, EVERY 3 WEEKS, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051012</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CISPLATIN</medicinalproduct>
        <drugdosagetext>180 MG, 3/W, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051012</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE TAB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYANOCOBALAMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TIOTROPOIUM (TIOTROPIUM)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SERETIDE ^ALLEN + HANBURYS LTD^ (FLUTICASONE PROPIONATE, SALMETEROL)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANTOPRAZOLE SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ESOMEPRAZOLE (ESOMEPRAZOLE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CIMETIDINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIAZEPAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUCONAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCODONE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SODIUM PICOSULFATE (SODIUM PICOSULFATE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DICILLIN DICLOXACILLIN SODIUM MONOHYDRATE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM CHLORIDE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053885-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006079438</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>92</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD CHLORIDE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD SODIUM DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVERDOSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HALCION</medicinalproduct>
        <drugauthorizationnumb>17892</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEPAS (ETIZOLAM)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEPROMEL (FLUVOXAMINE MALEATE)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053886-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060704</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-JNJFOC-20060604757</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>77</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>55</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL DISTURBANCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMINYL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMINYL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMINYL</medicinalproduct>
        <drugauthorizationnumb>021169</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MEMORY IMPAIRMENT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIVIAL</medicinalproduct>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INDAPAMIDE</medicinalproduct>
        <drugindication>DIURETIC THERAPY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053887-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060707</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20060401324</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>67.81</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ACUTE MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTRACARDIAC THROMBUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE CONTRACTIONS INVOLUNTARY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENOUS THROMBOSIS LIMB</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENTRICULAR FIBRILLATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ORTHO EVRA</medicinalproduct>
        <drugauthorizationnumb>21180</drugauthorizationnumb>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>CONTRACEPTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HABITROL</medicinalproduct>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>SMOKING CESSATION THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPROL-XL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVASTATIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERLIPIDAEMIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053888-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060421</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0602783A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>87</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DIPLOPIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HALLUCINATION, VISUAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEBROX DROPS</medicinalproduct>
        <drugbatchnumb>FL0601</drugbatchnumb>
        <drugdosagetext>10DROP SINGLE DOSE</drugdosagetext>
        <drugadministrationroute>001</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060420</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060420</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPROL-XL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CENTRUM SILVER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053889-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060707</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0611557A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DENTAL CARIES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FAECES DISCOLOURED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRIC HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATOCHEZIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HERNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NICOTINE DEPENDENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STOMACH DISCOMFORT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6E01</drugbatchnumb>
        <drugauthorizationnumb>21330</drugauthorizationnumb>
        <drugadministrationroute>002</drugadministrationroute>
        <drugindication>SMOKING CESSATION THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THYROID TAB</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053890-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060706</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-GLAXOSMITHKLINE-B0430687A</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORMIGRAN</medicinalproduct>
        <drugauthorizationnumb>20763</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MIGRAINE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053891-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060712</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-GLAXOSMITHKLINE-B0430739A</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>37</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PREGNANCY ON ORAL CONTRACEPTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UNINTENDED PREGNANCY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NICOTINE</medicinalproduct>
        <drugauthorizationnumb>20165</drugauthorizationnumb>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>SMOKING CESSATION THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MICROGYNON</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONTRACEPTION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053892-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060626</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA200606005653</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>55</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PROSTATIC SPECIFIC ANTIGEN INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugauthorizationnumb>21318</drugauthorizationnumb>
        <drugdosagetext>20 UG, DAILY (1/D)</drugdosagetext>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050919</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FORTEO PEN (FORTE PEN)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM (CALCIUM)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053893-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060621</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR200602000118</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>80</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BREAST CANCER FEMALE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugbatchnumb>FF4AN5C</drugbatchnumb>
        <drugauthorizationnumb>21318</drugauthorizationnumb>
        <drugdosagetext>20 UG, DAILY (1/D), SUBCUTANEOUS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051022</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060302</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FORTEO PEN (FORTEO PEN), PEN DISPOSABLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FENOFIBRATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRAXILENE (NAFTIDROFURYL OXALATE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VASTAREL (TRIMETRAZIDINE HYDROCHLORIDE)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053896-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060707</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2006US08781</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZELNORM</medicinalproduct>
        <drugauthorizationnumb>021200</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053897-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060706</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHO2006BR11153</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>23</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>57</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSENTERY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZELMAC / HTF 919A</medicinalproduct>
        <drugauthorizationnumb>21200</drugauthorizationnumb>
        <drugdosagetext>6 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONSTIPATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060701</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053898-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060707</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20060702054</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>63.05</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OCULAR VASCULAR DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ELMIRON</medicinalproduct>
        <drugauthorizationnumb>020193</drugauthorizationnumb>
        <drugdosagetext>1 CAPSULE AT AM AND 2 CAPSULES AT PM</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CYSTITIS INTERSTITIAL</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMITRIPTYLINE HCL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CYSTITIS INTERSTITIAL</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLARINEX</medicinalproduct>
        <drugindication>MULTIPLE ALLERGIES</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SINGULAIR</medicinalproduct>
        <drugindication>ASTHMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NASONEX</medicinalproduct>
        <drugindication>MULTIPLE ALLERGIES</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PATANOL</medicinalproduct>
        <drugindication>MULTIPLE ALLERGIES</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENAZEPRIL HYDROCHLORIDE</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053900-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060622</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR200606004016</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>45</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CAUSTIC INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCORRECT ROUTE OF DRUG ADMINISTRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TONGUE INJURY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROZAC</medicinalproduct>
        <drugauthorizationnumb>18936</drugauthorizationnumb>
        <drugdosagetext>20 MG DAILY (1/D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060616</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060616</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053903-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060622</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR200605006000</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>39</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>65</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANGIONEUROTIC OEDEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROZAC</medicinalproduct>
        <drugauthorizationnumb>18936</drugauthorizationnumb>
        <drugdosagetext>20 MG, DAILY (1/D/), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051015</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DAFLON (DIOSMIN)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053906-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006057226</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>73</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>45</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD LACTIC ACID INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CYANOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIALYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG TOXICITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAMMA-GLUTAMYLTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCYTOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VASOCONSTRICTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VERTIGO</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYVOX</medicinalproduct>
        <drugauthorizationnumb>21131</drugauthorizationnumb>
        <drugdosagetext>1200 MG (600 MG, 2 IN 1 D), INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060403</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060414</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAROXETINE</medicinalproduct>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060309</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060403</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAROXETINE</medicinalproduct>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060404</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060405</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAROXETINE</medicinalproduct>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060406</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060408</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HEPARIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOMPERIDONE (DOMPERIDONE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BISOPROLOL FUMARATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEXOMIL (BROMAZEPAM)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RIFADIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIAMOX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATARAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SINTROM (ACENOCUMAROL)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053908-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006056673</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>71</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <reaction>
        <reactionmeddrapt>DYSKINESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EARLY MORNING AWAKENING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</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>20060324</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060424</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053910-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060712</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20060302705</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>62.6</patientweight>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCYTOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YONDELIS</medicinalproduct>
        <drugauthorizationnumb>50286</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>OVARIAN CANCER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOXIL</medicinalproduct>
        <drugauthorizationnumb>050718</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>OVARIAN CANCER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROTONIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMBIEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MARINOL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053911-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060712</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-JNJFOC-20060702288</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>48</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>80</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MEMORY IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANIC REACTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EPITOMAX</medicinalproduct>
        <drugdosagetext>FOURTH WEEK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EPITOMAX</medicinalproduct>
        <drugdosagetext>THIRD WEEK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EPITOMAX</medicinalproduct>
        <drugdosagetext>SECOND WEEK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EPITOMAX</medicinalproduct>
        <drugauthorizationnumb>020505</drugauthorizationnumb>
        <drugdosagetext>FIRST WEEK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MIGRAINE PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INDORAMIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053912-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060713</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>SE-JNJFOC-20060702535</companynumb>
    <primarysource>
      <reportercountry>SWEDEN</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>55</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>NEPHRITIS INTERSTITIAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOPAMAX</medicinalproduct>
        <drugauthorizationnumb>020505</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MIGRAINE WITHOUT AURA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COZAAR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ESSENTIAL HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASASANTIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XANOR</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMILORID</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CIPRAMIL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NARAMIG</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053913-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060630</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006014158</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>47</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>91.6</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE FLUCTUATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC TAMPONADE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTRACRANIAL PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARTIAL SEIZURES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERICARDIAL EFFUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PUPILS UNEQUAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TORSADE DE POINTES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUTENT</medicinalproduct>
        <drugauthorizationnumb>21938</drugauthorizationnumb>
        <drugdosagetext>50 MG (50 MG, DAILY INTERVAL: EVERYDAY), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RENAL CELL CARCINOMA STAGE UNSPECIFIED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060113</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060125</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GABAPENTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ORAMORPH SR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROZAC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOPLICLONE (ZOPLICLONE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MST (MORPHINE SULFATE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROPANOLOL (PROPANOLOL)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053919-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060705</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2005070432</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>77</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>MESOTHELIOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ATORVASTATIN CALCIUM</medicinalproduct>
        <drugauthorizationnumb>20702</drugauthorizationnumb>
        <drugdosagetext>10 MG (DAILY)</drugdosagetext>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LACTULOSE</medicinalproduct>
        <drugdosagetext>3.35G/5ML (DAILY)</drugdosagetext>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SPIRONOLACTONE</medicinalproduct>
        <drugdosagetext>50 MG</drugdosagetext>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TEMAZEPAM</medicinalproduct>
        <drugdosagetext>10 MG, 1 - 2 NIGHTLY)</drugdosagetext>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMBIVENT</medicinalproduct>
        <drugdosagetext>(4 IN 1 D), INHALATION</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030617</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040513</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DILTIAZEM</medicinalproduct>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SALBUTAMOL (SALBUTAMOL)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BECLOMETHASONE (BECLOMETHASONE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FRUMIL (AMILORIDE HYDROCHLORIDE, FUROSEMIDE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE (DEAMETHASONE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOSULEPIN (DOSULEPIN)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GAVISCON</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANSOPRAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOCLOPRAMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NITROGLYCERIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTRIMEPRAZINE (LEVOMEPROMAZINE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCODONE (OXYCODONE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYGEN (OXYGEN)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYMBICORT (BUDESONIDE, FORMOTEROL FUMARATE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053921-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060625</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IL200606005256</companynumb>
    <primarysource>
      <reportercountry>ISRAEL</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>86</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>LUNG ADENOCARCINOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREATMENT NONCOMPLIANCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugauthorizationnumb>21318</drugauthorizationnumb>
        <drugdosagetext>20, DAILY (1/D), SUBCUTANEOUS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051006</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051104</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FORTEO PEN (FORTEO PEN)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LERCANIDIPINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM D3 (CALCIUM, COLECALCIFEROL)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053923-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060713</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0607USA02591</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>85</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>INTERNATIONAL NORMALISED RATIO INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROTHROMBIN LEVEL INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZETIA</medicinalproduct>
        <drugauthorizationnumb>021445</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERCHOLESTEROLAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060701</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROSCAR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLOMAX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053924-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060524</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>MY-MERCK-0605MYS00007</companynumb>
    <primarysource>
      <reportercountry>MALAYSIA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>15</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>50</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ACUTE MYELOID LEUKAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRESCRIBED OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CANCIDAS</medicinalproduct>
        <drugauthorizationnumb>21227</drugauthorizationnumb>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>FUNGAL INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060519</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060523</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053925-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060109</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0601USA00959</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>54</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>GINGIVAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POST PROCEDURAL COMPLICATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053926-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060509</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0605USA01722</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>69</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>LOWER LIMB FRACTURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>20560</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19960101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYZAAR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NASACORT</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADVAIR DISKUS 100/50</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053927-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060612</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-MERCK-0606USA02951</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>64</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>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 LACTATE DEHYDROGENASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAMMA-GLUTAMYLTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER FUNCTION TEST ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SINGULAIR</medicinalproduct>
        <drugauthorizationnumb>20829</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051227</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060609</drugenddate>
        <drugtreatmentduration>165</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THEO-DUR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040715</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060609</drugenddate>
        <drugtreatmentduration>695</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AROFUTO</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MUSCULOSKELETAL STIFFNESS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040519</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060609</drugenddate>
        <drugtreatmentduration>752</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MERISLON</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIZZINESS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041021</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060609</drugenddate>
        <drugtreatmentduration>597</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEPAS</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INSOMNIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040519</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060609</drugenddate>
        <drugtreatmentduration>752</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PURSENNID</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONSTIPATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040519</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060609</drugenddate>
        <drugtreatmentduration>752</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUTIDE</medicinalproduct>
        <drugadministrationroute>055</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050308</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053928-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050822</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0508USA03664</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>0</patientonsetage>
      <patientonsetageunit>804</patientonsetageunit>
      <patientweight>5</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PROLONGED LABOUR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SINGULAIR</medicinalproduct>
        <drugauthorizationnumb>020829</drugauthorizationnumb>
        <drugindication>ASTHMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLEGRA</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053929-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesscongenitalanomali>1</seriousnesscongenitalanomali>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060707</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-MERCK-0607USA02740</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>64</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ADVERSE EVENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ATRIOVENTRICULAR BLOCK THIRD DEGREE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRADYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ELECTROCARDIOGRAM QT CORRECTED INTERVAL PROLONGED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENTRICULAR TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEPCID RPD</medicinalproduct>
        <drugauthorizationnumb>020752</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTRITIS EROSIVE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041209</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050607</drugenddate>
        <drugtreatmentduration>181</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PURSENNID</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONSTIPATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM CARBONATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERPHOSPHATAEMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RHYTHMY</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INSOMNIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLETAL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CEREBRAL INFARCTION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053930-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060713</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0607USA02584</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053931-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050916</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0509USA02379</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>0</patientonsetage>
      <patientonsetageunit>804</patientonsetageunit>
      <reaction>
        <reactionmeddrapt>BRADYCARDIA FOETAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SINGULAIR</medicinalproduct>
        <drugauthorizationnumb>020829</drugauthorizationnumb>
        <drugindication>DERMATITIS ALLERGIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050916</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZYRTEC</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053932-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060711</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0607USA01830</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>61</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPEPSIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053933-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060608</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0606USA01584</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>51</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>JAW DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>20560</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19970601</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053934-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060502</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-MERCK-0605DEU00013</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>71</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>59</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BODY TEMPERATURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHILLS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISORIENTATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSSTASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZETIA</medicinalproduct>
        <drugauthorizationnumb>21445</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERCHOLESTEROLAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060422</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060426</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZETIA</medicinalproduct>
        <drugauthorizationnumb>021445</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CORONARY ARTERY DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060422</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060426</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE BESYLATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN E ACETATE DL-FORM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GINKGO</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060320</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053936-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060630</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006078706</companynumb>
    <primarysource>
      <reportercountry>FINLAND</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>53</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARYNGEAL OEDEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugauthorizationnumb>21446</drugauthorizationnumb>
        <drugdosagetext>225 MG (75 MG, 3 IN 1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>POLYNEUROPATHY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060601</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053939-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060705</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006077310</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>57</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD BILIRUBIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE SYSTOLIC INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOKALAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugauthorizationnumb>20702</drugauthorizationnumb>
        <drugdosagetext>10 MG, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060604</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>JUVELA (TOCOPHEROL)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTIHYPERTENSIVES (ANTIHYPERTENSIVES)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053942-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060612</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0606USA02287</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>54</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>68</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>RENAL EMBOLISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SCIATICA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MAXALT</medicinalproduct>
        <drugauthorizationnumb>20864</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MIGRAINE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060601</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREMPRO</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MENOPAUSE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19920101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDROL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCIATICA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053943-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060510</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0605USA01873</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>61</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD POTASSIUM ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZESTRIL</medicinalproduct>
        <drugauthorizationnumb>19558</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ESSENTIAL HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARDURA</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>ESSENTIAL HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053944-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060711</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0607USA01817</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>90</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ASPARTATE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CREATINE PHOSPHOKINASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CREATINE PHOSPHOKINASE MB INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULAR WEAKNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOGLOBINURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugauthorizationnumb>019766</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060422</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLIPIZIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DILTIAZEM CD</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GEMFIBROZIL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRILOSEC</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FORMOTEROL FUMARATE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AEROBID</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ETODOLAC</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053949-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006069920</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>87</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>60.782</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABNORMAL DREAMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BALANCE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DROOLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSKINESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugauthorizationnumb>21446</drugauthorizationnumb>
        <drugdosagetext>75 MG (75 MG, 1 IN 1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>FACIAL NEURALGIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060512</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060602</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugauthorizationnumb>21446</drugauthorizationnumb>
        <drugdosagetext>75 MG (75 MG, 1 IN 1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NEURALGIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060512</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060602</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CAFFEINE/CODEINE PHOSPHATE/PARACETAMOL (CAFFEINE, CODEINE PHOSPHATE, P</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYLENOL W/ CODEINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOPICLONE (ZOPICLONE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TELMISARTAN (TELMISARTAN)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COMBIVENT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANTOPRAZOLE SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INDAPAMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYMBICORT (BUDESONIDE, FORMOTEROL FUMARATE)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053952-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006079438</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>92</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD CHLORIDE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD SODIUM DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE DRUG OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HALCION</medicinalproduct>
        <drugauthorizationnumb>17892</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEPAS (ETIZOLAM)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEPROMEL (FLUVOXAMINE MALEATE)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053954-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060703</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BEWYE708909JUN06</companynumb>
    <primarysource>
      <reportercountry>BELGIUM</reportercountry>
      <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>FOCAL GLOMERULOSCLEROSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SIROLIMUS</medicinalproduct>
        <drugauthorizationnumb>21083</drugauthorizationnumb>
        <drugdosagetext>15 MG 1X PER 1 DAY ORAL; SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS AGAINST TRANSPLANT REJECTION</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</medicinalproduct>
        <drugauthorizationnumb>21083</drugauthorizationnumb>
        <drugdosagetext>15 MG 1X PER 1 DAY ORAL; SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS AGAINST TRANSPLANT REJECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041029</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041112</drugenddate>
        <drugtreatmentduration>15</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SIROLIMUS</medicinalproduct>
        <drugauthorizationnumb>21083</drugauthorizationnumb>
        <drugdosagetext>15 MG 1X PER 1 DAY ORAL; SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS AGAINST TRANSPLANT REJECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041018</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041118</drugenddate>
        <drugtreatmentduration>32</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SIROLIMUS</medicinalproduct>
        <drugauthorizationnumb>21083</drugauthorizationnumb>
        <drugdosagetext>15 MG 1X PER 1 DAY ORAL; SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS AGAINST TRANSPLANT REJECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041113</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041129</drugenddate>
        <drugtreatmentduration>17</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TACROLIMUS (TACROLIMUS)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZENAPAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CORTICOSTEROIDS (CORTICOSTEROIDS)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053956-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006079347</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>56</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugauthorizationnumb>21446</drugauthorizationnumb>
        <drugdosagetext>150 MG ( 75 MG, 2 IN 1 D) ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NEURALGIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060524</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMITRIPTYLINE (AMITRIPTYLINE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BACLOFEN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053958-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006051403</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>65</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>80</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugauthorizationnumb>21446</drugauthorizationnumb>
        <drugdosagetext>150 MG (75 MG, 2 IN 1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NEURALGIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060206</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCODONE (OXYCODONE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALL OTHER THERAPEUTIC PRODUCTS (ALL OTHER THERAPEUTIC PRODUCTS)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053961-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006021945</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>49</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL DISTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLISTER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMPAIRED WORK ABILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAROSMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUSITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN DISCOLOURATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GENOTROPIN</medicinalproduct>
        <drugauthorizationnumb>20280</drugauthorizationnumb>
        <drugdosagetext>0.4 MG (0.6 MG, 6 IN 1 WK), SUBCUTANEOUS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>BLOOD GROWTH HORMONE DECREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060103</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060401</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GENOTROPIN</medicinalproduct>
        <drugauthorizationnumb>20280</drugauthorizationnumb>
        <drugdosagetext>0.4 MG (0.6 MG, 6 IN 1 WK), SUBCUTANEOUS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>OFF LABEL USE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060103</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060401</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053963-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060706</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FRWYE030406JUL06</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>63</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ADVIL</medicinalproduct>
        <drugauthorizationnumb>18989</drugauthorizationnumb>
        <drugdosagetext>1200 MG 1X PER 1 DAY ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ERYSIPELAS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060512</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060522</drugenddate>
        <drugtreatmentduration>11</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IXPRIM (PARACETAMOL/TRAMADOL HYDROCHLORIDE, , 0)</medicinalproduct>
        <drugdosagetext>25 MG 4X PER 1 DAY ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ERYSIPELAS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060512</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060522</drugenddate>
        <drugtreatmentduration>11</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PYOSTACINE                 (PRISTINAMYCIN, , 0)</medicinalproduct>
        <drugdosagetext>500 MG 4X PER 1 DAY ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ERYSIPELAS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060512</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060522</drugenddate>
        <drugtreatmentduration>11</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FRAXODI (NADROPARIN CALCIUM)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMARYL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KORETIC (HYDROCHLOROTHIAZIDE/QUINAPRIL HYDROCHLORIDE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PHYSIOTENS (MOXONIDINE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FENOFIBRATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAXEPA (CITRIC ACID/FATTY ACIDS NOS/GLUCOSE /INSULIN/INSULIN HUMAN INJ</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRAVASTATIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053964-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006062236</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>61</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>67.2</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>CACHEXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIALYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ENDOTRACHEAL INTUBATION COMPLICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEMIPARESIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATOTOXICITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METABOLIC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METASTASES TO CENTRAL NERVOUS SYSTEM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OPPORTUNISTIC INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THERAPY NON-RESPONDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TUMOUR LYSIS SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUTENT</medicinalproduct>
        <drugbatchnumb>505160</drugbatchnumb>
        <drugauthorizationnumb>21968</drugauthorizationnumb>
        <drugdosagetext>50 MG (50 MG, 1 IN 1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>METASTATIC RENAL CELL CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060505</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060619</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLYBURIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MINOXIDIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM ACETATE (CALCIUM ACETATE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENALAPRIL MALEATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IRBESARTAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FERROUS SULFATE TAB</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053965-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060405</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006UW10441</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>30</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BIPOLAR DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugauthorizationnumb>20639</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060320</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PLACEBO</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BIPOLAR DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060306</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060319</drugenddate>
        <drugtreatmentduration>14</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PLACEBO</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060306</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060319</drugenddate>
        <drugtreatmentduration>14</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>STUDY PROCEDURE</medicinalproduct>
        <drugindication>BIPOLAR DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053966-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060713</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006UW14415</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>COMPLETED SUICIDE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugauthorizationnumb>020639</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053967-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060707</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GBWYE773424JUN05</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>46</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOBILITY DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE ATROPHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULAR WEAKNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</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>IMMUNOSUPPRESSANT DRUG THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050511</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050627</drugenddate>
        <drugtreatmentduration>48</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RAPAMUNE</medicinalproduct>
        <drugauthorizationnumb>21110</drugauthorizationnumb>
        <drugdosagetext>4 MG 1X PER 1 DAY ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RENAL TRANSPLANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050511</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050627</drugenddate>
        <drugtreatmentduration>48</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TACROLIMUS (TACROLIMUS)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MYCOPHENOLATE MOFETIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BISOPROLOL FUMARATE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053970-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060626</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006-145017-NL</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>47</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>THROMBOPHLEBITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENOUS THROMBOSIS LIMB</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIRTAZAPINE</medicinalproduct>
        <drugauthorizationnumb>21208</drugauthorizationnumb>
        <drugdosagetext>60 MG ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIRTAZAPINE</medicinalproduct>
        <drugauthorizationnumb>21208</drugauthorizationnumb>
        <drugdosagetext>60 MG ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051102</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VENLAFAXINE HCL</medicinalproduct>
        <drugdosagetext>75 MG/150 MG</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051101</drugenddate>
        <drugtreatmentduration>22</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VENLAFAXINE HCL</medicinalproduct>
        <drugdosagetext>75 MG/150 MG</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051102</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANTOPRAZOLE SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METAMIZOLE SODIUM MONOHYDRATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053973-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060703</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CHNY2006DE02000</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FACIAL PALSY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PENCICLOVIR</medicinalproduct>
        <drugauthorizationnumb>20629</drugauthorizationnumb>
        <drugdosagetext>APPLIED 3 TIMES, TOPICAL</drugdosagetext>
        <drugadministrationroute>061</drugadministrationroute>
        <drugindication>HERPES SIMPLEX</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060601</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053976-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060705</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200612628GDS</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>62</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>37</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>APLASIA PURE RED CELL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISEASE PROGRESSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugauthorizationnumb>21317</drugauthorizationnumb>
        <drugdosagetext>100 MG, TOTAL DAILY, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030222</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030807</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIGOXIN</medicinalproduct>
        <drugdosagetext>0.125 MG, TOTAL DAILY, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030222</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EPOGEN</medicinalproduct>
        <drugdosagetext>4500 U, QW, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19790101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPENON</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALTAN (PERCIPITATED CALCIUM CARBONATE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KALIMATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOUGHMAC E</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053980-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060705</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200610612BFR</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>59</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISEASE PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERAL PHYSICAL HEALTH DETERIORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METASTATIC RENAL CELL CARCINOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SORAFENIB</medicinalproduct>
        <drugauthorizationnumb>21923</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RENAL CELL CARCINOMA STAGE UNSPECIFIED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOPHAGE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BISOPROLOL FUMARATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIANTALVIC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DURAGESIC-100</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRIMPERAN TAB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIAMICRON</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MORPHINE SULFATE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053983-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060706</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006-145101-NL</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>61</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HAEMODIALYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMODYNAMIC INSTABILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPARIN-INDUCED THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPTIC SHOCK</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DANAPAROID SODIUM</medicinalproduct>
        <drugauthorizationnumb>20430</drugauthorizationnumb>
        <drugdosagetext>SUBCUTANEOUS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060531</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060602</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN CALCIUM</medicinalproduct>
        <drugdosagetext>SUBCUTANEOUS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060505</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060531</drugenddate>
        <drugtreatmentduration>27</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVULAR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RAMIPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SODIUM POLYSTYRENE SULFONATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACENOCOUMAROL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053986-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060626</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006RR-02850</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>49</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMODIALYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULAR WEAKNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHABDOMYOLYSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SIMVASTATIN FAMILY (SIMVASTATIN) TABLET, 10MG</medicinalproduct>
        <drugauthorizationnumb>76386</drugauthorizationnumb>
        <drugdosagetext>10 MG, QD, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERCHOLESTEROLAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010201</drugstartdate>
        <drugtreatmentduration>122</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUCONAZOLE FAMILY (FLUCONAZOLE) TABLET, 100MG</medicinalproduct>
        <drugdosagetext>100 MG, QD, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PNEUMOCYSTIS JIROVECI PNEUMONIA</drugindication>
        <drugtreatmentduration>122</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL ORAL FAMILY (ALLOPURINOL) TABLET</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MECOBALAMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SUCRALFATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SANILVUDINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LAMIVUDINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NELFINAVIR (NELFINAVIR)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053987-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060210</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>WAES 0602KOR00013</companynumb>
    <primarysource>
      <reportercountry>KOREA, REPUBLIC OF</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>5</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SINGULAIR</medicinalproduct>
        <drugauthorizationnumb>20830</drugauthorizationnumb>
        <drugdosagetext>5 MG/DAILY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050624</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053989-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060626</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006RR-02836</companynumb>
    <primarysource>
      <reportercountry>DENMARK</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>55</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PANCREATITIS ACUTE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERCHOLESTEROLAEMIA</drugindication>
        <drugtreatmentduration>377</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053991-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060707</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>222263</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>71</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ALANINE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASPARTATE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD URINE PRESENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGIC DIATHESIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THERAPY NON-RESPONDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACTIVACIN (ALTEPLASE) PWDR + SOLVENT, INFUSION SOLN</medicinalproduct>
        <drugdosagetext>38.38 MG, SINGLE, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CEREBRAL THROMBOSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051212</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051212</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TICLOPIDINE HCL</medicinalproduct>
        <drugdosagetext>100 MG, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CEREBRAL THROMBOSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051215</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PERDIPINE (NICARDIPINE HYDROCHLORIDE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NICOTINIC ACID (NIACIN)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTIBIOTICS NOS (ANTIBIOTICS NOS)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053992-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060706</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006-07-0143</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>60</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>KERATOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SQUAMOUS CELL CARCINOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RINDERON OPHTHALMIC SOLUTION</medicinalproduct>
        <drugauthorizationnumb>14602</drugauthorizationnumb>
        <drugdosagetext>0.1% EYE</drugdosagetext>
        <drugindication>CONJUNCTIVAL ULCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CICLOSPORIN OPHTHALMIC SOLUTION</medicinalproduct>
        <drugdosagetext>EYE</drugdosagetext>
        <drugindication>CONJUNCTIVAL ULCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053994-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060704</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006-07-0073</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>30</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>49</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PROCTALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SICKLE CELL ANAEMIA WITH CRISIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEG-INTERFERON ALFA-2B REDIPEN</medicinalproduct>
        <drugdosagetext>80 MCG QWK SUBCUTANEOUS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060518</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RIBAVIRIN</medicinalproduct>
        <drugdosagetext>400 MG BID ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060518</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROMORPHONE HCL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053996-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060704</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>NLWYE960804JUL06</companynumb>
    <primarysource>
      <reportercountry>NETHERLANDS</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>46</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BIPOLAR I DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG DISPENSING ERROR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG PRESCRIBING ERROR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EFFEXOR</medicinalproduct>
        <drugauthorizationnumb>20151</drugauthorizationnumb>
        <drugdosagetext>75 MG 1X PER 1 DAY; SEE IMAGE</drugdosagetext>
        <drugindication>ANXIETY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EFFEXOR</medicinalproduct>
        <drugauthorizationnumb>20151</drugauthorizationnumb>
        <drugdosagetext>75 MG 1X PER 1 DAY; SEE IMAGE</drugdosagetext>
        <drugindication>ANXIETY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXAZEPAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANTOPRAZOLE SODIUM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053997-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060705</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006-07-0158</companynumb>
    <primarysource>
      <reportercountry>SWEDEN</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>40</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>AGGRESSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AERIUS (DESLORATADINE) TABLETS</medicinalproduct>
        <drugauthorizationnumb>21165</drugauthorizationnumb>
        <drugdosagetext>5-2.5MG ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERSENSITIVITY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060620</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060601</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AERIUS (DESLORATADINE) TABLETS</medicinalproduct>
        <drugauthorizationnumb>21165</drugauthorizationnumb>
        <drugdosagetext>5-2.5MG ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERSENSITIVITY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060701</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5053999-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060710</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006-03-0953</companynumb>
    <primarysource>
      <reportercountry>ITALY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>50</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>72</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN EXFOLIATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEG-INTRON</medicinalproduct>
        <drugdosagetext>6-1 MCG/KG* SUBCUTANEOUS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>MALIGNANT MELANOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020520</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030215</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEG-INTRON</medicinalproduct>
        <drugdosagetext>6-1 MCG/KG* SUBCUTANEOUS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>MALIGNANT MELANOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020520</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030901</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEG-INTRON</medicinalproduct>
        <drugdosagetext>6-1 MCG/KG* SUBCUTANEOUS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>MALIGNANT MELANOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030317</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030901</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054000-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060705</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006-07-0149</companynumb>
    <primarysource>
      <reportercountry>CROATIA (local name: Hrvatska)</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>28</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>72</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ALANINE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASPARTATE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEG-INTRON</medicinalproduct>
        <drugdosagetext>450 MCG QWK SUBCUTANEOUS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>MALIGNANT MELANOMA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054001-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060711</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200610656BYL</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>37</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOVEMENT DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHABDOMYOLYSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVELOX</medicinalproduct>
        <drugauthorizationnumb>21085</drugauthorizationnumb>
        <drugdosagetext>400 MG, QD, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BRONCHITIS ACUTE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060510</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060511</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PELEX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DASEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOXONIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MUCODYNE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054002-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060623</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ENTC2006-0182</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>52</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL STIFFNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>STALEVO 100</medicinalproduct>
        <drugauthorizationnumb>21485</drugauthorizationnumb>
        <drugdosagetext>150 MG (50 MG, 3 IN 1 D) ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PARKINSON'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060621</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ROPINIROLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054003-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060705</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006-01638</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>95</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD CREATININE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEAD INJURY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KENTERA (WATSON LABORATORIES (OXYBUTYNIN) TRANSDERMAL  PATCH, 3.9MG</medicinalproduct>
        <drugauthorizationnumb>21351</drugauthorizationnumb>
        <drugdosagetext>TRANSDERMAL</drugdosagetext>
        <drugadministrationroute>062</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BISOPROLOL FUMARATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RAMIPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMOUR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLICLAZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORAZEPAM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054004-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060706</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200610879BYL</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>19</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>EOSINOPHIL COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVELOX</medicinalproduct>
        <drugauthorizationnumb>21085</drugauthorizationnumb>
        <drugdosagetext>400 MG, QD, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BRONCHITIS ACUTE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060621</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060624</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PL GRANULE</medicinalproduct>
        <drugdosagetext>3 G, TOTAL DAILY, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BRONCHITIS ACUTE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060619</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060624</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLARITHROMYCIN</medicinalproduct>
        <drugdosagetext>400 MG, TOTAL DAILY, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BRONCHITIS ACUTE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060621</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060624</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054005-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006-02660</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>84</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>61</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRANSIENT ISCHAEMIC ATTACK</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KENTERA (WATSON LABORATORIES (OXYBUTYNIN) TRANSDERMAL  PATCH, 3.9MG</medicinalproduct>
        <drugauthorizationnumb>21351</drugauthorizationnumb>
        <drugdosagetext>3.9 PATCH, DAILY, TRANSDERMAL</drugdosagetext>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>URGE INCONTINENCE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060406</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060430</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BISOPROLOL FUMARATE</medicinalproduct>
        <drugdosagetext>5 MG, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GODAMED TAH(ACETYLSALICYLIC ACID)</medicinalproduct>
        <drugdosagetext>100 MG</drugdosagetext>
        <drugindication>CEREBRAL DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054006-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060710</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200610886BYL</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>91</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>TOXIC EPIDERMAL NECROLYSIS</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>20060613</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060626</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054007-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060630</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006-02667</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>40</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OXYGEN SATURATION DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRELSTAR DEPOT</medicinalproduct>
        <drugauthorizationnumb>20715</drugauthorizationnumb>
        <drugdosagetext>INTRAMUSCULAR</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060330</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054008-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060630</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006-02597</companynumb>
    <primarysource>
      <reportercountry>ITALY</reportercountry>
    </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>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FERRLECIT</medicinalproduct>
        <drugauthorizationnumb>20955</drugauthorizationnumb>
        <drugdosagetext>125 MG, DAILY, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ANAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060609</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060609</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054009-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060704</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006-07-0147</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>40</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>68</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ECZEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEG-INTRON</medicinalproduct>
        <drugdosagetext>100 MCG</drugdosagetext>
        <drugindication>MALIGNANT MELANOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050721</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060306</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054011-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060705</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006-07-0117</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>58</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEG-INTERFERON ALFA-2B INJECTABLE</medicinalproduct>
        <drugdosagetext>SUBCUTANEOUS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060601</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RIBAVIRIN</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060601</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054012-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060710</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200611272GDS</companynumb>
    <primarysource>
      <reportercountry>RUSSIAN FEDERATION</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>44</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>101</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>PANCREATIC NECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCREATITIS ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERITONITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SHOCK</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DACARBAZINE</medicinalproduct>
        <drugauthorizationnumb>17575</drugauthorizationnumb>
        <drugdosagetext>1000 MG/M2, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MALIGNANT MELANOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060320</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GENASENSE</medicinalproduct>
        <drugdosagetext>7 MG/KG, TOTAL DAILY, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MALIGNANT MELANOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060315</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060320</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NOVOCAIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALCLOFENAC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOFRAN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054013-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060704</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006-06-0430</companynumb>
    <primarysource>
      <reportercountry>ISRAEL</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>52</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIAC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CYANOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING COLD</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FORMICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEG-INTRON</medicinalproduct>
        <drugdosagetext>120 MCG QW SUBCUTANEOUS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBETOL</medicinalproduct>
        <drugdosagetext>1000 MG QD ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN 36X21</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054015-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060626</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006RR-02851</companynumb>
    <primarysource>
      <reportercountry>SWITZERLAND</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>59</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>EPIDERMAL NECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPHOCYTIC INFILTRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYSTEMIC LUPUS ERYTHEMATOSUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugauthorizationnumb>76285</drugauthorizationnumb>
        <drugdosagetext>20 MG, QD, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERCHOLESTEROLAEMIA</drugindication>
        <drugtreatmentduration>730</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054016-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060630</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>33201</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>70</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CORNEAL GRAFT REJECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE INFLAMMATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTRAOCULAR PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISION BLURRED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL ACUITY REDUCED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRAVOPROST 0.004% SOLUTION</medicinalproduct>
        <drugauthorizationnumb>21699</drugauthorizationnumb>
        <drugdosagetext>1 GTT HS, OPHT</drugdosagetext>
        <drugadministrationroute>047</drugadministrationroute>
        <drugindication>OCULAR HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051021</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051024</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054017-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060630</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200612610GDS</companynumb>
    <primarysource>
      <reportercountry>SWITZERLAND</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>28</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>80</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABNORMAL BEHAVIOUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AGITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AMNESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COGNITIVE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DELIRIUM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISORIENTATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISTURBANCE IN ATTENTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMPAIRED WORK ABILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IRRITABILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MASTOID DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSYCHOMOTOR HYPERACTIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THERAPY NON-RESPONDER</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 MYCOPLASMAL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060402</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060415</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KLACID</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054019-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060704</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006-01632</companynumb>
    <primarysource>
      <reportercountry>SOUTH AFRICA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>61</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>81</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CAUDA EQUINA SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERAL PHYSICAL HEALTH DETERIORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HERPES ZOSTER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</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>20060303</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060301</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CHLORTHALIDONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMOVANE (ZOPICLONE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KYTRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAXOLON</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN B6</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CENTRUM (VITAMINS NOS, MINERALS NOS)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOPERAMIDE HYDROCHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TARGOCID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMIKACIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CEFEPIME</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAMADOL HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CIPROFLOXACIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054021-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060705</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200612762GDS</companynumb>
    <primarysource>
      <reportercountry>COLOMBIA</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>80</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>50</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ARRHYTHMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSARTHRIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STUPOR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</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>20060627</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054022-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060705</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006-01629</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>66</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>BRONCHIOLITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HERPES ZOSTER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLUENZA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY TOXICITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VIRAL INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VELCADE</medicinalproduct>
        <drugauthorizationnumb>21602</drugauthorizationnumb>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060613</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060605</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BACTRIM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMITRIPTYLINE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NYSTATIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALCICLOVIR</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054024-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060703</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006-01630</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>69</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>76</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</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>20040405</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040802</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE TAB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOFLOXACIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANTOZOL (PANTOPRAZOLE SODIUM)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENOXAPARIN SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VORICONAZOLE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054025-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060706</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200612904GDS</companynumb>
    <primarysource>
      <reportercountry>SINGAPORE</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>59</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>COMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXAVAR</medicinalproduct>
        <drugauthorizationnumb>21923</drugauthorizationnumb>
        <drugdosagetext>400 MG, BID, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RENAL CELL CARCINOMA STAGE UNSPECIFIED</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054026-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>35705</companynumb>
    <primarysource>
      <reportercountry>DENMARK</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>47</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CHOLINERGIC SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYDRIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARALYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY DISTRESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TROPICAMIDE</medicinalproduct>
        <drugauthorizationnumb>12111</drugauthorizationnumb>
        <drugdosagetext>OPHT</drugdosagetext>
        <drugadministrationroute>047</drugadministrationroute>
        <drugindication>OPHTHALMOLOGICAL EXAMINATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PYRIDOSTIGMINE BROMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATROPINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054027-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060704</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2005-01448</companynumb>
    <primarysource>
      <reportercountry>KOREA, REPUBLIC OF</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>63</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>COMPLETED SUICIDE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VELCADE</medicinalproduct>
        <drugauthorizationnumb>21602</drugauthorizationnumb>
        <drugdosagetext>1.30 MG/M2, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041221</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050412</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054028-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060630</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006-01633</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>0</patientsex>
      <reaction>
        <reactionmeddrapt>ERYTHEMA ELEVATUM DIUTINUM</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>5054030-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060704</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006-07-0035</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>43</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>60</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>EYE INFECTION SYPHILITIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOACUSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEUKOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SECONDARY SYPHILIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TINNITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL ACUITY REDUCED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBETOL</medicinalproduct>
        <drugdosagetext>800 MG QD ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051212</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060601</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEGASYS</medicinalproduct>
        <drugdosagetext>180 UG QWK SUBCUTANEOUS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051212</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060515</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ABACAVIR / LAMIVUDINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VIREAD</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KALETRA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEROXAT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>STILNOX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054032-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060705</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006-07-0162</companynumb>
    <primarysource>
      <reportercountry>SWITZERLAND</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>42</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>72</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ERYSIPELAS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEG-INTRON</medicinalproduct>
        <drugdosagetext>QWK SUBCUTANEOUS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>MALIGNANT MELANOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030114</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054033-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060704</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006-06-1641</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>57</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ILEUS</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>20060118</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060118</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>20060125</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060323</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBETOL</medicinalproduct>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060118</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060124</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBETOL</medicinalproduct>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060125</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060323</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALTAT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROMAC (POLAPREZINC)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PURSENNID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOXONIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LENDORMIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054036-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>35785</companynumb>
    <primarysource>
      <reportercountry>NORWAY</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>77</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CORNEAL ABRASION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CORNEAL THINNING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ULCERATIVE KERATITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MAXITROL</medicinalproduct>
        <drugauthorizationnumb>50023</drugauthorizationnumb>
        <drugdosagetext>OPHT</drugdosagetext>
        <drugadministrationroute>047</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060118</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060125</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUSIDIC ACID 1% EYE DROPS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARBOMER</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054037-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesscongenitalanomali>1</seriousnesscongenitalanomali>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060623</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006JP001744</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>1</patientonsetage>
      <patientonsetageunit>804</patientonsetageunit>
      <reaction>
        <reactionmeddrapt>ARRHYTHMIA NEONATAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CAESAREAN SECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE BEFORE PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FOETAL GROWTH RETARDATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIMB HYPOPLASIA CONGENITAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RADIOULNAR SYNOSTOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TALIPES</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROTOPIC</medicinalproduct>
        <drugauthorizationnumb>50777</drugauthorizationnumb>
        <drugdosagetext>TRANSPLACENTAL</drugdosagetext>
        <drugadministrationroute>064</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060111</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTEBATE (BETAMETHASONE BUTYRATE PROPIONATE) OINTMENT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HIRUDOID (HEPARINOID) OINTMENT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALESION (EPINASTINE HYDROCHLORIDE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WHITE PETROLEUM (PETROLATUM) OINTMENT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HIRUDOID (HEPARINOID) LOTION</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054038-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060630</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006-01641</companynumb>
    <primarysource>
      <reportercountry>NETHERLANDS</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>45</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <reaction>
        <reactionmeddrapt>ACUTE RESPIRATORY DISTRESS SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG INFILTRATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VELCADE</medicinalproduct>
        <drugauthorizationnumb>21602</drugauthorizationnumb>
        <drugindication>MULTIPLE MYELOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACYCLOVIR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MORFIN (MORPHINE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLINOMEL (GLUCOSE, AMINO ACIDS NOS, ELECTROLYTES NOS, LIPIDS NOS, CALC</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054039-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060704</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>MEDI-0004723</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>9</patientonsetage>
      <patientonsetageunit>802</patientonsetageunit>
      <reaction>
        <reactionmeddrapt>BRONCHIOLITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROSTOMY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SYNAGIS</medicinalproduct>
        <drugdosagetext>1 IN 1 M, INTRAMUSCULAR</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>ANTIVIRAL PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051011</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060207</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SYNAGIS</medicinalproduct>
        <drugdosagetext>1 IN 1 M, INTRAMUSCULAR</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>ANTIVIRAL PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051011</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SYNAGIS</medicinalproduct>
        <drugdosagetext>1 IN 1 M, INTRAMUSCULAR</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>ANTIVIRAL PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051110</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SYNAGIS</medicinalproduct>
        <drugdosagetext>1 IN 1 M, INTRAMUSCULAR</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>ANTIVIRAL PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051215</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SYNAGIS</medicinalproduct>
        <drugdosagetext>1 IN 1 M, INTRAMUSCULAR</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>ANTIVIRAL PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060110</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054041-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060630</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006-01655</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>65</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIOMYOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEFT VENTRICULAR FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VELCADE</medicinalproduct>
        <drugauthorizationnumb>21602</drugauthorizationnumb>
        <drugdosagetext>2.50 MG, UNK; INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MANTLE CELL LYMPHOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060502</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054042-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060706</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>URSO-2006-028</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>82</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERSTITIAL LUNG DISEASE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>URSODIOL</medicinalproduct>
        <drugauthorizationnumb>20675</drugauthorizationnumb>
        <drugdosagetext>300 MG, PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054043-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060705</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>MEDI-0004733</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>6</patientonsetage>
      <patientonsetageunit>802</patientonsetageunit>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SYNAGIS</medicinalproduct>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>ANTIVIRAL PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051020</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060223</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SYNAGIS</medicinalproduct>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>ANTIVIRAL PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051020</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SYNAGIS</medicinalproduct>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>ANTIVIRAL PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051122</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SYNAGIS</medicinalproduct>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>ANTIVIRAL PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051222</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SYNAGIS</medicinalproduct>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>ANTIVIRAL PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060120</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054044-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060704</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006-01661</companynumb>
    <primarysource>
      <reportercountry>ITALY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>52</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>85</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOPERFUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEGIONELLA INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLEURAL EFFUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VELCADE</medicinalproduct>
        <drugbatchnumb>VO5PH9323</drugbatchnumb>
        <drugauthorizationnumb>21602</drugauthorizationnumb>
        <drugdosagetext>2.60 MG, UNK; INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060606</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060616</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>THALIDOMIDE (THALIDOMIDE) TABLET</medicinalproduct>
        <drugbatchnumb>1214</drugbatchnumb>
        <drugdosagetext>100.00 MG, UNK; ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060606</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060630</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
        <drugdosagetext>40.00 MG, UNK, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060606</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054045-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060630</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006-01673</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>1</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG TOXICITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERAL PHYSICAL HEALTH DETERIORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALIGNANT NEOPLASM PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARYNGEAL INFLAMMATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VELCADE</medicinalproduct>
        <drugauthorizationnumb>21602</drugauthorizationnumb>
        <drugdosagetext>2.00 MG,</drugdosagetext>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050926</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051212</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
        <drugdosagetext>40.00 MG,</drugdosagetext>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050626</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051005</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOPHOSPHAMIDE</medicinalproduct>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060220</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060310</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ETOPOSIDE</medicinalproduct>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060220</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060310</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CISPLATIN</medicinalproduct>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060220</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060310</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MELPHALAN (MELPHALAN) VIAL</medicinalproduct>
        <drugdosagetext>250.00 MG,</drugdosagetext>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060317</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060317</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054046-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060704</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>MEDI-0004727</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>10</patientonsetage>
      <patientonsetageunit>802</patientonsetageunit>
      <reaction>
        <reactionmeddrapt>RESPIRATORY DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SYNAGIS</medicinalproduct>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>ANTIVIRAL PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051025</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060301</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SYNAGIS</medicinalproduct>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>ANTIVIRAL PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051025</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SYNAGIS</medicinalproduct>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>ANTIVIRAL PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051129</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SYNAGIS</medicinalproduct>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>ANTIVIRAL PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051228</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SYNAGIS</medicinalproduct>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>ANTIVIRAL PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060130</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054047-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060630</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006-01495</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MYOCLONUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VELCADE</medicinalproduct>
        <drugauthorizationnumb>21602</drugauthorizationnumb>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054048-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060703</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006-01449</companynumb>
    <primarysource>
      <reportercountry>NETHERLANDS</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>63</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <reaction>
        <reactionmeddrapt>ATELECTASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIVERTICULUM INTESTINAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>KLEBSIELLA INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MELAENA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA VIRAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROTEUS INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UPPER GASTROINTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VELCADE</medicinalproduct>
        <drugauthorizationnumb>21602</drugauthorizationnumb>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060526</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060618</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060618</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOXORUBICIN HCL</medicinalproduct>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060526</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060618</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054049-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060706</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>URSO-2006-027</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>73</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>GASTRIC CANCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPHADENOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALIGNANT NEOPLASM PROGRESSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>URSODIOL</medicinalproduct>
        <drugauthorizationnumb>20675</drugauthorizationnumb>
        <drugdosagetext>600 MG PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BILIARY CIRRHOSIS PRIMARY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030618</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050805</drugenddate>
        <drugtreatmentduration>780</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054050-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060703</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006-01545</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>38</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERONEAL NERVE PALSY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VELCADE</medicinalproduct>
        <drugauthorizationnumb>21602</drugauthorizationnumb>
        <drugdosagetext>INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOXORUBICIN HCL</medicinalproduct>
        <drugindication>MULTIPLE MYELOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
        <drugindication>MULTIPLE MYELOMA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054051-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006S1000122</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>84</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ACIDOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CREATININE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PH DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CREPITATIONS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DERMATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISEASE PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ELECTROLYTE IMBALANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMODIALYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HENOCH-SCHONLEIN PURPURA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENTAL STATUS CHANGES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PACEMAKER COMPLICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL TUBULAR NECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY DISTRESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STAPHYLOCOCCAL SEPSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VASCULITIS NECROTISING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENOUS PRESSURE JUGULAR INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CUBICIN</medicinalproduct>
        <drugauthorizationnumb>21572</drugauthorizationnumb>
        <drugindication>STAPHYLOCOCCAL SEPSIS</drugindication>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETYLSALICYLIC ACID SRT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLIPIZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOFLOXACIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CEFOTAXIME</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CEPHALEXIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VANCOMYCIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METRONIDAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MOXIFLOXACIN HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ISOSORBIDE DINITRATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDRALAZINE HCL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054053-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040115</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-356278</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>12</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>65.8</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL DISTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABSCESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AGITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AGNOSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ALANINE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ALOPECIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAEMIA MEGALOBLASTIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAL FISSURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AORTIC VALVE INCOMPETENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRITIS BACTERIAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AUTOIMMUNE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BENIGN INTRACRANIAL HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CHOLESTEROL INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD LACTATE DEHYDROGENASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD URIC ACID INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CELLULITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBELLAR INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CERVICOBRACHIAL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHROMATURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLITIS ULCERATIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CUSHING'S SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CYST RUPTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CYSTITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DERMAL CYST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DERMOID CYST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISEASE RECURRENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSMENORRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSTHYMIC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ENCOPRESIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ENDOMETRIOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAMMA-GLUTAMYLTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATOCHEZIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOLYTIC ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HALLUCINATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HERPES SIMPLEX</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ILL-DEFINED DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLAMMATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLAMMATORY BOWEL DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERVERTEBRAL DISC DEGENERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IRRITABILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IRRITABLE BOWEL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JOINT SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVEDO RETICULARIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUPUS NEPHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUPUS VASCULITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MASS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEGACOLON</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEMORY IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENTAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MITRAL VALVE INCOMPETENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOPIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NASAL DRYNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEPHROPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NERVOUS SYSTEM DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NITRITE URINE PRESENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOMYELITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCREATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCYTOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERICARDIAL EFFUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARYNGOLARYNGEAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POLYP</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROTEIN URINE PRESENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSEUDOMENINGOCELE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RECTAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RECTAL TENESMUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>REFUSAL OF TREATMENT BY PATIENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STAPHYLOCOCCAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYSTEMIC LUPUS ERYTHEMATOSUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TEMPERATURE INTOLERANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THINKING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRICUSPID VALVE INCOMPETENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UPPER RESPIRATORY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URETHRAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINE KETONE BODY PRESENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINE LEUKOCYTE ESTERASE POSITIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UROBILIN URINE PRESENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UROGENITAL PROLAPSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URTICARIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VAGINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VASCULITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VIRAL PHARYNGITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISION BLURRED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VULVOVAGINAL MYCOTIC INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEGENER'S GRANULOMATOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>18662</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19961229</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19970221</drugenddate>
        <drugtreatmentduration>55</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054054-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060711</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-13440276</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BREAST CANCER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ESTRACE</medicinalproduct>
        <drugauthorizationnumb>084499</drugauthorizationnumb>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROVERA</medicinalproduct>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054055-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060711</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-13439229</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>OVARIAN CANCER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ESTRACE</medicinalproduct>
        <drugauthorizationnumb>084499</drugauthorizationnumb>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054056-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060711</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-13439179</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BREAST CANCER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ESTRACE</medicinalproduct>
        <drugauthorizationnumb>084499</drugauthorizationnumb>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ESTRADIOL</medicinalproduct>
        <drugauthorizationnumb>084499</drugauthorizationnumb>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MEDROXYPROGESTERONE</medicinalproduct>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCRIN</medicinalproduct>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054057-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060404</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>MX-BRISTOL-MYERS SQUIBB COMPANY-13335716</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>71</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CISPLATIN</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>GASTRIC CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060313</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060313</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUOROURACIL</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>GASTRIC CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060313</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060318</drugenddate>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KETOROLAC TROMETHAMINE</medicinalproduct>
        <drugadministrationroute>060</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060326</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NYSTATIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>STOMATITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060325</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060328</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054058-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060707</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-BRISTOL-MYERS SQUIBB COMPANY-13444237</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>66</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ERBITUX</medicinalproduct>
        <drugindication>COLORECTAL CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030613</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060704</drugenddate>
        <drugtreatmentduration>21</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IRINOTECAN</medicinalproduct>
        <drugindication>COLORECTAL CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060613</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEUCOVORIN CALCIUM</medicinalproduct>
        <drugindication>COLORECTAL CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060613</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUOROURACIL</medicinalproduct>
        <drugindication>COLORECTAL CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060613</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054059-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060308</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-13307277</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>78</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>DISEASE PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HYDREA</medicinalproduct>
        <drugauthorizationnumb>16295</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ESSENTIAL THROMBOCYTHAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19920917</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050929</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NITROSTAT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIBRIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TIAZAC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CODEINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONIDINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054061-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060501</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-13364237</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>77</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HAEMATURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFUSION RELATED REACTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ERBITUX</medicinalproduct>
        <drugdosagetext>FIRST DOSE (400 MG).</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>HYPOPHARYNGEAL CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060420</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060420</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRONOLACTONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRAVACHOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOPRESSOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZANTAC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054062-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060320</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-13320973</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>21</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALIGNANT NEOPLASM PROGRESSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MEGACE</medicinalproduct>
        <drugauthorizationnumb>16979</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANOREXIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051001</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054063-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060630</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006-141427-NL</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>38</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HEPATIC STEATOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MARVELON</medicinalproduct>
        <drugauthorizationnumb>20071</drugauthorizationnumb>
        <drugdosagetext>DF ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONTRACEPTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060301</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054064-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060627</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>226595</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>50</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>57</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>GASTROENTERITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVASTIN</medicinalproduct>
        <drugdosagetext>279 MG, Q2W, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLORECTAL CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060509</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXALIPLATIN (OXALIPLATIN)</medicinalproduct>
        <drugdosagetext>139 MG, Q2W, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLORECTAL CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060509</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVOLEUCOVORIN CALCIUM (LEVOLEUCOVORIN CALCIUM)</medicinalproduct>
        <drugdosagetext>164 MG, Q2W, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLORECTAL CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060509</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUOROURACIL</medicinalproduct>
        <drugdosagetext>1637 MG, Q2W, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLORECTAL CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060509</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LACTOBACILLUS BIFIDUS (LACTOBACILLUS BIFIDUS)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGNESIUM OXIDE (MAGNESIUM OXIDE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONAZEPAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BETAMETHASONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CHLORHEXIDINE (CHLORHEXIDINE GLUCONATE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054065-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060627</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>223204</companynumb>
    <primarysource>
      <reportercountry>HONG KONG</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>44</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>39.2</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MENORRHAGIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVASTIN</medicinalproduct>
        <drugdosagetext>191MG, Q2W, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLORECTAL CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051104</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060615</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IRINOTECAN HCL</medicinalproduct>
        <drugdosagetext>170 MG, Q2W, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLORECTAL CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051104</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUOROURACIL</medicinalproduct>
        <drugdosagetext>2270 MG, Q2W, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLORECTAL CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051104</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEUCOVORIN (LEUCOVORIN CALCIIUM)</medicinalproduct>
        <drugdosagetext>190 MG, Q2W, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLORECTAL CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051104</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRANSAMIN (TRANEXAMIC ACID)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FERROUS FUMARATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIVER EXTRACT (LIVER EXTRACT)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN B (VITAMIN NOS)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMOVANE (ZOPICLONE)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054067-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>230041K06GBR</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>43</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABORTION SPONTANEOUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOOD SWINGS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBIF</medicinalproduct>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOCLOPRAMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054068-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>230008M06FRA</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>36</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IDIOPATHIC THROMBOCYTOPENIC PURPURA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE SCLEROSIS RELAPSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PREMATURE SEPARATION OF PLACENTA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROTEIN TOTAL INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STRESS AT WORK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VIRAL INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBIF</medicinalproduct>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050301</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBIF</medicinalproduct>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051214</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VENLAFAXINE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONAZEPAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLPIDEM TARTRATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ORAL CONTRACEPTIVE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054069-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060418</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006-141427-NL</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
    </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>MARVELON</medicinalproduct>
        <drugauthorizationnumb>20071</drugauthorizationnumb>
        <drugdosagetext>DF</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051201</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054071-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>230044M06GBR</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>43</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBIF</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054072-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060627</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ACO_0243_2006</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>71</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DELIRIUM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JOINT CONTRACTURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZANAFLEX</medicinalproduct>
        <drugbatchnumb>4K192</drugbatchnumb>
        <drugauthorizationnumb>20397</drugauthorizationnumb>
        <drugdosagetext>VAR 3X/DAY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NEURALGIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060613</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060622</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugbatchnumb>0039125</drugbatchnumb>
        <drugdosagetext>75 MG QDAY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NEURALGIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060622</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060624</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACTONEL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CILAZAPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANTOPRAZOLE SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COMTAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DETROL LA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONAZEPAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EZETROL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SINEMET</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENDOCET</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054074-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060630</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006MP000408</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>54</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG ERUPTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPHONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SALAGEN</medicinalproduct>
        <drugauthorizationnumb>20237</drugauthorizationnumb>
        <drugdosagetext>15 MG; QD; PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRY MOUTH</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060119</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALOSENN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOXONIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054075-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>224315</companynumb>
    <primarysource>
      <reportercountry>DENMARK</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>57</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>87</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>HEPATIC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATITIS B</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATOTOXICITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MABTHERA (RITUXIMAB)CONC FOR SOLUTION FOR INFUSION</medicinalproduct>
        <drugbatchnumb>B0032</drugbatchnumb>
        <drugdosagetext>800 MG, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CHRONIC LYMPHOCYTIC LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060131</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060330</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOPHOSPHAMIDE</medicinalproduct>
        <drugdosagetext>535 MG, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CHRONIC LYMPHOCYTIC LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060330</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUDARABINE</medicinalproduct>
        <drugdosagetext>53 MG, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CHRONIC LYMPHOCYTIC LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060131</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060330</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SULFATRIM (SULFAMETHOXAZOLE, TRIMETHOPRIM)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALMODAN (AMOXICILLIN SODIUM)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEUPOGEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054076-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060626</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-JNJFOC-20060606663</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE ROLLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POSTURE ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMINYL</medicinalproduct>
        <drugauthorizationnumb>021169</drugauthorizationnumb>
        <drugindication>DEMENTIA ALZHEIMER'S TYPE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EPILEM (EPIRUBICIN HYDROCHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THYROXINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPRO (ASCORBIC ACID/ACETYLSALICYLIC ACID)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054077-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060710</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-JNJFOC-20060702680</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>5</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>26</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYLENOL (CAPLET)</medicinalproduct>
        <drugbatchnumb>GEL085</drugbatchnumb>
        <drugauthorizationnumb>19872</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYLENOL (CAPLET)</medicinalproduct>
        <drugbatchnumb>GEL085</drugbatchnumb>
        <drugauthorizationnumb>019872</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PYREXIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054078-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060707</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-JNJFOC-20060200270</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>50</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PNEUMOCYSTIS JIROVECI PNEUMONIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SALAZOPYRIN</medicinalproduct>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RIMATIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLAMIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NASOPHARYNGITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLOMOX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NASOPHARYNGITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054079-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060707</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20050506099</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>102.06</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSARTHRIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ECONOMIC PROBLEM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOKINESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JOINT INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEMORY IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MIGRAINE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ROAD TRAFFIC ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN LACERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPEECH DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TINNITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREATMENT NONCOMPLIANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VITAMIN B12 DEFICIENCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOPAMAX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOPAMAX</medicinalproduct>
        <drugdosagetext>DOSE UNSPECIFIED</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>MIGRAINE</drugindication>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOPAMAX</medicinalproduct>
        <drugauthorizationnumb>020505</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HEADACHE</drugindication>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMOXICILLIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054080-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060707</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20051003796</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>117.48</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>AMNESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRONCHITIS ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONJUNCTIVITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIABETES MELLITUS NON-INSULIN-DEPENDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EJACULATION FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROOESOPHAGEAL REFLUX DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHOIDAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOOD SWINGS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POLLAKIURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSYCHOTIC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SCHIZOPHRENIA, PARANOID TYPE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UPPER RESPIRATORY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERDAL</medicinalproduct>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040701</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERDAL</medicinalproduct>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040701</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERDAL</medicinalproduct>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040701</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERDAL</medicinalproduct>
        <drugdosagetext>2 MG IN THE MORNING; 3 MG AT BEDTIME</drugdosagetext>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040701</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERDAL</medicinalproduct>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040701</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERDAL</medicinalproduct>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040701</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERDAL</medicinalproduct>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040701</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERDAL</medicinalproduct>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040701</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERDAL</medicinalproduct>
        <drugauthorizationnumb>020272</drugauthorizationnumb>
        <drugdosagetext>START TITRATE 1 TO 3 MG TWICE DAILY</drugdosagetext>
        <drugindication>SCHIZOAFFECTIVE DISORDER</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040701</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRILAFON</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAZODONE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BUSPAR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOTROL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOPHAGE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREVACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRECOSE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WELLBUTRIN SR</medicinalproduct>
        <drugdosagetext>150 MG DAILY X 1 WEEK THEN TWICE DAILY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054083-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060626</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006JP001905</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>17</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>LYMPHOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROTOPIC</medicinalproduct>
        <drugauthorizationnumb>50777</drugauthorizationnumb>
        <drugdosagetext>TOPICAL</drugdosagetext>
        <drugadministrationroute>061</drugadministrationroute>
        <drugindication>DERMATITIS ATOPIC</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054085-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060711</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006S1000134</companynumb>
    <primarysource>
      <reportercountry>BELGIUM</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>7</patientonsetage>
      <patientonsetageunit>804</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CANDIDA SEPSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CAPILLARY LEAK SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBRAL VENTRICLE DILATATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISSEMINATED INTRAVASCULAR COAGULATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTESTINAL PERFORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTRAVENTRICULAR HAEMORRHAGE NEONATAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEONATAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEONATAL HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEONATAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PATENT DUCTUS ARTERIOSUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INOMAX</medicinalproduct>
        <drugbatchnumb>02888</drugbatchnumb>
        <drugauthorizationnumb>20845</drugauthorizationnumb>
        <drugdosagetext>5 PPM; INH_GAS; INH, CONT INH</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>LUNG DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060626</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INOMAX</medicinalproduct>
        <drugbatchnumb>02888</drugbatchnumb>
        <drugauthorizationnumb>20845</drugauthorizationnumb>
        <drugdosagetext>5 PPM; INH_GAS; INH, CONT INH</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060626</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CAFFEINE (CAFFEINE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MICONAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VANCOMYCIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CEFOTAXIME SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METRONIDAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FENTANYL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATROPINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMPICILLIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUCONAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SODIUM BICARBONATE IN PLASTIC CONTAINER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FENTANYL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054086-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060627</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CERZ-11266</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>31</patientonsetage>
      <patientonsetageunit>802</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CEREZYME</medicinalproduct>
        <drugauthorizationnumb>20367</drugauthorizationnumb>
        <drugindication>GAUCHER'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041102</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054087-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060630</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GXKR2006ES03716</companynumb>
    <primarysource>
      <reportercountry>SPAIN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>7</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ENANTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EPSTEIN-BARR VIRUS ANTIBODY POSITIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA MULTIFORME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TYPE IV HYPERSENSITIVITY REACTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMOXICILLIN-CLAVULANIC ACID (NGX)(AMOXICILLIN, CLAVULANATE) UNKNOWN</medicinalproduct>
        <drugauthorizationnumb>89959</drugauthorizationnumb>
        <drugindication>PYREXIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
        <drugindication>MONONUCLEOSIS SYNDROME</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054089-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060703</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DEU-2006-0002311</companynumb>
    <primarysource>
      <reportercountry>AUSTRIA</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>20</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>INCORRECT ROUTE OF DRUG ADMINISTRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MORPHINE SULFATE</medicinalproduct>
        <drugauthorizationnumb>19516</drugauthorizationnumb>
        <drugdosagetext>INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>DRUG ABUSER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054090-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060706</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006BI009634</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>42</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>68</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <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>20060621</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACTRAPID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVEMIR</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054092-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>220195</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>56</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BENIGN PROSTATIC HYPERPLASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERECTILE DYSFUNCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROSTATE CANCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROSTATIC SPECIFIC ANTIGEN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSORIASIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EFALIZUMAB(EFALIZUMAB) PWDR + SOLVENT,INJECTION SOLN, 125MG</medicinalproduct>
        <drugdosagetext>0.8 ML, 1/WEEK, SUBCUTANEOUS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PSORIASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050411</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050921</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054093-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>226914</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
    </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>CHOLESTASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPLENOMEGALY</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>20060210</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060421</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROXYZINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BETAMETHASONE DIPROPIONATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SALICYLIC ACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DESLORATADINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SALICYLIC ACID</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054094-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060627</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>226859</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>45</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>62</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ECZEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XOLAIR</medicinalproduct>
        <drugdosagetext>225 , Q2W</drugdosagetext>
        <drugindication>ASTHMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050921</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051129</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XOLAIR</medicinalproduct>
        <drugdosagetext>225 MG, SUBCUTANEOUS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060619</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTIHISTAMINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054095-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060704</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>226976</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>12</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BIOPSY KIDNEY ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD AMYLASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CANDIDIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CELLULITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBRAL ATROPHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIALYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EMBOLISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ENCEPHALITIS BRAIN STEM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIPASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LISTERIA ENCEPHALITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEPHROPATHY TOXIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCREATIC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSEUDOMONAS INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL TUBULAR DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MABTHERA(RITUXIMAB) CONC FOR SOLUTION FOR INFUSION</medicinalproduct>
        <drugdosagetext>525 MG, 1/WEEK, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>SYSTEMIC LUPUS ERYTHEMATOSUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020419</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060425</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELLCEPT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THALIDOMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEORAL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COZAAR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE TAB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SOLU-MEDROL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POLARAMINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PERFALGAN (ACETAMINOPHEN)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054096-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060630</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>02100-JPN-05-0568</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>84</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>INTERSTITIAL LUNG DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CILOSTAZOL</medicinalproduct>
        <drugauthorizationnumb>20863</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030801</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054099-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>111200ISR</companynumb>
    <primarysource>
      <reportercountry>CROATIA (local name: Hrvatska)</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>30</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BILE DUCT STONE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLINDNESS UNILATERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CHOLESTEROL INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CREATINE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD TRIGLYCERIDES INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD URIC ACID INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>C-REACTIVE PROTEIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHILLS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHOLANGITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHOLECYSTITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHOLELITHIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATOCRIT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OBSTRUCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RED BLOOD CELL SEDIMENTATION RATE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RETICULOCYTE PERCENTAGE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RETINAL VEIN THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOSPORINE</medicinalproduct>
        <drugauthorizationnumb>50738</drugauthorizationnumb>
        <drugdosagetext>100 MILLIGRAM BID</drugdosagetext>
        <drugindication>TRANSPLANT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AZATHIOPRINE SODIUM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054100-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060626</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2005EU002413</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>56</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ASCITES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG TOXICITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATORENAL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPONATRAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>KIDNEY TRANSPLANT REJECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FK506(TACROLIMUS CAPSULES)(TACROLIMUS) CAPSULE</medicinalproduct>
        <drugauthorizationnumb>50708</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugindication>LIVER TRANSPLANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040125</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040125</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FK506(TACROLIMUS CAPSULES)(TACROLIMUS) CAPSULE</medicinalproduct>
        <drugauthorizationnumb>50708</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugindication>LIVER TRANSPLANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040126</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040126</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FK506(TACROLIMUS CAPSULES)(TACROLIMUS) CAPSULE</medicinalproduct>
        <drugauthorizationnumb>50708</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugindication>LIVER TRANSPLANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041229</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050124</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MYCOPHENOLATE MOFETIL</medicinalproduct>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugindication>LIVER TRANSPLANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041228</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041231</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MYCOPHENOLATE MOFETIL</medicinalproduct>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugindication>LIVER TRANSPLANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHYLPREDNISOLONE</medicinalproduct>
        <drugdosagetext>250.00 MG, UID/QD,</drugdosagetext>
        <drugindication>LIVER TRANSPLANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041229</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISONE TAB</medicinalproduct>
        <drugdosagetext>20.00 MG, UID/QD,</drugdosagetext>
        <drugindication>LIVER TRANSPLANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050119</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAZOCILLINE (PIPERACILLIN SODIUM, TAZOBACTAM SODIUM)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054101-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>SGB1-2006-00290</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>38</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD CALCIUM ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CHLORIDE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LACERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTH FRACTURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LANTHANUM CARBONATE(LANTHANUM CARBONATE) TABLET CHEWABLE</medicinalproduct>
        <drugauthorizationnumb>21468</drugauthorizationnumb>
        <drugdosagetext>750MG, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERPHOSPHATAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060508</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060520</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENALAPRIL MALEATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NIFEDIPINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOXAZOSIN MESYLATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BLOPRESS (CANDESARTAN CILEXETIL)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALFAROL (ALFACALCIDOL)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054102-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006JP001847</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>34</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>THROMBOTIC MICROANGIOPATHY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROGRAF</medicinalproduct>
        <drugauthorizationnumb>50708</drugauthorizationnumb>
        <drugindication>BONE MARROW TRANSPLANT</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054103-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060630</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006JP001556</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>66</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>56</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEPHROTIC SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROGRAF</medicinalproduct>
        <drugauthorizationnumb>50708</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MYASTHENIA GRAVIS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060525</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROGRAF</medicinalproduct>
        <drugauthorizationnumb>50708</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MYASTHENIA GRAVIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031023</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAKEPRON (LANSOPRAZOLE) TABLET</medicinalproduct>
        <drugdosagetext>30 MG, UID/QD, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031029</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MESTINON</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX (FUROSEMIDE SODIUM) TABLET</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDONINE (PREDNISOLONE SODIUM SUCCINATE) TABLET</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PERSANTIN (DIPYRIDAMOLE) CAPSULE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MUCOSTA (REBAMIPIDE) TABLET</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIN (AMLODIPINE BESILATE) TABLET</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FERRUM (SACCHARATED IRON OXIDE) CAPSULE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PURSENNID (SENNOSIDE A+B CALCIUM) TABLET</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADALAT CONTROLLED RELEASE TABLET</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FRANDOL (ISOSORBIDE DINITRATE) TAPE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054104-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060712</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PL-JNJFOC-20060701634</companynumb>
    <primarysource>
      <reportercountry>POLAND</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>80</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BLINDED; ABCIXIMA</medicinalproduct>
        <drugauthorizationnumb>8135</drugauthorizationnumb>
        <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>ATROPINE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BRADYCARDIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CORDARONE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>VENTRICULAR FIBRILLATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MORPHINE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ANALGESIC EFFECT</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054105-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006JP001418</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>69</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TACROLIMUS CAPSULES(TACROLIMUS CAPSULES)(TACROLIMUS) CAPSULE</medicinalproduct>
        <drugauthorizationnumb>50708</drugauthorizationnumb>
        <drugdosagetext>1 MG, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060407</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060417</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugdosagetext>5 MG, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MOBIC (MELOXICAM) PER ORAL NOS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MUCOSTA (REBAMIPIDE) PER ORAL NOS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ONEALFA (ALFACALCIDOL) PER ORAL NOS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANALDINE (TICLOPIDINE HYDROCHLORIDE) PER ORAL NOS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BAYASPIRIN PER ORAL NOS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054106-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060705</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006JP002011</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>72</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANOREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VESICARE</medicinalproduct>
        <drugauthorizationnumb>21518</drugauthorizationnumb>
        <drugdosagetext>5 MG, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060613</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060627</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BLOPRESS (CANDESARTAN CILEXETIL) PER ORAL NOS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALFAROL (ALFACALCIDOL) PER ORAL NOS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GASMOTIN (MOSAPRIDE CITRATE) PER ORAL NOS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAKEPRON (LANSOPRAZOLE) PER ORAL NOS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADALAT PER ORAL NOS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054107-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesscongenitalanomali>1</seriousnesscongenitalanomali>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060630</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006EU001962</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>1.3</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>APGAR SCORE LOW</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CAESAREAN SECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONGENITAL ANOMALY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE BEFORE PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FOETAL GROWTH RETARDATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMANGIOMA CONGENITAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEURAL TUBE DEFECT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PREMATURE BABY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SMALL FOR DATES BABY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPINA BIFIDA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VESICARE</medicinalproduct>
        <drugauthorizationnumb>21518</drugauthorizationnumb>
        <drugdosagetext>10 MG, UID/QD, TRANSPLACENTAL</drugdosagetext>
        <drugadministrationroute>064</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELESTONE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054108-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060630</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006EU001958</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>36</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>45</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CAESAREAN SECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OBSTETRIC PROCEDURE COMPLICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLACENTAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRE-ECLAMPSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SCAR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VESICARE</medicinalproduct>
        <drugauthorizationnumb>21518</drugauthorizationnumb>
        <drugdosagetext>10 MG, UID/QD, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTIHYPERTENSIVES</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELESTONE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054109-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060703</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>YEHQ20051443</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>LICHENOID KERATOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VESICARE</medicinalproduct>
        <drugauthorizationnumb>21518</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTONIC BLADDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054110-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060707</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006070321</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>74</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>50</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALNUTRITION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INTRALIPID 20%</medicinalproduct>
        <drugdosagetext>200 ML, 1 IN 1 D, INTRAVENOUS DRIP</drugdosagetext>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>PARENTERAL NUTRITION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060508</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MEROPEN (MEROPENEM) (MEROPENEM)</medicinalproduct>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>ANTIBIOTIC PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060407</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060421</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MEROPEN (MEROPENEM) (MEROPENEM)</medicinalproduct>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>ANTIBIOTIC PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060502</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060511</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLINDAMYCIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FULCALIQ (SOLUTIONS FOR PARENTERAL NUTRITION) (MULTIVITAMINS, DEXTROSE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GRAMALIL (TIAPRIDE HYDROCHLORIDE) (TIAPRIDE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PARIET (RABEPRAZOLE SODIUM) (RABEPRAZOLE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RENIVACE (ENALAPRIL MALEATE) (ENALAPRIL)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGMITT (MAGNESIUM OXIDE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THYRADIN S (LEVOTHYROXINE SODIUM) (LEVOTHYROXINE)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054111-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060524</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-AVENTIS-200611598JP</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>74</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ALANINE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AORTIC ARTERIOSCLEROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTERIOSCLEROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTERIOSCLEROSIS CORONARY ARTERY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASPARTATE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>C-REACTIVE PROTEIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISEASE RECURRENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISSEMINATED INTRAVASCULAR COAGULATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EMBOLISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ESCHERICHIA INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GLOMERULAR VASCULAR DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOLYTIC ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGIC DIATHESIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC NECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERKALAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JAUNDICE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER ABSCESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPHADENOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METASTASES TO LYMPH NODES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTI-ORGAN FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCREATIC NEOPLASM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL TUBULAR NECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SHOCK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENTRICULAR FIBRILLATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAXOTERE</medicinalproduct>
        <drugauthorizationnumb>20449</drugauthorizationnumb>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>GASTRIC CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060317</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060317</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAXOTERE</medicinalproduct>
        <drugauthorizationnumb>020449</drugauthorizationnumb>
        <drugadministrationroute>041</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060421</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060421</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZANTAC</medicinalproduct>
        <drugdosagetext>DOSE: 1 AMPULE</drugdosagetext>
        <drugindication>PREMEDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SEROTONE</medicinalproduct>
        <drugdosagetext>DOSE: 1 AMPULE</drugdosagetext>
        <drugindication>PREMEDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DECADRON</medicinalproduct>
        <drugdosagetext>DOSE: 3 AMPLES</drugdosagetext>
        <drugindication>PREMEDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054112-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060711</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-AVENTIS-200617183GDDC</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>62</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>82</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>CARDIAC ARREST</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOCETAXEL</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>20449</drugauthorizationnumb>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PROSTATE CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060509</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060620</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROSTATE CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060511</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOLEDRONIC ACID</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PROSTATE CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060509</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060620</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLOPIDOGREL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALSARTAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EZETIMIBE/SIMVASTATIN</medicinalproduct>
        <drugdosagetext>DOSE: 10/20</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054113-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060704</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-NOVOPROD-254621</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HYPOGLYCAEMIC COMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NOVONORM</medicinalproduct>
        <drugauthorizationnumb>20741</drugauthorizationnumb>
        <drugdosagetext>.5 MG, QID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS NON-INSULIN-DEPENDENT</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054114-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060301</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-NOVOPROD-251339</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>14</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>43</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANTI-INSULIN ANTIBODY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NOVORAPID CHU</medicinalproduct>
        <drugdosagetext>60 IU, QD</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>DIABETES MELLITUS INSULIN-DEPENDENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030301</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PENFILL N CHU</medicinalproduct>
        <drugauthorizationnumb>019959</drugauthorizationnumb>
        <drugdosagetext>69 IU, QD</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>DIABETES MELLITUS INSULIN-DEPENDENT</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054115-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060302</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-NOVOPROD-251276</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>8</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>39</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BENIGN INTRACRANIAL HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIPLOPIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STRABISMUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NORDITROPIN SIMPLEXX</medicinalproduct>
        <drugauthorizationnumb>21148</drugauthorizationnumb>
        <drugdosagetext>1.3 MG, QD</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>BODY HEIGHT BELOW NORMAL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050811</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051006</drugenddate>
        <drugtreatmentduration>80640</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUDROCORTISONE</medicinalproduct>
        <drugdosagetext>150 UG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ADRENOGENITAL SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19970418</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCORTISONE</medicinalproduct>
        <drugdosagetext>7.5 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ADRENOGENITAL SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031116</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugdosagetext>2 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ADRENOGENITAL SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031116</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEUPRORELIN</medicinalproduct>
        <drugdosagetext>11.25 MG, QD</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>BODY HEIGHT BELOW NORMAL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050725</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054116-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060706</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-NOVOPROD-254675</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>60</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BRAIN HERNIATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRAIN OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVERDOSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIXTARD HUMAN 70/30</medicinalproduct>
        <drugauthorizationnumb>19991</drugauthorizationnumb>
        <drugdosagetext>60 U, BID</drugdosagetext>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054117-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060707</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-NOVOPROD-254735</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>14</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>54</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VIRAL UPPER RESPIRATORY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NORDITROPIN SIMPLEXX</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021148</drugauthorizationnumb>
        <drugdosagetext>1.92 MG, QD</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>GROWTH HORMONE DEFICIENCY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19970403</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PULMICORT</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040630</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RITALIN-SR</medicinalproduct>
        <drugdosagetext>UNK, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATTENTION DEFICIT/HYPERACTIVITY DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040630</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054118-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060622</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-NOVOPROD-254354</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>71</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>62</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NOVORAPID PENFILL</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>20986</drugauthorizationnumb>
        <drugdosagetext>6 IU, QID</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>INSULIN-REQUIRING TYPE II DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060531</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060621</drugenddate>
        <drugtreatmentduration>30240</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NOVORAPID PENFILL</medicinalproduct>
        <drugauthorizationnumb>020986</drugauthorizationnumb>
        <drugdosagetext>4 IU, QD</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060621</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN GLARGINE</medicinalproduct>
        <drugdosagetext>48 IU, QD</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051006</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOFORMIN</medicinalproduct>
        <drugdosagetext>850 G, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000607</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugdosagetext>10 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050321</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugdosagetext>10 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990304</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054119-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060626</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-NOVOPROD-254554</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>75</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BALLISMUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PENFILL 30R CHU</medicinalproduct>
        <drugauthorizationnumb>19991</drugauthorizationnumb>
        <drugdosagetext>36 IU, QD</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>INSULIN-REQUIRING TYPE II DIABETES MELLITUS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040116</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>100 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054120-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060706</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-NOVOPROD-254804</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>43</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ELECTROCARDIOGRAM ST-T CHANGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EXTRASYSTOLES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROCEDURAL COMPLICATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NOVOSEVEN</medicinalproduct>
        <drugindication>SURGERY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054121-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060313</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-NOVOPROD-251559</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>100</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE VESICLES</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVEMIR</medicinalproduct>
        <drugauthorizationnumb>21536</drugauthorizationnumb>
        <drugindication>DIABETES MELLITUS INSULIN-DEPENDENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060211</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060227</drugenddate>
        <drugtreatmentduration>23040</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NOVORAPID</medicinalproduct>
        <drugindication>DIABETES MELLITUS INSULIN-DEPENDENT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOPHAGE                         /00082701/</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054122-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>SU-2006-005134</companynumb>
    <primarysource>
      <reportercountry>COLOMBIA</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>81</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD CREATININE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD POTASSIUM INCREASED</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>20060401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060601</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CONCOR</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054123-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060704</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006EU001824</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>BACTERIAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GRAFT VERSUS HOST DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTHERMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTI-ORGAN FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NIKOLSKY'S SIGN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PATHOGEN RESISTANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STAPHYLOCOCCAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOXIC EPIDERMAL NECROLYSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROGRAF</medicinalproduct>
        <drugauthorizationnumb>50708</drugauthorizationnumb>
        <drugdosagetext>UID/QD, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>LIVER TRANSPLANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060503</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060522</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELLCEPT</medicinalproduct>
        <drugdosagetext>D, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>LIVER TRANSPLANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060512</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060515</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SOLU-MEDROL</medicinalproduct>
        <drugdosagetext>IV NOS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060503</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054124-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060710</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>THQ2005A00807</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>70</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE FRAGMENTATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FACE INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GINGIVAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEAD INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN JAW</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SCRATCH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUS BRADYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ULCER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEUPROLIDE ACETATE</medicinalproduct>
        <drugauthorizationnumb>19010</drugauthorizationnumb>
        <drugdosagetext>22.5 MG (22.5 MG, 1 IN 3 M) INTRAMSUCULAR</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041012</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050110</drugenddate>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOLEDRONIC ACID</medicinalproduct>
        <drugdosagetext>(4.0 MG/100 ML) INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041018</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050818</drugenddate>
        <drugtreatmentduration>305</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
        <drugdosagetext>(50 MG)</drugdosagetext>
        <drugindication>HYPERTENSION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051024</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054125-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006US001422</companynumb>
    <primarysource>
      <reportercountry>CHILE</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>26</patientonsetage>
      <patientonsetageunit>802</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CENTRAL NERVOUS SYSTEM LYMPHOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EPSTEIN-BARR VIRUS ANTIBODY POSITIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPHOPROLIFERATIVE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NON-HODGKIN'S LYMPHOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROGRAF</medicinalproduct>
        <drugauthorizationnumb>50708</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS AGAINST TRANSPLANT REJECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MYCOPHENOLATE MOFETIL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054126-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060626</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006JP001897</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>73</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>54</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>LUMBAR VERTEBRAL FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA BACTERIAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TACROLIMUS CAPSULES (TACROLIMUS) CAPSULE</medicinalproduct>
        <drugauthorizationnumb>50708</drugauthorizationnumb>
        <drugdosagetext>2 MG, D, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051214</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060111</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060119</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060120</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060202</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060203</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060216</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060217</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060316</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060317</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060421</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060422</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060524</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060525</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, WEEKLY</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060111</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060502</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VOLTAREN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RABEPRAZOLE SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALFAROL(ALFACALCIDOL)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HARNAL (TAMSULOSIN HYDROCHLORIDE) ORODISPERSABLE CR TABLET</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ISONIAZID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PYDOXAL (PYRIDOXAL PHOSPHATE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGLAX (MAGNESIUM OXIDE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TICLOPIDINE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MYONAL (EPERISONE HYDROCHLORIDE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CEROCRAL (IFENPRODIL TARTRATE)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054127-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060705</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006JP001813</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>64</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>INTERSTITIAL LUNG DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMOCYSTIS JIROVECI PNEUMONIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TACROLIMUS CAPSULES (TACROLIMUS) CAPSULE</medicinalproduct>
        <drugauthorizationnumb>50708</drugauthorizationnumb>
        <drugdosagetext>2 MG, D, ORAL; 3 MG, D, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060302</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060315</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TACROLIMUS CAPSULES (TACROLIMUS) CAPSULE</medicinalproduct>
        <drugauthorizationnumb>50708</drugauthorizationnumb>
        <drugdosagetext>2 MG, D, ORAL; 3 MG, D, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060316</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060620</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugdosagetext>12 MG, D, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060620</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GASTER PER ORAL NOS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MOBIC (MELOXICAM) PER ORAL NOS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC (AMLODIPINE BESILATE) PER ORAL NOS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOXONIN (LOXOPROFEN) PER ORAL NOS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR (ATORVASTATIN CALCIUM) PER ORAL NOS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZON (OMEPRAZOLE) PER ORAL NOS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROMAC (POLAPREZINC) PER ORAL NOS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MUCOSTA (REBAMIPIDE) PER ORAL NOS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOSAMAC (ALENDRONATE SODIUM) PER ORAL NOS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054128-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060630</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006RL000166</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>57</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANAPHYLACTIC SHOCK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FOOD ALLERGY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RYTHMOL</medicinalproduct>
        <drugauthorizationnumb>19151</drugauthorizationnumb>
        <drugdosagetext>1 DF;QD;PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE W/IRBESARTAN (KARVEA HCT)</medicinalproduct>
        <drugdosagetext>PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060220</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHOLESTEROL COMPLEX (NO PREF. NAME)</medicinalproduct>
        <drugdosagetext>PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060220</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054129-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060703</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006EU001985</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>64</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>88</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>CYSTITIS HAEMORRHAGIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG TOXICITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATORENAL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENOOCCLUSIVE DISEASE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FK506 (TACROLIMUS) CAPSULE</medicinalproduct>
        <drugauthorizationnumb>50708</drugauthorizationnumb>
        <drugdosagetext>4 MG, D, ORAL; 0.001 MG/KG, D, IV</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GRAFT VERSUS HOST DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060515</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060612</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FK506 (TACROLIMUS) CAPSULE</medicinalproduct>
        <drugauthorizationnumb>50708</drugauthorizationnumb>
        <drugdosagetext>4 MG, D, ORAL; 0.001 MG/KG, D, IV</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GRAFT VERSUS HOST DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060622</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060625</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EVEROLIMUS(EVEROLIMUS)</medicinalproduct>
        <drugdosagetext>0.75 MG, D, ORAL; 1 MG, BID, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GRAFT VERSUS HOST DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060515</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060612</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EVEROLIMUS(EVEROLIMUS)</medicinalproduct>
        <drugdosagetext>0.75 MG, D, ORAL; 1 MG, BID, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GRAFT VERSUS HOST DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060620</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060624</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYCLOSPORINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054130-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006JP001385</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>51</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>APHASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBRAL ARTERITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBRAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBRAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR STENOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMMUNICATION DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSED LEVEL OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPEECH DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VASCULITIS CEREBRAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROGRAF</medicinalproduct>
        <drugauthorizationnumb>50708</drugauthorizationnumb>
        <drugdosagetext>3 MG, CONTINUOUS, IV DRIP</drugdosagetext>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>LIVER TRANSPLANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060304</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060331</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROGRAF</medicinalproduct>
        <drugdosagetext>BID, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>LIVER TRANSPLANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060516</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SOL MEDROL (METHYLPREDNISOLONE, SUCCINATE SODIUM) INJECTION</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDROL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAKEPRON (LANSOPRAZOLE) PER ORAL NOS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX (FUROSEMIDE) PER ORAL NOS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SULPERASON (CEFOPERAZONE, SULBACTAM) INJECTION</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>STRONG NEO-MINOPHAGEN C (AMINOACETIC ACID, GLYCYRRHIZIC ACID, CYSTEINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VENOGLOBULIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNASYN S (AMPICILIN SODIUM, SULBACTAM SODIUM) INJECTION</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PEG-INTRON</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROSTANDIN (ALPROSTADIL) INJECTION</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REBETOL (RIBAVIRIN) TABLET</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054131-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006JP001194</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>25</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>33</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENTAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE DRUG OVERDOSE INTENTIONAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERSECUTORY DELUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDE ATTEMPT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TACROLIMUS CAPSULES(TACROLIMUS) CAPSULE</medicinalproduct>
        <drugauthorizationnumb>50708</drugauthorizationnumb>
        <drugdosagetext>1 MG, UID/QD, ORAL; 2 MG UID/QD, ORAL; 54 DF D, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060112</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060208</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TACROLIMUS CAPSULES(TACROLIMUS) CAPSULE</medicinalproduct>
        <drugauthorizationnumb>50708</drugauthorizationnumb>
        <drugdosagetext>1 MG, UID/QD, ORAL; 2 MG UID/QD, ORAL; 54 DF D, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060209</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060424</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TACROLIMUS CAPSULES(TACROLIMUS) CAPSULE</medicinalproduct>
        <drugauthorizationnumb>50708</drugauthorizationnumb>
        <drugdosagetext>1 MG, UID/QD, ORAL; 2 MG UID/QD, ORAL; 54 DF D, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060424</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060424</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RHEUMATREX</medicinalproduct>
        <drugdosagetext>16 DF, D, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060424</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060424</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VOLTAREN</medicinalproduct>
        <drugdosagetext>25 MG, UID/QD, RECTAL</drugdosagetext>
        <drugadministrationroute>054</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VOLTAREN</medicinalproduct>
        <drugdosagetext>183 DF, D, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060424</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060424</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LENDORMIN (BROTIZOLAM) TABLET</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RIMATIL (BUCILLAMINE) TABLET</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ETODOLAC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>APLACE (TORXIPIDE) TABLET</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACINON (NIZATIDINE) CAPSULE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLEGRA (FEXOFENADINE HYDROCHLORIDE) TABLET</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054132-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006JP001166</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>74</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>46.2</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CREATINE PHOSPHOKINASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD SODIUM DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>C-REACTIVE PROTEIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERCREATININAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOKALAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULAR WEAKNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NERVOUS SYSTEM DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROGRAF</medicinalproduct>
        <drugauthorizationnumb>50708</drugauthorizationnumb>
        <drugdosagetext>1 MG, UID/QD, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060316</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060413</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RHEUMATREX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NABOAL SLOW RELEASE CAPSULES</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EVISTA</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054133-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060703</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>29479</companynumb>
    <primarysource>
      <reportercountry>SWEDEN</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>70</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>LUNG INFILTRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLEURAL EFFUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAMBOCOR</medicinalproduct>
        <drugauthorizationnumb>18830</drugauthorizationnumb>
        <drugdosagetext>200 MG (100 MG, 2 IN 1 DAY (S)) ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL SUCCINATE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054134-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060706</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>MEDI-0004742</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>12</patientonsetage>
      <patientonsetageunit>802</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>URINARY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SYNAGIS</medicinalproduct>
        <drugdosagetext>1 IN 1 M, INTRAMUSCULAR</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>ANTIVIRAL PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051018</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060210</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SYNAGIS</medicinalproduct>
        <drugdosagetext>1 IN 1 M, INTRAMUSCULAR</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>ANTIVIRAL PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051018</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SYNAGIS</medicinalproduct>
        <drugdosagetext>1 IN 1 M, INTRAMUSCULAR</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>ANTIVIRAL PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051118</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SYNAGIS</medicinalproduct>
        <drugdosagetext>1 IN 1 M, INTRAMUSCULAR</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>ANTIVIRAL PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051216</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SYNAGIS</medicinalproduct>
        <drugdosagetext>1 IN 1 M, INTRAMUSCULAR</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>ANTIVIRAL PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060113</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054135-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>29482</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>70</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DIABETES MELLITUS INSULIN-DEPENDENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALDARA</medicinalproduct>
        <drugauthorizationnumb>20723</drugauthorizationnumb>
        <drugdosagetext>1 DF, 3 TIMES WEEKLY (1 DOSAGE FORMS, 3 IN 1 WEEK (S)) TOPICAL</drugdosagetext>
        <drugadministrationroute>061</drugadministrationroute>
        <drugindication>ACTINIC KERATOSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOPHAGE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054136-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060704</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>MEDI-0004729</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>19</patientonsetage>
      <patientonsetageunit>802</patientonsetageunit>
      <reaction>
        <reactionmeddrapt>FEEDING DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAND-FOOT-AND-MOUTH DISEASE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SYNAGIS (PALIVUMAB)</medicinalproduct>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>ANTIVIRAL PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050922</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060113</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SYNAGIS (PALIVUMAB)</medicinalproduct>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>ANTIVIRAL PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050922</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SYNAGIS (PALIVUMAB)</medicinalproduct>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>ANTIVIRAL PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051021</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SYNAGIS (PALIVUMAB)</medicinalproduct>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>ANTIVIRAL PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051118</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SYNAGIS (PALIVUMAB)</medicinalproduct>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>ANTIVIRAL PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051216</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054137-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006-01634</companynumb>
    <primarysource>
      <reportercountry>KOREA, REPUBLIC OF</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DISEASE PROGRESSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VELCADE</medicinalproduct>
        <drugauthorizationnumb>21602</drugauthorizationnumb>
        <drugindication>MULTIPLE MYELOMA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054138-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060704</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>MEDI-0004728</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>14</patientonsetage>
      <patientonsetageunit>802</patientonsetageunit>
      <reaction>
        <reactionmeddrapt>BRONCHIOLITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SYNAGIS</medicinalproduct>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>ANTIVIRAL PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051010</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060130</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SYNAGIS</medicinalproduct>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>ANTIVIRAL PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051010</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SYNAGIS</medicinalproduct>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>ANTIVIRAL PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051107</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SYNAGIS</medicinalproduct>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>ANTIVIRAL PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051205</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SYNAGIS</medicinalproduct>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>ANTIVIRAL PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060102</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054139-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060703</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>TCI2006A02676</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>57</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG ERUPTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERALISED ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</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>20060412</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060511</drugenddate>
        <drugtreatmentduration>29</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TANATRIL (IMIDAPRIL HYDROCHLORIDE)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054140-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006-01635</companynumb>
    <primarysource>
      <reportercountry>KOREA, REPUBLIC OF</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DISEASE PROGRESSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VELCADE</medicinalproduct>
        <drugauthorizationnumb>21602</drugauthorizationnumb>
        <drugindication>MULTIPLE MYELOMA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054141-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060626</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006-01606</companynumb>
    <primarysource>
      <reportercountry>ITALY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>74</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MALIGNANT NEOPLASM PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METASTASES TO CENTRAL NERVOUS SYSTEM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METASTASES TO SKIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE MYELOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VELCADE</medicinalproduct>
        <drugauthorizationnumb>21602</drugauthorizationnumb>
        <drugdosagetext>1.30 MG/M2</drugdosagetext>
        <drugindication>MULTIPLE MYELOMA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054142-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060710</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2006IT10372</companynumb>
    <primarysource>
      <reportercountry>ITALY</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>72</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>OSTEOMYELITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MELPHALAN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugauthorizationnumb>021223</drugauthorizationnumb>
        <drugdosagetext>4 MG, QMO</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040605</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060605</drugenddate>
        <drugtreatmentduration>731</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054143-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060712</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006SE03901</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>20615</patientonsetage>
      <patientonsetageunit>804</patientonsetageunit>
      <patientweight>74</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CERVIX CARCINOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BLOPRESS</medicinalproduct>
        <drugauthorizationnumb>20838</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20001202</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SULFONAMIDES, UREA DERIVATIVES</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS NON-INSULIN-DEPENDENT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ORAL ANTIDIABETICS</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS NON-INSULIN-DEPENDENT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CHOLESTEROL- AND TRIGLYCERIDE REDUCERS</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HYPERLIPIDAEMIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054144-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060709</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006UW14261</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>55</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>63.5</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD TRIGLYCERIDES INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FAILURE OF IMPLANT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HIGH DENSITY LIPOPROTEIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRIGGER FINGER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARIMIDEX</medicinalproduct>
        <drugauthorizationnumb>020541</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BREAST CANCER FEMALE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SINGULAIR</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054145-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060705</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2005JP002283</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>73</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>74</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ALANINE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AORTIC ANEURYSM RUPTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASPARTATE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD BILIRUBIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISEASE PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC FUNCTION ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERBILIRUBINAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FUNGUARD(MICAFUNGIN) INJECTION</medicinalproduct>
        <drugauthorizationnumb>21506</drugauthorizationnumb>
        <drugdosagetext>100 MG, UID/QD, IV DRIP</drugdosagetext>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>RESPIRATORY MONILIASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050616</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050622</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TIENAM (IMIPENEM, CILASTATIN SODIUM)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TARGOCID</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054146-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060703</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>TCI2006A02637</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
    </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 BILIRUBIN 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>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>REFUSAL OF TREATMENT BY PATIENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACTOS</medicinalproduct>
        <drugauthorizationnumb>21073</drugauthorizationnumb>
        <drugdosagetext>30 MG (30 MG, 1 D) PER ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS NON-INSULIN-DEPENDENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060406</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060622</drugenddate>
        <drugtreatmentduration>77</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054147-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006JP001914</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>55</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRONCHOPULMONARY ASPERGILLOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSED LEVEL OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPHORIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FUNGUARD(MICAFUNGIN) INJECTION</medicinalproduct>
        <drugauthorizationnumb>21506</drugauthorizationnumb>
        <drugdosagetext>50 MG, BID, IV DRIP</drugdosagetext>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>BRONCHOPULMONARY ASPERGILLOSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060625</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060626</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FUNGUARD(MICAFUNGIN) INJECTION</medicinalproduct>
        <drugauthorizationnumb>21506</drugauthorizationnumb>
        <drugdosagetext>50 MG, BID, IV DRIP</drugdosagetext>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>BRONCHOPULMONARY ASPERGILLOSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054148-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060627</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006EU001976</companynumb>
    <primarysource>
      <reportercountry>IRELAND</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GROWTH RETARDATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SMALL FOR DATES BABY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROGRAF</medicinalproduct>
        <drugauthorizationnumb>50708</drugauthorizationnumb>
        <drugdosagetext>4 MG, /D, TRANSPLACENTAL</drugdosagetext>
        <drugadministrationroute>064</drugadministrationroute>
        <drugindication>LIVER TRANSPLANT</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060316</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054149-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060626</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006EU001924</companynumb>
    <primarysource>
      <reportercountry>TURKEY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>46</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BRAIN ABSCESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHOROIDITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CYTOMEGALOVIRUS INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERAL PHYSICAL HEALTH DETERIORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MASS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULAR WEAKNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NOCARDIA SEPSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NOCARDIOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OCULAR HYPERAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY MASS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RETINAL DETACHMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RETINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL ACUITY REDUCED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VITREOUS DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROGRAF</medicinalproduct>
        <drugauthorizationnumb>50708</drugauthorizationnumb>
        <drugindication>RENAL TRANSPLANT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOSPORINE</medicinalproduct>
        <drugindication>RENAL TRANSPLANT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugindication>RENAL TRANSPLANT</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054150-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060626</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006EU001923</companynumb>
    <primarysource>
      <reportercountry>TURKEY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>40</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CHOROIDITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HERPETIC STOMATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>KIDNEY TRANSPLANT REJECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NECROTISING RETINITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RETINAL ISCHAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RETINAL TEAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL DISTURBANCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROGRAF</medicinalproduct>
        <drugauthorizationnumb>50708</drugauthorizationnumb>
        <drugdosagetext>10 MG,</drugdosagetext>
        <drugindication>RENAL TRANSPLANT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MYCOPHENOLATE MOFETIL</medicinalproduct>
        <drugdosagetext>2000 MG,</drugdosagetext>
        <drugindication>RENAL TRANSPLANT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
        <drugdosagetext>20 MG,</drugdosagetext>
        <drugindication>RENAL TRANSPLANT</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054151-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060707</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>TCI2006A02225</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>74</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLADDER CANCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRANSITIONAL CELL CARCINOMA</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>20051018</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NATEGLINIDE</medicinalproduct>
        <drugdosagetext>60 MG, 90 MG, 120 MG, OR PLACEBO PER ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS NON-INSULIN-DEPENDENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051115</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HALCION</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MICARDIS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LENDORMIN D (BROTIZOLAM)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054152-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060711</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>THQ2006A00213</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>83</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL CELL CARCINOMA STAGE UNSPECIFIED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PIOGLITAZONE HCL</medicinalproduct>
        <drugauthorizationnumb>21073</drugauthorizationnumb>
        <drugdosagetext>8 MG</drugdosagetext>
        <drugindication>DIABETES MELLITUS INADEQUATE CONTROL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031216</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040301</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CIPRO (CIPROFLOXACIN)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054153-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060707</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20060701428</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>71.22</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>EYELID FUNCTION DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTRAOCULAR PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CONCERTA</medicinalproduct>
        <drugauthorizationnumb>021121</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATTENTION DEFICIT/HYPERACTIVITY DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RITALIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054154-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060707</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20050200328</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>47.17</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>B-CELL SMALL LYMPHOCYTIC LYMPHOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CROHN'S DISEASE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CROHN'S DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMODIUM</medicinalproduct>
        <drugauthorizationnumb>019487</drugauthorizationnumb>
        <drugindication>CROHN'S DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ANTIBIOTICS</medicinalproduct>
        <drugindication>CROHN'S DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugindication>CROHN'S DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BUDESONIDE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054155-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060713</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20060703076</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>82.56</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ULTRAM</medicinalproduct>
        <drugauthorizationnumb>020281</drugauthorizationnumb>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054156-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060626</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2006ES09553</companynumb>
    <primarysource>
      <reportercountry>SPAIN</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>49</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BONE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMPAIRED HEALING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA ORAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTH ABSCESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTH EXTRACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTHACHE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOLEDRONATE</medicinalproduct>
        <drugauthorizationnumb>21223</drugauthorizationnumb>
        <drugdosagetext>4 MG, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054157-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060707</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-ROCHE-454561</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>018662</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054158-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060710</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-ROCHE-455556</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>33</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>103.8</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XENICAL</medicinalproduct>
        <drugauthorizationnumb>020766</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OBESITY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060703</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN W/ CODEINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054159-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060706</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-ROCHE-454857</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>48</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>NODULAR VASCULITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LARIAM</medicinalproduct>
        <drugauthorizationnumb>019591</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MALARIA PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010815</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20011015</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
        <drugindication>HYPOTHYROIDISM</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980615</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054160-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060707</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006AC01260</companynumb>
    <primarysource>
      <reportercountry>SWITZERLAND</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>59</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <reaction>
        <reactionmeddrapt>ELECTROENCEPHALOGRAM ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROPOFOL</medicinalproduct>
        <drugauthorizationnumb>19627</drugauthorizationnumb>
        <drugindication>INDUCTION OF ANAESTHESIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054161-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060626</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2005-02473</companynumb>
    <primarysource>
      <reportercountry>POLAND</reportercountry>
      <qualification>1</qualification>
    </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>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA MULTIFORME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUID INTAKE REDUCED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HERPES ZOSTER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPONATRAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORTHOSTATIC HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALMAR-PLANTAR ERYTHRODYSAESTHESIA SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</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>20051014</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051114</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOXIL</medicinalproduct>
        <drugdosagetext>50.00 MG/M2, SINGLE, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051017</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051107</drugenddate>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CODEINE (CODEINE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CETIRIZINE (CETIRIZINE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOPERAMIDE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TORECAN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054162-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060626</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006-00824</companynumb>
    <primarysource>
      <reportercountry>ISRAEL</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>56</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>69</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>SEPTIC SHOCK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UROSEPSIS</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>20051229</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLEDRONATE (ZOLEDRONIC ACID)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EPREX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEUPOGEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE TAB</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054163-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060707</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006BI009756</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>55</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>55.3388</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MALIGNANT MELANOMA</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>20030212</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>5054164-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006-01647</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HEARING IMPAIRED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSYCHOTIC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL DISTURBANCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VELCADE</medicinalproduct>
        <drugauthorizationnumb>21602</drugauthorizationnumb>
        <drugindication>MULTIPLE MYELOMA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054165-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006-01638</companynumb>
    <primarysource>
      <reportercountry>KOREA, REPUBLIC OF</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VELCADE</medicinalproduct>
        <drugauthorizationnumb>21602</drugauthorizationnumb>
        <drugindication>MULTIPLE MYELOMA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054166-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006-01639</companynumb>
    <primarysource>
      <reportercountry>NETHERLANDS</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>59</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OESOPHAGITIS HAEMORRHAGIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>REFLUX OESOPHAGITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VELCADE</medicinalproduct>
        <drugauthorizationnumb>21602</drugauthorizationnumb>
        <drugindication>MULTIPLE MYELOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOXORUBICIN HCL</medicinalproduct>
        <drugindication>MULTIPLE MYELOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
        <drugindication>MULTIPLE MYELOMA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054167-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060710</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006BI008397</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>59</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CYSTITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>KIDNEY INFECTION</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>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990801</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>5054168-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006-01637</companynumb>
    <primarysource>
      <reportercountry>KOREA, REPUBLIC OF</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VELCADE</medicinalproduct>
        <drugauthorizationnumb>21602</drugauthorizationnumb>
        <drugindication>MULTIPLE MYELOMA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054169-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006-01636</companynumb>
    <primarysource>
      <reportercountry>KOREA, REPUBLIC OF</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>LUNG INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VELCADE</medicinalproduct>
        <drugauthorizationnumb>21602</drugauthorizationnumb>
        <drugindication>MULTIPLE MYELOMA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054170-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060705</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006BI008174</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>AORTIC ANEURYSM RUPTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugbatchnumb>P35064</drugbatchnumb>
        <drugdosagetext>30 UG; QW; IM</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054171-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060626</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006-01607</companynumb>
    <primarysource>
      <reportercountry>ITALY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>MALIGNANT NEOPLASM PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE MYELOMA</reactionmeddrapt>
      </reaction>
      <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>5054172-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050428</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-NOVOPROD-243855</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>61</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>60</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NOVORAPID</medicinalproduct>
        <drugauthorizationnumb>20986</drugauthorizationnumb>
        <drugdosagetext>48 IU, QD</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>INSULIN-REQUIRING TYPE II DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050308</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVEMIR</medicinalproduct>
        <drugdosagetext>32 IU, QD</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>INSULIN-REQUIRING TYPE II DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050308</drugstartdate>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLOTRIMAZOLE</medicinalproduct>
        <drugdosagetext>UNK, PRN</drugdosagetext>
        <drugadministrationroute>061</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
        <drugdosagetext>500 MG, TID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>75 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RAMIPRIL</medicinalproduct>
        <drugdosagetext>5 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRAVASTATIN</medicinalproduct>
        <drugdosagetext>40 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN W/ CODEINE</medicinalproduct>
        <drugdosagetext>4 TAB, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUOXETINE</medicinalproduct>
        <drugdosagetext>20 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENDROFLUAZIDE</medicinalproduct>
        <drugdosagetext>2.5 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SALMETEROL</medicinalproduct>
        <drugdosagetext>2 PUFF, TID</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BECOTIDE</medicinalproduct>
        <drugdosagetext>2 PUFF, TID</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DORZOLAMIDE</medicinalproduct>
        <drugdosagetext>2 %, BID</drugdosagetext>
        <drugadministrationroute>057</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACTRAPID</medicinalproduct>
        <drugindication>INSULIN-REQUIRING TYPE II DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SALBUTAMOL</medicinalproduct>
        <drugdosagetext>4 UNK, QID</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ERYTHROMYCIN</medicinalproduct>
        <drugdosagetext>500 MG, QID</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMPLE LINCTUS</medicinalproduct>
        <drugdosagetext>UNK, PRN</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054173-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
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    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060630</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006BI007650</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
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    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <patientonsetage>53</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CHOLELITHIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CYSTITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARYNGITIS STREPTOCOCCAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugdosagetext>IM</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020316</drugstartdate>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugbatchnumb>P35064</drugbatchnumb>
        <drugdosagetext>30 UG; QW; IM</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060401</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054174-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060630</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>MEDI-0004715</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>14</patientonsetage>
      <patientonsetageunit>802</patientonsetageunit>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SYNAGIS</medicinalproduct>
        <drugdosagetext>SEE IMAGE, INTRAMUSCULAR</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>ANTIVIRAL PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051011</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060210</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SYNAGIS</medicinalproduct>
        <drugdosagetext>SEE IMAGE, INTRAMUSCULAR</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>ANTIVIRAL PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051011</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SYNAGIS</medicinalproduct>
        <drugdosagetext>SEE IMAGE, INTRAMUSCULAR</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>ANTIVIRAL PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051114</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SYNAGIS</medicinalproduct>
        <drugdosagetext>SEE IMAGE, INTRAMUSCULAR</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>ANTIVIRAL PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051216</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SYNAGIS</medicinalproduct>
        <drugdosagetext>SEE IMAGE, INTRAMUSCULAR</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>ANTIVIRAL PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060116</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054175-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006US001285</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>ERYTHEMA MULTIFORME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMBISOME</medicinalproduct>
        <drugauthorizationnumb>50740</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMPICILLIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANTOZOL                    (PANTOPRAZOLE SODIUM)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIPIRONA (METAMIZOLE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENOXAPARIN SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMIODARONE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MERONEM (MEROPENEM)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALPRAZOLAM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054176-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060703</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006BI007152</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>48</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>65.7716</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANTIPHOSPHOLIPID SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE CONGESTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHILLS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLITIS ISCHAEMIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOVEMENT DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SCAN ABDOMEN ABNORMAL</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>19980101</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>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KLONOPIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ESTRACE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZANAFLEX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054177-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060626</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006-01604</companynumb>
    <primarysource>
      <reportercountry>ITALY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DISEASE PROGRESSION</reactionmeddrapt>
      </reaction>
      <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>5054178-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060626</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006-01593</companynumb>
    <primarysource>
      <reportercountry>SWEDEN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD CREATININE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER FUNCTION TEST ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPHADENOPATHY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VELCADE</medicinalproduct>
        <drugauthorizationnumb>21602</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054179-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006BI008931</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>58</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>61.2356</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLINDNESS UNILATERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COORDINATION ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CYSTITIS PSEUDOMONAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOTOR DYSFUNCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY RETENTION</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>20010101</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>20050401</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054180-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060626</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006-01600</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>63</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD LACTATE DEHYDROGENASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIALYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TUMOUR LYSIS SYNDROME</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>20050513</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054181-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060626</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006-01598</companynumb>
    <primarysource>
      <reportercountry>BELGIUM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HYPERPHOSPHATAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VELCADE</medicinalproduct>
        <drugauthorizationnumb>21602</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054182-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060710</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006BI008819</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>63</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>SPINAL COLUMN STENOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPINAL OSTEOARTHRITIS</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>19970201</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>5054183-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060626</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006-01468</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>63</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <reaction>
        <reactionmeddrapt>HEPATITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VELCADE</medicinalproduct>
        <drugauthorizationnumb>21602</drugauthorizationnumb>
        <drugdosagetext>INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOXORUBICIN HCL</medicinalproduct>
        <drugindication>MULTIPLE MYELOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
        <drugindication>MULTIPLE MYELOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METAMIZOLE SODIUM (METAMIZOLE SODIUM) DROP</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAMADOL HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANTOZOL (PANTOPRAZOLE SODIUM)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054184-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060626</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006-00941</companynumb>
    <primarysource>
      <reportercountry>SPAIN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>79</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>72</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>TOXIC EPIDERMAL NECROLYSIS</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>20060210</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060418</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOXIL</medicinalproduct>
        <drugdosagetext>30.00 MG/M2, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060213</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060418</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054185-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060710</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006BI008679</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>50</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>EXOSTOSIS</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>20031128</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054188-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060703</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>MEDI-0004720</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>14</patientonsetage>
      <patientonsetageunit>802</patientonsetageunit>
      <reaction>
        <reactionmeddrapt>LARYNGITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SYNAGIS</medicinalproduct>
        <drugdosagetext>100 MG, 1 IN 1 M, INTRAMUSCULAR</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>ANTIVIRAL PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051014</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060201</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054189-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060712</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-BRISTOL-MYERS SQUIBB COMPANY-13440763</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>53</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ESCHERICHIA INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PATHOGEN RESISTANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THERAPEUTIC RESPONSE DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
        <drugauthorizationnumb>9218</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PHLEBITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060405</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
        <drugauthorizationnumb>009218</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>THROMBOPHLEBITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060405</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INVANZ</medicinalproduct>
        <drugdosagetext>STOPPED (DATE UNSPECIFIED), RE-STARTED 16-MAR-2006, THEN WITHDRAWN 14-APR-2006</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PNEUMONIA BACTERIAL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060223</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060414</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREVISCAN</medicinalproduct>
        <drugdosagetext>START DATE: 19-FEB-2006 OR 20-FEB-2006</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PHLEBITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060228</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREVISCAN</medicinalproduct>
        <drugdosagetext>START DATE: 19-FEB-2006 OR 20-FEB-2006</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>THROMBOPHLEBITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060228</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MIXTARD HUMAN 70/30</medicinalproduct>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054190-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060703</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>MEDI-0004719</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>6</patientonsetage>
      <patientonsetageunit>802</patientonsetageunit>
      <patientweight>3.74</patientweight>
      <reaction>
        <reactionmeddrapt>LARYNGITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VIRAL INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SYNAGIS</medicinalproduct>
        <drugdosagetext>60 MG, INTRAMUSCULAR</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>ANTIVIRAL PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051207</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060306</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054191-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006081365</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>44</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD LACTATE DEHYDROGENASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEPHROLITHIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCYTOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SERUM FERRITIN INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLINDAMYCIN HYDROCHLORIDE</medicinalproduct>
        <drugauthorizationnumb>50162</drugauthorizationnumb>
        <drugdosagetext>1.2 GRAM (EVERY DAY), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CEREBRAL TOXOPLASMOSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050822</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060505</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PYRIMETHAMINE TAB</medicinalproduct>
        <drugdosagetext>1 DOSE FORM (EVERY DAY), ORAL</drugdosagetext>
        <drugadministrationroute>047</drugadministrationroute>
        <drugindication>CEREBRAL TOXOPLASMOSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050822</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060505</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SUSTIVA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRUVADA</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054192-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060703</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>MEDI-0004721</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>11</patientonsetage>
      <patientonsetageunit>802</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>GASTROENTERITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SYNAGIS</medicinalproduct>
        <drugdosagetext>90 MG, 1 IN 1 M, INTRAMUSCULAR</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>ANTIVIRAL PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051008</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060315</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054193-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060630</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>MEDI-0004718</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>BRONCHIOLITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SYNAGIS</medicinalproduct>
        <drugdosagetext>INTRAMUSCULAR</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>ANTIVIRAL PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051024</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060112</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054194-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060703</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>MEDI-0004722</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>12</patientonsetage>
      <patientonsetageunit>802</patientonsetageunit>
      <patientweight>7.5</patientweight>
      <reaction>
        <reactionmeddrapt>LUNG DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SYNAGIS</medicinalproduct>
        <drugdosagetext>100 MG, INTRAMUSCULAR</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>ANTIVIRAL PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051007</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060206</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054196-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060703</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>MEDI-0004725</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>13</patientonsetage>
      <patientonsetageunit>802</patientonsetageunit>
      <reaction>
        <reactionmeddrapt>ASTHMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SYNAGIS</medicinalproduct>
        <drugdosagetext>120 MG, INTRAMUSCULAR</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>ANTIVIRAL PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051021</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060208</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054197-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060630</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>MEDI-0004716</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>6</patientonsetage>
      <patientonsetageunit>802</patientonsetageunit>
      <reaction>
        <reactionmeddrapt>BRONCHIOLITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SYNAGIS</medicinalproduct>
        <drugdosagetext>71 MG, INTRAMUSCULAR</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>ANTIVIRAL PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051114</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060307</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054198-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060630</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>MEDI-0004714</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>6</patientonsetage>
      <patientonsetageunit>802</patientonsetageunit>
      <reaction>
        <reactionmeddrapt>BRONCHIOLITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SYNAGIS</medicinalproduct>
        <drugdosagetext>67 MG, 1 IN 1 M, INTRAMUSCULAR</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>ANTIVIRAL PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051205</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060217</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054200-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006079336</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>43</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>AGEUSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSGEUSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TONSILLITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HALCION</medicinalproduct>
        <drugauthorizationnumb>17892</drugauthorizationnumb>
        <drugdosagetext>AS NECESSARY, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SLEEP DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NITRAZEPAM</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEPAS (ETIZOLAM)</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054201-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060630</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>L06-ITA-01599-01</companynumb>
    <primarysource>
      <reportercountry>ITALY</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>23</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANTICONVULSANT DRUG LEVEL DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREATMENT NONCOMPLIANCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARBAMAZEPINE</medicinalproduct>
        <drugauthorizationnumb>70231</drugauthorizationnumb>
        <drugindication>PARTIAL SEIZURES</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEFLUNOMIDE</medicinalproduct>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054202-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060327</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-BRISTOL-MYERS SQUIBB COMPANY-13326921</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>78</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>45</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD IRON DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL SOFT TISSUE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARKINSONISM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SINEMET</medicinalproduct>
        <drugauthorizationnumb>17555</drugauthorizationnumb>
        <drugdosagetext>DOSAGE: 687.5 MG DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PARKINSON'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040301</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>FERROUS SULFATE TAB</medicinalproduct>
        <drugindication>BLOOD IRON DECREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060301</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CITALOPRAM</medicinalproduct>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060223</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUDROCORTISONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUROSAMIDE</medicinalproduct>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060301</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054203-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060711</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-13439286</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BREAST CANCER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ESTRACE</medicinalproduct>
        <drugauthorizationnumb>084499</drugauthorizationnumb>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROGESTERONE</medicinalproduct>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054204-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060711</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-13439161</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BREAST CANCER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ESTRACE</medicinalproduct>
        <drugauthorizationnumb>084499</drugauthorizationnumb>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROVERA</medicinalproduct>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054205-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006078761</companynumb>
    <primarysource>
      <reportercountry>SWITZERLAND</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>61</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugauthorizationnumb>21446</drugauthorizationnumb>
        <drugdosagetext>150 MG (75 MG, 2 IN 1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NEURALGIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060313</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAMBOCOR</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054206-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060630</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>S06-IRL-01557-01</companynumb>
    <primarysource>
      <reportercountry>IRELAND</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>85</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HAEMOPTYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEXAPRO</medicinalproduct>
        <drugauthorizationnumb>21323</drugauthorizationnumb>
        <drugdosagetext>5 MG QD PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANXIETY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060331</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEXAPRO</medicinalproduct>
        <drugauthorizationnumb>21323</drugauthorizationnumb>
        <drugdosagetext>5 MG QD PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060331</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054207-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060630</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>S06-FRA-02671-02</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>3</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>SPEECH DISORDER DEVELOPMENTAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRANSMISSION OF DRUG VIA SEMEN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CITALOPRAM HYDROBROMIDE</medicinalproduct>
        <drugauthorizationnumb>20822</drugauthorizationnumb>
        <drugdosagetext>20 MG QD TRANSPLACENTAL</drugdosagetext>
        <drugadministrationroute>064</drugadministrationroute>
        <drugindication>PANIC DISORDER WITH AGORAPHOBIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054208-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>S05-SWI-03565-01</companynumb>
    <primarysource>
      <reportercountry>SWITZERLAND</reportercountry>
      <qualification>3</qualification>
    </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>ATRIOVENTRICULAR BLOCK THIRD DEGREE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIOVASCULAR DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVERDOSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CITALOPRAM HYDROBROMIDE</medicinalproduct>
        <drugauthorizationnumb>20822</drugauthorizationnumb>
        <drugdosagetext>120 MG ONCE PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050921</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050921</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CITALOPRAM HYDROBROMIDE</medicinalproduct>
        <drugdosagetext>60 MG QD PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050920</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LITHIUM CARBONATE</medicinalproduct>
        <drugdosagetext>4 TABLET QD PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050920</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRAZODONE HCL</medicinalproduct>
        <drugdosagetext>200 MG QD PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050920</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SURMONTIL</medicinalproduct>
        <drugdosagetext>250  MG QD PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050920</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RITALIN</medicinalproduct>
        <drugindication>DEPRESSION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050920</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VASERETIC</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054210-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060616</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006PV017061</companynumb>
    <primarysource>
      <reportercountry>HUNGARY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXENATIDE (EXENATIDE)</medicinalproduct>
        <drugauthorizationnumb>21773</drugauthorizationnumb>
        <drugdosagetext>10 UG; BID; SC</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054211-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>S06-CAN-02556-01</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>61</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CELLULITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TIAZAC</medicinalproduct>
        <drugauthorizationnumb>20401</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060406</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CEFAZOLIN SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CEPHALEXIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>..</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054212-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006-DE-03303GD</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 FIBROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER FUNCTION TEST ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEVIRAPINE</medicinalproduct>
        <drugauthorizationnumb>20636</drugauthorizationnumb>
        <drugindication>HIV INFECTION</drugindication>
        <drugtreatmentduration>24</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIDANOSINE</medicinalproduct>
        <drugindication>HIV INFECTION</drugindication>
        <drugtreatmentduration>32</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>STAVUDINE</medicinalproduct>
        <drugindication>HIV INFECTION</drugindication>
        <drugtreatmentduration>24</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HYDROXYUREA</medicinalproduct>
        <drugindication>HIV INFECTION</drugindication>
        <drugtreatmentduration>32</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054213-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060703</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006-BP-07596RO</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 DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ACTIVATED PARTIAL THROMBOPLASTIN TIME PROLONGED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASCITES</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 UREA INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE MARROW FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>C-REACTIVE PROTEIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ENTEROBACTER INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEAN CELL VOLUME INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCYTOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERITONITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POST PROCEDURAL COMPLICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POST PROCEDURAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROTHROMBIN TIME PROLONGED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPTIC SHOCK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STOMATITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugauthorizationnumb>40054</drugauthorizationnumb>
        <drugdosagetext>7.5 TO 15 MG PER WEEK</drugdosagetext>
        <drugindication>PSORIATIC ARTHROPATHY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLATE (FOLATE SODIUM)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MELOXICAM (MELOXICAM)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARVEDILOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MODURETICS (MODURETIC)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMILORIDE HYDROCHLORIDE (AMILORIDE HYDROCHLORIDE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RAMIPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLOPIDOGREL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054214-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060627</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>062-C5013-06060845</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
    </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>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTI-ORGAN FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCYTOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LENALIDOMIDE (CAPSULES)</medicinalproduct>
        <drugauthorizationnumb>21880</drugauthorizationnumb>
        <drugdosagetext>25 MG, 1 IN 1 D</drugdosagetext>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060218</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060310</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
        <drugindication>MULTIPLE MYELOMA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054215-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>028-20785-04090595</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>45</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD HUMAN CHORIONIC GONADOTROPIN POSITIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEEP VEIN THROMBOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>THALOMID</medicinalproduct>
        <drugbatchnumb>0173X</drugbatchnumb>
        <drugauthorizationnumb>20785</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE, ORAL</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, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>THALOMID</medicinalproduct>
        <drugbatchnumb>0173X</drugbatchnumb>
        <drugauthorizationnumb>20785</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>THALOMID</medicinalproduct>
        <drugbatchnumb>0009A</drugbatchnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>THALOMID</medicinalproduct>
        <drugbatchnumb>0015A</drugbatchnumb>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DECADRON</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054216-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060627</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>028-20785-04070512</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>44</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD HUMAN CHORIONIC GONADOTROPIN INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>THALOMID</medicinalproduct>
        <drugbatchnumb>0173X</drugbatchnumb>
        <drugauthorizationnumb>20785</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE, ORAL</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, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>THALOMID</medicinalproduct>
        <drugbatchnumb>0173X</drugbatchnumb>
        <drugauthorizationnumb>20785</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>THALOMID</medicinalproduct>
        <drugbatchnumb>0015A</drugbatchnumb>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PAMIDRONATE DISODIUM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054217-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060630</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>T06-AUT-00057-01</companynumb>
    <primarysource>
      <reportercountry>AUSTRIA</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>29</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>96.5</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ALANINE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD ALKALINE PHOSPHATASE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BODY TEMPERATURE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRAIN OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DELIRIUM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISORIENTATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG LEVEL INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EOSINOPHIL PERCENTAGE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HALLUCINATION, VISUAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OBSESSIVE-COMPULSIVE PERSONALITY DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESTLESSNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ESCITALOPRAM OXALATE</medicinalproduct>
        <drugauthorizationnumb>21323</drugauthorizationnumb>
        <drugdosagetext>10 MG QD PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051119</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051206</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ESCITALOPRAM OXALATE</medicinalproduct>
        <drugdosagetext>10 MG BID PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051207</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZAPINE</medicinalproduct>
        <drugdosagetext>200 MG QD PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA, PARANOID TYPE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051119</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051121</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZAPINE</medicinalproduct>
        <drugdosagetext>300 MG QD PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA, PARANOID TYPE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051122</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051123</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZAPINE</medicinalproduct>
        <drugdosagetext>350 MG QD PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA, PARANOID TYPE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051124</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051124</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZAPINE</medicinalproduct>
        <drugdosagetext>500 MG QD PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA, PARANOID TYPE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051125</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051129</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZAPINE</medicinalproduct>
        <drugdosagetext>600 MG QD PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA, PARANOID TYPE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051130</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051213</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZAPINE</medicinalproduct>
        <drugdosagetext>800 MG QD PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA, PARANOID TYPE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051214</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AUGMENTIN '125'</medicinalproduct>
        <drugdosagetext>3000 MG QD PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051121</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051205</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SOLIAN (AMISULPRIDE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AERIUS (DESLORATADINE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLPIDEM TARTRATE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054218-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>S06-SWI-02669-01</companynumb>
    <primarysource>
      <reportercountry>SWITZERLAND</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>36</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ALANINE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASPARTATE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD BILIRUBIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATOCELLULAR DAMAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SERUM FERRITIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRANSAMINASES INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ESCITALOPRAM OXALATE</medicinalproduct>
        <drugauthorizationnumb>21323</drugauthorizationnumb>
        <drugdosagetext>20 MG QD PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060524</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugdosagetext>300 MG QD PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050503</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060524</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXJADE</medicinalproduct>
        <drugdosagetext>1500 MG QD</drugdosagetext>
        <drugindication>CONGENITAL ANAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060405</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054219-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060630</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>S06-HRV-02674-01</companynumb>
    <primarysource>
      <reportercountry>CROATIA (local name: Hrvatska)</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>33</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>LIBIDO INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALE ORGASMIC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEXUAL DYSFUNCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ESCITALOPRAM OXALATE</medicinalproduct>
        <drugauthorizationnumb>21323</drugauthorizationnumb>
        <drugdosagetext>5 MG QD PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060329</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SALOFALK (MESALAZINE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMURAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DECORTIN (PREDNISONE)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054220-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060630</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>L06-ITA-01599-03</companynumb>
    <primarysource>
      <reportercountry>ITALY</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>35</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG LEVEL DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHEUMATOID ARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREATMENT NONCOMPLIANCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARBAMAZEPINE</medicinalproduct>
        <drugauthorizationnumb>70231</drugauthorizationnumb>
        <drugindication>PARTIAL SEIZURES</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEFLUNOMIDE</medicinalproduct>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054221-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060630</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>L06-ITA-01599-02</companynumb>
    <primarysource>
      <reportercountry>ITALY</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>29</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANTICONVULSANT DRUG LEVEL DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREATMENT NONCOMPLIANCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARBAMAZEPINE</medicinalproduct>
        <drugauthorizationnumb>70231</drugauthorizationnumb>
        <drugindication>PARTIAL SEIZURES</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEFLUNOMIDE</medicinalproduct>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054222-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060630</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CHPA2006US06414</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>62</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>73</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DYSGEUSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTESTINAL OBSTRUCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RETCHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISION BLURRED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRANSDERM SCOP</medicinalproduct>
        <drugbatchnumb>0539060</drugbatchnumb>
        <drugauthorizationnumb>17874</drugauthorizationnumb>
        <drugdosagetext>1.5 MG, Q72H, TRANSDERMAL</drugdosagetext>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>MOTION SICKNESS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060624</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060626</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054223-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060703</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CHPA2006US06442</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>72</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>49.9</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG ABUSER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG DEPENDENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OESOPHAGEAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ULCER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXCEDRIN EXTRA STRENGTH</medicinalproduct>
        <drugauthorizationnumb>20802</drugauthorizationnumb>
        <drugdosagetext>2 DF, TID, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEADACHE</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054224-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060619</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006UW13271</companynumb>
    <primarysource>
      <reportercountry>MEXICO</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>64</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>94.4</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HYPERTENSIVE CRISIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ROSUVASTATIN</medicinalproduct>
        <drugauthorizationnumb>21366</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS NON-INSULIN-DEPENDENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060331</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060425</drugenddate>
        <drugtreatmentduration>26</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ROSUVASTATIN</medicinalproduct>
        <drugauthorizationnumb>021366</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLIBENCLAMIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS NON-INSULIN-DEPENDENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CAPTOPRIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054225-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060712</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006AC01293</companynumb>
    <primarysource>
      <reportercountry>NETHERLANDS</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>58</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WALKING DISABILITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugauthorizationnumb>021366</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051005</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOLBUTAMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOSEC</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054226-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060711</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006AP03201</companynumb>
    <primarysource>
      <reportercountry>HUNGARY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>24840</patientonsetage>
      <patientonsetageunit>804</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CAROTID ARTERY OCCLUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CAROTID ARTERY STENOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAMOXIFEN</medicinalproduct>
        <drugauthorizationnumb>17970</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030707</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054227-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060707</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006AC01261</companynumb>
    <primarysource>
      <reportercountry>SWITZERLAND</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>46</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <reaction>
        <reactionmeddrapt>ELECTROENCEPHALOGRAM ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROPOFOL</medicinalproduct>
        <drugauthorizationnumb>19627</drugauthorizationnumb>
        <drugindication>INDUCTION OF ANAESTHESIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054228-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060501</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006UW08441</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>79</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>77.1</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PULMICORT</medicinalproduct>
        <drugauthorizationnumb>020441</drugauthorizationnumb>
        <drugdosagetext>200 MCG 200 DOSES/UNIT</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030101</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054229-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060714</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006SE03948</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>66</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>INTERSTITIAL LUNG DISEASE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BLOPRESS</medicinalproduct>
        <drugauthorizationnumb>20838</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060628</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EUGLUCON</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054230-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060711</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006CG01211</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>95</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>75</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MOUTH ULCERATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TENORMIN</medicinalproduct>
        <drugauthorizationnumb>018240</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060518</drugenddate>
        <drugtreatmentduration>748</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060518</drugenddate>
        <drugtreatmentduration>748</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054231-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060630</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CHPA2006US06583</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <patientonsetage>47</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>65.8</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MASS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UNDERDOSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NICOTINE</medicinalproduct>
        <drugauthorizationnumb>20076</drugauthorizationnumb>
        <drugdosagetext>14 MG, QD, TRANSDERMAL</drugdosagetext>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>SMOKING CESSATION THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060601</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054232-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060707</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200612709BCC</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <patientonsetage>74</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>81.6475</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPEPSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HIATUS HERNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ULCER HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALEVE</medicinalproduct>
        <drugbatchnumb>208015E</drugbatchnumb>
        <drugauthorizationnumb>20204</drugauthorizationnumb>
        <drugdosagetext>440 MG, BID, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ABDOMINAL PAIN UPPER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALEVE COLD AND SINUS</medicinalproduct>
        <drugbatchnumb>299884P</drugbatchnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEADACHE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugbatchnumb>259322P</drugbatchnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALKA-SELTZER</medicinalproduct>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALKA-SELTZER PLUS</medicinalproduct>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MYLANTA               [ALUMINIUM HYDROXIDE, MAGNESIUM HYDROXIDE, SIMET</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIPHENHYDRAMINE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICATION FOR HIGH BLOOD PRESSURE  (ANTIHYPERTENSIVES)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICATION FOR DIABETES</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054233-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060626</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200612621BCC</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>79</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>86.1834</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALEVE (CAPLET)</medicinalproduct>
        <drugbatchnumb>223736C</drugbatchnumb>
        <drugauthorizationnumb>20204</drugauthorizationnumb>
        <drugdosagetext>220 MG, ONCE, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRALGIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060619</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BLOOD PRESSURE MEDICATION</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054234-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060703</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200612789BWH</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>66</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>79.3795</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ADRENOCORTICAL INSUFFICIENCY ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GOUT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL INTAKE REDUCED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SORAFENIB</medicinalproduct>
        <drugauthorizationnumb>21923</drugauthorizationnumb>
        <drugdosagetext>400 MG, BID, ORAL; SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RENAL CELL CARCINOMA STAGE UNSPECIFIED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030422</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030505</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SORAFENIB</medicinalproduct>
        <drugauthorizationnumb>21923</drugauthorizationnumb>
        <drugdosagetext>400 MG, BID, ORAL; SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RENAL CELL CARCINOMA STAGE UNSPECIFIED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030509</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060515</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HYDROCORTISONE</medicinalproduct>
        <drugindication>ADRENAL INSUFFICIENCY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARTIA [DILTIAZEM HYDROCHLORIDE]</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054235-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060418</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200612720BWH</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>77</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>46.2669</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CYANOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LARGE INTESTINE PERFORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN EXFOLIATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WOUND DEHISCENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXAVAR</medicinalproduct>
        <drugauthorizationnumb>21923</drugauthorizationnumb>
        <drugdosagetext>200 MG, BID, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RENAL CELL CARCINOMA STAGE UNSPECIFIED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060124</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054236-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060705</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200613088BWH</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>81</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>70.3075</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIET REFUSAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALNUTRITION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN DISCOLOURATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN EXFOLIATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXAVAR</medicinalproduct>
        <drugbatchnumb>5400PJN</drugbatchnumb>
        <drugauthorizationnumb>21923</drugauthorizationnumb>
        <drugdosagetext>200 MG, BID, ORAL; SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060308</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060326</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXAVAR</medicinalproduct>
        <drugbatchnumb>5400PJN</drugbatchnumb>
        <drugauthorizationnumb>21923</drugauthorizationnumb>
        <drugdosagetext>200 MG, BID, ORAL; SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060406</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060601</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALOPRIL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054237-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060705</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200614282BWH</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>77</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD MAGNESIUM DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD POTASSIUM DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE FLUCTUATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CLOSTRIDIAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CLOSTRIDIUM DIFFICILE COLITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERALISED OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OBSTRUCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXAVAR</medicinalproduct>
        <drugauthorizationnumb>21923</drugauthorizationnumb>
        <drugdosagetext>400 MG, BID, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RENAL CELL CARCINOMA STAGE UNSPECIFIED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060529</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060609</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054238-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060627</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-SANOFI-SYNTHELABO-A03200604141</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABNORMAL BEHAVIOUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AMNESIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMBIEN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054239-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060531</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BE-SANOFI-SYNTHELABO-A01200604153</companynumb>
    <primarysource>
      <reportercountry>BELGIUM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ANEURYSM RUPTURED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOPIDOGREL</medicinalproduct>
        <drugauthorizationnumb>020839</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054240-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060706</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-SANOFI-SYNTHELABO-A03200604336</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020839</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>VASCULAR OPERATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051001</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054241-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060503</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-SANOFI-SYNTHELABO-A04200600496</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>75</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>NEURALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTHACHE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugbatchnumb>500664</drugbatchnumb>
        <drugauthorizationnumb>020839</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>STENT PLACEMENT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SORTIS</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054242-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060707</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-SANOFI-SYNTHELABO-A01200605309</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>20</patientonsetage>
      <patientonsetageunit>804</patientonsetageunit>
      <reaction>
        <reactionmeddrapt>EXTRAVASATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VASOCONSTRICTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRIMACOR</medicinalproduct>
        <drugdosagetext>500 NANOGRAMS/KG/MIN</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CARDIAC DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054243-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060707</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-SANOFI-SYNTHELABO-A03200604428</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>77.1</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ALOPECIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEPHROLITHIASIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALTACE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GLUCOVANCE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19960101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRAVACHOL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020839</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CEREBROVASCULAR ACCIDENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054244-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060706</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-SANOFI-SYNTHELABO-A03200604381</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>58</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ERYTHEMA MULTIFORME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRIMACOR</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060627</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054245-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060515</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-SANOFI-SYNTHELABO-A03200603058</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>70</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>80</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>EJECTION FRACTION DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEUCOVORIN CALCIUM</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLON CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060509</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060509</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUOROURACIL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLON CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060509</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060511</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXALIPLATIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021492</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLON CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060509</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060509</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054246-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060627</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US184619</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ENDOPHTHALMITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IRIDOCYCLITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYCOBACTERIUM ABSCESSUS INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYCOBACTERIUM CHELONEI INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POSTOPERATIVE INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UVEITIS</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>20010101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INDOMETHACIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ROFECOXIB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TIMOLOL MALEATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DORZOLAMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE ACETATE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054247-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060627</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US185372</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>UVEITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>0.4 MG/KG, 2 IN 1 WEEKS</drugdosagetext>
        <drugindication>JUVENILE ARTHRITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054248-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060627</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US185375</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>UVEITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>0.4 MG/KG, 2 IN 1 WEEKS</drugdosagetext>
        <drugindication>JUVENILE ARTHRITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054250-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060627</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US185377</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>56</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>SCLERITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>25 MG, 2 IN 1 WEEKS</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CORTICOSTEROID NOS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054252-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060627</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US185385</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>UVEITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>0.4 MG/KG, 2 IN 1 WEEKS</drugdosagetext>
        <drugindication>JUVENILE ARTHRITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054253-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060627</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US185383</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>UVEITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>0.4 MG/KG, 2 IN 1 WEEKS</drugdosagetext>
        <drugindication>JUVENILE ARTHRITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054254-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060627</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US185382</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>46</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>UVEITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>25 MG, 2 IN 1 WEEKS</drugdosagetext>
        <drugindication>PSORIATIC ARTHROPATHY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054255-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060716</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060502</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>446787</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>84</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BONIVA</medicinalproduct>
        <drugauthorizationnumb>21455</drugauthorizationnumb>
        <drugdosagetext>1 PER MONTH ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060315</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVASTATIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MOBIC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLENDIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INDERAL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054256-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060627</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US185381</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>51</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>IRIDOCYCLITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>25 MG, 2 IN 1 WEEKS</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CORTICOSTEROID NOS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054258-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060627</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US185380</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>58</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>IRIDOCYCLITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>25 MG, 2 IN 1 WEEKS</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054260-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060627</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US185379</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>48</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>SCLERITIS</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>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>25 MG, 2 IN 1 WEEKS, SC</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>SJOGREN'S SYNDROME</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054261-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060627</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US185378</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>61</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>SCLERITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>25 MG, 2 IN 1 WEEKS</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNSPECIFIED MEDICATION</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054263-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060627</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US185376</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>45</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>SCLERITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>25 MG, 2 IN 1 WEEKS</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054264-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060627</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US185374</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>UVEITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>0.4 MG/KG, 2 IN 1 WEEKS</drugdosagetext>
        <drugindication>JUVENILE ARTHRITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054265-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060627</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US144716</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>52</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UVEITIS</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>20030701</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054267-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060626</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CHPA2006US06576</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>56</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>77.1</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRIVATE LABEL    (NICOTINE)        TRANS-THERAPEUTIC-SYSTEM</medicinalproduct>
        <drugbatchnumb>3015855</drugbatchnumb>
        <drugauthorizationnumb>20076</drugauthorizationnumb>
        <drugdosagetext>21 MG, QD, TRANSDERMAL</drugdosagetext>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>SMOKING CESSATION THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060626</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADVAIR DISKUS 100/50</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELEXA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LUNESTA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COMBIVENT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KELXIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NAPROXEN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054269-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060702</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CHPA2006US06350</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>59</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>63.5</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRANSDERM SCOP</medicinalproduct>
        <drugbatchnumb>11651001</drugbatchnumb>
        <drugauthorizationnumb>17874</drugauthorizationnumb>
        <drugdosagetext>1.5 MG, Q72H, TRANSDERMAL</drugdosagetext>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>MOTION SICKNESS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060618</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060625</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054271-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>SPI200600052</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>ABDOMINAL DISTENSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMITIZA</medicinalproduct>
        <drugdosagetext>24 MCG, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054273-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060627</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2006US09801</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>65</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD CREATININE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CELLULITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUID OVERLOAD</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FUNGAL SKIN INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART TRANSPLANT REJECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLAMMATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIMB INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYCOBACTERIUM ABSCESSUS INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANNICULITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PITTING OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH PAPULAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN INFLAMMATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THERAPY NON-RESPONDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOSPORINE</medicinalproduct>
        <drugauthorizationnumb>80336</drugauthorizationnumb>
        <drugdosagetext>25 MG</drugdosagetext>
        <drugindication>HEART TRANSPLANT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AZATHIOPRINE</medicinalproduct>
        <drugdosagetext>25 MG, QD</drugdosagetext>
        <drugindication>HEART TRANSPLANT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISONE (NGX) (PREDNISONE)</medicinalproduct>
        <drugdosagetext>10 MG, QD</drugdosagetext>
        <drugindication>HEART TRANSPLANT</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054274-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060707</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>007962</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BREAST CANCER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MEDROXYPROGESTERONE ACETATE</medicinalproduct>
        <drugauthorizationnumb>40159</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19870101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19870101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMPRO</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19870101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROVERA</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19870101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054275-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060705</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006084384</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>15</patientonsetage>
      <patientonsetageunit>802</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ACCIDENTAL DRUG INTAKE BY CHILD</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COORDINATION ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MINOXIDIL</medicinalproduct>
        <drugauthorizationnumb>20834</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ACCIDENTAL EXPOSURE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060703</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060703</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054276-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060707</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>007948</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BREAST CANCER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MEDROXYPROGESTERONE ACETATE</medicinalproduct>
        <drugauthorizationnumb>40159</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19910101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19910101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROVERA</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19910101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054277-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060707</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>007947</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BREAST CANCER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MEDROXYPROGESTERONE ACETATE</medicinalproduct>
        <drugauthorizationnumb>40159</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19860101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19860101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020101</drugenddate>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROVERA</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19860101</drugstartdate>
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        <drugenddate>20020101</drugenddate>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MENEST</medicinalproduct>
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        <drugadministrationroute>048</drugadministrationroute>
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        <drugenddate>20020101</drugenddate>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLIMARA</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19860101</drugstartdate>
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        <drugenddate>20020101</drugenddate>
      </drug>
    </patient>
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  <safetyreport>
    <safetyreportid>5054278-4</safetyreportid>
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      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BREAST CANCER</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MEDROXYPROGESTERONE ACETATE</medicinalproduct>
        <drugauthorizationnumb>40159</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19950101</drugstartdate>
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        <drugenddate>20000101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19950101</drugstartdate>
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        <drugenddate>20000101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROVERA</medicinalproduct>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ESTRACE</medicinalproduct>
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        <drugstartdate>19950101</drugstartdate>
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        <drugenddate>20000101</drugenddate>
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    </patient>
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  <safetyreport>
    <safetyreportid>5054279-6</safetyreportid>
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      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
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    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BREAST CANCER</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MEDROXYPROGESTERONE ACETATE</medicinalproduct>
        <drugauthorizationnumb>40159</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ESTROPIPATE</medicinalproduct>
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        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCRIN</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OGEN</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMPRO</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROVERA</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
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  <safetyreport>
    <safetyreportid>5054280-2</safetyreportid>
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      <reportercountry>UNITED STATES</reportercountry>
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    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BREAST CANCER FEMALE</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MEDROXYPROGESTERONE ACETATE</medicinalproduct>
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        <drugstartdate>19871001</drugstartdate>
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        <drugenddate>19981101</drugenddate>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
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        <drugstartdate>19871001</drugstartdate>
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        <drugenddate>19981101</drugenddate>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMPRO</medicinalproduct>
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        <drugadministrationroute>048</drugadministrationroute>
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        <drugstartdate>19871001</drugstartdate>
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        <drugenddate>19981101</drugenddate>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROVERA</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19871001</drugstartdate>
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        <drugenddate>19981101</drugenddate>
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    </patient>
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  <safetyreport>
    <safetyreportid>5054281-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
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    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
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      <reportercountry>PORTUGAL</reportercountry>
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    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHMA</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LISTERINE MENTHOL (MENTHOL, METHYL SALICYLATE, EUCALYPTOL, THYMOL)</medicinalproduct>
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        <drugstartdate>20060101</drugstartdate>
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        <drugenddate>20060101</drugenddate>
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  <safetyreport>
    <safetyreportid>5054282-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
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    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
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    <receiptdate>20060113</receiptdate>
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    <companynumb>DE-NOVOPROD-250022</companynumb>
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      <reportercountry>GERMANY</reportercountry>
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    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <patientonsetage>75</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>71</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
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      <reaction>
        <reactionmeddrapt>CEREBRAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY FAILURE</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NOVOSEVEN</medicinalproduct>
        <drugdosagetext>1 DOSE</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CEREBRAL HAEMORRHAGE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060111</drugstartdate>
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        <drugenddate>20060111</drugenddate>
        <drugtreatmentduration>10</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
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    </patient>
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  <safetyreport>
    <safetyreportid>5054283-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesscongenitalanomali>1</seriousnesscongenitalanomali>
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    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-BRISTOL-MYERS SQUIBB COMPANY-13255310</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
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    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>3</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HYPOTONIA</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>PREGNANCY</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ABILIFY</medicinalproduct>
        <drugadministrationroute>064</drugadministrationroute>
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        <drugenddate>20060101</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
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  <safetyreport>
    <safetyreportid>5054284-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
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    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
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    <receiptdate>20060711</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-13439195</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
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    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BREAST CANCER</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ESTRADIOL</medicinalproduct>
        <drugauthorizationnumb>084499</drugauthorizationnumb>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROVERA</medicinalproduct>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
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    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054285-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
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    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060704</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006-07-0121</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
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    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <patientonsetage>53</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEOPLASM RECURRENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVARIAN CANCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEDAPLATIN NO DOSE FORM</medicinalproduct>
        <drugdosagetext>240 MG INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IRINOTECAN NO DOSE FORM</medicinalproduct>
        <drugdosagetext>130 MG INTRAVENOUS</drugdosagetext>
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        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040806</drugstartdate>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZANTAC</medicinalproduct>
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        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIPHENHYDRAMINE HYDROCHLORIDE</medicinalproduct>
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      <drug>
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        <drugcharacterization>2</drugcharacterization>
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        <medicinalproduct>RAMOSETRON HCL</medicinalproduct>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>..</medicinalproduct>
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    </patient>
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  <safetyreport>
    <safetyreportid>5054286-3</safetyreportid>
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    <transmissiondate>20061208</transmissiondate>
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    <companynumb>CH-BRISTOL-MYERS SQUIBB COMPANY-13434675</companynumb>
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      <reportercountry>SWITZERLAND</reportercountry>
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    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <patientonsetage>71</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
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        <reactionmeddrapt>EOSINOPHILIA</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMIKIN INJ 1 G</medicinalproduct>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COLISTIN</medicinalproduct>
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        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
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    </patient>
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    <safetyreportid>5054287-5</safetyreportid>
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    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060704</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006-07-0339</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CATARACT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEG-INTRON</medicinalproduct>
        <drugdosagetext>SUBCUTANEOUS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBETOL</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054288-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060704</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006083274</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>108.8633</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DYSURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCORRECT DOSE ADMINISTERED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BENADRYL</medicinalproduct>
        <drugauthorizationnumb>5845</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INSOMNIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ESZOPICLONE (ESZOPICLONE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BUPROPION HYDROCHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALPRAZOLAM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054289-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060704</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006082512</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG DEPENDENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BENADRYL</medicinalproduct>
        <drugbatchnumb>03116V</drugbatchnumb>
        <drugauthorizationnumb>5845</drugauthorizationnumb>
        <drugdosagetext>2 KAPSEALS EVERY 4 HOURS, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SINUS DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ANTIDEPRESSANTS (ANTIDEPRESSANTS)</medicinalproduct>
        <drugindication>DEPRESSION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060704</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORAZEPAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCODONE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SERTRALINE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FAMOTIDINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANSOPRAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXCARBAZEPINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IPRATROPIUM BROMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAZODONE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COMBIVENT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCODONE HYDROCHLORIDE AND ACETAMINOPHEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DULOXETINE HYDROCHLORIDE (DULOXETINE HYDROCHLORIDE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYBUTYNIN CHLORIDE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054290-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060706</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006-06-1396</companynumb>
    <primarysource>
      <reportercountry>CROATIA (local name: Hrvatska)</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>41</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>62</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ALANINE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASPARTATE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEG-INTRON</medicinalproduct>
        <drugdosagetext>6 MCG/KG/WK SUBCUTANEOUS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>MALIGNANT MELANOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020719</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020906</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054291-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060705</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006084455</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BREAST CANCER FEMALE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ROGAINE</medicinalproduct>
        <drugauthorizationnumb>19501</drugauthorizationnumb>
        <drugdosagetext>TOPICAL</drugdosagetext>
        <drugadministrationroute>061</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054292-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US017858</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>13</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>119.6</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MODAFINIL</medicinalproduct>
        <drugauthorizationnumb>20717</drugauthorizationnumb>
        <drugdosagetext>400 MG QD ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERSOMNIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050908</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060203</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MODAFINIL</medicinalproduct>
        <drugauthorizationnumb>20717</drugauthorizationnumb>
        <drugdosagetext>400 MG QD ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NARCOLEPSY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050908</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060203</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MIDOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EX-LAX ^EX-LAX INC^</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054293-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CIP06001488</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>77</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTICULAR CALCIFICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPEPSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JAW DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOOSE TOOTH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEPHROLITHIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OESOPHAGEAL OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OESOPHAGEAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARYNGOLARYNGEAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTH LOSS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACTONEL</medicinalproduct>
        <drugauthorizationnumb>20835</drugauthorizationnumb>
        <drugdosagetext>5 MG DAILY, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACTONEL</medicinalproduct>
        <drugdosagetext>35 MG ONCE WEEKLY, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM (CALCIUM)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054294-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060703</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006RL000184</companynumb>
    <primarysource>
      <reportercountry>NORWAY</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>64</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CEREBRAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EXTRADURAL HAEMATOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTRACRANIAL PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OMACOR</medicinalproduct>
        <drugauthorizationnumb>21654</drugauthorizationnumb>
        <drugdosagetext>1 DF;QD;PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACETYLSALICYLIC ACID SRT</medicinalproduct>
        <drugdosagetext>100 MG;QD;PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CORONARY ARTERY BYPASS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BISOPROLOL FUMARATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE W/TRIAMTERENE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAMSULOSIN HCL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054295-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060703</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CIP06001069</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>82</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>74.8</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>IMPAIRED HEALING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN JAW</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PURULENT DISCHARGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTH EXTRACTION</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>20040101</drugstartdate>
        <drugtreatmentduration>730</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE TAB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVODART</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054296-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060627</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>34899</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>CULTURE POSITIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE INFECTION INTRAOCULAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LABORATORY TEST ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BSS PLUS</medicinalproduct>
        <drugauthorizationnumb>18469</drugauthorizationnumb>
        <drugindication>SURGERY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054297-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060703</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006RL000185</companynumb>
    <primarysource>
      <reportercountry>NORWAY</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>39</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PHARYNGEAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POST PROCEDURAL COMPLICATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OMACOR</medicinalproduct>
        <drugauthorizationnumb>21654</drugauthorizationnumb>
        <drugdosagetext>PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050901</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTERIAL DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030707</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050901</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INEGY 10/40 (EZETIMIB/SIMVASTATIN)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EZETROL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DELIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054298-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060706</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>TAP2006Q01158</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>71</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DIALYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LUPRON DEPOT-4</medicinalproduct>
        <drugauthorizationnumb>20517</drugauthorizationnumb>
        <drugdosagetext>30 MG, 1 IN 4 M, INTRAMUSCULAR</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>PROSTATE CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NIFEDIPINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONIDINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FERROUS SULFATE TAB</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054299-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060630</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006MP000843</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>48</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>BRAIN OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBRAL HAEMATOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEEP VEIN THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POST PROCEDURAL COMPLICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GLIADEL</medicinalproduct>
        <drugauthorizationnumb>20637</drugauthorizationnumb>
        <drugdosagetext>X1</drugdosagetext>
        <drugindication>GLIOBLASTOMA MULTIFORME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060502</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060514</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLIASITE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054300-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060703</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006RL000182</companynumb>
    <primarysource>
      <reportercountry>NORWAY</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>80</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OMACOR</medicinalproduct>
        <drugauthorizationnumb>21654</drugauthorizationnumb>
        <drugdosagetext>1000 MG;QD;PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACETYLSALICYLIC ACID SRT</medicinalproduct>
        <drugdosagetext>100 MG;QD;PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054301-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060705</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006-06-1033</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>54</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>84.369</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CAROTID ARTERY STENOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ISCHAEMIC CEREBRAL INFARCTION</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>20051101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060601</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RIBAVIRIN</medicinalproduct>
        <drugdosagetext>600 MG BID ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060601</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENADRYL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COLESTIPOL HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVAPRO</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054302-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060703</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2003-05-1141</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>40</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>73.0291</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIAC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRANSIENT ISCHAEMIC ATTACK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UPPER RESPIRATORY TRACT INFECTION</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>20020819</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030423</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>20051229</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBETOL</medicinalproduct>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020819</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030423</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBETOL</medicinalproduct>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051229</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMITREX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELEXA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SEROQUEL (QUETIAPINE FUMURATE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LITHOBID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM GLUCONATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENADRYL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGNESIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ESTRADIOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BUSPAR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLEXERIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROPOXYPHENE HYDROCHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUOXETINE HYDROCHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054303-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060705</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006-05-2138</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>37</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>94.3482</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>RETINOPATHY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NASONEX</medicinalproduct>
        <drugauthorizationnumb>20762</drugauthorizationnumb>
        <drugdosagetext>2PUFF/NARE QD NASAL SPRA</drugdosagetext>
        <drugindication>RHINITIS ALLERGIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060417</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054304-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2006TR09737</companynumb>
    <primarysource>
      <reportercountry>TURKEY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>26</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD CREATININE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GINGIVAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPHOPROLIFERATIVE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALIGNANT TUMOUR EXCISION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MASS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLASMACYTOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RED BLOOD CELL SEDIMENTATION RATE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOSPORINE</medicinalproduct>
        <drugauthorizationnumb>40194</drugauthorizationnumb>
        <drugdosagetext>200 MG/D</drugdosagetext>
        <drugindication>RENAL TRANSPLANT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AZATHIOPRINE</medicinalproduct>
        <drugdosagetext>50 MG/D</drugdosagetext>
        <drugindication>RENAL TRANSPLANT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHYLPREDNISOLONE</medicinalproduct>
        <drugdosagetext>6 MG/D</drugdosagetext>
        <drugindication>RENAL TRANSPLANT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RAPAMYCIN(SIROLIMUS)</medicinalproduct>
        <drugindication>RENAL TRANSPLANT</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054305-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-KINGPHARMUSA00001-K200501008</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>58</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE SYSTOLIC INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALTACE</medicinalproduct>
        <drugauthorizationnumb>019901</drugauthorizationnumb>
        <drugdosagetext>10 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041123</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALTACE</medicinalproduct>
        <drugauthorizationnumb>019901</drugauthorizationnumb>
        <drugdosagetext>5 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041124</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060709</drugenddate>
        <drugtreatmentduration>593</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALTACE</medicinalproduct>
        <drugauthorizationnumb>019901</drugauthorizationnumb>
        <drugdosagetext>2.5 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060710</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDAMET</medicinalproduct>
        <drugdosagetext>500/2 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS NON-INSULIN-DEPENDENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041118</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041123</drugenddate>
        <drugtreatmentduration>8640</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDAMET</medicinalproduct>
        <drugdosagetext>1/2 500/2MG , BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041124</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050118</drugenddate>
        <drugtreatmentduration>80640</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDAMET</medicinalproduct>
        <drugdosagetext>1/2 500/2MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050610</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugdosagetext>4 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS NON-INSULIN-DEPENDENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050610</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METFORMIN HCL</medicinalproduct>
        <drugdosagetext>250 MG, BID</drugdosagetext>
        <drugindication>DIABETES MELLITUS NON-INSULIN-DEPENDENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050610</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050621</drugenddate>
        <drugtreatmentduration>17280</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METFORMIN HCL</medicinalproduct>
        <drugdosagetext>500 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050622</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METFORMIN HCL</medicinalproduct>
        <drugdosagetext>1000 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060707</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METFORMIN HCL</medicinalproduct>
        <drugdosagetext>750 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060708</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATORVASTATIN CALCIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CINNAMOMUM VERUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054306-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060706</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006-02512</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>60</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>58.5</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FAECES DISCOLOURED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FREQUENT BOWEL MOVEMENTS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCREATITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ESTRADIOL</medicinalproduct>
        <drugauthorizationnumb>40114</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ESTRADIOL</medicinalproduct>
        <drugauthorizationnumb>40114</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060614</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THYROID TAB</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054307-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060630</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2003-07-1839</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>47</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>90.2658</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIABETES MELLITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MIGRAINE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</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>20030426</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030717</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>20030426</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030717</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ESTRADIOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOPRESSOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054308-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060707</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006-07-0330</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALBUTEROL</medicinalproduct>
        <drugauthorizationnumb>17559</drugauthorizationnumb>
        <drugdosagetext>ORAL AER INH</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054309-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesscongenitalanomali>1</seriousnesscongenitalanomali>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060705</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006BI009044</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>3.78</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PILONIDAL CYST</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugdosagetext>30 UG; QW; TRPL</drugdosagetext>
        <drugadministrationroute>064</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050729</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054310-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060627</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006BI008682</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>36</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>AMENORRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATOMEGALY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MIGRAINE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE SCLEROSIS RELAPSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STRESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugdosagetext>IM</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19961001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060501</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALIUM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054311-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060706</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006BI009680</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>45</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>VAGINAL 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>20010101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030801</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugbatchnumb>P35076</drugbatchnumb>
        <drugdosagetext>30 UG; QW; IM</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030901</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054312-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060705</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006BI009684</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugdosagetext>IM</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19970801</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054313-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060707</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006BI009753</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>53</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19970101</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>20060501</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054314-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060601</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-KINGPHARMUSA00001-K200600713</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>47</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>AGITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDE ATTEMPT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SONATA</medicinalproduct>
        <drugauthorizationnumb>20859</drugauthorizationnumb>
        <drugdosagetext>140 MG, SINGLE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060528</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060528</drugenddate>
        <drugtreatmentduration>1440</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIRTAZAPINE</medicinalproduct>
        <drugdosagetext>1500 MG, SINGLE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060528</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060528</drugenddate>
        <drugtreatmentduration>1440</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>UNKNOWN BLUE LIQUID</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060528</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060528</drugenddate>
        <drugtreatmentduration>1440</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054315-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060707</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006BI006780</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>42</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DIALYSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugdosagetext>30 UG; QW; IM</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990801</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROZAC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZAROXOLYN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BUMEX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOTROL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACCUPRIL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054316-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060703</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006BI006474</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>71</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>90.7194</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JOINT SPRAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOWER LIMB FRACTURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugdosagetext>30 UG; QW; IM</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19960101</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>5054317-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006BI006308</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>48</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFECTION</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>20040401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050901</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>20051115</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054320-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060711</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-13441605</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BREAST CANCER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ESTRADIOL</medicinalproduct>
        <drugauthorizationnumb>084499</drugauthorizationnumb>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROVERA</medicinalproduct>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054322-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060712</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-13440227</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>60</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>58</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PANCREATITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ESTRACE</medicinalproduct>
        <drugauthorizationnumb>084499</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060601</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ESTRADIOL</medicinalproduct>
        <drugauthorizationnumb>084499</drugauthorizationnumb>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THYROID TAB</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054323-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060706</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-BRISTOL-MYERS SQUIBB COMPANY-13435979</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>51</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>63</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD BILIRUBIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CREATINE PHOSPHOKINASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CREATININE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHOLELITHIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPHOEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POLYNEUROPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHABDOMYOLYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENOUS INSUFFICIENCY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REYATAZ</medicinalproduct>
        <drugauthorizationnumb>021567</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060519</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060621</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVIR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060519</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060621</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COMBIVIR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060519</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060621</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHADONE HCL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054324-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060705</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-BRISTOL-MYERS SQUIBB COMPANY-13444195</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>58</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ENTEROCOLITIS HAEMORRHAGIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN TOXICITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WATER POLLUTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ERBITUX</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLORECTAL CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060620</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060620</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CAMPTOSAR</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLORECTAL CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060620</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060620</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXALIPLATIN</medicinalproduct>
        <drugadministrationroute>013</drugadministrationroute>
        <drugindication>COLORECTAL CANCER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054325-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060706</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-BRISTOL-MYERS SQUIBB COMPANY-13442314</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>58</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERALISED ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFUSION RELATED REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPTIC SHOCK</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ERBITUX</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>COLORECTAL CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051005</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060531</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IRINOTECAN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLORECTAL CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051005</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060125</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUOROURACIL</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLORECTAL CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051005</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060125</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOLINIC ACID</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLORECTAL CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051005</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060125</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ESOMEPRAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENALAPRIL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054352-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060714</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2006-BP-08215NB</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>81</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>INTERSTITIAL LUNG DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPHOCYTE STIMULATION TEST POSITIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MOBIC</medicinalproduct>
        <drugauthorizationnumb>20938</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060524</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060601</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAKEPRON</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060524</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060524</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054353-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060703</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2006-FF-00563FF</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>50</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HEPATOTOXICITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPHADENOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN TOXICITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIRAMUNE</medicinalproduct>
        <drugauthorizationnumb>20636</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COMBIVIR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010830</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054354-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060711</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2006-BP-07896BP</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>OESOPHAGEAL CARCINOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROSTATE CANCER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLOMAX</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>020579</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054355-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060303</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2006-BP-02493NB</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBRAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIVERTICULITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRIC CANCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERCHOLESTEROLAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPH NODE TUBERCULOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIRAMUNE</medicinalproduct>
        <drugauthorizationnumb>20636</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000926</drugstartdate>
        <drugtreatmentduration>14</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RETROVIR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000926</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020404</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EPIVIR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000926</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZERIT</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020405</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ISCOTIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>LYMPH NODE TUBERCULOSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010209</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020419</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RIFAMPICIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>LYMPH NODE TUBERCULOSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010209</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020419</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ETHAMBUTOL AND PREPARATIONS</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>LYMPH NODE TUBERCULOSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010209</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010523</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PYRAMIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>LYMPH NODE TUBERCULOSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010209</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020512</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TENORMIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020512</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020626</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RENIVACE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020512</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BAKTAR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PNEUMOCYSTIS JIROVECI PNEUMONIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000825</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010712</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLARITHROMYCIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PNEUMONIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000628</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20000702</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054356-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060712</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2006-BP-08064NB</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>92</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG ERUPTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
        <drugauthorizationnumb>21395</drugauthorizationnumb>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060628</drugstartdate>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ROCALTROL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MUSCULOSKELETAL PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060708</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060712</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>JUVELA (TOCOPHEROL NICOTINATE)</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MUSCULOSKELETAL PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060712</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060712</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYANOCOBALAMIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MUSCULOSKELETAL PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060708</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060712</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MUSCULOSKELETAL PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060708</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060712</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEPTIN AIR (PROCATEROL HYDROCHLORIDE)</medicinalproduct>
        <drugadministrationroute>055</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060708</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060712</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PARIET</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MUSCULOSKELETAL PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060625</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060712</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SELBEX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MUSCULOSKELETAL PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060625</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060712</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THEO-DUR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060712</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054374-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060707</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>007963</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BREAST CANCER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MEDROXYPROGESTERONE ACETATE</medicinalproduct>
        <drugauthorizationnumb>40159</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19930101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19930101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMPRO</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19930101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROVERA</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19930101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ESTRATAB</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19930101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054377-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060626</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>225831</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>73</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANAPHYLACTIC REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NECK PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XOLAIR</medicinalproduct>
        <drugdosagetext>375  MG, SUBCUTANEOUS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060512</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060526</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SINGULAIR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOTREL (AMLODIPINE BESYLATE, BENAZEPRIL HYDROCHLORIDE)</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 (ALBUTEROL/ALBUTEROL SULFATE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZAROXOLYN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM (POTASSIUM NOS)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054379-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060705</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>224730</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>62</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>59</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>GINGIVAL SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWOLLEN TONGUE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XOLAIR</medicinalproduct>
        <drugbatchnumb>M51038</drugbatchnumb>
        <drugdosagetext>150 MG, SUBCUTANEOUS; 150 MG, Q4W, SUBCUTANEOUS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XOLAIR</medicinalproduct>
        <drugbatchnumb>M51038</drugbatchnumb>
        <drugdosagetext>150 MG, SUBCUTANEOUS; 150 MG, Q4W, SUBCUTANEOUS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060621</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XOLAIR</medicinalproduct>
        <drugbatchnumb>M69170</drugbatchnumb>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FORADIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SINGULAIR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>QVAR 40</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THEOPHYLLINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054380-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>225956</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>67</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>55.3</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACTERIA URINE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD POTASSIUM DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD SODIUM DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ENTERITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ENTEROCOLITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTESTINAL OBSTRUCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPHIL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RED BLOOD CELLS URINE POSITIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINE ANALYSIS ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELLS URINE POSITIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVASTIN</medicinalproduct>
        <drugbatchnumb>M71649</drugbatchnumb>
        <drugdosagetext>291 MG, Q2W, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLORECTAL CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060512</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CAPECITABINE(CAPECITABINE)</medicinalproduct>
        <drugbatchnumb>VSO86</drugbatchnumb>
        <drugdosagetext>2500 MG, BID, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>COLORECTAL CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060512</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXALIPLATN(OXALIPLATIN)</medicinalproduct>
        <drugbatchnumb>763325</drugbatchnumb>
        <drugdosagetext>135 MG, Q2W, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLORECTAL CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060512</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXALIPLATN(OXALIPLATIN)</medicinalproduct>
        <drugbatchnumb>824029</drugbatchnumb>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XALATAN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054382-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060630</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>226973</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>60</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANAPHYLACTIC REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRONCHIAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHILLS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFUSION RELATED REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NASAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URTICARIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RITUXAN</medicinalproduct>
        <drugdosagetext>1/WEEK</drugdosagetext>
        <drugindication>WALDENSTROM'S MACROGLOBULINAEMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>STEROIDS NOS (STEROID NOS)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054383-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060630</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>225743</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>60</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>90.7</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD POTASSIUM DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVASTIN</medicinalproduct>
        <drugbatchnumb>M55178</drugbatchnumb>
        <drugdosagetext>5 INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLON CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060328</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CAPECITABINE(CAPECITABINE)</medicinalproduct>
        <drugdosagetext>42000 QD, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>COLON CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060328</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXALIPLATIN(OXALIPLATIN)</medicinalproduct>
        <drugdosagetext>85 INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLON CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060328</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VERAPAMIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATIVAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLOMAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HALDOL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054385-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060707</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>227174</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>68</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>56.9</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>MALIGNANT NEOPLASM PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NON-SMALL CELL LUNG CANCER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVASTIN</medicinalproduct>
        <drugdosagetext>15 MG/KG, Q3W, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060517</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060517</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ERLOTINIB(ERLOTINIB) TABLET</medicinalproduct>
        <drugdosagetext>150 MG, QD</drugdosagetext>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060627</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060627</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARBOPLATIN</medicinalproduct>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAXOL</medicinalproduct>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054387-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060627</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DSA_60984_2006</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DRUG DISPENSING ERROR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCORRECT DOSE ADMINISTERED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANIC REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY DEPRESSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIASTAT</medicinalproduct>
        <drugauthorizationnumb>20648</drugauthorizationnumb>
        <drugdosagetext>20 MG ONCE RC</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054393-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060710</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>007973</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BREAST CANCER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MEDROXYPROGESTERONE ACETATE</medicinalproduct>
        <drugauthorizationnumb>40159</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19930101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROVERA</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19930101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19930101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMPRO</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19930101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054394-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060710</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>007971</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BREAST CANCER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MEDROXYPROGESTERONE ACETATE</medicinalproduct>
        <drugauthorizationnumb>40159</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19800101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19800101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROVERA</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19800101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMPRO</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19800101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054396-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060630</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>007755</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>47</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>74.8</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEEP VEIN THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OFF LABEL USE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLEURAL EFFUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KARIVA</medicinalproduct>
        <drugauthorizationnumb>75863</drugauthorizationnumb>
        <drugdosagetext>1 TABLET, QD, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MENOPAUSAL SYMPTOMS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060502</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SOMA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACIPHEX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROZAC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BUSPAR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COVERA-HS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054398-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060710</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>007969</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</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>MEDROXYPROGESTERONE ACETATE</medicinalproduct>
        <drugauthorizationnumb>40159</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ESTRATEST (EMTHYLTESTOSTERONE, ESTROGENS ESTERIFIED)</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ESTROSTEP FE (NORETHISTERONE ACETATE, ETHINYLESTRADIOL, FERROUS FUMARA</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054400-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060710</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>007968</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BREAST CANCER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MEDROXYPROGESTERONE ACETATE</medicinalproduct>
        <drugauthorizationnumb>40159</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ESTRADIOL</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ESTRACE</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCRIN</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054401-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060707</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>007967</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BREAST CANCER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MEDROXYPROGESTERONE ACETATE</medicinalproduct>
        <drugauthorizationnumb>40159</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19960101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMPRO</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19960101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROVERA</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19960101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMBIPATCH</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19960101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19960101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054403-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060707</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>007964</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BREAST CANCER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MEDROXYPROGESTERONE ACETATE</medicinalproduct>
        <drugauthorizationnumb>40159</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19900101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19980101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19900101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19980101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROVERA</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19900101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19980101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054404-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060707</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>007966</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BREAST CANCER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MEDROXYPROGESTERONE ACETATE</medicinalproduct>
        <drugauthorizationnumb>40159</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19940101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20000101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19940101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20000101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMPRO</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19940101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20000101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROVERA</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19940101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20000101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ESTRATEST</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19940101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20000101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ESTRADERM</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19940101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20000101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIVELLE</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19940101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20000101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054406-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060626</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CERZ-11263</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>51</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BONE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HIP ARTHROPLASTY</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>19970228</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054408-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>27602-1</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>66</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>64</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>AORTIC ANEURYSM RUPTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DACARBAZINE</medicinalproduct>
        <drugbatchnumb>2056-09-816104</drugbatchnumb>
        <drugauthorizationnumb>75812</drugauthorizationnumb>
        <drugdosagetext>1730-1710MG/IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>METASTATIC MALIGNANT MELANOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051010</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060501</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054409-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060509</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006-05-0659</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>66</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>64</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANEURYSM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DACARBAZINE</medicinalproduct>
        <drugbatchnumb>816104</drugbatchnumb>
        <drugauthorizationnumb>75812</drugauthorizationnumb>
        <drugdosagetext>1730-1710 MG INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>METASTATIC MALIGNANT MELANOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051010</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060501</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATIVAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EMEND</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054411-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060627</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>28489</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>65</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AORTIC THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEUCOVORIN CALCIUM</medicinalproduct>
        <drugauthorizationnumb>89384</drugauthorizationnumb>
        <drugdosagetext>390MG, 200MG/M2/EVERY 2 WEE</drugdosagetext>
        <drugindication>NEUROENDOCRINE TUMOUR</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060428</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054412-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060627</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>28514</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>56</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>79.8331</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEUCOVORIN CALCIUM</medicinalproduct>
        <drugauthorizationnumb>89384</drugauthorizationnumb>
        <drugdosagetext>400MG, 200MG/M2/ EVERY 2 WKS</drugdosagetext>
        <drugindication>PANCREATIC NEOPLASM</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060530</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054414-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DEU-2006-0002313</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>67</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CATHETER RELATED COMPLICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FAECAL INCONTINENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLANK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOREFLEXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLAMMATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE MASS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MASS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULAR WEAKNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SCAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SENSORY LOSS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPINAL CORD COMPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY INCONTINENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HYDROMORPHONE HCL</medicinalproduct>
        <drugauthorizationnumb>21044</drugauthorizationnumb>
        <drugdosagetext>10 MG, DAILY, INTRATHECAL</drugdosagetext>
        <drugadministrationroute>037</drugadministrationroute>
        <drugindication>BACK PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031106</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BUPIVACAINE</medicinalproduct>
        <drugdosagetext>20 MG, DAILY, INTRATHECAL</drugdosagetext>
        <drugadministrationroute>037</drugadministrationroute>
        <drugindication>BACK PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031106</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONIDINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054415-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060630</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DEU-2006-0002314</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>71</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANAL SPHINCTER ATONY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARACHNOIDITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CATHETER RELATED COMPLICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FAECAL INCONTINENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GRANULOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE ANAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE MASS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NERVOUS SYSTEM DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY INCONTINENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HYDROMORPHONE HCL</medicinalproduct>
        <drugauthorizationnumb>21044</drugauthorizationnumb>
        <drugdosagetext>110 MG, DAILY, INTRATHECAL</drugdosagetext>
        <drugadministrationroute>039</drugadministrationroute>
        <drugindication>BACK PAIN</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054416-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060630</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006BI009445</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>68</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>53.5244</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASTICITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VARICOSE VEIN RUPTURED</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>20040301</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SANCTURA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FAMPRIDINE SR</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054417-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ABRIP-06-0324</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ILEUS PARALYTIC</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ABRAXANE FOR INJECTABLE SUSPENSION (PACLITAXEL PROTEIN-BOUND) (PACLITA</medicinalproduct>
        <drugauthorizationnumb>21660</drugauthorizationnumb>
        <drugdosagetext>INTRAVENOUS DRIP</drugdosagetext>
        <drugadministrationroute>041</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054418-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060627</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006US001353</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>59</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>REFUSAL OF TREATMENT BY RELATIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMEVIVE</medicinalproduct>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>PSORIASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051223</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMEVIVE</medicinalproduct>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>PSORIASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060310</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054419-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060627</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GR-SANOFI-SYNTHELABO-A01200604939</companynumb>
    <primarysource>
      <reportercountry>GREECE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>71</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD BILIRUBIN UNCONJUGATED INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERNATIONAL NORMALISED RATIO INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEPHROLITHIASIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BIRACETAM</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MEMORY IMPAIRMENT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugauthorizationnumb>020839</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ISCHAEMIC STROKE</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060601</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugauthorizationnumb>020839</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANEURYSM</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060601</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugauthorizationnumb>020839</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>THROMBOSIS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060601</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054421-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060626</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006-01005</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>72</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ACUTE RESPIRATORY DISTRESS SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AORTIC ANEURYSM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ATRIAL FIBRILLATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD LACTIC ACID INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG TOXICITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMODIALYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTESTINAL ISCHAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA BACTERIAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VELCADE</medicinalproduct>
        <drugauthorizationnumb>21602</drugauthorizationnumb>
        <drugdosagetext>1.00 MG/M2, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MYELODYSPLASTIC SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060421</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060421</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>THALIDOMIDE (THALIDOMIDE)</medicinalproduct>
        <drugdosagetext>50.00 MG, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MYELODYSPLASTIC SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060421</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060422</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054422-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060704</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2005US001667</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>62</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>APHTHOUS STOMATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACTERIAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BUNDLE BRANCH BLOCK RIGHT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CULTURE URINE POSITIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>KIDNEY INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>KIDNEY TRANSPLANT REJECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEPHRITIS INTERSTITIAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENTRICULAR DYSFUNCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROGRAF</medicinalproduct>
        <drugauthorizationnumb>50708</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS AGAINST TRANSPLANT REJECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050115</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROGRAF</medicinalproduct>
        <drugauthorizationnumb>50708</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS AGAINST TRANSPLANT REJECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050118</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MYCOPHENOLATE MOFETIL</medicinalproduct>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS AGAINST TRANSPLANT REJECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050112</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MYCOPHENOLATE MOFETIL</medicinalproduct>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS AGAINST TRANSPLANT REJECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051108</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISONE TAB</medicinalproduct>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS AGAINST TRANSPLANT REJECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050116</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISONE TAB</medicinalproduct>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS AGAINST TRANSPLANT REJECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050711</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHYLPREDNISOLONUM (METHYLPREDNISOLONE)</medicinalproduct>
        <drugdosagetext>100 MG, IV NOS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PROPHYLAXIS AGAINST TRANSPLANT REJECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050111</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050115</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>THYMOGLOBULIN</medicinalproduct>
        <drugdosagetext>100 MG, UID/QD, IV NOS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PROPHYLAXIS AGAINST TRANSPLANT REJECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050111</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050115</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DAPSONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MORPHINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NYSTATIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANTOPRAZOLE SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN GLARGINE (INSULIN GLARGINE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALGANCICLOVIR HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NIFEDIPINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOXAZOSIN (DOXAZOSIN)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVODART</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROTONIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ISOPHANE INSULIN (ISOPHANE INSULIN)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054423-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060626</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CERZ-11267</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>76</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>80</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>AORTIC STENOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CEREZYME</medicinalproduct>
        <drugauthorizationnumb>20367</drugauthorizationnumb>
        <drugdosagetext>25 U/KG Q4WKS IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>GAUCHER'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010405</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060501</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054424-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006PV013090</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>40</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>108.8633</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BIPOLAR DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING OF DESPAIR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE HAEMATOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LACERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDE ATTEMPT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BYETTA</medicinalproduct>
        <drugauthorizationnumb>21773</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>DIABETES MELLITUS NON-INSULIN-DEPENDENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060501</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BYETTA</medicinalproduct>
        <drugauthorizationnumb>21773</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>DIABETES MELLITUS NON-INSULIN-DEPENDENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVAPRO</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACTOS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLIMEPIRIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEXAPRO</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRICOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROTONIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADVAIR DISKUS 100/50</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054425-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006PV016550</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>49</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DROOLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL CANDIDIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL INTAKE REDUCED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHINORRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SNEEZING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BYETTA</medicinalproduct>
        <drugauthorizationnumb>21773</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>DIABETES MELLITUS NON-INSULIN-DEPENDENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060318</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BYETTA</medicinalproduct>
        <drugauthorizationnumb>21773</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>DIABETES MELLITUS NON-INSULIN-DEPENDENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060619</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOPHAGE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACTOS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054426-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060627</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006PV016897</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>73</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>82.5547</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>APHASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IRRITABILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOTOR DYSFUNCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULAR WEAKNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BYETTA</medicinalproduct>
        <drugbatchnumb>9RY71M</drugbatchnumb>
        <drugauthorizationnumb>21773</drugauthorizationnumb>
        <drugdosagetext>5 MCG; BID; SC</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>DIABETES MELLITUS NON-INSULIN-DEPENDENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060427</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060601</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FISH OIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUNISOLIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLYBURIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOSAMINE W/CHONDROITIN SULFATES</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NICARDIPINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NITROGLYCERIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VIAGRA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054427-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060627</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006PV016561</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>58</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>JOINT SURGERY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAIL DISCOLOURATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ONYCHOMADESIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BYETTA</medicinalproduct>
        <drugbatchnumb>9RK01P</drugbatchnumb>
        <drugauthorizationnumb>21773</drugauthorizationnumb>
        <drugdosagetext>10 MCG; SC</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054429-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006-DE-03327GD</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>53</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ADRENAL MASS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD POTASSIUM DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE CONGESTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSIVE CRISIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERNICIOUS ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>REFUSAL OF TREATMENT BY PATIENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINE POTASSIUM INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
        <drugauthorizationnumb>18823</drugauthorizationnumb>
        <drugdosagetext>40 MG</drugdosagetext>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugdosagetext>80 MG (TWICE DAILY)</drugdosagetext>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARVEDILOL</medicinalproduct>
        <drugdosagetext>6.25 MG (, TWICE DAILY)</drugdosagetext>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMLODIPINE</medicinalproduct>
        <drugdosagetext>10 MG</drugdosagetext>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>POTASSIUM SUPPLEMENTS (POTASSIUM)</medicinalproduct>
        <drugdosagetext>80 MEQ</drugdosagetext>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054431-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006-DE-03304GD</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>52</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE CONGESTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART SOUNDS ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSIVE CRISIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOKALAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERNICIOUS ANAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
        <drugauthorizationnumb>18823</drugauthorizationnumb>
        <drugdosagetext>80 MG</drugdosagetext>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CAPTOPRIL</medicinalproduct>
        <drugdosagetext>75 MG</drugdosagetext>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LABETALOL HCL</medicinalproduct>
        <drugdosagetext>800 MG</drugdosagetext>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>POTASSIUM (POTASSIUM)</medicinalproduct>
        <drugdosagetext>40 MEQ,</drugdosagetext>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054433-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060630</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006PV016724</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>51</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>127.0072</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ATRIAL FIBRILLATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE FLUCTUATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE CONGESTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY OCCLUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERUCTATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREATMENT NONCOMPLIANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BYETTA</medicinalproduct>
        <drugauthorizationnumb>21773</drugauthorizationnumb>
        <drugdosagetext>10 MCG; BID; SC</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>DIABETES MELLITUS NON-INSULIN-DEPENDENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060620</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLIPIZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HUMALOG 70/30</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054435-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006PV016651</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>68</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>87.5442</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIOMEGALY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSGEUSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE URTICARIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISION BLURRED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BYETTA</medicinalproduct>
        <drugauthorizationnumb>21773</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>DIABETES MELLITUS NON-INSULIN-DEPENDENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060403</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060401</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BYETTA</medicinalproduct>
        <drugauthorizationnumb>21773</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>DIABETES MELLITUS NON-INSULIN-DEPENDENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060509</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060501</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BYETTA</medicinalproduct>
        <drugauthorizationnumb>21773</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>DIABETES MELLITUS NON-INSULIN-DEPENDENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060508</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BYETTA</medicinalproduct>
        <drugauthorizationnumb>21773</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>DIABETES MELLITUS NON-INSULIN-DEPENDENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060514</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NOVOLIN N</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054437-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060707</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>007944</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BREAST CANCER FEMALE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MEDROXYPROGESTERONE ACETATE</medicinalproduct>
        <drugauthorizationnumb>40159</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19930101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20000101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19930101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20000101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMPRO</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19930101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20000101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROVERA</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19930101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20000101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054438-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060707</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>007951</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BREAST CANCER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MEDROXYPROGESTERONE ACETATE</medicinalproduct>
        <drugauthorizationnumb>40159</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19790101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19790101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROVERA</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19790101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054440-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060713</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0607USA02576</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>OESOPHAGEAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054441-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060605</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0606USA00751</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>48</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>91</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ARRHYTHMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOKALAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HYZAAR</medicinalproduct>
        <drugauthorizationnumb>20387</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060119</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060301</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HYZAAR</medicinalproduct>
        <drugauthorizationnumb>020387</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060530</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPROL-XL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD PRESSURE INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ECOTRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANTICOAGULANT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054442-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060705</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-MERCK-0607USA02751</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>67</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>71</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD CREATINE PHOSPHOKINASE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROPECIA</medicinalproduct>
        <drugauthorizationnumb>20788</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ALOPECIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051227</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060616</drugenddate>
        <drugtreatmentduration>172</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NIVADIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SILECE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INSOMNIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEPAS</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>AUTONOMIC NERVOUS SYSTEM IMBALANCE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054443-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060627</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>MX-MERCK-0607MEX00009</companynumb>
    <primarysource>
      <reportercountry>MEXICO</reportercountry>
      <qualification>1</qualification>
    </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>CARDIAC ARREST</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INVANZ</medicinalproduct>
        <drugauthorizationnumb>21337</drugauthorizationnumb>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>ABDOMINAL INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060504</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060510</drugenddate>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054444-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060616</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-MERCK-0606USA04174</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>9</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISSEMINATED INTRAVASCULAR COAGULATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>REVERSIBLE POSTERIOR LEUKOENCEPHALOPATHY SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHABDOMYOLYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VARICELLA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEPCID</medicinalproduct>
        <drugauthorizationnumb>19510</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PROPHYLAXIS AGAINST GASTROINTESTINAL ULCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060606</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060611</drugenddate>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEPCID</medicinalproduct>
        <drugauthorizationnumb>019510</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060612</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060614</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEPCID</medicinalproduct>
        <drugauthorizationnumb>019510</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060615</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060615</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IRINOTECAN HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>NEUROBLASTOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060530</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060603</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PENTCILLIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>INFECTION PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060602</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060607</drugenddate>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KYTRIL</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NAUSEA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060529</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060612</drugenddate>
        <drugtreatmentduration>15</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054445-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060712</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0607USA02419</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>58</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DELUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG LEVEL DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HALLUCINATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANIC ATTACK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARANOIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEPCID</medicinalproduct>
        <drugauthorizationnumb>019462</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTROOESOPHAGEAL REFLUX DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARDIZEM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANOXIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLOMAX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</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>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054446-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060707</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>007950</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BREAST CANCER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MEDROXYPROGESTERONE ACETATE</medicinalproduct>
        <drugauthorizationnumb>40159</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19840101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19840101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROVERA</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19840101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROMETRIUM</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19940101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054447-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060613</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BE-MERCK-0606BEL00013</companynumb>
    <primarysource>
      <reportercountry>BELGIUM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>57</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>93</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ATRIAL FIBRILLATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRONCHITIS ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY STENOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERMITTENT CLAUDICATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugauthorizationnumb>19766</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERCHOLESTEROLAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020901</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BISOPROLOL FUMARATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000901</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALSARTAN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060116</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000901</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054449-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060705</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006BH011611</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>35</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>76</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA MULTIFORME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>REFUSAL OF TREATMENT BY PATIENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REGLAN</medicinalproduct>
        <drugauthorizationnumb>17862</drugauthorizationnumb>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TEMODAR</medicinalproduct>
        <drugdosagetext>150 MG; EVERY DAY; PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ASTROCYTOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060503</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060604</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRILEPTAL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BACTRIM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DILANTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DECADRON</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENADRYL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054450-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060706</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006AL001677</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>61</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPEPSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OESOPHAGEAL SPASM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ETODOLAC</medicinalproduct>
        <drugauthorizationnumb>74819</drugauthorizationnumb>
        <drugdosagetext>400 MG; BID; PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ROTATOR CUFF SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060623</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060701</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALSARTAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZINC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SAW PALMETTO</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054451-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040621</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>C04-027</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>49</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ADVERSE DRUG REACTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXYCODONE HYDROCHLORIDE</medicinalproduct>
        <drugauthorizationnumb>76636</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054452-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CLOF-10267</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>68</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD CREATININE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULAR WEAKNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOFARABINE</medicinalproduct>
        <drugauthorizationnumb>21673</drugauthorizationnumb>
        <drugdosagetext>62.7 MG QD X 5 IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MYELODYSPLASTIC SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060620</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060624</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054454-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>35751</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CORNEAL ABRASION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEVICE BREAKAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RETINAL DETACHMENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRAVATAN</medicinalproduct>
        <drugauthorizationnumb>21257</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054455-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060705</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>TPA2006A01072</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INTOLERANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERVERTEBRAL DISC PROTRUSION</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>DIABETES MELLITUS NON-INSULIN-DEPENDENT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VYTORIN (SIMVASTATIN, EZETIMIBE)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054466-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060705</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>TPA2006A01044</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>61</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>106.5953</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOVEMENT DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULAR WEAKNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TENDERNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACTOPLUS MET</medicinalproduct>
        <drugauthorizationnumb>21842</drugauthorizationnumb>
        <drugdosagetext>15/500 MG, TWICE DAILY, PER ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS NON-INSULIN-DEPENDENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN ACE INHIBITOR (ACE INHIBITOR NOS)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRICOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVANDAMET (METFORMIN HYDROCHLORIDE, ROSIGLITAZONE MALEATE)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054469-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060705</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>TPA2006A01046</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>57</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>89.8122</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MOVEMENT DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULAR WEAKNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TENDERNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACTOPLUS MET</medicinalproduct>
        <drugauthorizationnumb>21842</drugauthorizationnumb>
        <drugdosagetext>15/500 MG, 1 QAM + 2 QPM, PER ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS NON-INSULIN-DEPENDENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060601</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN ACE INHIBITOR (ACE INHIBITOR NOS)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN CALCIUM CHANNEL BLOCKER (CALCIUM CHANNEL BLOCKERS)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN DIURETIC (DIURETICS)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVANDAMET (METFORMIN HYDROCHLORIDE, ROSIGLITAZONE MALEATE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054471-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006-01134</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>68</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>57.2</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FAILURE TO THRIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATOCRIT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOMAGNESAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPONATRAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORTHOSTATIC HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRICUSPID VALVE INCOMPETENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VELCADE</medicinalproduct>
        <drugauthorizationnumb>21602</drugauthorizationnumb>
        <drugdosagetext>1.30 MG/M2, INTRAVENOUS; 1.00 MG/M2 INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>OVARIAN CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060222</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060426</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VELCADE</medicinalproduct>
        <drugauthorizationnumb>21602</drugauthorizationnumb>
        <drugdosagetext>1.30 MG/M2, INTRAVENOUS; 1.00 MG/M2 INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>OVARIAN CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060517</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060527</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARBOPLATIN</medicinalproduct>
        <drugdosagetext>270.00 MG, INTRAVENOUS; 325.00 MG, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>OVARIAN CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060222</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060419</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARBOPLATIN</medicinalproduct>
        <drugdosagetext>270.00 MG, INTRAVENOUS; 325.00 MG, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>OVARIAN CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060517</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060517</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROTONIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVENOX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPROL-XL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRONOLACTONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTIPLE VITAMINS (ERGOCALCIFEROL, VITAMIN B NOS, TOCOPHEROL, ASCORBIC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN B6</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGNESIUM (MAGNESIUM)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SENOKOT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORTAB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOFRAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054473-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060627</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>163-21880-06060890</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>59</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>72.5755</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>RETROPERITONEAL FIBROSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugauthorizationnumb>21880</drugauthorizationnumb>
        <drugdosagetext>10 MG, DAILY, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MYELODYSPLASTIC SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060223</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRILOSEC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEGACE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054475-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060627</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>163-21880-06060207</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>77</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BONE MARROW FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugauthorizationnumb>21880</drugauthorizationnumb>
        <drugdosagetext>10 MG, DAILY, ORAL; 5 MG, DAILY, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MYELODYSPLASTIC SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060303</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060301</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugauthorizationnumb>21880</drugauthorizationnumb>
        <drugdosagetext>10 MG, DAILY, ORAL; 5 MG, DAILY, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MYELODYSPLASTIC SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060329</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060501</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARANESP</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEUPOGEN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054476-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060623</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>163-21880-06040854</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>75</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>FULL BLOOD COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugauthorizationnumb>21880</drugauthorizationnumb>
        <drugdosagetext>1 IN 1 D, ORAL; QD, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MYELODYSPLASTIC SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060331</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060412</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugauthorizationnumb>21880</drugauthorizationnumb>
        <drugdosagetext>1 IN 1 D, ORAL; QD, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MYELODYSPLASTIC SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060425</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054478-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>163-21880-06070149</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CEREBRAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugauthorizationnumb>21880</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054479-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060701</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>163-21880-06070153</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>84</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugauthorizationnumb>21880</drugauthorizationnumb>
        <drugdosagetext>1 IN 1 D, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060523</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054480-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060701</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>163-21880-06070176</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>75</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugauthorizationnumb>21880</drugauthorizationnumb>
        <drugdosagetext>10 MG, 1 IN 1 D, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MYELODYSPLASTIC SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060516</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054481-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060627</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>163-21880-06060573</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>65</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>DISEASE PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYELODYSPLASTIC SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugauthorizationnumb>21880</drugauthorizationnumb>
        <drugdosagetext>10 MG, DAILY, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MYELODYSPLASTIC SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060503</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054482-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060630</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>163-21880-06050492</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>69</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>101.6057</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCREATITIS ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STOMACH DISCOMFORT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugauthorizationnumb>21880</drugauthorizationnumb>
        <drugdosagetext>5 MG, 1 IN 1 D, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MYELODYSPLASTIC SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060512</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROSCAR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLOMAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZESTRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054484-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>163-21880-06070155</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>77</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugauthorizationnumb>21880</drugauthorizationnumb>
        <drugdosagetext>20 MG, DAILY, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060407</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>THALOMID</medicinalproduct>
        <drugbatchnumb>0363W</drugbatchnumb>
        <drugdosagetext>50 MG, DAILY, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030514</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060401</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054486-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>163-21880-06060927</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>75</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG DOSE OMISSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HIP SURGERY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugauthorizationnumb>21880</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MYELODYSPLASTIC SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060130</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugauthorizationnumb>21880</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MYELODYSPLASTIC SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060221</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060301</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugauthorizationnumb>21880</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MYELODYSPLASTIC SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060628</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054487-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060703</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>EM2006-0364</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>44</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>86</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANAPHYLACTIC REACTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MACROLIN</medicinalproduct>
        <drugdosagetext>SUBCUTAN.</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060626</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060629</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KALETRA            (POTASSIUM CHLORIDE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COMBIVIR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VIREAD</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054489-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>163-20785-06070092</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>50</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HIP ARTHROPLASTY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POST PROCEDURAL COMPLICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>THALOMID</medicinalproduct>
        <drugauthorizationnumb>20785</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GAMMOPATHY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040706</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>THALOMID</medicinalproduct>
        <drugauthorizationnumb>20785</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GAMMOPATHY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050412</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054490-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060710</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>227212</companynumb>
    <primarysource>
      <reportercountry>INDIA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>66</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MABTHERA(RITUXIMAB) CONC FOR SOLUTION FOR INFUSION</medicinalproduct>
        <drugdosagetext>637.5 MG, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>B-CELL LYMPHOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051224</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOPHOSPHAMIDE</medicinalproduct>
        <drugdosagetext>1275 MG, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>B-CELL LYMPHOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051224</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOXORUBICIN HCL</medicinalproduct>
        <drugdosagetext>85 MG, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>B-CELL LYMPHOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051224</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VINCRISTINE</medicinalproduct>
        <drugdosagetext>2 MG, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>B-CELL LYMPHOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051224</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054491-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060706</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>S06-USA-02547-01</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HYPONATRAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEXAPRO</medicinalproduct>
        <drugauthorizationnumb>21323</drugauthorizationnumb>
        <drugdosagetext>10 MG QD PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054493-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060627</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>060627-0000571</companynumb>
    <primarysource>
      <reportercountry>ITALY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>ECHOCARDIOGRAM ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERAL PHYSICAL HEALTH DETERIORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEONATAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEONATAL HYPOXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS NEONATAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRICUSPID VALVE INCOMPETENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>L-LYSINE IBUPROFEN (IBUPROFEN LYSINE)</medicinalproduct>
        <drugauthorizationnumb>21903</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugindication>PATENT DUCTUS ARTERIOSUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SURFACTANT</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054494-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060706</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>USA-2006-0024254</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>81</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>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>LIVER DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CEFDITOREN PIVOXIL</medicinalproduct>
        <drugauthorizationnumb>21222</drugauthorizationnumb>
        <drugdosagetext>300 MG, DAILY, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BRONCHITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060407</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060410</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KIPRES (MONTELUKAST SODIUM)</medicinalproduct>
        <drugdosagetext>10 MG, DAILY</drugdosagetext>
        <drugindication>BRONCHITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060330</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060410</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HOKUNALIN   (TULOBUTEROL HYDROCHLORIDE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SEREVENT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>QVAR        (BECLOMETASONE DIPROPIONATE)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054497-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006PV015659</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>67</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>111.1313</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>AORTIC ANEURYSM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>APPENDIX DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHOLELITHIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DECREASED APPETITE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIVERTICULUM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCREATITIS ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROSTATE EXAMINATION ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL CYST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL MASS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BYETTA</medicinalproduct>
        <drugauthorizationnumb>21773</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>DIABETES MELLITUS NON-INSULIN-DEPENDENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060510</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060605</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BYETTA</medicinalproduct>
        <drugauthorizationnumb>21773</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>DIABETES MELLITUS NON-INSULIN-DEPENDENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060606</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060613</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREVACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPROL-XL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOXAZOSIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DYAZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VERAPAMIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MOTRIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054498-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060707</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>USA-2006-0024594</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>32</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANAPHYLACTIC SHOCK</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CEFDITOREN PIVOXIL</medicinalproduct>
        <drugauthorizationnumb>21222</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HY-STAMIN (DIPHENYLPYRALINE HYDROCHLORIDE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HISHIPHAGEN-C</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>B-RON</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRANDFEN (PRANOPROFEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GRIMAC (LEVOGLUTAMIDE, SODIUM GUALENATE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054499-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060627</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006PV015088</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>55</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>96.6162</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>COLITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BYETTA</medicinalproduct>
        <drugauthorizationnumb>21773</drugauthorizationnumb>
        <drugdosagetext>5 MCG;BID;SC</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060220</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RAMIPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELEXA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NITROGLYCERIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054500-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060626</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>MAG-2006-0000446</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>78</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>BLOOD ALKALINE PHOSPHATASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD URIC ACID ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROTEIN TOTAL ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXYCODONE HCL</medicinalproduct>
        <drugauthorizationnumb>20553</drugauthorizationnumb>
        <drugdosagetext>10 MG, DAILY, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CANCER PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050617</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050620</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugdosagetext>50 MG, DAILY, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050617</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050620</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALKERAN</medicinalproduct>
        <drugdosagetext>10 MG, DAILY, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050617</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050620</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AREDIA</medicinalproduct>
        <drugdosagetext>30 MG, DAILY, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050617</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050620</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGNESIUM OXIDE HEAVY (MAGNESIUM OXIDE HEAVY)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRIMPERAN TAB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RABEPRAZOLE SODIUM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054501-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060630</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>225625</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>71</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>68</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>GLIOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IRRITABILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RADIATION INJURY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEVACIZUMAB OR PLACEBO</medicinalproduct>
        <drugdosagetext>10 MG/KG, Q2W, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>METASTATIC RENAL CELL CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051006</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060522</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INTERFERON ALPHA-2A (INTERFERON ALFA-2A)</medicinalproduct>
        <drugdosagetext>3000000 IU, 3/WEEK, SUBCUTANEOUS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>METASTATIC RENAL CELL CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051006</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060522</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATACAND</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054502-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060627</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006PV014680</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>55</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>96.6162</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATOCHEZIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BYETTA</medicinalproduct>
        <drugauthorizationnumb>21773</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>DIABETES MELLITUS NON-INSULIN-DEPENDENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060220</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060320</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BYETTA</medicinalproduct>
        <drugauthorizationnumb>21773</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>DIABETES MELLITUS NON-INSULIN-DEPENDENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060321</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060601</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RAMIPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELEXA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NITROGLYCERIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOTROL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054504-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>227151</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <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>AVASTIN</medicinalproduct>
        <drugindication>RENAL CELL CARCINOMA STAGE UNSPECIFIED</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054506-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060705</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ST-2006-009119</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>75</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</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>20060528</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060529</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HERBESSER ^TANABE^</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ROCORNAL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BEZATOL - SLOW RELEASE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054507-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060703</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>VNL_0122_2006</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>68</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ARTERIAL OCCLUSIVE DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>APO-GO</medicinalproduct>
        <drugauthorizationnumb>21264</drugauthorizationnumb>
        <drugdosagetext>4 MG/HR INFUSION SC</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PARKINSON'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MADOPAR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MADOPAR L T</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MADOPAR DEPOT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PARKOTIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALMIRID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MIRTAZAPINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUNITRAZEPAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MOBIC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MOTILIUM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054509-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>S05-UKI-03649-01</companynumb>
    <primarysource>
      <reportercountry>DENMARK</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>61</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEEP VEIN THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ESCITALOPRAM OXALATE</medicinalproduct>
        <drugauthorizationnumb>21323</drugauthorizationnumb>
        <drugdosagetext>10 MG QD PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054511-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060630</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>VNL_0159_2006</companynumb>
    <primarysource>
      <reportercountry>IRELAND</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>67</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CATHETER RELATED INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFUSION SITE ABSCESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFUSION SITE ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFUSION SITE NECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WOUND SECRETION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>APO-GO</medicinalproduct>
        <drugauthorizationnumb>21264</drugauthorizationnumb>
        <drugdosagetext>3.5 MG/HR INFUSION SC</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PARKINSON'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RAMIPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMIODARONE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BISOPROLOL FUMARATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALDACTONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054514-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnesscongenitalanomali>1</seriousnesscongenitalanomali>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060630</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>S06-FRA-02671-03</companynumb>
    <primarysource>
      <reportercountry>DENMARK</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>9</patientonsetage>
      <patientonsetageunit>802</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CHROMOSOME ABNORMALITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONGENITAL ANOMALY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LISSENCEPHALY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRANSMISSION OF DRUG VIA SEMEN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CITALOPRAM HYDROBROMIDE</medicinalproduct>
        <drugauthorizationnumb>20822</drugauthorizationnumb>
        <drugdosagetext>20 MG QD TRANSPLACENTAL</drugdosagetext>
        <drugadministrationroute>064</drugadministrationroute>
        <drugindication>PANIC DISORDER WITH AGORAPHOBIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054516-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060703</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006083896</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
    </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>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IRRITABILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPHOCYTE COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISION BLURRED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEPO-PROVERA</medicinalproduct>
        <drugauthorizationnumb>20246</drugauthorizationnumb>
        <drugdosagetext>150 MG (150 MG, TRIMESTRAL, FIRST INJECTION)</drugdosagetext>
        <drugindication>MENSTRUAL DISCOMFORT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060621</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060621</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054518-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060701</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006084264</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>32</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>63</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SILDENAFIL (PAH)  (SILDENAFIL)</medicinalproduct>
        <drugauthorizationnumb>21845</drugauthorizationnumb>
        <drugdosagetext>37.5 MG (12. 5 MG,3 IN 1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060419</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRACLEER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALDACTONE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054519-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060702</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006084305</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>27</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>68.9467</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEPRESSED LEVEL OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CETIRIZINE HCL</medicinalproduct>
        <drugbatchnumb>A3119</drugbatchnumb>
        <drugauthorizationnumb>19835</drugauthorizationnumb>
        <drugindication>HYPERSENSITIVITY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060701</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LITHIUM CARBONATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRIQUILAR (ETHINYLESTRADIOL, LEVONORGESTREL)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054521-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>VNL_0162_2006</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>INFUSION SITE ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFUSION SITE HAEMATOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFUSION SITE INDURATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFUSION SITE MASS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFUSION SITE WARMTH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>APO-GO</medicinalproduct>
        <drugauthorizationnumb>21264</drugauthorizationnumb>
        <drugdosagetext>DF INFUSION SC</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060602</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060622</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PENICILLIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054523-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060703</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006082779</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
    </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>GASTRIC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARYNGITIS BACTERIAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSEUDOMONAS INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TONSILLITIS BACTERIAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLINDAMYCIN HCL</medicinalproduct>
        <drugauthorizationnumb>50162</drugauthorizationnumb>
        <drugindication>TOOTH INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054525-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060704</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006083889</companynumb>
    <primarysource>
      <reportercountry>NETHERLANDS</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>51</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>80</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>COMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSEUDOLYMPHOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SULFASALAZINE</medicinalproduct>
        <drugauthorizationnumb>7073</drugauthorizationnumb>
        <drugdosagetext>2 GRAM (1 GRAM, 2 IN 1 D)</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050430</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050601</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054526-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060705</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006083535</companynumb>
    <primarysource>
      <reportercountry>POLAND</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>52</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>INTRACRANIAL PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUPRIL</medicinalproduct>
        <drugauthorizationnumb>19885</drugauthorizationnumb>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054527-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060703</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006082971</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POOR QUALITY DRUG ADMINISTERED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XALATAN</medicinalproduct>
        <drugauthorizationnumb>20597</drugauthorizationnumb>
        <drugdosagetext>OPHTHALMIC</drugdosagetext>
        <drugadministrationroute>047</drugadministrationroute>
        <drugindication>INTRAOCULAR PRESSURE INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COSOPT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALPHAGAN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054529-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060701</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006083074</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>41</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>65</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY HYPERTENSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SILDENAFIL (PAH) (SILDENAFIL)</medicinalproduct>
        <drugauthorizationnumb>21845</drugauthorizationnumb>
        <drugdosagetext>75 MG (25 MG, 3 IN 1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040804</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BERAPROST (BERAPROST)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIGOXIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANSOPRAZOLE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054530-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060701</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006083080</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>51</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>45.2</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUROPATHY PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY VEIN STENOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SILDENAFIL (PAH) (SILDENAFIL)</medicinalproduct>
        <drugauthorizationnumb>21845</drugauthorizationnumb>
        <drugdosagetext>75 MG (25 MG, 3 IN 1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020928</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EPOPROSTENOL SODIUM (EPOPROSTENOL SODIUM)</medicinalproduct>
        <drugdosagetext>60 NG/KG/MIN INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PULMONARY HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020815</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRACLEER</medicinalproduct>
        <drugdosagetext>125 MG, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060408</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060501</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYGEN (OXYGEN)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALDACTONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054531-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060704</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006083427</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>0</patientsex>
      <reaction>
        <reactionmeddrapt>INTRAOCULAR PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XALATAN</medicinalproduct>
        <drugauthorizationnumb>20597</drugauthorizationnumb>
        <drugindication>OCULAR HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XALCOM</medicinalproduct>
        <drugindication>OCULAR HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054532-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060704</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006084626</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANGINA PECTORIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRADYCARDIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IRINOTECAN HCL</medicinalproduct>
        <drugauthorizationnumb>20571</drugauthorizationnumb>
        <drugdosagetext>INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>LUNG NEOPLASM MALIGNANT</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054533-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060706</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006084660</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>65</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>LIVER DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPITOR</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>20060201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060617</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054534-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060706</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006084665</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>0</patientsex>
      <reaction>
        <reactionmeddrapt>DISSEMINATED INTRAVASCULAR COAGULATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT DECREASED</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>20060301</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PLETAL</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054535-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060703</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006085055</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>79</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>77.5</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>BLOOD CALCIUM DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATOCRIT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHABDOMYOLYSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ATORVASTATIN CALCIUM</medicinalproduct>
        <drugauthorizationnumb>20702</drugauthorizationnumb>
        <drugdosagetext>40 MG (40 MG, 1 IN 1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MYOCARDIAL ISCHAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLOPIDOGREL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIGOXIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLOXACILLIN SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUCIDINE CAP</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ISOSORBIDE (ISOSORBIDE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054536-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060703</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006085057</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>MESOTHELIOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ATORVASTATIN CALCIUM</medicinalproduct>
        <drugauthorizationnumb>20702</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DILTIAZEM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LACTULOSE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
        <drugdosagetext>18 MCG</drugdosagetext>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030617</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040701</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BECLOMETHASONE (BECLOMETASONE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COMBIVENT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOSULEPIN (DOSULEPIN)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FRUMIL (AMILORIDE HYDROCHLORIDE, FUROSEMIDE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GAVISCON</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANSOPRAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOCLOPRAMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NITROLINGUAL (GLYCERYL TRINITRATE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NOZINAN (LEVOMEPROMAZINE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCODONE (OXYCODONE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYGEN (OXYGEN)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SALBUTAMOL (SALBUTAMOL)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRONOLACTONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYMBICORT (BUDESONIDE, FORMOTEROL FUMARATE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TEMAZEPAM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054537-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060706</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006084903</companynumb>
    <primarysource>
      <reportercountry>NETHERLANDS</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>47</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>82</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANGINA PECTORIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</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>HYPERCHOLESTEROLAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RHINOCORT</medicinalproduct>
        <drugdosagetext>ONE SPRAY (64 MCG, BID), NASAL</drugdosagetext>
        <drugadministrationroute>045</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060627</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060701</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PERINDOPRIL ERBUMINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054538-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>S06-IRL-00615-01</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>79</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>AGITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BALANCE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG WITHDRAWAL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HALLUCINATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARANOIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDAL BEHAVIOUR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MEMANTINE HCL</medicinalproduct>
        <drugauthorizationnumb>21487</drugauthorizationnumb>
        <drugdosagetext>10 MG BID PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEMENTIA ALZHEIMER'S TYPE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060131</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARICEPT</medicinalproduct>
        <drugdosagetext>10 MG BID PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEMENTIA ALZHEIMER'S TYPE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SINEMET</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CAPRIN (ACETYLSALICYLIC ACID)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XATRAL XL (ALFUZOSIN HYDROCHLORIDE)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054539-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060630</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>S06-AUS-02631-01</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>COMPLICATION OF DEVICE REMOVAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SHOCK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UTERINE DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CERVIDIL</medicinalproduct>
        <drugauthorizationnumb>20411</drugauthorizationnumb>
        <drugdosagetext>10 MG ONCE VG</drugdosagetext>
        <drugadministrationroute>067</drugadministrationroute>
        <drugindication>LABOUR INDUCTION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054540-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2006JP09844</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>49</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PNEUMOMEDIASTINUM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOSPORINE</medicinalproduct>
        <drugauthorizationnumb>80339</drugauthorizationnumb>
        <drugdosagetext>100 MG/D</drugdosagetext>
        <drugindication>DERMATOMYOSITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugdosagetext>25 MG/D</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054541-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2006JP09843</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>52</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PNEUMOMEDIASTINUM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOSPORINE</medicinalproduct>
        <drugauthorizationnumb>80339</drugauthorizationnumb>
        <drugdosagetext>150 MG/D</drugdosagetext>
        <drugindication>POLYMYOSITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugdosagetext>50 MG/D</drugdosagetext>
        <drugindication>POLYMYOSITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054542-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2006JP09425</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>65</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CYSTIC LYMPHANGIOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEOPLASM MALIGNANT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOSPORINE</medicinalproduct>
        <drugauthorizationnumb>80339</drugauthorizationnumb>
        <drugindication>SYSTEMIC LUPUS ERYTHEMATOSUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SYSTEMIC LUPUS ERYTHEMATOSUS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054543-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060705</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GXKR2006DE03802</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>77</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HYPOGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMITRIPTYLINE (NGX) (AMITRIPTYLINE)25MG</medicinalproduct>
        <drugauthorizationnumb>85966</drugauthorizationnumb>
        <drugdosagetext>25 MG, BID, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060702</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060704</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054544-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060703</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2006TW01638</companynumb>
    <primarysource>
      <reportercountry>TAIWAN, PROVINCE OF CHINA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>21</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD OSMOLARITY INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DERMATITIS EXFOLIATIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIABETES MELLITUS INSULIN-DEPENDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIABETIC KETOACIDOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG RASH WITH EOSINOPHILIA AND SYSTEMIC SYMPTOMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EOSINOPHILIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FACE OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HUMAN HERPESVIRUS 6 INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSULIN C-PEPTIDE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEUKOCYTOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LICHENOID KERATOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIP EROSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPHOCYTOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METABOLIC ACIDOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NORMOCHROMIC NORMOCYTIC ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCREATIC ENZYMES INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROTHROMBIN TIME PROLONGED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH MACULO-PAPULAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TONSILLITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DICLOFENAC (DICLOFENAC)</medicinalproduct>
        <drugauthorizationnumb>70733</drugauthorizationnumb>
        <drugindication>PHARYNGOLARYNGEAL PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
        <drugindication>PHARYNGOLARYNGEAL PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PENICILLIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054545-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060703</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GXKR2006AT03820</companynumb>
    <primarysource>
      <reportercountry>AUSTRIA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>47</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>48</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIOVASCULAR DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ENTERITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>THIAMAZOLE SANDOZ (NGX) (THIAMAZOLE)TABLET, 20MG</medicinalproduct>
        <drugauthorizationnumb>40411</drugauthorizationnumb>
        <drugdosagetext>20 MG, BID, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTHYROIDISM</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060529</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060610</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054546-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GXKR2006JP03957</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>85</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PNEUMOMEDIASTINUM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHYLPREDNISOLONE</medicinalproduct>
        <drugauthorizationnumb>40194</drugauthorizationnumb>
        <drugdosagetext>500 MG</drugdosagetext>
        <drugindication>INTERSTITIAL LUNG DISEASE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054547-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GXKR2006JP03956</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>58</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PNEUMOMEDIASTINUM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMOTHORAX</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHYLPREDNISOLONE</medicinalproduct>
        <drugauthorizationnumb>40194</drugauthorizationnumb>
        <drugdosagetext>250 MG</drugdosagetext>
        <drugindication>INTERSTITIAL LUNG DISEASE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054548-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060626</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP200511002972</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>64</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>66.4</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HYPERGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GEMZAR</medicinalproduct>
        <drugauthorizationnumb>20509</drugauthorizationnumb>
        <drugdosagetext>1800 MG, OTHER, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PANCREATIC CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051121</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SOLU-MEDROL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KYTRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANSOPRAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGNESIUM OXIDE (MAGNESIUM OXIDE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NAIXAN (NAPROXEN SODIUM)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NOVOLET 30 R CHU (INSULIN HUMAN INJECTION, ISOPHANE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANPEC (VERAPAMIL HYDROCHLORIDE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FENTANYL ^JANSSEN^ (FENTANYL CITRATE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PURSENNID /SCH/ (SENNOSIDE A+B, SENNOSIDE A+B CALCIUM)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054549-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060414</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>TR200604001756</companynumb>
    <primarysource>
      <reportercountry>TURKEY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>52</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>67</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEBRILE NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERAL PHYSICAL HEALTH DETERIORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG INFILTRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OXYGEN SATURATION DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GEMCITABINE</medicinalproduct>
        <drugauthorizationnumb>20509</drugauthorizationnumb>
        <drugdosagetext>1000 MG/M2, OTHER, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>LUNG NEOPLASM MALIGNANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051213</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051213</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CISPLATIN</medicinalproduct>
        <drugdosagetext>100 MG/M2, OTHER, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>LUNG NEOPLASM MALIGNANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051213</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051213</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054550-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060626</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP200606005866</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PANCREATITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GEMZAR</medicinalproduct>
        <drugauthorizationnumb>20509</drugauthorizationnumb>
        <drugdosagetext>INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>TRANSITIONAL CELL CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060203</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060601</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAXOTERE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054551-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP200606003953</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>69</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>56</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>BILIARY DILATATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHOLANGITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERAL PHYSICAL HEALTH DETERIORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALIGNANT NEOPLASM PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCREATIC CARCINOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GEMZAR</medicinalproduct>
        <drugauthorizationnumb>20509</drugauthorizationnumb>
        <drugdosagetext>1500 MG, OTHER, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PANCREATIC CARCINOMA STAGE IV</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060412</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060510</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOXONIN (LOXOPROFEN SODIUM) TABLET</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MUCOSTA (REBAMIPIDE) TABLET</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SULPERAZON (CEFOPERAZONE SODIUM, SULBACTAM SODIUM)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUTHAN (NAFAMOSTAT MESILATE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FAMOTIDINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054552-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE200606006135</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>48</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BODY TEMPERATURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFUSION RELATED REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMOTHORAX</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROCEDURAL COMPLICATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GEMZAR</medicinalproduct>
        <drugbatchnumb>5822A</drugbatchnumb>
        <drugauthorizationnumb>20509</drugauthorizationnumb>
        <drugdosagetext>1000 MG/M2, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PANCREATIC CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050801</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXALIPLATIN (OXALIPLATIN)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANEMET (DOLASETRON MESILATE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HAES-STERIL (HYETELLOSE, SODIUM CHLORIDE)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054553-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060627</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA200606005830</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>EPISTAXIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EXSANGUINATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GEMCITABINE HYDROCHLORIDE (GEMCITABINE HYDROCHLORIDE)</medicinalproduct>
        <drugauthorizationnumb>20509</drugauthorizationnumb>
        <drugdosagetext>1700 MG,</drugdosagetext>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060609</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARBOPLATIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054554-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060626</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ES200606005878</companynumb>
    <primarysource>
      <reportercountry>SPAIN</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>80</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugauthorizationnumb>21318</drugauthorizationnumb>
        <drugdosagetext>20 UG, DAILY (1/D), SUBCUTANEOUS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060526</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>URBAL (SUCRALFATE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIGOXIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NOVONORM /DEN/ (REPAGLINIDE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SINTROM /NET/ (ACENOCOUMAROL)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054555-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060627</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR200607000589</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>80</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>KNEE OPERATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugauthorizationnumb>21318</drugauthorizationnumb>
        <drugdosagetext>20 UG, DAILY (1/D), SUBCUTANEOUS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041021</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALTRATE (CALCIUM CARBONATE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054556-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060627</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ES200607000133</companynumb>
    <primarysource>
      <reportercountry>SPAIN</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>79</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HIP FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULAR WEAKNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugauthorizationnumb>21318</drugauthorizationnumb>
        <drugdosagetext>20 UG, DAILY (1/D), SUBCUTANEOUS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054557-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060626</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE200606005451</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>39</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ARRHYTHMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
        <drugauthorizationnumb>20592</drugauthorizationnumb>
        <drugdosagetext>20 MG, DAILY (1/D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060319</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060411</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POLAMIDON (METHADONE HYDROCHLORIDE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAVOR (LORAZEPAM)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANITOP (METILDIGOXIN)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ISOKET RETARD (ISOSORBIDE DINITRATE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HCT (HYDROCHLOROTHIAZIDE)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054558-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060627</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA200606006061</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>20</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>TYPE IV HYPERSENSITIVITY REACTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYPREXA ZYDIS</medicinalproduct>
        <drugauthorizationnumb>20592</drugauthorizationnumb>
        <drugdosagetext>5 MG</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054559-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060627</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU200607000239</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>24</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HODGKIN'S DISEASE NODULAR SCLEROSIS STAGE UNSPECIFIED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPHIL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
        <drugauthorizationnumb>20592</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugindication>SCHIZOPHRENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060627</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
        <drugauthorizationnumb>20592</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugindication>SCHIZOPHRENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RISPERIDONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOXORUBICIN HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BLEOMYCIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VINBLASTINE SULFATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DACARBAZINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054560-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AT200606005768</companynumb>
    <primarysource>
      <reportercountry>AUSTRIA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>68</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>73.7</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>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
        <drugauthorizationnumb>20592</drugauthorizationnumb>
        <drugindication>SCHIZOPHRENIA, RESIDUAL TYPE</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060616</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HCL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054561-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060703</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AT200607000176</companynumb>
    <primarysource>
      <reportercountry>AUSTRIA</reportercountry>
      <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 DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISEASE RECURRENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EXTRASYSTOLES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSYCHOTIC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENTRICULAR TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
        <drugauthorizationnumb>20592</drugauthorizationnumb>
        <drugdosagetext>5 MG, DAILY (1/D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060501</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054562-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060627</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR200606005647</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>52</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYSTEMIC LUPUS ERYTHEMATOSUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
        <drugauthorizationnumb>20592</drugauthorizationnumb>
        <drugdosagetext>10 MG, DAILY (1/D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PSYCHOTIC DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060301</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054563-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060626</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>NL200606005474</companynumb>
    <primarysource>
      <reportercountry>NETHERLANDS</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>46</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE FLUCTUATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSED LEVEL OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTHERMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDE ATTEMPT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
        <drugauthorizationnumb>20592</drugauthorizationnumb>
        <drugdosagetext>10 MG, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DELUSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VENLAFAXINE HCL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054564-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060707</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CHNY2006AU01939</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>64</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE FLUCTUATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EPISTAXIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE TIGHTNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NICOTINE DEPENDENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NICOTINE</medicinalproduct>
        <drugauthorizationnumb>20076</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>062</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060618</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NICOTINE</medicinalproduct>
        <drugauthorizationnumb>20076</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>062</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060618</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVAPRO</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054565-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060704</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0430470A</companynumb>
    <primarysource>
      <reportercountry>NETHERLANDS</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>72</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>AKATHISIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSED LEVEL OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERKALAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERREFLEXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METABOLIC ACIDOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCLONIC EPILEPSY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEROTONIN SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WRONG DRUG ADMINISTERED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRANYLCYPROMINE SULFATE</medicinalproduct>
        <drugauthorizationnumb>12342</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VENLAFAXINE HCL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054566-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060704</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0430302A</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>73</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANGLE CLOSURE GLAUCOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISION BLURRED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL ACUITY REDUCED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
        <drugauthorizationnumb>20031</drugauthorizationnumb>
        <drugindication>ANXIETY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054567-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US185483</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>61</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ARRHYTHMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISEASE PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METABOLIC ACIDOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY FIBROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHEUMATOID LUNG</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>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugdosagetext>25 MG</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054568-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060505</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CHNY2006FI01450</companynumb>
    <primarysource>
      <reportercountry>FINLAND</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEAD DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSYCHOMOTOR HYPERACTIVITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NICOTINELL LOZENGE (NCH) (NICOTINE)  LOZENGE</medicinalproduct>
        <drugauthorizationnumb>20076</drugauthorizationnumb>
        <drugdosagetext>1 MG, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SMOKING CESSATION THERAPY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054569-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US185491</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>64</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISEASE PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EMPHYSEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERSTITIAL LUNG DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHEUMATOID ARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THERAPY NON-RESPONDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>25 MG, 2 IN 1 WEEKS</drugdosagetext>
        <drugindication>SERONEGATIVE ARTHRITIS</drugindication>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugdosagetext>22.5 MG, 1 IN 1 WEEKS, PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054610-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060421</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-SP-2006-01375</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>75</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>68</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ADVERSE DRUG REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CYSTITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEDICATION ERROR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY TUBERCULOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMMUCYST</medicinalproduct>
        <drugbatchnumb>LOT NOT REP</drugbatchnumb>
        <drugadministrationroute>043</drugadministrationroute>
        <drugindication>BLADDER CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060317</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054611-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-SP-2006-01600</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>77</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLADDER TAMPONADE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBRAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERLIPIDAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMMUCYST</medicinalproduct>
        <drugbatchnumb>LOT NOT REP</drugbatchnumb>
        <drugadministrationroute>043</drugadministrationroute>
        <drugindication>BLADDER CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060421</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060605</drugenddate>
        <drugtreatmentduration>45</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMMUCYST</medicinalproduct>
        <drugbatchnumb>LOT NOT REP</drugbatchnumb>
        <drugadministrationroute>043</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060421</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060605</drugenddate>
        <drugtreatmentduration>45</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054612-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060607</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-SP-2006-01399</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>67</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BOVINE TUBERCULOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMMUCYST</medicinalproduct>
        <drugbatchnumb>LOT NOT REP</drugbatchnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>BLADDER CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060426</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060531</drugenddate>
        <drugtreatmentduration>35</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MECOBALAMIN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060426</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEUROTROPIN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060426</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIMAPROST ALFADEX</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060426</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054613-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060620</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-SP-2006-01569</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>74</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NASOPHARYNGITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMMUCYST</medicinalproduct>
        <drugbatchnumb>LOT NOT REP</drugbatchnumb>
        <drugadministrationroute>043</drugadministrationroute>
        <drugindication>CARCINOMA IN SITU OF BLADDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050928</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051206</drugenddate>
        <drugtreatmentduration>69</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMMUCYST</medicinalproduct>
        <drugbatchnumb>LOT NOT REP</drugbatchnumb>
        <drugadministrationroute>043</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050928</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051206</drugenddate>
        <drugtreatmentduration>69</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMMUCYST</medicinalproduct>
        <drugbatchnumb>LOT NOT REP</drugbatchnumb>
        <drugadministrationroute>043</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050928</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051206</drugenddate>
        <drugtreatmentduration>69</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054614-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060630</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-SP-2006-01629</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>84</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CYSTITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POLLAKIURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUBARACHNOID HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMMUCYST</medicinalproduct>
        <drugbatchnumb>LOT NOT REP</drugbatchnumb>
        <drugadministrationroute>043</drugadministrationroute>
        <drugindication>BLADDER CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060515</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060606</drugenddate>
        <drugtreatmentduration>22</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMMUCYST</medicinalproduct>
        <drugbatchnumb>LOT NOT REP</drugbatchnumb>
        <drugadministrationroute>043</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060515</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060606</drugenddate>
        <drugtreatmentduration>22</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NIFEDIPINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SODIUM AZULENE SULFONATE L-GLUTAMINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGNESIUM OXIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SENNOSIDE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054615-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060714</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-SP-2006-01801</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMMUCYST</medicinalproduct>
        <drugbatchnumb>LOT NOT REP</drugbatchnumb>
        <drugadministrationroute>043</drugadministrationroute>
        <drugindication>BLADDER CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060714</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054616-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060714</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-SP-2006-01809</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>71</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMMUCYST</medicinalproduct>
        <drugbatchnumb>LOT NOT REP</drugbatchnumb>
        <drugadministrationroute>043</drugadministrationroute>
        <drugindication>BLADDER CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060704</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060711</drugenddate>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054617-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060707</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>JP-JNJFOC-20060602559</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>53</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>VASCULITIC RASH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugdosagetext>2 INFUSIONS, DATES UNSPECIFIED</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RHEUMATREX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RHEUMATREX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MUCOSTA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ISCOTIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENET</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIAMIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDONINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MIYA BM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ENTEROCOLITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054618-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060707</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20051004185</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>81.65</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CYST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GLIOSIS</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>AZASAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PENTASA</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054619-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060707</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20060404448</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>78.02</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>RETINAL VEIN THROMBOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>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>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMURAN</medicinalproduct>
        <drugdosagetext>ALSO REPORTED AS 100 MG</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACTONEL</medicinalproduct>
        <drugindication>OSTEOPOROSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENTOCORT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLEXERIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENTYL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCONTIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054620-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060707</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20060604549</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>64.41</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PNEUMONIA LEGIONELLA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ANKYLOSING SPONDYLITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDROL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054621-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060707</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20060404092</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>43.09</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METASTASES TO LUNG</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEOPLASM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREVICID</medicinalproduct>
        <drugindication>GASTROOESOPHAGEAL REFLUX DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAQUENIL</medicinalproduct>
        <drugindication>EYE DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054622-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060707</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20060602728</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>AMNESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</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>ZOCOR</medicinalproduct>
        <drugindication>BLOOD CHOLESTEROL</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM GLUCONATE</medicinalproduct>
        <drugindication>VITAMIN SUPPLEMENTATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRANDATE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054623-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060707</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20060503856</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>112.49</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MULTIPLE MYELOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLASMACYTOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROSTATE CANCER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PSORIATIC ARTHROPATHY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054624-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060707</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20060505620</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DERMATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MILLER FISHER SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugtreatmentduration>15</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INFLUENZA VACCINE</medicinalproduct>
        <drugindication>PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugdosagetext>DOSE DECREASED</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SULFASALAZINE</medicinalproduct>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054625-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060707</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20060701413</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HISTOPLASMOSIS DISSEMINATED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugdosagetext>RECEIVED A TOTAL OF 2 INFUSIONS ON UNKNOWN DATES</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CROHN'S DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>STEROIDS</medicinalproduct>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMMUNOMODULATORS</medicinalproduct>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054626-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060707</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20060701455</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFUSION RELATED REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugdosagetext>THIRD INFUSION</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 INFUSION</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVAPRO</medicinalproduct>
        <drugindication>BLOOD PRESSURE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054627-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060707</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20060701715</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>83.01</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HEPATOCELLULAR DAMAGE</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>PREDNISONE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054628-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060710</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-JNJFOC-20060701780</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FISTULA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054629-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060710</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-JNJFOC-20060701926</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>39</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ALANINE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>C-REACTIVE PROTEIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHOLESTASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugdosagetext>1 INFUSION</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPALGIC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CORTANCYL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CORTANCYL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CORTANCYL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CORTICOTHERAPY</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054630-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060710</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-JNJFOC-20060503251</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>71</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>43</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFUSION RELATED REACTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugdosagetext>3RD INFUSION</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>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054631-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060710</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-JNJFOC-20060700097</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>50</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>55</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HODGKIN'S DISEASE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugdosagetext>12TH INFUSION</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>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CORTANCYL</medicinalproduct>
        <drugdosagetext>5-10MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugdosagetext>200-400MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054632-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060710</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>GB-JNJFOC-20060305522</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>35</patientweight>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>BRONCHOPNEUMONIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ANKYLOSING SPONDYLITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>B12</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMITRIPTYLINE HCL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BUPRENORPHINE HCL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCICHEW D3 FORTE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THYROXINE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOPERAMIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054633-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2006JP09941</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>ELECTROCARDIOGRAM QT PROLONGED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARDENALIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANALDINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LENDORMIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOXONIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KALLIKREIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COAX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMISIL</medicinalproduct>
        <drugauthorizationnumb>020539</drugauthorizationnumb>
        <drugdosagetext>125 MG/D</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054634-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060523</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2006BE07687</companynumb>
    <primarysource>
      <reportercountry>BELGIUM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>53</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>100</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BRADYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOOD ALTERED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMISIL</medicinalproduct>
        <drugauthorizationnumb>20539</drugauthorizationnumb>
        <drugdosagetext>250 MG/D</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NAIL TINEA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060412</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060522</drugenddate>
        <drugtreatmentduration>59040</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KREDEX</medicinalproduct>
        <drugdosagetext>25 MG/D</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TEVETEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTIPHLOGISTICS,OTHER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRAVASTATIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN B COMPLEX CAP</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054635-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060711</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2006BE10456</companynumb>
    <primarysource>
      <reportercountry>BELGIUM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>42</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>EPILEPSY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FACE INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JAW FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN LESION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUTURE INSERTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMISIL</medicinalproduct>
        <drugauthorizationnumb>020539</drugauthorizationnumb>
        <drugdosagetext>250 MG/D</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NAIL TINEA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060530</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TEGRETOL</medicinalproduct>
        <drugdosagetext>400 MG, BID</drugdosagetext>
        <drugindication>EPILEPSY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PHENYTOIN SODIUM CAP</medicinalproduct>
        <drugdosagetext>100 MG, QID</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugdosagetext>300 MG, BID</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPAMAX</medicinalproduct>
        <drugdosagetext>150 MG/D</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REMERGON</medicinalproduct>
        <drugdosagetext>30 MG/D</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054636-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060711</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2006JP10427</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>70</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANOREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD LACTATE DEHYDROGENASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATOCRIT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEAN CELL VOLUME ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCYTOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RED BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NIVADIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANALDINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19960101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HARNAL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMISIL</medicinalproduct>
        <drugauthorizationnumb>020539</drugauthorizationnumb>
        <drugdosagetext>125 MG/D</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NAIL TINEA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060710</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054637-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060710</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2006JP10380</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>52</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD CREATINE PHOSPHOKINASE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMISIL</medicinalproduct>
        <drugauthorizationnumb>20539</drugauthorizationnumb>
        <drugdosagetext>125 MG/D</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054638-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060710</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHNR2006AU00896</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>7</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HALLUCINATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NIGHTMARE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARANOIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEXAMFETAMINE</medicinalproduct>
        <drugindication>ATTENTION DEFICIT/HYPERACTIVITY DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTIPSYCHOTICS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RITALIN</medicinalproduct>
        <drugauthorizationnumb>010187</drugauthorizationnumb>
        <drugindication>ATTENTION DEFICIT/HYPERACTIVITY DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054642-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20020325</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-SOLVAY-00202000909</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>0</patientonsetage>
      <patientonsetageunit>804</patientonsetageunit>
      <patientweight>2.1</patientweight>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>BLOOD GASES ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRADYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CYANOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART DISEASE CONGENITAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METABOLIC ACIDOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALLOR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENTRICULAR FIBRILLATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPANTHYL</medicinalproduct>
        <drugdosagetext>DAILY DOSE: UNK.</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG EXPOSURE DURING PREGNANCY</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19960223</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COVERSYL</medicinalproduct>
        <drugauthorizationnumb>020184</drugauthorizationnumb>
        <drugdosagetext>DAILY DOSE: 4 MG.</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19940630</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19960227</drugenddate>
        <drugtreatmentduration>608</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ASPEGIC 1000</medicinalproduct>
        <drugdosagetext>DAILY DOSE: 100 MILLIGRAM(S)</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG EXPOSURE DURING PREGNANCY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19960403</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CATAPRES</medicinalproduct>
        <drugdosagetext>DAILY DOSE:  UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PREGNANCY INDUCED HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19960701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TORENTAL</medicinalproduct>
        <drugdosagetext>DAILY DOSE: 3 DF.</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG EXPOSURE DURING PREGNANCY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19940630</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19960223</drugenddate>
        <drugtreatmentduration>604</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASILIX</medicinalproduct>
        <drugdosagetext>DAILY DOSE:  UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PREGNANCY INDUCED HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19960701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ISOPTIN</medicinalproduct>
        <drugdosagetext>DAILY DOSE: 1 DF.</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG EXPOSURE DURING PREGNANCY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROZAC</medicinalproduct>
        <drugdosagetext>DAILY DOSE: 1 DF.</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG EXPOSURE DURING PREGNANCY</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19960131</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
        <drugdosagetext>DAILY DOSE: 2 DF.</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG EXPOSURE DURING PREGNANCY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19940630</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19960131</drugenddate>
        <drugtreatmentduration>581</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054654-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060707</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20050200328</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>47.17</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>B-CELL SMALL LYMPHOCYTIC LYMPHOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CROHN'S DISEASE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CROHN'S DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMODIUM</medicinalproduct>
        <drugauthorizationnumb>019487</drugauthorizationnumb>
        <drugindication>CROHN'S DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ANTIBIOTICS</medicinalproduct>
        <drugindication>CROHN'S DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugindication>CROHN'S DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BUDESONIDE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054655-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060710</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-JNJFOC-20060505365</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>83</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>LUNG NEOPLASM MALIGNANT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HRT</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ISONIAZID</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054660-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060710</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHRM2006FR02034</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>83</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ATRIAL FIBRILLATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD SODIUM DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC MURMUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBRAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUID INTAKE RESTRICTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART SOUNDS ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPONATRAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RALES</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EFFEXOR</medicinalproduct>
        <drugdosagetext>1 DF, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060530</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARICEPT</medicinalproduct>
        <drugdosagetext>UNK, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060530</drugenddate>
        <drugtreatmentduration>64800</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMOVANE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COTAREG</medicinalproduct>
        <drugauthorizationnumb>020818</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ESSENTIAL HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054665-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060609</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2006JP08668</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>71</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>60</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ASPARTATE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD ALBUMIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD LACTATE DEHYDROGENASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>C-REACTIVE PROTEIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CELL MARKER INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST X-RAY ABNORMAL</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>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERSTITIAL LUNG DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPHOCYTE COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPHIL COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMOTHORAX</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PO2 DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALEVIATIN</medicinalproduct>
        <drugdosagetext>250 MG/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONVULSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060530</drugenddate>
        <drugtreatmentduration>86400</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGNESIUM OXIDE</medicinalproduct>
        <drugdosagetext>1.5 G/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONSTIPATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060530</drugenddate>
        <drugtreatmentduration>86400</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LAC B</medicinalproduct>
        <drugdosagetext>3 G/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONSTIPATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060530</drugenddate>
        <drugtreatmentduration>86400</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TEGRETOL</medicinalproduct>
        <drugauthorizationnumb>016608</drugauthorizationnumb>
        <drugdosagetext>300 MG/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONVULSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060530</drugenddate>
        <drugtreatmentduration>86400</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054666-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060710</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-JNJFOC-20050606521</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>47.5</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL NEOPLASM</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>PREDNISOLONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugindication>CROHN'S DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AZATHIOPRINE</medicinalproduct>
        <drugindication>CROHN'S DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTIBIOTIC</medicinalproduct>
        <drugindication>CYSTITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COLIFOAM</medicinalproduct>
        <drugindication>CROHN'S DISEASE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054667-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060712</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHO2006CL11335</companynumb>
    <primarysource>
      <reportercountry>CHILE</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>18</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>GALLBLADDER OPERATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZELMAC / HTF 919A</medicinalproduct>
        <drugauthorizationnumb>21200</drugauthorizationnumb>
        <drugdosagetext>6 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ABDOMINAL PAIN UPPER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SALBUTAMOL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054669-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060710</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2006US08790</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </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>ASPARTATE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CREATININE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD LACTATE DEHYDROGENASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD UREA INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CREATININE RENAL CLEARANCE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTESTINAL ISCHAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ISCHAEMIC HEPATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LACTIC ACIDOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTI-ORGAN FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL TUBULAR NECROSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZELNORM</medicinalproduct>
        <drugauthorizationnumb>21200</drugauthorizationnumb>
        <drugdosagetext>6 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVENOX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ESTROGEN NOS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLORINEF</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROTONIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTISPASMODICS/ ANTICHOLINERGICS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054682-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060613</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2006JP08943</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>47</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>METASTASES TO PLEURA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOMYELITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERIODONTITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AREDIA</medicinalproduct>
        <drugauthorizationnumb>20036</drugauthorizationnumb>
        <drugdosagetext>45 MG/D</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>METASTASES TO BONE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020522</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060607</drugenddate>
        <drugtreatmentduration>1478</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FARMORUBICIN</medicinalproduct>
        <drugdosagetext>75 MG/D</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>METASTASES TO BONE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020523</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020802</drugenddate>
        <drugtreatmentduration>72</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUOROURACIL</medicinalproduct>
        <drugdosagetext>750 DF/D</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>METASTASES TO BONE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020523</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020802</drugenddate>
        <drugtreatmentduration>72</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENDOXAN</medicinalproduct>
        <drugdosagetext>750 DF/D</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>METASTASES TO BONE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020523</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020802</drugenddate>
        <drugtreatmentduration>72</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAXOTERE</medicinalproduct>
        <drugdosagetext>54 MG/D</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>METASTASES TO BONE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020821</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030616</drugenddate>
        <drugtreatmentduration>300</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054683-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060626</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2006ES09552</companynumb>
    <primarysource>
      <reportercountry>SPAIN</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>67</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BONE DEBRIDEMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GINGIVAL BLEEDING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GINGIVAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL SOFT TISSUE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTH EXTRACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WOUND DEBRIDEMENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAMIDRONATE DISODIUM</medicinalproduct>
        <drugauthorizationnumb>20036</drugauthorizationnumb>
        <drugdosagetext>90 MG, 20 CYCLES</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>METASTASES TO BONE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054684-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060626</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2006ES09554</companynumb>
    <primarysource>
      <reportercountry>SPAIN</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>71</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BONE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMPAIRED HEALING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOLYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLASTIC SURGERY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SURGERY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTH EXTRACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WOUND DEBRIDEMENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAMIDRONATE DISODIUM</medicinalproduct>
        <drugauthorizationnumb>20036</drugauthorizationnumb>
        <drugdosagetext>90 MG, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>HYPERCALCAEMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOLEDRONATE</medicinalproduct>
        <drugdosagetext>4 MG, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054691-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060310</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2006JP03879</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>66</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD ALBUMIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CALCIUM DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CHOLESTEROL INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CREATININE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD UREA INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD URINE PRESENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CREATININE RENAL CLEARANCE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FOCAL GLOMERULOSCLEROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEPHROTIC SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROTEINURIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARIMIDEX</medicinalproduct>
        <drugdosagetext>1 MG/D</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BREAST CANCER STAGE IV</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030801</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AREDIA</medicinalproduct>
        <drugauthorizationnumb>020036</drugauthorizationnumb>
        <drugdosagetext>90 MG EVERY 4 WEEKS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>METASTASES TO BONE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060220</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054697-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060710</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2006US08791</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>45</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>45.351</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIPLOPIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG ADMINISTRATION ERROR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRILEPTAL</medicinalproduct>
        <drugauthorizationnumb>021014</drugauthorizationnumb>
        <drugdosagetext>600 MG, TID</drugdosagetext>
        <drugindication>CONVULSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRILEPTAL</medicinalproduct>
        <drugauthorizationnumb>021014</drugauthorizationnumb>
        <drugdosagetext>900 MG, ONCE/SINGLE</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060710</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARDIAC THERAPY</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054710-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060706</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CH-BRISTOL-MYERS SQUIBB COMPANY-13442389</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>71</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CHILLS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRANSIENT ACANTHOLYTIC DERMATOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ERBITUX</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>COLON CANCER METASTATIC</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXALIPLATIN</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>COLON CANCER METASTATIC</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUOROURACIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>COLON CANCER METASTATIC</drugindication>
        <drugtreatmentduration>14</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054711-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060712</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-13440292</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</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>TEQUIN</medicinalproduct>
        <drugauthorizationnumb>021061</drugauthorizationnumb>
        <drugindication>INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040201</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054712-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060707</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-BRISTOL-MYERS SQUIBB COMPANY-13436092</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>NEPHROLITHIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL COLIC</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REYATAZ</medicinalproduct>
        <drugauthorizationnumb>021567</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060501</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KIVEXA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVIR</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054713-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060711</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DK-BRISTOL-MYERS SQUIBB COMPANY-13439641</companynumb>
    <primarysource>
      <reportercountry>DENMARK</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>38</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ALOPECIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BREAST CANCER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ABILIFY</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REMERON</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NITRAZEPAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IKTORIVIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORFLEX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054714-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060706</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-13434691</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>65</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>112</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAXOL</medicinalproduct>
        <drugauthorizationnumb>020262</drugauthorizationnumb>
        <drugindication>TONSIL CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051130</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051130</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARBOPLATIN</medicinalproduct>
        <drugauthorizationnumb>019880</drugauthorizationnumb>
        <drugindication>TONSIL CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051130</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051130</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
        <drugauthorizationnumb>009218</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054715-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060707</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-BRISTOL-MYERS SQUIBB COMPANY-13436456</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>56</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD AMYLASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIPASE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRAVASTATIN</medicinalproduct>
        <drugauthorizationnumb>019898</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERCHOLESTEROLAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060706</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREVISCAN</medicinalproduct>
        <drugindication>PHLEBITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19970101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DAFLON</medicinalproduct>
        <drugindication>PHLEBITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACTONEL</medicinalproduct>
        <drugindication>DYSKINESIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054716-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20051227</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-BRISTOL-MYERS SQUIBB COMPANY-13235569</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>56</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANOREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>APATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSED LEVEL OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EFAVIRENZ</medicinalproduct>
        <drugauthorizationnumb>20972</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051221</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051226</drugenddate>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TENOFOVIR DISOPROXIL FUMARATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051221</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051230</drugenddate>
        <drugtreatmentduration>10</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIFLUCAN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051212</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051230</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EPIVIR</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051221</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051230</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BAKTAR</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051214</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060106</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054723-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060528</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2006US06991</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>57</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HIP ARTHROPLASTY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FEMARA</medicinalproduct>
        <drugauthorizationnumb>20726</drugauthorizationnumb>
        <drugdosagetext>2.5 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ENDOMETRIAL CANCER STAGE I</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054733-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060621</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2006CH09326</companynumb>
    <primarysource>
      <reportercountry>SWITZERLAND</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>78</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD CREATININE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>C-REACTIVE PROTEIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CELLULITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHILLS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EPIDERMOLYSIS BULLOSA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ESCHERICHIA INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERALISED OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTHERMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEUKOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MELAENA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTI-ORGAN FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPTIC SHOCK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN NECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISON</medicinalproduct>
        <drugdosagetext>40 MG/D</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOSPORINE</medicinalproduct>
        <drugauthorizationnumb>050574</drugauthorizationnumb>
        <drugindication>NEPHROTIC SYNDROME</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054734-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060706</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2006ES10179</companynumb>
    <primarysource>
      <reportercountry>SPAIN</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>64</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD CREATININE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEPHROPATHY TOXIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROSTATIC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN CANCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN NEOPLASM EXCISION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TEMPORAL LOBE EPILEPSY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRANSURETHRAL PROSTATECTOMY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENTRICULAR HYPERTROPHY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOSPORINE</medicinalproduct>
        <drugauthorizationnumb>050574</drugauthorizationnumb>
        <drugdosagetext>10 MG/KG/D</drugdosagetext>
        <drugindication>RENAL TRANSPLANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19960101</drugstartdate>
        <drugtreatmentduration>2555</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOSPORINE</medicinalproduct>
        <drugauthorizationnumb>050574</drugauthorizationnumb>
        <drugdosagetext>100 MG, BID</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>CERTICAN</medicinalproduct>
        <drugdosagetext>1.5 MG/D</drugdosagetext>
        <drugindication>RENAL TRANSPLANT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>CERTICAN</medicinalproduct>
        <drugdosagetext>3 MG/D</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MYCOPHENOLATE MOFETIL</medicinalproduct>
        <drugdosagetext>1000 MG/D</drugdosagetext>
        <drugindication>RENAL TRANSPLANT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MYCOPHENOLATE MOFETIL</medicinalproduct>
        <drugdosagetext>800 MG/D</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugdosagetext>0.5 MG/KG/D</drugdosagetext>
        <drugindication>RENAL TRANSPLANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19960101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugdosagetext>10 MG/D</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOXAZOSIN</medicinalproduct>
        <drugdosagetext>4 MG/D</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
        <drugdosagetext>50 MG, BID</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOSARTAN POSTASSIUM</medicinalproduct>
        <drugdosagetext>50 MG/D</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATORVASTATIN CALCIUM</medicinalproduct>
        <drugdosagetext>10 MG/D</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLOPIDOGREL</medicinalproduct>
        <drugdosagetext>75 MG/D</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054739-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060710</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2006IT10341</companynumb>
    <primarysource>
      <reportercountry>ITALY</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>61</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>COLON CANCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLOSTOMY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CYTOMEGALOVIRUS INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EPSTEIN-BARR VIRUS INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IRRITABLE BOWEL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPHADENECTOMY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>STEROIDS NOS</medicinalproduct>
        <drugdosagetext>UNK, UNK</drugdosagetext>
        <drugindication>RENAL TRANSPLANT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>STEROIDS NOS</medicinalproduct>
        <drugdosagetext>2 MG/D</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOSPORINE</medicinalproduct>
        <drugauthorizationnumb>050574</drugauthorizationnumb>
        <drugindication>RENAL TRANSPLANT</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054740-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060710</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2006IT10344</companynumb>
    <primarysource>
      <reportercountry>ITALY</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>53</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>COLECTOMY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLON CANCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CYTOMEGALOVIRUS INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EPSTEIN-BARR VIRUS INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IRRITABLE BOWEL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPHADENECTOMY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>STEROIDS NOS</medicinalproduct>
        <drugdosagetext>2 MG/D</drugdosagetext>
        <drugindication>RENAL TRANSPLANT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>STEROIDS NOS</medicinalproduct>
        <drugdosagetext>UNK, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOSPORINE</medicinalproduct>
        <drugauthorizationnumb>050574</drugauthorizationnumb>
        <drugindication>RENAL TRANSPLANT</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054741-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060706</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2006IT10177</companynumb>
    <primarysource>
      <reportercountry>ITALY</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>59</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANGINA UNSTABLE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AORTIC DILATATION</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>HYPERLIPIDAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL ISCHAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERCUTANEOUS CORONARY INTERVENTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROTEINURIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOSPORINE</medicinalproduct>
        <drugauthorizationnumb>50715</drugauthorizationnumb>
        <drugdosagetext>8 MG/KG/D</drugdosagetext>
        <drugindication>RENAL TRANSPLANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19940501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20000101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AZATHIOPRINE</medicinalproduct>
        <drugdosagetext>125 MG/D</drugdosagetext>
        <drugindication>RENAL TRANSPLANT</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20000401</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISONE (NGX)</medicinalproduct>
        <drugdosagetext>120 MG/D</drugdosagetext>
        <drugindication>RENAL TRANSPLANT</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054742-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060710</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2006US08805</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>62</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DYSGEUSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA ORAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENTRICULAR EXTRASYSTOLES</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SANDIMMUNE</medicinalproduct>
        <drugauthorizationnumb>050625</drugauthorizationnumb>
        <drugdosagetext>100 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEART TRANSPLANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19910101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOSPORINE</medicinalproduct>
        <drugdosagetext>UNK, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEART TRANSPLANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054743-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060710</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHFR2006GB02210</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>38</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>SPERMATOZOA PROGRESSIVE MOTILITY ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ATORVASTATIN CALCIUM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HYPERLIPIDAEMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELLCEPT</medicinalproduct>
        <drugdosagetext>500 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RENAL TRANSPLANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020615</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060315</drugenddate>
        <drugtreatmentduration>1370</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOXAZOSIN MESYLATE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ISONIAZID</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMIVUDINE</medicinalproduct>
        <drugdosagetext>UNK, UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HEPATITIS B</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PERINDOPRIL ERBUMINE</medicinalproduct>
        <drugdosagetext>UNK, UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PYRIDOXINE HCL</medicinalproduct>
        <drugdosagetext>UNK, UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOSPORINE</medicinalproduct>
        <drugauthorizationnumb>050715</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054744-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060707</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-13436084</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>50</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BARACLUDE</medicinalproduct>
        <drugauthorizationnumb>021797</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NABI-HB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RAPAMUNE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054745-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060712</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2006JP10461</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>59</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD BETA-D-GLUCAN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD IMMUNOGLOBULIN G INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CYTOMEGALOVIRUS ANTIGEN POSITIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERSTITIAL LUNG DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPHOCYTE COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMOCYSTIS JIROVECI PNEUMONIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugdosagetext>38 MG/D</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONNECTIVE TISSUE INFLAMMATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOSPORINE</medicinalproduct>
        <drugauthorizationnumb>050574</drugauthorizationnumb>
        <drugdosagetext>150 MG/D</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONNECTIVE TISSUE INFLAMMATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054746-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060714</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ES-BRISTOL-MYERS SQUIBB COMPANY-13442447</companynumb>
    <primarysource>
      <reportercountry>SPAIN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>21</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD BILIRUBIN ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CREATINE PHOSPHOKINASE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ABILIFY</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060315</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RIVOTRIL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054752-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060621</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2006JP09311</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>51</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DIABETES MELLITUS INADEQUATE CONTROL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EPSTEIN-BARR VIRUS INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HISTIOCYTOSIS HAEMATOPHAGIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERLEUKIN LEVEL INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LARGE GRANULAR LYMPHOCYTOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPHOCYTE MORPHOLOGY ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCYTOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SERUM FERRITIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>T-CELL CHRONIC LYMPHOCYTIC LEUKAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOSPORINE</medicinalproduct>
        <drugauthorizationnumb>50574</drugauthorizationnumb>
        <drugdosagetext>200 MG/D</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>APLASIA PURE RED CELL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugdosagetext>30 MG/D</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>APLASIA PURE RED CELL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054756-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060616</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2783</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>15</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>EOSINOPHIL PERCENTAGE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPHIL PERCENTAGE DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMNESTEEM</medicinalproduct>
        <drugauthorizationnumb>75945</drugauthorizationnumb>
        <drugdosagetext>20 MG QD PO; 40 MG QD PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ACNE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060426</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060531</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMNESTEEM</medicinalproduct>
        <drugauthorizationnumb>75945</drugauthorizationnumb>
        <drugdosagetext>20 MG QD PO; 40 MG QD PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ACNE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060426</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060531</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054757-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060630</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2781</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>0</patientsex>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMNESTEEM</medicinalproduct>
        <drugauthorizationnumb>75945</drugauthorizationnumb>
        <drugindication>MYCOSIS FUNGOIDES</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054758-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060630</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2787</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE BEFORE PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PREGNANCY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMNESTEEM</medicinalproduct>
        <drugauthorizationnumb>75945</drugauthorizationnumb>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054760-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060710</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-AVENTIS-200617170GDDC</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>64</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLISTER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FOOD AVERSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GANGRENE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLANTAR FASCIITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>REFUSAL OF TREATMENT BY PATIENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VASCULITIS NECROTISING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARAVA</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>020905</drugauthorizationnumb>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030425</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEGA-3</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
        <drugindication>PAIN</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054761-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060710</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ES-AVENTIS-200613840EU</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>76</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HYPERKALAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPONATRAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEGURIL</medicinalproduct>
        <drugauthorizationnumb>16273</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050618</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALDACTONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050618</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RENITEC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050618</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054762-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060710</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-AVENTIS-200612449FR</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>51</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>SARCOIDOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARAVA</medicinalproduct>
        <drugauthorizationnumb>20905</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021205</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030805</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000105</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20021205</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030805</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054763-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060710</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-AVENTIS-200613822EU</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
    </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>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CHLORIDE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD POTASSIUM DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DECEREBRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GLASGOW COMA SCALE ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPONATRAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHABDOMYOLYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NATRIX</medicinalproduct>
        <drugauthorizationnumb>18538</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060106</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060119</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060119</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TENORMIN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060119</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BLOPRESS</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051121</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060119</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054764-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060711</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AVENTIS-200613845EU</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>32</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ACUTE RESPIRATORY DISTRESS SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENOXAPARIN SODIUM</medicinalproduct>
        <drugauthorizationnumb>020164</drugauthorizationnumb>
        <drugindication>THROMBOSIS PROPHYLAXIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054765-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060711</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AVENTIS-200613847EU</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>42</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENOXAPARIN SODIUM</medicinalproduct>
        <drugauthorizationnumb>020164</drugauthorizationnumb>
        <drugindication>THROMBOSIS PROPHYLAXIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054766-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060712</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AVENTIS-200615885US</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>65</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>88.6</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HAEMATOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LOVENOX</medicinalproduct>
        <drugbatchnumb>12080</drugbatchnumb>
        <drugauthorizationnumb>020164</drugauthorizationnumb>
        <drugindication>PULMONARY EMBOLISM</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060514</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060531</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054767-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040224</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200410598JP</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>62</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>45</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>AGRANULOCYTOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARRHYTHMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCYTOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STOMATITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARAVA</medicinalproduct>
        <drugauthorizationnumb>20905</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040117</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040123</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARAVA</medicinalproduct>
        <drugauthorizationnumb>020905</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040124</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040209</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARAVA</medicinalproduct>
        <drugauthorizationnumb>020905</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020910</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040220</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RHEUMATREX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19960601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040116</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RHEUMATREX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040210</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040215</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RHEUMATREX</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040216</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040219</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>D-PENICILLAMINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19931211</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040219</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOZYM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERURICAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19951202</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040219</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDONINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040219</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040219</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALFAROL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020910</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040220</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADALAT</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020910</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040220</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054773-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>056</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FAZACLO ODT</medicinalproduct>
        <drugauthorizationnumb>21590</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060501</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054779-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2029</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>21</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMNESTEEM</medicinalproduct>
        <drugauthorizationnumb>75945</drugauthorizationnumb>
        <drugdosagetext>40MG, QD, PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ACNE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060118</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054784-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060621</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2592</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>35</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABNORMAL BEHAVIOUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AGGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANHEDONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMNESTEEM</medicinalproduct>
        <drugauthorizationnumb>75945</drugauthorizationnumb>
        <drugindication>ACNE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EFFEXOR</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054785-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2560</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>24</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>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>AMNESTEEM</medicinalproduct>
        <drugauthorizationnumb>75945</drugauthorizationnumb>
        <drugdosagetext>40 MG, BID, PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060601</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ETHINYLESTRADIOL/NORGESTIMATE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054793-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060705</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006084625</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BREAST CANCER FEMALE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>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>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054794-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060620</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2006FR09401</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>33</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AFFECT LABILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DELUSIONAL DISORDER, PERSECUTORY TYPE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISINHIBITION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EMOTIONAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLIGHT OF IDEAS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INAPPROPRIATE AFFECT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MANIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOOD ALTERED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSYCHOMOTOR HYPERACTIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPEECH DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYPHRENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PARLODEL</medicinalproduct>
        <drugauthorizationnumb>17962</drugauthorizationnumb>
        <drugdosagetext>1.25 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SUPPRESSED LACTATION</drugindication>
        <drugtreatmentduration>1440</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PARLODEL</medicinalproduct>
        <drugauthorizationnumb>017962</drugauthorizationnumb>
        <drugdosagetext>1.25 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugtreatmentduration>1440</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PARLODEL</medicinalproduct>
        <drugauthorizationnumb>017962</drugauthorizationnumb>
        <drugdosagetext>2.5 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugtreatmentduration>10080</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054795-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060707</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-BRISTOL-MYERS SQUIBB COMPANY-13444211</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>65</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFUSION RELATED REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ERBITUX</medicinalproduct>
        <drugindication>OROPHARYNGEAL CANCER STAGE UNSPECIFIED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060518</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060518</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAMADOL HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CHLORHEXIDINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054796-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060630</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006AP03054</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>50</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IRESSA</medicinalproduct>
        <drugauthorizationnumb>21399</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>LUNG NEOPLASM MALIGNANT</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060401</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAXOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYANOCOBALAMIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054797-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060706</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006AP03090</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>31900</patientonsetage>
      <patientonsetageunit>804</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HEPATITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugauthorizationnumb>020639</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>AGITATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060518</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060525</drugenddate>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugauthorizationnumb>020639</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060526</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060608</drugenddate>
        <drugtreatmentduration>14</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ROHYPNOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INSOMNIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051019</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060608</drugenddate>
        <drugtreatmentduration>233</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAYBALANCE C LIQUID DIET</medicinalproduct>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060609</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054798-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060504</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006SE02585</companynumb>
    <primarysource>
      <reportercountry>HUNGARY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>22909</patientonsetage>
      <patientonsetageunit>804</patientonsetageunit>
      <patientweight>75</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ATRIAL FIBRILLATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE FLUCTUATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EXTRASYSTOLES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTHYROIDISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREATMENT NONCOMPLIANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugauthorizationnumb>21366</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERCHOLESTEROLAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060405</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060501</drugenddate>
        <drugtreatmentduration>27</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEBILET</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARDURA XL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOVAN HCT 160/12.5</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>EUTHYROX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPOTHYROIDISM</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060415</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054799-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060709</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006UW14433</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>60</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>JAUNDICE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRILOSEC</medicinalproduct>
        <drugauthorizationnumb>021229</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DYSPEPSIA</drugindication>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRILOSEC</medicinalproduct>
        <drugauthorizationnumb>021229</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>FLATULENCE</drugindication>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRILOSEC</medicinalproduct>
        <drugauthorizationnumb>021229</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>VOMITING</drugindication>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
        <drugindication>HEADACHE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
        <drugindication>NASOPHARYNGITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054806-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060708</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006084734</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EFFECT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
        <drugauthorizationnumb>19787</drugauthorizationnumb>
        <drugdosagetext>10 MG (10 MG,QD) ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054809-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060705</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006084776</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BREAST CANCER METASTATIC</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>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>PREMARIN</medicinalproduct>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMPRO</medicinalproduct>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054810-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060705</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006084748</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BREAST CANCER FEMALE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROVERA</medicinalproduct>
        <drugauthorizationnumb>11839</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19890101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20000101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19890101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20000101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054811-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060707</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006AC01277</companynumb>
    <primarysource>
      <reportercountry>SWEDEN</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>RHABDOMYOLYSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugauthorizationnumb>019810</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLARITHROMYCIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVASTATIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIAZEPAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054812-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050225</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2005PK00357</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>26806</patientonsetage>
      <patientonsetageunit>804</patientonsetageunit>
      <patientweight>70</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>BUNDLE BRANCH BLOCK LEFT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BUNDLE BRANCH BLOCK RIGHT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ELECTROCARDIOGRAM ST SEGMENT ELEVATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERAL PHYSICAL HEALTH DETERIORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALIGNANT NEOPLASM PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NON-SMALL CELL LUNG CANCER METASTATIC</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IRESSA</medicinalproduct>
        <drugauthorizationnumb>21399</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050131</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050324</drugenddate>
        <drugtreatmentduration>53</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOVAN HCT</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BRONCHORETARD</medicinalproduct>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXIS</medicinalproduct>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054813-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060621</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006AP02886</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>25302</patientonsetage>
      <patientonsetageunit>804</patientonsetageunit>
      <patientweight>55.7</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE SYSTOLIC INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERSTITIAL LUNG DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPHOCYTE STIMULATION TEST POSITIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OMEPRAL</medicinalproduct>
        <drugauthorizationnumb>19810</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTRIC ULCER HELICOBACTER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060427</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060503</drugenddate>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLARITHROMYCIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTRIC ULCER HELICOBACTER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060427</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060503</drugenddate>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMOLIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTRIC ULCER HELICOBACTER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060427</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060503</drugenddate>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060403</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060501</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRAVIT</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BRONCHITIS ACUTE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060424</drugstartdate>
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        <drugenddate>20060427</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRAVIT</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BRONCHITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060424</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060427</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRAVIT</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060506</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060501</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRAVIT</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060506</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060501</drugenddate>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SAWATENE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BRONCHITIS ACUTE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060424</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060427</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SAWATENE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BRONCHITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060424</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060427</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SAWATENE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060506</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060501</drugenddate>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SAWATENE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060506</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060501</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ETICALM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANXIETY DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060424</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060501</drugenddate>
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    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054814-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060512</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006UW09455</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>40</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>75</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>SUICIDE ATTEMPT</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugauthorizationnumb>020639</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030112</drugstartdate>
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        <drugenddate>20060426</drugenddate>
        <drugtreatmentduration>1200</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
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    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054815-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
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    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006084612</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
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    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BREAST CANCER FEMALE</reactionmeddrapt>
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      <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>19890101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19930101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19890101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19930101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054816-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
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    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006084545</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BREAST CANCER FEMALE</reactionmeddrapt>
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      <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>19850101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19930101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19850101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19930101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMEN</medicinalproduct>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19850101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19930101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054818-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060711</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-AVENTIS-200617174GDDC</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>31</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>90.35</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>NEUROPATHY PERIPHERAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVAQUIN</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ACUTE SINUSITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060515</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060615</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALLEGRA</medicinalproduct>
        <drugauthorizationnumb>020872</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SEASONAL ALLERGY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLONASE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054819-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060516</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AVENTIS-200614430US</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>89</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>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>LIVER DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KETEK</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>21144</drugauthorizationnumb>
        <drugindication>SINUSITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KETEK</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021144</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060330</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASMANEX                                 /CAN/</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAVIK</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EVISTA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPENIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRILOSEC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTROOESOPHAGEAL REFLUX DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLEGRA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE ALLERGIES</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACCOLATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
      </drug>
    </patient>
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  <safetyreport>
    <safetyreportid>5054823-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060705</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006084552</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BREAST CANCER FEMALE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROVERA</medicinalproduct>
        <drugauthorizationnumb>11839</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <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>5054826-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060705</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006084556</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BREAST CANCER FEMALE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>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>
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    </patient>
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  <safetyreport>
    <safetyreportid>5054828-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
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    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006084603</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
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    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BREAST CANCER FEMALE</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROVERA</medicinalproduct>
        <drugauthorizationnumb>11839</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MEDROXYPROGESTERONE ACETATE</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
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    </patient>
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  <safetyreport>
    <safetyreportid>5054831-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
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    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006084521</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
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    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BREAST CANCER FEMALE</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROVERA</medicinalproduct>
        <drugauthorizationnumb>11839</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMPRO</medicinalproduct>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCRIN</medicinalproduct>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054832-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060705</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006084529</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BREAST CANCER FEMALE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROVERA</medicinalproduct>
        <drugauthorizationnumb>11839</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMPRO</medicinalproduct>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054833-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060703</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006084501</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUTENT</medicinalproduct>
        <drugauthorizationnumb>21968</drugauthorizationnumb>
        <drugindication>RENAL CELL CARCINOMA STAGE UNSPECIFIED</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054834-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060613</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2006JP08957</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>61</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>48</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN LOWER</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>C-REACTIVE PROTEIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG ERUPTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EOSINOPHILIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAMMA-GLUTAMYLTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROTEINURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PURPURA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMISIL</medicinalproduct>
        <drugauthorizationnumb>20539</drugauthorizationnumb>
        <drugdosagetext>125 MG/D</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NAIL TINEA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060608</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054835-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060705</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006083981</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>74</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>86.1834</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BREAST CANCER FEMALE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GALLBLADDER OPERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>KNEE OPERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RECTAL FISTULA REPAIR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugauthorizationnumb>20702</drugauthorizationnumb>
        <drugdosagetext>10 MG (10 MG, 1 IN 1 D)</drugdosagetext>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DITROPAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMINS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREVACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETYLSALICYLIC ACID SRT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM GLUCONATE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054836-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060705</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006083701</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>17</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANIC ATTACK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
        <drugauthorizationnumb>19839</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHLOROQUINE PHOSPHATE</medicinalproduct>
        <drugdosagetext>500 MG (1 WK)</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054838-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060705</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006083498</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>72.1219</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ARTERIAL STENOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOTION SICKNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROSTATIC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RED BLOOD CELL SEDIMENTATION RATE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugauthorizationnumb>20702</drugauthorizationnumb>
        <drugdosagetext>10 MG (10 MG, 1 IN 1 D)</drugdosagetext>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060601</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROSCAR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALL OTHER THERAPEUTIC PRODUCTS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM GLUCONATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054840-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060608</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006083501</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>64.4108</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ALOPECIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLEPHAROSPASM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EAR PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FACIAL PALSY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NECK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEURALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</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>20060101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
        <drugdosagetext>200 MG (100 MG, 2 IN 1 D)</drugdosagetext>
        <drugindication>ANXIETY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19860101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
        <drugdosagetext>300 MG (100 MG, 3 IN 1 D)</drugdosagetext>
        <drugindication>NERVE INJURY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DESYREL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>QUINIDINE HCL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054844-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060705</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006083042</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>72</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DELIRIUM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCISION SITE COMPLICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POST PROCEDURAL COMPLICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WOUND SECRETION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SERTRALINE</medicinalproduct>
        <drugauthorizationnumb>19839</drugauthorizationnumb>
        <drugdosagetext>25 MG (1 D)</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LINEZOLID</medicinalproduct>
        <drugdosagetext>ONCE</drugdosagetext>
        <drugindication>POSTOPERATIVE WOUND INFECTION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054847-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060703</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006081250</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>53</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>54.4316</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CHILLS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG WITHDRAWAL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRY MOUTH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPHONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCONTINENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugauthorizationnumb>21446</drugauthorizationnumb>
        <drugdosagetext>300 MG (150 MG, 2 IN 1 D),ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONVULSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060624</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054849-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060703</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006082942</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>44</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GEODON</medicinalproduct>
        <drugauthorizationnumb>20825</drugauthorizationnumb>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEXAPRO</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COGENTIN</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HALDOL DECANOATE (HALOPERIDOL DECANOATE)</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054851-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060703</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006082967</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>45</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD CREATINE PHOSPHOKINASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BODY TEMPERATURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSTONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE RIGIDITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GEODON</medicinalproduct>
        <drugauthorizationnumb>20825</drugauthorizationnumb>
        <drugindication>SCHIZOPHRENIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KLONOPIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SSRI</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054854-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060703</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006074928</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>78</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>INCREASED UPPER AIRWAY SECRETION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA PRIMARY ATYPICAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRODUCTIVE COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHINORRHOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DETROL LA</medicinalproduct>
        <drugauthorizationnumb>21228</drugauthorizationnumb>
        <drugdosagetext>4 MG (4 MG, 1 IN 1 D)</drugdosagetext>
        <drugindication>BLADDER DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060511</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054855-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060706</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006076019</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>89</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>68.2</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HIP FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPONATRAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POSTOPERATIVE INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
        <drugauthorizationnumb>19787</drugauthorizationnumb>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DELTASONE</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050325</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALDACTONE</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEXTRA</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMERON</medicinalproduct>
        <drugdosagetext>15 MG (15 MG, 1 IN 1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050301</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EFFEXOR XR</medicinalproduct>
        <drugdosagetext>225 MG, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050301</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ADVAIR DISKUS 100/50</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ULTRAM</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOCUSATE SODIUM (DOCUSATE 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>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEPCID</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LOVENOX</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ANCEF</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRAZODONE HCL</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KEFLEX</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SLO-MAG (MAGNESIUM CHLORIDE ANHYDROUS)</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROBANTHINE (PROPANTHELINE BROMIDE)</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COZAAR</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DARVOCET-N 100</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DUONEB</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BUCINDOLOL HYDROCHLORIDE (BUCINDOLOL HYDROCHLORIDE)</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054856-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060705</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006063590</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugauthorizationnumb>21446</drugauthorizationnumb>
        <drugdosagetext>300 MG (150 MG, 2 IN 1 D)</drugdosagetext>
        <drugindication>COMPLEX REGIONAL PAIN SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugauthorizationnumb>21446</drugauthorizationnumb>
        <drugdosagetext>300 MG (150 MG, 2 IN 1 D)</drugdosagetext>
        <drugindication>RADICULOPATHY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REVLIMID (UK-14,275)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EFFEXOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHADONE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCODONE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NITROFURANTOIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054857-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060705</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006062031</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>85</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>70.3075</patientweight>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ULCER HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEXTRA</medicinalproduct>
        <drugauthorizationnumb>21341</drugauthorizationnumb>
        <drugindication>ARTHRITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054858-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060706</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006085639</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>63</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CHLOROMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GINGIVAL DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMLODIPINE</medicinalproduct>
        <drugauthorizationnumb>19787</drugauthorizationnumb>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054860-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060710</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006085247</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>COLONOSCOPY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DETROL LA</medicinalproduct>
        <drugauthorizationnumb>21228</drugauthorizationnumb>
        <drugdosagetext>4 MG</drugdosagetext>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIURETICS (DIURETICS)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054862-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060224</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>UG-GILEAD-2006-0009263</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPINAL COMPRESSION FRACTURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TENOFOVIR DISOPROXIL FUMARATE</medicinalproduct>
        <drugauthorizationnumb>21356</drugauthorizationnumb>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030820</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051108</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMIVUDINE</medicinalproduct>
        <drugindication>HIV INFECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EFAVIRENZ</medicinalproduct>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040217</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COTRIMOXAZOLE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030820</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054863-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060310</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-US172032</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>THERAPEUTIC RESPONSE DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EPOGEN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>DIALYSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054864-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060314</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL172771</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE BRUISING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>ANAEMIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054865-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060314</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL174543</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>104</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD IRON ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugindication>MYELODYSPLASTIC SYNDROME</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054866-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060316</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL172877</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>82</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>87.2</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FAECES DISCOLOURED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STOMACH DISCOMFORT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>ANAEMIA OF MALIGNANT DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060104</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054867-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060327</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL174296</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugindication>ANAEMIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054868-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060306</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL171912</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FAECES DISCOLOURED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RENAL FAILURE CHRONIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054869-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060306</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL171907</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>ANAEMIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054870-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20021210</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL024983</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>66.3</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRY SKIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE REACTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RENAL FAILURE CHRONIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021105</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20021202</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054871-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060321</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-US173292</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>24</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EPOGEN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>DIALYSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060203</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054872-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060321</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-US173197</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>THERAPEUTIC RESPONSE DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EPOGEN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>DIALYSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054873-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050822</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-US147411</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>41</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>47.2</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EPOGEN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RENAL FAILURE CHRONIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050815</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050921</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054874-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050930</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL152857</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>68.1</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugindication>MYELODYSPLASTIC SYNDROME</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054875-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050930</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-US152677</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>63</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EPOGEN</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DIALYSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054876-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20051003</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL153119</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>71.7</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>MYELODYSPLASTIC SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050927</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054877-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050722</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL143884</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE BRUISING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>P041196</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PRE-EXISTING DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050709</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054878-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20051003</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL153120</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>133</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVARIAN CANCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>ANAEMIA OF MALIGNANT DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030901</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054880-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20051006</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL153522</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>74</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>62.7</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DECREASED APPETITE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>ANAEMIA OF MALIGNANT DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050923</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054881-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20051007</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL153748</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>EOSINOPHILIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PRE-EXISTING DISEASE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054882-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20051007</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-US153568</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>THERAPEUTIC RESPONSE DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EPOGEN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DIALYSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054883-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20051017</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL154769</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugindication>ANAEMIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054884-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060705</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006085251</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>76</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>KNEE ARTHROPLASTY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugauthorizationnumb>20998</drugauthorizationnumb>
        <drugdosagetext>200 MG (100 MG, 2 IN 1 D)</drugdosagetext>
        <drugindication>SCIATICA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPROL-XL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMINS (VITAMINS)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054885-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060705</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006085325</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>56</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>86.1834</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROTEIN URINE PRESENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugauthorizationnumb>21446</drugauthorizationnumb>
        <drugdosagetext>150 MG (75 MG, 2 IN 1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BACK DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060704</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
        <drugdosagetext>1 D</drugdosagetext>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COZAAR</medicinalproduct>
        <drugindication>PROTEIN URINE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADVAIR DISKUS 100/50</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACCOLATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZYRTEC</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054891-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060707</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GILEAD-2006-0009847</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>43</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>62.425</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EMTRICITABINE</medicinalproduct>
        <drugauthorizationnumb>21500</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060617</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060622</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TENOFOVIR</medicinalproduct>
        <drugauthorizationnumb>021356</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060617</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060622</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EFAVIRENZ</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060617</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060622</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BACTRIM DS</medicinalproduct>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZITHROMAX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GABAPENTIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MORPHINE</medicinalproduct>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054892-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060705</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006084802</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BREAST CANCER FEMALE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROVERA</medicinalproduct>
        <drugauthorizationnumb>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>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054894-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060707</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006084808</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>58</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>95.2554</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPEPSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GALLBLADDER DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GALLBLADDER PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMPAIRED DRIVING ABILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMPAIRED WORK ABILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</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>20051216</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZETIA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLYBURIDE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054897-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060705</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006084785</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BREAST CANCER FEMALE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROVERA</medicinalproduct>
        <drugauthorizationnumb>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>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054898-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060706</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006084797</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHILLS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEMORY IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOOD SWINGS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PENIS DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSYCHOTIC DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
        <drugauthorizationnumb>18276</drugauthorizationnumb>
        <drugdosagetext>0.25 MG (0.25 MG, 1 IN 1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MENTAL DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060527</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060704</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054902-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060705</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006044891</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>72</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIAC ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugauthorizationnumb>20998</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990901</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054905-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060705</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006044890</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>75</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEXTRA</medicinalproduct>
        <drugauthorizationnumb>21341</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040601</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054907-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060302</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-NOVOPROD-251275</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>69</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>107</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LETHARGY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH MACULAR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NORDITROPIN SIMPLEXX</medicinalproduct>
        <drugauthorizationnumb>21148</drugauthorizationnumb>
        <drugdosagetext>.2 MG, QD</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>GROWTH HORMONE DEFICIENCY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060208</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCORTISONE</medicinalproduct>
        <drugdosagetext>10 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THYROXINE ^APS^</medicinalproduct>
        <drugdosagetext>100 UG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE</medicinalproduct>
        <drugdosagetext>10 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ROSUVASTATIN</medicinalproduct>
        <drugdosagetext>10 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SUSTANON                                /NET/</medicinalproduct>
        <drugdosagetext>250 MG, QD</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054910-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060705</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006061005</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>85</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIALYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSARTHRIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENTAL STATUS CHANGES</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugauthorizationnumb>21446</drugauthorizationnumb>
        <drugdosagetext>100 MG (50 MG, 2 IN 1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NEUROPATHY PERIPHERAL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060309</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054911-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060321</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-US173198</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>THERAPEUTIC RESPONSE DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EPOGEN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>DIALYSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060310</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054912-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060310</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL172531</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HAEMATOCRIT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugindication>ANAEMIA OF MALIGNANT DISEASE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054913-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060310</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL172565</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>ANAEMIA OF MALIGNANT DISEASE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054914-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060313</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL172568</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>41</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugindication>RENAL FAILURE CHRONIC</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054915-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060315</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-US172559</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>THERAPEUTIC RESPONSE DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EPOGEN</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugindication>DIALYSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SENSIPAR</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugindication>HYPERPARATHYROIDISM SECONDARY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054916-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060315</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL172773</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>83.5</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>ANAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060302</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054917-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060314</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL172691</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>LUNG NEOPLASM MALIGNANT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALIGNANT NEOPLASM PROGRESSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>ANAEMIA OF MALIGNANT DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051110</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051130</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054918-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060310</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-US171985</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>58</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>THERAPEUTIC RESPONSE DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EPOGEN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>DIALYSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054919-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060317</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-US173119</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>17</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EPOGEN</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugindication>ANAEMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENOXAPARIN SODIUM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054920-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060306</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-US171246</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>70</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>THERAPEUTIC RESPONSE DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EPOGEN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>DIALYSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060302</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EPOGEN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060302</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040221</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050107</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050107</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050107</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050107</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050103</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050103</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SENSIPAR</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050103</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040621</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040226</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031126</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030827</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030827</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030827</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054921-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060705</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006026893</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>74</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>79.3795</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MUSCLE INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</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>BLOOD CHOLESTEROL INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DILANTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054923-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060707</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006029894</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>54</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>GINGIVAL BLEEDING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GINGIVAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GINGIVITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THYROID NEOPLASM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
        <drugauthorizationnumb>19787</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050531</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
        <drugauthorizationnumb>19787</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060110</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL W/HYDROCHLOROTHIAZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRINIVIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XENICAL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054924-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060619</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2006JP09270</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>46</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>50</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHOIDAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TESTICULAR OPERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TESTICULAR SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TESTIS CANCER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GLEEVEC</medicinalproduct>
        <drugauthorizationnumb>21588</drugauthorizationnumb>
        <drugdosagetext>400 MG/D</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CHRONIC MYELOID LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050721</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050921</drugenddate>
        <drugtreatmentduration>90720</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GLEEVEC</medicinalproduct>
        <drugauthorizationnumb>021588</drugauthorizationnumb>
        <drugdosagetext>300 MG/D</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050922</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GLEEVEC</medicinalproduct>
        <drugauthorizationnumb>021588</drugauthorizationnumb>
        <drugdosagetext>400 MG/D</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060614</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KOLANTYL</medicinalproduct>
        <drugdosagetext>3G/D</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19981021</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054927-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060705</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2005131094</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>68</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>97.5234</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DIABETES MELLITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIABETIC NEUROPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FOOD ALLERGY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEARING IMPAIRED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEMORY IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MITRAL VALVE REPAIR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MITRAL VALVE REPLACEMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRICUSPID VALVE REPLACEMENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugauthorizationnumb>20702</drugauthorizationnumb>
        <drugdosagetext>20 MG (20 MG, 1 IN 1 D)</drugdosagetext>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPROL-XL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROZAC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GARLIC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SAW PALMETTO</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM GLUCONATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGNESIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZINC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTIPLE VITAMINS (ASCORBIC ACID, ERGOCALCIFEROL, FOLIC ACID, RETINOL,</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FISH OIL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054929-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060605</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2005161699</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>49</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>65.7716</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CEREBRAL THROMBOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugauthorizationnumb>20998</drugauthorizationnumb>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEXTRA</medicinalproduct>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRILOSEC</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054932-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060710</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AVENTIS-200615897US</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>58.63</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEVICE FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG DOSE OMISSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POSTOPERATIVE WOUND COMPLICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WOUND DEHISCENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021081</drugauthorizationnumb>
        <drugdosagetext>DOSE UNIT: UNITS</drugdosagetext>
        <drugindication>DIABETES MELLITUS NON-INSULIN-DEPENDENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060619</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OPTICLIK (INSULIN INJECTION PEN)</medicinalproduct>
        <drugauthorizationnumb>021081</drugauthorizationnumb>
        <drugindication>DIABETES MELLITUS NON-INSULIN-DEPENDENT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEMEROL</medicinalproduct>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOVANCE</medicinalproduct>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANALGESICS</medicinalproduct>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARDIOVASCULAR SYSTEM DRUGS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054933-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060614</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BE-AVENTIS-200616704GDDC</companynumb>
    <primarysource>
      <reportercountry>BELGIUM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>32</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FOETAL MACROSOMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021081</drugauthorizationnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>DIABETES MELLITUS INSULIN-DEPENDENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041203</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050902</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054934-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060705</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2005171807</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>32</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>114.3065</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AMENORRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLONOSCOPY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CYST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ENDOMETRIAL HYPERPLASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ENDOMETRIOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LACTOSE INTOLERANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UTERINE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UTERINE POLYP</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEPO-PROVERA</medicinalproduct>
        <drugauthorizationnumb>20246</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugindication>CONTRACEPTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040701</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEPO-PROVERA</medicinalproduct>
        <drugauthorizationnumb>20246</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugindication>CONTRACEPTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050601</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WELLBUTRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPAMAX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054937-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060706</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>06H-163-0308700-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEONATAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY INTERSTITIAL EMPHYSEMA SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MAGNESIUM SULFATE</medicinalproduct>
        <drugauthorizationnumb>20309</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BERACTANT</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054939-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060706</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>06H-163-0308701-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEONATAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY INTERSTITIAL EMPHYSEMA SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MAGNESIUM SULFATE</medicinalproduct>
        <drugauthorizationnumb>20309</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BERACTANT</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054941-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060706</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>06H-163-0308702-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEONATAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY INTERSTITIAL EMPHYSEMA SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SMALL FOR DATES BABY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MAGNESIUM SULFATE</medicinalproduct>
        <drugauthorizationnumb>20309</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BERACTANT</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054942-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060630</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AVENTIS-200616922GDDC</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>57</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>78.9</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERKALAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORTHOSTATIC HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAXOTERE</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>20449</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060626</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060626</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CISPLATIN</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060626</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060626</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE TAB</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugdosagetext>DOSE: 8 MG 12 HOURS AND 1 HOUR PRIOR TO CHEMO AND 12 HOURS POST CHEMO</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COMPAZINE</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COMPAZINE</medicinalproduct>
        <drugdosagetext>DOSE: 10 MG EVERY 6 HOURS FOR 48 HOURS</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVAPRO</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLYBURIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRAVACHOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLOMAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054943-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060705</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AVENTIS-200616972GDDC</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>65</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>62.4</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIAC ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRIC ULCER PERFORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUCOSAL INFLAMMATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPENIC SEPSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAXOTERE</medicinalproduct>
        <drugbatchnumb>D6A692</drugbatchnumb>
        <drugauthorizationnumb>020449</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060621</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060621</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARBOPLATIN</medicinalproduct>
        <drugbatchnumb>890376</drugbatchnumb>
        <drugdosagetext>DOSE: AUC 6</drugdosagetext>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060621</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060621</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KYTRIL</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>ZIAC</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLOVENT</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL SPIROS</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054944-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AVENTIS-200616835GDDC</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>66</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>54.4</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL DISTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAXOTERE</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>020449</drugauthorizationnumb>
        <drugdosagetext>DOSE UNIT: MILLIGRAM PER MILLILITRE</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>OVARIAN CANCER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOPOTECAN</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugdosagetext>DOSE UNIT: MILLIGRAM PER MILLILITRE</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>OVARIAN CANCER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NIFEDIPINE</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FERROUS SULFATE TAB</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>COMPAZINE</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054946-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060710</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006AP03202</companynumb>
    <primarysource>
      <reportercountry>SINGAPORE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>27214</patientonsetage>
      <patientonsetageunit>804</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IRESSA</medicinalproduct>
        <drugauthorizationnumb>021399</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060621</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NAPROXEN SODIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MUSCULOSKELETAL PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060615</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060622</drugenddate>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FAMOTIDINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060615</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060622</drugenddate>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MUSCULOSKELETAL PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060615</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060617</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054947-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060714</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006AP03272</companynumb>
    <primarysource>
      <reportercountry>KOREA, REPUBLIC OF</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>24404</patientonsetage>
      <patientonsetageunit>804</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IRESSA</medicinalproduct>
        <drugauthorizationnumb>021399</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>LUNG NEOPLASM MALIGNANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050429</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050521</drugenddate>
        <drugtreatmentduration>23</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054948-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060710</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006CG01184</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>58</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPONATRAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugauthorizationnumb>019810</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS AGAINST GASTROINTESTINAL ULCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060512</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060601</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARTREX</medicinalproduct>
        <drugindication>ARTHRALGIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060512</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLIMASTON</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NOCTAMID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RIVOTRIL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054949-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006UW01600</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>89</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>38.6</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>COLON NEOPLASM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugauthorizationnumb>20639</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HALLUCINATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060501</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugauthorizationnumb>020639</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PARAESTHESIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060501</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugauthorizationnumb>020639</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060501</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugauthorizationnumb>020639</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060501</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SINEMET</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COZAAR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMDUR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZANTAC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARICEPT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>JIFEREX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NITROSTAT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054950-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060706</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006UW14189</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>758</patientonsetage>
      <patientonsetageunit>802</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD BILIRUBIN INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FASLODEX</medicinalproduct>
        <drugbatchnumb>CW793</drugbatchnumb>
        <drugauthorizationnumb>21344</drugauthorizationnumb>
        <drugdosagetext>250 MG X 2</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060510</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060614</drugenddate>
        <drugtreatmentduration>36</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GABAPENTIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RANITIDINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE TAB</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054951-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060713</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006AP03232</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>68</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>50</patientweight>
      <reaction>
        <reactionmeddrapt>ANAPHYLACTIC SHOCK</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MEROPENEM</medicinalproduct>
        <drugauthorizationnumb>50706</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054952-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060707</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006GB01181</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMIG</medicinalproduct>
        <drugauthorizationnumb>021231</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MIGRAINE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054953-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060327</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006SE01825</companynumb>
    <primarysource>
      <reportercountry>GREECE</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>57</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANAEMIA HAEMOLYTIC AUTOIMMUNE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ATACAND HCT</medicinalproduct>
        <drugauthorizationnumb>021093</drugauthorizationnumb>
        <drugdosagetext>16/12.5 MG DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050601</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PEPTAN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050601</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAXUDIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054954-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060710</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006SE03854</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>852</patientonsetage>
      <patientonsetageunit>802</patientonsetageunit>
      <patientweight>54</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BLOPRESS</medicinalproduct>
        <drugauthorizationnumb>20838</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CARDIAC FAILURE CHRONIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060530</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060610</drugenddate>
        <drugtreatmentduration>12</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HALFDIGOXIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CARDIAC FAILURE CHRONIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030420</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054955-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060710</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006UW14138</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>58</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>87.5</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>COMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugauthorizationnumb>020639</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BIPOLAR DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugauthorizationnumb>020639</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANXIETY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054956-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060525</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006UW10270</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>42</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>90.9</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VERTIGO</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugauthorizationnumb>20639</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MORPHINE</medicinalproduct>
        <drugindication>BACK PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060601</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANXIETY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROZAC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054957-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041217</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0537933A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>21</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>85</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ABNORMAL BEHAVIOUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AGGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AGITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANGER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMPLETED SUICIDE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HOMICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MANIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OBSESSIVE-COMPULSIVE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARANOIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSYCHOTIC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREATMENT NONCOMPLIANCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
        <drugauthorizationnumb>20031</drugauthorizationnumb>
        <drugdosagetext>20MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020528</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020701</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RANITIDINE HYDROCHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAZODONE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALCOHOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EPHEDRINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054958-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050509</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0558621A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>47</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>71.8</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>AGGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AGORAPHOBIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANGER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISORIENTATION</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>HOSTILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOOD ALTERED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
        <drugauthorizationnumb>20031</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19970101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROZAC</medicinalproduct>
        <drugdosagetext>10MG IN THE MORNING</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MAJOR DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980430</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19980521</drugenddate>
        <drugtreatmentduration>22</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONAZEPAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WELLBUTRIN SR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDROXYPROGESTERONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054959-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050509</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0558625A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>64</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>83.6</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>AGGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BALANCE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG WITHDRAWAL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ENCEPHALOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IRRITABILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEMORY IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOOD SWINGS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULAR WEAKNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SENSATION OF BLOOD FLOW</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SENSORY DISTURBANCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAXIL CR</medicinalproduct>
        <drugauthorizationnumb>20936</drugauthorizationnumb>
        <drugdosagetext>12.5MG UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANXIETY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
        <drugauthorizationnumb>020710</drugauthorizationnumb>
        <drugdosagetext>10MG UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANXIETY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040804</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BEXTRA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KLONOPIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054960-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20051114</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0582936A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>68.2</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AGORAPHOBIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHILLS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DECREASED APPETITE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPERSONALISATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISTURBANCE IN ATTENTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG WITHDRAWAL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HOMICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HOT FLUSH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERACUSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IRRITABILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEUKOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIBIDO DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEMORY IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOOD SWINGS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANIC REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TEARFULNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TINNITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISION BLURRED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
        <drugauthorizationnumb>20031</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
        <drugauthorizationnumb>020710</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAROXETINE HCL</medicinalproduct>
        <drugauthorizationnumb>020031</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLEXERIL</medicinalproduct>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
        <drugdosagetext>25MG PER DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREMPRO</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEXAPRO</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROMETRIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVAPRO</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROVERA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WELLBUTRIN</medicinalproduct>
        <drugdosagetext>150MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REMERON</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELEXA</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054961-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0591946A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>24</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>90</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BUNDLE BRANCH BLOCK RIGHT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONTUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ELECTROCARDIOGRAM ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ELECTROCARDIOGRAM T WAVE INVERSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ROAD TRAFFIC ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENTRICULAR TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REQUIP</medicinalproduct>
        <drugauthorizationnumb>20658</drugauthorizationnumb>
        <drugdosagetext>4MG SEE DOSAGE TEXT</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RESTLESS LEGS SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050916</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060104</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SONATA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INSOMNIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051201</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054962-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060627</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006-004757</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>19</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>LIVER FUNCTION TEST ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLOLAN</medicinalproduct>
        <drugauthorizationnumb>20444</drugauthorizationnumb>
        <drugdosagetext>1.5MG CONTINUOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PULMONARY HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BOSENTAN</medicinalproduct>
        <drugindication>PULMONARY HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054963-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0610774A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>45</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PAPILLOEDEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REQUIP</medicinalproduct>
        <drugauthorizationnumb>20658</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RESTLESS LEGS SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060502</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060628</drugenddate>
        <drugtreatmentduration>58</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FESO4</medicinalproduct>
        <drugdosagetext>325MG TWICE PER DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugdosagetext>40MG PER DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNITHROID</medicinalproduct>
        <drugdosagetext>100MCG PER DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM GLUCONATE</medicinalproduct>
        <drugdosagetext>500MG THREE TIMES PER DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAXZIDE-25</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREVACID</medicinalproduct>
        <drugdosagetext>30MG PER DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMBIEN</medicinalproduct>
        <drugdosagetext>12.5MG AT NIGHT</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054964-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060622</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0610947A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG WITHDRAWAL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
        <drugauthorizationnumb>20031</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANXIETY DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19940101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KLONOPIN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19940101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ORTHO TRI-CYCLEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054965-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060712</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0612016A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>57</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SLEEP APNOEA SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDAMET</medicinalproduct>
        <drugauthorizationnumb>021410</drugauthorizationnumb>
        <drugdosagetext>1TAB TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051101</drugenddate>
        <drugtreatmentduration>18</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KLOR-CON</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYZAAR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DILTIAZEM HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ISOSORBIDE MONONITRATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GEMFIBROZIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMINS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLIPIZIDE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054966-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060712</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0612018A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>30</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANAPHYLACTIC REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOUTH ULCERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY DISTRESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN ULCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STEVENS-JOHNSON SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWELLING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMICTAL</medicinalproduct>
        <drugbatchnumb>UNKOWN</drugbatchnumb>
        <drugauthorizationnumb>020241</drugauthorizationnumb>
        <drugdosagetext>25MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BIPOLAR DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060629</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060701</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNSPECIFIED MEDICATION</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054967-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060712</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0612022A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MANIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>WELLBUTRIN XL</medicinalproduct>
        <drugauthorizationnumb>021515</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054968-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060712</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0612032A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>48</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BEDRIDDEN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRONCHITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISABILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISSOCIATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSGEUSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PEAK EXPIRATORY FLOW RATE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ADVAIR DISKUS 100/50</medicinalproduct>
        <drugbatchnumb>R195898</drugbatchnumb>
        <drugauthorizationnumb>021077</drugauthorizationnumb>
        <drugdosagetext>1PUFF PER DAY</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL SPIROS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNSPECIFIED MEDICATION</medicinalproduct>
        <drugindication>ATTENTION DEFICIT/HYPERACTIVITY DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SINGULAIR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMBIEN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054969-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060712</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0612046A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>69</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ESKALITH</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>016860</drugauthorizationnumb>
        <drugdosagetext>300MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BIPOLAR I DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19800101</drugstartdate>
        <drugtreatmentduration>21</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOPHAGE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054970-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060713</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0612181A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>23</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCREATITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>WELLBUTRIN</medicinalproduct>
        <drugauthorizationnumb>018644</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NO CONCURRENT MEDICATION</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054971-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060717</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0612481A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>49</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>AMNESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG WITHDRAWAL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE TWITCHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SCREAMING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>WELLBUTRIN XL</medicinalproduct>
        <drugauthorizationnumb>021515</drugauthorizationnumb>
        <drugdosagetext>150MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060711</drugenddate>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEGA 3 FATTY ACIDS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054972-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060717</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0612507A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>31</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MANIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BUPROPION HCL</medicinalproduct>
        <drugauthorizationnumb>020358</drugauthorizationnumb>
        <drugdosagetext>150MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BIPOLAR DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060701</drugstartdate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>WELLBUTRIN XL</medicinalproduct>
        <drugauthorizationnumb>021515</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BIPOLAR DISORDER</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060701</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LITHIUM CARBONATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEPAKOTE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KLONOPIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATIVAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLARITIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRILOSEC</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054973-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060714</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0612543A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ROAD TRAFFIC ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060501</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CONCURRENT MEDICATIONS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054974-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060713</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>HN-GLAXOSMITHKLINE-A0612553A</companynumb>
    <primarysource>
      <reportercountry>HONDURAS</reportercountry>
      <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>COMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LETHARGY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAROXETINE HCL</medicinalproduct>
        <drugauthorizationnumb>020031</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZIPRASIDONE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLONAZEPAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALPRAZOLAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMITRIPTYLINE HCL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054975-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060714</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AR-GLAXOSMITHKLINE-A0612555A</companynumb>
    <primarysource>
      <reportercountry>ARGENTINA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>34</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ILEUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AROPAX</medicinalproduct>
        <drugauthorizationnumb>20936</drugauthorizationnumb>
        <drugdosagetext>25MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060616</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060708</drugenddate>
        <drugtreatmentduration>23</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IRON</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054976-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060717</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0612658A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>95</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CATARACT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MACULAR OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL DISTURBANCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ADVAIR DISKUS 100/50</medicinalproduct>
        <drugbatchnumb>R228802</drugbatchnumb>
        <drugauthorizationnumb>021077</drugauthorizationnumb>
        <drugdosagetext>1PUFF TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060717</drugenddate>
        <drugtreatmentduration>80</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054977-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060717</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0612686A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EATING DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ENTEROCOLITIS INFECTIOUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMMUNE SYSTEM DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLAMMATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOUTH ULCERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PURPURA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN EXFOLIATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VAGINAL LESION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMICTAL</medicinalproduct>
        <drugauthorizationnumb>020241</drugauthorizationnumb>
        <drugdosagetext>50MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BIPOLAR DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060216</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060301</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EFFEXOR XR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADVAIR DISKUS 100/50</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEXAPRO</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THEOPHYLLINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KLONOPIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054978-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060630</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006RR-02883</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>21</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ACCIDENTAL OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AKATHISIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AMNESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSTONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GRIMACING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HALLUCINATION, VISUAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MICTURITION URGENCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POSTURE ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUS TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUOXETINE</medicinalproduct>
        <drugauthorizationnumb>76165</drugauthorizationnumb>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OLANZAPINE</medicinalproduct>
        <drugdosagetext>70 MG, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054979-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060717</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0612688A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>COMPLETED SUICIDE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MANIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANIC REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARANOIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>WELLBUTRIN XL</medicinalproduct>
        <drugauthorizationnumb>021515</drugauthorizationnumb>
        <drugdosagetext>300MG PER DAY</drugdosagetext>
        <drugtreatmentduration>10</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054980-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-GLAXOSMITHKLINE-B0359604A</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ALCOHOLIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMPLETED SUICIDE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISSOCIATIVE FUGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANIC ATTACK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYROMANIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEXUAL DYSFUNCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROXAT</medicinalproduct>
        <drugauthorizationnumb>20031</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990311</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054981-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20051021</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-GLAXOSMITHKLINE-B0397948A</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>80</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>BLADDER CANCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRONCHOPNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SERETIDE</medicinalproduct>
        <drugauthorizationnumb>21077</drugauthorizationnumb>
        <drugadministrationroute>055</drugadministrationroute>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENDROFLUAZIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054982-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060215</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-JPN-A200600647</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>50</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>90</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ALANINE AMINOTRANSFERASE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANOREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASPARTATE AMINOTRANSFERASE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD BILIRUBIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSED LEVEL OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HALLUCINATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC ENCEPHALOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATITIS B</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JAUNDICE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLEURAL EFFUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THIRST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINE OUTPUT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZEFIX</medicinalproduct>
        <drugauthorizationnumb>20564</drugauthorizationnumb>
        <drugdosagetext>100MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS B</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040927</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051221</drugenddate>
        <drugtreatmentduration>451</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GASTER</medicinalproduct>
        <drugdosagetext>20MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>GASTRIC ULCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051122</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051124</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HEPSERA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAL</medicinalproduct>
        <drugdosagetext>40MG PER DAY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>GASTRIC ULCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051205</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOSE</medicinalproduct>
        <drugdosagetext>1000ML PER DAY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051206</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051221</drugenddate>
        <drugtreatmentduration>16</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SANDIMMUNE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>IMMUNOSUPPRESSANT DRUG THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051204</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051221</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HUMULIN 70/30</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051206</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051221</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZANTAC</medicinalproduct>
        <drugdosagetext>200MG PER DAY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>GASTRIC ULCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051206</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051221</drugenddate>
        <drugtreatmentduration>16</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PENTCILLIN</medicinalproduct>
        <drugdosagetext>2G PER DAY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BRONCHITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051206</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051218</drugenddate>
        <drugtreatmentduration>13</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUMARIN</medicinalproduct>
        <drugdosagetext>2G PER DAY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BRONCHITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051219</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051221</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLYCYRRHIZIN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051119</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054983-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060330</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BE-GLAXOSMITHKLINE-B0419543A</companynumb>
    <primarysource>
      <reportercountry>BELGIUM</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>58</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>80</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANAPHYLACTIC REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZANTAC</medicinalproduct>
        <drugbatchnumb>5012,5013</drugbatchnumb>
        <drugauthorizationnumb>019090</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054984-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060508</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>NL-GLAXOSMITHKLINE-B0423614A</companynumb>
    <primarysource>
      <reportercountry>NETHERLANDS</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>59</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>99</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PANCYTOPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ROSIGLITAZONE MALEATE</medicinalproduct>
        <drugauthorizationnumb>21071</drugauthorizationnumb>
        <drugdosagetext>4MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DIABETES MELLITUS NON-INSULIN-DEPENDENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060412</drugenddate>
        <drugtreatmentduration>316</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
        <drugdosagetext>500MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NOVOMIX</medicinalproduct>
        <drugdosagetext>100IUML THREE TIMES PER DAY</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19950425</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HALDOL</medicinalproduct>
        <drugdosagetext>1MG UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19920723</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugdosagetext>20MG UNKNOWN</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051220</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054985-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060531</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-JPN-A200601819</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>55</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>58</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HYPERCHLORAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOKALAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHABDOMYOLYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEREVENT</medicinalproduct>
        <drugauthorizationnumb>20692</drugauthorizationnumb>
        <drugdosagetext>50MCG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060104</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060522</drugenddate>
        <drugtreatmentduration>139</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COLONEL</medicinalproduct>
        <drugdosagetext>1.2G THREE TIMES PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>IRRITABLE BOWEL SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050726</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SHAKUYAKU-KANZO-TO</medicinalproduct>
        <drugdosagetext>2.5G THREE TIMES PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060307</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060520</drugenddate>
        <drugtreatmentduration>75</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUTIDE DISKUS</medicinalproduct>
        <drugdosagetext>800MCG PER DAY</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060117</drugstartdate>
        <drugtreatmentduration>56</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PL</medicinalproduct>
        <drugdosagetext>1G THREE TIMES PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NASOPHARYNGITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060519</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060520</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GASMOTIN</medicinalproduct>
        <drugdosagetext>10MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>IRRITABLE BOWEL SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050617</drugstartdate>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KIPRES</medicinalproduct>
        <drugdosagetext>10MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060224</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VOLTAREN</medicinalproduct>
        <drugadministrationroute>054</drugadministrationroute>
        <drugindication>NASOPHARYNGITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060519</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060520</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050617</drugstartdate>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEILAX</medicinalproduct>
        <drugdosagetext>1MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030901</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEXOTAN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19940101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HUSTAZOL</medicinalproduct>
        <drugdosagetext>10MG THREE TIMES PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NASOPHARYNGITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060519</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060520</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEPROMEL</medicinalproduct>
        <drugdosagetext>150MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050617</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SEDIEL</medicinalproduct>
        <drugdosagetext>10MG THREE TIMES PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060519</drugstartdate>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANDSEN</medicinalproduct>
        <drugdosagetext>1.5MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040701</drugstartdate>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADETPHOS</medicinalproduct>
        <drugdosagetext>3G PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIZZINESS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050617</drugstartdate>
        <drugtreatmentduration>28</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHYLCOBAL</medicinalproduct>
        <drugdosagetext>750MCG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIZZINESS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050617</drugstartdate>
        <drugtreatmentduration>28</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CEPHADOL</medicinalproduct>
        <drugdosagetext>75MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIZZINESS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050117</drugstartdate>
        <drugtreatmentduration>28</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BUP-4</medicinalproduct>
        <drugdosagetext>20MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NEUROGENIC BLADDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060106</drugstartdate>
        <drugtreatmentduration>60</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
        <drugdosagetext>5MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040423</drugstartdate>
        <drugtreatmentduration>30</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CEREKINON</medicinalproduct>
        <drugdosagetext>300MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>IRRITABLE BOWEL SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000201</drugstartdate>
        <drugtreatmentduration>30</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PARIET</medicinalproduct>
        <drugdosagetext>10MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040213</drugstartdate>
        <drugtreatmentduration>30</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FERROMIA</medicinalproduct>
        <drugdosagetext>50MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010220</drugstartdate>
        <drugtreatmentduration>15</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNIPHYL</medicinalproduct>
        <drugdosagetext>400MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060224</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060421</drugenddate>
        <drugtreatmentduration>57</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054986-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060602</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-JPN-A200601857</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>24</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ADVERSE DRUG REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING OF DESPAIR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMPULSIVE BEHAVIOUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IRRITABILITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
        <drugauthorizationnumb>20031</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060515</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060531</drugenddate>
        <drugtreatmentduration>17</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ETIZOLAM</medicinalproduct>
        <drugdosagetext>.5MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060518</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>JAPANESE MEDICATION</medicinalproduct>
        <drugdosagetext>2U PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEADACHE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060510</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060612</drugenddate>
        <drugtreatmentduration>34</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MUCOSTA</medicinalproduct>
        <drugdosagetext>2U PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060510</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060612</drugenddate>
        <drugtreatmentduration>34</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEZOLAM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060510</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060612</drugenddate>
        <drugtreatmentduration>34</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RISPERDAL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060522</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060607</drugenddate>
        <drugtreatmentduration>17</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MYSLEE</medicinalproduct>
        <drugdosagetext>1U PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060529</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060529</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ISOTONIC SODIUM CHLORIDE</medicinalproduct>
        <drugdosagetext>1U PER DAY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060522</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060605</drugenddate>
        <drugtreatmentduration>15</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOGMATYL</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060522</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060605</drugenddate>
        <drugtreatmentduration>15</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>JAPANESE MEDICATION</medicinalproduct>
        <drugdosagetext>.5U PER DAY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060522</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060605</drugenddate>
        <drugtreatmentduration>15</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054988-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060601</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>NZ-GLAXOSMITHKLINE-B0427403A</companynumb>
    <primarysource>
      <reportercountry>NEW ZEALAND</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>28</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABORTION SPONTANEOUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTRA-UTERINE DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMICTAL</medicinalproduct>
        <drugauthorizationnumb>20241</drugauthorizationnumb>
        <drugdosagetext>400MG PER DAY</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>EPILEPSY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EPILIM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>EPILEPSY</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19980101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOBAZAM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>EPILEPSY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010901</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
        <drugdosagetext>5MG UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054989-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060601</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>NZ-GLAXOSMITHKLINE-B0427403B</companynumb>
    <primarysource>
      <reportercountry>NEW ZEALAND</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRISOMY 21</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMICTAL</medicinalproduct>
        <drugauthorizationnumb>20241</drugauthorizationnumb>
        <drugdosagetext>400MG PER DAY</drugdosagetext>
        <drugindication>EPILEPSY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EPILIM</medicinalproduct>
        <drugindication>EPILEPSY</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19980101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOBAZAM</medicinalproduct>
        <drugindication>EPILEPSY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010901</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
        <drugdosagetext>5MG UNKNOWN</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054990-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060615</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-JPN-A200602080</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>91</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>35</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DYSARTHRIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HALLUCINATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOXIC INDUCED ENCEPHALOPATHY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VALTREX</medicinalproduct>
        <drugauthorizationnumb>20487</drugauthorizationnumb>
        <drugdosagetext>500MG SEE DOSAGE TEXT</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HERPES ZOSTER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060612</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060620</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THYRADIN S</medicinalproduct>
        <drugdosagetext>25MCG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>THYROID MASS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRONON</medicinalproduct>
        <drugdosagetext>150MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALTAN</medicinalproduct>
        <drugdosagetext>1.8G PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054991-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060615</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-GLAXOSMITHKLINE-B0428013A</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>82</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ALANINE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD ALKALINE PHOSPHATASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD BILIRUBIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHOLECYSTITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAMMA-GLUTAMYLTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC FUNCTION ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JAUNDICE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER FUNCTION TEST ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>21071</drugauthorizationnumb>
        <drugdosagetext>8MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AUGMENTIN '125'</medicinalproduct>
        <drugauthorizationnumb>050564</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EFFEXOR</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RULIDE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054992-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-JPN-A200602354</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>64</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IRRITABILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDE ATTEMPT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
        <drugauthorizationnumb>20031</drugauthorizationnumb>
        <drugdosagetext>10MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060605</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060619</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BLOPRESS</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACINON</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CONAN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLIMICRON</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN DRUG</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN DRUG</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>YODEL S</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMOBAN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUNITRAZEPAM</medicinalproduct>
        <drugdosagetext>1MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INSOMNIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060612</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060616</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEXOTAN</medicinalproduct>
        <drugdosagetext>6MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPOCHONDRIASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060531</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060607</drugenddate>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN DRUG</medicinalproduct>
        <drugdosagetext>5MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INSOMNIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060531</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060607</drugenddate>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054993-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060630</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-JPN-A200602368</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>44</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANOREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DECREASED APPETITE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC FUNCTION ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VALTREX</medicinalproduct>
        <drugauthorizationnumb>20487</drugauthorizationnumb>
        <drugdosagetext>500MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HERPES SIMPLEX</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041204</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041205</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZITHROMAC</medicinalproduct>
        <drugdosagetext>500MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PHARYNGITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041204</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041206</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MUCOSOLVAN</medicinalproduct>
        <drugdosagetext>135MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BRONCHITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041204</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041208</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SELBEX</medicinalproduct>
        <drugdosagetext>1.5MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041204</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041208</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THEOLONG</medicinalproduct>
        <drugdosagetext>200MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BRONCHITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041204</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041208</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRAVIT</medicinalproduct>
        <drugdosagetext>300MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BRONCHITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041207</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041210</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NIPOLAZIN</medicinalproduct>
        <drugdosagetext>6MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHINITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041204</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041208</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GASTER D</medicinalproduct>
        <drugdosagetext>20MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041204</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041208</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BIOFERMIN</medicinalproduct>
        <drugdosagetext>.9G PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041204</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041208</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ISALON</medicinalproduct>
        <drugdosagetext>1.5G PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041209</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041210</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORMOSAN FIX</medicinalproduct>
        <drugdosagetext>1.5G PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041209</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041210</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KELNAC</medicinalproduct>
        <drugdosagetext>240MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041209</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041210</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALTAT</medicinalproduct>
        <drugdosagetext>150MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041209</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041210</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054994-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-JPN-A200602395</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>1</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>9</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA MULTIFORME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PURPURA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URTICARIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AUGMENTIN '125'</medicinalproduct>
        <drugauthorizationnumb>50575</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OTITIS MEDIA</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060626</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054995-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060710</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-GLAXOSMITHKLINE-B0430379A</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>86</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MELAENA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AUGMENTIN '125'</medicinalproduct>
        <drugauthorizationnumb>50564</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060306</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LASILIX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MOTILIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CALCIPARINE</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PULMONARY EMBOLISM</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060308</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054996-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060710</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-GLAXOSMITHKLINE-B0430405A</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>74</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOKINESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERNATIONAL NORMALISED RATIO INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARALYSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AUGMENTIN '125'</medicinalproduct>
        <drugauthorizationnumb>50564</drugauthorizationnumb>
        <drugdosagetext>3UNIT PER DAY</drugdosagetext>
        <drugadministrationroute>050</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060531</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060614</drugenddate>
        <drugtreatmentduration>15</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CALCIPARINE</medicinalproduct>
        <drugdosagetext>1.4ML PER DAY</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060529</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060603</drugenddate>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>1UNIT PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060606</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OFLOCET</medicinalproduct>
        <drugdosagetext>400MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060531</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060606</drugenddate>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAHOR</medicinalproduct>
        <drugdosagetext>1UNIT PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREVISCAN</medicinalproduct>
        <drugdosagetext>20MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060606</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRIATEC</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELIPROLOL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RIVOTRIL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054997-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060704</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-GLAXOSMITHKLINE-B0430464A</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>65</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>C-REACTIVE PROTEIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ENTEROCOLITIS HAEMORRHAGIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MELAENA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMOXICILLIN</medicinalproduct>
        <drugauthorizationnumb>050542</drugauthorizationnumb>
        <drugdosagetext>2000MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HELICOBACTER INFECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RABEPRAZOLE SODIUM</medicinalproduct>
        <drugdosagetext>40MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HELICOBACTER INFECTION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054998-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060704</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-GLAXOSMITHKLINE-B0430569A</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>4</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>12</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CRYOGLOBULINAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CUTANEOUS VASCULITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ECCHYMOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOE AMPUTATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VENTOLIN</medicinalproduct>
        <drugauthorizationnumb>018473</drugauthorizationnumb>
        <drugindication>ASTHMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060301</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLIXOTIDE</medicinalproduct>
        <drugauthorizationnumb>020121</drugauthorizationnumb>
        <drugdosagetext>50MCG PER DAY</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060301</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MOTILIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VFEND</medicinalproduct>
        <drugdosagetext>50MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040501</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BACTRIM</medicinalproduct>
        <drugdosagetext>5ML THREE TIMES PER WEEK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INFECTION PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020501</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GRANOCYTE</medicinalproduct>
        <drugdosagetext>13.4IU6 THREE TIMES PER WEEK</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GAVISCON</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5054999-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060711</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-GLAXOSMITHKLINE-B0430738A</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>78</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERAL PHYSICAL HEALTH DETERIORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSEUDOMEMBRANOUS COLITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AUGMENTIN '125'</medicinalproduct>
        <drugauthorizationnumb>050564</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060323</drugstartdate>
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        <drugenddate>20060329</drugenddate>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLAGYL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060323</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060329</drugenddate>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NORFLOXACIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060414</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060414</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PAROXETINE HCL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARICEPT</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TANAKAN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TIORFAN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPANTHYL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANZOR</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055000-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060712</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-GLAXOSMITHKLINE-B0430777A</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REQUIP</medicinalproduct>
        <drugauthorizationnumb>020658</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055001-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060711</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-GLAXOSMITHKLINE-B0430840A</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <patientonsetage>79</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL SYMPTOM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASCITES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHOLESTASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DECUBITUS ULCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DERMATITIS BULLOUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOALBUMINAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEUKOCYTOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PURPURA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOXIC SKIN ERUPTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AUGMENTIN '125'</medicinalproduct>
        <drugauthorizationnumb>050564</drugauthorizationnumb>
        <drugindication>ERYSIPELAS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051209</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051210</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GARDENAL 100</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPECIAFOLDINE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIFFU K</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055002-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060713</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-GLAXOSMITHKLINE-B0430923A</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>70</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL ACUITY REDUCED</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VENTOLIN</medicinalproduct>
        <drugauthorizationnumb>18473</drugauthorizationnumb>
        <drugdosagetext>100MCG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980701</drugstartdate>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN MEDICATION</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055003-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060710</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-JPN-A200602539</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>6</patientonsetage>
      <patientonsetageunit>802</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY VENO-OCCLUSIVE DISEASE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLOLAN</medicinalproduct>
        <drugauthorizationnumb>020444</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055004-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060711</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>453860</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>49</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARVEDILOL</medicinalproduct>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XENICAL</medicinalproduct>
        <drugdosagetext>12MG UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EPLERENONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BUMETANIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMILORIDE HYDROCHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATORVASTATIN CALCIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NICORANDIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALSARTAN</medicinalproduct>
      </drug>
    </patient>
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  <safetyreport>
    <safetyreportid>5055005-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060714</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-GLAXOSMITHKLINE-B0431416A</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>76</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>63</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HAEMOLYTIC ANAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALBENDAZOLE</medicinalproduct>
        <drugauthorizationnumb>20666</drugauthorizationnumb>
        <drugdosagetext>400MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051011</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051125</drugenddate>
        <drugtreatmentduration>28</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE</medicinalproduct>
        <drugdosagetext>5MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENDROFLUMETHIAZIDE</medicinalproduct>
        <drugdosagetext>2.5MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055006-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060712</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BG-GLAXOSMITHKLINE-B0431522A</companynumb>
    <primarysource>
      <reportercountry>BULGARIA</reportercountry>
      <qualification>1</qualification>
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    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <patientonsetage>75</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANGIONEUROTIC OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>4MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060601</drugenddate>
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  <safetyreport>
    <safetyreportid>5055007-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060710</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-JNJFOC-20060600028</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>2</qualification>
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    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEOPLASM PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DURAGESIC-100</medicinalproduct>
        <drugauthorizationnumb>019813</drugauthorizationnumb>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>PAIN</drugindication>
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  <safetyreport>
    <safetyreportid>5055008-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060710</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-JNJFOC-20060701896</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>3</qualification>
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    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>RASH GENERALISED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DURAGESIC-50</medicinalproduct>
        <drugauthorizationnumb>019813</drugauthorizationnumb>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ORAMORPH SR</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
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    </patient>
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  <safetyreport>
    <safetyreportid>5055009-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060711</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20060703082</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
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    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DURAGESIC-100</medicinalproduct>
        <drugauthorizationnumb>019813</drugauthorizationnumb>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
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    </patient>
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  <safetyreport>
    <safetyreportid>5055010-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
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    <receivedateformat>102</receivedateformat>
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    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
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    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <patientonsetage>56</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>57</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METASTASES TO LIVER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RECTAL CANCER</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LOCHOL</medicinalproduct>
        <drugauthorizationnumb>20261</drugauthorizationnumb>
        <drugdosagetext>30 MG, QD</drugdosagetext>
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        <drugindication>HYPERCHOLESTEROLAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20011122</drugstartdate>
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        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
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        <drugstartdate>20010828</drugstartdate>
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        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
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    <safetyreportid>5055011-2</safetyreportid>
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    <transmissiondate>20061208</transmissiondate>
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    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20051031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2005AP05633</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
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      <patientonsetage>7026</patientonsetage>
      <patientonsetageunit>804</patientonsetageunit>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ENCEPHALITIS VIRAL</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSCAVIR</medicinalproduct>
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        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MYELODYSPLASTIC SYNDROME</drugindication>
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        <drugstartdate>20051007</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
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        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIPRIVAN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
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        <drugstartdate>20051018</drugstartdate>
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        <drugenddate>20051030</drugenddate>
        <drugtreatmentduration>13</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUNGIZONE</medicinalproduct>
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        <drugstartdate>20051013</drugstartdate>
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        <drugenddate>20051103</drugenddate>
        <drugtreatmentduration>22</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ITRACONAZOLE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051018</drugstartdate>
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        <drugenddate>20051106</drugenddate>
        <drugtreatmentduration>20</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEROPEN</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051013</drugstartdate>
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        <drugenddate>20051103</drugenddate>
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        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAXIPIME</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051007</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051013</drugenddate>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MINOCYCLINE HCL</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051021</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051104</drugenddate>
        <drugtreatmentduration>15</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VFEND</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051012</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051018</drugenddate>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PHENOBAL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051017</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051031</drugenddate>
        <drugtreatmentduration>15</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TEGRETOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051009</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051018</drugenddate>
        <drugtreatmentduration>10</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TEGRETOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051012</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051023</drugenddate>
        <drugtreatmentduration>12</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEPAKENE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051017</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051023</drugenddate>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MYSTAN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051021</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051031</drugenddate>
        <drugtreatmentduration>11</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENTERONON-R</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051018</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051106</drugenddate>
        <drugtreatmentduration>20</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRAVIT</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051029</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051029</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYALEIN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051029</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051029</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DORMICUM</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051012</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051101</drugenddate>
        <drugtreatmentduration>21</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HORIZON</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051020</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051025</drugenddate>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALEVIATIN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051008</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051029</drugenddate>
        <drugtreatmentduration>22</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ROPION</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051007</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051023</drugenddate>
        <drugtreatmentduration>17</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INOVAN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051023</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051105</drugenddate>
        <drugtreatmentduration>14</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SOLDACTONE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051024</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051104</drugenddate>
        <drugtreatmentduration>12</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051021</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051105</drugenddate>
        <drugtreatmentduration>16</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HANP</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051017</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051105</drugenddate>
        <drugtreatmentduration>20</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLYCEOL</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051028</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051102</drugenddate>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BISOLVON</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051016</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051104</drugenddate>
        <drugtreatmentduration>20</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GASTER</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051007</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051105</drugenddate>
        <drugtreatmentduration>30</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SOLU-MEDROL</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051028</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051030</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SOLU-MEDROL</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051031</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051101</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NOR-ADRENALIN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051028</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051103</drugenddate>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCORTONE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051008</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051103</drugenddate>
        <drugtreatmentduration>27</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NOVOLIN R</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051007</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051102</drugenddate>
        <drugtreatmentduration>27</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTAMIN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051026</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051105</drugenddate>
        <drugtreatmentduration>11</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ELEMENMIC</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051007</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051105</drugenddate>
        <drugtreatmentduration>30</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOSE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051013</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051105</drugenddate>
        <drugtreatmentduration>24</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOSE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051015</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051025</drugenddate>
        <drugtreatmentduration>11</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOSE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051017</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051028</drugenddate>
        <drugtreatmentduration>12</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOSE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051017</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051103</drugenddate>
        <drugtreatmentduration>18</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOSE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051008</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051103</drugenddate>
        <drugtreatmentduration>27</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOSE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051028</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051104</drugenddate>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HICALIQ RF</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051026</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051105</drugenddate>
        <drugtreatmentduration>11</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEOAMIYU</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051026</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051105</drugenddate>
        <drugtreatmentduration>11</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORMAL SALINE INJECTION</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051007</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051027</drugenddate>
        <drugtreatmentduration>21</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORMAL SALINE INJECTION</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051007</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051105</drugenddate>
        <drugtreatmentduration>30</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ISOTONIC SODIUM CHLORIDE SOLUTION</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051007</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051101</drugenddate>
        <drugtreatmentduration>26</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ISOTONIC SODIUM CHLORIDE SOLUTION</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051008</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051105</drugenddate>
        <drugtreatmentduration>29</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SOLULACT</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051016</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051105</drugenddate>
        <drugtreatmentduration>21</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDIJECT K</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051014</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051104</drugenddate>
        <drugtreatmentduration>22</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051007</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051105</drugenddate>
        <drugtreatmentduration>30</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GRAN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051008</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051103</drugenddate>
        <drugtreatmentduration>27</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FULCALIQ 3</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051007</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051025</drugenddate>
        <drugtreatmentduration>19</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROGRAF</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051008</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051018</drugenddate>
        <drugtreatmentduration>11</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMMUNE GLOBULIN INTRAVENOUS (HUMAN)</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051009</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051015</drugenddate>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUMINAR</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051023</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051028</drugenddate>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WATER FOR INJECTION</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051017</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051105</drugenddate>
        <drugtreatmentduration>20</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055013-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060710</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>SE-JNJFOC-20060701619</companynumb>
    <primarysource>
      <reportercountry>SWEDEN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>67</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>EXTRAPYRAMIDAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HALDOL</medicinalproduct>
        <drugauthorizationnumb>15923</drugauthorizationnumb>
        <drugdosagetext>2-8MG DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
        <drugtreatmentduration>35</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HALDOL</medicinalproduct>
        <drugauthorizationnumb>015923</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LITHIONIT</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROPAVAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ERGENYL RETARD</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055014-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060710</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-JNJFOC-20060700948</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>LACUNAR INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HALDOL</medicinalproduct>
        <drugauthorizationnumb>015923</drugauthorizationnumb>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>AGITATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055015-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060710</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-JNJFOC-20060700004</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>40</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>LEUKOPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ITRACONAZOLE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ITRACONAZOLE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ITRACONAZOLE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ITRACONAZOLE</medicinalproduct>
        <drugauthorizationnumb>020083</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NAIL TINEA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055016-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060712</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20060503172</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLINDNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GLAUCOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTRAOCULAR PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOPIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISION BLURRED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOPAMAX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MIGRAINE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOPAMAX</medicinalproduct>
        <drugauthorizationnumb>020505</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONVULSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055017-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060710</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-JNJFOC-20051205147</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>15</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ACCIDENTAL DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBRAL ISCHAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG TOXICITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MORBID THOUGHTS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEAR DROWNING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRAMADOL HCL</medicinalproduct>
        <drugauthorizationnumb>20281</drugauthorizationnumb>
        <drugdosagetext>TOOK UP TO 40 TABLETS.</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INTENTIONAL OVERDOSE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055018-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060630</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006RR-02874</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>55</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSARTHRIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYASTHENIA GRAVIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugauthorizationnumb>76285</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERLIPIDAEMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ATORVASTATIN CALCIUM</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERLIPIDAEMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LOVASTATIN</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERLIPIDAEMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRAVASTATIN</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERLIPIDAEMIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055019-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060711</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-JNJFOC-20060702376</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>36</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG RASH WITH EOSINOPHILIA AND SYSTEMIC SYMPTOMS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
        <drugauthorizationnumb>017463</drugauthorizationnumb>
        <drugdosagetext>INTERMITTENTLY OVER 16-DAYS</drugdosagetext>
        <drugindication>HEADACHE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055022-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060707</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-JNJFOC-20060500279</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>61.6</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CEREBRAL ARTERY STENOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBRAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRANSIENT ISCHAEMIC ATTACK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VASCULITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CONCERTA</medicinalproduct>
        <drugauthorizationnumb>21121</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATTENTION DEFICIT/HYPERACTIVITY DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055023-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060707</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-JNJFOC-20060702246</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>MANIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CONCERTA</medicinalproduct>
        <drugauthorizationnumb>21121</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ATOMOXETINE</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055025-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060706</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006-07-0218</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>49</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ARTERIOVENOUS FISTULA SITE INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEBRILE NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCORRECT DOSE ADMINISTERED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>KIDNEY TRANSPLANT REJECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERINEPHRIC EFFUSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEG-INTRON</medicinalproduct>
        <drugdosagetext>1.5 MCG/KG/WK SUBCUTANEOUS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EPOGEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM CARBONATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACYCLOVIR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOCUSATE SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEPHROCAPS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTIVITAMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VANCOMYCIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GENTAMICIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055027-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060706</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006-04-0702</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>38</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>154.223</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL DISTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AGITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ALOPECIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEEP VEIN THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EAR PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FREQUENT BOWEL MOVEMENTS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTHYROIDISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MIGRAINE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN JAW</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROAT IRRITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREATMENT NONCOMPLIANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL ACUITY REDUCED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT DECREASED</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>20050509</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060403</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RIBAVIRIN</medicinalproduct>
        <drugdosagetext>600 MG BID ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050509</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060403</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARDIZEM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAXALT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VICODIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LITHIUM CARBONATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PAROXETINE HYDROCHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MORPHINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AZMACORT</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055029-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060711</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006BH011757</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MORPHINE SULFATE</medicinalproduct>
        <drugdosagetext>INTH</drugdosagetext>
        <drugadministrationroute>037</drugadministrationroute>
        <drugindication>PAIN</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055030-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060607</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0606USA01493</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>20560</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055031-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060714</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0607USA03247</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055032-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060327</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DK-MERCK-0603DNK00017</companynumb>
    <primarysource>
      <reportercountry>DENMARK</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>66</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HEPATIC NECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTI-ORGAN FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SHOCK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THERAPY NON-RESPONDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CANCIDAS</medicinalproduct>
        <drugauthorizationnumb>21227</drugauthorizationnumb>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>FUNGAL SEPSIS</drugindication>
        <drugtreatmentduration>135</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CANCIDAS</medicinalproduct>
        <drugauthorizationnumb>021227</drugauthorizationnumb>
        <drugadministrationroute>041</drugadministrationroute>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMPHOTERICIN B</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>FUNGAL SEPSIS</drugindication>
        <drugtreatmentduration>40</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VORICONAZOLE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugtreatmentduration>67</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CEFUROXIME</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOBRAMYCIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055033-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060704</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ES-MERCK-0607ESP00003</companynumb>
    <primarysource>
      <reportercountry>SPAIN</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>74</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>92</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BREAST CANCER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROSCAR</medicinalproduct>
        <drugauthorizationnumb>020180</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BENIGN PROSTATIC HYPERPLASIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060701</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAMSULOSIN HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>POLLAKIURIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060701</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055034-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060714</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0607USA03250</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>81</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DYSPHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROAT IRRITATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19931201</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055035-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060222</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-MERCK-0602FRA00084</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>85</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>74</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ALVEOLITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERSTITIAL LUNG DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY FIBROSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugauthorizationnumb>19766</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERCHOLESTEROLAEMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BUFLOMEDIL HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYBUTYNIN CHLORIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOPICLONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INSOMNIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PERINDOPRIL ERBUMINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CARDIAC FAILURE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUOXETINE HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051129</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUOXETINE HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051130</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060501</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUOXETINE HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060601</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055036-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060710</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-JNJFOC-20060701643</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>51</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HAEMOLYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER FUNCTION TEST ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CILEST</medicinalproduct>
        <drugauthorizationnumb>19653</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMOXICILLIN ^AL^</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ACUTE SINUSITIS</drugindication>
        <drugtreatmentduration>10</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055041-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060705</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-2006-017940</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>NEPHROGENIC FIBROSING DERMOPATHY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MAGNEVIST</medicinalproduct>
        <drugauthorizationnumb>19596</drugauthorizationnumb>
        <drugdosagetext>20 ML, 1 DOSE</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040226</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040226</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055043-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060713</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0607USA03291</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055044-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060710</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2006US08793</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>51</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXJADE</medicinalproduct>
        <drugauthorizationnumb>021882</drugauthorizationnumb>
        <drugdosagetext>2000 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060615</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060628</drugenddate>
        <drugtreatmentduration>20160</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055045-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060710</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2006KR10363</companynumb>
    <primarysource>
      <reportercountry>KOREA, REPUBLIC OF</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CATARACT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CORNEAL DEPOSITS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISION BLURRED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZARIL</medicinalproduct>
        <drugauthorizationnumb>019758</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALPROIC ACID</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055046-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060606</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2006US07477</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>74</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HEPATIC ENZYME INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FUNCTION TEST ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXJADE</medicinalproduct>
        <drugauthorizationnumb>021882</drugauthorizationnumb>
        <drugdosagetext>1500 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SICKLE CELL ANAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060516</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060701</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXJADE</medicinalproduct>
        <drugauthorizationnumb>021882</drugauthorizationnumb>
        <drugdosagetext>1000 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060701</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055048-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060420</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHFR2006GB01501</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>53</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>LOWER RESPIRATORY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENZODIAZEPINES</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZARIL</medicinalproduct>
        <drugauthorizationnumb>019758</drugauthorizationnumb>
        <drugdosagetext>325MG / DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050223</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060415</drugenddate>
        <drugtreatmentduration>417</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VALPROATE SODIUM</medicinalproduct>
        <drugdosagetext>400MG / DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MOOD ALTERED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060323</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060413</drugenddate>
        <drugtreatmentduration>31680</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LITHIUM CARBONATE</medicinalproduct>
        <drugdosagetext>800MG / DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MOOD ALTERED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PIZOTIFEN</medicinalproduct>
        <drugdosagetext>1.5MG / DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MIGRAINE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MOVICOL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FYBOGEL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYOSCINE HBR HYT</medicinalproduct>
        <drugdosagetext>300MCG / DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SALIVARY HYPERSECRETION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOCUSATE SODIUM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055049-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060707</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>232996K06USA</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </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>BLOOD POTASSIUM DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIPLOPIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROENTERITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SENSATION OF HEAVINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</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>20051209</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WELLBUTRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ESTRADIOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METAVEX (VITAMIN B)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZYRTEC D (CIRRUS)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROVIGIL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055052-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060712</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006-06-0163</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>13</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABNORMAL BEHAVIOUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NIGHT SWEATS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NIGHTMARE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ASMANEX TWISTHALER</medicinalproduct>
        <drugbatchnumb>5JS1</drugbatchnumb>
        <drugauthorizationnumb>21067</drugauthorizationnumb>
        <drugdosagetext>INHALATION</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060406</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060419</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL SPIROS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RHINOCORT</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055055-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060703</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006-144912-NL</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>26</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>55.8</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METRORRHAGIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NUVARING</medicinalproduct>
        <drugauthorizationnumb>21187</drugauthorizationnumb>
        <drugdosagetext>VAGINAL, 3 WEEKS IN, 1 WEEK OUT</drugdosagetext>
        <drugadministrationroute>067</drugadministrationroute>
        <drugindication>CONTRACEPTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055057-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060707</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20060302461</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HEMIANOPIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RETINAL ARTERY OCCLUSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERDAL CONSTA</medicinalproduct>
        <drugauthorizationnumb>21346</drugauthorizationnumb>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>BIPOLAR DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KLONOPIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANXIETY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLONASE</medicinalproduct>
        <drugadministrationroute>045</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PERCOCET</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055058-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060710</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-JNJFOC-20060601579</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>2</qualification>
    </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>PSYCHOMOTOR HYPERACTIVITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERDAL</medicinalproduct>
        <drugauthorizationnumb>20588</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055059-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060710</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-JNJFOC-20060700738</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERDAL</medicinalproduct>
        <drugauthorizationnumb>20272</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055060-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060710</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-JNJFOC-20060702550</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>84</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL HYPOMOTILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPEECH DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDE ATTEMPT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERDAL</medicinalproduct>
        <drugauthorizationnumb>20272</drugauthorizationnumb>
        <drugdosagetext>50X1MG TABLETS</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PLANUM MITE</medicinalproduct>
        <drugdosagetext>10X6MG TABLET</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRUXAL</medicinalproduct>
        <drugdosagetext>15X70MG TABLET</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055061-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060710</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-JNJFOC-20060700358</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>85</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRADYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSED LEVEL OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERDAL</medicinalproduct>
        <drugauthorizationnumb>20272</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RENIVACE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGNESIUM OXIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055062-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060714</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2006US09097</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>76</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>SINUSITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXJADE</medicinalproduct>
        <drugbatchnumb>F0009</drugbatchnumb>
        <drugauthorizationnumb>021882</drugauthorizationnumb>
        <drugdosagetext>2000 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060701</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055066-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060710</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>USA-2006-0024563</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </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>INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ROAD TRAFFIC ACCIDENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXYCONTIN</medicinalproduct>
        <drugauthorizationnumb>20553</drugauthorizationnumb>
        <drugindication>BACK PAIN</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055067-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060712</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>13570</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>81</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>72.6</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANOREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>APHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACTERAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD ALKALINE PHOSPHATASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CULTURE POSITIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEBRILE NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCYTOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STOMATITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYTARABINE</medicinalproduct>
        <drugauthorizationnumb>71868</drugauthorizationnumb>
        <drugindication>ACUTE MYELOID LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060116</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ETOPOSIDE</medicinalproduct>
        <drugindication>ACUTE MYELOID LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060116</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MITOXANTRONE</medicinalproduct>
        <drugindication>ACUTE MYELOID LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060116</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CEP-701</medicinalproduct>
        <drugdosagetext>80 MG BID PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ACUTE MYELOID LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060123</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060125</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CEP-701</medicinalproduct>
        <drugdosagetext>80 MG BID PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ACUTE MYELOID LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060126</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060131</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CEP-701</medicinalproduct>
        <drugdosagetext>60 MG BID PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ACUTE MYELOID LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060206</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CEP-701</medicinalproduct>
        <drugdosagetext>60 MG BID PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ACUTE MYELOID LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060217</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACYCLOVIR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRED FORTE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BIOTENE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATIVAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEXAPRO</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMBIEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTIVITAMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROTONIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENADRYL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MORPHINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SODIUM CHLORIDE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055069-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060705</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>28660</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>70</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>80</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD TEST ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BODY TEMPERATURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EJECTION FRACTION DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMODIALYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL TUBULAR NECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINE OUTPUT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEUCOVORIN CALCIUM</medicinalproduct>
        <drugauthorizationnumb>89384</drugauthorizationnumb>
        <drugdosagetext>400 MG/M2 IV DAY 1</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLON CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060509</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055070-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060710</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-GILEAD-2006-0009851</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>45</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DIFFUSE LARGE B-CELL LYMPHOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPHOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVERDOSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIREAD</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050203</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TMC114</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060306</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIDEX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060306</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NORVIR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010611</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FUZEON</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060306</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055071-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060707</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>28489-1</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>65</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AORTIC THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD GASTRIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISEASE RECURRENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JEJUNAL ULCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEUCOVORIN CALCIUM</medicinalproduct>
        <drugauthorizationnumb>89384</drugauthorizationnumb>
        <drugdosagetext>390MG, 200MG/M2/EVERY 2 WEEKS</drugdosagetext>
        <drugindication>PANCREATIC NEOPLASM</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060428</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055074-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060703</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>MEDI-0004726</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>35</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CHILLS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISEASE PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH ERYTHEMATOUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ETHYOL</medicinalproduct>
        <drugauthorizationnumb>20221</drugauthorizationnumb>
        <drugdosagetext>1 IN 1 D, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RADIOTHERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RADIATION THERAPY</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055075-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060705</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>226517</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>72</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DEMYELINATING POLYNEUROPATHY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RITUXAN</medicinalproduct>
        <drugindication>WALDENSTROM'S MACROGLOBULINAEMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE TAB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUDARABINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055076-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060706</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060620</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>13590</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>73</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY RETENTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PACLITAXEL</medicinalproduct>
        <drugauthorizationnumb>76131</drugauthorizationnumb>
        <drugdosagetext>297.5 MG DAILY IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>OVARIAN EPITHELIAL CANCER RECURRENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060202</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060202</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARBOPLATIN</medicinalproduct>
        <drugdosagetext>660 MG DAILY IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060202</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060202</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENDROFLUAZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ONDANSETRON HCL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055077-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060705</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>226494</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>67</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>98.5</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ADRENAL NEOPLASM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ATRIAL FIBRILLATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EPISTAXIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERICARDIAL EFFUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVASTIN</medicinalproduct>
        <drugdosagetext>15 MG/KG, Q3W, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051213</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060606</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEMETREXED(PEMETREXED)</medicinalproduct>
        <drugdosagetext>500 MG/M2, Q3W, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051213</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060606</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARBOPLATIN</medicinalproduct>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE TAB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SOTALOL HYDROCHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MORPHINE SULFATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MVI (MULTIVITAMINS NOS)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055080-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050311</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006069142</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>57</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LACUNAR INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEXTRA</medicinalproduct>
        <drugauthorizationnumb>21341</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055082-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060706</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>221334</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>54</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>55.1</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>SEPTIC SHOCK</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVASTIN</medicinalproduct>
        <drugdosagetext>247 , Q2W, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLORECTAL CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050927</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUOROURACIL</medicinalproduct>
        <drugindication>COLORECTAL CANCER METASTATIC</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEUCOVORIN CALCIUM</medicinalproduct>
        <drugindication>COLORECTAL CANCER METASTATIC</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXALIPLATIN (OXALIPLATIN)</medicinalproduct>
        <drugindication>COLORECTAL CANCER METASTATIC</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MEDICATION (UNK INGREDIENT) (GENERIC COMPONENT(S) NOT KNOWN)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055085-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060704</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BEWYE000305JUL06</companynumb>
    <primarysource>
      <reportercountry>BELGIUM</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>49</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>VASCULITIS NECROTISING</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>20030101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060628</drugenddate>
      </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>20060629</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060704</drugenddate>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055087-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060706</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>06H-163-0308703-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>0</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEONATAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY INTERSTITIAL EMPHYSEMA SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SMALL FOR DATES BABY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MAGNESIUM SULFATE</medicinalproduct>
        <drugauthorizationnumb>20309</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BERACTANT (BERACTANT)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055088-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041111</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL099461</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>126.7</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BALANCE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DECREASED APPETITE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRY MOUTH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSGEUSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VERTIGO</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RENAL FAILURE CHRONIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041112</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055089-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041117</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL100008</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>74</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RENAL FAILURE CHRONIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040801</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055090-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060704</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>HQWYE725610APR06</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
    </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>AORTIC ARTERIOSCLEROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CHOLESTEROL INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CALCIFICATION OF MUSCLE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC STEATOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATOMEGALY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOW DENSITY LIPOPROTEIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL CYST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UNEVALUABLE EVENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PANTOPRAZOLE SODIUM</medicinalproduct>
        <drugauthorizationnumb>20987</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DUODENAL ULCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050628</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050704</drugenddate>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PANTOPRAZOLE SODIUM</medicinalproduct>
        <drugauthorizationnumb>20987</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DUODENAL ULCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050705</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050719</drugenddate>
        <drugtreatmentduration>15</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PANTOPRAZOLE SODIUM</medicinalproduct>
        <drugauthorizationnumb>20987</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DUODENAL ULCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050909</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060328</drugenddate>
        <drugtreatmentduration>201</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055091-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041215</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-US103456</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>151.6</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOCHROMIC ANAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EPOGEN</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>ANAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040416</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031121</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055092-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050307</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL120321</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>42</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PRE-EXISTING DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041001</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055093-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050302</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL118928</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>78</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE BRUISING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>ANAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19920101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055094-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050307</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL120808</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugindication>ANAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEUPOGEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055095-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050303</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL119027</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>83</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>52.7</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH GENERALISED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugindication>RENAL FAILURE CHRONIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055096-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050303</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL119026</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CHILLS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugindication>MYELODYSPLASTIC SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050201</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055097-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050301</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL118931</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSYCHOMOTOR HYPERACTIVITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>ANAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055098-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050301</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL118709</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>95</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>59</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugindication>PRE-EXISTING DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055099-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050301</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL118711</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>119.9</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LETHARGY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugindication>RENAL FAILURE CHRONIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055100-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050309</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-US120007</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>115.5</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROAT TIGHTNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EPOGEN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>DIALYSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050302</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050226</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050226</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050226</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050304</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050226</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050226</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050226</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050226</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050226</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050226</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050226</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050226</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055102-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041210</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL103044</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>66.3</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD BILIRUBIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHILLS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HOT FLUSH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NIGHT SWEATS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSEUDOMONAS INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>PRE-EXISTING DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040929</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041215</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041001</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055103-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050304</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL119341</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH GENERALISED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugindication>ANAEMIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055104-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050302</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL120282</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>29</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>36.3</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEULASTA</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
        <drugadministrationroute>062</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055105-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060522</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL180575</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugindication>ANAEMIA OF MALIGNANT DISEASE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055106-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060522</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL180581</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ACCIDENTAL EXPOSURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE IRRITATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055107-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060523</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-US180082</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ARTERIOVENOUS FISTULA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THERAPEUTIC RESPONSE DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EPOGEN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>DIALYSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SENSIPAR</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HYPERPARATHYROIDISM SECONDARY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055108-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060525</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL181184</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugindication>RENAL FAILURE CHRONIC</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055109-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060526</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL181183</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE DIASTOLIC DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ANAEMIA OF MALIGNANT DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060522</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060522</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060525</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055110-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060525</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL181028</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INFLUENZA LIKE ILLNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>ANAEMIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055111-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060524</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-US180811</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>THERAPEUTIC RESPONSE DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EPOGEN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>DIALYSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050604</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SENSIPAR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055112-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060706</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ESWYE411220FEB06</companynumb>
    <primarysource>
      <reportercountry>SPAIN</reportercountry>
    </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>RENAL IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPUTUM PURULENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RAPAMUNE</medicinalproduct>
        <drugauthorizationnumb>21083</drugauthorizationnumb>
        <drugdosagetext>3 MG 1X PER 1 DAY ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS AGAINST TRANSPLANT REJECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040615</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYCLOSPORINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATORVASTATIN CALCIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAMSULOSIN HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARANESP</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE TAB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOSARTAN POTASSIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETYLSALICYLSYRE (ACETYLSALICYLIC ACID)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055113-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060526</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-US181026</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>THERAPEUTIC RESPONSE DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EPOGEN</medicinalproduct>
        <drugbatchnumb>P057701</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>DIALYSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EPOGEN</medicinalproduct>
        <drugbatchnumb>P057701</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060324</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060417</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055114-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060308</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL171904</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>67.2</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>P048851</drugbatchnumb>
        <drugindication>ANAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060125</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060228</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055115-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060522</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL180571</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CONTUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugindication>RENAL FAILURE CHRONIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060402</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060402</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055116-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060710</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>HQWYE799212APR06</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>56</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBRAL ARTERY EMBOLISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBRAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERSTITIAL LUNG DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARALYSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ANCARON (AMIODARONE, TABLET)</medicinalproduct>
        <drugauthorizationnumb>18972</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CARDIAC FAILURE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030918</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030918</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ANCARON (AMIODARONE, TABLET)</medicinalproduct>
        <drugauthorizationnumb>18972</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RENAL FAILURE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030918</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030918</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ANCARON (AMIODARONE, TABLET)</medicinalproduct>
        <drugauthorizationnumb>18972</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>VENTRICULAR ARRHYTHMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030918</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030918</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ANCARON (AMIODARONE, TABLET)</medicinalproduct>
        <drugauthorizationnumb>18972</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CARDIAC FAILURE</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060330</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ANCARON (AMIODARONE, TABLET)</medicinalproduct>
        <drugauthorizationnumb>18972</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RENAL FAILURE</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060330</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ANCARON (AMIODARONE, TABLET)</medicinalproduct>
        <drugauthorizationnumb>18972</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>VENTRICULAR ARRHYTHMIA</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060330</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BLOPRESS (CANDESARTAN CILEXETIL)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARVEDILOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MUCOSTA (REBAMIPIDE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMOBAN (ZOPICLONE)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055117-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060706</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>06H-163-0308704-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>0</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY INTERSTITIAL EMPHYSEMA SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY DISORDER NEONATAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MAGNESIUM SULFATE</medicinalproduct>
        <drugauthorizationnumb>20309</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BERACTANT (BERACTANT)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055118-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060706</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FRWYE125009MAY03</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>40</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANASTOMOTIC COMPLICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTERIOVENOUS FISTULA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EFFUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMODIALYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>KIDNEY FIBROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>KIDNEY TRANSPLANT REJECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERITONEAL HAEMATOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL TUBULAR NECROSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SIROLIMUS (SIROLIMUS)</medicinalproduct>
        <drugauthorizationnumb>21083</drugauthorizationnumb>
        <drugdosagetext>15 MG DAILY FOR 2 DAYS AND THEN 8 MG DAILY ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS AGAINST TRANSPLANT REJECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021024</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20021211</drugenddate>
        <drugtreatmentduration>49</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATG (ANTILYMPHOCYTE IMMUNOGLOBULIN (HORSE))</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MYCOPHENOLATE MOFETIL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055120-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060601</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>805#9#2006-00080</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>7</patientonsetage>
      <patientonsetageunit>804</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>APNOEIC ATTACK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN IRRITATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALPROSTADIL</medicinalproduct>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>HEART DISEASE CONGENITAL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050723</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050723</drugenddate>
        <drugtreatmentduration>30</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALPROSTADIL</medicinalproduct>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>HEART DISEASE CONGENITAL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050722</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050723</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALPROSTADIL</medicinalproduct>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>HEART DISEASE CONGENITAL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050723</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050724</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOPAMINE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOBUTAMINE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM CANRENOATE (POTASSIUM CANRENOATE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SODIUM BICARBONATE IN PLASTIC CONTAINER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MIDAZOLAM MALEATE (MIDAZOLAM MALEATE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VECURONIUM BROMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CEFOTAXIME SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM GLUCONATE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055121-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060519</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>805#9#2006-00078</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>1</patientonsetage>
      <patientonsetageunit>802</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CONGENITAL PULMONARY VALVE ATRESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DOUBLE OUTLET RIGHT VENTRICLE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFANTILE APNOEIC ATTACK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PATENT DUCTUS ARTERIOSUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALPROSTADIL</medicinalproduct>
        <drugdosagetext>50 NG/KG/MIN INTRAVENOUS DRIP</drugdosagetext>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>HEART DISEASE CONGENITAL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050517</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050520</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055122-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060706</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>06H-163-0308705-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>0</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY INTERSTITIAL EMPHYSEMA SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY DISORDER NEONATAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MAGNESIUM SULFATE</medicinalproduct>
        <drugauthorizationnumb>20309</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BERACTANT (BERACTANT)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055123-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060621</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>805#9#2006-00082</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>3</patientonsetage>
      <patientonsetageunit>804</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INFANTILE APNOEIC ATTACK</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALPROSTADIL</medicinalproduct>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>HEART DISEASE CONGENITAL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051114</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051117</drugenddate>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALPROSTADIL</medicinalproduct>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>HEART DISEASE CONGENITAL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051117</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051118</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALPROSTADIL</medicinalproduct>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>HEART DISEASE CONGENITAL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051118</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051122</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLOMEX SODIUM (FLOMEX SODIUM)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIAZEPAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PENTAZOCINE LACTATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM GLUCONATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMINOPHYLLINE (AMINOPHYLLINE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MIDAZOLAM (MIDAZOLAM MALEATE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HUMAN SERUM ALBUMIN (ALBUMIN NORMAL HUMAN SERUM)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055124-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060706</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>06H-163-0308635-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>0</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY INTERSTITIAL EMPHYSEMA SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY DISORDER NEONATAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MAGNESIUM SULFATE</medicinalproduct>
        <drugauthorizationnumb>20309</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BERACTANT (BERACTANT)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055126-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060704</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHFR2006GB00707</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>7</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>AGGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ALOPECIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MADAROSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RITALIN</medicinalproduct>
        <drugauthorizationnumb>70886</drugauthorizationnumb>
        <drugdosagetext>5 MG, QD, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATTENTION DEFICIT/HYPERACTIVITY DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLONIDINE                                      (CLONIDINE HYDROCHLORID</medicinalproduct>
        <drugdosagetext>25 UG, BID, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATTENTION DEFICIT/HYPERACTIVITY DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL SPIROS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BECONASE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055128-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060706</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006-05-2490</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>38</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>107.9561</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPHOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSEUDOLYMPHOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY MASS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT 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>PEG-INTRON</medicinalproduct>
        <drugdosagetext>SUBCUTANEOUS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060407</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060601</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RIBAVIRIN</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060407</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060601</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMBIEN (ZOLPIDEM TARTRATE) EXTENDED RELEASE TABLET</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KLONOPIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOPHAGE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENICAR TABLETS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055129-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060703</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GXKR2006GB03886</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>69</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>60</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HAEMODIALYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METABOLIC ACIDOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
        <drugauthorizationnumb>75985</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS NON-INSULIN-DEPENDENT</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060208</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PERINDOPRIL ERBUMINE</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETIC NEPHROPATHY</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060208</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACARBOSE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCICHEW (CALCIUM CARBONATE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FERROUS SULFATE TAB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLICLAZIDE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055130-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060630</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>SPV1-2006-00184</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>81</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANOREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMODIALYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSEUDOMONAS INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY DISTRESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STOMATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PENTASA</medicinalproduct>
        <drugauthorizationnumb>20049</drugauthorizationnumb>
        <drugdosagetext>2000 MG DAILY, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CROHN'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060510</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060612</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SODIUM ALGINATE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055132-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060706</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>SPV1-2006-00147</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>0</patientsex>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ADDERALL 10</medicinalproduct>
        <drugauthorizationnumb>21303</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055133-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20051107</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-423966</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>53</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASCITES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EPISTAXIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENTAL STATUS CHANGES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METABOLIC ACIDOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCYTOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERITONITIS BACTERIAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPTIC SHOCK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEGASYS</medicinalproduct>
        <drugdosagetext>ROUTE REPORTED AS INJECTABLE.</drugdosagetext>
        <drugadministrationroute>050</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050715</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051025</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RIBAVIRIN</medicinalproduct>
        <drugauthorizationnumb>021511</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050715</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051025</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055134-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060113</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-432363</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>15</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>52.2</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEILITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CLOSTRIDIUM DIFFICILE TOXIN TEST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLITIS ULCERATIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CROHN'S DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRY EYE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPEPSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ECZEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EPISTAXIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMANGIOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLAMMATORY BOWEL DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIP DRY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OCULAR HYPERAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PEPTIC ULCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLEURISY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RIB FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>18662</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19970113</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19970408</drugenddate>
        <drugtreatmentduration>86</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>018662</drugauthorizationnumb>
        <drugdosagetext>ACCUTANE INCREASED TO 80MG EVERY THIRD DAY.</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19970408</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19970509</drugenddate>
        <drugtreatmentduration>32</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>018662</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19970711</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19970810</drugenddate>
        <drugtreatmentduration>31</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>018662</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980223</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19980325</drugenddate>
        <drugtreatmentduration>31</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>018662</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980727</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19980923</drugenddate>
        <drugtreatmentduration>59</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>018662</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20001211</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010215</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>018662</drugauthorizationnumb>
        <drugdosagetext>05 FEBRUARY 2001: NOTED PATIENT IS ON ACCUTANE.</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>018662</drugauthorizationnumb>
        <drugdosagetext>40MG ONCE DAILY ALTERNATING WITH 80MG EVERY THIRD DAY.</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030902</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030930</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>018662</drugauthorizationnumb>
        <drugdosagetext>40MG ONCE DAILY ALTERNATING WITH 80MG EVERY THIRD DAY.</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040107</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLARAVIS</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPECTAZOLE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20001226</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DERMATOP</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20001226</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055135-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>MC200600420</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>79</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>80</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ATRIOVENTRICULAR BLOCK THIRD DEGREE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRADYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIO-RESPIRATORY ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY OCCLUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY STENOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOSIS IN DEVICE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENTRICULAR FIBRILLATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ANGIOMAX</medicinalproduct>
        <drugauthorizationnumb>20873</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugindication>PERCUTANEOUS CORONARY INTERVENTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055136-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060703</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>SPV1-2006-00021</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>63</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BILE DUCT STONE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD ALKALINE PHOSPHATASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD LACTATE DEHYDROGENASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHOLECYSTITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHOLELITHIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMODIALYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POSTOPERATIVE WOUND INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LANTHANUM CARBONATE</medicinalproduct>
        <drugauthorizationnumb>21468</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERPHOSPHATAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050314</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050424</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LANTHANUM CARBONATE</medicinalproduct>
        <drugauthorizationnumb>21468</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERPHOSPHATAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050425</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060601</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FAMOTIDINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALFAROL (ALFACALCIDOL)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMOBAN (ZOPICLONE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EPOGEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HEPARIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IRON</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055138-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060531</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>SGB1-2006-00301</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>48</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BREAST CANCER FEMALE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LANTHANUM CARBONATE</medicinalproduct>
        <drugauthorizationnumb>21468</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERPHOSPHATAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050329</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050508</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LANTHANUM CARBONATE</medicinalproduct>
        <drugauthorizationnumb>21468</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERPHOSPHATAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050510</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050523</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LANTHANUM CARBONATE</medicinalproduct>
        <drugauthorizationnumb>21468</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERPHOSPHATAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050524</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060525</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RINDERON VG           (GENTAMICIN SULFATE, BETAMETHASONE VALERATE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HEPARIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ROCALTROL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EPOGEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FERRICON (CIDEFERRON)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MS ONSHIPPU</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUNON (GLUCOSE)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055139-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060707</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006-07-0260</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>50</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>APHASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBRAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENTAL STATUS CHANGES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VASCULITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TEMOZOLOMIDE CAPSULES</medicinalproduct>
        <drugauthorizationnumb>21029</drugauthorizationnumb>
        <drugdosagetext>150 MG/M2 ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>METASTASES TO CENTRAL NERVOUS SYSTEM</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060615</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060616</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARBOPLATIN</medicinalproduct>
        <drugdosagetext>200 MG/M2 INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>METASTASES TO CENTRAL NERVOUS SYSTEM</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060615</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060616</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCONTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONIDINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PSEUDOEPHEDRINE/CHLORPHENIRAMINE/METHYLSCOPOLAMINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055140-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006BL002473</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>68</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EAR PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FACIAL PALSY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LACRIMATION INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NASAL CONGESTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NECK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWELLING FACE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL ACUITY REDUCED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUORESCEIN SODIUM AND BENOXINATE HYDROCHLORIDE OPTHALMIC SOLUTION</medicinalproduct>
        <drugdosagetext>1 TIME;OPHTHALMIC</drugdosagetext>
        <drugadministrationroute>047</drugadministrationroute>
        <drugindication>OPHTHALMOLOGICAL EXAMINATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060209</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060209</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TROPICAMIDE</medicinalproduct>
        <drugdosagetext>1 TIME;OPHTHALMIC</drugdosagetext>
        <drugadministrationroute>047</drugadministrationroute>
        <drugindication>OPHTHALMOLOGICAL EXAMINATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060209</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060209</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PHENYLEPHRINE</medicinalproduct>
        <drugdosagetext>1 TIME;OPHTHALMIC</drugdosagetext>
        <drugadministrationroute>047</drugadministrationroute>
        <drugindication>OPHTHALMOLOGICAL EXAMINATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060209</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060209</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THYROXINE SODIUM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055142-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060711</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-2006-018580</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>28</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BRAIN STEM INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIRENA</medicinalproduct>
        <drugauthorizationnumb>21225</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055143-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060706</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006-04-1477</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>86</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CEREBRAL ARTERY EMBOLISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISSEMINATED INTRAVASCULAR COAGULATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ECCHYMOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ESCHERICHIA INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GINGIVAL BLEEDING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEMIPLEGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEUKOCYTOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENTAL IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTI-ORGAN FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROCEDURAL HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPTIC SHOCK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INTEGRILIN</medicinalproduct>
        <drugauthorizationnumb>20718</drugauthorizationnumb>
        <drugdosagetext>INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ANGINA UNSTABLE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLOPIDOGREL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENALAPRIL MALEATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HEPARIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NITROGLYCERIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055145-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060707</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006-07-0267</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>51</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>107</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEG-INTRON</medicinalproduct>
        <drugbatchnumb>3IRG307</drugbatchnumb>
        <drugdosagetext>80-120 UG/WK SUBCUTANEOUS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060405</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060621</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBETOL</medicinalproduct>
        <drugdosagetext>0.8-1.2 G QD ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060405</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060702</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugdosagetext>40,000 U 2X/W SUBCUTANEOUS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>ANAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060418</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060627</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEUPOGEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEXAPRO</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DYRENIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTIVITAMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>QUININE SULFATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055146-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060710</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>146495USA</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>81</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ESCHERICHIA SEPSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PIMOZIDE</medicinalproduct>
        <drugdosagetext>4 MILLIGRAM ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010615</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060608</drugenddate>
        <drugtreatmentduration>1820</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055147-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060707</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CH-ROCHE-454666</companynumb>
    <primarysource>
      <reportercountry>SWITZERLAND</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>24</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>57</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>COORDINATION ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NYSTAGMUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VALCYTE</medicinalproduct>
        <drugauthorizationnumb>21304</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CYTOMEGALOVIRUS INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051125</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051213</drugenddate>
        <drugtreatmentduration>19</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BACTRIM</medicinalproduct>
        <drugdosagetext>STRENGTH REPORTED AS 800 MG / 160 MG.</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FRAXIFORTE</medicinalproduct>
        <drugdosagetext>FORM REPORTED AS VIALS.</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051219</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FRAXIPARINE</medicinalproduct>
        <drugdosagetext>FORM REPORTED AS VIALS.</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051219</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055148-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060301</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-438831</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>24</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>63.5</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CLOSTRIDIUM DIFFICILE COLITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLITIS ULCERATIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLON ADENOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CROHN'S DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ENDOMETRIOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ESSENTIAL HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLAMMATORY BOWEL DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MITRAL VALVE INCOMPETENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MITRAL VALVE PROLAPSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NASAL SEPTUM DEVIATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NON-HODGKIN'S LYMPHOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCREATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANIC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARYNGOLARYNGEAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RECTAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SALIVARY GLAND MASS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE VASOVAGAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYSTEMIC LUPUS ERYTHEMATOSUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRANSIENT ISCHAEMIC ATTACK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRICUSPID VALVE INCOMPETENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENTRICULAR EXTRASYSTOLES</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>18662</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ACNE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19830615</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19830615</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>018662</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19840813</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>018662</drugauthorizationnumb>
        <drugdosagetext>ACCUTANE DECREASED TO 1 DAILY OR ONE ONCE DAILY OR ONE TWICE WEEKLY.</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19850114</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19850314</drugenddate>
        <drugtreatmentduration>60</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>018662</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19870115</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19870615</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>1 CONCOMITANT DRUG</medicinalproduct>
        <drugdosagetext>DRUG REPORTED AS ASPIRIN/TYLENOL.</drugdosagetext>
        <drugindication>HEADACHE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055149-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060607</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-ROCHE-451217</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>52</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>70</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>EYE HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEBRILE BONE MARROW APLASIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEGASYS</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060315</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEGASYS</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COPEGUS</medicinalproduct>
        <drugauthorizationnumb>021511</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060315</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SUBUTEX</medicinalproduct>
        <drugdosagetext>DOSAGE REPORTED AS 60 MG PER WEEK.</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055150-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060711</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>THQ2005A00954</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>73</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METASTASES TO LIVER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METASTASES TO LUNG</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METASTATIC NEOPLASM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCREATIC CARCINOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEUPROLIDE ACETATE</medicinalproduct>
        <drugdosagetext>22.5 MG (22.5 MG, 1 IN 3 M)</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041108</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050131</drugenddate>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055151-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060703</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-454219</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>38</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HEPATIC NEOPLASM MALIGNANT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEGASYS</medicinalproduct>
        <drugadministrationroute>050</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060127</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COPEGUS</medicinalproduct>
        <drugauthorizationnumb>021511</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060127</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055152-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060605</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-ROCHE-450511</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>52</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>50</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEPHROTIC SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CAPECITABINE</medicinalproduct>
        <drugauthorizationnumb>20896</drugauthorizationnumb>
        <drugdosagetext>GIVEN ON DAYS 1-14 OF 21 DAY CYCLE.</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050727</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVASTIN</medicinalproduct>
        <drugauthorizationnumb>020896</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050727</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MITOMYCIN</medicinalproduct>
        <drugauthorizationnumb>020896</drugauthorizationnumb>
        <drugdosagetext>4 DOSES GIVEN AS PER PROTOCOL. REPORTED THAT THE DOSE WAS REDUCED DUE TO THROMBOCYTOPENIA.</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050727</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN W/ CODEINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ESOMEPRAZOLE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>1 CONCOMITANT DRUG</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060615</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLYCERYL TRINITRATE</medicinalproduct>
        <drugadministrationroute>061</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060615</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LACTULOSE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IRBESARTAN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060615</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060615</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060615</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FELODIPINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060615</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUSEMIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060615</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055153-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060405</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-443569</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>18</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>73.5</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEILITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CROHN'S DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHOIDS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ILL-DEFINED DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLAMMATORY BOWEL DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIP DRY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>18662</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000509</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20000611</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>018662</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000612</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20001121</drugenddate>
        <drugtreatmentduration>163</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055154-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060706</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006-07-0189</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>50</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FULL BLOOD COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENORRHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL INTAKE REDUCED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCREATIC ENLARGEMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEG-INTRON</medicinalproduct>
        <drugdosagetext>SUBCUTANEOUS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060526</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBETOL</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060526</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DARVOCET</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KLONOPIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SEROQUEL (QUETIAPINE FUMURATE)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055156-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060414</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>THQ2005A01108</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>72</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>0</patientsex>
      <reaction>
        <reactionmeddrapt>METASTASES TO OESOPHAGUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OESOPHAGEAL ADENOCARCINOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEUPROLIDE ACETATE</medicinalproduct>
        <drugdosagetext>22.5 MG (22.5 MG, 1 IN 3 M)</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050809</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051109</drugenddate>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOLEDRONIC ACID</medicinalproduct>
        <drugdosagetext>4.0 MG PER 100 ML</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050809</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051109</drugenddate>
        <drugtreatmentduration>93</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055157-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060706</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006-06-2199</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>38</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ALOPECIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEG-INTRON</medicinalproduct>
        <drugdosagetext>120 MCG QWK SUBCUTANEOUS</drugdosagetext>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060306</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RIBAVIRIN</medicinalproduct>
        <drugdosagetext>600 MG BID ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060306</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHADONE HYDROCHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REGLAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SEROQUEL QUETIAPINE FUMURATE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EFFEXOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055158-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>TCI2006A00788</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>73</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD TESTOSTERONE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE MARROW FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRONCHOPULMONARY ASPERGILLOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEBRILE NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYELODYSPLASTIC SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEUPLIN FOR INJECTION KIT3.75 ( LEUPRORLIDE  ACETATE) (INJECTION)</medicinalproduct>
        <drugdosagetext>3.75 MG (3.75 MG, 1 IN 28 D) SUBCUTANEOUS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PROSTATE CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051031</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060123</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CASODEX</medicinalproduct>
        <drugdosagetext>80 MG (80 MG, 1 IN 1 D) PER ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROSTATE CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051011</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060123</drugenddate>
        <drugtreatmentduration>105</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HALFDIGOXIN (DIGOXIN) (TABLETS)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CONIEL (BENIDIPINE HYDROCHLORIDE) (TABLETS)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LUPRAC (TORASEMIDE) (TABLETS)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055159-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060704</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>111345ISR</companynumb>
    <primarysource>
      <reportercountry>NETHERLANDS</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>43</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CYANOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIABETES MELLITUS INSULIN-DEPENDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIABETIC HYPEROSMOLAR COMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIABETIC KETOACIDOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIABETIC KETOACIDOTIC HYPERGLYCAEMIC COMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISORIENTATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERAL PHYSICAL HEALTH DETERIORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HALLUCINATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ILIAC ARTERY OCCLUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL STIFFNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEOPLASM PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPEECH DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY INCONTINENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CISPLATIN</medicinalproduct>
        <drugdosagetext>100 MG/M2</drugdosagetext>
        <drugindication>NASOPHARYNGEAL CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050501</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE TAB</medicinalproduct>
        <drugdosagetext>8 MILLIGRAM ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NAUSEA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050501</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055160-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060705</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006SS000059</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>79</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>95.2554</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CONTUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE DISCHARGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OFF LABEL USE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PURULENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MYOBLOC</medicinalproduct>
        <drugdosagetext>SEE IMAGE, INTRAMUSCULAR</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>APRAXIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060630</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060630</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTIVITAMIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055161-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060708</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006-145207-NL</companynumb>
    <primarysource>
      <reportercountry>THAILAND</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>41</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>COMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMODIALYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MIOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE DRUG OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STRESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDE ATTEMPT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIRTAZAPINE</medicinalproduct>
        <drugdosagetext>1800 MG ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060105</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060505</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMOBARBITAL SODIUM</medicinalproduct>
        <drugdosagetext>3000 MG ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SLEEP DISORDER THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060505</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHLORPROMAZINE</medicinalproduct>
        <drugdosagetext>1500 MG ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SLEEP DISORDER THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060505</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
        <drugdosagetext>15000 MG ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEADACHE</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060505</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
        <drugdosagetext>15000 MG ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060505</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIDZOLAM</medicinalproduct>
        <drugdosagetext>150 MG ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060505</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALPRAZOLAM</medicinalproduct>
        <drugdosagetext>DF ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060505</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055163-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060703</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>02100-JPN-06-0310</companynumb>
    <primarysource>
      <reportercountry>KOREA, REPUBLIC OF</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>76</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>EPIGASTRIC DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METASTASES TO PERITONEUM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ONE OF CILOSTAZOL</medicinalproduct>
        <drugdosagetext>100 MG OR 200MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CEREBRAL INFARCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060103</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060116</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ONE OF CILOSTAZOL</medicinalproduct>
        <drugdosagetext>100 MG OR 200MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CEREBRAL INFARCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060117</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOPIDOGREL</medicinalproduct>
        <drugdosagetext>200 MG OR 75 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CEREBRAL INFARCTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ITOPRIDE HYDROCHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIMETHICONE/GUAIAZULENE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GINGKO BILOBA EXTRACT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENEXATE HYDROCHLORIDE BETADEX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATORVASTATIN CALCIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETYL-L-CARNITINE HYDROCHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CHLORHEXIDINE GLUCONATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMMONIUM CHLORIDE/CHLORPHENIRAMINE MALEATE/DEXTROMETHORPHAN/DL-METHYLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MOSAPRIDE CITRATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANCREATIN/BROMELAIN/DIMETHICONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CILAZAPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ECABET 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>CALCIUM CARBONATE/CHOLECARCIFEROL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CANDESARTAN CILEXETIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INDAPAMIDE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055165-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060703</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>02100-JPN-06-0256</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>52</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANOREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>C-REACTIVE PROTEIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LABORATORY TEST ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CILOSTAZOL</medicinalproduct>
        <drugdosagetext>200  MG ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CEREBRAL INFARCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060605</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATORVASTATIN CALCIUM HYDRATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGNESIUM OXIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICAL DIET</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055166-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060706</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>0602269US</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>94</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD POTASSIUM DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRY MOUTH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE IRRITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATOCRIT INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHOTOPHOBIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RED BLOOD CELL COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STOMACH DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISION BLURRED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALPHAGAN</medicinalproduct>
        <drugauthorizationnumb>21770</drugauthorizationnumb>
        <drugdosagetext>2 GTT, BID, OPHTHALMIC</drugdosagetext>
        <drugadministrationroute>047</drugadministrationroute>
        <drugindication>GLAUCOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060601</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALPHAGAN P</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COSOPT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LUMGAN[R] (BIMATOPROST)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055167-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060710</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-455041</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>53</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANOREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY OCCLUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEGASYS</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060215</drugstartdate>
        <drugtreatmentduration>15</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RIBAVIRIN</medicinalproduct>
        <drugauthorizationnumb>021511</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060215</drugstartdate>
        <drugtreatmentduration>15</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLIPIZIDE</medicinalproduct>
        <drugdosagetext>REPORTED AS GLYPIZIDE.</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010615</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055168-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050413</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GBWYE594618APR05</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>87</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NON-HODGKIN'S LYMPHOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORBITAL OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RETINAL OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040226</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040601</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugdosagetext>7.5MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AZATHIOPRINE SODIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040301</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PARACETAMOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORAZEPAM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055169-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-432846</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>17</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>66.2</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLITIS ULCERATIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CROHN'S DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CYST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EMOTIONAL DISTRESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FRUSTRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHOIDS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ILEITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLAMMATORY BOWEL DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SLEEP DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT FLUCTUATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>018662</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020102</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020112</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>018662</drugauthorizationnumb>
        <drugdosagetext>DOSAGE REGIMEN REPORTED AS 40-80-40.</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020112</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020202</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>018662</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020418</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020904</drugenddate>
        <drugtreatmentduration>140</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055170-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060710</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-454989</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEGASYS</medicinalproduct>
        <drugdosagetext>ROUTE: INJECTABLE.</drugdosagetext>
        <drugadministrationroute>050</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RIBAVIRIN</medicinalproduct>
        <drugauthorizationnumb>021511</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055171-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060619</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-ROCHE-454117</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>69</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>56.4</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD CREATININE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CREATININE RENAL CLEARANCE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUID INTAKE REDUCED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL INTAKE REDUCED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BONIVA</medicinalproduct>
        <drugbatchnumb>MH6802504</drugbatchnumb>
        <drugauthorizationnumb>21858</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060327</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060606</drugenddate>
        <drugtreatmentduration>72</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>THALIDOMIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060327</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055172-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060522</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-449087</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>59</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>93.4</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>AMNESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTERIOVENOUS MALFORMATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BALANCE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEEP VEIN THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DELUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIVERTICULUM INTESTINAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FAT NECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHOIDS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUPUS NEPHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANIC ATTACK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARANOIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL ACUITY REDUCED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELLCEPT</medicinalproduct>
        <drugauthorizationnumb>50722</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>LUPUS NEPHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050615</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19970615</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLIPIZIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE TAB</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CAPITROL</medicinalproduct>
        <drugdosagetext>DRUG NAME REPORTED AS CAPTIPROL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARANESP</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055173-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060706</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-AMGEN-KDL185440</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021015</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060301</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055174-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060614</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-ROCHE-452564</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>68</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>117.5</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EATING DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BONIVA</medicinalproduct>
        <drugauthorizationnumb>021455</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060502</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055175-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060708</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-454879</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>55</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEGASYS</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060518</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COPEGUS</medicinalproduct>
        <drugauthorizationnumb>021511</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055176-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060707</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>HQWYE668707JUL06</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>C-REACTIVE PROTEIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060407</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060706</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugdosagetext>UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055177-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060703</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>0600425US</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>41</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CHEST DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CYSTITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULAR WEAKNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BOTOX</medicinalproduct>
        <drugdosagetext>26 UNITS, SINGLE, INTRAMUSCULAR</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>SKIN WRINKLING</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060216</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060216</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BIAXIN</medicinalproduct>
        <drugdosagetext>QD, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SINUSITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVAQUIN</medicinalproduct>
        <drugdosagetext>QD, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CYSTITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060510</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055178-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060703</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>HQWYE956905JUN06</companynumb>
    <primarysource>
      <reportercountry>CHILE</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>26</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HAEMODIALYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL TUBULAR NECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPUTUM PURULENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RAPAMUNE</medicinalproduct>
        <drugauthorizationnumb>21110</drugauthorizationnumb>
        <drugdosagetext>10 M G 1X PER 1 DAY, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS AGAINST TRANSPLANT REJECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060523</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MYCOPHENOLATE MOFETIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE TAB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NIFEDIPINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDRAZIDE                      (HYDROCHLOROTHIAZIDE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHYLDOPA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOXAZOSIN (DOXAZOSIN)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONIDINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROPRANOLOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SULFAMETHOXAZOLE + TRIMETHOPRIM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACYCLOVIR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NISTATIN (NYSTATIN)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RANITIDINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MORPHINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SODIUM BICARBONATE IN PLASTIC CONTAINER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORAZEPAM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055179-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060703</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006-01-0278</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>69</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>93</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ERYTHEMA MULTIFORME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEOPLASM PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STEVENS-JOHNSON SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TEMODAR</medicinalproduct>
        <drugauthorizationnumb>21029</drugauthorizationnumb>
        <drugdosagetext>160 MG QD ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OLIGODENDROGLIOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051214</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RADIATION THERAPY NO DOSE FORM</medicinalproduct>
        <drugdosagetext>2160 GY TOTAL</drugdosagetext>
        <drugindication>OLIGODENDROGLIOMA</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051230</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DECADRON</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMICTAL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEPAKOTE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KEPPRA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055180-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060705</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GBWYE755620JUN06</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>47</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ALOPECIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTRICHOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EFFEXOR XR</medicinalproduct>
        <drugauthorizationnumb>20699</drugauthorizationnumb>
        <drugdosagetext>150MG EVERY MORNING, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031014</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060625</drugenddate>
        <drugtreatmentduration>986</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROMAZINE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUPENTIXOL                    (FLUPENTIXOL)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055181-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060704</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>HQWYE561005JUL06</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>77</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BILIARY DILATATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHOLESTASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COAGULOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMA HEPATIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CRYPTOGENIC CIRRHOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GALLBLADDER POLYP</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERAL PHYSICAL HEALTH DETERIORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC ATROPHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC CIRRHOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC FIBROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC NECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATITIS TOXIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPHADENOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALNUTRITION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCREATIC DUCT DILATATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLEURAL EFFUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROTHROMBIN TIME PROLONGED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PANTOPRAZOLE SODIUM</medicinalproduct>
        <drugauthorizationnumb>20987</drugauthorizationnumb>
        <drugdosagetext>40 MG 1X PER 1 DAY, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTRIC DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PANTOPRAZOLE SODIUM</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>20060101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060201</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055182-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060707</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006-07-0194</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>54</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BENIGN PROSTATIC HYPERPLASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRY SKIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRODUCTIVE COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROSTATE INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN EXFOLIATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEG-INTRON</medicinalproduct>
        <drugdosagetext>SUBCUTANEOUS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060526</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RIBAVIRIN</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060526</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KLONOPIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055183-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060704</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>HQWYE731110APR06</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PANTOPRAZOLE SODIUM</medicinalproduct>
        <drugauthorizationnumb>20987</drugauthorizationnumb>
        <drugdosagetext>40 MG 1X PER 1 DAY, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugtreatmentduration>17</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOPICLONE                    (ZOPICLONE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALTACE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL                     (METOPROLOL)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055184-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060710</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006-07-0380</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>58</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>BRAIN HERNIATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGE INTRACRANIAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALBUTEROL</medicinalproduct>
        <drugauthorizationnumb>17559</drugauthorizationnumb>
        <drugdosagetext>ORAL AER INH</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARDIZEM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RHINOCORT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AEROBID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AEROBID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COMBIVENT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WELLBUTRIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055185-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060620</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FRWYE797126JUN06</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ERECTILE DYSFUNCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>ANKYLOSING SPONDYLITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050819</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IKOREL</medicinalproduct>
        <drugdosagetext>20 MG; FREQUENCY UNSPEC.</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugdosagetext>20 MG; FREQUENCY UNSPEC.</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEXOMIL</medicinalproduct>
        <drugdosagetext>6 MG; FREQUENCY UNSPEC.</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>75 MG; FREQUENCY UNSPEC.</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VASTAREL</medicinalproduct>
        <drugdosagetext>UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BISOPROLOL FUMARATE</medicinalproduct>
        <drugdosagetext>10 MG; FREQUENCY UNSPEC.</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMIX</medicinalproduct>
        <drugdosagetext>0.4 MG; FREQUENCY UNSPEC.</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055186-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060707</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-STX185721</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OOPHORECTOMY BILATERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UPPER LIMB FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WRIST FRACTURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>P071944</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19960101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055187-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060706</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>HQWYE568030MAY06</companynumb>
    <primarysource>
      <reportercountry>ARGENTINA</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>27</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>KIDNEY TRANSPLANT REJECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RAPAMUNE</medicinalproduct>
        <drugauthorizationnumb>21110</drugauthorizationnumb>
        <drugdosagetext>8 MG 1X PER 1 DAY, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS AGAINST TRANSPLANT REJECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060206</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060523</drugenddate>
        <drugtreatmentduration>107</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MYCOPHENOLATE MOFETIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COTRIM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055188-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060706</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FRWYE066210JUL06</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>57</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>COMPLICATIONS OF TRANSPLANTED KIDNEY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMODIALYSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RAPAMUNE</medicinalproduct>
        <drugauthorizationnumb>21083</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS AGAINST TRANSPLANT REJECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030526</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030527</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RAPAMUNE</medicinalproduct>
        <drugauthorizationnumb>21083</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS AGAINST TRANSPLANT REJECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030528</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055189-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>SP00891</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>77</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DROOLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FOREIGN BODY TRAUMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OESOPHAGEAL OBSTRUCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VISICOL</medicinalproduct>
        <drugauthorizationnumb>21097</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>COLONOSCOPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060328</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060329</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055190-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060706</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FRWYE030506JUL06</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>24</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HEPATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEUKOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ADVIL</medicinalproduct>
        <drugauthorizationnumb>18989</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PHARYNGITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060607</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060609</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ADVIL</medicinalproduct>
        <drugauthorizationnumb>18989</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHINITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060607</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060609</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AUGMENTIN '125'</medicinalproduct>
        <drugdosagetext>9 G 1X PER 1 DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PHARYNGITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060607</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060609</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AUGMENTIN '125'</medicinalproduct>
        <drugdosagetext>9 G 1X PER 1 DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHINITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060607</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060609</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
        <drugdosagetext>3 G 1X PER 1 DAY</drugdosagetext>
        <drugindication>PHARYNGITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060607</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060609</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
        <drugdosagetext>3 G 1X PER 1 DAY</drugdosagetext>
        <drugindication>RHINITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060607</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060609</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GESTODENE AND ETHINYL ESTRADIOL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055191-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060706</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FRWYE054307JUL06</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>59</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CYTOLYTIC HEPATITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOSPORINE</medicinalproduct>
        <drugauthorizationnumb>65025</drugauthorizationnumb>
        <drugdosagetext>225 MG 2X PER 1 DAY, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS AGAINST TRANSPLANT REJECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020918</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055192-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060706</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006-02711</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>27</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ASCITES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COAGULOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EOSINOPHILIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUID RETENTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JAUNDICE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPLENOMEGALY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRANSAMINASES INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MONODOX</medicinalproduct>
        <drugauthorizationnumb>50641</drugauthorizationnumb>
        <drugindication>HEADACHE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050428</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050501</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MONODOX</medicinalproduct>
        <drugauthorizationnumb>50641</drugauthorizationnumb>
        <drugindication>MALAISE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050428</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050501</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MONODOX</medicinalproduct>
        <drugauthorizationnumb>50641</drugauthorizationnumb>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050428</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050501</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TELITHROMYCIN (TELITHROMYCIN)</medicinalproduct>
        <drugindication>COUGH</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050411</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050415</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TELITHROMYCIN (TELITHROMYCIN)</medicinalproduct>
        <drugindication>HEADACHE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050411</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050415</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TELITHROMYCIN (TELITHROMYCIN)</medicinalproduct>
        <drugindication>MALAISE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050411</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050415</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TELITHROMYCIN (TELITHROMYCIN)</medicinalproduct>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050411</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050415</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TELITHROMYCIN (TELITHROMYCIN)</medicinalproduct>
        <drugindication>PHARYNGOLARYNGEAL PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050411</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050415</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TELITHROMYCIN (TELITHROMYCIN)</medicinalproduct>
        <drugindication>PULMONARY CONGESTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050411</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050415</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TELITHROMYCIN (TELITHROMYCIN)</medicinalproduct>
        <drugindication>RHINORRHOEA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050411</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050415</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHYLPHENIDATE HCL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055193-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060630</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>HQWYE926605JUN06</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>11</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD CREATININE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPONATRAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELLCEPT</medicinalproduct>
        <drugdosagetext> SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS AGAINST TRANSPLANT REJECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051020</drugenddate>
        <drugtreatmentduration>324</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELLCEPT</medicinalproduct>
        <drugdosagetext> SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS AGAINST TRANSPLANT REJECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051021</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060115</drugenddate>
        <drugtreatmentduration>87</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELLCEPT</medicinalproduct>
        <drugdosagetext> SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS AGAINST TRANSPLANT REJECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060116</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE TAB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TACROLIMUS (TACROLIMUS)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCITRIOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOCUSATE SODIUM (DOCUSATE SODIUM)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENALAPRIL MALEATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055194-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060707</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>227142</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>12</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PARTIAL SEIZURES</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NUTROPIN AQ</medicinalproduct>
        <drugauthorizationnumb>20522</drugauthorizationnumb>
        <drugdosagetext>2 MG, 7/WEEK</drugdosagetext>
        <drugindication>GROWTH HORMONE DEFICIENCY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19970214</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055195-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060706</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FRWYE066110JUL06</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>57</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>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS AGAINST TRANSPLANT REJECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030526</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030527</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RAPAMUNE</medicinalproduct>
        <drugauthorizationnumb>21083</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS AGAINST TRANSPLANT REJECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030528</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030614</drugenddate>
        <drugtreatmentduration>18</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RAPAMUNE</medicinalproduct>
        <drugauthorizationnumb>21083</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS AGAINST TRANSPLANT REJECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030615</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030620</drugenddate>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RAPAMUNE</medicinalproduct>
        <drugauthorizationnumb>21083</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS AGAINST TRANSPLANT REJECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030621</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055196-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060710</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>HQWYE442628JUN06</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>78</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD LACTATE DEHYDROGENASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLAMMATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERSTITIAL LUNG DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRODUCTIVE COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESTLESSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STRIDOR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ETODOLAC</medicinalproduct>
        <drugauthorizationnumb>18922</drugauthorizationnumb>
        <drugdosagetext>400 MG 1X PER 1 DAY ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060525</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060601</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ETIZOLAM (ETIZOLAM, )</medicinalproduct>
        <drugdosagetext>0.5 MG 1X PER 1 DAY ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INSOMNIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060501</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FAMOTIDINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE BESYLATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN TAB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGNESIUM OXIDE (MAGNESIUM OXIDE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAMSULOSIN HYDROCHLORIDE (TAMSULOSIN HYDROCHLORIDE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANTETHINE (PANTETHINE)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055197-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060707</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CHWYE054107JUL06</companynumb>
    <primarysource>
      <reportercountry>SWITZERLAND</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>38</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD LACTIC ACID INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EPILEPSY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY INCONTINENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EFFEXOR</medicinalproduct>
        <drugauthorizationnumb>20151</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060212</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055198-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060703</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>HQWYE267419JUN06</companynumb>
    <primarysource>
      <reportercountry>SOUTH AFRICA</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>81</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSEUDOMONAL SEPSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY FAILURE</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>19970101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060101</drugenddate>
        <drugtreatmentduration>9</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ISOPTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATACAND</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ISMO - SLOW RELEASE (ISOSORBIDE MONONITRATE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055199-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060703</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>HQWYE540903JUL06</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>20</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>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVLOCARDYL (PROPRANOLOL HYDROCHLORIDE, TABLET)</medicinalproduct>
        <drugauthorizationnumb>16418</drugauthorizationnumb>
        <drugdosagetext>40 MG 1X PER 1 DAY ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PARKINES (TRIHEXYPHENIDYL HYDROCHLORIDE, )</medicinalproduct>
        <drugdosagetext>5 MG 1X PER 1 DAY ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLONAZEPAM</medicinalproduct>
        <drugdosagetext>2 MG 1X PER 1 DAY ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060528</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRIENTINE (TRIENTINE, )</medicinalproduct>
        <drugdosagetext>1500 MG 1X PER 1 DAY ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATO-LENTICULAR DEGENERATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051115</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VALIUM</medicinalproduct>
        <drugdosagetext>10 MG 1X PER 1 DAY ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055200-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060705</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>HQWYE623306JUL06</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BREAST CANCER METASTATIC</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMPRO</medicinalproduct>
        <drugauthorizationnumb>20527</drugauthorizationnumb>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCRIN</medicinalproduct>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
        <drugindication>OESTROGEN REPLACEMENT THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROVERA</medicinalproduct>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055201-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060630</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>HQWYE726310APR06</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>51</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>TORTICOLLIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PANTOPRAZOLE SODIUM</medicinalproduct>
        <drugauthorizationnumb>20987</drugauthorizationnumb>
        <drugdosagetext>20 MG 1X PER 1 DAY ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugtreatmentduration>42</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROXYCHLOROQUINE SULFATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DICLOFENAC (DICLOFENAC)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055202-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060707</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GBWYE683402JUN06</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>45</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>EPILEPSY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PITTING OEDEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EFFEXOR</medicinalproduct>
        <drugauthorizationnumb>20151</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060501</drugenddate>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EFFEXOR</medicinalproduct>
        <drugauthorizationnumb>20151</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060501</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EFFEXOR</medicinalproduct>
        <drugauthorizationnumb>20151</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060501</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055203-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060705</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>HQWYE675910JUL06</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BREAST CANCER FEMALE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMPRO</medicinalproduct>
        <drugauthorizationnumb>20527</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROVERA</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055204-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060705</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>HQWYE676610JUL06</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BREAST CANCER FEMALE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
        <drugauthorizationnumb>4782</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055205-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>WAES 0403USA02322</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>34</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANOREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD ALKALINE PHOSPHATASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CHLORIDE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CHOLESTEROL INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CREATININE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD SODIUM DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD TRIGLYCERIDES INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CALCULUS URINARY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CERVIX OPERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CREATININE RENAL CLEARANCE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ELECTROLYTE IMBALANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE OPERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAMMA-GLUTAMYLTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HIV WASTING SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERLIPIDAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CRIXIVAN</medicinalproduct>
        <drugauthorizationnumb>20685</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980831</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19980909</drugenddate>
        <drugtreatmentduration>10</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CRIXIVAN</medicinalproduct>
        <drugauthorizationnumb>20685</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000310</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20001027</drugenddate>
        <drugtreatmentduration>232</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EFAVIRENZ</medicinalproduct>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000310</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20001027</drugenddate>
        <drugtreatmentduration>232</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EFAVIRENZ</medicinalproduct>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010130</drugstartdate>
        <drugtreatmentduration>232</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RITONAVIR</medicinalproduct>
        <drugdosagetext>400 MG/DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000310</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20001027</drugenddate>
        <drugtreatmentduration>232</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ABACAVIR SULFATE</medicinalproduct>
        <drugdosagetext>300 MG/BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010130</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LOPINAVIR (+) RITONAVIR</medicinalproduct>
        <drugdosagetext>6 CAPSULE/DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010130</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLARITHROMYCIN</medicinalproduct>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MYCOBACTERIUM AVIUM COMPLEX INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19981008</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19981201</drugenddate>
        <drugtreatmentduration>55</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLARITHROMYCIN</medicinalproduct>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MYCOBACTERIUM AVIUM COMPLEX INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20001028</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ETHAMBUTOL HCL</medicinalproduct>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MYCOBACTERIUM AVIUM COMPLEX INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19981025</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19981201</drugenddate>
        <drugtreatmentduration>38</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ETHAMBUTOL HCL</medicinalproduct>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MYCOBACTERIUM AVIUM COMPLEX INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19981212</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19990614</drugenddate>
        <drugtreatmentduration>185</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ETHAMBUTOL HCL</medicinalproduct>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MYCOBACTERIUM AVIUM COMPLEX INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20001028</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010101</drugenddate>
        <drugtreatmentduration>399</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SULFAMETHOXAZOLE + TRIMETHOPRIM</medicinalproduct>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ALLERGENIC DESENSITISATION PROCEDURE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20001219</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20001219</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SULFAMETHOXAZOLE + TRIMETHOPRIM</medicinalproduct>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PNEUMOCYSTIS JIROVECI INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20001219</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20001219</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SULFAMETHOXAZOLE + TRIMETHOPRIM</medicinalproduct>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ALLERGENIC DESENSITISATION PROCEDURE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20001220</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20001220</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SULFAMETHOXAZOLE + TRIMETHOPRIM</medicinalproduct>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PNEUMOCYSTIS JIROVECI INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20001220</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20001220</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SULFAMETHOXAZOLE + TRIMETHOPRIM</medicinalproduct>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ALLERGENIC DESENSITISATION PROCEDURE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20001221</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20001221</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SULFAMETHOXAZOLE + TRIMETHOPRIM</medicinalproduct>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PNEUMOCYSTIS JIROVECI INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20001221</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20001221</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SULFAMETHOXAZOLE + TRIMETHOPRIM</medicinalproduct>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ALLERGENIC DESENSITISATION PROCEDURE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20001222</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20001222</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SULFAMETHOXAZOLE + TRIMETHOPRIM</medicinalproduct>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PNEUMOCYSTIS JIROVECI INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20001222</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20001222</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SULFAMETHOXAZOLE + TRIMETHOPRIM</medicinalproduct>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ALLERGENIC DESENSITISATION PROCEDURE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20001223</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010112</drugenddate>
        <drugtreatmentduration>21</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SULFAMETHOXAZOLE + TRIMETHOPRIM</medicinalproduct>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PNEUMOCYSTIS JIROVECI INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20001223</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010112</drugenddate>
        <drugtreatmentduration>21</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SULFAMETHOXAZOLE + TRIMETHOPRIM</medicinalproduct>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ALLERGENIC DESENSITISATION PROCEDURE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010113</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020319</drugenddate>
        <drugtreatmentduration>431</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SULFAMETHOXAZOLE + TRIMETHOPRIM</medicinalproduct>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PNEUMOCYSTIS JIROVECI INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010113</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020319</drugenddate>
        <drugtreatmentduration>431</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSCAVIR (FOSCARNET NA)</medicinalproduct>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CYTOMEGALOVIRUS INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000125</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20000214</drugenddate>
        <drugtreatmentduration>21</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSCAVIR (FOSCARNET NA)</medicinalproduct>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CYTOMEGALOVIRUS INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000215</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20000303</drugenddate>
        <drugtreatmentduration>18</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSCAVIR (FOSCARNET NA)</medicinalproduct>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CYTOMEGALOVIRUS INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000404</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20000406</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSCAVIR (FOSCARNET NA)</medicinalproduct>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CYTOMEGALOVIRUS INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000407</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20000426</drugenddate>
        <drugtreatmentduration>20</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DENOSINE           (GANCICLOVIR SODIUM)</medicinalproduct>
        <drugdosagetext>10 MG/KG/DAILY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CYTOMEGALOVIRUS INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000215</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20000306</drugenddate>
        <drugtreatmentduration>21</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LACTEC D</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SOLITA T-3</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CIPROFLOXACIN HYDROCHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXTROSE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCORTISONE TAB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCORTISONE SODIUM PHOSPHATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROXYZINE HYDROCHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LAMIVUDINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MORPHINE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RIFAMPIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ROXITHROMYCIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZIDOVUDINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055206-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060703</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>34324</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>63</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLINDNESS TRANSIENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CORNEAL OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CORNEAL OPACITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CORNEAL SCAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE IRRITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IRIS DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>KERATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OCULAR HYPERAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TIMOLOL MALEATE</medicinalproduct>
        <drugauthorizationnumb>74262</drugauthorizationnumb>
        <drugdosagetext>1 GTT OD</drugdosagetext>
        <drugadministrationroute>047</drugadministrationroute>
        <drugindication>GLAUCOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060311</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055207-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060626</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>WAES 0606USA02432</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>81</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CHRONIC RESPIRATORY FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>20560</drugauthorizationnumb>
        <drugdosagetext>5 MG/DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050209</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060319</drugenddate>
        <drugtreatmentduration>404</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALFAROL (ALFACALCIDOL)</medicinalproduct>
        <drugdosagetext>1 MICROGM/DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050209</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060319</drugenddate>
        <drugtreatmentduration>404</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GASTER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PURSENNID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>QVAR 40</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SEREVENT</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055208-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060710</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2006US08837</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>73</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>SKIN CANCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THERAPEUTIC PROCEDURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LOTREL</medicinalproduct>
        <drugauthorizationnumb>020364</drugauthorizationnumb>
        <drugdosagetext>5/10 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051001</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055209-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060630</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-2004-035876</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>LIPOEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPHANGITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPHOEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BETASERON</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055210-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060711</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>HQWYE220608MAY06</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>51</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>83.99</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HAEMATOCRIT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>KIDNEY TRANSPLANT REJECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH PAPULAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RAPAMUNE</medicinalproduct>
        <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>20060110</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060429</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPROL-XL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COZAAR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELLCEPT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALCYTE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PEPCID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE TAB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SEPTRA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NYSTATIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLINDAMYCIN PHOSPHATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYLENOL PM (DIPHENHYDRAMINE/PARACETAMOL)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNISOM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMBIEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HUMALOG</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055213-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060703</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>HQWYE593105JUL06</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BREAST CANCER FEMALE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
        <drugauthorizationnumb>4782</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055214-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060705</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>E2020-00178-SPO-IT</companynumb>
    <primarysource>
      <reportercountry>ITALY</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>76</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HYPERTENSIVE CRISIS</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>COGNITIVE DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060520</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060620</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SINEMET</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMINE HYDROCHLORIDE (METFORMIN HYDROCHLORIDE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GABAPENTIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055215-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060630</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>E2020-00058-CLI-DE</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>84</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>67</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRADYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEMUR FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYARRHYTHMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DONEPEZIL HCL</medicinalproduct>
        <drugauthorizationnumb>20690</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEMENTIA ALZHEIMER'S TYPE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060309</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060406</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DONEPEZIL HCL</medicinalproduct>
        <drugauthorizationnumb>20690</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEMENTIA ALZHEIMER'S TYPE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060407</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060515</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETYLSALICYLIC ACID SRT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DORMICUM (MIDAZOLAM MALEATE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KETANEST (KETAMINE)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055216-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060707</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>E2020-00235-SPO-FR</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>79</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARICEPT</medicinalproduct>
        <drugauthorizationnumb>20690</drugauthorizationnumb>
        <drugdosagetext>10 MG, 1 IN 1 D, ORAL/ATLEAST 1 YEAR AGO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEMENTIA ALZHEIMER'S TYPE</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060601</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055217-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060705</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>E2020-00219-SPO-FR</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>84</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERAL PHYSICAL HEALTH DETERIORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTHERMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARICEPT</medicinalproduct>
        <drugauthorizationnumb>20690</drugauthorizationnumb>
        <drugdosagetext>1J, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEMENTIA ALZHEIMER'S TYPE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEPROBAMATE (EQUANIL) (MEPROBAMATE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVODOPA BENZERASIDE (MODOPAR)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXIN (LEVOTHYROX) (LEVOTHYROXINE SODIUM)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NIFEDIPINE (CHRONADALATE) (NIFEDIPINE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEMANTINE (EBIXA) (MEMANTINE HYDROCHLORIDE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALPHA TOCOPHEROL (TOCO 500) (TOCOPHEROL)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOMPERIDONE (DOMPERIDONE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMOXICILLIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HEALTH FOOD (CLINUTREN)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055218-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060704</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>E3810-00009-SPO-AU</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>RENAL IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RABEPRAZOLE SODIUM</medicinalproduct>
        <drugauthorizationnumb>20973</drugauthorizationnumb>
        <drugdosagetext>ORAL/NUMBER OF YEARS AGO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055219-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060707</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FRWYE054207JUL06</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>60</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>COMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPONATRAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EFFEXOR</medicinalproduct>
        <drugauthorizationnumb>20151</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060613</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INEXIUM (ESOMEPRAZOLE, , 0)</medicinalproduct>
        <drugdosagetext>20  MG 1X PER 1 DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONAZEPAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLPIDEM TARTRATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIDOSE (CALCIUM CARBONATE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAMADOL HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM CHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055220-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060705</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DEWYE149017NOV05</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>70</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <reaction>
        <reactionmeddrapt>ACUTE MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARRHYTHMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD LACTATE DEHYDROGENASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ELECTROCARDIOGRAM ST SEGMENT DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPTIC SHOCK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENTRICULAR TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GEMTUZUMAB OZOGAMICIN (GEMTUZUMAB OZOGAMICIN, INJECTION)</medicinalproduct>
        <drugauthorizationnumb>21174</drugauthorizationnumb>
        <drugdosagetext>12.18 MG</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051110</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYTARABINE</medicinalproduct>
        <drugdosagetext>1435 MG CUMULATIVE DOSE</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051122</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051130</drugenddate>
        <drugtreatmentduration>9</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ETOPOSIDE (ETOPOSIDE, , 0)</medicinalproduct>
        <drugdosagetext>615 MG CUMULATIVE DOSE</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051122</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051124</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NOVANTRONE</medicinalproduct>
        <drugdosagetext>28.7 MG CUMULATIVE DOSE</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051126</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051128</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RAMIPRIL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055221-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060707</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ESWYE416621FEB06</companynumb>
    <primarysource>
      <reportercountry>SPAIN</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>68</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HERNIAL EVENTRATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RAPAMUNE</medicinalproduct>
        <drugauthorizationnumb>21083</drugauthorizationnumb>
        <drugdosagetext>6 MG 1X PER 1 DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS AGAINST TRANSPLANT REJECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031025</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHYLPREDNISOLONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELLCEPT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DISTRANEURINE (CLOMETHIAZOLE EDISILATE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MYCOSTATIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RISPERDAL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055222-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060705</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DEWYE149017NOV05</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>70</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ACUTE MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARRHYTHMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD LACTATE DEHYDROGENASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ELECTROCARDIOGRAM ST SEGMENT DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPTIC SHOCK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENTRICULAR TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GEMTUZUMAB OZOGAMICIN (GEMTUZUMAB OZOGAMICIN, INJECTION)</medicinalproduct>
        <drugauthorizationnumb>21174</drugauthorizationnumb>
        <drugdosagetext>12.18 MG</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051110</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYTARABINE</medicinalproduct>
        <drugdosagetext>1435 MG CUMULATIVE DOSE</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051122</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051130</drugenddate>
        <drugtreatmentduration>9</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ETOPOSIDE (ETOPOSIDE, , 0)</medicinalproduct>
        <drugdosagetext>615 MG CUMULATIVE DOSE</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051122</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051124</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NOVANTRONE</medicinalproduct>
        <drugdosagetext>28.7 MG CUMULATIVE DOSE</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051126</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051128</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RAMIPRIL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055223-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060703</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>HQWYE574930JAN06</companynumb>
    <primarysource>
      <reportercountry>ITALY</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>63</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD PH INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RED BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STAPHYLOCOCCAL INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GEMTUZUMAB OZOGAMICIN (GEMTUZUMAB OZOGAMICIN, INJECTION)</medicinalproduct>
        <drugauthorizationnumb>21174</drugauthorizationnumb>
        <drugdosagetext>10 MG</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041229</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041229</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYTARABINE</medicinalproduct>
        <drugdosagetext>170 MG; CUMULATIVE DOSE 1190</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050111</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050117</drugenddate>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ETOPOSIDE</medicinalproduct>
        <drugdosagetext>DOSE 170 MG; CUMULATIVE DOSE 510 MG</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050111</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050113</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NOVANTRONE</medicinalproduct>
        <drugdosagetext>DOSE 12MG; CUMULATIVE DOSE 36 MG</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050111</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050115</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOFLOXACIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055224-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060711</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>HQWYE778611JUL06</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>65</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CYTOLYTIC HEPATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTOLERANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEUKOCYTOCLASTIC VASCULITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISION BLURRED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CORDARONE</medicinalproduct>
        <drugauthorizationnumb>18972</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060303</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060307</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055225-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060710</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>HQWYE702610JUL06</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>85</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ACUTE PULMONARY OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRONCHITIS ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRONCHOSPASM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIOGENIC SHOCK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTHYROIDISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESTRICTIVE PULMONARY DISEASE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CORDARONE</medicinalproduct>
        <drugauthorizationnumb>18972</drugauthorizationnumb>
        <drugdosagetext>200 MG 1X PER 1 DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041109</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060425</drugenddate>
        <drugtreatmentduration>533</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CORDARONE</medicinalproduct>
        <drugauthorizationnumb>18972</drugauthorizationnumb>
        <drugdosagetext>200 MG 1X PER 1 DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATRIAL FLUTTER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041109</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060425</drugenddate>
        <drugtreatmentduration>533</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055226-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060704</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>HQWYE626806JUL06</companynumb>
    <primarysource>
      <reportercountry>NEW ZEALAND</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>71</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONGESTIVE CARDIOMYOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY STENOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DILATATION VENTRICULAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ELECTROCARDIOGRAM ST SEGMENT ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EXERCISE TOLERANCE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL ISCHAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENTRICULAR HYPOKINESIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RAPAMUNE</medicinalproduct>
        <drugauthorizationnumb>21110</drugauthorizationnumb>
        <drugdosagetext>2 MG IN AM AND 3 MG AT NIGHT</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS AGAINST TRANSPLANT REJECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040914</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ROXITHROMYCIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INHIBACE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INHIBACE PLUS (CILAZAPRIL/HYDROCHLOROTHIAZIDE)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055227-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060711</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>HQWYE848912JUL06</companynumb>
    <primarysource>
      <reportercountry>MEXICO</reportercountry>
    </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>RAPAMUNE</medicinalproduct>
        <drugauthorizationnumb>21083</drugauthorizationnumb>
        <drugdosagetext>2 MG 1X PER 1 DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS AGAINST TRANSPLANT REJECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE TAB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MYCOPHENOLATE MOFETIL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055228-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060704</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006050317</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>70</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>DIVERTICULITIS INTESTINAL HAEMORRHAGIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMODIALYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MELAENA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROTEIN URINE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SELF-MEDICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VASCULITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AZULFIDINE EN-TABS</medicinalproduct>
        <drugauthorizationnumb>7073</drugauthorizationnumb>
        <drugdosagetext>1 GRAM (500 MG, 2 IN 1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060105</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060109</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MOVER (ACTARIT)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HERBAL PREPARATION (HERBAL PREPARATION)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055229-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041116</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004095783</companynumb>
    <primarysource>
      <reportercountry>CHINA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANOREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugauthorizationnumb>21156</drugauthorizationnumb>
        <drugdosagetext>800 MG (400 MG, BID), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ADENOMATOUS POLYPOSIS COLI</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041001</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055230-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060704</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2002128326CH</companynumb>
    <primarysource>
      <reportercountry>SWITZERLAND</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>55</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>90</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DISEASE PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERIPHERAL SENSORY NEUROPATHY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IRINOTECAN HCL</medicinalproduct>
        <drugauthorizationnumb>20571</drugauthorizationnumb>
        <drugdosagetext>160 MG (FREQUENCY:  CYCLIC), INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>SMALL CELL LUNG CANCER STAGE UNSPECIFIED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020814</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020925</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PLATIBLASTIN S (CISPLATIN)</medicinalproduct>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>SMALL CELL LUNG CANCER STAGE UNSPECIFIED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020814</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020911</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PLATIBLASTIN S (CISPLATIN)</medicinalproduct>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>SMALL CELL LUNG CANCER STAGE UNSPECIFIED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020925</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020925</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055231-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060630</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006P1000364</companynumb>
    <primarysource>
      <reportercountry>ROMANIA</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>72</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>95</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ACCELERATED IDIOVENTRICULAR RHYTHM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRADYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENTRICULAR FIBRILLATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RETEPLASE (RETEPLASE )</medicinalproduct>
        <drugdosagetext>IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ACUTE MYOCARDIAL INFARCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060623</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REOPRO</medicinalproduct>
        <drugdosagetext>IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ACUTE MYOCARDIAL INFARCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060623</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLOPIDOGREL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055232-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060706</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006P1000368</companynumb>
    <primarysource>
      <reportercountry>ITALY</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>68</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY DISEASE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RETEPLASE (RETEPLASE )</medicinalproduct>
        <drugindication>ACUTE MYOCARDIAL INFARCTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REOPRO</medicinalproduct>
        <drugdosagetext>IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ACUTE MYOCARDIAL INFARCTION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055233-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060630</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>02100-JPN-06-0108</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>68</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>AGGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISSOCIATIVE DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CILOSTAZOL</medicinalproduct>
        <drugdosagetext>ONE OF 200 MG OR 81 MG; ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CEREBRAL INFARCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060125</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060309</drugenddate>
        <drugtreatmentduration>44</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VERAPAMIL HYDROCHLORIDE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055234-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>530#5#2006-00031</companynumb>
    <primarysource>
      <reportercountry>POLAND</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>77</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANAESTHETIC COMPLICATION PULMONARY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRONCHOPNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATEMESIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEG AMPUTATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NECROSIS ISCHAEMIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN ULCER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROSTAVASIN-40UG (ALPROSTADIL (PAOD))</medicinalproduct>
        <drugdosagetext>2 X 40 MCG PER DAY; INTRAVENOUS DRIP</drugdosagetext>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>PERIPHERAL ISCHAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060516</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060612</drugenddate>
        <drugtreatmentduration>26</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KETOPROFEN 100MG, AMPOULES (KETOPROFEN)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PETHIDINE HYDROCHLORIDE 50 MG, AMPOULES</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PETHIDINE HYDROCHLORIDE 100MG, AMPOULES</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE 5 MG, TABLETS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TICLOPIDINE 250MG, TABLETS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM CHLORIDE 750MG, TABLETS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RANITIDINE HYDROCHLORIDE 150MG, TABLETS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM 24000IU, AMPOULES</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RANTIDINE 100MG, AMPOULES</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE 40MG, AMPOULES</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SODIUM CHLORIDE 0.9%, SOLUTION</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENOXAPARIN SODIUM 40MG, AMPOULES (HEPARIN-FRACTION, SODIUM SALT)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE 40MG, AMPOULES</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055235-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ENTC2006-0187</companynumb>
    <primarysource>
      <reportercountry>FINLAND</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GRUNTING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEDICATION ERROR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARKINSON'S DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>STALEVO 100</medicinalproduct>
        <drugdosagetext>150 MG,</drugdosagetext>
        <drugindication>PARKINSON'S DISEASE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055236-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060703</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006084228</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>20</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLISTER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHOTODERMATOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHOTOSENSITIVITY REACTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
        <drugauthorizationnumb>18276</drugauthorizationnumb>
        <drugdosagetext>1.5 MG (0.5 MG, 3 IN 1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PSYCHOTIC DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ATARAX</medicinalproduct>
        <drugdosagetext>200 MG (50 MG,4 IN 1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PSYCHOTIC DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
        <drugdosagetext>1 DOSE FORM (1 IN 1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PSYCHOTIC DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060512</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ABILIFY</medicinalproduct>
        <drugdosagetext>1 DOSE FORM (1 IN 1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PSYCHOTIC DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060415</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TERCIAN                   (CYAMEMAZINE)</medicinalproduct>
        <drugdosagetext>40MG/ML, 100 DOSES FORM (4 IN 1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PSYCHOTIC DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEPAKOTE</medicinalproduct>
        <drugdosagetext>1.5 GRAM (500 MG, 3 IN 1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PSYCHOTIC DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055237-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060704</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006083437</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CORNEAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTH DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CAMPTOSAR</medicinalproduct>
        <drugauthorizationnumb>20571</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUOROURACIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ERBITUX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055238-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060706</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006084581</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugauthorizationnumb>21446</drugauthorizationnumb>
        <drugdosagetext>150 MG (75 MG, 2 IN 1 D)</drugdosagetext>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEXOMIL                            (BROMAZEPAM)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055239-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060706</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006074034</companynumb>
    <primarysource>
      <reportercountry>SLOVENIA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>34</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGE INTRACRANIAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTRACRANIAL HAEMATOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugauthorizationnumb>21446</drugauthorizationnumb>
        <drugdosagetext>150 MG (75 MG, 2 IN 1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PARTIAL SEIZURES</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060410</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060416</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TEGRETOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KEPPRA</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055240-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060703</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006079521</companynumb>
    <primarysource>
      <reportercountry>POLAND</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>74</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>65</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY RETENTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLINDAMYCIN HCL</medicinalproduct>
        <drugauthorizationnumb>50162</drugauthorizationnumb>
        <drugdosagetext>1200 MG (300 MG, 4 IN 1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INFECTION PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060504</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060505</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EFFOX LONG                 (ISOSORBIDE MONONITRATE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MOLSIDOMINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVACARD                   (SIMVASTATIN)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>APO-PENTOXIFYLLINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LUCETAM (PIRACETAM)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055241-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060704</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006080099</companynumb>
    <primarysource>
      <reportercountry>SWEDEN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ACNE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>C-REACTIVE PROTEIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYSIPELAS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugauthorizationnumb>21446</drugauthorizationnumb>
        <drugdosagetext>600 MG (1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NEURALGIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060601</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALPRAZOLAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARISOPRODOL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055242-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060703</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006081331</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>24</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTRA-UTERINE DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PREGNANCY WITH INJECTABLE CONTRACEPTIVE</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>20060221</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060221</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>20060521</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060521</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055243-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060627</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006081807</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>77</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGIC STROKE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERNATIONAL NORMALISED RATIO INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUBDURAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAHOR                                 (ATORVASTATIN)</medicinalproduct>
        <drugauthorizationnumb>20702</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
        <drugdosagetext>2 MG, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060521</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PIRIBEDIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOPICLONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXAZEPAM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055244-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060703</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006082497</companynumb>
    <primarysource>
      <reportercountry>THAILAND</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>37</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>METABOLIC ACIDOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEDATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZELDOX (IM) (ZIPRASIDONE)</medicinalproduct>
        <drugauthorizationnumb>20919</drugauthorizationnumb>
        <drugdosagetext>40 MG (40 MG, ONCE), INTRAMUSCULAR</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>ABNORMAL BEHAVIOUR</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060703</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060703</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZELDOX (IM) (ZIPRASIDONE)</medicinalproduct>
        <drugauthorizationnumb>20919</drugauthorizationnumb>
        <drugdosagetext>40 MG (40 MG, ONCE), INTRAMUSCULAR</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>PSYCHOTIC DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060703</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060703</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEPAKENE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALL OTHER THERAPEUTIC PRODUCTS (ALL OTHER THERAPEUTIC PRODUCTS)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055245-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006082611</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>79</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DILATATION VENTRICULAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MITRAL VALVE INCOMPETENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CABERGOLINE</medicinalproduct>
        <drugauthorizationnumb>20664</drugauthorizationnumb>
        <drugindication>PARKINSONISM</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055246-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060706</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006064020</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>61</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>73.2</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD CREATINE PHOSPHOKINASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERCAPILLARY GLOMERULOSCLEROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEPHROTIC SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
        <drugauthorizationnumb>19787</drugauthorizationnumb>
        <drugdosagetext>5  MG (5 MG, QD), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060411</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060505</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugdosagetext>10 MG (10 MG, QD), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERLIPIDAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060411</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060413</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LOSARTAN POSTASSIUM</medicinalproduct>
        <drugdosagetext>50 MG (50 MG, QD), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060411</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060505</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRAVASTATIN</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060221</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060410</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NOVORAPID (INSULIN ASPART)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055247-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060712</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-BRISTOL-MYERS SQUIBB COMPANY-13439047</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEOPLASM MALIGNANT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SERZONE</medicinalproduct>
        <drugauthorizationnumb>020152</drugauthorizationnumb>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20000101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055248-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CH-BRISTOL-MYERS SQUIBB COMPANY-13445481</companynumb>
    <primarysource>
      <reportercountry>ITALY</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>64</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HOT FLUSH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERREFLEXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESTLESSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEROTONIN SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRITTICO</medicinalproduct>
        <drugauthorizationnumb>18207</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANXIETY DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060303</drugstartdate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SERALIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANXIETY DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060322</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOVAN HCT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BELOC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SERESTA</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055249-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060713</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-13442082</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BREAST CANCER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ESTRACE</medicinalproduct>
        <drugauthorizationnumb>084499</drugauthorizationnumb>
        <drugindication>MENOPAUSAL SYMPTOMS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROVERA</medicinalproduct>
        <drugindication>MENOPAUSAL SYMPTOMS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MEDROXYPROGESTERONE ACETATE</medicinalproduct>
        <drugindication>MENOPAUSAL SYMPTOMS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055250-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060619</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ES-BRISTOL-MYERS SQUIBB COMPANY-13415823</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>73</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MUCOSAL INFLAMMATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VAGINAL INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CISPLATIN</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060526</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060526</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUOROURACIL</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060526</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060526</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GRANISETRON HCL</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE TAB</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NAUSEA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060509</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOFRAN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOFRAN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>STILNOX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060525</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FORTASEC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060527</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060529</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ORFIDAL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060526</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060526</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NAUSEA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LARGACTIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NAUSEA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060531</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EPREX</medicinalproduct>
        <drugindication>ANAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060602</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055251-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060710</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-BRISTOL-MYERS SQUIBB COMPANY-13438460</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>41</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VERTIGO</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIDEX</medicinalproduct>
        <drugauthorizationnumb>20154</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KALETRA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KIVEXA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050821</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055252-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060710</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ES-BRISTOL-MYERS SQUIBB COMPANY-13437165</companynumb>
    <primarysource>
      <reportercountry>SPAIN</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>63</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ORENCIA</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060502</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010308</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19910101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19960101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IRBESARTAN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLINIC ACID</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010308</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055253-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060714</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-13443023</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>59</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLINDNESS UNILATERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBRAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ROAD TRAFFIC ACCIDENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVAPRO</medicinalproduct>
        <drugauthorizationnumb>020757</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVALIDE</medicinalproduct>
        <drugauthorizationnumb>020758</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DILTIAZEM HCL</medicinalproduct>
        <drugdosagetext>DOSE:  120 PM AND 240 AM</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055254-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060615</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>SI-BRISTOL-MYERS SQUIBB COMPANY-13417803</companynumb>
    <primarysource>
      <reportercountry>SLOVENIA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>67</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>101</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DEEP VEIN THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METASTASES TO LIVER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RECTOSIGMOID CANCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPTIC SHOCK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VERTIGO</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>APROVEL TABS 300 MG</medicinalproduct>
        <drugauthorizationnumb>20757</drugauthorizationnumb>
        <drugdosagetext>DOSE INCREASED TO 300 MG ON 03-JAN-2006; REDUCED TO 150 MG DAILY IN MAR-2006</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060511</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>APROVEL TABS 300 MG</medicinalproduct>
        <drugauthorizationnumb>020757</drugauthorizationnumb>
        <drugdosagetext>DOSE INCREASED TO 300 MG ON 03-JAN-2006; REDUCED TO 150 MG DAILY IN MAR-2006</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETIC NEPHROPATHY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060511</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLIBENKLAMID</medicinalproduct>
        <drugdosagetext>LOWERED DOSE FROM 2-2 TO 2-0-1 PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060601</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AGLURAB</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060601</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TERTENSIF</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VASILIP</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DYSLIPIDAEMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OLFEN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATACAND</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051124</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051220</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055255-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060707</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ES-BRISTOL-MYERS SQUIBB COMPANY-13435938</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>75</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>67</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HAEMOPTYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARBOPLATIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060504</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060504</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PACLITAXEL</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060504</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060504</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOXAZOSIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060323</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060323</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANTOPRAZOLE SODIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060323</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE TAB</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PREMEDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060504</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060504</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055256-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060608</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-13406947</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>79</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CHEST DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ORENCIA</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060530</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060530</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROTONIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOVAN HCT</medicinalproduct>
        <drugdosagetext>DOSAGE FORM = 160/12.5 MG</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL SPIROS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SINGULAIR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ECOTRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYLENOL W/ CODEINE NO. 3</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055257-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20051024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IT-BRISTOL-MYERS SQUIBB COMPANY-13155197</companynumb>
    <primarysource>
      <reportercountry>ITALY</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>63</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>HEPATITIS B</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTI-ORGAN FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SECONDARY IMMUNODEFICIENCY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOPHOSPHAMIDE</medicinalproduct>
        <drugauthorizationnumb>12142</drugauthorizationnumb>
        <drugindication>NEPHROTIC SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020501</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugindication>NEPHROTIC SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020501</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055258-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060704</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006077410</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>28</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>LOWER RESPIRATORY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEPO-PROVERA</medicinalproduct>
        <drugauthorizationnumb>20246</drugauthorizationnumb>
        <drugdosagetext>INTRAMUSCULAR</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>CONTRACEPTION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055259-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060714</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-13442769</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>ENDOPHTHALMITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KENALOG-40</medicinalproduct>
        <drugauthorizationnumb>014901</drugauthorizationnumb>
        <drugadministrationroute>031</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055260-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060707</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-13436019</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>75</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALIGNANT NEOPLASM PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARBOPLATIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060605</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060605</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PACLITAXEL</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060605</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060605</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BLINDED: SORAFENIB</medicinalproduct>
        <drugbatchnumb>100227</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060606</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060626</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BLINDED: PLACEBO</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060606</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060606</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ESTRADIOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NIFEDIPINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COMPAZINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORAZEPAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TUSSIONEX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TESSALON</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACTONEL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALOXI</medicinalproduct>
        <drugindication>ANTIEMETIC SUPPORTIVE CARE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060605</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060605</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENADRYL</medicinalproduct>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060605</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060605</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE TAB</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060605</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060605</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZANTAC</medicinalproduct>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060605</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060605</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055261-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060703</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006063774</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>52</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>AUTOIMMUNE THYROIDITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CACHEXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIABETES MELLITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTHYROIDISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugauthorizationnumb>20702</drugauthorizationnumb>
        <drugdosagetext>5-10 MG (1 IN 1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERCHOLESTEROLAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021120</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060506</drugenddate>
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    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055262-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050117</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2005012978</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>38</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>50</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>GASTRIC CANCER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugauthorizationnumb>21156</drugauthorizationnumb>
        <drugdosagetext>800 MG (400 MG, INTERVAL: EVERY DAY), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ADENOMA BENIGN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041218</drugenddate>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANTOLOC (PANTOPRAZOLE)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055263-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
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    <receiptdate>20060703</receiptdate>
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    <companynumb>2006029311</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>71</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>73</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ACUTE CORONARY SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTERIOSCLEROSIS CORONARY ARTERY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL ISCHAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SU-011, 248 (SUNITINIB MALEATE)</medicinalproduct>
        <drugauthorizationnumb>21968</drugauthorizationnumb>
        <drugdosagetext>50 MG (50 MG, 1 IN 1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RENAL CELL CARCINOMA STAGE UNSPECIFIED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060118</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060131</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETYLSALICYLATE LYSINE (ACETYLSALICYLATE LYSINE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EZETIMIBE (EZETIMIBE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ROSUVASTATIN (ROSUVASTATIN)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TELMISARTAN (TELMISARTAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BISOPROLOL FUMARATE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055264-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060703</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006063318</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>73</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>CARDIAC ARREST</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SU-011,248 (SUNITINIB MALATE)</medicinalproduct>
        <drugauthorizationnumb>21968</drugauthorizationnumb>
        <drugdosagetext>50 MG (50 MG, 1 IN 1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RENAL CELL CARCINOMA STAGE UNSPECIFIED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060427</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060508</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VERAPAMIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PERINDOPRIL ERBUMINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRAZOSIN GITS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COD-LIVER OIL (COD-LIVER OIL)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELERY SEED OIL (CELERY SEED OIL)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055265-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060704</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>VISP-UK-0607S-0437</companynumb>
    <primarysource>
      <reportercountry>NORWAY</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>51</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SIALOADENITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VISIPAQUE</medicinalproduct>
        <drugauthorizationnumb>20351</drugauthorizationnumb>
        <drugdosagetext>300 ML, SINGLE DOSE, I.V.</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PERIPHERAL VASCULAR DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051128</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051128</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM CARBONATE (CALCICHEW)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SODIUM BICARBONATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IPRATROPIUM BROMIDE AND ALBUTEROL SODIUM (COMBIVENT)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PULMICORT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARANESP</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALPHACALCIDOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOPICLONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ESOMEPRAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SEVELAMER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>QUININE SULFATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATORVASTATIN CALCIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN SUPPLEMENT (NEPHROVITE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUOXETINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055266-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041227</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL104977</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>73</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>58.1</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DECREASED APPETITE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>P032502</drugbatchnumb>
        <drugindication>MYELODYSPLASTIC SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055267-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060530</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL181406</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>65.8</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugindication>ANAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060526</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055268-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060531</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL181372</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>THERAPEUTIC RESPONSE DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EPOGEN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>DIALYSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055269-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060519</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL180324</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL STIFFNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>PRE-EXISTING DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060504</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055270-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060313</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL172511</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>54</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>P055809</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RENAL FAILURE CHRONIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060215</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055271-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060508</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL179224</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugindication>ANAEMIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055272-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060509</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL179315</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DEEP VEIN THROMBOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugindication>ANAEMIA OF MALIGNANT DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055273-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060510</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL179313</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HEPATIC ENZYME INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>ANAEMIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055274-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060512</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL179857</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugindication>ANAEMIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055275-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060516</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL180000</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>66.7</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>P053966</drugbatchnumb>
        <drugindication>ANAEMIA OF MALIGNANT DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060323</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055276-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060512</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL179866</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugindication>ANAEMIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055277-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060419</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-US176816</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>THERAPEUTIC RESPONSE DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EPOGEN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055278-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060419</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL177031</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>MYELODYSPLASTIC SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060407</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055279-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060418</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL177036</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>89</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugindication>RENAL FAILURE CHRONIC</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055280-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060511</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL179591</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>5</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ESSENTIAL TREMOR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>RENAL FAILURE CHRONIC</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055281-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060508</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-US178789</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>74</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>THERAPEUTIC RESPONSE DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EPOGEN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>DIALYSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055282-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060508</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-US178791</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EPOGEN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>DIALYSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055283-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060510</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL179312</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>BONE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugindication>ANAEMIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055284-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060511</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-US179335</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>49.5</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE CONGESTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THERAPEUTIC RESPONSE DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EPOGEN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>DIALYSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055285-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060421</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL177494</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>86</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POLLAKIURIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>ANAEMIA OF MALIGNANT DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060419</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055286-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060705</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>HQWYE592505JUL06</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>56</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>100</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD SODIUM INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYGACIL</medicinalproduct>
        <drugauthorizationnumb>21821</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ABDOMINAL INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060515</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060520</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYGACIL</medicinalproduct>
        <drugauthorizationnumb>21821</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ABDOMINAL INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060529</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055287-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060421</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL177493</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>63.6</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>ANAEMIA OF MALIGNANT DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055288-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060704</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>13862</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>33</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>49</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ALANINE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASPARTATE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHOTREXATE SODIUM</medicinalproduct>
        <drugauthorizationnumb>11719</drugauthorizationnumb>
        <drugdosagetext>15 G DAILY</drugdosagetext>
        <drugindication>BONE SARCOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060110</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060110</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHOTREXATE SODIUM</medicinalproduct>
        <drugdosagetext>15 G DAILY</drugdosagetext>
        <drugindication>BONE SARCOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060117</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060117</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEYLON</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIAMOX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEOPHAGEN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055289-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060426</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL177950</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>RENAL FAILURE CHRONIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050914</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060123</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055290-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060425</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL177941</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>89.4</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>ANAEMIA OF MALIGNANT DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060327</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055291-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060426</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL178452</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>136.2</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RENAL FAILURE CHRONIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060201</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055292-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060427</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL178462</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>ANAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060301</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055293-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20051201</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL159989</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>61.3</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCORRECT DOSE ADMINISTERED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>P041162,P048586</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055294-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060328</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-US174081</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>62</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CYTOMEGALOVIRUS ANTIBODY POSITIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOLYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THERAPEUTIC RESPONSE DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EPOGEN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>DIALYSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20001201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060301</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEUPOGEN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055295-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060503</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL178668</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>72.6</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>SKIN EXFOLIATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugindication>ANAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060301</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055296-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060508</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL179210</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>RASH PAPULAR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>MYELODYSPLASTIC SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060401</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055297-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060505</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL178974</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <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>PROCRIT</medicinalproduct>
        <drugbatchnumb>P050281,P057726</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>ANAEMIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055298-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060706</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006-01716</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BRADYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CREATININE RENAL CLEARANCE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SICK SINUS SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THERAPEUTIC RESPONSE DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VELCADE</medicinalproduct>
        <drugauthorizationnumb>21602</drugauthorizationnumb>
        <drugindication>MULTIPLE MYELOMA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055299-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060705</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006VX000759</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>64</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIAC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSED LEVEL OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUROLEPTIC MALIGNANT SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PERMAX</medicinalproduct>
        <drugauthorizationnumb>19385</drugauthorizationnumb>
        <drugdosagetext>1750 UG; QD; PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PARKINSON'S DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVODOPA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRAMIPEXOLE DIHYDROCHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SELEGILINE HYDROCHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMANTADINE HCL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055300-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHRM2006FR01984</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>92</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CHOLECYSTITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VISUDYNE</medicinalproduct>
        <drugauthorizationnumb>21119</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NUTRITIONAL SUPPLEMENTS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOXEN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055301-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060622</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>HQWYE081624MAY04</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>53</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>70.1</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHILLS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL INTAKE REDUCED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MYLOTARG</medicinalproduct>
        <drugauthorizationnumb>21174</drugauthorizationnumb>
        <drugdosagetext>15 MG 1X PER 1 DAY, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ACUTE MYELOID LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040503</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040503</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEXAPRO</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACYCLOVIR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOFRAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SODIUM CHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POLYVINYL ALCOHOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PHENERGAN (PROMETHAZINE HYDROCHLORIDE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCONTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCODONE (OXYCODONE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VANCOMYCIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOSYN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SCOPOLAMINE (HYOSCINE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROTONIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIFLUCAN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055302-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060704</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006-07-0092</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>46</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLARITIN REDITABS</medicinalproduct>
        <drugauthorizationnumb>19658</drugauthorizationnumb>
        <drugdosagetext>10 MG ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHINITIS ALLERGIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060630</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060703</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELESTAMINE TAB</medicinalproduct>
        <drugdosagetext>1 TAB ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHINITIS ALLERGIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060630</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060703</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KLARACID TABLETS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055303-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060630</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006001210</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>57</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DERMATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FOLLICULITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERAL PHYSICAL HEALTH DETERIORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEUKOCYTOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TARCEVA</medicinalproduct>
        <drugauthorizationnumb>21743</drugauthorizationnumb>
        <drugdosagetext>150 MG (QD), ORAL; 75 MG (QD), ORAL;  150 MG (QD), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060322</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060406</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AREDIA</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055305-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DSA_28394_2006</companynumb>
    <primarysource>
      <reportercountry>ITALY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>54</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>BLOOD BICARBONATE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CALCIUM INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRADYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ILL-DEFINED DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERICARDIAL EFFUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RADIAL PULSE ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENTRICULAR FIBRILLATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENTRICULAR HYPERTROPHY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE</medicinalproduct>
        <drugauthorizationnumb>19221</drugauthorizationnumb>
        <drugdosagetext>1 DF QD PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060614</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060617</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN B COMPLEX CAP</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055306-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DSA_28211_2006</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>3</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CAESAREAN SECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEEDING DISORDER NEONATAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOKINESIA NEONATAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEONATAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POOR SUCKING REFLEX</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LORAZEPAM</medicinalproduct>
        <drugauthorizationnumb>17794</drugauthorizationnumb>
        <drugdosagetext>1 MG Q DAY TRAN-P</drugdosagetext>
        <drugadministrationroute>064</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060215</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060302</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LORAZEPAM</medicinalproduct>
        <drugdosagetext>1.5 MG Q DAY TRAN-P</drugdosagetext>
        <drugadministrationroute>064</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060303</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060303</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LORAZEPAM</medicinalproduct>
        <drugdosagetext>0.5 MG Q DAY TRAN-P</drugdosagetext>
        <drugadministrationroute>064</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060305</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060308</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LORAZEPAM</medicinalproduct>
        <drugdosagetext>1.5 MG Q DAY TRAN-P</drugdosagetext>
        <drugadministrationroute>064</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060314</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
        <drugdosagetext>10 MG Q DAY TRAN-P</drugdosagetext>
        <drugadministrationroute>064</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060311</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060312</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
        <drugdosagetext>20 MG Q DAY TRAN-P</drugdosagetext>
        <drugadministrationroute>064</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060313</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BENZALIN</medicinalproduct>
        <drugdosagetext>5 MG Q DAY TRAN-P</drugdosagetext>
        <drugadministrationroute>064</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060311</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BENZALIN</medicinalproduct>
        <drugdosagetext>10 MG Q DAY TRAN-P</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LENDORMIN</medicinalproduct>
        <drugdosagetext>0.25 MG Q DAY TRAN-P</drugdosagetext>
        <drugadministrationroute>064</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055307-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060630</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PAR_0697_2006</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>13</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ACUTE RESPIRATORY DISTRESS SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CANDIDIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERSTITIAL LUNG DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OLIGURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHINITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYPNOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
        <drugauthorizationnumb>70481</drugauthorizationnumb>
        <drugdosagetext>DF PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHINITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060610</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>APRANAX</medicinalproduct>
        <drugdosagetext>750 MG QDAY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>TOOTH ABSCESS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060603</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060607</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BIRODOGYL</medicinalproduct>
        <drugdosagetext>DF PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>TOOTH ABSCESS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060603</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060607</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOLIPRANE</medicinalproduct>
        <drugdosagetext>DF PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>COUGH</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060610</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HELICIDINE</medicinalproduct>
        <drugdosagetext>DF PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>COUGH</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060610</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055308-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060511</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>MEDI-0004561</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>4</patientonsetage>
      <patientonsetageunit>802</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEAFNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUID INTAKE REDUCED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NASOPHARYNGITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMOCOCCAL INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SYNAGIS</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050927</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050927</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055309-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006001229</companynumb>
    <primarysource>
      <reportercountry>LEBANON</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>67</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FACE OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENA CAVA THROMBOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TARCEVA</medicinalproduct>
        <drugauthorizationnumb>21743</drugauthorizationnumb>
        <drugdosagetext>100 MG (QD), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>LUNG NEOPLASM MALIGNANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060530</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PHENYTOIN SODIUM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055310-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060703</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>033-14</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>76</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>69</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TEVETEN HCT</medicinalproduct>
        <drugauthorizationnumb>21268</drugauthorizationnumb>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060524</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETYLSALICYLIC ACID SRT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALTACE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATIVAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BISOPROLOL FUMARATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLYCERYL TRINITRATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALENDRONATE SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEO CAT-D</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPEDIT SUPRA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUTICASONE PROPIONATE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055311-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060707</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006-06-1475</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>71</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>79</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TEMODAL</medicinalproduct>
        <drugauthorizationnumb>21029</drugauthorizationnumb>
        <drugdosagetext>205 MG QD ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GLIOBLASTOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060613</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060619</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CONCOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMNIFLORA TABLETS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLEXANE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANTOPRAZOLE SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE TAB</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055312-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060708</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0611734A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>52</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>COAGULOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EXTRAVASATION BLOOD</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PIGMENTATION DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ECOTRIN</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055313-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060710</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0611770A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>47</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRIC PERFORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATEMESIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEAD INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOUTH HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RECTAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ULCER HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WOUND</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GOODY'S</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugindication>TENSION HEADACHE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19760101</drugstartdate>
        <drugtreatmentduration>30</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055314-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060718</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200613844EU</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEPENDENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NICORETTE</medicinalproduct>
        <drugauthorizationnumb>018612</drugauthorizationnumb>
        <drugadministrationroute>002</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060622</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055315-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060718</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0612595A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>64</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DYSPHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRIC ULCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NICORETTE</medicinalproduct>
        <drugbatchnumb>HA956A</drugbatchnumb>
        <drugauthorizationnumb>020066</drugauthorizationnumb>
        <drugdosagetext>4MG SEE DOSAGE TEXT</drugdosagetext>
        <drugadministrationroute>002</drugadministrationroute>
        <drugindication>SMOKING CESSATION THERAPY</drugindication>
        <drugtreatmentduration>10</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055316-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060626</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE200607000248</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>65</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>AGITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEROTONIN SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYPNOREX - SLOW RELEASE (LITHIUM CARBONATE)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055317-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060626</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP200606001231</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>68</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>62.1</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HEPATITIS C</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LISPRO(LISPRO 25LIS75NPL) PEN,DISPOSABLE</medicinalproduct>
        <drugauthorizationnumb>20563</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugindication>DIABETES MELLITUS NON-INSULIN-DEPENDENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051206</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051208</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LISPRO(LISPRO 25LIS75NPL) PEN,DISPOSABLE</medicinalproduct>
        <drugauthorizationnumb>20563</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugindication>DIABETES MELLITUS NON-INSULIN-DEPENDENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051209</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051214</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LISPRO(LISPRO 25LIS75NPL) PEN,DISPOSABLE</medicinalproduct>
        <drugauthorizationnumb>20563</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugindication>DIABETES MELLITUS NON-INSULIN-DEPENDENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051215</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051219</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LISPRO(LISPRO 25LIS75NPL) PEN,DISPOSABLE</medicinalproduct>
        <drugauthorizationnumb>20563</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugindication>DIABETES MELLITUS NON-INSULIN-DEPENDENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051220</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060322</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HUMALOG MIX 25L / 75NPL PEN (HUMALOG MIX 25L / 75NPL PEN)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055318-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060627</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP200606003392</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>63</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>70</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LISPRO(LISPRO 25LI75NPL) CARTRIDGE</medicinalproduct>
        <drugauthorizationnumb>20563</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugindication>DIABETES MELLITUS NON-INSULIN-DEPENDENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050920</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051111</drugenddate>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LISPRO(LISPRO 25LI75NPL) CARTRIDGE</medicinalproduct>
        <drugauthorizationnumb>20563</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugindication>DIABETES MELLITUS NON-INSULIN-DEPENDENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051112</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060216</drugenddate>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX  /SWE/  (FUROSEMIDE)  TABLET</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM POLYSTYRENE SULFONATE (CALCIUM POLYSTYRENE SULFONATE) JELLY</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIFLUCAN (FLUCONAZOLE) CAPSULE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOFLOXACIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BACTRIM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZANTAC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PURSENNID/SCH/ (SENNOSIDE A+B, SENNOSIDE A+B CALCIUM) TABLET</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NINJIN-TO (GINSENG)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055319-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060627</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IT200601001751</companynumb>
    <primarysource>
      <reportercountry>ITALY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>67</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>73.5</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <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 BILIRUBIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC TAMPONADE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATOCRIT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERICARDIAL EFFUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RED BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEMETREXED (PEMETREXED)</medicinalproduct>
        <drugauthorizationnumb>21462</drugauthorizationnumb>
        <drugdosagetext>910 MG INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MESOTHELIOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050812</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CISPLATIN</medicinalproduct>
        <drugdosagetext>136 MG INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MESOTHELIOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050812</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RADIATION (RADIATION)</medicinalproduct>
        <drugdosagetext>DAILY (1/D)</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051109</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051221</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYANOCOBALAMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE TAB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VERAPAMIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMIODARONE HYDROCHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ISOPTIN/GFR/ (VERAPAMIL HYDROCHLORIDE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN W/ CODEINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055320-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BE200604002730</companynumb>
    <primarysource>
      <reportercountry>BELGIUM</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>13</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FALLOPIAN TUBE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAROVARIAN CYST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMATROPE</medicinalproduct>
        <drugbatchnumb>FF5J68B / FF5J68B</drugbatchnumb>
        <drugauthorizationnumb>19640</drugauthorizationnumb>
        <drugdosagetext>DAILY (1/D) SUBCUTANEOUS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>TURNER'S SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051201</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055321-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060627</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA200606005751</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
    </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>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA FACIAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRANSIENT ISCHAEMIC ATTACK</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugbatchnumb>FF5S35E</drugbatchnumb>
        <drugauthorizationnumb>21318</drugauthorizationnumb>
        <drugdosagetext>20 UG DAILY (1/D)</drugdosagetext>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060113</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVAPRO</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055322-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060626</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP200512003648</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>56</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>45</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DISEASE PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JAUNDICE CHOLESTATIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALIGNANT NEOPLASM PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METASTASES TO LIVER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METASTASES TO LYMPH NODES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCREATIC CARCINOMA RECURRENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCREATIC CARCINOMA STAGE IV</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GEMZAR</medicinalproduct>
        <drugauthorizationnumb>20509</drugauthorizationnumb>
        <drugdosagetext>1000 MG/M2, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PANCREATIC CARCINOMA STAGE IV</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UFT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TS1 / JPN / (GIMERACIL OTERACIL POTASSIUM, TEGAFUR)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055323-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060626</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP200605002814</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>58</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ACTIVITIES OF DAILY LIVING IMPAIRED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASCITES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ATELECTASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMPUTERISED TOMOGRAM ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSED LEVEL OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISEASE PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EMPHYSEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRIC ULCER HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GUILLAIN-BARRE SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOREFLEXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG NEOPLASM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METASTASES TO LIVER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULAR WEAKNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEOPLASM PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NERVE CONDUCTION STUDIES ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERIPHERAL MOTOR NEUROPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMOTHORAX</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TUMOUR HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GEMZAR</medicinalproduct>
        <drugauthorizationnumb>20509</drugauthorizationnumb>
        <drugdosagetext>1200 MG, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PANCREATIC CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060426</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060426</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KYTRIL - FOR INFUSION (GRANISETRON HYDROCHLORIDE) INFUSION</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DECADRON #1 (DEXAMETHASONE SODIUM PHOSPHATE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RINDERON (BETAMETHASONE) TABLET</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ETODOLAC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PARIET /JPN/ (RABEPRAZOLE SODIUM)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MUCOSTA (REBAMIPIDE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THEOLONG (THEOPHYLLINE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIROPENT (CLENBUTEROL HYDROCHLORIDE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCONTIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055324-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060703</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>227107</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>52</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>90</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANAPHYLACTIC REACTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MABTHERA(RITUXIMAB) CONC FOR SOLUTION FOR INFUSION</medicinalproduct>
        <drugdosagetext>10 MG, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060411</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060411</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CHLORPHENIRAMINE MALEATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIHYDROCODEINE (DIHYDROCODEINE BITARTRATE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCORTISONE TAB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XENICAL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055325-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060630</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>222422</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>62</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>57</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CYSTITIS HAEMORRHAGIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUID INTAKE REDUCED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATOCRIT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JC VIRUS INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VIRUS URINE TEST POSITIVE</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>785 MG, Q4W, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CHRONIC LYMPHOCYTIC LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051103</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUDARABINE</medicinalproduct>
        <drugdosagetext>40 MG, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CHRONIC LYMPHOCYTIC LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051103</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOPHOSPHAMIDE</medicinalproduct>
        <drugdosagetext>390 MG, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CHRONIC LYMPHOCYTIC LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051103</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060221</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BACTRIM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALTREX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUCONAZOLE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055326-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060626</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>227281</companynumb>
    <primarysource>
      <reportercountry>KOREA, REPUBLIC OF</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUDDEN DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MABTHERA(RITUXIMAB) CONC FOR SOLUTION FOR INFUSION</medicinalproduct>
        <drugdosagetext>656 MG, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>B-CELL LYMPHOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060623</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060623</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYTOXAN</medicinalproduct>
        <drugdosagetext>INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060623</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VINCRISTINE</medicinalproduct>
        <drugdosagetext>INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060623</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055327-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>226480</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>68</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>45.4</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CHEST DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUROPATHY PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STOMATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUPRAVENTRICULAR EXTRASYSTOLES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENTRICULAR EXTRASYSTOLES</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVASTIN</medicinalproduct>
        <drugdosagetext>7.5 MG/KG, Q3W, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLORECTAL CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060511</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CAPECITABINE (CAPECITABINE)</medicinalproduct>
        <drugdosagetext>2000 MG/M2, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>COLORECTAL CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060511</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXALIPLATIN (OXALIPLATIN)</medicinalproduct>
        <drugdosagetext>130 MG/M2, Q32, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLORECTAL CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060511</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055328-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>224447</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>65</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD BILIRUBIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD LACTATE DEHYDROGENASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLD SWEAT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CYANOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATOCRIT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCONTINENCE</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>RESPIRATORY FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHEEZING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HERCEPTIN</medicinalproduct>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060413</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060413</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREMEDICATION DRUGS (ANESTHETIC PREMEDICATION NOS)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SOLU-MEDROL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMINOPHYLLINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOXOPROFEN (LOXOPROFEN SODIUM)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AKINETON</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SODIUM CHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOLOPELON (TIMIPERONE)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055329-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060626</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>224489</companynumb>
    <primarysource>
      <reportercountry>SPAIN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>56</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLINDNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATOTOXICITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OPTIC NEURITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OPTIC NEUROPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HERCEPTIN</medicinalproduct>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020515</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060315</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EPIRUBICIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VINORELBINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAXOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CISPLATIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055330-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>8017587</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>48</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>OBLITERATIVE BRONCHIOLITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>THEOPHYLLINE</medicinalproduct>
        <drugauthorizationnumb>87942</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXYTROPIUM BROMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INHALED CORTICOSTEROID</medicinalproduct>
        <drugdosagetext>INH</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055331-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060712</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006AP03262</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>60</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CRYPTOGENIC ORGANISING PNEUMONIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARIMIDEX</medicinalproduct>
        <drugauthorizationnumb>020541</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051019</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOXONIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051019</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051101</drugenddate>
        <drugtreatmentduration>14</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RADIATION</medicinalproduct>
        <drugdosagetext>50 GY</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051017</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLOMOX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CEFZON</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VOLTAREN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLARITHROMYCIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KYORIN-AP</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BIO THREE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CABAGIN-U</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055332-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060712</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006SE03909</companynumb>
    <primarysource>
      <reportercountry>NORWAY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>50</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ARRHYTHMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTERIOSCLEROSIS CORONARY ARTERY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIOMEGALY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG TOXICITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY CONGESTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugauthorizationnumb>020639</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BIPOLAR DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060201</drugenddate>
        <drugtreatmentduration>14</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALLERGAN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060201</drugenddate>
        <drugtreatmentduration>19</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALPROATE SODIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060201</drugenddate>
        <drugtreatmentduration>19</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055333-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060606</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006UW12550</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>2882</patientonsetage>
      <patientonsetageunit>804</patientonsetageunit>
      <patientweight>25.7</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CATARACT SUBCAPSULAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CORNEAL OPACITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSEUDOPAPILLOEDEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugauthorizationnumb>020639</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>IMPULSIVE BEHAVIOUR</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050420</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060331</drugenddate>
        <drugtreatmentduration>346</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugauthorizationnumb>020639</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANXIETY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050420</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060331</drugenddate>
        <drugtreatmentduration>346</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugauthorizationnumb>020639</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ABNORMAL BEHAVIOUR</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050420</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060331</drugenddate>
        <drugtreatmentduration>346</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CONCERTA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATTENTION DEFICIT/HYPERACTIVITY DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONIDINE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040503</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060615</drugenddate>
        <drugtreatmentduration>833</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RITALIN-SR</medicinalproduct>
        <drugindication>ATTENTION DEFICIT/HYPERACTIVITY DISORDER</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RISPERDAL</medicinalproduct>
        <drugindication>IMPULSIVE BEHAVIOUR</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040803</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050420</drugenddate>
        <drugtreatmentduration>261</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055334-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060706</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>EM2006-0194</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>49</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>75</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANOREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BURKITT'S LYMPHOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHOLESTASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EPSTEIN-BARR VIRUS TEST POSITIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEBRILE BONE MARROW APLASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL NECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERAL PHYSICAL HEALTH DETERIORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYDRONEPHROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERURICAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOKALAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JAUNDICE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALNUTRITION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NIGHT SWEATS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MACROLIN</medicinalproduct>
        <drugbatchnumb>TA9241A</drugbatchnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040705</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040709</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MACROLIN</medicinalproduct>
        <drugbatchnumb>TA9241A</drugbatchnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040906</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040910</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MACROLIN</medicinalproduct>
        <drugbatchnumb>TA9241A</drugbatchnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041103</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041107</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MACROLIN</medicinalproduct>
        <drugbatchnumb>TA9241A</drugbatchnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050105</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050109</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MACROLIN</medicinalproduct>
        <drugbatchnumb>UA3619A</drugbatchnumb>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRUVADA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REYATAZ</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVIR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COMBIVIR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KETOCONAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEBRIDAT ^IBRAHIM^ (TRIMEBUTINE MALEATE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BACTRIM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FASTURTEC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SOLU-MEDROL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEPO-MEDROL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARACYTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYCLOPHOSPHAMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VIREAD</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EMTRIVA</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055335-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU200607001025</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>43</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BREAST CANCER FEMALE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OLANZAPINE</medicinalproduct>
        <drugauthorizationnumb>20592</drugauthorizationnumb>
        <drugdosagetext>10MG,</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055336-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060627</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>SI200604002964</companynumb>
    <primarysource>
      <reportercountry>SLOVENIA</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>16</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>KIDNEY TRANSPLANT REJECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
        <drugauthorizationnumb>20592</drugauthorizationnumb>
        <drugdosagetext>5 MG, UNKNOWN; ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SOMATOFORM DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050801</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SANDIMMUN NEORAL /SWE/ (CICLOSPORIN)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MYCOPHENOLIC ACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALDIZEM (DILTIAZEM)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RANITAL (RANITIDINE)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055337-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-2006-018186</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>BREAST CANCER FEMALE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BETASERON</medicinalproduct>
        <drugdosagetext>SUBCUTANEOUS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055338-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-2006-018185</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>MULTIPLE MYELOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BETASERON</medicinalproduct>
        <drugdosagetext>SUBCUTANEOUS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055339-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060602</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DK-NOVOPROD-255077</companynumb>
    <primarysource>
      <reportercountry>DENMARK</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>58</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>68</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANGINA PECTORIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NOVORAPID FLEXPEN</medicinalproduct>
        <drugauthorizationnumb>20986</drugauthorizationnumb>
        <drugdosagetext>40 U, QD</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>INSULIN-REQUIRING TYPE II DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040819</drugenddate>
        <drugtreatmentduration>415</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NOVORAPID FLEXPEN</medicinalproduct>
        <drugauthorizationnumb>020986</drugauthorizationnumb>
        <drugdosagetext>40 U, QD</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040909</drugenddate>
        <drugtreatmentduration>11520</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NOVORAPID FLEXPEN</medicinalproduct>
        <drugauthorizationnumb>020986</drugauthorizationnumb>
        <drugdosagetext>40 U, QD</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040914</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BLINDED</medicinalproduct>
        <drugdosagetext>1 TAB, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INSULIN-REQUIRING TYPE II DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BLINDED</medicinalproduct>
        <drugdosagetext>2 TAB, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARDIL</medicinalproduct>
        <drugdosagetext>120 MG, QD</drugdosagetext>
        <drugindication>ANGINA PECTORIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19930101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENALAPRIL MALEATE</medicinalproduct>
        <drugdosagetext>10 MG, QD</drugdosagetext>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FURIX</medicinalproduct>
        <drugdosagetext>40 MG, QD</drugdosagetext>
        <drugindication>OEDEMA PERIPHERAL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19930101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040801</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FURIX</medicinalproduct>
        <drugdosagetext>80 MG, QD</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050501</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGNYL                             /00002701/</medicinalproduct>
        <drugdosagetext>75 MG, QD</drugdosagetext>
        <drugindication>THROMBOSIS PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19930101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOPID</medicinalproduct>
        <drugdosagetext>600 MG, QD</drugdosagetext>
        <drugindication>HYPERCHOLESTEROLAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19930101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040623</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NOBLIGAN</medicinalproduct>
        <drugdosagetext>150 MG, QD</drugdosagetext>
        <drugindication>ARTHRALGIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
        <drugdosagetext>1000 MG, QD</drugdosagetext>
        <drugindication>ARTHRALGIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SEREPAX</medicinalproduct>
        <drugdosagetext>15 MG, QD</drugdosagetext>
        <drugindication>NERVOUSNESS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19930101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRADOLAN</medicinalproduct>
        <drugdosagetext>150 MG, QD</drugdosagetext>
        <drugindication>PAIN IN EXTREMITY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031107</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051117</drugenddate>
        <drugtreatmentduration>741</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugdosagetext>20 MG, QD</drugdosagetext>
        <drugindication>HYPERCHOLESTEROLAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040624</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050526</drugenddate>
        <drugtreatmentduration>336</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055340-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060710</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20060702196</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>24</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEPENDENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EPISTAXIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHINORRHOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXTRA STRENGTH TYLENOL</medicinalproduct>
        <drugbatchnumb>LMA119</drugbatchnumb>
        <drugdosagetext>2 DOSES AT BEDTIME, AS NEEDED (4 TIMES PER WEEK)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEADACHE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055341-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060713</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20060703039</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HEPATIC CIRRHOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXTRA STRENGTH TYLENOL</medicinalproduct>
        <drugauthorizationnumb>019872</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXTRA STRENGTH TYLENOL</medicinalproduct>
        <drugauthorizationnumb>019872</drugauthorizationnumb>
        <drugdosagetext>^RECOMMMENDED DOSE^</drugdosagetext>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055342-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-2006-017096</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>38</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ABASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRONCHOPNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BETASERON</medicinalproduct>
        <drugdosagetext>UNK MIU, 3X/WEEK, SUBCUTANEOUS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060616</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055343-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060626</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006RR-02863</companynumb>
    <primarysource>
      <reportercountry>SWITZERLAND</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>67</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MUSCULAR WEAKNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOSITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SIMVASTATIN (SIMVASTATIN) TABLET</medicinalproduct>
        <drugauthorizationnumb>76285</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERCHOLESTEROLAEMIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055344-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006RR-02838</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>74</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANGIONEUROTIC OEDEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugauthorizationnumb>76285</drugauthorizationnumb>
        <drugdosagetext>20 MG, BID; ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MALLORY-WEISS SYNDROME</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugdosagetext>40 MG,</drugdosagetext>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060510</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADCAL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BISOPROLOL FUMARATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARBOCYSTEINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RAMIPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TEGRETOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055345-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060626</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006RR-02853</companynumb>
    <primarysource>
      <reportercountry>ITALY</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>55</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>NIGHTMARE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESTLESSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SLEEP DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SIMVASTATIN FAMILY (SIMVASTATIN) TABLET, 10MG</medicinalproduct>
        <drugauthorizationnumb>76285</drugauthorizationnumb>
        <drugdosagetext>10 MG, QD; ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERCHOLESTEROLAEMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
        <drugdosagetext>100 MG, BID; ORAL, 50 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugtreatmentduration>91</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NIFEDIPINE FAMILY (NIFEDIPINE) TABLET 60 MG</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRAVASTATIN FAMILY (PRAVASTATIN) TABLET, 20 MG</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055346-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060718</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>58</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>159</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HAEMATOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
        <drugdosagetext>6MG QD PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055347-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060718</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>46</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>62.5964</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CEREBRAL PALSY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENTAL RETARDATION SEVERITY UNSPECIFIED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TEGRETOL-XR</medicinalproduct>
        <drugdosagetext>40 MG BID PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONVULSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DILANTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEPAKOTE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055348-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060718</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>57</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ORTHOSTATIC HYPOTENSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
        <drugdosagetext>40 MG QD</drugdosagetext>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19950301</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BACLOFEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORTAB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIAZEPAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GABAPENTIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055349-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060718</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>87</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BRADYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
        <drugdosagetext>50 MG BID</drugdosagetext>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040501</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRAMADOL HCL</medicinalproduct>
        <drugdosagetext>50 MG TID PRN</drugdosagetext>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060404</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BACLOFEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ISOSORBIDE DINITRATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOSINOPRIL SODIUM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055350-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060703</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006_000019</companynumb>
    <primarysource>
      <reportercountry>POLAND</reportercountry>
    </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>DISORIENTATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISTURBANCE IN ATTENTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EXTRAPYRAMIDAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HALLUCINATION, VISUAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENINGISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NERVOUS SYSTEM DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEPOCYT</medicinalproduct>
        <drugauthorizationnumb>21041</drugauthorizationnumb>
        <drugdosagetext>50 MG; X1; INTH</drugdosagetext>
        <drugadministrationroute>037</drugadministrationroute>
        <drugindication>NERVOUS SYSTEM DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060428</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060428</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NYSTATIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUCONAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNSPECIFIED CORTICOSTEROIDS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055351-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060703</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006S1000162</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>60</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ALOPECIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLISTER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEILITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONJUNCTIVITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISEASE RECURRENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ECZEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EPISTAXIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTRICHOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIP BLISTER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROCTITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RECTAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACITRETIN</medicinalproduct>
        <drugauthorizationnumb>19821</drugauthorizationnumb>
        <drugdosagetext>20 MG, QD; PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CUTANEOUS LUPUS ERYTHEMATOSUS</drugindication>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROXYCHLOROQUINE SULFATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>STEROIDS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055352-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060705</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>14353</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>80</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>COMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUOROURACIL</medicinalproduct>
        <drugauthorizationnumb>8107</drugauthorizationnumb>
        <drugindication>COLON CANCER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEUCOVORIN CALCIUM</medicinalproduct>
        <drugindication>COLON CANCER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXALIPLATIN</medicinalproduct>
        <drugindication>COLON CANCER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055353-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060702</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>14342</companynumb>
    <primarysource>
      <reportercountry>ICELAND</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CRYPTOGENIC ORGANISING PNEUMONIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMIODARONE HCL</medicinalproduct>
        <drugauthorizationnumb>76108</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055354-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>14385</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>64</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANAESTHETIC COMPLICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAPHYLACTOID SHOCK</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ATRACURIUM</medicinalproduct>
        <drugauthorizationnumb>74740</drugauthorizationnumb>
        <drugdosagetext>0.5 MG/KG ONCE IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>GENERAL ANAESTHESIA</drugindication>
        <drugtreatmentduration>90</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MIDAZOLAM HYDROCHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FENTANYL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIPRIVAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRACRIUM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055355-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060710</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-06P-163-0337993-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>68.1</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>APHASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041206</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060614</drugenddate>
        <drugtreatmentduration>554</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>FOLIC ACID</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE TAB</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NAPROXEN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RAMIPRIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONIDINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARBAMAZEPINE</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>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FEMERA</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNSPECIFIED MEDICATION</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055356-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060614</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-ABBOTT-06P-167-0336115-00</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>92</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ACUTE MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTERIOSCLEROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEFT VENTRICULAR FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051031</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060215</drugenddate>
        <drugtreatmentduration>107</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE SODIUM</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>INDOMETHACIN</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN W/ CODEINE</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055357-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060405</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ES-ABBOTT-06P-144-0330120-01</companynumb>
    <primarysource>
      <reportercountry>SPAIN</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>80</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>LYMPHADENOPATHY MEDIASTINAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POLYMERASE CHAIN REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RED BLOOD CELL SEDIMENTATION RATE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPUTUM CULTURE POSITIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050225</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060227</drugenddate>
        <drugtreatmentduration>367</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEFLAZACORT</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19900101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NIFEDIPINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19870501</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MODURETIC 5-50</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000120</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PARACETAMOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000514</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELECOXIB</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010220</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETYLSALICYLIC ACID SRT</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000708</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCEVITA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>STEROID THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19900520</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS AGAINST GASTROINTESTINAL ULCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19900520</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COMMERCIAL HUMIRA</medicinalproduct>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040322</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ISONIAZID</medicinalproduct>
        <drugindication>ANTIBIOTIC PROPHYLAXIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055358-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060710</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-ABBOTT-06P-028-0337962-00</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>95.34</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY BYPASS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060505</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLYCERYL TRINITRATE</medicinalproduct>
        <drugdosagetext>PATCH</drugdosagetext>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATORVASTATIN CALCIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KARVEA HCT</medicinalproduct>
        <drugdosagetext>150/12.5 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BISOPROLOL FUMARATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETYLSALICYLIC ACID SRT</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055359-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060707</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>14370</companynumb>
    <primarysource>
      <reportercountry>KOREA, DEMOCRATIC PEOPLE'S REPUBLIC OF</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>46</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANAPLASTIC LARGE CELL LYMPHOMA T- AND NULL-CELL TYPES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASCITES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COSTOVERTEBRAL ANGLE TENDERNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATOSPLENOMEGALY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPHADENOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPHADENOPATHY MEDIASTINAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLEURAL EFFUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RED BLOOD CELL SEDIMENTATION RATE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugauthorizationnumb>11719</drugauthorizationnumb>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SULFASALAZINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROXYCHLOROQUINE SULFATE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055360-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060321</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GR-ABBOTT-06P-066-0328834-00</companynumb>
    <primarysource>
      <reportercountry>GREECE</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>68</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MONONEUROPATHY MULTIPLEX</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050613</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060127</drugenddate>
        <drugtreatmentduration>228</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PARACETAMOL</medicinalproduct>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugindication>ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM GLUCONATE</medicinalproduct>
        <drugindication>OSTEOPOROSIS PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE TAB</medicinalproduct>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055361-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060509</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ABBOTT-06P-087-0332951-00</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC ENZYME INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLAMMATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRANSAMINASES INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KLARICID</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>50662</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BRONCHITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060403</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060412</drugenddate>
        <drugtreatmentduration>9</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CEFTRIAXONE SODIUM</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BRONCHITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060403</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060412</drugenddate>
        <drugtreatmentduration>9</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOSFOMYCIN</medicinalproduct>
        <drugindication>ANTIBIOTIC PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060412</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060421</drugenddate>
        <drugtreatmentduration>9</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CIPROFLOXACIN</medicinalproduct>
        <drugindication>ANTIBIOTIC PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060422</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060424</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>DIABETES MELLITUS MANAGEMENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060425</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLICLAZIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS MANAGEMENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19930117</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060425</drugenddate>
        <drugtreatmentduration>13</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HCL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS MANAGEMENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19930117</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060425</drugenddate>
        <drugtreatmentduration>13</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055362-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060707</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ABBOTT-06P-087-0338116-00</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>48</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>38.8</patientweight>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>AGRANULOCYTOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISSEMINATED INTRAVASCULAR COAGULATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HISTIOCYTOSIS HAEMATOPHAGIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMMUNE SYSTEM DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOBAR PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENINGITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPTIC SHOCK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYSTEMIC INFLAMMATORY RESPONSE SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLARITHROMYCIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>050662</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BRONCHITIS ACUTE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050717</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050718</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLARITHROMYCIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>050662</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050723</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050724</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CEFCAPENE PIVOXIL HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BRONCHITIS ACUTE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050712</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050716</drugenddate>
        <drugtreatmentduration>4</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>PHENYTOIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>EPILEPSY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARBAMAZEPINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>EPILEPSY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN</medicinalproduct>
        <drugadministrationroute>050</drugadministrationroute>
        <drugindication>DIABETES MELLITUS NON-INSULIN-DEPENDENT</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055363-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20010919</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ABBOTT-01P-087-0111165-00</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ALANINE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASPARTATE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD BILIRUBIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC FUNCTION ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SENSORY DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWELLING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NORVIR</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>20945</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000425</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050328</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KALETRA</medicinalproduct>
        <drugauthorizationnumb>021226</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050329</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZIDOVUDINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19991213</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZIDOVUDINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19991101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19991212</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMIVUDINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19991101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INDINIVIR SULFATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000425</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050328</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INDINIVIR SULFATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS AGAINST DIARRHOEA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19991101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20000424</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055364-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050721</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-ABBOTT-05P-056-0306368-00</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>63</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>TUBERCULOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050623</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE TAB</medicinalproduct>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RISEDRONATE SODIUM</medicinalproduct>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROXYCHLOROQUINE</medicinalproduct>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040901</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TERBUTALINE SULFATE</medicinalproduct>
        <drugindication>ASTHMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031030</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055365-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060704</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ABBOTT-06P-087-0337494-00</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ELECTROENCEPHALOGRAM ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KLARICID</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>50662</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERSENSITIVITY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060630</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060703</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BETAMETHASONE/D-CHLORPHENIRAMINE MALEATE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERSENSITIVITY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060630</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060703</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LORATADINE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERSENSITIVITY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060630</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060703</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LORATADINE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN CAP</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERSENSITIVITY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060630</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060703</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>B-KOMPLEX ^LECIVA^</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONVULSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060703</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060703</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIAZEPAM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONVULSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060703</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060703</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055366-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060712</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ABBOTT-06P-087-0337950-00</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>70</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>54</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD CREATININE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD UREA INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEPHROTIC SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CEFZON</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>50739</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRAMIPEXOLE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PARKINSON'S DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DICLOFENAC</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TALIPEXOLE HYDROCHLORIDE</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REBAMIPIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVODOPA</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SELEGILINE HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOMPERIDONE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ETIZOLAM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AZOSEMIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055367-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20010524</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ABBOTT-01P-087-0107353-00</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ACUTE ABDOMEN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AFFECT LABILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CREATINE PHOSPHOKINASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRY SKIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NORVIR</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>20945</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000113</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20000118</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NORVIR</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020945</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000119</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010805</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NORVIR</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020945</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20011023</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041111</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NORVIR</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020945</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050315</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KALETRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021226</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010806</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20011014</drugenddate>
        <drugtreatmentduration>69</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIDANOSINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19991230</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIDANOSINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000113</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20000805</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIDANOSINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20011023</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIDANOSINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>STAVUDINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19991230</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>STAVUDINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000113</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010805</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>STAVUDINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20011015</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20011016</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INDINIVIR SULFATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19991230</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INDINIVIR SULFATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000119</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010805</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SAQUINAVIR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000113</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20000118</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SAQUINAVIR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20011023</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041111</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMIVUDINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20011023</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ABACAVIR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010806</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20011016</drugenddate>
        <drugtreatmentduration>71</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ATAZANAVIR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041112</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050314</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ATAZANAVIR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050315</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMPRENAVIR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20011015</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20011016</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EFAVIRENZ</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010806</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010930</drugenddate>
        <drugtreatmentduration>68</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EFAVIRENZ</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20011001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20011014</drugenddate>
        <drugtreatmentduration>68</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OCTOCOG ALFA</medicinalproduct>
        <drugindication>FACTOR VIII DEFICIENCY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19991101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19991206</drugenddate>
        <drugtreatmentduration>35</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RURIOCTOCOG ALFA</medicinalproduct>
        <drugindication>FACTOR VIII DEFICIENCY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19991207</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20000926</drugenddate>
        <drugtreatmentduration>293</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTIHEMOPHILIC FACTOR (HUMAN)</medicinalproduct>
        <drugindication>FACTOR VIII DEFICIENCY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000927</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTIVITAMIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000608</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERURICAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000829</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041104</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FAMOTIDINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTRIC ULCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040223</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041111</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FAMOTIDINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050118</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANSOPRAZOLE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTRIC ULCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041019</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041111</drugenddate>
        <drugtreatmentduration>23</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TEPRENONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTRIC ULCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041019</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRONOLACTONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEHYDRATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041109</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOPICLONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INSOMNIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050322</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055368-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060710</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>14366</companynumb>
    <primarysource>
      <reportercountry>SWITZERLAND</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>56</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>76</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>C-REACTIVE PROTEIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHILLS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHOLANGITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHOLECYSTITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUOROURACIL</medicinalproduct>
        <drugauthorizationnumb>8107</drugauthorizationnumb>
        <drugdosagetext>375 MG/M2 DAILY IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BILIARY NEOPLASM</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060424</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEUCOVORIN CALCIUM</medicinalproduct>
        <drugdosagetext>25 MG/M2 DAILY IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BILIARY NEOPLASM</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060424</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METAMIZOLE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055369-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2006HR09738</companynumb>
    <primarysource>
      <reportercountry>CROATIA (local name: Hrvatska)</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>30</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTERIOSCLEROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BILE DUCT OBSTRUCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BILIARY DILATATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BILIARY TRACT DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLINDNESS UNILATERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD ALKALINE PHOSPHATASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CHOLESTEROL INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CREATININE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD TRIGLYCERIDES INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD URIC ACID INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>C-REACTIVE PROTEIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHILLS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHOLANGITIS CHRONIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHOLECYSTITIS CHRONIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHOLELITHIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DILATATION INTRAHEPATIC DUCT ACQUIRED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATOCRIT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RED BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RED BLOOD CELL SEDIMENTATION RATE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RETICULOCYTE COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RETINAL VEIN THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOSPORINE</medicinalproduct>
        <drugauthorizationnumb>80336</drugauthorizationnumb>
        <drugdosagetext>100  MG,  BID</drugdosagetext>
        <drugindication>RENAL TRANSPLANT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AZATHIOPRINE</medicinalproduct>
        <drugindication>RENAL TRANSPLANT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISONE TAB</medicinalproduct>
        <drugindication>RENAL TRANSPLANT</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055370-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060718</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>79</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXYCONTIN</medicinalproduct>
        <drugdosagetext>80 MG Q8H</drugdosagetext>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000501</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYOSCYAMINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TERAZOSIN HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMIODARONE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLIPIZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ISOSORBIDE DINITRATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055371-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060509</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-13372651</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>75</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ERBITUX</medicinalproduct>
        <drugbatchnumb>06C0023B</drugbatchnumb>
        <drugdosagetext>LOADING DOSE OF 900 MG/EVENTS OCCURRED TWO MINUTES INTO THE INFUSION.</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLORECTAL CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060501</drugenddate>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENADRYL</medicinalproduct>
        <drugindication>PREMEDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
        <drugindication>PREMEDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATROPINE</medicinalproduct>
        <drugindication>PREMEDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANZEMET</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CAMPTOSAR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEUCOVORIN CALCIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVASTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DECADRON</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLYBURIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOPHAGE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRONOLACTONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACTOS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENICAR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUOROURACIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIGOXIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055372-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060619</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-BRISTOL-MYERS SQUIBB COMPANY-13418173</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>49</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>96</patientweight>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>BONE MARROW FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBRAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ETOPOPHOS</medicinalproduct>
        <drugauthorizationnumb>20457</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NON-HODGKIN'S LYMPHOMA RECURRENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060429</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060505</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENDOXAN</medicinalproduct>
        <drugauthorizationnumb>012142</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NON-HODGKIN'S LYMPHOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060119</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060328</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARACYTINE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NON-HODGKIN'S LYMPHOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060118</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060503</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugauthorizationnumb>086358</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NON-HODGKIN'S LYMPHOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060118</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060428</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOXORUBICIN HCL</medicinalproduct>
        <drugauthorizationnumb>062926</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NON-HODGKIN'S LYMPHOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060119</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060328</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VINCRISTINE</medicinalproduct>
        <drugauthorizationnumb>070867</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NON-HODGKIN'S LYMPHOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060119</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060328</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MABTHERA</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NON-HODGKIN'S LYMPHOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060119</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060428</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055373-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060718</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>40</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DUODENITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
        <drugdosagetext>800 MG TID</drugdosagetext>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PAROXETINE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLMITRIPTAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYCLOBENZAPRINE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORATADINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055380-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060718</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>66</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FEBRILE NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUDARABINE</medicinalproduct>
        <drugdosagetext>50 MG</drugdosagetext>
        <drugindication>NEOPLASM MALIGNANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060405</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060408</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MITOXANTRONE</medicinalproduct>
        <drugdosagetext>20 MG</drugdosagetext>
        <drugindication>NEOPLASM MALIGNANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060405</drugstartdate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055381-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060602</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-NOVOPROD-253848</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>65</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>72</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BILIARY CYST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC NEOPLASM MALIGNANT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PORTAL VEIN THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL NEOPLASM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NOVOSEVEN</medicinalproduct>
        <drugdosagetext>600 UG/KG, UNK</drugdosagetext>
        <drugindication>UPPER GASTROINTESTINAL HAEMORRHAGE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060523</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060524</drugenddate>
        <drugtreatmentduration>1200</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SANDOSTATINE                       /00821001/</medicinalproduct>
        <drugdosagetext>1200 UG, QD</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060523</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060528</drugenddate>
        <drugtreatmentduration>7200</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLAFORAN</medicinalproduct>
        <drugdosagetext>3 G, QD</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060524</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060526</drugenddate>
        <drugtreatmentduration>2880</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NOROXIN</medicinalproduct>
        <drugdosagetext>400 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060526</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055382-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060711</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2006-BP-07900AU</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>90</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FACE OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIP EXFOLIATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA ORAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MOBIC</medicinalproduct>
        <drugbatchnumb>NR</drugbatchnumb>
        <drugauthorizationnumb>20938</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051205</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051206</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DITHIAZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EPILIM EC (SODIUM VALPROATE)</medicinalproduct>
        <drugindication>EPILEPSY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OROXINE</medicinalproduct>
        <drugindication>HYPOTHYROIDISM</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055383-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060704</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2006-BP-07623NB</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>29</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MEXITIL</medicinalproduct>
        <drugauthorizationnumb>18873</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CARDIAC FAILURE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060523</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060608</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MEXITIL</medicinalproduct>
        <drugauthorizationnumb>018873</drugauthorizationnumb>
        <drugindication>EXTRASYSTOLES</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARICEPT</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060223</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLIMICRON</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041124</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041124</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANIRAPID</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041124</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060607</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALDACTONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041124</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060607</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIGOXIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060608</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055384-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2006-BP-07475BP</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>GASTRIC BYPASS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIRAPEX</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>20667</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055385-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060418</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2006-BP-04391BP</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>85</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE CONGESTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLOMAX</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>20579</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BENIGN PROSTATIC HYPERPLASIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN</medicinalproduct>
        <drugindication>HYPERGLYCAEMIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055386-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060711</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2006-BP-08013BP</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORTHOSTATIC HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VERTIGO</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL DISTURBANCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIRAPEX</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>020667</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PARKINSON'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060601</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMANTADINE HCL</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060301</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
        <drugindication>BLOOD PRESSURE</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060601</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055387-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060116</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2006-BP-00536BP</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ADVERSE DRUG REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AGITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>APHONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPHONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROOESOPHAGEAL REFLUX DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HIATUS HERNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LARYNGITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NASOPHARYNGITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUROPATHY PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OESOPHAGEAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THERMAL BURN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>21395</drugauthorizationnumb>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060115</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SINGULAIR</medicinalproduct>
        <drugindication>ASTHMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADVAIR DISKUS 100/50</medicinalproduct>
        <drugindication>ASTHMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLEGRA</medicinalproduct>
        <drugindication>ASTHMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RELAFEN</medicinalproduct>
        <drugindication>BACK PAIN</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055388-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060705</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2006-CN-00347CN</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>ACNE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TIPRANAVIR + RITONAVIR CO-ADMIN</medicinalproduct>
        <drugauthorizationnumb>21814</drugauthorizationnumb>
        <drugindication>ACQUIRED IMMUNODEFICIENCY SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060501</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VIDEX EC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LAMIVUDINE</medicinalproduct>
        <drugdosagetext>150 MG BID</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVIR</medicinalproduct>
        <drugdosagetext>200 MG BID</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VFEND</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DARAPRIM/DAPSONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEUCOVORIN CALCIUM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055389-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060523</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2006-BP-05942NB</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>66.5</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>INTERSTITIAL LUNG DISEASE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MICARDIS</medicinalproduct>
        <drugauthorizationnumb>20850</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060424</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060430</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZITHROMAC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLOMOX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PHARYNGITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060411</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060413</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVELOX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PHARYNGITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060417</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060421</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055390-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060712</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2006-BP-08011BP</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>EOSINOPHILIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH GENERALISED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIRAPEX</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>020667</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055391-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060413</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2006-BP-04223BP</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>51</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>RECTAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VAGINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AGGRENOX</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>20884</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>TRANSIENT ISCHAEMIC ATTACK</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060330</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AGGRENOX</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>020884</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COZAAR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPROL-XL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FORTAMET</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACTOS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLIMEPIRIDE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055392-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060228</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2006-BP-02755NB</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>51</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
        <drugauthorizationnumb>21395</drugauthorizationnumb>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>EMPHYSEMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051214</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060103</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIROPENT</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19900101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNIPHYL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19900101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SINGULAIR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19900101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUTIDE</medicinalproduct>
        <drugadministrationroute>055</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19900101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROCATEROL HCL</medicinalproduct>
        <drugadministrationroute>055</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19900101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROCATEROL HCL</medicinalproduct>
        <drugadministrationroute>055</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19900101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INTAL</medicinalproduct>
        <drugadministrationroute>055</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19900101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PENMALIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051212</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051231</drugenddate>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZITHROMAC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051230</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051231</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055393-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060718</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>72</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORTHOSTATIC HYPOTENSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRAMIPEXOLE DIHYDROCHLORIDE</medicinalproduct>
        <drugdosagetext>0.125 MG BID</drugdosagetext>
        <drugindication>RESTLESS LEGS SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055394-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060713</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CH-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2006-DE-03588SI</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>1</patientsex>
      <reaction>
        <reactionmeddrapt>PENIS DEVIATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRADIF</medicinalproduct>
        <drugauthorizationnumb>20579</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030901</drugstartdate>
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    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055395-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2006-CN-00065CN</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>95.25</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MICARDIS HCT</medicinalproduct>
        <drugauthorizationnumb>21162</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050526</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051215</drugenddate>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RAMIPRIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASK</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051205</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055396-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060714</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2006-DE-03616DE</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>SIFROL</medicinalproduct>
        <drugauthorizationnumb>20667</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>L-DOPA</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055399-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060718</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>67</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ACUTE RESPIRATORY FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LETHARGY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MORPHINE</medicinalproduct>
        <drugdosagetext>9.5 MG /DAY CI</drugdosagetext>
        <drugindication>PAIN</drugindication>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FINASTERIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ORLISTAT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORAZEPAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FELODIPINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RANITIDINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ISOSORBIDE DINITRATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055401-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060718</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>83</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GLYBURIDE</medicinalproduct>
        <drugdosagetext>5 MG BID</drugdosagetext>
        <drugindication>DIABETES MELLITUS NON-INSULIN-DEPENDENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030901</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCITOSIN NASAL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEGESTROL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055402-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060718</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>79</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
        <drugdosagetext>40 MG QD</drugdosagetext>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19950101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugdosagetext>10 MG QD</drugdosagetext>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIGOXIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DILTIAZEM HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GEMFIBROZIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055403-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060718</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>55</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HYPOKALAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
        <drugdosagetext>60 MG BID</drugdosagetext>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19970601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMIODARONE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIGOXIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOSINOPRIIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDRALAZINE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORTAB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ISOSORBIDE DINITRATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRONOLACTONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RISPERDAL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055404-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060718</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>68</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSINOPRIL SODIUM</medicinalproduct>
        <drugdosagetext>40 MG BID</drugdosagetext>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19960401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCITRIOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FELODIPINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOPERAMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PERECOCET</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NPH INSULIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055405-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060718</receiptdate>
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    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>61</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>INTERNATIONAL NORMALISED RATIO INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
        <drugdosagetext>4 MG QD</drugdosagetext>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIGOXIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENALAPRIL MALEATE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055407-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060718</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>56</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISION BLURRED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHLORDIAZEPOXIDE</medicinalproduct>
        <drugdosagetext>50 MG X 3 DAY AND 25 MG X 3 DYS</drugdosagetext>
        <drugindication>ALCOHOL DETOXIFICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060501</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GABAPENTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NPH INSULIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ISOSORBIDE DINITRATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055408-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060718</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>76</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HYPOGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ROSIGLITAZONE</medicinalproduct>
        <drugdosagetext>2 MG BID</drugdosagetext>
        <drugindication>DIABETES MELLITUS NON-INSULIN-DEPENDENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GLIPIZIDE</medicinalproduct>
        <drugdosagetext>5 MG QD</drugdosagetext>
        <drugindication>DIABETES MELLITUS NON-INSULIN-DEPENDENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060324</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
        <drugdosagetext>1000 MG BID</drugdosagetext>
        <drugindication>DIABETES MELLITUS NON-INSULIN-DEPENDENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19961101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SERTRALINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM ACETATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REGULAR INSULIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEGESTROL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMIODARONE HCL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055409-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060718</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INCORRECT DOSE ADMINISTERED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALBUTEROL SULFATE</medicinalproduct>
        <drugdosagetext>2 PUFF 4 TIMES A DAY</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060605</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055410-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060717</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>35</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>73.9</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SIMILAR REACTION ON PREVIOUS EXPOSURE TO DRUG</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWELLING FACE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROAT IRRITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHEEZING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROTONIX</medicinalproduct>
        <drugdosagetext>PO     (THERAPY DATES: PAST 2 WEEKS)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTROOESOPHAGEAL REFLUX DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugdosagetext>PO    (THERAPY DATES: PAST 2 WEEKS)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTROOESOPHAGEAL REFLUX DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NASONEX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MIRALAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZELNORM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARAFATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMBIEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PEPCID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMITREX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055411-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060717</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>85</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>70.3075</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CONTUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERNATIONAL NORMALISED RATIO INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL INTAKE REDUCED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
        <drugdosagetext>5MG PO DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PHENERGAN HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NITROGLYCERIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLIPIZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KLOR-CON</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055412-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060717</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>66</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>56.2</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ACCIDENTAL OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENTAL STATUS CHANGES</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXYCODONE AND ACETAMINOPHEN</medicinalproduct>
        <drugdosagetext>1-2 Q4H PRN PAIN  (THERAPY DATES: CHRONIC)</drugdosagetext>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLONAZEPAM</medicinalproduct>
        <drugdosagetext>1 MG PO BID   (THERAPY DATES: CHRONIC)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANXIETY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DILTIAZEM HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEGACE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROMETHAZINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM CHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIGITOXIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055413-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060717</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>69</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>82</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BRADYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STOMACH DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREATMENT NONCOMPLIANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROPRANOLOL</medicinalproduct>
        <drugdosagetext>20MG (?) X 1 DOSE  4/17  (STOP 3 WKS AGO, TOOK __)</drugdosagetext>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060417</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KLONOPIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WELLBUTRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZETIA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055414-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060717</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>79</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WRONG DRUG ADMINISTERED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KLONOPIN</medicinalproduct>
        <drugdosagetext>2MG  PO    (DURATION: OTO)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>WRONG DRUG ADMINISTERED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LITHIUM CARBONATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REGLAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONAZEPAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COLACE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLYCOLAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COMBIVENT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GABAPENTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GENEBS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055415-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060717</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>55</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEEP VEIN THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAMOXIFEN CITRATE</medicinalproduct>
        <drugdosagetext>20MG  PO  BID   (DURATION: SINCE 2002)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VYTORIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM GLUCONATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACTONEL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREVACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VERAPAMIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AGGRENOX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYZAAR</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055416-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060717</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>74</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>101</patientweight>
      <reaction>
        <reactionmeddrapt>DEEP VEIN THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POST PROCEDURAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENTRICULAR TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENOXAPARIN SODIUM</medicinalproduct>
        <drugdosagetext>100MG  SQ Q12H</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>DEEP VEIN THROMBOSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060330</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060331</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENOXAPARIN SODIUM</medicinalproduct>
        <drugdosagetext>100MG  SQ Q12H</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PULMONARY EMBOLISM</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060330</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060331</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
        <drugdosagetext>5MG  PO  DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEEP VEIN THROMBOSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060330</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060331</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
        <drugdosagetext>5MG  PO  DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY EMBOLISM</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060330</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060331</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EZETIMIBE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEXILITINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RAMIPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALDACTONE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055417-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060717</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>80</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>70.9</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HAEMATOCRIT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POST PROCEDURAL COMPLICATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FONDAPARINUX</medicinalproduct>
        <drugdosagetext>2.5MG  SQ DAILY</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>ANTICOAGULANT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060404</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FONDAPARINUX</medicinalproduct>
        <drugdosagetext>2.5MG  SQ DAILY</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>ANTICOAGULANT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060405</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARTIA XT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLOMAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPROL-XL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYLENOL (CAPLET)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055418-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060703</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AT200606003023</companynumb>
    <primarysource>
      <reportercountry>AUSTRIA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>16</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>LEUKOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RED BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
        <drugauthorizationnumb>20592</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANOREXIA NERVOSA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040517</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040618</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
        <drugauthorizationnumb>20592</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANOREXIA NERVOSA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040619</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040620</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
        <drugauthorizationnumb>20592</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANOREXIA NERVOSA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040621</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040802</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
        <drugauthorizationnumb>20592</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANOREXIA NERVOSA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040803</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAZODONE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONAZEPAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENEFIBER (GUAR GUM)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CAL-D-VITA (CALCIUM CARBONATE, COLECALCIFEROL)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAXI-KALZ (CALCIUM CITRATE)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055419-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060717</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>80.5</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE SYSTOLIC DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIO-RESPIRATORY ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FERRLECIT</medicinalproduct>
        <drugdosagetext>IV 250 MG /200 ML</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>IRON DEFICIENCY ANAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060307</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARANESP</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VASOTEC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055420-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR200602003922</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>70</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLADDER DISTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY RETENTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
        <drugauthorizationnumb>20592</drugauthorizationnumb>
        <drugdosagetext>2.5 MG, DAILY (1/D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEMENTIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CITALOPRAM HYDROBROMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATARAX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055421-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060717</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>54</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>88.4514</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PANCREATITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
        <drugdosagetext>PO [ HOME MED]</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRINIVIL</medicinalproduct>
        <drugdosagetext>PO 2 MG [HOME MED]</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VERAPAMIL EXTENDED-RELEASE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROBENECID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055422-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060717</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>69</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>69.4003</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ATRIOVENTRICULAR BLOCK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRADYCARDIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIDAZOLAM HYDROCHLORIDE</medicinalproduct>
        <drugdosagetext>2 MG IV OTO</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>SEDATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060306</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MEPERIDINE HCL</medicinalproduct>
        <drugdosagetext>50 MG IV OTO</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>SEDATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060306</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MONOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYTRIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055423-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060627</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CH200606001892</companynumb>
    <primarysource>
      <reportercountry>SWITZERLAND</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>53</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE SYSTOLIC INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FOREIGN BODY TRAUMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULSE ABSENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STRIDOR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
        <drugauthorizationnumb>20592</drugauthorizationnumb>
        <drugdosagetext>7.5 MG, DAILY (1/D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA, PARANOID TYPE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060228</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CAPTOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUANXOL ^BAYER^ (FLUPENTIXOL DIHYDROCHLORIDE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MST CONTINUS ^NAPP^ (MORPHINE SULFATE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TIZANIDINE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLPIDEM TARTRATE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055424-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060717</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CHEST DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONTRAST MEDIA REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URTICARIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OMNIPAQUE 300</medicinalproduct>
        <drugdosagetext>125 ML IV OTO</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>SCAN WITH CONTRAST</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060325</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPROL-XL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZETIA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL SPIROS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055425-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CZ200605003671</companynumb>
    <primarysource>
      <reportercountry>CZECH REPUBLIC</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>44</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ASPIRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREATMENT NONCOMPLIANCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
        <drugauthorizationnumb>20592</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BIPOLAR DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050317</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
        <drugauthorizationnumb>20592</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BIPOLAR DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060317</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LAMOTRIGINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROMETHAZINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLEGOMAZIN (CHLORPROMAZINE HYDROCHLORIDE)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055426-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060717</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>81</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>50.8029</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CHOKING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OESOPHAGEAL ULCER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugdosagetext>70 MG PO Q WEEK [CHRONIC]</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EXELON</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROSTAT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SINEMET</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEGACE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OSCAL +D</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLARINEX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055427-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060704</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR200606000967</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>41</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>68</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HAEMOPTYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
        <drugauthorizationnumb>20592</drugauthorizationnumb>
        <drugdosagetext>10 MG, DAILY (1/D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BIPOLAR DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060117</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060530</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RIVOTRIL /NOR/ (CLONAZEPAM)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TERCIAN (CYAMEMAZINE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TEGRETOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SULFARLEM (ANETHOLE TRITHIONE)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055428-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060717</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>59</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEPRESSED LEVEL OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OXYGEN SATURATION DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY ARREST</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXYCODONE AND ACETAMINOPHEN</medicinalproduct>
        <drugdosagetext>ONE PO OTO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060322</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PHENERGAN HCL</medicinalproduct>
        <drugdosagetext>12.5 MG PO OTO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NAUSEA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060322</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060322</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PEPCID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EFFEXOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACTOS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMOXICILLIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055429-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR200603006457</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>58</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>65</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
        <drugauthorizationnumb>20592</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BIPOLAR DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041007</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060306</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
        <drugauthorizationnumb>20592</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BIPOLAR DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060317</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMITRIPTYLINE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMOVANE (ZOPICLONE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KALETRA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COMBIVIR</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055430-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060717</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>76</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>59.1</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HAEMATEMESIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOPTYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERNATIONAL NORMALISED RATIO INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALLORY-WEISS SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MELAENA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
        <drugdosagetext>1 MG ALT 2 MG DAILY [CHRONIC]</drugdosagetext>
        <drugindication>CEREBROVASCULAR ACCIDENT PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>81 MG PO DAILY [CHRONIC]</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CEREBROVASCULAR ACCIDENT PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AGRYLIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEXAPRO</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VYTORIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055431-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DK200605004749</companynumb>
    <primarysource>
      <reportercountry>DENMARK</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>LEUKOCYTOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OLANZAPINE</medicinalproduct>
        <drugauthorizationnumb>20592</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055432-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060717</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>91</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>59.3</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENTAL STATUS CHANGES</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMALOG MIX 75/25</medicinalproduct>
        <drugdosagetext>SEE TEXT [CHRONIC]</drugdosagetext>
        <drugindication>DIABETES MELLITUS NON-INSULIN-DEPENDENT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HUMALOG MIX 75/25</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN REGULR HUMAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN -COMPLEX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAXZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DETROL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPROL-XL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VASOTEC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCITRATE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055433-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP200606004435</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>24</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BASOPHIL PERCENTAGE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EOSINOPHIL PERCENTAGE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GRANULOCYTE COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPHOCYTE 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>ZYPREXA</medicinalproduct>
        <drugauthorizationnumb>20592</drugauthorizationnumb>
        <drugdosagetext>5 MG, DAILY (1/D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060610</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060613</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALPROATE SODIUM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055434-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060626</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006RR-02847</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>51</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD CREATINE PHOSPHOKINASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERSTITIAL LUNG DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLEURAL FIBROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SIMVASTATINE  RANBAXY 5MG (SIMVASTATIN) TABLET, 5 MG</medicinalproduct>
        <drugauthorizationnumb>76285</drugauthorizationnumb>
        <drugdosagetext>5 MG, QD, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugtreatmentduration>2190</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BETAXOLOL (BEXTAXOLOL) 20MG</medicinalproduct>
        <drugdosagetext>20 MG, QD, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugtreatmentduration>2190</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GILGENCLAMIDE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055435-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060626</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006RR-02831</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>66</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ASPARTATE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD BILIRUBIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD LACTATE DEHYDROGENASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD URINE PRESENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEEP VEIN THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAMMA-GLUTAMYLTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROTEIN URINE ABSENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHABDOMYOLYSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugauthorizationnumb>76285</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERCHOLESTEROLAEMIA</drugindication>
        <drugtreatmentduration>549</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYPROTERONE ACETATE (CYPROTERONE ACETATE)</medicinalproduct>
        <drugdosagetext>100 MG, TID, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ADENOCARCINOMA</drugindication>
        <drugtreatmentduration>98</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CANDESARTAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055436-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006BI007074</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>63</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>159</patientweight>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ACUTE RESPIRATORY DISTRESS SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERAL PHYSICAL HEALTH DETERIORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEUKOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTI-ORGAN FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPHILIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCYTOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>REFUSAL OF TREATMENT BY RELATIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THERAPY NON-RESPONDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZEVALIN</medicinalproduct>
        <drugbatchnumb>IN-111 ZEVALIN</drugbatchnumb>
        <drugdosagetext>1X; IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CENTRAL NERVOUS SYSTEM LYMPHOMA</drugindication>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZEVALIN</medicinalproduct>
        <drugbatchnumb>YTRACIS</drugbatchnumb>
        <drugdosagetext>1X; IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CENTRAL NERVOUS SYSTEM LYMPHOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060330</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060330</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RITUXIMAB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FORTECORTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARMEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COSAAR PLUS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANTOZOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN B COMPLEX CAP</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMPHO-MORONAL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055437-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>190002L06JPN</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>28</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN LOWER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASCITES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVARIAN CYST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVARIAN HYPERSTIMULATION SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLEURAL EFFUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MENOTROPHIN (MENOTROPHIN)</medicinalproduct>
        <drugauthorizationnumb>17646</drugauthorizationnumb>
        <drugdosagetext>150 IU</drugdosagetext>
        <drugindication>OVULATION INDUCTION</drugindication>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMAN CHORIONIC GONADOTRIPIN (HCG)</medicinalproduct>
        <drugdosagetext>5000 IU</drugdosagetext>
        <drugindication>OVULATION INDUCTION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055438-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060627</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IE200606003688</companynumb>
    <primarysource>
      <reportercountry>IRELAND</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>66</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRY SKIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOUTH ULCERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUCOSAL INFLAMMATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERIORBITAL OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH GENERALISED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STOMACH DISCOMFORT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALIMTA</medicinalproduct>
        <drugauthorizationnumb>21462</drugauthorizationnumb>
        <drugdosagetext> SEE IMAGE</drugdosagetext>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060525</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALIMTA</medicinalproduct>
        <drugauthorizationnumb>21462</drugauthorizationnumb>
        <drugdosagetext> SEE IMAGE</drugdosagetext>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060615</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYANOCOBALAMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MOTILIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VERAPAMIL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055440-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060626</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA200606005608</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>16</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>65.8</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD BILIRUBIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OCULAR ICTERUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>STRATTERA</medicinalproduct>
        <drugbatchnumb>A129594</drugbatchnumb>
        <drugauthorizationnumb>21411</drugauthorizationnumb>
        <drugdosagetext>68MG, EACH MORNING, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATTENTION DEFICIT/HYPERACTIVITY DISORDER</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060625</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>STRATTERA</medicinalproduct>
        <drugbatchnumb>A164654</drugbatchnumb>
        <drugdosagetext>18 MG, EACH MORNING, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060625</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055441-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060626</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR200606005645</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>9</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BRAIN OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTRACRANIAL PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAPILLOEDEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>UMATROPE (SOMATROPIN) CARTRIDGE</medicinalproduct>
        <drugauthorizationnumb>19640</drugauthorizationnumb>
        <drugdosagetext>SUBCUTANEOUS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>GROWTH RETARDATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060501</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055442-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060626</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP200606005863</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>RETINAL VEIN OCCLUSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EVISTA</medicinalproduct>
        <drugauthorizationnumb>20815</drugauthorizationnumb>
        <drugdosagetext>60 MG, DAILY (1/D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060117</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060623</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055443-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060330</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ES200607001119</companynumb>
    <primarysource>
      <reportercountry>SPAIN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DIPLOPIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYELID OEDEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CIALIS</medicinalproduct>
        <drugauthorizationnumb>21368</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ERECTILE DYSFUNCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060201</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055444-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060713</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>TH-GILEAD-2006-0009860</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FACE OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRUVADA</medicinalproduct>
        <drugauthorizationnumb>21752</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060502</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060626</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LOPINAVIR/RITONAVIR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060502</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060626</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055445-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA200607000216</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XIGRIS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055446-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060626</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>SE200606005468</companynumb>
    <primarysource>
      <reportercountry>SWEDEN</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>29</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIAC FIBRILLATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>30 + 60MG, DAILY (1/D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PANIC DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041201</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055447-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060626</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB200606005476</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>KIDNEY INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YENTREVE (DULOXETINE HYDROCHLORIDE) CAPSULE</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055448-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060626</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE200607000055</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>50</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DELIRIUM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THERAPY REGIMEN CHANGED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>30  + 60 + 90MG, DAILY (1/D), ORAL - SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOAFFECTIVE DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060515</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLOZAPIN (CLOZAPINE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HALDOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRILEPTAL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055449-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060626</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE200606005887</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>47</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BUNDLE BRANCH BLOCK RIGHT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERAL PHYSICAL HEALTH DETERIORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MITRAL VALVE INCOMPETENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY VALVE INCOMPETENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUPRAVENTRICULAR TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRICUSPID VALVE INCOMPETENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>60 MG, DAILY (1/D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060303</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060311</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055450-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060626</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE200606005441</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>37</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>RESTLESS LEGS SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>60 + 90 MG, DAILY (1/D), ORAL - SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>60 + 90 MG, DAILY (1/D), ORAL - SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060202</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>60 + 90 MG, DAILY (1/D), ORAL - SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060215</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055451-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060626</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE200606005326</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>55</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>75</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIABETES MELLITUS NON-INSULIN-DEPENDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANIC ATTACK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY HYPERTENSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>30 MG, DAILY (1/D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050523</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRANXILIUM      /GFR/(CLORAZEPATE DIPOTASSIUM)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PERAZINE (PERAZINE)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055452-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060626</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE200606005312</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>65</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANGINA PECTORIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY STENOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>30 MG, DAILY (1/D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050423</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>30 MG, DAILY (1/D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051201</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055453-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060626</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006RR-02841</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>65</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG EFFECT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TENDONITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugauthorizationnumb>76285</drugauthorizationnumb>
        <drugdosagetext>20 MG, QD, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERCHOLESTEROLAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19970101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ATORVASTATIN CALCIUM</medicinalproduct>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERCHOLESTEROLAEMIA</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20000901</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DILTIAZEM RPG LP PROLONGED RELEASE CAPSULE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055454-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060626</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006RR-02861</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>65</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL DISTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL TENDERNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BODY TEMPERATURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLITIS ULCERATIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LARGE INTESTINE PERFORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEGACOLON</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTI-ORGAN FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROCTALGIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugauthorizationnumb>76285</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERCHOLESTEROLAEMIA</drugindication>
        <drugtreatmentduration>30</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugauthorizationnumb>76285</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERCHOLESTEROLAEMIA</drugindication>
        <drugtreatmentduration>183</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENALAPRIL MALEATE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055455-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060626</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006RR-02843</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>49</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>TENDONITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugauthorizationnumb>76285</drugauthorizationnumb>
        <drugdosagetext>20 MG, QD, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERCHOLESTEROLAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19991001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FENOFIBRATE RPG</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055456-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060626</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006RR-02839</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>56</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>TENDONITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TENOSYNOVITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugauthorizationnumb>76285</drugauthorizationnumb>
        <drugdosagetext>10 MG, QD, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERCHOLESTEROLAEMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENALAPRIL MALEATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NIFEDIPINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055457-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060712</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BE-ABBOTT-06P-013-0338014-00</companynumb>
    <primarysource>
      <reportercountry>BELGIUM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PANCREATITIS</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>20060224</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060419</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060224</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060419</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BISOPROLOL FUMARATE</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METILDIGOXIN</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055458-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060711</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ABBOTT-06P-087-0337982-00</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANOREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACTERIAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KLARICID</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>50662</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060620</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060620</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUDOSTEINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060620</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060622</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HERBAL MEDICINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060620</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060622</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TEPRENONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060620</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060622</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOFLOXACIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060522</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOFLOXACIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BRONCHIECTASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060622</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MOXIFLOXACIN HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PYREXIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060614</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ISEPAMICIN SULFATE</medicinalproduct>
        <drugindication>PYREXIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060614</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055459-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060710</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-06P-163-0337758-00</companynumb>
    <primarysource>
      <reportercountry>IRELAND</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>77.634</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD CREATINE PHOSPHOKINASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CREATINE PHOSPHOKINASE MB INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RITONAVIR SOFT GELATIN CAPSULES</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>20945</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060329</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TMC114</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060329</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055460-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060705</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-ABBOTT-06P-020-0337699-00</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>50</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ALANINE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASPARTATE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD BILIRUBIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHOLANGITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CORTISONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DICLOFENAC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ISONIAZID</medicinalproduct>
        <drugindication>ANTIBIOTIC PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE TAB</medicinalproduct>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEFLUNOMIDE</medicinalproduct>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CHLOROQUINE PHOSPHATE</medicinalproduct>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055461-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-ABBOTT-05P-056-0304481-00</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>54</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CELLULITIS</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>20040323</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050617</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>40 MILLIGRAMS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050713</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KETOPROFEN</medicinalproduct>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANSOPRAZOLE</medicinalproduct>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COMMERCIAL HUMIRA</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055462-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060711</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>STA-AE-05-MTX-014</companynumb>
    <primarysource>
      <reportercountry>PERU</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>64</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PNEUMOCYSTIS JIROVECI PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THERAPY NON-RESPONDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugauthorizationnumb>8085</drugauthorizationnumb>
        <drugdosagetext>15 MG - 1XW - ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041014</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ORENCIA</medicinalproduct>
        <drugdosagetext>IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050323</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugdosagetext>IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050323</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PLACEBO</medicinalproduct>
        <drugdosagetext>IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050323</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE TAB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RANITIDINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CAPTOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM CARBONATE (CALCIUM CARBONATE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055463-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2005S1009985</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>6</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE DENSITY DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEMUR FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRAUMATIC FRACTURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MERCAPTAMINE BITARTRATE (MERCAPTAMINE BITARTRATE) (150 MG)</medicinalproduct>
        <drugauthorizationnumb>20392</drugauthorizationnumb>
        <drugdosagetext>90 MG/KG; QD; ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CYSTINOSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20011007</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INDOMETHACIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SODIUM BICARBONATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ERGOCALCIFEROL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SODIUM BICARBONATE/POTASSIUM BICARBONATE/SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PHOSPHATE MONOBASIC (ANHYDRATE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>L-CARNITINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055464-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060703</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006BI008759</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>60</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ENCEPHALOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HERPES VIRUS INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERSTITIAL LUNG DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY TOXICITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZEVALIN</medicinalproduct>
        <drugbatchnumb>42014A Y-90 ZEVALIN</drugbatchnumb>
        <drugdosagetext>1174 MBQ; 1X; IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BONE MARROW CONDITIONING REGIMEN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060427</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060427</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MABTHERA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARMUSTINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ETOPOSIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARACYTINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MELPHALAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROZAC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPALGIC ^HOUDE^</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SOLU-MEDROL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLITICAN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055465-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060710</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>227208</companynumb>
    <primarysource>
      <reportercountry>INDIA</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>57</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>58</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MABTHERA (RITUXIMAB) CONC FOR SOLUTION FOR INFUSION</medicinalproduct>
        <drugdosagetext>615 MG, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>B-CELL LYMPHOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051224</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOPHOSPHAMIDE</medicinalproduct>
        <drugdosagetext>1230 MG, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>B-CELL LYMPHOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051224</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOXORUBICIN HCL</medicinalproduct>
        <drugdosagetext>22 MG, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>B-CELL LYMPHOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051224</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VINCRISTINE</medicinalproduct>
        <drugdosagetext>2 MG, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051224</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055466-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060626</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006RR-02869</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>68</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABNORMAL BEHAVIOUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COGNITIVE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEMORY IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULAR WEAKNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THERAPY CESSATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugauthorizationnumb>76285</drugauthorizationnumb>
        <drugdosagetext>20 MG, QD, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERLIPIDAEMIA</drugindication>
        <drugtreatmentduration>49</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ATORVASTATIN CALCIUM</medicinalproduct>
        <drugdosagetext>10 MG,QD, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERLIPIDAEMIA</drugindication>
        <drugtreatmentduration>274</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ESTRADIOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055467-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060627</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006RR-02834</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>70</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANGIONEUROTIC OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CAPILLARY LEAK SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FACE OEDEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ISOTRETINOIN</medicinalproduct>
        <drugauthorizationnumb>76041</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055468-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060617</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006-168</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>23</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>LIVER FUNCTION TEST ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER TRANSPLANT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DAPSONE, PRESUMABLY 25MG, PRESUMED JACOBUS</medicinalproduct>
        <drugauthorizationnumb>86841</drugauthorizationnumb>
        <drugdosagetext>50 MG 3X/D ORALLY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>FOLLICULAR MUCINOSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040123</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040126</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>.</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055469-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060705</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>COM # 06-109</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>31</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>LEUKOPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZAPINE</medicinalproduct>
        <drugauthorizationnumb>75713</drugauthorizationnumb>
        <drugindication>SCHIZOPHRENIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055470-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060607</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>COM # 06-096</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </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>CLONAZEPAM</medicinalproduct>
        <drugauthorizationnumb>75423</drugauthorizationnumb>
        <drugindication>CONVULSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055471-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060630</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>HQWYE661302AUG05</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>53</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>88.1</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CANDIDIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEBRILE NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG NEOPLASM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MYLOTARG</medicinalproduct>
        <drugauthorizationnumb>21174</drugauthorizationnumb>
        <drugdosagetext>11.6 MG 1X PER 1 DAY, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ACUTE MYELOID LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050708</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050708</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055472-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060630</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006S1006086</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>91</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG WITHDRAWAL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESTLESS LEGS SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THERAPEUTIC RESPONSE UNEXPECTED WITH DRUG SUBSTITUTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FENTANYL TRANSDERMAL SYSTEM</medicinalproduct>
        <drugbatchnumb>LOT 6N0190</drugbatchnumb>
        <drugauthorizationnumb>76258</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>062</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060601</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FENTANYL TRANSDERMAL SYSTEM</medicinalproduct>
        <drugbatchnumb>LOT 6N0190</drugbatchnumb>
        <drugauthorizationnumb>76258</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>062</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060629</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GABAPENTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RISEDRONATE SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LABETALOL HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055473-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006S1005673</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>49</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ROAD TRAFFIC ACCIDENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZAPINE</medicinalproduct>
        <drugauthorizationnumb>75417</drugauthorizationnumb>
        <drugdosagetext>25 MG;HS;ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA, PARANOID TYPE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060618</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZAPINE</medicinalproduct>
        <drugdosagetext>200 MG;HS;ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA, PARANOID TYPE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060618</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055474-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060627</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US200606000991</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>32</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRY MOUTH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EATING DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ENURESIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEDICAL DEVICE COMPLICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POLLAKIURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL FIELD DEFECT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMATROPE</medicinalproduct>
        <drugauthorizationnumb>19640</drugauthorizationnumb>
        <drugdosagetext>0.9 MG, DAILY (1/D)</drugdosagetext>
        <drugindication>GROWTH HORMONE DEFICIENCY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HUMATROPEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OSCAL 500-D (CALCIUM, COLECALCIFEROL)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CHILDRENS CHEWABLE VITAMINS (VITAMINS NOS)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ULTRAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE TAB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREMPHASE (PREMARIN;CYCRIN 14/14)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TEGRETOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAQUENIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055475-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060627</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US200601002134</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>23</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG EFFECT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>60 MG</drugdosagetext>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051201</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055476-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060717</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>84</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>95</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIOACTIVE DRUG LEVEL INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOLYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERNATIONAL NORMALISED RATIO INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UPPER GASTROINTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
        <drugdosagetext>4 MG PO DAILY [CHRONIC]</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>AORTIC VALVE REPLACEMENT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
        <drugdosagetext>4 MG PO DAILY [CHRONIC]</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
        <drugdosagetext>4 MG PO DAILY [CHRONIC]</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIGOXIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROTONIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IRON</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMARYL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALDACTONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEMADEX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055477-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060627</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US200604003211</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>50</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DIALYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOLYTIC URAEMIC SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTHAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALIMTA</medicinalproduct>
        <drugauthorizationnumb>21462</drugauthorizationnumb>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GEMZAR(GEMICITABINE HYDROCHLORIDE) VIAL</medicinalproduct>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYANOCOBALAMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DECADRON</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055478-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060717</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>85</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>91</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ARTERIOVENOUS MALFORMATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG LEVEL ABOVE THERAPEUTIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERNATIONAL NORMALISED RATIO INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOBAR PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOWER GASTROINTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
        <drugdosagetext>8 MG PO DAILY -[CHRONIC]</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANTICOAGULANT THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
        <drugdosagetext>8 MG PO DAILY -[CHRONIC]</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CEREBROVASCULAR ACCIDENT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEXAPRO</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CAPTOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BUMEX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VIT C</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM CHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FESO4</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COLACE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MOM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SENOKOT</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055479-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060627</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US200606005817</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>82</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLADDER CANCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPEPSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLATULENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STOMACH DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY BLADDER HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugauthorizationnumb>21318</drugauthorizationnumb>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051024</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugauthorizationnumb>21318</drugauthorizationnumb>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055480-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060717</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>41</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>97.0698</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ADVERSE DRUG REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN LESION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VANCOMYCIN</medicinalproduct>
        <drugdosagetext>IV 1 G BID</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>STAPHYLOCOCCAL INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060205</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060304</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM CHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRONOLACTONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADVAIR DISKUS 100/50</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL SPIROS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPROL-XL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLARINEX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIGOXIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SINGULAIR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SONATA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VANCOMYCIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055481-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060626</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US200606005600</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>76</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ATRIAL FIBRILLATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOPOROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugbatchnumb>FF5Z43A</drugbatchnumb>
        <drugauthorizationnumb>21318</drugauthorizationnumb>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060116</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EVISTA</medicinalproduct>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EVISTA</medicinalproduct>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIGOXIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055482-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060717</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>67</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>86.1834</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ACUTE CORONARY SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD UREA INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DUODENAL ULCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOVOLAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UPPER GASTROINTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENOXAPARIN SODIUM</medicinalproduct>
        <drugdosagetext>1 MG /KG SQ BID</drugdosagetext>
        <drugindication>ACUTE CORONARY SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060325</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060327</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>81 MG PO DAILY [CHRONIC]</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CORONARY ARTERY BYPASS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPROL-XL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VYTORIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MICARDIS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055483-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060717</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>62</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>89.1</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>GROIN PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PELVIC HAEMATOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POST PROCEDURAL COMPLICATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENOXAPARIN SODIUM</medicinalproduct>
        <drugdosagetext>90 MG SQ Q12 H</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PULMONARY EMBOLISM</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060421</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
        <drugdosagetext>7.5 MG PO DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY EMBOLISM</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060421</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADVAIR DISKUS 100/50</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLEGRA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLONASE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL SPIROS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORCO</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMBIEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MIRALAX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055484-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060626</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US200606005546</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugauthorizationnumb>21318</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055485-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060717</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>55</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>99.7913</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ADVERSE DRUG REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFUSION RELATED REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SCREAMING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAXOL</medicinalproduct>
        <drugdosagetext>140 MG IV Q WK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060310</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MOTRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MICARDIS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AROMIDEX</medicinalproduct>
      </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>BENADRYL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FAMOTIDINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MORPHINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055486-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060626</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US200606005419</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>71</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugauthorizationnumb>21318</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055487-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060717</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>59</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DYSPHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARYNGEAL OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPEECH DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWELLING FACE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWOLLEN TONGUE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REGLAN</medicinalproduct>
        <drugdosagetext>PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTROENTERITIS VIRAL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060302</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060303</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055488-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060717</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>37</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>94</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>SWELLING FACE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugdosagetext>10 MG PO DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VERAPAMIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLYBURIDE AND METFORMIN HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OC'S</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATARAX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055489-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US200607000755</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
        <drugauthorizationnumb>20592</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055490-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060717</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>70</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>49.8957</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANGIONEUROTIC OEDEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVOFLOXACIN</medicinalproduct>
        <drugdosagetext>250 G IV Q24H</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060319</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060320</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACTONEL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADVAIR DISKUS 100/50</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLETAL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENALAPRIL MALEATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KYTRIL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055491-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060707</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006084821</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL RIGIDITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE TWITCHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCLONUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugauthorizationnumb>21446</drugauthorizationnumb>
        <drugdosagetext>150 MG (50 MG, 3 IN 1 D)</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055492-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060717</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>51</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>97.7</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD POTASSIUM INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRADYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GLOMERULAR FILTRATION RATE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMODIALYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LACTIC ACIDOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METABOLIC ACIDOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTI-ORGAN FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY ARREST</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
        <drugdosagetext>850 MG PO TID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS NON-INSULIN-DEPENDENT</drugindication>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NIFEREX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLIPIZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENALAPRIL MALEATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOPHAGE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055493-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060705</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>20060804519</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BREAST CANCER FEMALE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROVERA</medicinalproduct>
        <drugauthorizationnumb>11839</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MEDROXYPROGESTERONE</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055494-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060717</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>39</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>86</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ACCIDENTAL OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSARTHRIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENTAL STATUS CHANGES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXYCONTIN</medicinalproduct>
        <drugdosagetext>80 MG PO BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOLPIDEM TARTRATE</medicinalproduct>
        <drugdosagetext>5 MG PO QHS</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SOMNOLENCE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MORINOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCONTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ROXICODONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LUNESTA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMBIEN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055495-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060717</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>68</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>74.3899</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIO-RESPIRATORY ARREST</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MEPERIDINE HCL</medicinalproduct>
        <drugdosagetext>75 MGIV Q3H PRN</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PROCEDURAL PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060227</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZESTRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVAQUIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TORADOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOFRAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DILAUDID</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055496-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060705</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006084813</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BREAST CANCER FEMALE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>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>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055497-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060717</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>52</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>90</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXYCODONE HCL</medicinalproduct>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugindication>PROCEDURAL PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060215</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060216</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ULTRAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REQUIP</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAZODONE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SINGULAIR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SKELAXIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROTONIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL SPIROS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADVAIR DISKUS 100/50</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROVIGIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENOXAPARIN SODIUM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055498-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060717</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>80</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>80</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARRHYTHMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIO-RESPIRATORY ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COAGULOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOVOLAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MELAENA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>REFUSAL OF TREATMENT BY RELATIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UPPER GASTROINTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENTRICULAR FIBRILLATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
        <drugdosagetext>5 MG PO DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
        <drugdosagetext>5 MG PO DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CARDIOVASCULAR EVENT PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLYBURIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>M.V.I.</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NAHCO3</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FESO4</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055499-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060705</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006084780</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugauthorizationnumb>21446</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055500-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060717</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>44</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>96.6162</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANGINA PECTORIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AZOTAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD POTASSIUM INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NON-CARDIAC CHEST PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
        <drugdosagetext>160 MG PO DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRINZIDE</medicinalproduct>
        <drugdosagetext>20/25 PO DAILY BID</drugdosagetext>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRINZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVAQUIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL SPIROS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONIDINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL AND HYDROCHLOROTHIAZIDE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055501-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060703</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006083847</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUTENT</medicinalproduct>
        <drugauthorizationnumb>21938</drugauthorizationnumb>
        <drugdosagetext>50 MG</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055502-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060717</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>88</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING JITTERY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOVEMENT DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROCEDURAL COMPLICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESTLESSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIDAZOLAM HYDROCHLORIDE</medicinalproduct>
        <drugdosagetext>1 MG OTO</drugdosagetext>
        <drugindication>SEDATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060220</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FENTANYL</medicinalproduct>
        <drugdosagetext>150 MCG OTO</drugdosagetext>
        <drugindication>SEDATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060220</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055503-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060705</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006084074</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>74</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>86.1834</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOW DENSITY LIPOPROTEIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN JAW</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TENDONITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugauthorizationnumb>20702</drugauthorizationnumb>
        <drugdosagetext>10 MG (10 MG, 1 IN 1 D)</drugdosagetext>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060627</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DITROPAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMINS (VITAMINS)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREVACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM (CALCIUM)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055504-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060705</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006084158</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>70</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>80.7403</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ATRIAL FIBRILLATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EFFECT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPEPSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROOESOPHAGEAL REFLUX DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INITIAL INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UNEVALUABLE EVENT</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>TREMOR</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
        <drugdosagetext>25 MG (25 MG, 1 IN 1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LOTENSIN</medicinalproduct>
        <drugdosagetext>10 MG (10 MG, 1 IN 1 D)</drugdosagetext>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SERZONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MELATONIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055505-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060717</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>64</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>44.9061</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEVICE MALFUNCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
        <drugbatchnumb>E044</drugbatchnumb>
        <drugdosagetext>40 UNITS  QDAY  SQ</drugdosagetext>
        <drugindication>DIABETES MELLITUS NON-INSULIN-DEPENDENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060614</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060717</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055506-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060526</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006010626</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>62</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>122.4712</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTRACARDIAC THROMBUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEXTRA</medicinalproduct>
        <drugauthorizationnumb>21341</drugauthorizationnumb>
        <drugdosagetext>10 MG (10 MG, 1 IN 1 D)</drugdosagetext>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040129</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055507-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060717</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>63.05</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARBIDOPA/LEVODOPA 25/100 EXTENDED RELEASE</medicinalproduct>
        <drugdosagetext>ONE AT HS</drugdosagetext>
        <drugindication>RESTLESS LEGS SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060622</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060625</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DILANTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONIDINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPROL-XL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AZMACORT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL SPIROS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREMPRO</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055508-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060706</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006067283</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIRACEPT</medicinalproduct>
        <drugauthorizationnumb>20779</drugauthorizationnumb>
        <drugdosagetext>2500 MG, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV TEST POSITIVE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060315</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060706</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMBIVIR</medicinalproduct>
        <drugdosagetext>2 TALBETS , ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV TEST POSITIVE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060315</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060706</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055509-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060717</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>49.8957</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CORNEAL EPITHELIUM DEFECT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE OPERATION COMPLICATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEVANAC</medicinalproduct>
        <drugdosagetext>ONE DROP   TID   LEFT EYE</drugdosagetext>
        <drugindication>OFF LABEL USE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051130</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051217</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEVANAC</medicinalproduct>
        <drugdosagetext>ONE DROP   TID   LEFT EYE</drugdosagetext>
        <drugindication>PAIN MANAGEMENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051130</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051217</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEVANAC</medicinalproduct>
        <drugdosagetext>ONE DROP   TID   LEFT EYE</drugdosagetext>
        <drugindication>SURGERY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051130</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051217</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055510-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060425</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0604USA03777</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>66</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055511-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesscongenitalanomali>1</seriousnesscongenitalanomali>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0606USA05760</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>0</patientonsetage>
      <patientonsetageunit>804</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>POLYDACTYLY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SINGULAIR</medicinalproduct>
        <drugauthorizationnumb>20829</drugauthorizationnumb>
        <drugindication>ASTHMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055512-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060717</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>73</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>67.586</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FAECES DISCOLOURED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLANK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATITIS ACUTE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KETEK</medicinalproduct>
        <drugdosagetext>800MG  DAILY  P.O.</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SINUSITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060603</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060623</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055513-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060623</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-MERCK-0606USA05682</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>72</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>LIVER DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEPCID RPD</medicinalproduct>
        <drugauthorizationnumb>20752</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTRIC ULCER</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060616</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACTOS</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060615</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERCHOLESTEROLAEMIA</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060616</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMARYL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SUCRALFATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HERBS (UNSPECIFIED)</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LENDORMIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INSOMNIA</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060616</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055514-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060502</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-MERCK-0605DEU00013</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>71</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>59</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CHILLS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISORIENTATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSSTASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZETIA</medicinalproduct>
        <drugauthorizationnumb>21445</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERCHOLESTEROLAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060422</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060426</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZETIA</medicinalproduct>
        <drugauthorizationnumb>021445</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CORONARY ARTERY DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060422</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060426</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE BESYLATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN E ACETATE DL-FORM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GINKGO</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060320</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055515-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20051026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CH-MERCK-0510USA09249</companynumb>
    <primarysource>
      <reportercountry>SWITZERLAND</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>20</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATOTOXICITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>STROMECTOL</medicinalproduct>
        <drugauthorizationnumb>050742</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>FILARIASIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055516-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060329</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CN-MERCK-0603CHN00031</companynumb>
    <primarysource>
      <reportercountry>CHINA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>51</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>BLOOD LACTATE DEHYDROGENASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD UREA INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FACE OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OLIGURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY DISTRESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CANCIDAS</medicinalproduct>
        <drugauthorizationnumb>21227</drugauthorizationnumb>
        <drugadministrationroute>051</drugadministrationroute>
        <drugindication>SEPSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060324</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060324</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CANCIDAS</medicinalproduct>
        <drugauthorizationnumb>021227</drugauthorizationnumb>
        <drugadministrationroute>051</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060325</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060326</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CANCIDAS</medicinalproduct>
        <drugauthorizationnumb>021227</drugauthorizationnumb>
        <drugadministrationroute>051</drugadministrationroute>
        <drugindication>LUNG INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060324</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060324</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CANCIDAS</medicinalproduct>
        <drugauthorizationnumb>021227</drugauthorizationnumb>
        <drugadministrationroute>051</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060325</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060326</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMPHOTERICIN B</medicinalproduct>
        <drugadministrationroute>051</drugadministrationroute>
        <drugindication>SEPSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060323</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060324</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMPHOTERICIN B</medicinalproduct>
        <drugadministrationroute>051</drugadministrationroute>
        <drugindication>LUNG INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060323</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060324</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CILASTATIN SODIUM AND IMIPENEM</medicinalproduct>
        <drugadministrationroute>051</drugadministrationroute>
        <drugindication>SEPSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060314</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060329</drugenddate>
        <drugtreatmentduration>16</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CILASTATIN SODIUM AND IMIPENEM</medicinalproduct>
        <drugadministrationroute>051</drugadministrationroute>
        <drugindication>LUNG INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060314</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060329</drugenddate>
        <drugtreatmentduration>16</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055517-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0410USA04001</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>59</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLADDER DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BODY HEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CLOSTRIDIUM DIFFICILE COLITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CROHN'S DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OESOPHAGEAL CANDIDIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOMYELITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SICCA SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TEMPOROMANDIBULAR JOINT SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTH ABSCESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>20560</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPENIA</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCONTIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCODONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055518-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060619</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BE-MERCK-0606BEL00017</companynumb>
    <primarysource>
      <reportercountry>BELGIUM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>81</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COZAAR</medicinalproduct>
        <drugauthorizationnumb>020386</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055519-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060424</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-MERCK-0604USA04076</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>53</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>55</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ALLERGIC GRANULOMATOUS ANGIITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SINGULAIR</medicinalproduct>
        <drugauthorizationnumb>20829</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060220</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060419</drugenddate>
        <drugtreatmentduration>59</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUTIDE</medicinalproduct>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060213</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060323</drugenddate>
        <drugtreatmentduration>39</drugtreatmentduration>
        <drugtreatmentdurationunit></drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUTIDE</medicinalproduct>
        <drugadministrationroute>055</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060224</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNIPHYL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060403</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNIPHYL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060320</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060402</drugenddate>
        <drugtreatmentduration>14</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNIPHYL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060213</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060319</drugenddate>
        <drugtreatmentduration>35</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HOKUNALIN</medicinalproduct>
        <drugadministrationroute>061</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060220</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060226</drugenddate>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDONINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060224</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060225</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDONINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060226</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060226</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MUCODYNE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060224</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060302</drugenddate>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BROCIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060224</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060302</drugenddate>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>[THERAPY UNSPECIFIED]</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060224</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060302</drugenddate>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAKEPRON</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060224</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060305</drugenddate>
        <drugtreatmentduration>10</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055520-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>COT_0628_2006</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>77</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>72.5755</patientweight>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY FIBROSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VENTAVIS</medicinalproduct>
        <drugauthorizationnumb>21779</drugauthorizationnumb>
        <drugdosagetext>2.5 MCG ONCE IH</drugdosagetext>
        <drugadministrationroute>025</drugadministrationroute>
        <drugindication>PULMONARY HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060609</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060609</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VENTAVIS</medicinalproduct>
        <drugdosagetext>5 MCG 6XD IH</drugdosagetext>
        <drugadministrationroute>025</drugadministrationroute>
        <drugindication>PULMONARY HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060609</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SILDENAFIL CITRATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KLOR-CON</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCODONE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CENTRUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRILOSEC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORAZEPAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM GLUCONATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYGEN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055521-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060717</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HAEMOPTYSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXALIPLATIN</medicinalproduct>
        <drugdosagetext>85 MG/M2 DAY 1-15 / CYCLE</drugdosagetext>
        <drugindication>LUNG NEOPLASM MALIGNANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060310</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060607</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOCETAXEL</medicinalproduct>
        <drugdosagetext>30 MG/M2 DAY 1 + 8/CYCLE</drugdosagetext>
        <drugindication>LUNG NEOPLASM MALIGNANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060310</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060607</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COMPAZINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE TAB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATIVAN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055522-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060717</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>61</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>91.173</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>POST PROCEDURAL COMPLICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY ARREST</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MORPHINE</medicinalproduct>
        <drugdosagetext>1 ML IV PRN (PCA)</drugdosagetext>
        <drugindication>PROCEDURAL PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060126</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZYRTEC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXAPROZIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRIZIVIR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAZODONE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLONASE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRICHLOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEXAPRO</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055523-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060717</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BODY TEMPERATURE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVASTIN</medicinalproduct>
        <drugdosagetext>820 MG IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RENAL CELL CARCINOMA STAGE UNSPECIFIED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060710</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPROL-XL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEXAPRO</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACIPHEX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055524-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060626</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>163-20785-06050464</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>13</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BENIGN INTRACRANIAL HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CSF TEST ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SCIATIC NERVE INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISION BLURRED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>THALOMID</medicinalproduct>
        <drugauthorizationnumb>20785</drugauthorizationnumb>
        <drugdosagetext>800 MG, 1 IN 1 D, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTERIOVENOUS MALFORMATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060428</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOXYCYCLINE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIAMOX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIGOXIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN TAB</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055525-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060717</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>71</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>77.5651</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>INTESTINAL PERFORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPTIC SHOCK</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVASTIN</medicinalproduct>
        <drugdosagetext>388 MG IV DRIP</drugdosagetext>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060705</drugstartdate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>805</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVASTIN</medicinalproduct>
        <drugdosagetext>388 MG IV DRIP</drugdosagetext>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060621</drugstartdate>
        <drugtreatmentduration>90</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PACLITAXEL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARBOPLATIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055526-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060705</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>163-20785-06040042</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>89</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISEASE PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE MYELOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA ASPIRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UNEVALUABLE EVENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>THALOMID</medicinalproduct>
        <drugbatchnumb>0118A</drugbatchnumb>
        <drugauthorizationnumb>20785</drugauthorizationnumb>
        <drugdosagetext>200 MG, 1 IN 1 D, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060314</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060301</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055527-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060706</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006085482</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>8</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYRTEC</medicinalproduct>
        <drugauthorizationnumb>20346</drugauthorizationnumb>
        <drugdosagetext>5 MG (1 IN 1 D)</drugdosagetext>
        <drugindication>HYPERSENSITIVITY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060630</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060704</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MOBIC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALL OTHER THERAPEUTIC PRODUCTS (ALL OTHER THERAPEUTIC PRODUCTS)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZANTAC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PENTASA ^PHARMACIA^ (MESALAZINE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREVACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055528-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060623</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0606USA04445</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>70</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE CONGESTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIOVASCULAR DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIABETES MELLITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRINIVIL</medicinalproduct>
        <drugauthorizationnumb>19558</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMDUR</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055529-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060717</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>79</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VARDENAFIL   10MG</medicinalproduct>
        <drugdosagetext>10-20MG  PRN  PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ERECTILE DYSFUNCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060112</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060308</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055530-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>163-20785-06060911</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>76</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>COLECTOMY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>THALOMID</medicinalproduct>
        <drugauthorizationnumb>20785</drugauthorizationnumb>
        <drugdosagetext>50 MG, 1 IN 1 D, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060224</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055531-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060717</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>82</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>66</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HYPOGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVAQUIN</medicinalproduct>
        <drugdosagetext>250MG  ONCE DAILY  PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ESCHERICHIA URINARY TRACT INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060712</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060713</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DILTIAZEM HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRILOSEC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTIVITAMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM GLUCONATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOCUSATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROZAC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SENNA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IRON SULFATETHIAMIN COMPOUND TAB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BETOPTIC EYEDROPS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055532-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060705</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>163-20785-06020154</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>81</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD URINE PRESENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CATHETER RELATED COMPLICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONTUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISEASE PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYELODYSPLASTIC SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUROPATHY PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET FUNCTION TEST ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POST PROCEDURAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY BLADDER HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>THALOMID</medicinalproduct>
        <drugauthorizationnumb>20785</drugauthorizationnumb>
        <drugdosagetext>100 MG, AT BEDTIME, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MYELODYSPLASTIC SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041022</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTIVITAMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN B6</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM (CALCIUM)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DARVOCET-N 100</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVAQUIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055533-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060717</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>53</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>68</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANGIONEUROTIC OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugdosagetext>20MG  QD  PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030124</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060605</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COCAINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055534-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006084996</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>LOW DENSITY LIPOPROTEIN INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugauthorizationnumb>20702</drugauthorizationnumb>
        <drugdosagetext>40 MG</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055535-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060717</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>50</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>103</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHADONE HCL</medicinalproduct>
        <drugdosagetext>150MG  QD  PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG DEPENDENCE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030109</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060606</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BACLOFEN</medicinalproduct>
        <drugdosagetext>20MG  QID  PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MYALGIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060606</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055536-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060706</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006085022</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>ENTERECTOMY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ILEOSTOMY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DETROL LA</medicinalproduct>
        <drugauthorizationnumb>21228</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055537-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060717</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>26</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>97</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRIAPISM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRAZODONE HCL</medicinalproduct>
        <drugdosagetext>50-100MG   QHS   PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060224</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060614</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRAZODONE HCL</medicinalproduct>
        <drugdosagetext>50-100MG   QHS   PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>POST-TRAUMATIC STRESS DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060224</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060614</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRAZOSIN HCL</medicinalproduct>
        <drugdosagetext>16MG  QHS   PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>POST-TRAUMATIC STRESS DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060207</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060614</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055538-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060717</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>65.7716</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CREATINE PHOSPHOKINASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPATOR   200 MG</medicinalproduct>
        <drugdosagetext>200 MG   ONCE A DAY   PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060509</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055539-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060717</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>64.6</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>LOWER GASTROINTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEVACIZUMAB 25 MG/ML GENENTECH</medicinalproduct>
        <drugdosagetext>15 MG/KG   EVERY 3 WEEKS   IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051214</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060707</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055540-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060717</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>18</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>76.6579</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AUTOIMMUNE THYROIDITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GOITRE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THERAPEUTIC AGENT TOXICITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LITHIUM CARBONATE  300MG   ROXAANE</medicinalproduct>
        <drugdosagetext>300MG  TWICE DAILY   PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BIPOLAR I DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060130</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055541-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060427</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL178326</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugindication>HIV INFECTION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055542-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060501</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL178429</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>51.3</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugindication>ANAEMIA OF MALIGNANT DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060301</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055543-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060216</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL169728</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>120.8</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HYPOGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>P047010</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>ANAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050901</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055544-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060503</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL178662</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugindication>ANAEMIA OF MALIGNANT DISEASE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055545-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060504</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL178975</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugindication>ANAEMIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055546-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060503</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL178783</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>ANAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19970101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055547-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060505</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL178967</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>AMNESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THERAPEUTIC RESPONSE DELAYED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>ANAEMIA OF MALIGNANT DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055548-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060505</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL178973</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <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>PROCRIT</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>ANAEMIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055549-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060505</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL178971</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>50</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BONE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>ANAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055550-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060505</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL178966</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>60</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VAGINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugindication>ANAEMIA OF MALIGNANT DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055551-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060327</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL174447</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>GRAND MAL CONVULSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>ANAEMIA OF MALIGNANT DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050401</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055552-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060327</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL174302</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>URTICARIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugindication>ANAEMIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055553-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060418</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL176896</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>77.2</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugindication>ANAEMIA OF MALIGNANT DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055554-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060329</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-US174403</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>EPISTAXIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SENSIPAR</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>HYPERPARATHYROIDISM SECONDARY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060301</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EPOGEN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>RENAL FAILURE CHRONIC</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EPOGEN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060301</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055555-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060331</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL175747</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE BRUISING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRANSPLANT REJECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RENAL FAILURE CHRONIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060228</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055556-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US200603000566</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>49</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>111.1</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD CHOLESTEROL ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD TRIGLYCERIDES INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIABETES MELLITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIABETIC COMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIABETIC KETOACIDOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GLUCOSE TOLERANCE IMPAIRED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERGLYCAEMIC HYPEROSMOLAR NONKETOTIC SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METABOLIC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL ISCHAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OBESITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCREATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
        <drugauthorizationnumb>20592</drugauthorizationnumb>
        <drugdosagetext>2.5 MG, 3/D</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030522</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040701</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GEODON</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HALDOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLIMARA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALIUM /NET/(DIAZEPAM)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COGENTIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055557-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060627</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US200606000400</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>75</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ANGIOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANOREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARRHYTHMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRESCRIBED OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
        <drugauthorizationnumb>20592</drugauthorizationnumb>
        <drugdosagetext>25 MG, DAILY (1/D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PSYCHOTIC DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REGLAN /USA/ (METOCLOPRAMIDE HYDROCHLORIDE)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055558-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060627</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US200606003040</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>47</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>104.3</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPEPSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRIC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NERVE INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL INTAKE REDUCED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
        <drugbatchnumb>A134511</drugbatchnumb>
        <drugauthorizationnumb>20592</drugauthorizationnumb>
        <drugdosagetext>10 MG, DAILY (1/D); SEE IMAGE</drugdosagetext>
        <drugindication>SLEEP DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
        <drugbatchnumb>A134511</drugbatchnumb>
        <drugauthorizationnumb>20592</drugauthorizationnumb>
        <drugdosagetext>10 MG, DAILY (1/D); SEE IMAGE</drugdosagetext>
        <drugindication>SLEEP DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060401</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEPAKOTE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WELLBUTRIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055559-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US_0509122426</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>50</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CHOLESTEROL INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHOLECYSTECTOMY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPEPSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FOOD INTOLERANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROOESOPHAGEAL REFLUX DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HALLUCINATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCREATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRESCRIBED OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSYCHOTIC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RETINAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
        <drugauthorizationnumb>20592</drugauthorizationnumb>
        <drugdosagetext>ORAL; SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEMENTIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000320</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20011221</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCODONE BITARTRATE + ACETAMINOPHEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEPAKOTE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055560-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060627</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US_0509121825</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>94.3</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>AMNESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIABETES MELLITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERAL PHYSICAL HEALTH DETERIORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJURY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
        <drugauthorizationnumb>20592</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19960101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055561-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>USA050290522</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>59</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE FLUCTUATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHOLECYSTITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIABETES MELLITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALIGNANT MELANOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEOPLASM MALIGNANT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OLIGURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCREATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POLLAKIURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL CYST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SCAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN CANCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN LESION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISION BLURRED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL ACUITY REDUCED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
        <drugbatchnumb>7EH18M</drugbatchnumb>
        <drugauthorizationnumb>20592</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19970101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
        <drugbatchnumb>7EH33P</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
        <drugbatchnumb>8EC35P</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XANAX (ALPRAZOLAM SODIUM)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MONOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055562-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060705</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-2006-017977</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>24</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>64</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CERVICAL STRICTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEVICE BREAKAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPLASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVARIAN CYST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POST PROCEDURAL COMPLICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROCEDURAL COMPLICATION</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>5055563-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060706</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-2005-026853</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>59</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>68</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BREAST CANCER FEMALE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLIMARA</medicinalproduct>
        <drugauthorizationnumb>20375</drugauthorizationnumb>
        <drugdosagetext>0.1 MG/D, CONT, TRANSDERMAL</drugdosagetext>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>MENOPAUSAL SYMPTOMS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ESTRADIOL</medicinalproduct>
        <drugdosagetext>0.05 AND 0.01 MG</drugdosagetext>
        <drugindication>MENOPAUSAL SYMPTOMS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OGEN</medicinalproduct>
        <drugdosagetext>1.25 MG</drugdosagetext>
        <drugindication>MENOPAUSAL SYMPTOMS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20000101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROTONIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLEGRA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZYRTEC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIQUIBID-D (PHENYLEPHRINE HYDROCHLORIDE, GUAIFENESIN)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055564-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060703</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>234194K06USA</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>58</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CHOLELITHIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CYSTITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE BRUISING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPLENIC ARTERY ANEURYSM</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>20051208</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EVISTA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN TAB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENABLEX (DARIFENACIN)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055565-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060703</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>430034M06USA</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>53</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>69.14</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ESCHERICHIA BACTERAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NOVANTRONE</medicinalproduct>
        <drugauthorizationnumb>19297</drugauthorizationnumb>
        <drugindication>ACUTE MYELOID LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060104</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060108</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ETOPOSIDE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060104</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060108</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYTARABINE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060104</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060108</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055566-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060710</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>232654K05USA</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>27</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSKINESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ELECTROENCEPHALOGRAM ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE ROLLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE TWITCHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NUCLEAR MAGNETIC RESONANCE IMAGING BRAIN ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARTIAL SEIZURES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TONGUE BITING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBIF</medicinalproduct>
        <drugdosagetext>44 MCG, 3 IN 1 WEEKS, SUBCUTANEOUS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ORTHO-CYCLEN (CILEST)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055567-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060706</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>234253K06USA</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>39</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DIABETES MELLITUS INSULIN-DEPENDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUID RETENTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUROPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>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>20040614</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055568-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060706</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>430035M06USA</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>62</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>97</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FEBRILE NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NOVANTRONE</medicinalproduct>
        <drugauthorizationnumb>19297</drugauthorizationnumb>
        <drugdosagetext>18 MG, 1 IN 1 DAYS, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ACUTE MYELOID LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060610</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060614</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ETOPOSIDE</medicinalproduct>
        <drugdosagetext>224 MG, 1 IN 1 DAYS, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ACUTE MYELOID LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060610</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060614</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYTARABINE</medicinalproduct>
        <drugdosagetext>2.24 G, 1 IN 1 DAYS, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ACUTE MYELOID LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060610</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060614</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055569-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060705</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>430080K06USA</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>29</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EJECTION FRACTION DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NOVANTRONE</medicinalproduct>
        <drugauthorizationnumb>19297</drugauthorizationnumb>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060112</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055570-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060707</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006BI009660</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>32</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>74.8435</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLADDER DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPEECH DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL DISTURBANCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugdosagetext>30 UG; QW; IM</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060301</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEPAKOTE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOMIG</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAMADOL HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CORGARD</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055571-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060706</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006BI009776</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>LUNG CARCINOMA CELL TYPE UNSPECIFIED STAGE II</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>19970701</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055572-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060705</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2005BI022172</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>62</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ARTERIAL OCCLUSIVE DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN JAW</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>20010321</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>5055573-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060710</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006BI009786</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>53</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugdosagetext>30 UG;QW;IM</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20001101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030701</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugbatchnumb>P35064</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>5055574-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060710</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006BI009787</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>36</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugbatchnumb>P35058</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>5055575-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060705</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006BI009683</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>32</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANKLE FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JOINT INJURY</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>20020501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060615</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055576-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060708</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006BI009772</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>50</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMPAIRED HEALING</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>20000301</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>20051215</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055577-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060705</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006BI009600</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>47</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</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>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055578-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060630</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A-US2006-12545</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>43</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOKALAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRACLEER</medicinalproduct>
        <drugauthorizationnumb>21290</drugauthorizationnumb>
        <drugdosagetext>125 BG, BID, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060501</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055579-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060327</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-US174025</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>63.2</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>THERAPEUTIC RESPONSE DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EPOGEN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>DIALYSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055580-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060330</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL175826</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugindication>ANAEMIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055581-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060331</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL175184</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>77.2</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>AGITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANGER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BALANCE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHILLS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYDRIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NERVOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSYCHOMOTOR HYPERACTIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHINORRHOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>ANAEMIA OF MALIGNANT DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060329</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060322</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060321</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060301</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055582-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060331</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-US174741</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>64</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>C-REACTIVE PROTEIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HELICOBACTER INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POLYP</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THERAPEUTIC RESPONSE DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EPOGEN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>DIALYSIS</drugindication>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055583-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060331</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL175749</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RENAL FAILURE CHRONIC</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055584-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060331</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL175191</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT 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>20060201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055585-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060402</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL175193</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>ANAEMIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055586-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060406</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL176279</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>79</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANOREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRONCHITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>MYELODYSPLASTIC SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055587-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060407</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL176289</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugindication>ANAEMIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055588-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060413</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL180672</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>THERAPEUTIC RESPONSE DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>RENAL FAILURE CHRONIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050901</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055589-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060413</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL180653</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>THERAPEUTIC RESPONSE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRANSPLANT REJECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RENAL FAILURE CHRONIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990810</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19900101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055590-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060412</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL176273</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DEEP VEIN THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN ULCER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>ANAEMIA OF MALIGNANT DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
        <drugadministrationroute>062</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
        <drugadministrationroute>061</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
        <drugadministrationroute>061</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055591-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060412</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL176270</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NERVOUSNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RENAL FAILURE CHRONIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060411</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055592-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060410</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-US175703</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HYPOGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EPOGEN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>ANAEMIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055593-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060410</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL176112</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>86.3</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugindication>ANAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060315</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
        <drugadministrationroute>055</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055594-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060705</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006-07-0378</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>39</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>89.8122</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD POTASSIUM DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHILLS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DECREASED APPETITE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEG-INTRON</medicinalproduct>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060615</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBETOL</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060615</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055595-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060627</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US200606006088</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>GENERAL PHYSICAL HEALTH DETERIORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJURY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
        <drugauthorizationnumb>20592</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055596-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060627</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US200606002882</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>83.9</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIABETES MELLITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIABETIC COMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL ISCHAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCREATITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
        <drugauthorizationnumb>20592</drugauthorizationnumb>
        <drugdosagetext>7.5 MG</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055597-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US200607000730</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
        <drugauthorizationnumb>20592</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055598-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US200607000737</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
        <drugauthorizationnumb>20592</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055599-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060626</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US200605001322</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>55</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLINDNESS TRANSIENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OPTIC ISCHAEMIC NEUROPATHY</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>20030101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANDROGEL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055600-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060627</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US200605003094</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>49</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>71.7</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>EJACULATION FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ESCHERICHIA INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL CYST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL CYST INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THERAPEUTIC RESPONSE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY TRACT INFECTION</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>CIALIS</medicinalproduct>
        <drugauthorizationnumb>21368</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ERECTILE DYSFUNCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060401</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CIALIS</medicinalproduct>
        <drugauthorizationnumb>21368</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ERECTILE DYSFUNCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060512</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LITHIUM CARBONATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PERCOCET</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARBAMAZEPINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055601-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060630</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US200605006836</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>69</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>DIABETIC NEPHROPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIALYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOSIS IN DEVICE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMULIN N</medicinalproduct>
        <drugauthorizationnumb>18780</drugauthorizationnumb>
        <drugdosagetext>30 UG, DAILY (1/D)</drugdosagetext>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055602-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060627</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>USA0510110659</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>74</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD CHOLESTEROL INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEMORY IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ROAD TRAFFIC ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPINAL COMPRESSION FRACTURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMULIN N</medicinalproduct>
        <drugbatchnumb>8RF60M</drugbatchnumb>
        <drugauthorizationnumb>18780</drugauthorizationnumb>
        <drugdosagetext>55 U, DAILY (1/D)</drugdosagetext>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACTOS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRONOLACTONE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055603-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US200607000756</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
        <drugauthorizationnumb>20592</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055604-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US200607000753</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJURY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
        <drugauthorizationnumb>20592</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055605-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060626</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US200606005413</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>58</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>COLLAPSE OF LUNG</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JOINT DISLOCATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RIB FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ROAD TRAFFIC ACCIDENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugauthorizationnumb>21318</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040826</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055606-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060405</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL175751</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG SCREEN POSITIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>ANAEMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055607-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060413</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL182100</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>70.4</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BEDRIDDEN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055608-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060410</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL176109</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>63</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>RENAL FAILURE CHRONIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055609-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US200607000751</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>0</patientsex>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJURY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
        <drugauthorizationnumb>20592</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055610-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060417</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL178286</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>MYELODYSPLASTIC SYNDROME</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055611-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060417</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL176870</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>LETHARGY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THERAPEUTIC RESPONSE DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>ANAEMIA OF MALIGNANT DISEASE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055612-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060417</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL176869</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>ANAEMIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055613-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060408</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL176177</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCREASED UPPER AIRWAY SECRETION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARYNGOLARYNGEAL PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugindication>ANAEMIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055614-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060407</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-US175449</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TINNITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EPOGEN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>PRE-EXISTING DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEULASTA</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055615-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060406</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-US171201</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>GOUT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THERAPEUTIC RESPONSE DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EPOGEN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>DIALYSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030901</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030918</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050303</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030918</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030918</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050915</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055616-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060417</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-US176499</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>THERAPEUTIC RESPONSE DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EPOGEN</medicinalproduct>
        <drugbatchnumb>P060926</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RENAL FAILURE CHRONIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030901</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EPOGEN</medicinalproduct>
        <drugbatchnumb>P060926</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040507</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050809</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EPOGEN</medicinalproduct>
        <drugbatchnumb>P060926</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040119</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040507</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EPOGEN</medicinalproduct>
        <drugbatchnumb>P060926</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040119</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050617</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050331</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020624</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010919</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010924</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055617-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060322</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-US173355</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>93</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>THERAPEUTIC RESPONSE DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EPOGEN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>DIALYSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055618-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060306</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL171905</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugindication>ANAEMIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055619-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060327</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL174301</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HAEMATOCHEZIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>ANAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050501</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055620-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060323</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL173814</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>72.6</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugindication>ANAEMIA OF MALIGNANT DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060213</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055621-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060307</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL171814</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>70.4</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>THERAPEUTIC RESPONSE DELAYED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>RENAL FAILURE CHRONIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055622-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US200607000731</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
        <drugauthorizationnumb>20592</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055623-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060627</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US200606006232</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>93</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANGINA PECTORIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTERIOSCLEROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BALANCE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD HOMOCYSTEINE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE DIASTOLIC DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRONCHITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BUTTOCK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>C-REACTIVE PROTEIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CANALITH REPOSITIONING PROCEDURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CAROTID ARTERY ATHEROMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CAROTID ARTERY STENOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CAROTID BRUIT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHOKING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHONDROCALCINOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONTUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRY SKIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEMUR FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROOESOPHAGEAL REFLUX DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENITAL BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEMIANOPIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LETHARGY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MIGRAINE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOBILITY DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NASAL CONGESTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NECK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEURITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERIARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHOTOPSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POST PROCEDURAL COMPLICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ROAD TRAFFIC ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPINAL FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TENDON RUPTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THORACIC VERTEBRAL FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TINNITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRANSIENT ISCHAEMIC ATTACK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VERTIGO POSITIONAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISION BLURRED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VITAMIN D DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugauthorizationnumb>21318</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031017</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugauthorizationnumb>21318</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041212</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugauthorizationnumb>21318</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AREDIA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BEXTRA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYCLOBENZAPRINE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN TAB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM W/MAGNESIUM/VITAMIN D (CALCIUM, MAGNESIUM, VITAMIN D NOS)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOTREL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TORSEMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PECTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BROMELAIN (BROMELAINS)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM MAGNESIUM ZINC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NIACIN TIME (NICOTINIC ACID)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GARLIC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALOE (ALOES)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HUMIBID (GUAIFENESIN)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CITRACAL + D (CALCIUM CITRATE, ERGOCALCIFEROL)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055624-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US200607000744</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>0</patientsex>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
        <drugauthorizationnumb>20592</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055625-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US200607000745</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
        <drugauthorizationnumb>20592</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055626-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060627</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US200606002967</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugauthorizationnumb>21318</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FORTEO PEN (FORTEO PEN)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055627-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060307</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL171818</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>ANAEMIA OF MALIGNANT DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055628-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060309</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL172340</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>92</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN 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>20051201</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055629-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060309</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-US171816</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>THERAPEUTIC RESPONSE DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EPOGEN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>DIALYSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055630-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060310</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL172520</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PAIN OF SKIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>ANAEMIA OF MALIGNANT DISEASE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055631-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060310</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL172509</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>SKIN DISCOLOURATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PRE-EXISTING DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060201</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055632-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060309</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL172344</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>77</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>GLOMERULAR FILTRATION RATE DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>ANAEMIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055633-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060308</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL171909</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>84</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD CREATINE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>RENAL FAILURE CHRONIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055634-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060308</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL171852</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THERAPEUTIC RESPONSE DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>RENAL FAILURE CHRONIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055635-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060207</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-US168038</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EPOGEN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>DIALYSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060201</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055636-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20051019</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL154641</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL CANDIDIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THERAPEUTIC RESPONSE DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EPOGEN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>ANAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055637-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060215</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL169116</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugindication>PRE-EXISTING DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055638-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060221</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL169993</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>74</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD CREATINE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>ANAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060206</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055639-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060303</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL171464</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRY MOUTH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugindication>MYELODYSPLASTIC SYNDROME</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055640-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060302</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL171459</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>72.6</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANOREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EPISTAXIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN DISCOLOURATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>ANAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055641-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060301</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL171253</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>55.8</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PRURITUS GENERALISED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RENAL FAILURE CHRONIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051028</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060105</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055642-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060627</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US200606004337</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>84</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugauthorizationnumb>21318</drugauthorizationnumb>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FORTEO PEN (FORTEO PEN)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055643-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060627</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US200606002701</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>81</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>CARDIOMYOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERCOAGULATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTRACARDIAC THROMBUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UROSEPSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugauthorizationnumb>21318</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FORTEO PEN (FORTEO PEN)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055644-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060627</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>USA031253708</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>53</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>85</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLINDNESS UNILATERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CATARACT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIABETIC RETINOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMPAIRED DRIVING ABILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCORRECT DOSE ADMINISTERED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEDICAL DEVICE COMPLICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL ACUITY REDUCED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL DISTURBANCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMALOG</medicinalproduct>
        <drugbatchnumb>FF2BL9A</drugbatchnumb>
        <drugauthorizationnumb>20563</drugauthorizationnumb>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ILETIN I</medicinalproduct>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19620101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ILETIN(INSULIN, ANIMAL BEEF/PORK SEMILENTE) VIAL</medicinalproduct>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19620101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HUMALOG PEN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055645-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060626</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US200606004167</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>67</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>AORTIC STENOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OXYGEN SUPPLEMENTATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINGLE VESSEL BYPASS GRAFT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMALOG</medicinalproduct>
        <drugauthorizationnumb>20563</drugauthorizationnumb>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMULIN N</medicinalproduct>
        <drugdosagetext>110 U, 2/D</drugdosagetext>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NOVOLOG</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055646-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060627</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US200606001988</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE CONGESTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugauthorizationnumb>21318</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMALOG</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FORTEO PEN (FORTEO PEN)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055647-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060627</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US200606001694</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERAL PHYSICAL HEALTH DETERIORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugauthorizationnumb>21318</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FORTEO PEN (FORTEO PEN)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055648-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060627</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US200606000155</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREATMENT NONCOMPLIANCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugauthorizationnumb>21318</drugauthorizationnumb>
        <drugindication>OSTEOPOROSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FORTEO PEN (FORTEO PEN)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROPRANOLOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MECLIZINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ERGOCALCIFEROL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN E</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055649-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060706</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-2005-004582</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>59</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>73.5</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METASTASES TO LARGE INTESTINE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVARIAN CANCER METASTATIC</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLIMARA</medicinalproduct>
        <drugauthorizationnumb>20375</drugauthorizationnumb>
        <drugdosagetext>0.075 MG/D, CONT, TRANSDERMAL</drugdosagetext>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19950101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
        <drugdosagetext>2.5 MG</drugdosagetext>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19850101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ESTRATEST</medicinalproduct>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ESTRATEST H.S.</medicinalproduct>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ESTRACE</medicinalproduct>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19900101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMPRO</medicinalproduct>
        <drugdosagetext>0.625/2.5MG</drugdosagetext>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ESTRADERM</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19900101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055650-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060627</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-2006-017065</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>42</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEAD INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE SCLEROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NYSTAGMUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WOUND</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BETASERON</medicinalproduct>
        <drugdosagetext>6 MIU, EVERY 2D, SUBCUTANEOUS; 8 MIU, EVERY 2D, SUBCUTANEOUS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RELAPSING-REMITTING MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19950327</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19960301</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BETASERON</medicinalproduct>
        <drugdosagetext>6 MIU, EVERY 2D, SUBCUTANEOUS; 8 MIU, EVERY 2D, SUBCUTANEOUS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RELAPSING-REMITTING MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055651-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-2006-010630</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>63</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>71</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>AORTIC STENOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BAND NEUTROPHIL COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARPAL TUNNEL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBRAL ATROPHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBRAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CREPITATIONS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CSF GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CYTOMEGALOVIRUS ANTIBODY POSITIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIASTOLIC DYSFUNCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ELECTROCARDIOGRAM QT PROLONGED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MITRAL VALVE INCOMPETENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NECK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRICUSPID VALVE INCOMPETENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINE ODOUR ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENTRICULAR DYSFUNCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUDARA</medicinalproduct>
        <drugauthorizationnumb>20038</drugauthorizationnumb>
        <drugdosagetext>25 MG/M2, D2, 3, 4, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CHRONIC LYMPHOCYTIC LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060314</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060316</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RITUXAN</medicinalproduct>
        <drugdosagetext>375 MG/M2 D1, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CHRONIC LYMPHOCYTIC LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060313</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060313</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYTOXAN</medicinalproduct>
        <drugdosagetext>250 MG/M2, D2, 3, 4, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CHRONIC LYMPHOCYTIC LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060314</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060316</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FENTANYL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SENOKOT (SENNA ALEXANDRINA FRUIT)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLORIDE                     (HYDROCODONE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POLYGAM (IMMUNOGLOBULIN HUMAN NORMAL)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BACTRIM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALTREX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARDURA /IRE/ (DOXAZOSIN MESILATE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR /NET/ (ATORVASTATIN CALCIUM)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VASOTEC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METAMUCIL                                   (PLANTAGO OVATA)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055652-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050313</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL121225</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugindication>ANAEMIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055653-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050114</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL107937</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRONCHITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>P032913</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>ANAEMIA OF MALIGNANT DISEASE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055654-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040929</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL093080</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>78.1</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>THROMBOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugindication>ANAEMIA OF MALIGNANT DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040817</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040909</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARANESP</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugindication>ANAEMIA OF MALIGNANT DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040909</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055655-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050321</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL122526</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>67</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>66.3</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD POTASSIUM DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>ANAEMIA OF MALIGNANT DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055656-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050321</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL122482</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugindication>ANAEMIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055657-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050315</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL122290</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>66</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>90.8</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>RECTAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugindication>MYELODYSPLASTIC SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055658-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050314</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL121226</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DECREASED APPETITE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>ANAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055659-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050126</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL113147</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>86.7</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RENAL FAILURE CHRONIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055660-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050119</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL109222</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>66</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>LEUKOCYTOCLASTIC VASCULITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH PRURITIC</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>RENAL FAILURE CHRONIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055661-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050323</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL123131</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>54.5</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>ANAEMIA OF MALIGNANT DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050310</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050310</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055662-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050314</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL122296</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>THERAPEUTIC RESPONSE DELAYED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>RENAL FAILURE CHRONIC</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055663-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041018</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL096420</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>101.7</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ARTHROPOD STING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSORIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH PAPULAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TESTICULAR SWELLING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>P027134</drugbatchnumb>
        <drugindication>ANAEMIA OF MALIGNANT DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040920</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055664-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050318</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL122244</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALIGNANT NEOPLASM PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEOPLASM MALIGNANT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugindication>ANAEMIA OF MALIGNANT DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055665-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050310</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL122449</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>16</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>59</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugindication>RENAL FAILURE CHRONIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040901</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055666-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050314</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL121994</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EPISTAXIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RENAL FAILURE CHRONIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050311</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055667-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060630</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>HQWYE321801DEC03</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>34</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CELLULITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ESCHERICHIA BACTERAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEBRILE NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCYTOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERIRECTAL ABSCESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MYLOTARG</medicinalproduct>
        <drugauthorizationnumb>21174</drugauthorizationnumb>
        <drugdosagetext>4 MG/M^2 1X PER 1 DAY, INTRAVENOUS; SEE IMAGE</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ACUTE MYELOID LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021014</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20021014</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MYLOTARG</medicinalproduct>
        <drugauthorizationnumb>21174</drugauthorizationnumb>
        <drugdosagetext>4 MG/M^2 1X PER 1 DAY, INTRAVENOUS; SEE IMAGE</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ACUTE MYELOID LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021029</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20021029</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055668-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060710</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>HQWYE415822MAY06</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>42</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>60</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANAPHYLACTIC REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANGIONEUROTIC OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>APNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPHAGIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYGACIL</medicinalproduct>
        <drugauthorizationnumb>21821</drugauthorizationnumb>
        <drugdosagetext>100 MG LOADING, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ABSCESS NECK</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060512</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060512</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYGACIL</medicinalproduct>
        <drugauthorizationnumb>21821</drugauthorizationnumb>
        <drugdosagetext>100 MG LOADING, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CELLULITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060512</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060512</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLINDAMYCIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLAGYL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ELAVIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROTONIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DECADRON</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVENOX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055669-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US200606006255</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>57</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>117.9</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BENIGN NEOPLASM OF BLADDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CHOLESTEROL INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY BYPASS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIVERTICULITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSGEUSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING DRUNK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GALLBLADDER DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMPAIRED DRIVING ABILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERVERTEBRAL DISC PROTRUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LABYRINTHITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIMB DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NERVE COMPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NERVE INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEURALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUROPATHY PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAROSMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ROAD TRAFFIC ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SCIATIC NERVE INJURY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMULIN R</medicinalproduct>
        <drugbatchnumb>9RJ91M</drugbatchnumb>
        <drugauthorizationnumb>18780</drugauthorizationnumb>
        <drugdosagetext>60 U, 2/D</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19900101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMULIN U</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19900101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060401</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMULIN N</medicinalproduct>
        <drugdosagetext>30 U, 2/D</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOTROL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055670-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060627</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US200606006016</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>72</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</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>20050831</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055671-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US200606006000</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FEBRILE NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEMETREXED (PEMETREXED) VIAL</medicinalproduct>
        <drugauthorizationnumb>21462</drugauthorizationnumb>
        <drugdosagetext>INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055672-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060627</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US200606005999</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>64</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</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>20050907</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARBOPLATIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYANOCOBALAMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE TAB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055673-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060208</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL168344</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>ANAEMIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055674-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060215</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL169327</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CONTUSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>ANAEMIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055675-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060223</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL170425</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>URTICARIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugindication>PRE-EXISTING DISEASE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055676-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050927</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL152669</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>77</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>101.7</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOKINESIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>MYELODYSPLASTIC SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19961101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055677-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060626</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US200606005578</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ARTHROPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EVISTA</medicinalproduct>
        <drugbatchnumb>A174573</drugbatchnumb>
        <drugauthorizationnumb>20815</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055678-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060224</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-US170480</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>76</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>54.5</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PULMONARY OEDEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>ANAEMIA OF MALIGNANT DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055679-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060224</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL170427</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>75</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BONE PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>ANAEMIA OF MALIGNANT DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060201</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055680-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20051221</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL162530</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>RETICULOCYTE COUNT 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>ANAEMIA OF MALIGNANT DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051013</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060119</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051019</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051110</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051018</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051119</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055681-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060221</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL170024</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>LUNG NEOPLASM MALIGNANT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALIGNANT NEOPLASM PROGRESSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugindication>ANAEMIA OF MALIGNANT DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050324</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050730</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055682-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060306</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL171867</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>79.5</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>RETICULOCYTE COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugindication>ANAEMIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055683-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060303</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL171483</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ATRIAL FIBRILLATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>ANAEMIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055684-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060206</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL168613</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>100.8</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PRE-EXISTING DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060110</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051028</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060110</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051028</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060110</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055685-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060223</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-US170094</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>66.6</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EPOGEN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>DIALYSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARANESP</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>DIALYSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060208</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060222</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055686-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060227</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-US170479</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>3.1</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ACCIDENTAL OVERDOSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EPOGEN</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugindication>PREMATURE BABY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060201</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055687-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060306</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL171466</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>45.4</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>THERAPEUTIC RESPONSE DELAYED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RENAL FAILURE CHRONIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060206</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050801</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055688-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060303</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL171806</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>48.6</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>THERAPEUTIC RESPONSE DELAYED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>RENAL FAILURE CHRONIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060224</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055689-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060627</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US200606005805</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>82</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE FLUCTUATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE IRREGULAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STENT PLACEMENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMALOG</medicinalproduct>
        <drugbatchnumb>9RT36M</drugbatchnumb>
        <drugauthorizationnumb>20563</drugauthorizationnumb>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060529</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055690-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060627</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US200606005685</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE ANAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE DISCOLOURATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSULIN RESISTANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IRRITABLE BOWEL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCREATIC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMALOG</medicinalproduct>
        <drugbatchnumb>9SD41M</drugbatchnumb>
        <drugauthorizationnumb>20563</drugauthorizationnumb>
        <drugdosagetext>SUBCUTANEOUS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMULIN R</medicinalproduct>
        <drugbatchnumb>9SE67M</drugbatchnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055691-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060627</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US200606005675</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>71</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CATARACT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FOOD ALLERGY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JAW DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LENS DISLOCATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOMYELITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POST PROCEDURAL COMPLICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH PRURITIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SCAB</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STRESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTH DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMALOG</medicinalproduct>
        <drugbatchnumb>8SE17Y</drugbatchnumb>
        <drugauthorizationnumb>20563</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMULIN N</medicinalproduct>
        <drugbatchnumb>9RL87M</drugbatchnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19870101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMULIN R</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19870101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060201</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055692-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060626</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US200606005562</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>71</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMULIN 70/30</medicinalproduct>
        <drugauthorizationnumb>18780</drugauthorizationnumb>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19940101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COZAAR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIURETICS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLOVENT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASA TABS (ACETYLSALICYLIC ACID)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055693-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060626</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US200606005579</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>84</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>LIP ULCERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOUTH ULCERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STOMATITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EVISTA</medicinalproduct>
        <drugauthorizationnumb>20815</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060525</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060616</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055694-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060626</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US200606003118</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ADENOMYOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ENDOMETRIAL ATROPHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ENDOMETRIAL HYPERTROPHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HOT FLUSH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARYNGOLARYNGEAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHINITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UTERINE LEIOMYOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UTERINE POLYP</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VAGINAL DISCHARGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VAGINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VULVOVAGINAL DRYNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EVISTA</medicinalproduct>
        <drugauthorizationnumb>20815</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EVISTA</medicinalproduct>
        <drugauthorizationnumb>20815</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060201</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055695-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060703</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>HQWYE103719OCT05</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>85</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>72.64</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACTERIAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLAST CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CULTURE POSITIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISEASE PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LETHARGY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEUKOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</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>20050928</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050928</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>20051012</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051012</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055696-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060703</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>HQWYE593305JUL06</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>16</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROTONIX</medicinalproduct>
        <drugauthorizationnumb>20987</drugauthorizationnumb>
        <drugdosagetext>40 MG 1X PER 1 DAY, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060703</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055697-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060707</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>HQWYE012507JUN06</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>30</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>97.16</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIALYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>KIDNEY TRANSPLANT REJECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEUKOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL TUBULAR NECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL VEIN OCCLUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VASCULAR STENOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RAPAMUNE</medicinalproduct>
        <drugauthorizationnumb>21083</drugauthorizationnumb>
        <drugdosagetext>10 MG 1X PER 1 DAY, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS AGAINST TRANSPLANT REJECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060603</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDRALAZINE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LABETALOL HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NILSTAT (NYSTATIN)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BACTRIM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NIFEDIPINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FENOLDOPAM             (FENOLDOPAM)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONIDINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055698-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060703</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>HQWYE038215APR05</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>63</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>71.73</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ADENOCARCINOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BREAST CANCER METASTATIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METASTASES TO LYMPH NODES</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
        <drugauthorizationnumb>4782</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19900101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROVERA</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19900101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055699-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060208</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL168361</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>RENAL FAILURE CHRONIC</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055700-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060223</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL170436</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>67.2</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANGINA PECTORIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugindication>ANAEMIA OF MALIGNANT DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060222</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055701-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060228</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL170820</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>53</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>81.7</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>ANAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055702-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060302</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL171248</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANOREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>ANAEMIA OF MALIGNANT DISEASE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055703-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060303</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL171477</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>JOINT SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugindication>ANAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060301</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055704-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060207</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL168479</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugindication>PRE-EXISTING DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055705-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060301</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-US170765</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>90.8</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>RETICULOCYTE COUNT ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THERAPEUTIC RESPONSE DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EPOGEN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>DIALYSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055706-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20051222</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL162913</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>88.5</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>THERAPEUTIC RESPONSE DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>P048851</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RENAL FAILURE CHRONIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055707-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060221</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL169994</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>THROMBOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>ANAEMIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055708-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060210</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL169016</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugindication>ANAEMIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055709-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060210</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL169023</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANOREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHILLS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RENAL FAILURE CHRONIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060119</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060206</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055710-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060214</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL169333</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>56.8</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY INCONTINENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>RENAL FAILURE CHRONIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050901</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055711-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060208</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-US168113</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EPOGEN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>RENAL FAILURE CHRONIC</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055712-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060127</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL167153</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>LUNG NEOPLASM MALIGNANT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALIGNANT NEOPLASM PROGRESSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>ANAEMIA OF MALIGNANT DISEASE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055713-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060127</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL167229</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>61</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEXUAL DYSFUNCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>RENAL FAILURE CHRONIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055714-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060127</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-US166655</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>81</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>THERAPEUTIC RESPONSE DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EPOGEN</medicinalproduct>
        <drugbatchnumb>P048588</drugbatchnumb>
        <drugindication>MYELODYSPLASTIC SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050531</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055715-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060130</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL167361</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>71.7</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MENISCUS LESION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugindication>PRE-EXISTING DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051122</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055716-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060130</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL167366</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>83.3</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>THERAPEUTIC RESPONSE DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugindication>ANAEMIA OF MALIGNANT DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050220</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060123</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051011</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060108</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055717-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060206</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL167946</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>BLOOD BLISTER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN LESION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>ANAEMIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055718-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060202</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL167721</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ALOPECIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EXPOSURE TO TOXIC AGENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAIL DISCOLOURATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URTICARIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RENAL FAILURE CHRONIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
        <drugadministrationroute>051</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055719-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060201</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-US167131</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>THERAPEUTIC RESPONSE DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EPOGEN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>RENAL FAILURE CHRONIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055720-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060123</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL166127</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugindication>ANAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051216</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055721-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060123</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL166310</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>PRE-EXISTING DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060117</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060117</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055722-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060127</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL167156</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>68.1</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>THERAPEUTIC RESPONSE DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>P048851</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RENAL FAILURE CHRONIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051111</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055723-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060113</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-US164879</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>65</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>THERAPEUTIC RESPONSE DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EPOGEN</medicinalproduct>
        <drugbatchnumb>P050254</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>DIALYSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055724-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060123</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL166356</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>59.9</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BURSITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BUTTOCK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RENAL FAILURE CHRONIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055725-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060203</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL167861</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugindication>ANAEMIA OF MALIGNANT DISEASE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055726-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060203</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL167866</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>ANAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060120</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055727-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050921</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL151447</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>79.5</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GINGIVAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LABILE BLOOD PRESSURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RENAL FAILURE CHRONIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050721</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055728-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060202</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-US167429</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>THERAPEUTIC RESPONSE DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EPOGEN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>RENAL FAILURE CHRONIC</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055729-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060127</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL167157</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWELLING FACE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>ANAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051201</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055730-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060127</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-US166727</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>THERAPEUTIC RESPONSE DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EPOGEN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>DIALYSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055731-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060127</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-US166849</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>THERAPEUTIC RESPONSE DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EPOGEN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>DIALYSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055732-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060130</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-US166818</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>THERAPEUTIC RESPONSE DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EPOGEN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>RENAL FAILURE CHRONIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050301</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055733-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060130</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL167380</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>67.2</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>ANAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060126</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060126</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055734-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060123</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL179823</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </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>PROCRIT</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PRE-EXISTING DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060120</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060120</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051230</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060120</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060120</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055735-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060703</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>HQWYE190805JAN06</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>60</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>89.89</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BREAST CANCER METASTATIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METASTASES TO LYMPH NODES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OESTROGEN RECEPTOR ASSAY POSITIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROGESTERONE RECEPTOR ASSAY POSITIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMPRO</medicinalproduct>
        <drugauthorizationnumb>20527</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ESTROPIPATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MEDROXYPROGESTERONE ACETATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROVERA</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055736-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060125</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL166653</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>ANAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055737-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060125</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-US166321</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>THERAPEUTIC RESPONSE DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EPOGEN</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugindication>DIALYSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055738-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060125</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL166845</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>THERAPEUTIC RESPONSE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRANSPLANT REJECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RENAL FAILURE CHRONIC</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
        <drugadministrationroute>062</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055739-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060126</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL166659</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>82.6</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>THERAPEUTIC RESPONSE DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RENAL FAILURE CHRONIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020805</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055740-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060126</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL167023</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>40</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD CREATININE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RENAL FAILURE CHRONIC</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055741-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20051206</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-US160330</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>THERAPEUTIC RESPONSE DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EPOGEN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>DIALYSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051130</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055742-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060126</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL167858</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>THERAPEUTIC RESPONSE DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugindication>RENAL FAILURE CHRONIC</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055743-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060126</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-US164519</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>33.6</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EPOGEN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>DIALYSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051103</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055744-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060119</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL166133</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>81.3</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CYANOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugindication>ANAEMIA OF MALIGNANT DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051212</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060111</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055745-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060713</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060703</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>HQWYE332109SEP05</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>51</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BREAST CANCER FEMALE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BREAST CANCER IN SITU</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BREAST CANCER METASTATIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BREAST FIBROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BREAST MICROCALCIFICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GALLBLADDER POLYP</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLAMMATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPH NODE CANCER METASTATIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NUCLEAR MAGNETIC RESONANCE IMAGING ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMPRO</medicinalproduct>
        <drugauthorizationnumb>20527</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20011101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055746-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060705</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>SPV1-2006-00170</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG DEPENDENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EUPHORIC MOOD</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ADDERALL 10</medicinalproduct>
        <drugauthorizationnumb>11522</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OPIATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHAMPHETAMINE       (METAMPETAMINE HYDROCHLORIDE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATIVAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALIUM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055747-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>SPV1-2006-00009</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>16</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>52.2</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>AGITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSKINESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HALLUCINATION, VISUAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARANOIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>REFUSAL OF TREATMENT BY RELATIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUPRAVENTRICULAR TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TETANY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TONGUE DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ADDERALL 10</medicinalproduct>
        <drugauthorizationnumb>21303</drugauthorizationnumb>
        <drugdosagetext>15 MG, ONCE DOSE, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060519</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060519</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055748-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060706</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006068033</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>63</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>83.4619</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD CHOLESTEROL INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HIGH DENSITY LIPOPROTEIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOW DENSITY LIPOPROTEIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THERAPY NON-RESPONDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
        <drugauthorizationnumb>19787</drugauthorizationnumb>
        <drugdosagetext>10 MG (10 MG, QD), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugdosagetext>40 MG (40 MG, QD), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060401</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CADUET</medicinalproduct>
        <drugbatchnumb>0559115</drugbatchnumb>
        <drugdosagetext>DAILY INTERVAL: EVERY DAY</drugdosagetext>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060501</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZETIA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACTOS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENICAR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACEON</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLOMAX ^CSL^ (TAMSULOSIN HYDROCHLORIDE)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055749-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060705</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006045129</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </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>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEXTRA</medicinalproduct>
        <drugauthorizationnumb>21341</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055750-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060706</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006075945</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>69</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>80.72</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>AORTIC VALVE INCOMPETENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ELECTROCARDIOGRAM ST-T CHANGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG HYPERINFLATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MITRAL VALVE INCOMPETENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLEURAL EFFUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUS BRADYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRICUSPID VALVE INCOMPETENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TROPONIN I INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ATORVASTATIN CALCIUM</medicinalproduct>
        <drugauthorizationnumb>20702</drugauthorizationnumb>
        <drugdosagetext>40 MG (40 MG, 1 IN 1 D)</drugdosagetext>
        <drugindication>HYPERCHOLESTEROLAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060406</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060602</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALL OTHER THERAPEUTIC PRODUCTS (ALL OTHER THERAPEUTIC PRODUCTS)</medicinalproduct>
        <drugdosagetext>10 MCG (1 IN 1 D)</drugdosagetext>
        <drugindication>HYPERCHOLESTEROLAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050505</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060602</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SERTRALINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COMBIVENT</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055751-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060630</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006073480</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>61</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANGINA UNSTABLE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIOMEGALY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEXTRA</medicinalproduct>
        <drugauthorizationnumb>21341</drugauthorizationnumb>
        <drugdosagetext>20 MG (20 MG, 1 IN 1 D)</drugdosagetext>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031021</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055752-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesscongenitalanomali>1</seriousnesscongenitalanomali>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060705</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006078842</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>2.763</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIAC MURMUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONGENITAL EYELID MALFORMATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYELID PTOSIS CONGENITAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FACIAL PALSY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYDROCELE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIRACEPT</medicinalproduct>
        <drugauthorizationnumb>20779</drugauthorizationnumb>
        <drugdosagetext>2500 MG (1250 MG, 2 IN 1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV TEST POSITIVE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050916</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMBIVIR</medicinalproduct>
        <drugdosagetext>2 TABS (2 IN 1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV TEST POSITIVE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980122</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EFAVIRENZ</medicinalproduct>
        <drugdosagetext>600 MG (600 MG, 1 IN 1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV TEST POSITIVE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010228</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RETROVIR</medicinalproduct>
        <drugdosagetext>2 MG/KG/HOUR, INTRAVENOUS; SEE IMAGE</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>HIV TEST POSITIVE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060119</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060119</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RETROVIR</medicinalproduct>
        <drugdosagetext>2 MG/KG/HOUR, INTRAVENOUS; SEE IMAGE</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>HIV TEST POSITIVE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060119</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060122</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055753-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060705</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006083045</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>OPTIC ISCHAEMIC NEUROPATHY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIAGRA</medicinalproduct>
        <drugauthorizationnumb>20895</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055754-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060701</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006083450</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>80</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>90.7194</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HYPOACUSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugauthorizationnumb>21446</drugauthorizationnumb>
        <drugdosagetext>50 MG (50 MG, 1 IN 1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NEUROPATHY PERIPHERAL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060628</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GABAPENTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN A (NATURAL) CAP</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN C (VITAMIN C)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALL OTHER THERAPEUTIC PRODUCTS (ALL OTHER THERAPEUTIC PRODUCTS)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055755-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060701</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006003808</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>86</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>72.5755</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCONTINENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTESTINAL OBSTRUCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MICTURITION URGENCY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DETROL LA</medicinalproduct>
        <drugauthorizationnumb>21228</drugauthorizationnumb>
        <drugdosagetext>4 MG (4 MG, 1 IN 1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTONIC BLADDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DETROL LA</medicinalproduct>
        <drugauthorizationnumb>21228</drugauthorizationnumb>
        <drugdosagetext>4 MG (4 MG, 1 IN 1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MICTURITION URGENCY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYZAAR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMINS (VITAMINS)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055756-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060621</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006041685</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>63</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>113.8529</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ATRIAL FIBRILLATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE CONGESTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENTAL STATUS CHANGES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRANSIENT ISCHAEMIC ATTACK</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEXTRA</medicinalproduct>
        <drugauthorizationnumb>21341</drugauthorizationnumb>
        <drugdosagetext>40 MG (20 MG, 2 IN 1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INFLAMMATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEXTRA</medicinalproduct>
        <drugauthorizationnumb>21341</drugauthorizationnumb>
        <drugdosagetext>40 MG (20 MG, 2 IN 1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055757-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050412</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2005047427</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>60</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>70.3075</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEAFNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URTICARIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VIRAL INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugauthorizationnumb>21156</drugauthorizationnumb>
        <drugdosagetext>1000 MG (200 MG, 5 IN 1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>COLONIC POLYP</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030528</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055758-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060703</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>227029</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>79</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DYSARTHRIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGE INTRACRANIAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPEECH DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVASTIN</medicinalproduct>
        <drugindication>MACULAR DEGENERATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055759-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060707</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>OSCN-PR-0607S-0188</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>63</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLD SWEAT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY OEDEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OMNISCAN</medicinalproduct>
        <drugauthorizationnumb>20123</drugauthorizationnumb>
        <drugdosagetext>40 MG. SINGLE DOSE, I.V.</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PAIN IN EXTREMITY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060620</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060620</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055760-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060705</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006BI007099</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>52</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</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>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021209</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>AVANDIA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOPHAGE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPROL-XL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055761-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060707</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006BI009641</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>51</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>70.7611</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE INCREASED</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>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>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055762-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060705</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006-06-0676</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>40</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>83.4619</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEG-INTRON</medicinalproduct>
        <drugdosagetext>180 MCG QWK SUBCUTANEOUS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060515</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RIBASPHERE             (RIVAVIRIN)</medicinalproduct>
        <drugdosagetext>800 MG QD ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060515</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL SULFATE AEROSOL SOLUTION</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLONASE                         PRN NAS AER SPRAY</medicinalproduct>
        <drugadministrationroute>055</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADVIL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055763-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060630</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>0601756US</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>24</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABORTION SPONTANEOUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD HUMAN CHORIONIC GONADOTROPIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMPLICATION OF PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE BEFORE PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ULTRASOUND SCAN ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAZORAC</medicinalproduct>
        <drugauthorizationnumb>21184</drugauthorizationnumb>
        <drugdosagetext>UNK, QD, TOPICAL</drugdosagetext>
        <drugadministrationroute>061</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060413</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060608</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055764-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060711</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>17453</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>34</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>88.4514</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URTICARIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
        <drugbatchnumb>5DE0013</drugbatchnumb>
        <drugauthorizationnumb>72095</drugauthorizationnumb>
        <drugdosagetext>400MG/ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DENTAL DISCOMFORT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060205</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060301</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055765-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060706</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>06H-163-0308634-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>15</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HAEMODIALYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
        <drugauthorizationnumb>18667</drugauthorizationnumb>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOBRAMYCIN</medicinalproduct>
        <drugdosagetext>INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ANTI-INFECTIVE THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VANCOMYCIN INJECTION                (VANCOMYCIN HYDROCHLORIDE)</medicinalproduct>
        <drugindication>ANTI-INFECTIVE THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TACROLIMUS                                (TACROLIMUS)</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMPHOTERICIN B</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOBRAMYCIN</medicinalproduct>
        <drugdosagetext>INHALATION</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>ANTI-INFECTIVE THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CEFTAZIDIME                    (CEFTAZIDIME)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055766-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060630</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006001328</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>84</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DYSGRAPHIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOVEMENT DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULAR WEAKNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TARCEVA</medicinalproduct>
        <drugauthorizationnumb>21743</drugauthorizationnumb>
        <drugdosagetext>150 MG (QD), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060501</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE TAB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WELLBUTRIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055767-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060622</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006-07-0462</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>49</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ALOPECIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIBIDO DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEMORY IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NASOPHARYNGITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ONYCHOMYCOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRODUCTIVE COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPUTUM DISCOLOURED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHEEZING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEG-INTRON</medicinalproduct>
        <drugdosagetext>SUBCUTANEOUS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>HEPATITIS B</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051118</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060520</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEG-INTRON</medicinalproduct>
        <drugdosagetext>SUBCUTANEOUS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051118</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060520</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RIBAVIRIN</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS B</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051118</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060520</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RIBAVIRIN</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051118</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060520</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055768-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060705</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>T200600535</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>56</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>63.5</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BACTERIAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLEPHARITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHILLS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIABETIC RETINOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EAR DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EAR HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EAR INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYELID OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FURUNCLE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARYNGOLARYNGEAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RETINAL ANEURYSM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISION BLURRED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL ACUITY REDUCED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ULTRA-TECHNEKOW DTE (TECHNETIUM TC 99M GENERATOR)</medicinalproduct>
        <drugauthorizationnumb>17243</drugauthorizationnumb>
        <drugdosagetext>SINGLE, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE GATED ACQUISITION SCAN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051115</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051115</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROPRANOLOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOTROL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN TAB</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055769-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060706</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>T200600660</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>50</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>90.7</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BRUXISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DELUSIONAL PERCEPTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GLAUCOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE TWITCHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TUNNEL VISION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINE AMPHETAMINE POSITIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXYCODONE HCL</medicinalproduct>
        <drugdosagetext>20 MG, 6 TIMES DAILY, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MUSCULOSKELETAL PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FENTANYL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAVATAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIAZEPAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAZODONE HCL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055770-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060705</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006US-02842</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>62</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CHEST DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY OCCLUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CIPROFLOXACIN</medicinalproduct>
        <drugauthorizationnumb>75747</drugauthorizationnumb>
        <drugdosagetext>500 MG, BID</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060616</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060619</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055771-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060703</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006US-02844</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>14</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CRYING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPERSONALISATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HALLUCINATION, VISUAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ISOTRETINOIN</medicinalproduct>
        <drugauthorizationnumb>76041</drugauthorizationnumb>
        <drugdosagetext>40 MG, QD</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060518</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060701</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055772-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006SP002602</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANAPHYLACTIC SHOCK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWELLING FACE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LUNESTA</medicinalproduct>
        <drugauthorizationnumb>21476</drugauthorizationnumb>
        <drugdosagetext>3 MG; ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MUSCLE RELAXANTS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLERGY MEDICATION</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055773-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060707</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>14369</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>53</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>69.14</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ESCHERICHIA BACTERAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYTARABINE</medicinalproduct>
        <drugauthorizationnumb>71868</drugauthorizationnumb>
        <drugindication>ACUTE MYELOID LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060104</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060108</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ETOPOSIDE</medicinalproduct>
        <drugindication>ACUTE MYELOID LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060104</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060108</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MITOXANTRONE</medicinalproduct>
        <drugindication>ACUTE MYELOID LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060104</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060108</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CEP-701</medicinalproduct>
        <drugindication>ACUTE MYELOID LEUKAEMIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055774-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060702</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>14359</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>66</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BACILLARY ANGIOMATOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMANGIOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALIGNANT HISTIOCYTOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NODULE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSORIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH ERYTHEMATOUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH PRURITIC</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugauthorizationnumb>11719</drugauthorizationnumb>
        <drugindication>PSORIASIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugauthorizationnumb>11719</drugauthorizationnumb>
        <drugindication>PSORIATIC ARTHROPATHY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIPOTRIENE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUOCINONIDE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055775-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060706</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>14362</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>75</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>83.9154</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HEPATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCREATITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUOROURACIL</medicinalproduct>
        <drugauthorizationnumb>8107</drugauthorizationnumb>
        <drugindication>COLON CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060424</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUOROURACIL</medicinalproduct>
        <drugindication>COLON CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060508</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEUCOVORIN CALCIUM</medicinalproduct>
        <drugindication>COLON CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060424</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEUCOVORIN CALCIUM</medicinalproduct>
        <drugindication>COLON CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060508</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ELOXATIN</medicinalproduct>
        <drugdosagetext>168 MG FORTNIGHTLY IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLON CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060424</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ELOXATIN</medicinalproduct>
        <drugdosagetext>168 MG FORTNIGHTLY IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLON CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060508</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055776-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060216</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>35692</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>0</patientsex>
      <reaction>
        <reactionmeddrapt>INFLAMMATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POSTOPERATIVE INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STAPHYLOCOCCAL INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BSS</medicinalproduct>
        <drugauthorizationnumb>20742</drugauthorizationnumb>
        <drugindication>SURGERY</drugindication>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DISCOVISC</medicinalproduct>
        <drugindication>SURGERY</drugindication>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055777-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060630</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>TRP_0791_2006</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>58</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>90.7194</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CREATINE PHOSPHOKINASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD THYROID STIMULATING HORMONE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTI-ORGAN DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALLOR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THYROID DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RIBASPHERE</medicinalproduct>
        <drugauthorizationnumb>76203</drugauthorizationnumb>
        <drugdosagetext>600 MG BID PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEG-INTRON</medicinalproduct>
        <drugdosagetext>1 DF QWK SC</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RIBASPHERE</medicinalproduct>
        <drugdosagetext>600 MG PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEG-INTRON</medicinalproduct>
        <drugdosagetext>0.5 DF QWK SC</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RIBASPHERE</medicinalproduct>
        <drugdosagetext>600 MG BID PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEG-INTRON</medicinalproduct>
        <drugdosagetext>1 DF QWK SC</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RIBASPHERE</medicinalproduct>
        <drugdosagetext>600 MG PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050701</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEG-INTRON</medicinalproduct>
        <drugdosagetext>0.5 DF QWK SC</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050601</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055778-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060630</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>TRP_0756_2006</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>53</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>95.2554</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DELUSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RIBASPHERE</medicinalproduct>
        <drugauthorizationnumb>76203</drugauthorizationnumb>
        <drugdosagetext>600 MG BID PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051122</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INFERGEN</medicinalproduct>
        <drugdosagetext>15 MCG QDAY SC</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051121</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EFFEXOR XR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REPAGLINIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALSARTAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM GLUCONATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEGA 3</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLAXSEED OIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGNESIUM SULFATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RISPERDAL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ABILIFY</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EFFEXOR</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055779-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060705</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006-06-1619</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>64</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ALANINE AMINOTRANSFERASE ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INTRON A</medicinalproduct>
        <drugdosagetext>3-6 MIU TIW SUBCUTANEOUS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>METASTATIC RENAL CELL CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060504</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060531</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUTENT</medicinalproduct>
        <drugdosagetext>37.5 MG QD ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>METASTATIC RENAL CELL CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060504</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060531</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPROL-XL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ECOTRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE ORAL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTIVITAMIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055780-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060705</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006-07-0253</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>BREAST CANCER FEMALE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THERAPY NON-RESPONDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VICTIM OF HOMICIDE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEG-INTRON</medicinalproduct>
        <drugindication>HEPATITIS C</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060401</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBETOL</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060401</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055781-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060705</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006-07-0384</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>44</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEAT STROKE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</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>20060504</drugstartdate>
      </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>20060504</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COMPAZINE SUSTAINED RELEASE CAPSULES</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEXAPRO</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MOTRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055782-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060704</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006-07-0334</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>40</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>81.6475</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLISTER INFECTED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD POTASSIUM INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE WARMTH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL INTAKE REDUCED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN LESION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEG-INTRON</medicinalproduct>
        <drugdosagetext>SUBCUTANEOUS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060310</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RIBAVIRIN</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060310</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CITALOPRAM HYDROBROMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONAZEPAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HEPATITIS B VACCINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055783-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060705</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006-07-0377</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATEMESIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RED BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEG-INTRON</medicinalproduct>
        <drugdosagetext>SUBCUTANEOUS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060624</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055784-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060720</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060713</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>LU-SP-2006-01807</companynumb>
    <primarysource>
      <reportercountry>LUXEMBOURG</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>74</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CYSTITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CYSTITIS NONINFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMMUCYST</medicinalproduct>
        <drugbatchnumb>LOT NOT REP</drugbatchnumb>
        <drugadministrationroute>043</drugadministrationroute>
        <drugindication>BLADDER CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050127</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050804</drugenddate>
        <drugtreatmentduration>188</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EUTHYROX</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19900101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUDEX</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050821</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055785-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060720</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060710</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20060501813</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA MULTIFORME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPHADENOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SARCOIDOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugindication>COLITIS ULCERATIVE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TEGRETOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>EPILEPSY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLEGRA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SINUSITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NASONEX</medicinalproduct>
        <drugadministrationroute>045</drugadministrationroute>
        <drugindication>SINUSITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ROBINUL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>COLITIS ULCERATIVE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMODIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>COLITIS ULCERATIVE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE TAB</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>COLITIS ULCERATIVE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASACOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>COLITIS ULCERATIVE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROZAC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055786-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060720</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060710</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20060702066</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>56.7</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OCULAR HYPERAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH MACULAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CROHN'S DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ESTROGENS SOL/INJ</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENADRYL</medicinalproduct>
        <drugdosagetext>ONE EVERY SIX HOURS</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMODIUM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055787-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060720</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060711</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-JNJFOC-20060606507</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>62</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>76</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MYCOBACTERIUM CHELONEI 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>POLYARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>VASCULITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>POLYARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDROL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>POLYARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RENITEC</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYPERIUM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SECTRAL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XATRAL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CACIT</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACTONEL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULINE NPH</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPECIAFOLDINE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055789-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060720</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060710</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20060600557</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HIP ARTHROPLASTY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFUSION RELATED REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>KNEE ARTHROPLASTY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055790-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060720</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060713</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2006JP10606</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <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>ANOREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCYTOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOXIC SKIN ERUPTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TEGRETOL</medicinalproduct>
        <drugauthorizationnumb>016608</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055791-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060720</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060714</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHFR2006GB02237</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>60</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>85</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ALCOHOLIC LIVER DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD SODIUM DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPONATRAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOSARTAN POSTASSIUM</medicinalproduct>
        <drugdosagetext>25 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DILATATION VENTRICULAR</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060418</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugdosagetext>20 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DUODENITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031028</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROPRANOLOL</medicinalproduct>
        <drugdosagetext>40 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060526</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SERETIDE</medicinalproduct>
        <drugdosagetext>2 PUFFS, BID</drugdosagetext>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041007</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARBAMAZEPINE</medicinalproduct>
        <drugauthorizationnumb>016608</drugauthorizationnumb>
        <drugdosagetext>200 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NEURALGIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19981125</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060608</drugenddate>
        <drugtreatmentduration>2753</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055792-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060720</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060320</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHNU2006DE01369</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD CREATININE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD UREA INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAMMA-GLUTAMYLTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOKALAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPONATRAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MANIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SCHIZOAFFECTIVE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY INCONTINENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIOVAN HCT</medicinalproduct>
        <drugauthorizationnumb>20818</drugauthorizationnumb>
        <drugdosagetext>160 MG/D</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TEGRETOL</medicinalproduct>
        <drugdosagetext>200 MG/D</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>AFFECTIVE DISORDER</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050516</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HALDOL</medicinalproduct>
        <drugdosagetext>2 MG/D</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050429</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOXACOR</medicinalproduct>
        <drugdosagetext>4 MG/D</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050607</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OLANZAPINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055793-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060720</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060714</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHMT2006CA01525</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>28</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>GALACTORRHOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TEGRETOL</medicinalproduct>
        <drugauthorizationnumb>016608</drugauthorizationnumb>
        <drugdosagetext>200 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NEURALGIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060401</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055794-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060720</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060712</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>NO-JNJFOC-20060702228</companynumb>
    <primarysource>
      <reportercountry>NORWAY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BASAL CELL CARCINOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFUSION RELATED REACTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CROHN'S DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ANKYLOSING SPONDYLITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SULFASALAZINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CROHN'S DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SULFASALAZINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANKYLOSING SPONDYLITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PARACETAMOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CETIRIZINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055795-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060720</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060712</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>GB-JNJFOC-20060204334</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>60</patientweight>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>BRONCHOPNEUMONIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCICHEW</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FERROUS SULFATE TAB</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055796-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060718</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>52</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>96.7</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ACTIVITIES OF DAILY LIVING IMPAIRED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PACLITAXEL</medicinalproduct>
        <drugdosagetext>345 MG-175 MG/M2 EVERY 3 WEEKS IV [4 CYCLES]</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050809</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055797-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060720</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060714</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IL-NOVOPROD-255051</companynumb>
    <primarysource>
      <reportercountry>ISRAEL</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DEATH NEONATAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NOVOSEVEN</medicinalproduct>
        <drugdosagetext>90 UG/KG, UNK</drugdosagetext>
        <drugindication>PULMONARY HAEMORRHAGE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060702</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055798-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060718</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>60</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>79.3795</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METASTASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NERVE COMPRESSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EVEROLIMUS</medicinalproduct>
        <drugdosagetext>10 MG PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RENAL CELL CARCINOMA STAGE UNSPECIFIED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060608</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055799-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060718</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>63.4</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>ERBITUX</medicinalproduct>
        <drugdosagetext>69.6 MG/435 MG  WEEKLY EVERY OTHER WEEK IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ADENOCARCINOMA PANCREAS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060620</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ERBITUX</medicinalproduct>
        <drugdosagetext>69.6 MG/435 MG  WEEKLY EVERY OTHER WEEK IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ADENOCARCINOMA PANCREAS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060627</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ERBITUX</medicinalproduct>
        <drugdosagetext>69.6 MG/435 MG  WEEKLY EVERY OTHER WEEK IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ADENOCARCINOMA PANCREAS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060705</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GEMZAR</medicinalproduct>
        <drugdosagetext>1740 MG WEEKLY EVERY OTHER WEEK IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ADENOCARCINOMA PANCREAS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060620</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GEMZAR</medicinalproduct>
        <drugdosagetext>1740 MG WEEKLY EVERY OTHER WEEK IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ADENOCARCINOMA PANCREAS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060705</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXALIPLATIN</medicinalproduct>
        <drugdosagetext>174 MG EVERY OTHER WEEK IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ADENOCARCINOMA PANCREAS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060620</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXALIPLATIN</medicinalproduct>
        <drugdosagetext>174 MG EVERY OTHER WEEK IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ADENOCARCINOMA PANCREAS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060705</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENAZEPRIL HYDROCHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTIVITAMIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055800-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060720</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060714</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IL-NOVOPROD-255045</companynumb>
    <primarysource>
      <reportercountry>ISRAEL</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DEATH NEONATAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NOVOSEVEN</medicinalproduct>
        <drugdosagetext>90 UG/KG, UNK</drugdosagetext>
        <drugindication>PULMONARY HAEMORRHAGE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060705</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055801-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060718</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>95.2554</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FACIAL PALSY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OCULAR HYPERAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOBENZAPRINE HCL</medicinalproduct>
        <drugdosagetext>ONE TABLET 3 TIMES A DAY ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANTIINFLAMMATORY THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060606</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060614</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCODONE BITARTRATE + ACETAMINOPHEN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055802-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060718</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>3</patientonsetage>
      <patientonsetageunit>804</patientonsetageunit>
      <patientweight>3.1752</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ADHESION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PENIS DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POSTOPERATIVE WOUND INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN IRRITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN SWELLING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CREAMY PETROLEUM JELLY SAV-ON OSCO BY ALBERTSONS</medicinalproduct>
        <drugdosagetext>1/2 TEASPOON ON (SEE IMAGE) WITH DIAPER CHANGE TOP</drugdosagetext>
        <drugadministrationroute>061</drugadministrationroute>
        <drugindication>CIRCUMCISION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060627</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060710</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055803-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060718</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIRAPEX</medicinalproduct>
        <drugbatchnumb>656247A</drugbatchnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055804-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060718</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>54</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>65.7716</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEEP VEIN THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMPLANT SITE THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POST PROCEDURAL COMPLICATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN</medicinalproduct>
        <drugindication>THROMBOSIS PROPHYLAXIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055805-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060718</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>40</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DIALYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG TOXICITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEPHROPATHY TOXIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POLYURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL TUBULAR NECROSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIREAD</medicinalproduct>
        <drugdosagetext>300 MG DAILY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060516</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055806-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060718</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD CORTICOTROPHIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CORTISOL DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CUSHING'S SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERECTILE DYSFUNCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IATROGENIC INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POOR QUALITY DRUG ADMINISTERED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROCEDURAL COMPLICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THERAPEUTIC PRODUCT CONTAMINATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KENALOG</medicinalproduct>
        <drugbatchnumb>6B18043</drugbatchnumb>
        <drugdosagetext>80 MG EPIDURAL</drugdosagetext>
        <drugadministrationroute>008</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060615</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060615</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KENALOG</medicinalproduct>
        <drugbatchnumb>6D13648</drugbatchnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KENALOG</medicinalproduct>
        <drugbatchnumb>6D1363</drugbatchnumb>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ISOVUE-300</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BUPIVICINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NSS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055807-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060718</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>54.7</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CUSHING'S SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IATROGENIC INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POOR QUALITY DRUG ADMINISTERED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POST PROCEDURAL COMPLICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THERAPEUTIC PRODUCT CONTAMINATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KENALOG</medicinalproduct>
        <drugbatchnumb>3D18043</drugbatchnumb>
        <drugdosagetext>80 MG X1 EPIDURAL</drugdosagetext>
        <drugadministrationroute>008</drugadministrationroute>
        <drugindication>EPIDURAL ANAESTHESIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060523</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060523</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KENALOG</medicinalproduct>
        <drugbatchnumb>3D18043</drugbatchnumb>
        <drugdosagetext>80 MG X1 EPIDURAL</drugdosagetext>
        <drugadministrationroute>008</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060523</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060523</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KENALOG</medicinalproduct>
        <drugbatchnumb>6D136</drugbatchnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KENALOG</medicinalproduct>
        <drugbatchnumb>6D13639</drugbatchnumb>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BUPIVACAINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NSS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ISOVUE-300</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055808-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060718</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>59</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>90.7</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD CREATINE PHOSPHOKINASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CREATINE PHOSPHOKINASE MB INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD ELECTROLYTES ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD THYROID STIMULATING HORMONE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOKALAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPONATRAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METABOLIC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NON-CARDIAC CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINE ELECTROLYTES ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINE POTASSIUM ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METOLAZONE</medicinalproduct>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055809-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060718</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>80</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>91.5</patientweight>
      <reaction>
        <reactionmeddrapt>HEPATITIS ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATOTOXICITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugdosagetext>10 MG QD PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERLIPIDAEMIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055810-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060718</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>40</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>88.1</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANGIONEUROTIC OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>REFUSAL OF TREATMENT BY PATIENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugdosagetext>10 MG QD PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055811-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060718</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>37</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>74.3899</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CAFFEINE CONSUMPTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CIPROFLOXACIN</medicinalproduct>
        <drugdosagetext>1 TABLET PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>STAPHYLOCOCCAL INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051027</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051110</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CIPROFLOXACIN</medicinalproduct>
        <drugdosagetext>1 TABLET PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>STAPHYLOCOCCAL INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051220</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051230</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055812-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060718</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>16</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>58.0604</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>EPIPHYSES PREMATURE FUSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugdosagetext>10 MG TWICE A DAY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ACNE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041110</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050310</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLARAVIS</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050915</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051115</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055813-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060718</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>75</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>90.7</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HYPERCALCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERKALAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERNATRAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ILEUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSEUDOMONAS INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL TUBULAR NECROSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NAFCILLIN SODIUM</medicinalproduct>
        <drugdosagetext>2 GM Q4H IV DRIP</drugdosagetext>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>WOUND</drugindication>
        <drugtreatmentduration>14</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055814-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060720</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060425</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-13357082</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>LIVER FUNCTION TEST ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VUMON</medicinalproduct>
        <drugauthorizationnumb>020119</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055815-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060720</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050725</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-13050299</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EURAX</medicinalproduct>
        <drugauthorizationnumb>006927</drugauthorizationnumb>
        <drugindication>ACARODERMATITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055816-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060720</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060503</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-13365465</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EURAX CREAM</medicinalproduct>
        <drugauthorizationnumb>6927</drugauthorizationnumb>
        <drugadministrationroute>061</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060502</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060502</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055817-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060720</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060509</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-13372669</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EURAX</medicinalproduct>
        <drugauthorizationnumb>006927</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055818-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060720</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060517</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-13381603</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>SKIN ATROPHY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EURAX</medicinalproduct>
        <drugauthorizationnumb>006927</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055819-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060718</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>71</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>74.8</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POLYURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
        <drugdosagetext>40 MG BID PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CARDIAC FAILURE CONGESTIVE</drugindication>
        <drugtreatmentduration>24</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
        <drugdosagetext>40 MG BID PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugtreatmentduration>24</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055820-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060718</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>67</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>63.5036</patientweight>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>CROHN'S DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL NECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMODIALYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMODYNAMIC INSTABILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERBILIRUBINAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ILL-DEFINED DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLAMMATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTESTINAL ISCHAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTESTINAL STENOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER FUNCTION TEST ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUCOSAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SMALL INTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RENAGEL</medicinalproduct>
        <drugdosagetext>2400-4000 MG WITH MEALS TID PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERPHOSPHATAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020117</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060610</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PHOSLO</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOSRENOL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055821-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060718</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>72.5755</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PLIVA 648</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROZAC</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055822-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060718</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>65</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>89.6</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD CREATININE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINE OUTPUT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>THALIDOMIDE 100 MG</medicinalproduct>
        <drugdosagetext>100 MG ONCE DAILY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MYELODYSPLASTIC SYNDROME</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GENTAMICIN</medicinalproduct>
        <drugdosagetext>180 MG Q12H IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PYREXIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060710</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060711</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055823-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060718</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>68</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>54.4316</patientweight>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>COMPLETED SUICIDE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEXAPRO</medicinalproduct>
        <drugdosagetext>20 MG DAILY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060515</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060525</drugenddate>
        <drugtreatmentduration>10</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055824-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060720</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060710</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2006JP10384</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>33</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD CREATINE PHOSPHOKINASE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMISIL</medicinalproduct>
        <drugauthorizationnumb>020539</drugauthorizationnumb>
        <drugdosagetext>125 MG/D</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055825-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060720</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060601</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHRM2006FR01741</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>63</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>60</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>C-REACTIVE PROTEIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHROMATURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RED BLOOD CELL SEDIMENTATION RATE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMISIL</medicinalproduct>
        <drugauthorizationnumb>020539</drugauthorizationnumb>
        <drugdosagetext>250 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NAIL TINEA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060207</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060509</drugenddate>
        <drugtreatmentduration>92</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055826-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060720</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060609</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2006JP08785</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>68</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HYPOGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VOLTAREN</medicinalproduct>
        <drugauthorizationnumb>19201</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VOLTAREN</medicinalproduct>
        <drugadministrationroute>054</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055827-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060720</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060711</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2006US08892</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE IRREGULAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMISIL</medicinalproduct>
        <drugauthorizationnumb>020539</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055828-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060718</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROCEDURAL SITE REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BACITRACIN</medicinalproduct>
        <drugdosagetext>TOP</drugdosagetext>
        <drugadministrationroute>061</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055829-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060717</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NASOPHARYNGEAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WRONG DRUG ADMINISTERED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVAQUIN</medicinalproduct>
        <drugdosagetext>500 MG DAILY PO [ONE DOSE]</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SINUSITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060531</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060531</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055830-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060717</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>81</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>49.8957</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>INTERNATIONAL NORMALISED RATIO INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UPPER GASTROINTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
        <drugdosagetext>5 MG QD PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19950614</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060519</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
        <drugdosagetext>5 MG QD PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>TRANSIENT ISCHAEMIC ATTACK</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19950614</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060519</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COMBIVENT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BRIMONIDINE TARTRATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSTILL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUNISOLIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLYBURIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METORMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MOXIFLOXACIN HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>QUININE SULFATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAMSULOSIN HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAZODONE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055831-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060717</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>49.8957</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ALOPECIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEXAPRO</medicinalproduct>
        <drugdosagetext>1 TABLET DAILY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055832-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060718</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>98.4</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ELECTROCARDIOGRAM T WAVE ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPHIL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORTHOSTATIC HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE VASOVAGAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TROPONIN INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARBOPLATIN</medicinalproduct>
        <drugdosagetext>524 MG</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060629</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAXOL</medicinalproduct>
        <drugdosagetext>355 MG</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060629</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055833-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060718</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>74.7</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>APNOEIC ATTACK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLON CANCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULSE ABSENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUOROURACIL</medicinalproduct>
        <drugdosagetext>744 MG , IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060712</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEUCOVORIN CALCIUM</medicinalproduct>
        <drugdosagetext>748 MG</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060712</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ELOXATIN</medicinalproduct>
        <drugdosagetext>159 MG</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060712</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PERCOCET</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPROL-XL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZESTRIL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055834-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060720</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060606</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CN-NOVOPROD-253852</companynumb>
    <primarysource>
      <reportercountry>CHINA</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>56</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>70</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>COLD SWEAT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS GENERALISED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SHOCK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NOVOLOG MIX 70/30</medicinalproduct>
        <drugbatchnumb>RP50430</drugbatchnumb>
        <drugauthorizationnumb>21172</drugauthorizationnumb>
        <drugdosagetext>14+10 IU</drugdosagetext>
        <drugindication>INSULIN-REQUIRING TYPE II DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050815</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051120</drugenddate>
        <drugtreatmentduration>97</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055835-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060718</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>51.81</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LETHARGY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PETECHIAE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CISPLATIN</medicinalproduct>
        <drugdosagetext>76 MG</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOPOTECAN</medicinalproduct>
        <drugdosagetext>2.7 MG</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055836-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060718</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>80</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ACUTE RESPIRATORY DISTRESS SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACTERIAL SEPSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERALISED OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMODIALYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UROSEPSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOPHOSPHAMIDE</medicinalproduct>
        <drugdosagetext>1860 MG</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYTARABINE</medicinalproduct>
        <drugdosagetext>1124 MG</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE TAB</medicinalproduct>
        <drugdosagetext>189 MG</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOXORUBICIN HYDROCHLORIDE</medicinalproduct>
        <drugdosagetext>137 MG</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugdosagetext>45 MG</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEG-L-ASPARAGINASE (K-H)</medicinalproduct>
        <drugdosagetext>9150 UNIT</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>THIOGUANINE</medicinalproduct>
        <drugdosagetext>1480 MG</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VINCRISTINE SULFATE</medicinalproduct>
        <drugdosagetext>8 MG</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055837-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060717</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>40.45</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD CREATININE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD POTASSIUM INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD UREA INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATOCRIT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYDRONEPHROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMOTHORAX</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POST PROCEDURAL COMPLICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINE OUTPUT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARBOPLATIN</medicinalproduct>
        <drugdosagetext>792 MG</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAXOL</medicinalproduct>
        <drugdosagetext>243 MG</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>.</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055838-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060720</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060712</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-SOLVAY-00206002304</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>19808</patientonsetage>
      <patientonsetageunit>804</patientonsetageunit>
      <patientweight>90</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CYTOLYTIC HEPATITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COVERSYL</medicinalproduct>
        <drugauthorizationnumb>20184</drugauthorizationnumb>
        <drugdosagetext>DAILY DOSE: 4 MILLIGRAM(S)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060707</drugenddate>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055839-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060720</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060616</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHO2006JP09778</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>23</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>LIVER FUNCTION TEST ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GABALON</medicinalproduct>
        <drugauthorizationnumb>17851</drugauthorizationnumb>
        <drugdosagetext>100 UG, QD</drugdosagetext>
        <drugadministrationroute>037</drugadministrationroute>
        <drugindication>MUSCLE SPASTICITY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055840-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060717</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>55</patientweight>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ABDOMINAL DISTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CATHETER RELATED INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSED LEVEL OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISEASE PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTESTINAL OBSTRUCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARBOPLATIN</medicinalproduct>
        <drugdosagetext>576 MG</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060511</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAXOL</medicinalproduct>
        <drugdosagetext>290 MG</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060511</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055841-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060717</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>53.6</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD CHLORIDE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD SODIUM DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOKALAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GEMCITABINE HYDROCHLORIDE</medicinalproduct>
        <drugdosagetext>3140 MG</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CISPLATIN</medicinalproduct>
        <drugdosagetext>78 MG</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055842-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060717</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>91</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ABDOMINAL DISTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BODY TEMPERATURE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS POSTURAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPHIL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL INTAKE REDUCED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>REFUSAL OF TREATMENT BY PATIENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY RATE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THERAPY NON-RESPONDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAXOTERE</medicinalproduct>
        <drugdosagetext>70 MG</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060626</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LOVENOX</medicinalproduct>
        <drugdosagetext>320 MG</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060703</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CAMPTOSAR</medicinalproduct>
        <drugdosagetext>100 MG</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060626</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055843-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060720</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060711</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2006US08909</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FEMUR FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOPOROTIC FRACTURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXJADE</medicinalproduct>
        <drugauthorizationnumb>021882</drugauthorizationnumb>
        <drugdosagetext>20 MG/KG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055844-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060720</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060711</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2006US08963</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ADRENAL CARCINOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FEMARA</medicinalproduct>
        <drugauthorizationnumb>20726</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055845-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060720</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20030117</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHFR2003IE00600</companynumb>
    <primarysource>
      <reportercountry>IRELAND</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>17</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG LEVEL ABOVE THERAPEUTIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LISTLESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVERWEIGHT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEDATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZARIL</medicinalproduct>
        <drugauthorizationnumb>19758</drugauthorizationnumb>
        <drugdosagetext>275 MG/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060425</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZARIL</medicinalproduct>
        <drugauthorizationnumb>019758</drugauthorizationnumb>
        <drugdosagetext>12.5 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZARIL</medicinalproduct>
        <drugauthorizationnumb>019758</drugauthorizationnumb>
        <drugdosagetext>25 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060502</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZARIL</medicinalproduct>
        <drugauthorizationnumb>019758</drugauthorizationnumb>
        <drugdosagetext>37.50MG/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030114</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055846-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060720</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2006US08397</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>51</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ALANINE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASPARTATE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CREATININE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD UREA INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHILLS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPHONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH GENERALISED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH PRURITIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SERUM FERRITIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISION BLURRED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXJADE</medicinalproduct>
        <drugauthorizationnumb>021882</drugauthorizationnumb>
        <drugdosagetext>2000 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060616</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060625</drugenddate>
        <drugtreatmentduration>14400</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055847-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060720</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060712</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2006US08945</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>29</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FAECALOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXJADE</medicinalproduct>
        <drugauthorizationnumb>021882</drugauthorizationnumb>
        <drugdosagetext>2000 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SICKLE CELL ANAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060528</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055848-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060720</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060707</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-KINGPHARMUSA00001-K200600894</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>AGITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVERDOSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KEMADRIN</medicinalproduct>
        <drugauthorizationnumb>009818</drugauthorizationnumb>
        <drugdosagetext>85 MG, SINGLE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG ABUSER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060703</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060703</drugenddate>
        <drugtreatmentduration>1440</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055849-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060718</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>48</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>84.8226</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>AMNESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEMIPARESIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NICODERM CQ</medicinalproduct>
        <drugdosagetext>1 PATCH OF 21 MG 1 PER DAY TRANSDERMAL</drugdosagetext>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>SMOKING CESSATION THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060412</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060524</drugenddate>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055850-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060718</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>77</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>71.7</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CLOSTRIDIAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISEASE RECURRENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ILEUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CIPROFLOXACIN</medicinalproduct>
        <drugdosagetext>500MG  BID  PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>URINARY TRACT INFECTION</drugindication>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055851-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060720</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060712</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PT-JNJFOC-20060702538</companynumb>
    <primarysource>
      <reportercountry>PORTUGAL</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>6</patientonsetage>
      <patientonsetageunit>800</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TUMOUR MARKER INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055852-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060720</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060710</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-NOVOPROD-255026</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>3</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANAEMIA MACROCYTIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD ALDOSTERONE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CHOLESTEROL INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD ERYTHROPOIETIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD THYROID STIMULATING HORMONE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD TRIGLYCERIDES INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE MARROW FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGIC CEREBRAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERCHLORAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERLACTACIDAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERNATRAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METABOLIC ACIDOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEPHROGENIC DIABETES INSIPIDUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINE OUTPUT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NORDITROPIN SIMPLEXX</medicinalproduct>
        <drugauthorizationnumb>21148</drugauthorizationnumb>
        <drugdosagetext>.5 IU/KG, UNK</drugdosagetext>
        <drugindication>BODY HEIGHT BELOW NORMAL</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055853-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060718</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>55</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>107</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DELIRIUM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL EROSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHOID OPERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>REFUSAL OF TREATMENT BY PATIENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PENTOXIFYLLINE</medicinalproduct>
        <drugdosagetext>400 MG TID PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PERIPHERAL VASCULAR DISORDER</drugindication>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOPIDOGREL</medicinalproduct>
        <drugdosagetext>75 MG QD PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CORONARY ARTERY BYPASS</drugindication>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055854-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060718</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>93.441</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN JAW</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTH ABSCESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTH EXTRACTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugdosagetext>4 MG Q MONTH IV DRIP</drugdosagetext>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060616</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugdosagetext>4 MG Q MONTH IV DRIP</drugdosagetext>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>METASTASES TO BONE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060616</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055855-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060718</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>75</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>83.5</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CLOSTRIDIUM DIFFICILE COLITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERNATIONAL NORMALISED RATIO INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STAPHYLOCOCCAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVOFLOXACIN</medicinalproduct>
        <drugdosagetext>500 MG QD PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RESPIRATORY TRACT INFECTION</drugindication>
        <drugtreatmentduration>10</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
        <drugdosagetext>5 MG QD PO [SEVERAL YEARS]</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055856-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060718</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>75.2971</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DECREASED ACTIVITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NUVARING</medicinalproduct>
        <drugindication>CONTRACEPTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060102</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060620</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055857-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060720</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040323</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ABBOTT-04P-087-0254739-00</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD ALKALINE PHOSPHATASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD ELECTROLYTES ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CALCULUS URINARY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CREATININE RENAL CLEARANCE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAMMA-GLUTAMYLTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HIV WASTING SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERLIPIDAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMOCYSTIS JIROVECI PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NORVIR</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>20945</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000310</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20001027</drugenddate>
        <drugtreatmentduration>230</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KALETRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021226</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010130</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLARITHROMYCIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>050662</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MYCOBACTERIUM AVIUM COMPLEX INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20011028</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLARITHROMYCIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>050662</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GENERAL SYMPTOM</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19981008</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19981201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ABACAVIR SULFATE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010130</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INDINIVIR SULFATE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980831</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20001027</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INDINIVIR SULFATE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000310</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20001027</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NELFINAVIR</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980910</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19981118</drugenddate>
        <drugtreatmentduration>365</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NELFINAVIR</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990223</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19991216</drugenddate>
        <drugtreatmentduration>365</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>20000310</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EFAVIRENZ</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010130</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GANCICLOVIR</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>050</drugadministrationroute>
        <drugindication>CYTOMEGALOVIRUS INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000215</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20000306</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GANCICLOVIR</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>050</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000307</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20000402</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GANCICLOVIR</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>050</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000403</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20000424</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GANCICLOVIR</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000425</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20000426</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BACTRIM</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20001219</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20001219</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BACTRIM</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>HYPERSENSITIVITY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20001220</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20001220</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BACTRIM</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20001221</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20001221</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BACTRIM</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20001222</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20001222</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BACTRIM</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20001223</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20001223</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ETHAMBUTOL HCL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>MYCOBACTERIUM AVIUM COMPLEX INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20001028</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20011130</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ETHAMBUTOL HCL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20001028</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20011130</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ETHAMBUTOL HCL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19981025</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19981201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ETHAMBUTOL HCL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19981212</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19990614</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSCARNET SODIUM</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>050</drugadministrationroute>
        <drugindication>CYTOMEGALOVIRUS INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000125</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20000214</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSCARNET SODIUM</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000215</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20000303</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSCARNET SODIUM</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000404</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20000406</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSCARNET SODIUM</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000407</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20000426</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZIDOVUDINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980831</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19980909</drugenddate>
        <drugtreatmentduration>45</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZIDOVUDINE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19991119</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19991216</drugenddate>
        <drugtreatmentduration>45</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZIDOVUDINE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000831</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20000909</drugenddate>
        <drugtreatmentduration>45</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LAMIVUDINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980831</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19981118</drugenddate>
        <drugtreatmentduration>454</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LAMIVUDINE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990223</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19991216</drugenddate>
        <drugtreatmentduration>454</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LAMIVUDINE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000831</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20001118</drugenddate>
        <drugtreatmentduration>454</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>STAVUDINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980910</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19981118</drugenddate>
        <drugtreatmentduration>337</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>STAVUDINE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990223</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19991118</drugenddate>
        <drugtreatmentduration>337</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RIFABUTIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MYCOBACTERIUM AVIUM COMPLEX INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980923</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19981021</drugenddate>
        <drugtreatmentduration>136</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RIFABUTIN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20001028</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010213</drugenddate>
        <drugtreatmentduration>136</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMIKACIN SULFATE</medicinalproduct>
        <drugadministrationroute>050</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980922</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19981009</drugenddate>
        <drugtreatmentduration>174</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMIKACIN SULFATE</medicinalproduct>
        <drugadministrationroute>050</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19981114</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19981117</drugenddate>
        <drugtreatmentduration>174</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMIKACIN SULFATE</medicinalproduct>
        <drugadministrationroute>050</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19981118</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19981217</drugenddate>
        <drugtreatmentduration>174</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMIKACIN SULFATE</medicinalproduct>
        <drugadministrationroute>050</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19981214</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19990408</drugenddate>
        <drugtreatmentduration>174</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMIKACIN SULFATE</medicinalproduct>
        <drugadministrationroute>050</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20001028</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20001108</drugenddate>
        <drugtreatmentduration>174</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AZITHROMYCIN DIHYDRATE</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19981210</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19990715</drugenddate>
        <drugtreatmentduration>216</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPARFLOXACIN</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19981216</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19991115</drugenddate>
        <drugtreatmentduration>334</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ROXITHROMYCIN</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990705</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19991115</drugenddate>
        <drugtreatmentduration>402</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ROXITHROMYCIN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000131</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20001027</drugenddate>
        <drugtreatmentduration>402</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PENTAMIDINE ISETHIONATE</medicinalproduct>
        <drugadministrationroute>050</drugadministrationroute>
        <drugindication>ANTIBIOTIC PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980918</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19990331</drugenddate>
        <drugtreatmentduration>443</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PENTAMIDINE ISETHIONATE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990430</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20000104</drugenddate>
        <drugtreatmentduration>443</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SALINE</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980918</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19990331</drugenddate>
        <drugtreatmentduration>253</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SALINE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000125</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20000214</drugenddate>
        <drugtreatmentduration>253</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SALINE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000215</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20000303</drugenddate>
        <drugtreatmentduration>253</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SALINE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000404</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20000426</drugenddate>
        <drugtreatmentduration>253</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980928</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20000321</drugenddate>
        <drugtreatmentduration>540</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCORTISONE SODIUM PHOSPHATE</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980502</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19980530</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCORTISONE SODIUM PHOSPHATE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000322</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20000406</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCORTISONE SODIUM PHOSPHATE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000407</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MORPHINE SULFATE</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19991108</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19991129</drugenddate>
        <drugtreatmentduration>52</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MORPHINE SULFATE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19991130</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19991205</drugenddate>
        <drugtreatmentduration>52</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MORPHINE SULFATE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19991206</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20000101</drugenddate>
        <drugtreatmentduration>52</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATOVAQUONE</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000105</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20000125</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATOVAQUONE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000126</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20000126</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATOVAQUONE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20001214</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20001222</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCORTISONE</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000407</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20001027</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCORTISONE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20001029</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20011002</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCORTISONE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021003</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IV FLUID</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000125</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20000303</drugenddate>
        <drugtreatmentduration>43</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IV FLUID</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010202</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010207</drugenddate>
        <drugtreatmentduration>43</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROXYZINE EMBONATE</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000102</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20000501</drugenddate>
        <drugtreatmentduration>143</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROXYZINE EMBONATE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19991130</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19991224</drugenddate>
        <drugtreatmentduration>143</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MORPHINE</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000102</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20000501</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MORPHINE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000113</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOSE</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000102</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20000501</drugenddate>
        <drugtreatmentduration>119</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CIPROFLOXACIN</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20001119</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020220</drugenddate>
        <drugtreatmentduration>458</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXTROSE</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000102</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20000301</drugenddate>
        <drugtreatmentduration>59</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROXYZINE HYDROCHLORIDE</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000102</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20000501</drugenddate>
        <drugtreatmentduration>119</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055858-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060718</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>133.8</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HAEMATOCRIT DECREASED</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>TRASTUZMAB</medicinalproduct>
        <drugdosagetext>6 MG/KG Q3 WEEKS IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BREAST CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010420</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060609</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LETROZOLE</medicinalproduct>
        <drugdosagetext>2.5 MG DAILY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BREAST CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010420</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060628</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOTENSIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZYRTEC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DETROL LA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055859-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060718</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>58</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>56.9</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ALCOHOL USE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPONATRAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVERDOSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HYDROCODONE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055860-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060720</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060706</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>HQWYE652607JUL06</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060506</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060622</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOXONIN</medicinalproduct>
        <drugdosagetext>UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GASTER</medicinalproduct>
        <drugdosagetext>UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055861-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060720</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060707</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-US185538</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>KERATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NUCLEAR MAGNETIC RESONANCE IMAGING BRAIN ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055862-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060720</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060710</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-JNJFOC-20060300563</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>DRUG TOXICITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERDAL CONSTA</medicinalproduct>
        <drugbatchnumb>522025</drugbatchnumb>
        <drugauthorizationnumb>21346</drugauthorizationnumb>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040121</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051130</drugenddate>
        <drugtreatmentduration>680</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055863-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060720</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060627</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GBWYE840927JUN06</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>80</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEEP VEIN THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VEIN DISORDER</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>20051024</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM PHOSPHATE/CALCIUM SODIUM LACTATE/ERGOCALCIFEROL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CO-DYDRAMOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANSOPRAZOLE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055864-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060720</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060710</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-US185716</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>55.8</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PNEUMONIA BACTERIAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TUBERCULOSIS SKIN TEST POSITIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030422</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROTONIX</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PATANOL</medicinalproduct>
        <drugadministrationroute>047</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RELAFEN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACTONEL</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041208</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREMPRO 14/14</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055865-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060720</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060710</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-US185975</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>KNEE ARTHROPLASTY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHEUMATOID ARTHRITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>D071308</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000801</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060708</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055866-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060707</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006084213</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>59</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>72.5755</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HERNIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ROGAINE</medicinalproduct>
        <drugauthorizationnumb>20834</drugauthorizationnumb>
        <drugdosagetext>RECOMMENDED DOSAGE ONCE A DAY, TOPICAL</drugdosagetext>
        <drugadministrationroute>061</drugadministrationroute>
        <drugindication>ALOPECIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055867-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>SP00892</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>73</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ACQUIRED OESOPHAGEAL WEB</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DROOLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EFFECT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FOREIGN BODY TRAUMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OESOPHAGEAL OBSTRUCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VISICOL</medicinalproduct>
        <drugauthorizationnumb>21097</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>COLONOSCOPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060612</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060613</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055868-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060711</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>TAP2005Q00366</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>80</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>64.8644</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CSF VIRUS IDENTIFIED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSED LEVEL OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HERPES VIRUS INFECTION</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>20040701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORCO</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CERVICAL EPIDURAL INJECTION</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055869-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060720</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060711</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-JNJFOC-20060702751</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>18</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>INTENTIONAL SELF-INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCREATITIS ACUTE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
        <drugauthorizationnumb>17463</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055870-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060720</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060711</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>NL-JNJFOC-20060703423</companynumb>
    <primarysource>
      <reportercountry>NETHERLANDS</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ATTENTION DEFICIT/HYPERACTIVITY DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MAJOR DEPRESSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMODIUM</medicinalproduct>
        <drugauthorizationnumb>017694</drugauthorizationnumb>
        <drugdosagetext>AVERAGE OF 4 CAPSULES/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONGENITAL MEGACOLON</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055871-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060720</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060710</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20051104999</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>99.79</patientweight>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>BRONCHITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRONCHOPNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BURNS SECOND DEGREE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEVICE LEAKAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PELVIC FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPTIC SHOCK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY INCONTINENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DURAGESIC-100</medicinalproduct>
        <drugbatchnumb>0327192</drugbatchnumb>
        <drugadministrationroute>062</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DURAGESIC-100</medicinalproduct>
        <drugbatchnumb>0327192</drugbatchnumb>
        <drugadministrationroute>062</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DURAGESIC-100</medicinalproduct>
        <drugbatchnumb>0327192</drugbatchnumb>
        <drugadministrationroute>062</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DURAGESIC-100</medicinalproduct>
        <drugbatchnumb>0327192</drugbatchnumb>
        <drugadministrationroute>062</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DURAGESIC-100</medicinalproduct>
        <drugbatchnumb>0327192</drugbatchnumb>
        <drugauthorizationnumb>019813</drugauthorizationnumb>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLOTRIMAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ESOMEPRAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUOXETINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE TAB</medicinalproduct>
        <drugdosagetext>40 MG DAILY, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAZODONE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLOBETASOL PROPIONATE</medicinalproduct>
        <drugdosagetext>0.05%, APPLIED DAILY</drugdosagetext>
        <drugadministrationroute>061</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MORPHINE SULFATE</medicinalproduct>
        <drugdosagetext>15 MG, 4 TO 5 EVERY 4 HOURS</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYCLOBENZAPRINE HCL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055872-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060720</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060711</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20060702748</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>49.44</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>RHEUMATOID ARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYSTEMIC LUPUS ERYTHEMATOSUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DURAGESIC-100</medicinalproduct>
        <drugbatchnumb>0538665</drugbatchnumb>
        <drugauthorizationnumb>019813</drugauthorizationnumb>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>MIGRAINE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KLONOPIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANXIETY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAZODONE HCL</medicinalproduct>
        <drugdosagetext>60 MG DOSE, 20 MG TABLET, THREE IN THE EVENING</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCODONE</medicinalproduct>
        <drugdosagetext>10/500 MG TABLET, AS NEEDED IN 24 HOURS ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055873-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060717</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>68.0396</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN REACTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ANDRODERM</medicinalproduct>
        <drugbatchnumb>91341469</drugbatchnumb>
        <drugdosagetext>ONE DAILY TOP</drugdosagetext>
        <drugadministrationroute>061</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060710</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060712</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055874-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060717</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>26</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEEP VEIN THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ORTHO EVRA</medicinalproduct>
        <drugdosagetext>APPLY ONE PATCH EVERY WEEK TRANSDERMAL</drugdosagetext>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>CONTRACEPTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051102</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060712</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055875-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060717</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>53</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>99.3377</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CHILLS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BACTRIM DS</medicinalproduct>
        <drugdosagetext>PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>STAPHYLOCOCCAL INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060616</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060621</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055876-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060630</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>TPA2006A01067</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>53</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>57.6068</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCORRECT DOSE ADMINISTERED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ROZEREM</medicinalproduct>
        <drugauthorizationnumb>21782</drugauthorizationnumb>
        <drugdosagetext>8 MG, QHS, PER ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INSOMNIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060629</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060629</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ROZEREM</medicinalproduct>
        <drugauthorizationnumb>21782</drugauthorizationnumb>
        <drugdosagetext>8 MG, QHS, PER ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INSOMNIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060630</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060630</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TIMOLOL (TIMOLOL) (EYE DROPS)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055877-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060717</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>13</patientonsetage>
      <patientonsetageunit>802</patientonsetageunit>
      <patientweight>8.1647</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG DISPENSING ERROR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EAR INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WRONG DRUG ADMINISTERED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZITHROMAX</medicinalproduct>
        <drugdosagetext>1 TEASPOON 2X A DAY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>EAR INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060206</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060208</drugenddate>
        <drugtreatmentduration>36</drugtreatmentduration>
        <drugtreatmentdurationunit>805</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AUGENTEN (AHOULD HAVE BEEN)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055878-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060711</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>230643K06USA</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>37</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PARALYSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBIF</medicinalproduct>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040316</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040701</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZYRTEC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOXEPIN HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMANTADINE HCL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055879-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060630</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>163-21880-06070020</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>91</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>DYSPHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HIP FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENTAL STATUS CHANGES</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugauthorizationnumb>21880</drugauthorizationnumb>
        <drugdosagetext>10 MG, DAILY FOR 21 DAYS, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MYELODYSPLASTIC SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060405</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060427</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARICEPT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PEPCID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVAQUIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055880-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060717</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>51</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>81.6475</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANGER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CRYING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FRUSTRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HOMICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMPAIRED WORK ABILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IRRITABILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENTAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POST-TRAUMATIC STRESS DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOCIAL PROBLEM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VERSED</medicinalproduct>
        <drugdosagetext>7 MLS IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PREOPERATIVE CARE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060518</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060518</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>805</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055881-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060717</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>108.8633</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACTIMMUNE</medicinalproduct>
        <drugbatchnumb>403607</drugbatchnumb>
        <drugdosagetext>200 MCG THREE TIMES WEEK SQ</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>IDIOPATHIC PULMONARY FIBROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060515</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060714</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055882-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060720</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060712</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-JNJFOC-20060702231</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>66</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HALDOL</medicinalproduct>
        <drugdosagetext>HALOPERIDOL DOSE READJUSTED TO 7.5MG IN THE MORNING AND 5MG IN THE EVENING.</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HALDOL</medicinalproduct>
        <drugauthorizationnumb>015923</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOTYPAL PERSONALITY DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMOVANE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SLEEP DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TERCIAN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TERCIAN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOTYPAL PERSONALITY DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>EPILEPSY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEPAMIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOTYPAL PERSONALITY DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>EMBOLISM VENOUS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055883-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060720</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060712</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-JNJFOC-20060605721</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>60</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ACCIDENTAL OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HALDOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HALDOL</medicinalproduct>
        <drugdosagetext>PATIENT TOOK 3 TIMES DOSE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HALDOL</medicinalproduct>
        <drugauthorizationnumb>015923</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PSYCHOTIC DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NOZINAN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NOZINAN</medicinalproduct>
        <drugdosagetext>PATIENT TOOK 3 TIMES DOSE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NOZINAN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PSYCHOTIC DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HEPTAMYL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AKINETON</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055884-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060720</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060711</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-JNJFOC-20060405358</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>49</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERAL PHYSICAL HEALTH DETERIORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMMOBILE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HALOPERIDOL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>ABNORMAL BEHAVIOUR</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HALOPERIDOL</medicinalproduct>
        <drugauthorizationnumb>015923</drugauthorizationnumb>
        <drugdosagetext>EVENT OCCURRED AFTER ONE DOSE</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EPILON</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SULPHERIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALPROATE SODIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>EPILEPSY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055885-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060717</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>118.3888</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MIGRAINE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEPO-PROVERA</medicinalproduct>
        <drugdosagetext>SHOT EVERY 3 MONTHS IM</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>CONTRACEPTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000210</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060413</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055886-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060701</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>163-20785-06070219</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>CRANIAL NEUROPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>THALOMID</medicinalproduct>
        <drugauthorizationnumb>20785</drugauthorizationnumb>
        <drugdosagetext>200 MG X1 WK, THEN INCREASED BY BY 50 MG ON A WEEKLY BASES AS TOLERATED: UP TO 1000 MG, QD, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MYELODYSPLASTIC SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20011123</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040926</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055887-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060720</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060623</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHO2006US10317</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>82</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>78.82</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEUKOCYTOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLEURAL EFFUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY GAS EXCHANGE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHEEZING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORADIL</medicinalproduct>
        <drugauthorizationnumb>20831</drugauthorizationnumb>
        <drugdosagetext>TREATMENT PHASE</drugdosagetext>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
        <drugdosagetext>18 UG, QD</drugdosagetext>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENOXAPARIN SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FELODIPINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLYBURIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IPRATROPIUM BROMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOSARTAN POSTASSIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHYLPREDNISOLONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MOXIFLOXACIN HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM CHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVENOX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE TAB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055888-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060701</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>163-20785-06070276</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>0</patientsex>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSED LEVEL OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GRANULOCYTE COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOLYTIC ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPHIL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERIPHERAL SENSORY NEUROPATHY</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>20010630</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020814</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>20010727</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055889-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060720</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060627</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2006BR09617</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>49</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>82</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HAEMOPTYSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORASEQ</medicinalproduct>
        <drugauthorizationnumb>20831</drugauthorizationnumb>
        <drugdosagetext>UNK, BID</drugdosagetext>
        <drugindication>PNEUMONIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060301</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055890-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060717</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>41</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>57.1532</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VANDAZOLE</medicinalproduct>
        <drugdosagetext>1APPLICATOR AT BEDTIME VAG</drugdosagetext>
        <drugadministrationroute>067</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060707</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060714</drugenddate>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055891-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060704</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006069685</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>71</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>54.5</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG TOXICITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GLOMERULAR VASCULAR DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IATROGENIC INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>KIDNEY FIBROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEPHROLITHIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEPHROTIC SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLEURAL EFFUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL ARTERIOSCLEROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL TUBULAR ATROPHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOTIC MICROANGIOPATHY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUTENT</medicinalproduct>
        <drugauthorizationnumb>21968</drugauthorizationnumb>
        <drugdosagetext>(37.5 MG, INTERVAL:  4 WKS ON/2 OFF), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>METASTATIC RENAL CELL CARCINOMA</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060525</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CATAPRES</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVEENO CREAM (ALLANTOIN, AVENA, GLYCEROL)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COLACE (DOCUSATE SODIUM)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LACTULOSE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOPRESSOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SENOKOT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALDACTONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARDURA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATIVAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANTOPRAZOLE SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALUMINUM HYDROXIDE AND MAGNESIUM TRISILICATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>APRESOLINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055892-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060720</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060601</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-RB-3396-2006</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>68.1</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUBOXONE</medicinalproduct>
        <drugauthorizationnumb>20733</drugauthorizationnumb>
        <drugadministrationroute>060</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055893-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060720</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060119</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL166309</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>76.7</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>ANAEMIA OF MALIGNANT DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051212</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051222</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055894-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060720</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060119</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-US165770</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FURUNCLE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LABILE BLOOD PRESSURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EPOGEN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>DIALYSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055895-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060720</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060119</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-US165799</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>26.8</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEDICATION ERROR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EPOGEN</medicinalproduct>
        <drugbatchnumb>P044993</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>DIALYSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050401</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055896-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060720</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20051223</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-US162787</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>THERAPEUTIC RESPONSE DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EPOGEN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>DIALYSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055897-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060720</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20051108</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-US157128</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>102.9</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</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>20050601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051024</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055898-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060720</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060104</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-US163651</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>THERAPEUTIC RESPONSE DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EPOGEN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>DIALYSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055899-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060720</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060104</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL163940</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>84</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>ANAEMIA OF MALIGNANT DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055900-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060720</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060104</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL163938</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>MYELODYSPLASTIC SYNDROME</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055901-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060720</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050720</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL143673</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>79</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RENAL FAILURE CHRONIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055902-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060720</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060117</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL165461</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>61</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>MYELODYSPLASTIC SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055903-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060720</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060116</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL165467</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PHARYNGOLARYNGEAL PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugindication>ANAEMIA OF MALIGNANT DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060109</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060109</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055904-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060720</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060117</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL165621</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>80</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>LABORATORY TEST INTERFERENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>MYELODYSPLASTIC SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055905-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060720</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060117</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-US165395</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>66.3</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>POLYP</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THERAPEUTIC RESPONSE DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EPOGEN</medicinalproduct>
        <drugbatchnumb>P063017</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>DIALYSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SENSIPAR</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugindication>HYPERPARATHYROIDISM SECONDARY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055906-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060720</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060117</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-US165160</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>46</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>THERAPEUTIC RESPONSE DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EPOGEN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>ANAEMIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055907-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060720</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20051228</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-US162962</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>35</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>THERAPEUTIC RESPONSE DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EPOGEN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>DIALYSIS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051201</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055908-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060704</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006069697</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>89</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>35.7</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ALANINE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASPARTATE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG ERUPTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC FUNCTION ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOXIC SKIN ERUPTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLINDAMYCIN PHOSPHATE</medicinalproduct>
        <drugauthorizationnumb>50441</drugauthorizationnumb>
        <drugdosagetext>1200 MG (600 MG, 2 IN 1 D), INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PNEUMONIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060516</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060522</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CEFTAZIDIME</medicinalproduct>
        <drugdosagetext>2 GRAM (1 GRAM, 2 IN 1 D), INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PNEUMONIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060516</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060522</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ELASPOL (SIVELESTAT)</medicinalproduct>
        <drugdosagetext>200 MG (INTERVAL:  CONTINUOUSLY), INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PNEUMONIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060516</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060522</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055909-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060717</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>60</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ACTIVITIES OF DAILY LIVING IMPAIRED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ATRIAL FIBRILLATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE CONGESTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EATING DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEPHROGENIC FIBROSING DERMOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NERVOUS SYSTEM DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OESOPHAGEAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAINFUL DEFAECATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLEURAL EFFUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA ASPIRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GADOLINIUM 15CC MAGNEVIST</medicinalproduct>
        <drugdosagetext>10 - 15 CC</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021119</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051222</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REDICAT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ISOVUE-300</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055910-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060720</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060705</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2006JP10232</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>67</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>IMPLANTABLE DEFIBRILLATOR MALFUNCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENTRICULAR TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
        <drugauthorizationnumb>17963</drugauthorizationnumb>
        <drugdosagetext>UNK, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055911-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060720</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060712</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-JNJFOC-20060602336</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>57</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>85</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PUSTULAR PSORIASIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ANKYLOSING SPONDYLITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERURICAEMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>APRANAX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANKYLOSING SPONDYLITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TENSTATEN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055912-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060720</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060411</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-RB-3110-2006</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>35</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>74</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSED LEVEL OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORTHOSTATIC HYPOTENSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BUPRENORPHINE HYDROCHLORIDE</medicinalproduct>
        <drugauthorizationnumb>20732</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060302</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060512</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALCOHOL</medicinalproduct>
        <drugdosagetext>DOSAGE UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055913-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060720</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060621</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-RB-3464-2006</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>63.56</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>APRAXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COORDINATION ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSARTHRIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ENCEPHALOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCOHERENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LETHARGY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUBOXONE</medicinalproduct>
        <drugauthorizationnumb>20733</drugauthorizationnumb>
        <drugadministrationroute>060</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060615</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060616</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUBOXONE</medicinalproduct>
        <drugauthorizationnumb>020733</drugauthorizationnumb>
        <drugadministrationroute>060</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060617</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060617</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUBOXONE</medicinalproduct>
        <drugauthorizationnumb>020733</drugauthorizationnumb>
        <drugadministrationroute>060</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060618</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060618</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055914-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060717</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>57</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>107.9561</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>AGGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG DEPENDENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EAR DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMPRISONMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SLEEP DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANXIETY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980907</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060717</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980907</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060717</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055915-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060703</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006071154</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>76</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>C-REACTIVE PROTEIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLAMMATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPHOCYTE STIMULATION TEST POSITIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY ALVEOLAR HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CEFPODOXIME PROXETIL</medicinalproduct>
        <drugauthorizationnumb>50674</drugauthorizationnumb>
        <drugdosagetext>200 MG, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050218</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050222</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PIPERACILLIN SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALSARTAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CILNIDIPINE (CILNIDIPINE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BUCILLAMINE (BUCILLAMINE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REBAMIPIDE (REBAMIPIDE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROPAFENONE HCL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055916-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060717</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>56</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>80</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HEPATITIS ACUTE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EFFEXOR</medicinalproduct>
        <drugdosagetext>150 MG   ONCE DAILY   PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020613</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055917-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060706</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>227158</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>63</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>AGRANULOCYTOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MABTHERA (RITUXIMAB) CONC FOR SOLUTION FOR INFUSION</medicinalproduct>
        <drugdosagetext>800 MG,</drugdosagetext>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050421</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050907</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOPHOSPHAMIDE</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050424</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050810</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISONE TAB</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050421</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050810</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VINCRISTINE</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050421</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050810</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ADRIAMYCIN PFS</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050421</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050810</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055918-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060717</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>54.4316</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>AFFECT LABILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AGITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AMNESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHILLS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISTURBANCE IN ATTENTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG DEPENDENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG WITHDRAWAL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EUPHORIC MOOD</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HALLUCINATIONS, MIXED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOREFLEXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTHERMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANIC ATTACK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARANOIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STUPOR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THINKING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VIRAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUOXETINE</medicinalproduct>
        <drugdosagetext>20MG CAPSULE PER EACH TIME   1 PER DAY   PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050315</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060630</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055919-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060706</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>226309</companynumb>
    <primarysource>
      <reportercountry>SPAIN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>52</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>76</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>LEUKOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MABTHERA (RITUXIMAB)</medicinalproduct>
        <drugbatchnumb>B0077</drugbatchnumb>
        <drugdosagetext>670 MG, Q3W, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NON-HODGKIN'S LYMPHOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041210</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050322</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MABTHERA (RITUXIMAB)</medicinalproduct>
        <drugbatchnumb>B2004</drugbatchnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOPHOSPHAMIDE</medicinalproduct>
        <drugdosagetext>1342 MG, Q3W, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NON-HODGKIN'S LYMPHOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041209</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOXORUBICIN</medicinalproduct>
        <drugdosagetext>90 MG, Q3W, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NON-HODGKIN'S LYMPHOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041209</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VINCRISTINE</medicinalproduct>
        <drugdosagetext>2 MG, Q3W, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NON-HODGKIN'S LYMPHOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041209</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugdosagetext>125 MG, Q3W, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NON-HODGKIN'S LYMPHOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041209</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>QUINAPRIL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055920-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060717</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>25</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>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 ALKALINE PHOSPHATASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD BILIRUBIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DALTEPARIN SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FONDAPARINUX   2.5MG</medicinalproduct>
        <drugdosagetext>2.5 MG   DAILY</drugdosagetext>
        <drugindication>THROMBOSIS PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060227</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060305</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055921-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060717</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>21</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>95.2554</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>OCCUPATIONAL EXPOSURE TO AIR CONTAMINANTS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NITRIOUS OXIDE   100%</medicinalproduct>
        <drugdosagetext>100%   DAILY   PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19981201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060714</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ANESTHESIA AGENTS   100%   ABBOTT BAXTER</medicinalproduct>
        <drugdosagetext>100%  DAILY  PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19981201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060714</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NITRIOUS OXIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DESFLURANE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SEVOFLURANE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ISOFLURANE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HALOTHANE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055922-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060717</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>55</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>108.8633</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EFFECT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WALKING AID USER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BONIVA</medicinalproduct>
        <drugdosagetext>1   PER MONTH   PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060308</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060608</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055923-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060720</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060710</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-ABBOTT-06P-028-0337899-00</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>40</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DYSURIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BIAXIN XL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>050775</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RESPIRATORY TRACT INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060702</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055924-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060717</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>24</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>115.6672</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>IUCD COMPLICATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COPPER T MODEL TCU 380A</medicinalproduct>
        <drugindication>CONTRACEPTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060112</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060705</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055925-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060717</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>96</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>54.4316</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABNORMAL BEHAVIOUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HALLUCINATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GENTAMICIN</medicinalproduct>
        <drugbatchnumb>85562F</drugbatchnumb>
        <drugdosagetext>1 TO 2 DROPS   3 TO 4 TIMES A DAY   OPHTHALMIC</drugdosagetext>
        <drugadministrationroute>047</drugadministrationroute>
        <drugindication>EYE INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060710</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060713</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055926-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060703</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>227036</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>77</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MABTHERA (RITUXIMAB) CONC FOR SOLUTION FOR INFUSION</medicinalproduct>
        <drugindication>NON-HODGKIN'S LYMPHOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060602</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LAXATIVES (LAXATIVES NOS)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055927-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>226475</companynumb>
    <primarysource>
      <reportercountry>TURKEY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>59</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>55</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>APHASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBRAL ISCHAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEVICE FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEMIPARESIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVASTIN</medicinalproduct>
        <drugdosagetext>275 MG, Q2W, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLORECTAL CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050613</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060424</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXALIPLATIN (OXALIPLATIN)</medicinalproduct>
        <drugdosagetext>185 MG, Q2W, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLORECTAL CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050613</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060424</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUOROURACIL</medicinalproduct>
        <drugdosagetext>1600 MG, Q2W, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLORECTAL CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050613</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060424</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CALCIUM FOLINATE (LEUCOVORIN CALCIUM)</medicinalproduct>
        <drugdosagetext>300 MG, Q2W, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLORECTAL CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040613</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060424</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055928-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006RR-02868</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>56</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RECTAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ETODOLAC</medicinalproduct>
        <drugauthorizationnumb>75226</drugauthorizationnumb>
        <drugdosagetext>600 MG, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060526</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEFLUNOMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055929-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006RR-02877</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>49</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>81</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>EPISTAXIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LETHARGY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugauthorizationnumb>76285</drugauthorizationnumb>
        <drugdosagetext>10 MG, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051205</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060517</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055930-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006RR-02833</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>67</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLATULENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugauthorizationnumb>76285</drugauthorizationnumb>
        <drugdosagetext>40 MG, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060407</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060428</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SILDENAFIL CITRATE FAMILY (SILDENAFIL CITRATE) TABLET</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055931-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060720</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060530</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-NOVOPROD-253783</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>CAESAREAN SECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FOETAL DISTRESS SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PREMATURE BABY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVEMIR</medicinalproduct>
        <drugauthorizationnumb>21536</drugauthorizationnumb>
        <drugadministrationroute>064</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055932-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006RR-02830</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>77</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>RECTAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugauthorizationnumb>76285</drugauthorizationnumb>
        <drugdosagetext>75 MG, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051107</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLOMIPRAMINE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DILTIEM TABLETS (DILTIAZEM)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLYCERYL TRINITRATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OLANZAPINE FAMILY (OLANZAPINE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055933-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006RR-02825</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>64</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>JAUNDICE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER FUNCTION TEST ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS GENERALISED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CO-AMOXICLAV TABLET 625MG (AMOXICILLIN TRIHYDRATE 500 MG, CLAVULANIC A</medicinalproduct>
        <drugauthorizationnumb>65102</drugauthorizationnumb>
        <drugdosagetext>625 MG, TID, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060510</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060517</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METRONIDAZOLE</medicinalproduct>
        <drugdosagetext>200 MG, TID, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ABSCESS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060511</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060518</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055934-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006RR-02871</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>53</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>87</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHABDOMYOLYSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FENOFIBRATE</medicinalproduct>
        <drugauthorizationnumb>76635</drugauthorizationnumb>
        <drugdosagetext>267.5 MG</drugdosagetext>
        <drugindication>DYSLIPIDAEMIA</drugindication>
        <drugtreatmentduration>1095</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GLICLAZIDE (GLICLAZIDE) 30-60MG</medicinalproduct>
        <drugdosagetext>0</drugdosagetext>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PERINDOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BISOPROLOL RPG (BISOPROLOL FUMARATE)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055935-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060720</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060710</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2006US08905</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CATARACT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMISIL</medicinalproduct>
        <drugauthorizationnumb>020539</drugauthorizationnumb>
        <drugdosagetext>250 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugtreatmentduration>90</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055936-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060717</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>58</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>81</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMMUNE GLOBULIN INTRAVENOUS (HUMAN)</medicinalproduct>
        <drugbatchnumb>01L0SAX11</drugbatchnumb>
        <drugdosagetext>80 GM Q 3 WKS IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>IDIOPATHIC THROMBOCYTOPENIC PURPURA</drugindication>
        <drugtreatmentduration>14</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SOLU-CORTEF</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055937-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060630</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006RR-02882</companynumb>
    <primarysource>
      <reportercountry>SWITZERLAND</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>23</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <reaction>
        <reactionmeddrapt>ABORTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FOETAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY MALFORMATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ISOTRETINOIN</medicinalproduct>
        <drugauthorizationnumb>76041</drugauthorizationnumb>
        <drugdosagetext>30 MG, QD</drugdosagetext>
        <drugindication>ACNE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055938-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060717</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>58</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>81</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ARTERIAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBRAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IGIV (BAXTER) - RECONSTITUTED TO 10%</medicinalproduct>
        <drugbatchnumb>02A14AX11</drugbatchnumb>
        <drugdosagetext>80 GM Q 3 WKS IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>IDIOPATHIC THROMBOCYTOPENIC PURPURA</drugindication>
        <drugtreatmentduration>14</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SOLU-CORTEF</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055939-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060630</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006RR-02884</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>77</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>AUTOIMMUNE THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONTUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EPISTAXIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugauthorizationnumb>76285</drugauthorizationnumb>
        <drugdosagetext>10 MG, QD, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERCHOLESTEROLAEMIA</drugindication>
        <drugtreatmentduration>335</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DILTIAZEM BASICS (DILTIAZEM HYDROCHLORIDE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055940-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060720</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060713</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-SOLVAY-00206002303</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>45</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BEDRIDDEN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SCIATICA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
        <drugdosagetext>DAILY DOSE:  UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COVERSYL</medicinalproduct>
        <drugauthorizationnumb>020184</drugauthorizationnumb>
        <drugdosagetext>DAILY DOSE: 4 MILLIGRAM(S)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060413</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060701</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
        <drugdosagetext>DAILY DOSE:  UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TERAZOSIN HCL</medicinalproduct>
        <drugdosagetext>DAILY DOSE:  UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugdosagetext>DAILY DOSE:  UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRYPTOPHAN-L</medicinalproduct>
        <drugdosagetext>DAILY DOSE:  UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CODEINE</medicinalproduct>
        <drugdosagetext>DAILY DOSE:  UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIAMICRON</medicinalproduct>
        <drugdosagetext>DAILY DOSE:  UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055941-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060720</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060712</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-JNJFOC-20060604274</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>76</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>50</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DISSEMINATED TUBERCULOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>SPONDYLOARTHROPATHY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055942-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060720</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060710</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2006IT10348</companynumb>
    <primarysource>
      <reportercountry>ITALY</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>61</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CYTOMEGALOVIRUS INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPEPSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EPSTEIN-BARR VIRUS INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRECTOMY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRIC CANCER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MYCOPHENOLIC ACID</medicinalproduct>
        <drugdosagetext>2 G/D</drugdosagetext>
        <drugindication>RENAL TRANSPLANT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>STEROIDS NOS</medicinalproduct>
        <drugdosagetext>2 MG/D</drugdosagetext>
        <drugindication>RENAL TRANSPLANT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOSPORINE</medicinalproduct>
        <drugauthorizationnumb>050574</drugauthorizationnumb>
        <drugindication>RENAL TRANSPLANT</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055943-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060720</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060710</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2006FI10337</companynumb>
    <primarysource>
      <reportercountry>FINLAND</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>39</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLADDER DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHRONIC ALLOGRAFT NEPHROPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIALYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISEASE PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTRA-ABDOMINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>KIDNEY TRANSPLANT REJECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPHADENOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METASTASES TO BONE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METASTASES TO LIVER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METASTASES TO SPLEEN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METASTASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULAR WEAKNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROSTATE CANCER METASTATIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL TRANSPLANT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SMALL CELL CARCINOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPLENIC RUPTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URETHRAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHYLPREDNISOLONE</medicinalproduct>
        <drugindication>RENAL TRANSPLANT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AZATHIOPRINE</medicinalproduct>
        <drugindication>RENAL TRANSPLANT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TACROLIMUS</medicinalproduct>
        <drugindication>RENAL TRANSPLANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MYCOPHENOLATE MOFETIL</medicinalproduct>
        <drugindication>RENAL TRANSPLANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOSPORINE</medicinalproduct>
        <drugauthorizationnumb>050574</drugauthorizationnumb>
        <drugdosagetext>UNK, UNK</drugdosagetext>
        <drugindication>RENAL TRANSPLANT</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20000101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055944-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006RR-02840</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>65</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>TACHYARRHYTHMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENTRICULAR EXTRASYSTOLES</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugauthorizationnumb>76285</drugauthorizationnumb>
        <drugdosagetext>20 MG, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060505</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060517</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMOXICILLIN CAPSULE (AMOXICILLIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IBUPROFEN FAMILY (IBUPROFEN)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PARACETAMOL FAMILY (PARACETAMOL)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055945-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060717</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PPD INTRADERMAL TEST 5TU PER 0.1ML PARKDALE</medicinalproduct>
        <drugdosagetext>0.1 ML  ONCE ID</drugdosagetext>
        <drugadministrationroute>023</drugadministrationroute>
        <drugindication>TUBERCULIN TEST</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060201</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055946-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060717</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PPD INTRADERMAL TEST 5TU PER 0.1ML PARKDALE</medicinalproduct>
        <drugdosagetext> 0.1ML  ONCE ID</drugdosagetext>
        <drugadministrationroute>023</drugadministrationroute>
        <drugindication>TUBERCULIN TEST</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060201</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055947-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006S1005827</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>48</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>INCORRECT ROUTE OF DRUG ADMINISTRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVERDOSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FENTANYL TRANSDERMAL SYSTEM</medicinalproduct>
        <drugauthorizationnumb>76258</drugauthorizationnumb>
        <drugdosagetext>PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055948-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060630</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006S1005502</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>47</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>GRANULOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZAPINE</medicinalproduct>
        <drugauthorizationnumb>75417</drugauthorizationnumb>
        <drugdosagetext>50 MG;HS;ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PSYCHOTIC DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20011201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060601</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZAPINE</medicinalproduct>
        <drugauthorizationnumb>75417</drugauthorizationnumb>
        <drugdosagetext>50 MG;HS;ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20011201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060601</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZAPINE</medicinalproduct>
        <drugauthorizationnumb>75417</drugauthorizationnumb>
        <drugdosagetext>50 MG;HS;ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PSYCHOTIC DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZAPINE</medicinalproduct>
        <drugauthorizationnumb>75417</drugauthorizationnumb>
        <drugdosagetext>50 MG;HS;ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALPROATE SODIUM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055949-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060717</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PPD INTRADERMAL TEST 5TU PER 0.1 ML PARKDALE</medicinalproduct>
        <drugdosagetext>0.1 ML ONCE ID</drugdosagetext>
        <drugadministrationroute>023</drugadministrationroute>
        <drugindication>TUBERCULIN TEST</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060201</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055950-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060720</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060710</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-BRISTOL-MYERS SQUIBB COMPANY-13438486</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>66</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OESOPHAGITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUBCUTANEOUS HAEMATOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
        <drugauthorizationnumb>9218</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>EMBOLISM</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060115</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060408</drugenddate>
        <drugtreatmentduration>84</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
        <drugauthorizationnumb>009218</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>THROMBOSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060115</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060408</drugenddate>
        <drugtreatmentduration>84</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMOVANE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SLEEP DISORDER</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060411</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>EPILEPSY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051115</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ODRIK</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060408</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEPAMIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060411</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TERCIAN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOXEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATHYMIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDIATENSYL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AKINETON</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055951-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060720</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060620</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ES-BRISTOL-MYERS SQUIBB COMPANY-13418850</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>47</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ALANINE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HBV DNA INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENTECAVIR</medicinalproduct>
        <drugindication>HEPATITIS B</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050121</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADEFOVIR DIPIVOXIL KIT</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020426</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050514</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055952-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060720</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060701</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2006US08554</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>COMPUTERISED TOMOGRAM ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SCAR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIVELLE-DOT</medicinalproduct>
        <drugauthorizationnumb>20538</drugauthorizationnumb>
        <drugdosagetext>0.0375 MG/DAY, BIW</drugdosagetext>
        <drugadministrationroute>062</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055953-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060720</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060711</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-13438742</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>50</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>75</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG WITHDRAWAL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC CIRRHOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMPHOTERICIN B</medicinalproduct>
        <drugauthorizationnumb>60517</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NUBAIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ADRIAMYCIN PFS</medicinalproduct>
        <drugauthorizationnumb>062926</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055954-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060720</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060710</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-BRISTOL-MYERS SQUIBB COMPANY-13441100</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>78</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ACIDOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CREATINE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERKALAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPONATRAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GLUCOPHAGE</medicinalproduct>
        <drugauthorizationnumb>020357</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS NON-INSULIN-DEPENDENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050905</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060522</drugenddate>
        <drugtreatmentduration>259</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADANCOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOPICLONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RANITIDINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAREG</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LERCAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HEMI-DAONIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXTROPROPOXYPHENE HCL + APAP</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREVISCAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DISCOTRINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RILMENIDINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMIODARONE CHLORHYDRATE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055955-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060720</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060707</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-BRISTOL-MYERS SQUIBB COMPANY-13444138</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>75</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIAC ENZYMES INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ERBITUX</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLORECTAL CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060606</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060706</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CAMPTOSAR</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060606</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060706</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POLARAMINE</medicinalproduct>
        <drugindication>PREMEDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHYLPREDNISOLONE</medicinalproduct>
        <drugindication>PREMEDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055956-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060720</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060714</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-13443080</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>73</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>84</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
        <drugauthorizationnumb>009218</drugauthorizationnumb>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19960101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050801</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANOXIN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19960101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19960101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050801</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REQUIP</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19960101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMANTADINE HCL</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19960101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050801</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROSCAR</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19960101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060401</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLOMAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TIMOLOL MALEATE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19960101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055957-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060630</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006S1006091</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>44</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZAPINE</medicinalproduct>
        <drugauthorizationnumb>75417</drugauthorizationnumb>
        <drugdosagetext>25 MG;BID;PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060501</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZAPINE</medicinalproduct>
        <drugdosagetext>300 MG;HS;PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060501</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COMBIVENT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATIVAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GABAPENIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLEGRA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENZOTROPINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055958-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060720</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060710</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-BRISTOL-MYERS SQUIBB COMPANY-13438379</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>55</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CAPTOPRIL</medicinalproduct>
        <drugauthorizationnumb>074472</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055959-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060720</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060713</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-13441993</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BREAST CANCER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ESTRACE</medicinalproduct>
        <drugauthorizationnumb>084499</drugauthorizationnumb>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ESTRADIOL</medicinalproduct>
        <drugauthorizationnumb>084499</drugauthorizationnumb>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROVERA</medicinalproduct>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCRIN</medicinalproduct>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MEDROXYPROGESTERONE ACETATE</medicinalproduct>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055960-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060720</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060717</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-AVENTIS-200612514FR</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>26</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>90</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANOREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CYTOLYTIC HEPATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VERTIGO</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BIRODOGYL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PERIODONTITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060405</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060417</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055961-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060720</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-BRISTOL-MYERS SQUIBB COMPANY-12776415</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>54</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>66</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EXFOLIATIVE RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PETECHIAE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PURPURA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ERBITUX</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLORECTAL CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041012</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055962-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060720</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060614</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-AVENTIS-200613360EU</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>DEEP VEIN THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG DOSE OMISSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLEXANE</medicinalproduct>
        <drugauthorizationnumb>20164</drugauthorizationnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>KNEE ARTHROPLASTY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060411</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060619</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
        <drugindication>ANALGESIC EFFECT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAMADOL HCL</medicinalproduct>
        <drugindication>ANALGESIC EFFECT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugindication>ANALGESIC EFFECT</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055963-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060720</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060606</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-AVENTIS-200612046FR</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>72</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>90</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DERMATITIS BULLOUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ESCHERICHIA URINARY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERNATRAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEUKOCYTOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PURPURA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH PUSTULAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN NECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STAPHYLOCOCCAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STREPTOCOCCAL INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LASILIX</medicinalproduct>
        <drugauthorizationnumb>16273</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060428</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOZITEC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060224</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060505</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060509</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAROXETINE HCL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060510</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMIODARONE HCL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060510</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060510</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GABAPENTIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PERMIXON</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN B1 AND B6</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055964-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060720</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060619</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-AVENTIS-200612225FR</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>93</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HYPERSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LASILIX</medicinalproduct>
        <drugauthorizationnumb>16273</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060207</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMLOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060207</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DISCOTRINE</medicinalproduct>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060207</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VASTAREL</medicinalproduct>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060207</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEROXAT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KALEORID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREVISCAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DITROPAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055965-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060720</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060711</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-AVENTIS-200612492FR</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>85</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>83</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHABDOMYOLYSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LASILIX</medicinalproduct>
        <drugauthorizationnumb>16273</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CIBADREX ^CIBA-GEIGY^</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ANAFRANIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060620</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMLOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055966-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060720</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060713</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AVENTIS-200615850US</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UPPER LIMB FRACTURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DDAVP</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>019955</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NOCTURIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060623</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055967-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060720</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060710</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-BRISTOL-MYERS SQUIBB COMPANY-13440599</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>67</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>COGNITIVE DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PARAPLATIN</medicinalproduct>
        <drugauthorizationnumb>019880</drugauthorizationnumb>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>OVARIAN CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060613</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060613</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055968-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060720</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060710</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-BRISTOL-MYERS SQUIBB COMPANY-13444856</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>53</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>101</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>HEAT STROKE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ABILIFY</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060621</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060709</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OLANZAPINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060621</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060709</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PAROXETINE HCL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060621</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PEROSPIRONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060709</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROTOPORPHYRIN DISODIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060709</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUVASTATIN SODIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060709</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLPIDEM TARTRATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060709</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BIPERIDEN HYDROCHLORIDE TAB</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOTEPINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060627</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060709</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARBAMAZEPINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060627</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060709</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>QUETIAPINE FUMARATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060709</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055969-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060717</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PPD TEST INTRADERMAL 5TU PER 0.1ML PARKDALE</medicinalproduct>
        <drugdosagetext>0.1ML ONCE ID</drugdosagetext>
        <drugadministrationroute>023</drugadministrationroute>
        <drugindication>TUBERCULIN TEST</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060201</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055970-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060707</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>226648</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>48</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD ALBUMIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CHLORIDE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD SODIUM DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CANDIDIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DECREASED APPETITE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUCOSAL INFLAMMATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPHIL COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL INTAKE REDUCED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARYNGOLARYNGEAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINE FLOW DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINE KETONE BODY PRESENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ERLOTINIB (ERLOTINIB) TABLET</medicinalproduct>
        <drugdosagetext>100 MG, QD, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>TONSIL CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060603</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEVACIZUMAB (BEVACIZUMAB) PWDR + SOLVENT, INFUSION SOLN, 100MG</medicinalproduct>
        <drugdosagetext>10 MG/KG, QW2, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>TONSIL CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060517</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RADIATION THERAPY</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CISPLATIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AUGMENTIN '250'</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NYSTATIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DURAGESIC-100</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055971-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060717</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>57</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PPD TEST INTRADERMAL 5TU PER 0.1ML PARKDALE</medicinalproduct>
        <drugdosagetext> 0.1ML ONCE ID</drugdosagetext>
        <drugadministrationroute>023</drugadministrationroute>
        <drugindication>TUBERCULIN TEST</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060201</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055972-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060706</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>226268</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>67</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANAPHYLACTIC REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHILLS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OXYGEN SATURATION DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HERCEPTIN</medicinalproduct>
        <drugdosagetext>530 MG</drugdosagetext>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060530</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AROMASIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FEMARA</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055973-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060717</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PPD TEST INTRADERMAL 5TU PER 0.1ML PARKDALE</medicinalproduct>
        <drugdosagetext>0.1ML ONCE ID</drugdosagetext>
        <drugadministrationroute>023</drugadministrationroute>
        <drugindication>TUBERCULIN TEST</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060201</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055974-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060630</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006S1006176</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>77</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZAPINE</medicinalproduct>
        <drugauthorizationnumb>75417</drugauthorizationnumb>
        <drugdosagetext>100 MG;HS;PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060601</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEPAKOTE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HALDOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RESTORIL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055975-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060720</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060711</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2006US08873</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>66</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CONCOMITANT DISEASE AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VAGINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENABLEX</medicinalproduct>
        <drugauthorizationnumb>021513</drugauthorizationnumb>
        <drugdosagetext>7.5 MG, QD</drugdosagetext>
        <drugindication>HYPERTONIC BLADDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060612</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060701</drugenddate>
        <drugtreatmentduration>28800</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROMETRIUM</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COZAAR</medicinalproduct>
        <drugdosagetext>100 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPROL-XL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055976-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060720</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060711</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2006US09003</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>60</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>SURGERY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TENDON RUPTURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LESCOL</medicinalproduct>
        <drugauthorizationnumb>020261</drugauthorizationnumb>
        <drugdosagetext>40 MG, QD</drugdosagetext>
        <drugtreatmentduration>2190</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055977-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060720</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060621</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2006US08099</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>46</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>97.505</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CHEST DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARYNGOLARYNGEAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWOLLEN TONGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROAT TIGHTNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENABLEX</medicinalproduct>
        <drugbatchnumb>F0015</drugbatchnumb>
        <drugauthorizationnumb>21513</drugauthorizationnumb>
        <drugdosagetext>7.5 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>URINARY INCONTINENCE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060510</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060517</drugenddate>
        <drugtreatmentduration>11520</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LAMICTAL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055978-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060720</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060714</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2006JP10473</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>60</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ALANINE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASPARTATE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CREATINE PHOSPHOKINASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CREATINE PHOSPHOKINASE MB INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE CONGESTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSSTASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAMMA-GLUTAMYLTRANSFERASE ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATITIS FULMINANT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEPAS</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060712</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LENDORMIN</medicinalproduct>
        <drugdosagetext>0.25 MG/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060712</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MYSLEE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060703</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060712</drugenddate>
        <drugtreatmentduration>14400</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LOCHOL</medicinalproduct>
        <drugauthorizationnumb>020261</drugauthorizationnumb>
        <drugdosagetext>20 MG/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060712</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACINON</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060712</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OLMETEC</medicinalproduct>
        <drugdosagetext>UNK, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060712</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALBLOCK</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060712</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FERROMIA</medicinalproduct>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060712</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EBASTEL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060712</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055979-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060705</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>430079K06USA</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>44</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPEPSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NOVANTRONE</medicinalproduct>
        <drugauthorizationnumb>19297</drugauthorizationnumb>
        <drugdosagetext>ONCE, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050701</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COPAXONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055980-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060707</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>430036M06USA</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>51</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIAC OUTPUT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIOMYOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EXERCISE TOLERANCE DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NOVANTRONE</medicinalproduct>
        <drugauthorizationnumb>19297</drugauthorizationnumb>
        <drugdosagetext>1 IN 3 MONTHS</drugdosagetext>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060601</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055981-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060705</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>001-0902-M0100041</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>59</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>63.5036</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHAPPED LIPS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRY MOUTH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NERVOUS SYSTEM DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NARDIL</medicinalproduct>
        <drugauthorizationnumb>11909</drugauthorizationnumb>
        <drugdosagetext>SEEI MAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19900101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NARDIL</medicinalproduct>
        <drugauthorizationnumb>11909</drugauthorizationnumb>
        <drugdosagetext>SEEI MAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19990101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NARDIL</medicinalproduct>
        <drugauthorizationnumb>11909</drugauthorizationnumb>
        <drugdosagetext>SEEI MAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19990101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NARDIL</medicinalproduct>
        <drugauthorizationnumb>11909</drugauthorizationnumb>
        <drugdosagetext>SEEI MAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010426</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NARDIL</medicinalproduct>
        <drugauthorizationnumb>11909</drugauthorizationnumb>
        <drugdosagetext>SEEI MAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010426</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010509</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NARDIL</medicinalproduct>
        <drugauthorizationnumb>11909</drugauthorizationnumb>
        <drugdosagetext>SEEI MAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19900101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NARDIL</medicinalproduct>
        <drugauthorizationnumb>11909</drugauthorizationnumb>
        <drugdosagetext>SEEI MAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010509</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>STELAZINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CENTRUM (MINERALS NOS, VITAMINS NOS)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EVISTA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN E</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN C (VITAMIN C)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POSTURE-D ^WHITEHALL^ (CALCIUM PHOSPHATE, COLECALCIFEROL, ERGOCALCIFER</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055982-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060720</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060614</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHO2006JP09828</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>81</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ACUTE MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENTRICULAR FIBRILLATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LOCHOL</medicinalproduct>
        <drugauthorizationnumb>20261</drugauthorizationnumb>
        <drugdosagetext>20 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERCHOLESTEROLAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010904</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030701</drugenddate>
        <drugtreatmentduration>666</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LOCHOL</medicinalproduct>
        <drugauthorizationnumb>020261</drugauthorizationnumb>
        <drugdosagetext>30 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030702</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051104</drugenddate>
        <drugtreatmentduration>857</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LANDEL</medicinalproduct>
        <drugdosagetext>20 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ESSENTIAL HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980611</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LANDEL</medicinalproduct>
        <drugdosagetext>40 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LANDEL</medicinalproduct>
        <drugdosagetext>20 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051104</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BLOPRESS</medicinalproduct>
        <drugindication>ESSENTIAL HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THEOLONG</medicinalproduct>
        <drugindication>ASTHMA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055983-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060720</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060703</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHO2006JP10846</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>56</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>57</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METASTASES TO LIVER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RECTAL CANCER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LOCHOL</medicinalproduct>
        <drugauthorizationnumb>20261</drugauthorizationnumb>
        <drugdosagetext>30 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERCHOLESTEROLAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20011122</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060313</drugenddate>
        <drugtreatmentduration>1573</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MELBIN</medicinalproduct>
        <drugdosagetext>750 MG, UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010828</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060313</drugenddate>
        <drugtreatmentduration>1659</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055984-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060720</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060712</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHRM2006FR02111</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>2</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PALATAL OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZADITEN</medicinalproduct>
        <drugauthorizationnumb>021066</drugauthorizationnumb>
        <drugdosagetext>1 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>FOOD ALLERGY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055985-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060720</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060622</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHRM2006FR01954</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>65</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IRON DEFICIENCY ANAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>STALEVO 100</medicinalproduct>
        <drugauthorizationnumb>021485</drugauthorizationnumb>
        <drugdosagetext>200/150/37.5 X4/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PARKINSON'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050614</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060623</drugenddate>
        <drugtreatmentduration>375</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SINEMET</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MANTADIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EFFEXOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRIVASTAL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIFROL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MOTILIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055986-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060711</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>HQWYE038515APR05</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>57</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>49.03</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL DISTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BREAST CANCER IN SITU</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BREAST CANCER METASTATIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BREAST CANCER STAGE II</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BREAST MASS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BREAST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG ADMINISTRATION ERROR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUID RETENTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAIR GROWTH ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HOT FLUSH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCORRECT DOSE ADMINISTERED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPHOEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENORRHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METASTASES TO LYMPH NODES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METRORRHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOOD SWINGS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OESTROGEN RECEPTOR ASSAY POSITIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PREMENSTRUAL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROGESTERONE RECEPTOR ASSAY POSITIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WITHDRAWAL BLEEDING IRREGULAR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMPRO</medicinalproduct>
        <drugauthorizationnumb>20527</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19930101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030909</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MEDROXYPROGESTERONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19930101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROVERA</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055987-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060720</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060614</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-STX183154</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MIGRAINE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PSORIASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050601</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055988-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesscongenitalanomali>1</seriousnesscongenitalanomali>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060720</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060711</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-JNJFOC-20060702230</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>ABORTION INDUCED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CLEFT LIP</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EPITOMAX</medicinalproduct>
        <drugauthorizationnumb>20505</drugauthorizationnumb>
        <drugindication>EPILEPSY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055989-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060720</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060712</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-JNJFOC-20060702236</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>22</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HODGKIN'S DISEASE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ORTHO EVRA</medicinalproduct>
        <drugauthorizationnumb>021180</drugauthorizationnumb>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>CONTRACEPTION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055990-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060720</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060711</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-JNJFOC-20060702648</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>4</patientonsetage>
      <patientonsetageunit>800</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>STATUS EPILEPTICUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERDAL</medicinalproduct>
        <drugauthorizationnumb>020272</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055991-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060720</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060711</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-SOLVAY-00206002250</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>78</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>CARDIAC ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CIRCULATORY COLLAPSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EJECTION FRACTION DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERAL PHYSICAL HEALTH DETERIORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMODIALYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERKALAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYDRIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SHOCK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENTRICULAR TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COVERSYL</medicinalproduct>
        <drugauthorizationnumb>20184</drugauthorizationnumb>
        <drugdosagetext>DAILY DOSE: 1 DOSAGE FORM</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060301</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>COVERSYL</medicinalproduct>
        <drugauthorizationnumb>020184</drugauthorizationnumb>
        <drugdosagetext>DAILY DOSE: 1 DOSAGE FORM</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060616</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADANCOR</medicinalproduct>
        <drugdosagetext>DAILY DOSE:  UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060616</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>ALDACTONE</medicinalproduct>
        <drugdosagetext>DAILY DOSE: 25 MILLIGRAM(S)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060301</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>ALDACTONE</medicinalproduct>
        <drugdosagetext>DAILY DOSE: 25 MILLIGRAM(S)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060427</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060616</drugenddate>
        <drugtreatmentduration>51</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAHOR</medicinalproduct>
        <drugdosagetext>DAILY DOSE:  UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060616</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>LASILIX</medicinalproduct>
        <drugdosagetext>DAILY DOSE: 80 MILLIGRAM(S)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060301</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>LASILIX</medicinalproduct>
        <drugdosagetext>DAILY DOSE: 80 MILLIGRAM(S)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060616</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DISCOTRINE</medicinalproduct>
        <drugdosagetext>DAILY DOSE:  UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</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>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060616</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055992-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060720</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060713</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-SOLVAY-00206002280</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>17452</patientonsetage>
      <patientonsetageunit>804</patientonsetageunit>
      <patientweight>94</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANKLE FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FIBULA FRACTURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ANDROGEL</medicinalproduct>
        <drugauthorizationnumb>021015</drugauthorizationnumb>
        <drugdosagetext>DAILY DOSE: 5 GRAM(S)</drugdosagetext>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>BLOOD TESTOSTERONE DECREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060526</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
        <drugdosagetext>DAILY DOSE: 50 MILLIGRAM(S)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050901</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CONCERTA</medicinalproduct>
        <drugdosagetext>DAILY DOSE: 36 MILLIGRAM(S)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATTENTION DEFICIT/HYPERACTIVITY DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugdosagetext>DAILY DOSE: 40 MILLIGRAM(S)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERCHOLESTEROLAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055993-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060718</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>73.9363</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RABAVERT</medicinalproduct>
        <drugbatchnumb>383011A</drugbatchnumb>
        <drugdosagetext>1.0 ML IM DAY 0,3,7,14,28,IM</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>ANIMAL SCRATCH</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060603</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060627</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055994-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060720</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060215</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-JNJFOC-20060703157</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>45</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>COMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG TOXICITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SHOCK</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZALDIAR</medicinalproduct>
        <drugauthorizationnumb>21123</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INTENTIONAL OVERDOSE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055995-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060720</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060711</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2006BR10475</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>31</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>60</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>EPILEPSY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PARLODEL</medicinalproduct>
        <drugauthorizationnumb>017962</drugauthorizationnumb>
        <drugdosagetext>2.5 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD PROLACTIN ABNORMAL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060708</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060708</drugenddate>
        <drugtreatmentduration>1440</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055996-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060720</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060711</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHRM2006FR02055</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
    </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>BLOOD BILIRUBIN UNCONJUGATED INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHROMATURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EOSINOPHIL COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOLYTIC ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RETICULOCYTE COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SERUM FERRITIN INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOLI RHUME</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHINORRHOEA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060315</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060330</drugenddate>
        <drugtreatmentduration>23040</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOMPERIDONE</medicinalproduct>
        <drugdosagetext>10 MG, TID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060331</drugenddate>
        <drugtreatmentduration>84960</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TETANUS VACCINE</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>TETANUS IMMUNISATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060320</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060320</drugenddate>
        <drugtreatmentduration>1440</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NISIS</medicinalproduct>
        <drugauthorizationnumb>021283</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060215</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060404</drugenddate>
        <drugtreatmentduration>70560</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CONTINUOUS POSITIVE AIRWAY PRESSURE</medicinalproduct>
        <drugindication>SLEEP APNOEA SYNDROME</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIFLURIL</medicinalproduct>
        <drugdosagetext>UNK, UNK</drugdosagetext>
        <drugadministrationroute>059</drugadministrationroute>
        <drugindication>MYALGIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060320</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055997-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060720</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060615</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2006JP09167</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD CREATINE PHOSPHOKINASE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
        <drugauthorizationnumb>20665</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055998-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060720</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060707</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-BRISTOL-MYERS SQUIBB COMPANY-13442710</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>64</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CEREBRAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EFAVIRENZ</medicinalproduct>
        <drugauthorizationnumb>020972</drugauthorizationnumb>
        <drugdosagetext>600 MG DAILY FROM 13-FEB-2001 TO 05-APR-2005 THEN DECREASED TO 400 MG DAILY ON 06-APR-2005</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010213</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RETROVIR</medicinalproduct>
        <drugdosagetext>GIVEN: 06-JAN-2000 TO 17-JAN-2000, 13-FEB-2001 TO 06-DEC-2005, 12-JAN-2006 TO CONT.</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000106</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EPIVIR</medicinalproduct>
        <drugdosagetext>GIVEN: SEP-1999 TO 06-DEC-2005, 12-JAN-2006 TO CONT.</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990901</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5055999-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060720</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060710</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-BRISTOL-MYERS SQUIBB COMPANY-13438619</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>45</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPHOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIDANOSINE</medicinalproduct>
        <drugauthorizationnumb>21183</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060306</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NORVIR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010611</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIREAD</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050203</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FUZEON</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060306</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TMC114</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060306</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056000-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060720</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060222</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-13352794</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>72</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ACUTE RESPIRATORY DISTRESS SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEEP VEIN THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLEURAL EFFUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA ASPIRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ERBITUX</medicinalproduct>
        <drugbatchnumb>05C00076B</drugbatchnumb>
        <drugdosagetext>5TH INFUSION. LOAD DOSE (400 MG/M2, 850 MG) GIVEN ON 13-JAN-06.</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060210</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060210</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOCETAXEL</medicinalproduct>
        <drugdosagetext>2ND DOSE. THERAPY START DATE 13-JAN-06 (160 MG).</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060203</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060203</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CILOSTAZOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTIVITAMIN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060214</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060228</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NAPROSYN</medicinalproduct>
        <drugdosagetext>220 MG, 1-2 TABLETS TWICE PER DAY AS NEEDED.</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056001-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060720</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060710</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-BRISTOL-MYERS SQUIBB COMPANY-13437389</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>59</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>72</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BRONCHOPULMONARY ASPERGILLOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LITALIR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GLIOBLASTOMA MULTIFORME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060412</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GLEEVEC</medicinalproduct>
        <drugindication>GLIOBLASTOMA MULTIFORME</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056002-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060717</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PPD INTRADERMAL TEST 5TU PER 0.1 ML PARKDALE</medicinalproduct>
        <drugdosagetext>0.1 ML ONCE ID</drugdosagetext>
        <drugadministrationroute>023</drugadministrationroute>
        <drugindication>TUBERCULIN TEST</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060201</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056003-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060717</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PPD INTRADERMAL TEST 5TU PER 0.1ML PARKDALE</medicinalproduct>
        <drugdosagetext>0.1ML ONCE ID</drugdosagetext>
        <drugadministrationroute>023</drugadministrationroute>
        <drugindication>TUBERCULIN TEST</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060201</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056004-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060705</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>HQWYE675410JUL06</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BREAST CANCER RECURRENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
        <drugauthorizationnumb>4782</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROVERA</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056005-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060720</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060707</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006CG01182</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>85</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>GENERAL PHYSICAL HEALTH DETERIORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugauthorizationnumb>019810</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DYSPEPSIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARICEPT</medicinalproduct>
        <drugindication>SENILE DEMENTIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATARAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CACIT D3</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SURBRONC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056006-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060720</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060711</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006AP03254</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MULTIPLE MYELOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CASODEX</medicinalproduct>
        <drugauthorizationnumb>020498</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROSTATE CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060612</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ODYNE</medicinalproduct>
        <drugindication>PROSTATE CANCER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056007-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060720</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060717</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006CG01235</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>25</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DIABETES MELLITUS INSULIN-DEPENDENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugauthorizationnumb>19810</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VASTEN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROGRAF</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELLCEPT</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020401</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056008-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060720</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060711</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006CG01213</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>8440</patientonsetage>
      <patientonsetageunit>804</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>APHTHOUS STOMATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GRANULOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUCOSAL INFLAMMATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OESOPHAGITIS ULCERATIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STOMACH GRANULOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugauthorizationnumb>21153</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060318</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060410</drugenddate>
        <drugtreatmentduration>24</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>BIPROFENID</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060318</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>BIPROFENID</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060410</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugdosagetext>5 MG ON MONDAY + 2.5 MG ON TUESDAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060124</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060410</drugenddate>
        <drugtreatmentduration>77</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051104</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060318</drugenddate>
        <drugtreatmentduration>135</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPECIAFOLDINE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060124</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROTON PUMP INHIBITORS</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050401</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROTON PUMP INHIBITORS</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051004</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060401</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056009-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060705</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>HQWYE824816FEB06</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>67</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>68.1</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>AGITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD THYROID STIMULATING HORMONE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CAROTID ARTERY ATHEROMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CAROTID ARTERY STENOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ELECTROCARDIOGRAM ST-T CHANGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HIGH DENSITY LIPOPROTEIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINGLE PHOTON EMISSION COMPUTERISED TOMOGRAM ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RALOXIFENE HCL</medicinalproduct>
        <drugbatchnumb>2005P0820</drugbatchnumb>
        <drugauthorizationnumb>20815</drugauthorizationnumb>
        <drugdosagetext>60 MG 1X PER 1 DAY, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020801</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTIVITAMINS, PLAIN (MULTIVITAMINS, PLAIN)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</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>5056010-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060717</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PPD INTRADERMAL TEST 5TU PER 0.1ML PARKDALE</medicinalproduct>
        <drugdosagetext>0.1 ML ONCE ID</drugdosagetext>
        <drugadministrationroute>023</drugadministrationroute>
        <drugindication>TUBERCULIN TEST</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060201</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056011-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060705</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>HQWYE676010JUL06</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BREAST CANCER FEMALE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
        <drugauthorizationnumb>4782</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056012-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060720</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060320</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006UW04762</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>20245</patientonsetage>
      <patientonsetageunit>804</patientonsetageunit>
      <patientweight>90.5</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG DISPENSING ERROR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEDICATION ERROR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUPRAVENTRICULAR TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOPROL-XL</medicinalproduct>
        <drugauthorizationnumb>019962</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SUPRAVENTRICULAR TACHYCARDIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOPROL-XL</medicinalproduct>
        <drugauthorizationnumb>019962</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOPAMAX</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050926</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOTREL</medicinalproduct>
        <drugdosagetext>5/10 MG</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GEMFIBROZIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056013-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060720</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060623</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006UW13316</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>41</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>46.1</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PANCREATITIS ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IRESSA</medicinalproduct>
        <drugauthorizationnumb>21399</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BREAST CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050819</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060618</drugenddate>
        <drugtreatmentduration>304</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XELODA</medicinalproduct>
        <drugindication>BREAST CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050819</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060618</drugenddate>
        <drugtreatmentduration>304</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056014-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060720</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060710</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006PK01519</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>23802</patientonsetage>
      <patientonsetageunit>804</patientonsetageunit>
      <patientweight>100</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>AUTOIMMUNE THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MERONEM</medicinalproduct>
        <drugauthorizationnumb>50706</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020224</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020227</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIFLUCANE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020213</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020227</drugenddate>
        <drugtreatmentduration>15</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GENTAMICIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020207</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020209</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GENTAMICIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020218</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020226</drugenddate>
        <drugtreatmentduration>9</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMBROXOL</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020130</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020227</drugenddate>
        <drugtreatmentduration>29</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN B1/B6</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020227</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ROCEPHIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020206</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020210</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FRAXIPARIN</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020216</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FRAXIPARIN</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020217</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020219</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORCURON</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020203</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORCURON</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020204</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020227</drugenddate>
        <drugtreatmentduration>24</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DORMICUM</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020204</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DORMICUM</medicinalproduct>
        <drugdosagetext>15-20 MG/HR</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020211</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SUFENTA</medicinalproduct>
        <drugdosagetext>6-7 ML/HR</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020227</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KETANEST</medicinalproduct>
        <drugdosagetext>4-11 ML/HR</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020211</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM CHLORIDE</medicinalproduct>
        <drugdosagetext>0.2-1.0 ML/HR</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020227</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CEBION</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020227</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HALDOL</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020203</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALDACTONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020221</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TORSEMIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020131</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEBILET</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020131</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AKINETON</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020131</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DELIX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020131</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIPIPERON</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020131</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HEPA MERZ</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020131</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMOZENT/ATROVENT</medicinalproduct>
        <drugadministrationroute>055</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020131</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SALBULAIR</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020211</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BRONCHOPARAT</medicinalproduct>
        <drugdosagetext>2 ML/HR</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020218</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMINO ACIDS WITH FAT</medicinalproduct>
        <drugdosagetext>6.3-9.4 ML/HR</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020218</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FURESIS</medicinalproduct>
        <drugdosagetext>10-60 MG/DAY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020211</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NOREPINEPHRINE BITARTRATE</medicinalproduct>
        <drugdosagetext>1.0-2.4 ML/HR</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020202</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020204</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROPOFOL</medicinalproduct>
        <drugdosagetext>400-800 MG/DAY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020203</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020227</drugenddate>
        <drugtreatmentduration>25</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LACTULOSE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020202</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020227</drugenddate>
        <drugtreatmentduration>26</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CERNEVIT-12</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020202</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020227</drugenddate>
        <drugtreatmentduration>26</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RANITIDINE HCL</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020206</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020227</drugenddate>
        <drugtreatmentduration>22</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CIPROBAY</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020208</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020218</drugenddate>
        <drugtreatmentduration>11</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CIPROBAY</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020219</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020222</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ERYTHROCIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020207</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020217</drugenddate>
        <drugtreatmentduration>11</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FENISTIL</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020207</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020227</drugenddate>
        <drugtreatmentduration>21</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACTRAPID</medicinalproduct>
        <drugdosagetext>8-24 ML/DAY</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020210</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020227</drugenddate>
        <drugtreatmentduration>18</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACTRAPID</medicinalproduct>
        <drugdosagetext>8 ML/HR</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020210</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020227</drugenddate>
        <drugtreatmentduration>18</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONIDIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020211</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020212</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FORTUM</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020218</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020218</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CORDAREX</medicinalproduct>
        <drugdosagetext>2.1-4.2 ML/HR</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020218</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020218</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VANCOMYCIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020218</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020218</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMINOMEL NEPHRO</medicinalproduct>
        <drugdosagetext>44-46 ML/HR</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020217</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020227</drugenddate>
        <drugtreatmentduration>11</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOSE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020220</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020227</drugenddate>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020217</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020227</drugenddate>
        <drugtreatmentduration>11</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HEPARIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020220</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020227</drugenddate>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SALOFALK</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020221</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020227</drugenddate>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NOVAMIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020217</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020220</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NOVAMIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020221</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020227</drugenddate>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MELNEURIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020224</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020227</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056015-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060720</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060713</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006UW14467</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>76</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>RESPIRATORY ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRACHEAL STENOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PULMICORT SUSPENSION</medicinalproduct>
        <drugauthorizationnumb>020929</drugauthorizationnumb>
        <drugdosagetext>ONE DOSE</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>COUGH</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060703</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060703</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PULMICORT SUSPENSION</medicinalproduct>
        <drugauthorizationnumb>020929</drugauthorizationnumb>
        <drugdosagetext>ONE DOSE</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>FATIGUE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060703</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060703</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BEROTEC</medicinalproduct>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>COUGH</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060613</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BEROTEC</medicinalproduct>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>FATIGUE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060613</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATROVENT</medicinalproduct>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>COUGH</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060613</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATROVENT</medicinalproduct>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>FATIGUE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060613</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056016-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060720</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060717</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006CG01234</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>56</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>63</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INTESTINAL ISCHAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugauthorizationnumb>21153</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIATUS HERNIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060409</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIACALCIN</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>COMPLEX REGIONAL PAIN SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060430</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060508</drugenddate>
        <drugtreatmentduration>9</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EUTHYRAL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPOTHYROIDISM</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056017-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060720</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060627</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>TR-AVENTIS-200617245GDDC</companynumb>
    <primarysource>
      <reportercountry>TURKEY</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>22</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>69.1</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DIABETIC KETOACIDOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INSULIN GLARGINE</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021081</drugauthorizationnumb>
        <drugdosagetext>DOSE UNIT: UNITS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OPTIPEN (INSULIN PUMP)</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040405</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HUMALOG</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20011004</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056018-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060717</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PPD INTRADERMAL TEST 5TU PER 0.1ML PARKDALE</medicinalproduct>
        <drugdosagetext>0.1 ML ONCE ID</drugdosagetext>
        <drugadministrationroute>023</drugadministrationroute>
        <drugindication>TUBERCULIN TEST</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060201</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056019-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060705</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>HQWYE722910JUL06</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>57</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>NEOPLASM MALIGNANT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMPRO</medicinalproduct>
        <drugauthorizationnumb>20527</drugauthorizationnumb>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056020-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060705</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>HQWYE623906JUL06</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BREAST CANCER METASTATIC</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMPRO</medicinalproduct>
        <drugauthorizationnumb>20527</drugauthorizationnumb>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCRIN</medicinalproduct>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056021-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060717</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PPD INTRADERMAL TEST 5TU PER 0.1ML PARKDALE</medicinalproduct>
        <drugdosagetext>0.1 ML ONCE ID</drugdosagetext>
        <drugadministrationroute>023</drugadministrationroute>
        <drugindication>TUBERCULIN TEST</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060201</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056022-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060717</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PPD INTRADERMAL TEST 5TU PER 0.1ML PARKDALE</medicinalproduct>
        <drugdosagetext>0.1ML ONCE ID</drugdosagetext>
        <drugadministrationroute>023</drugadministrationroute>
        <drugindication>TUBERCULIN TEST</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060201</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056023-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060705</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>HQWYE298711MAY06</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>72</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>68.1</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BREAST CANCER RECURRENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
        <drugauthorizationnumb>4782</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ESTRACE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056024-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060717</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PPD INTRADERMAL TEST 5TU PER 0.1 ML PARKDALE</medicinalproduct>
        <drugdosagetext>0.1 ML ONCE ID</drugdosagetext>
        <drugadministrationroute>023</drugadministrationroute>
        <drugindication>TUBERCULIN TEST</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060201</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056025-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060717</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>43</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PPD INTRADERMAL TEST 5TU PER 0.1 ML PARKDALE</medicinalproduct>
        <drugdosagetext>0.1 ML ONCE ID</drugdosagetext>
        <drugadministrationroute>023</drugadministrationroute>
        <drugindication>TUBERCULIN TEST</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060202</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060202</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056026-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060717</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>41</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>114</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PPD INTRADERMAL TEST 5TU PER 0.1ML PARKDALE</medicinalproduct>
        <drugdosagetext>0.1ML ONCE ID</drugdosagetext>
        <drugadministrationroute>023</drugadministrationroute>
        <drugindication>TUBERCULIN TEST</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060202</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060202</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056027-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060717</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>42</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>95.2554</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABNORMAL SENSATION IN EYE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISORIENTATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG DOSE OMISSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SENSORY DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CIPROFLOXACIN HCL</medicinalproduct>
        <drugdosagetext>500 MG   2X DAILY  PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MASTITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060707</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060713</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056028-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060717</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>57</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THERAPEUTIC RESPONSE DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VARDENAFIL    20MG</medicinalproduct>
        <drugdosagetext>20MG PRN  PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ERECTILE DYSFUNCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051219</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060301</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056029-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060717</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>51</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>85.2762</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIMB DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugdosagetext>80 MG  1 PER DAY  PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060315</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060705</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056030-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060717</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>67</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GLOSSITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARYNGEAL OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWOLLEN TONGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROAT IRRITATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALBUTEROL HFA  MULTIDOSE INHALER</medicinalproduct>
        <drugdosagetext>1 TO 2 PUFFS   PRN 4 TO 6 HOURS  PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060707</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060710</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056031-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060717</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>67</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>78.4723</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARYNGEAL OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH PRURITIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STRIDOR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEULASTA</medicinalproduct>
        <drugbatchnumb>P057739</drugbatchnumb>
        <drugdosagetext>6MG  ONCE  SQ</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>BONE MARROW FAILURE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060623</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060623</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEULASTA</medicinalproduct>
        <drugbatchnumb>P057739</drugbatchnumb>
        <drugdosagetext>6MG  ONCE  SQ</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060623</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060623</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEULASTA</medicinalproduct>
        <drugbatchnumb>P057739</drugbatchnumb>
        <drugdosagetext>6MG  ONCE  SQ</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060623</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060623</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056032-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060717</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>34</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>111.1</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>GASTROENTERITIS CRYPTOSPORIDIAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>1ML   EVERY WEEK   SQ</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PSORIATIC ARTHROPATHY</drugindication>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOMOTIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SULFASALAZINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLAGYL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVAQUIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NITOZOXANIDE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056033-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060626</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>163-20785-06060857</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>29</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>56</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BUTTOCK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIPLOPIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYDRONEPHROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPONATRAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPHOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULAR WEAKNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PELVIC ABSCESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STAPHYLOCOCCAL SEPSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY INCONTINENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>THALOMID</medicinalproduct>
        <drugauthorizationnumb>20785</drugauthorizationnumb>
        <drugdosagetext>100 MG, QD, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>METASTATIC NEOPLASM</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021209</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040412</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TEMODAR</medicinalproduct>
        <drugdosagetext>240 MG, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>METASTATIC NEOPLASM</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021209</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040412</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PHENOXYBENZAMINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NIFEDIPINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATIVAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIBENZYLINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCODONE HCL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056034-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060623</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>163-20785-06060870</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>47</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD HUMAN CHORIONIC GONADOTROPIN INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>THALOMID</medicinalproduct>
        <drugauthorizationnumb>20785</drugauthorizationnumb>
        <drugdosagetext>200 MG, 1 IN 1 D, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060303</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060621</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056035-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060717</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>81</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>110</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DYSPHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPHONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LARYNGEAL OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEUKOCYTOCLASTIC VASCULITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOCAL SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NECK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARYNGOLARYNGEAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MOXIFLOXACIN HCL</medicinalproduct>
        <drugdosagetext>400MG  QD  IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PNEUMONIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060523</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060523</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MOXIFLOXACIN HCL</medicinalproduct>
        <drugdosagetext>400MG  QD  PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PNEUMONIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060524</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060529</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL / IPRATROPINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BRIMONIDINE TARTRATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUNISOLIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLYBURIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HYDROCHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NYSTATIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>QUININE SULFATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAMSULOSIN HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAZODONE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056036-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060630</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>163-20785-06070174</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>85</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BACK DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</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>20040701</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>20040801</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056037-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060720</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060714</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-GILEAD-2006-0009866</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>58</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CHOLECYSTITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPSERA</medicinalproduct>
        <drugauthorizationnumb>021449</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS B</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060617</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056038-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060717</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>BELGIUM</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>31</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHILLS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH PAPULAR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEPTRA</medicinalproduct>
        <drugdosagetext>ORAL;</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060524</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060526</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056039-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060701</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>163-20785-06070201</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD BILIRUBIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CANCER PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOALBUMINAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOCALCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOKALAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERIPHERAL SENSORY NEUROPATHY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>THALOMID</medicinalproduct>
        <drugauthorizationnumb>20785</drugauthorizationnumb>
        <drugdosagetext>QHS (CYCLE = 28 DAYS);INITIAL DOSE 200 MG, 200 MG INCREMENTS Q2WKS TO A MAXIMUM OF 1000MG/DAY, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ENDOMETRIAL CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020503</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030327</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056041-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060717</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>BELGIUM</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>33</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050822</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060207</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056044-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060717</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>BELGIUM</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>32</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMOXICILLIN + CLAVULANATE POTASSIUM</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060609</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060610</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMOXICILLIN + CLAVULANATE POTASSIUM</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060609</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060610</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056045-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060717</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>106</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD TEST ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISEASE PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INVESTIGATION ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IRINOTECAN HCL</medicinalproduct>
        <drugdosagetext>125MG/M2   DAY 1, 8, 22, 29  IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>GLIOBLASTOMA MULTIFORME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060420</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IRINOTECAN HCL</medicinalproduct>
        <drugdosagetext>125MG/M2   DAY 1, 8, 22, 29  IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>GLIOBLASTOMA MULTIFORME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060427</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IRINOTECAN HCL</medicinalproduct>
        <drugdosagetext>125MG/M2   DAY 1, 8, 22, 29  IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>GLIOBLASTOMA MULTIFORME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060511</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TEMODAR</medicinalproduct>
        <drugdosagetext>200MG/M2   DAYS 1-5   PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GLIOBLASTOMA MULTIFORME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060420</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060424</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WELLBUTRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DECADRON</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROVIGIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROTONIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZANTAC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCODONE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLEXERIL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056046-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060717</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>63.5036</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JOINT SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENOUS THROMBOSIS LIMB</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ESTRADIOL</medicinalproduct>
        <drugdosagetext>6 MG PO TID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060509</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060630</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BI-FLEX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN E</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056047-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060717</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>BELGIUM</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>33</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG EFFECT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050822</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060207</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056048-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060717</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>66</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>70</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OXYGEN SATURATION DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROAT IRRITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URTICARIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CETUXIMAB 400MG/ M2</medicinalproduct>
        <drugdosagetext>400MG/M2 IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060710</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056049-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060717</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>20</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>70.9</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IDIOPATHIC THROMBOCYTOPENIC PURPURA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERITONSILLAR ABSCESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARYNGITIS STREPTOCOCCAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RETROPHARYNGEAL ABSCESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TONSILLAR HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TONSILLITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KALETRA</medicinalproduct>
        <drugdosagetext>200MG/50MG  4 TABS DAILY  PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060512</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060630</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EPZICOM</medicinalproduct>
        <drugdosagetext>600MG/300MG  1 TAB DAILY  PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060512</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060629</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BACTRIM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PENICILLIN VK</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PERCOCET</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056051-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060717</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>77.3</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLINDNESS TRANSIENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLINDNESS UNILATERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NIGHT SWEATS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RETINAL ARTERY OCCLUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL DISTURBANCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IRESSA</medicinalproduct>
        <drugbatchnumb>P/4026/8</drugbatchnumb>
        <drugdosagetext>250 MG   DAILY   ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>METASTATIC NEOPLASM</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060621</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060630</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MINERAL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HERBAL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056053-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060705</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>L06-USA-02654-01</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>41</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANGLE CLOSURE GLAUCOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHOROIDAL EFFUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CILIARY BODY DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ESCITALOPRAM</medicinalproduct>
        <drugauthorizationnumb>21323</drugauthorizationnumb>
        <drugindication>DEPRESSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056056-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060711</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>S06-USA-00290-01</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>82</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANOREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>APATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CREATININE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD UREA INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEPHRITIS INTERSTITIAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEXAPRO</medicinalproduct>
        <drugauthorizationnumb>21323</drugauthorizationnumb>
        <drugdosagetext>22.5 MG QD PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060118</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEXAPRO</medicinalproduct>
        <drugdosagetext>20 MG QD PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEXAPRO</medicinalproduct>
        <drugdosagetext>15 MG QD PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060119</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEXAPRO</medicinalproduct>
        <drugdosagetext>20 MG QD PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACIPHEX</medicinalproduct>
        <drugindication>GASTROOESOPHAGEAL REFLUX DISEASE</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACIPHEX</medicinalproduct>
        <drugindication>GASTROOESOPHAGEAL REFLUX DISEASE</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060117</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LOTREL</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRIAMTERENE AND HYDROCHLOROTHIAZIDE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056060-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060706</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>S06-USA-02553-01</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>20</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIAC VALVE DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</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>20051201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GARLIC PILLS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056063-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060711</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>S06-USA-01912-01</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>67</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CREATININE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE FLUCTUATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD UREA INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD UREA NITROGEN/CREATININE RATIO INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>C-REACTIVE PROTEIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHONDROCALCINOSIS PYROPHOSPHATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLD SWEAT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALLOR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHEUMATOID FACTOR INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SLEEP APNOEA SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>THYROID TAB</medicinalproduct>
        <drugdosagetext>60 MG QD PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPOTHYROIDISM</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060425</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>THYROID TAB</medicinalproduct>
        <drugdosagetext>30 MG BID PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPOTHYROIDISM</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TARKA</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060425</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060427</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BROMALINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMINS NOS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056064-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060717</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>71</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>160</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DYSPNOEA EXERTIONAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugdosagetext>50MG   DAILY  PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETIC NEUROPATHY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060713</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056066-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060712</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200611797BCC</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>68.0396</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DUODENAL POLYP</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRIC DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALEVE</medicinalproduct>
        <drugbatchnumb>204095C</drugbatchnumb>
        <drugauthorizationnumb>20204</drugauthorizationnumb>
        <drugdosagetext>220 MG, PRN, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060301</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEXAPRO</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAMADOL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056068-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060717</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>26</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugindication>DEPRESSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056069-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060630</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>8017618</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>22</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABORTION SPONTANEOUS</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>
        <drugdosagetext>1500 MG/D PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>EPILEPSY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLARITIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056071-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060717</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>16</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>77.1115</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BREATH ODOUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN DISCOLOURATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN ODOUR ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SELSUN BLUE SHAMPOO</medicinalproduct>
        <drugindication>DANDRUFF</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060714</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SELSUN BLUE  ( PYRITHIONE ZINC)</medicinalproduct>
        <drugindication>DANDRUFF</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060714</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056072-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060717</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG EFFECT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THERAPEUTIC RESPONSE UNEXPECTED WITH DRUG SUBSTITUTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLONAZEPAM</medicinalproduct>
        <drugdosagetext>1 MG ONE Q AM</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19800101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056073-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060703</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>8017753</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD URINE PRESENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PREGNANCY WITH CONTRACEPTIVE DEVICE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UNINTENDED PREGNANCY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KEPPRA</medicinalproduct>
        <drugauthorizationnumb>21035</drugauthorizationnumb>
        <drugdosagetext>PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060510</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PLACEBO</medicinalproduct>
        <drugdosagetext>D PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060510</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MOXIFLOXACIN HCL</medicinalproduct>
        <drugdosagetext>400 MG /D PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060503</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060510</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056074-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060706</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>8017356</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>47</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABSTAINS FROM ALCOHOL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIABETES MELLITUS INADEQUATE CONTROL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIPIDS ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METABOLIC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KEPPRA</medicinalproduct>
        <drugauthorizationnumb>21035</drugauthorizationnumb>
        <drugdosagetext>750 MG 2/D PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONVULSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KEPPRA</medicinalproduct>
        <drugdosagetext>1500 MG 2/D PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONVULSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MESALAMINE</medicinalproduct>
        <drugindication>COLITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARBATROL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056075-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060717</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>16</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWELLING FACE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEGASPARGASE ONCASPAR 750 IU PER ML ENZON PHARMACEUTICALS</medicinalproduct>
        <drugbatchnumb>AL0533</drugbatchnumb>
        <drugdosagetext>1650 UNITS IM [4 TIMES]</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060122</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060713</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056076-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060706</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>8017259</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>25</patientonsetage>
      <patientonsetageunit>802</patientonsetageunit>
      <patientweight>12</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG ADMINISTRATION ERROR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCORRECT DOSE ADMINISTERED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POSTURE ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KEPPRA</medicinalproduct>
        <drugauthorizationnumb>21505</drugauthorizationnumb>
        <drugdosagetext>100 MG 2/D PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONVULSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060309</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KEPPRA</medicinalproduct>
        <drugdosagetext>500 MG 2/D PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONVULSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060310</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060516</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KEPPRA</medicinalproduct>
        <drugdosagetext>1000 MG 2/D PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONVULSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060517</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060601</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PHENOBARBITAL TAB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPAMAX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056077-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060717</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>81.6475</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>IMPAIRED HEALING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POST PROCEDURAL COMPLICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISION BLURRED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEVANAC</medicinalproduct>
        <drugdosagetext>ONE DROP TID LEFT EYE</drugdosagetext>
        <drugindication>EYE LASER SURGERY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051130</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051212</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEVANAC</medicinalproduct>
        <drugdosagetext>ONE DROP TID LEFT EYE</drugdosagetext>
        <drugindication>PROCEDURAL PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051130</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051212</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056080-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060718</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>68</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>116.1208</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE SYSTOLIC DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIVERTICULITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ERLOTINIB</medicinalproduct>
        <drugbatchnumb>X101862</drugbatchnumb>
        <drugdosagetext>100 MG P.O. DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RENAL CELL CARCINOMA STAGE UNSPECIFIED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040909</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060703</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RHUMAB VEG-F</medicinalproduct>
        <drugbatchnumb>M55636</drugbatchnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RENAL CELL CARCINOMA STAGE UNSPECIFIED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040909</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060629</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METAMUCIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HUMULIN 70/30</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HUMULIN R SLIDING SCALE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RYTHMOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENOXAPARIN SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVAQUIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZELNORM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056081-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060720</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060707</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHNU2006DE02491</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>43</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLISTER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERKERATOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MYFORTIC</medicinalproduct>
        <drugauthorizationnumb>050791</drugauthorizationnumb>
        <drugdosagetext>720 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060529</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056082-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060711</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>146004USA</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>54</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>83.0083</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIAC ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EPISTAXIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STRESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FAMOTIDINE</medicinalproduct>
        <drugauthorizationnumb>75311</drugauthorizationnumb>
        <drugdosagetext>20 MILLIGRAM</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VERSED</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19911121</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19911121</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRAVACHOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRIAMTERENE AND HYDROCHLOROTHIAZIDE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056083-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060706</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CERZ-11270</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>15</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CEREZYME</medicinalproduct>
        <drugauthorizationnumb>20367</drugauthorizationnumb>
        <drugdosagetext>60 U/KG QWKS IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>GAUCHER'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056084-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060718</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>72</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>77.1115</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENTAL STATUS CHANGES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THERAPEUTIC RESPONSE UNEXPECTED WITH DRUG SUBSTITUTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METFORMIN HCL</medicinalproduct>
        <drugbatchnumb>LN076073</drugbatchnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060505</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060619</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056085-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060709</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006084426</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>62</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN EXFOLIATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN IRRITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWELLING FACE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWOLLEN TONGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URTICARIA GENERALISED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ROGAINE</medicinalproduct>
        <drugbatchnumb>24MPJ</drugbatchnumb>
        <drugauthorizationnumb>19501</drugauthorizationnumb>
        <drugdosagetext>1 ML TWICE DAILY, TOPICAL</drugdosagetext>
        <drugadministrationroute>061</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060621</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060703</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ISOSORBIDE MONONITRATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FELODIPINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056086-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060718</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>39</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
        <drugdosagetext>1 MG AT HS</drugdosagetext>
        <drugindication>GENERALISED ANXIETY DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XANAX XR</medicinalproduct>
        <drugdosagetext>3 MG QAM</drugdosagetext>
        <drugindication>PANIC DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056087-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060718</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>77.1115</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGE INTRACRANIAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVITRA</medicinalproduct>
        <drugbatchnumb>5400 KGH</drugbatchnumb>
        <drugdosagetext>10 MG TOOK AT 0700 7/15/06 PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ERECTILE DYSFUNCTION</drugindication>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENALAPRIL MALEATE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056088-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060718</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>PHARYNGEAL OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWOLLEN TONGUE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugdosagetext>20 MG BID PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG HYPERSENSITIVITY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KEFLEX</medicinalproduct>
        <drugdosagetext>500 MG TID PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056090-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060718</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>84.369</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THERAPEUTIC RESPONSE UNEXPECTED WITH DRUG SUBSTITUTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PERCOCET-5</medicinalproduct>
        <drugdosagetext>2 TABS Q 6 PRN PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060607</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060711</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXYCONTIN</medicinalproduct>
        <drugdosagetext>2 TABS TID PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050901</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056091-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060717</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>54.4316</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>IMPAIRED HEALING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISION BLURRED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL DISTURBANCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEVANAC</medicinalproduct>
        <drugdosagetext>ONE DROP TID LEFT EYE</drugdosagetext>
        <drugindication>PROCEDURAL PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060208</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060212</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056096-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060717</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>51.2565</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>IMPAIRED HEALING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISION BLURRED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL DISTURBANCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEVANAC</medicinalproduct>
        <drugdosagetext>ONE DROP  TID  LEFT EYE</drugdosagetext>
        <drugindication>PROCEDURAL PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051123</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051202</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056097-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006001310</companynumb>
    <primarysource>
      <reportercountry>SPAIN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>70</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISORIENTATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENTAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ERLOTINIB (TABLET)</medicinalproduct>
        <drugauthorizationnumb>21743</drugauthorizationnumb>
        <drugdosagetext>150 MG (QD), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060408</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060429</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FRUMIL FORTE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIGOXIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALDACTACINE (ALDACTAZINE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CIMAL (CIMETIDINE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAMADOL HCL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056098-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060428</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>8017860</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE BEFORE PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UNINTENDED PREGNANCY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KEPPRA</medicinalproduct>
        <drugauthorizationnumb>21035</drugauthorizationnumb>
        <drugdosagetext>500 MG/D</drugdosagetext>
        <drugindication>EPILEPSY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050801</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056099-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060707</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006P1000349</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>72</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>77</patientweight>
      <reaction>
        <reactionmeddrapt>ARRHYTHMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE SYSTOLIC INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RETEPLASE (RETEPLASE)</medicinalproduct>
        <drugbatchnumb>CT000807</drugbatchnumb>
        <drugdosagetext>5 IU;X2;IV</drugdosagetext>
        <drugindication>ACUTE MYOCARDIAL INFARCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060319</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REOPRO</medicinalproduct>
        <drugbatchnumb>09330367</drugbatchnumb>
        <drugdosagetext>9.6 ML;X1;IVBOL; SEE IMAGE</drugdosagetext>
        <drugadministrationroute>040</drugadministrationroute>
        <drugindication>ACUTE MYOCARDIAL INFARCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060319</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060319</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HEPARIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056100-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060710</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006P1000354</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>70</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY RESTENOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY STENOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL ISCHAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SURGICAL PROCEDURE REPEATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENTRICULAR HYPOKINESIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RETEPLASE (RETEPLASE)</medicinalproduct>
        <drugdosagetext>IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ACUTE MYOCARDIAL INFARCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060131</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060131</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REOPRO</medicinalproduct>
        <drugdosagetext>IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ACUTE MYOCARDIAL INFARCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060131</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060131</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETYLSALICYLIC ACID SRT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLOPIDOGREL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACEBUTOLOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RAMIPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATORVASTATIN CALCIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HYDROCHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATORVASTATIN CALCIUM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056101-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060703</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-2006-016411</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>45</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>85</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BREAST CANCER FEMALE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OESTROGEN RECEPTOR ASSAY POSITIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROGESTERONE RECEPTOR ASSAY POSITIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIRENA</medicinalproduct>
        <drugauthorizationnumb>21225</drugauthorizationnumb>
        <drugdosagetext>20 UG/DAY, CONT, INTRA-UTERINE</drugdosagetext>
        <drugadministrationroute>015</drugadministrationroute>
        <drugindication>CONTRACEPTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIRENAL(LEVONORGESTREL)</medicinalproduct>
        <drugdosagetext>20 UG/DAY, CONT, INTRA-UTERINE</drugdosagetext>
        <drugadministrationroute>015</drugadministrationroute>
        <drugindication>CONTRACEPTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056102-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060711</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-2006-002229</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>28</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>55</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>AMENORRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CERVIX CARCINOMA STAGE 0</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEVICE BREAKAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HUMAN PAPILLOMA VIRUS TEST 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>20020701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060109</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056103-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060720</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060713</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0607USA02956</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>73</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>LIP AND/OR ORAL CAVITY CANCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SQUAMOUS CELL CARCINOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CORTICOSTEROIDS (UNSPECIFIED)</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANOREX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056104-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060720</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060717</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0607USA03698</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>72</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSGEUSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EXOPHTHALMOS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH GENERALISED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESORPTION BONE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRAVACHOL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056105-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060720</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-MERCK-0606FRA00076</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>79</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HYPOKALAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPONATRAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugauthorizationnumb>19766</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DYSLIPIDAEMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPOTHYROIDISM</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19890615</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060517</drugenddate>
        <drugtreatmentduration>6181</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060518</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYANOCOBALAMIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010615</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALTHIAZIDE AND SPIRONOLACTONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060516</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONAZEPAM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990615</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TIAPRIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060516</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056106-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060720</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060711</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0607USA01859</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>39</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>182</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BRAIN ABSCESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SINGULAIR</medicinalproduct>
        <drugauthorizationnumb>20829</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHINITIS ALLERGIC</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056107-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesscongenitalanomali>1</seriousnesscongenitalanomali>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060720</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060707</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-MERCK-0607USA02740</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>64</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ADVERSE EVENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ATRIOVENTRICULAR BLOCK THIRD DEGREE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRADYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ELECTROCARDIOGRAM QT CORRECTED INTERVAL PROLONGED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENTRICULAR TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEPCID RPD</medicinalproduct>
        <drugauthorizationnumb>20752</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTRITIS EROSIVE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041209</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050607</drugenddate>
        <drugtreatmentduration>181</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PURSENNID</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONSTIPATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM CARBONATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERPHOSPHATAEMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RHYTHMY</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INSOMNIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLETAL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CEREBRAL INFARCTION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056108-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060720</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060630</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0606USA05702</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>48</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>86</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA FACIAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VYTORIN</medicinalproduct>
        <drugauthorizationnumb>21687</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VYTORIN</medicinalproduct>
        <drugauthorizationnumb>021687</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060403</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACIPHEX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BARRETT'S OESOPHAGUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020201</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056109-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060720</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20030630</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0414361A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>38</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABNORMAL BEHAVIOUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AGGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANGER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHYSICAL ASSAULT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDE ATTEMPT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
        <drugauthorizationnumb>20031</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20011029</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056110-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060720</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040712</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0517817A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>17</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>56.8</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABNORMAL BEHAVIOUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AGITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AKATHISIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPERSONALISATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLAT AFFECT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENTAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOCIAL AVOIDANT BEHAVIOUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDE ATTEMPT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
        <drugauthorizationnumb>20031</drugauthorizationnumb>
        <drugdosagetext>10MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020926</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ATIVAN</medicinalproduct>
        <drugdosagetext>2TAB SINGLE DOSE</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BENADRYL</medicinalproduct>
        <drugdosagetext>2TAB SINGLE DOSE</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
        <drugdosagetext>4TAB SINGLE DOSE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CHEMOTHERAPY</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugdosagetext>10MG WEEKLY</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020501</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PURINETHOL</medicinalproduct>
        <drugdosagetext>50MG ALTERNATE DAYS</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020501</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VENTOLIN</medicinalproduct>
        <drugadministrationroute>055</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BACTRIM</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020501</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056111-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060720</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050224</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0547271A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>57</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ADJUSTMENT DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AGITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BIPOLAR DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DECREASED APPETITE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISTURBANCE IN ATTENTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSTHYMIC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NERVOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OBSESSIVE-COMPULSIVE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDE ATTEMPT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
        <drugauthorizationnumb>20031</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19960522</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020119</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020119</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DESYREL</medicinalproduct>
        <drugdosagetext>50MG AT NIGHT</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WELLBUTRIN</medicinalproduct>
        <drugdosagetext>200MGD UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEPAKOTE</medicinalproduct>
        <drugdosagetext>250MG TWICE PER DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CHEMOTHERAPY</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NICOTINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056112-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060720</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050329</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0555645A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>16</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>AGGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BIPOLAR DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG WITHDRAWAL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
        <drugauthorizationnumb>20031</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PANIC ATTACK</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020815</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATIVAN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ORTHO TRI-CYCLEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAZODONE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KLONOPIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056113-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060720</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050329</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0555656A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>15</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>60.2</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>AGGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AGITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AMNESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CRYING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISSOCIATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISTURBANCE IN ATTENTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG SCREEN POSITIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSKINESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEAD BANGING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HOSTILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERVENTILATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA FACIAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMPULSIVE BEHAVIOUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL SELF-INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IRRITABILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOGORRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENTAL STATUS CHANGES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NIGHTMARE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANIC ATTACK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERSONALITY CHANGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSYCHOMOTOR HYPERACTIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SELF MUTILATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOCIAL AVOIDANT BEHAVIOUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDE ATTEMPT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAXIL CR</medicinalproduct>
        <drugauthorizationnumb>20936</drugauthorizationnumb>
        <drugdosagetext>12.5MG IN THE MORNING</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040918</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADDERALL 10</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
        <drugdosagetext>1MG IN THE MORNING</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMBIEN</medicinalproduct>
        <drugdosagetext>10MG AS REQUIRED</drugdosagetext>
        <drugindication>INSOMNIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATIVAN</medicinalproduct>
        <drugdosagetext>1MG AS REQUIRED</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KLONOPIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056114-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060720</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050509</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0558603A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>32</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CRYING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISSOCIATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG DEPENDENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG WITHDRAWAL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRY MOUTH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERECTILE DYSFUNCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HOMICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMPULSIVE BEHAVIOUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IRRITABILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSYCHOMOTOR HYPERACTIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEXUAL DYSFUNCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TEARFULNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
        <drugauthorizationnumb>20031</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANXIETY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19970501</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAXIL CR</medicinalproduct>
        <drugauthorizationnumb>020936</drugauthorizationnumb>
        <drugdosagetext>37.5MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANXIETY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051230</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAROXETINE HCL</medicinalproduct>
        <drugauthorizationnumb>020031</drugauthorizationnumb>
        <drugdosagetext>40MG UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANXIETY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BUSPIRONE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALTREX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056115-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060720</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050509</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0558615A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>40</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>60.5</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AGGRESSION</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>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VERTIGO</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
        <drugauthorizationnumb>20031</drugauthorizationnumb>
        <drugdosagetext>20MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANXIETY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19991221</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAXIL CR</medicinalproduct>
        <drugauthorizationnumb>020936</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANXIETY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEXAPRO</medicinalproduct>
        <drugdosagetext>10MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANXIETY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELEXA</medicinalproduct>
        <drugdosagetext>20MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANXIETY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYOSCYAMINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONAZEPAM</medicinalproduct>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050501</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALIUM</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050501</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056116-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060720</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050627</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0564635A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>38</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>99.1</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>AGGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AGITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANGER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMPLETED SUICIDE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CRYING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EMOTIONAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOCIAL AVOIDANT BEHAVIOUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>WELLBUTRIN SR</medicinalproduct>
        <drugauthorizationnumb>20358</drugauthorizationnumb>
        <drugdosagetext>100MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030613</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030601</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KLONOPIN</medicinalproduct>
        <drugdosagetext>.5MG TWICE PER DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugdosagetext>200MG PER DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VOLTAREN</medicinalproduct>
        <drugdosagetext>50MG TWICE PER DAY</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056117-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060720</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050817</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0570763A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>20</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>61.4</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>COMPLETED SUICIDE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SELF MUTILATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
        <drugauthorizationnumb>20031</drugauthorizationnumb>
        <drugdosagetext>10MG AT NIGHT</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANXIETY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010723</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAXIL CR</medicinalproduct>
        <drugauthorizationnumb>020936</drugauthorizationnumb>
        <drugdosagetext>12.5MG UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TENEX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADDERALL 10</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CONCERTA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VERELAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONIDINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056118-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060720</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20051212</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0585509A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>62</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CATARACT NUCLEAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL DISTURBANCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ADVAIR DISKUS 100/50</medicinalproduct>
        <drugauthorizationnumb>21077</drugauthorizationnumb>
        <drugdosagetext>1PUFF TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20011009</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060201</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYOSCYAMINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EFFEXOR</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056119-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060720</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0591348A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>35</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>AFFECTIVE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BIPOLAR I DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DELUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MANIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEDICATION ERROR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSYCHOTIC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THEFT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THINKING ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
        <drugauthorizationnumb>020031</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANXIETY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040722</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AUGMENTIN '125'</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIFLUCAN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041111</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056120-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060720</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060420</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-GLAXOSMITHKLINE-A0602737A</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>92</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>66</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANGIOPLASTY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARRHYTHMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE CONGESTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
        <drugauthorizationnumb>020031</drugauthorizationnumb>
        <drugdosagetext>20MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060601</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMIODARONE HCL</medicinalproduct>
        <drugdosagetext>200MG PER DAY</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL</medicinalproduct>
        <drugdosagetext>150MG PER DAY</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
        <drugdosagetext>40MG PER DAY</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050801</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056121-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060720</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060322</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0603547A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>STATUS ASTHMATICUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEREVENT</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>20692</drugauthorizationnumb>
        <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>5056122-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060720</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060426</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>4913</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>36</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CHILLS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URTICARIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MEPRON</medicinalproduct>
        <drugbatchnumb>5K004</drugbatchnumb>
        <drugauthorizationnumb>20259</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>LYME DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060421</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060422</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056123-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060720</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060322</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0603609A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>STATUS ASTHMATICUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEREVENT</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>20692</drugauthorizationnumb>
        <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>5056124-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060720</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060503</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0604754A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>61</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>54.5</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>COMPLETED SUICIDE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENOUS INJURY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAXIL CR</medicinalproduct>
        <drugauthorizationnumb>20936</drugauthorizationnumb>
        <drugdosagetext>12.5MG UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040501</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056125-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060720</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060526</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0607485A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>19</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABORTION SPONTANEOUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EPZICOM</medicinalproduct>
        <drugauthorizationnumb>21652</drugauthorizationnumb>
        <drugdosagetext>900MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060224</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIDANOSINE</medicinalproduct>
        <drugdosagetext>400MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060224</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATAZANAVIR</medicinalproduct>
        <drugdosagetext>800MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060224</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RITONAVIR</medicinalproduct>
        <drugdosagetext>1200MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060224</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060314</drugenddate>
        <drugtreatmentduration>19</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056126-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060720</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060601</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-GLAXOSMITHKLINE-A0607955A</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>47</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLINDNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLINDNESS UNILATERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIABETIC RETINOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MACULAR OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL ACUITY REDUCED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>21071</drugauthorizationnumb>
        <drugdosagetext>4MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030721</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050101</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCONORM</medicinalproduct>
        <drugdosagetext>1MG THREE TIMES PER DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
        <drugdosagetext>850MG THREE TIMES PER DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MONOPRIL</medicinalproduct>
        <drugdosagetext>20MG PER DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugdosagetext>75MG PER DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CIALIS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE</medicinalproduct>
        <drugdosagetext>5MG PER DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugdosagetext>40MG PER DAY</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056127-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060720</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060703</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0611010A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>45</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BIPOLAR DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HOMICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HOMICIDE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MAJOR DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSYCHOTIC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
        <drugauthorizationnumb>20031</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROZAC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LUNESTA</medicinalproduct>
        <drugindication>SLEEP DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAZODONE HCL</medicinalproduct>
        <drugindication>ANXIETY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMBIEN</medicinalproduct>
        <drugindication>SLEEP DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056128-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060720</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060705</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0611305A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>39</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>AGGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AGITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ALCOHOL POISONING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DELUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IRRITABILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MANIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSYCHOTIC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMICTAL</medicinalproduct>
        <drugauthorizationnumb>20241</drugauthorizationnumb>
        <drugdosagetext>25MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BIPOLAR DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060625</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060601</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NO CONCURRENT MEDICATION</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056129-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060720</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060712</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0612025A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>84</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>COORDINATION ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEAFNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VALTREX</medicinalproduct>
        <drugauthorizationnumb>020487</drugauthorizationnumb>
        <drugdosagetext>1G THREE TIMES PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HERPES ZOSTER</drugindication>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056130-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060720</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060712</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0612352A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>28</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABORTION INDUCED</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>BUPROPION HCL</medicinalproduct>
        <drugauthorizationnumb>018644</drugauthorizationnumb>
        <drugdosagetext>300MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MAJOR DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060224</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056131-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060720</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060713</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>HN-GLAXOSMITHKLINE-A0612553A</companynumb>
    <primarysource>
      <reportercountry>HONDURAS</reportercountry>
      <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>CARDIO-RESPIRATORY ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LETHARGY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
        <drugauthorizationnumb>20031</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GEODON</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLONAZEPAM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALPRAZOLAM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRIPTANOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056132-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060720</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060717</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0612658A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>95</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CATARACT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MACULAR OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL DISTURBANCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ADVAIR DISKUS 100/50</medicinalproduct>
        <drugbatchnumb>R228802</drugbatchnumb>
        <drugauthorizationnumb>21077</drugauthorizationnumb>
        <drugdosagetext>1PUFF TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060717</drugenddate>
        <drugtreatmentduration>80</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056133-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesscongenitalanomali>1</seriousnesscongenitalanomali>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060720</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060718</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0612693A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>2.7</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CYSTIC FIBROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PREMATURE BABY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMBIVIR</medicinalproduct>
        <drugauthorizationnumb>020857</drugauthorizationnumb>
        <drugdosagetext>1TAB TWICE PER DAY</drugdosagetext>
        <drugindication>HIV INFECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEVIRAPINE</medicinalproduct>
        <drugdosagetext>200MG TWICE PER DAY</drugdosagetext>
        <drugindication>HIV INFECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KALETRA</medicinalproduct>
        <drugdosagetext>4CAP TWICE PER DAY</drugdosagetext>
        <drugindication>HIV INFECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AZT</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056134-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060720</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060718</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0612713A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLINDNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
        <drugauthorizationnumb>020031</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLURBIPROFEN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056135-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesscongenitalanomali>1</seriousnesscongenitalanomali>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060720</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060719</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0612838A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>3.3</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPINA BIFIDA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMICTAL</medicinalproduct>
        <drugauthorizationnumb>020241</drugauthorizationnumb>
        <drugdosagetext>300MG UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>EPILEPSY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DILANTIN</medicinalproduct>
        <drugdosagetext>200MG UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>EPILEPSY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPAMAX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>EPILEPSY</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060201</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056136-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060720</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060719</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0612840A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>27</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABORTION SPONTANEOUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMICTAL</medicinalproduct>
        <drugauthorizationnumb>020241</drugauthorizationnumb>
        <drugdosagetext>400MG UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>EPILEPSY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMINS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056137-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060720</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060714</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AR-GLAXOSMITHKLINE-A0612870A</companynumb>
    <primarysource>
      <reportercountry>ARGENTINA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>29</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HAEMATOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VASCULITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMICTAL</medicinalproduct>
        <drugauthorizationnumb>020241</drugauthorizationnumb>
        <drugdosagetext>100MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060704</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CITALOPRAM HYDROBROMIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056138-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060720</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050517</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ES-GLAXOSMITHKLINE-B0382056A</companynumb>
    <primarysource>
      <reportercountry>SPAIN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>66</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLINDNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONJUNCTIVITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUCOSAL ULCERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUCOUS MEMBRANE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ODYNOPHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHIMOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN EXFOLIATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STEVENS-JOHNSON SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTH DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMICTAL</medicinalproduct>
        <drugauthorizationnumb>020241</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BIPOLAR I DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041209</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041222</drugenddate>
        <drugtreatmentduration>14</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DISTRANEURINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NOCTAMID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRANXILIUM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056139-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060720</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060309</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHC2-003</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>72</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ALANINE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANOREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD ALKALINE PHOSPHATASE 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>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HICCUPS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPHOCYTE COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MONOCYTE COUNT DECREASED</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>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NOGITECAN HYDROCHLORIDE</medicinalproduct>
        <drugauthorizationnumb>20671</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060213</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060421</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CISPLATIN</medicinalproduct>
        <drugdosagetext>60MGM2 PER DAY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060213</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060417</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEUPOGEN</medicinalproduct>
        <drugdosagetext>75MCG PER DAY</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060218</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060303</drugenddate>
        <drugtreatmentduration>14</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056140-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060720</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060518</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-JPN-A200601640</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>81</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>31</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BOWEL SOUNDS ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTESTINAL OBSTRUCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
        <drugauthorizationnumb>20031</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060427</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060518</drugenddate>
        <drugtreatmentduration>22</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THYRADIN S</medicinalproduct>
        <drugdosagetext>25MCG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPOTHYROIDISM</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060512</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056141-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060720</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060619</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-JPN-A200602148</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>38</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>59</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEPRESSED LEVEL OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG TOXICITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IRRITABILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDE ATTEMPT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
        <drugauthorizationnumb>20031</drugauthorizationnumb>
        <drugdosagetext>10MG SEE DOSAGE TEXT</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060529</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060617</drugenddate>
        <drugtreatmentduration>20</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN DRUG</medicinalproduct>
        <drugdosagetext>200MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060529</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060617</drugenddate>
        <drugtreatmentduration>20</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEILAX</medicinalproduct>
        <drugdosagetext>1MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060529</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060611</drugenddate>
        <drugtreatmentduration>14</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GASMOTIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060529</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060617</drugenddate>
        <drugtreatmentduration>20</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEILAX</medicinalproduct>
        <drugdosagetext>2MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060612</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060617</drugenddate>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056142-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060720</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060619</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-JPN-A200602164</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>72</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>APTYALISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSGEUSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NASAL MUCOSA ATROPHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL MUCOSA ATROPHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THIRST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TONGUE DRY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZANTAC</medicinalproduct>
        <drugauthorizationnumb>18703</drugauthorizationnumb>
        <drugdosagetext>300MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050415</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MEVALOTIN</medicinalproduct>
        <drugdosagetext>5MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050930</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060619</drugenddate>
        <drugtreatmentduration>263</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>100MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050415</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MUCOSTA</medicinalproduct>
        <drugdosagetext>100MG THREE TIMES PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050415</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARTIST</medicinalproduct>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>20MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050415</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056143-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>LB-2006-017164</companynumb>
    <primarysource>
      <reportercountry>LEBANON</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>66</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>BLOOD CREATININE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD LACTATE DEHYDROGENASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD POTASSIUM INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD UREA INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD URIC ACID INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATOCRIT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEAN CELL VOLUME INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TUMOUR LYSIS SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUDARA</medicinalproduct>
        <drugauthorizationnumb>20038</drugauthorizationnumb>
        <drugdosagetext>25 MG/M2, 1X/DAY, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CHRONIC LYMPHOCYTIC LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060527</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060529</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYCLOPHOSPHAMIDE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056144-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060720</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060623</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-JPN-A200602257</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>71</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>58</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANOREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CREATININE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</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>VALTREX</medicinalproduct>
        <drugauthorizationnumb>20487</drugauthorizationnumb>
        <drugdosagetext>500MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HERPES ZOSTER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060603</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060611</drugenddate>
        <drugtreatmentduration>9</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMARYL</medicinalproduct>
        <drugdosagetext>1MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020906</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060614</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIGMART</medicinalproduct>
        <drugdosagetext>5MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANGINA PECTORIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020906</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENALAPRIL MALEATE</medicinalproduct>
        <drugdosagetext>5MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050228</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALSLOT</medicinalproduct>
        <drugdosagetext>10MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040618</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BLOPRESS</medicinalproduct>
        <drugdosagetext>8MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051104</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOXONIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060606</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SOLON</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060606</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARASENA-A</medicinalproduct>
        <drugadministrationroute>061</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060606</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056145-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060720</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060627</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>452247</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARTIST</medicinalproduct>
        <drugauthorizationnumb>20297</drugauthorizationnumb>
        <drugdosagetext>1.25MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CARDIAC FAILURE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060420</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060504</drugenddate>
        <drugtreatmentduration>15</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HERBESSER</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NU-LOTAN</medicinalproduct>
        <drugdosagetext>25MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056146-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060720</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060630</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-JPN-A200602401</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>65</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>EPISTAXIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGE SUBCUTANEOUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC FUNCTION ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
        <drugauthorizationnumb>20031</drugauthorizationnumb>
        <drugdosagetext>20MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060530</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060629</drugenddate>
        <drugtreatmentduration>30</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDONINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARTIST</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>URALYT</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEVALOTIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SELBEX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEPAS</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEILAX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGNESIUM OXIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056147-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060720</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060630</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IT-GLAXOSMITHKLINE-B0429995A</companynumb>
    <primarysource>
      <reportercountry>ITALY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>60</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DIABETIC RETINOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MACULAR OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHOTOCOAGULATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RETINAL CYST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RETINAL OEDEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050112</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN</medicinalproduct>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050112</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056148-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060720</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060703</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ES-GLAXOSMITHKLINE-B0430118A</companynumb>
    <primarysource>
      <reportercountry>SPAIN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>55</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ORAL SOFT TISSUE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHOTOSENSITIVITY REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMICTAL</medicinalproduct>
        <drugauthorizationnumb>020241</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BIPOLAR DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060505</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIRTAZAPINE</medicinalproduct>
        <drugdosagetext>30MG AT NIGHT</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BIPOLAR DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALPROIC ACID</medicinalproduct>
        <drugdosagetext>100MG AT NIGHT</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BIPOLAR DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056149-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesscongenitalanomali>1</seriousnesscongenitalanomali>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060720</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060627</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-GLAXOSMITHKLINE-B0430222A</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DOUBLE OUTLET RIGHT VENTRICLE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STILLBIRTH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENTRICULAR SEPTAL DEFECT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMBIVIR</medicinalproduct>
        <drugauthorizationnumb>20857</drugauthorizationnumb>
        <drugdosagetext>1U TWICE PER DAY</drugdosagetext>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060306</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KALETRA</medicinalproduct>
        <drugdosagetext>3U TWICE PER DAY</drugdosagetext>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060306</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056150-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060720</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060710</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-GLAXOSMITHKLINE-B0430389A</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>41</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MITOCHONDRIAL CYTOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULAR WEAKNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VERTIGO</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KIVEXA</medicinalproduct>
        <drugauthorizationnumb>21652</drugauthorizationnumb>
        <drugdosagetext>1TAB PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050821</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIDEX</medicinalproduct>
        <drugdosagetext>1UNIT PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KALETRA</medicinalproduct>
        <drugdosagetext>3UNIT TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056151-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060720</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060710</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-GLAXOSMITHKLINE-B0430402A</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>83</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>DEPRESSED LEVEL OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMODYNAMIC INSTABILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PEMPHIGOID</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEROXAT</medicinalproduct>
        <drugauthorizationnumb>20031</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060213</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060313</drugenddate>
        <drugtreatmentduration>29</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIRLIX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060213</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060313</drugenddate>
        <drugtreatmentduration>29</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056152-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060720</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060707</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-JPN-A200602538</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>78</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>49</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CHLORIDE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>C-REACTIVE PROTEIN INCREASED</reactionmeddrapt>
      </reaction>
      <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>
        <drugauthorizationnumb>020031</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060307</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060330</drugenddate>
        <drugtreatmentduration>24</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugdosagetext>20MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CARDIAC FAILURE CONGESTIVE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060304</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060327</drugenddate>
        <drugtreatmentduration>24</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALDACTONE</medicinalproduct>
        <drugdosagetext>25MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CARDIAC FAILURE CONGESTIVE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HOKUNALIN</medicinalproduct>
        <drugadministrationroute>062</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LUVOX</medicinalproduct>
        <drugdosagetext>50MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060331</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060406</drugenddate>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LUVOX</medicinalproduct>
        <drugdosagetext>25MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUMARIN</medicinalproduct>
        <drugdosagetext>2G PER DAY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PNEUMONIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060218</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060222</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUMARIN</medicinalproduct>
        <drugdosagetext>2G PER DAY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ROCEPHIN</medicinalproduct>
        <drugdosagetext>1G PER DAY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PNEUMONIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060223</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060225</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN</medicinalproduct>
        <drugdosagetext>.5G PER DAY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PNEUMONIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060307</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060317</drugenddate>
        <drugtreatmentduration>11</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MINOPEN</medicinalproduct>
        <drugdosagetext>1G PER DAY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PNEUMONIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060310</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060313</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZITHROMAC</medicinalproduct>
        <drugdosagetext>500MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PNEUMONIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060218</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060220</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZITHROMAC</medicinalproduct>
        <drugdosagetext>500MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060227</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060301</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HOCHU-EKKI-TO</medicinalproduct>
        <drugdosagetext>7.5G PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANOREXIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060222</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060224</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOGMATYL</medicinalproduct>
        <drugdosagetext>150MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANOREXIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060224</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060226</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRAVIT</medicinalproduct>
        <drugdosagetext>400MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PNEUMONIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060224</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060226</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYPEN</medicinalproduct>
        <drugdosagetext>400MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CHONDROCALCINOSIS PYROPHOSPHATE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060315</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056153-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060720</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060710</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-GLAXOSMITHKLINE-B0430549A</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>41</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRIZIVIR</medicinalproduct>
        <drugauthorizationnumb>21205</drugauthorizationnumb>
        <drugdosagetext>2TAB PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020204</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUSTIVA</medicinalproduct>
        <drugdosagetext>1CAP PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020204</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056154-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060720</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060710</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-GLAXOSMITHKLINE-B0430590A</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>8</patientonsetage>
      <patientonsetageunit>802</patientonsetageunit>
      <patientweight>8</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ACCIDENTAL OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEDICATION ERROR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALLOR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMICTAL</medicinalproduct>
        <drugauthorizationnumb>020764</drugauthorizationnumb>
        <drugdosagetext>120MG SINGLE DOSE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060710</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060710</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056155-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060720</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060710</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-GLAXOSMITHKLINE-B0430696A</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>9</patientonsetage>
      <patientonsetageunit>802</patientonsetageunit>
      <patientweight>9.5</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BRONCHITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRODUCTIVE COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VARICELLA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLIXOTIDE</medicinalproduct>
        <drugauthorizationnumb>20548</drugauthorizationnumb>
        <drugdosagetext>50MCG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VENTOLIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AUGMENTIN '125'</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RESPIRATORY PHYSIOTHERAPY</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056156-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060720</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060712</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-GLAXOSMITHKLINE-B0430777A</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY DISTRESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REQUIP</medicinalproduct>
        <drugauthorizationnumb>20658</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PARKINSON'S DISEASE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056157-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060720</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060712</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-GLAXOSMITHKLINE-B0430937A</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DEPRESSED MOOD</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDAMET</medicinalproduct>
        <drugauthorizationnumb>021410</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056158-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060720</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060714</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-JPN-A200602643</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>57</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>53</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PROTHROMBIN TIME PROLONGED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY RETENTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
        <drugauthorizationnumb>020031</drugauthorizationnumb>
        <drugdosagetext>10MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060625</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060630</drugenddate>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BLOPRESS</medicinalproduct>
        <drugdosagetext>8MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
        <drugdosagetext>3.5U PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060609</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SERENACE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060609</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060621</drugenddate>
        <drugtreatmentduration>13</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARTANE</medicinalproduct>
        <drugdosagetext>1U TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PARKINSONISM</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060609</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ROHYPNOL</medicinalproduct>
        <drugdosagetext>1U PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INSOMNIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060609</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGMITT</medicinalproduct>
        <drugdosagetext>3U PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INSOMNIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060609</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LAXOBERON</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INSOMNIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060609</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTOMIN</medicinalproduct>
        <drugdosagetext>1U PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INSOMNIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060609</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIGOXIN</medicinalproduct>
        <drugdosagetext>2U PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060623</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060630</drugenddate>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RISPERDAL</medicinalproduct>
        <drugdosagetext>2U PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060621</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056159-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060720</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060714</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-JPN-A200602655</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
        <drugauthorizationnumb>020031</drugauthorizationnumb>
        <drugdosagetext>10MG FOUR TIMES PER DAY</drugdosagetext>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060707</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRYPTANOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEXOTAN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056160-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060720</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060717</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-GLAXOSMITHKLINE-B0431566A</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>38</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>AGGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IRRITABILITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYBAN</medicinalproduct>
        <drugauthorizationnumb>018644</drugauthorizationnumb>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056161-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060720</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060717</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>453942</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>4</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC OUTPUT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CIRCULATORY COLLAPSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUID INTAKE REDUCED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLUENZA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL INTAKE REDUCED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALLOR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARALYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARYNGOLARYNGEAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SHOCK HYPOGLYCAEMIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARTIST</medicinalproduct>
        <drugauthorizationnumb>20297</drugauthorizationnumb>
        <drugdosagetext>3MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050413</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENALAPRIL MALEATE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANGINAL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM GLUCONATE TAB</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALDACTONE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056162-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060720</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060717</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-GLAXOSMITHKLINE-B0431589A</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>26</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIABETIC KETOACIDOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG WITHDRAWAL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POLYURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THIRST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LITHIUM CARBONATE</medicinalproduct>
        <drugauthorizationnumb>016860</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BIPOLAR DISORDER</drugindication>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056163-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060720</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060718</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>454525</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>65</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BRADYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS POSTURAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMODYNAMIC INSTABILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OLIGURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SICK SINUS SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARTIST</medicinalproduct>
        <drugauthorizationnumb>20297</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANGINA PECTORIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051111</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CALBLOCK</medicinalproduct>
        <drugdosagetext>8MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040910</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051111</drugenddate>
        <drugtreatmentduration>428</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARDENALIN</medicinalproduct>
        <drugdosagetext>2MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050114</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051111</drugenddate>
        <drugtreatmentduration>302</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056164-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060706</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006P1000369</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>68</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY DISEASE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RETEPLASE (RETEPLASE)</medicinalproduct>
        <drugindication>ACUTE MYOCARDIAL INFARCTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REOPRO</medicinalproduct>
        <drugindication>ACUTE MYOCARDIAL INFARCTION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056165-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060706</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006P1000370</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>60</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY DISEASE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RETEPLASE (RETEPLASE)</medicinalproduct>
        <drugindication>ACUTE MYOCARDIAL INFARCTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REOPRO</medicinalproduct>
        <drugindication>ACUTE MYOCARDIAL INFARCTION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056166-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060630</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-2006-017817</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>34</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABNORMAL BEHAVIOUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AMNESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE NECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BETASERON</medicinalproduct>
        <drugdosagetext>1 ML, UNK, SUBCUTANEOUS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUOXETINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONAZEPAM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056168-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060710</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006P1000107</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>43</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>76</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HYPERTHYROIDISM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RETEPLASE (RETEPLASE)</medicinalproduct>
        <drugdosagetext>IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ACUTE MYOCARDIAL INFARCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051129</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051129</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REOPRO</medicinalproduct>
        <drugdosagetext>IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ACUTE MYOCARDIAL INFARCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051129</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLOPIDOGREL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRIMETAZIDINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DILTIAZEM HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROPRANOLOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PERINDOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHIOVIT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROPRANOLOL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056169-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060710</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006P1000265</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>64</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BRONCHITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RETEPLASE (RETEPLASE)</medicinalproduct>
        <drugdosagetext>IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ACUTE MYOCARDIAL INFARCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050921</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050921</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REOPRO</medicinalproduct>
        <drugdosagetext>IV</drugdosagetext>
        <drugindication>ACUTE MYOCARDIAL INFARCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050921</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FENOTEROL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM CHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VERAPAMIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INDAPAMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TICLOPIDINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUTICASONE PROPIONATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FORMOTEROL FUMARATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RANITIDINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ISOSORBIDE MONONITRATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENALAPRIL MALEATE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056171-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060707</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006P1000268</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>38</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>106</patientweight>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY STENOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RETEPLASE (RETEPLASE)</medicinalproduct>
        <drugbatchnumb>CT001626</drugbatchnumb>
        <drugdosagetext>5 IU;2X;IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ACUTE MYOCARDIAL INFARCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060113</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060113</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REOPRO</medicinalproduct>
        <drugbatchnumb>CT000800</drugbatchnumb>
        <drugdosagetext>13.3 ML;1X;IV; SEE IMAGE</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ACUTE MYOCARDIAL INFARCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060113</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060113</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056175-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060627</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US200604004572</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>69</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>55.8</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BASAL CELL CARCINOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEBORRHOEIC KERATOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugbatchnumb>FF5T49A</drugbatchnumb>
        <drugauthorizationnumb>21318</drugauthorizationnumb>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051012</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FORTEO PEN (FORTEO PEN)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056177-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060627</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US200604003676</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD ANTIDIURETIC HORMONE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD SODIUM DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENTAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SLEEP APNOEA SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugauthorizationnumb>21318</drugauthorizationnumb>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FORTEO PEN (FORTEO PEN)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056178-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060627</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US200604001281</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>83</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PH INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BODY TEMPERATURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CAROTID ARTERY STENOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIFFICULT TO WEAN FROM VENTILATOR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MITRAL VALVE CALCIFICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MITRAL VALVE INCOMPETENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MITRAL VALVE PROLAPSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PCO2 INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PO2 DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PO2 INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY RATE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRICUSPID VALVE INCOMPETENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugbatchnumb>FF5L27C</drugbatchnumb>
        <drugauthorizationnumb>21318</drugauthorizationnumb>
        <drugdosagetext>20 UG, DAILY (1/D)</drugdosagetext>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FORTEO PEN (FORTEO PEN)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KLONOPIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056179-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060630</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-2006-017392</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>47</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HOSPITALISATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RADIOTHERAPY</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>20041225</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056180-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060626</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>USA0510110132</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>56</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DIPLOPIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRANSIENT ISCHAEMIC ATTACK</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugauthorizationnumb>21318</drugauthorizationnumb>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TENORMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EASPRIN (ACETYLSALICYLIC ACID)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FORTEO PEN (FORTEO PEN)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056181-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060706</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-2006-018052</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CLAUSTROPHOBIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYDRIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY OEDEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MAGNEVIST</medicinalproduct>
        <drugauthorizationnumb>19596</drugauthorizationnumb>
        <drugindication>ANGIOGRAM</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060705</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060705</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056182-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060711</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-2006-018556</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>36</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>GENERAL PHYSICAL CONDITION ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUDDEN DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MAGNEVIST</medicinalproduct>
        <drugauthorizationnumb>19596</drugauthorizationnumb>
        <drugdosagetext>0.3 ML, 1 DOSE, INTRA-ARTICULAR</drugdosagetext>
        <drugadministrationroute>014</drugadministrationroute>
        <drugindication>NUCLEAR MAGNETIC RESONANCE IMAGING</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060703</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060703</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056183-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060626</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US200606003652</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>65</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>66.8</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HIP FRACTURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugauthorizationnumb>21318</drugauthorizationnumb>
        <drugdosagetext>20 UG</drugdosagetext>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FORTEO PEN (FORTEO PEN)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INDERAL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLOVENT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARICEPT /JPN/ (DONEPEZIL HYDROCHLORIDE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WELLBUTRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALUPENT</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056184-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060720</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060710</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2006BR10479</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>29</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>58</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>COELIAC DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRIC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZELMAC</medicinalproduct>
        <drugauthorizationnumb>021200</drugauthorizationnumb>
        <drugdosagetext>6 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONSTIPATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LUFTAL</medicinalproduct>
        <drugdosagetext>40 DRP, TID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>FLATULENCE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ESXOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DICETEL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BUSCOPAN COMP.</medicinalproduct>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugdosagetext>40 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MOTILIUM</medicinalproduct>
        <drugdosagetext>30 MG/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>REFLUX OESOPHAGITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FRONTAL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SLEEP DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056185-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060720</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060715</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHO2006BR11531</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>62</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>62</patientweight>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INADEQUATELY CONTROLLED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DECREASED APPETITE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALIGNANT NEOPLASM PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENTAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTI-ORGAN FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SHOCK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SURGERY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THERAPY NON-RESPONDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZELMAC / HTF 919A</medicinalproduct>
        <drugauthorizationnumb>21200</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KAVA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ONDANSETRON HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MELILOT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARGININE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MOTILIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRIMEBUTINE MALEATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEXOTAN</medicinalproduct>
        <drugindication>SLEEP DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056186-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060720</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060627</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2006US08358</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>48</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>87.074</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ALOPECIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN ULCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPINAL OSTEOARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WALKING AID USER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZELNORM</medicinalproduct>
        <drugauthorizationnumb>21200</drugauthorizationnumb>
        <drugdosagetext>6 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONSTIPATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051213</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060113</drugenddate>
        <drugtreatmentduration>46080</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056187-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060705</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006BH011720</companynumb>
    <primarysource>
      <reportercountry>TURKEY</reportercountry>
      <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>DRUG SPECIFIC ANTIBODY PRESENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOLYTIC ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEPHRITIS INTERSTITIAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERITONEAL DIALYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CEFTRIAXONE IN PLASTIC CONTAINER (CEFTRIAXONE SODIUM)</medicinalproduct>
        <drugauthorizationnumb>65224</drugauthorizationnumb>
        <drugindication>PNEUMONIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMPICILLIN SODIUM/SULBACTAM SODIUM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056188-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060626</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US200601000799</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>71</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>72.6</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ALANINE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASPARTATE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD ALKALINE PHOSPHATASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHOLECYSTITIS ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHOLELITHIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUID RETENTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCREASED APPETITE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugbatchnumb>FF5J48A</drugbatchnumb>
        <drugauthorizationnumb>21318</drugauthorizationnumb>
        <drugdosagetext>20 UG, DAILY (1/D)</drugdosagetext>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050913</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugbatchnumb>FF5H40A</drugbatchnumb>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FORTEO PEN (FORTEO PEN)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMINS NOS (VITAMINS NOS)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM (CALCIUM)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAXZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SUDAFED 12 HOUR</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056189-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060626</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US200606005669</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>75</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY BYPASS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEAFNESS UNILATERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPHOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMULIN N</medicinalproduct>
        <drugauthorizationnumb>18780</drugauthorizationnumb>
        <drugdosagetext>34 U, DAILY (1/D)</drugdosagetext>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19940101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMULIN R</medicinalproduct>
        <drugdosagetext>2 U, DAILY (1/D)</drugdosagetext>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19860101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRINIVIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN TAB</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056191-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060720</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060710</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AVENTIS-200617219GDDC</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>65</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>97.52</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ALANINE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASPARTATE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ATRIAL FIBRILLATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CREATINE PHOSPHOKINASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OESOPHAGITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHABDOMYOLYSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOCETAXEL</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>20449</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NEOPLASM MALIGNANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060626</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060626</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ERBITUX</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugdosagetext>DOSE: LOADING DOSE 400 MG/M2 THEN 250 MG/M2</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NEOPLASM MALIGNANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060522</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060522</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RADIOTHERAPY</medicinalproduct>
        <drugindication>NEOPLASM MALIGNANT</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060629</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CIALIS</medicinalproduct>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYZAAR</medicinalproduct>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCODONE HCL</medicinalproduct>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PILOCARPINE</medicinalproduct>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056192-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060720</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060711</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IT-AVENTIS-200617213GDDC</companynumb>
    <primarysource>
      <reportercountry>ITALY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>70</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DERMATITIS BULLOUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EPILEPSY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUCOSAL INFLAMMATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ONYCHOLYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAXOTERE</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>020449</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PROSTATE CANCER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN DRUG</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056193-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060720</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060712</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-AVENTIS-200612158JP</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>AORTIC ANEURYSM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEUKOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OESOPHAGITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OESOPHAGOBRONCHIAL FISTULA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAXOTERE</medicinalproduct>
        <drugauthorizationnumb>020449</drugauthorizationnumb>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>OESOPHAGEAL CARCINOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUOROURACIL</medicinalproduct>
        <drugindication>OESOPHAGEAL CARCINOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RADIOTHERAPY</medicinalproduct>
        <drugdosagetext>DOSE: 40 TO 60 GY/TOTAL</drugdosagetext>
        <drugindication>OESOPHAGEAL CARCINOMA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056194-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060720</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060713</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GR-AVENTIS-200617284GDDC</companynumb>
    <primarysource>
      <reportercountry>GREECE</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>56</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>LOCKED-IN SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MANIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HYDROCORTISONE TAB</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>80473</drugauthorizationnumb>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>ADDISON'S DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HYDROCORTISONE TAB</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>080473</drugauthorizationnumb>
        <drugadministrationroute>030</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HYDROCORTISONE TAB</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>080473</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HYDROCORTISONE TAB</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>080473</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUDROCORTISONE</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugindication>ADDISON'S DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MIRTAZAPINE</medicinalproduct>
        <drugindication>DEPRESSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056195-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060705</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006083212</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>71</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>77</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GLYCOSYLATED HAEMOGLOBIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POLYDIPSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POLYURIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugauthorizationnumb>21446</drugauthorizationnumb>
        <drugdosagetext>300 MG 150 MG, 2 IN 1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>POST HERPETIC NEURALGIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050803</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATORVASTATIN CALCIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AZITHROMYCIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CITALOPRAM HYDROBROMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUDROCORTISONE ACETATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANSOPRAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LERCANIDIPINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PERINDOPRIL ERBUMINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REPAGLINIDE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056196-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060704</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006084650</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>42</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>NEUTROPENIC SEPSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCYTOPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PHENYTOIN SODIUM</medicinalproduct>
        <drugauthorizationnumb>8762</drugauthorizationnumb>
        <drugdosagetext>(375 MG), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KEPPRA</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056197-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060703</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006083386</companynumb>
    <primarysource>
      <reportercountry>ITALY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>8</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>LARYNGEAL OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LARYNGOSPASM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMPICILLIN/SULBACTAM (SULBACTAM, AMPICILLIN)</medicinalproduct>
        <drugauthorizationnumb>50608</drugauthorizationnumb>
        <drugdosagetext>(1 TOTAL),  INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056198-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060707</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006084608</companynumb>
    <primarysource>
      <reportercountry>SWEDEN</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>58</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SULFASALAZINE</medicinalproduct>
        <drugauthorizationnumb>7073</drugauthorizationnumb>
        <drugindication>COLITIS ULCERATIVE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056200-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060706</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006084424</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>HAEMATURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROTEINURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TUBULOINTERSTITIAL NEPHRITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SILDENAFIL (PAH) (SILDENAFIL)</medicinalproduct>
        <drugauthorizationnumb>21845</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056201-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060626</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US200606005591</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>66</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLINDNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMULIN 70/30</medicinalproduct>
        <drugauthorizationnumb>18780</drugauthorizationnumb>
        <drugindication>DIABETES MELLITUS NON-INSULIN-DEPENDENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19960101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056202-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060703</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006082782</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>4</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMMOBILE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOSITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHABDOMYOLYSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AZITHROMYCIN</medicinalproduct>
        <drugauthorizationnumb>50710</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PNEUMONIA MYCOPLASMAL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060619</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060621</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056203-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060706</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006084508</companynumb>
    <primarysource>
      <reportercountry>DENMARK</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ECZEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN EXFOLIATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN FISSURES</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AROMASIN</medicinalproduct>
        <drugauthorizationnumb>20753</drugauthorizationnumb>
        <drugdosagetext>25 MG (25 MG, DAILY), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056204-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060706</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006084055</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
    </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>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEMORAL NECK FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOKINESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OBSESSIVE-COMPULSIVE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>REPETITIVE SPEECH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SLEEP DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
        <drugauthorizationnumb>19839</drugauthorizationnumb>
        <drugdosagetext>25 MG (25 MG, 1 IN 1 D)</drugdosagetext>
        <drugindication>OBSESSIVE-COMPULSIVE DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060630</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TIAPRIDAL (TIAPRIDE)</medicinalproduct>
        <drugdosagetext>6 DROP (3 IN 1 D)</drugdosagetext>
        <drugindication>OBSESSIVE-COMPULSIVE DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060630</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEXOMIL (BROMAZEPAM)</medicinalproduct>
        <drugdosagetext>3/4 OF A DOSE (3 IN 1 D),</drugdosagetext>
        <drugindication>OBSESSIVE-COMPULSIVE DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060630</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMLODIPINE</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZESTRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056205-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060704</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006084091</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>59</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AUTOMATISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DELIRIUM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DELUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPERSONALISATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HALLUCINATION, AUDITORY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOSTINEX</medicinalproduct>
        <drugauthorizationnumb>20664</drugauthorizationnumb>
        <drugdosagetext>(1 IN 1 WK), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROLACTINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060619</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056206-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060707</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006080393</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>94</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERIPHERAL VASCULAR DISORDER</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>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MONTELUKAST SODIUM (MONTELUKAST SODIUM)</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALLEGRA</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>THEOPHYLLINE</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MUCODYNE (CARBOCISTEINE)</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALFAROL (ALFACALCIDOL)</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MARZULENE (SODIUM GUALENATE)</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LENDORM</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICON (DEXTROMETHORPHAN HYDROBROMIDE)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056207-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060705</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006084134</companynumb>
    <primarysource>
      <reportercountry>ITALY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>56</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>89</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEEP VEIN THROMBOSIS</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</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060526</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOXORUBICIN HCL</medicinalproduct>
        <drugdosagetext>120 MG (50 MG, 3 WK), INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060526</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060616</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PACLITAXEL</medicinalproduct>
        <drugdosagetext>400 MG (300 MG, 3 WK), INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060526</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060616</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALSARTAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRAZEPAM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056208-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060704</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006084146</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>APNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERVENTILATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SOLU-MEDROL</medicinalproduct>
        <drugauthorizationnumb>11856</drugauthorizationnumb>
        <drugdosagetext>(1 GRAM)</drugdosagetext>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060703</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056209-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060706</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006080608</companynumb>
    <primarysource>
      <reportercountry>TURKEY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>69</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>COORDINATION ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROENTERITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCLONUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GABAPENTIN</medicinalproduct>
        <drugauthorizationnumb>20235</drugauthorizationnumb>
        <drugdosagetext>900 MG (300 MG, 3 IN 1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>TRIGEMINAL NEURALGIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060619</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060622</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMITRIPTYLINE (AMITRIPTYLINE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CANDESARTAN CILEXETIL (CANDESARTAN CILEXETIL)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAMADOL HCL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056210-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060703</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006080930</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>35</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANOREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASCITES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FACE OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLEURAL EFFUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SU-011,248 (SUNITINIB MALATE)</medicinalproduct>
        <drugauthorizationnumb>21968</drugauthorizationnumb>
        <drugdosagetext>50 MG (50 MG, DAILY - INTERVAL:  EVERY DAY), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RENAL CELL CARCINOMA STAGE UNSPECIFIED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060519</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060604</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RINGERS INJECTION IN PLASTIC CONTAINER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ELECTROLYTE SOLUTIONS (ELECTROLYTE SOLUTIONS)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FENTANYL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MORPHINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROCHLORPERAZINE MALEATE (PROCHLORPERAZINE MALEATE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOCLOPRAMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGNESIUM OXIDE (MAGNESIUM OXIDE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SENNOSIDE A+B (SENNOSIDE A+B)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOXOPROFEN SODIUM (LOXOPROFEN SODIUM)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FAMOTIDINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HERBAL PREPARATION INGREDIENTS UNKNOWN (HERBAL PREPARATION INGREDIENTS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LACTOMIN (LACTOBACILLUS SPOROGENES)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056211-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060707</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006085211</companynumb>
    <primarysource>
      <reportercountry>GREECE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EPISTAXIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERNATIONAL NORMALISED RATIO INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROTHROMBIN TIME PROLONGED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INSPRA</medicinalproduct>
        <drugauthorizationnumb>21437</drugauthorizationnumb>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SINTROM</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056212-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060705</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006084829</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POLYDIPSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POLYURIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugauthorizationnumb>21446</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056213-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060706</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006085128</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>72</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>AGGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DELIRIUM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERSECUTORY DELUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY RETENTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALPRAZOLAM</medicinalproduct>
        <drugauthorizationnumb>18276</drugauthorizationnumb>
        <drugdosagetext>10 MG (10 MG, DAILY), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060411</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISONE TAB</medicinalproduct>
        <drugdosagetext>40 MG (20 MG, DAILY); ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060315</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060411</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALDALIX (SPIRONOLACTONE, FUROSEMIDE)</medicinalproduct>
        <drugdosagetext>50 MG/20 MG (DAILY); ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060411</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LANSOPRAZOLE</medicinalproduct>
        <drugdosagetext>30 MG (30 MG, DAILY) ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060411</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LORAZEPAM</medicinalproduct>
        <drugdosagetext>1 MG (1 MG, DAILY); ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060411</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALGOTROPYL PROMETHAZINE (PARACETAMOL PROMETHAZINE HYDROCHLORIDE)</medicinalproduct>
        <drugdosagetext>2 DF (DAILY), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060411</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056214-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006081170</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>2</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>ARTHROPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHEUMATOID ARTHRITIS</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>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060221</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VASOTEC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARVEDILOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INDOMETHACIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NITRO-SPRAY (ISOSORBIDE DINITRATE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>APO-FUROSEMIDE (FUROSEMIDE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056215-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060710</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006084784</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>29</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CHILLS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FACE OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH MACULO-PAPULAR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SULFASALAZINE</medicinalproduct>
        <drugauthorizationnumb>7073</drugauthorizationnumb>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060609</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KETOPROFEN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056216-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060706</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006084791</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>83</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRADYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERKALAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPONATRAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IATROGENIC INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OXYGEN SATURATION DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL CYST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINOATRIAL BLOCK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALDACTONE</medicinalproduct>
        <drugauthorizationnumb>12151</drugauthorizationnumb>
        <drugdosagetext>50 MG (25 MG, 2 IN 1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ESSENTIAL HYPERTENSION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060205</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SECTRAL</medicinalproduct>
        <drugdosagetext>100 MG (100 MG, 1 IN 1 D); ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ESSENTIAL HYPERTENSION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060205</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VALSARTAN</medicinalproduct>
        <drugdosagetext>80 MG (80 MG, 1 IN 1 D); ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ESSENTIAL HYPERTENSION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060205</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056217-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060708</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006084788</companynumb>
    <primarysource>
      <reportercountry>SPAIN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANGINA UNSTABLE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYTOTEC</medicinalproduct>
        <drugauthorizationnumb>19268</drugauthorizationnumb>
        <drugdosagetext>VAGINAL</drugdosagetext>
        <drugadministrationroute>067</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056218-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006-US-00590</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>21</patientonsetage>
      <patientonsetageunit>804</patientonsetageunit>
      <reaction>
        <reactionmeddrapt>PULMONARY HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROGLYCEM CAPSULES (DIAZOXIDE)</medicinalproduct>
        <drugauthorizationnumb>17425</drugauthorizationnumb>
        <drugdosagetext>10 MG/KG QD; ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERINSULINISM</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060115</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060119</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056219-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060113</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006-US-00372</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>81</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ECZEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROGLYCEM CAPSULES (DIAZOXIDE)</medicinalproduct>
        <drugauthorizationnumb>17425</drugauthorizationnumb>
        <drugindication>HYPOGLYCAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051128</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051202</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056220-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060703</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006078839</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>70</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>45</patientweight>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ANURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUID INTAKE REDUCED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMODIALYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTI-ORGAN FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STENOTROPHOMONAS INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYVOX</medicinalproduct>
        <drugauthorizationnumb>21131</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugindication>PNEUMONIA STAPHYLOCOCCAL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060607</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060612</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYVOX</medicinalproduct>
        <drugauthorizationnumb>21131</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugindication>PNEUMONIA STAPHYLOCOCCAL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060613</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060616</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TIENAM (CILASTATIN, IMIPENEM)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRODIF (FOSFLUCONAZOLE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ELASPOL (SIVELESTAT)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SOLU-MEDROL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDROL ACETATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FIRSTCIN (CEFOZOPRAN HYDROCHLORIDE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYCLOPHOSPHAMIDE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056223-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060706</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>MEDI-0004556</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>14</patientonsetage>
      <patientonsetageunit>802</patientonsetageunit>
      <patientweight>12.17</patientweight>
      <reaction>
        <reactionmeddrapt>ASTHMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRONCHIOLITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SYNAGIS</medicinalproduct>
        <drugdosagetext>1 IN 1 M, INTRAMUSCULAR</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>ANTIVIRAL PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051207</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060209</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SYNAGIS</medicinalproduct>
        <drugdosagetext>1 IN 1 M, INTRAMUSCULAR</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>ANTIVIRAL PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051207</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SYNAGIS</medicinalproduct>
        <drugdosagetext>1 IN 1 M, INTRAMUSCULAR</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>ANTIVIRAL PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060112</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SALBUTAMOL (SALBUTAMOL)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056224-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060705</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>MEDI-0004743</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>2</patientonsetage>
      <patientonsetageunit>802</patientonsetageunit>
      <patientweight>4.115</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>APNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRADYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRONCHIOLITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SYNAGIS</medicinalproduct>
        <drugdosagetext>INTRAMUSCULAR</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>ANTIVIRAL PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051119</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051119</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056225-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060706</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006-01708</companynumb>
    <primarysource>
      <reportercountry>NETHERLANDS</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>62</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>55</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PANCYTOPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VELCADE</medicinalproduct>
        <drugauthorizationnumb>21602</drugauthorizationnumb>
        <drugindication>MULTIPLE MYELOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FERROFUMARAT (FERROUS FUMARATE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CAPOTEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DURAGESIC-100</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIFLUCAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056227-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060706</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>HQWYE620201JUN06</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>65</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERSTITIAL LUNG DISEASE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAZOCIN (PIPERACILLIN/TAZOBACTAM, INJECTION)</medicinalproduct>
        <drugauthorizationnumb>50684</drugauthorizationnumb>
        <drugdosagetext>4.5 G 3X PER 1 DAY</drugdosagetext>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>PNEUMONIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060525</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060529</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SEREVENT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUTIDE DISKUS (FLUTICASONE PROPIONATE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056228-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060707</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>MEDI-0004581</companynumb>
    <primarysource>
      <reportercountry>INDIA</reportercountry>
      <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>ABNORMAL BEHAVIOUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANGIOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE IMMEASURABLE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBRAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ESCHERICHIA INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FACIAL PARESIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERAL PHYSICAL HEALTH DETERIORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEMIPARESIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUCOSAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUCOSAL INFLAMMATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL INTAKE REDUCED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARYNGOLARYNGEAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA ASPIRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PUPIL FIXED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN EXFOLIATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPUTUM CULTURE POSITIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ETHYOL</medicinalproduct>
        <drugauthorizationnumb>20221</drugauthorizationnumb>
        <drugdosagetext>INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RADIOTHERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060324</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060505</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RADIATION THERAPY</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN ANTIBIOTICS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056229-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060714</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006-145292-NL</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>38</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>AKATHISIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEMENTIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPONATRAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIRTAZAPINE</medicinalproduct>
        <drugdosagetext>15 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060502</drugenddate>
        <drugtreatmentduration>32</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CO-TRIMOXAZOLE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>LUNG INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060502</drugenddate>
        <drugtreatmentduration>32</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056230-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060709</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006-145364-NL</companynumb>
    <primarysource>
      <reportercountry>SWITZERLAND</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>95</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>AGGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AGITATION</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 MAGNESIUM DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD POTASSIUM DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD THYROID STIMULATING HORMONE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD UREA INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>C-REACTIVE PROTEIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMMUNICATION DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATOCRIT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMMOBILE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOBILITY DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL STIFFNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUTISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUROLEPTIC MALIGNANT SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARANOIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RED BLOOD CELL MICROCYTES PRESENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEDATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPEECH DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIRTAZAPINE</medicinalproduct>
        <drugdosagetext>15 MG</drugdosagetext>
        <drugindication>INSOMNIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PIPAMPERONE</medicinalproduct>
        <drugdosagetext>20 MG/30 MG/40 MG/60 MG</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>QUETIAPINE FUMARATE</medicinalproduct>
        <drugdosagetext>12.5 MG</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>QUETIAPINE FUMARATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLOMETHIAZOLE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056232-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060710</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006-07-0320</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>70</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>68</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ALANINE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASPARTATE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TEMODAL</medicinalproduct>
        <drugauthorizationnumb>21029</drugauthorizationnumb>
        <drugdosagetext>250 MG IV INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>GLIOBLASTOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060506</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060510</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RADIATION THERAPY</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056233-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060606</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006-140387-NL</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>61</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEOPLASM MALIGNANT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DANAPAROID SODIUM</medicinalproduct>
        <drugdosagetext>INTRAVENOUS (NOS)</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>DISSEMINATED INTRAVASCULAR COAGULATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030624</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030627</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DANAPAROID SODIUM</medicinalproduct>
        <drugdosagetext>INTRAVENOUS (NOS)</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>DISSEMINATED INTRAVASCULAR COAGULATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030628</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030628</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ULINASTATIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIVELESTAT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTITHROMBIN III</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMMUNE GLOBULIN INTRAVENOUS (HUMAN)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLOMEX SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FAMOTIDINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROPOFOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM GLUCONATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RED BLOOD CELLS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORMAL HUMAN PLASMA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLATELETS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLASMANATE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056234-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060707</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006-142902-NL</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>43</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ACTIVATED PARTIAL THROMBOPLASTIN TIME PROLONGED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACTERAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ENTEROCOLITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEBRILE NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FIBRIN DEGRADATION PRODUCTS INCREASED</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>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DANAPAROID SODIUM</medicinalproduct>
        <drugdosagetext>INTRAVENOUS (NOS)</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>DISSEMINATED INTRAVASCULAR COAGULATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060308</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060311</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DANAPAROID SODIUM</medicinalproduct>
        <drugdosagetext>INTRAVENOUS (NOS)</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>DISSEMINATED INTRAVASCULAR COAGULATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060312</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060312</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLASMA PROTEIN FRACTION (HUMAN)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRANEXAMIC ACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ETOPOSIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NOVANTRONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ISEPAMICIN SULFATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CEFTAZIDIME</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUCONAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CEFCAPENE PIVOXIL HYDROCHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLPIDEM TARTRATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RAMOSETRON HYDROCHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLATELETS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXCHLORPHENIRAMINE MALEATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>STREPTOCOCCUS FAECALIS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056235-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060710</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006-01756</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>61</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>86</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>INAPPROPRIATE ANTIDIURETIC HORMONE SECRETION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VELCADE</medicinalproduct>
        <drugauthorizationnumb>21602</drugauthorizationnumb>
        <drugdosagetext>3.00 MG</drugdosagetext>
        <drugindication>T-CELL LYMPHOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060623</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060627</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISONE (PREDNISONE) VIAL</medicinalproduct>
        <drugdosagetext>120.00 MG</drugdosagetext>
        <drugindication>T-CELL LYMPHOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060623</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060627</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOPHOSPHAMIDE</medicinalproduct>
        <drugdosagetext>2400.00 MG</drugdosagetext>
        <drugindication>T-CELL LYMPHOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060623</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060623</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOXIL</medicinalproduct>
        <drugdosagetext>150.00 MG</drugdosagetext>
        <drugindication>T-CELL LYMPHOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060623</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060623</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VINCRISTINE</medicinalproduct>
        <drugdosagetext>4.00 MG</drugdosagetext>
        <drugindication>T-CELL LYMPHOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060623</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060627</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BLEOMYCIN</medicinalproduct>
        <drugdosagetext>10.00 IU</drugdosagetext>
        <drugindication>T-CELL LYMPHOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060623</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060627</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LENOGRASTIM (LENOGRASTIM)</medicinalproduct>
        <drugindication>T-CELL LYMPHOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060628</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060630</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056236-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060706</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2005-09-0042</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>22</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <reaction>
        <reactionmeddrapt>ABORTION THREATENED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CERVICITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FORCEPS DELIVERY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IRON DEFICIENCY ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PREGNANCY OF PARTNER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THREATENED LABOUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRANSMISSION OF DRUG VIA SEMEN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UTERINE HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VACUUM EXTRACTOR DELIVERY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INTRON A</medicinalproduct>
        <drugauthorizationnumb>20903</drugauthorizationnumb>
        <drugdosagetext>6 MIU QD INTRAMUSCULAR; 6 MIU TIW INTRAMUSCULAR</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041020</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041107</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INTRON A</medicinalproduct>
        <drugauthorizationnumb>20903</drugauthorizationnumb>
        <drugdosagetext>6 MIU QD INTRAMUSCULAR; 6 MIU TIW INTRAMUSCULAR</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041020</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050303</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INTRON A</medicinalproduct>
        <drugauthorizationnumb>20903</drugauthorizationnumb>
        <drugdosagetext>6 MIU QD INTRAMUSCULAR; 6 MIU TIW INTRAMUSCULAR</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041108</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050303</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBETOL</medicinalproduct>
        <drugdosagetext>600 MG ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041020</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050228</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056237-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060427</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006-142904-NL</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>73</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ACTIVATED PARTIAL THROMBOPLASTIN TIME PROLONGED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD FIBRINOGEN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD LACTATE DEHYDROGENASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD POTASSIUM DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FIBRIN DEGRADATION PRODUCTS INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAMMA-GLUTAMYLTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEUKOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALNUTRITION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROTEIN TOTAL DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROTHROMBIN TIME PROLONGED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DANAPAROID SODIUM</medicinalproduct>
        <drugdosagetext>INTRAVENOUS DRIP</drugdosagetext>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>DISSEMINATED INTRAVASCULAR COAGULATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060307</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060316</drugenddate>
        <drugtreatmentduration>10</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYTARABINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GEMTUZUMAB OZOGAMICIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTITHROMBIN III</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CEFOZOPRAN HYDROCHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MICAFUNGIN SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRANEXAMIC ACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BIAPENEM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLINDAMYCIN PHOSPHATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VORICONAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VANCOMYCIN HYDROCHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLATELETS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HUMAN RED BLOOD CELLS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEUPOGEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLIMEPIRIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HYDROCHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALSARTAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUCONAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CIPROFLOXACIN HYDROCHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056239-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060707</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006-142904-NL</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>73</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ACTIVATED PARTIAL THROMBOPLASTIN TIME PROLONGED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD FIBRINOGEN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD LACTATE DEHYDROGENASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD POTASSIUM DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISEASE PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FIBRIN DEGRADATION PRODUCTS INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAMMA-GLUTAMYLTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEUKOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALNUTRITION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROTEIN TOTAL DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROTHROMBIN TIME PROLONGED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DANAPAROID SODIUM</medicinalproduct>
        <drugdosagetext>INTRAVENOUS DRIP</drugdosagetext>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>DISSEMINATED INTRAVASCULAR COAGULATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060307</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060316</drugenddate>
        <drugtreatmentduration>10</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYTARABINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GEMTUZUMAB OZOGAMICIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTITHROMBIN III</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CEFOZOPRAN HYDROCHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MICAFUNGIN SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRANEXAMIC ACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BIAPENEM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLINDAMYCIN PHOSPHATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VORICONAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VANCOMYCIN HYDROCHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLATELETS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HUMAN RED BLOOD CELLS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEUPOGEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLIMEPIRIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HYDROCHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALSARTAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUCONAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CIPROFLOXACIN HYDROCHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056240-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060221</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006-138971-NL</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>33</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PREGNANCY WITH IMPLANT CONTRACEPTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ETONOGESTREL</medicinalproduct>
        <drugdosagetext>DF</drugdosagetext>
        <drugindication>CONTRACEPTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SERTRALIA IUD</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056241-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060704</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GXKR2006TR03784</companynumb>
    <primarysource>
      <reportercountry>TURKEY</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>36</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>APNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD BILIRUBIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CREATININE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD URIC ACID INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISEASE PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERAL PHYSICAL HEALTH DETERIORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMODIALYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER FUNCTION TEST ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAPILLOEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>REVERSIBLE POSTERIOR LEUKOENCEPHALOPATHY SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
        <drugauthorizationnumb>80399</drugauthorizationnumb>
        <drugdosagetext>40 MG, QD,</drugdosagetext>
        <drugindication>LYMPHOMA</drugindication>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CISPLATIN</medicinalproduct>
        <drugdosagetext>100 MG/M2, INFUSION</drugdosagetext>
        <drugindication>LYMPHOMA</drugindication>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugdosagetext>INTRATHECAL</drugdosagetext>
        <drugadministrationroute>037</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ETOPOSIDE (NGX) (ETOPOSIDE)(UNKNOWN)</medicinalproduct>
        <drugdosagetext>150 MG/M2, DAYS 1-5,</drugdosagetext>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYTARABINE</medicinalproduct>
        <drugdosagetext>2 G/MA,A2,</drugdosagetext>
        <drugindication>LYMPHOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRIMIDONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IFOSFAMIDE</medicinalproduct>
        <drugdosagetext>1000 MG/M2</drugdosagetext>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MESNA</medicinalproduct>
        <drugdosagetext>600 MG/M2</drugdosagetext>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IDARUBICIN HCL</medicinalproduct>
        <drugdosagetext>10 MG/M2, DAYS 1-2; 5MG/M2</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056242-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060720</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060711</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006AP03261</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANGINA PECTORIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARRHYTHMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARIMIDEX</medicinalproduct>
        <drugauthorizationnumb>020541</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056243-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060720</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060717</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006CG01244</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>27</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ACUTE PULMONARY OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG ABUSER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCREATITIS HAEMORRHAGIC</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROPOFOL</medicinalproduct>
        <drugauthorizationnumb>19627</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIDOCAINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056244-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060720</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060619</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006UW13265</companynumb>
    <primarysource>
      <reportercountry>MEXICO</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>63</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>83.8</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DERMATITIS ALLERGIC</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ROSUVASTATIN</medicinalproduct>
        <drugauthorizationnumb>21366</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERCHOLESTEROLAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060329</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060527</drugenddate>
        <drugtreatmentduration>60</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ROSUVASTATIN</medicinalproduct>
        <drugauthorizationnumb>021366</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060608</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLIBENCLAMIDA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS NON-INSULIN-DEPENDENT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVAPENA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056246-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060703</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006074690</companynumb>
    <primarysource>
      <reportercountry>HONG KONG</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>69</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>DISEASE PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISSEMINATED INTRAVASCULAR COAGULATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTHYROIDISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POSTOPERATIVE INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN DISCOLOURATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUTENT</medicinalproduct>
        <drugauthorizationnumb>21968</drugauthorizationnumb>
        <drugdosagetext>50 MG (50 MG, INTERVAL:  EVERY DAY), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RENAL CELL CARCINOMA STAGE UNSPECIFIED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060508</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060603</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DILTIAZEM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENALAPRIL MALEATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAXOLON</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOLGESIC (PARACETAMOL)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHYLDOPA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMIKACIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLOXACILLIN (CLOXACILLIN)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOFLOXACIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENZYPLEX (ENZYMES NOS, VITAMINS NOS)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PEPCIDIN (FAMOTIDINE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MORPHINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITA K1 (PHYTOMENADIONE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAZOCIN (PIPERACILLIN SODIUM, TAZOBACTAM SODIUM)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRANSAMIN (TRANEXAMIC ACID)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALDACTONE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056247-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060704</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006072766</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>52</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MACULAR OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISION BLURRED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL ACUITY REDUCED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOLTERODINE TARTRATE</medicinalproduct>
        <drugauthorizationnumb>21228</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLADDER DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056248-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060703</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006085975</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
    </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>DERMATITIS EXFOLIATIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EOSINOPHILIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERALISED ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERTRIGO</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ATARAX</medicinalproduct>
        <drugauthorizationnumb>10392</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020108</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020109</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RANITIDINE HCL</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020108</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020109</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VISIPAQUE (IODIXANOL, TROMETAMOL)</medicinalproduct>
        <drugdosagetext>INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020109</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020109</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020109</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020111</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SOLU-MEDROL</medicinalproduct>
        <drugdosagetext>(240 MG), INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020109</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020109</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ASPEGIC 1000</medicinalproduct>
        <drugdosagetext>(250 MG), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20011230</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INDAPAMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BISOPROLOL FUMARATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RAMIPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRAVASTATIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056250-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006086057</companynumb>
    <primarysource>
      <reportercountry>ITALY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>69</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>AMNESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BALANCE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugauthorizationnumb>21446</drugauthorizationnumb>
        <drugdosagetext>150 MG (75 MG, 2 IN 1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056251-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060704</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006086330</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>69</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>70</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POLYNEUROPATHY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOSTINEX</medicinalproduct>
        <drugauthorizationnumb>20664</drugauthorizationnumb>
        <drugdosagetext>(0.25 MG, 2 IN 1 WK), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROLACTINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20011201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BROMOCRIPTINE MESYLATE</medicinalproduct>
        <drugdosagetext>5 MG, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROLACTINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19930101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056253-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060720</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060710</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006GB01184</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>79</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD POTASSIUM DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ILEUS PARALYTIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREATMENT NONCOMPLIANCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>QUETIAPINE FUMARATE</medicinalproduct>
        <drugauthorizationnumb>020639</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060522</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYBUTYNIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SENNA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056254-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060706</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006085359</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FULL BLOOD COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugauthorizationnumb>21446</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NEURALGIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056255-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060720</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060713</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006PK01536</companynumb>
    <primarysource>
      <reportercountry>SWITZERLAND</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>97</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>45</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ATRIOVENTRICULAR BLOCK FIRST DEGREE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEYNE-STOKES RESPIRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERAL PHYSICAL HEALTH DETERIORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STUPOR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BELOC-ZOK</medicinalproduct>
        <drugauthorizationnumb>19962</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050821</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEDATIVUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050820</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050820</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NITRODERM</medicinalproduct>
        <drugadministrationroute>062</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIMAGON-D3</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KENDURAL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050824</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>STUGERON</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050824</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NOVALGIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050821</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056256-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060720</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060719</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006UW14697</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>INTRAOCULAR MELANOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugauthorizationnumb>021153</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056257-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060720</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060621</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AVENTIS-200616669GDDC</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>53</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>50.8</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CELLULITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISEASE PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPONATRAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SQUAMOUS CELL CARCINOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOCETAXEL</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>20449</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>SQUAMOUS CELL CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060607</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060607</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PLACEBO</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SQUAMOUS CELL CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060510</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060615</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PERCOCET-5</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugdosagetext>DOSE: FOUR TIMES DAILY PRN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056258-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060703</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006085836</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CATARACT OPERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XALATAN</medicinalproduct>
        <drugauthorizationnumb>20597</drugauthorizationnumb>
        <drugdosagetext>1.5 MCG (1.5 MCG, 1 IN 1 D), OPHTHALMIC</drugdosagetext>
        <drugadministrationroute>047</drugadministrationroute>
        <drugindication>GLAUCOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056259-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060705</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006-01647</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>76</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CATHETER RELATED INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HALLUCINATION, AUDITORY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HALLUCINATION, VISUAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEARING IMPAIRED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>KLEBSIELLA INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSYCHOTIC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL DISTURBANCE</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>20050101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVAQUIN</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CATHETER SITE INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUOXETINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLOXAZOLAM (CLOXAZOLAM)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NOCTAL (PROPALLYONAL)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TEGRETOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACYCLOVIR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OSCAL (CALCIUM CARBONATE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AREDIA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANTOPRAZOLE SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MICOSTATIN (NYSTATIN)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056260-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060703</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006085865</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
    </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>DIZZINESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PHENYTOIN SODIUM</medicinalproduct>
        <drugauthorizationnumb>84349</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONVULSION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060401</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PHENYTOIN</medicinalproduct>
        <drugindication>CONVULSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056263-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060707</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006-07-0176</companynumb>
    <primarysource>
      <reportercountry>SWITZERLAND</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CHOLESTASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATOCELLULAR DAMAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL CANDIDIASIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TEMODAL</medicinalproduct>
        <drugauthorizationnumb>21029</drugauthorizationnumb>
        <drugdosagetext>100 MG OD ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GLIOBLASTOMA MULTIFORME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060406</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060517</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIFLUCAN</medicinalproduct>
        <drugdosagetext>50MG OD ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ORAL CANDIDIASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060515</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060519</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RADIATION THERAPY</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056264-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060704</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006078880</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>58</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLEPHAROSPASM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>UNASYN</medicinalproduct>
        <drugauthorizationnumb>50608</drugauthorizationnumb>
        <drugdosagetext>1.5 GRAM (1.5 GRAM, 1 IN 1 D), INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ENDOCARDITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060618</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MINOCYCLINE HYDROCHLORIDE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056265-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060707</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006079372</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>61</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>RHABDOMYOLYSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CABERGOLINE</medicinalproduct>
        <drugauthorizationnumb>20664</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARTANE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYMMETREL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MUCOSTA (REBAMIPIDE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEILAX (ETHYL LOFLAZEPATE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIFROL (PRAMIPEXOLE DIHYDROCHLORIDE)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056266-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060705</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006080143</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>73</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>LUNG NEOPLASM MALIGNANT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</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>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MENESIT (CARBIDOPA, LEVODOPA)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056268-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060703</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006075400</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>39</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>55</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>RESPIRATORY DISTRESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUS ARRHYTHMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROAT TIGHTNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RELPAX</medicinalproduct>
        <drugauthorizationnumb>21016</drugauthorizationnumb>
        <drugdosagetext>20 MG (AS NECESSARY), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MIGRAINE WITH AURA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060527</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060527</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOMPERIDONE (DOMPERIDONE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TIZANIDINE HCL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056269-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>MAG-2006-0000463</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>61</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>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>DYSURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAMMA-GLUTAMYLTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERAL PHYSICAL CONDITION ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXYCODONE HCL CONTROLLED RELEASE TABLETS (OXYCODONE HYDROCHLORIDE) PRO</medicinalproduct>
        <drugauthorizationnumb>20553</drugauthorizationnumb>
        <drugdosagetext>5 MG, TID, ORAL; SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CANCER PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060621</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060621</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXYCODONE HCL CONTROLLED RELEASE TABLETS (OXYCODONE HYDROCHLORIDE) PRO</medicinalproduct>
        <drugauthorizationnumb>20553</drugauthorizationnumb>
        <drugdosagetext>5 MG, TID, ORAL; SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CANCER PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060622</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060623</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FAMOTIDINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM CARBONATE (CALCIUM CARBONATE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ESTAZOLAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FENTANYL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056270-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060704</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006077413</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>61</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>91</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HUMERUS FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOPOROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POST PROCEDURAL COMPLICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWELLING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AROMASIN</medicinalproduct>
        <drugauthorizationnumb>20753</drugauthorizationnumb>
        <drugdosagetext>25 MG (25 MG, 1 IN 1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BREAST CANCER FEMALE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031001</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056271-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060706</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GXKR2006IT03851</companynumb>
    <primarysource>
      <reportercountry>ITALY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>63</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHOLESTASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC STEATOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATITIS B</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERPYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMMUNODEFICIENCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTI-ORGAN FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCYTOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugauthorizationnumb>80336</drugauthorizationnumb>
        <drugdosagetext>25 MG, QD,</drugdosagetext>
        <drugindication>NEPHROTIC SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020501</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOPHOSPHAMIDE</medicinalproduct>
        <drugdosagetext>100 MG, QD,</drugdosagetext>
        <drugindication>NEPHROTIC SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020501</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056272-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060703</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006074239</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>43</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>40</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIOVASCULAR DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEURALGIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZELDOX (CAPSULES) (ZIPRASIDONE)</medicinalproduct>
        <drugauthorizationnumb>20825</drugauthorizationnumb>
        <drugdosagetext>20 MG, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060301</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CITALOPRAM HYDROBROMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORAZEPAM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056274-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060704</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006074301</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>47</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>45.3597</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD SODIUM DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG TOLERANCE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERIPHERAL COLDNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PREMATURE MENOPAUSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CORTEF</medicinalproduct>
        <drugauthorizationnumb>8697</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ADDISON'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060615</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CORTEF</medicinalproduct>
        <drugauthorizationnumb>8697</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ADDISON'S DISEASE</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060615</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CORTEF</medicinalproduct>
        <drugauthorizationnumb>8697</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ADDISON'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROVERA</medicinalproduct>
        <drugdosagetext>2.5 MG (2.5 MG, 1 IN 1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISONE TAB</medicinalproduct>
        <drugdosagetext>(5 MG, 2 IN 1 D</drugdosagetext>
        <drugindication>ADDISON'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CORTISONE ACETATE</medicinalproduct>
        <drugdosagetext>200 MG (100 MG, 2 IN 1 D)</drugdosagetext>
        <drugindication>ADDISON'S DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
        <drugdosagetext>0.3 MG (0.3 MG, 1 IN 1 D)</drugdosagetext>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLORINEF</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THYROID TAB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RADIOACTIVE IODINE SOLUTION (SODIUM IODINE)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056275-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060704</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006074348</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>LARYNGEAL OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALDACTONE</medicinalproduct>
        <drugauthorizationnumb>12151</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENALAPRIL MALEATE</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056276-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060706</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GXKR2006DK03939</companynumb>
    <primarysource>
      <reportercountry>DENMARK</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>32</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>97</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIABETIC COMPLICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SENSORY LOSS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CITALOPRAM (NGX)(CITALOPRAM) TABLET 20MG</medicinalproduct>
        <drugauthorizationnumb>77040</drugauthorizationnumb>
        <drugdosagetext>20 MG, QD, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ESCITALOPRAM (ESCITALOPRAM) TABLET, 10MG</medicinalproduct>
        <drugdosagetext>10 MG, QD, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN INJECTION (ISOPHANE INSULIN) INJECTION</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ISOPHANE INSULIN (ISOPHANE INSULIN)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056278-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060720</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060714</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AVENTIS-200615904US</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KETEK</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021144</drugauthorizationnumb>
        <drugdosagetext>DOSE: UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANALGESICS</medicinalproduct>
        <drugdosagetext>DOSE: UNKNOWN</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056279-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060708</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>14380</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>KERATOPATHY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMIODARONE HCL</medicinalproduct>
        <drugauthorizationnumb>76108</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056280-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060720</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050722</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-AVENTIS-200516681GDDC</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>78</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC ENZYME INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KETEK</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021144</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SINUSITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050113</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050120</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MONOCOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DYAZIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM GLUCONATE</medicinalproduct>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056281-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060720</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060306</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-AVENTIS-200610884FR</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>77</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>60</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>NERVOUS SYSTEM DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESTLESSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SCIATICA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLAGYL</medicinalproduct>
        <drugauthorizationnumb>020743</drugauthorizationnumb>
        <drugadministrationroute>067</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060228</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060305</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALDACTONE</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GINGKO FORT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERCHOLESTEROLAEMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MOTILIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLECAINIDE ACETATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>TACHYCARDIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRAXILENE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTERITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HORMONES AND RELATED AGENTS</medicinalproduct>
        <drugadministrationroute>062</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056282-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060703</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006083824</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>72</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>60</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>INTESTINAL OBSTRUCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCYTOPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUTENT</medicinalproduct>
        <drugauthorizationnumb>21938</drugauthorizationnumb>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060609</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056283-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060705</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GXKR2006IE03861</companynumb>
    <primarysource>
      <reportercountry>IRELAND</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>71</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
        <drugauthorizationnumb>73025</drugauthorizationnumb>
        <drugdosagetext>50 MG, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060522</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060531</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MICARDISPLUS (HYDROCHLOROTHIAZIDE, TELMISARTAN)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANTOPRAZOLE SODIUM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056284-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060704</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GXKR2006GB03874</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>70</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>CIRCULATORY COLLAPSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMODIALYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LACTIC ACIDOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugauthorizationnumb>75999</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060416</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS NON-INSULIN-DEPENDENT</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060416</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN TAB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATORVASTATIN CALCIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BISOPROLOL FUMARATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOXAZOSIN (DOXAZOSIN)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SILDENAFIL CITRATE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056285-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060705</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>14378</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>32</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABORTION SPONTANEOUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD ALKALINE PHOSPHATASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GINGIVAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAINFUL RESPIRATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAMIDRONATE DISODIUM ANHYDROUS</medicinalproduct>
        <drugauthorizationnumb>75841</drugauthorizationnumb>
        <drugdosagetext>90 MG TOTAL IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COMPLEX REGIONAL PAIN SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060410</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060410</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PAROXETINE HCL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056286-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060704</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2005099539</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>49</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>AGITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCOHERENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESTLESSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SOLU-MEDROL</medicinalproduct>
        <drugauthorizationnumb>11856</drugauthorizationnumb>
        <drugdosagetext>INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050310</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050426</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IFOSFAMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MOVICOL (MACROGOL, POTASSIUM CHLORIDE, SODIUM BICARBONATE, SODIUM CHLO</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MESNA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOFRAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOXORUBICIN HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IFOSFAMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SODIUM BICARBONATE IN PLASTIC CONTAINER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ONDANSETRON</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALL OTHER THERAPEUTIC PRODUCTS (ALL OTHER THERAPEUTIC PRODUCTS)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056287-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060630</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006083843</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>78</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>59.4</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>CHILLS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ELECTROCARDIOGRAM QRS COMPLEX PROLONGED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERSTITIAL LUNG DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SHOCK</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IRINOTECAN HCL</medicinalproduct>
        <drugauthorizationnumb>20571</drugauthorizationnumb>
        <drugdosagetext>95 MG, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>LUNG NEOPLASM MALIGNANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060615</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060622</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DECADRON</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KYTRIL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056288-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>8017582</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>67</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>76.6</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CHLORIDE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CREATININE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD SODIUM DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZAROXOLYN</medicinalproduct>
        <drugauthorizationnumb>17386</drugauthorizationnumb>
        <drugdosagetext>2.5 MG PRN PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CARDIAC FAILURE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NESIRITIDE</medicinalproduct>
        <drugdosagetext>1/W</drugdosagetext>
        <drugindication>CARDIAC FAILURE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060228</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MONOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALDACTONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NITRO-DUR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CORDARONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>K-DUR 10</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FE SO4</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARANESP</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM GLUCONATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELEXA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLYBURIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NPH INSULIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PENTOXIFYLLINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANTOPRAZOLE SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COLACE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RESTORIL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056289-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060707</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>14146</companynumb>
    <primarysource>
      <reportercountry>NEW ZEALAND</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>70</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLUENZA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPENIC SEPSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRODUCTIVE COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPUTUM CULTURE POSITIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PACLITAXEL</medicinalproduct>
        <drugauthorizationnumb>76517</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARBOPLATIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DMXAA</medicinalproduct>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060302</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060323</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DICLOFENAC SODIUM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056290-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060710</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006BL003513</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>55</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>AMYOTROPHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENINGIOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARTEOLOL HYDROCHLORIDE</medicinalproduct>
        <drugauthorizationnumb>75546</drugauthorizationnumb>
        <drugdosagetext>1 DROP; DAILY; OPHTHALMIC</drugdosagetext>
        <drugadministrationroute>047</drugadministrationroute>
        <drugindication>GLAUCOMA</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060706</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARTEOLOL HYDROCHLORIDE</medicinalproduct>
        <drugdosagetext>1 DROP; DAILY; OPHTHALMIC</drugdosagetext>
        <drugadministrationroute>047</drugadministrationroute>
        <drugindication>GLAUCOMA</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060706</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056291-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060703</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006083869</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>45</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>EXCORIATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SENSORY LOSS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TONGUE BITING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TONGUE HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugauthorizationnumb>21446</drugauthorizationnumb>
        <drugdosagetext>300 MG (150 MG, 2 IN 1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NEURALGIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056292-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060710</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>0602094US</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>86</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>PANCREATIC CARCINOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMBIGAN (BRIMONIDINE TARTRATE, TIMOLOL MALEATE) EYE DROPS, SOLUTION</medicinalproduct>
        <drugauthorizationnumb>21398</drugauthorizationnumb>
        <drugdosagetext>BID, OPHTHALMIC</drugdosagetext>
        <drugadministrationroute>047</drugadministrationroute>
        <drugindication>GLAUCOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060123</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060418</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056293-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060705</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006083861</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>TENDON RUPTURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SORTIS (ATORBASTATIN)</medicinalproduct>
        <drugauthorizationnumb>20702</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056294-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060720</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060206</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-AVENTIS-200610411JP</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>75</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>HYPOGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOGLYCAEMIC COMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOTIC STROKE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMARYL</medicinalproduct>
        <drugauthorizationnumb>20496</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060204</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PARIET</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PURSENNID</medicinalproduct>
        <drugdosagetext>DOSE: 2 TABLETS/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANTOSIN</medicinalproduct>
        <drugdosagetext>DOSE: 3 PACKS/DAY</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>ALDACTONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>DOSE: 1 TABLET/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060122</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060124</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MICARDIS</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARTIST</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>URINORM</medicinalproduct>
        <drugdosagetext>DOSE: 3 TABLET/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NICHOLIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SOLCOSERYL</medicinalproduct>
        <drugdosagetext>DOSE: 2AMPULE</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EPOGEN</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUMIN</medicinalproduct>
        <drugdosagetext>DOSE: 2VIAL</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060122</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060124</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADALAT</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056295-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060720</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060308</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2006PE03761</companynumb>
    <primarysource>
      <reportercountry>PERU</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>70</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAL SPHINCTER ATONY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>APHASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLADDER SPHINCTER ATONY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXELON</medicinalproduct>
        <drugbatchnumb>B5004</drugbatchnumb>
        <drugauthorizationnumb>20823</drugauthorizationnumb>
        <drugdosagetext>1.5 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEMENTIA ALZHEIMER'S TYPE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060126</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXELON</medicinalproduct>
        <drugbatchnumb>B5004</drugbatchnumb>
        <drugauthorizationnumb>020823</drugauthorizationnumb>
        <drugdosagetext>3 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060210</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CAPTOPRIL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056296-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060720</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060704</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHO2006BR11019</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>51</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>60</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZELMAC / HTF 919A</medicinalproduct>
        <drugauthorizationnumb>21200</drugauthorizationnumb>
        <drugdosagetext>3 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>IRRITABLE BOWEL SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060601</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZELMAC / HTF 919A</medicinalproduct>
        <drugbatchnumb>Z0026</drugbatchnumb>
        <drugauthorizationnumb>021200</drugauthorizationnumb>
        <drugdosagetext>6 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060601</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056297-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060710</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006-07-0243</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>58</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>51</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIPASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCREATIC ENLARGEMENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELESTONE</medicinalproduct>
        <drugauthorizationnumb>14215</drugauthorizationnumb>
        <drugdosagetext>0.5 MG BID ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OTITIS MEDIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060603</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060606</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056298-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060630</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DSA_28405_2006</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>85</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN LOWER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSEUDOLYMPHOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE</medicinalproduct>
        <drugauthorizationnumb>19221</drugauthorizationnumb>
        <drugdosagetext>1 DF QD PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060405</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN LYSINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ETIFOXINE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LACTULOSE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRIMETAZIDINE HYDROCHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOPICLONE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056299-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060704</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006083651</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>34</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CROSS SENSITIVITY REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DERMATITIS BULLOUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHOTOSENSITIVITY REACTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugauthorizationnumb>21446</drugauthorizationnumb>
        <drugdosagetext>100 MG (1 D)</drugdosagetext>
        <drugindication>EPILEPSY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPIRAMATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARBAMAZEPINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PHENOBARBITAL TAB</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056300-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060630</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>224231</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>71</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>65</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HERCEPTIN</medicinalproduct>
        <drugdosagetext>SEE IMAGE, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060207</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060329</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAXOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZANTAC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RESTAMIN (CHLORPHENIRAMINE MALEATE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DECADRON</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056302-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060705</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006083696</companynumb>
    <primarysource>
      <reportercountry>ROMANIA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>AKATHISIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY INCONTINENCE</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>SCHIZOPHRENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056303-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060704</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2005136266</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>39</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>52</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANIC ATTACK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREGABALIN (PREGABALIN)</medicinalproduct>
        <drugbatchnumb>CF-0020103</drugbatchnumb>
        <drugauthorizationnumb>21446</drugauthorizationnumb>
        <drugdosagetext>450 MG (75 MG, 6 IN 1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>EPILEPSY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050704</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KEPPRA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LAMICTAL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GABACET (PIRACETAM)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056304-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesscongenitalanomali>1</seriousnesscongenitalanomali>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060704</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2002099730FR</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>2.1</patientweight>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRADYCARDIA NEONATAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CAESAREAN SECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONGENITAL ANOMALY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONGENITAL TRICUSPID VALVE ATRESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CYANOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART DISEASE CONGENITAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MATERNAL CONDITION AFFECTING FOETUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METABOLIC ACIDOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA NEONATAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALLOR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PREMATURE BABY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY VASCULAR DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENTRICULAR FIBRILLATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
        <drugauthorizationnumb>18276</drugauthorizationnumb>
        <drugdosagetext>0.5 MG, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19960131</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ASPEGIC 1000</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TORENTAL (PENTOXIFYLLINE)</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19960223</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ISOPTIN</medicinalproduct>
        <drugdosagetext>240 MG, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROZAC</medicinalproduct>
        <drugdosagetext>20  MG</drugdosagetext>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19960131</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PERINDOPRIL ERBUMINE</medicinalproduct>
        <drugdosagetext>4 MG, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FENOFIBRATE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056305-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>MEDI-0004304(1)</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>4</patientonsetage>
      <patientonsetageunit>802</patientonsetageunit>
      <reaction>
        <reactionmeddrapt>BRONCHIAL OBSTRUCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SYNAGIS</medicinalproduct>
        <drugdosagetext>100 MG, 1 IN 30 D, INTRAMUSCULAR;SEE IMAGE</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>ANTIVIRAL PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051014</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051014</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SYNAGIS</medicinalproduct>
        <drugdosagetext>100 MG, 1 IN 30 D, INTRAMUSCULAR;SEE IMAGE</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>ANTIVIRAL PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051106</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SYNAGIS</medicinalproduct>
        <drugdosagetext>100 MG, 1 IN 30 D, INTRAMUSCULAR;SEE IMAGE</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>ANTIVIRAL PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051208</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SYNAGIS</medicinalproduct>
        <drugdosagetext>100 MG, 1 IN 30 D, INTRAMUSCULAR;SEE IMAGE</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>ANTIVIRAL PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060103</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056307-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060720</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050907</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHNU2005DE03109</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>76</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>60</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>AGGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HALLUCINATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENTAL DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EMSELEX EXTENDED RELEASE</medicinalproduct>
        <drugauthorizationnumb>21513</drugauthorizationnumb>
        <drugdosagetext>1 DF, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>URGE INCONTINENCE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050831</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050905</drugenddate>
        <drugtreatmentduration>8640</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARBIDOPA + LEVODOPA</medicinalproduct>
        <drugdosagetext>1 DF, TID</drugdosagetext>
        <drugindication>PARKINSON'S DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIFROL</medicinalproduct>
        <drugdosagetext>1 DF, TID</drugdosagetext>
        <drugindication>PARKINSON'S DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugindication>HALLUCINATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056308-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060720</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060707</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2006US08818</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>24</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DISEASE RECURRENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THERAPEUTIC RESPONSE UNEXPECTED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZELNORM</medicinalproduct>
        <drugauthorizationnumb>021200</drugauthorizationnumb>
        <drugdosagetext>UNK, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZELNORM</medicinalproduct>
        <drugauthorizationnumb>021200</drugauthorizationnumb>
        <drugdosagetext>UNK, UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROTONIX</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROTONIX</medicinalproduct>
        <drugdosagetext>UNK, UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056309-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060720</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060706</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2006BR10652</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugauthorizationnumb>021223</drugauthorizationnumb>
        <drugdosagetext>UNK, UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PROSTATE CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056310-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060703</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2005047340</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>53</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>100</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ACTIVITIES OF DAILY LIVING IMPAIRED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>APHASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>APRAXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BALANCE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CHOLESTEROL INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PH DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD TRIGLYCERIDES INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CANDIDIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBRAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DENTAL CARIES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISTURBANCE IN ATTENTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPHASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPRAXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EXTENSOR PLANTAR RESPONSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FACIAL PARESIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GRAND MAL CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERREFLEXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LACTOBACILLUS INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MASTICATION DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEMORY IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MONOPARESIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOTOR DYSFUNCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUROGENIC BLADDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL CANDIDIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL MUCOSAL DISCOLOURATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARTIAL SEIZURES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERIODONTITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PUPILS UNEQUAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPASTIC PARAPLEGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPEECH DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STREPTOCOCCAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TARDIVE DYSKINESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TEMPERATURE INTOLERANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TONGUE BLACK HAIRY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTH DECALCIFICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTH DISCOLOURATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTH EROSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTH HYPOPLASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTH LOSS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugauthorizationnumb>21446</drugauthorizationnumb>
        <drugdosagetext>150 MG (75 MG, 2 IN 1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>EPILEPSY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040930</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050316</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CITALOPRAM HYDROBROMIDE</medicinalproduct>
        <drugdosagetext>(1 IN 1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BLOPRESS (CANDESARTAN CILEXETIL)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONIDINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL SUCCINATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALL OTHER THERAPEUTIC PRODUCTS (ALL OTHER THERAPEUTIC PRODUCTS)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPAMAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BACLOFEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CHLORHEXAMED (CHLORHEXIDINE GLUCONATE)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056312-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060703</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006073800</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>51</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUCOUS MEMBRANE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA MOUTH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWELLING FACE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugauthorizationnumb>21446</drugauthorizationnumb>
        <drugdosagetext>75 MG (75 MG, 1 IN 1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANXIETY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060604</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060604</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXAMPHETAMINE (DEXAMFETAMINE)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056313-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060706</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>MEDI-0004741</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>10</patientonsetage>
      <patientonsetageunit>802</patientonsetageunit>
      <reaction>
        <reactionmeddrapt>BRONCHIOLITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SYNAGIS</medicinalproduct>
        <drugdosagetext>100 MG, 1 IN 1 M, INTRAMUSCULAR; SEE IMAGE</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>ANTIVIRAL PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051025</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060221</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SYNAGIS</medicinalproduct>
        <drugdosagetext>100 MG, 1 IN 1 M, INTRAMUSCULAR; SEE IMAGE</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>ANTIVIRAL PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050124</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SYNAGIS</medicinalproduct>
        <drugdosagetext>100 MG, 1 IN 1 M, INTRAMUSCULAR; SEE IMAGE</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>ANTIVIRAL PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051025</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SYNAGIS</medicinalproduct>
        <drugdosagetext>100 MG, 1 IN 1 M, INTRAMUSCULAR; SEE IMAGE</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>ANTIVIRAL PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051129</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SYNAGIS</medicinalproduct>
        <drugdosagetext>100 MG, 1 IN 1 M, INTRAMUSCULAR; SEE IMAGE</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>ANTIVIRAL PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051220</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056314-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060703</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006073816</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>73</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>32.9</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ANOREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CREATININE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD POTASSIUM INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD UREA INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERNATIONAL NORMALISED RATIO INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METABOLIC ACIDOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTI-ORGAN FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROTHROMBIN TIME PROLONGED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOSIS IN DEVICE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYVOX</medicinalproduct>
        <drugauthorizationnumb>21130</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugindication>STAPHYLOCOCCAL INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040318</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040426</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYVOX</medicinalproduct>
        <drugauthorizationnumb>21130</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugindication>STAPHYLOCOCCAL INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040523</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040624</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYVOX</medicinalproduct>
        <drugauthorizationnumb>21130</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugindication>STAPHYLOCOCCAL INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040713</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040907</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYVOX</medicinalproduct>
        <drugauthorizationnumb>21130</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugindication>STAPHYLOCOCCAL INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040702</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOGMATYL (SULPIRIDE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MUCOSTA (REBAMIPIDE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMEDIN CAPSULE (BENFOTIAMINE, CYANOCOBALAMIN, PYRIDOXINE HYDROCHLOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FAMOTIDINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POSTERISAN FORTE (ESCHERICHIA COLI, LYOPHILIZED, HYDROCORTISONE, LANOL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056315-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060706</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006074044</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>68</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SURGERY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELEBRA (CELECOXIB)</medicinalproduct>
        <drugauthorizationnumb>20998</drugauthorizationnumb>
        <drugdosagetext>200 MG (200 MG, 1 IN 1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SYNOVITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NATRILIX (INDAPAMIDE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056316-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060705</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006065610</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>71</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>86</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SOMAVERT</medicinalproduct>
        <drugauthorizationnumb>21106</drugauthorizationnumb>
        <drugdosagetext>10 MG (10 MG, DAILY), SUBCUTANEOUS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>ACROMEGALY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROZAC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FORLAX (MACROGOL)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KERLONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAHOR (ATORVASTATIN)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MIXTARD HUMAN 70/30</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056317-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060710</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006P1000303</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>42</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>100</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ATELECTASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATOCRIT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RETEPLASE (RETEPLASE)</medicinalproduct>
        <drugdosagetext>IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ACUTE MYOCARDIAL INFARCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060328</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060328</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REOPRO</medicinalproduct>
        <drugdosagetext>IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ACUTE MYOCARDIAL INFARCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060328</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060328</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BISOPROLOL FUMARATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETYLSALICYLATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM GLUCONATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLOPIDOGREL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056318-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060711</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DEWYE828827JUN06</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>14</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>EXTRAPYRAMIDAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VENLAFAXINE HCL</medicinalproduct>
        <drugauthorizationnumb>20151</drugauthorizationnumb>
        <drugdosagetext>UNKNOWN OVERDOSE AMOUNT</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060626</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060626</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHADONE HCL</medicinalproduct>
        <drugdosagetext>UNKNOWN OVERDOSE AMOUNT</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060626</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060626</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIRTAZAPINE</medicinalproduct>
        <drugdosagetext>UNKNOWN OVERDOSE AMOUNT</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060626</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060626</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OPIOIDS (OPIOIDS)</medicinalproduct>
        <drugdosagetext>UNKNOWN OVERDOSE AMOUNT</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060626</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060626</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAXILAN (PERAZINE)</medicinalproduct>
        <drugdosagetext>30 TABLETS (OVERDOSE AMOUNT UNKNOWN)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060626</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060626</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOPICLONE (ZOPICLONE)</medicinalproduct>
        <drugdosagetext>UNKNOWN OVERDOSE AMOUNT</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060626</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060626</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056319-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060720</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2006US08530</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>50</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BONE MARROW FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EXPOSURE TO TOXIC AGENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HERPETIC STOMATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIP HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL FUNGAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCYTOPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GLEEVEC</medicinalproduct>
        <drugauthorizationnumb>021588</drugauthorizationnumb>
        <drugdosagetext>UNK MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CHRONIC MYELOID LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031126</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060616</drugenddate>
        <drugtreatmentduration>934</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN E</medicinalproduct>
        <drugdosagetext>100 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN CAP</medicinalproduct>
        <drugdosagetext>1 DF, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASCORBIC ACID</medicinalproduct>
        <drugdosagetext>1 DF, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056320-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060720</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060710</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2006IT10442</companynumb>
    <primarysource>
      <reportercountry>ITALY</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>74</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ORAL SURGERY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOMYELITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugauthorizationnumb>021223</drugauthorizationnumb>
        <drugdosagetext>4 MG, EVERY 1 MONTH</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>METASTASES TO BONE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050401</drugenddate>
        <drugtreatmentduration>732</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENANTONE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056321-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060705</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DEWYE149017NOV05</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>70</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPTIC SHOCK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENTRICULAR TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GEMTUZUMAB OZOGAMICIN</medicinalproduct>
        <drugauthorizationnumb>21174</drugauthorizationnumb>
        <drugdosagetext>12.18 MG</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051110</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYTARABINE</medicinalproduct>
        <drugdosagetext>1435 MG CUMULATIVE DOSE</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051122</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051130</drugenddate>
        <drugtreatmentduration>9</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ETOPOSIDE</medicinalproduct>
        <drugdosagetext>615 MG CUMULATIVE DOSE</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051122</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051124</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NOVANTRONE</medicinalproduct>
        <drugdosagetext>28.7 MG CUMULATIVE DOSE</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051126</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051128</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056322-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060704</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>HQWYE374826JUN06</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>20</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NASOPHARYNGITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY ARTERY THROMBOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVONORGESTREL + ETHINYL ESTRADIOL</medicinalproduct>
        <drugauthorizationnumb>19192</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ENDOMETRIOSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060620</drugenddate>
        <drugtreatmentduration>20</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056323-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060703</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GBWYE942803JUL06</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ACOUSTIC STIMULATION TESTS ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FACIAL PARESIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEMIPARESIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEONATAL DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EFFEXOR XR</medicinalproduct>
        <drugauthorizationnumb>20699</drugauthorizationnumb>
        <drugdosagetext>225 MG ; 150 MG</drugdosagetext>
        <drugadministrationroute>064</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051230</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOPLICLONE (ZOPLICLONE)</medicinalproduct>
        <drugdosagetext>7.5 MG</drugdosagetext>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050201</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056324-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060713</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DEWYE828827JUN06</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>14</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG SCREEN POSITIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EXTRAPYRAMIDAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDE ATTEMPT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VENLAFAXINE HCL</medicinalproduct>
        <drugauthorizationnumb>20151</drugauthorizationnumb>
        <drugdosagetext>UNKNOWN OVERDOSE AMOUNT</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060626</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060626</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHADONE HCL</medicinalproduct>
        <drugdosagetext>UNKNOWN OVERDOSE AMOUNT</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060626</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060626</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIRTAZAPINE</medicinalproduct>
        <drugdosagetext>UNKNOWN OVERDOSE AMOUNT</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OPIOIDS (OPIOIDS)</medicinalproduct>
        <drugdosagetext>UNKNOWN OVERDOSE AMOUNT</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060626</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060626</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAXILAN       (PERAZINE)</medicinalproduct>
        <drugdosagetext>30 TABLETS (OVERDOSE AMOUNT UNKNOWN)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060626</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060626</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOPICLONE (ZOPICLONE)</medicinalproduct>
        <drugdosagetext>UNKNOWN OVERDOSE AMOUNT</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060626</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060626</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056325-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060704</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006062262</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>69</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONJUNCTIVAL IRRITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DERMATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENITAL LESION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GLOSSITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOALBUMINAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PENIS DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN LESION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN ULCER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUTENT</medicinalproduct>
        <drugauthorizationnumb>21968</drugauthorizationnumb>
        <drugdosagetext>50 MG (50 MG, 1 IN 1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RENAL CELL CARCINOMA STAGE UNSPECIFIED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060115</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060212</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUTENT</medicinalproduct>
        <drugauthorizationnumb>21968</drugauthorizationnumb>
        <drugdosagetext>50 MG (50 MG, 1 IN 1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RENAL CELL CARCINOMA STAGE UNSPECIFIED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060228</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060328</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUTENT</medicinalproduct>
        <drugauthorizationnumb>21968</drugauthorizationnumb>
        <drugdosagetext>50 MG (50 MG, 1 IN 1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RENAL CELL CARCINOMA STAGE UNSPECIFIED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060414</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060508</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CEFTRIAXONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMOXICILINA  CLAVULANICO (AMOXICILLIN TRIHYDRATE, CLAVULANIC ACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANTOPRAZOLE SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ESOMEPRAZOLE (ESOMEPRAZOLE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROXYZINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MACROGOL (MACROGOL)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LACRYVISC (CARBOMER)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BETAMETHASONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PAROXETINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONAZEPAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMITRIPTYLINE (AMITRIPTYLINE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MICROLAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALACYCLOVIR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SULFADIAZINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLEDRONIC ACID (ZOLEDRONIC ACID)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENOXAPARIN SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHYLPREDNISOLONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MORPHINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LERCANIDIPINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACITRETIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BLOOD TRANSFUSION, AUXILIARY PRODUCTS (BLOOD TRANSFUSION, AUXILIARY PR</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056326-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060720</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050908</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2005US10088</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>63</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ATRIAL FIBRILLATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD ELECTROLYTES ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUID RETENTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPONATRAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GLEEVEC</medicinalproduct>
        <drugauthorizationnumb>21588</drugauthorizationnumb>
        <drugdosagetext>300 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CHRONIC MYELOID LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060705</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GLEEVEC</medicinalproduct>
        <drugauthorizationnumb>021588</drugauthorizationnumb>
        <drugdosagetext>UNK, NO TREATMENT</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060605</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GLEEVEC</medicinalproduct>
        <drugauthorizationnumb>021588</drugauthorizationnumb>
        <drugdosagetext>600 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050613</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050722</drugenddate>
        <drugtreatmentduration>57600</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GLEEVEC</medicinalproduct>
        <drugauthorizationnumb>021588</drugauthorizationnumb>
        <drugdosagetext>100 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HUMALOG</medicinalproduct>
        <drugdosagetext>SLIDING SCALE PRN</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOXYL</medicinalproduct>
        <drugdosagetext>0.75 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPOTHYROIDISM</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugdosagetext>20 MG, QHS</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TENORMIN</medicinalproduct>
        <drugdosagetext>75 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
        <drugdosagetext>2.5 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050810</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ELAVIL</medicinalproduct>
        <drugdosagetext>20 MG, QHS</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REGLAN                                  /USA/</medicinalproduct>
        <drugdosagetext>10 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACTONEL</medicinalproduct>
        <drugdosagetext>35 MG, QW</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOPROX</medicinalproduct>
        <drugdosagetext>UNK, BID</drugdosagetext>
        <drugadministrationroute>061</drugadministrationroute>
        <drugindication>ONYCHOMYCOSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMOXICILLIN</medicinalproduct>
        <drugdosagetext>UNK, PRN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANTIBIOTIC PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETYLSALICYLIC ACID SRT</medicinalproduct>
        <drugdosagetext>81 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM WITH VITAMIN D</medicinalproduct>
        <drugdosagetext>1 DF, TID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN B COMPLEX CAP</medicinalproduct>
        <drugdosagetext>1 DF, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056327-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060720</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060703</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2006MX10630</companynumb>
    <primarysource>
      <reportercountry>MEXICO</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>63</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPHIL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCYTOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GLEEVEC</medicinalproduct>
        <drugauthorizationnumb>021588</drugauthorizationnumb>
        <drugdosagetext>200 MG/D</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CHRONIC MYELOID LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060410</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060508</drugenddate>
        <drugtreatmentduration>41760</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056328-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060720</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060712</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2006NL10434</companynumb>
    <primarysource>
      <reportercountry>NETHERLANDS</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>52</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCAGON DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL STROMAL TUMOUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSULIN C-PEPTIDE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSULIN-LIKE GROWTH FACTOR DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSULIN-LIKE GROWTH FACTOR INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALIGNANT NEOPLASM PROGRESSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMATINIB</medicinalproduct>
        <drugauthorizationnumb>21588</drugauthorizationnumb>
        <drugdosagetext>400 MG, QD</drugdosagetext>
        <drugindication>GASTROINTESTINAL STROMAL TUMOUR</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056329-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060720</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060711</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHFR2006GB02199</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>NEOPLASM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GLEEVEC</medicinalproduct>
        <drugauthorizationnumb>021588</drugauthorizationnumb>
        <drugdosagetext>400 MG/DAY</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>CHRONIC MYELOID LEUKAEMIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056330-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060704</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006065076</companynumb>
    <primarysource>
      <reportercountry>PORTUGAL</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>71</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>63</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BRADYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugauthorizationnumb>21446</drugauthorizationnumb>
        <drugdosagetext>150 MG (75 MG, 2 IN 1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCIATICA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060426</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060427</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADALGUR (GLAFENINE, MEPROBAMATE, THIOCOLCHICOSIDE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ISMO</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BISOPROLOL FUMARATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLINDIX (ISOSORBIDE DINITRATE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALPRAZOLAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056332-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060710</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>L06-KOR-02677-01</companynumb>
    <primarysource>
      <reportercountry>KOREA, REPUBLIC OF</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG RASH WITH EOSINOPHILIA AND SYSTEMIC SYMPTOMS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARBAMAZEPINE</medicinalproduct>
        <drugauthorizationnumb>70231</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VALPROATE SODIUM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056333-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060627</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006065400</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>39</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>72.5755</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCREASED APPETITE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugauthorizationnumb>21446</drugauthorizationnumb>
        <drugdosagetext>150 MG 75 MG, 2 IN 1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NEURALGIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060411</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060501</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CITALOPRAM HYDROBROMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONAZEPAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMITRIPTYLINE (AMITRIPTYLINE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GABAPENTIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056335-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060705</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>L06-CAN-02655-01</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>50</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANAEMIA MACROCYTIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BALANCE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE MARROW TOXICITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DERMATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG LEVEL INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EPIDERMAL NECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAMMA-GLUTAMYLTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOREFLEXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEAN CELL VOLUME INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPHIL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SENSORY DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARBAMAZEPINE</medicinalproduct>
        <drugauthorizationnumb>70231</drugauthorizationnumb>
        <drugdosagetext>400 MG TID</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARBAMAZEPINE</medicinalproduct>
        <drugdosagetext>400 MG BID</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARBAMAZEPINE</medicinalproduct>
        <drugdosagetext>400 MG TID</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARBAMAZEPINE</medicinalproduct>
        <drugdosagetext>400 MG BID</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LOPINAVIR/ RITONAVIR</medicinalproduct>
        <drugdosagetext>3 CAPSULE BID</drugdosagetext>
        <drugindication>HIV INFECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NELFINAVIR</medicinalproduct>
        <drugindication>HIV INFECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NELFINAVIR</medicinalproduct>
        <drugdosagetext>1250 MG BID</drugdosagetext>
        <drugindication>HIV INFECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TENOFOVIR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LAMIVUDINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056337-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060703</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006057187</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>57</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>49</patientweight>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ASCITES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTERIXIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD ALBUMIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD FIBRINOGEN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMA HEPATIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ENCEPHALOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATITIS B</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATITIS FULMINANT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMMUNOSUPPRESSION</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>IDARUBICIN HYDROCHORIDE POWDER, STERILE (IDARUBICIN HYDROCHLORIDE)</medicinalproduct>
        <drugauthorizationnumb>50661</drugauthorizationnumb>
        <drugdosagetext>18 MG (18 MG, QD), INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ACUTE MYELOID LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050614</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050616</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYTARABINE</medicinalproduct>
        <drugdosagetext>280 MG (93.3 MG, TID), INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ACUTE MYELOID LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050614</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050724</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MITOXANTRONE</medicinalproduct>
        <drugdosagetext>10 MG (10 MG, QD), INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ACUTE MYELOID LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050720</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050724</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VANCOMYCIN HYDROCHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ITRACONAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SULFAMETHOXAZOLE + TRIMETHOPRIM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEROPEN (MEROPENEM)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMIKACIN SULFATE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056338-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060720</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-ROCHE-453551</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>56</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>LEUKOCYTOCLASTIC VASCULITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VASCULAR PURPURA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VALIUM</medicinalproduct>
        <drugauthorizationnumb>13263</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060516</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERDAL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060503</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TERCIAN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060503</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>THERALENE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060516</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ANAFRANIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060516</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056339-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060720</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040827</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ROCHE-379225</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>9</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>23</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CHOLECYSTITIS CHRONIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHOLELITHIASIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ROCEPHIN</medicinalproduct>
        <drugauthorizationnumb>50585</drugauthorizationnumb>
        <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 HCL</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>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NICARDIPINE HYDROCHLORIDE</medicinalproduct>
        <drugdosagetext>0.4MCG/KG/MIN</drugdosagetext>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</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>HEPARIN SODIUM</medicinalproduct>
        <drugdosagetext>10IU/KG/H</drugdosagetext>
        <drugadministrationroute>041</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040721</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056340-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060720</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060710</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-454545</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>63</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>57.8</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ATRIAL FIBRILLATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHILLS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEBRILE NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CAPECITABINE</medicinalproduct>
        <drugbatchnumb>U5089</drugbatchnumb>
        <drugauthorizationnumb>20896</drugauthorizationnumb>
        <drugdosagetext>DAYS 1 TO 14</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060608</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CAPECITABINE</medicinalproduct>
        <drugbatchnumb>U5089</drugbatchnumb>
        <drugauthorizationnumb>020896</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060629</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAXOTERE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060608</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAXOTERE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060629</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAPAZOL</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000615</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TUMS</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030615</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
        <drugdosagetext>DOSING FREQUENCY :PRN</drugdosagetext>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060612</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056341-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060720</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041001</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-382207</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>28</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>81.6</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ALCOHOLISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRITIS ENTEROPATHIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CORTISOL DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD IRON DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRONCHITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARPAL TUNNEL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLITIS ULCERATIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONTUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CORNEAL ABRASION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CROHN'S DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CRUSH INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CYST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DECREASED APPETITE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DERMATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG DOSE OMISSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EUSTACHIAN TUBE OBSTRUCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING COLD</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUID INTAKE REDUCED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FOREIGN BODY IN EYE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROOESOPHAGEAL REFLUX DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GRAND MAL CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAND FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC STEATOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HORDEOLUM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFECTIOUS MONONUCLEOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LETHARGY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOCALISED INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE STRAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NIGHT SWEATS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ONYCHOCLASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OTITIS EXTERNA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OTITIS MEDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARONYCHIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PEPTIC ULCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSEUDOPOLYPOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHEUMATOID ARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHINITIS ALLERGIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ROAD TRAFFIC ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SACROILIITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUSITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPONDYLITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THIRST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TONGUE GEOGRAPHIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRACHEOBRONCHITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRIGGER FINGER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TYMPANIC MEMBRANE PERFORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UPPER RESPIRATORY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VARICOSE VEIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VASOCONSTRICTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VIRAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VIRAL PHARYNGITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WOUND</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>18662</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19851122</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19860624</drugenddate>
        <drugtreatmentduration>215</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056342-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060720</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ROCHE-453330</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>68</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>INTERSTITIAL LUNG DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STOMACH DISCOMFORT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HORIZON</medicinalproduct>
        <drugauthorizationnumb>13263</drugauthorizationnumb>
        <drugdosagetext>TAKEN WHEN NEEDED</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INSOMNIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010615</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060620</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERLIPIDAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060315</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060615</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEPRICOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARRHYTHMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010615</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060615</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056343-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060720</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-453656</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>55</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>63.5</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DUPUYTREN'S CONTRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERKERATOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALMAR-PLANTAR ERYTHRODYSAESTHESIA SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XELODA</medicinalproduct>
        <drugauthorizationnumb>020896</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060115</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FEMARA</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056344-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060720</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20051019</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-ROCHE-422286</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>2.5</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>NO ADVERSE EFFECT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NORMAL NEWBORN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PREGNANCY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ROACUTAN</medicinalproduct>
        <drugauthorizationnumb>18662</drugauthorizationnumb>
        <drugindication>ACNE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050930</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051015</drugenddate>
        <drugtreatmentduration>16</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEPAKOTE</medicinalproduct>
        <drugindication>DEPRESSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056345-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060720</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060602</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-451166</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>33</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>48.5</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEMALE SEXUAL AROUSAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INADEQUATE LUBRICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORGASM ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEXUAL DYSFUNCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>018662</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050315</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051001</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056346-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060712</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GBWYE130312JUL06</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>18</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>INTENTIONAL SELF-INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCREATITIS ACUTE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
        <drugauthorizationnumb>18989</drugauthorizationnumb>
        <drugdosagetext>400 MG 7X PER 1 DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056347-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060703</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>HQWYE550325MAY06</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>31</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CHRONIC ALLOGRAFT NEPHROPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATOCRIT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MICROANGIOPATHY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RAPAMUNE</medicinalproduct>
        <drugauthorizationnumb>21110</drugauthorizationnumb>
        <drugdosagetext>2 MG 1X PER 1 DAY ; 4X MG 1X PER 1 DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS AGAINST TRANSPLANT REJECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050614</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060523</drugenddate>
        <drugtreatmentduration>344</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RAPAMUNE</medicinalproduct>
        <drugauthorizationnumb>21110</drugauthorizationnumb>
        <drugdosagetext>2 MG 1X PER 1 DAY ; 4X MG 1X PER 1 DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS AGAINST TRANSPLANT REJECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060524</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060628</drugenddate>
        <drugtreatmentduration>36</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE TAB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SULFAMETHOXAZOLE + TRIMETHOPRIM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056348-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060703</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006034468</companynumb>
    <primarysource>
      <reportercountry>BELGIUM</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>54</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>85</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BRADYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CRYING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ELECTROLYTE IMBALANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FOAMING AT MOUTH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERAL PHYSICAL HEALTH DETERIORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GRAND MAL CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IATROGENIC INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NOSOCOMIAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMOTHORAX</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRODUCTIVE COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY ARTERIAL PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY VENO-OCCLUSIVE DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATION ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SLEEP DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TONIC CLONIC MOVEMENTS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENTRICULAR DYSFUNCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SILDENAFIL (PAH) (SILDENAFIL)</medicinalproduct>
        <drugauthorizationnumb>21845</drugauthorizationnumb>
        <drugdosagetext>240 MG (80 MG, 3 IN 1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030903</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLOLAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRACLEER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LESCOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM CARBONATE (CALCIUM CARBONATE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGNESIUM CARBONATE (MAGNESIUM CARBONATE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SODIUM HYDROGEN CARBONATE (SODIUM BICARBONATE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZESTRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANTOZOL (PANTOPRAZOLE SODIUM)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SACCHAROMYCES BOULARDII (SACCHAROMYCES BOULARDII)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EPOETIN BETA (EPOETIN BETA)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MYOLASTAN (TETRAZEPAM)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTIVITAMINS, COMBINATIONS (MULTIVITAMINS, COMBINATIONS)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENGERIX-B</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOPERAMIDE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IRON PREPARTIONS (IRON PREPARATIONS)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LITICAN (ALIZAPRIDE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYOSCINE HBR HYT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PHENPROCOUMON (PHENPROCOUMON)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HERBAL NOS/VITAMINS NOS (HERBAL NOS, VITAMINS NOS)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METRONIDAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TREPROSTINOL (TREPROSTINOL)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056349-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060713</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>HQWYE408420MAR06</companynumb>
    <primarysource>
      <reportercountry>SINGAPORE</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>44</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ATELECTASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD GASES ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CALCINOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHOLECYSTITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EOSINOPHILIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GRANULOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEUKOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG CONSOLIDATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MARROW HYPERPLASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLEURAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RAPAMUNE</medicinalproduct>
        <drugauthorizationnumb>21110</drugauthorizationnumb>
        <drugdosagetext>2 MG 2X PER 1 DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS AGAINST TRANSPLANT REJECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051026</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060401</drugenddate>
        <drugtreatmentduration>158</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELLCEPT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056350-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060710</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>L06-GER-02679-01</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>60</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ACUTE GENERALISED EXANTHEMATOUS PUSTULOSIS</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>CONJUNCTIVITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DERMATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMPAIRED HEALING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUCOSAL EROSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL MUCOSA EROSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN EXFOLIATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN TEST POSITIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DILTIAZEM HCL</medicinalproduct>
        <drugauthorizationnumb>20401</drugauthorizationnumb>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056351-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060703</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>HQWYE542503JUL06</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>80</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ALANINE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ALDOLASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ALVEOLITIS</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>HYPOXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOSITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CORDARONE</medicinalproduct>
        <drugauthorizationnumb>18972</drugauthorizationnumb>
        <drugdosagetext>200 MG 1X PER 1 DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATRIAL FLUTTER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060413</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060523</drugenddate>
        <drugtreatmentduration>41</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ATACAND</medicinalproduct>
        <drugdosagetext>8 MG 1X PER 1 DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ESSENTIAL HYPERTENSION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060520</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugdosagetext>20 G 1X PER 1 DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060520</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREVISCAN (FLUINDIONE)</medicinalproduct>
        <drugdosagetext>20 MG FREQUENCY UNSPECIFIED</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060522</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TENORMIN</medicinalproduct>
        <drugdosagetext>25 MG 1X PER 1 DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ESSENTIAL HYPERTENSION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060522</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugdosagetext>40 MG 1X PER 1 DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CARDIOVASCULAR EVENT PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060522</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056352-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060704</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>HQWYE561205JUL06</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>84</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HAEMATURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERNATIONAL NORMALISED RATIO INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY RETENTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PANTOPRAZOLE SODIUM</medicinalproduct>
        <drugauthorizationnumb>20987</drugauthorizationnumb>
        <drugdosagetext>40 MG 1X PER 1 DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060522</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIGOXIN</medicinalproduct>
        <drugdosagetext>0.125 MG 1X PER 1 DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060522</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LORAZEPAM</medicinalproduct>
        <drugdosagetext>1 MG 1X PER 1 DAY</drugdosagetext>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060522</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACARBOSE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REPAGLINIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MIRTAZAPINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056353-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006037240</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>78</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>71.3</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ALANINE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASPARTATE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD GASES ABNORMAL</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 URINE PRESENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BODY TEMPERATURE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC FUNCTION ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERAMYLASAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERBILIRUBINAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERSTITIAL LUNG DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METABOLIC ACIDOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLEURAL EFFUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL TUBULAR DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>YELLOW SKIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUTENT</medicinalproduct>
        <drugauthorizationnumb>21968</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RENAL CELL CARCINOMA STAGE UNSPECIFIED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060313</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUTENT</medicinalproduct>
        <drugauthorizationnumb>21968</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RENAL CELL CARCINOMA STAGE UNSPECIFIED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060412</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060420</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CANDESARTAN CILEXETIL (CANDESARTAN CILEXETIL)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>I.V. SOLUTIONS (I.V. SOLUTIONS)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOSE (GLUCOSE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FAMOTIDINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIFLUCORTOLONE VALERATE (DIFLUCORTOLONE VALERATE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIDOCAINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE BESILATE (AMLODIPINE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SENNOSIDE A+B (SENNOSIDE A+B)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056354-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060704</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>HQWYE561505JUL06</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>81</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>AGRANULOCYTOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CREATININE RENAL CLEARANCE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INIPOMP (PANTOPRAZOLE)</medicinalproduct>
        <drugauthorizationnumb>20987</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
        <drugdosagetext>DF</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060402</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060504</drugenddate>
        <drugtreatmentduration>33</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INDAPAMIDE</medicinalproduct>
        <drugdosagetext>DF</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060412</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060510</drugenddate>
        <drugtreatmentduration>29</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIRTAZAPINE</medicinalproduct>
        <drugdosagetext>DF</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060323</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060510</drugenddate>
        <drugtreatmentduration>49</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OFLOXACIN</medicinalproduct>
        <drugdosagetext>DF</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060427</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060508</drugenddate>
        <drugtreatmentduration>12</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugdosagetext>DF</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060506</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060510</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CITALOPRAM HYDROBROMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAHOR (ATORVASTATIN)</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RAMIPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIGOXIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM CHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIPARINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVENOX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENOXAPARIN SODIUM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056355-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060711</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>HQWYE408420MAR06</companynumb>
    <primarysource>
      <reportercountry>SINGAPORE</reportercountry>
    </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>ATELECTASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD ALKALINE PHOSPHATASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHOLECYSTITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EOSINOPHILIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMMUNOSUPPRESSANT DRUG LEVEL DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMMUNOSUPPRESSANT DRUG LEVEL INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG CONSOLIDATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MARROW HYPERPLASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEPHROLITHIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLEURAL FIBROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POSTOPERATIVE ILEUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY CALCIFICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY CONGESTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL CYST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RAPAMUNE</medicinalproduct>
        <drugauthorizationnumb>21110</drugauthorizationnumb>
        <drugdosagetext>2 MG 2X PER 1 DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS AGAINST TRANSPLANT REJECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051026</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060401</drugenddate>
        <drugtreatmentduration>158</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELLCEPT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056356-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060704</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>S06-FRA-02576-01</companynumb>
    <primarysource>
      <reportercountry>DENMARK</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>54</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CLONUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HOT FLUSH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SALIVARY HYPERSECRETION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPEECH DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROPLEX (ESCITALOPRAM)</medicinalproduct>
        <drugauthorizationnumb>21323</drugauthorizationnumb>
        <drugdosagetext>1 UNITS QD PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060516</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060516</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BUFLOMEDIL</medicinalproduct>
        <drugdosagetext>300 MG BID PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060516</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANSOPRAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXAZEPAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FORLAX (MACROGOL)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROPOFOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SEDATIF PC</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056357-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060720</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-434355</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>28</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>NO ADVERSE EFFECT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PREGNANCY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>18662</drugauthorizationnumb>
        <drugdosagetext>IT WAS REPORTED THAT SHE RECEIVED SOME ISOTRETINOIN (ACCUTANE) AND SOME GENERIC ISOTRETINOIN (CLARA+</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ACNE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050320</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050626</drugenddate>
        <drugtreatmentduration>99</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLARAVIS</medicinalproduct>
        <drugdosagetext>IT WAS REPORTED THAT SHE RECEIVED SOME ISOTRETINOIN (ACCUTANE) AND SOME GENERIC ISOTRETINOIN (CLARA+</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>ACNE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050320</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050625</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>YASMIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056359-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060720</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060527</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-449866</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>53</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>90.7</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEGASYS</medicinalproduct>
        <drugbatchnumb>B0091</drugbatchnumb>
        <drugdosagetext>WEEKLY.</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060519</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060526</drugenddate>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEGASYS</medicinalproduct>
        <drugbatchnumb>B0091</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060616</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060623</drugenddate>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RIBAVIRIN</medicinalproduct>
        <drugauthorizationnumb>021511</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060519</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060526</drugenddate>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RIBAVIRIN</medicinalproduct>
        <drugauthorizationnumb>021511</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060616</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
        <drugdosagetext>WITHHELD DURING HOSPITALISATION.</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GOUT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ESTRADIOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MENOPAUSE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDROXYPROGESTERONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MENOPAUSE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
        <drugdosagetext>600 MG QID PRN.</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROTONIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTIVITAMIN NOS</medicinalproduct>
        <drugdosagetext>DAILY.</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MILK THISTLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOSAMINE SULFATE/CHONDROITIN</medicinalproduct>
        <drugdosagetext>DAILY.</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056360-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060710</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>HQWYE516124MAY06</companynumb>
    <primarysource>
      <reportercountry>ARGENTINA</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>50</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SMALL INTESTINAL OBSTRUCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RAPAMUNE (SIROLIMUS, TABLET) LOT NO.: 2005P0566</medicinalproduct>
        <drugauthorizationnumb>21110</drugauthorizationnumb>
        <drugdosagetext>5 MG 1X PER 1 DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS AGAINST TRANSPLANT REJECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060521</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEPREDNISONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MYCOPHENOLATE MOFETIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENALAPRIL MALEATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATORVASTATIN CALCIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BACTRIM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEUCOVORIN CALCIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALPRAZOLAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN TAB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIPYRONE METAMIZOLE SODIUM)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HEPARIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056361-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060703</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006056004</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>80</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>50</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG TOXICITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERSTITIAL LUNG DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEUKOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IRINOTECAN HCL</medicinalproduct>
        <drugauthorizationnumb>20571</drugauthorizationnumb>
        <drugdosagetext>100 MG/M2 (INTERMITTENT (100 MG)), INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLON CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050802</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060131</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056362-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060720</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20030415</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-336268</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>16</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>65.3</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN UPPER</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>ARTHROPATHY</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>BLOOD MAGNESIUM DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COGNITIVE DISORDER</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>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRY SKIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSARTHRIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EMOTIONAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ENCEPHALOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FIBROMYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FRUSTRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEAD INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ILL-DEFINED DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMMUNE SYSTEM DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMPETIGO</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IRRITABILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JOINT DISLOCATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEARNING DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LETHARGY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEMORY IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOOD ALTERED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE CHEMICAL SENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULAR WEAKNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUROTOXICITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN OF SKIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANIC ATTACK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARALYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUS BRADYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUS TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUSITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SLEEP APNOEA SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SLUGGISHNESS</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>VOMITING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugbatchnumb>2510</drugbatchnumb>
        <drugauthorizationnumb>18662</drugauthorizationnumb>
        <drugdosagetext>LOT NUMBER REPORTED AS 0496, EXP 06/2000</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ACNE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990612</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19990614</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugbatchnumb>2510</drugbatchnumb>
        <drugauthorizationnumb>018662</drugauthorizationnumb>
        <drugdosagetext>LOT NUMBER REPORTED AS 2510, EXP DATE 12/2000</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990614</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19990629</drugenddate>
        <drugtreatmentduration>16</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>3</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>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19960615</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>OMNICEF</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990628</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990629</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADVIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056363-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060720</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060616</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-452298</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>55</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>EMPHYSEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERIPHERAL COLDNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEGASYS</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060331</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COPEGUS</medicinalproduct>
        <drugauthorizationnumb>021511</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060331</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056364-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060720</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060711</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-ROCHE-454771</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>57</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD FIBRINOGEN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>C-REACTIVE PROTEIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RETINAL VEIN THROMBOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RIBAVIRIN</medicinalproduct>
        <drugauthorizationnumb>21511</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051021</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060216</drugenddate>
        <drugtreatmentduration>119</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INTERFERON ALFACON-1</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051021</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060216</drugenddate>
        <drugtreatmentduration>119</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056365-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesscongenitalanomali>1</seriousnesscongenitalanomali>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060720</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060708</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ROCHE-454969</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENTRICULAR SEPTAL DEFECT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAMIFLU</medicinalproduct>
        <drugauthorizationnumb>021087</drugauthorizationnumb>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056366-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesscongenitalanomali>1</seriousnesscongenitalanomali>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060720</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060710</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-455169</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CONGENITAL ANOMALY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PREGNANCY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>018662</drugauthorizationnumb>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19870615</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056367-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060720</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-433858</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>16</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>59</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>COLITIS ULCERATIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROOESOPHAGEAL REFLUX DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ILEUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLAMMATORY BOWEL DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OESOPHAGITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>018662</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ACNE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010515</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20011215</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>018662</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020506</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020815</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056368-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060705</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006018248</companynumb>
    <primarysource>
      <reportercountry>IRELAND</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>77</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBRAL ISCHAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JOINT SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL STIFFNESS</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>CEREBROVASCULAR DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANTOPRAZOLE SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CENTYL K (BENDROFLUMETHIAZIDE, POTASSIUM CHLORIDE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MESULID (NIMESULIDE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOGEN (ATENOLOL)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056369-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060704</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>056-C5013-06070018</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>71</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANGIONEUROTIC OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CC-5013 (LENALIDOMIDE)</medicinalproduct>
        <drugauthorizationnumb>21880</drugauthorizationnumb>
        <drugdosagetext>25 MG, 1 IN 1 D, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060621</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060627</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056370-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060505</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006BH009696</companynumb>
    <primarysource>
      <reportercountry>ITALY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
        <drugauthorizationnumb>87702</drugauthorizationnumb>
        <drugdosagetext>40 MG; EVERY DAY; IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOPHOSPHAMIDE</medicinalproduct>
        <drugdosagetext>400 MG/M**2; IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ETOPOSIDE</medicinalproduct>
        <drugdosagetext>40 MG/M**2; IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CISPLATIN</medicinalproduct>
        <drugdosagetext>10 MG/M**2; IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056371-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060705</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006083828</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE ATROPHY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MEDROXYPROGESTERONE ACETATE</medicinalproduct>
        <drugauthorizationnumb>20246</drugauthorizationnumb>
        <drugdosagetext>(MOST RECENT INJECTION)</drugdosagetext>
        <drugindication>CONTRACEPTION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056372-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060505</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006BH009695</companynumb>
    <primarysource>
      <reportercountry>ITALY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
        <drugauthorizationnumb>87702</drugauthorizationnumb>
        <drugdosagetext>40 MG; EVERY DAY; IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOPHOSPHAMIDE</medicinalproduct>
        <drugdosagetext>400 MG/M**2, IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ETOPOSIDE</medicinalproduct>
        <drugdosagetext>40 MG/M**2; IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CISPLATIN</medicinalproduct>
        <drugdosagetext>10 MG/M**2; IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056373-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060703</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>TAP2006Q01209</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>86</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LUPRON DEPOT-4</medicinalproduct>
        <drugauthorizationnumb>20517</drugauthorizationnumb>
        <drugdosagetext>30 MG, 1 IN 4 M, INTRAMUSCULAR</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>PROSTATE CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050823</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060412</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPIDIL SUPRA (FENOFIBRATE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLOMAX (MORNIFLUMATE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL (METOPROLOL)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANTOLOC (PANTOPRAZOLE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PERINDOPRIL ERBUMINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>APO-HYDRO (HYDROCHLOROTHIAZIDE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TEGRETOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EYE DROPS (TETRYZOLINE HYDROCHLORIDE)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056374-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060704</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006083573</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>79</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EPISTAXIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATEMESIS</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>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZITHROMAX</medicinalproduct>
        <drugauthorizationnumb>50670</drugauthorizationnumb>
        <drugdosagetext>(250 MG), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CAT SCRATCH DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREVISCAN (FLUINDIONE)</medicinalproduct>
        <drugdosagetext>0.5 DF (20 MG, EVERY DAY), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060512</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060521</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GEMFIBROZIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BISOPROLOL FUMARATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CORDARONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056375-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060223</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006BH003804</companynumb>
    <primarysource>
      <reportercountry>TURKEY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>ATRIAL FIBRILLATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIDAZOLAM HCL</medicinalproduct>
        <drugauthorizationnumb>75243</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>SEDATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATROPINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056376-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060720</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060710</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-455006</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>40</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BACK DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BIPOLAR DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUROPATHY PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHOTOPSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STAPHYLOCOCCAL INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEGASYS</medicinalproduct>
        <drugdosagetext>ROUTE REPORTED AS INJECTABLE.</drugdosagetext>
        <drugadministrationroute>050</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RIBAVIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060201</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056377-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060720</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060707</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-454740</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JOINT LOCK</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BONIVA</medicinalproduct>
        <drugauthorizationnumb>021455</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051115</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060515</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056378-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060720</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060710</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-ROCHE-455004</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>31</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>56</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CAESAREAN SECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE BEFORE PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFERTILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POSTPARTUM DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ROACUTAN</medicinalproduct>
        <drugauthorizationnumb>18662</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ACNE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050930</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051015</drugenddate>
        <drugtreatmentduration>16</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEPAKOTE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056379-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060720</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060224</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-438218</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>28</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>81.6</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>EMOTIONAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLAMMATORY BOWEL DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERNAL INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IRRITABLE BOWEL SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>18662</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ACNE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19960606</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19960812</drugenddate>
        <drugtreatmentduration>68</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>018662</drugauthorizationnumb>
        <drugdosagetext>STRENGTH REPORTED BETWEEN 06 JUL 1996 TO 12 AUG 1996 AS 40 MG, AND BETWEEN 23 MAY 1997 TO 25 JUN 19+</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19970523</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19970625</drugenddate>
        <drugtreatmentduration>34</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056380-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060720</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060712</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-455426</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>BREAST CANCER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEGASYS</medicinalproduct>
        <drugdosagetext>ROUTE REPORTED AS INJECTABLE.</drugdosagetext>
        <drugadministrationroute>050</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056381-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060720</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-BRISTOL-MYERS SQUIBB COMPANY-13429550</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>66</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CYANOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAXOL</medicinalproduct>
        <drugauthorizationnumb>20262</drugauthorizationnumb>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060615</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060615</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DECADRON</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>PREMEDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060615</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060615</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RESTAMIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PREMEDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060615</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060615</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KYTRIL</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PREMEDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060615</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060615</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GASTER</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>PREMEDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060615</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060615</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056382-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060720</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20051123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-13193990</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>38</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>106</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEBRILE NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ERBITUX</medicinalproduct>
        <drugdosagetext>INITIATED ON 01-SEP-2005/INTERRUPTED (DATE NOT REPORTED).</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BREAST CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050908</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050908</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARBOPLATIN</medicinalproduct>
        <drugdosagetext>INITIATED ON 01-SEP-2005/INTERRUPTED (DATE NOT REPORTED).</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BREAST CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050908</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050908</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CPT-11</medicinalproduct>
        <drugdosagetext>INITIATED ON 01-SEP-2005/INTERRUPTED (DATE NOT REPORTED).</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BREAST CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050908</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050908</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ERYTHROMYCIN OINTMENT</medicinalproduct>
        <drugindication>RASH</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATIVAN</medicinalproduct>
        <drugindication>PROPHYLAXIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056383-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060720</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060714</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-13443643</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>66</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>70</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROAT IRRITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URTICARIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ERBITUX</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060710</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056384-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060720</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060710</receiptdate>
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      <reportercountry>SOUTH AFRICA</reportercountry>
      <qualification>5</qualification>
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    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PREGNANCY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>018662</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056385-9</safetyreportid>
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    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060720</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060718</receiptdate>
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    <companynumb>PL-BRISTOL-MYERS SQUIBB COMPANY-13446794</companynumb>
    <primarysource>
      <reportercountry>IRELAND</reportercountry>
      <qualification>3</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>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CISPLATIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051010</drugstartdate>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ERBITUX</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051017</drugstartdate>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VINORELBINE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051017</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056386-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060720</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060228</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-BRISTOL-MYERS SQUIBB COMPANY-13297866</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>3</qualification>
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    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>57</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>84</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEBRILE NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEURALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VIRAL INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOPHOSPHAMIDE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060412</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060510</drugenddate>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PACLITAXEL</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060222</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060322</drugenddate>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EPIRUBICIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060105</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060208</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAVANIC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060428</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060505</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EPOETIN BETA</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060105</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060524</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEULASTA</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060106</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060511</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056387-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060720</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060522</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-13385554</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>64</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>GASTROENTERITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ORENCIA</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051110</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051007</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOVAN HCT</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GABAPENTIN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056388-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060720</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20051109</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-BRISTOL-MYERS SQUIBB COMPANY-13177126</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>71</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>73</patientweight>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ACUTE PULMONARY OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>C-REACTIVE PROTEIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEFT VENTRICULAR FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ERBITUX</medicinalproduct>
        <drugbatchnumb>CT1639/2500</drugbatchnumb>
        <drugdosagetext>02 SEP 05, THE MOST RECENT INFUSIONS OF CETUXIMAB(8TH INFUSION)</drugdosagetext>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050714</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CISPLATIN</medicinalproduct>
        <drugdosagetext>27 AUG 05, THE MOST RECENT INFUSION OF CISPLATIN (3RD INFUSION)</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050714</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VINORELBINE</medicinalproduct>
        <drugdosagetext>ON 02 SEP 05, THE MOST RECENT INFUSIONS (6TH INFUSION).</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050714</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ISOSORBIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MOLSIDOMINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETYLSALICYLIC ACID SRT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ONDANSETRON HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE TAB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLEMASTINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RANITIDINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM CHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IPRATROPIUM BROMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FENOTEROL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXAZEPAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOXYCYCLINE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MOVICOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADAPALENE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ESOMEPRAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IBROPROFEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CIPROFLOXACIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUCONAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PIPERACILLIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAZOBACTAM SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SODIUM CHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>STEROFUNDIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYGEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM GLUCONATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMIPENEM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIMENHYDRINATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOLASETRON</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIAZEPAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LENOGRASTIM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOCLOPRAMIDE HCL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056389-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060720</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060522</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-BRISTOL-MYERS SQUIBB COMPANY-13388475</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>68</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>SHOCK</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAXOL</medicinalproduct>
        <drugauthorizationnumb>020262</drugauthorizationnumb>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>LUNG NEOPLASM MALIGNANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060519</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060519</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PARAPLATIN</medicinalproduct>
        <drugauthorizationnumb>019880</drugauthorizationnumb>
        <drugindication>LUNG NEOPLASM MALIGNANT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DECADRON</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>PREMEDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060519</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060519</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GASTER</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>PREMEDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060519</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060519</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CHLOR-TRIMETON</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>PREMEDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060519</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060519</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056390-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060705</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006083582</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>68</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URTICARIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugauthorizationnumb>20702</drugauthorizationnumb>
        <drugdosagetext>(40 MG), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056391-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060720</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060711</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-455409</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </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>IRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UVEITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEGASYS</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050521</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060601</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RIBAVIRIN</medicinalproduct>
        <drugauthorizationnumb>021511</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050521</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060601</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056392-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060720</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060718</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BE-BRISTOL-MYERS SQUIBB COMPANY-13447164</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>77</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ERBITUX</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>SQUAMOUS CELL CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051025</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARBOPLATIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>SQUAMOUS CELL CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051025</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUOROURACIL</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>SQUAMOUS CELL CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051025</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051029</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056393-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060720</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060712</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-455330</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CROHN'S DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLAMMATORY BOWEL DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RECTAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>018662</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980615</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056394-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060720</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060712</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-455464</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>59</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>136.1</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOKALAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEDICATION ERROR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POST PROCEDURAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POST-TRAUMATIC STRESS DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEMADEX</medicinalproduct>
        <drugauthorizationnumb>020136</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040215</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040315</drugenddate>
        <drugtreatmentduration>11</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAXZIDE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040615</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugdosagetext>REPORTED AS LOW DOSE</drugdosagetext>
        <drugindication>SYSTEMIC LUPUS ERYTHEMATOSUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugindication>SYSTEMIC LUPUS ERYTHEMATOSUS</drugindication>
      </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>PLAQUENIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SINGULAIR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL SPIROS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>1 CONCOMITANT DRUG</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056395-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060703</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006-138971-NL</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>33</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEONATAL RESPIRATORY DISTRESS SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PREGNANCY WITH IMPLANT CONTRACEPTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOXOPLASMOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ETONOGESTREL (BATCH #: 761032/774684)</medicinalproduct>
        <drugdosagetext>DF</drugdosagetext>
        <drugindication>CONTRACEPTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050808</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051213</drugenddate>
        <drugtreatmentduration>128</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SERTRALIA IUD</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRAMYCIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056396-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060703</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>EM2006-0335</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>39</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>60</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>METAMORPHOPSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RETINAL DETACHMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VITREOUS FLOATERS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROLEUKIN</medicinalproduct>
        <drugdosagetext>9 MIU, QD, SUBCUTAN.; SEE IMAGE</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021202</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20021206</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROLEUKIN</medicinalproduct>
        <drugdosagetext>9 MIU, QD, SUBCUTAN.; SEE IMAGE</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030217</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030221</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROLEUKIN</medicinalproduct>
        <drugdosagetext>9 MIU, QD, SUBCUTAN.; SEE IMAGE</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030414</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030418</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROLEUKIN</medicinalproduct>
        <drugdosagetext>9 MIU, QD, SUBCUTAN.; SEE IMAGE</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031105</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031109</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROLEUKIN</medicinalproduct>
        <drugdosagetext>9 MIU, QD, SUBCUTAN.; SEE IMAGE</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040409</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040413</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROLEUKIN</medicinalproduct>
        <drugdosagetext>9 MIU, QD, SUBCUTAN.; SEE IMAGE</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040705</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040709</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROLEUKIN</medicinalproduct>
        <drugdosagetext>9 MIU, QD, SUBCUTAN.; SEE IMAGE</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050527</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050531</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROLEUKIN</medicinalproduct>
        <drugbatchnumb>UB1450B</drugbatchnumb>
        <drugdosagetext>9 MIU, QD, SUBCUTAN.</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051028</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEG INTERFERON (INTERFERON ALFA)</medicinalproduct>
        <drugdosagetext>180 UG, QW</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041103</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041130</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RIBAVIRIN</medicinalproduct>
        <drugdosagetext>1200 MG, QD</drugdosagetext>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041103</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041130</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EMTRIVA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VIREAD</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KALETRA</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056397-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060703</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006-145036-NL</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <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>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ETONOGESTREL (BATCH #: 761032/774684)</medicinalproduct>
        <drugdosagetext>DF</drugdosagetext>
        <drugadministrationroute>064</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050809</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051213</drugenddate>
        <drugtreatmentduration>128</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRAMYCIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056398-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060705</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006083603</companynumb>
    <primarysource>
      <reportercountry>IRELAND</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>74</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MUSCULAR WEAKNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugauthorizationnumb>20702</drugauthorizationnumb>
        <drugdosagetext>(10 MG)</drugdosagetext>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALL OTHER THERAPEUTIC PRODUCTS (ALL OTHER THERAPEUTIC  PRODUCTS)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056399-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060704</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006-144948-NL</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HAEMATEMESIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ETONOGESTREL</medicinalproduct>
        <drugdosagetext>DF</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056400-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060705</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>111387ISR</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>70</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LACTIC ACIDOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060416</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS NON-INSULIN-DEPENDENT</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060416</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETYLSALICYLIC ACID SRT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATORVASTATIN CALCIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BISOPROLOL FUMARATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOXAZOSIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SILDENAFIL CITRATE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056401-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060704</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006083619</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>2</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>DISEASE PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPHANGIOSIS CARCINOMATOSA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUTENT</medicinalproduct>
        <drugauthorizationnumb>21938</drugauthorizationnumb>
        <drugdosagetext>50 MG (50 MG, 1 IN 1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060524</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060630</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUCONAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRIMEBUTINE MALEATE (TRIMEBUTINE MALEATE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMITRIPTYLINE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOMPERIDONE (DOMPERIDONE)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056402-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060707</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>111426ISR</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOXYCYCLINE HCL</medicinalproduct>
        <drugdosagetext>200 MILLIGRAMS</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLIGHTED OVUM</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051012</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051019</drugenddate>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CO-DYDRAMOL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056403-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060704</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006083443</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>68</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUTENT</medicinalproduct>
        <drugauthorizationnumb>21968</drugauthorizationnumb>
        <drugdosagetext>1400 MG (50 MG, 1 IN 1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RENAL CELL CARCINOMA STAGE UNSPECIFIED</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056404-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060712</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>THQ2006A00523</companynumb>
    <primarysource>
      <reportercountry>MEXICO</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>69</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD UREA INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PIOGLITAZONE HCL</medicinalproduct>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLYBURIDE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056405-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060703</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FABR-11526</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>58</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERAL PHYSICAL HEALTH DETERIORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTI-ORGAN FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUROLOGICAL SYMPTOM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERITONEAL EFFUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERITONITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SIGMOIDITIS</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>FABRAZYME</medicinalproduct>
        <drugindication>FABRY'S DISEASE</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060504</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FABRAZYME</medicinalproduct>
        <drugdosagetext>1 MG/KG Q2WKS IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>FABRY'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20001219</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEORAL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELLCEPT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SOLUPRED</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056406-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060704</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006083449</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>47</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>63</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DERMATITIS ACNEIFORM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEMUR FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAIR COLOUR CHANGES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUCOSAL INFLAMMATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PATHOLOGICAL FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN DISCOLOURATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUTENT</medicinalproduct>
        <drugauthorizationnumb>21938</drugauthorizationnumb>
        <drugdosagetext>50 MG (50 MG, 1 IN 1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060320</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUCONAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXERYL (GLYCEROL, PARAFFIN, LIQUID, WHITE SOFT PARAFFIN)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MOSCONTIN (MORPHINE SULFATE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056407-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060711</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>THQ2006A00330</companynumb>
    <primarysource>
      <reportercountry>NEW ZEALAND</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>76</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ACUTE MYELOID LEUKAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATOCRIT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEAN CELL HAEMOGLOBIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MONOCYTE COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPHIL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RED BLOOD CELL SEDIMENTATION RATE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACTOS</medicinalproduct>
        <drugdosagetext>30 MG (15 MG, 2 IN 1 D)</drugdosagetext>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050714</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUTICASONE PROPIONATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXIS (FORMOTEROL)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DILTIAZEM HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EFORMOTEROL FUMARATE DIHYDRATE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056408-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060720</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060711</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-ROCHE-454660</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>22</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANAPHYLACTIC SHOCK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLANAX</medicinalproduct>
        <drugauthorizationnumb>18164</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060620</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060620</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056409-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060720</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060712</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ROCHE-455831</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>5</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BILIARY DILATATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHOLELITHIASIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ROCEPHIN</medicinalproduct>
        <drugauthorizationnumb>050585</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PNEUMONIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056410-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060720</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060711</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-ROCHE-454569</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>46</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COORDINATION ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEUKOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUROPATHY PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUROTOXICITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XELODA</medicinalproduct>
        <drugauthorizationnumb>020896</drugauthorizationnumb>
        <drugdosagetext>FROM DAYS ONE TO FOURTEEN OF A THREE WEEK CYCLE.</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>COLON CANCER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXALIPLATIN</medicinalproduct>
        <drugdosagetext>OXALIPLATIN DOSE WAS SUBSEQUENTLY REDUCED BY 25%.</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>COLON CANCER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056411-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesscongenitalanomali>1</seriousnesscongenitalanomali>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060626</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>6023765</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIMB REDUCTION DEFECT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZACTIN (FLUOXETINE HYDROCHLORIDE)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056412-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060720</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060710</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-454999</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>52</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEGASYS</medicinalproduct>
        <drugdosagetext>PATIENT TAKES 1/2 DOSE PEGASYS WEEKLY.</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060403</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COPEGUS</medicinalproduct>
        <drugauthorizationnumb>021511</drugauthorizationnumb>
        <drugdosagetext>PATIENT TAKES 4 200MG TABLETS/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060403</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEUPOGEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARANESP</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056413-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060720</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060712</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-455493</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLITIS ULCERATIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IRRITABLE BOWEL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RECTAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>018662</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000515</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20001215</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056414-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060720</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060712</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-455543</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>64</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>86.2</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRY SOCKET</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JAW OPERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STOMATITIS NECROTISING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BONIVA</medicinalproduct>
        <drugbatchnumb>B1008</drugbatchnumb>
        <drugauthorizationnumb>021455</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060115</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060504</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugdosagetext>START DATE WAS REPORTED TO BE YEARS AGO.</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugdosagetext>START DATE WAS REPORTED TO BE YEARS AGO.</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DITROPAN XL</medicinalproduct>
        <drugdosagetext>STRAT DATE REPORTED TO BE YEARS AGO.</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>URINARY INCONTINENCE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROZAC</medicinalproduct>
        <drugdosagetext>START DATE REPORTED TO BE YEARS AGO.</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056415-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060720</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060717</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0612411A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FAECES DISCOLOURED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MELAENA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GAVISCON</medicinalproduct>
        <drugbatchnumb>5H2601</drugbatchnumb>
        <drugauthorizationnumb>018685</drugauthorizationnumb>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056416-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060704</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006083085</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SILDENAFIL (PAH)  (SILDENAFIL)</medicinalproduct>
        <drugauthorizationnumb>21845</drugauthorizationnumb>
        <drugindication>PULMONARY HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRACLEER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALL OTHER THERAPEUTIC PRODUCTS (ALL OTHER THERAPEUTIC PRODUCTS)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056417-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060720</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060717</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0612418A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>85</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CERUMEN IMPACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EAR HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEBROX DROPS</medicinalproduct>
        <drugbatchnumb>6D2801</drugbatchnumb>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROSCAR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMDUR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOXYL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056418-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060720</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060711</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0612469A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE IMMEASURABLE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ROAD TRAFFIC ACCIDENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIVARIN</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060127</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056419-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060720</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060627</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>SG-GLAXOSMITHKLINE-B0430466A</companynumb>
    <primarysource>
      <reportercountry>SINGAPORE</reportercountry>
      <qualification>5</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>INTENTIONAL OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
        <drugdosagetext>120TAB SINGLE DOSE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INTENTIONAL OVERDOSE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050621</drugstartdate>
        <drugtreatmentduration>30</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CODEINE COUGH SYRUP</medicinalproduct>
        <drugdosagetext>360MG SINGLE DOSE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INTENTIONAL OVERDOSE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050621</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056420-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060720</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050407</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2005UW05398</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>83</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>58.2</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHROPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FOOT FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIMB INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOBILITY DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARIMIDEX</medicinalproduct>
        <drugauthorizationnumb>020541</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NOLVADEX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19850101</drugstartdate>
        <drugtreatmentduration>9</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NOLVADEX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990101</drugstartdate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056421-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060720</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060710</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006UW14042</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>AMPUTATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLINDNESS UNILATERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBRAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ROAD TRAFFIC ACCIDENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
        <drugauthorizationnumb>018240</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DILTIAZEM HCL</medicinalproduct>
        <drugdosagetext>120 HS + 240 AM</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVALIDE</medicinalproduct>
        <drugdosagetext>150/12.5</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVAPRO</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056422-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060720</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060710</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006UW14192</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>59</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>71.2</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CATATONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULAR WEAKNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUROPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOPROL-XL</medicinalproduct>
        <drugauthorizationnumb>019962</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060301</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOPROL-XL</medicinalproduct>
        <drugauthorizationnumb>019962</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060301</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WELLBUTRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL AND HYDROCHLOROTHIAZIDE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056423-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060720</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060717</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006UW14572</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </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>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NECK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUDDEN DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugauthorizationnumb>021366</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugauthorizationnumb>021366</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056424-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060720</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060421</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006UW07365</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>55</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>84.1</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ALANINE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASPARTATE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BILE DUCT STONE</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>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugauthorizationnumb>021366</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060203</drugenddate>
        <drugtreatmentduration>1040</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRINIVIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ELTROXIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VENTOLIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLOVENT</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056425-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060707</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006084624</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>54</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEAFNESS UNILATERAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MINOXIDIL</medicinalproduct>
        <drugauthorizationnumb>19501</drugauthorizationnumb>
        <drugdosagetext>1 ML, TOPICAL</drugdosagetext>
        <drugadministrationroute>061</drugadministrationroute>
        <drugindication>FEMALE PATTERN BALDNESS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE BESYLATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ISOSORBIDE (ISOSORBIDE)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056426-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060704</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>8017791</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>31</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>GRAND MAL CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARTIAL SEIZURES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KEPPRA</medicinalproduct>
        <drugauthorizationnumb>21035</drugauthorizationnumb>
        <drugdosagetext>2500 MG/D</drugdosagetext>
        <drugindication>EPILEPSY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060516</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KEPPRA</medicinalproduct>
        <drugdosagetext>3000 MG/D</drugdosagetext>
        <drugindication>EPILEPSY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060517</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060613</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KEPPRA</medicinalproduct>
        <drugdosagetext>3500 MG/D</drugdosagetext>
        <drugindication>EPILEPSY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060614</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ERGENYL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TIMOX D</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TIMOX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056427-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060703</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>8017644</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG LEVEL DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KEPPRA</medicinalproduct>
        <drugbatchnumb> 8609</drugbatchnumb>
        <drugauthorizationnumb>21035</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056428-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060706</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006-01209</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>62</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>84</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>LEUKOPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VELCADE</medicinalproduct>
        <drugauthorizationnumb>21602</drugauthorizationnumb>
        <drugdosagetext>1.30 MG, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060505</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060512</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOPHOSPHAMIDE</medicinalproduct>
        <drugdosagetext>1500.00 MG, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060505</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060512</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROMORPHONE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NOVALGIN (METAMIZOLE SODIUM)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RAMIPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LACTULOSE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAVOR (LORAZEPAM)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENOXAPARIN SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TEMAZEPAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOREM (TORASEMIDE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUID INFUSION</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOCLOPRAMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANTOPRAZOLE SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SOLUTIONS FOR PARENTERAL NUTRITION</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PAMIDRONATE DISODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CATAPRESSAN (CLODNIDINE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADALAT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIMENHYDRINATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BELOC-ZOC MITE (METOPROLOL SUCCINATE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAVAMOC (LEVOFLOXACIN)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MIRTAZAPINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOFLOXACIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056429-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060707</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006-01447</companynumb>
    <primarysource>
      <reportercountry>BELGIUM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>56</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>92.6</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BURSITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALMAR-PLANTAR ERYTHRODYSAESTHESIA SYNDROME</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>20060221</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOXIL</medicinalproduct>
        <drugdosagetext>30.00 MG/M2, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060224</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060523</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TEGRETOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARDIO ASPIRINA (ACETYLSALICYLIC ACID)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZANTAC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXCHLORPHENIRAMINE MALEATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LITICAN (ALIZAPRIDE)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056430-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesscongenitalanomali>1</seriousnesscongenitalanomali>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060703</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200612117GDS</companynumb>
    <primarysource>
      <reportercountry>CHINA</reportercountry>
    </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>FOETAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FOETAL MOVEMENTS DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTRA-UTERINE DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POLYHYDRAMNIOS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UMBILICAL CORD AROUND NECK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY INCONTINENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CANESTAN (CLOTRIMAZOLE)</medicinalproduct>
        <drugbatchnumb>5K4020097</drugbatchnumb>
        <drugauthorizationnumb>18182</drugauthorizationnumb>
        <drugdosagetext>500 MG, TOTAL DAILY, VAGINAL</drugdosagetext>
        <drugadministrationroute>067</drugadministrationroute>
        <drugindication>PRURITUS GENITAL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060512</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PIFUKANG</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056431-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060720</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060627</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GR-SANOFI-SYNTHELABO-A01200604939</companynumb>
    <primarysource>
      <reportercountry>GREECE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>71</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD BILIRUBIN UNCONJUGATED INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERNATIONAL NORMALISED RATIO INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BIRACETAM</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MEMORY IMPAIRMENT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugauthorizationnumb>020839</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ISCHAEMIC STROKE</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060601</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugauthorizationnumb>020839</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANEURYSM</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060601</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugauthorizationnumb>020839</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>THROMBOSIS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060601</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056432-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060720</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060223</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-SANOFI-SYNTHELABO-A01200601402</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ACCIDENTAL OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ACUTE PULMONARY OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ATRIAL FIBRILLATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WRONG DRUG ADMINISTERED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MOTILIUM</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIANTALVIC</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SERESTA</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BISOPROLOL FUMARATE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRINITRINE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugauthorizationnumb>020839</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG ADMINISTRATION ERROR</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060223</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060223</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056433-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060710</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>14384</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>58</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUOROURACIL</medicinalproduct>
        <drugauthorizationnumb>8107</drugauthorizationnumb>
        <drugindication>COLON CANCER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUOROURACIL</medicinalproduct>
        <drugauthorizationnumb>8107</drugauthorizationnumb>
        <drugindication>METASTASES TO OVARY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IRINOTECAN HCL</medicinalproduct>
        <drugindication>COLON CANCER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IRINOTECAN HCL</medicinalproduct>
        <drugindication>METASTASES TO OVARY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CALCIUM FOLINATE</medicinalproduct>
        <drugindication>COLON CANCER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CALCIUM FOLINATE</medicinalproduct>
        <drugindication>METASTASES TO OVARY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIAMORPHINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056434-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060705</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>MX-2006-017824</companynumb>
    <primarysource>
      <reportercountry>MEXICO</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BREAST CANCER FEMALE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BREAST CYST</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ANGELIQ</medicinalproduct>
        <drugauthorizationnumb>21355</drugauthorizationnumb>
        <drugdosagetext>1 TAB(S, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060301</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056435-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060707</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CH-2006-018085</companynumb>
    <primarysource>
      <reportercountry>SWITZERLAND</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>51</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>COMPLICATION OF DEVICE REMOVAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEVICE BREAKAGE</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>20040101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056436-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060720</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060710</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-SANOFI-SYNTHELABO-A03200604398</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020839</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056437-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060720</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060710</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-SANOFI-SYNTHELABO-A03200604404</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>71</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CONTUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG NEOPLASM MALIGNANT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACETYLSALICYLIC ACID SRT</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19950101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060601</drugenddate>
        <drugtreatmentduration>11</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZETIA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020839</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MYOCARDIAL INFARCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060607</drugenddate>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056438-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060720</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060714</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-SANOFI-SYNTHELABO-A03200604472</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>90</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN LACERATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMBIEN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>019908</drugauthorizationnumb>
        <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>1</drugcharacterization>
        <medicinalproduct>AMBIEN</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>019908</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056439-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060720</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060711</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-SANOFI-SYNTHELABO-A03200604403</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FOOT FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SLEEP WALKING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPAMAX</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AXERT</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMBIEN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>019908</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INSOMNIA</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060602</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056440-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060720</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060710</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-SANOFI-SYNTHELABO-A03200604401</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>62</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABNORMAL BEHAVIOUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AMNESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYROMANIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VERAPAMIL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMBIEN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>019908</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INSOMNIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060701</drugenddate>
        <drugtreatmentduration>12</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056441-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060720</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060711</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-SANOFI-SYNTHELABO-A03200604427</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>COMPLETED SUICIDE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HALLUCINATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMBIEN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>019908</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INSOMNIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040407</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056442-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060720</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060530</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-SANOFI-SYNTHELABO-A03200603419</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>68.9</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABNORMAL BEHAVIOUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AMNESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEMENTIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE TIGHTNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ROAD TRAFFIC ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SLEEP TALKING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SLEEP WALKING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHIPLASH INJURY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMBIEN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>019908</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INSOMNIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060420</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060502</drugenddate>
        <drugtreatmentduration>13</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYCLOBENZAPRINE HCL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EFFEXOR</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056443-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060711</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IE-2006-018087</companynumb>
    <primarysource>
      <reportercountry>IRELAND</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>40</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>66</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN LOWER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENITAL INFECTION BACTERIAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</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>20060530</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060626</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056444-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060720</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060713</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-13441639</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>39</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>116</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA FACIAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULAR WEAKNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEFINITY</medicinalproduct>
        <drugbatchnumb>4558</drugbatchnumb>
        <drugauthorizationnumb>21064</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>STRESS ECHOCARDIOGRAM</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060712</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060712</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BARIUM SULFATE</medicinalproduct>
        <drugindication>GASTROINTESTINAL DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CATAPRES-TTS-1</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALTACE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056445-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060706</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-2006-016784</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>43</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>79</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLINDNESS UNILATERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC NEUROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSYCHOSOMATIC DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SENSATION OF FOREIGN BODY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPEECH DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL DISTURBANCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PETIBELLE 30 (DROSPIRENONE, ETHINYLESTRADIO) FILM TABLET</medicinalproduct>
        <drugauthorizationnumb>21098</drugauthorizationnumb>
        <drugdosagetext>1 TAB(S), 21D/28D</drugdosagetext>
        <drugindication>CONTRACEPTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060620</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056446-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060720</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060626</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ES-BRISTOL-MYERS SQUIBB COMPANY-13423900</companynumb>
    <primarysource>
      <reportercountry>SPAIN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>58</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>45</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HYPERTENSIVE CRISIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAXOL</medicinalproduct>
        <drugauthorizationnumb>20262</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CERVIX CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060616</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060616</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CISPLATIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CERVIX CARCINOMA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056447-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060720</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060713</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-BRISTOL-MYERS SQUIBB COMPANY-13442041</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>59</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ENCEPHALOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCYTOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STOMATITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENDOXAN</medicinalproduct>
        <drugauthorizationnumb>12142</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060117</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060117</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUOROURACIL</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060117</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060117</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EPIRUBICIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060117</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060117</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARDIOXANE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060117</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060117</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056448-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060720</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060625</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-SANOFI-SYNTHELABO-A03200604148</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ATRIOVENTRICULAR BLOCK SECOND DEGREE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DILATATION VENTRICULAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EXTRASYSTOLES</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMBIEN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>19908</drugauthorizationnumb>
        <drugdosagetext>10 MG, TWO TO THREE TIMES/MONTH</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INSOMNIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050401</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMBIEN</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>019908</drugauthorizationnumb>
        <drugdosagetext>10 MG,  TWO TO THREE TIMES/WEEK HS</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060101</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REMERON</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CATAPRES</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050901</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056449-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060720</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20051216</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IT-SANOFI-SYNTHELABO-F01200502807</companynumb>
    <primarysource>
      <reportercountry>ITALY</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>54</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISEASE PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STOMATITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051117</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BUSCOPAN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051104</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE TAB</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051013</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051116</drugenddate>
        <drugtreatmentduration>35</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOBETIN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051004</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLINIC ACID</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051004</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051128</drugenddate>
        <drugtreatmentduration>56</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEMETREXED</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>GASTRIC CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051014</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXALIPLATIN</medicinalproduct>
        <drugauthorizationnumb>021492</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>GASTRIC CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051014</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056450-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060720</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060714</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>NL-SANOFI-SYNTHELABO-F01200601657</companynumb>
    <primarysource>
      <reportercountry>NETHERLANDS</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVASTIN</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060629</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060629</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CAPECITABINE</medicinalproduct>
        <drugdosagetext>DAYS 1-14 (1250 MG/M2 AFTER CYCLE 6)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060629</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060629</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXALIPLATIN</medicinalproduct>
        <drugauthorizationnumb>021492</drugauthorizationnumb>
        <drugdosagetext>210 MG</drugdosagetext>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>COLORECTAL CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060629</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060629</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056451-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060720</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060717</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-SANOFI-SYNTHELABO-F01200601665</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>67</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLATULENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL PERFORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ILEAL PERFORATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVASTIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLON CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060620</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060620</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUOROURACIL</medicinalproduct>
        <drugdosagetext>722MG/BODY=417.3MG/M2 IN BOLUS THEN 1083MG/BODY=626MG/M2 AS CONTINUOUS INFUSION</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLON CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060620</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060620</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUOROURACIL</medicinalproduct>
        <drugdosagetext>722MG/BODY=417.3MG/M2 IN BOLUS THEN 1083MG/BODY=626MG/M2 AS CONTINUOUS INFUSION</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060620</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060621</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOXOPROFEN</medicinalproduct>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060704</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGNESIUM OXIDE</medicinalproduct>
        <drugdosagetext>0.9-1.2 G</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONSTIPATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060620</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MINOCYCLINE HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060608</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060704</drugenddate>
        <drugtreatmentduration>27</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIMETICONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>FLATULENCE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060606</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POVIDONE IODINE</medicinalproduct>
        <drugindication>STOMATITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060510</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060620</drugenddate>
        <drugtreatmentduration>42</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONAZEPAM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HICCUPS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060525</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060526</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BUTYRIC ACID BACTERIUM AGENT</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONSTIPATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DAI-KENCHU-TO</medicinalproduct>
        <drugdosagetext>7.5 G - 15.0 G</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ILEUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CALCIUM LEVOFOLINATE</medicinalproduct>
        <drugdosagetext>181MG/BODY=104.6MG/M2 AS INFUSION ON DAYS 1 AND 2</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLON CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060620</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060621</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXALIPLATIN</medicinalproduct>
        <drugauthorizationnumb>021492</drugauthorizationnumb>
        <drugdosagetext>153MG/BODY=88.4MG/M2 IN INFUSION ON DAY 1</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLON CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060620</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060620</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>805</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056452-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060706</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-2006-017291</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>33</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DIPLOPIA</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>20060201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060623</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CENTRUM (MINERALS NOS, VITAMINS NOS)</medicinalproduct>
        <drugdosagetext>1 TAB(S), 1X/DAY, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060301</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056453-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060505</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006BH009700</companynumb>
    <primarysource>
      <reportercountry>ITALY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
        <drugauthorizationnumb>87702</drugauthorizationnumb>
        <drugdosagetext>40 MG; EVERY DAY; IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOPHOSPHAMIDE</medicinalproduct>
        <drugdosagetext>400  MG/M**2; IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ETOPOSIDE</medicinalproduct>
        <drugdosagetext>40 MG/M**2; IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CISPLATIN</medicinalproduct>
        <drugdosagetext>10 MG/M**2; IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056454-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060505</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006BH009698</companynumb>
    <primarysource>
      <reportercountry>ITALY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
        <drugauthorizationnumb>87702</drugauthorizationnumb>
        <drugdosagetext>40 MG; EVERY DAY; IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOPHOSPHAMIDE</medicinalproduct>
        <drugdosagetext>400 MG/M**2; IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ETOPOSIDE</medicinalproduct>
        <drugdosagetext>40 MG/M**2; IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CISPLATIN</medicinalproduct>
        <drugdosagetext>10 MG/M**2; IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056455-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060505</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006BH009697</companynumb>
    <primarysource>
      <reportercountry>ITALY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
        <drugauthorizationnumb>87702</drugauthorizationnumb>
        <drugdosagetext>40 MG; EVERY DAY; IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOPHOSPHAMIDE</medicinalproduct>
        <drugdosagetext>400 MG/M**2; IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ETOPOSIDE</medicinalproduct>
        <drugdosagetext>40 MG; M**2; IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CISPLATIN</medicinalproduct>
        <drugdosagetext>10 MG/M**2; IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056458-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060720</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060606</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20060601862</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>54.43</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSSTASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOPAMAX</medicinalproduct>
        <drugauthorizationnumb>020505</drugauthorizationnumb>
        <drugdosagetext>THREE 25 MG TABLETS TWICE DAILY</drugdosagetext>
        <drugindication>MIGRAINE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VICODIN</medicinalproduct>
        <drugindication>MIGRAINE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMITRIPTYLINE HCL</medicinalproduct>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>MIGRAINE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056459-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060720</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060710</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20050705989</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>83.92</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>COMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISSEMINATED INTRAVASCULAR COAGULATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTHERMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTI-ORGAN FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOPAMAX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOPAMAX</medicinalproduct>
        <drugdosagetext>TAKEN AS 125 MG IN THE AM AND 450 MG IN THE PM FOR APPROX. 6 MONTHS+</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>EPILEPSY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOPAMAX</medicinalproduct>
        <drugauthorizationnumb>020505</drugauthorizationnumb>
        <drugdosagetext>(200 MG DAILY IN AM, AND 400 MG DAILY IN PM)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>COMPLEX PARTIAL SEIZURES</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056460-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060720</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060710</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20060504378</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>46</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLINDNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOPAMAX</medicinalproduct>
        <drugauthorizationnumb>20505</drugauthorizationnumb>
        <drugdosagetext>FOR 5 DAYS</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MIGRAINE PROPHYLAXIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056461-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060720</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060711</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-JNJFOC-20060404966</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>46.7</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABORTION SPONTANEOUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CONCERTA</medicinalproduct>
        <drugauthorizationnumb>21121</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATTENTION DEFICIT/HYPERACTIVITY DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056462-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060720</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060714</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20060702886</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>95</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVAQUIN</medicinalproduct>
        <drugindication>SEPSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVAQUIN</medicinalproduct>
        <drugauthorizationnumb>020634</drugauthorizationnumb>
        <drugindication>PNEUMONIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056464-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060720</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060712</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20060702784</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>113.4</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD CHOLESTEROL INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIABETES MELLITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUID RETENTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GOUT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUROPATHY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DURAGESIC-100</medicinalproduct>
        <drugbatchnumb>0426843</drugbatchnumb>
        <drugadministrationroute>062</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DURAGESIC-100</medicinalproduct>
        <drugbatchnumb>0426843</drugbatchnumb>
        <drugadministrationroute>062</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DURAGESIC-100</medicinalproduct>
        <drugbatchnumb>0426843</drugbatchnumb>
        <drugauthorizationnumb>019813</drugauthorizationnumb>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACIPHEX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTROOESOPHAGEAL REFLUX DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADVAIR DISKUS 100/50</medicinalproduct>
        <drugdosagetext>FLUTICASONE PROPIONATE 500 MCG/  SALMETEROL 50 MCG, TWICE A DAY, INHALATION</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056465-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060720</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060626</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20040306766</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>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>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>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-100</medicinalproduct>
        <drugbatchnumb>0327192</drugbatchnumb>
        <drugadministrationroute>062</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040207</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DURAGESIC-100</medicinalproduct>
        <drugbatchnumb>0327192</drugbatchnumb>
        <drugadministrationroute>062</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040207</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DURAGESIC-100</medicinalproduct>
        <drugbatchnumb>0327192</drugbatchnumb>
        <drugadministrationroute>062</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040207</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DURAGESIC-100</medicinalproduct>
        <drugbatchnumb>0327192</drugbatchnumb>
        <drugadministrationroute>062</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040207</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DURAGESIC-100</medicinalproduct>
        <drugbatchnumb>0327192</drugbatchnumb>
        <drugadministrationroute>062</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040207</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DURAGESIC-100</medicinalproduct>
        <drugbatchnumb>0327192</drugbatchnumb>
        <drugadministrationroute>062</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040207</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DURAGESIC-100</medicinalproduct>
        <drugbatchnumb>0327192</drugbatchnumb>
        <drugauthorizationnumb>019813</drugauthorizationnumb>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040207</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MORPHINE</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>5056466-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060720</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060712</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20060703544</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>54.43</patientweight>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>BREAST CANCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BREAST CANCER FEMALE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DURAGESIC-100</medicinalproduct>
        <drugauthorizationnumb>019813</drugauthorizationnumb>
        <drugdosagetext>TWO 75 UG/HR PATCHES</drugdosagetext>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>CANCER PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056467-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060720</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060607</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20060404170</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>74</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ATRIOVENTRICULAR BLOCK THIRD DEGREE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLUENZA LIKE ILLNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUS BRADYCARDIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DURAGESIC-100</medicinalproduct>
        <drugbatchnumb>0327192;0327193</drugbatchnumb>
        <drugadministrationroute>062</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DURAGESIC-100</medicinalproduct>
        <drugbatchnumb>0327192;0327193</drugbatchnumb>
        <drugadministrationroute>062</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DURAGESIC-100</medicinalproduct>
        <drugbatchnumb>0327192;0327193</drugbatchnumb>
        <drugadministrationroute>062</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DURAGESIC-100</medicinalproduct>
        <drugbatchnumb>0327192;0327193</drugbatchnumb>
        <drugauthorizationnumb>019813</drugauthorizationnumb>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MORPHINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MORPHINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORAZEPAM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MIRALAX</medicinalproduct>
        <drugdosagetext>1 CAPFULL DAILY, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056468-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060720</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060623</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-JNJFOC-20060605279</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FACIAL PALSY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRANSIENT ISCHAEMIC ATTACK</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERDAL CONSTA</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERDAL CONSTA</medicinalproduct>
        <drugauthorizationnumb>021346</drugauthorizationnumb>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056469-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060720</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060712</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-JNJFOC-20060702683</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CONTUSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRAMACET</medicinalproduct>
        <drugauthorizationnumb>21123</drugauthorizationnumb>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056470-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060720</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060712</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20060600540</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>REACTION TO DRUG EXCIPIENTS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXTRA STRENGTH TYLENOL</medicinalproduct>
        <drugauthorizationnumb>19872</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXTRA STRENGTH TYLENOL</medicinalproduct>
        <drugauthorizationnumb>019872</drugauthorizationnumb>
        <drugdosagetext>AS NECCESSARY</drugdosagetext>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SODIUM STEARATE</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056473-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060720</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060713</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>NSADSS2002010807</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>79</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTHERMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LETHARGY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENTAL STATUS CHANGES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL INTAKE REDUCED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMINYL</medicinalproduct>
        <drugauthorizationnumb>21169</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERDAL</medicinalproduct>
        <drugauthorizationnumb>020272</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAROXETINE HCL</medicinalproduct>
        <drugindication>DEPRESSION</drugindication>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOCUSATE SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELECOXIB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM CITRATE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056483-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>163-C5013-06050382</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>74</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>72.1</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ILEUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CC-5013 (LENALIDOMIDE) (CAPSULES)</medicinalproduct>
        <drugauthorizationnumb>21880</drugauthorizationnumb>
        <drugdosagetext>25 MG, 1 IN 1 D, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060228</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060502</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
        <drugdosagetext>40 MG ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060228</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060502</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056484-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060706</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>163-21880-06070302</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>72</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugbatchnumb>0077A-A</drugbatchnumb>
        <drugauthorizationnumb>21880</drugauthorizationnumb>
        <drugdosagetext>5 MG, 1 IN 1 D, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MYELODYSPLASTIC SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060517</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060601</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056485-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060720</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060608</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-BRISTOL-MYERS SQUIBB COMPANY-13406194</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>6</patientonsetage>
      <patientonsetageunit>800</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>JAUNDICE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAXOL</medicinalproduct>
        <drugauthorizationnumb>20262</drugauthorizationnumb>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>GASTRIC CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050725</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060105</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TS-1</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTRIC CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050725</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060111</drugenddate>
        <drugtreatmentduration>98</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056486-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060720</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060620</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PE-BRISTOL-MYERS SQUIBB COMPANY-13417274</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>75</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>LEUKOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUCOSAL INFLAMMATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPTIC SHOCK</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CISPLATIN</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>GASTRIC CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060601</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUOROURACIL</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060606</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXTROSE 5%</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>FLUID REPLACEMENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060606</drugenddate>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PALONOSETRON</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ANTIEMETIC SUPPORTIVE CARE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060601</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE TAB</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ANTIEMETIC SUPPORTIVE CARE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060605</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MANNITOL</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>DIURETIC THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060601</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>DIURETIC THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060601</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGNESIUM SULFATE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060601</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM CHLORIDE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>FLUID REPLACEMENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060601</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SODIUM CHLORIDE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>FLUID REPLACEMENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060601</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CAPTOPRIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETYLSALICYLIC ACID SRT</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056487-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060720</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060116</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-BRISTOL-MYERS SQUIBB COMPANY-13252200</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>68</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ERBITUX</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060104</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CISPLATIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060104</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VINORELBINE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060104</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOCLOPRAMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ONDANSETRON HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYMBICORT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVENOX</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051213</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXCHLORPHENIRAMINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BECLOMETHASONE DIPROPIONATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SALBUTAMOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DICLOFENAC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM CHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALSARTAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIANTALVIC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHYLPREDNISOLONE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056488-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060720</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060711</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-BRISTOL-MYERS SQUIBB COMPANY-13443312</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>NEUROLEPTIC MALIGNANT SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ABILIFY</medicinalproduct>
        <drugdosagetext>DOSE INCREASED TO 10 MG DAILY ON 29-JUN-2006.</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060626</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLIANIMON</medicinalproduct>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060628</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LAMICTAL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>APONAL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NACL INFUSION</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAVOR</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056489-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060720</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060705</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-BRISTOL-MYERS SQUIBB COMPANY-13432471</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>55</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INTESTINAL PERFORATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CISPLATIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>GASTRIC CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060612</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060612</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUOROURACIL</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>GASTRIC CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060612</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060617</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SERTRALINE HCL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANXIETY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ESOMEPRAZOLE MAGNESIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTRIC CANCER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056490-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060720</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060711</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ES-BRISTOL-MYERS SQUIBB COMPANY-13441407</companynumb>
    <primarysource>
      <reportercountry>SPAIN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>44</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BRONCHOSPASM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REYATAZ</medicinalproduct>
        <drugauthorizationnumb>021567</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060519</drugstartdate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056491-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060720</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PL-BRISTOL-MYERS SQUIBB COMPANY-13427505</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>54</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>102</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>AZOTAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLITIS ISCHAEMIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTI-ORGAN FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERITONITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CISPLATIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060613</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060613</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GEMCITABINE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060613</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060613</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETYLSALICYLIC ACID SRT</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000406</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BISOPROLOL FUMARATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRANDOLAPRIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000406</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MONONIT</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000406</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056492-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060720</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060703</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-BRISTOL-MYERS SQUIBB COMPANY-13437660</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>32</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PSYCHIATRIC SYMPTOM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ABILIFY</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060621</drugstartdate>
        <drugtreatmentduration>10</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOMEPROMAZINE MALEATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SLEEP DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060621</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ETIZOLAM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SLEEP DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060621</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056493-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060720</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060410</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-BRISTOL-MYERS SQUIBB COMPANY-13345178</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>88</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIABETIC HYPERGLYCAEMIC COMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIALYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEPHROPATHY TOXIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GATIFLOXACIN</medicinalproduct>
        <drugauthorizationnumb>21061</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060328</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060401</drugenddate>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLOMOX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060325</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060327</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060402</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060403</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RISPERDAL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060405</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SENNOSIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060405</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAZODONE HCL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060405</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056494-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060720</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060717</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-13444070</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>60</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>91</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>NEUTROPENIC INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOCETAXEL</medicinalproduct>
        <drugindication>PANCREATIC CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060626</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060626</drugenddate>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENOXAPARIN SODIUM</medicinalproduct>
        <drugindication>PANCREATIC CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060703</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060703</drugenddate>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IRINOTECAN</medicinalproduct>
        <drugindication>PANCREATIC CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060626</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060626</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056495-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060705</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>163-21880-06070299</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>62</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
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      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugauthorizationnumb>21880</drugauthorizationnumb>
        <drugdosagetext>10 MG, 1 IN 1 D, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MYELODYSPLASTIC SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060524</drugstartdate>
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    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056496-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060720</receivedate>
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    <receiptdate>20060718</receiptdate>
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    <companynumb>DE-BRISTOL-MYERS SQUIBB COMPANY-13447263</companynumb>
    <primarysource>
      <reportercountry>IRELAND</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>68</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD CREATININE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ERBITUX</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050805</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050930</drugenddate>
        <drugtreatmentduration>49</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CISPLATIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051017</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051017</drugenddate>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VINORELBINE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051024</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051024</drugenddate>
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  <safetyreport>
    <safetyreportid>5056497-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060720</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-BRISTOL-MYERS SQUIBB COMPANY-13435342</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>25</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DEPRESSED MOOD</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAZE PALSY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDE ATTEMPT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ABILIFY</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERIDONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060512</drugstartdate>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOPICLONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INSOMNIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060512</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NITRAZEPAM</medicinalproduct>
        <drugdosagetext>20 MG, THEN DECR. TO 10 MG ON 07-JUN-2006, THEN DECR. TO 5 MG ON 22-JUN-2006.</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INSOMNIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060512</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060627</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRIHEXYPHENIDYL HCL</medicinalproduct>
        <drugdosagetext>6 MG, THEN DECR. 4 MG TO 14-JUN-2006, THEN DECR. TO 2 MG 21-JUN-2006</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>EXTRAPYRAMIDAL DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060512</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056498-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060720</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060713</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ES-BRISTOL-MYERS SQUIBB COMPANY-13439096</companynumb>
    <primarysource>
      <reportercountry>SPAIN</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>42</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ORAL DISCOMFORT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EFAVIRENZ</medicinalproduct>
        <drugauthorizationnumb>20972</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>STAVUDINE</medicinalproduct>
        <drugauthorizationnumb>020412</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19970101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMIVUDINE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19970101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SAQUINAVIR</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19970101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056499-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060720</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060718</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CL-BRISTOL-MYERS SQUIBB COMPANY-13447248</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>54</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ERBITUX</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050901</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ERBITUX</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CISPLATIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050901</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VINORELBINE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050901</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056500-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060720</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060601</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-13399605</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>80</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>80</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>RADIATION PNEUMONITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUDDEN DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CISPLATIN</medicinalproduct>
        <drugauthorizationnumb>18057</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PLEURAL MESOTHELIOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051207</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051207</drugenddate>
        <drugtreatmentduration>79</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALIMTA</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PLEURAL MESOTHELIOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051207</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051207</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RADIATION THERAPY</medicinalproduct>
        <drugindication>PLEURAL MESOTHELIOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060412</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060412</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056501-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060705</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>163-21880-06070297</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>82</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugauthorizationnumb>21880</drugauthorizationnumb>
        <drugdosagetext>1 IN 1 D ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MYELODYSPLASTIC SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060518</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060501</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056504-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060630</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006-DE-03345GD</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>72</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DELIRIUM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG ADMINISTRATION ERROR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG PRESCRIBING ERROR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCISION SITE COMPLICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POST PROCEDURAL COMPLICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WOUND SECRETION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SERTRALINE</medicinalproduct>
        <drugauthorizationnumb>76934</drugauthorizationnumb>
        <drugdosagetext>25 MG</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LINEZOLID</medicinalproduct>
        <drugindication>INCISION SITE COMPLICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LINEZOLID</medicinalproduct>
        <drugindication>WOUND SECRETION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056505-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>COT_0627_2006</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>52</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>59.8748</patientweight>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ARRHYTHMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LETHARGY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUBARACHNOID HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENTRICULAR TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VENTAVIS</medicinalproduct>
        <drugbatchnumb>54143A</drugbatchnumb>
        <drugauthorizationnumb>21779</drugauthorizationnumb>
        <drugdosagetext>5 MCG 4 TIMES A DAY IH</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>PULMONARY HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021202</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
        <drugdosagetext>DF</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROTONIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIGOXIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDRAZALINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FENTANYL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELEXA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAZODONE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EPOGEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IRON</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL SPIROS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SILDENAFIL CITRATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RENAGEL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056516-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060720</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060710</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHRM2006FR02036</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>83</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD CREATININE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD UREA INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRADYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERKALAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL CYST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINOATRIAL BLOCK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALDACTONE</medicinalproduct>
        <drugdosagetext>25 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060205</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SECTRAL</medicinalproduct>
        <drugdosagetext>100 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060205</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAREG</medicinalproduct>
        <drugauthorizationnumb>021283</drugauthorizationnumb>
        <drugdosagetext>80 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060205</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056517-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US200606006035</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>49</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>68</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD OESTROGEN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POST PROCEDURAL COMPLICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UTERINE HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UTERINE LEIOMYOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMULIN 70/30</medicinalproduct>
        <drugauthorizationnumb>18780</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugindication>BLOOD GLUCOSE ABNORMAL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056518-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060720</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060711</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-ABBOTT-06P-167-0337908-00</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>42</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>BLOOD ALCOHOL INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG LEVEL INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVERDOSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VALPROATE SODIUM</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>018081</drugauthorizationnumb>
        <drugindication>OVERDOSE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051222</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051222</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VALPROATE SODIUM</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>018081</drugauthorizationnumb>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056519-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060720</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060607</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-06P-163-0335517-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>72.64</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHEUMATOID ARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY RETENTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OEDEMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HUMULIN 70/30</medicinalproduct>
        <drugdosagetext>20 UNITS IN AM, 8 UNITS IN PM</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugdosagetext>1 INJECTION IN ONE WEEK</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NABUMETONE</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXTROPROPOXYPHENE HYDROCHLORIDE</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALPRAZOLAM</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DESIPRAMINE HCL</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056520-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060720</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060714</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-ABBOTT-06P-062-0338098-00</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>54</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>SYNOVECTOMY</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>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060401</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060513</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060301</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAMADOL HCL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050901</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CSA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040803</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENALAPRIL MALEATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM WITH VITAMIN D</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MCP</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS AGAINST GASTROINTESTINAL ULCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050301</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COXIBE</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056521-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060720</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20031020</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-ABBOTT-03P-062-0237832-02</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>54</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIAC TAMPONADE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERICARDITIS CONSTRICTIVE</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>20001127</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021220</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANSOPRAZOLE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS AGAINST GASTROINTESTINAL ULCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020801</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COLECALCIFEROL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERURICAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020221</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRONOLACTONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PERICARDITIS CONSTRICTIVE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIGOXIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PERICARDITIS CONSTRICTIVE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COLECALCIFEROL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056522-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060720</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060710</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-ABBOTT-06P-056-0337920-00</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>41</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIOVASCULAR DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLEURAL EFFUSION</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>20060501</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056523-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060720</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060711</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ABBOTT-06P-087-0337873-00</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>NEUROLEPTIC MALIGNANT SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AKINETON</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>012003</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PARKINSONISM</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020715</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041227</drugenddate>
        <drugtreatmentduration>896</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LITHIUM CARBONATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BIPOLAR I DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020715</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041227</drugenddate>
        <drugtreatmentduration>896</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAPROTILINE HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BIPOLAR I DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041224</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041227</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056524-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesscongenitalanomali>1</seriousnesscongenitalanomali>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060720</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060626</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-ABBOTT-06P-167-0337013-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>0.13</patientweight>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>DOUBLE OUTLET RIGHT VENTRICLE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STILLBIRTH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENTRICULAR SEPTAL DEFECT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KALETRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>21226</drugauthorizationnumb>
        <drugindication>DRUG EXPOSURE DURING PREGNANCY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMIVUDINE AND ZIDOVUDINE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>DRUG EXPOSURE DURING PREGNANCY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056525-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060720</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060713</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-06P-163-0338168-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>80</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FAECALOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTI-ORGAN FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PSORIATIC ARTHROPATHY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056526-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060720</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060408</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-ABBOTT-06P-062-0330375-00</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>74</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STENOSIS OF VESICOURETHRAL ANASTOMOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUBILEUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZEMPLAR</medicinalproduct>
        <drugbatchnumb>315468E03</drugbatchnumb>
        <drugauthorizationnumb>20819</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>SECONDARY HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060222</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM ACETATE</medicinalproduct>
        <drugindication>RENAL FAILURE CHRONIC</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056527-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060720</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060208</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>SE-ABBOTT-06P-150-0324665-00</companynumb>
    <primarysource>
      <reportercountry>SWEDEN</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHEUMATOID NODULE</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>20030506</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050223</drugenddate>
        <drugtreatmentduration>659</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOJECT</medicinalproduct>
        <drugadministrationroute>050</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEKOVIT CA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HEPARIN-FRACTION, SODIUM SALT</medicinalproduct>
        <drugdosagetext>WHEN PROTHROMBIN IN COMPLEX { 1.8</drugdosagetext>
        <drugadministrationroute>050</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOPICLONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BUDESONIDE</medicinalproduct>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETYLCYSTEINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORFLOXACIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056528-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060720</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060606</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>NO-ABBOTT-06P-122-0335537-00</companynumb>
    <primarysource>
      <reportercountry>NORWAY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>39</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>115</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PROTEIN S DEFICIENCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REDUCTIL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>20632</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OBESITY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060506</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060603</drugenddate>
        <drugtreatmentduration>28</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REDUCTIL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020632</drugauthorizationnumb>
        <drugindication>OVERWEIGHT</drugindication>
        <drugtreatmentduration>28</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056529-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060720</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060711</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ABBOTT-06P-087-0337919-00</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>52</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPIDIL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>019304</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERLIPIDAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060111</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060427</drugenddate>
        <drugtreatmentduration>105</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NICORANDIL</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051222</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060427</drugenddate>
        <drugtreatmentduration>125</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETYLSALICYLIC ACID SRT</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060130</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060427</drugenddate>
        <drugtreatmentduration>86</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PIOGLITAZONE HCL</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051222</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060416</drugenddate>
        <drugtreatmentduration>114</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VOGLIBOSE</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060403</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060416</drugenddate>
        <drugtreatmentduration>13</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056530-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060720</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060406</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-ABBOTT-06P-062-0330094-00</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>55</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PERIPHERAL ARTERIAL OCCLUSIVE DISEASE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZEMPLAR</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>20819</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>HYPERPARATHYROIDISM SECONDARY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060213</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060313</drugenddate>
        <drugtreatmentduration>36</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZEMPLAR</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020819</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060314</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060322</drugenddate>
        <drugtreatmentduration>36</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GASTAL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERPARATHYROIDISM SECONDARY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM CARBONATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERPARATHYROIDISM SECONDARY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THEOPHYLLINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040913</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040913</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FRAGMIN P FORTE</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060222</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EPOGEN</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FERRUM</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056531-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060720</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060712</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BE-ABBOTT-06P-013-0338101-00</companynumb>
    <primarysource>
      <reportercountry>BELGIUM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060112</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060328</drugenddate>
        <drugtreatmentduration>75</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</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>NAPROXEN</medicinalproduct>
        <drugdosagetext>500MG DAILY WHEN NECESSARY</drugdosagetext>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056532-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US200606005924</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>64</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>62.6</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL DISTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STRESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VASCULAR OCCLUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMULIN 70/30</medicinalproduct>
        <drugauthorizationnumb>18780</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMULIN 70/30</medicinalproduct>
        <drugauthorizationnumb>18780</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060628</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NOVOLOG</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056533-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060720</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060208</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>SE-ABBOTT-06P-150-0324664-00</companynumb>
    <primarysource>
      <reportercountry>SWEDEN</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABSCESS SOFT TISSUE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031208</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040807</drugenddate>
        <drugtreatmentduration>242</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056534-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060720</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060421</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-ABBOTT-06P-056-0331609-00</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>62.5</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>RESTLESS LEGS SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PSORIATIC ARTHROPATHY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051107</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060305</drugenddate>
        <drugtreatmentduration>118</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NIMESULIDE</medicinalproduct>
        <drugindication>PSORIATIC ARTHROPATHY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THIAMINE CHLORHYDRATE, QUININE BENZOATE</medicinalproduct>
        <drugindication>MUSCLE SPASMS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DESLORATADINE</medicinalproduct>
        <drugindication>ARTHRALGIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056535-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060720</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060208</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>SE-ABBOTT-06P-150-0324660-00</companynumb>
    <primarysource>
      <reportercountry>SWEDEN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>METASTASES TO SPINE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>ANKYLOSING SPONDYLITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040704</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>FELODIPINE</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>POTASSIUM CHLORIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEKOVIT CA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALENDRONATE SODIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCODONE HYDROCHLORIDE</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050428</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCODONE HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050428</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BICALUTAMIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLEDRONIC ACID</medicinalproduct>
        <drugadministrationroute>050</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056536-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060720</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060428</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ABBOTT-06P-087-0331938-00</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BILIRUBINURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHOLESTASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAMMA-GLUTAMYLTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLAMMATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JAUNDICE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEPEKENE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>18081</drugauthorizationnumb>
        <drugadministrationroute>050</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060320</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060402</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEPEKENE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>018081</drugauthorizationnumb>
        <drugadministrationroute>050</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051229</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEPEKENE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>018081</drugauthorizationnumb>
        <drugadministrationroute>050</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060319</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEPEKENE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>018081</drugauthorizationnumb>
        <drugadministrationroute>050</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051207</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051228</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEUPLIN SR FOR INJECTION KIT</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PROSTATE CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060330</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060330</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TUBE FEEDING</medicinalproduct>
        <drugadministrationroute>051</drugadministrationroute>
        <drugindication>PARENTERAL NUTRITION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060402</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TUBE FEEDING</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060406</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056537-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060720</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060407</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20060703819</companynumb>
    <primarysource>
      <reportercountry>SPAIN</reportercountry>
      <qualification>3</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>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUBARACHNOID HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REOPRO</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CARDIAC DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>ENOXAPARIN SODIUM</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>ACETYLSALICYLIC ACID SRT</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056538-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060427</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006-027</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>3.99</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG ADMINISTRATION ERROR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN LACERATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PHYTONADIONE</medicinalproduct>
        <drugbatchnumb>ER059A6</drugbatchnumb>
        <drugauthorizationnumb>83722</drugauthorizationnumb>
        <drugdosagetext>1 MG, 1X, 1M</drugdosagetext>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060314</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056539-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060711</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>HQWYE800912APR06</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>70</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>90</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ACUTE MYELOID LEUKAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ALANINE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>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>BLOOD LACTATE DEHYDROGENASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE MARROW TRANSPLANT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHILLS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISEASE PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEBRILE NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUID OVERLOAD</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GRAFT VERSUS HOST DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMODIALYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFUSION RELATED REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER FUNCTION TEST ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG CONSOLIDATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PATHOGEN RESISTANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STAPHYLOCOCCAL SEPSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOTIC THROMBOCYTOPENIC PURPURA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MYLOTARG</medicinalproduct>
        <drugauthorizationnumb>21174</drugauthorizationnumb>
        <drugdosagetext>18.9 MG 1X PER 1 DAY, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ACUTE MYELOID LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051027</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051027</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056540-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060712</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060707</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>HQWYE411619MAY06</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>35</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>53.57</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>KIDNEY TRANSPLANT REJECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TUBULOINTERSTITIAL NEPHRITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RAPAMUNE</medicinalproduct>
        <drugauthorizationnumb>21110</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS AGAINST TRANSPLANT REJECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060425</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060501</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RAPAMUNE</medicinalproduct>
        <drugauthorizationnumb>21110</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS AGAINST TRANSPLANT REJECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060511</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELLCEPT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE TAB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SEPTRA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROTONIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COZAAR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOPRESSOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARANESP</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NOVOLOG</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056541-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006S1001772</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>40</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>106.5953</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ACCIDENTAL OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRONCHOPNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG ABUSER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG SCREEN POSITIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ROAD TRAFFIC ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SELF-MEDICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UPPER LIMB FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHIPLASH INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WRIST FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WRONG TECHNIQUE IN DRUG USAGE PROCESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FENTANYL TRANSDERMAL SYSTEM</medicinalproduct>
        <drugauthorizationnumb>76258</drugauthorizationnumb>
        <drugdosagetext>50 UG/HR; Q3D; TRANS</drugdosagetext>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FENTANYL TRANSDERMAL SYSTEM</medicinalproduct>
        <drugauthorizationnumb>76258</drugauthorizationnumb>
        <drugdosagetext>50 UG/HR; Q3D; TRANS</drugdosagetext>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>UPPER LIMB FRACTURE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FENTANYL TRANSDERMAL SYSTEM</medicinalproduct>
        <drugauthorizationnumb>76258</drugauthorizationnumb>
        <drugdosagetext>50 UG/HR; Q3D; TRANS</drugdosagetext>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>WRIST FRACTURE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCODONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PERCOCET</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056542-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006S1004663</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>84</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG WITHDRAWAL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INADEQUATE ANALGESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FENTANYL TRANSDERMAL SYSTEM</medicinalproduct>
        <drugauthorizationnumb>76258</drugauthorizationnumb>
        <drugdosagetext>100 UG/HR; Q3D; TRANS</drugdosagetext>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>ABDOMINAL PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060217</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FENTANYL TRANSDERMAL SYSTEM</medicinalproduct>
        <drugauthorizationnumb>76258</drugauthorizationnumb>
        <drugdosagetext>100 UG/HR; Q3D; TRANS</drugdosagetext>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>BREAST CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060217</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOTENSIN HCT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FEMARA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SENNA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOCUSATE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056543-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060720</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060711</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2006-BP-08002NB</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>72</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PULMONARY ALVEOLAR HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MICARDIS</medicinalproduct>
        <drugauthorizationnumb>20850</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ATELEC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056544-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060720</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060718</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2006-BP-08334NB</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>61</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CEREBRAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MICARDIS</medicinalproduct>
        <drugauthorizationnumb>020850</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040723</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050315</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OTHER MEDICATION</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040723</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050315</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056545-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060720</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060717</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CO-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2006-BP-08326CL</companynumb>
    <primarysource>
      <reportercountry>COLOMBIA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MICARDIS</medicinalproduct>
        <drugbatchnumb>NR</drugbatchnumb>
        <drugauthorizationnumb>020850</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056546-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060720</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060719</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2006-BP-08285BP</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>84</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>021395</drugauthorizationnumb>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056547-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060720</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050414</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2005-BP-06605NB</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>58.5</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ATRIAL FIBRILLATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MICARDIS</medicinalproduct>
        <drugauthorizationnumb>020850</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040117</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040517</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERLIPIDAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040517</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMARYL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030116</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040517</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEPHROX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030109</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040517</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HAJIME (ATENOLOL)</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030228</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040517</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TORSEMIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OEDEMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031226</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040517</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056548-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060720</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060713</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2006-BP-08069BR</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 PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THERAPEUTIC RESPONSE DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MICARDIS</medicinalproduct>
        <drugbatchnumb>6640</drugbatchnumb>
        <drugauthorizationnumb>020850</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056549-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060720</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060714</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AR-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2006-BP-08110RA</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>40</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ACUTE ABDOMEN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TIPRANAVIR/RITONAVIR SOLUTION</medicinalproduct>
        <drugdosagetext>800 MG/320 MG TPV/RTV</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060420</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060711</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056550-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060720</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060713</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2006-BP-08111AU</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>65</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ASASANTIN SR (CAPSULE, LONG ACTING)</medicinalproduct>
        <drugbatchnumb>NR</drugbatchnumb>
        <drugauthorizationnumb>20884</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>TRANSIENT ISCHAEMIC ATTACK</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056551-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060720</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060717</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2006-BP-08217BP</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>INTERNATIONAL NORMALISED RATIO INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>APTIVUS/RITONAVIR CAPSULES</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>21814</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056552-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060720</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060713</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2006-DE-03550GD</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>31</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE 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>HYPOVOLAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METABOLIC ACIDOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PREMATURE LABOUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROTEIN URINE PRESENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUS TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINE KETONE BODY PRESENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALBUTEROL SPIROS</medicinalproduct>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALBUTEROL SPIROS</medicinalproduct>
        <drugadministrationroute>055</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HYDROCORTISONE TAB</medicinalproduct>
        <drugdosagetext>200 MG IMMEDIATELY AND THEN 100 MG FOUR TIMES DAILY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IPRATROPIUM BROMIDE</medicinalproduct>
        <drugauthorizationnumb>019085</drugauthorizationnumb>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMINOPHYLLINE</medicinalproduct>
        <drugauthorizationnumb>088126</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXYGEN</medicinalproduct>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056553-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060626</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006RR-02865</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>53</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ACTIVATED PARTIAL THROMBOPLASTIN TIME PROLONGED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANOREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROTHROMBIN TIME PROLONGED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHABDOMYOLYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugauthorizationnumb>76285</drugauthorizationnumb>
        <drugdosagetext>40 MG, QD, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugtreatmentduration>1095</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DILTIAZEM</medicinalproduct>
        <drugdosagetext>30  MG, QID, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD PRESSURE</drugindication>
        <drugtreatmentduration>91</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056554-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060720</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060712</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ES-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2006-ES-00260ES</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>67</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>LYMPHOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>APTIVUS</medicinalproduct>
        <drugdosagetext>TIPRANAVIR 1000 MG + RITONAVIR 400 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060207</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VIREAD</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040326</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZIAGEN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000427</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUZEON</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060207</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056555-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060720</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060530</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2006-FF-00401FF</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>84</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BENIGN PROSTATIC HYPERPLASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY RETENTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMBIVENT</medicinalproduct>
        <drugauthorizationnumb>020291</drugauthorizationnumb>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19970101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FORADIL</medicinalproduct>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MIFLONIL</medicinalproduct>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OGAST</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
        <drugindication>GOUT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASILIX</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056556-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060720</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050923</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2005-BP-16949BP</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>74</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>77.11</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>IRIS DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MIOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLOMAX</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>20579</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BENIGN PROSTATIC HYPERPLASIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050215</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056557-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060720</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050923</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2005-BP-16942BP</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>74</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>77.11</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>IRIS DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MIOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLOMAX</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>20579</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BENIGN PROSTATIC HYPERPLASIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050215</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056558-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060720</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060714</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2006-BP-08113BP</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>76</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FUNGAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>021395</drugauthorizationnumb>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056559-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060720</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060714</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2006-BP-08145BP</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>71</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CHEST DISCOMFORT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ATROVENT</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>019085</drugauthorizationnumb>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19960101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060531</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL SPIROS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugindication>GASTROOESOPHAGEAL REFLUX DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZANTAC</medicinalproduct>
        <drugindication>GASTROOESOPHAGEAL REFLUX DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAALOX FAST BLOCKER</medicinalproduct>
        <drugindication>GASTROOESOPHAGEAL REFLUX DISEASE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056560-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060720</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060717</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2006-BP-08165BR</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>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THERAPEUTIC RESPONSE DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
        <drugbatchnumb>601649</drugbatchnumb>
        <drugauthorizationnumb>021395</drugauthorizationnumb>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>EMPHYSEMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BAMIFIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALVESCO</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FORADIL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056561-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060720</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060717</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ES-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2006-ES-00267ES</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>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH ERYTHEMATOUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIRAMUNE</medicinalproduct>
        <drugauthorizationnumb>020636</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060525</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060603</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COMBIVIR</medicinalproduct>
        <drugdosagetext>(150 MG ZIDOVUDINE + 300 MG LAMIVUDINE) / 2 TIME AT DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060603</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056562-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060720</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060511</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2006-CN-00260CN</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>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POLLAKIURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MOBICOX TABLETS</medicinalproduct>
        <drugauthorizationnumb>20938</drugauthorizationnumb>
        <drugdosagetext>1 PER DAY IF NEEDED</drugdosagetext>
        <drugindication>ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020111</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056563-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060720</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060712</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CO-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2006-BP-08007CL</companynumb>
    <primarysource>
      <reportercountry>COLOMBIA</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>60</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SECOTEX CAPSULES</medicinalproduct>
        <drugbatchnumb>NR</drugbatchnumb>
        <drugauthorizationnumb>20579</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BENIGN PROSTATIC HYPERPLASIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051013</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051031</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANITOP</medicinalproduct>
        <drugindication>CARDIAC FAILURE CONGESTIVE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056564-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060720</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060706</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FI-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2006-SW-00299SF</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUDDEN ONSET OF SLEEP</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNOVIAL RUPTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VARICOSE ULCERATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SIFROL TAB. 0.18 MG</medicinalproduct>
        <drugauthorizationnumb>20667</drugauthorizationnumb>
        <drugdosagetext>VARYING 0,18MG 3 X 3 AT MAXIMUM</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PARKINSON'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060228</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SIFROL TAB. 0.18 MG</medicinalproduct>
        <drugauthorizationnumb>020667</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060301</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MADOPAR DEPOT</medicinalproduct>
        <drugdosagetext>STRENGTH: 100MG LEVODOPA + 25MG BENSERAZIDE; DAILY DOSE: 400MG LEVODOPA + 100MG BENSERAZIDE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PARKINSON'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19970101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CORONARY ARTERY DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugindication>HYPERCHOLESTEROLAEMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ELDEPRYL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PARKINSON'S DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMNIC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BENIGN PROSTATIC HYPERPLASIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FURESIS</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CORONARY ARTERY DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARDIOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CORONARY ARTERY DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DISPERIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CORONARY ARTERY DISEASE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056565-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060720</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060630</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2006-BP-07523NB</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>76</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MICARDIS</medicinalproduct>
        <drugauthorizationnumb>20850</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060629</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056566-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060720</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060713</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2006-CN-00363CN</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HEMIPARESIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUBDURAL HAEMATOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIRAMUNE</medicinalproduct>
        <drugauthorizationnumb>020636</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050705</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LAMIVUDINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATAZANAVIR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RITONAVIR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ABACAVIR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACYCLOVIR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUCONAZOLE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056567-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060720</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060518</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2006-BP-05637BP</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>34</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMBIVENT</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>20291</drugauthorizationnumb>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>DYSPNOEA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060418</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060425</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMBIVENT</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>020291</drugauthorizationnumb>
        <drugindication>ASTHMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADVAIR DISKUS 100/50</medicinalproduct>
        <drugindication>DYSPNOEA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060328</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugindication>DYSPNOEA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XOPENEX/IPRATROPIUM NEBULIZER</medicinalproduct>
        <drugindication>DYSPNOEA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugindication>GASTROOESOPHAGEAL REFLUX DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
        <drugindication>HYPOTHYROIDISM</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPAMAX</medicinalproduct>
        <drugindication>MIGRAINE PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XOPENEX HFA</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060328</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056568-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060720</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060712</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2006-UK-03182UK</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>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRIC ULCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LETHARGY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIPYRIDAMOLE</medicinalproduct>
        <drugauthorizationnumb>012836</drugauthorizationnumb>
        <drugdosagetext>2/1 DAYS</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CEREBROVASCULAR ACCIDENT</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060529</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>1/1 DAYS</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CEREBROVASCULAR ACCIDENT</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060529</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENDROFLUMETHIAZIDE</medicinalproduct>
        <drugdosagetext>1/1 DAYS</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD PRESSURE INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HUMULIN M3</medicinalproduct>
        <drugdosagetext>2/1 DAYS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PERINDOPRIL</medicinalproduct>
        <drugdosagetext>1/1 DAYS</drugdosagetext>
        <drugindication>BLOOD PRESSURE INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>QUININE SULFATE</medicinalproduct>
        <drugdosagetext>1/1 DAYS</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MUSCLE SPASMS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugdosagetext>1/1 DAYS</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056569-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060720</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060414</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2006-BP-04278BP</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
        <drugbatchnumb>506603,4C2232</drugbatchnumb>
        <drugauthorizationnumb>21395</drugauthorizationnumb>
        <drugadministrationroute>055</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056570-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060703</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>HQWYE972712OCT05</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BREAST CANCER FEMALE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BREAST CANCER METASTATIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BREAST CANCER RECURRENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METASTASES TO NECK</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMPRO</medicinalproduct>
        <drugauthorizationnumb>20527</drugauthorizationnumb>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056571-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060601</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CLOF-10237</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>72</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>BLOOD CREATININE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RECTAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOFARABINE</medicinalproduct>
        <drugauthorizationnumb>21673</drugauthorizationnumb>
        <drugdosagetext>40 MG/M2 QD X 3 IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ACUTE LYMPHOCYTIC LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060428</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060430</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOPHOSPHAMIDE</medicinalproduct>
        <drugdosagetext>200 MG/M2 Q12HR IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ACUTE LYMPHOCYTIC LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060427</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGNESIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PIPERACILLIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056572-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060630</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CLOF-10279</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>48</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FEBRILE NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PATHOGEN RESISTANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STAPHYLOCOCCAL BACTERAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOFARABINE</medicinalproduct>
        <drugauthorizationnumb>21673</drugauthorizationnumb>
        <drugdosagetext>46.8 MG QD X 5 IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ACUTE MYELOID LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060517</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060521</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IDARUBICIN HCL</medicinalproduct>
        <drugdosagetext>21 MG QD X 3 IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ACUTE MYELOID LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060517</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060519</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGNESIUM SULFATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM CHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM PHOSPHATES</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SODIUM PHOSPHATES</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BACLOFEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LINEZOLID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCORTIZONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SODIUM CHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM GLUCONATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FENTANYL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEUPOGEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMPHOTERICIN B</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIPHENHYDRAMINE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEPERIDINE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVALBUTEROL HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CILASTIN AND IMIPENEM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACYCLOVIR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BISACODYL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FILODIPINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NYSTATIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ESOMEPRAZOLE MAGNESIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MUPIRICIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEUKINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VORICONAZOLE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056573-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>007875</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>38</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>81.6</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>APHASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>APRAXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEMIPARESIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA FACIAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MIGRAINE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VASOCONSTRICTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIRCETTE</medicinalproduct>
        <drugauthorizationnumb>20713</drugauthorizationnumb>
        <drugdosagetext>1 TABLET, QD, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MENSTRUATION IRREGULAR</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050920</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIRCETTE</medicinalproduct>
        <drugauthorizationnumb>20713</drugauthorizationnumb>
        <drugdosagetext>1 TABLET, QD, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ORAL CONTRACEPTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050920</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALLEGRA-D(PSEUDOEPHEDRINE HYDROCHLORIDE, FEXOFENADINE)</medicinalproduct>
        <drugdosagetext>QD, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050920</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056574-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041220</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004118091</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLADDER CANCER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugauthorizationnumb>21156</drugauthorizationnumb>
        <drugdosagetext>400 MG (200 MG, 2 IN 1 D)</drugdosagetext>
        <drugindication>POLYP</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056575-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060705</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>163-21880-06030273</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>82</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>74.8435</patientweight>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ACUTE LEUKAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISEASE PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FULL BLOOD COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEUKAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG INFILTRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYELITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYELODYSPLASTIC SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCYTOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugbatchnumb>0077A-A</drugbatchnumb>
        <drugauthorizationnumb>21880</drugauthorizationnumb>
        <drugdosagetext>1 IN 1 D, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MYELODYSPLASTIC SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060220</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060302</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMBIEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IRON (IRON)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056576-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>163-21880-06050521</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>71</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>INTESTINAL OBSTRUCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugauthorizationnumb>21880</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MYELODYSPLASTIC SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060410</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060428</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugauthorizationnumb>21880</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MYELODYSPLASTIC SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060506</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN TAB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMARYL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056577-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060623</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>163-21880-06050517</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>50</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugbatchnumb>427924</drugbatchnumb>
        <drugauthorizationnumb>21880</drugauthorizationnumb>
        <drugdosagetext>10 MG, 1 IN 1 D, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060412</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060505</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056578-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060630</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006US001041</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>45</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DIFFUSE LARGE B-CELL LYMPHOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMEVIVE</medicinalproduct>
        <drugdosagetext>15 MG, WEEKLY, INTRAMUSCULAR</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>PSORIASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040903</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041217</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056579-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-2006-016482</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>57</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BURNS SECOND DEGREE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLUENZA LIKE ILLNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOCALISED INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SLEEP WALKING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THERMAL BURN</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>20060418</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056580-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-2006-013949</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>36</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>90.7</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>GANGRENE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE INFECTION</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>20050401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN B-12</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056581-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060720</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060621</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2006US09204</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>27</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>60.8</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXJADE</medicinalproduct>
        <drugauthorizationnumb>021882</drugauthorizationnumb>
        <drugdosagetext>1500 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060513</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060501</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXJADE</medicinalproduct>
        <drugauthorizationnumb>021882</drugauthorizationnumb>
        <drugdosagetext>1500 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060531</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060609</drugenddate>
        <drugtreatmentduration>14400</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056582-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-2006-014813</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>41</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>54.4</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BETASERON</medicinalproduct>
        <drugdosagetext>8 MIU, EVERY 2D, SUBCUTANEOUS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>SECONDARY PROGRESSIVE MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041202</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORAZEPAM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056583-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-2006-017404</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>61</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLINDNESS TRANSIENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHILLS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG DOSE OMISSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARALYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BETASERON</medicinalproduct>
        <drugbatchnumb>UA7639A</drugbatchnumb>
        <drugdosagetext>8 MIU, EVERY 2D, SUBCUTANEOUS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19940412</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056584-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-2006-017397</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG DOSE OMISSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</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>20030911</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056585-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060720</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060425</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-MERCK-0604FRA00072</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>74</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANGINA PECTORIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENTRICULAR TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VYTORIN</medicinalproduct>
        <drugauthorizationnumb>021687</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERCHOLESTEROLAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060302</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CORONARY ARTERY DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CAPTOPRIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>THROMBOSIS PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERCHOLESTEROLAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060301</drugenddate>
        <drugtreatmentduration>18</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZETIA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERCHOLESTEROLAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060301</drugenddate>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MOLSIDOMINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CORONARY ARTERY DISEASE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056586-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060720</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050921</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-MERCK-0509GBR00145</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>81</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BONE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JAW FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL CAVITY FISTULA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PATHOLOGICAL FRACTURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>20560</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050524</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056587-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060720</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060329</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CH-MERCK-0603CHE00314</companynumb>
    <primarysource>
      <reportercountry>SWITZERLAND</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>69</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ACUTE RESPIRATORY DISTRESS SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INVANZ</medicinalproduct>
        <drugauthorizationnumb>21337</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>SEPSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060323</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060326</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit></drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMOXICILLIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>SEPSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060322</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060326</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOBRAMYCIN SULFATE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>SEPSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060320</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060320</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056588-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-2006-017709</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>42</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RETINAL VEIN OCCLUSION</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>20020215</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056589-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060720</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060621</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-MERCK-0606USA05688</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>35</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>40</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>AMNIOTIC FLUID VOLUME INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIALYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOLYTIC ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALDOMET</medicinalproduct>
        <drugauthorizationnumb>13400</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050811</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050923</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALDOMET</medicinalproduct>
        <drugauthorizationnumb>013400</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031219</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALDOMET</medicinalproduct>
        <drugauthorizationnumb>013400</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050807</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANDEL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050804</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050804</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050922</drugenddate>
        <drugtreatmentduration>50</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>[THERAPY UNSPECIFIED]</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ZINC DEFICIENCY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050807</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060207</drugenddate>
        <drugtreatmentduration>185</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SODIUM BICARBONATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ACID BASE BALANCE ABNORMAL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050807</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051121</drugenddate>
        <drugtreatmentduration>107</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056590-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060720</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060714</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-MERCK-0607GBR00075</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>88</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD CREATINE PHOSPHOKINASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE NECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugauthorizationnumb>019766</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ISCHAEMIC HEART DISEASE PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051209</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060517</drugenddate>
        <drugtreatmentduration>160</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMIODARONE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLARITHROMYCIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060428</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060505</drugenddate>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLOPIDOGREL BISULFATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ACUTE MYOCARDIAL INFARCTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN AND PROPOXYPHENE HYDROCHLORIDE</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>LEVOTHYROXINE SODIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPOTHYROIDISM</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAPILLARY MUSCLE RUPTURE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RISEDRONATE SODIUM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056591-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060720</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060605</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-MERCK-0606USA00797</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>48</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FOCAL GLOMERULOSCLEROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENOVASCULAR HYPERTENSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COZAAR</medicinalproduct>
        <drugauthorizationnumb>20386</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENIDIPINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TEMOCAPRIL HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056592-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060720</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060626</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0606USA05084</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>78</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>91</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 ALKALINE PHOSPHATASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERNATIONAL NORMALISED RATIO INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VYTORIN</medicinalproduct>
        <drugauthorizationnumb>021687</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051017</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060611</drugenddate>
        <drugtreatmentduration>238</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VYTORIN</medicinalproduct>
        <drugauthorizationnumb>021687</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CORONARY ARTERY DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051017</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060611</drugenddate>
        <drugtreatmentduration>238</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NIACIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>LIPIDS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060507</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NIACIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060508</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060611</drugenddate>
        <drugtreatmentduration>35</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZESTRIL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056593-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060706</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>HQWYE771211JUL06</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>66</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>65.83</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ADVIL PM</medicinalproduct>
        <drugbatchnumb>B50140</drugbatchnumb>
        <drugauthorizationnumb>21394</drugauthorizationnumb>
        <drugdosagetext>1 CAPLET 1 TIME ONLY, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INSOMNIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060629</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060629</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056594-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060720</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060323</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ES-MERCK-0603ESP00042</companynumb>
    <primarysource>
      <reportercountry>SPAIN</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>HYPOCALCAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALDOMET</medicinalproduct>
        <drugauthorizationnumb>13400</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ESCITALOPRAM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056595-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060720</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060713</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-MERCK-0607USA03688</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROPECIA</medicinalproduct>
        <drugauthorizationnumb>20788</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MALE PATTERN BALDNESS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MINOXIDIL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056596-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060720</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060718</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-MERCK-0607GBR00079</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>75</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URTICARIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRUSOPT</medicinalproduct>
        <drugauthorizationnumb>020408</drugauthorizationnumb>
        <drugadministrationroute>047</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060403</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060605</drugenddate>
        <drugtreatmentduration>63</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BEZAFIBRATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051208</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LATANOPROST</medicinalproduct>
        <drugadministrationroute>047</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050721</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056597-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060720</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060329</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-MERCK-0603FRA00113</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>42</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MUSCLE RIGIDITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRESCRIBED OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TENDONITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NOROXIN</medicinalproduct>
        <drugauthorizationnumb>19384</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>URINARY TRACT INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050827</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050903</drugenddate>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOSFOMYCIN TROMETHAMINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>URINARY TRACT INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050827</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050827</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056811-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060503</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-SP-2006-01038</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>18</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ROAD TRAFFIC ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MENACTRA</medicinalproduct>
        <drugbatchnumb>U1662A</drugbatchnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>IMMUNISATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060502</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TUBERSOL</medicinalproduct>
        <drugbatchnumb>C2214A</drugbatchnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>IMMUNISATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060502</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056812-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060717</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>TR-NOVOPROD-255114</companynumb>
    <primarysource>
      <reportercountry>TURKEY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>67</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE IRREGULAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NOVOSEVEN</medicinalproduct>
        <drugdosagetext>7.2 MG, SINGLE</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>HAEMORRHAGE CONTROL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060706</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060706</drugenddate>
        <drugtreatmentduration>1440</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FRESH FROZEN PLASMA</medicinalproduct>
        <drugdosagetext>30 IU, UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060627</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060708</drugenddate>
        <drugtreatmentduration>15840</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056840-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060718</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2006NO10814</companynumb>
    <primarysource>
      <reportercountry>NORWAY</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>69</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BALANCE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>C-REACTIVE PROTEIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COORDINATION ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DELIRIUM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISORIENTATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPHIL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCYTOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RETICULOCYTE COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ESCITALOPRAM OXALATE</medicinalproduct>
        <drugdosagetext>20 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANXIETY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENERVA</medicinalproduct>
        <drugdosagetext>300 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ABSTAINS FROM ALCOHOL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TEGRETOL</medicinalproduct>
        <drugauthorizationnumb>016608</drugauthorizationnumb>
        <drugdosagetext>200 MG, TID</drugdosagetext>
        <drugadministrationroute>047</drugadministrationroute>
        <drugindication>ABSTAINS FROM ALCOHOL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060628</drugenddate>
        <drugtreatmentduration>14400</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056841-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060615</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2006US07840</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>41</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>75.283</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLINDNESS TRANSIENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRY MOUTH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUID INTAKE REDUCED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERVERTEBRAL DISC PROTRUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIBIDO DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NERVE COMPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VULVOVAGINAL DRYNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIOVAN HCT</medicinalproduct>
        <drugauthorizationnumb>20818</drugauthorizationnumb>
        <drugdosagetext>80MG VAL/12.5MG HCT, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060414</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060501</drugenddate>
        <drugtreatmentduration>25920</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIOVAN HCT</medicinalproduct>
        <drugauthorizationnumb>020818</drugauthorizationnumb>
        <drugdosagetext>40 MG</drugdosagetext>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060430</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056842-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060627</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2006US08334</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>55</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLISTER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CELLULITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH MACULAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN DISCOLOURATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIOVAN HCT</medicinalproduct>
        <drugauthorizationnumb>20818</drugauthorizationnumb>
        <drugdosagetext>80MG VAL/12.5MG HCT, QD</drugdosagetext>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060531</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060601</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIOVAN HCT</medicinalproduct>
        <drugauthorizationnumb>020818</drugauthorizationnumb>
        <drugdosagetext>80MG VAL/12.5MG HCT, QD</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060626</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056847-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060612</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ABBOTT-06P-087-0335723-00</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>14.9</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HEPATITIS CHOLESTATIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOXIC EPIDERMAL NECROLYSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CEFZON FINE GRANULE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>50749</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>UPPER RESPIRATORY TRACT INFLAMMATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040616</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040618</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CEFZON FINE GRANULE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>050749</drugauthorizationnumb>
        <drugindication>PHARYNGITIS</drugindication>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ANHIBA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>054</drugadministrationroute>
        <drugindication>HYPERTHERMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040616</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040626</drugenddate>
        <drugtreatmentduration>10</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CEFPODOXIME PROXETIL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>UPPER RESPIRATORY TRACT INFLAMMATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040627</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040628</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTHERMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040627</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040628</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BIOFERMIN</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060627</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056848-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060712</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-ABBOTT-06P-167-0338016-00</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060531</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060623</drugenddate>
        <drugtreatmentduration>23</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056849-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060711</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-ABBOTT-06P-062-0337896-00</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>OSTEOARTHRITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051121</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060524</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060704</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOCORTICOIDS</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056850-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060711</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-06P-163-0337943-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>81.72</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABORTION SPONTANEOUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060509</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060530</drugenddate>
        <drugtreatmentduration>21</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRENATAL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>VITAMIN SUPPLEMENTATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060509</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060620</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRENATAL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060621</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060509</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060613</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060614</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SERENOA REPENS</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MELATONIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INSOMNIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060509</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FISH OIL WITH OMEGA 3 FATTY ACIDS</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060509</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOSAMINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060509</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM W/MAGNESIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060509</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IRON</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060509</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYROSINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060509</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CHEMICALS</medicinalproduct>
        <drugindication>DIARRHOEA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060528</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060531</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056851-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060713</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>LB-ABBOTT-06P-093-0338065-00</companynumb>
    <primarysource>
      <reportercountry>LEBANON</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>35</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DUODENAL ULCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DUODENITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EPIDIDYMITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROENTERITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATEMESIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATOMEGALY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MICROLITHIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCREATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PURPURA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VASCULITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <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>5056852-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060609</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-06P-163-0335652-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>47</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>DIET REFUSAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ENCEPHALOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOXOPLASMOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RITONAVIR SOFT GELATIN CAPSULES</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>20945</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050622</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050714</drugenddate>
        <drugtreatmentduration>22</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RITONAVIR SOFT GELATIN CAPSULES</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>020945</drugauthorizationnumb>
        <drugindication>MULTIPLE-DRUG RESISTANCE</drugindication>
        <drugtreatmentduration>22</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>APTIVUS</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050622</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050714</drugenddate>
        <drugtreatmentduration>22</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>APTIVUS</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugindication>MULTIPLE-DRUG RESISTANCE</drugindication>
        <drugtreatmentduration>22</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLINDAMYCIN</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050714</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PYRIMETHAMINE TAB</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010714</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DAPSONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050714</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ITRACONAZOLE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050507</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050714</drugenddate>
        <drugtreatmentduration>68</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZITHROMAX</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050309</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050714</drugenddate>
        <drugtreatmentduration>126</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLINIC ACID</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050714</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRUVADA</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050714</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCODONE HYDROCHLORIDE</medicinalproduct>
        <drugindication>PALLIATIVE CARE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056874-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060707</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2006US08705</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FACIAL PALSY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMISIL</medicinalproduct>
        <drugauthorizationnumb>020539</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALEVE (CAPLET)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056876-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060712</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2006AU10569</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>27</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE SYSTOLIC DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BROAD LIGAMENT HAEMATOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXYTOCIN</medicinalproduct>
        <drugauthorizationnumb>018245</drugauthorizationnumb>
        <drugdosagetext>5 IU, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BUPIVACAINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FENTANYL TRANSDERMAL SYSTEM</medicinalproduct>
        <drugdosagetext>15 UG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PHENYLEPHRINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056877-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060627</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2006JP09712</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>33</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>71</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ACUTE GENERALISED EXANTHEMATOUS PUSTULOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CANDIDIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG ERUPTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRIC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERALISED ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENITAL PRURITUS MALE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PIGMENTATION DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH PUSTULAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN EROSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOXIC SKIN ERUPTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMISIL</medicinalproduct>
        <drugauthorizationnumb>20539</drugauthorizationnumb>
        <drugdosagetext>125 MG/D</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>TINEA PEDIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060530</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060603</drugenddate>
        <drugtreatmentduration>7200</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PEKIRON</medicinalproduct>
        <drugadministrationroute>061</drugadministrationroute>
        <drugindication>TINEA PEDIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060530</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060605</drugenddate>
        <drugtreatmentduration>10080</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056882-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060710</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-JNJFOC-20060504076</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>4</patientonsetage>
      <patientonsetageunit>800</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ACUTE LEUKAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ITRACONAZOLE</medicinalproduct>
        <drugauthorizationnumb>20083</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NAIL TINEA</drugindication>
        <drugtreatmentduration>28</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056883-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060621</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-JNJFOC-20060703447</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ELECTROCARDIOGRAM QT PROLONGED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENTRICULAR FIBRILLATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ITRACOL HEXAL</medicinalproduct>
        <drugauthorizationnumb>20083</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056884-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060713</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-JNJFOC-20060702528</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>90</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PULMONARY OEDEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DURAGESIC-100</medicinalproduct>
        <drugauthorizationnumb>019813</drugauthorizationnumb>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>BACK PAIN</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056885-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060713</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20060703581</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>70</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>70.31</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>APPLICATION SITE DERMATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FENTANYL TRANSDERMAL SYSTEM</medicinalproduct>
        <drugbatchnumb>0541699</drugbatchnumb>
        <drugauthorizationnumb>019813</drugauthorizationnumb>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CORTEF</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARDIZEM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EDECRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056886-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060710</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20060701849</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>5</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CONCERTA</medicinalproduct>
        <drugauthorizationnumb>021121</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056887-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060710</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20060702015</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>54.43</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PARANOIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CONCERTA</medicinalproduct>
        <drugauthorizationnumb>021121</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DISTURBANCE IN ATTENTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RISPERDAL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RISPERDAL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BIPOLAR DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056888-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060710</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20060702741</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>10</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <reaction>
        <reactionmeddrapt>HALLUCINATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CONCERTA</medicinalproduct>
        <drugauthorizationnumb>021121</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATTENTION DEFICIT/HYPERACTIVITY DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOCALIN XR</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056889-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060712</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20060702657</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BREAST DISCHARGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ORTHO EVRA</medicinalproduct>
        <drugauthorizationnumb>021180</drugauthorizationnumb>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050301</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056890-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060710</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20060504033</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>113.4</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>THROMBOTIC THROMBOCYTOPENIC PURPURA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERDAL CONSTA</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>PSYCHOTIC DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERDAL CONSTA</medicinalproduct>
        <drugauthorizationnumb>021346</drugauthorizationnumb>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056891-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060711</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20030904436</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>101.61</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL DISTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARPAL TUNNEL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIASTOLIC DYSFUNCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DILATATION ATRIAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EAR PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHOIDS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IRON DEFICIENCY ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MAMMOGRAM ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENORRHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MITRAL VALVE PROLAPSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NOCTURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARYNGOLARYNGEAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POLLAKIURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUS DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN LESION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE VASOVAGAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRICUSPID VALVE INCOMPETENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINE ANALYSIS ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENTRICULAR DYSFUNCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENTRICULAR HYPERTROPHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL ACUITY REDUCED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERDAL</medicinalproduct>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERDAL</medicinalproduct>
        <drugauthorizationnumb>020272</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MAJOR DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EFFEXOR XR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EFFEXOR XR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EFFEXOR XR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EFFEXOR XR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MAJOR DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOTROL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZYRTEC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMINS WITH IRON</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOPHAGE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENTERIC ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RANITIDINE HYDROCHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOVANCE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MUCINEX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NAPROSYN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056892-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060713</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>NL-JNJFOC-20060703162</companynumb>
    <primarysource>
      <reportercountry>NETHERLANDS</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>JOINT DISLOCATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERDAL</medicinalproduct>
        <drugauthorizationnumb>020272</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056893-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060327</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>HQWYE554028MAR06</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>61</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ALBUMIN URINE PRESENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANTINEUTROPHIL CYTOPLASMIC ANTIBODY POSITIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CHLORIDE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD SODIUM DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GLOMERULONEPHRITIS PROLIFERATIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATOCRIT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MICROSCOPIC POLYANGIITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEPHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RED BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060127</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060330</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BISOLVON</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060324</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MUCOSTA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTRITIS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060324</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RESPLEN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060329</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRAVIT</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INFECTION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060305</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZANTAC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS AGAINST GASTROINTESTINAL ULCER</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060330</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MOBIC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060310</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056897-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060215</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DEWYE020206FEB06</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>77</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DERMATITIS ALLERGIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ENCEPHALITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC STEATOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>ANKYLOSING SPONDYLITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050923</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040801</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056900-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060710</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006GB01191</companynumb>
    <primarysource>
      <reportercountry>IRELAND</reportercountry>
      <qualification>2</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>SEROQUEL</medicinalproduct>
        <drugauthorizationnumb>020639</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056901-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060717</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006CG01233</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>68</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ALVEOLITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERSTITIAL LUNG DISEASE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugauthorizationnumb>19810</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CORTANCYL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060623</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SPECIAFOLDINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060621</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VOLTARENE LP 75</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060621</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NOVATREX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060622</drugenddate>
        <drugtreatmentduration>53</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056902-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060712</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006UW14378</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>47</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWOLLEN TONGUE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugauthorizationnumb>020639</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
        <drugdosagetext>LOW DOSE</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056903-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060712</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006UW14327</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>17</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>OPTIC NERVE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAPILLOEDEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugauthorizationnumb>020639</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BIPOLAR I DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056904-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060718</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006UW14667</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>71</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>NEUROLEPTIC MALIGNANT SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugauthorizationnumb>020639</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MAJOR DEPRESSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056905-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060405</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006AP01609</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>85</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>65</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOPTYSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CASODEX</medicinalproduct>
        <drugauthorizationnumb>20498</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROSTATE CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051221</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060317</drugenddate>
        <drugtreatmentduration>87</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEUPLIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROSTATE CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060126</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060220</drugenddate>
        <drugtreatmentduration>26</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAMSULOSIN HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EVIPROSTAT</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALESION</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZANTAC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LAXOBERON</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056911-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060713</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-ABBOTT-06P-062-0338103-00</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIOMEGALY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIVERTICULAR PERFORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLATULENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMPAIRED HEALING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERICARDIAL EFFUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERITONITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PSORIASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060410</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060601</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>PSORIATIC ARTHROPATHY</drugindication>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TORSEMIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARVEDILOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TILIDINE</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056932-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060621</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AVENTIS-200616580GDDC</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>10</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>33</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD ALKALINE PHOSPHATASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ECCHYMOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEAD INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOGLYCAEMIC SEIZURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POST CONCUSSION SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWELLING FACE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>APIDRA</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugdosagetext>DOSE UNIT: UNITS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>DIABETES MELLITUS INSULIN-DEPENDENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060405</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AUTOPEN INSULIN INJECTION PEN</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060405</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
        <drugbatchnumb>1E552</drugbatchnumb>
        <drugauthorizationnumb>021081</drugauthorizationnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>DIABETES MELLITUS INSULIN-DEPENDENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060405</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OPTIPEN (INSULIN PUMP)</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060405</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056943-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060706</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2006TR10116</companynumb>
    <primarysource>
      <reportercountry>TURKEY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CONJUNCTIVAL HYPERAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTRAOCULAR PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OPEN ANGLE GLAUCOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORASEQ</medicinalproduct>
        <drugauthorizationnumb>20831</drugauthorizationnumb>
        <drugdosagetext>UNK, UNK</drugdosagetext>
        <drugindication>ASTHMA</drugindication>
        <drugtreatmentduration>365</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056949-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20030619</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2003US12110</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEVICE MALFUNCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORADIL</medicinalproduct>
        <drugauthorizationnumb>020831</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050601</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056950-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060710</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHO2006US11119</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>82</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>59.6</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ATRIOVENTRICULAR BLOCK SECOND DEGREE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRADYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LOTREL</medicinalproduct>
        <drugdosagetext>LEVEL 1</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031204</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LOTREL</medicinalproduct>
        <drugdosagetext>LEVEL 3</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METOPROLOL</medicinalproduct>
        <drugauthorizationnumb>017963</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056951-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060717</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060717</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CORNEAL OPACITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POST PROCEDURAL COMPLICATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEVANAC</medicinalproduct>
        <drugdosagetext>ONE DROP TID RIGHT EYE</drugdosagetext>
        <drugindication>PAIN PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051214</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051221</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056955-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060718</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-RB-3599-2006</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>GLOSSODYNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA ORAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWELLING FACE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BUPRENORPHINE, NALOXONE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>20733</drugauthorizationnumb>
        <drugadministrationroute>060</drugadministrationroute>
        <drugindication>DRUG DEPENDENCE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060115</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056956-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006UW13655</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>49</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>68</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugauthorizationnumb>20639</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BIPOLAR DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>KETOCONAZOLE</medicinalproduct>
        <drugindication>TINEA PEDIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LITHIUM CARBONATE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056957-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060718</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006UW14725</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>70</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>RHABDOMYOLYSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugauthorizationnumb>021366</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZETIA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COLESTID</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056959-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060712</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-13440722</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MEGACE</medicinalproduct>
        <drugauthorizationnumb>016979</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056960-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060712</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-13440706</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MEGACE</medicinalproduct>
        <drugauthorizationnumb>016979</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056961-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050819</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-BRISTOL-MYERS SQUIBB COMPANY-13090964</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>66</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>CATARACT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>KERATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ULCERATIVE KERATITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ERBITUX</medicinalproduct>
        <drugindication>RECTAL CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050412</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IRINOTECAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMINS NOS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROSTIGMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLOXAL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOVIRAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOCLOPRAMIDE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056962-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060710</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20060701759</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>74.84</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HODGKIN'S DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFECTIOUS MONONUCLEOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CROHN'S DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MERCAPTOPURINE</medicinalproduct>
        <drugindication>CROHN'S DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASACOL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056963-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060710</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20060701773</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>89.36</patientweight>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>MENINGIOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARAVA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VOLTAREN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOZOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BETAINE HYDROCHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KLOR-CON</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPROL-XL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056971-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060616</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHRM2006FR01840</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>50</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABSCESS JAW</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE DEBRIDEMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE EROSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FISTULA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FISTULA REPAIR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA TEETH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLAMMATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MANDIBULECTOMY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PATHOLOGICAL FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLASTIC SURGERY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRIMARY SEQUESTRUM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PURULENT DISCHARGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTH DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugdosagetext>4 MG, QMO</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BONE PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030724</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AREDIA</medicinalproduct>
        <drugauthorizationnumb>020036</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BONE PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020702</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030620</drugenddate>
        <drugtreatmentduration>354</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056984-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060714</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHFR2006GB02244</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>CONCOMITANT DISEASE AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXELON</medicinalproduct>
        <drugauthorizationnumb>020823</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056985-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060710</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20060701796</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>LOWER LIMB FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UPPER LIMB FRACTURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056986-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060710</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20060702123</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>88.45</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CHILLS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DECREASED APPETITE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFUSION RELATED REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</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>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROZAC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATIVAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOTRELL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPREM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIULUS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOSIUM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056987-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060711</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20060702143</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>56</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANKLE FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL DISTURBANCE</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>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SULFASALAZINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ULTRAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DARVOCET</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZANAFLEX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VICODIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM GLUCONATE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056989-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060710</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-JNJFOC-20060200927</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>75.1</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CHORIORETINOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HERPES ZOSTER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METHICILLIN-RESISTANT STAPHYLOCOCCAL AUREUS TEST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUROPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA LEGIONELLA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RHEUMATREX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SODIUM RISEDRONATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GASTER</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTROINTESTINAL DISORDER THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIAMIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ADVERSE DRUG REACTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VOLTAREN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SELBEX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTROINTESTINAL DISORDER THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ISCOTIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANTIBIOTIC PROPHYLAXIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056990-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060711</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-JNJFOC-20060702261</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>36</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>60.6</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CHEST DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSED LEVEL OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRY THROAT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFUSION RELATED REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL DISTURBANCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugbatchnumb>6RMKA70101</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CROHN'S DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENADRYL</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PREMEDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCORTISONE TAB</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PREMEDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GRAVOL TAB</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PREMEDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5056992-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060710</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20060603739</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>71.67</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFUSION RELATED REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA ORAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARYNGOLARYNGEAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWELLING FACE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROAT TIGHTNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URTICARIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugbatchnumb>06B173P1;06B065P1</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugbatchnumb>06B173P1;06B065P1</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugbatchnumb>06B173P1;06B065P1</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>M.V.I.</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRAVACHOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLIMARA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVAPRO</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057004-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060714</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CN-BRACCO-BRO-010339</companynumb>
    <primarysource>
      <reportercountry>CHINA</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>79</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IOPAMIRO</medicinalproduct>
        <drugbatchnumb>0603003F</drugbatchnumb>
        <drugauthorizationnumb>18735</drugauthorizationnumb>
        <drugadministrationroute>050</drugadministrationroute>
        <drugindication>ALLERGY TEST</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060714</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060714</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057017-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesscongenitalanomali>1</seriousnesscongenitalanomali>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20020418</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-AVENTIS-200211607FR</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>2.1</patientweight>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>APGAR SCORE LOW</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRADYCARDIA NEONATAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CAESAREAN SECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONGENITAL TRICUSPID VALVE ATRESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CYANOSIS NEONATAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMODYNAMIC INSTABILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART DISEASE CONGENITAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METABOLIC ACIDOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEONATAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEONATAL HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA NEONATAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PREMATURE BABY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENTRICULAR FIBRILLATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TORENTAL</medicinalproduct>
        <drugauthorizationnumb>18631</drugauthorizationnumb>
        <drugadministrationroute>064</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19940630</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19960223</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ASPEGIC 1000</medicinalproduct>
        <drugadministrationroute>064</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19960403</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ISOPTIN</medicinalproduct>
        <drugadministrationroute>064</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROZAC</medicinalproduct>
        <drugadministrationroute>064</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19960131</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COVERSYL</medicinalproduct>
        <drugadministrationroute>064</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19940630</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19960227</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
        <drugadministrationroute>064</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19940630</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19960131</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIXTARD HUMAN 70/30</medicinalproduct>
        <drugadministrationroute>064</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19960227</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPANTHYL</medicinalproduct>
        <drugadministrationroute>064</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19940101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19960227</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INSULATARD NPH HUMAN</medicinalproduct>
        <drugadministrationroute>064</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19960227</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACTRAPID</medicinalproduct>
        <drugadministrationroute>064</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19960227</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SOTALOL HCL</medicinalproduct>
        <drugadministrationroute>064</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ISOPTIN</medicinalproduct>
        <drugadministrationroute>064</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CATAPRES</medicinalproduct>
        <drugadministrationroute>064</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19960701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LASILIX</medicinalproduct>
        <drugadministrationroute>064</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19960701</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057018-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20051207</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-AVENTIS-200513719JP</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>50</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ALANINE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASPARTATE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD ALKALINE PHOSPHATASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRIC ULCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IRON DEFICIENCY ANAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARAVA</medicinalproduct>
        <drugauthorizationnumb>20905</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031009</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031206</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>THROMBOSIS PROPHYLAXIS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031212</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ISCOTIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DISSEMINATED TUBERCULOSIS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031212</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACECOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031212</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SELECTOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031212</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROMAC                                  /JPN/</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS AGAINST GASTROINTESTINAL ULCER</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031212</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACINON</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS AGAINST GASTROINTESTINAL ULCER</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031212</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BONALON</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031212</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PURSENNID</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONSTIPATION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031212</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DORAL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INSOMNIA</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031212</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BAKTAR</medicinalproduct>
        <drugdosagetext>DOSE: 1TABLET</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANTIBIOTIC PROPHYLAXIS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031212</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGNESIUM OXIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONSTIPATION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031212</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEXOTAN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NEUROSIS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031212</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031212</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BEHCET'S SYNDROME</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031212</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057019-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060710</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-AVENTIS-200612488FR</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>72</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>LICHENOID KERATOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LASILIX</medicinalproduct>
        <drugauthorizationnumb>16273</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CARDIAC FAILURE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ATARAX</medicinalproduct>
        <drugindication>ANXIETY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIGOXIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIGOXIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATRIAL FLUTTER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREVISCAN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREVISCAN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NOCTRAN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SLEEP DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CORDARONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CORDARONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATRIAL FLUTTER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SEROPRAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRAZEPAM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057020-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-AVENTIS-200612211JP</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>28</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>75</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>GAMMA-GLUTAMYLTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PURPURA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARAVA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040608</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040809</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARAVA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040810</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040818</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARAVA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040819</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARAVA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041002</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041213</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARAVA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050423</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050814</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELESTONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040313</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040731</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METALCAPTASE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040214</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040703</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PYDOXAL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040214</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040703</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THEO-DUR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SEREVENT</medicinalproduct>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUTIDE</medicinalproduct>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LULLAN                                  /JPN/</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TASMOLIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LENDORMIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MELBIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040918</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057021-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060421</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-AVENTIS-200612478EU</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>85</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANGINA PECTORIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NITROLINGUAL PUMPSPRAY</medicinalproduct>
        <drugbatchnumb>DIN02238998/ LOT 116676</drugbatchnumb>
        <drugauthorizationnumb>86132</drugauthorizationnumb>
        <drugadministrationroute>060</drugadministrationroute>
        <drugindication>ANGINA PECTORIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060328</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONAZEPAM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060201</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057027-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060710</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHO2006US11116</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>62</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIASTOLIC DYSFUNCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA EXERTIONAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SANDOSTATIN LAR</medicinalproduct>
        <drugauthorizationnumb>21008</drugauthorizationnumb>
        <drugdosagetext>30MG EVERY 28 DAYS</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>NEUROENDOCRINE CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060413</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060703</drugenddate>
        <drugtreatmentduration>82</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RAD001</medicinalproduct>
        <drugdosagetext>10 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NEUROENDOCRINE CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060413</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060703</drugenddate>
        <drugtreatmentduration>82</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KENALOG</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPROL-XL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRILOSEC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADVIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DULCOLAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOMOTIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VICODIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALEVE (CAPLET)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057044-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060706</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006-145297-NL</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <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>CYTOLYTIC HEPATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JAUNDICE CHOLESTATIC</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIRTAZAPINE</medicinalproduct>
        <drugdosagetext>DF</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060607</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060612</drugenddate>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BISOPROLOL FUMARATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUINDIONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM CHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMPHOTERICIN B</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYGEN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057048-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060517</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-13380969</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>76</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ILEUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SMALL INTESTINAL OBSTRUCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ERBITUX</medicinalproduct>
        <drugdosagetext>THERAPY START DATE 19-APR-06. DELAYED/OMITTED.</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060509</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060509</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARBOPLATIN</medicinalproduct>
        <drugdosagetext>THERAPY START DATE 19-APR-06.</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060509</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060509</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAXOTERE</medicinalproduct>
        <drugdosagetext>THERAPY START DATE 19-APR-2006.</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060509</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060509</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VERAPAMIL</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19830101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060425</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANOXIN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19960101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>QUESTRAN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19710101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19660101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENICAR</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060425</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOMOTIL</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19700101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIAZEPAM</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19760101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>M.V.I.</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19460101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASCORBIC ACID</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19460101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN B6</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19960101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>B12</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19700101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM GLUCONATE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19810101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>QUININE SULFATE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060418</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOFRAN</medicinalproduct>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060419</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DECADRON</medicinalproduct>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060419</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENADRYL</medicinalproduct>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060419</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDRATION</medicinalproduct>
        <drugindication>HYPOTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060425</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AREDIA</medicinalproduct>
        <drugindication>METASTASES TO BONE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060425</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARANESP</medicinalproduct>
        <drugindication>CHEMOTHERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060502</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COMPAZINE</medicinalproduct>
        <drugindication>NAUSEA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060419</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057050-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060525</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-13390703</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>66</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>105</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAEMIA OF MALIGNANT DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE CONGESTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEBRILE NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY CONGESTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUS TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUPRAVENTRICULAR TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYTOXAN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BREAST CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060405</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060522</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ADRIAMYCIN PFS</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060405</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060522</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ABRAXANE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060407</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060525</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>ANAEMIA OF MALIGNANT DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060417</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060528</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057051-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060105</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL164055</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>66</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>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>20050701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057052-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060110</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL164488</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugindication>HIV INFECTION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057053-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060110</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL164568</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>RENAL FAILURE CHRONIC</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057054-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060114</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-US164880</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EPOGEN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PRE-EXISTING DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051216</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057055-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060112</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL165121</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>63</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugindication>MYELODYSPLASTIC SYNDROME</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057056-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060110</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-US164208</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>THERAPEUTIC RESPONSE DELAYED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EPOGEN</medicinalproduct>
        <drugbatchnumb>P050259</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>DIALYSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057057-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060106</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-US163975</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>GRAFT THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THERAPEUTIC RESPONSE DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EPOGEN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>DIALYSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SENSIPAR</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057058-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060106</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-US163891</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>THERAPEUTIC RESPONSE DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EPOGEN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>DIALYSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021207</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021207</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021203</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057059-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060106</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL164283</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD VISCOSITY INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>ANAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050801</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057060-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060105</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-US164133</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>64</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>THERAPEUTIC RESPONSE DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>ANAEMIA OF MALIGNANT DISEASE</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057061-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060105</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL165130</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>70</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RENAL FAILURE CHRONIC</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057062-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060105</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL164300</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>82.6</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>THERAPEUTIC RESPONSE DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>ANAEMIA OF MALIGNANT DISEASE</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051130</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEUPOGEN</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057063-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050517</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL134700</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>70</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>70.4</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HAEMATOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERONEAL NERVE PALSY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POST PROCEDURAL COMPLICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SCIATIC NERVE INJURY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugindication>PREOPERATIVE CARE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057064-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060113</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-US165109</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EPOGEN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>PRE-EXISTING DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050301</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057065-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060112</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-US164543</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALNUTRITION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EPOGEN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>DIALYSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051006</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057066-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060705</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ENT 2006-0010</companynumb>
    <primarysource>
      <reportercountry>DENMARK</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>74</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ALANINE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD ALKALINE PHOSPHATASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD AMYLASE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD AMYLASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHROMATURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COOMBS DIRECT TEST POSITIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLATULENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAMMA-GLUTAMYLTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HALLUCINATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JAUNDICE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RETICULOCYTE COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMTESS            (ENTACAPONE)</medicinalproduct>
        <drugdosagetext>1400 MG ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PARKINSON'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050822</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050928</drugenddate>
        <drugtreatmentduration>37</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MADOPAR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>APOMORFIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMANTADINE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIFROL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DETRUSITOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARICEPT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MOTILIUM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057067-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060707</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>WAES 0607CHN00010</companynumb>
    <primarysource>
      <reportercountry>CHINA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>52</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ADENOMYOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BREATH SOUNDS ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC MURMUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHOLECYSTITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ENTERITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL CARCINOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</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>20031222</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060706</drugenddate>
        <drugtreatmentduration>928</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRONOLACTONE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057070-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060718</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-BRACCO-BRO-010340</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL STIFFNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROHANCE</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>020131</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NUCLEAR MAGNETIC RESONANCE IMAGING BRAIN</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057072-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060703</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>WAES 0607USA00148</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>59</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ALOPECIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONTUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DERMATITIS CONTACT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL STIFFNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUS BRADYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STOMACH DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY INCONTINENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MK-0869 (APREPITANT)</medicinalproduct>
        <drugauthorizationnumb>21549</drugauthorizationnumb>
        <drugdosagetext>40 MG/1X PO; 25 MG/DAILY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS OF NAUSEA AND VOMITING</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060622</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060622</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MK-0869 (APREPITANT)</medicinalproduct>
        <drugauthorizationnumb>21549</drugauthorizationnumb>
        <drugdosagetext>40 MG/1X PO; 25 MG/DAILY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS OF NAUSEA AND VOMITING</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060623</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060626</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARVEDILOL</medicinalproduct>
        <drugdosagetext>10 MG DAILY</drugdosagetext>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060630</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACTOS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CATLEP</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CISPLATIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EURODIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GASTER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LACTEC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MG OXIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRORENAL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SELBEX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SOLITA T-1</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SOLITA T-3</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GEMCITABINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GRANISETRON HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SENNOSIDES</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLPIDEM TARTRATE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057075-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060530</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-AVENTIS-200611944FR</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>55</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ASPARTATE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATOCELLULAR DAMAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KETEK</medicinalproduct>
        <drugauthorizationnumb>21144</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BRONCHITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060315</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060320</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMOXICILLIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BRONCHITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060320</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060327</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PYOSTACINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060329</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060409</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CIFLOX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060329</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060403</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057076-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060714</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AVENTIS-200615919US</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>43</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>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>CHRONIC HEPATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATOCELLULAR DAMAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLUENZA LIKE ILLNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JAUNDICE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MICTURITION URGENCY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KETEK</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021144</drugauthorizationnumb>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
        <drugindication>SINUSITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057077-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060718</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>RE-AVENTIS-200612523FR</companynumb>
    <primarysource>
      <reportercountry>REUNION</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>AMNESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ROAD TRAFFIC ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL DISTURBANCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KETEK</medicinalproduct>
        <drugauthorizationnumb>021144</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057078-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060404</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-AVENTIS-200613609GDDC</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>78</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>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>BLOOD LACTATE DEHYDROGENASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAMMA-GLUTAMYLTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC ENZYME INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KETEK</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>21144</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SINUSITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050113</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050120</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MONOCOR</medicinalproduct>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DYAZIDE</medicinalproduct>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM GLUCONATE</medicinalproduct>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057079-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060504</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AVENTIS-200614109US</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>89.9</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ALANINE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASPARTATE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BILIRUBIN CONJUGATED INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD ALKALINE PHOSPHATASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD BILIRUBIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD BILIRUBIN UNCONJUGATED INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CHLORIDE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GLYCOSYLATED HAEMOGLOBIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KETEK</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>21144</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SINUSITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HUMALOG</medicinalproduct>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL W/HYDROCHLOROTHIAZIDE</medicinalproduct>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057081-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060418</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AVENTIS-200613694US</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HEPATOCELLULAR DAMAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HOSPITALISATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER FUNCTION TEST ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KETEK</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>21144</drugauthorizationnumb>
        <drugdosagetext>DOSE: UNKNOWN</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRACLEER</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>PULMONARY HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRACLEER</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057082-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060712</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>TR-AVENTIS-200617248GDDC</companynumb>
    <primarysource>
      <reportercountry>TURKEY</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OESOPHAGITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KETEK</medicinalproduct>
        <drugauthorizationnumb>021144</drugauthorizationnumb>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ACUTE SINUSITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057083-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060713</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AVENTIS-200615903US</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>81.81</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ALANINE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASPARTATE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SERUM FERRITIN INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KETEK</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021144</drugauthorizationnumb>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>LARYNGITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051224</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051201</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057086-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060717</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AVENTIS-200615967US</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>100</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>APPENDICITIS PERFORATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLADDER CANCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLON CANCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021081</drugauthorizationnumb>
        <drugindication>DIABETES MELLITUS NON-INSULIN-DEPENDENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021081</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060716</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060716</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021081</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060717</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENALAPRIL MALEATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
        <drugdosagetext>DOSE: 2 TABS</drugdosagetext>
        <drugindication>RESTLESS LEGS SYNDROME</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057087-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060627</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>TR-AVENTIS-200617242GDDC</companynumb>
    <primarysource>
      <reportercountry>TURKEY</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>17</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>62</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DIABETIC KETOACIDOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INSULIN GLARGINE</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>21081</drugauthorizationnumb>
        <drugindication>DIABETES MELLITUS INSULIN-DEPENDENT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OPTIPEN (INSULIN PUMP)</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugindication>DIABETES MELLITUS INSULIN-DEPENDENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040617</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HUMALOG</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>DIABETES MELLITUS INSULIN-DEPENDENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20001208</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057091-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060706</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>WAES 0606DEU00084</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>78</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>20560</drugauthorizationnumb>
        <drugdosagetext>10 MG/DAILY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041126</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PLACEBO (UNSPECIFIED)</medicinalproduct>
        <drugdosagetext>SC</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041126</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM GLUCONATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057094-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>WAES 0607ARG00005</companynumb>
    <primarysource>
      <reportercountry>ARGENTINA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>48</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CRIXIVAN</medicinalproduct>
        <drugauthorizationnumb>20685</drugauthorizationnumb>
        <drugtreatmentduration>44</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LAMIVUDINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEVIRAPINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>STAVUDINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057098-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060316</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-AMGEN-UK172781</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>CEREBRAL CIRCULATORY FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CIRCULATORY COLLAPSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EPILEPSY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DARBEPOETIN ALFA</medicinalproduct>
        <drugauthorizationnumb>7413</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>DIALYSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050524</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057101-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060525</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006030423</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>21</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>STEVENS-JOHNSON SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEXTRA</medicinalproduct>
        <drugauthorizationnumb>21341</drugauthorizationnumb>
        <drugindication>ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040302</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057104-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060525</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006030421</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>76</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>STEVENS-JOHNSON SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URTICARIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEXTRA</medicinalproduct>
        <drugauthorizationnumb>21341</drugauthorizationnumb>
        <drugdosagetext>10 MG (10 MG, 1 IN 1 D),</drugdosagetext>
        <drugindication>BURSITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050323</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050329</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057105-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060322</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-AMGEN-US171807</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>7.9</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACTERIAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE MARROW FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CATHETER RELATED COMPLICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMODIALYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INDWELLING CATHETER MANAGEMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY SYNCYTIAL VIRUS INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STREPTOCOCCAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THERAPEUTIC RESPONSE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UPPER RESPIRATORY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VIRAL INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARANESP</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>DIALYSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050706</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCITRIOL</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050708</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FERROUS SULFATE TAB</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050323</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SODIUM CHLORIDE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050303</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RANITIDINE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050915</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057106-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060609</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-US182432</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>APLASIA PURE RED CELL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARANESP</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>DIALYSIS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060601</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EPOGEN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>DIALYSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEPHRO-CAPS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOPRESSOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057107-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060707</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-US181928</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>45</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>100</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANTI-ERYTHROPOIETIN ANTIBODY POSITIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANTINEUTROPHIL CYTOPLASMIC ANTIBODY POSITIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>C-REACTIVE PROTEIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EPISTAXIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMODIALYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HOT FLUSH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERPARATHYROIDISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IRON DEFICIENCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>KIDNEY TRANSPLANT REJECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OCCULT BLOOD POSITIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THERAPEUTIC RESPONSE DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EPOGEN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>DIALYSIS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060501</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARANESP</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>RENAL FAILURE CHRONIC</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VENOFER</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RAPAMUNE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYCLOSPORINE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057108-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060105</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL164057</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>74</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>55.8</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CATARACT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>MYELODYSPLASTIC SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19940101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057109-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060105</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-US163753</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>45</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>90</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>THERAPEUTIC RESPONSE DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EPOGEN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>DIALYSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057110-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060106</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL164281</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SERUM FERRITIN INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RENAL FAILURE CHRONIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051001</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057111-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060106</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL164280</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>RENAL FAILURE CHRONIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050301</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057112-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060110</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL164517</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CHILLS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING COLD</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RENAL FAILURE CHRONIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057113-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20051221</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-US162345</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>47</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THERAPEUTIC RESPONSE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VASCULAR ACCESS COMPLICATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EPOGEN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>DIALYSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040317</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SENSIPAR</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057115-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20051223</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-US162796</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>81</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>THERAPEUTIC RESPONSE DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EPOGEN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>DIALYSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010416</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051122</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051031</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SENSIPAR</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050428</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050404</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030526</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030526</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030526</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030526</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057116-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20051227</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL163002</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>82</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>47.7</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>ANAEMIA OF MALIGNANT DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051220</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057117-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20051209</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-US160873</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EPOGEN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>DIALYSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057118-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20051011</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL154589</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>86.3</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RENAL FAILURE CHRONIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051001</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057119-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060103</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL163724</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>62</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>THERAPEUTIC RESPONSE DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RENAL FAILURE CHRONIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040223</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057120-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060104</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL163936</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>THERAPEUTIC RESPONSE DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugindication>RENAL FAILURE CHRONIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050412</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057121-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060103</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL163723</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>78.1</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>ANAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057122-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20051227</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL163027</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LISTLESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>ANAEMIA OF MALIGNANT DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057123-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20051227</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL163003</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>95.3</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>ANAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051005</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057127-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060705</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2005123897</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>42</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>82.5547</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ARTERIOSCLEROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUS ARRHYTHMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUPRAVENTRICULAR EXTRASYSTOLES</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEXTRA</medicinalproduct>
        <drugauthorizationnumb>21341</drugauthorizationnumb>
        <drugdosagetext>10 MG (10 MG, 1 IN 1 D),</drugdosagetext>
        <drugindication>ARTHRALGIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057128-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20051221</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>SE-AMGEN-UK142924</companynumb>
    <primarysource>
      <reportercountry>SWEDEN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ACUTE MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRIC ULCER HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CINACALCET</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERPARATHYROIDISM SECONDARY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050425</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050919</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TROMBYL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057130-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060705</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2005124521</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>72</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>75.2971</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ATRIAL FIBRILLATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ATRIAL THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CAROTID ARTERY DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBRAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SICK SINUS SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugauthorizationnumb>20998</drugauthorizationnumb>
        <drugdosagetext>400 MG (200 MG, 2 IN 1 D),</drugdosagetext>
        <drugindication>BACK PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041115</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057131-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060705</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2005125826</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>46</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BENIGN NEOPLASM OF SKIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DERMATITIS ALLERGIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PITYRIASIS RUBRA PILARIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STEVENS-JOHNSON SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEXTRA</medicinalproduct>
        <drugauthorizationnumb>21341</drugauthorizationnumb>
        <drugdosagetext>40 MG (20 MG, 2 IN 1 D),</drugdosagetext>
        <drugindication>ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041011</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057133-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060526</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2005161541</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>82</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>76.2043</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ATRIOVENTRICULAR BLOCK FIRST DEGREE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BURSITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIOVASCULAR DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CAROTID ARTERY STENOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBRAL THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEEP VEIN THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WOUND</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugauthorizationnumb>20998</drugauthorizationnumb>
        <drugindication>PAIN</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>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057134-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060526</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006057918</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>53</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>149.687</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BALANCE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORTHOPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSYCHIATRIC SYMPTOM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugauthorizationnumb>20998</drugauthorizationnumb>
        <drugdosagetext>200 MG (200 MG, 1 IN 1 D),</drugdosagetext>
        <drugindication>PAIN IN EXTREMITY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000405</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20001101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057135-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060705</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006056846</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HIP ARTHROPLASTY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugauthorizationnumb>20998</drugauthorizationnumb>
        <drugindication>ARTHRALGIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057154-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060720</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0612927A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>62</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FREQUENT BOWEL MOVEMENTS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATOCHEZIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RECTAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CITRUCEL SUGAR-FREE SUSPENSION ORANGE</medicinalproduct>
        <drugbatchnumb>05D094</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONSTIPATION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060720</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADVAIR DISKUS 100/50</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACCOLATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ISOSORBIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057155-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060712</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-GLAXOSMITHKLINE-B0430687A</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORMIGRAN</medicinalproduct>
        <drugauthorizationnumb>20763</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MIGRAINE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057156-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060712</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHO2006RU11297</companynumb>
    <primarysource>
      <reportercountry>RUSSIAN FEDERATION</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>59</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>64</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>LYMPHOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>*CGP 57148B*</medicinalproduct>
        <drugauthorizationnumb>21588</drugauthorizationnumb>
        <drugdosagetext>600MG DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CHRONIC MYELOID LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051205</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BARALGIN</medicinalproduct>
        <drugindication>ARTHRALGIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057157-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHO2005GB10271</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>13</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>60</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD CREATININE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>C-REACTIVE PROTEIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYDRONEPHROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLEURAL EFFUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RETROPERITONEAL FIBROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URETERAL STENT INSERTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URETERIC OBSTRUCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMATINIB</medicinalproduct>
        <drugauthorizationnumb>21588</drugauthorizationnumb>
        <drugdosagetext>450 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ACUTE LYMPHOCYTIC LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050314</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050516</drugenddate>
        <drugtreatmentduration>92160</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057162-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050209</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHNU2005DE00905</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>50</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RADIOTHERAPY TO BONE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SCINTIGRAPHY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugauthorizationnumb>21223</drugauthorizationnumb>
        <drugdosagetext>4 MG EVERY 6 WEEKS</drugdosagetext>
        <drugindication>METASTASES TO BONE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030924</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041201</drugenddate>
        <drugtreatmentduration>435</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057164-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060710</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHRM2006FR02050</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>OSTEITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTH EXTRACTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugauthorizationnumb>021223</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057165-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060616</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHRM2006FR01840</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>50</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABSCESS JAW</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE DEBRIDEMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE EROSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FISTULA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FISTULA REPAIR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA TEETH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLAMMATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MANDIBULECTOMY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PATHOLOGICAL FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLASTIC SURGERY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRIMARY SEQUESTRUM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PURULENT DISCHARGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTH DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugauthorizationnumb>21223</drugauthorizationnumb>
        <drugdosagetext>4 MG, QMO</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BONE PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030724</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AREDIA</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BONE PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020702</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030620</drugenddate>
        <drugtreatmentduration>354</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057168-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20030911</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0425518A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>79</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWELLING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>21071</drugauthorizationnumb>
        <drugdosagetext>4MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROPRANOLOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOVANCE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZESTRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANOXIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INDERAL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>B12</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057169-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040308</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0501610A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>68</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>89.5</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT LOSS POOR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>21071</drugauthorizationnumb>
        <drugdosagetext>4MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040123</drugstartdate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GEMFIBROZIL</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORAZEPAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONAZEPAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COZAAR</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VYTORIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIAZEPAM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DARVOCET</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CORTISONE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EPIDURAL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NIACIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057170-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040901</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0524223A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>53</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG ADMINISTRATION ERROR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUID RETENTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GLYCOSYLATED HAEMOGLOBIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NOCTURIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>21071</drugauthorizationnumb>
        <drugdosagetext>4MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDAMET</medicinalproduct>
        <drugauthorizationnumb>021410</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057171-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041118</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0534499A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>72</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>21071</drugauthorizationnumb>
        <drugdosagetext>4MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOTROL XL</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACCUPRIL</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPROL-XL</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057172-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050218</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0546321A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>44</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE FLUCTUATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLATULENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ILL-DEFINED DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JOINT ANKYLOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VIRAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>21071</drugauthorizationnumb>
        <drugdosagetext>8MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDAMET</medicinalproduct>
        <drugauthorizationnumb>021410</drugauthorizationnumb>
        <drugdosagetext>1TAB TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOPHAGE XR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMARYL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN E</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057173-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050121</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHNU2005DE00641</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>76</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>72</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DENTAL DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMPAIRED HEALING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLAMMATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRIMARY SEQUESTRUM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTH EXTRACTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugauthorizationnumb>21223</drugauthorizationnumb>
        <drugdosagetext>4 MG, QMO</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>METASTASES TO BONE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030218</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031217</drugenddate>
        <drugtreatmentduration>303</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057174-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050405</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0552835A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>80</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD TEST ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>21071</drugauthorizationnumb>
        <drugdosagetext>4MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050501</drugstartdate>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMARYL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZETIA</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROTONIX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRAVACHOL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057175-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050418</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0554902A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>78</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD CAFFEINE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>21071</drugauthorizationnumb>
        <drugdosagetext>2MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050401</drugstartdate>
        <drugtreatmentduration>17</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COZAAR</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057176-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050527</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0560401A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>58</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>4MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050426</drugstartdate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
        <drugdosagetext>1000MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050426</drugstartdate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENALAPRIL MALEATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>STARLIX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057177-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050527</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0560405A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>55</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>4MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMARYL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORAZEPAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GABITRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMBIEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050524</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057178-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050527</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0560414A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>2MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057179-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050531</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0560567A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>84</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>RHINORRHOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>4MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ISOSORBIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL SPIROS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057180-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050531</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0560593A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CRYING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY SIGHS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>4MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYGEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACCUPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM CHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROVENTIL-HFA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLOVENT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOVANCE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREVACID</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057181-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050601</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0560738A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>84</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>81.8</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HYPERSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JOINT SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>8MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMINS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN E</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HUMULIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYZAAR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONIDINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLONASE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SINGULAIR</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057182-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050601</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0560750A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>74</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>21071</drugauthorizationnumb>
        <drugdosagetext>4MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMARYL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COZAAR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACTONEL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHROID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVASTATIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ECOTRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYLENOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IRON SUPPLEMENT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057183-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050601</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0560757A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>LIVER DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>8MG UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057184-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050601</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0560780A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUID RETENTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>8MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOTROL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOTROL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNSPECIFIED MEDICATION</medicinalproduct>
        <drugindication>GOUT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BLOOD PRESSURE MEDICATION</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIURETIC</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057185-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050601</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0560792A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ILL-DEFINED DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>4MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOVANCE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DILTIAZEM HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANOXIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISON</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROVENTIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEBULIZER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057186-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050531</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0560848A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>HYPOGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>2MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057187-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050602</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0560927A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>54</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>4MG UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050530</drugstartdate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANTEX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOVANCE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>STATINS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057189-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050602</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0560928A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>75</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057190-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050602</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0560929A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>70</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>4MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050506</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050517</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057191-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050602</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0560941A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE FLUCTUATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>4MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NO CONCURRENT MEDICATION</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057192-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050602</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0560953A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>74</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>OEDEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057193-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050602</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0560964A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>66</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>4MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLIPIZIDE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057194-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050601</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>S2005US07783</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>58</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>GLYCOSYLATED HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057195-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050606</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0561372A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>21071</drugauthorizationnumb>
        <drugdosagetext>4MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050301</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CORTISONE INJECTION</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PLANTAR FASCIITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZETIA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SALSALATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057196-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050606</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0561390A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>55</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>OEDEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>8MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050602</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPROL-XL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057197-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050606</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0561403A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>72</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>4MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMARYL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLYSET</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VERAPAMIL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLTX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NIFEREX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FISH OIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UROXATRAL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057198-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050607</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0561608A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>4MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050301</drugstartdate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NO CONCURRENT MEDICATION</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057199-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050607</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0561628A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>51</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>4MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050306</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057200-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050608</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0561827A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>36</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFECTED SKIN ULCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUROPATHY PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>4MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050501</drugstartdate>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVANDAMET</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057201-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050609</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0562002A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE FLUCTUATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>2MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLYBURIDE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057202-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050609</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0562010A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>4MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOTENSIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057203-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050609</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0562013A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>76</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugbatchnumb>[NOT ENTERED]</drugbatchnumb>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>8MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050516</drugstartdate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METAGLIP</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENALAPRIL MALEATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CENTRUM SILVER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASCORBIC ACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALPHA LIPOIC ACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VASOTEC</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057204-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050609</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0562015A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHINORRHOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>4MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SECTRAL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVAPRO</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRAVACHOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EVISTA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZETIA</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057205-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050609</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0562036A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>8MG UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057206-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050610</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0562107A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>72</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>4MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050602</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVAPRO</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREVACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOPHAGE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLYBURIDE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057207-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050610</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0562116A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>63</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>2MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050605</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057208-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050610</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0562117A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE FLUCTUATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>8MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL SPIROS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IPRATROPIUM BROMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BUDESONIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYGEN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057209-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050610</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0562120A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>60</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>40MG UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050301</drugstartdate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057210-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050610</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0562121A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>70</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>134.5</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE CONGESTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GALLOP RHYTHM PRESENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JUGULAR VEIN DISTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NOCTURNAL DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>8MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040411</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050607</drugenddate>
        <drugtreatmentduration>60</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLIPIZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVAPRO</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROCARDIA</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057211-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050613</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0562408A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>85</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>4MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040701</drugenddate>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIABETA</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057212-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050614</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0562635A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>62</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>2MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050501</drugstartdate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
        <drugdosagetext>500MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050501</drugstartdate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMARYL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057213-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050614</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0562642A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DYSPEPSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROOESOPHAGEAL REFLUX DISEASE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>4MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050201</drugstartdate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOPHAGE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZYRTEC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRINIVIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DARVOCET</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLYCILAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELEXA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057214-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050614</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0562649A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>70</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>NIGHT SWEATS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057215-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050614</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0562713A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ROSIGLITAZONE</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057216-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050615</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0562794A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>61</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STOMACH DISCOMFORT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>4MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050612</drugstartdate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057217-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050615</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0562797A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL DISTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JOINT SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWELLING FACE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>4MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041201</drugstartdate>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOPHAGE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057218-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050615</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0562802A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>47</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>12MG VARIABLE DOSE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLIPIZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TARKA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEXAPRO</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057219-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050408</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0562807A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>4MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057220-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050615</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0562822A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>64</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>2MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050512</drugstartdate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COZAAR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KLONOPIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057221-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050616</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0562831A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DIABETES MELLITUS INADEQUATE CONTROL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>4MG UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD GLUCOSE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057222-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050615</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0562860A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ADVERSE DRUG REACTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057223-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050615</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0562883A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>GLYCOSYLATED HAEMOGLOBIN INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057224-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050616</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0562973A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057225-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050616</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0562985A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>41</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>4MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050613</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOPHAGE</medicinalproduct>
        <drugdosagetext>1000MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EVISTA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VERAPAMIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIAVAN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057226-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050616</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0562990A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>77</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>SWELLING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>4MG UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050601</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057227-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050616</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0563006A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>52</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugbatchnumb>3214469</drugbatchnumb>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>4MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050606</drugstartdate>
        <drugtreatmentduration>10</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIAVAN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057228-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050617</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0563248A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057229-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050620</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0563394A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN DISCOLOURATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057230-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050620</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0563402A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>60</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSSTASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>4MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLYBURIDE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057231-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050620</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0563404A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>44</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUID RETENTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>4MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051201</drugenddate>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GEMFIBROZIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FISH OIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057232-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050621</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0563596A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>53</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>8MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050614</drugstartdate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FEMARA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORAZEPAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057233-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050621</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0563605A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>57</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugbatchnumb>NOT AVAIL.</drugbatchnumb>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>4MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040601</drugstartdate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMARYL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACIPHEX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THYROID TAB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOTREL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057234-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050622</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0563810A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>COLD SWEAT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>REGURGITATION OF FOOD</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050617</drugstartdate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADVAIR DISKUS 100/50</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057235-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050622</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0563820A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DIABETES MELLITUS INADEQUATE CONTROL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>8MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050501</drugstartdate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NO CONCURRENT MEDICATION</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057236-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050622</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0563839A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>67</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>4MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VERAPAMIL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLYBURIDE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057237-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050622</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0563861A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>OEDEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057238-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050622</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0563868A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>ALANINE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057239-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050622</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0563879A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>MUSCLE HYPERTROPHY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057240-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050627</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0564271A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DIABETES MELLITUS INADEQUATE CONTROL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>8MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057241-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050627</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0564275A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>4MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NO CONCURRENT MEDICATION</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057242-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050627</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0564279A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRIC DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>8MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOPHAGE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057243-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050627</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0564306A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>68</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHINORRHOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>4MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOTRIMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
        <drugdosagetext>850MG THREE TIMES PER DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOTROL</medicinalproduct>
        <drugdosagetext>10MG THREE TIMES PER DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMINS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057244-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050624</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0564341A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE FLUCTUATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACTOS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057245-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050624</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0564398A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE FLUCTUATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057246-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050628</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0564497A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>66</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUID RETENTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>4MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOPHAGE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYZAAR</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057247-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050630</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0564741A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>66</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLYBURIDE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057248-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050701</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0564825A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>56</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FACE OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>8MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050630</drugstartdate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THYROID TAB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPROL-XL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SINGULAIR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACIPHEX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057249-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050701</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0564836A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANOREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERITONSILLAR ABSCESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STOMACH DISCOMFORT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugbatchnumb>6A2834A59</drugbatchnumb>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>4MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050622</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NO CONCURRENT MEDICATION</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057250-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050705</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0564938A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>76</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugbatchnumb>5ZP0393</drugbatchnumb>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>4MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLYBURIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVASTATIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>STOOL SOFTENER</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057251-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050705</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0564943A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>48</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HUNGER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERIORBITAL OEDEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>4MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050201</drugstartdate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NO CONCURRENT MEDICATION</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057252-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050705</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0564955A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>4MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOPHAGE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEXAPRO</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRILAFON</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WEIGHT LOSS MEDICATION</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057253-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050705</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0564971A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>66</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>4MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRICOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNIVASC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OSCAL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057254-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050630</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0564981A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>ADVERSE DRUG REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EJECTION FRACTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057255-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050701</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0565081A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057256-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050706</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0565167A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>4MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVAPRO</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057257-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050707</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0565333A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>79</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>EYE SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWELLING FACE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>8MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLYBURIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057258-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050707</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0565344A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>49</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>4MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050625</drugstartdate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMARYL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057259-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050708</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0565541A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>68</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>OESOPHAGEAL PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>4MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050601</drugstartdate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057261-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050708</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0565570A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>SWELLING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLIPIZIDE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057262-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050711</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0565740A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>67</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>2MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050505</drugstartdate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLYBURIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOTENSIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVANDAMET</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057263-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050711</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0565746A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>46</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRY SKIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>4MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NO CONCURRENT MEDICATION</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057264-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050711</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0565757A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>63</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LARYNGITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>4MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050707</drugstartdate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit></drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TORSEMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BISOPROLOL FUMARATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COZAAR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRAVACHOL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057265-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050711</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0565767A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>75</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>8MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugtreatmentduration>10</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VICODIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROTONIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIGITEK</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ROXICODONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COSOPT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLOMAX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057266-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050711</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0565776A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>55</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>4MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050601</drugstartdate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BISOPROLOL FUMARATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057267-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050712</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0565917A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD CALCIUM INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057268-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050712</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0565918A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>TRIGEMINAL NEURALGIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057269-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050712</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0565936A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OFF LABEL USE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>4MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HUMULIN INSULIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INDAPAMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM + VITAMIN D</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057270-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050712</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0565947A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG ADMINISTRATION ERROR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOBILITY DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SENSORY DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugbatchnumb>2364A59</drugbatchnumb>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>4MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050301</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VERAPAMIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRIAMTERENE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLYBURIDE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057272-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050713</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0566126A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>48</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>8MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BLOOD PRESSURE MED</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057273-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050713</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0566129A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>86</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>OEDEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>4MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050501</drugstartdate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MICRONASE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VASOTEC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLYBURIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HCT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057274-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050714</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0566223A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>48</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>TOOTH DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>8MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMARYL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RITALIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROZAC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SINGULAIR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYZAAR</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057275-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050714</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0566230A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>8MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENICAR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057276-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050715</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0566439A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057277-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050715</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0566440A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>55</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>2MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN MEDICATION</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057278-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050715</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0566463A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>47</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GLYCOSYLATED HAEMOGLOBIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JOINT SWELLING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZETIA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LESCOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVANDAMET</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057279-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050715</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0566489A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>82</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE CONGESTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>8MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </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>MOBIC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROTONIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZETIA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOXYL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROPOXYPHENE HYDROCHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057280-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050714</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>2005-01090</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>53</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH GENERALISED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>21071</drugauthorizationnumb>
        <drugdosagetext>2MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050317</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METFORMIN HYDROCHLORIDE</medicinalproduct>
        <drugdosagetext>1000MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050317</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050322</drugenddate>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOTROL XL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAQUENIL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MONOPRIL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INDOCIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057281-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050715</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0566524A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057282-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050718</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0566677A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>83</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>4MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050526</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIURETIC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOVANCE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057283-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050718</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0566746A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>OEDEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>4MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057284-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050719</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0566776A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057285-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050719</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0566785A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057286-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050719</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0566890A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOPHAGE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057287-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050719</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0566897A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>71</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057288-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050719</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0566905A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>37</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050501</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050501</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRIAMTERENE AND HYDROCHLOROTHIAZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALEVE (CAPLET)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057289-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050720</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0567035A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD LACTATE DEHYDROGENASE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOPHAGE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057290-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050720</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0567048A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>81</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050801</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLIPIZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANOXIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KAPTOPRIL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057291-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050721</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0567190A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ACCIDENTAL OVERDOSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>8MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOTROL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057292-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050720</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0567222A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057293-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050722</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0567239A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>75</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL DISTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>8MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACCUPRIL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057294-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050722</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0567277A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>59</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL DISTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>4MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLTX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREVACID</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057295-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050721</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0567386A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057296-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050725</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0567551A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>73</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>4MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050701</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM WITH VITAMIN D</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057297-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050725</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0567555A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>43</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>4MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050701</drugstartdate>
        <drugtreatmentduration>10</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMARYL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOTREL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057298-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050725</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0567628A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>59</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JOINT SWELLING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>8MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLYBURIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057299-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050726</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0567715A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>68</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CHILLS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>8MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050721</drugstartdate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVAPRO</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CORGARD</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057300-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050726</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0567737A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>76</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050101</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDAMET</medicinalproduct>
        <drugauthorizationnumb>021410</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050101</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRICOR</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057301-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050726</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0567757A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NASOPHARYNGITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugbatchnumb>264A60</drugbatchnumb>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>8MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050725</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOPHAGE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOTROL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPROL-XL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057302-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050725</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0567762A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057303-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050727</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0567937A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>77</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>4MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050727</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NPH INSULIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MILK OF MAGNESIA TAB</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057304-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050727</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0567952A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>66</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>KIDNEY INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugbatchnumb>2414458</drugbatchnumb>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>4MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050401</drugstartdate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOTREL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GEMFIBROZIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSAMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HUMAN INSULIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLEGRA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VICODIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057306-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050727</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>S2005US10715</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>61</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VOLTAREN-XR</medicinalproduct>
        <drugdosagetext>100MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>FIBROMYALGIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050505</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050531</drugenddate>
        <drugtreatmentduration>27</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MICRONASE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAGAMET</medicinalproduct>
        <drugindication>REGURGITATION OF FOOD</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TENORMIN</medicinalproduct>
        <drugindication>HEART RATE INCREASED</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057307-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050728</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0568117A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>81</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>4MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NO CONCURRENT MEDICATION</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057308-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050727</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0568171A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE FLUCTUATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NIGHT SWEATS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057309-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050727</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0568177A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057310-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050729</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0568285A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>52</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STOMACH DISCOMFORT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLONASE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020121</drugauthorizationnumb>
        <drugadministrationroute>045</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONIDINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057311-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050729</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0568290A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>68</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050713</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050719</drugenddate>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>STOOL SOFTENER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRONOLACTONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CATAPRES-TTS-1</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057312-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050801</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0568449A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>81</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>4MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057313-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050802</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0568612A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>80</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BALANCE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>8MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLOMAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HEART MEDICATION</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FISH OIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CENTRUM SILVER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ISOSORBIDE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057314-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050802</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0568642A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>48</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>VISION BLURRED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>8MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050701</drugstartdate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057315-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050801</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0568696A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MEMORY IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057316-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050803</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0568791A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>66</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>4MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050803</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOPRESSOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLTX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROTONIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RESCUE REMEDY</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CHROMIUM PICOLINATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLAXSEED OIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CONJUGATED LINOLEIC ACID</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057318-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050803</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0568827A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>75</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>JOINT SWELLING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>4MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040201</drugstartdate>
        <drugtreatmentduration>18</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057319-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050804</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0568970A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>URTICARIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>4MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050728</drugenddate>
        <drugtreatmentduration>13</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVANDAMET</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057320-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050808</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0569231A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>62</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>4MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050805</drugstartdate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZETIA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ISOSORBIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NIACIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ECOTRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN E</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057321-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050808</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0569257A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HOT FLUSH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>4MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMARYL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057322-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050801</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0569372A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TETANY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057323-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050809</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0569529A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>60</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL DISTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISION BLURRED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>4MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVALIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057324-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050809</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0569535A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>44</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>72.3</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugdosagetext>20MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugdosagetext>40MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057325-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050810</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0569693A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>66</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>8MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057326-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050810</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0569699A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>50</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ALOPECIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>4MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050701</drugenddate>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOTROL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WELLBUTRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREVACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEXAPRO</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057327-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050810</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0569700A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>55</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ALOPECIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>4MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAMADOL HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NABUMETONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CEPHALEXIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057328-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050810</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0569711A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>62</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>96.4</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>4MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050801</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMARYL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057329-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050810</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0569721A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>39</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>21071</drugauthorizationnumb>
        <drugdosagetext>4MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050801</drugstartdate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LESCOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVAPRO</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLIPIZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACTOS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057330-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050809</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0569761A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057331-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050812</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0570061A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>44</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>SKIN REACTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>8MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057332-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050815</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0570253A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL DISTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>2MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050623</drugstartdate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
        <drugdosagetext>400MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050623</drugstartdate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPROL-XL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057333-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050815</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0570258A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>GASTRIC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>2MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050802</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
        <drugdosagetext>500MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DILTIAZEM HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENALAPRIL MALEATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN E</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRILOSEC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RANITIDINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057334-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050815</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0570268A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>71</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUID RETENTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>4MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDAMET</medicinalproduct>
        <drugauthorizationnumb>021410</drugauthorizationnumb>
        <drugdosagetext>1TAB TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLIPIZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VYTORIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOPHAGE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057335-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050810</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0570302A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>44</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DERMATITIS ALLERGIC</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>4MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057336-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050816</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0570424A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>43</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>2TAB TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050301</drugstartdate>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORAZEPAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ESTRAVAL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057337-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050817</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0570632A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>67</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugbatchnumb>F3264859</drugbatchnumb>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>4MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050817</drugstartdate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VASOTEC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DILTIA XT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALPRAZOLAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYLENOL W/ CODEINE NO. 3</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRILOSEC</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057338-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050818</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0570845A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>75</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN EXFOLIATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>2MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050701</drugstartdate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GLUCOPHAGE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>2.5MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050701</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLYBURIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIGOXIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057339-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050819</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0570965A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>67</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>4MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050526</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050601</drugenddate>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COZAAR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMDUR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XALATAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MS CONTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MORPHINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATIVAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MECLIZINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ECOTRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REGLAN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057340-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050819</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0570971A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>53</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMPAIRED HEALING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH PUSTULAR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>4MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050701</drugstartdate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CATAPRES</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLYBURIDE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057341-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050819</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0571125A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057342-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050822</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0571216A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>72</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HUNGER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>4MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLYBURIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOPHAGE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TIAZAC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALOPURINOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLOMAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRINZIDE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057343-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050822</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0571229A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>76</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugbatchnumb>2364A59</drugbatchnumb>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>4MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050819</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050819</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NOVOLIN 70/30</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYTRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LESCOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BETA PROSTATE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057344-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050822</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0571337A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057345-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050823</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0571433A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>67</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>4MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050701</drugstartdate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057346-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050823</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0571473A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057347-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050816</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0571475A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>OEDEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057348-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050823</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0571476A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>65</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>4MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENICAR</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INDAPAMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREVACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORAZEPAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057349-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050824</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0571628A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>61</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DYSURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>4MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRIAMTERENE AND HYDROCHLOROTHIAZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DILANTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMARYL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057350-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050824</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0571646A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG ADMINISTRATION ERROR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>4MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMARYL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVAPRO</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACIPHEX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057351-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050824</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0571664A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>78</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>91.4</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLEURAL EFFUSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>8MG PER DAY</drugdosagetext>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050811</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLOPIDOGREL BISULFATE</medicinalproduct>
        <drugdosagetext>75MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugdosagetext>20MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLYBURIDE</medicinalproduct>
        <drugdosagetext>2.5MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARICEPT</medicinalproduct>
        <drugdosagetext>5MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NITRO-BID</medicinalproduct>
        <drugdosagetext>6.5MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BIOTIN</medicinalproduct>
        <drugdosagetext>1000MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METAMUCIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IRBESARTAN</medicinalproduct>
        <drugdosagetext>150MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASCORBIC ACID</medicinalproduct>
        <drugdosagetext>500MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HYDROCHLORIDE</medicinalproduct>
        <drugdosagetext>1000MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugdosagetext>40MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PENTOXIFYLLINE</medicinalproduct>
        <drugdosagetext>400MG THREE TIMES PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GEMFIBROZIL</medicinalproduct>
        <drugdosagetext>600MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
        <drugdosagetext>25MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057352-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050824</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0571671A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>75</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISION BLURRED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>4MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050801</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOTROL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZETIA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRICOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COZAAR</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057353-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050825</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0571840A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>44</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NERVOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH MACULAR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZANTAC</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057354-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050825</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0571848A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>76</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DYSPHAGIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>4MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050816</drugstartdate>
        <drugtreatmentduration>10</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CONCURRENT MEDICATIONS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057355-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050823</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0571999A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057356-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060711</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2006US08868</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugauthorizationnumb>021223</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057357-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050825</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0572027A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VERTIGO</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>8MG UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057358-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050114</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHNU2005DE00563</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>60</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BIOPSY SITE UNSPECIFIED ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE DEBRIDEMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE FISTULA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLAMMATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOMYELITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLASTIC SURGERY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRIMARY SEQUESTRUM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEQUESTRECTOMY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTH EXTRACTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugauthorizationnumb>21223</drugauthorizationnumb>
        <drugdosagetext>4 MG, QMO</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THALIDOMID</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030401</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RADIOTHERAPY</medicinalproduct>
        <drugdosagetext>40 GY</drugdosagetext>
        <drugadministrationroute>061</drugadministrationroute>
        <drugindication>RADIOTHERAPY TO BONE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VINCRISTINE</medicinalproduct>
        <drugdosagetext>UNK, UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PLASMACYTOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010601</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IDARUBICIN HCL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PLASMACYTOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010601</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE TAB</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PLASMACYTOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010601</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENDOXAN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PLASMACYTOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MELPHALAN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PLASMACYTOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010901</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MELPHALAN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020201</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057360-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050829</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0572190A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>75</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050601</drugstartdate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOTROL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOPHAGE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREVACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SINEQUAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057361-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060711</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2006US08866</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugauthorizationnumb>021223</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057362-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050829</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0572204A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>59</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CRYING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>4MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050728</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050827</drugenddate>
        <drugtreatmentduration>31</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VYTORIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugindication>ANTICOAGULANT THERAPY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057363-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060711</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2006US08865</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugauthorizationnumb>021223</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057364-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050829</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0572206A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>75</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>4MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOPHAGE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIURETIC</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057365-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060711</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2006US08864</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugauthorizationnumb>021223</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057366-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050829</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0572209A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>49</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>4MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050826</drugstartdate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERDAL</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugdosagetext>2MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN MEDICATION</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRIHEXYPHENIDYL HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RISPERDAL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROZAC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PERPHENAZINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057367-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050829</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0572228A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>57</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>4MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NITROGLYCERIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZELNORM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROTONIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>QUINAPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOXYL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KLONOPIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057368-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050829</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0572231A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>64</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugbatchnumb>5ZP7641</drugbatchnumb>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>4MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050829</drugstartdate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BLOOD PRESSURE MEDICATION</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THYROID TAB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTI-CHOLESTEROL MEDICATION</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM GLUCONATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMINS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057369-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050830</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0572397A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>71</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>4MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLETAL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRICOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZETIA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZESTRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARAFATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRILOSEC</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057370-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050830</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0572412A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>29</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUS HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050816</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050817</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLONASE</medicinalproduct>
        <drugauthorizationnumb>020121</drugauthorizationnumb>
        <drugdosagetext>1SPR THREE TIMES PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050701</drugstartdate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NO CONCURRENT MEDICATION</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057371-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050831</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0572538A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>76</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>4MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057372-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050831</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0572567A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>51</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>8MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRICOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CORGARD</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057373-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050831</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0572569A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>60</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRICOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057374-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050901</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0572747A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>69</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>4MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugdosagetext>5MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050617</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLYBURIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057375-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050901</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0572759A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>76</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>4MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLYCLAZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHYCLOTHIAZIDE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057376-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050901</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0572770A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>52</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FLUID RETENTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>4MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020703</drugstartdate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAXZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATIVAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057377-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050902</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0572830A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057378-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050902</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0572867A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>38</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>4MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050801</drugstartdate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NO CONCURRENT MEDICATION</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057379-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050902</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0572882A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>76</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISION BLURRED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>8MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050701</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREVACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMDUR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ECOTRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057380-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050906</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0573144A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>90</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URTICARIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugbatchnumb>[NOT ENTERED]</drugbatchnumb>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>8MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050904</drugstartdate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYZAAR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057381-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050907</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0573321A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>84</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>1MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLYBURIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACYCLOVIR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYBUTYNIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENALAPRIL MALEATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVANDAMET</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057382-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050908</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0573496A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>47</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BREAST SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COELIAC DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOCAL SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URTICARIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>2MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDAMET</medicinalproduct>
        <drugbatchnumb>27-4A63</drugbatchnumb>
        <drugauthorizationnumb>021410</drugauthorizationnumb>
        <drugdosagetext>1TAB PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050801</drugstartdate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEFAZODONE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROTONIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DAPSONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN B-12</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTIVITAMIN LIQUID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAR SHAMPOO</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057383-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050909</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0573603A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>72</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugbatchnumb>NAV</drugbatchnumb>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050401</drugenddate>
        <drugtreatmentduration>48</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COZAAR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RANITIDINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057384-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050909</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0573947A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>72</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>2MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050301</drugstartdate>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVANDAMET</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057385-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050913</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0574118A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>8MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>STARLIX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057386-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050914</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0574259A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>8MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MONOPRIL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057387-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050915</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0574444A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>70</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>JOINT SWELLING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050101</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057388-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040818</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0574468A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>82</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE CONGESTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>2MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057389-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050512</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0574482A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DYSURIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTIPLE MEDICATIONS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057390-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050916</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0574535A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>NIGHTMARE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057391-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050916</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0574541A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>65</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>4MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROVICAL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRICOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DITROPAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOPID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZYRTEC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMITRIPTYLINE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMARYL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057392-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041215</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0574660A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>65</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>8MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041115</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041207</drugenddate>
        <drugtreatmentduration>23</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057393-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050915</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0574706A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>73</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>115.9</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL DISTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE CONGESTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUID RETENTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM</medicinalproduct>
        <drugdosagetext>500MG UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPROL-XL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TIAZAC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOVAN HCT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugdosagetext>20MG AT NIGHT</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMARYL</medicinalproduct>
        <drugdosagetext>4MG PER DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAZODONE HCL</medicinalproduct>
        <drugdosagetext>200MG AT NIGHT</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057394-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050919</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0574837A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>56</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040220</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040401</drugenddate>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACTOS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOVANCE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COZAAR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROPRANOLOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRIAMTERENE AND HYDROCHLOROTHIAZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOTROL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057395-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050916</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0574849A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057396-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050920</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0575031A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>55</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>4MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPROL-XL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057397-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050920</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0575037A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>63</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>8MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MICRONASE</medicinalproduct>
        <drugdosagetext>10MG TWICE PER DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IRON</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM GLUCONATE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057398-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050920</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0575040A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>80</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ARTERIAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugbatchnumb>073004RI1</drugbatchnumb>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>8MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS NON-INSULIN-DEPENDENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050301</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HUMALOG</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NOVOLIN R</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOSARTAN POSTASSIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRONOLACTONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DUONEB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MUCINEX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EZETIMIBE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NIACIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLONASE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TERAZOSIN HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM GLUCONATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM CHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COLACE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057399-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050920</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0575052A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>68</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ALOPECIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISION BLURRED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>4MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLIPIZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CHLORTHALIDONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057400-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050920</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0575059A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>44</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE FLUCTUATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STOMACH DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>4MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEPAKOTE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREVACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAZODONE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENAZEPRIL HYDROCHLORIDE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057401-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050921</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0575217A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugbatchnumb>5ZP4515</drugbatchnumb>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>8MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPROL-XL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057402-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050921</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0575228A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>79</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PULMONARY OEDEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>4MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057403-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050921</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0575231A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>68</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JOINT SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPHADENOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARYNGOLARYNGEAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SENSORY DISTURBANCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugbatchnumb>5ZP6692</drugbatchnumb>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>4MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050920</drugstartdate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROTONIX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057404-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050921</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0575233A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>51</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VERTIGO</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugbatchnumb>52P6692</drugbatchnumb>
        <drugauthorizationnumb>21071</drugauthorizationnumb>
        <drugdosagetext>4MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050801</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMALOG</medicinalproduct>
        <drugdosagetext>1INJ TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROCARDIA XL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONIDINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOTENSIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAXZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057405-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050921</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0575262A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>8MG UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057406-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050921</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0575329A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>COORDINATION ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057407-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050921</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0575367A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>4MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LOVASTATIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057408-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050922</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0575468A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>59</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>4MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPROL-XL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GEMFIBROZIL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057409-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050922</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0575469A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>SWELLING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050922</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057410-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050923</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0575720A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>62</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCREASED APPETITE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>8MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOTROL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOPHAGE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALTACE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEMADEX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IRON</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057412-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050926</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0575887A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>82</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>2MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057413-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050926</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0575914A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>70</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HOT FLUSH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>4MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050601</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COZAAR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACIPHEX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057414-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050926</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0575915A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>46</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FLUID RETENTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JOINT SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>4MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASACOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLIPIZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZANTAC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPAMAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLARITIN-D</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057415-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050926</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0575918A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>50</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>4MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050719</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ESTRADIOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XANAX SR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EFFEXOR XR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYTOMEL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL AND HYDROCHLOROTHIAZIDE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057416-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050920</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0575922A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>OEDEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>21071</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CALCIUM CHANNEL BLOCKER</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057417-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050926</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0575930A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>46</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>4MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050831</drugstartdate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WELLBUTRIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057418-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050927</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0576055A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIAC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>4MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MICRO-K</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BETAXOLOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PILOCARPINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLEGRA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057419-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050927</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0576059A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>73</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JOINT SWELLING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>4MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMARYL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COZAAR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057420-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050927</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0576065A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>71</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>8MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NAMENDA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NYSTATIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EYE DROPS</medicinalproduct>
        <drugadministrationroute>061</drugadministrationroute>
        <drugindication>GLAUCOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REMERON</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057421-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050928</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0576213A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>67</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHONDROCALCINOSIS PYROPHOSPHATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWELLING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>8MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041201</drugstartdate>
        <drugtreatmentduration>10</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOSINOPRIL SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
        <drugdosagetext>2000MG TWICE PER DAY</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057422-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050928</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0576232A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>45</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>STOMACH DISCOMFORT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>4MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALTACE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVANDAMET</medicinalproduct>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057423-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050928</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0576247A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>ACCIDENTAL EXPOSURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057424-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050928</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0576257A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>69</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>4MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENICAR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REFRESH</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057425-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050929</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0576373A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>75</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL DISTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050505</drugstartdate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NOVOLOG</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057426-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050929</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0576379A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>SINUSITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057427-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050929</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0576385A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>LIVER DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057428-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050929</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0576392A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>67</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugbatchnumb>2743A59</drugbatchnumb>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>4MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050926</drugstartdate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOPHAGE XR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOTREL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CHILDREN'S ASPIRIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057429-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050929</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0576405A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>VISION BLURRED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050929</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057430-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050929</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0576433A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUID RETENTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THYROID TAB</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057431-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050927</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0576474A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>JOINT SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057432-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050927</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0576475A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ADVERSE EVENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057433-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050930</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0576590A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>32</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PRESCRIBED OVERDOSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>8MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050929</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050930</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMARYL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRAVACHOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRICOR</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057434-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050930</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0576598A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>78</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULAR WEAKNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>6MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOTROL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057435-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050930</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0576609A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>71</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MUSCLE TWITCHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>4MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HUMALOG</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VASOTEC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZETIA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057436-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050930</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0576610A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>37</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NO CONCURRENT MEDICATION</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057437-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050929</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0576667A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>IMPAIRED DRIVING ABILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SLEEP DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041213</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050509</drugenddate>
        <drugtreatmentduration>148</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057438-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050929</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0576668A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057439-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20051003</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0576679A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>59</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>4MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050923</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOPID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALTACE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057440-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20051003</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0576696A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>47</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUID RETENTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHINITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>2MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050801</drugenddate>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOPHAGE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057441-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050928</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0576708A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>EYE DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NO CONCURRENT MEDICATION</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057442-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20051003</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0576717A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>79</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANOREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JOINT SWELLING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>4MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040901</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPROL-XL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIGOXIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057443-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20051003</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0576729A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>72</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>4MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLONASE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUDROCORTISONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMDUR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOTROL XL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVAPRO</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NITROGLYCERIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEXITIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PERCOCET</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLOVENT</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057444-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20051004</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0576970A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>74</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HUNGER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugbatchnumb>Y385A60</drugbatchnumb>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>4MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050818</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORABID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EYE DROPS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057445-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20051004</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0576989A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NO CONCURRENT MEDICATION</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057446-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20051005</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0577189A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>37</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>4MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050928</drugstartdate>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLYBURIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057447-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20051005</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0577194A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>67</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LACRIMATION INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL DISTURBANCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>4MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050901</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENAZEPRIL HYDROCHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZETIA</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057448-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20051005</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0577202A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>4MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050825</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GARCINIA CAMBOGIA</medicinalproduct>
        <drugtreatmentduration>12</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057449-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20051006</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0577350A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>62</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>4MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050901</drugstartdate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
        <drugdosagetext>1000MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057450-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20051006</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0577369A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>58</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050701</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057451-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20051006</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0577377A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ELECTROCARDIOGRAM CHANGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>4MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NO CONCURRENT MEDICATION</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057452-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20051010</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0577674A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>77</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INADEQUATELY CONTROLLED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCORRECT DOSE ADMINISTERED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWELLING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>4MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL AND CHLORTHALIDONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANOXIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057453-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20051008</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0577688A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NO CONCURRENT MEDICATION</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACE INHIBITOR</medicinalproduct>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050801</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057454-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20051010</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0577693A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>67</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>JOINT SWELLING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>4MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050315</drugstartdate>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOCHOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPROL-XL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NITROGLYCERIN</medicinalproduct>
        <drugadministrationroute>062</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREMPRO</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057455-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20051010</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>20050800236</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>42</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERDAL</medicinalproduct>
        <drugdosagetext>50MG SEE DOSAGE TEXT</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NOVOLOG</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRICOR</medicinalproduct>
        <drugdosagetext>1TAB PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057456-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20051011</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0577828A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>69</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JOINT SWELLING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>8MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FEMHRT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CITRACAL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMINS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENICAR</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057457-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20051011</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0577869A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>43</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ACANTHOSIS NIGRICANS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PIGMENTATION DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
        <drugtreatmentduration>18</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NO CONCURRENT MEDICATION</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057458-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20051012</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0577992A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>75</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL DISTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLATULENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCREASED APPETITE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POLLAKIURIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugbatchnumb>2414A59</drugbatchnumb>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>4MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051009</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMARYL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYZAAR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VASOTEC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACTOS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057459-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20051012</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0578018A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>63</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>WEIGHT LOSS POOR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>4MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050101</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WELLBUTRIN XL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOPHAGE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MONOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SINGULAIR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPAMAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROTONIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZYRTEC</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057460-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20051013</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0578147A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>74</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050101</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050101</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NO CONCURRENT MEDICATION</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVANDAMET</medicinalproduct>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057461-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20051013</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0578148A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>65</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN LOWER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISION BLURRED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>8MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOTREL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057462-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20051013</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0578154A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>SWELLING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVANDAMET</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057463-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20051014</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0578279A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>58</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugbatchnumb>Y2605A59</drugbatchnumb>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>4MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MONOPRIL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057464-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20051014</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0578306A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>38</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugbatchnumb>5ZP6691</drugbatchnumb>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>4MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051014</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051014</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRONOLACTONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENADRYL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLERGY INJECTION</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057465-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20051014</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0578308A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>33</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>4MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALTACE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ABILIFY</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057466-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20051014</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0578336A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>BLOOD TRIGLYCERIDES INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057467-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20051017</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0578444A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SLUGGISHNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>8MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLYBURIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYTRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VERAPAMIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACIPHEX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057468-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20051017</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0578452A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>64</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugbatchnumb>5ZP6691</drugbatchnumb>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>4MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOTROL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BLOOD PRESSURE MEDICATION</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARTHRITIS MEDICATION</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057470-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20051017</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0578474A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>66</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>63.6</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>8MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050901</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VERAPAMIL</medicinalproduct>
        <drugdosagetext>240MG TWICE PER DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONIDINE</medicinalproduct>
        <drugdosagetext>.2MG FOUR TIMES PER DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPROL-XL</medicinalproduct>
        <drugdosagetext>100MG TWICE PER DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRICOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057471-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20051017</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0578477A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>66</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL DISTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HERPES ZOSTER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugbatchnumb>NOT  AVAIL.</drugbatchnumb>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>2MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050929</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051009</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057472-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20051017</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0578478A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057473-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20051017</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0578545A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ALOPECIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057474-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20051018</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0578627A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>56</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL DISTENSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>4MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051017</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLIPIZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENICAR HCT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASCORBIC ACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN E</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057475-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20051018</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0578642A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>42</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>4MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051015</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRICOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLIPIZIDE</medicinalproduct>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051015</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057476-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20051018</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0578643A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>63</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugtreatmentduration>18</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOPHAGE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057477-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20051018</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0578650A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>84</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>SWELLING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>8MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057478-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20051018</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0578657A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>58</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>4MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOTROL XL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057479-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20051018</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0578662A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>50</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>4MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANVIS</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOTREL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOPHAGE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057480-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20051018</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0578681A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057481-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20051019</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0578763A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>62</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG ADMINISTRATION ERROR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWELLING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>2MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051018</drugstartdate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057482-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20051019</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0578797A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>40</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>4MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051018</drugstartdate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DARVOCET</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057483-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20051019</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0578882A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057484-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20051020</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0578981A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057485-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20051020</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0578985A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTIPLE MEDICATIONS</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057486-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20051020</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0578994A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>67</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>100</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>8MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOTROL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057487-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20051021</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0579171A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>52</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHANGE OF BOWEL HABIT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>2MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051011</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>500MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051011</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RANITIDINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMITRIPTYLINE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ESTRADIOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORAZEPAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALPRAZOLAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROPOXYPHENE HYDROCHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MECLIZINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057488-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20051024</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0579403A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>57</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>4MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051010</drugstartdate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LITHIUM CARBONATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONAZEPAM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057489-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20051024</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0579404A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STOMACH DISCOMFORT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>1TAB PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METOCLOPRAMIDE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>5MG FOUR TIMES PER DAY</drugdosagetext>
        <drugindication>NAUSEA</drugindication>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057490-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20051025</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0579575A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>65</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugbatchnumb>UNAVAILABLE</drugbatchnumb>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>2MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030101</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZEBETA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANOXIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYZAAR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POLY-DM</medicinalproduct>
        <drugindication>MULTIPLE ALLERGIES</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CORTISONE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057491-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20051025</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0579587A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>56</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>JOINT SWELLING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>8MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010101</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREVACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HEART MEDICATION</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057492-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20051024</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0579591A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>HEPATIC ENZYME INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>4MG UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MONOPRIL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057493-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20051026</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0579749A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>33</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>4MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOTREL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LABETALOL HCL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057494-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20051026</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0579764A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>48</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>8MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050701</drugstartdate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOVANCE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057495-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20051026</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0579780A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>77</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JOINT SWELLING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>4MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLYBURIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NIFEDIPINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057496-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20051026</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>423070</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>HIGH DENSITY LIPOPROTEIN DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRICOR</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057497-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20051026</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0579806A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>BLOOD TRIGLYCERIDES INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057498-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20051026</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0579813A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>67</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <reaction>
        <reactionmeddrapt>LIVER DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057499-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20051027</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0579893A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057500-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20051027</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0579897A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>84</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugbatchnumb>2354A59</drugbatchnumb>
        <drugauthorizationnumb>21071</drugauthorizationnumb>
        <drugdosagetext>4MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051001</drugstartdate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CADUET</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057501-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20051027</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0579919A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>64</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>4MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050401</drugstartdate>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
        <drugdosagetext>4TAB AT NIGHT</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLYBURIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLETAL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057502-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20051019</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0579988A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>OEDEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057503-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20051028</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0580102A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>72</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>8MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050901</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOPHAGE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNIVASC</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057504-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20051028</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0580105A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>74</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>4MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041001</drugstartdate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRINIVIL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057505-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20051031</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0580322A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>66</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD CREATININE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD UREA INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>4MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugtreatmentduration>18</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLYBURIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPROL-XL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENICAR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZETIA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057506-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20051031</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0580326A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>79</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FLUID RETENTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOVANCE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057507-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20051031</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0580467A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugbatchnumb>U/K</drugbatchnumb>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>8MG UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057508-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20051101</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0580472A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOPHAGE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057509-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20051101</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0580479A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>76</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANOREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHROMATURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>4MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050901</drugstartdate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANAPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZETIA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUOXETINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONAZEPAM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057510-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20051101</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0580480A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>89</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050701</drugstartdate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057511-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20051101</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0580488A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HYPOGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>4MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050301</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLYBURIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIURETIC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GEMFIBROZIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPROL-XL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANOXIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057512-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20051101</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0580505A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>68</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>127.3</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>WEIGHT LOSS POOR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>4MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZETIA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOPRESSOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COZAAR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ROGAINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMINS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057513-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20051031</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0580551A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URTICARIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057514-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20051031</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0580623A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MORPHINE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057515-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20051102</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0580642A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DYSPHONIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugbatchnumb>3214A59</drugbatchnumb>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>4MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMARYL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057516-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20051102</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0580646A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>74</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugbatchnumb>5ZP2876</drugbatchnumb>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>8MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLIPIZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZETIA</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057517-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20051102</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0580652A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>50</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FLUID RETENTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>4MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050901</drugstartdate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057519-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20051102</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0580653A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>2MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTIHYPERTENSIVES</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
        <drugdosagetext>500MG AT NIGHT</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057520-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20051102</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0580657A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>49</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HYPOGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>8MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NOVOLOG</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOXEPIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LITHIUM CARBONATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057521-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20051102</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0580703A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE FLUCTUATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>8MG UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057522-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20051103</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0580789A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>URTICARIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>8MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugtreatmentduration>12</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PEPCID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPROL-XL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ELAVIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COZAAR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDRALAZINE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CATAPRES</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057523-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20051103</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-423645</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>18</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>72.6</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CROHN'S DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIVERTICULUM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DUODENITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROOESOPHAGEAL REFLUX DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HERNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLAMMATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLAMMATORY BOWEL DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERVERTEBRAL DISC PROTRUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OESOPHAGEAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>18662</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19821026</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19821230</drugenddate>
        <drugtreatmentduration>66</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>018662</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19821231</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19830220</drugenddate>
        <drugtreatmentduration>52</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057524-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20051103</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0580792A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>4MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYZAAR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLIPIZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057525-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060711</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHFR2006GB02225</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugauthorizationnumb>021223</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057526-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20051103</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0580799A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>63</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>4MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOTROL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPROL-XL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCONTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCODONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARDIAC MEDICATION</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALTACE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLIPIZIDE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057527-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-385470</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>22</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>45.4</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ADJUSTMENT DISORDER WITH MIXED ANXIETY AND DEPRESSED MOOD</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AUTOIMMUNE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD ALBUMIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CALCIUM DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHRONIC FATIGUE SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLITIS ULCERATIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CROHN'S DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPEPSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ENTERITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLAMMATORY BOWEL DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LABORATORY TEST ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTI-ORGAN DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NIGHT BLINDNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROTEIN TOTAL DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROTEINURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RECTAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYSTEMIC LUPUS ERYTHEMATOSUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>18662</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ACNE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980515</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19981015</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057528-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20051104</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0580919A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>VISION BLURRED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLIPIZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COZAAR</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057529-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050208</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-394881</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>44</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>56.7</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>AMENORRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANOREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AUTOIMMUNE HEPATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIOVASCULAR DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHAPPED LIPS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FIBROMYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROOESOPHAGEAL REFLUX DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GRANULOMATOUS LIVER DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC FUNCTION ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATOCELLULAR DAMAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMMUNE SYSTEM DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLAMMATORY BOWEL DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LARYNGITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPHADENOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPLENOMEGALY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STAPHYLOCOCCAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYSTEMIC LUPUS ERYTHEMATOSUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL ACUITY REDUCED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOCAL CORD CYST</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>18662</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ACNE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040204</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040313</drugenddate>
        <drugtreatmentduration>39</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMNESTEEM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>ACNE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040315</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOXYL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOMIG</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPAMAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BROMPHEN</medicinalproduct>
        <drugdosagetext>REPORTED AS BROMPHEN PD.</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZYRTEC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PONSTEL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOXYCYCLINE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VERAPAMIL</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041203</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
        <drugindication>HYPOTHYROIDISM</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041015</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041115</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>1 CONCOMITANT DRUG</medicinalproduct>
        <drugdosagetext>DRUG REPORTED AS PROPOXY.</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041015</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYMAX</medicinalproduct>
        <drugindication>IRRITABLE BOWEL SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050515</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLEXERIL</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050615</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RHINOCORT</medicinalproduct>
        <drugindication>SINUSITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050615</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MUCINEX</medicinalproduct>
        <drugindication>SINUSITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050615</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIFLUCAN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19850615</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040615</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVAQUIN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030615</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050615</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TEQUIN</medicinalproduct>
        <drugdosagetext>AS NEEDED 2004 AND 2005.</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLINDAMYCIN</medicinalproduct>
        <drugdosagetext>FOR TWO WEEKS.</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050115</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CIPRO</medicinalproduct>
        <drugdosagetext>FOR TWO WEEKS. REPORTED AS CIPRO XR.</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050115</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VICODIN</medicinalproduct>
        <drugdosagetext>FOR THREE WEEKS.</drugdosagetext>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050115</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CULTURELLE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041215</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050115</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROBIOTIC</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041215</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050115</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BROMFENAC</medicinalproduct>
        <drugindication>SINUSITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040115</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041015</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAGAMET</medicinalproduct>
        <drugdosagetext>REPORTED AS TAGAMENT HB. FOR ONE DAY.</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040615</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BEXTRA</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030915</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENDOCET</medicinalproduct>
        <drugdosagetext>IN NOVEMBER 2001 AND JANUARY 2005.</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RANITIDINE</medicinalproduct>
        <drugindication>SINUSITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041015</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>1 CONCOMITANT DRUG</medicinalproduct>
        <drugindication>HYPOTHYROIDISM</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19910615</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041015</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ELIDEL</medicinalproduct>
        <drugindication>ECZEMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040615</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIFFERIN</medicinalproduct>
        <drugindication>ACNE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040215</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROTONIX</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031115</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040215</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>1 CONCOMITANT DRUG</medicinalproduct>
        <drugdosagetext>REPORTED AS TRIACINOLONE ACETONIDE.</drugdosagetext>
        <drugindication>ECZEMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040215</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>JOINTFLEX</medicinalproduct>
        <drugadministrationroute>061</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031215</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIQUIBID</medicinalproduct>
        <drugindication>LARYNGITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041115</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041115</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACIPHEX</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041115</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADVAIR DISKUS 100/50</medicinalproduct>
        <drugindication>LARYNGITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041015</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041115</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PAMINE</medicinalproduct>
        <drugindication>IRRITABLE BOWEL SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040915</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040915</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALEVE (CAPLET)</medicinalproduct>
        <drugdosagetext>AS NEEDED.</drugdosagetext>
        <drugindication>HEADACHE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ST. JOHN'S WORT</medicinalproduct>
        <drugdosagetext>FOR PAST YEAR.</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057530-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20051103</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0580948A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057531-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041027</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-384554</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>20</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>65.8</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ADJUSTMENT DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COAGULOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLITIS ULCERATIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CROHN'S DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRY SKIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ECZEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROENTERITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLAMMATORY BOWEL DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERNAL INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERVERTEBRAL DISC DEGENERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IRRITABLE BOWEL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENOMETRORRHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RECTAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SCOLIOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TENDERNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>18662</drugauthorizationnumb>
        <drugdosagetext>DOSAGE REGIMEN: EVERY DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19991206</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20000515</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MINOCYCLINE HCL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19991206</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ORTHO CYCLEN-28</medicinalproduct>
        <drugdosagetext>DRUG NAME REPORTED AS ORTHO TRI-CYCLEN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057532-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20051104</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0580951A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>64</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SNEEZING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>8MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051026</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051104</drugenddate>
        <drugtreatmentduration>10</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057533-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040526</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ROCHE-369344</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>59</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ASCITES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEG-INTERFERON A-2A (RO 25-8310)</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040512</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040512</drugenddate>
        <drugtreatmentduration>1</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>20040519</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040611</drugenddate>
        <drugtreatmentduration>24</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>URSO</medicinalproduct>
        <drugdosagetext>DOSE FORM REPORTED AS ORAL FORMULATION (NOT OTHERWISE SPECIFIED).</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040502</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051108</drugenddate>
        <drugtreatmentduration>556</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040521</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040523</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugdosagetext>DOSE FORM REPORTED AS ORAL FORMULATION (NOT OTHERWISE SPECIFIED).</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040524</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051108</drugenddate>
        <drugtreatmentduration>534</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALDACTONE</medicinalproduct>
        <drugdosagetext>DOSE FORM REPORTED AS ORAL FORMULATION (NOT OTHERWISE SPECIFIED).</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040521</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040615</drugenddate>
        <drugtreatmentduration>26</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIVACT</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040608</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051108</drugenddate>
        <drugtreatmentduration>519</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057534-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20051107</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0581191A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>38</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>AGITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051001</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOTROL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOPHAGE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOTREL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057535-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050217</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-ROCHE-395567</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>81</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>71.9</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HYPONATRAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LETHARGY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INTERFERON ALFA-2A</medicinalproduct>
        <drugbatchnumb>B1097</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>METASTATIC RENAL CELL CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050125</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050209</drugenddate>
        <drugtreatmentduration>16</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BLINDED BEVACIZUMAB</medicinalproduct>
        <drugbatchnumb>15977/19196</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>METASTATIC RENAL CELL CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041222</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROCHLORPERAZINE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050208</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050208</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040914</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAXOLON</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050212</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TEMAZEPAM</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050121</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057536-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20051107</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0581224A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>GLYCOSYLATED HAEMOGLOBIN INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>8MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITORIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057537-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesscongenitalanomali>1</seriousnesscongenitalanomali>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20051028</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-ROCHE-423517</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>30</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABORTION INDUCED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONGENITAL CENTRAL NERVOUS SYSTEM ANOMALY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG TOXICITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>18662</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041015</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050325</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057538-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20051107</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0581260A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FREQUENT BOWEL MOVEMENTS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMARYL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057539-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20051108</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0581464A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUID RETENTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ISOSORBIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057540-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20051108</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0581700A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057541-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20051110</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0581823A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>67</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>4MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041001</drugstartdate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>QUINAPRIL + HYDROCHLOROTHIAZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THYROID TAB</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057542-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20051110</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0581835A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>79</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>LIMB DISCOMFORT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugbatchnumb>[NOT ENTERED]</drugbatchnumb>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>4MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20011101</drugstartdate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057543-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20051111</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0581932A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>78</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE FLUCTUATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GLYCOSYLATED HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NOCTURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWELLING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugbatchnumb>5ZP6691,5ZP6691</drugbatchnumb>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>4MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051105</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XALATAN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057544-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20051110</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0582050A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057545-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20051114</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0582055A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>PAROTID GLAND ENLARGEMENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057546-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20051114</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0582143A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>75</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>8MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLIPIZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TEMAZEPAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMODIUM</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 COMPLEX CAP</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057547-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20051115</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0582367A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>65</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050901</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDAMET</medicinalproduct>
        <drugauthorizationnumb>021410</drugauthorizationnumb>
        <drugdosagetext>1TAB TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTIBIOTICS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENICAR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLARINEX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057548-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20051115</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0582396A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>75</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MEDICATION RESIDUE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>2MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051109</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZETIA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIGOXIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLIPIZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ISOSORBIDE DINITRATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057549-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20051116</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0582587A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>39</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>4MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051001</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOVANCE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOPHAGE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057550-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20051117</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0582779A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>83</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JOINT SWELLING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>4MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLYBURIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACTONEL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057551-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20051118</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0582900A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>54</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CHEST DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugbatchnumb>SAMPLE PACK</drugbatchnumb>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>8MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051117</drugstartdate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOTROL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPROL-XL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057552-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20051118</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0582901A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>62</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>2MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050901</drugenddate>
        <drugtreatmentduration>18</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZIAC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRICOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOTREL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057553-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20051118</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0582910A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>74</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>WEIGHT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOTROL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>STARLIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRINIVIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057554-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20051114</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0582949A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>4MG UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050616</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYZAAR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PAROXETINE HCL</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050428</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FAMOTIDINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVASTATIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057555-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20051116</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0583120A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057556-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20051117</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0583133A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>59</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>AMENORRHOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057557-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20051123</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0583307A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>104.5</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ALANINE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASPARTATE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD ALKALINE PHOSPHATASE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDAMET</medicinalproduct>
        <drugauthorizationnumb>021410</drugauthorizationnumb>
        <drugdosagetext>1TAB TWICE PER DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057558-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20051121</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0583319A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>48</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugbatchnumb>5ZP0450</drugbatchnumb>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>8MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NOVOLIN</medicinalproduct>
        <drugdosagetext>40UNIT TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOPHAGE</medicinalproduct>
        <drugdosagetext>1G TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACCUPRIL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
        <drugdosagetext>150MCG PER DAY</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>81MG PER DAY</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROTONIX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057560-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20051123</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0583413A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>82</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIABETES MELLITUS INADEQUATE CONTROL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>4MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOVAN HCT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMARYL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLYBURIDE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057561-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20051122</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0583455A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>64</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugbatchnumb>3393859</drugbatchnumb>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>4MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MOTRIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLYBURIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVAPRO</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOSAMINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057562-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20051122</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0583479A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DIABETES MELLITUS INADEQUATE CONTROL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GLUCOPHAGE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057563-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20051128</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0583677A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>64</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugbatchnumb>17460</drugbatchnumb>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>4MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051126</drugstartdate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057564-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20051128</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0583698A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>80</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>4MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050901</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLYBURIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>STOOL SOFTENER</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057565-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20051128</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0583704A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>41</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>21071</drugauthorizationnumb>
        <drugdosagetext>2.5MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050601</drugstartdate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOVANCE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HUMULIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057566-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20051129</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0583841A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>52</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BREAST ENGORGEMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METRORRHAGIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057567-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20051129</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0583842A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>66</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>8MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051020</drugstartdate>
        <drugtreatmentduration>38</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DONATUSSIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLIPIZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DICLOFENAC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COZAAR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVASTATIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DITROPAN XL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORTRIPTYLINE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCODONE BITARTRATE + ACETAMINOPHEN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057568-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20051121</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0583892A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUID RETENTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>4MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOTROL XL</medicinalproduct>
        <drugdosagetext>20MG PER DAY</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057569-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20051130</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0584069A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>59</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>21071</drugauthorizationnumb>
        <drugdosagetext>4MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050401</drugstartdate>
        <drugtreatmentduration>9</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057570-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20051201</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0584290A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>69</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>8MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SINGULAIR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PEPCID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAXZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DARVOCET</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EFFEXOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATIVAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIURETIC</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057571-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20051202</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0584456A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>54</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CHEST DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>21071</drugauthorizationnumb>
        <drugdosagetext>8MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990101</drugstartdate>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOPHAGE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SINGULAIR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADVAIR DISKUS 100/50</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRICOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZETIA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACCUPRIL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057572-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20051202</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0584457A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>60</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>2MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051130</drugenddate>
        <drugtreatmentduration>61</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CENTRUM SILVER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ESTRADERM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057573-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20051202</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0584482A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE FLUCTUATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>8MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057574-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20051205</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0584653A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>LIMB DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugbatchnumb>[NOT ENTERED]</drugbatchnumb>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>4MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOPHAGE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLYBURIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057575-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20051205</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0584657A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>81</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ALOPECIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>2MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAQUENIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREVACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVAPRO</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OSTEO BIFLEX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENALAPRIL MALEATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLTX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057576-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20051205</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0584666A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>59</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>8MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLYBURIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENALAPRIL MALEATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057577-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20051128</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0584694A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057578-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20051206</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0584841A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>64</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugbatchnumb>034</drugbatchnumb>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>8MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050914</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVASTATIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057579-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20051206</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0584851A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DIABETES MELLITUS INADEQUATE CONTROL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>4MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYZAAR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057580-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20051206</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0584859A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>4MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>WELLBUTRIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020358</drugauthorizationnumb>
        <drugdosagetext>150MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19940101</drugstartdate>
        <drugtreatmentduration>11</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOTREL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RELAFEN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057581-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20051130</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0584908A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057582-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20051208</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0585117A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>72</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY OEDEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>4MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051208</drugenddate>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMARYL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057583-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20051208</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0585126A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>50</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugbatchnumb>NOT AVAIL.</drugbatchnumb>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>4MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051001</drugstartdate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOPHAGE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARDIZEM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROTONIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANAPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLARITIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GEMFIBROZIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BUPROPION HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057584-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20051208</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0585129A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>80</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HUNGER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>2MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOVANCE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVAPRO</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BETAXOLOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHROID</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057585-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20051208</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0585131A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>RED BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>2MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugtreatmentduration>18</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMARYL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057586-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20051208</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0585144A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>58</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>GLYCOSYLATED HAEMOGLOBIN INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>8MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOVANCE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVASTATIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057587-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20051130</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0585147A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>4MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLYBURIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057588-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20051209</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0585229A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>60</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLATULENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>4MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051206</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
        <drugdosagetext>500MG TWICE PER DAY</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051206</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057589-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20051209</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0585233A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>52</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>EYE DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>4MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>METABOLIC SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051117</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EFFEXOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIAVAN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057590-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20051208</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0585235A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057591-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20051206</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0585282A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>OEDEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057592-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20051212</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0585488A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>70</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>4MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAMOXIFEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057593-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20051212</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0585508A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>VISION BLURRED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057594-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20051212</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0585517A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>56</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POLLAKIURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugbatchnumb>174A60</drugbatchnumb>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>8MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051205</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051208</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOPHAGE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMARYL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DILTIAZEM HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COZAAR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONOPIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ESTRADIOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROMETRIUM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYTOMEL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057595-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20051212</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0585522A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugbatchnumb>Y385A60</drugbatchnumb>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>4MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRICOR</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057596-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20051213</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0585692A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DIABETES MELLITUS INADEQUATE CONTROL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRICOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROSCAR</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057597-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20051213</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0585693A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>36</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>2MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050301</drugstartdate>
        <drugtreatmentduration>9</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VYTORIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057598-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20051213</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0585695A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>83</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWELLING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>1MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051210</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THYROID TAB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057599-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20051213</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0585699A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>73</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>2MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051209</drugstartdate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLIMEPIRIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WELLBUTRIN XL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CENTRUM SILVER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROSCAR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XALATAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMITRIPTYLINE HCL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057600-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20051214</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0585855A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWELLING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugbatchnumb>793A60</drugbatchnumb>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>8MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051209</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITORIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057601-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20051214</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0585879A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>72</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>8MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOVANCE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COZAAR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057603-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20051215</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0585996A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>52</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>4MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMARYL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOPHAGE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057604-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20051216</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0586113A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>63</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugbatchnumb>UNAVAILABLE</drugbatchnumb>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>4MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051214</drugstartdate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
        <drugdosagetext>500MG IN THE MORNING</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVANDAMET</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057605-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20051212</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0586306A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057606-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20051220</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0586458A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>45</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FACIAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugbatchnumb>74A80</drugbatchnumb>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>8MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051213</drugstartdate>
        <drugtreatmentduration>15</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REQUIP</medicinalproduct>
        <drugbatchnumb>5PX3542A</drugbatchnumb>
        <drugauthorizationnumb>020658</drugauthorizationnumb>
        <drugdosagetext>.5MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RESTLESS LEGS SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051215</drugstartdate>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WATER PILL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOPHAGE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057607-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20051220</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0586461A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>58</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050601</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057608-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20051220</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0586478A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>OEDEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>8MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040329</drugstartdate>
        <drugtreatmentduration>9</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOPHAGE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACTONEL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMARYL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UROXATRAL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057609-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20051216</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0586484A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PLEURAL EFFUSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057610-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20051220</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0586485A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>66</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STOMACH DISCOMFORT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>2MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051213</drugstartdate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NIACIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEGA 3 FISH OIL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057611-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20051221</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0586645A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD TRIGLYCERIDES INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>4MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GEMFIBROZIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLYBURIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OCUVITE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057612-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20051221</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0586653A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>64</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>JOINT SWELLING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>4MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050901</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRANDIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROCARDIA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPROL-XL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRAVACHOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WELLBUTRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN MEDICATION</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057613-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20051222</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0586831A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>AMMONIA INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057614-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20051222</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0586854A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>42</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>2MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051201</drugstartdate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FORTAMET</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057615-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20051220</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0586857A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUID RETENTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JOINT SWELLING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>10MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057616-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20051216</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0586870A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>40</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>67.3</patientweight>
      <reaction>
        <reactionmeddrapt>RASH PRURITIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN EXFOLIATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051102</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051212</drugenddate>
        <drugtreatmentduration>41</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057617-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20051221</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0586885A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>78</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRY MOUTH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL DISCOMFORT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>4MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOPHAGE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNSPECIFIED MEDICATION</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIABETA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOPRESSOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CATAPRES</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057618-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20051223</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0586926A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>54</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>4MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMARYL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOPHAGE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057619-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20051227</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0587035A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>69</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARDIZEM CD</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SINGULAIR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMARYL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENICAR</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057620-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20051227</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0587043A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>67</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>4MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050601</drugstartdate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>500MG TWICE PER DAY</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050601</drugstartdate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALTACE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOTROL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRIAMTERENE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOXYL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DICLOFENAC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057621-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20051227</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0587047A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>70</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>4MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051227</drugstartdate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOPHAGE XR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYZAAR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARDIZEM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZETIA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057622-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20051228</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0587062A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>33</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>4MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOPHAGE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLIPIZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOSINOPRIL SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WELLBUTRIN XL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057623-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20051230</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0587308A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>62</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>4MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051219</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOVANCE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057624-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20051229</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0587352A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>71</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ALOPECIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>8MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051121</drugstartdate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LABETALOL HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADALAT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOTENSIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL SPIROS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AZMACORT</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057625-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060103</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0587542A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>70</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLATULENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLUENZA LIKE ILLNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>4MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051201</drugstartdate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROZAC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057626-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060103</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0587556A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>64</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>8MG AT NIGHT</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050501</drugstartdate>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYZAAR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORAZEPAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VYTORIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EFFEXOR</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057627-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060104</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0587733A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>83</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EAR CONGESTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NASAL CONGESTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>8MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>500MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057628-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060104</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0587734A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>60</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>2MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050801</drugenddate>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CORGARD</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROTONIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACCURETIC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITORIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057629-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060104</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0587742A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>60</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EMOTIONAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE DISCHARGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051221</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOXYL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPROL-XL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYZAAR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057630-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060104</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0587751A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>60</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>4MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRICOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057631-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060104</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0587757A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>58</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ERECTILE DYSFUNCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>8MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051101</drugenddate>
        <drugtreatmentduration>13</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057632-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060104</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0587758A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>73</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>4MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRAVACHOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPROL-XL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALTACE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN B COMPLEX CAP</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FISH OIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057633-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20051230</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0587811A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>80</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL DISTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EATING DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>4MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugtreatmentduration>12</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>STARLIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMINS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOVANCE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057634-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060104</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0587919A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057635-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060105</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0587943A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>66</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUID RETENTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>4MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOXAZOSIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057636-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060105</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0587967A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>58</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>4MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>500MG PER DAY</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPAMAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KEPPRA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEPAKOTE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROPANOL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057637-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060106</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0588150A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>52</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL DISTURBANCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>8MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLYBURIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HEART MEDICATION</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057638-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060106</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0588153A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>4MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010801</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>QUININE SULFATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYOSCYAMINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057639-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060106</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0588155A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>53</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>VISUAL DISTURBANCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>4MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>STATINS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057640-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060106</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0588158A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>55</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE MOVEMENT DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISION BLURRED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>4MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051201</drugenddate>
        <drugtreatmentduration>10</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BLOOD PRESSURE MEDICATION</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057641-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060106</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0588160A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>75</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>IMPULSIVE BEHAVIOUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LACRIMATION INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>4MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041001</drugstartdate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIAZEPAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENICAR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VYTORIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRIAMTERENE AND HYDROCHLOROTHIAZIDE</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>5057642-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060106</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>431134</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>64</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>VISION BLURRED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>8MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>12.5MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050301</drugstartdate>
        <drugtreatmentduration>10</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ECOTRIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057644-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060106</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0588177A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INTRAOCULAR PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL DISTURBANCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugbatchnumb>UNAVAILABLE</drugbatchnumb>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SODIUM BICARBONATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLARITIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057645-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060106</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0588181A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>72</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NODULE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>4MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACCUPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZETIA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THYROID TAB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREVACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOVANCE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057646-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060106</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0588183A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>59</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MACULAR OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWELLING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>8MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050601</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOVANCE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057647-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060106</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0588191A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>84</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>JOINT SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISION BLURRED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051013</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NO CONCURRENT MEDICATION</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057648-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060105</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>4868768</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>67</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>4MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOPHAGE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENICAR</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOTIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEVACOR</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057649-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20051229</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0588229A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STOMACH DISCOMFORT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057650-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060109</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0588331A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>68</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>4MG PER DAY</drugdosagetext>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLIPIZIDE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057651-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060109</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0588339A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>71</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>POLLAKIURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RETINAL DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>4MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVASTATIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057652-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060109</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0588342A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>72</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>NASOPHARYNGITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHINORRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SNEEZING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>4MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
        <drugtreatmentduration>10</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLYBURIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLU SHOT</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057653-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060109</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0588345A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>72</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>4MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057654-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060109</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0588349A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>82</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIURETIC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BLOOD PRESSURE MEDICATION</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057655-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060109</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0588351A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>54</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GINGIVAL BLEEDING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>1TAB TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
        <drugdosagetext>1TAB TWICE PER DAY</drugdosagetext>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LESCOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NAPROXEN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057656-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060109</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0588356A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>73</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DIPLOPIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugbatchnumb>UNAVAILABLE</drugbatchnumb>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>2MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060108</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVALIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VESICARE</medicinalproduct>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057657-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060109</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0588366A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>75</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISION BLURRED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>8MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugtreatmentduration>10</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLYBURIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057658-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060105</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0588403A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057659-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060109</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0588570A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PULMONARY OEDEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>8MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057660-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060110</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0588578A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>85</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL DISTURBANCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>4MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060105</drugenddate>
        <drugtreatmentduration>31</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLIPIZIDE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057661-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060110</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0588585A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>77</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050401</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIURETIC</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057662-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060110</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0588611A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>77</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>VISION BLURRED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL DISTURBANCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>4MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIABETA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOPRESSOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMDUR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIURETIC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRONOLACTONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITORIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLETAL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057663-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060106</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0588613A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>84</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JOINT SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISION BLURRED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051013</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057664-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060111</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0588787A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEPAKOTE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALTACE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DICYCLOMINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057665-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060111</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0588791A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>62</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUID RETENTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>8MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050801</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLYBURIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMITRIPTYLINE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALTACE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057666-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060111</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0588815A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>78</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057667-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060112</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0589011A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>50</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NERVOUSNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>4MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057668-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060112</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0589012A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>40</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STOMACH DISCOMFORT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BLOOD PRESSURE MEDICATION</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VYTORIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057669-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060112</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0589055A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>70</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>EYE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISION BLURRED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugbatchnumb>UNAVAILABLE</drugbatchnumb>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>8MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOVANCE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057670-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060112</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0589056A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>72</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>101.8</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>8MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19991113</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060111</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZESTRIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057671-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060113</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0589211A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>61</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>EYE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISION BLURRED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>4MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051230</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SOTALOL HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OSTEOBIFLEX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057672-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060116</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0589410A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>71</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>4MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRAVACHOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRANDIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057673-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060116</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0589414A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>65</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MACULAR OEDEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>21071</drugauthorizationnumb>
        <drugdosagetext>8MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOVANCE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPROL-XL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACCUPRIL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057674-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060116</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0589417A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>69</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>4MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XOLAIR</medicinalproduct>
        <drugindication>ASPERGILLOSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BLOOD PRESSURE MEDICATION</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057675-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060116</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0589426A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>54</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>21071</drugauthorizationnumb>
        <drugdosagetext>4MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060110</drugstartdate>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HEART MEDICATION</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057676-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060116</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0589440A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>80</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MACULAR OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>4MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060113</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057677-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060112</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>432255</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>74</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FLUID RETENTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOCAL SWELLING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>21071</drugauthorizationnumb>
        <drugdosagetext>4MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>3.125MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VASOTEC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUID</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057678-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060112</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0589495A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>VISUAL DISTURBANCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057679-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060115</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0589527A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVANDAMET</medicinalproduct>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057680-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060117</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0589641A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>57</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>4MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060109</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057681-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060117</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0589653A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>68</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>2MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050401</drugstartdate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
        <drugdosagetext>500MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMBIEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLARINEX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZETIA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACIPHEX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPROL-XL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KLOR-CON</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALTACE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BYETTA</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057682-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060117</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0589659A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PHOTOPHOBIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISION BLURRED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL DISTURBANCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>4MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057683-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060117</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0589662A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>8MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENALAPRIL MALEATE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057684-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060117</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0589664A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL DISTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DECREASED APPETITE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALTACE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EPIVIR</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057685-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060117</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0589675A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FEELING JITTERY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>2MG UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
        <drugdosagetext>500MG UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057686-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050928</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-419573</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>13</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>52.2</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ALANINE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLITIS ULCERATIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CROHN'S DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRIC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLAMMATORY BOWEL DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IRRITABLE BOWEL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANIC ATTACK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARYNGEAL ULCERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSEUDOPOLYP</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>18662</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19940815</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19940915</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>018662</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980115</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19980615</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>018662</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980815</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19990915</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>018662</drugauthorizationnumb>
        <drugdosagetext>ONGOING ON 25 AUGUST 2000.</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>018662</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021115</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030415</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057687-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060113</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0589688A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057688-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060113</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0589690A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>VISION BLURRED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057689-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041027</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-384554</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>20</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>65.8</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ADJUSTMENT DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COAGULOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLITIS ULCERATIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CROHN'S DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRY SKIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ECZEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROENTERITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLAMMATORY BOWEL DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERNAL INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERVERTEBRAL DISC DEGENERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IRRITABLE BOWEL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENOMETRORRHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RECTAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SCOLIOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TENDERNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>18662</drugauthorizationnumb>
        <drugdosagetext>DOSAGE REGIMEN: EVERY DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19991206</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20000515</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MINOCYCLINE HCL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19991206</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ORTHO CYCLEN-28</medicinalproduct>
        <drugdosagetext>DRUG NAME REPORTED AS ORTHO TRI-CYCLEN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057690-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060113</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0589750A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL DISTURBANCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>4MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050501</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057691-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-431089</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>55</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROOESOPHAGEAL REFLUX DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HIATUS HERNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALNUTRITION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH PRURITIC</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEGASYS</medicinalproduct>
        <drugdosagetext>ROUTE REPORTED AS: INJ.</drugdosagetext>
        <drugadministrationroute>050</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COPEGUS</medicinalproduct>
        <drugauthorizationnumb>021511</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051025</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051215</drugenddate>
        <drugtreatmentduration>52</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057692-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060112</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0589756A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057693-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20011130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-302932</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>14</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANGER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANORECTAL DISORDER</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>BRONCHIAL HYPERREACTIVITY</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>CHRONIC FATIGUE SYNDROME</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>FEELING JITTERY</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>HYDROCELE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFECTED VARICOSE VEIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLAMMATORY BOWEL DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INGROWING NAIL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INGUINAL HERNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LACERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIMB INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOCALISED INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOW DENSITY LIPOPROTEIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENISCUS LESION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOOD SWINGS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE TWITCHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NIGHT SWEATS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PENIS DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PILONIDAL CYST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POSTOPERATIVE INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROCTALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS ANI</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSEUDOPOLYPOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RECTAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RED BLOOD CELLS SEMEN POSITIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SCROTAL CYST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUSITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN PAPILLOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TENDONITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TINEA PEDIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VASCULITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WOUND INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>18662</drugauthorizationnumb>
        <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>
        <drugauthorizationnumb>018662</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>018662</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19920424</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>018662</drugauthorizationnumb>
        <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>
        <drugauthorizationnumb>018662</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19940715</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19940801</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>018662</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19940801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19940815</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>018662</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19940815</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19941015</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>018662</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>018662</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19950328</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19950815</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>018662</drugauthorizationnumb>
        <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>
        <drugauthorizationnumb>018662</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19951116</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19960315</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>018662</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19960513</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>018662</drugauthorizationnumb>
        <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>
        <drugauthorizationnumb>018662</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980827</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19990615</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>018662</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19991209</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20000615</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>018662</drugauthorizationnumb>
        <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 (CAPLET)</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>5057694-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060118</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0589860A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>44</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE FLUCTUATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>2MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057695-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060206</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-435347</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>62</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>85.3</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABSCESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THYROID FUNCTION TEST ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENTRICULAR TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEGASYS</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051210</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEGASYS</medicinalproduct>
        <drugdosagetext>PEG INTERFERON ALFA 2A DOSE WAS CUT IN HALF.</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060315</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COPEGUS</medicinalproduct>
        <drugauthorizationnumb>021511</drugauthorizationnumb>
        <drugdosagetext>600 MG IN THE MORNING, 600 MG IN THE EVENING.</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051210</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COPEGUS</medicinalproduct>
        <drugauthorizationnumb>021511</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RIBAVIRIN</medicinalproduct>
        <drugauthorizationnumb>021511</drugauthorizationnumb>
        <drugdosagetext>PATIENT STOPPED RIBAVIRIN ON HIS OWN BECAUSE IT WAS MAKING HIM FEEL SICK.</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051210</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060715</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCODONE HCL</medicinalproduct>
        <drugdosagetext>MAXIMALLY 3 TABLETS PER DAY.</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BACK PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19910615</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATIVAN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>POST-TRAUMATIC STRESS DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19910615</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEUPOGEN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057696-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060118</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0589877A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057698-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-432854</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>19</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>59</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLITIS ULCERATIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CROHN'S DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ELECTROLYTE IMBALANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EPISTAXIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOPROTEINAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMPAIRED HEALING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLAMMATORY BOWEL DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SMALL INTESTINAL OBSTRUCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VITILIGO</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>018662</drugauthorizationnumb>
        <drugdosagetext>ACCUTANE ALTERNATING BETWEEN 40 MG AND 80 MG.</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ACNE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19921023</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19930625</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>018662</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19930626</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057699-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060118</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0589887A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MACULAR OEDEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057700-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnesscongenitalanomali>1</seriousnesscongenitalanomali>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060530</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-ROCHE-449935</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>CONGENITAL CENTRAL NERVOUS SYSTEM ANOMALY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONGENITAL CEREBELLAR AGENESIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONGENITAL EYE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONGENITAL IRIS ANOMALY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE BEFORE PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EAR MALFORMATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART DISEASE CONGENITAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE CONGENITAL ABNORMALITIES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYDRIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OLFACTORY NERVE DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>18662</drugauthorizationnumb>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050630</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057701-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060119</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0590060A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>70</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DYSPEPSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>WELLBUTRIN</medicinalproduct>
        <drugbatchnumb>05L021P</drugbatchnumb>
        <drugauthorizationnumb>021515</drugauthorizationnumb>
        <drugdosagetext>300MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060112</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060119</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVAPRO</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HUMAN INSULIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LUNESTA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DUONEB</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057702-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060525</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-449768</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>3.3</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE BEFORE PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVE BIRTH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NO ADVERSE EFFECT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PREGNANCY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>18662</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980212</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19980317</drugenddate>
        <drugtreatmentduration>34</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>018662</drugauthorizationnumb>
        <drugdosagetext>INDICATION REPORTED AS CYSTIC ACNE.</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980318</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19980719</drugenddate>
        <drugtreatmentduration>124</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTIBIOTIC NOS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057703-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060119</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0590070A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INTOLERANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057704-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-432844</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>21</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>86.2</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLITIS ULCERATIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLAMMATORY BOWEL DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTESTINAL OBSTRUCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>018662</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ACNE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19940110</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19950105</drugenddate>
        <drugtreatmentduration>361</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057705-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060119</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0590076A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>63</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>VISION BLURRED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>4MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLYBURIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057706-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060425</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-446002</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>50</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ALOPECIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLADDER PROLAPSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ENTEROCELE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SURGICAL PROCEDURE REPEATED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEGASYS</medicinalproduct>
        <drugdosagetext>ROUTE REPORTED AS INJ.</drugdosagetext>
        <drugadministrationroute>050</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051014</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060101</drugenddate>
        <drugtreatmentduration>80</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COPEGUS</medicinalproduct>
        <drugauthorizationnumb>021511</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051014</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060101</drugenddate>
        <drugtreatmentduration>80</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057707-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060119</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0590079A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>67</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>VISION BLURRED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>4MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057708-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060510</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IT-ROCHE-447169</companynumb>
    <primarysource>
      <reportercountry>NETHERLANDS</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>57</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BILE DUCT STENOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISEASE RECURRENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG LEVEL INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATITIS C</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MYCOPHENOLATE MOFETIL</medicinalproduct>
        <drugauthorizationnumb>50722</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060125</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FK506</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060125</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FK506</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BACTRIM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CIPROFLOXACIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057709-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060119</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0590085A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NO CONCURRENT MEDICATION</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057710-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060118</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0590182A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>76</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>91.8</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057711-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060120</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0590271A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>73</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>4MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARTHROTEC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CORGARD</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057712-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060120</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0590283A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>56</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050419</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050801</drugenddate>
        <drugtreatmentduration>15</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLEGRA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROXYZINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057713-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060123</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0590507A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>56</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>2MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050701</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CONCURRENT MEDICATIONS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057714-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060123</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0590553A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>LYMPHADENITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OFF LABEL USE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057715-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060124</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0590710A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>53</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>4MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057716-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060124</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0590732A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ADVERSE DRUG REACTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057717-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060123</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0590755A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>4MG UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060119</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
        <drugdosagetext>500MG UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060119</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVANDAMET</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060118</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057718-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060119</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0590775A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>50</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>4MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060101</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ESTRACE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057719-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060125</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0590912A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>75</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DIABETES MELLITUS INADEQUATE CONTROL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>4MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOTROL XL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENICAR</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPROL-XL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONIDINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057720-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060126</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0590971A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIAC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATOMEGALY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057721-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060126</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0590975A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057722-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060126</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0590979A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057723-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060124</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0591122A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057724-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060127</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0591161A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057725-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060127</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0591273A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD GLUCOSE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>BLOOD GLUCOSE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057726-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060127</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0591276A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>55</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>INTRAOCULAR PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>8MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMARYL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COSOPT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALPHAGAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LUMIGAN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057727-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060127</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0591296A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>67</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>4MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051001</drugstartdate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPROL-XL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORAZEPAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DARVOCET</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057728-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060127</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0591307A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>72</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISION BLURRED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>4MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRANDIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALTACE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENTYL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057729-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060130</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0591467A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057730-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060130</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0591506A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>AGGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NO CONCURRENT MEDICATION</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057731-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060130</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0591526A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>EYE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LACRIMATION INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUS HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISION BLURRED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugbatchnumb>NAV</drugbatchnumb>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>4MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057732-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060131</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0591711A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>53</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>4MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050901</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057733-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060131</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0591712A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>4MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVANDARYL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057734-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060131</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0591713A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>4MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZETIA</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057735-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060131</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0591717A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOCAL SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN DISCOLOURATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWELLING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>4MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOPHAGE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VERAPAMIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DITROPAN XL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLEGRA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MIRAPEX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057736-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060131</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0591735A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>65</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>4MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLIPIZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VERAPAMIL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057737-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060131</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0591739A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>45</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>8MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VERELAN PM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057738-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060131</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0591740A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>50</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugbatchnumb>NAV</drugbatchnumb>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>8MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPROL-XL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREVACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VICODIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NITRO</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057739-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060201</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0591918A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>62</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL DISTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>8MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057740-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060201</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0591924A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>71</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANOREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BALANCE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH GENERALISED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VIRAL INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>7MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057741-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060201</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0591947A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>70</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HEART RATE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugbatchnumb>NAV</drugbatchnumb>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>8MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051201</drugstartdate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOTROL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057742-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060201</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0591952A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>59</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>2MG UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMARYL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROGRAM 20</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MYFORTIC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MINOXIDIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM SUPPLEMENT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGNESIUM SUPPLEMENT</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057743-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060201</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0591960A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057744-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060202</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0592120A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>78</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>4MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit></drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARDIZEM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RANITIDINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MONOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZYRTEC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMINS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057745-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060202</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0592126A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>80</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GLYCOSYLATED HAEMOGLOBIN INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>21071</drugauthorizationnumb>
        <drugdosagetext>2MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS NON-INSULIN-DEPENDENT</drugindication>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CORTISONE INJECTION</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLIPIZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DILTIAZEM HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIGOXIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FISH OIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN B COMPLEX CAP</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASCORBIC ACID</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057747-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060202</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0592131A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>78</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>8MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051201</drugenddate>
        <drugtreatmentduration>9</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLYBURIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TERAZOSIN HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FENOFIBRATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FINASTERIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM WITH VITAMIN D</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SELENIUM SULFIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GINSENG</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SAW PALMETTO</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM GLUCONATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGNESIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZINC</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057748-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060202</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0592142A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD CREATINE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>2MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRICOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057749-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060202</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0592147A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>8MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRICOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLIMEPIRIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIGOXIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENALAPRIL MALEATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOLAZONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENALAPRIL MALEATE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057750-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060201</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0592190A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>55</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>93.6</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BYETTA</medicinalproduct>
        <drugdosagetext>10MCG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050801</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOPHAGE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACTOS</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057751-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060203</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0592274A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>74</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD CREATININE DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>2MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050401</drugstartdate>
        <drugtreatmentduration>10</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>500MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050401</drugstartdate>
        <drugtreatmentduration>10</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRICOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNSPECIFIED MEDICATION</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVANDAMET</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050401</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057752-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060203</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0592302A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>52</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRY SKIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POLLAKIURIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>4MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>801</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>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057753-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060206</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0592476A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NO CONCURRENT MEDICATION</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057754-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060206</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0592486A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>51</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMARYL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057755-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060206</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0592503A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>61</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>4MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057756-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060203</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0592504A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MACULAR OEDEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057757-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060206</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0592520A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>53</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>8MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLYBURIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057758-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060207</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0592650A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>44</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF EMPLOYMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>4MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050707</drugstartdate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOPHAGE XR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BYETTA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>B12</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057759-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060206</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0592651A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>BLOOD BILIRUBIN INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057760-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060207</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0592661A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STOMACH DISCOMFORT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050101</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057761-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060207</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0592677A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ILL-DEFINED DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>4MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPROL-XL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARTIA XT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALOPURINOL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057762-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060207</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0592700A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STOMACH DISCOMFORT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050101</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057763-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060207</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0592701A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STOMACH DISCOMFORT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050101</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057764-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060208</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0592840A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>SWELLING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057765-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060208</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0592841A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>52</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ERECTILE DYSFUNCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>4MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060201</drugenddate>
        <drugtreatmentduration>9</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOVANCE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057766-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060208</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0592842A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>45</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>4MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>1000MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BETIMOL</medicinalproduct>
        <drugadministrationroute>047</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLIPIZIDE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057767-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060208</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0592857A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>60</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>2MG THREE TIMES PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060207</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>500MG THREE TIMES PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060207</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KLOR-CON</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXAPROZIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PAROXETINE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLARINEX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROTONIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOTREL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057768-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060208</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0592870A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SCROTAL OEDEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugbatchnumb>UNAVAILABLE</drugbatchnumb>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>8MG UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM CHANNEL BLOCKER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACE-INHIBITOR</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057769-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060209</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0593060A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057770-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060209</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0593072A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>72</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>4MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPROL-XL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVASTATIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057771-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060210</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0593269A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOTREL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057772-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060210</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0593274A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>4MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VIAGRA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057773-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060210</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0593298A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>44</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>8MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GLUCOPHAGE</medicinalproduct>
        <drugdosagetext>500MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALTACE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057774-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060213</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0593477A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>46</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>4MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>1000MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENICAR</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057775-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060213</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0593482A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>60</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DYSGEUSIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>4MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLIPIZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRAVACHOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOTREL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BRIMONIDINE TARTRATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CITRUCEL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057776-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060213</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0593483A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057777-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060214</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0593653A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>56</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BOWEL SOUNDS ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>4MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060101</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>1000MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060101</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMARYL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057778-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060214</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0593660A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>8MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057779-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060214</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0593678A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FUNGAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FURUNCLE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>8MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALTACE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTIBIOTIC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057780-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060210</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0593701A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>EYE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JOINT SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISION BLURRED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057781-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060215</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0593848A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>4MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLIPIZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZANTAC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAZODONE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057782-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060215</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0593875A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>78</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>4MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>STARLIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057783-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060215</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0593876A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ADVERSE EVENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>8MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BYETTA</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057784-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060216</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0594006A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057786-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060216</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0594014A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>65</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>2MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALTACE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057787-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060217</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0594142A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>4MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NO CONCURRENT MEDICATION</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057788-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060217</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0594146A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>56</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051201</drugenddate>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GLUCOPHAGE</medicinalproduct>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051201</drugenddate>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XELODA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RED BLOOD CELLS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVALIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRAVACHOL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057789-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060217</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0594149A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>55</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT LOSS POOR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>4MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>500MG TWICE PER DAY</drugdosagetext>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYZAAR</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057790-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060217</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0594167A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVERDOSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>8MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NO CONCURRENT MEDICATION</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057791-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060220</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0594387A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>64</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HEART RATE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>4MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BLOOD PRESSURE MEDICATION</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057792-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060220</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0594388A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>65</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LETHARGY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>2MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060130</drugstartdate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROZAC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVASTATIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORTRIPTYLINE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENADRYL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPROL-XL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057793-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060220</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0594395A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>57</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>2MG UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057794-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060217</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0594432A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GLUCOPHAGE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057795-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060221</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0594609A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>2MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROTONIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NADOLOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLYBURIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057796-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060221</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0594631A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>62</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>4MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050101</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>1000MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050101</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPROL-XL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL SPIROS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMINS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057797-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060221</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0594645A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057798-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060221</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0594654A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>54</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugbatchnumb>6ZT8052</drugbatchnumb>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>4MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METFORMIN HCL</medicinalproduct>
        <drugbatchnumb>LN075158</drugbatchnumb>
        <drugdosagetext>1000MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DETROL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COZAAR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTICOAGULANT</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057799-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060222</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0594779A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>61</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOCAL SWELLING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>4MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LESCOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLEGRA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EVISTA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SINGULAIR</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057800-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060222</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0594786A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>4MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057801-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060222</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0594810A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>77</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>EYE SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugbatchnumb>[NOT ENTERED]</drugbatchnumb>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>2MCG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060119</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060209</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLIBURIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NIFEDIPINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROTONIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVASTATIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACTOS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057802-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060202</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0594811A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HEPATIC ENZYME INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACTOS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057803-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060223</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0594941A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>79</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>4MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050901</drugstartdate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVASTATIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057804-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060223</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0594953A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>40</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>8MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugtreatmentduration>18</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057805-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060223</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0594976A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057806-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060223</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0594977A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SLEEP APNOEA SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057807-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060224</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0595113A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>LACRIMATION INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057808-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060224</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0595124A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>62</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>4MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
        <drugdosagetext>500MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVANDAMET</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057809-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060227</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0595301A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>54</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GLYCOSYLATED HAEMOGLOBIN INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>4MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050301</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>1000MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050301</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>STARLIX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057810-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060227</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0595310A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>4MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLIPIZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CHLORZOXAZONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCODONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMBIEN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057811-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060227</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0595319A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM GLUCONATE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057812-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060227</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0595322A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>30</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THOUGHT BLOCKING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>4MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060215</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OVCON-35</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DICLOFENAC</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057813-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060227</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0595345A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>39</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANOREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUID RETENTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENTAL IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MICTURITION DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARYNGEAL OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWELLING FACE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>2MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CHOLESTEROL REDUCING AGENT</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057814-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060228</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0595558A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>57</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANOREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>2MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INDERAL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COZAAR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVASTATIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057815-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060301</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0595730A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>39</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>EYE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISION BLURRED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>4MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTIVITAMIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057816-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060302</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0595889A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>70</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057817-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060302</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0595890A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>80</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057818-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060302</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0595893A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>66</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MEDICATION RESIDUE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>2MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050806</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLIPIZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GABAPENTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATORVASTATIN CALCIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOSARTAN POSTASSIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SILDENAFIL CITRATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUTICASONE PROPIONATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORATADINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057819-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060302</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0595895A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>58</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EFFECT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>1TAB TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugtreatmentduration>10</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMINS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057820-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060302</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0595907A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>45</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>4MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041001</drugstartdate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREVACID</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057821-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060303</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0596006A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>72</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>97.3</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VERTIGO</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>4MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060303</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOPHAGE</medicinalproduct>
        <drugdosagetext>1000MG TWICE PER DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOTREL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROTONIX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057822-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060301</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>1-52936504</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUID RETENTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057823-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060306</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0596311A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>4TAB PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVANDAMET</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057824-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060306</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0596483A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057825-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060307</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0596503A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUID RETENTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057826-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060307</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0596517A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>72</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>SLEEP DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057827-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060303</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0596538A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>OEDEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057828-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060301</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0596541A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>ADVERSE EVENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUID RETENTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057829-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060308</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0596748A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>58</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>90.9</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>RHINORRHOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>4MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZYRTEC</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050801</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLONASE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050801</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLYBURIDE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRICOR</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031201</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057830-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060308</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0596753A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>67</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>4MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057831-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060303</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0596825A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HIGH DENSITY LIPOPROTEIN DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>21071</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>UNSPECIFIED FIBRATE MEDICATION</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057832-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060309</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0596916A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>48</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>2MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIAVAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057833-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060309</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0596938A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057834-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060309</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0596946A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>MACULAR OEDEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NO CONCURRENT MEDICATION</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057835-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060310</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0597134A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>68</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MACULAR OEDEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>4MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060309</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CAPTOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THYROID TAB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IRON</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057836-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060309</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0597145A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>AMNESIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NO CONCURRENT MEDICATION</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057837-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060309</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0597146A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>AMNESIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NO CONCURRENT MEDICATION</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057838-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060310</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0597157A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>47</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>4MG UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057839-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060309</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0597216A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057840-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060313</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0597330A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>72</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>2MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugtreatmentduration>40</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIABETA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVANDAMET</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057841-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060313</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0597331A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>63</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>4MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050901</drugstartdate>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLYBURIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREMARIN CREAM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057842-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060313</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0597335A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>63</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057843-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060309</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>S2006US03484</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>58</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWELLING FACE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057844-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060314</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0597512A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>67</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE CONGESTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>21071</drugauthorizationnumb>
        <drugdosagetext>4MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000215</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030101</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUBICIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057845-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060314</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0597529A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>55</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DYSGEUSIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>21071</drugauthorizationnumb>
        <drugdosagetext>4MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS NON-INSULIN-DEPENDENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060307</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIGAPLEX II</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>2TAB THREE TIMES PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060313</drugstartdate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VASOTEC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057847-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060315</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0597667A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>69</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MOBILITY DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>4MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060101</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENICAR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057848-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060315</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0597669A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>69</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>4MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051122</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRAVACHOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIAZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPROL-XL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVANDAMET</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057849-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060315</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0597676A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>77</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>4MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPROL-XL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALTACE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057850-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060315</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0597688A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>39</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>1TAB PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugtreatmentduration>18</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
        <drugdosagetext>1TAB PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugtreatmentduration>18</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NO CONCURRENT MEDICATION</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057851-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060315</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0597711A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>2MG UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057852-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060316</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0597860A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>69</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PRURITUS GENERALISED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TINNITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>8MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060208</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLONASE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLEGRA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHROID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN E</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZYMAR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN MEDICATION</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057853-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060316</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0597871A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KADIAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN MEDICATION</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057854-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060525</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-449761</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>26</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE BEFORE PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GESTATIONAL DIABETES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NO ADVERSE EFFECT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>18662</drugauthorizationnumb>
        <drugdosagetext>INDICATION REPORTED AS CYSTIC ACNE.</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ACNE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980318</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19980719</drugenddate>
        <drugtreatmentduration>124</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>018662</drugauthorizationnumb>
        <drugdosagetext>INDICATION REPORTED AS NODULAR ACNE.</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980212</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19980317</drugenddate>
        <drugtreatmentduration>34</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057855-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060316</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0597891A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057856-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-432854</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>19</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>59</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ADHESION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLITIS ULCERATIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CROHN'S DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ELECTROLYTE IMBALANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ENTERITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EPISTAXIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOPROTEINAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMPAIRED HEALING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLAMMATORY BOWEL DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SMALL INTESTINAL OBSTRUCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VITILIGO</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>18662</drugauthorizationnumb>
        <drugdosagetext>ACCUTANE ALTERNATING BETWEEN 40 MG AND 80 MG.</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ACNE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19921023</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19930625</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>018662</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19930626</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057857-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060316</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0597899A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>53</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>4MG UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAZODONE HCL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EFFEXOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYCLOBENZAPRINE HCL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAMADOL HCL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACTOS</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCODONE BITARTRATE + ACETAMINOPHEN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057858-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060405</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PL-ROCHE-443458</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>74</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CHEST X-RAY ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOPTYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERSTITIAL LUNG DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TICLOPIDINE HCL</medicinalproduct>
        <drugauthorizationnumb>019979</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMIODARONE HCL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>VENTRICULAR FIBRILLATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOPIDOGREL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057859-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060317</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0598038A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>82</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE FLUCTUATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH PRURITIC</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>4MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLIPIZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FEXOFENADINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DETROL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>QUINAPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOXAZOSIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROSCAR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057861-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060317</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0598048A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057862-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060516</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-448391</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>63</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>63</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>JAW DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BONIVA</medicinalproduct>
        <drugauthorizationnumb>21455</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051103</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060501</drugenddate>
        <drugtreatmentduration>180</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZETIA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERLIPIDAEMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPOTHYROIDISM</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057863-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060317</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0598061A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>57</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA FACIAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA ORAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NO CONCURRENT MEDICATION</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057864-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060324</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CH-ROCHE-441833</companynumb>
    <primarysource>
      <reportercountry>SWITZERLAND</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>65</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HAEMOLYTIC ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TORSEMIDE</medicinalproduct>
        <drugauthorizationnumb>20136</drugauthorizationnumb>
        <drugdosagetext>INDICATION REPORTED AS ^HYPERTENSIVE HEART DISEASE WITH (CONGESTIVE) HEART FAILURE^</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSIVE HEART DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050315</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>QUININE SULFATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051215</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051228</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugdosagetext>STRENGTH: REPORTED AS ^MG/ML^ DOSING: REPORTED AS ^DOSE REDUCED^</drugdosagetext>
        <drugadministrationroute>040</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051208</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugdosagetext>DOSING: REPORTED AS ^DOSE REDUCED^</drugdosagetext>
        <drugadministrationroute>040</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040615</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DYSPEPSIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051202</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060112</drugenddate>
        <drugtreatmentduration>42</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FERRUM HAUSMANN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050315</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051228</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALDACTONE</medicinalproduct>
        <drugdosagetext>FORM: REPORTED AS ^ COATED TABLETS, FILM^</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FRAXIPARINE</medicinalproduct>
        <drugdosagetext>FORM: REPORTED AS ^VIALS^</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugdosagetext>FORM: REPORTED AS ^ COATED TABLETS, FILM^</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LESCOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COZAAR</medicinalproduct>
        <drugdosagetext>FORM: REPORTED AS ^COATED TABLETS, FILM^</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DAFALGAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIFROL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>STILNOX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MOCLOBEMIDE</medicinalproduct>
        <drugdosagetext>DRUG NAME: REPORTED AS ^MOCLO A^ FORM: REPORTED AS ^COATED TABLETS, FILM^</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057865-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060320</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0598202A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>40</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE FLUCTUATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEDICATION RESIDUE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051001</drugstartdate>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051001</drugstartdate>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZESTRIL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057866-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060527</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-449866</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>53</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>90.7</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEGASYS</medicinalproduct>
        <drugbatchnumb>B0091</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060519</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060526</drugenddate>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RIBAVIRIN</medicinalproduct>
        <drugauthorizationnumb>021511</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060519</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060526</drugenddate>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
        <drugdosagetext>WITHHELD DURING HOSPITALISATION.</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GOUT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ESTRADIOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MENOPAUSE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDROXYPROGESTERONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MENOPAUSE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
        <drugdosagetext>600 MG QID PRN.</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROTONIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTIVITAMIN NOS</medicinalproduct>
        <drugdosagetext>DAILY.</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MILK THISTLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOSAMINE SULFATE/CHONDROITIN</medicinalproduct>
        <drugdosagetext>DAILY.</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057867-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060320</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0598204A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>53</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>77.3</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL DISTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STOMACH DISCOMFORT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>4MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>1000MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCODONE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057868-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060711</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-ROCHE-454889</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>65</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ASCITES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISTURBANCE IN ATTENTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC CIRRHOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LETHARGY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL INTAKE REDUCED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RIBAVIRIN</medicinalproduct>
        <drugauthorizationnumb>21511</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040622</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041130</drugenddate>
        <drugtreatmentduration>162</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INTERFERON ALFACON-1</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040324</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041130</drugenddate>
        <drugtreatmentduration>252</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BISOPROLOL FUMARATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRONOLACTONE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057869-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060320</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0598205A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>GASTROOESOPHAGEAL REFLUX DISEASE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>2MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOTREL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREVACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZETIA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEGA 3 CAPS (MULTIVIT + MINERALS)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057870-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060320</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0598209A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>50</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>2MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>500MG TWICE PER DAY</drugdosagetext>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COZAAR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZETIA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOPRESSOR</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057871-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060320</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0598222A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>2MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugtreatmentduration>18</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALTACE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMARYL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057872-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060321</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0598413A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>74</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>4MG IN THE MORNING</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
        <drugdosagetext>500MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROVICAL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057873-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060321</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0598420A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>57</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>4MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAVIK</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057874-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060321</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0598428A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>57</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD CHOLESTEROL INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>4MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRANDIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEXAPRO</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RESTORIL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057875-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060321</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0598431A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>66</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>8MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMIODARONE HCL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARRHYTHMIA</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GLYBURIDE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLYBURIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMIODARONE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVASTATIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RANITIDINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM CHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALEVE (CAPLET)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057876-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060321</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0598441A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>46</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>4MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050801</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
        <drugdosagetext>1000MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050801</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057877-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060322</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0598609A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057878-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060323</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0598811A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>49</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>21071</drugauthorizationnumb>
        <drugdosagetext>2MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057879-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060323</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0598826A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>LACTOSE INTOLERANCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOVANCE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057880-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060323</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0598837A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>57</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>THERAPEUTIC RESPONSE DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>4MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>1000MG TWICE PER DAY</drugdosagetext>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLIMEPIRIDE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057881-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060320</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0598850A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>8MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057882-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060324</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0598946A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>66</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>8MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060321</drugenddate>
        <drugtreatmentduration>10</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRAVACHOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVAPRO</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057883-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060324</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0598979A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>68</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>4MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060309</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEXAPRO</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLOBETASOL PROPIONATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057884-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060322</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0599003A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>GASTRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051015</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051015</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATACAND</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARAFATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREVACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARAFATE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057885-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060327</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0599142A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>57</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MACULAR OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>4MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050821</drugenddate>
        <drugtreatmentduration>15</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDAMET</medicinalproduct>
        <drugauthorizationnumb>021410</drugauthorizationnumb>
        <drugdosagetext>4MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMARYL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057886-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060327</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0599144A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>59</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>4MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060316</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
        <drugdosagetext>1000MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060316</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVANDAMET</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057887-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060327</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0599149A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>56</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>4MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060318</drugstartdate>
        <drugtreatmentduration>10</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLIPIZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZESTORETIC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRAVACHOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLEGRA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM GLUCONATE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057888-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060328</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0599329A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>64</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>APPETITE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>2MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057889-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060328</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0599331A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>57</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THERAPEUTIC RESPONSE DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>2MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>500MCG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRIAMTERENE AND HYDROCHLOROTHIAZIDE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057891-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060328</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0599332A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>65</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>LACRIMATION INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISION BLURRED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>4MG AT NIGHT</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KLOR-CON</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057892-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060328</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0599341A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </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>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NO CONCURRENT MEDICATION</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057893-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060328</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0599351A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>VISION BLURRED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057894-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060328</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0599365A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>60</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INCREASED APPETITE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THERAPEUTIC RESPONSE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>4MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>1000MG UNKNOWN</drugdosagetext>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPROL-XL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRAVACHOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZETIA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONIDINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057895-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060328</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0599370A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>78</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EFFECT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>4MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugtreatmentduration>10</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>1000MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugtreatmentduration>10</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COZAAR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057896-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060328</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0599376A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>60</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>4MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060315</drugstartdate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOSAMINE CHONDROITIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057897-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060329</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0599500A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>66</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>77.7</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>2MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
        <drugdosagetext>500MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARICEPT</medicinalproduct>
        <drugdosagetext>5MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITORIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOTREL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
        <drugdosagetext>.075MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPOTHYROIDISM</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MILK OF MAGNESIA TAB</medicinalproduct>
        <drugindication>CONSTIPATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVANDAMET</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057898-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060329</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0599508A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>79</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>8MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INSULIN</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOTROL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057899-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060329</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0599510A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>72</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUID RETENTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>4MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
        <drugtreatmentduration>15</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>STARLIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALTACE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZETIA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACTOS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057900-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060329</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0599515A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>72</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE FLUCTUATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>4MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
        <drugdosagetext>500MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRICOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMARYL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRAVACHOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVANDAMET</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057901-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060328</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0599533A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE CONGESTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NO CONCURRENT MEDICATION</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057902-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060329</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0599537A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYZAAR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057903-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060329</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0599544A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>56</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLUENZA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INSULIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugtreatmentduration>30</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOPHAGE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PAIN MEDICATION</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICATION FOR HIGH BLOOD PRESSURE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RANITIDINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057904-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060329</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0599559A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057905-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060324</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0599622A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG EFFECT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVANDAMET</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057906-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060330</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0599731A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>51</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>4MG UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPROL-XL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVALIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ESTROGENS SOL/INJ</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057907-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060330</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0599736A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>59</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE FLUCTUATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>4MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057908-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060330</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0599752A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NO CONCURRENT MEDICATION</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057909-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060330</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0599774A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>75</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>21071</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040101</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOPHAGE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOTROL XL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057910-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060330</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0599797A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>STOMACH DISCOMFORT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVANDAMET</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMARYL</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057911-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060331</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0599904A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>79</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVERDOSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>8MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVALIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVASTATIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IRON SUPPLEMENT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRILOSEC</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057912-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060331</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0599918A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>63</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>126.4</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DIABETES MELLITUS INADEQUATE CONTROL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THERAPEUTIC RESPONSE DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NO CONCURRENT MEDICATION</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVANDAMET</medicinalproduct>
        <drugdosagetext>1TAB TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057913-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060331</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0599923A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>27</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>4MG TWO TIMES PER WEEK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HUMALOG</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057914-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060331</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0599924A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE FLUCTUATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>2MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPROL-XL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRONOLACTONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREVACID</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057915-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060331</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0599929A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>68</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>4MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041101</drugstartdate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOVAN HCT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOTREL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN MEDICATION</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITORIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057916-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060331</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0599948A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>2MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060328</drugstartdate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLYBURIDE</medicinalproduct>
        <drugdosagetext>2.5MG TWICE PER DAY</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057917-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060331</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0599949A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>64</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>8MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOVANCE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPROL-XL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOTREL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057918-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060403</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0600084A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>41</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugbatchnumb>5ZP9942</drugbatchnumb>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>4MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEPAKOTE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAZODONE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GEODON</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENZODIAZEPINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN MEDICATION</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THIOTHIXENE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LITHIUM CARBONATE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057919-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060403</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0600100A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>55</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>4MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTIDEPRESSANT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMARYL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057920-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060403</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0600105A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>59</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZETIA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM GLUCONATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLAX OIL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057921-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060403</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0600109A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>40</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>4MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057922-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060403</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0600114A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057923-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060328</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0600175A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ADVERSE EVENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDAMET</medicinalproduct>
        <drugauthorizationnumb>021410</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACTOS</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057924-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060328</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0600176A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>63</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>113.6</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>EYE SWELLING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTI-HYPERTENSIVE</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057925-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060404</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0600317A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>59</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPROL-XL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLEGRA</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057926-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060404</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0600361A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>61</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STOMACH DISCOMFORT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>21071</drugauthorizationnumb>
        <drugdosagetext>4MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>1000MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057928-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060405</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0600562A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>54</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>2MG THREE TIMES PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EFFEXOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN MEDICATION</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZETIA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMDUR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPROL-XL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLYCOSIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VICODIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057929-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060405</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0600573A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>70</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>8MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLYBURIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVAPRO</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057930-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060329</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0600632A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DIABETES MELLITUS INADEQUATE CONTROL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EFFECT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ROSIGLITAZONE MALEATE</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD GLUCOSE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD GLUCOSE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVANDAMET</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD GLUCOSE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057931-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060406</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0600763A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>LACRIMATION INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057932-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060406</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0600771A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>45</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>4MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050401</drugstartdate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>1000MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050401</drugstartdate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NO CONCURRENT MEDICATION</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057933-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050403</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0600804A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>61</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>2MG UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLEGRA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057934-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060407</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0600920A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>76</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>2MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060406</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MONOPRIL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057935-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060407</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0600947A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>63</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THERAPEUTIC RESPONSE DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>2MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051201</drugenddate>
        <drugtreatmentduration>18</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
        <drugdosagetext>1000MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051201</drugenddate>
        <drugtreatmentduration>18</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNSPECIFIED MEDICATION</medicinalproduct>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLIPIZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVANDAMET</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057936-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060410</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0600992A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057937-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060410</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0601182A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>60</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>2MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060408</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
        <drugdosagetext>500MG TWICE PER DAY</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060408</drugstartdate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ROBAXIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057938-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060405</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0601237A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057939-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060404</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>2006PV009808</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>74</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>4MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BYETTA</medicinalproduct>
        <drugdosagetext>10MCG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060119</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19860101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>STARLIX</medicinalproduct>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060119</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057940-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060411</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0601365A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>45</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>116.8</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>4MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060321</drugstartdate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDAMET</medicinalproduct>
        <drugauthorizationnumb>021410</drugauthorizationnumb>
        <drugdosagetext>1TAB TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060321</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
        <drugdosagetext>1000MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060321</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NOVOLOG</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057941-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060411</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0601378A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWELLING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>8MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057942-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060412</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0601571A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>72</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISION BLURRED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>4MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRILOSEC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOPHAGE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MICRONASE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BUMEX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057943-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060412</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0601591A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL DISTENSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>8MG UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057944-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060413</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0601662A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>42</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>4MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060410</drugstartdate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NO CONCURRENT MEDICATION</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057945-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060414</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0601819A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>65</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL DISTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060201</drugstartdate>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057946-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060414</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0601833A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>64</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>4MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060407</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOPHAGE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INDERAL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057947-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060417</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0601927A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MACULAR OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL ACUITY REDUCED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>4MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOPHAGE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CADUET</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057948-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060417</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0601940A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>65</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>59.1</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DIABETES MELLITUS INADEQUATE CONTROL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>1.5TAB IN THE MORNING</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
        <drugdosagetext>500MG THREE TIMES PER DAY</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057949-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060417</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0601941A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>2MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIGOXIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROPRANOLOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057950-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060417</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0601950A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>47</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>2MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060317</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>500MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060317</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPROL-XL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TIZANIDINE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPAMAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KLONOPIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN MEDICATION</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOXAZOSIN MESYLATE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057951-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060417</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0601952A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>8MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057952-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060417</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0601983A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057953-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060417</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0601987A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>57</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>4MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>1000MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NO CONCURRENT MEDICATION</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057954-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060412</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0602145A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PHOTOSENSITIVITY REACTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057955-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060413</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0602163A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>46</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>EYE OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THERAPEUTIC RESPONSE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL ACUITY REDUCED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL DISTURBANCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>8MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060201</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOPHAGE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALTACE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMARYL</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051201</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057956-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060418</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0602167A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>60</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BALANCE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LETHARGY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>4MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDAMET</medicinalproduct>
        <drugauthorizationnumb>021410</drugauthorizationnumb>
        <drugdosagetext>1TAB TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLIPIZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOXYL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRICOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALPRAZOLAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057957-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060418</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0602181A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>MACULAR OEDEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057958-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060418</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0602197A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>66</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CHROMATURIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>4MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREVACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVODART</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOPID</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057959-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060412</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0602209A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>FLUID RETENTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDARYL</medicinalproduct>
        <drugauthorizationnumb>021700</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057960-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060418</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0602374A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>MACULAR OEDEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057961-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060419</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0602493A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>68</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>APPETITE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE FLUCTUATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>8MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050401</drugstartdate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLEGRA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLONASE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONOPIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THEOPHYLLINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL SPIROS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENAPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>QVAR 40</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SEREVENT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PAROXETINE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THYROID TAB</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057962-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060417</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0602552A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057963-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060424</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0603011A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>28</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>8MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060410</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060410</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENICAR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRANDIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057964-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060424</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0603021A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>64</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050701</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRICOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ESTRADIOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVAPRO</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057965-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060425</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0603216A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>55</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL DISTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLATULENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STOMACH DISCOMFORT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VYTORIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COZAAR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADVAIR DISKUS 100/50</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057967-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060425</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0603259A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>57</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DYSPEPSIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>6MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060407</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>850MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060407</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VIVELLE-DOT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HUMALOG</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HUMULIN N</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOXYL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORTRIPTYLINE HCL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057968-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060425</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0603264A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>76</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>4MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060417</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060424</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057969-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060426</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0603382A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>MACULAR OEDEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NO CONCURRENT MEDICATION</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057970-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060426</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0603393A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>61</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THERAPEUTIC RESPONSE DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DETROL LA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIAZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057971-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060426</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0603395A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>72</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLIPIZIDE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057972-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060424</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0603417A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DIABETES MELLITUS INADEQUATE CONTROL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNSPECIFIED MEDICATION</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BLOOD PRESSURE MEDICATION</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CHOLESTEROL REDUCING AGENT</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057973-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060427</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0603530A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DIABETES MELLITUS INADEQUATE CONTROL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057974-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060427</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0603540A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD URIC ACID DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NO CONCURRENT MEDICATION</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057975-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060427</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0603544A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>47</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>URTICARIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057976-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060426</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0603599A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>GINGIVAL PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACTOS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOPHAGE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057977-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060428</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0603631A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>79</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>8MG UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLIPIZIDE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057978-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060428</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0603636A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>61</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>4MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031105</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TERAZOSIN HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INDAPAMIDE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057979-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060428</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0603643A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>41</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>8MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060412</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAXZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOPRESSOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NIFEDIPINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENALAPRIL MALEATE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057980-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060428</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0603650A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>62</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>4MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOVANCE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057981-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060501</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0603836A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>EYE INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>4MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057982-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060501</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0603843A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>JOINT SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>4MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLYBURIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIAVAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN MEDICATION</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057983-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060501</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0603850A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>4MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060322</drugstartdate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLIPIZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057984-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060427</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0603883A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD GLUCOSE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD GLUCOSE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVANDAMET</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD GLUCOSE</drugindication>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057985-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060502</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0604076A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>OEDEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>1TAB PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugtreatmentduration>18</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057986-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060501</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0604111A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EXERCISE TOLERANCE DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057987-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060503</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0604218A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>79</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>4MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057988-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060503</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0604220A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>74</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE FLUCTUATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STOMACH DISCOMFORT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>2MG FOUR TIMES PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051101</drugenddate>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
        <drugdosagetext>500MG THREE TIMES PER DAY</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051101</drugenddate>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057989-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060503</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0604232A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>75</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GLYCOSYLATED HAEMOGLOBIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugbatchnumb>UNAVAILABLE</drugbatchnumb>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>4MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLIPIZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVAPRO</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN E</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057990-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060503</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0604238A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>67</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>4MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
        <drugdosagetext>500MG TWICE PER DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BLOOD PRESSURE MEDICATION</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057991-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060428</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0604288A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057992-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060501</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0604308A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INTOLERANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRIC DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057993-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060504</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0604375A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>65</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057994-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060504</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0604399A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>.5TAB PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060301</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SATOLOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIGITEK</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOXYL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057995-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060504</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0604409A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HEPATIC ENZYME INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SULFONYLUREA</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057996-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060501</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0604420A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>SWELLING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>8MG UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057997-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060504</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0604496A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057998-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060502</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0604524A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>BLOOD GLUCOSE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>BLOOD GLUCOSE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5057999-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060508</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0604685A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CHEST DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THERAPEUTIC RESPONSE DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058000-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060508</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0604722A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugbatchnumb>5ZP7982</drugbatchnumb>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>4MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060503</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060506</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCORTISONE TAB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLOVENT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INTAL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAXAIR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOXYL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLONASE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IPRATROPIUM BROMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NASALCROM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASTELIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZANTAC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYOSCYAMINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANDROGEL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058001-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060509</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0604860A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>53</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>LOW DENSITY LIPOPROTEIN INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>4MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060206</drugstartdate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058002-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060509</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0604870A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>66</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MACULAR OEDEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>8MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLIMEPIRIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058003-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060509</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0604878A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>69</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST DISCOMFORT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>4MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030715</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050501</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058004-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060505</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0604930A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058005-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060509</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>37089</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>49</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>100</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>GLYCOSYLATED HAEMOGLOBIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>21071</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS NON-INSULIN-DEPENDENT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVANDAMET</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS NON-INSULIN-DEPENDENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060421</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058006-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060510</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0605083A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>STOMACH DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWELLING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>QUINAPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058007-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060510</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0605086A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>78</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL DISTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISION BLURRED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>2MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060301</drugstartdate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOTROL XL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOXYL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPROL-XL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM + D</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058008-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060510</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0605088A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058009-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060510</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0605092A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>86</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>86.8</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MACULAR OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL DISTURBANCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>8MG UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060428</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugdosagetext>40MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOTROL XL</medicinalproduct>
        <drugdosagetext>2.5MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MACRODANTIN</medicinalproduct>
        <drugdosagetext>50MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058010-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060507</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0605133A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>EYELID PTOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>8MG UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060430</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058011-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060510</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0605214A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DYSPEPSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058012-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060511</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0605245A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>68</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugbatchnumb>UNAVAILABLE</drugbatchnumb>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>4MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
        <drugbatchnumb>UNAVAILABLE</drugbatchnumb>
        <drugdosagetext>500MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOTREL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058013-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060512</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0605402A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>49</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>POLLAKIURIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>8MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVAPRO</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GEMFIBROZIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLIMEPIRIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLIBOMET</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058015-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060512</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0605423A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>2MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAZODONE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZYRTEC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMBIEN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058016-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060512</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0605428A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>4MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060412</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHROID</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058017-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060509</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0605511A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>59</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>THERAPEUTIC RESPONSE UNEXPECTED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060201</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058018-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060515</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0605612A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>36</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GLYCOSYLATED HAEMOGLOBIN INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>1MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060510</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN MEDICATION</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058019-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060515</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0605613A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>61</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>4MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMARYL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058020-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060515</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0605637A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>75</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060322</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060322</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VICODIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EXTRA STRENGTH TYLENOL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058021-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060516</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0605815A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>41</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>4MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060401</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>1000MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060401</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058022-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060516</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0605828A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>63</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMARYL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058023-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060613</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-451853</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>30</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTHYROIDISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THYROID CYST</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEGASYS</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060302</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060525</drugenddate>
        <drugtreatmentduration>85</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COPEGUS</medicinalproduct>
        <drugauthorizationnumb>021511</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060302</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060525</drugenddate>
        <drugtreatmentduration>85</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058024-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060517</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0606061A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>57</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>4MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLIPIZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLONASE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VIDOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FISH OIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTIVITAMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM GLUCONATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN B12 INJECTION</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMINS C + E</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CAPTOPRIL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058025-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060710</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CZ-ROCHE-454817</companynumb>
    <primarysource>
      <reportercountry>CZECH REPUBLIC</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>41</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CHEST DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GUILLAIN-BARRE SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISION BLURRED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEGASYS</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060512</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEGASYS</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060624</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058026-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060518</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0606204A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>48</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD POTASSIUM DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STOMACH DISCOMFORT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>2MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>500MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOTENSIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058027-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060531</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-450334</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>50</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>86.6</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLADDER CYST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD TRIGLYCERIDES INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL CYST</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEGASYS</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051014</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060401</drugenddate>
        <drugtreatmentduration>170</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COPEGUS</medicinalproduct>
        <drugauthorizationnumb>021511</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051014</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060401</drugenddate>
        <drugtreatmentduration>170</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058028-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060518</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0606229A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>66</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>4MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREVACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN MEDICATION</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACTONEL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORATADINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COD LIVER OIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENADRYL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASCORBIC ACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN B COMPLEX CAP</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058029-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060622</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-453085</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>59</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>88.5</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>APHTHOUS STOMATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STOMATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWOLLEN TONGUE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BONIVA</medicinalproduct>
        <drugauthorizationnumb>021455</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060303</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058030-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060519</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0606349A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>51</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA FACIAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWELLING FACE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL DISTURBANCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>4MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLIPIZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENADRYL</medicinalproduct>
        <drugdosagetext>50MGM UNKNOWN</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058031-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060626</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-ROCHE-453595</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>3</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>15</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CHOLELITHIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCREATITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ROCEPHIN</medicinalproduct>
        <drugauthorizationnumb>50585</drugauthorizationnumb>
        <drugdosagetext>FORM REPORTED AS INJECTABLE SOLUTION.</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060519</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060524</drugenddate>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MEDIALIPIDE</medicinalproduct>
        <drugdosagetext>FORM REPORTED AS INJECTABLE SOLUTION.</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PARENTERAL NUTRITION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060423</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRIMENE</medicinalproduct>
        <drugindication>PARENTERAL NUTRITION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNSPECIFIED DRUG</medicinalproduct>
        <drugdosagetext>DRUG REPORTED AS HPV (VITAMINE).</drugdosagetext>
        <drugindication>PARENTERAL NUTRITION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NONAN</medicinalproduct>
        <drugdosagetext>GENERIC REPORTED AS OLIGO-ELEMENTS.</drugdosagetext>
        <drugindication>PARENTERAL NUTRITION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAG 2</medicinalproduct>
        <drugindication>PARENTERAL NUTRITION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PHOCYTAN</medicinalproduct>
        <drugindication>PARENTERAL NUTRITION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM GLUCONATE</medicinalproduct>
        <drugindication>PARENTERAL NUTRITION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RANIPLEX</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060415</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060415</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058032-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060519</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0606352A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>63</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>4MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060515</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRINIVIL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058033-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060710</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-ROCHE-454723</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>84</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HYPOGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LOXEN LP</medicinalproduct>
        <drugauthorizationnumb>19488</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058034-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060522</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0606541A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>JOINT SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>4MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VASOTEC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONAZEPAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCODONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROTONIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARIMIDEX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058035-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060710</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-ROCHE-454642</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>36</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>44.4</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BRONCHITIS ACUTE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEG-INTERFERON ALFA 2A (RO 25-8310)</medicinalproduct>
        <drugdosagetext>DOSAGE FORM REPORTED AS VIALS.</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060329</drugenddate>
        <drugtreatmentduration>302</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROPRANOLOL</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19960615</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NIFEDIPINE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19960615</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMINE D</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19960615</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EPOGEN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19960615</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IRON</medicinalproduct>
        <drugadministrationroute>051</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19960615</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIPIRONE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050602</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYSTOPURIN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19960615</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058036-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060523</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0606684A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>78</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>8MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MOBIC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058037-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060621</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ROCHE-452573</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>81</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>AGRANULOCYTOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TORSEMIDE</medicinalproduct>
        <drugauthorizationnumb>20136</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060425</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060612</drugenddate>
        <drugtreatmentduration>49</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PANALDINE</medicinalproduct>
        <drugauthorizationnumb>019979</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>THROMBOSIS PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060425</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060612</drugenddate>
        <drugtreatmentduration>49</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALDACTONE</medicinalproduct>
        <drugauthorizationnumb>019979</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAKEPRON</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OESOPHAGITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060425</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060612</drugenddate>
        <drugtreatmentduration>49</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPOVAS</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERCHOLESTEROLAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060425</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060612</drugenddate>
        <drugtreatmentduration>49</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BLOPRESS</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060425</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060612</drugenddate>
        <drugtreatmentduration>49</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ACUTE MYOCARDIAL INFARCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060425</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058038-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060524</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0606757A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>21071</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FEOSOL IRON THERAPY CAPLETS</medicinalproduct>
        <drugbatchnumb>5G62</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VITAMIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058039-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060524</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0606785A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>65</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CANCER IN REMISSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THERAPEUTIC RESPONSE UNEXPECTED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>THYROID CANCER METASTATIC</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058040-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060519</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0606807A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HIGH DENSITY LIPOPROTEIN DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060101</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058041-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060524</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0606825A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>65</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FLUID RETENTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>4MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRANDIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPROL-XL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058042-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060516</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0606860A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>LABORATORY TEST ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INSULIN RESISTANCE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INSULIN RESISTANCE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058043-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060525</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0606946A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>69</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>8MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060516</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLIPIZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GABAPENTIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058044-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060517</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0607023A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTAMET</medicinalproduct>
        <drugdosagetext>1000U TWICE PER DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
        <drugdosagetext>22UD PER DAY</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058045-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060517</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0607025A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>TINNITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058046-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060522</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0607156A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SECRETION DISCHARGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN LACERATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058047-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060522</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0607169A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>LOCAL SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHOTOSENSITIVITY REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH MACULAR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058048-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060523</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0607298A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058049-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060524</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0607500A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>4MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNSPECIFIED MEDICATION</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058050-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060525</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0607664A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>2MG IN THE MORNING</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOPHAGE</medicinalproduct>
        <drugdosagetext>500MG TWICE PER DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOTROL</medicinalproduct>
        <drugdosagetext>10MG TWICE PER DAY</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058054-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060630</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IE-ROCHE-453860</companynumb>
    <primarysource>
      <reportercountry>IRELAND</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>49</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XENICAL</medicinalproduct>
        <drugauthorizationnumb>20766</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARVEDILOL</medicinalproduct>
        <drugauthorizationnumb>020766</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SC-66110</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BUMETANIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BURAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATORVASTATIN CALCIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EZETIMIBE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NICORANDIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALSARTAN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058055-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-453666</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>42</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BIPOLAR DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEGASYS</medicinalproduct>
        <drugdosagetext>ROUTE REPORTED AS INJECTABLE (INJ).</drugdosagetext>
        <drugadministrationroute>050</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060613</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060627</drugenddate>
        <drugtreatmentduration>15</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COPEGUS</medicinalproduct>
        <drugauthorizationnumb>021511</drugauthorizationnumb>
        <drugdosagetext>DOSAGE REGIMEN REPORTED AS 3 AM, 2 PM.</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060613</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060627</drugenddate>
        <drugtreatmentduration>15</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LAMICTAL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BIPOLAR DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KLONOPIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NERVOUSNESS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE/LISINOPRIL</medicinalproduct>
        <drugdosagetext>REPORTED AS HCTZ/LISINOPRIL.</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KLOR-CON</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058056-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-453666</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>42</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANOREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BIPOLAR DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD URINE PRESENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSSTASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IRRITABILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEGASYS</medicinalproduct>
        <drugdosagetext>ROUTE REPORTED AS INJECTABLE (INJ).</drugdosagetext>
        <drugadministrationroute>050</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060613</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060627</drugenddate>
        <drugtreatmentduration>15</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COPEGUS</medicinalproduct>
        <drugauthorizationnumb>021511</drugauthorizationnumb>
        <drugdosagetext>DOSAGE REGIMEN REPORTED AS 3 AM, 2 PM.</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060613</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060627</drugenddate>
        <drugtreatmentduration>15</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LAMICTAL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BIPOLAR DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KLONOPIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NERVOUSNESS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE/LISINOPRIL</medicinalproduct>
        <drugdosagetext>REPORTED AS HCTZ/LISINOPRIL.</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KLOR-CON</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058057-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060711</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006AC01288</companynumb>
    <primarysource>
      <reportercountry>NETHERLANDS</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>58</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ARTHROPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENTAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARIMIDEX</medicinalproduct>
        <drugauthorizationnumb>020541</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050615</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050929</drugenddate>
        <drugtreatmentduration>107</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058058-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060717</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006AC01319</companynumb>
    <primarysource>
      <reportercountry>SWITZERLAND</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>54</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HYPERKALAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUS ARREST</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
        <drugauthorizationnumb>018240</drugauthorizationnumb>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DILTIAZEM HCL</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IRBESARTAN</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058059-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060616</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006AP02781</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>887</patientonsetage>
      <patientonsetageunit>802</patientonsetageunit>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>CEREBRAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC FUNCTION ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOLADEX</medicinalproduct>
        <drugauthorizationnumb>20578</drugauthorizationnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PROSTATE CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040811</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060606</drugenddate>
        <drugtreatmentduration>665</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROSTAL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROSTATE CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021106</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060606</drugenddate>
        <drugtreatmentduration>1308</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLADEX</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021120</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040811</drugenddate>
        <drugtreatmentduration>631</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058060-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060713</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006AP03317</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>38</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOLADEX</medicinalproduct>
        <drugauthorizationnumb>019726</drugauthorizationnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>ENDOMETRIOSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060619</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IRON</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058061-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060317</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006CG00529</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>26581</patientonsetage>
      <patientonsetageunit>804</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CYTOLYTIC HEPATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESTLESSNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ROSUVASTATIN</medicinalproduct>
        <drugauthorizationnumb>21366</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ACUTE CORONARY SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060308</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060310</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ACUTE CORONARY SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060307</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060319</drugenddate>
        <drugtreatmentduration>13</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZESTRIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060308</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060314</drugenddate>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS AGAINST GASTROINTESTINAL ULCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060307</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RISORDAN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ACUTE CORONARY SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060307</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060308</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVENOX</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>ACUTE CORONARY SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060307</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060313</drugenddate>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>THROMBOSIS PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060308</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPOTHYROIDISM</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANXIETY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060308</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060309</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASILIX</medicinalproduct>
        <drugindication>CARDIAC FAILURE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060308</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060308</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASILIX</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060310</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060310</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TIAPRIDAL</medicinalproduct>
        <drugindication>RESTLESSNESS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060309</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060310</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EQUANIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RESTLESSNESS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060309</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060309</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATARAX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060309</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060309</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANEXATE TAB</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CONFUSIONAL STATE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060310</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060310</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SOLUDACTONE</medicinalproduct>
        <drugindication>CARDIAC FAILURE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060310</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060310</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VASTAREL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CORONARY ARTERY DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060311</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060312</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060312</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058062-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060712</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006CG01222</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>26</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>SUDDEN DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
        <drugauthorizationnumb>18240</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>VENTRICULAR TACHYCARDIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060706</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CORGARD</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>VENTRICULAR TACHYCARDIA</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060705</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058063-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060718</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006CG01246</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>71</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORTHOSTATIC HYPOTENSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ATACAND</medicinalproduct>
        <drugauthorizationnumb>20838</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IPERTEN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051017</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPANTHYL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051017</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PIASCLEDINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OGAST</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TEMESTA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CEMAFLAVONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DAFALGAN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058064-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060714</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006PK01544</companynumb>
    <primarysource>
      <reportercountry>AUSTRIA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>15952</patientonsetage>
      <patientonsetageunit>804</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HYSTEROSCOPY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OOPHORECTOMY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UTERINE DILATION AND CURETTAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NOLVADEX</medicinalproduct>
        <drugauthorizationnumb>17970</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOLEDRONAT</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058065-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060622</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-ROCHE-452964</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>71</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>85</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>THROMBOPHLEBITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KEVATRIL</medicinalproduct>
        <drugauthorizationnumb>20239</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051219</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051219</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUOROURACIL</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051219</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051219</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYCLOPHOSPHAMIDE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051219</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051219</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EPIRUBICIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051219</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051219</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058066-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060711</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006SE03878</companynumb>
    <primarysource>
      <reportercountry>ITALY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>22094</patientonsetage>
      <patientonsetageunit>804</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMODIALYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERKALAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METABOLIC ACIDOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CANDESARTAN CILEXETIL</medicinalproduct>
        <drugbatchnumb>8862</drugbatchnumb>
        <drugauthorizationnumb>20838</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTROPHIC CARDIOMYOPATHY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060504</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060620</drugenddate>
        <drugtreatmentduration>48</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENAPREN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONGESTIVE CARDIOMYOPATHY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KANRENOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONGESTIVE CARDIOMYOPATHY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ORAL ANTICOAGULANT DRUGS</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ORAL HYPOGLYCEMIC DRUGS</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058067-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060314</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006UW05055</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>31</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GESTATIONAL DIABETES</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugauthorizationnumb>20639</drugauthorizationnumb>
        <drugdosagetext>100-900 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INSOMNIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060131</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugauthorizationnumb>020639</drugauthorizationnumb>
        <drugdosagetext>100-900 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>AFFECTIVE DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060131</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugauthorizationnumb>020639</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050506</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugauthorizationnumb>020639</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050506</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058068-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060503</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006UW08806</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>23</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>COMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE DRUG OVERDOSE INTENTIONAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDE ATTEMPT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugauthorizationnumb>20639</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HALLUCINATION, AUDITORY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060212</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060212</drugenddate>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugauthorizationnumb>020639</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050117</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060212</drugenddate>
        <drugtreatmentduration>392</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALCOHOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EFFEXOR XR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADDERALL 10</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATTENTION DEFICIT/HYPERACTIVITY DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058069-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060717</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006UW14630</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugauthorizationnumb>020639</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058070-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060711</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006UW14368</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>17236</patientonsetage>
      <patientonsetageunit>804</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASPARTATE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD POTASSIUM DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DELIRIUM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEMENTIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIABETES MELLITUS NON-INSULIN-DEPENDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIABETIC HYPEROSMOLAR COMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIALYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ELECTROLYTE IMBALANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ENCEPHALOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERLIPIDAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOMAGNESAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ISCHAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METABOLIC ACIDOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL ISCHAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUROLEPTIC MALIGNANT SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCREATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCREATITIS ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCREATITIS NECROTISING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PELVIC FLUID COLLECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERITONEAL EFFUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLEURAL EFFUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL TUBULAR NECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WRONG TECHNIQUE IN DRUG USAGE PROCESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugauthorizationnumb>20639</drugauthorizationnumb>
        <drugdosagetext>25-50 MG HS + 25 MG BID PRN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>AFFECTIVE DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041206</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugauthorizationnumb>020639</drugauthorizationnumb>
        <drugdosagetext>25-50 MG HS + 25 MG BID PRN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BIPOLAR DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041206</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SERTRALINE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19991025</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SERTRALINE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020829</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORAZEPAM</medicinalproduct>
        <drugdosagetext>Q4 HRS PRN</drugdosagetext>
        <drugindication>ANXIETY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19991025</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORAZEPAM</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020829</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAZODONE HCL</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19991025</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAZODONE HCL</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020829</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCODONE</medicinalproduct>
        <drugindication>BACK PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZETIA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FEXOFENADINE HCL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE ALLERGIES</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD PRESSURE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PAROXETIENE HCL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>AFFECTIVE DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRAVASTATIN SODIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RANITIDINE HCL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTRIC DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058071-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060711</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-ROCHE-455216</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>16</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NO ADVERSE EFFECT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PREGNANCY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ROACUTAN</medicinalproduct>
        <drugauthorizationnumb>18662</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ACNE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060420</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058072-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060712</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>TH-ROCHE-454992</companynumb>
    <primarysource>
      <reportercountry>THAILAND</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>34</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY DISTRESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ROCEPHIN</medicinalproduct>
        <drugauthorizationnumb>050585</drugauthorizationnumb>
        <drugdosagetext>INTRAVENOUS PUSH.</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PHARYNGITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060705</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060705</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AUGMENTIN '125'</medicinalproduct>
        <drugdosagetext>THE PATIENT RECEIVED THREE SHOTS.</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PHARYNGITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060702</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060704</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058073-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060712</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-455389</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>47</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>GASTROOESOPHAGEAL REFLUX DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLUENZA LIKE ILLNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEGASYS</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050815</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060315</drugenddate>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RIBAVIRIN</medicinalproduct>
        <drugauthorizationnumb>021511</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050815</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051015</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RIBAVIRIN</medicinalproduct>
        <drugauthorizationnumb>021511</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051015</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060315</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058074-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060712</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-455450</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD IRON INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SERUM FERRITIN INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEGASYS</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RIBAVIRIN</medicinalproduct>
        <drugauthorizationnumb>021511</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058075-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060710</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-455002</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>67</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SHOULDER OPERATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BONIVA</medicinalproduct>
        <drugauthorizationnumb>021455</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051215</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060615</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058076-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060712</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-455415</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>46</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHILLS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRIC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEGASYS</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060415</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RIBAVIRIN</medicinalproduct>
        <drugauthorizationnumb>021511</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060415</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058077-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060712</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006GB01203</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>SUPRAVENTRICULAR TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CASODEX</medicinalproduct>
        <drugauthorizationnumb>020498</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058078-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060622</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-ROCHE-452964</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>71</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>85</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>THROMBOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KEVATRIL</medicinalproduct>
        <drugauthorizationnumb>21238</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051219</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051219</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUOROURACIL</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051219</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051219</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYCLOPHOSPHAMIDE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051219</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051219</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EPIRUBICIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051219</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051219</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058079-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060713</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006UW14416</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>51</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>113.6</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG SCREEN POSITIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugauthorizationnumb>020639</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050913</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058080-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060710</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-455218</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>CAESAREAN SECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTRA-UTERINE DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PREMATURE BABY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TWIN PREGNANCY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>018662</drugauthorizationnumb>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19870615</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19870915</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058081-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060710</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-454978</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>RETINAL VEIN OCCLUSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VALCYTE</medicinalproduct>
        <drugauthorizationnumb>021304</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTIPLE UNSPECIFIED MEDICATIONS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058082-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060712</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-455333</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>COLITIS ULCERATIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLAMMATORY BOWEL DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IRRITABLE BOWEL SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>018662</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19930615</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19930615</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058083-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060608</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-AMGEN-UK182358</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</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>MIMPARA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050302</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KAYEXALATE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DAFALGAN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19991210</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZANTAC</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020621</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060206</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACEBUTOLOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19991201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TARDYFERON</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PYOSTACINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050124</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALFACALCIDOL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050411</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM CARBONATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050411</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>APROVEL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FENOFIBRATE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLYCERYL TRINITRATE</medicinalproduct>
        <drugadministrationroute>062</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058084-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060710</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-ROCHE-454947</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>5</patientonsetage>
      <patientonsetageunit>803</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>APNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE VIA BREAST MILK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROOESOPHAGEAL REFLUX DISEASE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RIVOTRIL</medicinalproduct>
        <drugauthorizationnumb>17533</drugauthorizationnumb>
        <drugadministrationroute>063</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058085-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060713</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-455317</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>76</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>45</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PELVIC VENOUS THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SMALL INTESTINAL OBSTRUCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CAPECITABINE</medicinalproduct>
        <drugauthorizationnumb>20896</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>NEOPLASM MALIGNANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060621</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVENOX</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060301</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058086-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060711</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>HR-ROCHE-454960</companynumb>
    <primarysource>
      <reportercountry>CROATIA (local name: Hrvatska)</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>73</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ELECTROCARDIOGRAM CHANGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TROPONIN INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XELODA</medicinalproduct>
        <drugauthorizationnumb>020896</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RECTOSIGMOID CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060604</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058087-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060713</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-455252</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>56</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>76.2</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CAPECITABINE</medicinalproduct>
        <drugbatchnumb>71905</drugbatchnumb>
        <drugauthorizationnumb>20896</drugauthorizationnumb>
        <drugdosagetext>FOR 14 DAYS</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060614</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060621</drugenddate>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HERCEPTIN</medicinalproduct>
        <drugbatchnumb>M72798</drugbatchnumb>
        <drugauthorizationnumb>020896</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060613</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOCETAXEL</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060614</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060621</drugenddate>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060613</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060613</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANZEMET</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060614</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DECADRON</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060614</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENADRYL</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060614</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060614</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PERCOCET</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060613</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KEFLEX</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060613</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060623</drugenddate>
        <drugtreatmentduration>11</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060613</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVACOR</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060613</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058088-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060712</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-ROCHE-454891</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>1</patientonsetage>
      <patientonsetageunit>805</patientonsetageunit>
      <reaction>
        <reactionmeddrapt>ANAEMIA NEONATAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CAESAREAN SECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEONATAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALLOR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY DISTRESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VALIUM</medicinalproduct>
        <drugauthorizationnumb>013263</drugauthorizationnumb>
        <drugdosagetext>DISCONTINUED</drugdosagetext>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058089-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20021211</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0389469A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABNORMAL DREAMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>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>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL DISORDER</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 SPASMS</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>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL DISTURBANCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
        <drugauthorizationnumb>20031</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACYCLOVIR</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058090-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040311</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0502390A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>37</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAXIL CR</medicinalproduct>
        <drugauthorizationnumb>20936</drugauthorizationnumb>
        <drugdosagetext>37.5MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058091-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050509</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0558624A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>21</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>AGORAPHOBIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CRYING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG WITHDRAWAL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FRUSTRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HALLUCINATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOTION SICKNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE TWITCHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NERVOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
        <drugauthorizationnumb>20031</drugauthorizationnumb>
        <drugdosagetext>30MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANXIETY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020326</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040601</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAXIL CR</medicinalproduct>
        <drugauthorizationnumb>020936</drugauthorizationnumb>
        <drugdosagetext>25MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANXIETY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020819</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATIVAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WELLBUTRIN SR</medicinalproduct>
        <drugdosagetext>150MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030129</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058092-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050516</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0559050A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG WITHDRAWAL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCORRECT DOSE ADMINISTERED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDE ATTEMPT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
        <drugauthorizationnumb>20031</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMBIEN</medicinalproduct>
        <drugdosagetext>17TAB SINGLE DOSE</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>INSOMNIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACIPHEX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROVERA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VERAPAMIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COMPAZINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FIORICET</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KLONOPIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010201</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058093-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050714</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0566547A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</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>BLOOD PRESSURE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG WITHDRAWAL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING OF DESPAIR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELINGS OF WORTHLESSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OBSESSIVE THOUGHTS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANIC ATTACK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
        <drugauthorizationnumb>20031</drugauthorizationnumb>
        <drugdosagetext>20MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SOCIAL PHOBIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAXIL CR</medicinalproduct>
        <drugauthorizationnumb>020936</drugauthorizationnumb>
        <drugdosagetext>37.5MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OBSESSIVE-COMPULSIVE DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATIVAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RESTORIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugdosagetext>50MG AT NIGHT</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058094-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesscongenitalanomali>1</seriousnesscongenitalanomali>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0591786A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>16</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CHLAMYDIAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MATERNAL CONDITION AFFECTING FOETUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRICHOMONIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ULTRASOUND SCAN ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENTRICULAR SEPTAL DEFECT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMBIVIR</medicinalproduct>
        <drugauthorizationnumb>20857</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051209</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060419</drugenddate>
        <drugtreatmentduration>132</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NELFINAVIR</medicinalproduct>
        <drugdosagetext>1250MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051209</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060419</drugenddate>
        <drugtreatmentduration>132</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VIRACEPT</medicinalproduct>
        <drugdosagetext>2500MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051209</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZIDOVUDINE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060419</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060419</drugenddate>
        <drugtreatmentduration>12</drugtreatmentduration>
        <drugtreatmentdurationunit>805</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRENATAL VITAMINS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IRON</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058095-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesscongenitalanomali>1</seriousnesscongenitalanomali>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060718</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0591786B</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>1.9</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DEAFNESS UNILATERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENTRICULAR SEPTAL DEFECT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMBIVIR</medicinalproduct>
        <drugauthorizationnumb>020857</drugauthorizationnumb>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051209</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060419</drugenddate>
        <drugtreatmentduration>132</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NELFINAVIR</medicinalproduct>
        <drugdosagetext>1250MG TWICE PER DAY</drugdosagetext>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051209</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060419</drugenddate>
        <drugtreatmentduration>132</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VIRACEPT</medicinalproduct>
        <drugdosagetext>2500MG PER DAY</drugdosagetext>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051209</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZIDOVUDINE</medicinalproduct>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060419</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060419</drugenddate>
        <drugtreatmentduration>12</drugtreatmentduration>
        <drugtreatmentdurationunit>805</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRENATAL VITAMINS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IRON</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058096-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060313</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>20060303419</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>44</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>AGITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISORIENTATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING JITTERY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMPAIRED DRIVING ABILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THINKING ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>WELLBUTRIN SR</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>20358</drugauthorizationnumb>
        <drugdosagetext>150MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SMOKING CESSATION THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060225</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060307</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SIMPLY SLEEP</medicinalproduct>
        <drugdosagetext>50MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SLEEP DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060301</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOXYL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058097-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060609</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-GLAXOSMITHKLINE-A0608528A</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>80</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>63.5</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE CONGESTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DECREASED APPETITE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA EXERTIONAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUID OVERLOAD</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOBAR PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLEURAL EFFUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE CHRONIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UPPER GASTROINTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>21071</drugauthorizationnumb>
        <drugdosagetext>4MG PER DAY</drugdosagetext>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060606</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugdosagetext>20MG PER DAY</drugdosagetext>
        <drugindication>CARDIAC FAILURE CONGESTIVE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADALAT</medicinalproduct>
        <drugdosagetext>60MG PER DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FERROUS GLUCONATE</medicinalproduct>
        <drugdosagetext>900MG PER DAY</drugdosagetext>
        <drugindication>ANAEMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PARIET</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058098-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060612</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0608718A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>26</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABORTION INDUCED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EPIVIR</medicinalproduct>
        <drugauthorizationnumb>20564</drugauthorizationnumb>
        <drugdosagetext>300MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060222</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIREAD</medicinalproduct>
        <drugdosagetext>300MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060222</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REYATAZ</medicinalproduct>
        <drugdosagetext>400MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060222</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058099-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060627</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0610489A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>88</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>56.8</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DECREASED APPETITE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SLEEP DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDE ATTEMPT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REQUIP</medicinalproduct>
        <drugauthorizationnumb>20658</drugauthorizationnumb>
        <drugdosagetext>.5MG AT NIGHT</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RESTLESS LEGS SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060401</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DURAGESIC-100</medicinalproduct>
        <drugdosagetext>50MCG UNKNOWN</drugdosagetext>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SLEEPING PILLS</medicinalproduct>
        <drugdosagetext>8TAB SINGLE DOSE</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058100-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060713</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PE-GLAXOSMITHKLINE-A0612358A</companynumb>
    <primarysource>
      <reportercountry>PERU</reportercountry>
      <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>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH GENERALISED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URTICARIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
        <drugbatchnumb>0501000206</drugbatchnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060707</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060707</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PENTA VACCINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058101-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060717</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0612644A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>36</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANGIONEUROTIC OEDEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REQUIP</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020658</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RESTLESS LEGS SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060101</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MORPHINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058102-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060718</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0612659A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>35</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PETIT MAL EPILEPSY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STARING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>WELLBUTRIN XL</medicinalproduct>
        <drugauthorizationnumb>021515</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058103-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060718</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0612665A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>79</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>UPPER RESPIRATORY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URTICARIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VALTREX</medicinalproduct>
        <drugauthorizationnumb>020487</drugauthorizationnumb>
        <drugdosagetext>2G TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HERPES SIMPLEX</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060629</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLEGRA</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058104-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060717</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2005145284</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>49</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>71</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BODY TEMPERATURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>C-REACTIVE PROTEIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT AND COLD</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROAT TIGHTNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EPOPROSTENOL</medicinalproduct>
        <drugauthorizationnumb>20444</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PULMONARY HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050321</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SILDENAFIL CITRATE</medicinalproduct>
        <drugdosagetext>20MG THREE TIMES PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050623</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRONOLACTONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCICHEW</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BUMETANIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLEXANE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEBEVERINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYGEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058105-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060719</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0612800A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>75</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BALANCE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG WITHDRAWAL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULAR WEAKNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
        <drugauthorizationnumb>020031</drugauthorizationnumb>
        <drugdosagetext>10MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PANIC DISORDER</drugindication>
        <drugtreatmentduration>10</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATIVAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058106-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060719</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0612804A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>SUICIDE ATTEMPT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REQUIP</medicinalproduct>
        <drugauthorizationnumb>020658</drugauthorizationnumb>
        <drugdosagetext>1MG UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RESTLESS LEGS SYNDROME</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058107-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060719</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0612808A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>48</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEVICE INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEDICAL DEVICE COMPLICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMITREX</medicinalproduct>
        <drugauthorizationnumb>020080</drugauthorizationnumb>
        <drugdosagetext>1MG AS REQUIRED</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>MIGRAINE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058108-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060719</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0612824A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REQUIP</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020658</drugauthorizationnumb>
        <drugdosagetext>1MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RESTLESS LEGS SYNDROME</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058109-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060717</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>MX-GLAXOSMITHKLINE-A0612890A</companynumb>
    <primarysource>
      <reportercountry>MEXICO</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENE MUTATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATITIS B VIRUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VIRAL LOAD INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMIVUDINE</medicinalproduct>
        <drugauthorizationnumb>020564</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPSERA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058110-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060720</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0613017A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>37</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABORTION SPONTANEOUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BUPROPION HCL</medicinalproduct>
        <drugauthorizationnumb>018644</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>MAJOR DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALTREX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRENATAL VITAMINS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058111-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050419</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-GLAXOSMITHKLINE-B0378531A</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>8</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>23</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEBRILE NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATOCHEZIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUCOUS MEMBRANE DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALKERAN</medicinalproduct>
        <drugauthorizationnumb>20207</drugauthorizationnumb>
        <drugdosagetext>70MGM2 PER DAY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ALLOGENIC BONE MARROW TRANSPLANTATION THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040823</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040824</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUDARABINE PHOSPHATE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ALLOGENIC BONE MARROW TRANSPLANTATION THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040820</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040824</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEUTROGIN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040913</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEU-UP</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040914</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040915</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TACROLIMUS HYDRATE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>IMMUNOSUPPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040825</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>IMMUNOSUPPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040827</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040829</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040831</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>IMMUNOSUPPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041115</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BAKTAR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040914</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POLYMYXIN B SULFATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040820</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040902</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIFLUCAN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>FUNGAL INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040820</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040830</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOVIRAX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HERPES VIRUS INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040819</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041008</drugenddate>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOVIRAX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041016</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>URSO</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>VENOOCCLUSIVE LIVER DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040820</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040902</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MORPHINE</medicinalproduct>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040907</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040921</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PENTAZOCINE LACTATE</medicinalproduct>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040829</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040902</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATARAX</medicinalproduct>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040827</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041008</drugenddate>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BROACT</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>FEBRILE NEUTROPENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040831</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040906</drugenddate>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BROACT</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040930</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041008</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BROACT</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041108</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041115</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMPICILLIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040831</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040913</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MINOCYCLINE HCL</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>FEBRILE NEUTROPENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040903</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040913</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEROPEN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>FEBRILE NEUTROPENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040906</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040913</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADENOSINE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040928</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041013</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADENOSINE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041124</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041207</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOVIRAX</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041009</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041015</drugenddate>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CHLOR-TRIMETON</medicinalproduct>
        <drugindication>HYPERSENSITIVITY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040825</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041122</drugenddate>
        <drugtreatmentduration>13</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SOLU-MEDROL</medicinalproduct>
        <drugindication>HYPERSENSITIVITY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040829</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040916</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ROPION</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ANTIPYRESIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040912</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KYTRIL</medicinalproduct>
        <drugindication>VOMITING</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040820</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040831</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VENOGLOBULIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>SECONDARY IMMUNODEFICIENCY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040825</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041009</drugenddate>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEPETAN</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040902</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040906</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CONTOMIN</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>INSOMNIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040922</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041008</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058112-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050928</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2005-0008678</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>34</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DECREASED APPETITE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING COLD</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATITIS VIRAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HOT FLUSH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LETHARGY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NIGHT SWEATS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMBIVIR</medicinalproduct>
        <drugauthorizationnumb>20857</drugauthorizationnumb>
        <drugdosagetext>2U PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EFAVIRENZ</medicinalproduct>
        <drugdosagetext>600MG PER DAY</drugdosagetext>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020201</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058113-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesscongenitalanomali>1</seriousnesscongenitalanomali>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060323</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DK-GLAXOSMITHKLINE-B0417434A</companynumb>
    <primarysource>
      <reportercountry>DENMARK</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENTRICULAR SEPTAL DEFECT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMICTAL</medicinalproduct>
        <drugauthorizationnumb>20241</drugauthorizationnumb>
        <drugdosagetext>400MG PER DAY</drugdosagetext>
        <drugindication>EPILEPSY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058114-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060418</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-GLAXOSMITHKLINE-B0420717A</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>11</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ASTHMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CIRCULATORY COLLAPSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY OEDEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEREVENT</medicinalproduct>
        <drugbatchnumb>E1071</drugbatchnumb>
        <drugauthorizationnumb>20236</drugauthorizationnumb>
        <drugdosagetext>25MCG UNKNOWN</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050517</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050518</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN MEDICATION</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VENTOLIN</medicinalproduct>
        <drugdosagetext>2PUFF AS REQUIRED</drugdosagetext>
        <drugindication>WHEEZING</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050507</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050517</drugenddate>
        <drugtreatmentduration>11</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058115-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060511</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-2006-009367</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>66</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>112</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>NEUTROPENIC SEPSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STEVENS-JOHNSON SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CEFTAZIDIME</medicinalproduct>
        <drugauthorizationnumb>50634</drugauthorizationnumb>
        <drugdosagetext>1G THREE TIMES PER DAY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NEUTROPENIC SEPSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060310</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZEVALIN</medicinalproduct>
        <drugdosagetext>1U UNKNOWN</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NON-HODGKIN'S LYMPHOMA STAGE IV</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060209</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060209</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YTTRIUM</medicinalproduct>
        <drugdosagetext>1U UNKNOWN</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NON-HODGKIN'S LYMPHOMA STAGE IV</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060209</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060209</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RITUXIMAB</medicinalproduct>
        <drugdosagetext>1U UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>NON-HODGKIN'S LYMPHOMA STAGE IV</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060209</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060209</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MEROPENEM</medicinalproduct>
        <drugdosagetext>1G THREE TIMES PER DAY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NEUTROPENIC SEPSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060305</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CIPROFLOXACIN</medicinalproduct>
        <drugdosagetext>500MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NEUTROPENIC SEPSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060317</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058116-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060525</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IN-GLAXOSMITHKLINE-B0425449A</companynumb>
    <primarysource>
      <reportercountry>INDIA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>60</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA ASPIRATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TIMENTIN</medicinalproduct>
        <drugauthorizationnumb>50590</drugauthorizationnumb>
        <drugdosagetext>3.1G THREE TIMES PER DAY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060515</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060520</drugenddate>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMIKACIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METROGYL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMPICILLIN SODIUM/SULBACTAM SODIUM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PNEUMONIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOFLOXACIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PNEUMONIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058117-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060607</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-GLAXOSMITHKLINE-B0426665A</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>68</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>COLOUR BLINDNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REQUIP</medicinalproduct>
        <drugauthorizationnumb>20658</drugauthorizationnumb>
        <drugdosagetext>4MG THREE TIMES PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PARKINSON'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060201</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058118-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060615</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-JPN-A200602080</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>91</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>35</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DYSARTHRIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HALLUCINATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOXIC INDUCED ENCEPHALOPATHY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VALTREX</medicinalproduct>
        <drugauthorizationnumb>20487</drugauthorizationnumb>
        <drugdosagetext>500MG SEE DOSAGE TEXT</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HERPES ZOSTER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060612</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060620</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THYRADIN S</medicinalproduct>
        <drugdosagetext>25MCG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>THYROID MASS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRONON</medicinalproduct>
        <drugdosagetext>150MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALTAN</medicinalproduct>
        <drugdosagetext>1.8G PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058119-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-GLAXOSMITHKLINE-B0429132A</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>43</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD ALKALINE PHOSPHATASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAMMA-GLUTAMYLTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATITIS CHOLESTATIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATITIS TOXIC</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AUGMENTIN '125'</medicinalproduct>
        <drugauthorizationnumb>50564</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>FEBRILE INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060507</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060515</drugenddate>
        <drugtreatmentduration>9</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLINOMEL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060502</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060515</drugenddate>
        <drugtreatmentduration>14</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYMEVAN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060504</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060509</drugenddate>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOSPHENYTOIN SODIUM</medicinalproduct>
        <drugdosagetext>3UNIT PER DAY</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>CONVULSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060430</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060501</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
        <drugdosagetext>1G THREE TIMES PER DAY</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>BACTERIAL INFECTION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060504</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KEPPRA</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>EPILEPSY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CORTICOIDS</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>EPILEPSY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BACTRIM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060401</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058120-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-GLAXOSMITHKLINE-B0429234A</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>75</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>78</patientweight>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>AGITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ALANINE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASPARTATE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BILIARY TRACT DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD BILIRUBIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PHOSPHORUS INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHOLESTASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COAGULATION FACTOR DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSED LEVEL OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUID OVERLOAD</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GALLBLADDER ENLARGEMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAMMA-GLUTAMYLTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC ENCEPHALOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATITIS ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATOCELLULAR DAMAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATORENAL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JAUNDICE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUROLOGICAL SYMPTOM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OLIGURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AUGMENTIN '125'</medicinalproduct>
        <drugauthorizationnumb>50564</drugauthorizationnumb>
        <drugdosagetext>2G PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CYSTITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060525</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MOTILIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SPASFON</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FURADANTIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CETIRIZINE HCL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACECLOFENAC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PIRACETAM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D3</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPLEXIL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOFENOPRIL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058121-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060627</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-JPN-A200602312</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>94</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>43</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANOREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DECREASED APPETITE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEMENTIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EATING DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL INTAKE REDUCED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UNRESPONSIVE TO STIMULI</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY RETENTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VALTREX</medicinalproduct>
        <drugauthorizationnumb>20487</drugauthorizationnumb>
        <drugdosagetext>2TAB THREE TIMES PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HERPES ZOSTER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060624</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060626</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MUCOSTA</medicinalproduct>
        <drugdosagetext>300MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060624</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060626</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOXOPROFEN</medicinalproduct>
        <drugdosagetext>182MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NEURALGIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VIDARABINE</medicinalproduct>
        <drugadministrationroute>061</drugadministrationroute>
        <drugindication>HERPES ZOSTER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060624</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060626</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIGOSIN</medicinalproduct>
        <drugdosagetext>.063MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CARDIAC FAILURE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19981125</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TORSEMIDE</medicinalproduct>
        <drugdosagetext>4MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CARDIAC FAILURE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060518</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN DRUG</medicinalproduct>
        <drugdosagetext>400MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CARDIAC FAILURE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060518</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SENNOSIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONSTIPATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROCYLIN</medicinalproduct>
        <drugdosagetext>40MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060315</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SUCRALFATE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060624</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058122-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesscongenitalanomali>1</seriousnesscongenitalanomali>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060630</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-JPN-A200602391</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>37</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>68</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANIC ATTACK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STILLBIRTH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
        <drugauthorizationnumb>20031</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PANIC DISORDER</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060404</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RIZE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PANIC DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060410</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SEPAZON</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PANIC DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051125</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HANGE-KOBOKU-TO</medicinalproduct>
        <drugdosagetext>7.5G PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PANIC DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060206</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060401</drugenddate>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058123-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-JPN-A200602412</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>40</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ACUTE ABDOMEN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIPASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCREATIC ENZYMES INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCREATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPLENOMEGALY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EPIVIR</medicinalproduct>
        <drugauthorizationnumb>20564</drugauthorizationnumb>
        <drugdosagetext>150MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040628</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZERIT</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050427</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REYATAZ</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040628</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RETROVIR</medicinalproduct>
        <drugauthorizationnumb>019655</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050428</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVIR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050822</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058124-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060703</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ES-GLAXOSMITHKLINE-B0430238A</companynumb>
    <primarysource>
      <reportercountry>SPAIN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>78</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>AMAUROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLINDNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AUGMENTIN '125'</medicinalproduct>
        <drugauthorizationnumb>50564</drugauthorizationnumb>
        <drugdosagetext>1000MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060702</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058125-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060712</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-GLAXOSMITHKLINE-B0430773A</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REQUIP</medicinalproduct>
        <drugauthorizationnumb>020658</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RESTLESS LEGS SYNDROME</drugindication>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058126-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060712</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-GLAXOSMITHKLINE-B0430778A</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABNORMAL DREAMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HALLUCINATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMBIVIR</medicinalproduct>
        <drugauthorizationnumb>20857</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058127-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060710</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-JPN-A200602565</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>67</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SNORING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VALTREX</medicinalproduct>
        <drugauthorizationnumb>020487</drugauthorizationnumb>
        <drugdosagetext>1000MG THREE TIMES PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HERPES ZOSTER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060629</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060629</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOCLOPRAMIDE</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060629</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058128-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060713</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-GLAXOSMITHKLINE-B0431023A</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>44</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>EPIGASTRIC DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC FUNCTION ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EPIVIR</medicinalproduct>
        <drugauthorizationnumb>020564</drugauthorizationnumb>
        <drugdosagetext>300MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060115</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZIAGEN</medicinalproduct>
        <drugauthorizationnumb>020977</drugauthorizationnumb>
        <drugdosagetext>300MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060115</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>STOCRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060115</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZITHROMAC</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051219</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BAKTAR</medicinalproduct>
        <drugdosagetext>4 PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051217</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058129-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060717</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-GLAXOSMITHKLINE-B0431219A</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>47</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DERMATITIS BULLOUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPHADENOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PETECHIAE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURIGO</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PURPURA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH GENERALISED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH MACULO-PAPULAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN LESION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLAMOXYL</medicinalproduct>
        <drugauthorizationnumb>50542</drugauthorizationnumb>
        <drugdosagetext>1G FOUR TIMES PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INFECTED INSECT BITE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030806</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030812</drugenddate>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MUPIDERM</medicinalproduct>
        <drugadministrationroute>061</drugadministrationroute>
        <drugindication>INFECTED INSECT BITE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058130-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060714</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>NL-GLAXOSMITHKLINE-B0431298A</companynumb>
    <primarysource>
      <reportercountry>NETHERLANDS</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>36</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOPTYSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUTICASONE PROPIONATE + SALMETEROL XINAFOATE</medicinalproduct>
        <drugauthorizationnumb>21077</drugauthorizationnumb>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALBUTEROL SPIROS</medicinalproduct>
        <drugauthorizationnumb>018473</drugauthorizationnumb>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058131-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060713</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>J200602315</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>56</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOXIC SKIN ERUPTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SAWACILLIN</medicinalproduct>
        <drugauthorizationnumb>50542</drugauthorizationnumb>
        <drugdosagetext>750MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTRIC ULCER HELICOBACTER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050713</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050719</drugenddate>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLARITHROMYCIN</medicinalproduct>
        <drugdosagetext>400MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTRIC ULCER HELICOBACTER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050713</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050719</drugenddate>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugdosagetext>20MG FOUR TIMES PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTRIC ULCER HELICOBACTER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050613</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050722</drugenddate>
        <drugtreatmentduration>40</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MIYA BM</medicinalproduct>
        <drugdosagetext>1G TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTRIC ULCER HELICOBACTER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050713</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050719</drugenddate>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLOSTRIDIUM BUTYRICUM</medicinalproduct>
        <drugdosagetext>1G TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTRIC ULCER HELICOBACTER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050713</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050719</drugenddate>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058132-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060713</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ES-GLAXOSMITHKLINE-B0431325A</companynumb>
    <primarysource>
      <reportercountry>SPAIN</reportercountry>
      <qualification>2</qualification>
    </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>AUGMENTIN '125'</medicinalproduct>
        <drugauthorizationnumb>050564</drugauthorizationnumb>
        <drugindication>BARTHOLINITIS</drugindication>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058133-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060713</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-GLAXOSMITHKLINE-B0431331A</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>74</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HENOCH-SCHONLEIN PURPURA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDAMET</medicinalproduct>
        <drugauthorizationnumb>021410</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COTAREG</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYPERIUM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIAMICRON</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058134-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060713</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CH-GLAXOSMITHKLINE-B0431370A</companynumb>
    <primarysource>
      <reportercountry>SWITZERLAND</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>81</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRY MOUTH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERAL PHYSICAL HEALTH DETERIORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPONATRAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEROXAT</medicinalproduct>
        <drugauthorizationnumb>20031</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>AFFECTIVE DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DARIFENACIN</medicinalproduct>
        <drugdosagetext>7.5ML PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>URINARY INCONTINENCE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060601</drugstartdate>
        <drugtreatmentduration>27</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ISOPTIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CIPROFLOXACIN HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>URINARY TRACT INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060626</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060627</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVELOX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>URINARY TRACT INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060626</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060627</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058135-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060718</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-JPN-A200602673</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>75</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSED LEVEL OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPONATRAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
        <drugauthorizationnumb>020031</drugauthorizationnumb>
        <drugdosagetext>20MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060301</drugstartdate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058136-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060718</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-GLAXOSMITHKLINE-B0431548A</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>AGGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANGER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SCREAMING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLIXOTIDE</medicinalproduct>
        <drugauthorizationnumb>20121</drugauthorizationnumb>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058137-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060718</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-JPN-A200602703</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANOREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSED LEVEL OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VALTREX</medicinalproduct>
        <drugauthorizationnumb>020487</drugauthorizationnumb>
        <drugdosagetext>1000MG THREE TIMES PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HERPES ZOSTER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058138-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060717</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>454231</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>81</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLISTER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DERMATITIS BULLOUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARVEDILOL</medicinalproduct>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>12.5MCG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CARDIAC FAILURE CONGESTIVE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050511</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050512</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIGOXIN</medicinalproduct>
        <drugauthorizationnumb>020405</drugauthorizationnumb>
        <drugdosagetext>6.25MCG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CARDIAC FAILURE CONGESTIVE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050512</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATORVASTATIN CALCIUM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETYLCYSTEINE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058139-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060713</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-GLAXOSMITHKLINE-B0431687A</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>79</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>62</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MUSCLE HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARALYSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARIXTRA</medicinalproduct>
        <drugauthorizationnumb>021345</drugauthorizationnumb>
        <drugdosagetext>7.5MG PER DAY</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>THROMBOPHLEBITIS SUPERFICIAL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060623</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>75MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VASTEN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KALEORID</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ESBERIVEN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MOLSIDOMINE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058140-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060719</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-GLAXOSMITHKLINE-B0431691A</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>68</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>4MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIAMICRON</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058141-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060711</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-GLAXOSMITHKLINE-D0050283A</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>66</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>58</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>LEUKOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUBILEUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HYCAMTIN</medicinalproduct>
        <drugauthorizationnumb>20671</drugauthorizationnumb>
        <drugdosagetext>340UG PER DAY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060606</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060606</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PASPERTIN</medicinalproduct>
        <drugdosagetext>2ML PER DAY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060606</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060606</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATROVENT</medicinalproduct>
        <drugadministrationroute>055</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GALACORDIN FORTE</medicinalproduct>
        <drugdosagetext>700MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARBOPLATIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051201</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAXOL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051201</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058142-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060712</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-GLAXOSMITHKLINE-Z0000158A</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>71</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>80</patientweight>
      <reaction>
        <reactionmeddrapt>BRADYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ROPINIROLE HYDROCHLORIDE</medicinalproduct>
        <drugauthorizationnumb>20658</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RESTLESS LEGS SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060616</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058143-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060714</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-MERCK-0607DEU00122</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>75</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HEPATITIS TOXIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHABDOMYOLYSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VYTORIN</medicinalproduct>
        <drugauthorizationnumb>21687</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERCHOLESTEROLAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060601</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOPIDOGREL BISULFATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CORONARY ARTERY DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060601</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>[THERAPY UNSPECIFIED]</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058144-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050525</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-MERCK-0506USA04004</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>16</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>43</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ACUTE LYMPHOCYTIC LEUKAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ACUTE RESPIRATORY DISTRESS SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CANDIDA SEPSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DECADRON</medicinalproduct>
        <drugauthorizationnumb>11664</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ACUTE LYMPHOCYTIC LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020722</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020724</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DECADRON</medicinalproduct>
        <drugauthorizationnumb>011664</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020704</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020721</drugenddate>
        <drugtreatmentduration>18</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DECADRON</medicinalproduct>
        <drugauthorizationnumb>011664</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020725</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020726</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DECADRON</medicinalproduct>
        <drugauthorizationnumb>011664</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020727</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020728</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HYDROCORTONE</medicinalproduct>
        <drugadministrationroute>051</drugadministrationroute>
        <drugindication>ACUTE LYMPHOCYTIC LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020705</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020705</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HYDROCORTONE</medicinalproduct>
        <drugadministrationroute>051</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020708</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020708</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HYDROCORTONE</medicinalproduct>
        <drugadministrationroute>051</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020711</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020711</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HYDROCORTONE</medicinalproduct>
        <drugadministrationroute>051</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020715</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020715</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FILDESIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ACUTE LYMPHOCYTIC LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020716</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020716</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENDOXAN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ACUTE LYMPHOCYTIC LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020716</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020716</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>THERARUBICIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ACUTE LYMPHOCYTIC LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020717</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020718</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEUNASE</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>ACUTE LYMPHOCYTIC LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020717</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020721</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugadministrationroute>051</drugadministrationroute>
        <drugindication>ACUTE LYMPHOCYTIC LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020705</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020715</drugenddate>
        <drugtreatmentduration>11</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYTARABINE</medicinalproduct>
        <drugadministrationroute>051</drugadministrationroute>
        <drugindication>ACUTE LYMPHOCYTIC LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020705</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020715</drugenddate>
        <drugtreatmentduration>11</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KYTRIL</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>VOMITING</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020716</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020721</drugenddate>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRIMPERAN TAB</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>VOMITING</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020719</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020721</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PEPCID</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>UPPER GASTROINTESTINAL HAEMORRHAGE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020719</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020728</drugenddate>
        <drugtreatmentduration>10</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058145-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060713</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0607USA02551</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>COMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRIMAXIN</medicinalproduct>
        <drugauthorizationnumb>050587</drugauthorizationnumb>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>KLEBSIELLA INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060705</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060711</drugenddate>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRIMAXIN</medicinalproduct>
        <drugauthorizationnumb>050587</drugauthorizationnumb>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>ENTEROCOCCAL INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060705</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060711</drugenddate>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058146-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060717</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0607USA03653</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <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>
        <drugauthorizationnumb>020829</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058147-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060718</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0607USA03970</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>49</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ALLERGIC GRANULOMATOUS ANGIITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SINGULAIR</medicinalproduct>
        <drugauthorizationnumb>020829</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058148-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060621</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-MERCK-0606USA05689</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>79</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>38</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANAPHYLACTIC SHOCK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTERIOSCLEROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTERIOSCLEROSIS OBLITERANS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COZAAR</medicinalproduct>
        <drugauthorizationnumb>20386</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050830</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COZAAR</medicinalproduct>
        <drugauthorizationnumb>020386</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050831</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM</medicinalproduct>
        <drugadministrationroute>051</drugadministrationroute>
        <drugindication>THROMBOSIS PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050816</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050816</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit></drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CEREBROVASCULAR DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THEOLONG</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANPLAG</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTERIOSCLEROSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OPALMON</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTERIOSCLEROSIS OBLITERANS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGNESIUM OXIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM POLYCARBOPHIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONSTIPATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058149-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060619</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-MERCK-0606USA04450</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>48</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BALANCE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE INFECTION TOXOPLASMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPONATRAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENINGITIS CRYPTOCOCCAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOXOPLASMOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VITRITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HYDROCORTONE</medicinalproduct>
        <drugauthorizationnumb>8506</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUDROCORTISONE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058150-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060717</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-MERCK-0607GBR00078</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>71</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>STEATORRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREATMENT NONCOMPLIANCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZETIA</medicinalproduct>
        <drugauthorizationnumb>021445</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060619</drugenddate>
        <drugtreatmentduration>323</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058151-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060525</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-449763</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>3.7</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFANT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>18662</drugauthorizationnumb>
        <drugdosagetext>INDICATION REPORTED AS CYSTIC ACNE.</drugdosagetext>
        <drugindication>ACNE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980318</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19980719</drugenddate>
        <drugtreatmentduration>124</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>018662</drugauthorizationnumb>
        <drugdosagetext>INDICATION REPORTED AS NODULAR ACNE.</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980212</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19980317</drugenddate>
        <drugtreatmentduration>34</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugdosagetext>TREATED WITH PREDNISONE 40 MG FOR THREE DAYS, 30 MG FOR THREE DAYS, 20 MG FOR A WEEK AND 10 MG FOR +</drugdosagetext>
        <drugindication>CROHN'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020716</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN AND MINERAL PRENATAL SUPPLEMENT W/ FOLIC ACID CAP</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IRON TABLETS</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030108</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASACOL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058152-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060418</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>MX-MERCK-0604MEX00016</companynumb>
    <primarysource>
      <reportercountry>MEXICO</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>14</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ALLERGIC GRANULOMATOUS ANGIITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CORTICOSTEROIDS (UNSPECIFIED)</medicinalproduct>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>ALLERGIC GRANULOMATOUS ANGIITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CORTICOSTEROIDS (UNSPECIFIED)</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SINGULAIR</medicinalproduct>
        <drugauthorizationnumb>020829</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058153-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060601</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0606USA00216</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>75</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ARTHROPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>20560</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19940101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>[THERAPY UNSPECIFIED]</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058154-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060620</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-MERCK-0606USA04088</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>63</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>55</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DERMATITIS PSORIASIFORM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COZAAR</medicinalproduct>
        <drugauthorizationnumb>20386</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060329</drugenddate>
        <drugtreatmentduration>119</drugtreatmentduration>
        <drugtreatmentdurationunit></drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMLODIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19900101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058163-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060227</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006UW03457</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>56</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>121.4</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRAIN SCAN ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CALCINOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSGEUSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GLOBAL AMNESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TEARFULNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugauthorizationnumb>021366</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERLIPIDAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060112</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060120</drugenddate>
        <drugtreatmentduration>9</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERLIPIDAEMIA</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060106</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SUDAFED 12 HOUR</medicinalproduct>
        <drugindication>NASAL CONGESTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060118</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058164-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060712</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006AC01300</companynumb>
    <primarysource>
      <reportercountry>NETHERLANDS</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>17974</patientonsetage>
      <patientonsetageunit>804</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>VISUAL ACUITY REDUCED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugauthorizationnumb>021153</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>REFLUX OESOPHAGITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060530</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058165-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060711</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006AC01304</companynumb>
    <primarysource>
      <reportercountry>BELGIUM</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugauthorizationnumb>020639</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEMENTIA ALZHEIMER'S TYPE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058166-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060718</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006AP03314</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>430</patientonsetage>
      <patientonsetageunit>802</patientonsetageunit>
      <patientweight>112</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC HYPERTROPHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OBESITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugauthorizationnumb>20639</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041225</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUDECASIN</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040826</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HALOMONTH</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20011006</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOPICOOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051126</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NITRAZEPAM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051126</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALERIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051220</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGNESIUM OXIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONSTIPATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051126</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AKIRIDEN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PARKINSONISM</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051126</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SOFMIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040522</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HALRACK</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051216</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058167-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060411</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006UW06425</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>26908</patientonsetage>
      <patientonsetageunit>804</patientonsetageunit>
      <patientweight>105.5</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>EYE HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARIMIDEX</medicinalproduct>
        <drugauthorizationnumb>20541</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BREAST CANCER FEMALE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050718</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATIVAN</medicinalproduct>
        <drugindication>ANXIETY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19810101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060403</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ROLAIDS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058168-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060710</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006UW14212</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>59</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>86.2</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CARCINOID SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URTICARIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URTICARIA GENERALISED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugauthorizationnumb>21153</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DYSPEPSIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060629</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALTACE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVACOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZYRTEC</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058169-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060713</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006UW14536</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>81</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ARTHROPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSSTASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOWER RESPIRATORY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugauthorizationnumb>021366</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060622</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060713</drugenddate>
        <drugtreatmentduration>22</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RHOTRAL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVAPRO</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOSEC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058170-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060713</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006UW14543</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>80</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOBILITY DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH PRURITIC</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugauthorizationnumb>021366</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugauthorizationnumb>021366</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SLOW-K</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLYBURIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FERROUS SULFATE TAB</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN B-12</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORAZEPAM</medicinalproduct>
        <drugindication>NERVOUSNESS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORAZEPAM</medicinalproduct>
        <drugindication>INSOMNIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOSEC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>STOMACH DISCOMFORT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060615</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EZETROL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060523</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058171-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060711</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-JNJFOC-20060703274</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>12</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZALDIAR</medicinalproduct>
        <drugauthorizationnumb>21123</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>POST-TRAUMATIC PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BI-PROFENID</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>POST-TRAUMATIC PAIN</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058172-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060713</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>SE-JNJFOC-20060702919</companynumb>
    <primarysource>
      <reportercountry>SWEDEN</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>21</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>112.5</patientweight>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>BENIGN INTRACRANIAL HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLEURISY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THIRST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRINOVUM</medicinalproduct>
        <drugauthorizationnumb>18985</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONTRACEPTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DESOLETT</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>CONTRACEPTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BETAPRED</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058173-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060711</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20051205752</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>71.22</patientweight>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>INTRACARDIAC THROMBUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ORTHO EVRA</medicinalproduct>
        <drugauthorizationnumb>21180</drugauthorizationnumb>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031217</drugenddate>
        <drugtreatmentduration>16</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL SPIROS</medicinalproduct>
        <drugdosagetext>AS NECESSARY, DOSAGE UNKNOWN</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058174-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060711</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IT-JNJFOC-20060701877</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>83</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>OPTIC NERVE NEOPLASM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STRABISMUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL ACUITY REDUCED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRIXAR</medicinalproduct>
        <drugauthorizationnumb>20634</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CYSTITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060415</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060416</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058175-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060509</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006SE02631</companynumb>
    <primarysource>
      <reportercountry>AUSTRIA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>883</patientonsetage>
      <patientonsetageunit>802</patientonsetageunit>
      <patientweight>79</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>SALIVARY HYPERSECRETION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BLOPRESS</medicinalproduct>
        <drugauthorizationnumb>20838</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041206</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041219</drugenddate>
        <drugtreatmentduration>14</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BLOPRESS</medicinalproduct>
        <drugauthorizationnumb>020838</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041220</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060412</drugenddate>
        <drugtreatmentduration>479</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BLOPRESS PLUS</medicinalproduct>
        <drugdosagetext>8 MG CANDESARTAN CILEXETIL/12.5 MG HYDROCHLOROTHIAZIDE EVERY EVENING</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041206</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041219</drugenddate>
        <drugtreatmentduration>14</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BLOPRESS PLUS</medicinalproduct>
        <drugdosagetext>16 MG CANDESARTAN CILEXETIL/12.5 MG HYDROCHLOROTHIAZIDE EVERY EVENING</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041220</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060401</drugenddate>
        <drugtreatmentduration>16</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRAVACHOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PARIET</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>REFLUX OESOPHAGITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL COMP.</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CONCOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAXICALC</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMINE D3</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THYREX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058176-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060711</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20060701987</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>52</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>86.18</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERDAL</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERDAL</medicinalproduct>
        <drugauthorizationnumb>021346</drugauthorizationnumb>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA, PARANOID TYPE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058177-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060711</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20060702604</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>55</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>COLD SWEAT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERDAL CONSTA</medicinalproduct>
        <drugauthorizationnumb>021346</drugauthorizationnumb>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058178-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060712</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20050703997</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>102.51</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>AGGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TEMPERATURE INTOLERANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREATMENT NONCOMPLIANCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERDAL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERDAL</medicinalproduct>
        <drugdosagetext>1 MG IN AM, 3 MG IN PM</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERDAL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERDAL</medicinalproduct>
        <drugdosagetext>0.5 MG IN AM, 1 MG IN PM</drugdosagetext>
        <drugindication>ANXIETY DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERDAL</medicinalproduct>
        <drugauthorizationnumb>020272</drugauthorizationnumb>
        <drugindication>AUTISM</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
        <drugindication>ANXIETY DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
        <drugindication>AUTISM</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRILEPTAL</medicinalproduct>
        <drugindication>MOOD ALTERED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPAMAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPAMAX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058180-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060714</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-JNJFOC-20060703174</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>PHYSICAL ASSAULT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERDAL</medicinalproduct>
        <drugauthorizationnumb>020272</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERDAL CONSTA</medicinalproduct>
        <drugauthorizationnumb>021346</drugauthorizationnumb>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058181-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060711</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2006US08862</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugauthorizationnumb>021223</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058182-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-BRISTOL-MYERS SQUIBB COMPANY-13428339</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>49</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>67</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>GASTROENTERITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEUKOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOPHOSPHAMIDE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060422</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060522</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAXOL</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060606</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060619</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EPIRUBICIN</medicinalproduct>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060410</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060522</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CAPECITABINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060607</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060620</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARANESP</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060412</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060612</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FERROUS</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060410</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058183-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060717</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-13443999</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>82</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANOREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>APPLICATION SITE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHILLS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPHIL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RADIATION INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RADIATION SKIN INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN EXFOLIATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STOMATITIS</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>ERBITUX</medicinalproduct>
        <drugdosagetext>LOADING DOSE 15-MAY-06 (400 MG/M2) 250 MG/M2 X 6 WEEKS (22-MAY, 31-MAY, 07-JUN, 12-JUN, 19-JUN-06)</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>SQUAMOUS CELL CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060619</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060619</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAXOTERE</medicinalproduct>
        <drugdosagetext>15 MG/M2 (30 MG) 22-MAY, 31-MAY, 07-JUN HELD: LIVER FUNCTION TESTS + FEVER DECREASED 19JUN (24MG)</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>SQUAMOUS CELL CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060619</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060619</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RADIATION THERAPY</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060623</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060623</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058184-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-BRISTOL-MYERS SQUIBB COMPANY-13431085</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>76</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>75</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PHOTOPHOBIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRAVASIN</medicinalproduct>
        <drugauthorizationnumb>19898</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERLIPIDAEMIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058185-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060404</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-BRISTOL-MYERS SQUIBB COMPANY-13338397</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>56</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ECZEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOXIC SKIN ERUPTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VIRAL INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HYDREA</medicinalproduct>
        <drugauthorizationnumb>16295</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RED BLOOD CELL COUNT INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060213</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060316</drugenddate>
        <drugtreatmentduration>32</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FRACTAL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058186-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060712</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-BRISTOL-MYERS SQUIBB COMPANY-13441258</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>25</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>SUDDEN DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CORGARD</medicinalproduct>
        <drugauthorizationnumb>018063</drugauthorizationnumb>
        <drugdosagetext>DURATION: MANY YEARS</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTROPHIC CARDIOMYOPATHY</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060701</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
        <drugauthorizationnumb>073318</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTROPHIC CARDIOMYOPATHY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060706</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060710</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058192-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060710</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006UW14207</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>77</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>81.6</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYSTERECTOMY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STOMACH DISCOMFORT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARIMIDEX</medicinalproduct>
        <drugauthorizationnumb>020541</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040801</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM GLUCONATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZESTRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEXAPRO</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMBIEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MOBIC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIGITEK</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058193-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060711</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-JNJFOC-20060702712</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>1</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>SUICIDE ATTEMPT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HALDOL</medicinalproduct>
        <drugauthorizationnumb>015923</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058194-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060711</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-JNJFOC-20060702633</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>69</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ITRACONAZOLE</medicinalproduct>
        <drugauthorizationnumb>020083</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NAIL TINEA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060615</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060621</drugenddate>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058195-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060712</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-JNJFOC-20050200410</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIOMEGALY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONGESTIVE CARDIOMYOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLEURAL EFFUSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ITRACONAZOLE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugtreatmentduration>69</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ITRACONAZOLE</medicinalproduct>
        <drugauthorizationnumb>020083</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ACUTE PULMONARY HISTOPLASMOSIS</drugindication>
        <drugtreatmentduration>69</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058196-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060714</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006PK01538</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>55</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARIMIDEX</medicinalproduct>
        <drugauthorizationnumb>020541</drugauthorizationnumb>
        <drugindication>BREAST CANCER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>CORTISONE ACETATE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058197-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060707</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006CG01204</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>3.2</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>C-REACTIVE PROTEIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTONIA NEONATAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYDRIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEONATAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEONATAL RESPIRATORY ARREST</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XYLOCAINE</medicinalproduct>
        <drugauthorizationnumb>6488</drugauthorizationnumb>
        <drugadministrationroute>064</drugadministrationroute>
        <drugindication>LOCAL ANAESTHESIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050216</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ANTASOL</medicinalproduct>
        <drugadministrationroute>064</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050215</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050215</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PETHIDINE</medicinalproduct>
        <drugadministrationroute>064</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060215</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060215</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NARCAN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050216</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050216</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058198-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006SE00033</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>28597</patientonsetage>
      <patientonsetageunit>804</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SHOCK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TORSADE DE POINTES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENTRICULAR FIBRILLATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENTRICULAR TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BLOPRESS</medicinalproduct>
        <drugauthorizationnumb>20838</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051118</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KLARICID</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NASOPHARYNGITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051114</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051118</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RYTHMODAN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051027</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051118</drugenddate>
        <drugtreatmentduration>23</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050823</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051118</drugenddate>
        <drugtreatmentduration>88</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VASOLAN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051006</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANGINA PECTORIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050819</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051118</drugenddate>
        <drugtreatmentduration>92</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GASTER</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050819</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051118</drugenddate>
        <drugtreatmentduration>92</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERURICAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050823</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051118</drugenddate>
        <drugtreatmentduration>88</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DORNER</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTERIOSCLEROSIS OBLITERANS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051004</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051118</drugenddate>
        <drugtreatmentduration>46</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058200-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060613</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006UW12887</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>21189</patientonsetage>
      <patientonsetageunit>804</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugauthorizationnumb>21366</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERLIPIDAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060216</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060316</drugenddate>
        <drugtreatmentduration>29</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PIOGLITAZONE HCL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS NON-INSULIN-DEPENDENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050207</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050725</drugenddate>
        <drugtreatmentduration>169</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANXIETY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COLACE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ABDOMINAL HERNIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CARDIOVASCULAR EVENT PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARDURA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYZAAR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERLIPIDAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050518</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060215</drugenddate>
        <drugtreatmentduration>274</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
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    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058201-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060710</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2006IT10369</companynumb>
    <primarysource>
      <reportercountry>ITALY</reportercountry>
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    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <patientonsetage>58</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>OSTEOMYELITIS</reactionmeddrapt>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUOROURACIL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugauthorizationnumb>021223</drugauthorizationnumb>
        <drugdosagetext>4 MG, QMO</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050201</drugenddate>
        <drugtreatmentduration>824</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
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    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058202-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
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    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2006IT10370</companynumb>
    <primarysource>
      <reportercountry>ITALY</reportercountry>
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    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <patientonsetage>66</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>JAW OPERATION</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>OSTEOMYELITIS</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugauthorizationnumb>021223</drugauthorizationnumb>
        <drugdosagetext>4 MG, EVERY 1 MONTH</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>METASTASES TO BONE</drugindication>
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        <drugstartdate>20010420</drugstartdate>
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        <drugtreatmentduration>1250</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUOROURACIL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
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    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058203-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
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    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
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    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2006IT10421</companynumb>
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      <reportercountry>ITALY</reportercountry>
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    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <patientonsetage>60</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>JAW OPERATION</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>OSTEOMYELITIS</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugauthorizationnumb>021223</drugauthorizationnumb>
        <drugdosagetext>4 MG, QMO</drugdosagetext>
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        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040412</drugstartdate>
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        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
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  <safetyreport>
    <safetyreportid>5058204-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060711</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
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    <primarysource>
      <reportercountry>ITALY</reportercountry>
      <qualification>3</qualification>
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    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <patientonsetage>62</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>OSTEOMYELITIS</reactionmeddrapt>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EXEMESTANE</medicinalproduct>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYCLOPHOSPHAMIDE + 5-FU + METHOTREXATE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
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        <drugdosagetext>4 MG, QMO</drugdosagetext>
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        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030116</drugstartdate>
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        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUOROURACIL</medicinalproduct>
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  <safetyreport>
    <safetyreportid>5058205-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
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    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
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    <receiptdateformat>102</receiptdateformat>
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      <reportercountry>ITALY</reportercountry>
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    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <patientonsetage>64</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
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        <reactionmeddrapt>OSTEOMYELITIS</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
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        <drugdosagetext>4 MG, QMO</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FEMARA</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
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  <safetyreport>
    <safetyreportid>5058206-7</safetyreportid>
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    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060710</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2006IT10422</companynumb>
    <primarysource>
      <reportercountry>ITALY</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>69</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>JAW OPERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOMYELITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugauthorizationnumb>021223</drugauthorizationnumb>
        <drugdosagetext>4 MG, QMO</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050301</drugenddate>
        <drugtreatmentduration>366</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CORTISONE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALKERAN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058207-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060711</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2006US08858</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugauthorizationnumb>021223</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058208-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060710</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2006IT10379</companynumb>
    <primarysource>
      <reportercountry>ITALY</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>60</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>JAW OPERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOMYELITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugauthorizationnumb>021223</drugauthorizationnumb>
        <drugdosagetext>4 MG, QMO</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030509</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050509</drugenddate>
        <drugtreatmentduration>732</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MELPHALAN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE TAB</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058209-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050114</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHNU2005DE00564</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>61</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>85</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BIOPSY SITE UNSPECIFIED ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMPAIRED HEALING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALIGNANT NEOPLASM PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE MYELOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOMYELITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOTOMY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEQUESTRECTOMY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTH EXTRACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WOUND DEBRIDEMENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugauthorizationnumb>21223</drugauthorizationnumb>
        <drugdosagetext>4 MG, QMO</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020920</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE TAB</medicinalproduct>
        <drugdosagetext>4 CYCLES</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PLASMACYTOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030601</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE TAB</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYCLOPHOSPHAMID W/DOXORUBICIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>HAEMATOPOIETIC STEM CELL MOBILISATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030701</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYCLOPHOSPHAMIDE W/VINCRISTINE/PREDNISONE</medicinalproduct>
        <drugdosagetext>2 CYCLES</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PLASMACYTOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOXORUBICIN HCL</medicinalproduct>
        <drugdosagetext>2 CYCLES</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PLASMACYTOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYCLOPHOSPHAMIDE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PLASMACYTOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ETOPOSIDE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PLASMACYTOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLATINUM COMPOUNDS</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PLASMACYTOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THALIDOMIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PLASMACYTOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MELPHALAN</medicinalproduct>
        <drugdosagetext>4 CYCLES</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PLASMACYTOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030601</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058213-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060718</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006UW14729</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>52</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ALANINE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC ENZYME INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugauthorizationnumb>021366</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTIBIOTIC</medicinalproduct>
        <drugindication>INFECTION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058214-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060711</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2006IT10368</companynumb>
    <primarysource>
      <reportercountry>ITALY</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>79</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>OSTEOMYELITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugauthorizationnumb>021223</drugauthorizationnumb>
        <drugdosagetext>4 MG, QMO</drugdosagetext>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040627</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050627</drugenddate>
        <drugtreatmentduration>366</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058215-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060317</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2006US03625</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>72</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BONE SCAN ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BURSITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JOINT EFFUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALIGNANT NEOPLASM PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugauthorizationnumb>21223</drugauthorizationnumb>
        <drugdosagetext>4 MG EVERY MONTH</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040501</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LUPRON</medicinalproduct>
        <drugdosagetext>EVERY MONTH</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058216-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060711</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2006US08860</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugauthorizationnumb>021223</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058217-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060712</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20060703360</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>DRUG TOXICITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
        <drugauthorizationnumb>019872</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
        <drugauthorizationnumb>019872</drugauthorizationnumb>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058218-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2006JP09847</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>64</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>77</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BONE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSED LEVEL OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATOCRIT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SHOCK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VAGUS NERVE DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugauthorizationnumb>021223</drugauthorizationnumb>
        <drugdosagetext>4 MG, ONCE/SINGLE</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>METASTASES TO BONE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060623</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060623</drugenddate>
        <drugtreatmentduration>1440</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CEFMETAZON</medicinalproduct>
        <drugdosagetext>2 MG/D</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>URINARY TRACT INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060616</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060616</drugenddate>
        <drugtreatmentduration>1440</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CEFMETAZON</medicinalproduct>
        <drugdosagetext>1 MG/D</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060617</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLOMOX</medicinalproduct>
        <drugdosagetext>300 MG/D</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>URINARY TRACT INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060617</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060623</drugenddate>
        <drugtreatmentduration>10080</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ODYNE</medicinalproduct>
        <drugdosagetext>250 MG/D</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>METASTASES TO BONE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060617</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060630</drugenddate>
        <drugtreatmentduration>20160</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SALOBEL</medicinalproduct>
        <drugdosagetext>100 MG/D</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERURICAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060616</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060630</drugenddate>
        <drugtreatmentduration>21600</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
        <drugdosagetext>5 MG/D</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060616</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060630</drugenddate>
        <drugtreatmentduration>21600</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLADEX</medicinalproduct>
        <drugdosagetext>3.6 MG/D</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>METASTASES TO BONE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060623</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060623</drugenddate>
        <drugtreatmentduration>1440</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOXONIN</medicinalproduct>
        <drugdosagetext>180 MG/D</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BACK PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060621</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060626</drugenddate>
        <drugtreatmentduration>8640</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYPEN</medicinalproduct>
        <drugdosagetext>40 MG/D</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BACK PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060627</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060630</drugenddate>
        <drugtreatmentduration>5760</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058219-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060712</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2006IT10497</companynumb>
    <primarysource>
      <reportercountry>ITALY</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>79</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>OSTEOMYELITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugauthorizationnumb>021223</drugauthorizationnumb>
        <drugdosagetext>4 MG, QMO</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040423</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050823</drugenddate>
        <drugtreatmentduration>488</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MELPHALAN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058223-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060623</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BRACCO-BDI-008370</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>83</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>45.45</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BRAIN OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSED LEVEL OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ISOVUE-300</medicinalproduct>
        <drugbatchnumb>5J82578</drugbatchnumb>
        <drugauthorizationnumb>18735</drugauthorizationnumb>
        <drugadministrationroute>037</drugadministrationroute>
        <drugindication>BACK PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060621</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060621</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ISOVUE-300</medicinalproduct>
        <drugbatchnumb>5J82578</drugbatchnumb>
        <drugauthorizationnumb>018735</drugauthorizationnumb>
        <drugadministrationroute>037</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060621</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060621</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ISOVUE-300</medicinalproduct>
        <drugbatchnumb>5J82578</drugbatchnumb>
        <drugauthorizationnumb>018735</drugauthorizationnumb>
        <drugadministrationroute>037</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060621</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060621</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058224-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060713</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2006IE10458</companynumb>
    <primarysource>
      <reportercountry>IRELAND</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>LETHARGY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
        <drugauthorizationnumb>020665</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058225-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060712</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2006RU10433</companynumb>
    <primarysource>
      <reportercountry>RUSSIAN FEDERATION</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>76</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LARYNGEAL OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URTICARIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHEEZING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
        <drugauthorizationnumb>20665</drugauthorizationnumb>
        <drugdosagetext>80 MG/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
        <drugauthorizationnumb>020665</drugauthorizationnumb>
        <drugdosagetext>160 MG/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LOKREN</medicinalproduct>
        <drugdosagetext>10 MG/DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LOKREN</medicinalproduct>
        <drugdosagetext>5 MG/DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVASTATIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058236-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060705</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2006JP10230</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>50</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD CREATINE PHOSPHOKINASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE RIGIDITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUROLEPTIC MALIGNANT SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOFRANIL</medicinalproduct>
        <drugauthorizationnumb>11838</drugauthorizationnumb>
        <drugdosagetext>150 MG/D</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MAJOR DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERIDONE</medicinalproduct>
        <drugdosagetext>6 MG/D</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OLANZAPINE</medicinalproduct>
        <drugdosagetext>25 MG/D</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHLORPROMAZINE</medicinalproduct>
        <drugdosagetext>25 MG/D</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SULPIRIDE (NGX)</medicinalproduct>
        <drugdosagetext>150 MG/D</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMOXAPINE</medicinalproduct>
        <drugdosagetext>225 MG/D</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAROXETINE</medicinalproduct>
        <drugdosagetext>20 MG/D</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAROXETINE</medicinalproduct>
        <drugdosagetext>40 MG/D</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUVOXAMINE MALEATE</medicinalproduct>
        <drugdosagetext>50 MG/D</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LITHIUM CARBONATE</medicinalproduct>
        <drugdosagetext>800 MG/D</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058237-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20051026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2005JP16003</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>72</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>32</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG EFFECT INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FENTANEST</medicinalproduct>
        <drugdosagetext>50 UG, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ANAESTHESIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050422</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050422</drugenddate>
        <drugtreatmentduration>1440</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
        <drugauthorizationnumb>020665</drugauthorizationnumb>
        <drugdosagetext>40 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROPOFOL</medicinalproduct>
        <drugdosagetext>50 MG/DAY</drugdosagetext>
        <drugindication>ANAESTHESIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FENTANYL TRANSDERMAL SYSTEM</medicinalproduct>
        <drugdosagetext>50 UG, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ANAESTHESIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050422</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050422</drugenddate>
        <drugtreatmentduration>1440</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NITROUS OXIDE W/ OXYGEN</medicinalproduct>
        <drugdosagetext>50 %/DAY</drugdosagetext>
        <drugindication>ANAESTHESIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050422</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050422</drugenddate>
        <drugtreatmentduration>1440</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEVOFLURANE</medicinalproduct>
        <drugdosagetext>1%/DAY</drugdosagetext>
        <drugindication>ANAESTHESIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050422</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050422</drugenddate>
        <drugtreatmentduration>1440</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATRIAL NATRIURETIC PEPTIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HANP</medicinalproduct>
        <drugdosagetext>0.02 UG/KG/DAY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RENAL FAILURE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050422</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050422</drugenddate>
        <drugtreatmentduration>1440</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIART</medicinalproduct>
        <drugdosagetext>60 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OEDEMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MUSCULAX</medicinalproduct>
        <drugdosagetext>4 MG, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>HYPOTONIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050422</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050422</drugenddate>
        <drugtreatmentduration>1440</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058238-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060710</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHO2006JP11195</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>55</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>90</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BIPOLAR I DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
        <drugauthorizationnumb>021283</drugauthorizationnumb>
        <drugdosagetext>40 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030407</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050830</drugenddate>
        <drugtreatmentduration>877</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>THROMBOSIS PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMARYL</medicinalproduct>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugindication>CARDIAC FAILURE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIGOXIN</medicinalproduct>
        <drugindication>CARDIAC FAILURE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030407</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058239-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20051122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHO2005JP18430</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>90</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>45</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ACUTE MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>UNK, UNK</drugdosagetext>
        <drugindication>CEREBRAL INFARCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030405</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GASTER D</medicinalproduct>
        <drugindication>GASTRIC ULCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030405</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYANOCOBALAMIN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030405</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGNESIUM OXIDE</medicinalproduct>
        <drugindication>CONSTIPATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THYRADIN S</medicinalproduct>
        <drugindication>HYPOTHYROIDISM</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
        <drugauthorizationnumb>021283</drugauthorizationnumb>
        <drugdosagetext>80 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030530</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050127</drugenddate>
        <drugtreatmentduration>609</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058240-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060627</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHO2006AU10389</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>65</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL DISTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG WITHDRAWAL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HALLUCINATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ILEUS PARALYTIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SURGERY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINE OUTPUT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RAD001</medicinalproduct>
        <drugdosagetext>NO TREATMENT</drugdosagetext>
        <drugindication>RENAL TRANSPLANT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEORAL</medicinalproduct>
        <drugauthorizationnumb>050715</drugauthorizationnumb>
        <drugdosagetext>800 MG / DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RENAL TRANSPLANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060620</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060626</drugenddate>
        <drugtreatmentduration>10080</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MYFORTIC</medicinalproduct>
        <drugdosagetext>720 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RENAL TRANSPLANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060620</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NITRAZEPAM</medicinalproduct>
        <drugdosagetext>PRN</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NORMISON</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058241-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060711</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHNR2006AU00902</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD CREATININE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRIC BANDING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEORAL</medicinalproduct>
        <drugauthorizationnumb>050715</drugauthorizationnumb>
        <drugindication>TRANSPLANT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEORAL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060626</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058242-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060712</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2006JP10430</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>71</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CEREBELLAR ATAXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEORAL</medicinalproduct>
        <drugauthorizationnumb>050737</drugauthorizationnumb>
        <drugdosagetext>100 MG/D</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PSORIASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060607</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058243-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060704</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHO2006DE10802</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>61</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>80</patientweight>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>IMMUNOSUPPRESSANT DRUG LEVEL INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIFE SUPPORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUROLOGICAL SYMPTOM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PUPILLARY REFLEX IMPAIRED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SANDIMMUNE</medicinalproduct>
        <drugauthorizationnumb>50573</drugauthorizationnumb>
        <drugdosagetext>200 MG, BID</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>LIVER TRANSPLANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060610</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058244-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060710</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2006BE10250</companynumb>
    <primarysource>
      <reportercountry>BELGIUM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG DEPENDENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG WITHDRAWAL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NERVOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NIGHT SWEATS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOFRANIL</medicinalproduct>
        <drugauthorizationnumb>011838</drugauthorizationnumb>
        <drugdosagetext>25 MG, QID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTIHYPERTENSIVE DRUGS</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058245-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060718</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-BRACCO-BRO-010335</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>27</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>94</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY TRACT DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WRONG DRUG ADMINISTERED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IOPAMIRON</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>18735</drugauthorizationnumb>
        <drugdosagetext>INFUSION</drugdosagetext>
        <drugadministrationroute>037</drugadministrationroute>
        <drugindication>SPINAL MYELOGRAM</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19981228</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19981228</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>UROMIRON</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugadministrationroute>050</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19981228</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19981228</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058268-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20051205</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0584680A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>65</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>1TAB PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051101</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELEXA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARDIZEM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WELLBUTRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVSIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DITROPAN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058269-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060608</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006UW12170</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>64</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG ADMINISTRATION ERROR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ATACAND HCT</medicinalproduct>
        <drugauthorizationnumb>21093</drugauthorizationnumb>
        <drugdosagetext>CANDESARTAN CILEXETIL  32 MG + HYDROCHLOROTHIAZIDE 12.5 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CATAPRES</medicinalproduct>
        <drugdosagetext>0.1/24 HR</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058270-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060712</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006UW14311</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>COGNITIVE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG DISPENSING ERROR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEDICATION ERROR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOPROL-XL</medicinalproduct>
        <drugauthorizationnumb>019962</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOPAMAX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058271-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060616</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-13414966</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>71</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>59</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BREAST CANCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHILLS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVAPRO</medicinalproduct>
        <drugbatchnumb>6A11931A</drugbatchnumb>
        <drugauthorizationnumb>20757</drugauthorizationnumb>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NOVADEX</medicinalproduct>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058272-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060615</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ES-NOVOPROD-254158</companynumb>
    <primarysource>
      <reportercountry>SPAIN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>58</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>70</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ACUTE PULMONARY OEDEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NOVOSEVEN</medicinalproduct>
        <drugdosagetext>80 UG/KG, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CEREBRAL HAEMORRHAGE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060613</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060613</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
        <drugdosagetext>1 G, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PYREXIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060614</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMOXICILINA + CLAVULANICO</medicinalproduct>
        <drugdosagetext>1 G, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PYREXIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060614</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LABETALOL HCL</medicinalproduct>
        <drugdosagetext>100 MG, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060613</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN ACTRAPID                   /00646001/</medicinalproduct>
        <drugdosagetext>24 IU, UNK</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>HYPERGLYCAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060614</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYCLOSPORINE</medicinalproduct>
        <drugdosagetext>25 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>IMMUNOSUPPRESSANT DRUG THERAPY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058284-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060630</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006UW13863</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>21553</patientonsetage>
      <patientonsetageunit>804</patientonsetageunit>
      <patientweight>85.9</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ATELECTASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD ALCOHOL INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CALCIUM DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CHLORIDE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD MAGNESIUM DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD POTASSIUM DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CACHEXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARPAL TUNNEL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CATHETER BACTERAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CATHETER RELATED INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONTRAST MEDIA REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DILATATION ATRIAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GRAND MAL CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMODIALYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERPHOSPHATAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPONATRAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG CONSOLIDATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL ISCHAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUROLEPTIC MALIGNANT SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUROPATHY PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARALYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RED MAN SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL CYST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL TUBULAR NECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHABDOMYOLYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STAPHYLOCOCCAL BACTERAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STAPHYLOCOCCAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ULNAR NERVE PALSY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENTRICULAR EXTRASYSTOLES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENTRICULAR HYPERTROPHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugauthorizationnumb>21366</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040418</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051007</drugenddate>
        <drugtreatmentduration>538</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALCOHOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VANCOMYCIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRAVACHOL</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040401</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DITROPAN XL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCODONE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050509</drugstartdate>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NAPROXEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DETROL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ELMIRON</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040416</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROXYZINE HYDROCHLORIDE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040616</drugstartdate>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOXEPIN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040623</drugstartdate>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PIROXICAM</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040629</drugstartdate>
        <drugtreatmentduration>14</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IONIL-T</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040716</drugstartdate>
        <drugtreatmentduration>21</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLOBEX</medicinalproduct>
        <drugadministrationroute>061</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040827</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058305-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060630</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2006BE09997</companynumb>
    <primarysource>
      <reportercountry>BELGIUM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>73</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ACTINOMYCOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugauthorizationnumb>21223</drugauthorizationnumb>
        <drugdosagetext>UNK, UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>METASTASES TO BONE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NOVANTRONE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058306-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060711</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2006IT10423</companynumb>
    <primarysource>
      <reportercountry>ITALY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>70</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ORAL SURGERY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOMYELITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CHEMOTHERAPEUTICS,OTHER</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugauthorizationnumb>021223</drugauthorizationnumb>
        <drugdosagetext>4 MG, EVERY 1 MONTH</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040112</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060112</drugenddate>
        <drugtreatmentduration>732</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058307-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060530</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2006US06993</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>79</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>72.562</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>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>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHILLS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHOLELITHIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CIRCULATORY COLLAPSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERNATIONAL NORMALISED RATIO INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER FUNCTION TEST ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METASTATIC NEOPLASM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TENDERNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TUMOUR NECROSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OCTREOTIDE ACETATE</medicinalproduct>
        <drugdosagetext>20 UG, MONTHLY</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
        <drugdosagetext>100 MG, DAILY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETYLSALICYLIC ACID SRT</medicinalproduct>
        <drugdosagetext>81 MG, DAILY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLIPIZIDE</medicinalproduct>
        <drugdosagetext>5 MG, DAILY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
        <drugdosagetext>12.5 MG, DAILY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL</medicinalproduct>
        <drugdosagetext>25 MG, BID</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOSARTAN POSTASSIUM</medicinalproduct>
        <drugdosagetext>50 MG, DAILY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
        <drugdosagetext>0.175 MG, DAILY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTIVITAMINS, COMBINATIONS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRILOSEC</medicinalproduct>
        <drugdosagetext>20 MG, DAILY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IRON SULFATETHIAMIN COMPOUND TAB</medicinalproduct>
        <drugdosagetext>324 MG, BID</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>QUININE SULFATE</medicinalproduct>
        <drugdosagetext>250 MG, HS PRN FOR LEG SPASM</drugdosagetext>
        <drugindication>MUSCLE SPASMS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN B-12</medicinalproduct>
        <drugdosagetext>100 UG, DAILY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VICODIN</medicinalproduct>
        <drugdosagetext>1 Q4HR PRN FOR PAIN</drugdosagetext>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROTONIX</medicinalproduct>
        <drugdosagetext>40MG QD</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugauthorizationnumb>021223</drugauthorizationnumb>
        <drugdosagetext>4MG QMO</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>METASTASES TO BONE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060104</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060104</drugenddate>
        <drugtreatmentduration>1440</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugauthorizationnumb>021223</drugauthorizationnumb>
        <drugdosagetext>4MG QMO</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060130</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060130</drugenddate>
        <drugtreatmentduration>1440</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugauthorizationnumb>021223</drugauthorizationnumb>
        <drugdosagetext>4MG QMO</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060228</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060228</drugenddate>
        <drugtreatmentduration>1440</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugauthorizationnumb>021223</drugauthorizationnumb>
        <drugdosagetext>4MG QMO</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060328</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060328</drugenddate>
        <drugtreatmentduration>1440</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugauthorizationnumb>021223</drugauthorizationnumb>
        <drugdosagetext>4MG QMO</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060425</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060425</drugenddate>
        <drugtreatmentduration>1440</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugauthorizationnumb>021223</drugauthorizationnumb>
        <drugdosagetext>4MG QMO</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060523</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060523</drugenddate>
        <drugtreatmentduration>1440</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugauthorizationnumb>021223</drugauthorizationnumb>
        <drugdosagetext>4 MG, ONCE/SINGLE</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051125</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051125</drugenddate>
        <drugtreatmentduration>1440</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugauthorizationnumb>021223</drugauthorizationnumb>
        <drugdosagetext>4 MG, ONCE/SINGLE</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050121</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050121</drugenddate>
        <drugtreatmentduration>1440</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058312-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060713</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006AP03327</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>63</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>LUNG DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IRESSA</medicinalproduct>
        <drugauthorizationnumb>021399</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>LUNG NEOPLASM MALIGNANT</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058313-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060711</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2006IT10371</companynumb>
    <primarysource>
      <reportercountry>ITALY</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>61</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>OSTEOMYELITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SURGERY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugauthorizationnumb>021223</drugauthorizationnumb>
        <drugdosagetext>4 MG, QMO</drugdosagetext>
        <drugindication>METASTASES TO BONE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040429</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060429</drugenddate>
        <drugtreatmentduration>731</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058323-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060712</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>TH-ROCHE-454992</companynumb>
    <primarysource>
      <reportercountry>THAILAND</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>34</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CYST RUPTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAROSMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY DISTRESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VAGINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ROCEPHIN</medicinalproduct>
        <drugauthorizationnumb>50585</drugauthorizationnumb>
        <drugdosagetext>INTRAVENOUS PUSH.</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PHARYNGITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060705</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060705</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AUGMENTIN '125'</medicinalproduct>
        <drugdosagetext>THE PATIENT RECEIVED THREE SHOTS.</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PHARYNGITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060702</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060704</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058324-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060710</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2006IT10373</companynumb>
    <primarysource>
      <reportercountry>ITALY</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>52</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ORAL SURGERY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOMYELITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THALIDOMIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE TAB</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugauthorizationnumb>021223</drugauthorizationnumb>
        <drugdosagetext>4 MG, EVERY 1 MONTH</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020226</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040226</drugenddate>
        <drugtreatmentduration>731</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058325-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060707</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2006JP10287</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>76</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HYPONATRAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLEANAL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GASCON</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
        <drugauthorizationnumb>020665</drugauthorizationnumb>
        <drugdosagetext>UNK, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058326-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060712</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHRM2006FR02104</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>13</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>101</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVERWEIGHT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RITALIN</medicinalproduct>
        <drugauthorizationnumb>010187</drugauthorizationnumb>
        <drugdosagetext>60 MG/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATTENTION DEFICIT/HYPERACTIVITY DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058327-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060711</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2006TR10351</companynumb>
    <primarysource>
      <reportercountry>TURKEY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>70</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BRADYKINESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDE ATTEMPT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>STALEVO 100</medicinalproduct>
        <drugauthorizationnumb>21485</drugauthorizationnumb>
        <drugdosagetext>60 DF, ONCE/SINGLE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PARKINSON'S DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>STALEVO 100</medicinalproduct>
        <drugauthorizationnumb>021485</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CABASER</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PARKINSON'S DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CABASER</medicinalproduct>
        <drugdosagetext>70 DF, ONCE/SINGLE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058328-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060718</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-KINGPHARMUSA00001-K200600927</companynumb>
    <primarysource>
      <reportercountry>PHILIPPINES</reportercountry>
      <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>CEREBRAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREATMENT NONCOMPLIANCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALTACE</medicinalproduct>
        <drugauthorizationnumb>019901</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FELODIPINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONIDINE</medicinalproduct>
        <drugdosagetext>150 UG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060525</drugenddate>
        <drugtreatmentduration>36000</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058329-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060712</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHO2006JP11433</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>77</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>LIBIDO INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESTLESSNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENTACAPONE</medicinalproduct>
        <drugauthorizationnumb>20796</drugauthorizationnumb>
        <drugdosagetext>800 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PARKINSON'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030903</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEODOPASOL</medicinalproduct>
        <drugdosagetext>1000 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PARKINSON'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19960125</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FP</medicinalproduct>
        <drugindication>PARKINSON'S DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PARLODEL</medicinalproduct>
        <drugindication>PARKINSON'S DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>YODEL S</medicinalproduct>
        <drugindication>PARKINSON'S DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOXONIN</medicinalproduct>
        <drugindication>BACK PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MUCOSTA</medicinalproduct>
        <drugindication>GASTRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYANOCOBALAMIN</medicinalproduct>
        <drugindication>HYPOAESTHESIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OPALMON</medicinalproduct>
        <drugindication>HYPOAESTHESIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PURSENNID</medicinalproduct>
        <drugindication>CONSTIPATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058330-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060713</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2006DK10575</companynumb>
    <primarysource>
      <reportercountry>DENMARK</reportercountry>
      <qualification>1</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>DISTURBANCE IN ATTENTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HALLUCINATION, AUDITORY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RITALIN</medicinalproduct>
        <drugauthorizationnumb>010187</drugauthorizationnumb>
        <drugdosagetext>20 MG/D</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATTENTION DEFICIT/HYPERACTIVITY DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060605</drugenddate>
        <drugtreatmentduration>95040</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058331-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060626</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2006BE09664</companynumb>
    <primarysource>
      <reportercountry>BELGIUM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>14</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABNORMAL BEHAVIOUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>APNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG WITHDRAWAL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY RATE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RITALIN</medicinalproduct>
        <drugauthorizationnumb>010187</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058350-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060511</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHNU2006DE01939</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>16</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ALCOHOL USE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RITALIN</medicinalproduct>
        <drugauthorizationnumb>10187</drugauthorizationnumb>
        <drugdosagetext>^AS NEEDED^</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATTENTION DEFICIT/HYPERACTIVITY DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALCOHOL</medicinalproduct>
        <drugdosagetext>UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058351-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060713</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2006US09048</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>57</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLISTER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD IMMUNOGLOBULIN E INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHROMATURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EOSINOPHIL COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EOSINOPHILIC PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULAR WEAKNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMOTHORAX TRAUMATIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN TEST POSITIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPUTUM ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINE ODOUR ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMTAN</medicinalproduct>
        <drugauthorizationnumb>020796</drugauthorizationnumb>
        <drugindication>PARKINSON'S DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SELEGILINE HCL</medicinalproduct>
        <drugindication>PARKINSON'S DISEASE</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060613</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SINEMET</medicinalproduct>
        <drugdosagetext>200 MG, TID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058373-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060626</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-ABBOTT-06P-167-0337112-00</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KALETRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>21906</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060427</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060615</drugenddate>
        <drugtreatmentduration>49</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LAMIVUDINE AND ZIDOVUDINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060427</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060615</drugenddate>
        <drugtreatmentduration>49</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PHENOBARBITAL TAB</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>EPILEPSY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PHENYTOIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>EPILEPSY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TENOFOVIR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060427</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060615</drugenddate>
        <drugtreatmentduration>49</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BACTRIM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANTIBIOTIC PROPHYLAXIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058374-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060711</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-ABBOTT-06P-028-0337957-00</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATEMESIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL INTAKE REDUCED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BIAXIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>050662</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>LUNG INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060417</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060418</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058375-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060711</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-ABBOTT-06P-167-0337834-00</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION POTENTIATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL TUBULAR ACIDOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LOPINAVIR/RITONAVIR</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>21906</drugauthorizationnumb>
        <drugdosagetext>400/100 MG TWICE DAILY</drugdosagetext>
        <drugindication>HIV INFECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TENOFOVIR</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugindication>HIV INFECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIDANOSINE</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugindication>HIV INFECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIDANOSINE</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>200 OR 250 MG DAILY</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058376-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060711</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-ABBOTT-06P-167-0338154-00</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION POTENTIATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FANCONI SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LOPINAVIR/RITONAVIR</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>21906</drugauthorizationnumb>
        <drugdosagetext>400/100 MG TWICE DAILY</drugdosagetext>
        <drugindication>HIV INFECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TENOFOVIR</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugindication>HIV INFECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIDANOSINE</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugindication>HIV INFECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIDANOSINE</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>200 OR 250 MG DAILY</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058377-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060713</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-ABBOTT-06P-020-0338126-00</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VALPAKINE TABLETS</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>18081</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>EPILEPSY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060601</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VALPAKINE TABLETS</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>018081</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19960101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060601</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LAMOTRIGINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>EPILEPSY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19960101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058378-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060718</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ABBOTT-06P-087-0338238-00</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>28</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HEPATIC ADENOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POLYCYSTIC OVARIES</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VALPROATE SODIUM</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>018081</drugauthorizationnumb>
        <drugindication>EPILEPSY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058379-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GR-ABBOTT-05P-066-0306683-00</companynumb>
    <primarysource>
      <reportercountry>GREECE</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>104</patientweight>
      <patientsex>1</patientsex>
      <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>20050204</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050721</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050805</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IRBESARTAN</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050721</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEBIVOLOL HYDROCHLORIDE</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050721</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BEGDIN</medicinalproduct>
        <drugindication>PULMONARY EMBOLISM</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BEGDIN</medicinalproduct>
        <drugindication>PYREXIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COMMERCIAL HUMIRA</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031226</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058381-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060711</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-ABBOTT-06P-167-0338158-00</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION POTENTIATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LOPINAVIR/RITONAVIR</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>21906</drugauthorizationnumb>
        <drugdosagetext>400/100 MG TWICE DAILY</drugdosagetext>
        <drugindication>HIV INFECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TENOFOVIR</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugindication>HIV INFECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIDANOSINE</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugindication>HIV INFECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIDANOSINE</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>200 OR 250 MG DAILY</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058382-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060712</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-06P-163-0338072-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>88.53</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FREQUENT BOWEL MOVEMENTS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROSTATITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021402</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPOTHYROIDISM</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19950101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19950101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021402</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19950101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021402</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTIVITAMIN</medicinalproduct>
        <drugindication>VITAMIN SUPPLEMENTATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
        <drugindication>PAIN</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058383-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060713</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BE-ABBOTT-06P-013-0338015-00</companynumb>
    <primarysource>
      <reportercountry>BELGIUM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>51</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAPROTEINAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WALDENSTROM'S MACROGLOBULINAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060308</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060608</drugenddate>
        <drugtreatmentduration>91</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
        <drugindication>PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058384-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060221</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-ABBOTT-06P-167-0325637-00</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>43</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>AMNESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY DISTRESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEPAKOTE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>18723</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INTENTIONAL OVERDOSE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060116</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060116</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALPRAZOLAM</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060116</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060116</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MIRTAZAPINE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AZATHIOPRINE SODIUM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058385-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-ABBOTT-06P-056-0337372-00</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DIPLOPIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MACULAR DEGENERATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060601</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>RISEDRONIC ACID</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM GLUCONATE</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058386-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060712</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-ABBOTT-06P-028-0337964-00</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>15</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BRAIN HERNIATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRAIN OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERAMMONAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VALPROIC ACID</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>018081</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>ATTENTION DEFICIT/HYPERACTIVITY DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VALPROIC ACID</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>018081</drugauthorizationnumb>
        <drugindication>LEARNING DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VALPROIC ACID</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>018081</drugauthorizationnumb>
        <drugindication>ABNORMAL BEHAVIOUR</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VALPROIC ACID</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>018081</drugauthorizationnumb>
        <drugindication>AFFECTIVE DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXEDRINE</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RISPERIDONE</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYPROHEPTADINE HCL</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058387-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060208</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>SE-ABBOTT-06P-150-0324651-00</companynumb>
    <primarysource>
      <reportercountry>SWEDEN</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ATRIAL FIBRILLATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC VALVE DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STATUS ASTHMATICUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030327</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030919</drugenddate>
        <drugtreatmentduration>175</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ROFECOXIB</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BISOPROLOL FUMARATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM CARBONATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUPREDNISOLONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALVEDON DOSE POWDER</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALENDRONATE SODIUM</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058389-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060410</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-ABBOTT-06P-020-0330617-00</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>35</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BRONCHITIS CHRONIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CYTOMEGALOVIRUS INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERICARDITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060322</drugenddate>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEFLAZACORT</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HEPARIN</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060510</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058390-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060713</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>SE-ABBOTT-06P-150-0338017-00</companynumb>
    <primarysource>
      <reportercountry>SWEDEN</reportercountry>
      <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>ABDOMINAL DISTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENITAL NEOPLASM MALIGNANT FEMALE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTESTINAL PERFORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METASTASES TO ABDOMINAL WALL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040602</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060228</drugenddate>
        <drugtreatmentduration>636</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SERETIDE MITE</medicinalproduct>
        <drugdosagetext>50MICROGRAMS/250 MICROGRAMS</drugdosagetext>
        <drugadministrationroute>055</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>CYANOCOBALAMIN</medicinalproduct>
        <drugadministrationroute>050</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AZATHIOPRINE SODIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TERBUTALINE SULFATE</medicinalproduct>
        <drugadministrationroute>050</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VERAPAMIL HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXAZEPAM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN W/ CODEINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MODURETIC 5-50</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOPERAMIDE HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOPICLONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETYLCYSTEIN EFFERVESCENT TAB</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MIRTAZAPINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058391-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060208</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>SE-ABBOTT-06P-150-0324656-00</companynumb>
    <primarysource>
      <reportercountry>SWEDEN</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANTINEUTROPHIL CYTOPLASMIC ANTIBODY POSITIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANTINUCLEAR ANTIBODY POSITIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030613</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030801</drugenddate>
        <drugtreatmentduration>49</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ORUDIS GEL</medicinalproduct>
        <drugadministrationroute>061</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058392-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060711</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-ABBOTT-06P-056-0337972-00</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>45</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIFFUSE LARGE B-CELL LYMPHOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMMUNE SYSTEM DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THERAPEUTIC PRODUCT INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NORVIR</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>20945</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010611</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TMC 114</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060306</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIDANOSINE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060306</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TENOFOVIR</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050203</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EMFUVIRTIDE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060306</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058393-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060712</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-06P-163-0338080-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RITONAVIR SOFT GELATIN CAPSULES</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>20945</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>APTIVUS</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MARAVIROX</medicinalproduct>
        <drugindication>HIV INFECTION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058394-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnesscongenitalanomali>1</seriousnesscongenitalanomali>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060328</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-06P-163-0329156-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>49.032</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ACQUIRED BRONCHIAL CYST</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031217</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050105</drugenddate>
        <drugtreatmentduration>385</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ROFECOXIB</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040901</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEFLUNOMIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058396-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060712</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-ABBOTT-06P-020-0337954-00</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATOTOXICITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VALPROIC ACID</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>018081</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>VALPROIC ACID</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>018081</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>CLOZAPINE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058397-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060711</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-06P-163-0337830-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PSORIATIC ARTHROPATHY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060620</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060706</drugenddate>
        <drugtreatmentduration>16</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE BESYLATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VYTORIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058399-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060712</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>NO-ABBOTT-06P-122-0338064-00</companynumb>
    <primarysource>
      <reportercountry>NORWAY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>VASCULAR ENCEPHALOPATHY</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>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>ARRHYTHMIA PROPHYLAXIS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>ARRHYTHMIA PROPHYLAXIS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058400-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060712</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-06P-163-0337933-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>43.956</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE SCLEROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OPTIC NEURITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN OF SKIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>CROHN'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060614</drugenddate>
        <drugtreatmentduration>10</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058401-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060608</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ABBOTT-06P-087-0335646-00</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>73</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>DECREASED APPETITE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METASTASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NASOPHARYNGEAL CANCER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NORVIR</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>20945</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050630</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050904</drugenddate>
        <drugtreatmentduration>66</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZIDOVUDINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050629</drugenddate>
        <drugtreatmentduration>88</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LAMIVUDINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050904</drugenddate>
        <drugtreatmentduration>155</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ABACAVIR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050629</drugenddate>
        <drugtreatmentduration>88</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EFAVIRENZ</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050629</drugenddate>
        <drugtreatmentduration>88</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATAZANAVIR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050630</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050904</drugenddate>
        <drugtreatmentduration>66</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TENOFOVIR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050630</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050904</drugenddate>
        <drugtreatmentduration>66</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BACTRIM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANTIBIOTIC PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050904</drugenddate>
        <drugtreatmentduration>155</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058408-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20031106</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-03P-163-0240414-00</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>34</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EOSINOPHIL COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LETHARGY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENTAL STATUS CHANGES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY EOSINOPHILIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH MACULAR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VALPROIC ACID</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>018081</drugauthorizationnumb>
        <drugindication>SCHIZOPHRENIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VALPROIC ACID</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>018081</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLOZAPINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENZTROPEINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HALOPERIDOL</medicinalproduct>
        <drugindication>SCHIZOPHRENIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HALOPERIDOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OLANZAPINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROPRANOLOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIPHENHYDRAMINE HCL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058428-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060308</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2006US03131</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </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>MANIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LITHIUM CARBONATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZARIL</medicinalproduct>
        <drugauthorizationnumb>019758</drugauthorizationnumb>
        <drugdosagetext>400 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZARIL</medicinalproduct>
        <drugauthorizationnumb>019758</drugauthorizationnumb>
        <drugdosagetext>GRADUALLY INCREASED</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040901</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058430-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060327</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2006US04068</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>70</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD ALBUMIN 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 POTASSIUM INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD UREA INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CREATININE RENAL CLEARANCE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GLOBULINS INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GLOMERULAR FILTRATION RATE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROTEIN TOTAL DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROTEIN TOTAL INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VESSEL PUNCTURE SITE HAEMATOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXJADE</medicinalproduct>
        <drugauthorizationnumb>21882</drugauthorizationnumb>
        <drugdosagetext>UNK, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD IRON INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060504</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060522</drugenddate>
        <drugtreatmentduration>27360</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXJADE</medicinalproduct>
        <drugauthorizationnumb>021882</drugauthorizationnumb>
        <drugdosagetext>250 MG, QD</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060214</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060218</drugenddate>
        <drugtreatmentduration>7200</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASCORBIC ACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMICAR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARDIZEM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BERICAR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN B6</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAMBOCOR</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058431-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060424</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2006US05389</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>75</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>67.12</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CREATININE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD UREA INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD URINE PRESENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHOLECYSTITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA EXERTIONAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROTEIN URINE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RALES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINE OUTPUT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISION BLURRED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXJADE</medicinalproduct>
        <drugauthorizationnumb>21882</drugauthorizationnumb>
        <drugdosagetext>1250 MG, QD</drugdosagetext>
        <drugindication>SERUM FERRITIN INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060314</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060405</drugenddate>
        <drugtreatmentduration>33120</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058439-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060714</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2006US09097</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>76</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>BONE MARROW FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMPUTERISED TOMOGRAM ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUCORMYCOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NUCLEAR MAGNETIC RESONANCE IMAGING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORBITAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCYTOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAROPHTHALMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUSITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXJADE</medicinalproduct>
        <drugbatchnumb>F0009</drugbatchnumb>
        <drugauthorizationnumb>21882</drugauthorizationnumb>
        <drugdosagetext>2000 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD IRON</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060620</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060702</drugenddate>
        <drugtreatmentduration>18720</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>81 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTERIOSCLEROSIS CORONARY ARTERY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugdosagetext>75 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTERIOSCLEROSIS CORONARY ARTERY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050901</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMDUR</medicinalproduct>
        <drugdosagetext>30 MG, QD</drugdosagetext>
        <drugindication>ARTERIOSCLEROSIS CORONARY ARTERY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugdosagetext>40 MG, QD</drugdosagetext>
        <drugindication>ARTERIOSCLEROSIS CORONARY ARTERY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058440-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060608</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHO2006FR09362</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>21</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>42</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ALANINE AMINOTRANSFERASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ALANINE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASPARTATE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIOMYOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FACE OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VERTIGO</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EFFERALGAN</medicinalproduct>
        <drugindication>HEADACHE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060604</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060605</drugenddate>
        <drugtreatmentduration>2880</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ICL670A</medicinalproduct>
        <drugauthorizationnumb>021882</drugauthorizationnumb>
        <drugdosagetext>875 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD IRON INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060524</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060605</drugenddate>
        <drugtreatmentduration>18720</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ICL670A</medicinalproduct>
        <drugauthorizationnumb>021882</drugauthorizationnumb>
        <drugdosagetext>NO TREATMENT</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060606</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060609</drugenddate>
        <drugtreatmentduration>5760</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ICL670A</medicinalproduct>
        <drugauthorizationnumb>021882</drugauthorizationnumb>
        <drugdosagetext>875 MG, QD</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060610</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060622</drugenddate>
        <drugtreatmentduration>18720</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058441-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060717</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2006US09148</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>48</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>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 IRON ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEEP VEIN THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ELECTROLYTE IMBALANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUID OVERLOAD</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GRAFT VERSUS HOST DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMODIALYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTUBATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RADIOTHERAPY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPTIC SHOCK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STEM CELL TRANSPLANT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENOOCCLUSIVE LIVER DISEASE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXJADE</medicinalproduct>
        <drugauthorizationnumb>021882</drugauthorizationnumb>
        <drugdosagetext>2500 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD IRON</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060512</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TACROLIMUS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058442-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060707</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2006US08732</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>69</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPTIC SHOCK</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXJADE</medicinalproduct>
        <drugbatchnumb>F0010</drugbatchnumb>
        <drugauthorizationnumb>021882</drugauthorizationnumb>
        <drugdosagetext>2000 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MYELODYSPLASTIC SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060608</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugdosagetext>10 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058443-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060714</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060712</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>DL2006324</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>21</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ENDOMETRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIFEPRISTONE TABLETS, 200 MG (DANCO LABS)</medicinalproduct>
        <drugbatchnumb>05004005762</drugbatchnumb>
        <drugauthorizationnumb>20687</drugauthorizationnumb>
        <drugdosagetext>200 MG, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ABORTION INDUCED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060428</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MISOPROSTOL</medicinalproduct>
        <drugdosagetext>800 MCG, BUCCAL</drugdosagetext>
        <drugadministrationroute>002</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060430</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058444-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060626</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-NOVOPROD-254519</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>43</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>83</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GLUCAGEN</medicinalproduct>
        <drugbatchnumb>SW60023</drugbatchnumb>
        <drugauthorizationnumb>20918</drugauthorizationnumb>
        <drugdosagetext>1 MG, SINGLE</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>GLUCOSE TOLERANCE TEST</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060612</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060612</drugenddate>
        <drugtreatmentduration>1440</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GLUCAGEN</medicinalproduct>
        <drugbatchnumb>SW60172</drugbatchnumb>
        <drugauthorizationnumb>020918</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIAMICRON</medicinalproduct>
        <drugindication>DIABETES MELLITUS NON-INSULIN-DEPENDENT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
        <drugindication>DIABETES MELLITUS NON-INSULIN-DEPENDENT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPERGIC</medicinalproduct>
        <drugdosagetext>160 MG, UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058445-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060710</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-NOVOPROD-254776</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>11</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>25</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>COLITIS ULCERATIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NORDITROPIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021148</drugauthorizationnumb>
        <drugdosagetext>1.8 MG, QD 6 DAYS A WEEK</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>TURNER'S SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050301</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058446-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060626</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-NOVOPROD-254511</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>2</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>CARDIAC ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GLUCAGEN</medicinalproduct>
        <drugbatchnumb>SW60172</drugbatchnumb>
        <drugauthorizationnumb>20918</drugauthorizationnumb>
        <drugdosagetext>1 MG, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>GLUCAGON TOLERANCE TEST</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060626</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060626</drugenddate>
        <drugtreatmentduration>1440</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
        <drugdosagetext>4 IU, UNK</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>DIABETES MELLITUS INSULIN-DEPENDENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050701</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058447-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060324</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHO2006JP05130</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>63</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BACTERIAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CANDIDA PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FUNGAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LARYNGEAL OPERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG INFILTRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NASOPHARYNGEAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ODYNOPHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OESOPHAGEAL ULCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARYNGOLARYNGEAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRODUCTIVE COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXJADE</medicinalproduct>
        <drugauthorizationnumb>021882</drugauthorizationnumb>
        <drugdosagetext>750 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MYELODYSPLASTIC SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060614</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRAVIT</medicinalproduct>
        <drugdosagetext>UNK, NO TREATMENT</drugdosagetext>
        <drugindication>PNEUMONIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060320</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060412</drugenddate>
        <drugtreatmentduration>34560</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRAVIT</medicinalproduct>
        <drugdosagetext>400 MG, QD</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060413</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRAVIT</medicinalproduct>
        <drugdosagetext>400 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050728</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060319</drugenddate>
        <drugtreatmentduration>235</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NAPA</medicinalproduct>
        <drugdosagetext>2 G, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060223</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TEGRETOL</medicinalproduct>
        <drugdosagetext>600 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XYLOCAINE</medicinalproduct>
        <drugdosagetext>12 ML, UNK</drugdosagetext>
        <drugadministrationroute>061</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058448-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060710</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-NOVOPROD-254779</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>2</patientonsetage>
      <patientonsetageunit>803</patientonsetageunit>
      <reaction>
        <reactionmeddrapt>INTRACARDIAC THROMBUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NOVOSEVEN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>UNKNOWN</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058449-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060710</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-NOVOPROD-254836</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>60</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>101</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEPRESSED LEVEL OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GLUCAGEN</medicinalproduct>
        <drugbatchnumb>SW60172</drugbatchnumb>
        <drugauthorizationnumb>020918</drugauthorizationnumb>
        <drugdosagetext>1 MG, SINGLE</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>GLUCAGON TOLERANCE TEST</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060613</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060613</drugenddate>
        <drugtreatmentduration>1440</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GLUCAGEN</medicinalproduct>
        <drugbatchnumb>SW60023</drugbatchnumb>
        <drugauthorizationnumb>020918</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>STAGID</medicinalproduct>
        <drugdosagetext>700 MG, QD</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058450-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060710</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-NOVOPROD-254777</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>4</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>VENA CAVA THROMBOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NOVOSEVEN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>UNKNOWN</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058451-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060707</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CHNY2006JP01793</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>0</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEUKAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAVEGYL</medicinalproduct>
        <drugauthorizationnumb>20925</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058452-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040508</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CHNY2004AU02891</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG TOXICITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSGEUSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISION BLURRED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL ACUITY REDUCED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALPHAPHARM QUITX  (NICOTINE)</medicinalproduct>
        <drugbatchnumb>306000</drugbatchnumb>
        <drugauthorizationnumb>20076</drugauthorizationnumb>
        <drugdosagetext>21 MG, TRANSDERMAL</drugdosagetext>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>SMOKING CESSATION THERAPY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058453-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050613</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CHNY2005NL02980</companynumb>
    <primarysource>
      <reportercountry>NETHERLANDS</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>46</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>51</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EAR PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLUENZA LIKE ILLNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARYNGOLARYNGEAL PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NICOTINE TTS</medicinalproduct>
        <drugauthorizationnumb>20076</drugauthorizationnumb>
        <drugdosagetext>21 MG, QD, TRANSDERMAL</drugdosagetext>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>SMOKING CESSATION THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050502</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050503</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058454-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060710</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CHNY2006JP02089</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANGIONEUROTIC OEDEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NICOTINELL TTS             (NICOTINE)</medicinalproduct>
        <drugauthorizationnumb>20076</drugauthorizationnumb>
        <drugdosagetext>TRANSDERMAL</drugdosagetext>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>SMOKING CESSATION THERAPY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058455-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060706</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0430766A</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>77</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>63.5489</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ATRIAL FIBRILLATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EXTRAPYRAMIDAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IATROGENIC INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARKINSONISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROTEIN TOTAL INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
        <drugauthorizationnumb>20031</drugauthorizationnumb>
        <drugdosagetext>20 MG / PER DAY</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
        <drugtreatmentduration>46</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VALPROATE SODIUM</medicinalproduct>
        <drugdosagetext>1200 MG / PER DAY / INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>EPILEPSY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VALPROATE SODIUM</medicinalproduct>
        <drugdosagetext>PER DAY / ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>EPILEPSY</drugindication>
        <drugtreatmentduration>63</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMIODARONE HCL</medicinalproduct>
        <drugdosagetext>PER DAY</drugdosagetext>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BUFLOMEDIL HYDROCHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GABAPENTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CITALOPRAM HYDROBROMIDE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058457-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060713</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-2006-016821</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>68</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CHOLANGITIS SCLEROSING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CAMPATH</medicinalproduct>
        <drugdosagetext>30 MG, 3X/WEEK, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CHRONIC LYMPHOCYTIC LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050420</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050820</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BACTRIM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALACYCLOVIR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEDERFOLIN  (CALCIUM FOLINATE)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058458-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060704</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-2006-018003</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>65</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>93</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>APHTHOUS STOMATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EAR PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MIDDLE EAR DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TONGUE NEOPLASM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CAMPATH</medicinalproduct>
        <drugdosagetext>30 MG, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CHRONIC LYMPHOCYTIC LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050926</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060223</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUDARABINE PHOSPHAT (SH L 573)</medicinalproduct>
        <drugdosagetext>63 MG, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CHRONIC LYMPHOCYTIC LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051004</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060223</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COTRIM DS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FAMVIR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORMOC (BROMAZEPAM)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANTOZOL (PANTOPRAZOLE SODIUM)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAMADOL HCL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058460-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060704</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DSA_28482_2006</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>84</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>INTERNATIONAL NORMALISED RATIO INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY BLADDER HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY RETENTION</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>20060522</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EUPANTOL</medicinalproduct>
        <drugdosagetext>40 MG Q DAY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060522</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEMIGOXINE NATIVELLE</medicinalproduct>
        <drugdosagetext>0.125 MG Q DAY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060522</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NOVONORM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORSET</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058461-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060710</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-JNJFOC-20060701660</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DIARRHOEA HAEMORRHAGIC</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugdosagetext>INFUSION # 12</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugdosagetext>INFUSION # 11</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugdosagetext>TEN INFUSIONS ON UNSPECIFIED DATES</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058462-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060710</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20050805739</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CHRONIC RESPIRATORY FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL CANDIDIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMOCYSTIS JIROVECI PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</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>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RANITIDINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CAPTOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM CARBONATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058463-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060710</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20060701774</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>63.5</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CROHN'S DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFUSION RELATED REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRISMUS</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>
        <drugdosagetext>2 INFUSIONS PRIOR TO BASELINE</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CROHN'S DISEASE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058464-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060711</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-JNJFOC-20060702112</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFUSION RELATED REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN JAW</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARYNGOLARYNGEAL PAIN</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>STATEX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCONTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALTACE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMYTRIPTYLINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHYAZIDE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058465-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060710</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-JNJFOC-20060605836</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>40</patientweight>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>INTERSTITIAL LUNG DISEASE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RHEUMATREX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELESTONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAGAMET</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BONALON</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIAMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MOHRUS TAPE</medicinalproduct>
        <drugadministrationroute>047</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058466-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060711</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-JNJFOC-20050800184</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>57</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD LACTATE DEHYDROGENASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG ERUPTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JOINT ARTHROPLASTY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NASOPHARYNGITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMOCYSTIS JIROVECI PNEUMONIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </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>6 INFUSIONS, DATES UNSPECIFIED</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>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050627</drugenddate>
        <drugtreatmentduration>29</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050627</drugenddate>
        <drugtreatmentduration>29</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050627</drugenddate>
        <drugtreatmentduration>29</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BACTRIM</medicinalproduct>
        <drugindication>PNEUMONIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BENAMBAX</medicinalproduct>
        <drugindication>PNEUMONIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GASTER D</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS AGAINST GASTROINTESTINAL ULCER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VOLTAREN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRALGIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYTOTEC</medicinalproduct>
        <drugdosagetext>DOSE=RG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOSAMAC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEPAS</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INSOMNIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030829</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050627</drugenddate>
        <drugtreatmentduration>669</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIAPHENYLSULFONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058467-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060703</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DSA_28403_2006</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>24</patientonsetage>
      <patientonsetageunit>802</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ACCIDENTAL OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAVOR</medicinalproduct>
        <drugauthorizationnumb>17794</drugauthorizationnumb>
        <drugdosagetext>2 MG ONCE PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060703</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060703</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058468-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060711</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-JNJFOC-20050805471</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>49</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD ALKALINE PHOSPHATASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISSEMINATED TUBERCULOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAMMA-GLUTAMYLTRANSFERASE 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>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RHEUMATREX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RHEUMATREX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RHEUMATREX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RHEUMATREX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RHEUMATREX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDONINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VOLTAREN</medicinalproduct>
        <drugadministrationroute>054</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADRENAL HORMONE PREPARATIONS</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIAMIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GASTER</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DAONIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGTECT</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PURSENNID</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058469-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060711</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20060600129</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>68.49</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>COLON ADENOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROOESOPHAGEAL REFLUX DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OESOPHAGITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCREATIC DISORDER</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>RHEUMATOID ARTHRITIS</drugindication>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SULFASALAZINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROTONIX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058470-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060711</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20060501051</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>TUBERCULOSIS SKIN TEST POSITIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058471-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060718</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2006-BP-08236BR</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>ARRHYTHMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
        <drugbatchnumb>NR</drugbatchnumb>
        <drugauthorizationnumb>021395</drugauthorizationnumb>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050601</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COMBIVENT</medicinalproduct>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050601</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058472-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060714</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2006-BP-08112NB</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DEPRESSED LEVEL OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MEXITIL</medicinalproduct>
        <drugauthorizationnumb>018873</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060426</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060426</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ANAFRANIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060426</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOXONIN (LOXOPROFEN SODIUM)</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060301</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SELBEX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060321</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYANOCOBALAMIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>TRIGEMINAL NEURALGIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060321</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058473-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060719</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2006-BP-08337NB</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>68</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MICARDIS</medicinalproduct>
        <drugauthorizationnumb>020850</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058474-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050818</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2005-BP-15278NB</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>KAPOSI'S SARCOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIRAMUNE</medicinalproduct>
        <drugauthorizationnumb>20636</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041011</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EPIVIR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040917</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZERIT</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041126</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NORVIR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040917</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040927</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>STOCRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041005</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041010</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REYATAZ</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040917</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040927</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIREAD</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040917</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041123</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MYCOSYST</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MENINGITIS CRYPTOCOCCAL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040716</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041106</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DENOSINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041011</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041106</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058475-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060719</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2006-BP-08306BR</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>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ATENSINA</medicinalproduct>
        <drugbatchnumb>NR</drugbatchnumb>
        <drugauthorizationnumb>17407</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060301</drugstartdate>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OLCADIL</medicinalproduct>
        <drugindication>DEPRESSION</drugindication>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058476-5</safetyreportid>
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    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
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    <receivedate>20060721</receivedate>
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    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>0</patientonsetage>
      <patientonsetageunit>805</patientonsetageunit>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POTTER'S SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY HYPOPLASIA</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CATAPRES</medicinalproduct>
        <drugauthorizationnumb>017407</drugauthorizationnumb>
        <drugadministrationroute>015</drugadministrationroute>
        <drugindication>ESSENTIAL HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030201</drugstartdate>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADEPAL</medicinalproduct>
        <drugadministrationroute>015</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030131</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
        <drugadministrationroute>015</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TEMESTA</medicinalproduct>
        <drugadministrationroute>015</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE</medicinalproduct>
        <drugadministrationroute>015</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030131</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALPRAZOLAM</medicinalproduct>
        <drugadministrationroute>015</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030131</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058477-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060710</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>14389</companynumb>
    <primarysource>
      <reportercountry>ITALY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>62</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CHILLS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEBRILE NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE TAB</medicinalproduct>
        <drugauthorizationnumb>71484</drugauthorizationnumb>
        <drugdosagetext>40 MG DAILY IV</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>CERVIX CARCINOMA RECURRENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060524</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060527</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOXORUBICINE</medicinalproduct>
        <drugdosagetext>100 MG DAILY IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060527</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060528</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VINCRISTINE</medicinalproduct>
        <drugdosagetext>2 MG DAILY IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060527</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060527</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOPHOSPHAMIDE</medicinalproduct>
        <drugdosagetext>620 MG BID IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060524</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060526</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RITUXIMAB</medicinalproduct>
        <drugdosagetext>780 MG DAILY</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060529</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060529</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEUPOGEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUCONAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOFLOXACIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALACYCLOVIR HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HALOPURINOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CEFTRIAXONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAZOCIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCORTISONE TAB</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058478-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060713</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>STA-AE-05-MTX-017</companynumb>
    <primarysource>
      <reportercountry>ZAIRE</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>57</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABSCESS SOFT TISSUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACTERIAL INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugauthorizationnumb>8085</drugauthorizationnumb>
        <drugdosagetext>15 MG - ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041203</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ORENCIA</medicinalproduct>
        <drugdosagetext>IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050511</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugdosagetext>IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050511</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PLACEBO</medicinalproduct>
        <drugdosagetext>IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050511</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE TAB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VELTEX (DICLOFENAC SODIUM)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058479-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060710</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200610498BFR</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>78</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>83</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBRAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MELAENA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METASTASES TO CENTRAL NERVOUS SYSTEM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXAVAR</medicinalproduct>
        <drugauthorizationnumb>21923</drugauthorizationnumb>
        <drugdosagetext>200 MG, BID, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>METASTATIC RENAL CELL CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060519</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060524</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MOVICOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEBRIDAT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058480-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060705</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>RENA-11746</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>61</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIVERTICULITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIVERTICULUM INTESTINAL HAEMORRHAGIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ENTERITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRITIS EROSIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STRESS AT WORK</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PHOSBLOCK</medicinalproduct>
        <drugauthorizationnumb>21179</drugauthorizationnumb>
        <drugdosagetext>0.75 G DAILY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERPHOSPHATAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060208</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060323</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HERBAL MEDICINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ETHYL (ICOSAPENTATE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RANITIDINE HYDROCHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TEPRENONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRECIPITATED CALCIUM CARBONATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE BESYLATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CANDESARTAN CILEXETIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FEXOFENADINE HYDROCHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM POLYSTYRENE SULFONATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EPOETIN ALPHA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RABEPRAZOLE SODIUM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058481-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060703</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>280001M06JPN</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>34</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>48</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ARTIFICIAL INSEMINATION BY PARTNER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALSE POSITIVE LABORATORY RESULT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATITIS C</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFECTIOUS MONONUCLEOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FERTINORM P                 (MENOTROPHIN)</medicinalproduct>
        <drugauthorizationnumb>19415</drugauthorizationnumb>
        <drugdosagetext>75 IU, 1 IN 1 DAYS</drugdosagetext>
        <drugindication>INFERTILITY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060518</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060521</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PERGOGREEN (MENOTROPHIN)</medicinalproduct>
        <drugdosagetext>75 IU, 1 IN 1 DAYS</drugdosagetext>
        <drugindication>INFERTILITY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060522</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060524</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BUSERELIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDROXYPROGESTERONE ACETATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EUGYNON</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058482-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060711</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>E2090-00035-SPO-GB</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>40</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>AGGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSYCHOTIC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREATMENT NONCOMPLIANCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZONEGRAN</medicinalproduct>
        <drugauthorizationnumb>20789</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>EPILEPSY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PHENYTOIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KEPPRA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPIRAMATE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058483-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060711</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20060702036</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>85.28</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INFUSION RELATED REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY ARREST</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058484-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060711</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20060702068</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MENINGIOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugdosagetext>4 INFUSIONS IN 2006</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PSORIATIC ARTHROPATHY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058485-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060711</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20060702069</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>AMNESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISORIENTATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058486-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060711</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20060702127</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>58.06</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>NODULE ON EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARALYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLANTAR ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISION BLURRED</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>DURAGESIC-100</medicinalproduct>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugdosagetext>.75 MG AND .5 MG DAILY</drugdosagetext>
        <drugindication>NERVE INJURY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUID PILLS</medicinalproduct>
        <drugindication>FLUID RETENTION</drugindication>
        <drugtreatmentduration>34</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PERCOCET</medicinalproduct>
        <drugindication>PAIN</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058487-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060711</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20060702149</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>85.73</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ATRIAL FIBRILLATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC 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>CROHN'S DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM CHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENTOCORT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PENTASA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACIPHEX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOMOTIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COLESTID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMITREX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVSINEX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058488-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060711</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20060702167</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CELLULITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIMB INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CROHN'S DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugindication>CROHN'S DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASACOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AXID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIAZEPAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>B-12</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058489-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060713</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BE-ABBOTT-06P-013-0338013-00</companynumb>
    <primarysource>
      <reportercountry>BELGIUM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>POLYNEUROPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNOVITIS</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>20060615</drugenddate>
        <drugtreatmentduration>744</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058490-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060713</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DK-ABBOTT-06P-044-0337984-00</companynumb>
    <primarysource>
      <reportercountry>DENMARK</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>80</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BUNDLE BRANCH BLOCK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FUNGAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENTRICULAR FIBRILLATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KLACID I.V.</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>50662</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PNEUMONIA LEGIONELLA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060707</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>FLUCONAZOLE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>INFUSION</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>FUNGAL INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060710</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060710</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMIODARONE HYDROCHLORIDE</medicinalproduct>
        <drugdosagetext>INFUSION</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060707</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMIODARONE HYDROCHLORIDE</medicinalproduct>
        <drugindication>PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CIPROFLOXACIN LACTATE</medicinalproduct>
        <drugdosagetext>INFUSION</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PNEUMONIA LEGIONELLA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060707</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAXOCIN</medicinalproduct>
        <drugdosagetext>INFUSION</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PNEUMONIA LEGIONELLA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060707</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HEPARIN</medicinalproduct>
        <drugdosagetext>INFUSION 1500 IE</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NONADRENALINE INFUSION</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOBUTAMINE HCL</medicinalproduct>
        <drugdosagetext>INFUSION</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DORMICUM</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FENTANYL TRANSDERMAL SYSTEM</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANTOPRAZOLE SODIUM</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058491-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041223</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>MX-ABBOTT-04P-107-0284578-00</companynumb>
    <primarysource>
      <reportercountry>MEXICO</reportercountry>
    </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>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ELECTROLYTE IMBALANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC STEATOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPONATRAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NORMOCHROMIC NORMOCYTIC ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL CANDIDIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYELONEPHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPLENOMEGALY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KALETRA</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>21226</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV TEST POSITIVE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040414</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BACTRIM</medicinalproduct>
        <drugindication>INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041212</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ITRACONAZOLE</medicinalproduct>
        <drugindication>INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041212</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RANITIDINE</medicinalproduct>
        <drugindication>PROPHYLAXIS AGAINST GASTROINTESTINAL ULCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041212</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOPERAMIDE</medicinalproduct>
        <drugindication>DIARRHOEA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041212</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CEFTRIAXONE</medicinalproduct>
        <drugindication>INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041214</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LAMIVUDINE AND ZIDOVUDINE</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040414</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058492-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060714</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-ABBOTT-06P-167-0338099-00</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>92</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>VARICOSE VEIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VASCULITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031212</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELECOXIB</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN W/ PROPOXYPHENE HCL</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>MULTIVITAMIN</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VENLAFAXINE HCL</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASCORBIC ACID</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058493-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060602</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-ABBOTT-06P-056-0334940-00</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABNORMAL DREAMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HALLUCINATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HALLUCINATION, AUDITORY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HALLUCINATION, VISUAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL DISTURBANCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KALETRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>21226</drugauthorizationnumb>
        <drugdosagetext>3 DOSAGE FORM AT AM AND 3 DOSAGE FORM AT PM</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060321</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ABACAVIR/LAMIVUDINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060321</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATOVAQUONE</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060219</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZLOPIDEM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROXYZINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058494-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060612</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ABBOTT-06P-087-0335723-00</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>14.9</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>CHEILITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONJUNCTIVAL HYPERAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAMMA-GLUTAMYLTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATITIS CHOLESTATIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESTLESSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STEVENS-JOHNSON SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOXIC EPIDERMAL NECROLYSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CEFZON FINE GRANULE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>50749</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>UPPER RESPIRATORY TRACT INFLAMMATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040616</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040618</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CEFZON FINE GRANULE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>050749</drugauthorizationnumb>
        <drugindication>PHARYNGITIS</drugindication>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ANHIBA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>054</drugadministrationroute>
        <drugindication>HYPERTHERMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040616</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040626</drugenddate>
        <drugtreatmentduration>10</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CEFPODOXIME PROXETIL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>UPPER RESPIRATORY TRACT INFLAMMATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040627</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040628</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTHERMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040627</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040628</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BIOFERMIN</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060627</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058495-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060713</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-ABBOTT-06P-056-0338130-00</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>25</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABORTION INDUCED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEPAKENE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>018081</drugauthorizationnumb>
        <drugindication>EPILEPSY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LAMOTRIGINE</medicinalproduct>
        <drugindication>EPILEPSY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058496-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060713</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-ABBOTT-06P-062-0338083-00</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HYPOACUSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TINNITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLARITHROMYCIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>50662</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HELICOBACTER INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PANTOPRAZOLE SODIUM</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HELICOBACTER INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMOXICILLIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HELICOBACTER INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058497-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060516</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-ABBOTT-06P-028-0333531-00</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>91</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD SODIUM DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051214</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EMTEC</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>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DILTIAZEM HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANTOPRAZOLE SODIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ESTROGENS CONJUGATED</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BROMAZEPAM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugadministrationroute>050</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM WITH VITAMIN D</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EURO D</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058498-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060712</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ES-ABBOTT-06P-144-0337949-00</companynumb>
    <primarysource>
      <reportercountry>SPAIN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>69</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ARTHRITIS BACTERIAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPTIC SHOCK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STREPTOCOCCAL INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060627</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060627</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEFLUNOMIDE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DICLOFENAC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058499-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060714</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-06P-163-0338102-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FAECALOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STREPTOCOCCAL INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060401</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058500-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060714</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GR-ABBOTT-06P-066-0338088-00</companynumb>
    <primarysource>
      <reportercountry>GREECE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>51</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <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>20060614</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEFLUNOMIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KARVEA HCT</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>20030101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058501-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesscongenitalanomali>1</seriousnesscongenitalanomali>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060713</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-ABBOTT-06P-056-0338131-00</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>ARNOLD-CHIARI MALFORMATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRAIN HERNIATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONGENITAL HAND MALFORMATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENINGOMYELOCELE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MICROCEPHALY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY MALFORMATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKULL MALFORMATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPINA BIFIDA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TALIPES</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEPAKENE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>018081</drugauthorizationnumb>
        <drugindication>DRUG EXPOSURE DURING PREGNANCY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058502-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060712</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FI-ABBOTT-06P-055-0337942-00</companynumb>
    <primarysource>
      <reportercountry>FINLAND</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ARRHYTHMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUDDEN DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REDUCTIL 15MG</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>20632</drugauthorizationnumb>
        <drugindication>WEIGHT CONTROL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060115</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060603</drugenddate>
        <drugtreatmentduration>138</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058503-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060626</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CZ-ABBOTT-06P-217-0336909-00</companynumb>
    <primarysource>
      <reportercountry>CZECH REPUBLIC</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>66.5</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>AORTIC ARTERIOSCLEROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIOMEGALY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBRAL ATROPHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSED MOOD</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISORIENTATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FISTULA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEMIPLEGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ISCHAEMIC STROKE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARESIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY CONGESTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VERTIGO</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZEMPLAR</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>20819</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>HYPERPARATHYROIDISM</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060405</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENALAPRIL MALEATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASCORUTIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RENAL FAILURE CHRONIC</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETYLSALICYLIC ACID SRT</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PLATELET AGGREGATION INHIBITION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NITRENDIPINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TELMISARTAN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYNT</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SEVELAMER HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RENAL FAILURE CHRONIC</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM CARBONATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RENAL FAILURE CHRONIC</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SULODEXIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MYOCARDIAL ISCHAEMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CAPIVEN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>VENOUS INSUFFICIENCY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOCLOPRAMIDE HYDROCHLORIDE</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONAZEPAM</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>F1/1 200 ML + OXANTIL + NACL + RANITAL</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>BISULEPIN 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>GABAPENTIN</medicinalproduct>
        <drugindication>INITIAL INSOMNIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060501</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GABAPENTIN</medicinalproduct>
        <drugindication>RESTLESS LEGS SYNDROME</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOMOTIL</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PYRIDOXINE HYDROCHLORIDE INJ</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GABAPENTIN</medicinalproduct>
        <drugindication>INSOMNIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GABAPENTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GABAPENTIN</medicinalproduct>
        <drugindication>PARAESTHESIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058530-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050327</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL124140</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>88</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>ANAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050322</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058531-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050324</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL123236</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>RED BLOOD CELL SEDIMENTATION RATE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugindication>ANAEMIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058532-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040211</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-US066803</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>69.9</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CHILLS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHROMATURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRY SKIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE BRUISING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>ANAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030108</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058533-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050328</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL124300</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEEP VEIN THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>ANAEMIA OF MALIGNANT DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058534-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050314</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL121237</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugindication>MYELODYSPLASTIC SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040601</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058535-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050318</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL122413</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>80</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugindication>ANAEMIA OF MALIGNANT DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050301</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058536-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050316</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL122278</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>70</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>71.7</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>PREOPERATIVE CARE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040901</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058537-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050316</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL122279</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>76</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>MYELODYSPLASTIC SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058538-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050320</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL122537</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugindication>ANAEMIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058539-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050323</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL123127</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <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>PROCRIT</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugindication>ANAEMIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058540-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20051209</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-US160911</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD IRON DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EPOGEN</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRE-EXISTING DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050901</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058541-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20051209</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-US160928</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>74</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>THERAPEUTIC RESPONSE DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EPOGEN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>RENAL FAILURE CHRONIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051205</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058542-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20051210</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL161304</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>48</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>LEUKOCYTOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>RENAL FAILURE CHRONIC</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058543-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20051212</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL161302</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>58</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>78.1</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ACTIVITIES OF DAILY LIVING IMPAIRED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RENAL FAILURE CHRONIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058544-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20051212</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL161303</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>41.6</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RETICULOCYTE COUNT 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>20020501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051214</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031001</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058545-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20051212</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL161311</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>80.4</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>THERAPEUTIC RESPONSE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TIBIA FRACTURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RENAL FAILURE CHRONIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020717</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051216</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058546-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20051213</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL161519</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugindication>ANAEMIA OF MALIGNANT DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058547-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20051213</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL161521</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BONE PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugindication>RENAL FAILURE CHRONIC</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058548-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20051213</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-US161319</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>THERAPEUTIC RESPONSE DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EPOGEN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>DIALYSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058549-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20051213</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-US161326</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>79</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HYPERKALAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugindication>RENAL FAILURE CHRONIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058550-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040817</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL087638</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>90.8</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ALOPECIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>RENAL FAILURE CHRONIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040504</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058551-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050324</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL123229</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BODY TEMPERATURE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHILLS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugindication>RENAL FAILURE CHRONIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050301</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058552-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050329</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL124450</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>86</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>73.5</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLUENZA LIKE ILLNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugindication>ANAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050301</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058553-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050311</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL120775</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BONE PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugindication>ANAEMIA OF MALIGNANT DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058554-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050311</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-US120414</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>69.5</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>THERAPEUTIC RESPONSE DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EPOGEN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>DIALYSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040510</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040615</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040615</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040616</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040616</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040622</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050312</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050203</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040615</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040525</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040601</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058555-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050209</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-US112696</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>57.8</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>THERAPEUTIC RESPONSE DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EPOGEN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>DIALYSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990301</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030626</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050122</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040514</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030724</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010621</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050218</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990726</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20000526</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058557-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050316</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL122276</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT AND COLD</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PRE-EXISTING DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058558-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041207</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL102422</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>86</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PRODUCTIVE COUGH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugindication>ANAEMIA OF MALIGNANT DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058559-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050323</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL123129</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>68.1</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH PAPULAR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>ANAEMIA OF MALIGNANT DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050301</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058560-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050329</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL124447</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>PRE-EXISTING DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050326</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058569-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20051214</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL161688</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>71.5</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN 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>19990901</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058570-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20051214</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL161690</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>78</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HICCUPS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>ANAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050907</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058571-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20051214</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-US161737</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>RENAL FAILURE CHRONIC</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058572-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20051215</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL161799</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD BILIRUBIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RETICULOCYTE COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugindication>ANAEMIA OF MALIGNANT DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050901</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058573-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20051215</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL161903</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>73</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>94</patientweight>
      <patientsex>2</patientsex>
      <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>20041116</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051130</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058574-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20051216</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL161800</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugindication>MYELODYSPLASTIC SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050513</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051214</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058575-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20051216</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-US161861</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>27</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>RETICULOCYTE COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THERAPEUTIC RESPONSE DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EPOGEN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>DIALYSIS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051201</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058576-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20051219</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL162280</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>76.3</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LACRIMATION INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POLLAKIURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THERAPEUTIC RESPONSE DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>RENAL FAILURE CHRONIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050714</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058577-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20051219</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL162282</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHOTOPSIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PRE-EXISTING DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051216</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058578-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20051219</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL162420</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>73.5</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>THERAPEUTIC RESPONSE DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RENAL FAILURE CHRONIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058579-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050930</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL153743</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>72.6</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>RENAL FAILURE CHRONIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050920</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058580-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20051220</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-US162076</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEDICATION ERROR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EPOGEN</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugindication>ANAEMIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058581-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050919</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL151043</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>36</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>53.6</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INFLUENZA LIKE ILLNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>ANAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058582-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20051221</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL162422</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>THERAPEUTIC RESPONSE DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugindication>RENAL FAILURE CHRONIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050925</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051204</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058583-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20051221</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL162597</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>63.6</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPHIL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>ANAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050621</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEULASTA</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058584-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050408</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL126404</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>48</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LETHARGY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PRE-EXISTING DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050201</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058585-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050407</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL126588</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>JOINT RANGE OF MOTION DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugindication>ANAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058586-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050417</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL127899</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JOINT STIFFNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULAR WEAKNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugindication>ANAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058587-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050416</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL128023</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>60</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>THERAPEUTIC RESPONSE DELAYED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugindication>RENAL FAILURE CHRONIC</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058588-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050330</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL124437</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INFLUENZA LIKE ILLNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS GENERALISED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>RENAL FAILURE CHRONIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050325</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058589-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050409</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL126831</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>JOINT SWELLING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugindication>ANAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058590-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050405</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL125379</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>THERAPEUTIC RESPONSE DELAYED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugindication>PREOPERATIVE CARE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050201</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058591-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050420</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL128355</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>81</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EAR INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARYNGOLARYNGEAL PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugindication>ANAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058592-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050405</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL125371</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>THERAPEUTIC RESPONSE DELAYED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugindication>PREOPERATIVE CARE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050301</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058593-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050222</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL117033</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>64.5</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URTICARIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>ANAEMIA OF MALIGNANT DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050208</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050215</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058594-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050224</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL117834</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>81</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</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>5058595-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050418</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL128098</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LACERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugindication>MYELODYSPLASTIC SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050221</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050321</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058596-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041214</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL103491</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>79.9</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RENAL FAILURE CHRONIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041123</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
        <drugadministrationroute>055</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058598-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050406</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL125573</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>IRON DEFICIENCY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugindication>PRE-EXISTING DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058599-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050418</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL128006</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>97.6</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugindication>MYELODYSPLASTIC SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050301</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058604-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20051208</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL161092</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>BONE PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugindication>ANAEMIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058605-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20051208</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL161090</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>ANAEMIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058606-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20051208</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL161400</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>86.3</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugindication>RENAL FAILURE CHRONIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051120</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051207</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058607-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20051208</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-US160629</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EPOGEN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>DIALYSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051122</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058608-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20051208</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL161094</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URTICARIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VIRAL RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugindication>ANAEMIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058609-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20051208</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-US160671</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EPOGEN</medicinalproduct>
        <drugbatchnumb>P031211</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>DIALYSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058610-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20051208</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL161091</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>64</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>THERAPEUTIC RESPONSE DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>RENAL FAILURE CHRONIC</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058611-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20051209</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL161098</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>99.9</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BALANCE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugindication>ANAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051125</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058612-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20051209</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-US160870</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>THERAPEUTIC RESPONSE DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EPOGEN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>DIALYSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARANESP</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>DIALYSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051001</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058614-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20051206</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL160682</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>66.3</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CONTUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN OF SKIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>RENAL FAILURE CHRONIC</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058615-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20051206</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL160680</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>ANAEMIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058616-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20051206</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL160676</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>77</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RENAL FAILURE CHRONIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051001</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058617-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20051206</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL160625</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>RENAL FAILURE CHRONIC</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058618-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20051205</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-US160235</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>93.5</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FURUNCLE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POLYPECTOMY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THERAPEUTIC RESPONSE DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EPOGEN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>DIALYSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051206</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058619-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20051205</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL160668</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>78.1</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>MALIGNANT NEOPLASM PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METASTATIC MALIGNANT MELANOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>ANAEMIA OF MALIGNANT DISEASE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058622-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060713</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0607USA02619</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>76</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MUSCULAR WEAKNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPINAL COLUMN STENOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZETIA</medicinalproduct>
        <drugauthorizationnumb>21445</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROSCAR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060601</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADVIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058623-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060714</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0607USA03950</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>PANCREATITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COZAAR</medicinalproduct>
        <drugauthorizationnumb>020386</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058624-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060714</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0607USA03219</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLINDNESS UNILATERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRINIVIL</medicinalproduct>
        <drugauthorizationnumb>019558</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058625-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060622</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0606USA04386</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>54</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>103</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DYSPNOEA EXERTIONAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MIGRAINE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZETIA</medicinalproduct>
        <drugauthorizationnumb>021445</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZETIA</medicinalproduct>
        <drugauthorizationnumb>021445</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060201</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058626-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060711</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-MERCK-0607FRA00032</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>71</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PERIARTHRITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NOROXIN</medicinalproduct>
        <drugauthorizationnumb>019384</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>URINARY TRACT INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIATUS HERNIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM (UNSPECIFIED)</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOSFOMYCIN TROMETHAMINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>URINARY TRACT INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060201</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058627-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060117</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0601USA01862</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>76</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOMYELITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050217</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TIMOLOL</medicinalproduct>
        <drugadministrationroute>047</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACIPHEX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAXZIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOXYL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FERROUS SULFATE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOCARBAMOL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMBIEN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058628-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060718</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>TH-MERCK-0607THA00007</companynumb>
    <primarysource>
      <reportercountry>THAILAND</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>39</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SINGULAIR</medicinalproduct>
        <drugauthorizationnumb>020829</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>[COMPOSITION UNSPECIFIED]</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>ACQUIRED IMMUNODEFICIENCY SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058629-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060711</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BE-MERCK-0607BEL00011</companynumb>
    <primarysource>
      <reportercountry>BELGIUM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>25</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG RESISTANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPTIC SHOCK</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRIMAXIN</medicinalproduct>
        <drugauthorizationnumb>050587</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>SEPTIC SHOCK</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CEFOTAXIME SODIUM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>SEPTIC SHOCK</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METRONIDAZOLE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>SEPTIC SHOCK</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GENTAMICIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>SEPTIC SHOCK</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XIGRIS</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>SEPTIC SHOCK</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058630-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050405</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL125563</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>ANAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058631-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050413</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL126841</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>66</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugindication>ANAEMIA OF MALIGNANT DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050412</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050401</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058632-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050412</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL126691</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</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>PROCRIT</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugindication>ANAEMIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058633-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050413</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL126836</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugindication>PRE-EXISTING DISEASE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058634-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050401</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL124934</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>THROMBOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugindication>PRE-EXISTING DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050201</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058635-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050402</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL125359</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>88</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>54.5</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>ANAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050301</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058636-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050406</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL125568</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugindication>ANAEMIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058637-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050408</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-US125754</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>47</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>THERAPEUTIC RESPONSE DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EPOGEN</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugindication>ANAEMIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058638-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050404</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-US124639</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>54</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EPOGEN</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PRE-EXISTING DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058639-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050411</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-US126038</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>36</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHILLS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EPOGEN</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>DIALYSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058640-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050415</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-US127809</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EPOGEN</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugindication>RENAL FAILURE CHRONIC</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058641-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050419</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL128114</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>73.1</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DIVERTICULITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHOIDS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERBILIRUBINAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTESTINAL POLYP</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RENAL FAILURE CHRONIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050419</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050415</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
        <drugadministrationroute>061</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058642-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050419</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-US127677</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABSCESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THERAPEUTIC RESPONSE DECREASED</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>20041101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EPOGEN</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugindication>RENAL FAILURE CHRONIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RENAL FAILURE CHRONIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040316</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058643-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041224</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL104992</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>113</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>RENAL FAILURE CHRONIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058644-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050330</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL124921</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugindication>MYELODYSPLASTIC SYNDROME</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058645-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050429</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL130396</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>80</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>79.5</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>ANAEMIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058646-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050502</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL130845</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>77</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>THERAPEUTIC RESPONSE DELAYED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugindication>RENAL FAILURE CHRONIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050401</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058647-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050429</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL130709</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>69</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DYSARTHRIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THERAPEUTIC RESPONSE DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugindication>RENAL FAILURE CHRONIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058648-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050422</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL129350</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>80</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>90.8</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING COLD</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALLOR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>ANAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058649-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050411</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL126596</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugindication>PRE-EXISTING DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050408</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050301</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058650-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050415</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL127330</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STOMACH DISCOMFORT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>RENAL FAILURE CHRONIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050407</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050409</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058651-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050408</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL126445</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>77</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>84</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DYSPNOEA EXERTIONAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugindication>ANAEMIA OF MALIGNANT DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058652-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050408</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL126416</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>84</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TINNITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>MYELODYSPLASTIC SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058653-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050405</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL126004</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugindication>ANAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050404</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058654-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050201</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL111639</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>80</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRY MOUTH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRY THROAT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOUTH ULCERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>ANAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058655-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20051208</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-US160755</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>69.5</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HEPATIC ENZYME INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOPATHY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EPOGEN</medicinalproduct>
        <drugbatchnumb>P039090</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RENAL FAILURE CHRONIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051021</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051123</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058656-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20051209</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL161096</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>63</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>47</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>EPISTAXIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>ANAEMIA OF MALIGNANT DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEUPOGEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058657-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20051129</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL159612</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>76.7</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ALOPECIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>P047020,P047021,P050279</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RENAL FAILURE CHRONIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030401</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058658-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20051130</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL159940</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>60.8</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>ANAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058659-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20051209</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL161099</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>49.9</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugindication>ANAEMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058660-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20051205</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL160469</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>40.9</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>THERAPEUTIC RESPONSE DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugindication>RENAL FAILURE CHRONIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031004</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051205</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19991228</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058661-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20051207</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL160832</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>48</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>URINARY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PRE-EXISTING DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050608</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058662-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20051208</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL160833</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>45.4</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ECZEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>RENAL FAILURE CHRONIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020422</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058663-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20051207</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-US160481</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>THERAPEUTIC RESPONSE DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EPOGEN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>DIALYSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021001</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058664-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20051205</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL160516</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>HYPERCALCAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>ANAEMIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058665-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20051003</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL153068</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>78.1</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ATELECTASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUID RETENTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOKALAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JOINT SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NASOPHARYNGITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARYNGOLARYNGEAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLEURAL EFFUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POSTNASAL DRIP</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UPPER RESPIRATORY TRACT CONGESTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>ANAEMIA OF MALIGNANT DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058666-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20051201</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL159985</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>THERAPEUTIC RESPONSE DELAYED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>RENAL FAILURE CHRONIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058667-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20051201</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL160006</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>48</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>64.5</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>PREOPERATIVE CARE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058668-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050927</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL152658</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>61.3</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>P027130</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>ANAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050927</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058669-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20051202</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-US160025</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EPOGEN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>DIALYSIS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040701</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058670-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20051122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0511USA03979</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BREAST CANCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTH EXTRACTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>20560</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19970101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040101</drugenddate>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058671-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060712</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-MERCK-0607FRA00030</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>53</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THERAPEUTIC RESPONSE DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INVANZ</medicinalproduct>
        <drugauthorizationnumb>21337</drugauthorizationnumb>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060223</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INVANZ</medicinalproduct>
        <drugauthorizationnumb>021337</drugauthorizationnumb>
        <drugadministrationroute>041</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060316</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060414</drugenddate>
        <drugtreatmentduration>30</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>THROMBOPHLEBITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060405</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUINDIONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>THROMBOPHLEBITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060219</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060223</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUINDIONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060224</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN, BIPHASIC ISOPHANE [INJECTION]</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058672-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060711</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AT-MERCK-0607AUT00007</companynumb>
    <primarysource>
      <reportercountry>AUSTRIA</reportercountry>
      <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>BLOOD UREA INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CIRCULATORY COLLAPSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAMMA-GLUTAMYLTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUDDEN DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZETIA</medicinalproduct>
        <drugauthorizationnumb>21445</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>LIPID METABOLISM DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050704</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060612</drugenddate>
        <drugtreatmentduration>344</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN, BIPHASIC ISOPHANE [INJECTION]</medicinalproduct>
        <drugadministrationroute>051</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COZAAR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE AND LOSARTAN POTASSIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BISOPROLOL FUMARATE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRAVASTATIN SODIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOXAZOSIN MESYLATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058673-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20030908</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0309USA00892</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>69</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DENTAL CARIES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GLOSSODYNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMPAIRED HEALING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JAW DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOOSE TOOTH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOMYELITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWOLLEN TONGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TONGUE DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030523</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060428</drugenddate>
        <drugtreatmentduration>1072</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058674-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060210</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-MERCK-0602USA04315</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>51</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>52</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD POTASSIUM INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METABOLIC ACIDOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL TUBULAR ACIDOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOFT TISSUE DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TIMOPTIC</medicinalproduct>
        <drugauthorizationnumb>18086</drugauthorizationnumb>
        <drugadministrationroute>047</drugadministrationroute>
        <drugindication>GLAUCOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021224</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060208</drugenddate>
        <drugtreatmentduration>1143</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XALATAN</medicinalproduct>
        <drugadministrationroute>047</drugadministrationroute>
        <drugindication>GLAUCOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050324</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060208</drugenddate>
        <drugtreatmentduration>322</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMINS (UNSPECIFIED)</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058675-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20051202</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-US160027</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EPOGEN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>RENAL FAILURE CHRONIC</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058676-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20051104</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL157068</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>88</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>ANAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058677-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20051107</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL157228</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>78.5</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugindication>ANAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050926</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058678-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20051107</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL157231</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>P047020,P050277</drugbatchnumb>
        <drugindication>ANAEMIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058679-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20051107</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL157230</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>P041461</drugbatchnumb>
        <drugindication>ANAEMIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058680-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20051107</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL157229</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PRURITUS GENERALISED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>ANAEMIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058681-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20051107</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL157232</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>P047009,P048586</drugbatchnumb>
        <drugindication>ANAEMIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058682-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20051107</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL157234</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>P047049</drugbatchnumb>
        <drugindication>ANAEMIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058683-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20051108</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-US157122</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>96.5</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EPOGEN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>DIALYSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051105</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INTERFERON</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050916</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DULOXETINE HCL</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050916</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARANESP</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058684-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20051115</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL158434</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>THERAPEUTIC RESPONSE DELAYED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PREOPERATIVE CARE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058685-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20051115</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL158164</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>48</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <reaction>
        <reactionmeddrapt>THERAPEUTIC RESPONSE DELAYED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PREOPERATIVE CARE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058686-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20051115</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL158160</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>101.2</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>RECTAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VAGINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>ANAEMIA OF MALIGNANT DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050608</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058687-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20051115</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL158159</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugindication>RENAL FAILURE CHRONIC</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058688-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20051115</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL158158</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>76.3</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG ADMINISTRATION ERROR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THERAPEUTIC RESPONSE DELAYED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PREOPERATIVE CARE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051003</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051012</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058689-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20051114</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL158162</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>ANAEMIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058690-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20051107</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL157233</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>P048586,P044995</drugbatchnumb>
        <drugindication>ANAEMIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058691-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20051108</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL157513</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>73.5</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCISION SITE COMPLICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE ABSCESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SCAR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PRE-EXISTING DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040623</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041014</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058692-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20051109</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL157600</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>75</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>74.9</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RENAL FAILURE CHRONIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058693-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20051027</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL156048</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>ANAEMIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058694-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20051028</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-US156088</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>73</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>THERAPEUTIC RESPONSE DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EPOGEN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>DIALYSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058695-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20051111</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL158166</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>79.5</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>SKIN DISCOLOURATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RENAL FAILURE CHRONIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050917</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058696-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20051110</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL157728</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>44</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugindication>ANAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051018</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058697-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20051117</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL158418</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>78.5</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PRE-EXISTING DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051030</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051114</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058698-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20051117</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL158429</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>63</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>116.2</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugindication>RENAL FAILURE CHRONIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050901</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058699-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20051129</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL159610</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>70.8</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugindication>ANAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051121</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058700-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20051128</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL159607</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>37</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>URTICARIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>ANAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051107</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058701-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20051123</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL159286</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>54</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>158.4</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>P 047020</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>MYELODYSPLASTIC SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051123</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058702-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050720</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL143667</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>72</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>68.1</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE BRUISING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>ANAEMIA OF MALIGNANT DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058703-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20051121</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL159293</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>158.9</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>P041166</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RENAL FAILURE CHRONIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051118</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058704-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20051121</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL159289</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>64</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>ANAEMIA OF MALIGNANT DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051116</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058705-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20051117</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL158428</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>70.4</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>TRANSIENT ISCHAEMIC ATTACK</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>P041166</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RENAL FAILURE CHRONIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050719</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050829</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058706-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20051118</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL159106</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>81</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BONE PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>ANAEMIA OF MALIGNANT DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051001</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058707-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20051118</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-US158514</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>178</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>SKIN INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THERAPEUTIC RESPONSE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EPOGEN</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>DIALYSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021118</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058708-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20051031</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL156380</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>73</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>86.3</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISION BLURRED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>ANAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040401</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058709-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20051031</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL156383</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>73.5</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>RETICULOCYTE COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>P041196</drugbatchnumb>
        <drugindication>ANAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050713</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058710-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20051031</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL156564</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>62</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>79.5</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>MYELODYSPLASTIC SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058711-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20051102</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL156606</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>62.2</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>P039074</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>ANAEMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058712-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20051104</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL156873</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>63.6</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>URINARY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>ANAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050804</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058713-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20051102</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-US156485</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN INFLAMMATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EPOGEN</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugindication>DIALYSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058714-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20051004</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-US153013</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>49.9</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CHILLS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENORRHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EPOGEN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>DIALYSIS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050930</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19850101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058715-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20051006</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL153544</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>79</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>68.1</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>ANAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051005</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058716-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20051010</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL153923</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CONTUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PETECHIAE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RENAL FAILURE CHRONIC</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058717-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20051012</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL154521</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>71</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>74</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RED BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>ANAEMIA OF MALIGNANT DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050920</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058718-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20051007</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-US153438</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EPOGEN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>ANAEMIA OF MALIGNANT DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058719-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20051013</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL154519</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>ANAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051006</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058720-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041025</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL097191</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>55.4</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HERPES SIMPLEX</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugindication>ANAEMIA OF MALIGNANT DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041014</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEULASTA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EPOGEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EPOGEN</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugindication>ANAEMIA OF MALIGNANT DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058721-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050429</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL130415</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FULL BLOOD COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugindication>ANAEMIA OF MALIGNANT DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058722-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050421</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL128557</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ARTHRITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugindication>ANAEMIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058723-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050421</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL128534</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>83</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NASOPHARYNGITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugindication>ANAEMIA OF MALIGNANT DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050418</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058724-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050422</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL128812</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>NASOPHARYNGITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugindication>RENAL FAILURE CHRONIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050211</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058725-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050503</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL131593</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugindication>ANAEMIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058726-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050503</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL131588</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>ANAEMIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058727-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050426</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL129242</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugindication>RENAL FAILURE CHRONIC</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058728-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050502</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL130849</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD TEST ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugindication>ANAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050401</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058729-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050427</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL129924</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>47</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URTICARIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugindication>ANAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050301</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058730-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050422</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL129245</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>73.5</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>ANAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058731-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050426</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL129542</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugindication>ANAEMIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058732-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050426</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL129309</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>16</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>38.6</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PRE-EXISTING DISEASE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058733-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050424</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL129312</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>83</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugindication>ANAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050401</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058734-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050422</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL128807</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugindication>ANAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
        <drugadministrationroute>047</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058735-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20051013</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL154660</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>ANAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050721</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058736-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20051014</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL154643</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>97</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>61.3</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>ANAEMIA OF MALIGNANT DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050926</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058737-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20051014</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL154659</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>72.6</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RENAL FAILURE CHRONIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051005</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058738-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20051017</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL154942</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>BONE PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugindication>HIV INFECTION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058739-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20051017</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL154768</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>ANAEMIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058740-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20051014</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-US154346</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>THERAPEUTIC RESPONSE DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EPOGEN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>DIALYSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058741-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20051019</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL155193</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>ANAEMIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058742-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20051020</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL155778</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>59</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THERAPEUTIC RESPONSE DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>P050277</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>MYELODYSPLASTIC SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058743-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20051024</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL155602</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>66</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>GASTROENTERITIS VIRAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>ANAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020201</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058744-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20051025</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL155984</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>MYELODYSPLASTIC SYNDROME</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058745-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20051021</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL155505</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <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>PROCRIT</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>ANAEMIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058746-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20051020</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL155192</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugindication>ANAEMIA OF MALIGNANT DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050613</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051004</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058747-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050921</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL151470</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugindication>RENAL FAILURE CHRONIC</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058748-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050921</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL151448</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>64.5</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>ANAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050828</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058749-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050315</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-US122401</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ACUTE MYELOID LEUKAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALIGNANT NEOPLASM PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugindication>ANAEMIA OF MALIGNANT DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040512</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058750-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050504</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL131655</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNOVIAL CYST</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PRE-EXISTING DISEASE</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058751-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050426</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-US129004</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>THERAPEUTIC RESPONSE DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EPOGEN</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugindication>RENAL FAILURE CHRONIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058752-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050504</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL131661</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugindication>ANAEMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058753-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050505</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-US131336</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>80</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARANESP</medicinalproduct>
        <drugbatchnumb>P027156</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RENAL FAILURE CHRONIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050501</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EPOGEN</medicinalproduct>
        <drugindication>RENAL FAILURE CHRONIC</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058754-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050506</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-US131673</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>55.4</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BONE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH PUSTULAR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEUPOGEN</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugindication>CHEMOTHERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020801</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EPOGEN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020801</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020801</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020801</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020801</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020801</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020801</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058755-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050505</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL131992</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DERMAL CYST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE REACTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>ANAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058756-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050504</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL131660</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugindication>ANAEMIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058757-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050422</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL129315</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>ANAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050418</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058758-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050504</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL131648</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>39</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HYPERLIPIDAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>PRE-EXISTING DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050415</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058759-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050428</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-US129998</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARANESP</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugindication>ANAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugindication>ANAEMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058760-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050922</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL152117</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <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>PRURITUS GENERALISED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>ANAEMIA OF MALIGNANT DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050301</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058761-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050923</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL151986</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>ANAEMIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058762-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050929</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL152729</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>AGITATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>ANAEMIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058763-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050929</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL152731</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>64</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HOT FLUSH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugindication>ANAEMIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058764-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050926</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-US152002</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>THERAPEUTIC RESPONSE DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EPOGEN</medicinalproduct>
        <drugbatchnumb>P048576</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>DIALYSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058765-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050914</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL150972</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THERAPEUTIC RESPONSE DELAYED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugindication>ANAEMIA OF MALIGNANT DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050801</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058766-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050915</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL150967</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>ANAEMIA OF MALIGNANT DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058767-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050918</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL151040</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>80</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>69</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>ANAEMIA OF MALIGNANT DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058768-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050919</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL151212</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>76</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>ANAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050919</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058769-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050908</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-US149757</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EPOGEN</medicinalproduct>
        <drugbatchnumb>P039084</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>DIALYSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030707</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058770-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050907</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL149725</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSORIASIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>ANAEMIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058771-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050907</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL149543</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA EXERTIONAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THERAPEUTIC RESPONSE DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>RENAL FAILURE CHRONIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050301</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058772-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050930</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL152855</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRANSIENT ISCHAEMIC ATTACK</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>MYELODYSPLASTIC SYNDROME</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058773-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050919</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-US151087</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>88.8</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EPOGEN</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugindication>DIALYSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050901</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050901</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058774-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050919</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL151472</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>63.6</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>P041163</drugbatchnumb>
        <drugindication>ANAEMIA OF MALIGNANT DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEULASTA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058775-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050929</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL152734</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>ANAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050917</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058776-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050930</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL152853</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>93.1</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>RASH PRURITIC</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RENAL FAILURE CHRONIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050922</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058777-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050915</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL150962</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>THERAPEUTIC RESPONSE DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugindication>RENAL FAILURE CHRONIC</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058778-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050915</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL150970</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>THERAPEUTIC RESPONSE DELAYED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RENAL FAILURE CHRONIC</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058779-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050914</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL150499</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>79.5</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EAR DISCOMFORT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>ANAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040901</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058780-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050919</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL151189</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>SALIVARY HYPERSECRETION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>MYELODYSPLASTIC SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050909</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058781-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050919</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL151468</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>75</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>64.9</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANOSMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROSTATE EXAMINATION ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RENAL FAILURE CHRONIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041214</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058782-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050909</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL150148</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>87</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>59.9</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RENAL FAILURE CHRONIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041001</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058783-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050912</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-US150267</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOVENTILATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EPOGEN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>ANAEMIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058784-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050909</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL150151</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STOMACH DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THIRST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>RENAL FAILURE CHRONIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050801</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058785-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050913</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL150935</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE CHRONIC</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>ANAEMIA OF MALIGNANT DISEASE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058786-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050913</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-US150157</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EPOGEN</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugindication>ANAEMIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058787-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050914</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL150496</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL DISCOMFORT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>ANAEMIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058788-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050914</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL150495</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>51</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>72.6</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>P041163</drugbatchnumb>
        <drugindication>ANAEMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058789-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050913</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-US146323</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>97.6</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANGINA PECTORIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THERAPEUTIC RESPONSE DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EPOGEN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>DIALYSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20011001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050628</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050628</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050701</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050711</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050111</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040731</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030825</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050517</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020305</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040731</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058790-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050331</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL124584</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOBILITY DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugindication>ANAEMIA OF MALIGNANT DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040601</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058791-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050824</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL148003</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>81</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>90.8</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>EXFOLIATIVE RASH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RENAL FAILURE CHRONIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041015</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050420</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058792-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050824</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-US147734</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>THERAPEUTIC RESPONSE DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EPOGEN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>DIALYSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058793-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050825</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL148637</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>90</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugindication>ANAEMIA OF MALIGNANT DISEASE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058794-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050824</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL148007</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>76</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>72.6</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>ANAEMIA OF MALIGNANT DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050823</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058795-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050826</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL148456</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH MACULO-PAPULAR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugindication>RENAL FAILURE CHRONIC</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058796-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050826</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL148617</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>67.2</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BONE PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugindication>ANAEMIA OF MALIGNANT DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050723</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058797-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050826</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-US148128</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>53</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHILLS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHEEZING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EPOGEN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>ANAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050823</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058798-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050829</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL148619</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>ANAEMIA OF MALIGNANT DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058799-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050307</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL120319</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>68.6</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD IRON INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugindication>ANAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058800-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050906</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL149752</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>73</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>72.6</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPLENOMEGALY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>ANAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEUPOGEN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058801-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050906</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL149541</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>65</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JOINT SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>ANAEMIA OF MALIGNANT DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050823</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058802-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050903</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL149540</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>66</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>ANAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050401</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058803-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050830</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-US148632</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>THERAPEUTIC RESPONSE DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EPOGEN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>DIALYSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058804-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050421</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL128560</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>86.7</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ECCHYMOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EPOGEN</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugindication>RENAL FAILURE CHRONIC</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058805-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050826</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL148601</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>65</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugindication>MYELODYSPLASTIC SYNDROME</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058806-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050826</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL148618</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>68.6</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>MYELODYSPLASTIC SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050623</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050629</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CIPRO IV</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050629</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058807-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050829</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL148622</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>80.8</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>ANAEMIA OF MALIGNANT DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058808-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050829</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL149678</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>76.7</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MASS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>ANAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058809-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050827</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL148625</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>85</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIMB INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>MYELODYSPLASTIC SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058810-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050829</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-US148391</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>41</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>THERAPEUTIC RESPONSE DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EPOGEN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>DIALYSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058811-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050812</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL146576</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>ANAEMIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058812-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050815</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL146832</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>82</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>40</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ALOPECIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATOCHEZIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>ANAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020601</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058813-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050817</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-US146837</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING COLD</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EPOGEN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>DIALYSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SENSIPAR</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>HYPERPARATHYROIDISM SECONDARY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050801</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058814-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050823</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-US147582</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>74.5</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>THERAPEUTIC RESPONSE DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EPOGEN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>ANAEMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARANESP</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050825</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058815-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050823</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL147725</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>ANAEMIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058816-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050706</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-US141287</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PORPHYRIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EPOGEN</medicinalproduct>
        <drugbatchnumb>P032441</drugbatchnumb>
        <drugindication>ANAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040831</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050412</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058817-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050819</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL147935</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>RENAL FAILURE CHRONIC</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058818-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050413</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL126850</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>126.2</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HAEMATOCRIT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>RENAL FAILURE CHRONIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058819-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050817</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-US146922</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>THERAPEUTIC RESPONSE DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EPOGEN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>DIALYSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040610</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058820-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050907</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL149542</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>VISUAL DISTURBANCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugindication>RENAL FAILURE CHRONIC</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058821-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050815</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL146581</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>ANAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050315</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058822-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050817</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL147120</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>ANAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050601</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058823-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050810</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL146205</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG ADMINISTRATION ERROR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>ANAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058824-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050810</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL146211</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>134.8</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RENAL FAILURE CHRONIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058825-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050810</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL146213</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>68</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>147.6</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RENAL FAILURE CHRONIC</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058826-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050810</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL146216</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>159.8</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>THERAPEUTIC RESPONSE DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RENAL FAILURE CHRONIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058827-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050719</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-US143168</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EPOGEN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>ANAEMIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058828-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050811</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL146203</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HERPES ZOSTER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STOMACH DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THERAPEUTIC RESPONSE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>ANAEMIA OF MALIGNANT DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040628</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058829-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050812</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL146574</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>THROMBOCYTHAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugindication>ANAEMIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058830-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050811</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL146362</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>MYELODYSPLASTIC SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050729</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058831-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050810</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL146283</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>79.9</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RENAL FAILURE CHRONIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058832-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050718</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL143568</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>90</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugindication>ANAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058833-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050718</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL143324</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>RASH MACULAR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>ANAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058834-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050810</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL146282</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>63.1</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>VASCULITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RENAL FAILURE CHRONIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058835-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050523</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL135546</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>74.9</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THERAPEUTIC RESPONSE DECREASED</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>5058836-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050519</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL135006</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CHILLS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>ANAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050411</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058837-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040618</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL080644</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>61.3</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE CONGESTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>ANAEMIA OF MALIGNANT DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058838-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050601</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL137358</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>80</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HYPERGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugindication>RENAL FAILURE CHRONIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058839-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050506</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-US132816</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>81</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS GENERALISED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EPOGEN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>RENAL FAILURE CHRONIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugindication>RENAL FAILURE CHRONIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058840-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050519</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-US135286</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</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>PROCRIT</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugindication>ANAEMIA OF MALIGNANT DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050401</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058841-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050518</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-US134967</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>55</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>ANAEMIA OF MALIGNANT DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050501</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058842-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050503</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL131598</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>GINGIVAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>REFLUX OESOPHAGITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>ANAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020710</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058843-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050503</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL131651</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>87</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STOMACH DISCOMFORT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugindication>ANAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050401</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058844-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050504</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL131646</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>82</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>81.7</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugindication>RENAL FAILURE CHRONIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050401</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058845-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050721</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL143780</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>81</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>64.5</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPHONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>ANAEMIA OF MALIGNANT DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050601</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058846-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050721</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL143781</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>ANAEMIA OF MALIGNANT DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050712</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058847-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050722</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL143782</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>76</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>86.3</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN WRINKLING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>ANAEMIA OF MALIGNANT DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050601</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058848-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050723</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL143900</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>ANAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050722</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058849-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050726</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL144548</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INCREASED TENDENCY TO BRUISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN ATROPHY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RENAL FAILURE CHRONIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040301</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058850-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050725</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL144274</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>77.2</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GLAUCOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>ANAEMIA OF MALIGNANT DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058851-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050725</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL144264</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE REACTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>P041194</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PRE-EXISTING DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058852-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050722</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-US143830</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>105</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>THERAPEUTIC RESPONSE DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EPOGEN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>DIALYSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041025</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058853-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050301</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL118932</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>80</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BALANCE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULAR WEAKNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OCULAR HYPERAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>ANAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058854-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050801</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL145112</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>64.9</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE MASS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE TIGHTNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>ANAEMIA OF MALIGNANT DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050718</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058855-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050801</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL145033</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>89</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>68.1</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ECZEMA ASTEATOTIC</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RENAL FAILURE CHRONIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058856-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050729</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL145013</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>ANAEMIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058857-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050729</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL144876</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugindication>RENAL FAILURE CHRONIC</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058858-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050727</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL144874</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>43.6</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DISTURBANCE IN ATTENTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSSTASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>P041162</drugbatchnumb>
        <drugindication>RENAL FAILURE CHRONIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050615</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058859-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050727</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL144556</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FUNGAL INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>ANAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050601</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058860-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050727</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL144552</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>45</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>ANAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050722</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058861-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050727</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL144554</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>P041184</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PRE-EXISTING DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058862-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050727</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL144555</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>54</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>ANAEMIA OF MALIGNANT DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050712</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050712</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058863-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050803</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL145465</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>93</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>49.9</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BONE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JOINT SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>ANAEMIA OF MALIGNANT DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050729</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058864-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050804</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL145587</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>APNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MIDDLE INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugindication>PRE-EXISTING DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058865-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050803</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL145591</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>77</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ALOPECIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHOTOSENSITIVITY REACTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>ANAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058866-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050803</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL145588</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>88</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>ANAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058867-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050802</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL145176</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>60.8</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>MYELODYSPLASTIC SYNDROME</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058868-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050804</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL145592</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>64</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>MYELODYSPLASTIC SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058869-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050809</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL146066</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>RENAL FAILURE CHRONIC</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058870-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050808</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL146064</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>RASH PAPULAR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>RENAL FAILURE CHRONIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050401</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058871-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050809</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL146062</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>66</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>90.8</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THERAPEUTIC RESPONSE DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugindication>RENAL FAILURE CHRONIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058872-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050708</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-US141671</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EPOGEN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>DIALYSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058873-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050711</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL142301</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>62</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>GRAND MAL CONVULSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>ANAEMIA OF MALIGNANT DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058874-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050711</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL142302</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>86</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>ANAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058875-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050711</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL142305</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>78</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>44.5</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FAECES HARD</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>ANAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
        <drugadministrationroute>047</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
        <drugadministrationroute>047</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
        <drugadministrationroute>045</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058876-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050713</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL142821</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>PRE-EXISTING DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058877-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050714</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL142895</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <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>PROCRIT</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>ANAEMIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058878-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050717</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL143316</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>ANAEMIA OF MALIGNANT DISEASE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058879-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050620</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL139670</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>65</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>68.1</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWELLING FACE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RENAL FAILURE CHRONIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058880-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050620</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL139671</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>METRORRHAGIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RENAL FAILURE CHRONIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058881-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050718</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL143313</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>ANAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058882-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050714</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL142897</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>65.8</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>P039062</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>ANAEMIA OF MALIGNANT DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058883-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050714</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL142892</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>61.3</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEEP VEIN THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>P037458</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PREOPERATIVE CARE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050614</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050705</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
        <drugadministrationroute>045</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058884-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050712</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL143164</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <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>PROCRIT</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>RENAL FAILURE CHRONIC</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058885-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050711</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL142707</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>75</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RECTAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>ANAEMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058886-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050428</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL130372</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FACE OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH ERYTHEMATOUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN DEPIGMENTATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN EXFOLIATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugindication>ANAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050126</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050224</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058887-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050630</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL141173</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>ANAEMIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058888-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050701</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL141461</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PRURITUS GENERALISED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>ANAEMIA OF MALIGNANT DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050630</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058889-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050701</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL141462</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>54</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>P039109</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PRE-EXISTING DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050623</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058890-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050621</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL140254</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>MYELODYSPLASTIC SYNDROME</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058891-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050627</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL140883</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugindication>RENAL FAILURE CHRONIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050203</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050503</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058892-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050629</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL140976</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>86.7</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RENAL FAILURE CHRONIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050623</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058893-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050706</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL141580</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>54</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>54.5</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>WEIGHT 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>20041201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050401</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058894-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050707</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL137611</companynumb>
    <primarysource>
      <qualification>1</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>PROCRIT</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>ANAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058895-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050622</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL140252</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>66</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>95.3</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD IRON INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC ENZYME INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULAR WEAKNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>P010971</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RENAL FAILURE CHRONIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058896-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050620</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-US139526</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EPOGEN</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PRE-EXISTING DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058897-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050408</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL126426</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>90</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA HAEMORRHAGIC</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>ANAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050331</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058898-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050628</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL140881</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HAEMATOCRIT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugindication>RENAL FAILURE CHRONIC</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058899-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050707</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL141685</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BONE PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugindication>PREOPERATIVE CARE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050531</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058900-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050708</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL141910</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>69</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>47.2</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ALOPECIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD IRON INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>P041194,P041167</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>ANAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058901-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050708</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL141930</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>85</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISTURBANCE IN ATTENTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugindication>ANAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058902-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050707</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL142706</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>80</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>LABORATORY TEST ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PRE-EXISTING DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058903-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050707</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL141682</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugindication>ANAEMIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058904-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050706</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL141576</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>63</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>72.6</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE BRUISING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>P039109</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PRE-EXISTING DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050608</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058905-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050630</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL141171</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>RENAL FAILURE CHRONIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050501</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058906-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050607</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL137832</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugindication>ANAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050606</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058907-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050608</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL137830</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>74</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugindication>ANAEMIA OF MALIGNANT DISEASE</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058908-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050608</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-US137704</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>65</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH GENERALISED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWELLING FACE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EPOGEN</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugindication>RENAL FAILURE CHRONIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050501</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058909-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050610</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL138321</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>118.9</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>ANAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050528</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050609</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058940-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060712</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHNR2006AU00917</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CAESAREAN SECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FOETAL ARRHYTHMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>APRESOLINE</medicinalproduct>
        <drugauthorizationnumb>008303</drugauthorizationnumb>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058941-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060711</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2006US08849</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>OVARIAN CANCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SURGERY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ESTRADERM</medicinalproduct>
        <drugauthorizationnumb>019081</drugauthorizationnumb>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLIMARA</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058942-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060412</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2006US04882</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>31</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABORTION SPONTANEOUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OLIGOMENORRHOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRILEPTAL</medicinalproduct>
        <drugauthorizationnumb>21014</drugauthorizationnumb>
        <drugdosagetext>150 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONVULSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060119</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRILEPTAL</medicinalproduct>
        <drugauthorizationnumb>021014</drugauthorizationnumb>
        <drugdosagetext>600 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LAMICTAL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058943-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060712</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHNU2006DE02508</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>AGITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NERVOUSNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRILEPTAL</medicinalproduct>
        <drugauthorizationnumb>021014</drugauthorizationnumb>
        <drugdosagetext>1 DF, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>EPILEPSY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRILEPTAL</medicinalproduct>
        <drugauthorizationnumb>021014</drugauthorizationnumb>
        <drugdosagetext>1500 MG/D (900-0-600)</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRILEPTAL</medicinalproduct>
        <drugauthorizationnumb>021014</drugauthorizationnumb>
        <drugdosagetext>1 DF, BID</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRILEPTAL</medicinalproduct>
        <drugauthorizationnumb>021014</drugauthorizationnumb>
        <drugdosagetext>REIMPORT FROM SPAIN</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060501</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058944-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHNU2006DE02408</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>64</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>95</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>OLIGODENDROGLIOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ROAD TRAFFIC ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRILEPTAL</medicinalproduct>
        <drugauthorizationnumb>21014</drugauthorizationnumb>
        <drugdosagetext>150 MG, BID</drugdosagetext>
        <drugindication>EPILEPSY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058945-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060627</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2006US08359</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>4</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>30.839</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>AGGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EPILEPSY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OBESITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWELLING FACE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRILEPTAL</medicinalproduct>
        <drugauthorizationnumb>021285</drugauthorizationnumb>
        <drugdosagetext>420 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>COMPLEX PARTIAL SEIZURES</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRILEPTAL</medicinalproduct>
        <drugauthorizationnumb>021285</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060301</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058946-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060718</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2006PH10705</companynumb>
    <primarysource>
      <reportercountry>PHILIPPINES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZELNORM</medicinalproduct>
        <drugauthorizationnumb>021200</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058947-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060606</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2006US07374</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>49</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHOLECYSTECTOMY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EJECTION FRACTION DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GALLBLADDER DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ORAL CONTRACEPTIVE NOS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLARITIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACIPHEX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZELNORM</medicinalproduct>
        <drugauthorizationnumb>021200</drugauthorizationnumb>
        <drugdosagetext>6 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>IRRITABLE BOWEL SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060201</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058948-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060411</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2006US04771</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>16</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>75</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ALANINE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASPARTATE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACTERIA URINE IDENTIFIED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD BILIRUBIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHOLELITHIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHOLESTASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COAGULOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATITIS ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATOSPLENOMEGALY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLAMMATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERNATIONAL NORMALISED RATIO INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JAUNDICE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINE ANALYSIS ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINE BILIRUBIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELLS URINE POSITIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZELNORM</medicinalproduct>
        <drugauthorizationnumb>21200</drugauthorizationnumb>
        <drugdosagetext>6 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>IRRITABLE BOWEL SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060207</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060211</drugenddate>
        <drugtreatmentduration>7200</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MACRODANTIN</medicinalproduct>
        <drugdosagetext>1 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>URINARY TRACT INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060209</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058960-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060711</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-SANOFI-SYNTHELABO-A01200605542</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CATHETER RELATED INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHOLESTASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FUNGAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JAUNDICE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARBENIN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>FUNGAL INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060529</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060604</drugenddate>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALBUMIN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060607</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOXONIN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060607</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALBLOCK</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060507</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060607</drugenddate>
        <drugtreatmentduration>32</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FUNGUARD</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>FUNGAL INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060529</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060604</drugenddate>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PENTAGIN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060607</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058962-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060321</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-SANOFI-SYNTHELABO-F01200600828</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>114.5</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD UREA INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATOCRIT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RECTAL ULCER HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALDACTONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENICAR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRAVACHOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KLOR-CON</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONIDINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOPHAGE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOPIDOGREL</medicinalproduct>
        <drugauthorizationnumb>020839</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ACUTE CORONARY SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060221</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060313</drugenddate>
        <drugtreatmentduration>21</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058963-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060505</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>TN-SANOFI-SYNTHELABO-A01200603572</companynumb>
    <primarysource>
      <reportercountry>TUNISIA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>57</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD CREATININE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ELECTROLYTE IMBALANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEPHROPATHY TOXIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL TUBULAR NECROSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVASTIN</medicinalproduct>
        <drugdosagetext>DOSE NOT SPECIFIED</drugdosagetext>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>COLORECTAL CANCER METASTATIC</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLINIC ACID</medicinalproduct>
        <drugdosagetext>DOSE NOT SPECIFIED</drugdosagetext>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>COLORECTAL CANCER METASTATIC</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUOROURACIL</medicinalproduct>
        <drugdosagetext>DOSE NOT SPECIFIED</drugdosagetext>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>COLORECTAL CANCER METASTATIC</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ELOXATIN</medicinalproduct>
        <drugauthorizationnumb>021492</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060417</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060417</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058964-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060711</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-SANOFI-SYNTHELABO-A01200605590</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>58</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>PULMONARY OEDEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEUCOVORIN CALCIUM</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060615</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060616</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUOROURACIL</medicinalproduct>
        <drugdosagetext>400MG/M2 IN BOLUS THEN 600MG/M2 AS CONTINOUS INFUSION ON DAYS 1 AND 2 UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060615</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060616</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXALIPLATIN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060615</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060615</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058965-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060421</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-SANOFI-SYNTHELABO-F01200601088</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>78</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD CREATININE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CALCIUM LEVOFOLINATE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050930</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051001</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUOROURACIL</medicinalproduct>
        <drugdosagetext>400 MG (226. MG/M2 ) IV BOLUS FOLLOWED 600 MG (339 MG/M2) INFUSION ON D1+2</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050930</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051001</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXALIPLATIN</medicinalproduct>
        <drugauthorizationnumb>021492</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLON CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050930</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050930</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>805</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058966-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-SANOFI-SYNTHELABO-A03200600432</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE NECROSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ELIGARD</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>21379</drugauthorizationnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PROSTATE CANCER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058967-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060712</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-SANOFI-SYNTHELABO-A03200604414</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>AMNESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SLEEP WALKING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMBIEN CR</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021774</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058968-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060601</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-SANOFI-SYNTHELABO-A03200603791</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>49</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DYSARTHRIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMPAIRED DRIVING ABILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THERAPEUTIC RESPONSE DELAYED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMBIEN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>019908</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INSOMNIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMBIEN</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>019908</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058969-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060711</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-SANOFI-SYNTHELABO-A02200601811</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>67</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>EPILEPSY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOXAN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XATRAL</medicinalproduct>
        <drugauthorizationnumb>021287</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060701</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058970-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060503</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-SANOFI-SYNTHELABO-A02200601185</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>80</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>AGRANULOCYTOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RED BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPTIC SHOCK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STAPHYLOCOCCAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>STENT PLACEMENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060414</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugauthorizationnumb>020839</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>STENT PLACEMENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060407</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060414</drugenddate>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GENTALLINE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>SEPTIC SHOCK</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060414</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ORBENIN CAP</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>SEPTIC SHOCK</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060414</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLAFORAN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>SEPTIC SHOCK</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060414</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060401</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PACLITAXEL</medicinalproduct>
        <drugdosagetext>NOT APPLICABLE</drugdosagetext>
        <drugadministrationroute>022</drugadministrationroute>
        <drugindication>STENT PLACEMENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060414</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TICLID</medicinalproduct>
        <drugdosagetext>PROGRESSIVE DAILY DOSE FROM 75 TO 300 MG OVER FOUR DAYS</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>STENT PLACEMENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060419</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058987-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060714</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-ABBOTT-06P-062-0338087-00</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>59</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL ADHESIONS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051010</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060429</drugenddate>
        <drugtreatmentduration>201</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE SODIUM</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040108</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060421</drugenddate>
        <drugtreatmentduration>833</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058988-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060703</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>VER_0012_2006</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>37</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>56.6996</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANAPHYLACTOID REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONTUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG ADMINISTRATION ERROR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TWINJECT</medicinalproduct>
        <drugbatchnumb>T0508021M</drugbatchnumb>
        <drugauthorizationnumb>20800</drugauthorizationnumb>
        <drugdosagetext>1 DF ONCE SC</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>ANAPHYLACTIC REACTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060501</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058989-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060703</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>TRP_0807_2006</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>51</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CHILLS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EATING DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENTAL STATUS CHANGES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RIBASPHERE</medicinalproduct>
        <drugauthorizationnumb>76203</drugauthorizationnumb>
        <drugdosagetext>DF PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060615</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEG-INTRON</medicinalproduct>
        <drugdosagetext>DF SC</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060615</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM CARBONATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM WITH VITAMIN D</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ESTERIFIED ESTROGENS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUOXETINE HYDROCHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDROXYPROGESTERONE ACETATE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058990-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060712</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>14390</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>46</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFUSION RELATED REACTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PACLITAXEL</medicinalproduct>
        <drugbatchnumb>S036865</drugbatchnumb>
        <drugauthorizationnumb>76131</drugauthorizationnumb>
        <drugdosagetext>306 MG IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060711</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058991-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060703</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>TRP_0809_2006</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>47</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLISTER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ECZEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE URTICARIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH PUSTULAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN LESION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ULCER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RIBASPHERE</medicinalproduct>
        <drugauthorizationnumb>76203</drugauthorizationnumb>
        <drugdosagetext>DF PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060501</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEG-INTRON</medicinalproduct>
        <drugdosagetext>DF SC</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060501</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058992-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060712</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>14395</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>62</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>97</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FEBRILE NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYTARABINE</medicinalproduct>
        <drugauthorizationnumb>71868</drugauthorizationnumb>
        <drugdosagetext>2.24 G DAILY IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ACUTE MYELOID LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060610</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060614</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ETOPOSIDE</medicinalproduct>
        <drugdosagetext>224 MG DAILY IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ACUTE MYELOID LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060610</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060614</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MITOXANTRONE</medicinalproduct>
        <drugdosagetext>18 MG DAILY IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ACUTE MYELOID LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060610</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060614</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058993-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060717</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>008028</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BREAST CANCER FEMALE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MEDROXYPROGESTERONE ACETATE</medicinalproduct>
        <drugauthorizationnumb>40159</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19890101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19990501</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ESTRATAB</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19890101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19990501</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19890101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19990501</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROVERA</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19890101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19990501</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058994-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060712</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CLOF-10280</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>0</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>HAEMODIALYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTI-ORGAN FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPTIC SHOCK</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOFARABINE</medicinalproduct>
        <drugauthorizationnumb>21673</drugauthorizationnumb>
        <drugindication>ACUTE LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060629</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCORTISONE TAB</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058995-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060710</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CLOF-10281</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>71</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>DISEASE PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY DISTRESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOFARABINE</medicinalproduct>
        <drugauthorizationnumb>21673</drugauthorizationnumb>
        <drugdosagetext>81.2 MG, QD</drugdosagetext>
        <drugindication>MYELOID LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060630</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060630</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACYCLOVIR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOFRAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGNESIUM SULFATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM PHOSPHATES</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DILANTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENADRYL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEXAPRO</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XOPENIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATIVAN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058996-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060711</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006-07-0705</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>55</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BALANCE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHILLS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS POSTURAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL INTAKE REDUCED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY CONGESTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN DISCOLOURATION</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>20060519</drugstartdate>
      </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>20060519</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AUGMENTIN '125'</medicinalproduct>
        <drugindication>COUGH</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060501</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYZAAR TABELTS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIBRIUM CAPSULES</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOPID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TARTRATE TABLETS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MOTRIN IB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NASONEX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ULTRAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZANTAC</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058997-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060709</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006-07-0609</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>51</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>70.3075</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANOREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE ABSCESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GLAUCOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLUENZA LIKE ILLNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RETINAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEG-INTRON</medicinalproduct>
        <drugdosagetext>SUBCUTANEOUS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>HEPATITIS B</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060419</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEG-INTRON</medicinalproduct>
        <drugdosagetext>SUBCUTANEOUS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060419</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBETOL</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS B</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060419</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBETOL</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060419</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIAZEPAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCODONE HYDROCHLORIDE TABLETS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROMETHAZINE HYDROCHLORIDE WITH CODEINE SYRUP</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARDIZEM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RHINOCORT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AEROBID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AEROBID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COMBIVENT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WELLBUTRIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058998-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060717</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006-07-0380</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>58</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>NO ADVERSE DRUG EFFECT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALBUTEROL SULFATE AUTOHALER</medicinalproduct>
        <drugauthorizationnumb>17559</drugauthorizationnumb>
        <drugdosagetext>ORAL AER INH</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARDIZEM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RHINOCORT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AEROBID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AEROBID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COMBIVENT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WELLBUTRIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5058999-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060710</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>163-21880-06070307</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>94</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugauthorizationnumb>21880</drugauthorizationnumb>
        <drugdosagetext>2 IN 1 D, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MYELODYSPLASTIC SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060128</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060601</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059000-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060710</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>163-21880-06040315</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>79</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugauthorizationnumb>21880</drugauthorizationnumb>
        <drugdosagetext>10 MG, 1 IN 1 D, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MYELODYSPLASTIC SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060322</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059001-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060710</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>163-21880-06070312</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>66</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>HOSPITALISATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugbatchnumb>673624-01</drugbatchnumb>
        <drugauthorizationnumb>21880</drugauthorizationnumb>
        <drugdosagetext>5MG, 1 IN 1 D, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060505</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060602</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059002-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060712</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006BI009956</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>58</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BREAST INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</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>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059003-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060712</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006BI009957</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>47</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOWER LIMB FRACTURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugdosagetext>30 UG; QW; IM</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</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>5059004-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060706</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>HQWYE355425MAR05</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>64</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>42.2</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ATRIAL FIBRILLATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHILLS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLEURAL EFFUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MYLOTARG</medicinalproduct>
        <drugauthorizationnumb>21174</drugauthorizationnumb>
        <drugdosagetext>5.5 MG, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ACUTE MYELOID LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020520</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020520</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MYLOTARG</medicinalproduct>
        <drugauthorizationnumb>21174</drugauthorizationnumb>
        <drugdosagetext>5.5 MG, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ACUTE MYELOID LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020527</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020527</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059005-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060711</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006085960</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>38</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>54.4316</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NERVOUS SYSTEM DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HYDROCORTISONE</medicinalproduct>
        <drugdosagetext>AN INCH ON BOTH FOREARMS ONCE, TOPICAL</drugdosagetext>
        <drugadministrationroute>061</drugadministrationroute>
        <drugindication>DERMATITIS CONTACT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060501</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUTICASONE PROPIONATE</medicinalproduct>
        <drugdosagetext>AN INCH (FREQUENCY UNSPECIFIED), TOPICAL</drugdosagetext>
        <drugadministrationroute>061</drugadministrationroute>
        <drugindication>DERMATITIS CONTACT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060501</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059006-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060710</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>HQWYE072814MAR03</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>63</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>49</patientweight>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ABDOMINAL DISTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL TENDERNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ACTIVATED PARTIAL THROMBOPLASTIN TIME PROLONGED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ALANINE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASCITES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASPARTATE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD ALBUMIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD ALKALINE PHOSPHATASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD BILIRUBIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CHLORIDE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD FIBRINOGEN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD LACTATE DEHYDROGENASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD SODIUM DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD UREA INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE MARROW FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COAGULOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CREPITATIONS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISEASE PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEBRILE NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUID OVERLOAD</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GALLBLADDER DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GALLOP RHYTHM PRESENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERALISED OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATOCRIT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC FUNCTION ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATOMEGALY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JAUNDICE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENTAL STATUS CHANGES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METASTASES TO CENTRAL NERVOUS SYSTEM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METASTASES TO KIDNEY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METASTASES TO LIVER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTI-ORGAN FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OCULAR ICTERUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PELVIC NEOPLASM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERFORMANCE STATUS DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET MORPHOLOGY ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROTHROMBIN TIME PROLONGED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RED BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPLENOMEGALY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINE ANALYSIS ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MYLOTARG</medicinalproduct>
        <drugauthorizationnumb>21174</drugauthorizationnumb>
        <drugdosagetext>13 MG 1X PER 1 DAY, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CHRONIC MYELOID LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030307</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030307</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUDARABINE PHOSPHATE</medicinalproduct>
        <drugdosagetext>39 MG TOTAL DAILY DOSE, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CHRONIC MYELOID LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030320</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030324</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GEMCITABINE</medicinalproduct>
        <drugdosagetext>5652 MG TOTAL DAILY DOSE, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CHRONIC MYELOID LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030320</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030320</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NOVANTRONE</medicinalproduct>
        <drugdosagetext>16 MG TOTAL DAILY DOSE, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CHRONIC MYELOID LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030320</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030320</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIFLUCAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DILAUDID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATIVAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVAQUIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLEEVEC</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059007-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060712</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>163-21880-06070348</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>52</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugauthorizationnumb>21880</drugauthorizationnumb>
        <drugdosagetext>QD, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MYELODYSPLASTIC SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060330</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060628</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059008-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060712</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006BI009958</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>40</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD MAGNESIUM DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>KIDNEY 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>20020515</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059009-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060713</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006BI009964</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>63</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BIPOLAR I DISORDER</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>20020328</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>5059010-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060705</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006BI009677</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugdosagetext>30 UG; QW; IM</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20011001</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059011-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060710</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006BI009830</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>79.3795</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHOKING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>REGURGITATION OF FOOD</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHEUMATOID ARTHRITIS</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>
        <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>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATROVENT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DILANTIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059012-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060714</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006BI010049</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>67</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059013-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060711</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006BI009875</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>105</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ACUTE RESPIRATORY DISTRESS SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE CONGESTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENTAL STATUS CHANGES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZEVALIN</medicinalproduct>
        <drugbatchnumb>IN-111 ZEVALIN</drugbatchnumb>
        <drugdosagetext>1X; IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NON-HODGKIN'S LYMPHOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060705</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060705</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RITUXAN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059014-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060705</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>163-20785-06050182</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>81</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>SUBDURAL HAEMATOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>THALOMID</medicinalproduct>
        <drugbatchnumb>M9930401</drugbatchnumb>
        <drugauthorizationnumb>20785</drugauthorizationnumb>
        <drugdosagetext>200 MG, DAILY, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>AMYLOIDOSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060501</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059015-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060707</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US017900</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>15</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>COMPLETED SUICIDE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJURY ASPHYXIATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROVIGIL</medicinalproduct>
        <drugauthorizationnumb>20717</drugauthorizationnumb>
        <drugdosagetext>50 MG QD ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060601</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROVIGIL</medicinalproduct>
        <drugbatchnumb>PB30205</drugbatchnumb>
        <drugdosagetext>100 MG QD ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060601</drugstartdate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059016-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060706</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>227091</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>67</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MONOCYTE PERCENTAGE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPHIL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RAPTIVA</medicinalproduct>
        <drugdosagetext>0.6 ML, 1/WEEK, SUBCUTANEOUS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PSORIASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051220</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059017-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060707</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>227149</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>26</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>109</patientweight>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EFALIZUMAB (EFALIZUMAB) PWDR + SOLVENT, INJECTION SOLN, 125MG</medicinalproduct>
        <drugdosagetext>1.1 ML, 1/WEEK, SUBCUTANEOUS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PSORIASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050622</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060526</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EFALIZUMAB (EFALIZUMAB) PWDR + SOLVENT, INJECTION SOLN, 125MG</medicinalproduct>
        <drugdosagetext>1.1 ML, 1/WEEK, SUBCUTANEOUS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PSORIASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060606</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLOBEX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROTOPIC OINTMENT (TACROLIMUS)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WELLBUTRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPICAL STEROIDS (UNKNONW INGREDIENTS) (TOPICAL STEROIDS NOS)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059018-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060713</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>TAP2006Q01197</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>33</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>61.6</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>VISUAL FIELD DEFECT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LUPRON DEPOT-3</medicinalproduct>
        <drugauthorizationnumb>20708</drugauthorizationnumb>
        <drugdosagetext>11.25 MG, 1 IN 3 M, INTRAMUSCULAR</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>ENDOMETRIOSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060515</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LUPRON DEPOT-3</medicinalproduct>
        <drugauthorizationnumb>20708</drugauthorizationnumb>
        <drugdosagetext>11.25 MG, 1 IN 3 M, INTRAMUSCULAR</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>PELVIC PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060515</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059019-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060710</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>TPA2006A01029</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>66</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>107.7</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLADDER CANCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROSTATE CANCER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PIOGLITAZONE HCL</medicinalproduct>
        <drugauthorizationnumb>21073</drugauthorizationnumb>
        <drugdosagetext>1 IN 1 D, PER ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GLUCOSE TOLERANCE IMPAIRED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040416</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GEMFIBROZIL (GEMFIBROZIL) (600 MILLIGRAM, TABLETS)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE (METOPROLOL TARTRATE) (50 MILLIGRAM, TABLETS)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN (SIMVASTATIN) (80, TABLETS)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059020-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060710</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200611680BWH</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>73</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>90.7194</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>AMNESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLISTER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SENSATION OF HEAVINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STOMATITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXAVAR</medicinalproduct>
        <drugauthorizationnumb>21923</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RENAL CELL CARCINOMA STAGE UNSPECIFIED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060202</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060215</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXAVAR</medicinalproduct>
        <drugauthorizationnumb>21923</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RENAL CELL CARCINOMA STAGE UNSPECIFIED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060222</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMARYL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VASOTEC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTIHYPERTENSIVE MEDICATION</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059021-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060709</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200612915BCC</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>ATRIAL FIBRILLATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALEVE</medicinalproduct>
        <drugauthorizationnumb>20204</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059022-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060705</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>163-20785-06040126</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>57</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>CALCIPHYLAXIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DERMATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISEASE PROGRESSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>THALOMID</medicinalproduct>
        <drugauthorizationnumb>20785</drugauthorizationnumb>
        <drugdosagetext>200 MG, 2 IN 1 D, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CALCIPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060401</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059023-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060706</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>163-20785-06030913</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>70</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CHOLECYSTECTOMY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>THALOMID</medicinalproduct>
        <drugauthorizationnumb>20785</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051104</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>THALOMID</medicinalproduct>
        <drugauthorizationnumb>20785</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060410</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059024-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060705</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>163-20785-06070171</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>67</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>LABORATORY TEST ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>THALOMID</medicinalproduct>
        <drugauthorizationnumb>20785</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040801</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>THALOMID</medicinalproduct>
        <drugauthorizationnumb>20785</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060501</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>THALOMID</medicinalproduct>
        <drugauthorizationnumb>20785</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040901</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>THALOMID</medicinalproduct>
        <drugauthorizationnumb>20785</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041001</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059025-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060714</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>HQWYE166504MAY06</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>51</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>53</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>COLITIS</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>RENAL AND PANCREAS TRANSPLANT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROGRAF</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOPRESSOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE TAB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZELNORM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEMADEX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BACTRIM DS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALGANCICLOVIR HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDRALAZINE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMDUR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRAVACHOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EPOGEN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059026-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060711</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>HQWYE868613JUL06</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>57</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>49.4</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>LUNG ADENOCARCINOMA STAGE IV</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METASTASES TO ADRENALS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOSPORINE</medicinalproduct>
        <drugdosagetext>125 MG 2X PER 1 DAY, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS AGAINST TRANSPLANT REJECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050601</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059027-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060707</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>HQWYE012507JUN06</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>30</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>97.16</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIALYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>KIDNEY TRANSPLANT REJECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEUKOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL TUBULAR NECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL VESSEL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VASCULAR STENOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RAPAMUNE</medicinalproduct>
        <drugauthorizationnumb>21083</drugauthorizationnumb>
        <drugdosagetext>10 MG 1X PER 1 DAY, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS AGAINST TRANSPLANT REJECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060603</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDRALAZINE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LABETALOL HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NILSTAT (NYSTATIN)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BACTRIM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NIFEDIPINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FENOLDOPAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONIDINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059028-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060709</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060707</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>HQWYE743011JUL06</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BREAST CANCER METASTATIC</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMPRO</medicinalproduct>
        <drugauthorizationnumb>20527</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCRIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059029-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060706</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>HQWYE682510JUL06</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>66</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>53.57</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ARTHROPOD BITE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE DENSITY DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SLEEP DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
        <drugauthorizationnumb>4782</drugauthorizationnumb>
        <drugdosagetext>1.25 MG DAILY ORAL ; 0.45 MG ORAL ; 0.9 MG ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ENDOMETRIOSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19660101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
        <drugauthorizationnumb>4782</drugauthorizationnumb>
        <drugdosagetext>1.25 MG DAILY ORAL ; 0.45 MG ORAL ; 0.9 MG ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ENDOMETRIOSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
        <drugauthorizationnumb>4782</drugauthorizationnumb>
        <drugdosagetext>1.25 MG DAILY ORAL ; 0.45 MG ORAL ; 0.9 MG ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ENDOMETRIOSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059030-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060713</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006BI007519</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>40</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>EXTRAVASATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCORRECT DRUG ADMINISTRATION RATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEDICAL DEVICE COMPLICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWELLING</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>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059031-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060705</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006BI007625</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>70</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROENTERITIS BACTERIAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMMUNE SYSTEM DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX LYOPHILIZED</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>
        <drugdosagetext>30 UG QW IM</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060301</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCODONE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059032-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060717</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006BI008089</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>56</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLADDER PROLAPSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHOLELITHIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GALLBLADDER DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY INCONTINENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UTERINE 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>20011015</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>5059033-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060707</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>189394</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>39</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>117.9352</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BASAL CELL CARCINOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROGRESSIVE MULTIPLE SCLEROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN CANCER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugdosagetext>IM ; 30 UG QW IM</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000724</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20000801</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugdosagetext>IM ; 30 UG QW IM</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000801</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BLADDER MEDICATION (NOS)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTIDEPRESSANT (NOS)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SONATA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPAMAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREVACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARDURA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELLCEPT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PHENERGAN HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NOVANTRONE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059034-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060713</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006BI009983</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>60</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UPPER LIMB FRACTURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugdosagetext>30 UG QW IM</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030710</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>5059035-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060713</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006BI009986</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>50</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STAPHYLOCOCCAL INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugdosagetext>30 UG QW IM</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19991001</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>5059036-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060713</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CLOF-10283</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>0</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ACUTE MYELOID LEUKAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ATRIAL FIBRILLATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISEASE PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THERAPY NON-RESPONDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOFARABINE</medicinalproduct>
        <drugauthorizationnumb>21673</drugauthorizationnumb>
        <drugindication>ACUTE MYELOID LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051106</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051109</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYTARABINE</medicinalproduct>
        <drugindication>ACUTE MYELOID LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051106</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051109</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059037-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060717</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>008027</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BREAST CANCER FEMALE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MEDROXYPROGESTERONE ACETATE</medicinalproduct>
        <drugauthorizationnumb>40159</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19860101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19980501</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19860101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19980501</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMPRO</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19860101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19980501</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROVERA</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19860101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19980501</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059038-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060717</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>008031</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BREAST CANCER FEMALE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MEDROXYPROGESTERONE ACETATE</medicinalproduct>
        <drugauthorizationnumb>40159</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19870101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020801</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19870101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020801</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMPRO</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19870101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020801</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROVERA</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19870101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020801</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059039-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060717</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>008025</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BREAST CANCER FEMALE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MEDROXYPROGESTERONE ACETATE</medicinalproduct>
        <drugauthorizationnumb>40159</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19600101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19990801</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19960101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19990801</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMPRO</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19960101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19990801</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROVERA</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19960101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19990801</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ESTRACE</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19960101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19990801</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ESTRADIOL</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19960101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19990801</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059040-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060717</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>008022</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BREAST CANCER FEMALE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MEDROXYPROGESTERONE ACETATE</medicinalproduct>
        <drugauthorizationnumb>40159</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19960101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020401</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19960101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020401</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROVERA</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19960101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020401</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059041-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060717</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>008023</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BREAST CANCER FEMALE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MEDROXYPROGESTERONE ACETATE</medicinalproduct>
        <drugauthorizationnumb>40159</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19950101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20021101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCRIN</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19950101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20021101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19950101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20021101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMPRO</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19950101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20021101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROVERA</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19950101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20021101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059042-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060703</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>TRP_0808_2006</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>63</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ULNA FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WRIST FRACTURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RIBASPHERE</medicinalproduct>
        <drugauthorizationnumb>76203</drugauthorizationnumb>
        <drugdosagetext>DF PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060426</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEG-INTRON</medicinalproduct>
        <drugdosagetext>DF SC</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060426</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CENTRUM SILVER</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059043-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060705</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2827</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PREGNANCY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMNESTEEM</medicinalproduct>
        <drugauthorizationnumb>75945</drugauthorizationnumb>
        <drugdosagetext>60 MG QD PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060425</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060622</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059044-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060707</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2625</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>24</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABORTION INDUCED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREATMENT NONCOMPLIANCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMNESTEEM</medicinalproduct>
        <drugauthorizationnumb>75945</drugauthorizationnumb>
        <drugdosagetext>40 MG QD PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ACNE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060215</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060412</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059045-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060708</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>E3810-00028-CLI-US</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>31</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>102</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EROSIVE OESOPHAGITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATEMESIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACIPHEX</medicinalproduct>
        <drugauthorizationnumb>20973</drugauthorizationnumb>
        <drugdosagetext>1 TAB ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DYSPEPSIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060424</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060616</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TUMS (CALCIUM CARBONATE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN ANTIBIOTIC (ANTIBIOTICS)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BRONCHADILATOR (BRONCHILATOR)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACID REDUCER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VIODIN (POVIDONE-IODINE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTACID (TITRALAC)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENADRYL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059046-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060705</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>226807</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>62</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>85.3</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLD SWEAT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISEASE PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA EXERTIONAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERAL PHYSICAL HEALTH DETERIORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLEURAL EFFUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVASTIN</medicinalproduct>
        <drugdosagetext>100 MG</drugdosagetext>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060414</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ELOXATIN</medicinalproduct>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060414</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALIMTA</medicinalproduct>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060414</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTIBIOTICS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>STEROIDS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYGEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MORPHINE SULFATE DRIP (MORPHINE SULFATE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMARYL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORTAB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INHALER</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059047-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060706</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>227052</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>75</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>73</patientweight>
      <patientsex>0</patientsex>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVASTIN</medicinalproduct>
        <drugdosagetext>737 MG INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>LYMPHOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060427</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RITUXAN</medicinalproduct>
        <drugdosagetext>697 MG, 1/WEEK, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>LYMPHOMA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059048-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060705</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>227020</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHEUMATOID ARTHRITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RITUXAN</medicinalproduct>
        <drugdosagetext>1000 MG SINGLE INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060626</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059049-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060705</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>227021</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>64</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>94.1</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>SMALL CELL LUNG CANCER STAGE UNSPECIFIED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RITUXAN</medicinalproduct>
        <drugdosagetext>375 MG/M2, Q28D, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>B-CELL LYMPHOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050211</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050408</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUDARABINE</medicinalproduct>
        <drugdosagetext>25 MG/M2, Q28D, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>B-CELL LYMPHOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050211</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050412</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROTONIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACYCLOVIR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEPRON</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZYRTEC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENADRYL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059050-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060705</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>226930</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>54</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>55.1</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RITUXIMAB OR PLACEBO (RITUXIMAB) CONC FOR SOLUTION FOR INFUSION</medicinalproduct>
        <drugbatchnumb>30417, 30434, 30641, 30690, 30656</drugbatchnumb>
        <drugdosagetext>2 G, DAYS 1+15</drugdosagetext>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050818</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060216</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059051-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060714</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>S06-USA-02484-01</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>53</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POSTICTAL STATE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEXAPRO</medicinalproduct>
        <drugauthorizationnumb>21323</drugauthorizationnumb>
        <drugdosagetext>20 MG QD PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060601</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRAMADOL HCL</medicinalproduct>
        <drugdosagetext>50 MG PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BACK PAIN</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060601</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRAMADOL HCL</medicinalproduct>
        <drugdosagetext>50 MG PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RADICULAR PAIN</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060601</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORTAB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLARITIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RELAFEN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059052-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060711</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>S06-USA-00386-01</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>18</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERNATIONAL NORMALISED RATIO INCREASED</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>20060131</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059053-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesscongenitalanomali>1</seriousnesscongenitalanomali>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060710</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>S06-USA-02720-01</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>41</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ATRIOVENTRICULAR SEPTAL DEFECT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FOETAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>REFUSAL OF TREATMENT BY PATIENT</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>20051101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRENATAL VITAMINS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059054-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060707</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>R301638-PAP-USA</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>67</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>71</patientweight>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ACUTE RESPIRATORY FAILURE</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>20030101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOPHAGE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CONEQ</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZYRTEC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059055-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060710</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200613793BWH</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>42</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>68.9467</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANGIONEUROTIC OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHROPOD BITE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA MULTIFORME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GUN SHOT WOUND</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMPAIRED WORK ABILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL SELF-INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE RUPTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAIL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANIC ATTACK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH GENERALISED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>REBOUND EFFECT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RECTAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN LESION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SURGERY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWELLING FACE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TENDON RUPTURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CIPRO</medicinalproduct>
        <drugauthorizationnumb>19537</drugauthorizationnumb>
        <drugdosagetext>500 MG BID ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CIPRO XR</medicinalproduct>
        <drugdosagetext>1000 MG BID ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EFFEXOR XR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATIVAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DURAGESIC-100</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORCET-HD</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COMBUNOX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SKELAXIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLEXERIL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059056-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060712</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200612407BWH</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>74</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>51.8</patientweight>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ANAPHYLACTIC REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ATELECTASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METABOLIC ACIDOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORGAN FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POST PROCEDURAL COMPLICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENTRICULAR FIBRILLATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENTRICULAR HYPOKINESIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRASYLOL</medicinalproduct>
        <drugauthorizationnumb>20304</drugauthorizationnumb>
        <drugdosagetext>1 ML ONCE INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>AORTIC VALVE REPLACEMENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040804</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREOPERATIVE ANAESTHESIA (ANAESTHETICS)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LESCOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DARVOCET</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IRON SULFATETHIAMIN COMPOUND TAB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM GLUCONATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIGOXIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASCORBIC ACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HEPARIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEO SYNEPHRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORMOSOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MANNITOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROTAMINE SULFATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SONATA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZITHROMAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMIODARONE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMINS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM CHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VERSED</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CEFAZOLIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LACTATED RINGER'S</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORMAL SALINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOPAMINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EPINEPHRINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZANTAC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SOLU-CORTEF</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NACL              (SODIUM CHLORIDE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KANAMYCIN SULFATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENADRYL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGNESIUM SULFATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROTAMINE SULFATE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059057-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060704</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DEU-2006-0002332</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>54</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE MASS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MORPHINE SULFATE</medicinalproduct>
        <drugdosagetext>15.8 MG DAILY INTRATHECAL</drugdosagetext>
        <drugadministrationroute>037</drugadministrationroute>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BUPIVACAINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059058-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060704</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DEU-2006-0002331</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>52</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE MASS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MONOPLEGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEURALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPINAL CORD COMPRESSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MORPHINE SULFATE</medicinalproduct>
        <drugdosagetext>16 MG DAILY INTRATHECAL</drugdosagetext>
        <drugadministrationroute>037</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugtreatmentduration>762</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BUPIVACAINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059059-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060712</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006-07-0470</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>ATRIAL TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NASONEX</medicinalproduct>
        <drugauthorizationnumb>20762</drugauthorizationnumb>
        <drugdosagetext>NASAL SPRAY</drugdosagetext>
        <drugadministrationroute>045</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059060-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060706</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>SU-2006-005001</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>63</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>72.5755</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CHILLS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COELIAC DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BENICAR</medicinalproduct>
        <drugauthorizationnumb>21286</drugauthorizationnumb>
        <drugdosagetext>40 MG QD PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060509</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060509</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FEXOFENADINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUOXETINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059061-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060704</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2006US09994</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>65</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CYTOMEGALOVIRUS ANTIGEN POSITIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROENTERITIS CRYPTOSPORIDIAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMODIALYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART TRANSPLANT REJECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEPROMATOUS LEPROSY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOCALISED OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL TRANSPLANT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SENSORY LOSS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THERAPEUTIC AGENT TOXICITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOSPORINE</medicinalproduct>
        <drugauthorizationnumb>80336</drugauthorizationnumb>
        <drugdosagetext>100 MG, BID, UNK</drugdosagetext>
        <drugindication>HEART TRANSPLANT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugdosagetext>5 MG/D, UNK</drugdosagetext>
        <drugindication>HEART TRANSPLANT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MYCOPHENOLATE MOFETIL</medicinalproduct>
        <drugdosagetext>1250 MG, BID, UNK</drugdosagetext>
        <drugindication>HEART TRANSPLANT</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059062-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060705</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200612734BWH</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLINDNESS UNILATERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>REFUSAL OF TREATMENT BY PATIENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVITRA</medicinalproduct>
        <drugauthorizationnumb>21400</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059063-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060713</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>14397</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DIARRHOEA HAEMORRHAGIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugauthorizationnumb>11719</drugauthorizationnumb>
        <drugdosagetext>50 MG/M2 IM</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>ECTOPIC PREGNANCY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059064-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060706</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>14364</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>65</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AORTIC DISSECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AORTIC THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATEMESIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUOROURACIL</medicinalproduct>
        <drugauthorizationnumb>8107</drugauthorizationnumb>
        <drugdosagetext>2490 MG PER_CYCLE IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NEUROENDOCRINE TUMOUR</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060426</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060428</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUOROURACIL</medicinalproduct>
        <drugauthorizationnumb>8107</drugauthorizationnumb>
        <drugdosagetext>2490 MG PER_CYCLE IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PANCREATIC DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060426</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060428</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEUCOVORIN CALCIUM</medicinalproduct>
        <drugdosagetext>390 MG PER_CYCLE IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NEUROENDOCRINE TUMOUR</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060428</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060428</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEUCOVORIN CALCIUM</medicinalproduct>
        <drugdosagetext>390 MG PER_CYCLE IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PANCREATIC DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060428</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060428</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXALIPLATIN</medicinalproduct>
        <drugdosagetext>125 MG PER_CYCLE IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NEUROENDOCRINE TUMOUR</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060428</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060428</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXALIPLATIN</medicinalproduct>
        <drugdosagetext>125 MG PER_CYCLE IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PANCREATIC DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060428</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060428</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVASTIN</medicinalproduct>
        <drugdosagetext>375 MG PER_CYCLE IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NEUROENDOCRINE TUMOUR</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060428</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060428</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVASTIN</medicinalproduct>
        <drugdosagetext>375 MG PER_CYCLE IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PANCREATIC DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060428</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060428</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE TAB</medicinalproduct>
        <drugdosagetext>10 MG PER_CYCLE IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060102</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060428</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PALONOSETRON</medicinalproduct>
        <drugdosagetext>0.25 MG PER_CYCLE IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060102</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060428</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN AND HYDROCODONE BITARTRATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANCRELIPASE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CITALOPRAM HYDROBROMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROCHLORPERAZINE TAB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORAZEPAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GRANISETRON  HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOCUSATE SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCODONE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANTOPRAZOLE SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SUCRALFATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059065-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060710</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>14368</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>63</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BONE MARROW FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE CONTRACTIONS INVOLUNTARY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCLONUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUOROURACIL</medicinalproduct>
        <drugauthorizationnumb>8107</drugauthorizationnumb>
        <drugindication>COLON CANCER STAGE III</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEUCOVORIN CALCIUM</medicinalproduct>
        <drugindication>COLON CANCER STAGE III</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ELOXATIN</medicinalproduct>
        <drugdosagetext>170 MG FORTNIGHTLY IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLON CANCER STAGE III</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM GLUCONATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGNESIUM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059066-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060706</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>14361</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>67</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>113.3993</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASPARTATE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACTERAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHILLS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLATULENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STOMATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE TAB</medicinalproduct>
        <drugauthorizationnumb>8107</drugauthorizationnumb>
        <drugdosagetext>20 MG PER_CYCLE IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ENDOCRINE PANCREATIC DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060411</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060425</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE TAB</medicinalproduct>
        <drugauthorizationnumb>8107</drugauthorizationnumb>
        <drugdosagetext>20 MG PER_CYCLE IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PANCREATIC NEOPLASM</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060411</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060425</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUOROURACIL</medicinalproduct>
        <drugdosagetext>950 MG PER_CYCLE IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ENDOCRINE PANCREATIC DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060425</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060425</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUOROURACIL</medicinalproduct>
        <drugdosagetext>950 MG PER_CYCLE IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PANCREATIC NEOPLASM</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060425</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060425</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GRANISETRON  HCL</medicinalproduct>
        <drugdosagetext>1200 MICROGRAM PER_CYCLE IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ENDOCRINE PANCREATIC DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060411</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060425</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GRANISETRON  HCL</medicinalproduct>
        <drugdosagetext>1200 MICROGRAM PER_CYCLE IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PANCREATIC NEOPLASM</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060411</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060425</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEUCOVORIN CALCIUM</medicinalproduct>
        <drugdosagetext>475 MG PER_CYCLE IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ENDOCRINE PANCREATIC DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060425</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060425</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEUCOVORIN CALCIUM</medicinalproduct>
        <drugdosagetext>475 MG PER_CYCLE IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PANCREATIC NEOPLASM</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060425</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060425</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXALIPLATIN</medicinalproduct>
        <drugdosagetext>200 MG PER_CYCLE IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ENDOCRINE PANCREATIC DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060425</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060425</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXALIPLATIN</medicinalproduct>
        <drugdosagetext>200 MG PER_CYCLE IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PANCREATIC NEOPLASM</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060425</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060425</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVASTIN</medicinalproduct>
        <drugdosagetext>570 MG PER_CYCLE IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ENDOCRINE PANCREATIC DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060425</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060425</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVASTIN</medicinalproduct>
        <drugdosagetext>570 MG PER_CYCLE IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PANCREATIC NEOPLASM</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060425</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060425</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LORAZEPAM</medicinalproduct>
        <drugdosagetext>1 MG PER_CYCLE PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ENDOCRINE PANCREATIC DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060411</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060425</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LORAZEPAM</medicinalproduct>
        <drugdosagetext>1 MG PER_CYCLE PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PANCREATIC NEOPLASM</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060411</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060425</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROTONIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SANDOSTATIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SANDOSTATIN LAR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>D10</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETYLSALICYLIC ACID SRT</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059067-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060703</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DSA_60994_2006</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>4</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>17.2367</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCORRECT DOSE ADMINISTERED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY DEPRESSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIASTAT</medicinalproduct>
        <drugbatchnumb>WKDT</drugbatchnumb>
        <drugauthorizationnumb>20648</drugauthorizationnumb>
        <drugdosagetext>DF ONCE RC</drugdosagetext>
        <drugadministrationroute>054</drugadministrationroute>
        <drugindication>CONVULSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060702</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060702</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RANITIDINE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREVACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BACLOFEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRILEPTAL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059068-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060707</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>T200600536</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OPTIMARK IN GLASS VIALS(GADEVERSETAMIDE) SOLUTION</medicinalproduct>
        <drugauthorizationnumb>20937</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059069-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060710</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>T200600717</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>74</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANAPHYLACTIC REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MD-GASTROVIEW</medicinalproduct>
        <drugbatchnumb>L187A</drugbatchnumb>
        <drugauthorizationnumb>87388</drugauthorizationnumb>
        <drugdosagetext>60 ML, SINGLE, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>COMPUTERISED TOMOGRAM ABDOMEN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060622</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060622</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPROL-XL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONAZEPAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VERAPAMIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VICODIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059070-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060703</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CIP06001558</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>76</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CHEST DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRIC ULCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERLIPIDAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCISIONAL HERNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OESOPHAGEAL STENOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUPRAVENTRICULAR TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACTONEL</medicinalproduct>
        <drugauthorizationnumb>20835</drugauthorizationnumb>
        <drugdosagetext>35 MG ONCE WEEKLY, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DRUG NOS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059071-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060706</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US017657</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>24</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>54.4316</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INCORRECT DOSE ADMINISTERED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY ARREST</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACTIQ</medicinalproduct>
        <drugauthorizationnumb>20747</drugauthorizationnumb>
        <drugdosagetext>800 UG BUCCAL</drugdosagetext>
        <drugadministrationroute>002</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACTIQ</medicinalproduct>
        <drugauthorizationnumb>20747</drugauthorizationnumb>
        <drugdosagetext>800 UG BUCCAL</drugdosagetext>
        <drugadministrationroute>002</drugadministrationroute>
        <drugindication>STIFF-MAN SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACTIQ</medicinalproduct>
        <drugdosagetext>1600 UG Q4HR BUCCAL</drugdosagetext>
        <drugadministrationroute>002</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACTIQ</medicinalproduct>
        <drugdosagetext>1600 UG Q4HR BUCCAL</drugdosagetext>
        <drugadministrationroute>002</drugadministrationroute>
        <drugindication>STIFF-MAN SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MORPHINE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOFRAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BACLOFEN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059072-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060713</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>USA-2006-0024409</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>OVERDOSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXYCODONE HCL</medicinalproduct>
        <drugauthorizationnumb>20553</drugauthorizationnumb>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059073-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060711</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>USA-2006-0024440</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>58</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PANCREATITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXYCONTIN</medicinalproduct>
        <drugauthorizationnumb>20553</drugauthorizationnumb>
        <drugdosagetext>160 MG, DAILY</drugdosagetext>
        <drugindication>BACK PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MIRALAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMBIEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATIVAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYANOCOBALAMIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059074-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060710</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>USA-2006-0024579</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>43</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>86.2</patientweight>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>BRONCHOPNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG TOXICITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRIC HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC NECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC STEATOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG ABSCESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERITONEAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY OEDEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MORPHINE SULFATE</medicinalproduct>
        <drugauthorizationnumb>19516</drugauthorizationnumb>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HYDROMORPHONE HCL</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BENZODIAZEPINE DERIVATIVES ()</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059075-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060707</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006085154</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BREAST CANCER FEMALE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>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>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>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19920101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CENESTIN</medicinalproduct>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19920101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059076-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060707</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006085162</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BREAST CANCER FEMALE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>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>MEDROXYPROGESTERONE ACETATE</medicinalproduct>
        <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>PREMARIN</medicinalproduct>
        <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>PREMPRO</medicinalproduct>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19930101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ESTRATAB</medicinalproduct>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19930101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059077-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060707</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006085165</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BREAST CANCER FEMALE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>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>20000101</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>19940101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20000101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19940101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20000101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMPRO</medicinalproduct>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19940101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20000101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ESTRATEST</medicinalproduct>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19940101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20000101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ESTRADERM</medicinalproduct>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19940101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20000101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIVELLE</medicinalproduct>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19940101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20000101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059078-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060707</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006085169</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BREAST CANCER FEMALE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>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>20020101</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>19960101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19960101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMPRO</medicinalproduct>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19960101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMBIPATCH</medicinalproduct>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19960101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059079-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US200607002089</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>63</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>136.1</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY OCCLUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMALOG</medicinalproduct>
        <drugauthorizationnumb>20563</drugauthorizationnumb>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050701</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMULIN N</medicinalproduct>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050701</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BYETTA</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059080-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US200602003308</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>50</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>131.5</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ACTIVATED PARTIAL THROMBOPLASTIN TIME PROLONGED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ACUTE RESPIRATORY FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AORTIC STENOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ATELECTASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AZOTAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BILE DUCT STONE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CORTICOTROPHIN ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CORTISOL ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CREATINE PHOSPHOKINASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE CONGESTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHOLELITHIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COAGULOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONJUNCTIVITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COR PULMONALE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIABETES MELLITUS NON-INSULIN-DEPENDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG RESISTANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE IRRITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GALLBLADDER DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATOCRIT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOPHILUS INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC STEATOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERNATRAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INADEQUATE DIET</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERNATIONAL NORMALISED RATIO INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG INFILTRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALNUTRITION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OBESITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PITTING OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRESCRIBED OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRODUCTIVE COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SERUM FERRITIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SLEEP APNOEA SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPUTUM CULTURE POSITIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THIRST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREATMENT NONCOMPLIANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRICUSPID VALVE INCOMPETENCE</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>SEE IMAGE</drugdosagetext>
        <drugindication>SCHIZOAFFECTIVE DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20011202</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
        <drugauthorizationnumb>20592</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugindication>SCHIZOAFFECTIVE DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20011203</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
        <drugauthorizationnumb>20592</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugindication>SCHIZOAFFECTIVE DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020108</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030126</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
        <drugauthorizationnumb>20592</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugindication>SCHIZOAFFECTIVE DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030127</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030312</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
        <drugauthorizationnumb>20592</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugindication>SCHIZOAFFECTIVE DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030313</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030426</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
        <drugauthorizationnumb>20592</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugindication>SCHIZOAFFECTIVE DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030427</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030818</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
        <drugauthorizationnumb>20592</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugindication>SCHIZOAFFECTIVE DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030819</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031113</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
        <drugauthorizationnumb>20592</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugindication>SCHIZOAFFECTIVE DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031114</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040121</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
        <drugauthorizationnumb>20592</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugindication>SCHIZOAFFECTIVE DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040122</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040410</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
        <drugauthorizationnumb>20592</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugindication>SCHIZOAFFECTIVE DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040411</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040504</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
        <drugauthorizationnumb>20592</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugindication>SCHIZOAFFECTIVE DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040505</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040616</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
        <drugauthorizationnumb>20592</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugindication>SCHIZOAFFECTIVE DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040617</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040818</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
        <drugauthorizationnumb>20592</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugindication>SCHIZOAFFECTIVE DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040819</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040913</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
        <drugauthorizationnumb>20592</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugindication>SCHIZOAFFECTIVE DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040914</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050719</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
        <drugauthorizationnumb>20592</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugindication>SCHIZOAFFECTIVE DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050720</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
        <drugauthorizationnumb>20592</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugindication>SCHIZOAFFECTIVE DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060102</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUOXETINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREMPRO</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROMETHAZINE W/CODEINE (CODEINE PHOSPHATE, PROMETHAZINE HYDROCHLORIDE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059081-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060630</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>06071799</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </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>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISTURBANCE IN ATTENTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EPISTAXIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OVIDE</medicinalproduct>
        <drugauthorizationnumb>18613</drugauthorizationnumb>
        <drugdosagetext>ONCE TOPICAL</drugdosagetext>
        <drugadministrationroute>061</drugadministrationroute>
        <drugindication>LICE INFESTATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060506</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060506</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059082-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060711</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>SU-2006-004953</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>65</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>66.6788</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ALANINE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASPARTATE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD MAGNESIUM DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ELECTROENCEPHALOGRAM ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAMMA-GLUTAMYLTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GRAND MAL CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC ENZYME INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPONATRAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENTAL STATUS CHANGES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE ENZYME INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARYNGEAL OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWELLING FACE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL DISTURBANCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BENICAR HCT</medicinalproduct>
        <drugauthorizationnumb>21532</drugauthorizationnumb>
        <drugdosagetext>40.125 MG QD PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060217</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVAQUIN</medicinalproduct>
        <drugdosagetext>500 MG QD PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SINUSITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060216</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060217</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MUCINEX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOPRESSOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EVISTA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRIAVIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CENTRUM SILVER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM GLUCONATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLAXSEED OIL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059083-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060705</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006084899</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>53</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>113.3993</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY DISEASE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugauthorizationnumb>20998</drugauthorizationnumb>
        <drugdosagetext>400 MG (200 MG, 2 IN 1 D),</drugdosagetext>
        <drugindication>ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030601</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059084-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060705</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006084908</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>72</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>77.1115</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIOMEGALY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUID RETENTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCREASED TENDENCY TO BRUISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN ATROPHY</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>5059085-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060705</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006084735</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>48</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>63.5036</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEFORMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE ATROPHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugauthorizationnumb>20998</drugauthorizationnumb>
        <drugdosagetext>200 MG (200 MG, 1 IN 1 D)</drugdosagetext>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19991201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059086-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060706</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006085131</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BREAST CANCER FEMALE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>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>19980101</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>19940101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19980101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059087-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060707</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006085194</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>61</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD POTASSIUM DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugauthorizationnumb>20702</drugauthorizationnumb>
        <drugdosagetext>(80 MG,), 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>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NIFEDIPINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059088-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060707</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006085223</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BREAST CANCER FEMALE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROVERA</medicinalproduct>
        <drugauthorizationnumb>11839</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19790101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030101</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>19790101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19790101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059089-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060705</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006085233</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DETROL LA</medicinalproduct>
        <drugauthorizationnumb>21228</drugauthorizationnumb>
        <drugdosagetext>4 MG</drugdosagetext>
        <drugindication>POLLAKIURIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059090-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060707</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006085246</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BREAST CANCER FEMALE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROVERA</medicinalproduct>
        <drugauthorizationnumb>11839</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19840101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030101</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>19840101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19840101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROMETRIUM</medicinalproduct>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19840101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059091-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060620</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006044793</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>127.0072</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD CHOLESTEROL INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIABETES MELLITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIAGRA</medicinalproduct>
        <drugauthorizationnumb>20895</drugauthorizationnumb>
        <drugdosagetext>50 MG (50 MG, AS NECESSARY), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ERECTILE DYSFUNCTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CIALIS</medicinalproduct>
        <drugindication>ERECTILE DYSFUNCTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCONTIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059092-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060705</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006044703</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </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>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEXTRA</medicinalproduct>
        <drugauthorizationnumb>21341</drugauthorizationnumb>
        <drugdosagetext>10 MG</drugdosagetext>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041001</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059093-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060710</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006061842</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COORDINATION ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
        <drugauthorizationnumb>20235</drugauthorizationnumb>
        <drugdosagetext>900 MG (300 MG, 3 IN 1 D)</drugdosagetext>
        <drugindication>DIABETIC NEUROPATHY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059094-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060526</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006058956</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>71</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CEREBRAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGE INTRACRANIAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENTAL STATUS CHANGES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRANSIENT ISCHAEMIC ATTACK</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>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021220</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059095-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060705</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006060672</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>39</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>102.0593</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIOMYOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIOVASCULAR DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugauthorizationnumb>20998</drugauthorizationnumb>
        <drugdosagetext>200 MG (200 MG, 1 IN 1 D)</drugdosagetext>
        <drugindication>PAIN MANAGEMENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990806</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19991011</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEXTRA</medicinalproduct>
        <drugdosagetext>20 MG</drugdosagetext>
        <drugindication>PAIN MANAGEMENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030318</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030401</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059096-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060705</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006063340</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>70</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SMALL INTESTINAL RESECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIFLUCAN</medicinalproduct>
        <drugauthorizationnumb>19950</drugauthorizationnumb>
        <drugdosagetext>100 MG (100 MG, 1 IN 1 D), INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060506</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYVOX</medicinalproduct>
        <drugdosagetext>1200 MG (600 MG, 1 IN 12 HR), INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060506</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLAGYL I.V.</medicinalproduct>
        <drugdosagetext>2400 MG (800 MG, 1 IN 8 HR), INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060430</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOSYN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059097-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060705</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006063946</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>88.4514</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>EMOTIONAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GALLBLADDER OPERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL SURGERY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugauthorizationnumb>20998</drugauthorizationnumb>
        <drugdosagetext>200 MG</drugdosagetext>
        <drugindication>ARTHRALGIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19990601</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059098-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060705</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006072801</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>68</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>71.2147</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGIC STROKE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUTENT</medicinalproduct>
        <drugauthorizationnumb>21968</drugauthorizationnumb>
        <drugdosagetext>(50 MG, CYCLIC), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RENAL CELL CARCINOMA STAGE UNSPECIFIED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060327</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060602</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GLYNASE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059099-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060705</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006082926</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>82</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ALPHA HAEMOLYTIC STREPTOCOCCAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE MARROW FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CANDIDIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHOLESTASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GRAFT VERSUS HOST DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERBILIRUBINAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL CANDIDIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARYNGOLARYNGEAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH ERYTHEMATOUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STEVENS-JOHNSON SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYSTEMIC CANDIDA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
        <drugauthorizationnumb>20235</drugauthorizationnumb>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PANTOPRAZOLE SODIUM</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METOPROLOL (METOPROLOL)</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMIODARONE (AMIODARONE)</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASCRIPTIN (ACETYLSALICYLIC ACID, ALUMINIUM HYDROXIDE, MAGNESIUM HYDROX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM CHLORIDE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059100-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060705</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006084107</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DEMENTIA ALZHEIMER'S TYPE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG PRESCRIBING ERROR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROOESOPHAGEAL REFLUX DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POLLAKIURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRANSIENT ISCHAEMIC ATTACK</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DETROL LA</medicinalproduct>
        <drugauthorizationnumb>21228</drugauthorizationnumb>
        <drugdosagetext>4 MG (4 MG 1 IN 1 D)</drugdosagetext>
        <drugindication>HYPERTONIC BLADDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMOXICILLIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RHINOCORT</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059101-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060705</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006084479</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>46</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>45.3597</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ARTERIAL OCCLUSIVE DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugauthorizationnumb>20998</drugauthorizationnumb>
        <drugdosagetext>400 MG (200 MG 2 IN 1 D)</drugdosagetext>
        <drugindication>PAIN</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059102-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060707</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006084646</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>12</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>40</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>NEOPLASM RECURRENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RADIATION INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPINAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TERATOMA BENIGN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GENOTROPIN</medicinalproduct>
        <drugauthorizationnumb>20280</drugauthorizationnumb>
        <drugdosagetext>(1.8 MG EVERY DAY) SUBCUTANEOUS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>GROWTH HORMONE DEFICIENCY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041209</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060419</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VIVELLE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059103-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060705</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006084119</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>62.3696</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD CHOLESTEROL INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERAL PHYSICAL HEALTH DETERIORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MIDDLE INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NOCTURIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DETROL LA</medicinalproduct>
        <drugauthorizationnumb>21228</drugauthorizationnumb>
        <drugdosagetext>4 MG</drugdosagetext>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALL OTHER THERAPEUTIC PRODUCTS (ALL OTHER THERAPEUTIC PRODUCTS)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059104-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060705</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006084568</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>58</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>76.2043</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UNDERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UNEVALUABLE EVENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugauthorizationnumb>21446</drugauthorizationnumb>
        <drugdosagetext>150 MG (75 MG 2 IN 1 D) ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETIC NEUROPATHY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060703</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060705</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NOVOLOG</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOTREL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MONTELEUKAST                   (MONTELEUKAST)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059105-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060707</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006085152</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </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>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19950101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20000101</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>19950101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20000101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19950101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20000101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ESTRACE</medicinalproduct>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19950101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20000101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059106-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060705</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006084865</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD HOMOCYSTEINE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPEPSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VITAMIN D DEFICIENCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WRONG TECHNIQUE IN DRUG USAGE PROCESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
        <drugbatchnumb>34726L</drugbatchnumb>
        <drugauthorizationnumb>20235</drugauthorizationnumb>
        <drugdosagetext>2400 MG (600 MG 4 IN 1 D)</drugdosagetext>
        <drugindication>TRIGEMINAL NEURALGIA</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060621</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DILANTIN</medicinalproduct>
        <drugdosagetext>(1 IN 1 D)</drugdosagetext>
        <drugindication>CONVULSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060623</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GABAPENTIN</medicinalproduct>
        <drugdosagetext>2400 MG (600 MG 4 IN 1 D)</drugdosagetext>
        <drugindication>TRIGEMINAL NEURALGIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALL OTHER THERAPEUTIC PRODUCTS</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROZAC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NITRO PATCH                  (GLYCERYL TRINITRATE)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059107-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060705</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006084892</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</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>
      <reaction>
        <reactionmeddrapt>ARRHYTHMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugauthorizationnumb>20998</drugauthorizationnumb>
        <drugdosagetext>400 MG (200 MG 2 IN 1 D)</drugdosagetext>
        <drugindication>NECK INJURY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059108-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060708</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006BI009760</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>40</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BASAL CELL CARCINOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059109-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060706</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006PV017122</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIAC DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BYETTA</medicinalproduct>
        <drugauthorizationnumb>21773</drugauthorizationnumb>
        <drugdosagetext>SC</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059110-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060707</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006BI009773</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>56</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BALANCE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UPPER LIMB FRACTURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugdosagetext>30 UG; QW; IM</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050701</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>20060301</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059111-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060705</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006PV016257</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>46</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>93.441</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIABETIC GASTROPARESIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BYETTA</medicinalproduct>
        <drugbatchnumb>9SF00M</drugbatchnumb>
        <drugauthorizationnumb>21773</drugauthorizationnumb>
        <drugdosagetext>5 MCG; BID; SC</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>DIABETES MELLITUS NON-INSULIN-DEPENDENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060427</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060608</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BYETTA</medicinalproduct>
        <drugbatchnumb>9SF00M</drugbatchnumb>
        <drugauthorizationnumb>21773</drugauthorizationnumb>
        <drugdosagetext>5 MCG; BID; SC</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>DIABETES MELLITUS NON-INSULIN-DEPENDENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060613</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060613</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BYETTA</medicinalproduct>
        <drugbatchnumb>9SF00M</drugbatchnumb>
        <drugauthorizationnumb>21773</drugauthorizationnumb>
        <drugdosagetext>5 MCG; BID; SC</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>DIABETES MELLITUS NON-INSULIN-DEPENDENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060626</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SINGULAIR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADVAIR DISKUS 100/50</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REGLAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRILOSEC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FENTANYL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059112-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060707</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006BI009774</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BREAST CANCER FEMALE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059113-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060706</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006PV016650</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>62</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>136.0791</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ACUTE CORONARY SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANOREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY INSUFFICIENCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY OCCLUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BYETTA</medicinalproduct>
        <drugauthorizationnumb>21773</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>DIABETES MELLITUS NON-INSULIN-DEPENDENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050627</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050711</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BYETTA</medicinalproduct>
        <drugauthorizationnumb>21773</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>DIABETES MELLITUS NON-INSULIN-DEPENDENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050712</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HUMULIN N</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HUMALOG</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059114-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060710</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006BI009784</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>25</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE SCLEROSIS</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>RELAPSING-REMITTING MULTIPLE SCLEROSIS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060710</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059115-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060706</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006PV016651</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>68</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>87.5442</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTERIOSCLEROSIS CORONARY ARTERY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ATRIAL FIBRILLATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIOMEGALY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIOMYOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY STENOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSGEUSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE URTICARIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENTRICULAR DYSFUNCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENTRICULAR HYPOKINESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISION BLURRED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BYETTA</medicinalproduct>
        <drugauthorizationnumb>21773</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>DIABETES MELLITUS NON-INSULIN-DEPENDENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060403</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060401</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BYETTA</medicinalproduct>
        <drugauthorizationnumb>21773</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>DIABETES MELLITUS NON-INSULIN-DEPENDENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060509</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060501</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BYETTA</medicinalproduct>
        <drugauthorizationnumb>21773</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>DIABETES MELLITUS NON-INSULIN-DEPENDENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060508</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BYETTA</medicinalproduct>
        <drugauthorizationnumb>21773</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>DIABETES MELLITUS NON-INSULIN-DEPENDENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060514</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NOVOLIN N</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059116-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060706</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006PV017057</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>63</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CATHETERISATION CARDIAC</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BYETTA</medicinalproduct>
        <drugauthorizationnumb>21773</drugauthorizationnumb>
        <drugdosagetext>5 MCG; BID; SC</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>DIABETES MELLITUS NON-INSULIN-DEPENDENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059117-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060703</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006PV016862</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>48</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BYETTA</medicinalproduct>
        <drugauthorizationnumb>21773</drugauthorizationnumb>
        <drugdosagetext>5 MCG; BID;</drugdosagetext>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059118-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060710</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006BI009789</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>63</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>RESPIRATORY ARREST</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>20030801</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugbatchnumb>P35076</drugbatchnumb>
        <drugdosagetext>30 UG; QW; IM</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030901</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059119-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060703</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2006US09902</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>61</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ACUTE GRAFT VERSUS HOST DISEASE IN INTESTINE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ACUTE GRAFT VERSUS HOST DISEASE IN SKIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OBLITERATIVE BRONCHIOLITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SQUAMOUS CELL CARCINOMA OF SKIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOSPORINE</medicinalproduct>
        <drugauthorizationnumb>80336</drugauthorizationnumb>
        <drugdosagetext>3 MG/KG/D, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>STEM CELL TRANSPLANT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOSPORINE</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>STEM CELL TRANSPLANT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugindication>STEM CELL TRANSPLANT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugindication>STEM CELL TRANSPLANT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MYCOPHENOLATE MOFETIL</medicinalproduct>
        <drugindication>STEM CELL TRANSPLANT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PUVA (NO INGREDIENTS/SUBSTANCES)</medicinalproduct>
        <drugindication>STEM CELL TRANSPLANT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOCORTICOSTEROIDS (NO INGREDIENTS/SUBSTANCES)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYCLOPHOSPHAMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUDARABINE PHOSPHATE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059120-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060710</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>S06-USA-00149-01</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>40</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANTICONVULSANT DRUG LEVEL DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRAIN NATRIURETIC PEPTIDE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEMENTIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISORIENTATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GRAND MAL CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GRANULOCYTE COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MONOCYTE COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOGLOBIN BLOOD INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NASAL CYST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POSTICTAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ROAD TRAFFIC ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SCREAMING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREATMENT NONCOMPLIANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NAMENDA</medicinalproduct>
        <drugauthorizationnumb>21487</drugauthorizationnumb>
        <drugdosagetext>10 MG QD PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>AMNESIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060131</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NAMENDA</medicinalproduct>
        <drugdosagetext>15 MG QD PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>AMNESIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051227</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060102</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NAMENDA</medicinalproduct>
        <drugdosagetext>10 MG BID PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>AMNESIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060103</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060109</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>20051213</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051219</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NAMENDA</medicinalproduct>
        <drugdosagetext>5 MG BID PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>AMNESIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051220</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051226</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>20060101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NAMENDA</medicinalproduct>
        <drugdosagetext>5 MG BID PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>AMNESIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NAMENDA</medicinalproduct>
        <drugdosagetext>15 MG QD PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>AMNESIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NAMENDA</medicinalproduct>
        <drugdosagetext>10 MG BID PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>AMNESIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEXAPRO</medicinalproduct>
        <drugdosagetext>10 MG QD PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANXIETY</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEXAPRO</medicinalproduct>
        <drugdosagetext>10 MG QD PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RISPERDAL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059121-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060705</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006PV015748</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>27</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>137.4399</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ACCIDENT AT WORK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ENERGY INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE BRUISING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIGAMENT RUPTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THERAPEUTIC RESPONSE UNEXPECTED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BYETTA</medicinalproduct>
        <drugbatchnumb>9RY71M</drugbatchnumb>
        <drugauthorizationnumb>21773</drugauthorizationnumb>
        <drugdosagetext>5 MCG; BID; SC</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>INSULIN RESISTANCE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060320</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060511</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BYETTA</medicinalproduct>
        <drugbatchnumb>9RY71M</drugbatchnumb>
        <drugauthorizationnumb>21773</drugauthorizationnumb>
        <drugdosagetext>5 MCG; BID; SC</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>INSULIN RESISTANCE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060520</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059122-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060712</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006BI008477</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>67</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CELLULITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugdosagetext>30 UG; QW; IM</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030523</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>5059123-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060713</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006BI005029</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <patientonsetage>61</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
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        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
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      <reaction>
        <reactionmeddrapt>ROAD TRAFFIC ACCIDENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugdosagetext>30 UG; QW; IM</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
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        <drugstartdate>19980101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REBIF</medicinalproduct>
      </drug>
    </patient>
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  <safetyreport>
    <safetyreportid>5059124-0</safetyreportid>
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    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060706</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006PV016246</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
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    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <patientonsetage>71</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>77.1115</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MEDICAL DEVICE IMPLANTATION</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BYETTA</medicinalproduct>
        <drugbatchnumb>9SF12M</drugbatchnumb>
        <drugauthorizationnumb>21773</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>DIABETES MELLITUS NON-INSULIN-DEPENDENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060501</drugstartdate>
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        <drugenddate>20060601</drugenddate>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BYETTA</medicinalproduct>
        <drugbatchnumb>9SF12M</drugbatchnumb>
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        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>DIABETES MELLITUS NON-INSULIN-DEPENDENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060601</drugstartdate>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPAMAX</medicinalproduct>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZETIA</medicinalproduct>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRIMIDONE</medicinalproduct>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAZODONE HCL</medicinalproduct>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMIPRAMINE</medicinalproduct>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGNESIUM</medicinalproduct>
      </drug>
    </patient>
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  <safetyreport>
    <safetyreportid>5059125-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
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    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
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    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060705</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
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      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
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    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <patientonsetage>64</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>77.1</patientweight>
      <patientsex>1</patientsex>
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        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
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      <reaction>
        <reactionmeddrapt>HAEMOPTYSIS</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>THROMBOTIC THROMBOCYTOPENIC PURPURA</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VELCADE</medicinalproduct>
        <drugauthorizationnumb>21602</drugauthorizationnumb>
        <drugdosagetext>1.75 .4 MG</drugdosagetext>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040827</drugstartdate>
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        <drugenddate>20050505</drugenddate>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TARCEVA</medicinalproduct>
        <drugdosagetext>150.00 MG, QD, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050610</drugstartdate>
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        <drugenddate>20050629</drugenddate>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DECADRON</medicinalproduct>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL SUCCINATE</medicinalproduct>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZESTORETIC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DECADRON</medicinalproduct>
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    </patient>
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    <safetyreportid>5059126-4</safetyreportid>
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    <transmissiondate>20061208</transmissiondate>
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    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
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      <reportercountry>UNITED STATES</reportercountry>
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    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BREAST CANCER FEMALE</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MEDROXYPROGESTERONE ACETATE</medicinalproduct>
        <drugauthorizationnumb>40159</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
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        <drugstartdate>19971001</drugstartdate>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ESTRACE</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
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        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20000601</drugenddate>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROVERA</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19971001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
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    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059127-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
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    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
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    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
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    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
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    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BREAST CANCER FEMALE</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MEDROXYPROGESTERONE ACETATE</medicinalproduct>
        <drugauthorizationnumb>40159</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19940301</drugstartdate>
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        <drugenddate>20000501</drugenddate>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
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        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
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        <drugenddate>20000501</drugenddate>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMPHASE (PREMARIN;CYCRIN 14/14)</medicinalproduct>
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        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROVERA</medicinalproduct>
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        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19940301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20000501</drugenddate>
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    </patient>
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  <safetyreport>
    <safetyreportid>5059128-8</safetyreportid>
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    <receivedate>20060718</receivedate>
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    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
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    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
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    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <patientonsetage>17</patientonsetage>
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      <reaction>
        <reactionmeddrapt>HYPOTHYROIDISM</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEXAPRO</medicinalproduct>
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        <drugindication>DEPRESSION</drugindication>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
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        <drugindication>DEPRESSION</drugindication>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WELLBUTRIN XL (BUPROPION)</medicinalproduct>
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    </patient>
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  <safetyreport>
    <safetyreportid>5059129-X</safetyreportid>
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      <reportercountry>UNITED STATES</reportercountry>
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    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
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      <reaction>
        <reactionmeddrapt>BREAST CANCER FEMALE</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MEDROXYPROGESTERONE ACETATE</medicinalproduct>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROVERA</medicinalproduct>
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        <drugenddate>19961201</drugenddate>
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      <reportercountry>UNITED STATES</reportercountry>
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    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
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        <reactionmeddrapt>BREAST CANCER FEMALE</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
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      <drug>
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      <drug>
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    <receiver></receiver>
    <patient>
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      <drug>
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      <drug>
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      <drug>
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      <drug>
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    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BREAST CANCER FEMALE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MEDROXYPROGESTERONE ACETATE</medicinalproduct>
        <drugauthorizationnumb>40159</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19910101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19991001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19910101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19991001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMPRO</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19910101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19991001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ESTRATEST</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19910101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19991001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROVERA</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19910101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19991001</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059133-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060714</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>008014</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BREAST CANCER FEMALE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MEDROXYPROGESTERONE ACETATE</medicinalproduct>
        <drugauthorizationnumb>40159</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19900101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19980401</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMPRO</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19900101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19980401</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROVERA</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19900101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19980401</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OGEN</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19900101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19980401</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059134-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060713</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>S06-USA-01074-01</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>46</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HYPERREFLEXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERVERTEBRAL DISC PROTRUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE SCLEROSIS</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>20050901</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEPAKOTE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059135-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060713</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>S06-USA-02724-01</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>50</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>LOSS OF EMPLOYMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OBSESSIVE-COMPULSIVE DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEXAPRO</medicinalproduct>
        <drugauthorizationnumb>21323</drugauthorizationnumb>
        <drugdosagetext>20 MG BID PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANXIETY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEXAPRO</medicinalproduct>
        <drugauthorizationnumb>21323</drugauthorizationnumb>
        <drugdosagetext>20 MG BID PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOPHAGE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INDERAL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059146-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060707</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>234291K06USA</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>40</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MEASLES</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>20050722</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPROL-XL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRILOSEC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KARIVA (MARVELON)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059147-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060705</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006PV016925</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ACUTE MYELOID LEUKAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SYMLIN</medicinalproduct>
        <drugauthorizationnumb>21332</drugauthorizationnumb>
        <drugdosagetext>SC</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059148-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060706</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>234279K06USA</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>59</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>79.8331</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANGINA PECTORIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY OCCLUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBIF</medicinalproduct>
        <drugdosagetext>44 MCG, 1 IN 1 WEEKS, SUBCUTANEOUS; 44 MCG; 2 IN 1 WEEKS, SUBCUTANEOUS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050624</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBIF</medicinalproduct>
        <drugdosagetext>44 MCG, 1 IN 1 WEEKS, SUBCUTANEOUS; 44 MCG; 2 IN 1 WEEKS, SUBCUTANEOUS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051209</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BACLOFEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROTONIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM (CALCIUM-SANDOZ)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTIVITAMIN (MULTIVITAMIN)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059149-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060707</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>S06-USA-02722-01</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEXAPRO</medicinalproduct>
        <drugauthorizationnumb>21323</drugauthorizationnumb>
        <drugdosagetext>10 MG QD PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MAJOR DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060608</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARIPIPRAZOLE</medicinalproduct>
        <drugdosagetext>10 MG QD PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MAJOR DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060608</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059150-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060710</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006BI009661</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>48</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLINDNESS UNILATERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE SCLEROSIS</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>19960101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020101</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>20030806</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059151-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US200606006180</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG TOXICITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING JITTERY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE TWITCHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060601</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059152-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060710</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006BI007775</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>48</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CERVICAL VERTEBRAL FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ROAD TRAFFIC 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>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>5059153-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060630</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US200607001552</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>78.5</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BIOPSY LIVER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIABETES MELLITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERECTILE DYSFUNCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METABOLIC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRANSPLANT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
        <drugauthorizationnumb>20592</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020624</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WELLBUTRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOPRESSOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE TAB</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059154-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060713</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006BI008386</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>56</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugdosagetext>30 UG; QW; IM</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060316</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059155-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060705</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2005-01826</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>70</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>71.7</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ACUTE PULMONARY OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ALPHA HAEMOLYTIC STREPTOCOCCAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ATRIAL FIBRILLATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PH INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRAIN NATRIURETIC PEPTIDE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRONCHOPNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIOMEGALY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CATHETER RELATED COMPLICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERNATIONAL NORMALISED RATIO INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG INFILTRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY CONGESTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHONCHI</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TROPONIN I INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VELCADE</medicinalproduct>
        <drugauthorizationnumb>21602</drugauthorizationnumb>
        <drugdosagetext>1.00 MG/M2, IV BOLUS</drugdosagetext>
        <drugadministrationroute>040</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040229</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040624</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GEMCITABINE HYDROCHLORIDE(GEMCITABINE HYDROCHLORIDE)</medicinalproduct>
        <drugdosagetext>1000.00 MG/M2, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040229</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040608</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARBOPLATIN</medicinalproduct>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FERROUS SULFATE TAB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ROXICET</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PEPCID AC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN TAB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALTACE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTIVITAMINS (ERGOCALCIFEROL, PANTHENOL, NICOTINAMIDE, RIBOFLAVIN, TH</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAZOLAMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CEPHALEXIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059156-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060710</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006085262</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>59</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>58.9676</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLINDNESS UNILATERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL ACUITY REDUCED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VISINE (OXYMETAZOLINE)</medicinalproduct>
        <drugauthorizationnumb>19407</drugauthorizationnumb>
        <drugdosagetext>1 DROP PER EYE ONCE</drugdosagetext>
        <drugindication>DRY EYE</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059157-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060712</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006086242</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>39</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>103.4201</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWELLING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ROGAINE</medicinalproduct>
        <drugbatchnumb>88MWS</drugbatchnumb>
        <drugauthorizationnumb>19501</drugauthorizationnumb>
        <drugdosagetext>1 ML TWICE DAILY TOPICAL</drugdosagetext>
        <drugadministrationroute>061</drugadministrationroute>
        <drugindication>ALOPECIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060606</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060705</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MONTELEUKAST SODIUM (MONTELEUKAST SODIUM)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059158-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060712</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006086242</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>39</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>103.4201</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWELLING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ROGAINE</medicinalproduct>
        <drugbatchnumb>88MWS</drugbatchnumb>
        <drugauthorizationnumb>19501</drugauthorizationnumb>
        <drugdosagetext>1 ML TWICE DAILY TOPICAL</drugdosagetext>
        <drugadministrationroute>061</drugadministrationroute>
        <drugindication>ALOPECIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060606</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060705</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MONTELEUKAST SODIUM(MONTELEUKAST SODIUM)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059159-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060705</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2005-01933</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>28</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>69.6</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIOVASCULAR DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DILATATION VENTRICULAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EJECTION FRACTION DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESTRICTIVE CARDIOMYOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RIGHT VENTRICLE OUTFLOW TRACT OBSTRUCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VELCADE</medicinalproduct>
        <drugauthorizationnumb>21602</drugauthorizationnumb>
        <drugdosagetext>1.00 MG/M2, IV BOLUS</drugdosagetext>
        <drugadministrationroute>040</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GEMCITABINE</medicinalproduct>
        <drugdosagetext>1000.00 MG/M2, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040917</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041029</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARBOPLATIN</medicinalproduct>
        <drugdosagetext>5.00 INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040917</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041029</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059160-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060710</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006076133</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>21</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>72.5755</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>APPLICATION SITE IRRITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>APPLICATION SITE VESICLES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CAUSTIC INJURY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PURELL WITH ALOE (ETHYL ALCOHOL)</medicinalproduct>
        <drugbatchnumb>Q800683</drugbatchnumb>
        <drugdosagetext>ONCE TOPICAL</drugdosagetext>
        <drugadministrationroute>061</drugadministrationroute>
        <drugindication>ANTIBIOTIC PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALPROATE SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLOAZEPAM(CLONAZEPAM)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059161-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060708</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006085321</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>1</patientonsetage>
      <patientonsetageunit>804</patientonsetageunit>
      <patientweight>2.7216</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE VIA BREAST MILK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEONATAL RESPIRATORY ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING NEONATAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEOSPORIN</medicinalproduct>
        <drugbatchnumb>1985L</drugbatchnumb>
        <drugdosagetext>ONCE, TRANSMAMMARY</drugdosagetext>
        <drugadministrationroute>063</drugadministrationroute>
        <drugindication>ACCIDENTAL EXPOSURE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060708</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060708</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059162-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060706</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200612571BCC</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>IMMOBILE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RECTAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SMALL INTESTINE ULCER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALEVE</medicinalproduct>
        <drugauthorizationnumb>20204</drugauthorizationnumb>
        <drugdosagetext>440 MG, TOTAL DAILY, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEADACHE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060407</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060413</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMINS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PERCOCET</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOTREL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059163-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>05-000599</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>63</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANISOCYTOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CYANOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA EXERTIONAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EOSINOPHILIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EPIGASTRIC DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OXYGEN SATURATION DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POLYCHROMASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SULPHAEMOGLOBINAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PYRIDIUM (PHENAZOPYRIDINE HYDROCHLORIDE) TABLET 100 MG</medicinalproduct>
        <drugauthorizationnumb>13294</drugauthorizationnumb>
        <drugdosagetext>100 MG TID ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>URINARY TRACT INFECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RANITIDINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALPRAZOLAM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059165-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060707</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006US-02859</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>31</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PREGNANCY OF PARTNER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PREGNANCY ON ORAL CONTRACEPTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRANSMISSION OF DRUG VIA SEMEN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ISOTRETINOIN</medicinalproduct>
        <drugauthorizationnumb>76041</drugauthorizationnumb>
        <drugdosagetext>20 MG BID</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060526</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059171-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060627</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US200606005725</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>58</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>GASTRIC BYPASS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROZAC</medicinalproduct>
        <drugauthorizationnumb>18936</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059174-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060714</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>008005</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BREAST CANCER FEMALE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MEDROXYPROGESTERONE ACETATE</medicinalproduct>
        <drugauthorizationnumb>40159</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19970101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19991201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19970101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19991201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OGEN</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19970101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19991201</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059176-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060706</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2005BI012930</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>59</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>49.8957</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD POTASSIUM DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HALLUCINATION, VISUAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE SCLEROSIS RELAPSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL INTAKE REDUCED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UNEVALUABLE EVENT</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>20040926</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMANTADINE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLARINEX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AN INHALER</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059178-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060703</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006BI004277</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>47</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ACUTE RESPIRATORY DISTRESS SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCONTINENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PELVIC FLOOR REPAIR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLEURISY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugdosagetext>30 UG; QW; IM</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030801</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugbatchnumb>P35037</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>5059179-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060711</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006BI007884</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>53</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>EPILEPSY</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>20020731</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugdosagetext>30 UG; BIW; IM</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BEE VENOM THERAPY</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MODAFINIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOLTERODINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NAPROXIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARICEPT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TERAZOSIN HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVASTATIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZINC SULFATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BACLOFEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONAZEPAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VENLAFAXIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059185-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060707</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006BI009650</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>42</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>74.8435</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CYSTITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JOINT DISLOCATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVARIAN CYST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTH EXTRACTION</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>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>5059186-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060710</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006BI009803</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>51</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ARTERIAL OCCLUSIVE DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugdosagetext>30 UG; QW; IM</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060501</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059188-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060707</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006BI009954</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>53</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>LUNG SQUAMOUS CELL CARCINOMA STAGE UNSPECIFIED</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>19990408</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>5059190-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060710</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006BI009807</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>37</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BREAST INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMPAIRED HEALING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFECTION IN AN IMMUNOCOMPROMISED HOST</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>20041008</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050722</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>20060210</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059192-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060630</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US200607000544</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
        <drugauthorizationnumb>20592</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059194-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US200606006244</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>72</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BONE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BURSITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JOINT EFFUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POLYARTHRITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EVISTA</medicinalproduct>
        <drugauthorizationnumb>20815</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPENIA</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059196-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060705</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>VNL_0160_2006</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ACUTE PSYCHOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDE ATTEMPT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>APOKYN</medicinalproduct>
        <drugauthorizationnumb>21264</drugauthorizationnumb>
        <drugdosagetext>DF SC</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060601</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059197-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US200606006260</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>58</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INTERNATIONAL NORMALISED RATIO INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>30 MG, DAILY (1/D)</drugdosagetext>
        <drugindication>NEUROPATHY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060524</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZETIA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRAVACHOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIDODERM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLEGRA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TORSEMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SONATA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NITRO PATCH (GLYCERYL TRINITRATE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MICARDIS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIGOXIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRONOLACTONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLEXERIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAMADOL HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IRON</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVENOX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059198-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060630</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US200607000615</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE SYSTOLIC INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>60 MG, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060601</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059199-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US200607000637</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>LIVER FUNCTION TEST ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059200-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060630</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US200607000612</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIO-RESPIRATORY ARREST</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
        <drugauthorizationnumb>21253</drugauthorizationnumb>
        <drugdosagetext>10 MG</drugdosagetext>
        <drugindication>AGITATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059201-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US200605000177</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>62</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>86.2</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BONE GRAFT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CELLULITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugauthorizationnumb>21318</drugauthorizationnumb>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060224</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059202-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060722</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060711</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20060702346</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>71.67</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ARTHRITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLITIS ULCERATIVE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMODIUM A-D</medicinalproduct>
        <drugdosagetext>DURATION: SEVERAL YEARS.</drugdosagetext>
        <drugindication>DIARRHOEA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOMOTIL</medicinalproduct>
        <drugdosagetext>DURATION: SEVERAL YEARS.</drugdosagetext>
        <drugindication>DIARRHOEA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASACOL</medicinalproduct>
        <drugindication>DIARRHOEA</drugindication>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059203-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060722</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060711</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20060600897</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>88.45</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BREAST CANCER IN SITU</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMPLANT SITE OEDEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugbatchnumb>03E013A;04F113A;4G082P1 +MORE</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugbatchnumb>03E013A;04F113A;4G082P1 +MORE</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugbatchnumb>03E013A;04F113A;4G082P1 +MORE</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugbatchnumb>03E013A;04F113A;4G082P1 +MORE</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugbatchnumb>03E013A;04F113A;4G082P1 +MORE</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugbatchnumb>03E013A;04F113A;4G082P1 +MORE</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugbatchnumb>03E013A;04F113A;4G082P1 +MORE</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugbatchnumb>03E013A;04F113A;4G082P1 +MORE</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugbatchnumb>03E013A;04F113A;4G082P1 +MORE</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugbatchnumb>03E013A;04F113A;4G082P1 +MORE</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugbatchnumb>03E013A;04F113A;4G082P1 +MORE</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugbatchnumb>03E013A;04F113A;4G082P1 +MORE</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugbatchnumb>03E013A;04F113A;4G082P1 +MORE</drugbatchnumb>
        <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>ENTOCORT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENTOCORT</medicinalproduct>
        <drugindication>CROHN'S DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMURAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMURAN</medicinalproduct>
        <drugindication>CROHN'S DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PENTASA</medicinalproduct>
        <drugindication>CROHN'S DISEASE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059204-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060722</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060711</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20060600896</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>76.2</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BREAST CANCER IN SITU</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugbatchnumb>03J084A;03K035A;03L022A +MORE</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugbatchnumb>03J084A;03K035A;03L022A +MORE</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugbatchnumb>03J084A;03K035A;03L022A +MORE</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugbatchnumb>03J084A;03K035A;03L022A +MORE</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugbatchnumb>03J084A;03K035A;03L022A +MORE</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugbatchnumb>03J084A;03K035A;03L022A +MORE</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugbatchnumb>03J084A;03K035A;03L022A +MORE</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugbatchnumb>03J084A;03K035A;03L022A +MORE</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugbatchnumb>03J084A;03K035A;03L022A +MORE</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugbatchnumb>03J084A;03K035A;03L022A +MORE</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugbatchnumb>03J084A;03K035A;03L022A +MORE</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugbatchnumb>03J084A;03K035A;03L022A +MORE</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugbatchnumb>03J084A;03K035A;03L022A +MORE</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugbatchnumb>03J084A;03K035A;03L022A +MORE</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugbatchnumb>03J084A;03K035A;03L022A +MORE</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugbatchnumb>03J084A;03K035A;03L022A +MORE</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugbatchnumb>03J084A;03K035A;03L022A +MORE</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugbatchnumb>03J084A;03K035A;03L022A +MORE</drugbatchnumb>
        <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>PREDNISONE</medicinalproduct>
        <drugindication>PREMEDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059205-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR200601004222</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>69</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLINDNESS UNILATERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COAGULOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RETINAL VEIN OCCLUSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugbatchnumb>FF5K73F</drugbatchnumb>
        <drugauthorizationnumb>21318</drugauthorizationnumb>
        <drugdosagetext>20 UG, DAILY (1/D), SUBCUTANEOUS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050923</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE TAB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIDOSE (CALCIUM CARBONATE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM CHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEXOMIL (BROMAZEPAM) TABLET, 6 MG</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MOTILIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MUCOMYST</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYMBICORT TURBUHALER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DURAGESIC-100</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRAXILENE                      (NAFTIDROFURYL OXALATE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPECIAFOLDINE                     (FOLIC ACID)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TANGANIL              (ETHANOLAMINE ACETYLLEUCINATE)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059206-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR200603002754</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>83</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SENSORY DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRANSIENT ISCHAEMIC ATTACK</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugbatchnumb>FF5E23A</drugbatchnumb>
        <drugauthorizationnumb>21318</drugauthorizationnumb>
        <drugdosagetext>20 UG, DAILY (1/D), SUBCUTANEOUS, 20UG, DAILY (1/D), SUBCUTANEOUS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060228</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugbatchnumb>FF5E23A</drugbatchnumb>
        <drugauthorizationnumb>21318</drugauthorizationnumb>
        <drugdosagetext>20 UG, DAILY (1/D), SUBCUTANEOUS, 20UG, DAILY (1/D), SUBCUTANEOUS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060308</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FORTEO PEN (250MCG/ML)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COZAAR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DAFLON 500 (DIOSMIN, HESPERIDIN) TABLET</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARICEPT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATARAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FERROUS SULFATE TAB</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059207-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>SE200605003887</companynumb>
    <primarysource>
      <reportercountry>SWEDEN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>71</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MALIGNANT MELANOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPINAL COLUMN STENOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugauthorizationnumb>21318</drugauthorizationnumb>
        <drugdosagetext>20 UG, DAILY (1/D), SUBCUTANEOUS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041029</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FORTEO PEN (250MCG/ML)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM GLUCONATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ETALPHA (ALFACALCIDOL)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TEGRETOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>APPROVEL (IRBESARTAN)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059208-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060630</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR200604002835</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>54</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAL CANCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD THYROID STIMULATING HORMONE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHOIDAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugbatchnumb>FF5S34F</drugbatchnumb>
        <drugauthorizationnumb>21318</drugauthorizationnumb>
        <drugdosagetext>20 UG, DAILY (1/D), SUBCUTANEOUS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050419</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FAMALINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRILEPTAL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059209-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AR200604003818</companynumb>
    <primarysource>
      <reportercountry>ARGENTINA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>64</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>79</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DYSPHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN LESION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DULOXETINE HYDROCHLORIDE</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>DAILY (1/D); ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>FIBROMYALGIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051213</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060515</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059210-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060630</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>SE200605002973</companynumb>
    <primarysource>
      <reportercountry>SWEDEN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>46</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>80</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CEREBRAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBRAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEMIANOPIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL DISTURBANCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
        <drugauthorizationnumb>20592</drugauthorizationnumb>
        <drugdosagetext>5 MG, DAILY (1/D); ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030901</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LITHIONIT (LITHIUM SULFATE)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059211-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>TR200606002715</companynumb>
    <primarysource>
      <reportercountry>TURKEY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>23</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>80</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BODY TEMPERATURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDE ATTEMPT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
        <drugauthorizationnumb>20592</drugauthorizationnumb>
        <drugdosagetext>5 MG, DAILY (1/D); ORAL, 280 MG, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PSYCHOTIC DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059212-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>MX200603003216</companynumb>
    <primarysource>
      <reportercountry>MEXICO</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>14</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>55</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL SELF-INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENTAL STATUS CHANGES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDE ATTEMPT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>STRATTERA</medicinalproduct>
        <drugauthorizationnumb>21411</drugauthorizationnumb>
        <drugdosagetext>60 MG, DAILY (1/D) ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATTENTION DEFICIT/HYPERACTIVITY DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059213-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060704</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-2006-017685</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</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>BETASERON</medicinalproduct>
        <drugdosagetext>SUBCUTANEOUS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059214-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060704</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-2006-017694</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROTEINURIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BETASERON</medicinalproduct>
        <drugdosagetext>SUBCUTANEOUS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050526</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059215-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060707</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AR-2006-015875</companynumb>
    <primarysource>
      <reportercountry>ARGENTINA</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>33</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIAC MYXOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BETASERON</medicinalproduct>
        <drugdosagetext>SUBCUTANEOUS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059216-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060703</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2006ES09908</companynumb>
    <primarysource>
      <reportercountry>SPAIN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>52</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ATRIAL FIBRILLATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHOLECYSTITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHRONIC ALLOGRAFT NEPHROPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY STENOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GINGIVAL HYPERPLASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERCHOLESTEROLAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTRACARDIAC THROMBUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POST PROCEDURAL COMPLICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENTRICULAR DYSKINESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENTRICULAR FIBRILLATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOSPORINE</medicinalproduct>
        <drugauthorizationnumb>80336</drugauthorizationnumb>
        <drugdosagetext>4 MG/KG, BID,</drugdosagetext>
        <drugindication>RENAL TRANSPLANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19930101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20011101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugdosagetext>0.5 MG/D,</drugdosagetext>
        <drugindication>RENAL TRANSPLANT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TACROLIMUS (TACROLIMUS)</medicinalproduct>
        <drugindication>RENAL TRANSPLANT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUVASTATIN (FLUVASTATIN)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATORVASTATIN CALCIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TELMISARTAN (TELMISARTAN)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059217-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060608</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>226482</companynumb>
    <primarysource>
      <reportercountry>FINLAND</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>GASTRIC ULCER HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OESOPHAGITIS ULCERATIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVASTIN</medicinalproduct>
        <drugdosagetext>INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ERLOTINIB (ERLOTINIB) TABLET</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GEMCITABINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059219-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060707</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>02H-153-0205480-00</companynumb>
    <primarysource>
      <reportercountry>TAIWAN, PROVINCE OF CHINA</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>3.415</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD CREATINE PHOSPHOKINASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRADYCARDIA NEONATAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRAIN OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBRAL CYST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMA NEONATAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEVELOPMENTAL DELAY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTONIA NEONATAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOXIC ENCEPHALOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFANTILE APNOEIC ATTACK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LATE METABOLIC ACIDOSIS OF NEWBORN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEDICATION ERROR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEONATAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEONATAL HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEONATAL RESPIRATORY ACIDOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEONATAL RESPIRATORY ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL EVOKED POTENTIALS ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WRONG DRUG ADMINISTERED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ATRACURIUM BESYLATE INJ 10MG/ML, 5ML GLASS VIAL (ATRACURIUM BESYLATE I</medicinalproduct>
        <drugbatchnumb>7639 1DK</drugbatchnumb>
        <drugauthorizationnumb>74633</drugauthorizationnumb>
        <drugdosagetext>10 MG, ONCE, INTRAMUSCULAR</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021129</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20021129</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059220-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060707</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>02H-153-0205481-00</companynumb>
    <primarysource>
      <reportercountry>TAIWAN, PROVINCE OF CHINA</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD CREATINE PHOSPHOKINASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRADYCARDIA FOETAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTONIA NEONATAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOXIC ENCEPHALOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEDICATION ERROR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEONATAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEONATAL RESPIRATORY ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEONATAL RESPIRATORY FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WRONG DRUG ADMINISTERED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ATRACURIUM BESYLATE INJ 10MG/ML, 5ML GLASS VIAL (ATRACURIUM BESYLATE I</medicinalproduct>
        <drugbatchnumb>76391 DK</drugbatchnumb>
        <drugauthorizationnumb>74633</drugauthorizationnumb>
        <drugdosagetext>10 MG, ONCE, INTRAMUSCULAR</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021129</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20021129</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059221-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060705</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006083859</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>53</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>UNASYN</medicinalproduct>
        <drugauthorizationnumb>50608</drugauthorizationnumb>
        <drugdosagetext>6 GRAM, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060630</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060703</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FAMOTIDINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LUDIOMIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMITRIPTYLINE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZONISAMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KETAS (IBUDILAST)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONAZEPAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPARA K (ASPARTATE POTASSIUM)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGNESIUM OXIDE (MAGNESIUM OXIDE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PURSENNID (SENNA LEAF)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYALEIN (HYALURONATE SODIUM)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OZAGREL SODIUM (OZAGREL SODIUM)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMINOFLUID (AMINO ACIDS NOS, ELECTROLYTES NOS, GLUCOSE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEPAKENE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059223-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060705</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006083960</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>38</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FACIAL PALSY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UNDERDOSE</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>TRACHEOBRONCHITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060704</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060705</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SINUPRET (ASCORBIC ACID, GENTIAN, PRIMULA FLOWERS, RUMICIS ASETOSA, SA</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059225-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060705</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006084013</companynumb>
    <primarysource>
      <reportercountry>ITALY</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>39</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HAEMATURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHOTOPHOBIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSEUDOMONAS INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOXIC EPIDERMAL NECROLYSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VORICONAZOLE (VORICONAZOLE)</medicinalproduct>
        <drugauthorizationnumb>21267</drugauthorizationnumb>
        <drugdosagetext>6 MG/KG, INTRAVENOUS; SEE IMAGE</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BRONCHOPULMONARY ASPERGILLOSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALL OTHER THERAPEUTIC PRODUCTS (ALL OTHER THERAPEUTIC PRODUCTS)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059228-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060705</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006084461</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ROAD TRAFFIC ACCIDENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HALCION</medicinalproduct>
        <drugauthorizationnumb>17892</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059230-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060705</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006084150</companynumb>
    <primarysource>
      <reportercountry>PHILIPPINES</reportercountry>
    </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>CARDIAC FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIAGRA</medicinalproduct>
        <drugauthorizationnumb>20895</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTIHYPERTENSIVE (ANTIHYPERTENSIVE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTI-DIABETICS (ANTI-DIABETICS)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059232-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060707</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006084594</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>17</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>55</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CEREBRAL CYST</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GENOTROPIN</medicinalproduct>
        <drugauthorizationnumb>20280</drugauthorizationnumb>
        <drugdosagetext>11.2 MG, WEEKLY, SUBCUTANEOUS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>GROWTH HORMONE DEFICIENCY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19960827</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060506</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059235-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060705</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006084760</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>61</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>72</patientweight>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSGEUSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALIGNANT NEOPLASM PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METASTASES TO LUNG</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUCOSAL INFLAMMATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SCAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SU-011,248 (SUNITINIB MALATE)</medicinalproduct>
        <drugauthorizationnumb>21968</drugauthorizationnumb>
        <drugdosagetext>50 MG, ONCE - INTERVAL: DAYLY), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>METASTATIC RENAL CELL CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060331</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060427</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SU-011,248 (SUNITINIB MALATE)</medicinalproduct>
        <drugauthorizationnumb>21968</drugauthorizationnumb>
        <drugdosagetext>50 MG, ONCE - INTERVAL: DAYLY), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>METASTATIC RENAL CELL CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060512</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060608</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SU-011,248 (SUNITINIB MALATE)</medicinalproduct>
        <drugauthorizationnumb>21968</drugauthorizationnumb>
        <drugdosagetext>50 MG, ONCE - INTERVAL: DAYLY), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>METASTATIC RENAL CELL CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060623</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060703</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FORTECORTIN (DEXAMETHASONE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BERLTHYROX (LEVOTHYROXINE SODIUM)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059236-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060705</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006084855</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABSCESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLADDER PERFORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL STROMAL TUMOUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LARGE INTESTINE PERFORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALIGNANT NEOPLASM PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STOMATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUTENT</medicinalproduct>
        <drugauthorizationnumb>21938</drugauthorizationnumb>
        <drugdosagetext>50 MG (50 MG, INTERVAL : EVERY DAY), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTROINTESTINAL STROMAL TUMOUR</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059237-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060706</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP200607000781</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>65</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL ACUITY REDUCED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EVISTA</medicinalproduct>
        <drugauthorizationnumb>20815</drugauthorizationnumb>
        <drugdosagetext>60 MG, DAILY (1/D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS POSTMENOPAUSAL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060619</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059239-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060702</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB200607000266</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>TRANSAMINASES INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XIGRIS</medicinalproduct>
        <drugdosagetext>24 UG</drugdosagetext>
        <drugindication>SEPTIC SHOCK</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060701</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059240-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060712</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>060713-0000677</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>4</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALIGNANT NEOPLASM OF THORAX</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE SCLEROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OPTIC NEURITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RECURRENT CANCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STEM CELL TRANSPLANT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DACTINOMYCIN</medicinalproduct>
        <drugauthorizationnumb>50682</drugauthorizationnumb>
        <drugdosagetext>0.45 MG/KG</drugdosagetext>
        <drugindication>LUNG NEOPLASM</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CISPLATIN</medicinalproduct>
        <drugdosagetext>525 MG/M**2</drugdosagetext>
        <drugindication>LUNG NEOPLASM</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOXORUBICIN HCL</medicinalproduct>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugindication>LUNG NEOPLASM</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOPHOSPHAMIDE</medicinalproduct>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugindication>LUNG NEOPLASM</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VINCRISTINE</medicinalproduct>
        <drugdosagetext>2400 MG/M**2</drugdosagetext>
        <drugindication>LUNG NEOPLASM</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>THIOTEPA</medicinalproduct>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugindication>LUNG NEOPLASM</drugindication>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>THIOTEPA</medicinalproduct>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugindication>LUNG NEOPLASM</drugindication>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOPOTECAN (TOPOTECAN)</medicinalproduct>
        <drugdosagetext>0.75 MG/M**2</drugdosagetext>
        <drugindication>LUNG NEOPLASM</drugindication>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059241-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060705</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PAR_0700_2006</companynumb>
    <primarysource>
      <reportercountry>NETHERLANDS</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>91</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HEPATITIS CHOLESTATIC</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ISOPTIN SR</medicinalproduct>
        <drugauthorizationnumb>19152</drugauthorizationnumb>
        <drugdosagetext>240 MG QDAY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CARDIAC FAILURE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030827</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060608</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALFUZOSIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DETRUSITOL SR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIUMACID PCH</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COMBIVENT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NULYTELY</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059246-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060712</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>0602488US</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>74</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CATARACT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CATARACT OPERATION COMPLICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONJUNCTIVITIS ALLERGIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POSTERIOR CAPSULE OPACIFICATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OCUFEN</medicinalproduct>
        <drugauthorizationnumb>19404</drugauthorizationnumb>
        <drugdosagetext>OPHTHALMIC</drugdosagetext>
        <drugadministrationroute>047</drugadministrationroute>
        <drugindication>POSTOPERATIVE CARE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059248-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060705</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>TAP2006Q00245</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>77</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBRAL ATROPHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL CARCINOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC NEOPLASM MALIGNANT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEOPLASM MALIGNANT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LUPRON DEPOT-3</medicinalproduct>
        <drugauthorizationnumb>20517</drugauthorizationnumb>
        <drugdosagetext>22.5 MG , 1 IN 3 M</drugdosagetext>
        <drugindication>PROSTATE CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031110</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM GLUCONATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ESLON (MORPHINE SULFATE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VASOTEC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LABETALON (LABETALOL)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RANITIDINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROMORPH (HYDROMORPHONE HYDROCHLORIDE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOCUSATE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059250-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060707</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006-02604</companynumb>
    <primarysource>
      <reportercountry>JORDAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>1</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>12</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MENINGITIS ASEPTIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRELSTAR DEPOT</medicinalproduct>
        <drugauthorizationnumb>20715</drugauthorizationnumb>
        <drugdosagetext>3.75 MG, MONTHLY, INTRAMUSCULAR</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>PRECOCIOUS PUBERTY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060213</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060416</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059251-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060703</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006-02691</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>68</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>67</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HYPOGLYCAEMIC COMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KENTERA (WATSON LABORATORIES) (OXYBUTYNIN)TRANSDERMAL PATCH, 3.9MG</medicinalproduct>
        <drugauthorizationnumb>21351</drugauthorizationnumb>
        <drugdosagetext>1 PATCH, 2/WEEK, TRANSDERMAL</drugdosagetext>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>URGE INCONTINENCE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060428</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMARYL</medicinalproduct>
        <drugdosagetext>2 MG, DAILY, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060527</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MELOXICAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENALAPRIL MALEATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALENDRONAT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NITROXOLIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059264-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060705</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006072033</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>66</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL CARCINOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTESTINAL OBSTRUCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CAVERJECT</medicinalproduct>
        <drugauthorizationnumb>20379</drugauthorizationnumb>
        <drugdosagetext>20 MCG (20 MCG, AS NECESSARY)</drugdosagetext>
        <drugindication>ERECTILE DYSFUNCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LAXATIVES</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059267-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnesscongenitalanomali>1</seriousnesscongenitalanomali>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060706</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006077872</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>84</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>36.1</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CEREBELLAR INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DECUBITUS ULCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSED LEVEL OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG LEVEL BELOW THERAPEUTIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STAPHYLOCOCCAL INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYVOX</medicinalproduct>
        <drugauthorizationnumb>21131</drugauthorizationnumb>
        <drugdosagetext>1200 MG (600 MG, 2 IN 1 D), INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>STAPHYLOCOCCAL INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060613</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VALPROATE SODIUM</medicinalproduct>
        <drugdosagetext>8 ML (4 ML,2 IN 1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONVULSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060208</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROMAC (POLAPREZINC)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENALAPRIL MALEATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGNESIUM OXIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALL OTHER THERAPEUTIC PRODUCTS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPARA K (ASPARTATE POTASSIUM)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TIENAM (CILASTATIN, IMIPENEM)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059270-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060619</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006083018</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>92</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARYNGEAL OEDEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XALATAN</medicinalproduct>
        <drugauthorizationnumb>20597</drugauthorizationnumb>
        <drugdosagetext>TOPICAL</drugdosagetext>
        <drugadministrationroute>061</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLICLAZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CO-AMILOFRUSE (AMILORIDE HYDROCHLORIDE, FUROSEMIDE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRONOLACTONE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059273-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060710</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006080852</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABNORMAL BEHAVIOUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AGITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVERDOSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REACTINE SYRUP (CETIRIZINE)</medicinalproduct>
        <drugauthorizationnumb>20346</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060624</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMINS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059275-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060710</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006082340</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>54</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG ERUPTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHOTOSENSITIVITY REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
        <drugauthorizationnumb>19787</drugauthorizationnumb>
        <drugdosagetext>5 MG, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060613</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059277-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060711</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2005054358</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>69</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EOSINOPHILIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FIBROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERSTITIAL LUNG DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHABDOMYOLYSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAHOR (ATORVASTATIN)</medicinalproduct>
        <drugauthorizationnumb>20702</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERCHOLESTEROLAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031111</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059283-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060707</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200612930GDS</companynumb>
    <primarysource>
      <reportercountry>BELGIUM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>30</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>TENDONITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UVEITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVELOX</medicinalproduct>
        <drugauthorizationnumb>21085</drugauthorizationnumb>
        <drugdosagetext>400 MG, QD,ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OTITIS MEDIA</drugindication>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059285-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060707</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200610889BVD</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>80</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>62</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ATRIAL FIBRILLATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUDDEN CARDIAC DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVELOX</medicinalproduct>
        <drugauthorizationnumb>21085</drugauthorizationnumb>
        <drugdosagetext>400 MG, TOTAL DAILY, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060329</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059289-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060724</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060718</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20060703712</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY THROMBOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REOPRO</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059290-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060724</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060711</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20060606367</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>70.31</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFUSION RELATED REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TETANUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URTICARIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugdosagetext>WEEK 0;  FIRST RETREATMENT</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugdosagetext>4-5 INFUSIONS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CROHN'S DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASACOL</medicinalproduct>
        <drugindication>CROHN'S DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugindication>BONE DENSITOMETRY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ULTRAM</medicinalproduct>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM GLUCONATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DARVOCET</medicinalproduct>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugindication>PREMEDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059291-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060724</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060712</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20060702188</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>140.62</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PSORIATIC ARTHROPATHY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059292-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060724</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060712</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20060503287</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>79.83</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CATARACT OPERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CYSTITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG ERUPTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSKINESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</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>AZULFADINE</medicinalproduct>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059293-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060724</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060712</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20060506452</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>56</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>POLYCYTHAEMIA VERA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugindication>PREMEDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059294-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060724</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060712</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20060604175</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</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>CROHN'S DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALTACE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPROL-XL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DYNACIRC CR</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059295-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060724</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060712</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20060603654</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>90.72</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD ALKALINE PHOSPHATASE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARAVA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VICODIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NOVALOG</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MIRALAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DURAGESIC-100</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059297-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060724</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060712</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20060600803</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>97.52</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>APPENDICITIS PERFORATED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANALGESICS</medicinalproduct>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE SODIUM</medicinalproduct>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLIPIZIDE</medicinalproduct>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059298-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060724</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060712</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20060500654</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>95.26</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>APPENDICITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEPHROLITHIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY CALCIFICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY GRANULOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugdosagetext>3 YEARS</drugdosagetext>
        <drugindication>CROHN'S DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMURAN</medicinalproduct>
        <drugdosagetext>ABOUT A YEAR</drugdosagetext>
        <drugindication>ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASACOL</medicinalproduct>
        <drugdosagetext>3 YEARS OR MORE</drugdosagetext>
        <drugindication>INTESTINAL FUNCTIONAL DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMBIEN</medicinalproduct>
        <drugdosagetext>1 YEAR</drugdosagetext>
        <drugindication>SLEEP DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
        <drugdosagetext>4 OR 5 YEARS</drugdosagetext>
        <drugindication>NERVOUSNESS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059299-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060724</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060712</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20060702397</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABORTION SPONTANEOUS</reactionmeddrapt>
      </reaction>
      <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>6-MP</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COLAZOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRENATAL VITAMINS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASAPHILOS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059300-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060724</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060712</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20060702495</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>53.07</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JOINT STIFFNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NECK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugdosagetext>PREVIOUSLY RECEIVED APPROXIMATELY 5-6 YEARS AGO</drugdosagetext>
        <drugindication>CROHN'S DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
        <drugindication>PREMEDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENADRYL</medicinalproduct>
        <drugindication>PREMEDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CIPRO</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MOTRIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059301-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060724</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060712</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20060702501</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>63.05</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CROHN'S DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>5-ASA</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059302-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060724</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060712</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20060702708</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>GALLBLADDER DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROAT TIGHTNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ANTIBIOTICS</medicinalproduct>
        <drugindication>INFECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IV THERAPY</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>INFECTION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059303-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060724</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060712</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20060702724</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>138.8</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>INTESTINAL ULCER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <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>AMIODARONE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROTONIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VICODIN</medicinalproduct>
        <drugindication>BACK PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059304-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060724</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060712</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20060702749</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PARALYSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059305-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060724</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060713</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-JNJFOC-20060602649</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>51</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>75</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CROHN'S DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MESACOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROGESTERON</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ESTROGENS SOL/INJ</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059306-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060724</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060712</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-JNJFOC-20050806029</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>74</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INFUSION RELATED REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLEURAL EFFUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TUBERCULOUS PLEURISY</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 SODIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RHEUMATREX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RHEUMATREX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RHEUMATREX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIAMIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDONINE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALDACTONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OEDEMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>OEDEMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAKEPRON</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>REFLUX OESOPHAGITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HALCION</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INSOMNIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BASEN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BASEN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MARZULENE S</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOXONIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOXONIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NOVOLIN R</medicinalproduct>
        <drugdosagetext>DOSE: 22 UT</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADRENAL HORMONE PREPARATION</medicinalproduct>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059307-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060724</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060713</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20060702621</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>83</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFUSION RELATED REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALLOR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059308-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060724</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060713</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>SA-JNJFOC-20060703003</companynumb>
    <primarysource>
      <reportercountry>SAUDI ARABIA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>31</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>POLYARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UVEITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugindication>ANKYLOSING SPONDYLITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INDOMETHACIN</medicinalproduct>
        <drugindication>ANKYLOSING SPONDYLITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059309-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060724</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060713</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-JNJFOC-20060602559</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>53</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VASCULITIC RASH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugdosagetext>2 INFUSIONS, DATES UNSPECIFIED</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RHEUMATREX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RHEUMATREX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MUCOSTA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ISCOTIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENET</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIAMIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDONINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MIYA BM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ENTEROCOLITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059310-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060724</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060713</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ES-JNJFOC-20060502930</companynumb>
    <primarysource>
      <reportercountry>SPAIN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>11</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FURUNCLE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSORIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STAPHYLOCOCCAL INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugdosagetext>THIRD DOSE</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CROHN'S DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMUREL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PENTASA</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059313-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060724</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060713</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-JNJFOC-20060702618</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ACTIVITIES OF DAILY LIVING IMPAIRED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWELLING FACE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CROHN'S DISEASE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059314-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060724</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060712</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-JNJFOC-20060702915</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>71</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>NON-HODGKIN'S LYMPHOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RHEUMATREX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RHEUMATREX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RHEUMATREX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RHEUMATREX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RHEUMATREX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDONINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AZULFIDINE EN-TABS</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BASEN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GASTER D</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADRENAL HORMONE PREPARATIONS</medicinalproduct>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VOLTAREN</medicinalproduct>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GASTROM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BASEN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASTOMIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MUCOSOLVAN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MUCOSTA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059315-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060724</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060713</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-JNJFOC-20060702918</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>52</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BREAST CANCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BREAST CANCER MALE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INFLIXIMAB, RECOMBINANT</medicinalproduct>
        <drugdosagetext>BLINDED DOSAGE OF 3, 6, OR 10 MG/KG</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INFLIXIMAB, RECOMBINANT</medicinalproduct>
        <drugdosagetext>BLINDED DOSAGE OF 3, 6, OR 10 MG/KG</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INFLIXIMAB, RECOMBINANT</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INFLIXIMAB, RECOMBINANT</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INFLIXIMAB, RECOMBINANT</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RHEUMATREX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDONINE</medicinalproduct>
        <drugdosagetext>START DATE: BEFORE 29-NOV-2005</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLAKAY</medicinalproduct>
        <drugdosagetext>START DATE: BEFORE 29-NOV-2005</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SELBEX</medicinalproduct>
        <drugdosagetext>START DATE: BEFORE 29-NOV-2005</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTROINTESTINAL DISORDER THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MOBIC</medicinalproduct>
        <drugdosagetext>START DATE: BEFORE 29-NOV-2005</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ISCOTIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ISCOTIN</medicinalproduct>
        <drugdosagetext>START DATE: BEFORE 29-NOV-2005</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ISCOTIN</medicinalproduct>
        <drugdosagetext>START DATE: BEFORE 29-NOV-2005</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANTIBIOTIC PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BONALON</medicinalproduct>
        <drugdosagetext>START DATE: BEFORE 22-DEC-2005</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059316-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060724</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060713</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20060702988</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>55</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>86.3</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFUSION RELATED REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URTICARIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugbatchnumb>06B162P1</drugbatchnumb>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059317-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060724</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2005CA10993</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEPHRECTOMY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL CELL CARCINOMA STAGE III</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMISIL</medicinalproduct>
        <drugauthorizationnumb>20539</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NAIL TINEA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
        <drugtreatmentduration>122</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059335-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060724</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060713</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2006US09031</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>63</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>97.052</patientweight>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ABNORMAL BEHAVIOUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ALANINE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASPARTATE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BILE DUCT OBSTRUCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BILIRUBIN CONJUGATED INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BIOPSY LIVER ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD ALKALINE PHOSPHATASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD BILIRUBIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHILLS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHROMATURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DECREASED APPETITE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISTURBANCE IN ATTENTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ENDOTHELIAL DYSFUNCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATOCHEZIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC FIBROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATITIS CHOLESTATIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLAMMATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JAUNDICE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPHADENOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL INTAKE REDUCED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENOOCCLUSIVE LIVER DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMISIL</medicinalproduct>
        <drugauthorizationnumb>20539</drugauthorizationnumb>
        <drugdosagetext>250 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060227</drugstartdate>
        <drugtreatmentduration>11520</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059336-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060706</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006084860</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>73</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HAEMOLYTIC ANAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IRINOTECAN HCL</medicinalproduct>
        <drugauthorizationnumb>20571</drugauthorizationnumb>
        <drugdosagetext>180 MG/M*2 (DAILY), INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PANCREATIC CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060221</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060307</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUOROURACIL</medicinalproduct>
        <drugdosagetext>400 MG/M*2 (DAILY) INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PANCREATIC CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060221</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060307</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXALIPLATIN (OXALIPLATIN)</medicinalproduct>
        <drugdosagetext>85 MG/M*2 (DAILY) INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PANCREATIC CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060221</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060307</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHYLPREDNISOLONE SODIUM SUCCINATE</medicinalproduct>
        <drugdosagetext>INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PANCREATIC CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060221</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060307</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATROPINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059341-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060705</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006084720</companynumb>
    <primarysource>
      <reportercountry>POLAND</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>47</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>70</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>CARDIAC ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SU-011, 248 (SUNITINIB MALATE)</medicinalproduct>
        <drugbatchnumb>507372</drugbatchnumb>
        <drugauthorizationnumb>21968</drugauthorizationnumb>
        <drugdosagetext>50 MG (50 MG, QD INTERVAL: EVERY DAY) ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>METASTATIC RENAL CELL CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060607</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060703</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059342-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060724</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060712</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHFR2006GB02219</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ORAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STOMATITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FEMARA</medicinalproduct>
        <drugauthorizationnumb>020726</drugauthorizationnumb>
        <drugdosagetext>2.5 MG/DAY</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059343-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060724</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060712</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHFR2006GB02221</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HYPERPROTEINAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROTEIN TOTAL INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FEMARA</medicinalproduct>
        <drugauthorizationnumb>020726</drugauthorizationnumb>
        <drugdosagetext>2.5MG/DAY</drugdosagetext>
        <drugindication>ENDOMETRIAL CANCER</drugindication>
        <drugtreatmentduration>122</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059344-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060724</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060712</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHO2006BE11197</companynumb>
    <primarysource>
      <reportercountry>BELGIUM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ERYSIPELAS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN OF SKIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FEMARA</medicinalproduct>
        <drugauthorizationnumb>020726</drugauthorizationnumb>
        <drugindication>BREAST CANCER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059345-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060705</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006084504</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>59</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABNORMAL BEHAVIOUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARCINOEMBRYONIC ANTIGEN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIHYDROPYRIMIDINE DEHYDROGENASE DEFICIENCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ENCEPHALITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL STIFFNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSYCHOTIC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RETICULOCYTE COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EPIRUBICIN</medicinalproduct>
        <drugauthorizationnumb>50778</drugauthorizationnumb>
        <drugdosagetext>160 MG INTRAVENOUS ; 120 MG INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051227</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051227</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EPIRUBICIN</medicinalproduct>
        <drugauthorizationnumb>50778</drugauthorizationnumb>
        <drugdosagetext>160 MG INTRAVENOUS ; 120 MG INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060117</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060117</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EPIRUBICIN</medicinalproduct>
        <drugauthorizationnumb>50778</drugauthorizationnumb>
        <drugdosagetext>160 MG INTRAVENOUS ; 120 MG INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060210</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060210</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUOROURACIL</medicinalproduct>
        <drugdosagetext>950 MG INTRAVENOUS ; 750 MG INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051227</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051227</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUOROURACIL</medicinalproduct>
        <drugdosagetext>950 MG INTRAVENOUS ; 750 MG INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060117</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060117</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUOROURACIL</medicinalproduct>
        <drugdosagetext>950 MG INTRAVENOUS ; 750 MG INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060210</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060210</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOPHOSPHAMIDE</medicinalproduct>
        <drugdosagetext>950 MG INTRAVENOUS ; 750 MG INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051227</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051227</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOPHOSPHAMIDE</medicinalproduct>
        <drugdosagetext>950 MG INTRAVENOUS ; 750 MG INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060117</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060117</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOPHOSPHAMIDE</medicinalproduct>
        <drugdosagetext>950 MG INTRAVENOUS ; 750 MG INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060210</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060210</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEXRAZOXANE</medicinalproduct>
        <drugdosagetext>1600 MG INTRAVENOUS ; 1200 MG INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060117</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060117</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEXRAZOXANE</medicinalproduct>
        <drugdosagetext>1600 MG INTRAVENOUS ; 1200 MG INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060210</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060210</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059346-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060724</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060511</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2006US06221</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>45</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>AMNESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBRAL HAEMATOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CRANIOTOMY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ENCEPHALOMALACIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCISION SITE OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEAN CELL VOLUME DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENINGIOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEOPLASM PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POST PROCEDURAL COMPLICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSEUDOMENINGOCELE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RADIOTHERAPY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RED BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISION BLURRED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PEPCID</medicinalproduct>
        <drugdosagetext>20 MG, UNK</drugdosagetext>
        <drugindication>STOMACH DISCOMFORT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19930701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LOPRESSOR</medicinalproduct>
        <drugauthorizationnumb>017963</drugauthorizationnumb>
        <drugdosagetext>50 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19930701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANALGESICS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VICODIN</medicinalproduct>
        <drugdosagetext>5/500 MG 1-2 TABS PO Q6H</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050901</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059347-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060705</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006084920</companynumb>
    <primarysource>
      <reportercountry>LUXEMBOURG</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>EPILEPSY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugauthorizationnumb>21446</drugauthorizationnumb>
        <drugdosagetext>DAILY, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NEURALGIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059348-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060705</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006084921</companynumb>
    <primarysource>
      <reportercountry>LUXEMBOURG</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>EPILEPSY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugauthorizationnumb>21446</drugauthorizationnumb>
        <drugdosagetext>DAILY ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NEURALGIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059349-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060724</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060606</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-BRISTOL-MYERS SQUIBB COMPANY-13409628</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>72</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DERMATITIS BULLOUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PURPURA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH PUSTULAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN NECROSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOZITEC</medicinalproduct>
        <drugauthorizationnumb>19915</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060224</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060505</drugenddate>
        <drugtreatmentduration>70</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GABAPENTIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060428</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060509</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAROXETINE HCL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060510</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMIODARONE HCL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060510</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060510</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LASILIX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060428</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PERMIXON</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060428</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VITAMIN B1 + B6</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060501</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059350-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060724</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060712</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-BRISTOL-MYERS SQUIBB COMPANY-13445945</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>95</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MOUTH ULCERATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOZIRETIC TABS</medicinalproduct>
        <drugauthorizationnumb>20286</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MALIGNANT HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060518</drugenddate>
        <drugtreatmentduration>747</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOZIRETIC TABS</medicinalproduct>
        <drugauthorizationnumb>020286</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>AORTIC VALVE INCOMPETENCE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060518</drugenddate>
        <drugtreatmentduration>747</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>DURATION: 8 YEARS</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
        <drugauthorizationnumb>073318</drugauthorizationnumb>
        <drugdosagetext>DURATION: 8 YEARS</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOXEN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060501</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059351-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060724</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060717</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-13444054</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>44</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>106</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GLUCOPHAGE</medicinalproduct>
        <drugauthorizationnumb>020357</drugauthorizationnumb>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOTROL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPROL-XL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRINIVIL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059352-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060724</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060314</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2006US03386</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>50</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>CARDIOMEGALY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMPLETED SUICIDE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CYANOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHYSICAL ASSAULT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ULTRAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EFFEXOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONIDINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADALAT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADVAIR DISKUS 100/50</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL SPIROS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATROVENT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZANTAC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ANALGESICS</medicinalproduct>
        <drugindication>BACK PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
        <drugauthorizationnumb>017963</drugauthorizationnumb>
        <drugdosagetext>100 MG, BID</drugdosagetext>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059353-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060704</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006078217</companynumb>
    <primarysource>
      <reportercountry>SPAIN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>54</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>COLD SWEAT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVARIAN CANCER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARDYL (ATORVASTATIN)</medicinalproduct>
        <drugauthorizationnumb>20702</drugauthorizationnumb>
        <drugdosagetext>40 MG (40 MG DAILY) ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERCHOLESTEROLAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORAZEPAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLPIDEM TARTRATE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059354-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060705</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006079793</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>54</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>90.5</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATOCELLULAR DAMAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERKALAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEOPLASM PROGRESSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SU-011, 248 (SUNITINIB MALATE)</medicinalproduct>
        <drugauthorizationnumb>21968</drugauthorizationnumb>
        <drugdosagetext>50 MG (50 MG, 1 IN 1 D) ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>METASTATIC RENAL CELL CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060331</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060606</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RANEZIDE (BEVANTOLOL HYDROCHLORIDE, HYDROCHLOROTHIAZIDE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RANITIDINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEPHROTRANS (SODIUM BICARBONATE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACTRAPID INSULIN NOVO (INSULIN)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DICLAC (DICLOFENAC SODIUM)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RED BLOOD CELLS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOBAY</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROTAPHAN (INSULIN ISOPHANE, HUMAN BIOSYNTHETIC)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLAFORAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CIPROFLOXACIN HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RELIV (PARACETAMOL)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NSA (ALBUMIN NORMAL HUMAN SERUM)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059355-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060710</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006080850</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>15</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>EYE SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CETIRIZINE HCL</medicinalproduct>
        <drugauthorizationnumb>19835</drugauthorizationnumb>
        <drugdosagetext>10 MG (10 MG, 1 IN 1 D)</drugdosagetext>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060622</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059356-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060703</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>MX200604000069</companynumb>
    <primarysource>
      <reportercountry>MEXICO</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>23</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>65</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD BILIRUBIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CREATINE PHOSPHOKINASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JAUNDICE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRANSAMINASES INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>STRATTERA(ATOMOXETINE HYDROCDHLORIDE) CAPSULE</medicinalproduct>
        <drugauthorizationnumb>21411</drugauthorizationnumb>
        <drugdosagetext>80 MG, DAILY (1/D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATTENTION DEFICIT/HYPERACTIVITY DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050901</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059357-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB200606000520</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>58</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>89.9</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CONVERSION DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>60 MG, UNK, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060314</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060324</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LITHIUM CARBONATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATORVASTATIN CALCIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMDUR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NITRAZEPAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SEREVENT   /UNK/ (SALMETEROL XINAFOATE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PULMICORT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIAZEPAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GAVISCON</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EPANUTIN /UNK/ (PHENYTOIN SODIUM)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GTN (GLCERYL TRINITRATE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALPROATE SODIUM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059358-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060523</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE200607001732</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>50</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>GAMMA-GLUTAMYLTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>60 MG, DAILY (1/D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PSYCHOTIC DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MUCOSOLVAN (AMBROXOL HYDROCHLORIDE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CAPTOHEXAL (CAPTOPRIL0</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANTOZOL /GFR/(PANTOPRAZOLE SODIUM)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059359-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060627</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR200606005650</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>56</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DIABETES MELLITUS INADEQUATE CONTROL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSIVE CRISIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>60 MG, DAILY (1/D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060601</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTIHYPERTENSIVES</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTIHYPERTENSIVES</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANIT-DIABETICS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059360-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060724</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060712</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-JNJFOC-20060702910</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>22</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>LISTERIA ENCEPHALITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>JUVENILE ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>STEROID</medicinalproduct>
        <drugindication>JUVENILE ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE SODIUM</medicinalproduct>
        <drugindication>JUVENILE ARTHRITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059361-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060724</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060713</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2006RU10573</companynumb>
    <primarysource>
      <reportercountry>RUSSIAN FEDERATION</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>35</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANGINA PECTORIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LESCOL XL</medicinalproduct>
        <drugauthorizationnumb>021192</drugauthorizationnumb>
        <drugdosagetext>80 MG/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DYSLIPIDAEMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BETA BLOCKING AGENTS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059362-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA200606004869</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>82</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugbatchnumb>FF5S35E</drugbatchnumb>
        <drugauthorizationnumb>21318</drugauthorizationnumb>
        <drugdosagetext>20 UG, DAILY (1/D), UNK</drugdosagetext>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060609</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FORTEO PEN (250MCG/ML) PEN, DISPOSABLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALTACE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRONOLACTONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANOXIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYLENOL    /USA/(PARACETAMOL)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM (CALCIUM)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059363-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060703</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IL-2006-015396</companynumb>
    <primarysource>
      <reportercountry>ISRAEL</reportercountry>
      <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>ALANINE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASPARTATE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD LACTATE DEHYDROGENASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHOLECYSTITIS ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHOLELITHIASIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BETAFERON 250 UG, 500 UG AND COPAXONE(BETAFERON (SH Y 579E)) INJECTION</medicinalproduct>
        <drugdosagetext>8 OR 16 MUI, EVERY 2D, SUBCUTANEOUS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RELAPSING-REMITTING MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060308</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059364-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060703</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-2006-008576</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>28</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIAC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIOMYOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUID RETENTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERVOLAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BETASERON</medicinalproduct>
        <drugdosagetext>SUBUCTANEOUS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RELAPSING-REMITTING MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060601</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059365-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060707</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>02H-153-0205484-00</companynumb>
    <primarysource>
      <reportercountry>TAIWAN, PROVINCE OF CHINA</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>3.775</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BRADYCARDIA NEONATAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRONCHIOLITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRONCHOPNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMA NEONATAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CYANOSIS NEONATAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEVELOPMENTAL COORDINATION DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEVELOPMENTAL DELAY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFANTILE APNOEIC ATTACK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEDICATION ERROR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEONATAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEONATAL RESPIRATORY ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NUCLEAR MAGNETIC RESONANCE IMAGING BRAIN ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSYCHOMOTOR SKILLS IMPAIRED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ATRACURIUM BESYLATE</medicinalproduct>
        <drugbatchnumb>76391 DK</drugbatchnumb>
        <drugauthorizationnumb>74633</drugauthorizationnumb>
        <drugdosagetext>10 MG, ONCE, INTRAMUSCULAR</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021129</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20021129</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059366-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2006JP09425</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>65</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>NEOPLASM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNOVIAL CYST</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOSPORINE</medicinalproduct>
        <drugauthorizationnumb>80339</drugauthorizationnumb>
        <drugindication>SYSTEMIC LUPUS ERYTHEMATOSUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SYSTEMIC LUPUS ERYTHEMATOSUS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059367-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060703</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2006BR10175</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>69</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DERMATITIS EXFOLIATIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMPRENE</medicinalproduct>
        <drugauthorizationnumb>64150</drugauthorizationnumb>
        <drugdosagetext>100 MG</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RIFAMPICIN</medicinalproduct>
        <drugdosagetext>300 MG</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DAPSONE</medicinalproduct>
        <drugdosagetext>100 MG</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THALIDOMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059368-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060704</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2006HK09987</companynumb>
    <primarysource>
      <reportercountry>HONG KONG</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>47</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD GASES ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIOVASCULAR DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMPLICATIONS OF TRANSPLANTED HEART</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIABETES MELLITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERLIPIDAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE CHRONIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENTRICULAR DYSFUNCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOSPORINE</medicinalproduct>
        <drugauthorizationnumb>80339</drugauthorizationnumb>
        <drugdosagetext>75 MG, BID</drugdosagetext>
        <drugindication>HEART TRANSPLANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990901</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SIROLIMUS(SIROLIMUS)</medicinalproduct>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugindication>HEART TRANSPLANT</drugindication>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugdosagetext>5 MG , BID</drugdosagetext>
        <drugindication>HEART TRANSPLANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990901</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MYCOPHENOLATE MOFETIL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059370-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060704</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IL-2006-017610</companynumb>
    <primarysource>
      <reportercountry>ISRAEL</reportercountry>
      <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>CHOLECYSTITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JAUNDICE CHOLESTATIC</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BETAFERON 250 UG, 500 UG AND COPAXONE(BETAFER (SH Y 579E)) INJECTION, </medicinalproduct>
        <drugdosagetext>8 MIU, 1 DOSE, SUBCUTANEOUS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RELAPSING-REMITTING MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050308</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060624</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BETAFERON 250 UG, 500 UG AND COPAXONE(BETAFER (SH Y 579E)) INJECTION, </medicinalproduct>
        <drugdosagetext>8 MIU, 1 DOSE, SUBCUTANEOUS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RELAPSING-REMITTING MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060701</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059371-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060724</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050609</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-US137729</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>55</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CHILLS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EPOGEN</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>DIALYSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARANESP</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugindication>DIALYSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059372-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060724</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050609</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-US138027</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>37</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ERYTHEMA INFECTIOSUM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>KIDNEY TRANSPLANT REJECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NORMOCHROMIC NORMOCYTIC ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THERAPEUTIC RESPONSE DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EPOGEN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>RENAL FAILURE CHRONIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19930101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EPOGEN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>RENAL TRANSPLANT</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059373-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060724</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050610</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-US138676</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>5</patientonsetage>
      <patientonsetageunit>803</patientonsetageunit>
      <patientweight>5</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ACCIDENTAL OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEDICATION ERROR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EPOGEN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>ANAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050603</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059374-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060724</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050615</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL139018</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugindication>ANAEMIA OF MALIGNANT DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050531</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEULASTA</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059375-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060706</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006BI004601</companynumb>
    <primarysource>
      <reportercountry>BELGIUM</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>63</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>LUNG DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOPATHY STEROID</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POLYNEUROPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>QUADRIPARESIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STEM CELL TRANSPLANT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZEVALIN</medicinalproduct>
        <drugbatchnumb>Y-90 ZEVALIN</drugbatchnumb>
        <drugdosagetext>0.4 MCI/KG;1X;IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BONE MARROW CONDITIONING REGIMEN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RITUXIMIB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARMUSTINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ETOPOSIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARACYTINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MELPHALAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHYLPREDNISOLONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEROPENEM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACYCLOVIR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEDERVORIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059376-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060724</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050615</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL139021</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>94</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugindication>RENAL FAILURE CHRONIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040801</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059377-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060724</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050613</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL134986</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>70</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugindication>ANAEMIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059378-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060724</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050612</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL139500</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>85</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>UPPER RESPIRATORY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugindication>ANAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050501</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059379-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060724</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050615</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL139245</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>ANAEMIA OF MALIGNANT DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050603</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059380-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060724</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050615</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL139280</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PROTHROMBIN TIME PROLONGED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>RENAL FAILURE CHRONIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050526</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059381-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060724</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL101702</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>85.8</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABNORMAL FAECES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACTERIA BLOOD IDENTIFIED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAIR GROWTH ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFECTION PARASITIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>KNEE ARTHROPLASTY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALLOR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN EXFOLIATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URTICARIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugindication>ANAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030801</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059382-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060724</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050602</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL136855</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>81.7</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ACCIDENTAL OVERDOSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059383-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060724</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050214</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL114538</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>111.2</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugindication>ANAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041115</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059384-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060724</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050616</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL139294</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>97.6</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANOREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugindication>RENAL FAILURE CHRONIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059385-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060705</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006BI008430</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>53</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>52</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BALANCE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIOVASCULAR DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEAFNESS UNILATERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EAR PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOACUSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE SCLEROSIS RELAPSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugdosagetext>30 UG;QW;IM</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19970101</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>5059386-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060724</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050616</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL139289</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>92.6</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE BRUISING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>ANAEMIA OF MALIGNANT DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030801</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059387-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060706</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2005BI018978</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>50</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CROHN'S DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLAMMATORY BOWEL DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET 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>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>FLUOXETINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAMADOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TEMAZEPAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIAZEPAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BACLOFEN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059388-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060724</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050510</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-US134006</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>THERAPEUTIC RESPONSE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRANSPLANT REJECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EPOGEN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>RENAL FAILURE CHRONIC</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059389-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060724</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050509</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL132655</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>80</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>NASOPHARYNGITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugindication>ANAEMIA OF MALIGNANT DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050429</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059390-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060724</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050524</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL135545</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugindication>ANAEMIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059391-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060724</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041214</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL103492</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>65.4</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN LOWER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIVERTICULITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>KIDNEY INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>MYELODYSPLASTIC SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041110</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041202</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010523</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059392-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060724</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050528</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL136636</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING COLD</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STOMACH DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROAT TIGHTNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL DISTURBANCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>ANAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050520</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059393-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060724</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050526</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL136829</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugindication>ANAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059395-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060724</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050526</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL136641</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>47</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>61.7</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EMBOLISM VENOUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERIPHERAL ISCHAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>ANAEMIA OF MALIGNANT DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050501</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050522</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050322</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059396-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060724</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050526</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL136474</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NECK MASS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THERAPEUTIC RESPONSE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>P031222</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>ANAEMIA OF MALIGNANT DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059397-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060724</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050523</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL135562</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MOUTH ULCERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugindication>PRE-EXISTING DISEASE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059398-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060724</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050516</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL134042</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>THERAPEUTIC RESPONSE DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugindication>RENAL FAILURE CHRONIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19900101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059399-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060724</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050512</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL134026</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>83</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>118.9</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD IRON INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>MYELODYSPLASTIC SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040126</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059400-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060724</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050527</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-US136121</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC ENZYME INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EPOGEN</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugindication>DIALYSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059401-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060724</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050531</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL133510</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>68.1</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LACRIMATION INCREASED</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>PROCRIT</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>ANAEMIA OF MALIGNANT DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050512</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059403-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060724</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050601</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL137162</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugindication>ANAEMIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059404-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060724</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050601</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL137356</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>52</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HYPERGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugindication>RENAL FAILURE CHRONIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050525</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059405-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060724</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050606</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL137455</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>70.4</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugindication>RENAL FAILURE CHRONIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059406-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060724</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050607</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL137608</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYELID OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugindication>RENAL FAILURE CHRONIC</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059407-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060724</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050607</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL137829</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>85.4</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWELLING FACE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URTICARIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050603</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059408-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060724</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050531</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL136631</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>37.2</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEASONAL ALLERGY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugindication>MYELODYSPLASTIC SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050520</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059409-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060724</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050601</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL136882</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>HYPOKALAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>ANAEMIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059410-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060724</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050512</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL134012</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>88.5</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD IRON INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMOTHORAX</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>MYELODYSPLASTIC SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020417</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040922</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059411-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060724</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050512</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-US132799</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BONE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHEEZING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARANESP</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugindication>RENAL FAILURE CHRONIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EPOGEN</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugindication>DIALYSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059412-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060724</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050517</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL134708</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISION BLURRED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugindication>ANAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041201</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059413-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060724</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050523</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-US135415</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>31.3</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>THERAPEUTIC RESPONSE DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EPOGEN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>014</drugadministrationroute>
        <drugindication>RENAL FAILURE CHRONIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030620</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040301</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050501</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040901</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059414-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060724</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050524</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL135548</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NIGHTMARE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugindication>ANAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059415-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060724</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050524</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL135907</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>62</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>63.6</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugindication>ANAEMIA OF MALIGNANT DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050301</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059416-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060724</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20020702</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL015290</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>82.2</patientweight>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>MALIGNANT NEOPLASM PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEDICATION TAMPERING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THERAPEUTIC RESPONSE DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>P002384</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>ANAEMIA OF MALIGNANT DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020327</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059417-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060724</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050526</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL136470</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>181.6</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>RENAL FAILURE CHRONIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050601</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059418-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060724</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050526</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL136473</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PSORIASIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>ANAEMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059419-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060724</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060713</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-JNJFOC-20060102401</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>53</patientweight>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>BILE DUCT CANCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METASTATIC NEOPLASM</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 SODIUM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CO-PROXAMOL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RISEDRONATE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCICHEW</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059421-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060710</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>THQ2006A00458</companynumb>
    <primarysource>
      <reportercountry>VENEZUELA</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>68</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DIABETIC COMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LUPRON</medicinalproduct>
        <drugdosagetext>11.25 MG (11.25 MG, 1 IN 3 M); SUBCUTANEOUS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PROSTATE CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLIBENCLAMIDE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059423-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060705</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>THQ2006A00440</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>65</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANOREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASPARTATE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD ALBUMIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD ALKALINE PHOSPHATASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD BILIRUBIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE MARROW FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CANDIDIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRY MOUTH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATOSPLENOMEGALY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARYNGOLARYNGEAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LANSOPRAZOLE</medicinalproduct>
        <drugindication>HELICOBACTER INFECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AZATHIOPRINE SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLARITHROMYCIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METRONIDAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN W/ PROPOXYPHENE HCL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059424-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060705</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006AP000456</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>59</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANGIONEUROTIC OEDEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CAPTOPRIL</medicinalproduct>
        <drugbatchnumb>GT7489</drugbatchnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ADALAT CC</medicinalproduct>
        <drugdosagetext>60 MG; CAP; PO; QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059426-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060703</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ENTC2006-0179</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>COLITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>STALEVO 100</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059428-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060705</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>29356</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>70</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOPTYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERSTITIAL LUNG DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY CONGESTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAMBOCOR</medicinalproduct>
        <drugdosagetext>100 MG, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060127</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060404</drugenddate>
        <drugtreatmentduration>67</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEPRICOR</medicinalproduct>
        <drugdosagetext>100 MG, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060209</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060404</drugenddate>
        <drugtreatmentduration>54</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARTIST</medicinalproduct>
        <drugdosagetext>5 MG; ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060127</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060322</drugenddate>
        <drugtreatmentduration>54</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAINTATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059430-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060712</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006-140766-NL</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>66</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIAC TAMPONADE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERICARDIAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLEURAL EFFUSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DANAPAROID SODIUM</medicinalproduct>
        <drugdosagetext>2500 ANTI_XA; INTRAVENOUS (NOS)</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>DISSEMINATED INTRAVASCULAR COAGULATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040922</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040925</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLYCEOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EDARAVONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CEFPIROME SULFATE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059432-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060706</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006-143981-NL</companynumb>
    <primarysource>
      <reportercountry>SWITZERLAND</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>EPILEPSY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIRTAZAPINE</medicinalproduct>
        <drugdosagetext>DF; ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ESCITALOPRAM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059434-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060706</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006-143978-NL</companynumb>
    <primarysource>
      <reportercountry>SWITZERLAND</reportercountry>
    </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>
        <drugdosagetext>DF; ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059436-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060705</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2005090829</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>77</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>73</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ALANINE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD ALKALINE PHOSPHATASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD BILIRUBIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERNATIONAL NORMALISED RATIO INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYVOX</medicinalproduct>
        <drugauthorizationnumb>21131</drugauthorizationnumb>
        <drugdosagetext>1200 MG (600 MG, 2 IN 1 D), UNKNOWN</drugdosagetext>
        <drugindication>STAPHYLOCOCCAL INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050104</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050120</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LANSOPRAZOLE</medicinalproduct>
        <drugdosagetext>30 MG (30 MG, 1 IN 1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050127</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LANSOPRAZOLE</medicinalproduct>
        <drugdosagetext>30 MG (30 MG, 1 IN 1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>STRESS ULCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050127</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PANTOPRAZOLE SODIUM</medicinalproduct>
        <drugdosagetext>40 MG (40 MG, 1 IN 1 D), INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050102</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050127</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PANTOPRAZOLE SODIUM</medicinalproduct>
        <drugdosagetext>40 MG (40 MG, 1 IN 1 D), INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>STRESS ULCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050102</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050127</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLOXACILLIN SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TEICOPLANIN (TEICOPLANIN)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAZOCIN (PIPERACILLIN SODIUM, TAZOBACTAM SODIUM)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMIODARONE (AMIODARONE)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059437-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060724</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060713</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-KINGPHARMUSA00001-K200600914</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>67</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ATRIOVENTRICULAR BLOCK FIRST DEGREE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CREATININE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD UREA INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRADYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIOACTIVE DRUG LEVEL INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERNATIONAL NORMALISED RATIO INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALLOR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENTRICULAR EXTRASYSTOLES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VITAMIN K DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALTACE</medicinalproduct>
        <drugauthorizationnumb>019901</drugauthorizationnumb>
        <drugdosagetext>2.5 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SOTALOL HCL</medicinalproduct>
        <drugdosagetext>80 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOPERAMIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugdosagetext>20 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREVISCAN</medicinalproduct>
        <drugdosagetext>25 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060602</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREVISCAN</medicinalproduct>
        <drugdosagetext>25 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060605</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SMECTA ^DAE WOONG^</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN</medicinalproduct>
        <drugdosagetext>26 IU AM, 22 IU PM</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059438-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060724</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060714</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-KINGPHARMUSA00001-K200600920</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>83</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BRONCHITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ESCHERICHIA INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MORAXELLA INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OBSTRUCTIVE AIRWAYS DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPUTUM CULTURE POSITIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALTACE</medicinalproduct>
        <drugauthorizationnumb>019901</drugauthorizationnumb>
        <drugdosagetext>UNK, UNK</drugdosagetext>
        <drugindication>DIURETIC THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALTACE</medicinalproduct>
        <drugauthorizationnumb>019901</drugauthorizationnumb>
        <drugdosagetext>UNK, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
        <drugdosagetext>UNK, UNK</drugdosagetext>
        <drugindication>DIURETIC THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
        <drugdosagetext>UNK, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>STUDY DRUG CODE UNBROKEN</medicinalproduct>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050305</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050320</drugenddate>
        <drugtreatmentduration>23040</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>STUDY DRUG CODE UNBROKEN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THIENOPYRIDINES</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMIODARONE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMOXICILLIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059439-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060707</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006003991</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>41</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>119</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DELUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HALLUCINATION, AUDITORY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTHYROIDISM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GENOTROPIN</medicinalproduct>
        <drugauthorizationnumb>20280</drugauthorizationnumb>
        <drugdosagetext>0.1 + 0.2 MG (0.1 MG, DAILY), SUBCUTANEOUS - SEE IMAGE</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>HYPOPITUITARISM</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030730</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031118</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GENOTROPIN</medicinalproduct>
        <drugauthorizationnumb>20280</drugauthorizationnumb>
        <drugdosagetext>0.1 + 0.2 MG (0.1 MG, DAILY), SUBCUTANEOUS - SEE IMAGE</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>HYPOPITUITARISM</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040121</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040304</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GENOTROPIN</medicinalproduct>
        <drugauthorizationnumb>20280</drugauthorizationnumb>
        <drugdosagetext>0.1 + 0.2 MG (0.1 MG, DAILY), SUBCUTANEOUS - SEE IMAGE</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>HYPOPITUITARISM</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040305</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MECOBALAMIN (MECOBALAMIN)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADENOSINE TRIPHOSPHATE, DISODIUM SALT (ADENOSINE TRIPHOSPHATE, DISODIU</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BETAHISTINE MESILATE (BETAHISTINE MESILATE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OFLOXACIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUTICASONE PROPIONATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORATADINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CORTISONE ACETATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DESMOPRESSIN ACETATE (DESMORPRESSIN ACETATE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ROXATIDNE ACETATE HYDROCHLORIDE (ROXATIDINE ACETATE HYDROCHLORIDE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALPROATE SODIUM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059440-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060724</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060404</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006GB00565</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>22505</patientonsetage>
      <patientonsetageunit>804</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>EXOSTOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERVERTEBRAL DISC SPACE NARROWING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUROPATHY PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPINAL OSTEOARTHRITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOLADEX</medicinalproduct>
        <drugbatchnumb>BNCW396, CL955</drugbatchnumb>
        <drugauthorizationnumb>19726</drugauthorizationnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PROSTATE CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060104</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CASODEX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROSTATE CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051221</drugstartdate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059441-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060724</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060622</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006UW13161</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>AMNESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERSONALITY CHANGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRANSIENT ISCHAEMIC ATTACK</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAMOXIFEN</medicinalproduct>
        <drugauthorizationnumb>17970</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BREAST CANCER RECURRENT</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059442-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060724</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060719</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006UW14659</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>45</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>SPLENOMEGALY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAMOXIFEN</medicinalproduct>
        <drugauthorizationnumb>17970</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059443-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060705</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006061602</companynumb>
    <primarysource>
      <reportercountry>NETHERLANDS</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>70</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>81</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHILLS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEBRILE NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL STROMAL TUMOUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERAL PHYSICAL HEALTH DETERIORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATEMESIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEUKOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALIGNANT NEOPLASM PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SU-011,248 (SUNITINIB MALATE)</medicinalproduct>
        <drugauthorizationnumb>21938</drugauthorizationnumb>
        <drugdosagetext>(50 MG, CYCLIC, INTERVAL: 4 OF 6 WEEKS), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTROINTESTINAL STROMAL TUMOUR</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050209</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060503</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANTOZOL (PANTOPRAZOLE SODIUM)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACTONEL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL (METOPROLOL)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059444-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060707</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006067961</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>76</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CONJUNCTIVAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
        <drugauthorizationnumb>19787</drugauthorizationnumb>
        <drugdosagetext>5 MG (UNKNOWN), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060501</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugdosagetext>10 MG (UNKNOWN), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERCHOLESTEROLAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050408</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
        <drugdosagetext>25 AND 50 UG/DAY FROM DAY TO DAY (25 MCG), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPOTHYROIDISM</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050408</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059445-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060710</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006068705</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>38</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>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>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAMMA-GLUTAMYLTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SULFASALAZINE</medicinalproduct>
        <drugauthorizationnumb>7073</drugauthorizationnumb>
        <drugdosagetext>4 GRAM (1 IN 1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>COLITIS ULCERATIVE</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060520</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BIOFERMIN R (STREPTOCOCCUS FAECALIS)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MARZULENE S (LEVOGLUTAMIDE, SODIUM GUALENATE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MESALAMINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059446-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060705</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006073819</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>36</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>60.2</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EPSTEIN-BARR VIRUS INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOLYTIC ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMMUNISATION REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTRA-ABDOMINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SULPERAZON (SULBACTAM, CEFOPERAZONE)</medicinalproduct>
        <drugauthorizationnumb>50551</drugauthorizationnumb>
        <drugdosagetext>2 GRAM (1 GRAM, 2 IN 1 D), INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BILIARY TRACT INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060519</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060522</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LOXONIN (LOXOPROFEN SODIUM)</medicinalproduct>
        <drugdosagetext>60 MG (60 MG, AS NEEDED), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PYREXIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060519</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VOLTAREN</medicinalproduct>
        <drugdosagetext>25 MG (25 MG, AS NEEDED), RECTAL</drugdosagetext>
        <drugadministrationroute>054</drugadministrationroute>
        <drugindication>PYREXIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060519</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059447-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060705</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006076041</companynumb>
    <primarysource>
      <reportercountry>POLAND</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>59</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>74</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ASCITES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CACHEXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ELECTROLYTE IMBALANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALIGNANT NEOPLASM PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SU-011,248 (SUNITINIB MALATE)</medicinalproduct>
        <drugauthorizationnumb>21968</drugauthorizationnumb>
        <drugdosagetext>50 MG (50 MG, 1 IN 1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RENAL CELL CARCINOMA STAGE UNSPECIFIED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060419</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060517</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TORECAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRONOL (SPIRONOLACTONE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOSE (GLUCOSE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SODIUM CHLORIDE 0.9%</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACTRAPID (INSULIN)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM (CALCIUM)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUDROCORTISONE ACETATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCORTISONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANZUL (LANSOPRAZOLE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAMADOL HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KETONAL (KETOPROFEN)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BLOOD AND RELATED PRODUCTS (BLOOD AND RELATED PRODUCTS)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059448-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060724</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060517</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BE-AVENTIS-200612836EU</companynumb>
    <primarysource>
      <reportercountry>BELGIUM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>1</patientonsetage>
      <patientonsetageunit>804</patientonsetageunit>
      <patientweight>1.35</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD CREATININE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD UREA INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCORRECT DOSE ADMINISTERED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEUKOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POLYURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WRONG TECHNIQUE IN DRUG USAGE PROCESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugauthorizationnumb>16363</drugauthorizationnumb>
        <drugdosagetext>DOSE: 10MG/KG</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>OEDEMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060514</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060514</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOBUTAMINE HCL</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CARDIAC FAILURE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060513</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOPAMINE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CARDIAC FAILURE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060513</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MORPHINE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>SEDATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060513</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059449-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060724</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060717</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-AVENTIS-200612534FR</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>68</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERSTITIAL LUNG DISEASE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CORTANCYL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060623</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SPECIAFOLDINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LASILIX</medicinalproduct>
        <drugauthorizationnumb>016273</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060621</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VOLTAREN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060621</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NOVATREX ^LEDERLE^</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060622</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059450-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060724</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060612</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PL-AVENTIS-200616289GDDC</companynumb>
    <primarysource>
      <reportercountry>POLAND</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>70</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>63</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRANSAMINASES INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARAVA</medicinalproduct>
        <drugbatchnumb>509</drugbatchnumb>
        <drugauthorizationnumb>20905</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050824</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060523</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRESTARIUM</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BETALOC ZOK</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACARD</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059451-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060724</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060713</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ES-AVENTIS-200613888EU</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>41</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>APHASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBRAL ARTERY EMBOLISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEMIPARESIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLEXANE</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>20164</drugauthorizationnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010312</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010321</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059452-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060724</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060717</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IT-AVENTIS-200617450GDDC</companynumb>
    <primarysource>
      <reportercountry>ITALY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INTERSTITIAL LUNG DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUROPATHY PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAPARESIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARAVA</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>020905</drugauthorizationnumb>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059454-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060713</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006P1000378</companynumb>
    <primarysource>
      <reportercountry>ROMANIA</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>47</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>75</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RETEPLASE (RETEPLASE)</medicinalproduct>
        <drugdosagetext>IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ACUTE MYOCARDIAL INFARCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060620</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060620</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REOPRO</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060620</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060623</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HEPARIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLOPIDOGREL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETYLSALICYLIC ACID SRT</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059457-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060724</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060713</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2006US09043</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLINDNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRILEPTAL</medicinalproduct>
        <drugauthorizationnumb>021014</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059462-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060724</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060713</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AVENTIS-200616003US</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANGINA PECTORIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIABETA</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>17532</drugauthorizationnumb>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS NON-INSULIN-DEPENDENT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN DRUG</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059463-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060724</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060711</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2006IT10382</companynumb>
    <primarysource>
      <reportercountry>ITALY</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>68</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>OSTEOMYELITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugauthorizationnumb>021223</drugauthorizationnumb>
        <drugdosagetext>4 MG, QMO</drugdosagetext>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041105</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060202</drugenddate>
        <drugtreatmentduration>455</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059464-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060724</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060712</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2006IT10492</companynumb>
    <primarysource>
      <reportercountry>ITALY</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>78</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>OSTEOMYELITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SURGERY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugauthorizationnumb>021223</drugauthorizationnumb>
        <drugdosagetext>4 MG, QMO</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BREAST CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050801</drugenddate>
        <drugtreatmentduration>1309</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FEMARA</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059465-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060724</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060712</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHNU2006DE02509</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ARRHYTHMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CREATININE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SANDIMMUNE</medicinalproduct>
        <drugauthorizationnumb>050715</drugauthorizationnumb>
        <drugdosagetext>200 MG DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>LIVER TRANSPLANT</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059466-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060724</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060711</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2006IT10378</companynumb>
    <primarysource>
      <reportercountry>ITALY</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>54</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>OSTEOMYELITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE TAB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THALIDOMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugauthorizationnumb>021223</drugauthorizationnumb>
        <drugdosagetext>4 MG, QMO</drugdosagetext>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050320</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060320</drugenddate>
        <drugtreatmentduration>366</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059467-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060724</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060713</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHNU2006DE02535</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD CREATININE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SCOTOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISION BLURRED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DECORTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SANDIMMUNE</medicinalproduct>
        <drugauthorizationnumb>050574</drugauthorizationnumb>
        <drugdosagetext>250MG/DAY</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugtreatmentduration>1825</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SANDIMMUNE</medicinalproduct>
        <drugauthorizationnumb>050574</drugauthorizationnumb>
        <drugdosagetext>125MG/DAY</drugdosagetext>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060709</drugenddate>
        <drugtreatmentduration>365</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059468-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060724</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060712</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2006JP10460</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>36</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ARRHYTHMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELLCEPT</medicinalproduct>
        <drugindication>STEM CELL TRANSPLANT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHYLPREDNISOLONE</medicinalproduct>
        <drugindication>STEM CELL TRANSPLANT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOSPORINE</medicinalproduct>
        <drugauthorizationnumb>050574</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>STEM CELL TRANSPLANT</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059469-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060724</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060713</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20060702622</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CANDIDIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugdosagetext>THREE INFUSIONS</drugdosagetext>
        <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>B-12</medicinalproduct>
        <drugadministrationroute>050</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>6-MP</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZITHROMAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCODONE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONOPIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NARDIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUCONAZOLE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059470-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060724</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060710</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHFR2006GB02210</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>38</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>SPERMATOZOA PROGRESSIVE MOTILITY ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ATORVASTATIN CALCIUM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HYPERLIPIDAEMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELLCEPT</medicinalproduct>
        <drugdosagetext>500 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RENAL TRANSPLANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020615</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060315</drugenddate>
        <drugtreatmentduration>1370</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOXAZOSIN (NGX)</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ISONIAZID</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMIVUDINE</medicinalproduct>
        <drugdosagetext>UNK, UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HEPATITIS B</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PERINDOPRIL</medicinalproduct>
        <drugdosagetext>UNK, UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PYRIDOXINE HCL</medicinalproduct>
        <drugdosagetext>UNK, UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOSPORINE</medicinalproduct>
        <drugauthorizationnumb>050715</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059471-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060724</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060711</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2006IT10412</companynumb>
    <primarysource>
      <reportercountry>ITALY</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>68</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>OSTEOMYELITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SURGERY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MELPHALAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugauthorizationnumb>021223</drugauthorizationnumb>
        <drugdosagetext>4 MG, QMO</drugdosagetext>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050228</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060228</drugenddate>
        <drugtreatmentduration>366</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059472-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060724</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060712</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2006IT10494</companynumb>
    <primarysource>
      <reportercountry>ITALY</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>46</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>OSTEOMYELITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugauthorizationnumb>021223</drugauthorizationnumb>
        <drugdosagetext>4 MG, QMO</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050721</drugenddate>
        <drugtreatmentduration>599</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYCLOPHOSPHAMIDE + 5-FU + METHOTREXATE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EPIRUBICIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAMOXIFEN CITRATE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059473-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060706</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>146452USA</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>73</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>REVERSIBLE POSTERIOR LEUKOENCEPHALOPATHY SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PHENYLEPHRINE</medicinalproduct>
        <drugauthorizationnumb>88761</drugauthorizationnumb>
        <drugindication>SUBARACHNOID HAEMORRHAGE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PHENYLEPHRINE</medicinalproduct>
        <drugauthorizationnumb>88761</drugauthorizationnumb>
        <drugindication>VASOSPASM</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059474-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060724</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060712</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2006IT10561</companynumb>
    <primarysource>
      <reportercountry>ITALY</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>75</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>OSTEOMYELITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SURGERY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugauthorizationnumb>021223</drugauthorizationnumb>
        <drugdosagetext>4 MG, QMO</drugdosagetext>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031205</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051205</drugenddate>
        <drugtreatmentduration>732</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MELPHALAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DELTACORTENE</medicinalproduct>
        <drugindication>MULTIPLE MYELOMA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059475-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060724</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060711</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2006US08927</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>64</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CHAPPED LIPS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIP PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUCOSAL INFLAMMATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL INTAKE REDUCED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STOMATITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugauthorizationnumb>021223</drugauthorizationnumb>
        <drugdosagetext>4 MG EVERY FOUR WEEKS</drugdosagetext>
        <drugindication>METASTASES TO BONE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALOXI</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HERCEPTIN ^HOFFMANN-LA ROCHE^</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NAVELBINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARANESP</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEULASTA</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059476-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060724</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060712</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHFR2006GB02222</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugauthorizationnumb>021223</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059477-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060724</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060712</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2006IT10495</companynumb>
    <primarysource>
      <reportercountry>ITALY</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>54</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>OSTEOMYELITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SURGERY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugauthorizationnumb>021223</drugauthorizationnumb>
        <drugdosagetext>4 MG, QMO</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050701</drugenddate>
        <drugtreatmentduration>488</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAMOXIFEN CITRATE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYCLOPHOSPHAMIDE + 5-FU + METHOTREXATE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059478-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060724</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060712</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2006US08972</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>59</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ALOPECIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPAREUNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMPAIRED HEALING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OPEN WOUND</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL INTAKE REDUCED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALLOR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARYNGITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARYNGOLARYNGEAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUSITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TEETH BRITTLE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTH EXTRACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTH INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UPPER RESPIRATORY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CEFTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAXOTERE</medicinalproduct>
        <drugdosagetext>60 MG EVERY OTHER WEEK</drugdosagetext>
        <drugindication>BREAST CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050512</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HERCEPTIN</medicinalproduct>
        <drugindication>BREAST CANCER METASTATIC</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADRIAMYCIN PFS</medicinalproduct>
        <drugdosagetext>106 MG, 4 TREATMENTS</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990408</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19990708</drugenddate>
        <drugtreatmentduration>92</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADRIAMYCIN PFS</medicinalproduct>
        <drugdosagetext>18 MG EVERY WEEK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030211</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050421</drugenddate>
        <drugtreatmentduration>801</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FEMARA</medicinalproduct>
        <drugdosagetext>2.5 MG, QD</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010806</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030515</drugenddate>
        <drugtreatmentduration>648</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARIMIDEX</medicinalproduct>
        <drugdosagetext>1 MG, QD</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030522</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031002</drugenddate>
        <drugtreatmentduration>134</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FASLODEX</medicinalproduct>
        <drugdosagetext>250 MG MONTHLY</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031022</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030311</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugauthorizationnumb>021223</drugauthorizationnumb>
        <drugdosagetext>MONTHLY</drugdosagetext>
        <drugindication>METASTASES TO BONE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020808</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060712</drugenddate>
        <drugtreatmentduration>1435</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059479-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060724</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040630</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2004US07121</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>61</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ACTINOMYCOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DENTAL CARIES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GINGIVITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMPAIRED HEALING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OROANTRAL FISTULA</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>
        <drugauthorizationnumb>21223</drugauthorizationnumb>
        <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>1</drugcharacterization>
        <medicinalproduct>AREDIA</medicinalproduct>
        <drugdosagetext>90MG QMO</drugdosagetext>
        <drugindication>BREAST CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010313</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20011018</drugenddate>
        <drugtreatmentduration>220</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </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>5059480-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060711</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200612725BCC</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>71</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>63.5036</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CONTUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG NEOPLASM MALIGNANT</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>19950101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060606</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060607</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZETIA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059481-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060724</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060703</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-BRISTOL-MYERS SQUIBB COMPANY-13432364</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>65</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PURPURA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAXOL</medicinalproduct>
        <drugauthorizationnumb>20262</drugauthorizationnumb>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>LUNG ADENOCARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060529</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060529</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMOBAN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060527</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060625</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SENNA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060526</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060625</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZYRTEC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060526</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060625</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MUCODYNE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060526</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060625</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MUCOSOLVAN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060526</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060625</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BIOFERMIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060527</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060625</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELESTONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060527</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060625</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZANTAC</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060607</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060607</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SOLU-MEDROL</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060608</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060630</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059482-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060710</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200612916BCC</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>48</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>71.6683</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY OCCLUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN JAW</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXTRA STRENGTH BAYER PLUS CAPLETS</medicinalproduct>
        <drugbatchnumb>2123751</drugbatchnumb>
        <drugdosagetext>1000 MG, PRN, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CHEST PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060626</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXTRA STRENGTH BAYER PLUS CAPLETS</medicinalproduct>
        <drugbatchnumb>2123751</drugbatchnumb>
        <drugdosagetext>1000 MG, PRN, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN IN JAW</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060626</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXTRA STRENGTH BAYER PLUS CAPLETS</medicinalproduct>
        <drugbatchnumb>2123751</drugbatchnumb>
        <drugdosagetext>1000 MG, PRN, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CHEST PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060630</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXTRA STRENGTH BAYER PLUS CAPLETS</medicinalproduct>
        <drugbatchnumb>2123751</drugbatchnumb>
        <drugdosagetext>1000 MG, PRN, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN IN JAW</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060630</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059483-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060724</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060704</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PE-BRISTOL-MYERS SQUIBB COMPANY-13432562</companynumb>
    <primarysource>
      <reportercountry>PERU</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>45</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HAEMATOMA INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DASATINIB</medicinalproduct>
        <drugdosagetext>INTERRUPT: 30JUN06 RESTART: 10JUL06</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CHRONIC MYELOID LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050613</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050630</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059484-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060724</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060331</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CL-BRISTOL-MYERS SQUIBB COMPANY-13333273</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>66</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CLOSTRIDIUM DIFFICILE COLITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUCOSAL INFLAMMATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CISPLATIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>GASTRIC CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060301</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUOROURACIL</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>GASTRIC CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060306</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOMPERIDONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANTIEMETIC SUPPORTIVE CARE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051215</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060406</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DYSPHAGIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060222</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONAZEPAM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANXIETY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051215</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM</medicinalproduct>
        <drugindication>HYPOKALAEMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KETOROLAC TROMETHAMINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DYSPHAGIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060222</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOPERAMIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060405</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059485-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060724</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060222</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-BRISTOL-MYERS SQUIBB COMPANY-13293113</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>79</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>INTERSTITIAL LUNG DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAXOL</medicinalproduct>
        <drugauthorizationnumb>20262</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>GASTRIC CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060209</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060216</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>L-GLUTAMINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NICORANDIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGNESIUM OXIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRAVASTATIN SODIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ISOSORBIDE MONONITRATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NITRAZEPAM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MOSAPRIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059486-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060724</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060712</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ZA-BRISTOL-MYERS SQUIBB COMPANY-13439351</companynumb>
    <primarysource>
      <reportercountry>SOUTH AFRICA</reportercountry>
      <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>BALANCE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRAIN DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIO-RESPIRATORY ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALIGNANT NEOPLASM PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARYNGOLARYNGEAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>REFUSAL OF TREATMENT BY PATIENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPLEEN DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL ACUITY REDUCED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DASATINIB</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060315</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060710</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMOXICILLIN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060705</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060701</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PHARMATON</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060530</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060701</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060701</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059487-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060724</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060714</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AVENTIS-200616053US</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>CARDIAC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC ENZYMES INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021081</drugauthorizationnumb>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059488-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060724</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060505</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-13370440</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>74</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>MALIGNANT NEOPLASM PROGRESSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MEGACE</medicinalproduct>
        <drugauthorizationnumb>16979</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059489-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060724</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060717</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-BRISTOL-MYERS SQUIBB COMPANY-13446422</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CONTUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUDDEN DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARBIDOPA + LEVODOPA</medicinalproduct>
        <drugauthorizationnumb>019856</drugauthorizationnumb>
        <drugindication>PARKINSON'S DISEASE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059490-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060724</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060622</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-13420047</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>72</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>61</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARBOPLATIN</medicinalproduct>
        <drugauthorizationnumb>019880</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>OVARIAN CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060412</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PACLITAXEL</medicinalproduct>
        <drugauthorizationnumb>020262</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>OVARIAN CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060412</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEULASTA</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060525</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZANTAC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONIDINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATIVAN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060412</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COMPAZINE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060412</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VICODIN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060412</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALEVE (CAPLET)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACTONEL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059491-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060724</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060713</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHFR2006GB02231</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABNORMAL BEHAVIOUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLIGHT OF IDEAS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSYCHOTIC DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugauthorizationnumb>021223</drugauthorizationnumb>
        <drugdosagetext>4MG</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PROSTATE CANCER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059492-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060712</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200610366BWH</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>88</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>66.452</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ATRIAL FIBRILLATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CREATINE PHOSPHOKINASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CREATININE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FIBRIN D DIMER INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG CANCER METASTATIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALIGNANT NEOPLASM PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENTRICULAR EXTRASYSTOLES</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SORAFENIB</medicinalproduct>
        <drugauthorizationnumb>21923</drugauthorizationnumb>
        <drugdosagetext>400 MG, BID, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>METASTATIC RENAL CELL CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051215</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051228</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYZAAR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPROL-XL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTIVITAMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ISORBIDE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059493-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060724</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060712</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2006IT10560</companynumb>
    <primarysource>
      <reportercountry>ITALY</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>71</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>OSTEOMYELITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugauthorizationnumb>021223</drugauthorizationnumb>
        <drugdosagetext>4 MG, QD</drugdosagetext>
        <drugindication>PROSTATE CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031121</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051121</drugenddate>
        <drugtreatmentduration>732</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059494-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060724</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060424</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2006US05344</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>54</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DENTAL CARIES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRY MOUTH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GINGIVAL SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GINGIVITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL SOFT TISSUE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN JAW</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOFT TISSUE INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugauthorizationnumb>21223</drugauthorizationnumb>
        <drugdosagetext>4 MG EVERY MONTH, OVER 30 MINS.</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030507</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060212</drugenddate>
        <drugtreatmentduration>1013</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THALIDOMIDE</medicinalproduct>
        <drugdosagetext>200 MG, QD</drugdosagetext>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030606</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VIAGRA</medicinalproduct>
        <drugdosagetext>UNK, PRN</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCONTIN</medicinalproduct>
        <drugdosagetext>UNK, PRN</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCODONE HCL</medicinalproduct>
        <drugdosagetext>UNK, PRN</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE TAB</medicinalproduct>
        <drugdosagetext>PULSED DOSING PRN</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARANESP</medicinalproduct>
        <drugdosagetext>200 MG, Q 2WK</drugdosagetext>
        <drugindication>ANAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030507</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041014</drugenddate>
        <drugtreatmentduration>527</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059495-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060724</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050407</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHO2005IT05655</companynumb>
    <primarysource>
      <reportercountry>ITALY</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>65</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>AUTOIMMUNE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD THYROID STIMULATING HORMONE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRIMARY HYPOTHYROIDISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THYROXINE FREE DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOLEDRONIC ACID</medicinalproduct>
        <drugauthorizationnumb>21223</drugauthorizationnumb>
        <drugdosagetext>4 MG, QMO</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021126</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEGASYS</medicinalproduct>
        <drugdosagetext>35 UG, QW</drugdosagetext>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020920</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050325</drugenddate>
        <drugtreatmentduration>918</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059496-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060724</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060713</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>LU-SP-2006-01807</companynumb>
    <primarysource>
      <reportercountry>LUXEMBOURG</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>74</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CYSTITIS NONINFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMMUCYST</medicinalproduct>
        <drugbatchnumb>LOT NOT REP</drugbatchnumb>
        <drugadministrationroute>043</drugadministrationroute>
        <drugindication>BLADDER CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050127</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050804</drugenddate>
        <drugtreatmentduration>188</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EUTHYROX</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19900101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUDEX</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050821</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059497-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060724</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060711</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2006BR10475</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>31</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>60</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INTOLERANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EPILEPSY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PARLODEL</medicinalproduct>
        <drugauthorizationnumb>17962</drugauthorizationnumb>
        <drugdosagetext>2.5 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD PROLACTIN ABNORMAL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060708</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060708</drugenddate>
        <drugtreatmentduration>1440</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059498-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060724</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060601</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHRM2006FR01694</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>92</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>80.5</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>AGGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AGITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEMENTIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EPILEPSY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERAL PHYSICAL HEALTH DETERIORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HALLUCINATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMPAIRED SELF-CARE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STATUS EPILEPTICUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY INCONTINENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>160 MG/DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HEPT-A-MYL</medicinalproduct>
        <drugdosagetext>2 DF, TID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>STILNOX</medicinalproduct>
        <drugdosagetext>1 DF/DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TANAKAN</medicinalproduct>
        <drugdosagetext>1 DF, TID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXELON</medicinalproduct>
        <drugauthorizationnumb>020823</drugauthorizationnumb>
        <drugdosagetext>9 MG DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEMENTIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060314</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060318</drugenddate>
        <drugtreatmentduration>7200</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXELON</medicinalproduct>
        <drugauthorizationnumb>020823</drugauthorizationnumb>
        <drugdosagetext>3 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060319</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060422</drugenddate>
        <drugtreatmentduration>50400</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXELON</medicinalproduct>
        <drugauthorizationnumb>020823</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060105</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060313</drugenddate>
        <drugtreatmentduration>97920</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059501-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060724</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050209</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHNU2005DE00907</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>81</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DENTAL OPERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FUNGAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOMYELITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRIMARY SEQUESTRUM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugauthorizationnumb>21223</drugauthorizationnumb>
        <drugdosagetext>4 MG, Q3MO</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>METASTASES TO BONE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugauthorizationnumb>021223</drugauthorizationnumb>
        <drugdosagetext>4 MG EVERY 6 WEEKS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20001101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MITOXANTRONE</medicinalproduct>
        <drugdosagetext>6 CYCLES</drugdosagetext>
        <drugindication>PROSTATE CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugdosagetext>5 MG, BID</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ESTRAMUSTINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20001101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010301</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059502-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060724</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060712</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2006US08949</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </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>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZELNORM</medicinalproduct>
        <drugauthorizationnumb>021200</drugauthorizationnumb>
        <drugdosagetext>2 MG, ONCE/SINGLE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONSTIPATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060711</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060711</drugenddate>
        <drugtreatmentduration>1440</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059503-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060724</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060614</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHNU2006DE02273</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>63</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>65</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONTUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DECREASED APPETITE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALIGNANT NEOPLASM PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugauthorizationnumb>21223</drugauthorizationnumb>
        <drugdosagetext>4 MG, QMO</drugdosagetext>
        <drugindication>METASTASES TO BONE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040826</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAMOXIFEN</medicinalproduct>
        <drugdosagetext>30 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19970101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040801</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FEMARA</medicinalproduct>
        <drugdosagetext>2.5 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VIVINOX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RESTLESSNESS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORMOC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RESTLESSNESS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FASLODEX</medicinalproduct>
        <drugdosagetext>250 MG, QMO</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MIRTAZAPINE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRANSTEC TTS</medicinalproduct>
        <drugdosagetext>35 UG, Q72H</drugdosagetext>
        <drugadministrationroute>062</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NOVAMINSULFON ^LICHTENSTEIN^</medicinalproduct>
        <drugdosagetext>30 - 30 - 40 DRPS/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059504-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060724</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060714</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2006BR10664</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>8</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>26</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BONE GRAFT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMPAIRED HEALING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TIBIA FRACTURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugauthorizationnumb>21223</drugauthorizationnumb>
        <drugdosagetext>0.1 MG/KG, EVERY 4 MONTHS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>OSTEOGENESIS IMPERFECTA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020612</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugauthorizationnumb>021223</drugauthorizationnumb>
        <drugdosagetext>0.05 MG/KG, EVERY 6 MONTHS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IRON</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCAREOUS PHOSPHORIC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CHOLECALCIFEROL</medicinalproduct>
        <drugdosagetext>4000 UI/WEEK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLORAL DE BACH</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059505-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060724</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060703</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHO2006IT10945</companynumb>
    <primarysource>
      <reportercountry>ITALY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>68</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>68</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>OSTEITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN JAW</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOLEDRONATE VS PLACEBO</medicinalproduct>
        <drugdosagetext>TREATMENT PERIOD</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>METASTASES TO BONE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000616</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugauthorizationnumb>021223</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>METASTASES TO BONE</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060509</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LHRH FERRING</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTIANDROGENS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ESTRAMUSTINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DELTACORTENE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAXOTERE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOCETAXEL</medicinalproduct>
        <drugdosagetext>120 MG, TIW</drugdosagetext>
        <drugindication>METASTASES TO BONE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050314</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060426</drugenddate>
        <drugtreatmentduration>409</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugdosagetext>10 MG</drugdosagetext>
        <drugindication>METASTASES TO BONE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050313</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060509</drugenddate>
        <drugtreatmentduration>423</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059506-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060720</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060501</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>DL2006305</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>20</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABORTION INCOMPLETE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENORRHAGIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIFEPRISTONE TABLETS, 200 MG (DANCO LABS)</medicinalproduct>
        <drugbatchnumb>05002</drugbatchnumb>
        <drugauthorizationnumb>20687</drugauthorizationnumb>
        <drugdosagetext>200 MG, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ABORTION INDUCED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060302</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MISOPROSTOL</medicinalproduct>
        <drugdosagetext>800 MCG, VAGINAL</drugdosagetext>
        <drugadministrationroute>067</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060303</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059507-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060724</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050615</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL139249</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>ANAEMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059508-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060724</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050615</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL139283</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POLLAKIURIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>ANAEMIA OF MALIGNANT DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059509-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060724</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050318</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL122241</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOKINESIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugindication>RENAL FAILURE CHRONIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040702</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040915</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059510-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060724</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050617</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL139293</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>82</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ACTIVATED PARTIAL THROMBOPLASTIN TIME PROLONGED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERNATIONAL NORMALISED RATIO INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEDICATION ERROR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PREOPERATIVE CARE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050602</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059511-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060724</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050617</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL139493</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>DYSURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>ANAEMIA OF MALIGNANT DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050501</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059512-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060724</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050422</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL129305</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BAND NEUTROPHIL COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METAMYELOCYTE COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RED BLOOD CELL NUCLEATED MORPHOLOGY PRESENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugindication>ANAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040213</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059513-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060720</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060525</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>DL2006273</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>30</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POST ABORTION COMPLICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POST ABORTION INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIFEPRISTONE TABLETS, 200 MG (DANCO LABS)</medicinalproduct>
        <drugbatchnumb>04005004701</drugbatchnumb>
        <drugauthorizationnumb>20687</drugauthorizationnumb>
        <drugdosagetext>200 MG, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ABORTION INDUCED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051104</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MISOPROSTOL</medicinalproduct>
        <drugdosagetext>800 MCG, VAGINAL</drugdosagetext>
        <drugadministrationroute>067</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051105</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059514-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060724</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050318</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL122286</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugindication>PRE-EXISTING DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031016</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059515-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060724</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050618</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL139666</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>81</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>LOWER RESPIRATORY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VAGINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>ANAEMIA OF MALIGNANT DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050429</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059516-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060724</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050620</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL139668</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugindication>RENAL FAILURE CHRONIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050610</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
        <drugadministrationroute>060</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059517-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060724</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050602</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL137159</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>86.3</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>ANAEMIA OF MALIGNANT DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050517</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059518-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060724</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050602</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL137354</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>81</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>RASH ERYTHEMATOUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugindication>ANAEMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059519-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060720</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060525</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>DL2006273</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>30</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABORTION INCOMPLETE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POST ABORTION COMPLICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POST ABORTION INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIFEPRISTONE TABLETS, 200 MG (DANCO LABS)</medicinalproduct>
        <drugbatchnumb>04005004701</drugbatchnumb>
        <drugauthorizationnumb>20687</drugauthorizationnumb>
        <drugdosagetext>200 MG, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ABORTION INDUCED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051104</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MISOPROSTOL</medicinalproduct>
        <drugdosagetext>800  MCG, VAGINAL</drugdosagetext>
        <drugadministrationroute>067</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051105</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059520-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060724</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050603</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL137171</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>ANAEMIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059521-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060724</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050606</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL137452</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>ANAEMIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059522-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060724</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050603</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL137355</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VERTIGO</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>ANAEMIA OF MALIGNANT DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059523-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060724</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050603</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL137174</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>66.7</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PETECHIAE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>P027379</drugbatchnumb>
        <drugindication>ANAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050602</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059524-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060724</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060712</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>HU-SP-2006-01742</companynumb>
    <primarysource>
      <reportercountry>HUNGARY</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>68</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>EPIDIDYMITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SCROTAL PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMMUCYST</medicinalproduct>
        <drugbatchnumb>LOT NOT REP</drugbatchnumb>
        <drugadministrationroute>043</drugadministrationroute>
        <drugindication>BLADDER CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051213</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060620</drugenddate>
        <drugtreatmentduration>188</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BETALOC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NITROMINT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EDNYT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIAPREL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059525-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060724</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060607</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-SP-2006-01781</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>61</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DYSURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELLS URINE POSITIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMMUCYST</medicinalproduct>
        <drugbatchnumb>LOT NOT REP</drugbatchnumb>
        <drugadministrationroute>043</drugadministrationroute>
        <drugindication>BLADDER CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060303</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060407</drugenddate>
        <drugtreatmentduration>34</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMMUCYST</medicinalproduct>
        <drugbatchnumb>LOT NOT REP</drugbatchnumb>
        <drugadministrationroute>043</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060303</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060407</drugenddate>
        <drugtreatmentduration>34</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMMUCYST</medicinalproduct>
        <drugbatchnumb>LOT NOT REP</drugbatchnumb>
        <drugadministrationroute>043</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060303</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060407</drugenddate>
        <drugtreatmentduration>34</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059527-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060724</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060714</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2006BR10649</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>42</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>53.3</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHOID OPERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHOIDS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROCTALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWELLING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACLASTA</medicinalproduct>
        <drugauthorizationnumb>021223</drugauthorizationnumb>
        <drugdosagetext>5 MG, ONCE/SINGLE</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MELORHEOSTOSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060324</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060324</drugenddate>
        <drugtreatmentduration>1440</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
        <drugdosagetext>25 MG/D</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059528-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060724</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060714</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2006CH10457</companynumb>
    <primarysource>
      <reportercountry>SWITZERLAND</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>64</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ACCIDENTAL EXPOSURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ACCIDENTAL OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ELECTROCARDIOGRAM QT PROLONGED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEPONEX</medicinalproduct>
        <drugauthorizationnumb>19758</drugauthorizationnumb>
        <drugdosagetext>150 MG, ONCE/SINGLE</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>ACCIDENTAL EXPOSURE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060523</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060523</drugenddate>
        <drugtreatmentduration>1440</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEXOTANIL</medicinalproduct>
        <drugdosagetext>1.5 MG/D</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>STILNOX</medicinalproduct>
        <drugdosagetext>1.5 MG, AS NECESSARY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIMAGON-D3</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059529-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060724</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060713</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2006US09020</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>54</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>THYROID NEOPLASM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZARIL</medicinalproduct>
        <drugauthorizationnumb>019758</drugauthorizationnumb>
        <drugdosagetext>75 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOAFFECTIVE DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059530-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060724</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060420</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2006JP05781</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>75</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <reaction>
        <reactionmeddrapt>BLOOD CREATINE PHOSPHOKINASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUROLEPTIC MALIGNANT SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIMAS</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PARKINSON'S DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRYPTANOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PARKINSON'S DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PARLODEL</medicinalproduct>
        <drugauthorizationnumb>017962</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PARKINSON'S DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SYMMETREL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PARKINSON'S DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CONTOMIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SERENACE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059531-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060724</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060616</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHNU2006DE02298</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>56</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CROHN'S DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DELIRIUM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG LEVEL INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEPONEX</medicinalproduct>
        <drugauthorizationnumb>19758</drugauthorizationnumb>
        <drugdosagetext>UP TO 150 MG/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOAFFECTIVE DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060613</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEPONEX</medicinalproduct>
        <drugauthorizationnumb>019758</drugauthorizationnumb>
        <drugdosagetext>25 MG/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060705</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugdosagetext>60 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOAFFECTIVE DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060613</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOPICLON</medicinalproduct>
        <drugdosagetext>7.5 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOAFFECTIVE DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BELOC ZOK</medicinalproduct>
        <drugdosagetext>71.25 MG/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050801</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ESIDRIX</medicinalproduct>
        <drugdosagetext>25 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOMINAL ^DRESDEN^</medicinalproduct>
        <drugdosagetext>80 MG/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOAFFECTIVE DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030701</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059532-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060724</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060712</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHNU2006DE02516</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DENTAL DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugauthorizationnumb>021223</drugauthorizationnumb>
        <drugdosagetext>4 MG, QMO</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060301</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059534-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060724</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060713</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHO2006GB11299</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>53</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>94.2</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BACTERIAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GINGIVAL ABSCESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOMYELITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTH EXTRACTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOLEDRONIC ACID</medicinalproduct>
        <drugauthorizationnumb>21223</drugauthorizationnumb>
        <drugdosagetext>4 MG, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>METASTASES TO BONE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040512</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060206</drugenddate>
        <drugtreatmentduration>636</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059539-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060720</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060525</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>DL2006275</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>29</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABORTION INCOMPLETE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ENDOMETRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENORRHAGIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIFEPRISTONE TABLETS, 200 MG (DANCO LABS)</medicinalproduct>
        <drugbatchnumb>05002001886</drugbatchnumb>
        <drugauthorizationnumb>20687</drugauthorizationnumb>
        <drugdosagetext>200 MG, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ABORTION INDUCED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060120</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MISOPROSTOL</medicinalproduct>
        <drugdosagetext>800 MCG, VAGINAL</drugdosagetext>
        <drugadministrationroute>067</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060121</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059542-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060720</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060510</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>DL2006246</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>27</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIFEPRISTONE TABLETS, 200 MG (DANCO LABS)</medicinalproduct>
        <drugbatchnumb>05004001552</drugbatchnumb>
        <drugauthorizationnumb>20687</drugauthorizationnumb>
        <drugdosagetext>200 MG, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ABORTION INDUCED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060414</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MISOPROSTOL</medicinalproduct>
        <drugdosagetext>800 MCG, BUCCAL</drugdosagetext>
        <drugadministrationroute>002</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060415</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059543-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060724</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060711</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AT-NOVOPROD-254761</companynumb>
    <primarysource>
      <reportercountry>AUSTRIA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>THROMBOPHLEBITIS SUPERFICIAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NOVOSEVEN</medicinalproduct>
        <drugdosagetext>1 DOSE</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CEREBRAL HAEMORRHAGE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060607</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060607</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059544-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060724</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060707</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHRM2006FR02015</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>87</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPONATRAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COVERSYL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ATORVASTATIN CALCIUM</medicinalproduct>
        <drugdosagetext>80 MG/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEXOMIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TANAKAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TARDYFERON</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAREG</medicinalproduct>
        <drugauthorizationnumb>021283</drugauthorizationnumb>
        <drugdosagetext>80 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060401</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059545-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060720</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060501</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>DL2006236</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>29</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABORTION INCOMPLETE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ENDOMETRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENORRHAGIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIFEPRISTONE TABLETS, 200 MG (DANCO LABS)</medicinalproduct>
        <drugbatchnumb>05001</drugbatchnumb>
        <drugauthorizationnumb>20687</drugauthorizationnumb>
        <drugdosagetext>200 MG, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ABORTION INDUCED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060207</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MISOPROSTOL</medicinalproduct>
        <drugdosagetext>800 MCG, VAGINAL</drugdosagetext>
        <drugadministrationroute>067</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060208</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059547-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060720</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060501</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>DL2006237</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>17</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ENDOMETRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIFEPRISTONE TABLETS, 200 MG (DANCO LABS)</medicinalproduct>
        <drugbatchnumb>04008008273</drugbatchnumb>
        <drugauthorizationnumb>20687</drugauthorizationnumb>
        <drugdosagetext>200 MG, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ABORTION INDUCED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060331</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MISOPROSTOL</medicinalproduct>
        <drugdosagetext>800 MCG, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060402</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059549-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060720</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060501</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>DL2006237</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>17</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABORTION INCOMPLETE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ENDOMETRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIFEPRISTONE TABLETS, 200 MG (DANCO LABS)</medicinalproduct>
        <drugbatchnumb>04008008273</drugbatchnumb>
        <drugauthorizationnumb>20687</drugauthorizationnumb>
        <drugdosagetext>200 MG, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ABORTION INDUCED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060331</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MISOPROSTOL</medicinalproduct>
        <drugdosagetext>800 MCG, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060402</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059551-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060724</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060710</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHRM2006FR02048</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>76</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DERMATITIS EXFOLIATIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EOSINOPHILIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA MULTIFORME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH MACULO-PAPULAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOXIC SKIN ERUPTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAREG</medicinalproduct>
        <drugauthorizationnumb>21283</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060429</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIAMICRON</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060429</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060405</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMISIL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060310</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060311</drugenddate>
        <drugtreatmentduration>2880</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KERLONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060429</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
        <drugdosagetext>850 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060429</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>75 MG/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059552-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060724</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060718</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2006US09212</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>77</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANGIONEUROTIC OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BREAST TENDERNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URTICARIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
        <drugauthorizationnumb>020665</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060717</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059553-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060724</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20051228</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHO2005JP20084</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>52</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL STIFFNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VERTIGO</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
        <drugauthorizationnumb>21283</drugauthorizationnumb>
        <drugdosagetext>80 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040304</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040701</drugenddate>
        <drugtreatmentduration>120</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059557-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060720</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060511</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>DL2006243</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>16</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CHILLS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PELVIC INFLAMMATORY DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PELVIC PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIFEPREX</medicinalproduct>
        <drugbatchnumb>04005</drugbatchnumb>
        <drugauthorizationnumb>20687</drugauthorizationnumb>
        <drugdosagetext>200 MG, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ABORTION INDUCED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051109</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MISOPROSTOL</medicinalproduct>
        <drugdosagetext>800 MCG, VAGINAL</drugdosagetext>
        <drugadministrationroute>067</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051110</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059562-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060720</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060501</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>DL2006233</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>37</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABORTION INCOMPLETE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIFEPRISTONE TABLETS, 200 MG (DANCO LABS)</medicinalproduct>
        <drugbatchnumb>05002005316</drugbatchnumb>
        <drugauthorizationnumb>20687</drugauthorizationnumb>
        <drugdosagetext>200 MG, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ABORTION INDUCED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060313</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MISOPROSTOL</medicinalproduct>
        <drugdosagetext>800 MCG, VAGINAL</drugdosagetext>
        <drugadministrationroute>067</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060313</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059567-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060720</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060405</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>DL2006270</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>30</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABORTION INCOMPLETE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIFEPRISTONE TABLETS, 200 MG (DANCO LABS)</medicinalproduct>
        <drugbatchnumb>05003</drugbatchnumb>
        <drugauthorizationnumb>20687</drugauthorizationnumb>
        <drugdosagetext>200 MG, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ABORTION INDUCED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060218</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MISOPROSTOL</medicinalproduct>
        <drugdosagetext>800 MCG, VAGINAL</drugdosagetext>
        <drugadministrationroute>067</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060220</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059568-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060720</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060525</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>DL2006276</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>21</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ENDOMETRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POST ABORTION COMPLICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SALPINGITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIFEPRISTONE TABLETS, 200 MG (DANCO LABS)</medicinalproduct>
        <drugbatchnumb>05003000609</drugbatchnumb>
        <drugauthorizationnumb>20687</drugauthorizationnumb>
        <drugdosagetext>200 MG, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ABORTION INDUCED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060505</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MISOPROSTOL</medicinalproduct>
        <drugdosagetext>800 MCG, BUCCAL</drugdosagetext>
        <drugadministrationroute>002</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060506</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059569-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060720</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060525</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>DL2006280</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>24</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIFEPRISTONE TABLETS, 200 MG (DANCO LABS)</medicinalproduct>
        <drugbatchnumb>05002000932</drugbatchnumb>
        <drugauthorizationnumb>20687</drugauthorizationnumb>
        <drugdosagetext>200 MG, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ABORTION INDUCED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060113</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MISOPROSTOL</medicinalproduct>
        <drugdosagetext>800 MCG, VAGINAL</drugdosagetext>
        <drugadministrationroute>067</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060113</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059570-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060720</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060525</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>DL2006281</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>34</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ENDOMETRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UTERINE HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIFEPRISTONE TABLETS, 200 MG (DANCO LABS)</medicinalproduct>
        <drugbatchnumb>05002001679</drugbatchnumb>
        <drugauthorizationnumb>20687</drugauthorizationnumb>
        <drugdosagetext>200 MG, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ABORTION INDUCED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060310</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MISOPROSTOL</medicinalproduct>
        <drugdosagetext>800 MCG, VAGINAL</drugdosagetext>
        <drugadministrationroute>067</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060310</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059571-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060724</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060714</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006UW14683</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>64</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULAR WEAKNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NIGHTMARE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SLEEP WALKING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugauthorizationnumb>21366</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugtreatmentduration>31</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GENFERIOFIBRATE</medicinalproduct>
        <drugtreatmentduration>45</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLYBURIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059572-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060630</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US200607000411</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>LUNG NEOPLASM MALIGNANT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugauthorizationnumb>21318</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059573-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US200606006246</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>76</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ADHESION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AORTIC ANEURYSM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG DOSE OMISSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FUNGAL OESOPHAGITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRIC ULCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IRRITABLE BOWEL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugbatchnumb>FF5H77A</drugbatchnumb>
        <drugauthorizationnumb>21318</drugauthorizationnumb>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EFFEXOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRANXENE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN TAB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADVAIR DISKUS 100/50</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANTOPRAZOLE SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENTYL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MILK OF MAGNESIA TAB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYGEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059574-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060720</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060515</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>DL2006283</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>22</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABORTION INCOMPLETE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIFEPRISTONE TABLETS, 200 MG (DANCO LABS)</medicinalproduct>
        <drugbatchnumb>05001007936</drugbatchnumb>
        <drugauthorizationnumb>20687</drugauthorizationnumb>
        <drugdosagetext>200 MG, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ABORTION INDUCED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051118</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MISOPROSTOL</medicinalproduct>
        <drugdosagetext>800 MCG, VAGINAL</drugdosagetext>
        <drugadministrationroute>067</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051119</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059575-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060630</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US200607000463</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLUENZA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugbatchnumb>FF5X33A</drugbatchnumb>
        <drugauthorizationnumb>21318</drugauthorizationnumb>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060301</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059576-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060720</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060525</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>DL2006290</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>25</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABORTION INCOMPLETE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIFEPRISTONE TABLETS, 200 MG (DANCO LABS)</medicinalproduct>
        <drugbatchnumb>05004000349</drugbatchnumb>
        <drugauthorizationnumb>20687</drugauthorizationnumb>
        <drugdosagetext>200 MG, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ABORTION INDUCED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060411</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MISOPROSTOL</medicinalproduct>
        <drugdosagetext>800 MCG, BUCCAL</drugdosagetext>
        <drugadministrationroute>002</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060412</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059577-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060630</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US200607000570</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>63</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GRAND MAL CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANIC ATTACK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TONGUE INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UPPER LIMB FRACTURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugauthorizationnumb>21318</drugauthorizationnumb>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060620</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059578-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060720</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060612</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>DL2006293</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>31</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VAGINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIFEPRISTONE TABLETS, 200 MG (DANCO LABS)</medicinalproduct>
        <drugbatchnumb>05003</drugbatchnumb>
        <drugauthorizationnumb>20687</drugauthorizationnumb>
        <drugdosagetext>200 MG, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ABORTION INDUCED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060315</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MISOPROSTOL</medicinalproduct>
        <drugdosagetext>800 MCG, VAGINAL</drugdosagetext>
        <drugadministrationroute>067</drugadministrationroute>
        <drugindication>ABORTION INDUCED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060316</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059579-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060630</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US200607000583</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugauthorizationnumb>21318</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059580-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060720</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060525</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>DL2006300</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>18</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABORTION INCOMPLETE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIFEPRISTONE TABLETS, 200 MG (DANCO LABS)</medicinalproduct>
        <drugbatchnumb>05004007202</drugbatchnumb>
        <drugauthorizationnumb>20687</drugauthorizationnumb>
        <drugdosagetext>200 MG, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ABORTION INDUCED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060412</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MISOPROSTOL</medicinalproduct>
        <drugdosagetext>800 MCG, BUCCAL</drugdosagetext>
        <drugadministrationroute>002</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060413</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059581-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US200606006291</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>92</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROCTALGIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugbatchnumb>FF5X10A</drugbatchnumb>
        <drugauthorizationnumb>21318</drugauthorizationnumb>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059582-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US200606006295</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD SODIUM DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FAECES DISCOLOURED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OCCULT BLOOD POSITIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugbatchnumb>FF5150A</drugbatchnumb>
        <drugauthorizationnumb>21318</drugauthorizationnumb>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060530</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060624</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059583-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060720</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060612</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>DL2006306</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>34</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABORTION INCOMPLETE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIFEPRISTONE TABLETS, 200 MG (DANCO LABS)</medicinalproduct>
        <drugbatchnumb>05004</drugbatchnumb>
        <drugauthorizationnumb>20687</drugauthorizationnumb>
        <drugdosagetext>200 MG, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ABORTION INDUCED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060504</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MISOPROSTOL</medicinalproduct>
        <drugdosagetext>800 MCG, BUCCAL</drugdosagetext>
        <drugadministrationroute>002</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060505</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059585-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US200606006273</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>78</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEMUR FRACTURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugauthorizationnumb>21318</drugauthorizationnumb>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060519</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059586-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060720</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060612</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>DL2006307</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>23</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIFEPRISTONE TABLETS, 200 MG (DANCO LABS)</medicinalproduct>
        <drugbatchnumb>05003006058</drugbatchnumb>
        <drugauthorizationnumb>20687</drugauthorizationnumb>
        <drugdosagetext>200 MG, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ABORTION INDUCED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060407</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MISOPROSTOL</medicinalproduct>
        <drugdosagetext>800 MCG, BUCCAL</drugdosagetext>
        <drugadministrationroute>002</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060409</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059588-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060720</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060612</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>DL2006308</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>29</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABORTION INCOMPLETE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POST ABORTION INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIFEPRISTONE TABLETS, 200 MG (DANCO LABS)</medicinalproduct>
        <drugbatchnumb>05002002691</drugbatchnumb>
        <drugauthorizationnumb>20687</drugauthorizationnumb>
        <drugdosagetext>200 MG, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ABORTION INDUCED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060320</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MISOPROSTOL</medicinalproduct>
        <drugdosagetext>800 MCG, BUCCAL</drugdosagetext>
        <drugadministrationroute>002</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060321</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059591-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US200606006144</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE CONGESTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIABETES MELLITUS INADEQUATE CONTROL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART VALVE INSUFFICIENCY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMALOG MIX 75/25</medicinalproduct>
        <drugbatchnumb>FF5M42A</drugbatchnumb>
        <drugauthorizationnumb>20563</drugauthorizationnumb>
        <drugdosagetext>14 U EACH MORNING</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HUMALOG MIX 25 L / 75NPL PEN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059592-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060720</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060612</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>DL2006309</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>18</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABORTION INCOMPLETE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIFEPRISTONE TABLETS, 200 MG (DANCO LABS)</medicinalproduct>
        <drugbatchnumb>05002002023</drugbatchnumb>
        <drugauthorizationnumb>20687</drugauthorizationnumb>
        <drugdosagetext>200 MG, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ABORTION INDUCED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060323</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MISOPROSTOL</medicinalproduct>
        <drugdosagetext>800 MCG, BUCCAL</drugdosagetext>
        <drugadministrationroute>002</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060324</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059594-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060630</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US200605001906</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>38</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>CARDIAC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIABETIC NEPHROPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIALYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL TRANSPLANT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMALOG (LISPRO)VIAL</medicinalproduct>
        <drugauthorizationnumb>20563</drugauthorizationnumb>
        <drugdosagetext>SUB, PUMP</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051010</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059595-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060720</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060612</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>DL2006310</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>37</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABORTION INCOMPLETE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIFEPRISTONE TABLETS, 200 MG (DANCO LABS)</medicinalproduct>
        <drugbatchnumb>05002004713</drugbatchnumb>
        <drugauthorizationnumb>20687</drugauthorizationnumb>
        <drugdosagetext>200 MG, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ABORTION INDUCED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060410</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MISOPROSTOL</medicinalproduct>
        <drugdosagetext>800 MCG, BUCCAL</drugdosagetext>
        <drugadministrationroute>002</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060411</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059597-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US200606006240</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugauthorizationnumb>21318</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059598-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060724</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060713</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FRWYE140313JUL06</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>38</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>56</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CENTRAL NERVOUS SYSTEM LESION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEMYELINATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE SCLEROSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugdosagetext>REPORTEDLY 37 MG TOTAL WEEKLY</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>ANKYLOSING SPONDYLITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050415</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060604</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059599-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060724</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060718</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-AVENTIS-200612532FR</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>79</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOALBUMINAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERNATIONAL NORMALISED RATIO INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALNUTRITION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROTHROMBIN LEVEL DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLAGYL</medicinalproduct>
        <drugauthorizationnumb>20743</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CHOLECYSTITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OFLOXACINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CHOLECYSTITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060603</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MINISINTROM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CARDIAC FAILURE</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060529</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MINISINTROM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060531</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060602</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASILIX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIGOXIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EFFEXOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIFFU K</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CONTRAMAL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRANSIPEG</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMOVANE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DAFALGAN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059600-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060724</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060620</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AVENTIS-200615319US</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>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>HEPATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KETEK</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>21144</drugauthorizationnumb>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BRONCHITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KETEK</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021144</drugauthorizationnumb>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREVACID</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTROOESOPHAGEAL REFLUX DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADVAIR DISKUS 100/50</medicinalproduct>
        <drugdosagetext>DOSE: 250/50</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL SPIROS</medicinalproduct>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059601-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060720</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060424</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>DL2006217</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>21</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABORTION INCOMPLETE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIFEPRISTONE TABLETS 200 MG (DANCO LABS)</medicinalproduct>
        <drugbatchnumb>05003003330</drugbatchnumb>
        <drugauthorizationnumb>20687</drugauthorizationnumb>
        <drugdosagetext>200 MG, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ABORTION INDUCED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060224</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MISOPROSTOL</medicinalproduct>
        <drugdosagetext>800 MCG, BUCCAL</drugdosagetext>
        <drugadministrationroute>002</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060227</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060308</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059602-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060720</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060501</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>DL2006229</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>29</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EXCORIATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIFEPRISTONE TABLETS, 200 MG (DANCO LABS)</medicinalproduct>
        <drugbatchnumb>05003002001</drugbatchnumb>
        <drugauthorizationnumb>20687</drugauthorizationnumb>
        <drugdosagetext>200 MG, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ABORTION INDUCED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060414</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MISOPROSTOL</medicinalproduct>
        <drugdosagetext>800 MCG, VAGINAL, NOT TAKEN</drugdosagetext>
        <drugadministrationroute>067</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059604-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060720</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060530</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>DL2006244</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>20</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABORTION INCOMPLETE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIFEPRISTONE TABLETS, 200 MG (DANCO LABS)</medicinalproduct>
        <drugbatchnumb>05004</drugbatchnumb>
        <drugauthorizationnumb>20687</drugauthorizationnumb>
        <drugdosagetext>200 MG, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ABORTION INDUCED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060428</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MISOPROSTAL TABLETS 200 MCG (DANCO LABS)</medicinalproduct>
        <drugdosagetext>800 MCG, VAGINAL</drugdosagetext>
        <drugadministrationroute>067</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060430</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060512</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059607-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060720</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060510</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>DL2006252</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>26</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PELVIC INFLAMMATORY DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POST ABORTION COMPLICATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIFEPRISTONE TABLETS, 200 MG (DANCO LABS)</medicinalproduct>
        <drugbatchnumb>05002004545</drugbatchnumb>
        <drugauthorizationnumb>20687</drugauthorizationnumb>
        <drugdosagetext>200 MG, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ABORTION INDUCED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060121</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MISOPROSTOL</medicinalproduct>
        <drugbatchnumb>K22514504V</drugbatchnumb>
        <drugdosagetext>800 MCG, VAGINAL</drugdosagetext>
        <drugadministrationroute>067</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060122</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059608-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060720</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060510</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>DL2006253</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>34</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PELVIC INFLAMMATORY DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VAGINAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIFEPRISTONE TABLETS, 200 MG (DANCO LABS)</medicinalproduct>
        <drugbatchnumb>05002007026</drugbatchnumb>
        <drugauthorizationnumb>20687</drugauthorizationnumb>
        <drugdosagetext>200 MG, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ABORTION INDUCED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060218</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MISOPROSTOL</medicinalproduct>
        <drugdosagetext>800 MCG, VAGINAL</drugdosagetext>
        <drugadministrationroute>067</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060218</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059609-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060720</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060510</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>DL2006256</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>33</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CHILLS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ENDOMETRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIFEPRISTONE TABLETS, 200 MG (DANCO LABS)</medicinalproduct>
        <drugbatchnumb>05002001716</drugbatchnumb>
        <drugauthorizationnumb>20687</drugauthorizationnumb>
        <drugdosagetext>200 MG, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ABORTION INDUCED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060324</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MISOPROSTOL</medicinalproduct>
        <drugdosagetext>800 MCG, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060325</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059610-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060720</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060510</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>DL2006257</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>24</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIFEPRISTONE TABLETS, 200 MG (DANCO LABS)</medicinalproduct>
        <drugbatchnumb>05003</drugbatchnumb>
        <drugauthorizationnumb>20687</drugauthorizationnumb>
        <drugdosagetext>200 MG, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ABORTION INDUCED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060407</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MISOPROSTOL</medicinalproduct>
        <drugdosagetext>800 MCG, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060408</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059611-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060720</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060510</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>DL2006262</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>30</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIFEPRISTONE TABLETS, 200 MG (DANCO LABS)</medicinalproduct>
        <drugbatchnumb>05002005916</drugbatchnumb>
        <drugauthorizationnumb>20687</drugauthorizationnumb>
        <drugdosagetext>200 MG, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ABORTION INDUCED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060106</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MISOPROSTOL</medicinalproduct>
        <drugdosagetext>800 MCG, VAGINAL</drugdosagetext>
        <drugadministrationroute>067</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060107</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059612-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060724</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20051115</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GBWYE144716NOV05</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>62</patientweight>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>PULMONARY FIBROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050427</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050910</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
        <drugdosagetext>UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE SODIUM</medicinalproduct>
        <drugdosagetext>UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059614-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060720</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060510</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>DL2006264</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>29</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIFEPRISTONE TABLETS, 200 MG (DANCO LABS)</medicinalproduct>
        <drugbatchnumb>05002003657</drugbatchnumb>
        <drugauthorizationnumb>20687</drugauthorizationnumb>
        <drugdosagetext>200 MG, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ABORTION INDUCED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060127</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MISOPROSTOL</medicinalproduct>
        <drugdosagetext>800 MCG, VAGINAL</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060128</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059615-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060720</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060606</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>DL2006267</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>35</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABORTION INCOMPLETE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIFEPRISTONE TABLETS, 200 MG (DANCO LABS)</medicinalproduct>
        <drugauthorizationnumb>20687</drugauthorizationnumb>
        <drugdosagetext>200 MG, ORALO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ABORTION INDUCED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060323</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MISOPROSTOL</medicinalproduct>
        <drugdosagetext>800 MCG, VAGINAL</drugdosagetext>
        <drugadministrationroute>067</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060325</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060408</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059617-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060724</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060706</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006AC01244</companynumb>
    <primarysource>
      <reportercountry>NETHERLANDS</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>65</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL STIFFNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugauthorizationnumb>021366</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>LOW DENSITY LIPOPROTEIN INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060627</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLICLAZIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCLOORTHIAZIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059618-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060724</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060608</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006AP02716</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>60</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>AGRANULOCYTOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>C-REACTIVE PROTEIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JAUNDICE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OMEPRAL</medicinalproduct>
        <drugauthorizationnumb>19810</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTRIC ULCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060529</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060602</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDONINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060529</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060602</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDONINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060602</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060602</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDONINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060602</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059619-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060720</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060605</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>DL2006193</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>23</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABORTION INCOMPLETE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIFEPRISTONE TABLETS, 200 MG (DANCO LABS)</medicinalproduct>
        <drugbatchnumb>05003006058</drugbatchnumb>
        <drugauthorizationnumb>20687</drugauthorizationnumb>
        <drugdosagetext>200 MG, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ABORTION INDUCED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060407</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MISOPROSTOL</medicinalproduct>
        <drugdosagetext>800 MCG, VAGINAL</drugdosagetext>
        <drugadministrationroute>067</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060409</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>.</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059620-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060724</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060713</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006PK01535</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CAESAREAN SECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PREMATURE LABOUR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugauthorizationnumb>021153</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>REFLUX GASTRITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059622-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060720</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060413</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>DL2006199</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>23</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABORTION INCOMPLETE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ENDOMETRITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIFEPRISTONE TABLETS, 200 MG (DANCO LABS)</medicinalproduct>
        <drugbatchnumb>05001005539</drugbatchnumb>
        <drugauthorizationnumb>20687</drugauthorizationnumb>
        <drugdosagetext>200 MG, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ABORTION INDUCED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060105</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MISOPROSTOL</medicinalproduct>
        <drugdosagetext>800 MCG, VAGINAL</drugdosagetext>
        <drugadministrationroute>067</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060106</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MISOPROSTOL</medicinalproduct>
        <drugdosagetext>800 MCG, VAGINAL</drugdosagetext>
        <drugadministrationroute>067</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060113</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059623-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060720</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060413</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>DL2006201</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>24</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABORTION INCOMPLETE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIFEPRISTONE TABLETS, 200 MG (DANCO LABS)</medicinalproduct>
        <drugbatchnumb>05002003816</drugbatchnumb>
        <drugauthorizationnumb>20687</drugauthorizationnumb>
        <drugdosagetext>200 MG, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ABORTION INDUCED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060308</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MISOPROSTOL</medicinalproduct>
        <drugdosagetext>800 MCG, VAGINAL</drugdosagetext>
        <drugadministrationroute>067</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060309</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059624-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US200606006216</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>88</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD SODIUM DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HIP FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugauthorizationnumb>21318</drugauthorizationnumb>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059625-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060720</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060412</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>DL2006202</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>30</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABORTION INCOMPLETE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGE</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>20060210</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MISOPROSTOL</medicinalproduct>
        <drugdosagetext>800 MCG, VAGINAL</drugdosagetext>
        <drugadministrationroute>067</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060212</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MISOPROSTOL</medicinalproduct>
        <drugdosagetext>800 MCG, VAGINAL</drugdosagetext>
        <drugadministrationroute>067</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060224</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059627-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060724</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060713</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2006JP10588</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>84</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SHOCK</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VOLTAREN</medicinalproduct>
        <drugauthorizationnumb>019201</drugauthorizationnumb>
        <drugdosagetext>25 MG, ONCE/SINGLE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NEURALGIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060710</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060710</drugenddate>
        <drugtreatmentduration>1440</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059628-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060724</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060712</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHFR2006GB02218</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>50</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>AGGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FACIAL PALSY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCOHERENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NO THERAPEUTIC RESPONSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALLOR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DICLOFENAC</medicinalproduct>
        <drugauthorizationnumb>19201</drugauthorizationnumb>
        <drugdosagetext>100 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN IN EXTREMITY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060602</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060602</drugenddate>
        <drugtreatmentduration>1440</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASCORBIC ACID</medicinalproduct>
        <drugdosagetext>UNK, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRALGIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN W/ CODEINE</medicinalproduct>
        <drugdosagetext>UNK, PRN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRALGIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COD-LIVER OIL</medicinalproduct>
        <drugdosagetext>UNK, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EVENING PRIMROSE OIL</medicinalproduct>
        <drugdosagetext>UNK, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRALGIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOSAMINE</medicinalproduct>
        <drugdosagetext>UNK, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRALGIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059629-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060724</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060712</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-GILEAD-2006-0009861</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE MARROW FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EMTRIVA</medicinalproduct>
        <drugauthorizationnumb>021500</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060111</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RETROVIR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060111</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060515</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KALETRA</medicinalproduct>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060111</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>URSO</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060111</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZITHROMAC</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060111</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060515</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALIXA</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060111</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060403</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059630-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US200606006231</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>GLOBAL AMNESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugbatchnumb>FF5X21A</drugbatchnumb>
        <drugauthorizationnumb>21318</drugauthorizationnumb>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051003</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059631-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060724</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060619</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-GILEAD-2006-0009776</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ALANINE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASPARTATE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD ALKALINE PHOSPHATASE 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>LIVER DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRUVADA</medicinalproduct>
        <drugauthorizationnumb>21752</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050528</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RETROVIR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050527</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EPIVIR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050527</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NORVIR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050528</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>STOCRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050527</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REYATAZ</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050528</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059632-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060724</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060103</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0587522A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>63</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MOUTH ULCERATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HYCAMTIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020671</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NYSTATIN SOLUTION</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FENTANYL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CORTISONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059633-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060724</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060123</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0590493A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>70</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HYCAMTIN</medicinalproduct>
        <drugauthorizationnumb>20671</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060103</drugstartdate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059634-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060724</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060321</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>S2006US04220</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOPOTECAN</medicinalproduct>
        <drugauthorizationnumb>20671</drugauthorizationnumb>
        <drugindication>OVARIAN CANCER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059635-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060724</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060324</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0598969A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>72</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>67.3</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DYSPHONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HYCAMTIN</medicinalproduct>
        <drugauthorizationnumb>020671</drugauthorizationnumb>
        <drugdosagetext>1.74MG PER DAY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060227</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060228</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPROL-XL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIGOXIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059636-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060724</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060328</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0599344A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PANCYTOPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HYCAMTIN</medicinalproduct>
        <drugauthorizationnumb>020671</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059637-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060724</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060412</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>136-288879</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>70</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>114.5</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CARBOHYDRATE ANTIGEN 125 INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HYCAMTIN</medicinalproduct>
        <drugauthorizationnumb>020671</drugauthorizationnumb>
        <drugdosagetext>7MGM2 CYCLIC</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060303</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAXOTERE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HUMULIN 70/30</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMBIEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VASOTEC</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059639-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060724</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060427</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0603896A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CARBOHYDRATE ANTIGEN 125 INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOPOTECAN</medicinalproduct>
        <drugauthorizationnumb>20671</drugauthorizationnumb>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059640-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060724</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060518</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0606345A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>SOMATOFORM DISORDER CARDIOVASCULAR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HYCAMTIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020671</drugauthorizationnumb>
        <drugdosagetext>3.5MGM2 WEEKLY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060501</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059642-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060720</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060424</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>DL2006205</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>34</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABORTION INCOMPLETE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIFEPRISTONE TABLETS, 200 MG (DANCO LABS)</medicinalproduct>
        <drugbatchnumb>05003001085</drugbatchnumb>
        <drugauthorizationnumb>20687</drugauthorizationnumb>
        <drugdosagetext>200 MG, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ABORTION INDUCED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060228</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MISOPROSTOL</medicinalproduct>
        <drugdosagetext>800 MCG, VAGINAL</drugdosagetext>
        <drugadministrationroute>067</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060301</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059643-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060630</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US200606002671</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMALOG</medicinalproduct>
        <drugauthorizationnumb>20563</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059644-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060720</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060424</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>DL2006206</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>28</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABORTION INCOMPLETE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIFEPRISTONE TABLETS, 200 MG (DANCO LABS)</medicinalproduct>
        <drugbatchnumb>05003003482</drugbatchnumb>
        <drugauthorizationnumb>20687</drugauthorizationnumb>
        <drugdosagetext>200 MG, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ABORTION INDUCED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060209</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MISOPROSTOL</medicinalproduct>
        <drugdosagetext>800 MCG, VAGINAL</drugdosagetext>
        <drugadministrationroute>067</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060211</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059645-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060630</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US200607000360</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>57</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>77.6</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANION GAP DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASPARTATE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD ALBUMIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD ALKALINE PHOSPHATASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD BILIRUBIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERCALCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOKALAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOMAGNESAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PCO2 INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROTEIN TOTAL INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TERIPARATIDE (TERIPARATIDE)PEN, DISPOSABLE</medicinalproduct>
        <drugauthorizationnumb>21318</drugauthorizationnumb>
        <drugdosagetext>20 MEQ DAILY (1/D) SUBCUTANEOUS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060210</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM GLUCONATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ROCALTROL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059646-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060720</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060424</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>DL2006210</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>19</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ENDOMETRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VAGINAL DISCHARGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VAGINAL ODOUR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIFEPRISTONE TABLETS, 200 MG (DANCO LABS)</medicinalproduct>
        <drugbatchnumb>05002000011</drugbatchnumb>
        <drugauthorizationnumb>20687</drugauthorizationnumb>
        <drugdosagetext>200 MG, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ABORTION INDUCED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051214</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MISOPROSTOL</medicinalproduct>
        <drugdosagetext>800 MCG, VAGINAL</drugdosagetext>
        <drugadministrationroute>067</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051214</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059647-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060630</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US200606003378</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMALOG</medicinalproduct>
        <drugauthorizationnumb>20563</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059648-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060724</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060714</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006AP03322</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MYDRIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SHOCK</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ANAPEINE</medicinalproduct>
        <drugauthorizationnumb>20533</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>ANAESTHESIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059649-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060724</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060718</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006AP03346</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
    </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>DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE ROLLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUDDEN DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WRONG TECHNIQUE IN DRUG USAGE PROCESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XYLOCAINE</medicinalproduct>
        <drugauthorizationnumb>006488</drugauthorizationnumb>
        <drugdosagetext>GIVEN TO BREAST BONE AREA</drugdosagetext>
        <drugindication>LOCAL ANAESTHESIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060712</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060712</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XYLOCAINE</medicinalproduct>
        <drugauthorizationnumb>006488</drugauthorizationnumb>
        <drugdosagetext>GIVEN TO BREAST BONE AREA</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060712</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060712</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059650-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060724</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060718</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006AP03318</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>26</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLISTER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHABDOMYOLYSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugauthorizationnumb>020639</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAILAX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORAZEPAM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SILECE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059651-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060724</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20051228</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-NOVOPROD-249620</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>73</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>90</patientweight>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>BRADYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GRAND MAL CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NOVOSEVEN</medicinalproduct>
        <drugdosagetext>80 UG/KG, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CEREBRAL HAEMORRHAGE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051218</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051218</drugenddate>
        <drugtreatmentduration>1440</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ESIDRIX</medicinalproduct>
        <drugdosagetext>1 TAB, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XANEF</medicinalproduct>
        <drugdosagetext>20 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
        <drugdosagetext>10 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DICLOFENAC DIETHYLAMINE</medicinalproduct>
        <drugdosagetext>25 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM CHLORIDE</medicinalproduct>
        <drugdosagetext>1 TAB, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059652-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060720</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060424</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>DL2006214</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>26</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABORTION INCOMPLETE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIFEPRISTONE TABLETS, 200 MG (DANCO LABS)</medicinalproduct>
        <drugbatchnumb>05002006520</drugbatchnumb>
        <drugauthorizationnumb>20687</drugauthorizationnumb>
        <drugdosagetext>200 MG, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ABORTION INDUCED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060304</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MISOPROSTOL</medicinalproduct>
        <drugdosagetext>800 MCG, VAGINAL</drugdosagetext>
        <drugadministrationroute>067</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060304</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059653-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060720</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060424</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>DL2006216</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>35</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABORTION INCOMPLETE</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>20051223</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MISOPROSTOL</medicinalproduct>
        <drugdosagetext>800 MCG, VAGINAL</drugdosagetext>
        <drugadministrationroute>067</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051223</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059656-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060720</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060403</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>DL2006173</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>24</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABORTION INCOMPLETE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIFEPRISTONE TABLETS, 200 MG (DANCO LABS)</medicinalproduct>
        <drugauthorizationnumb>20687</drugauthorizationnumb>
        <drugdosagetext>200 MG, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ABORTION INDUCED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060216</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MISOPROSTOL</medicinalproduct>
        <drugdosagetext>800 MCG, VAGINAL</drugdosagetext>
        <drugadministrationroute>067</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060218</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059658-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060720</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060403</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>DL2006174</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>24</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABORTION INCOMPLETE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</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>20060208</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MISOPROSTOL</medicinalproduct>
        <drugdosagetext>800 MCG, VAGINAL</drugdosagetext>
        <drugadministrationroute>067</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060210</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059659-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060724</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050121</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-393401</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>19</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>72.6</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ACROCHORDON EXCISION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLITIS ULCERATIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CROHN'S DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIVERTICULUM INTESTINAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHOIDS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLAMMATORY BOWEL DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTI-ORGAN DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROCTITIS ULCERATIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RECTAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN CYST EXCISION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SLEEP APNOEA SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>18662</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>ACNE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19860615</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19870615</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>018662</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19880715</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19890115</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059660-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060724</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060407</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-ROCHE-443617</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>43</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>80.4</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PELVIC ABSCESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STAPHYLOCOCCAL ABSCESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZENAPAX</medicinalproduct>
        <drugdosagetext>DOSAGE FORM REPORTED AS INFUSION.</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050824</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050824</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZENAPAX</medicinalproduct>
        <drugdosagetext>DAY 14.</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050907</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050907</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MYCOPHENOLATE MOFETIL</medicinalproduct>
        <drugauthorizationnumb>050723</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050824</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SIROLIMUS</medicinalproduct>
        <drugauthorizationnumb>050723</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051116</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOSPORINE</medicinalproduct>
        <drugauthorizationnumb>050723</drugauthorizationnumb>
        <drugdosagetext>DOSE REPORTED AS 25 X 2.</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050823</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051121</drugenddate>
        <drugtreatmentduration>91</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CORTANCYL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050823</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NOVONORM</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051222</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugdosagetext>TOTAL DAILY DOSE REPORTED AS: 1/J.</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050824</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CACIT D3</medicinalproduct>
        <drugdosagetext>TOTAL DAILY DOSE REPORTED AS: 1/J.</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051011</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATORVASTATIN CALCIUM</medicinalproduct>
        <drugdosagetext>TOTAL DAILY DOSE REPORTED AS: 1/J.</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050923</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
        <drugdosagetext>TOTAL DAILY DOSE REPORTED AS: 2/J.</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050828</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
        <drugdosagetext>TOTAL DAILY DOSE REPORTED AS: 1/J</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060427</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMOVANE</medicinalproduct>
        <drugdosagetext>TOTAL DAILY DOSE REPORTED AS: 1/J</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060406</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059661-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060724</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20051206</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-427599</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>45</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>74.8</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCREATIC MASS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEG-INTERFERON ALFA 2A (RO 25-8310)</medicinalproduct>
        <drugbatchnumb>C213325-01,C36252</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050907</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RIBAVIRIN</medicinalproduct>
        <drugbatchnumb>C213515-01</drugbatchnumb>
        <drugauthorizationnumb>021511</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050907</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRIAMCINOLON ACETONID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIUREX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORATADINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DICYCLOMINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREVACID</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059662-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060724</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-432858</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>56.7</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLITIS ULCERATIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EPISTAXIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLAMMATORY BOWEL DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIP DRY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENISCUS LESION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>018662</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19960708</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19960826</drugenddate>
        <drugtreatmentduration>50</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>018662</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19970402</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19970723</drugenddate>
        <drugtreatmentduration>113</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>018662</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19981002</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19981130</drugenddate>
        <drugtreatmentduration>60</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059663-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060724</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060505</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-447154</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>78</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANOREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ATRIAL FIBRILLATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CLOSTRIDIAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DILATATION ATRIAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPONATRAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INAPPROPRIATE ANTIDIURETIC HORMONE SECRETION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOBAR PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL STIFFNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN WRINKLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BONIVA</medicinalproduct>
        <drugauthorizationnumb>21455</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060315</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOPRESSOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVASTATIN</medicinalproduct>
        <drugdosagetext>FREQUENCY REPORTED AS HS</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTIVERT</medicinalproduct>
        <drugdosagetext>DOSING INFO REPORTD AS 12.5 TID PRN</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARDIZEM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVENOX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMIODARONE HCL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059664-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060720</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060424</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>DL2006177</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>29</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABORTION INCOMPLETE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIFEPRISTONE TABLETS, 200 MG (DANCO LABS)</medicinalproduct>
        <drugbatchnumb>04005002674</drugbatchnumb>
        <drugauthorizationnumb>20687</drugauthorizationnumb>
        <drugdosagetext>200 MG, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ABORTION INDUCED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MISOPROSTOL</medicinalproduct>
        <drugdosagetext>800 MCG, VAGINAL</drugdosagetext>
        <drugadministrationroute>067</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051203</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059665-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060720</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060331</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>DL2006178</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>35</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABORTION INCOMPLETE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIFEPRISTONE TABLETS, 200 MG (DANCO LABS)</medicinalproduct>
        <drugbatchnumb>05002002109</drugbatchnumb>
        <drugauthorizationnumb>20687</drugauthorizationnumb>
        <drugdosagetext>200 MG, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ABORTION INDUCED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060221</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MISOPROSTOL</medicinalproduct>
        <drugdosagetext>800 MCG, VAGINAL</drugdosagetext>
        <drugadministrationroute>067</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060222</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059667-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060720</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060331</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>DL2006181</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>21</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABORTION INCOMPLETE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANOREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHILLS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIFEPRISTONE TABLETS, 200 MG (DANCO LABS)</medicinalproduct>
        <drugbatchnumb>05002002577</drugbatchnumb>
        <drugauthorizationnumb>20687</drugauthorizationnumb>
        <drugdosagetext>200 MG, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ABORTION INDUCED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060105</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MISOPROSTOL</medicinalproduct>
        <drugdosagetext>800 MCG, VAGINAL</drugdosagetext>
        <drugadministrationroute>067</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060106</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059669-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060720</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060331</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>DL2006182</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>37</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABORTION INCOMPLETE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIFEPRISTONE TABLETS, 200 MG (DANCO LABS)</medicinalproduct>
        <drugbatchnumb>05003000997</drugbatchnumb>
        <drugauthorizationnumb>20687</drugauthorizationnumb>
        <drugdosagetext>200 MG, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ABORTION INDUCED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060207</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MISOPROSTOL</medicinalproduct>
        <drugdosagetext>800 MCG, VAGINAL</drugdosagetext>
        <drugadministrationroute>067</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060208</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059670-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060724</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060322</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-441610</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>49</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>82.6</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPEPSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTRAOCULAR PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NUCLEAR MAGNETIC RESONANCE IMAGING BRAIN ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NYSTAGMUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>REFRACTION DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VERTIGO</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VESTIBULAR NEURONITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BONIVA</medicinalproduct>
        <drugauthorizationnumb>21455</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060303</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060303</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>NAPROXEN</medicinalproduct>
        <drugauthorizationnumb>017581</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BACK PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060225</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060303</drugenddate>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VALIUM</medicinalproduct>
        <drugauthorizationnumb>013263</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>VERTIGO</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060311</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060320</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRAVACHOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZESTRIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROPOXYPHENE NAPSYLATE AND ACETAMINOPHEN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060311</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060321</drugenddate>
        <drugtreatmentduration>11</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059671-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060724</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060301</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-438849</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>18</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>60.8</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ATELECTASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE CONGESTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CROHN'S DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROOESOPHAGEAL REFLUX DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLAMMATORY BOWEL DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IRON DEFICIENCY ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLEURAL EFFUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUBCUTANEOUS ABSCESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>18662</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ACNE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19950911</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19960215</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059672-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060724</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060113</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-432376</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>16</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>95.7</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CROHN'S DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EMOTIONAL DISTRESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA NODOSUM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ILEITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLAMMATORY BOWEL DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IRRITABLE BOWEL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIP DRY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NASOPHARYNGITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUSITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UPPER RESPIRATORY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>18662</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19920615</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19930615</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059673-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060724</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060410</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-444045</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>17</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMPULSIVE BEHAVIOUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIP BLISTER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDE ATTEMPT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>18662</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060117</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>018662</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BIRTH CONTROL PILLS NOS</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ORAL CONTRACEPTION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059674-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060724</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060301</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-438831</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>24</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>63.5</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CLOSTRIDIUM DIFFICILE COLITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLITIS ULCERATIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLON ADENOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CROHN'S DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ENDOMETRIOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ESSENTIAL HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLAMMATORY BOWEL DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MITRAL VALVE INCOMPETENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MITRAL VALVE PROLAPSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NASAL SEPTUM DEVIATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NON-HODGKIN'S LYMPHOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCREATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANIC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARYNGOLARYNGEAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RECTAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SALIVARY GLAND MASS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE VASOVAGAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYSTEMIC LUPUS ERYTHEMATOSUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRANSIENT ISCHAEMIC ATTACK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRICUSPID VALVE INCOMPETENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENTRICULAR EXTRASYSTOLES</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>18662</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ACNE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19830615</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19830615</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>018662</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19840813</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>018662</drugauthorizationnumb>
        <drugdosagetext>ACCUTANE DECREASED TO 1 DAILY OR ONE ONCE DAILY OR ONE TWICE WEEKLY.</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19850114</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19850314</drugenddate>
        <drugtreatmentduration>60</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>018662</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19870115</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19870615</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>1 CONCOMITANT DRUG</medicinalproduct>
        <drugdosagetext>DRUG REPORTED AS ASPIRIN/TYLENOL.</drugdosagetext>
        <drugindication>HEADACHE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059675-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060724</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-435234</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>34</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANOREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONTUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISEASE RECURRENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEPHROLITHIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STAPHYLOCOCCAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUBCUTANEOUS ABSCESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEGASYS</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060110</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COPEGUS</medicinalproduct>
        <drugauthorizationnumb>021511</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060110</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059676-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060724</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060706</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>SE-ROCHE-454148</companynumb>
    <primarysource>
      <reportercountry>SWEDEN</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>24</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANGIONEUROTIC OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SENSATION OF FOREIGN BODY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LARIAM</medicinalproduct>
        <drugauthorizationnumb>19591</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MALARIA PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060613</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060620</drugenddate>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059677-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060724</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20051121</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-425897</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>47</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>65.8</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEGASYS</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051028</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COPEGUS</medicinalproduct>
        <drugauthorizationnumb>021511</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051028</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050815</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
        <drugdosagetext>REPORTED AS HYDROCHLOROTHYAZIDE.</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050815</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EFFEXOR</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059679-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060724</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060623</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-ROCHE-453510</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>17</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>GINGIVITIS ULCERATIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>018662</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ACNE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040615</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>018662</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>018662</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060624</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060627</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059680-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060724</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060113</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-432360</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>24</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLITIS ULCERATIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CROHN'S DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERALISED ANXIETY DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLAMMATORY BOWEL DISEASE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>018662</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19870727</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19871129</drugenddate>
        <drugtreatmentduration>126</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>018662</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19940802</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19940902</drugenddate>
        <drugtreatmentduration>32</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059681-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060720</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060331</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>DL2006185</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>23</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABORTION INCOMPLETE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PELVIC PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIFEPRISTONE TABLETS, 200 MG (DANCO LABS)</medicinalproduct>
        <drugbatchnumb>05003004719</drugbatchnumb>
        <drugauthorizationnumb>20687</drugauthorizationnumb>
        <drugdosagetext>200 MG, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ABORTION INDUCED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060308</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MISOPROSTOL</medicinalproduct>
        <drugdosagetext>800 MCG, VAGINAL</drugdosagetext>
        <drugadministrationroute>067</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060310</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059682-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060720</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060406</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>DL2006190</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>24</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABORTION INCOMPLETE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIFEPRISTONE TABLETS, 200 MG (DANCO LABS)</medicinalproduct>
        <drugbatchnumb>05003001825</drugbatchnumb>
        <drugauthorizationnumb>20687</drugauthorizationnumb>
        <drugdosagetext>200 MG, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ABORTION INDUCED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060221</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MISOPROSTOL</medicinalproduct>
        <drugdosagetext>800 MCG, VAGINAL</drugdosagetext>
        <drugadministrationroute>067</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060222</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059683-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060710</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200610654BFR</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>68</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>55</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHOLESTASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CYTOLYTIC HEPATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ESCHERICHIA URINARY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERAL PHYSICAL HEALTH DETERIORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALNUTRITION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TYPE IV HYPERSENSITIVITY REACTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CIFLOX (CIPROFLOXACIN)</medicinalproduct>
        <drugauthorizationnumb>19847</drugauthorizationnumb>
        <drugdosagetext>INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060501</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ROCEPHIN</medicinalproduct>
        <drugdosagetext>INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ESCHERICHIA URINARY TRACT INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060509</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060501</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059684-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060720</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060407</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>DL2006191</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>18</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABORTION INCOMPLETE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIFEPRISTONE TABLETS, 200 MG (DANCO LABS)</medicinalproduct>
        <drugbatchnumb>05003</drugbatchnumb>
        <drugauthorizationnumb>20687</drugauthorizationnumb>
        <drugdosagetext>200 MG, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ABORTION INDUCED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MISOPROSTOL</medicinalproduct>
        <drugdosagetext>800 MCG, VAGINAL</drugdosagetext>
        <drugadministrationroute>067</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060401</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059686-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060724</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060627</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-453506</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>27</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>49.9</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DECOMPRESSION SICKNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>18662</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>018662</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060625</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059687-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060724</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060515</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-ROCHE-448340</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PREGNANCY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>018662</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059688-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060720</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060413</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>DL2006192</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>25</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABORTION INCOMPLETE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIFEPRISTONE TABLETS, 200 MG (DANCO LABS)</medicinalproduct>
        <drugbatchnumb>04007000914</drugbatchnumb>
        <drugauthorizationnumb>20687</drugauthorizationnumb>
        <drugdosagetext>200 MG, ORAL, TWICE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ABORTION INDUCED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050923</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MISOPROSTOL</medicinalproduct>
        <drugdosagetext>800 MCG, VAGINAL</drugdosagetext>
        <drugadministrationroute>067</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050924</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059689-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060724</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20051103</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-ROCHE-423783</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>27</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>NO ADVERSE EFFECT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PREGNANCY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ROACUTAN</medicinalproduct>
        <drugauthorizationnumb>18662</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ACNE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050115</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050715</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GENERIC UNKNOWN</medicinalproduct>
        <drugdosagetext>TRADE NAME: INIBINE.</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BUSCOPAN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059691-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060724</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060705</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GR-ROCHE-454127</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>46</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>EJECTION FRACTION DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CAPECITABINE</medicinalproduct>
        <drugauthorizationnumb>20896</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050426</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAPATINIB</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050426</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HERCEPTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTHRACYCLINE NOS</medicinalproduct>
        <drugdosagetext>DRUG REPORTED AS ^ANTHRACYCLINES^.</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059692-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060724</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060609</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IE-ROCHE-451739</companynumb>
    <primarysource>
      <reportercountry>IRELAND</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>49</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XENICAL</medicinalproduct>
        <drugauthorizationnumb>020766</drugauthorizationnumb>
        <drugdosagetext>DOSAGE REGIMEN: DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060608</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060609</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARVEDILOL</medicinalproduct>
        <drugauthorizationnumb>020766</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SC-66110</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BUMETANIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BURAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATORVASTATIN CALCIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EZETIMIBE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NICORANDIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALSARTAN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059693-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060724</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060710</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ZA-ROCHE-454828</companynumb>
    <primarysource>
      <reportercountry>SOUTH AFRICA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>61</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>LIPOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>018662</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ACNE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060314</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059694-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060724</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060608</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-ROCHE-451062</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>51</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>51</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABNORMAL BEHAVIOUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COGNITIVE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEG-INTERFERON ALFA 2A (RO 25-8310)</medicinalproduct>
        <drugdosagetext>DOSAGE FORM = LIQUID</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060329</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060607</drugenddate>
        <drugtreatmentduration>71</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RIBAVIRIN</medicinalproduct>
        <drugauthorizationnumb>021511</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060329</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060607</drugenddate>
        <drugtreatmentduration>71</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059695-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060724</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060710</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-ROCHE-455049</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>45</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>B-CELL LYMPHOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPHOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FUZEON</medicinalproduct>
        <drugauthorizationnumb>021481</drugauthorizationnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060306</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIREAD</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050203</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NORVIR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010611</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIDEX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060306</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TMC114</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060306</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059697-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060724</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060710</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-ROCHE-454605</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>CEREBELLAR HYPOPLASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONGENITAL CENTRAL NERVOUS SYSTEM ANOMALY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONGENITAL EYE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONGENITAL IRIS ANOMALY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE BEFORE PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EAR MALFORMATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART DISEASE CONGENITAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE CONGENITAL ABNORMALITIES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYDRIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OLFACTORY NERVE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TWIN PREGNANCY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ROACCUTANE GEL</medicinalproduct>
        <drugauthorizationnumb>18662</drugauthorizationnumb>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050630</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059698-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060705</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200610558BFR</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>66</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANOREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERAL PHYSICAL HEALTH DETERIORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALIGNANT NEOPLASM PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALNUTRITION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERFORMANCE STATUS DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SORAFENIB</medicinalproduct>
        <drugauthorizationnumb>21923</drugauthorizationnumb>
        <drugdosagetext>200 MG QD ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RENAL CELL CARCINOMA STAGE UNSPECIFIED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060414</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060531</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEXOMIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>STILNOX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IXPRIM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIANTALVIC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPALGIC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SKENAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MORPHINE SULFATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LAMALINE (CAFFEINE, PAPAVER SOMNIFERUM LATEX, PARACETAMOL)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCONTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYNORM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SEROPRAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SOTALOL HCL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059699-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060630</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE200606005441</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>37</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISEASE PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESTLESS LEGS SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>60 MG DAILY (1/D) ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051001</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059700-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060706</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE200606004477</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>11</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>526</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DISTURBANCE IN ATTENTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FRUSTRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESTLESSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPEECH DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENTRICULAR EXTRASYSTOLES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENTRICULAR TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>STRATTERA</medicinalproduct>
        <drugauthorizationnumb>21411</drugauthorizationnumb>
        <drugdosagetext>DAILY (1/D) ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATTENTION DEFICIT/HYPERACTIVITY DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050601</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059701-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060630</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP200606001242</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>45</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URTICARIA GENERALISED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMALOG</medicinalproduct>
        <drugauthorizationnumb>20563</drugauthorizationnumb>
        <drugdosagetext>SUBCUTANEOUS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060601</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMALOG</medicinalproduct>
        <drugdosagetext>SUBCUTANEOUS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060601</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059702-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060724</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060710</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PR-ROCHE-454811</companynumb>
    <primarysource>
      <reportercountry>PUERTO RICO</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>65</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>64.3</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BRONCHITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEG-INTERFERON ALFA 2A (RO 25-8310)</medicinalproduct>
        <drugbatchnumb>B0085</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060530</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RIBAVIRIN</medicinalproduct>
        <drugauthorizationnumb>021511</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060602</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060613</drugenddate>
        <drugtreatmentduration>12</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RIBAVIRIN</medicinalproduct>
        <drugauthorizationnumb>021511</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060618</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALEVE (CAPLET)</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060412</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SINGULAIR</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060527</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060527</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PULMICORT</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060527</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060613</drugenddate>
        <drugtreatmentduration>18</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GILTUSS</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060527</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060613</drugenddate>
        <drugtreatmentduration>18</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELESTONE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060527</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060613</drugenddate>
        <drugtreatmentduration>18</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059703-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060724</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060616</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-452298</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>55</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DISORIENTATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EMPHYSEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCREASED APPETITE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEGASYS</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060331</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COPEGUS</medicinalproduct>
        <drugauthorizationnumb>021511</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060331</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059704-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060724</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060703</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-454193</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>28</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>SKIN BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>018662</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ACNE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060302</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060327</drugenddate>
        <drugtreatmentduration>26</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059705-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060724</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060711</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GR-ROCHE-455364</companynumb>
    <primarysource>
      <reportercountry>GREECE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CREATINE PHOSPHOKINASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BONIVA</medicinalproduct>
        <drugauthorizationnumb>021455</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE BESYLATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOSARTAN POSTASSIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059706-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060724</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060712</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-ROCHE-455607</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>49</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPEPSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLUENZA LIKE ILLNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OESOPHAGITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWELLING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BONIVA</medicinalproduct>
        <drugauthorizationnumb>021455</drugauthorizationnumb>
        <drugdosagetext>DOSE REPORTED AS 150 MG/MONTH</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060709</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060709</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OSCAL</medicinalproduct>
        <drugdosagetext>DRUD REPORTED AS CALCIUM CARBONATE, VIATMIN D/ OSCAL D</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EUTHYROX</medicinalproduct>
        <drugdosagetext>INDICATION REPORTED AS THYROID.</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059707-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060724</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060704</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ROCHE-453977</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>12</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>CARDIO-RESPIRATORY ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE FRACTURES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PELVIC FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SELF-MEDICATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAMIFLU</medicinalproduct>
        <drugauthorizationnumb>21087</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060703</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060703</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALONAL</medicinalproduct>
        <drugdosagetext>FORMULATION: ORAL FORMULATION (NOT OTHERWISE SPECIFIED).</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060703</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060703</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059708-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060724</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060714</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-ROCHE-455955</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>NEOPLASM MALIGNANT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEGASYS</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059709-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060724</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060713</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-455609</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>THROMBOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FUZEON</medicinalproduct>
        <drugauthorizationnumb>021481</drugauthorizationnumb>
        <drugdosagetext>ROUTE REPORTED AS INJ. PATIENT INJECTED IN THE ABDOMEN.</drugdosagetext>
        <drugadministrationroute>050</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KALETRA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNSPECIFIED DRUG</medicinalproduct>
        <drugdosagetext>REPORTED AS ^SOMETHING LIKE TRIVA^.</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BLOOD PRESSURE MEDICATIONS NOS</medicinalproduct>
        <drugdosagetext>THE PATIENT TOOK TWO BLOOD PRESSURE MEDICATIONS.</drugdosagetext>
        <drugindication>BLOOD PRESSURE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059710-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060724</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060714</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-456042</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NO ADVERSE EFFECT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NORMAL DELIVERY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>018662</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19920930</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19930111</drugenddate>
        <drugtreatmentduration>104</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>018662</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19950710</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19951016</drugenddate>
        <drugtreatmentduration>99</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059711-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060724</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060713</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-455573</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>52</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>APPENDICITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IRRITABILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOOD SWINGS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEGASYS</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050615</drugenddate>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEGASYS</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060616</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COPEGUS</medicinalproduct>
        <drugauthorizationnumb>021511</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050615</drugenddate>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COPEGUS</medicinalproduct>
        <drugauthorizationnumb>021511</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060616</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059712-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060724</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060714</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-455820</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>39</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>83.5</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY OCCLUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROTEIN TOTAL DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEGASYS</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060213</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COPEGUS</medicinalproduct>
        <drugauthorizationnumb>021511</drugauthorizationnumb>
        <drugdosagetext>DOSAGE REPORTED AS 3AM/ 3PM</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060213</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VERAPAMIL</medicinalproduct>
        <drugdosagetext>FORM REPORTED AS CAP</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MIDRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEADACHE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEPAKOTE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEADACHE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREVACID</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059713-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP200606000027</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>65</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD THYROID STIMULATING HORMONE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EVISTA</medicinalproduct>
        <drugauthorizationnumb>20815</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THYRADIN        (THYROID)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059714-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060627</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB200606002823</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>74</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>AMNESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD POTASSIUM DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD SODIUM DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONTUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERAL PHYSICAL HEALTH DETERIORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEAD INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WALKING DISABILITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>30 MG 2/D ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BIPOLAR I DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060509</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060518</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEPAKOTE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENDROFLUMETHIAZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LAMOTRIGINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLICLAZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOXAZOSIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059716-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA200604004180</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>77</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HEART RATE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugauthorizationnumb>21318</drugauthorizationnumb>
        <drugdosagetext>20 UG DAILY (1/D)</drugdosagetext>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060324</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PERINDOPRIL ERBUMINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATORVASTATIN CALCIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059717-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060711</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200610900BVD</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>64</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>88.9</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BRAIN OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CENTRAL NERVOUS SYSTEM NECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GRAND MAL CONVULSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SORAFENIB</medicinalproduct>
        <drugauthorizationnumb>21923</drugauthorizationnumb>
        <drugdosagetext>400 MG, BID, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RENAL CELL CARCINOMA STAGE UNSPECIFIED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060616</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060705</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NITRENDIPIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOSS [ALFACALCIDOL]</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BONDRONAT [IBANDRONATE SODIUM]</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCORTISON</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEP</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059718-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060710</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200610651BFR</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>70</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>96</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACARBOSE</medicinalproduct>
        <drugauthorizationnumb>20482</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GLYBURIDE</medicinalproduct>
        <drugdosagetext>15 MG, TOTAL DAILY, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>STAGID (METFORMIN EMBONATE)</medicinalproduct>
        <drugdosagetext>1400 MG, TOTAL DAILY, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPANTHYL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KERLONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FORTZAAR</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059720-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060713</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200610558BVD</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
    </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>BRAIN OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBRAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugauthorizationnumb>21317</drugauthorizationnumb>
        <drugdosagetext>BID, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEADACHE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050609</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059721-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060711</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200610879BYL</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>19</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>45</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>EOSINOPHILIC PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA MYCOPLASMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY OEDEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVELOX</medicinalproduct>
        <drugauthorizationnumb>21085</drugauthorizationnumb>
        <drugdosagetext>400 MG, QD, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BRONCHITIS ACUTE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060621</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060624</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PL GRANULE</medicinalproduct>
        <drugdosagetext>1 G, TID, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BRONCHITIS ACUTE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060619</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060624</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEXTROMETHORPHAN HYDROBROMIDE</medicinalproduct>
        <drugdosagetext>30 MG, BID, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BRONCHITIS ACUTE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060619</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060624</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KLARICID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MUCOSAL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HOKUNALIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059722-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060724</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050523</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2005US05831</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>48</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ACTINOMYCOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE OPERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FISTULA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMPAIRED HEALING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERIODONTAL OPERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRIMARY SEQUESTRUM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEQUESTRECTOMY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWELLING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AREDIA</medicinalproduct>
        <drugauthorizationnumb>20036</drugauthorizationnumb>
        <drugindication>BREAST CANCER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAMOXIFEN</medicinalproduct>
        <drugindication>BREAST CANCER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMINS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HERBAL PREPARATION</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059723-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060724</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060712</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2006US08961</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AREDIA</medicinalproduct>
        <drugauthorizationnumb>020036</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059724-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060724</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20051020</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2005US11718</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AREDIA</medicinalproduct>
        <drugauthorizationnumb>20036</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059725-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060724</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060713</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-JNJFOC-20060506166</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>55</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PARAPARESIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSEUDARTHROSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ANKYLOSING SPONDYLITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059726-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060724</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060713</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-JNJFOC-20060702706</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>60</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HENOCH-SCHONLEIN PURPURA</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>ISCOTIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PENTASA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ELENTAL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059727-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060724</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060713</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20060307151</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>126.55</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLANTAR FASCIITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYSTEMIC LUPUS ERYTHEMATOSUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TENDONITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugdosagetext>600 MG DOSE</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugdosagetext>600 MG DOSE</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugdosagetext>600 MG DOSE</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLITIS ULCERATIVE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAQUENIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLEXERIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREVACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COLAZAL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMURAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCODONE</medicinalproduct>
        <drugdosagetext>DOSE 7.5/500</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPICORT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SINGULAIR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZYRTEC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLONASE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROCTOCORT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZETIA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NASONEX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEXAPRO</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RESTASIS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMINS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FISH OIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM GLUCONATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENADRYL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEOSYNEPHRINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZINC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PAPAYA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LUTEIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BILBERRY</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL SPIROS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059728-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060724</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060621</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-MERCK-0606USA05034</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>83</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANOREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSED LEVEL OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEPCID RPD</medicinalproduct>
        <drugauthorizationnumb>20752</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTRIC ULCER</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060619</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>[THERAPY UNSPECIFIED]</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERAMMONAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060410</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060619</drugenddate>
        <drugtreatmentduration>71</drugtreatmentduration>
        <drugtreatmentdurationunit></drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FERROMIA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>IRON DEFICIENCY ANAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060410</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060619</drugenddate>
        <drugtreatmentduration>71</drugtreatmentduration>
        <drugtreatmentdurationunit></drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CINAL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>IRON DEFICIENCY ANAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060410</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060619</drugenddate>
        <drugtreatmentduration>71</drugtreatmentduration>
        <drugtreatmentdurationunit></drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATIC CIRRHOSIS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060619</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALDACTONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATIC CIRRHOSIS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060619</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LACTULOSE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERAMMONAEMIA</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060619</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGNESIUM OXIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATIC CIRRHOSIS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060619</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NOVORAPID</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060418</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060619</drugenddate>
        <drugtreatmentduration>63</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059729-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesscongenitalanomali>1</seriousnesscongenitalanomali>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060724</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060707</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-MERCK-0607USA02740</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>64</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ADVERSE EVENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ATRIOVENTRICULAR BLOCK THIRD DEGREE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRADYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ELECTROCARDIOGRAM QT CORRECTED INTERVAL PROLONGED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENTRICULAR TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEPCID RPD</medicinalproduct>
        <drugauthorizationnumb>20752</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTRITIS EROSIVE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041209</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050607</drugenddate>
        <drugtreatmentduration>181</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PURSENNID</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONSTIPATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM CARBONATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERPHOSPHATAEMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RHYTHMY</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INSOMNIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLETAL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CEREBRAL INFARCTION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059730-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060724</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060620</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-MERCK-0606USA04158</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>81</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ALANINE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASPARTATE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD ALKALINE PHOSPHATASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD LACTATE DEHYDROGENASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAMMA-GLUTAMYLTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>20560</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060606</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ONEALFA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060606</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059731-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060724</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20051117</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0511USA03093</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>58</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DENTAL FISTULA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMPAIRED HEALING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOMYELITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERIODONTITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREATMENT NONCOMPLIANCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>20560</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>[THERAPY UNSPECIFIED]</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059732-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060724</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060717</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0607USA03705</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>46</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OESOPHAGEAL DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPINAL FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STOMACH DISCOMFORT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060501</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FORTAL (PENTAZOCINE)</medicinalproduct>
        <drugadministrationroute>051</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060531</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCODONE BITARTRATE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050501</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050701</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059733-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060724</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060703</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CG-MERCK-0607USA00708</companynumb>
    <primarysource>
      <reportercountry>CONGO</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>42</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABNORMAL BEHAVIOUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AGITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISORIENTATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OCULAR HYPERAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>STROMECTOL</medicinalproduct>
        <drugauthorizationnumb>50742</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ONCHOCERCIASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060512</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060512</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059734-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BE200604002912</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>60</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>80</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>APATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STATUS EPILEPTICUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>60 MG, DAILY (1/D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060330</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060403</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMITRIPTYLINE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DURAGESIC-100</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALIUM /NET/ (DIAZEPAM)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDROL ACETATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COLCHICUM JTL LIQ</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOPHAGE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EMCONCOR /BEL/ (BISOPROLOL FUMARATE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DANDROLIN (NANDROLONE PHENPROPIONATE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AACIFEMINE (ESTRIOL)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059736-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060710</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200610743BWH</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>71</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ALOPECIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE CONGESTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPEPSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GALLBLADDER DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GINGIVITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH GENERALISED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWELLING FACE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXAVAR</medicinalproduct>
        <drugauthorizationnumb>21923</drugauthorizationnumb>
        <drugdosagetext>400 MG, BID, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RENAL CELL CARCINOMA STAGE UNSPECIFIED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060114</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060130</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PERCOCET</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VICODIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059737-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060710</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200611270BWH</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>67</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>TRANSIENT ISCHAEMIC ATTACK</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXAVAR</medicinalproduct>
        <drugauthorizationnumb>21923</drugauthorizationnumb>
        <drugdosagetext>400 MG, BID, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RENAL CELL CARCINOMA STAGE UNSPECIFIED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060324</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEGACE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MIRTAZAPINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORAZEPAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NIFEDIPINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEXAPRO</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CATAPRES</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059738-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060724</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060703</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CG-MERCK-0607USA00707</companynumb>
    <primarysource>
      <reportercountry>CONGO</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>35</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHILLS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NECK PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>STROMECTOL</medicinalproduct>
        <drugauthorizationnumb>050742</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ONCHOCERCIASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060518</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060518</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059739-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060724</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060718</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-MERCK-0607USA04025</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DEMENTIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROPECIA</medicinalproduct>
        <drugauthorizationnumb>020788</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MALE PATTERN BALDNESS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059740-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060724</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060703</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-BRISTOL-MYERS SQUIBB COMPANY-13448600</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>AGRANULOCYTOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VASTEN TABS 20 MG</medicinalproduct>
        <drugauthorizationnumb>19898</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060320</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RIFATER</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BONE TUBERCULOSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060202</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060320</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MYAMBUTOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BONE TUBERCULOSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060202</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060320</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>STILNOX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060320</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPEGIC 1000</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAMADOL HCL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059741-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060724</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060314</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-BRISTOL-MYERS SQUIBB COMPANY-13314919</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>49</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>76</patientweight>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE CONGESTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONGESTIVE CARDIOMYOPATHY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PLATINEX</medicinalproduct>
        <drugauthorizationnumb>18057</drugauthorizationnumb>
        <drugindication>CERVIX CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050614</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050712</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RADIOTHERAPY</medicinalproduct>
        <drugindication>CERVIX CARCINOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUOXETINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GABAPENTIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANSOPRAZOLE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DALTEPARIN</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IPRATROPIUM BROMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SALBUTAMOL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059742-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060724</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060712</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-13440714</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VEPESID</medicinalproduct>
        <drugauthorizationnumb>018768</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059743-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060724</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060620</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-BRISTOL-MYERS SQUIBB COMPANY-13421300</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>69</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CEREBRAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ERBITUX</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>COLORECTAL CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050704</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060119</drugenddate>
        <drugtreatmentduration>199</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IRINOTECAN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLORECTAL CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050704</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060119</drugenddate>
        <drugtreatmentduration>199</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOLINIC ACID</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLORECTAL CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050704</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060119</drugenddate>
        <drugtreatmentduration>199</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUOROURACIL</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLORECTAL CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050704</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060119</drugenddate>
        <drugtreatmentduration>199</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059744-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060724</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060717</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-BRISTOL-MYERS SQUIBB COMPANY-13445606</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>57</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>49</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD CREATININE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FANCONI SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOPHOSPHATAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUSTIVA</medicinalproduct>
        <drugauthorizationnumb>020972</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030901</drugstartdate>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KALETRA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030901</drugstartdate>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIREAD</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060408</drugenddate>
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  <safetyreport>
    <safetyreportid>5059745-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060724</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060714</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-13442462</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <patientonsetage>73</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>58</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOBAR PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY TOXICITY</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAXOL</medicinalproduct>
        <drugauthorizationnumb>020262</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060609</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060623</drugenddate>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARBOPLATIN</medicinalproduct>
        <drugauthorizationnumb>019880</drugauthorizationnumb>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060609</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060609</drugenddate>
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  <safetyreport>
    <safetyreportid>5059746-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060724</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060718</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-BRISTOL-MYERS SQUIBB COMPANY-13449939</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <patientonsetage>71</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FEBRILE NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METASTASES TO LIVER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>RESPIRATORY TRACT INFECTION</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ERBITUX</medicinalproduct>
        <drugdosagetext>1ST DOSE: 18JUL05</drugdosagetext>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>COLORECTAL CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050920</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050920</drugenddate>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IRINOTECAN</medicinalproduct>
        <drugdosagetext>1ST DOSE: 18JUL05</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLORECTAL CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050920</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050920</drugenddate>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOLINIC ACID</medicinalproduct>
        <drugdosagetext>1ST DOSE: 18JUL05</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLORECTAL CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050920</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050920</drugenddate>
        <drugtreatmentduration>64</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUOROURACIL</medicinalproduct>
        <drugdosagetext>1ST DOSE: 18JUL05</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLORECTAL CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050920</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050920</drugenddate>
        <drugtreatmentduration>64</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
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    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059747-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060724</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060517</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-13380464</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>40</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>83</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ATROPHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SENSORY LOSS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KENALOG-40</medicinalproduct>
        <drugauthorizationnumb>14901</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060417</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060417</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
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  <safetyreport>
    <safetyreportid>5059748-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060724</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060713</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-MERCK-0607GBR00068</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>64</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ULCER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20011009</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060509</drugenddate>
        <drugtreatmentduration>1674</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
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    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059753-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060705</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200612734BWH</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLINDNESS UNILATERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>REFUSAL OF TREATMENT BY PATIENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVITRA</medicinalproduct>
        <drugauthorizationnumb>21400</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059754-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060724</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060712</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2006US08913</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>41</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CROHN'S DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NODULE ON EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GLEEVEC</medicinalproduct>
        <drugauthorizationnumb>021588</drugauthorizationnumb>
        <drugdosagetext>800 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CHRONIC MYELOID LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031217</drugstartdate>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENTOCORT EC</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060622</drugstartdate>
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    </patient>
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  <safetyreport>
    <safetyreportid>5059757-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060627</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>NL200606003867</companynumb>
    <primarysource>
      <reportercountry>NETHERLANDS</reportercountry>
      <qualification>2</qualification>
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    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <patientonsetage>10</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>34</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANOREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING COLD</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FOOD POISONING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTHERMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SHOCK</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>STRATTERA</medicinalproduct>
        <drugauthorizationnumb>21411</drugauthorizationnumb>
        <drugdosagetext>40 MG, DAILY (1/D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATTENTION DEFICIT/HYPERACTIVITY DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XAZOL (LEVOCETIRIZINE DIHYDROCHLORIDE)</medicinalproduct>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MELATONIN (MELATONIN)</medicinalproduct>
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    </patient>
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  <safetyreport>
    <safetyreportid>5059758-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060705</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200612695BWH</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
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    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <patientonsetage>56</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARKINSON'S DISEASE</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>UNEVALUABLE EVENT</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVELOX</medicinalproduct>
        <drugauthorizationnumb>21085</drugauthorizationnumb>
        <drugdosagetext>400 MG, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NUCLEAR MAGNETIC RESONANCE IMAGING BRAIN</drugindication>
        <drugtreatmentduration>12</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORAZEPAM</medicinalproduct>
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    </patient>
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  <safetyreport>
    <safetyreportid>5059759-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
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    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060724</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060710</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHRM2006FR02064</companynumb>
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      <reportercountry>FRANCE</reportercountry>
      <qualification>3</qualification>
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    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
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      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>61</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BONE DEBRIDEMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISEASE PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FISTULA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMPAIRED HEALING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLAMMATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOSYNTHESIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PURULENT DISCHARGE</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>RESORPTION BONE INCREASED</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AREDIA</medicinalproduct>
        <drugauthorizationnumb>020036</drugauthorizationnumb>
        <drugdosagetext>90 MG, QMO</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010805</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040605</drugenddate>
        <drugtreatmentduration>1036</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
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  <safetyreport>
    <safetyreportid>5059760-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060724</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHO2006EG10485</companynumb>
    <primarysource>
      <reportercountry>EGYPT</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>18</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>53</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HEPATOMEGALY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYDRONEPHROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERINEPHRIC ABSCESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERINEPHRIC COLLECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ICL670A</medicinalproduct>
        <drugauthorizationnumb>21882</drugauthorizationnumb>
        <drugdosagetext>30 MG/KG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HAEMOSIDEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060315</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059761-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060724</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060321</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2006US03797</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>54</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CATARACT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CATARACT OPERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYELID OEDEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GLEEVEC</medicinalproduct>
        <drugauthorizationnumb>21588</drugauthorizationnumb>
        <drugdosagetext>600 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTROINTESTINAL STROMAL TUMOUR</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060301</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GLEEVEC</medicinalproduct>
        <drugauthorizationnumb>021588</drugauthorizationnumb>
        <drugdosagetext>UNK, NO TREATMENT</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060301</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GLEEVEC</medicinalproduct>
        <drugauthorizationnumb>021588</drugauthorizationnumb>
        <drugdosagetext>400 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050601</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059762-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060724</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060719</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2006IE10892</companynumb>
    <primarysource>
      <reportercountry>IRELAND</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GLEEVEC</medicinalproduct>
        <drugauthorizationnumb>021588</drugauthorizationnumb>
        <drugdosagetext>400 MG/D</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059763-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060724</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060713</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2006BE10580</companynumb>
    <primarysource>
      <reportercountry>BELGIUM</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>51</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>RASH ERYTHEMATOUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWEAT GLAND TUMOUR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GLEEVEC</medicinalproduct>
        <drugauthorizationnumb>021588</drugauthorizationnumb>
        <drugdosagetext>400 MG/D</drugdosagetext>
        <drugindication>CHRONIC MYELOID LEUKAEMIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059764-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060724</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060718</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-JNJFOC-20060604185</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>60</patientweight>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>SUDDEN DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMINYL ER</medicinalproduct>
        <drugauthorizationnumb>21615</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEMENTIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTI-HYPERTENSIVE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CHOLESTEROL-LOWERING</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059765-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060724</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060713</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-JNJFOC-20060605511</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>63</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYME DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MICTURITION DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULAR WEAKNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TENDONITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAVANIC</medicinalproduct>
        <drugauthorizationnumb>20634</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SINUSITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060313</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060323</drugenddate>
        <drugtreatmentduration>11</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SOLUPRED</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SINUSITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060204</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059766-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060724</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060714</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-JNJFOC-20060703452</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>71</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ITRACONAZOLE</medicinalproduct>
        <drugauthorizationnumb>20083</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NAIL TINEA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>CONIEL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARDENALIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARTIST</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059767-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060724</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060714</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-JNJFOC-20060703468</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </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>ITRACONAZOLE</medicinalproduct>
        <drugauthorizationnumb>020083</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NAIL TINEA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059768-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060724</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060712</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-JNJFOC-20050403627</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>65</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROOESOPHAGEAL REFLUX DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERALISED OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STOMACH DISCOMFORT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SPORANOX</medicinalproduct>
        <drugbatchnumb>V01</drugbatchnumb>
        <drugauthorizationnumb>20083</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>FUNGAL INFECTION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMISIL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FELODIPINE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059769-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060724</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060711</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-JNJFOC-20060601589</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>10</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>33</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIAC MURMUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CONCERTA</medicinalproduct>
        <drugauthorizationnumb>21121</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATTENTION DEFICIT/HYPERACTIVITY DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059770-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060724</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060713</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-JNJFOC-20060505405</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ALANINE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASPARTATE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD ALKALINE PHOSPHATASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CREATINE PHOSPHOKINASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD LACTATE DEHYDROGENASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PHOSPHORUS INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRANSAMINASES INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CONCERTA</medicinalproduct>
        <drugauthorizationnumb>21121</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059771-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060724</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060703</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CG-MERCK-0607USA00709</companynumb>
    <primarysource>
      <reportercountry>CONGO</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>54</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>62</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OCULAR HYPERAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL ACUITY REDUCED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>STROMECTOL</medicinalproduct>
        <drugauthorizationnumb>050742</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ONCHOCERCIASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060520</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060520</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059772-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BE200604003183</companynumb>
    <primarysource>
      <reportercountry>BELGIUM</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>11</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DIABETES MELLITUS INSULIN-DEPENDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GLYCOSYLATED HAEMOGLOBIN INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SOMATROPIN (SOMATROPIN UNKNOWN FORMULATION) UNKNOWN</medicinalproduct>
        <drugauthorizationnumb>19640</drugauthorizationnumb>
        <drugdosagetext>0.025 MG/KG, DAILY (1/D), SUBCUTANEOUS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>GROWTH HORMONE DEFICIENCY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040310</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059773-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060724</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060713</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0607USA02569</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HORSESHOE KIDNEY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEPHROLITHIASIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CRIXIVAN</medicinalproduct>
        <drugauthorizationnumb>020685</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS AGAINST HIV INFECTION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059774-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060724</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060630</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHO2006IT10671</companynumb>
    <primarysource>
      <reportercountry>ITALY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>82</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>74</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ABDOMINAL OPERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTESTINAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYELOPROLIFERATIVE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ICL670A</medicinalproduct>
        <drugauthorizationnumb>21882</drugauthorizationnumb>
        <drugdosagetext>1500 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD IRON INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060526</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059775-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060724</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060712</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-GILEAD-2006-0009856</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>58</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ASCITES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUROPATHY PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLEURAL EFFUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIREAD</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060630</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRUVADA</medicinalproduct>
        <drugindication>HIV INFECTION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060601</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KALETRA</medicinalproduct>
        <drugindication>HIV INFECTION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060601</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATAZANAVIR</medicinalproduct>
        <drugindication>HIV INFECTION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060601</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>D4T</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060601</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059776-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060724</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0518181A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>32</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANXIETY</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>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IRRITABILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERFORMANCE STATUS DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
        <drugauthorizationnumb>20031</drugauthorizationnumb>
        <drugdosagetext>10MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PANIC ATTACK</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
        <drugauthorizationnumb>020710</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANXIETY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEXAPRO</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059777-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060724</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040719</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0519846A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG WITHDRAWAL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOOD SWINGS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANIC ATTACK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
        <drugauthorizationnumb>20031</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANXIETY DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040813</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAXIL CR</medicinalproduct>
        <drugauthorizationnumb>020936</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040901</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059778-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060724</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050503</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0558213A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>16</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>50</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISSOCIATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG WITHDRAWAL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING COLD</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HOT FLUSH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SELF INJURIOUS BEHAVIOUR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
        <drugauthorizationnumb>20031</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20001001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAXIL CR</medicinalproduct>
        <drugauthorizationnumb>020936</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030724</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATIVAN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059779-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060724</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050516</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0559053A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>AGGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANGER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BIPOLAR DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISORIENTATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EFFECT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG WITHDRAWAL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESTLESSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TINNITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
        <drugauthorizationnumb>20031</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANXIETY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000501</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYZAAR</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059780-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060724</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050728</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0568193A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>40</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>116.8</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>AGITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AKATHISIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG WITHDRAWAL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSTHYMIC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HOSTILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMPULSIVE BEHAVIOUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERMITTENT EXPLOSIVE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IRRITABILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOOD SWINGS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NIGHTMARE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSYCHIATRIC SYMPTOM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESTLESSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOCIAL AVOIDANT BEHAVIOUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDE ATTEMPT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VERTIGO</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
        <drugauthorizationnumb>20031</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19940504</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031106</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030830</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ERYTHROMYCIN 2% TOPICAL GEL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLARITIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
        <drugdosagetext>5MG AT NIGHT</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030901</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059781-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060724</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060710</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0611656A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>41</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ILL-DEFINED DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUS CONGESTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROAT IRRITATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ADVAIR DISKUS 100/50</medicinalproduct>
        <drugbatchnumb>R221819</drugbatchnumb>
        <drugauthorizationnumb>21077</drugauthorizationnumb>
        <drugdosagetext>1PUFF TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060424</drugstartdate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NASACORT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENADRYL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNSPECIFIED MEDICATION</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLERGY SHOT</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059782-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060724</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060712</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0612042A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>72</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>C-REACTIVE PROTEIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY CONGESTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UPPER RESPIRATORY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>12.5MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051101</drugstartdate>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOSARTAN POSTASSIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLIPIZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLARITIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SINGULAIR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLONASE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLOVENT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL SPIROS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059783-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesscongenitalanomali>1</seriousnesscongenitalanomali>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060724</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060718</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0612693A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>2.7</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CYSTIC FIBROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMBIVIR</medicinalproduct>
        <drugauthorizationnumb>20857</drugauthorizationnumb>
        <drugdosagetext>1TAB TWICE PER DAY</drugdosagetext>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050818</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEVIRAPINE</medicinalproduct>
        <drugdosagetext>200MG TWICE PER DAY</drugdosagetext>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051223</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060120</drugenddate>
        <drugtreatmentduration>29</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KALETRA</medicinalproduct>
        <drugdosagetext>4CAP TWICE PER DAY</drugdosagetext>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050818</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AZT</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060120</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060120</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059784-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060724</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060719</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0612826A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARIXTRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021345</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059785-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060724</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060720</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0612993A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FACIAL PALSY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THERAPEUTIC RESPONSE UNEXPECTED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VALTREX</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020487</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060501</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059786-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesscongenitalanomali>1</seriousnesscongenitalanomali>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060724</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060719</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0613028A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>3.7</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CONGENITAL ANOMALY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMICTAL</medicinalproduct>
        <drugauthorizationnumb>020241</drugauthorizationnumb>
        <drugindication>EPILEPSY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050611</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051217</drugenddate>
        <drugtreatmentduration>190</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KEPPRA</medicinalproduct>
        <drugindication>EPILEPSY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050611</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051027</drugenddate>
        <drugtreatmentduration>139</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRIMACARE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050601</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059787-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060724</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060720</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>NONE</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>50.9</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BALANCE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VALTREX</medicinalproduct>
        <drugauthorizationnumb>020487</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ULTRAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VICODIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059788-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060724</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20010508</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-GLAXOSMITHKLINE-B0107035A</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>18</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>74</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>AGGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ALCOHOLISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANOREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMPLETED SUICIDE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPERSONALISATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEREALISATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISSOCIATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISTURBANCE IN ATTENTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG ABUSER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRY MOUTH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING OF DESPAIR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEAD INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOCHONDRIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IRRITABILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MANIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENTAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOOD SWINGS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERSONALITY CHANGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERSONALITY DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSYCHIATRIC SYMPTOM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESTLESSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOCIAL AVOIDANT BEHAVIOUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISION BLURRED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYBAN</medicinalproduct>
        <drugauthorizationnumb>20711</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20001116</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20001206</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CHLOROQUINE PHOSPHATE</medicinalproduct>
        <drugdosagetext>37.5MG PER DAY</drugdosagetext>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20001101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059789-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060724</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050419</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-GLAXOSMITHKLINE-B0378683A</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>7</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>25</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAL STENOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FUNGAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL MUCOSAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATOCHEZIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC VEIN OCCLUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOALBUMINAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUCOUS MEMBRANE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARYNGOLARYNGEAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHABDOMYOSARCOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENOOCCLUSIVE LIVER DISEASE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALKERAN</medicinalproduct>
        <drugauthorizationnumb>14691</drugauthorizationnumb>
        <drugdosagetext>64MG PER DAY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>STEM CELL TRANSPLANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040618</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040624</drugenddate>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>THIOTEPA</medicinalproduct>
        <drugdosagetext>184MG PER DAY</drugdosagetext>
        <drugindication>STEM CELL TRANSPLANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040618</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040624</drugenddate>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEUTROGIN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040630</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040712</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEU-UP</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040713</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040713</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BROACT</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>FEBRILE NEUTROPENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040626</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040630</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BROACT</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040823</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040827</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRODIF</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>FUNGAL INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040626</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040709</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MINOCYCLINE HCL</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>FEBRILE NEUTROPENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040630</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040706</drugenddate>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEROPEN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>FEBRILE NEUTROPENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040630</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040707</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VANCOMYCIN</medicinalproduct>
        <drugadministrationroute>042</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>MODACIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>FEBRILE NEUTROPENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040707</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040720</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUMIN</medicinalproduct>
        <drugindication>HYPOALBUMINAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040708</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040710</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BAKTAR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040616</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POLYMYXIN B SULFATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040616</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040706</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIFLUCAN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>FUNGAL INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040616</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040625</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>URSO</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>VENOOCCLUSIVE LIVER DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040616</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040713</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOVIRAX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HERPES VIRUS INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040621</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040711</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VENOGLOBULIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>INFECTION PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040622</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040802</drugenddate>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATARAX</medicinalproduct>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040618</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040801</drugenddate>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GASTER</medicinalproduct>
        <drugindication>GASTROINTESTINAL MUCOSAL DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040705</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040716</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ROPION</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ANTIPYRESIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040703</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040711</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CONTOMIN</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>INSOMNIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040708</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040101</drugenddate>
        <drugtreatmentduration>98</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRIMPERAN TAB</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>VOMITING</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040627</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040706</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PENTAZOCINE LACTATE</medicinalproduct>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040626</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040705</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METILON</medicinalproduct>
        <drugindication>ANTIPYRESIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040704</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040101</drugenddate>
        <drugtreatmentduration>94</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TATHION</medicinalproduct>
        <drugindication>LIVER DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040621</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040626</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KYTRIL</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>VOMITING</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040616</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040625</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>JAPANESE MEDICATION</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>LIVER DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040621</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040626</drugenddate>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059790-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060724</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050504</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CH-GLAXOSMITHKLINE-B0381097A</companynumb>
    <primarysource>
      <reportercountry>SWITZERLAND</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>44</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>NORMAL DELIVERY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEROXAT</medicinalproduct>
        <drugauthorizationnumb>20031</drugauthorizationnumb>
        <drugdosagetext>20MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050320</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMOVANE</medicinalproduct>
        <drugdosagetext>7.5MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050320</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059791-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060724</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060222</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-GLAXOSMITHKLINE-B0413176A</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>74</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>94.7</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>AMAUROSIS FUGAX</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANGIONEUROTIC OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTERIOPATHIC DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLINDNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CAROTID ARTERY DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CAROTID ARTERY STENOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CATARACT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIABETIC RETINOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LENTICULAR OPACITIES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MACULOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAPILLOEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RETINAL ARTERY EMBOLISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RETINAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RETINAL EXUDATES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RETINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRANSIENT ISCHAEMIC ATTACK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL ACUITY REDUCED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL ACUITY TESTS ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL FIELD DEFECT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugbatchnumb>059</drugbatchnumb>
        <drugauthorizationnumb>21071</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010813</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLICLAZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RAMIPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLOPIDOGREL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059792-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060724</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060323</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-GLAXOSMITHKLINE-B0417232A</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>18</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMPLETED SUICIDE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISTURBANCE IN ATTENTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERSONALITY CHANGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMATOFORM DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYBAN</medicinalproduct>
        <drugauthorizationnumb>020711</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059793-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060724</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060502</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IT-GLAXOSMITHKLINE-B0423013A</companynumb>
    <primarysource>
      <reportercountry>ITALY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>33</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HAEMOLYTIC ANAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TELZIR</medicinalproduct>
        <drugauthorizationnumb>021548</drugauthorizationnumb>
        <drugdosagetext>1400MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060130</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060415</drugenddate>
        <drugtreatmentduration>76</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RITONAVIR</medicinalproduct>
        <drugdosagetext>200MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>STAVUDINE</medicinalproduct>
        <drugdosagetext>80MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TENOFOVIR</medicinalproduct>
        <drugdosagetext>200MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059794-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060724</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060516</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-GLAXOSMITHKLINE-B0424128A</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>43</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>71</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CONJUNCTIVAL HYPERAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATOCELLULAR DAMAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH MACULO-PAPULAR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TELZIR</medicinalproduct>
        <drugauthorizationnumb>21548</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060225</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060309</drugenddate>
        <drugtreatmentduration>13</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EMTRIVA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060225</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060309</drugenddate>
        <drugtreatmentduration>13</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RETROVIR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060225</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060309</drugenddate>
        <drugtreatmentduration>13</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVIR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060225</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060309</drugenddate>
        <drugtreatmentduration>13</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059795-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060724</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060518</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-JPN-A200601615</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>66</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>43</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANOREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISORIENTATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSARTHRIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA ORAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NERVOUS SYSTEM DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESTLESSNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VALTREX</medicinalproduct>
        <drugauthorizationnumb>20487</drugauthorizationnumb>
        <drugdosagetext>1000MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HERPES ZOSTER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060516</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060517</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARASENA-A</medicinalproduct>
        <drugdosagetext>1G THREE TIMES PER DAY</drugdosagetext>
        <drugadministrationroute>061</drugadministrationroute>
        <drugindication>HERPES ZOSTER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060513</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060515</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
        <drugdosagetext>10MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041230</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADALAT</medicinalproduct>
        <drugdosagetext>3 PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BLOPRESS</medicinalproduct>
        <drugdosagetext>4MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041230</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALTAT</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TANKARU</medicinalproduct>
        <drugdosagetext>1500MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERPARATHYROIDISM</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041230</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>JAPANESE MEDICATION</medicinalproduct>
        <drugdosagetext>15MCG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041230</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RAMITALATE L</medicinalproduct>
        <drugdosagetext>60MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041230</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANPLAG</medicinalproduct>
        <drugdosagetext>150MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041230</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANALDINE</medicinalproduct>
        <drugdosagetext>200MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041230</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLELOCK</medicinalproduct>
        <drugdosagetext>10MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DERMATITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041230</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
        <drugdosagetext>40MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041230</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANZIEF</medicinalproduct>
        <drugdosagetext>50MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041230</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARTIST</medicinalproduct>
        <drugdosagetext>5MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041230</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN DRUG</medicinalproduct>
        <drugdosagetext>15MCG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041230</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059796-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060724</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060522</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-GLAXOSMITHKLINE-B0424879A</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>76</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>86</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DEPRESSED LEVEL OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISTURBANCE IN ATTENTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESTLESS LEGS SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ADARTREL</medicinalproduct>
        <drugauthorizationnumb>20658</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RESTLESS LEGS SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEXAQUINE</medicinalproduct>
        <drugdosagetext>2TAB PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIANTALVIC</medicinalproduct>
        <drugdosagetext>2CAP PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADANCOR</medicinalproduct>
        <drugdosagetext>10MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTERITIS CORONARY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059797-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060724</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-GLAXOSMITHKLINE-B0429094A</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>2</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>15</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANALGESIC DRUG LEVEL INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COAGULATION FACTOR DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSED LEVEL OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ELECTROENCEPHALOGRAM ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ENCEPHALITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATEMESIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC ENCEPHALOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATITIS FULMINANT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATOCELLULAR DAMAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MELAENA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLAMOXYL IV</medicinalproduct>
        <drugdosagetext>150MG PER DAY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>GASTROENTERITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060503</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060503</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOLIPRANE</medicinalproduct>
        <drugdosagetext>15MGK FOUR TIMES PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTROENTERITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060503</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060503</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRIMPERAN TAB</medicinalproduct>
        <drugdosagetext>1UNIT PER DAY</drugdosagetext>
        <drugadministrationroute>054</drugadministrationroute>
        <drugindication>GASTROENTERITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060503</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060503</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059798-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060724</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-JPN-A200602354</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>64</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMPLETED SUICIDE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJURY ASPHYXIATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IRRITABILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARTNER STRESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
        <drugauthorizationnumb>20031</drugauthorizationnumb>
        <drugdosagetext>10MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060605</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060616</drugenddate>
        <drugtreatmentduration>12</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BLOPRESS</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060616</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060616</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACINON</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060616</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CONAN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060616</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLIMICRON</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060616</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN DRUG</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060616</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN DRUG</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060616</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>YODEL S</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060616</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMOBAN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060616</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUNITRAZEPAM</medicinalproduct>
        <drugdosagetext>1MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INSOMNIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060612</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060616</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEXOTAN</medicinalproduct>
        <drugdosagetext>6MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPOCHONDRIASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060531</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060607</drugenddate>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN DRUG</medicinalproduct>
        <drugdosagetext>5MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INSOMNIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060531</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060607</drugenddate>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059799-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060701</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP200606000016</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>58</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>59</patientweight>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>AMMONIA INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBELLAR INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBRAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBRAL ISCHAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHOLANGITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAZE PALSY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATEMESIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALIGNANT NEOPLASM PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MELAENA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GEMZAR</medicinalproduct>
        <drugauthorizationnumb>20509</drugauthorizationnumb>
        <drugdosagetext>1000 MG, OTHER, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PANCREATIC CARCINOMA STAGE IV</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060403</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060403</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CISPLATIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDONINE-1 (PREDNISOLONE ACETATE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KYTRIL - FOR INFUSION (GRANISETRON HYDROCHLORIDE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCONTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059800-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060713</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006P1000318</companynumb>
    <primarysource>
      <reportercountry>ITALY</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>62</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ATRIOVENTRICULAR BLOCK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RETEPLASE (RETEPLASE)</medicinalproduct>
        <drugbatchnumb>CT001626</drugbatchnumb>
        <drugdosagetext>5 IU;2X;IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ACUTE MYOCARDIAL INFARCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060414</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060414</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REOPRO</medicinalproduct>
        <drugbatchnumb>CT000800</drugbatchnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>040</drugadministrationroute>
        <drugindication>ACUTE MYOCARDIAL INFARCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060414</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060414</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HEPARIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059801-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060724</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-GLAXOSMITHKLINE-B0429458A</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>70</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ATRIAL FIBRILLATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INADEQUATELY CONTROLLED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTHYROIDISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>21071</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS NON-INSULIN-DEPENDENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060620</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOR</medicinalproduct>
        <drugdosagetext>200MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS NON-INSULIN-DEPENDENT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOPHAGE</medicinalproduct>
        <drugdosagetext>1000MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS NON-INSULIN-DEPENDENT</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059802-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060724</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060704</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-GLAXOSMITHKLINE-B0430464A</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>65</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>C-REACTIVE PROTEIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CLOSTRIDIUM DIFFICILE COLITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MELAENA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SAWACILLIN</medicinalproduct>
        <drugauthorizationnumb>62216</drugauthorizationnumb>
        <drugdosagetext>2CAP FOUR TIMES PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060124</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060127</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RABEPRAZOLE SODIUM</medicinalproduct>
        <drugdosagetext>1TAB FOUR TIMES PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060124</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060127</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059803-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060724</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060711</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-GLAXOSMITHKLINE-B0430538A</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>65</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>80</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSKINESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEROXAT</medicinalproduct>
        <drugauthorizationnumb>20031</drugauthorizationnumb>
        <drugdosagetext>30MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEPAMIDE</medicinalproduct>
        <drugdosagetext>300MG THREE TIMES PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TERCIAN</medicinalproduct>
        <drugdosagetext>37MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
        <drugdosagetext>10MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PARKINANE</medicinalproduct>
        <drugdosagetext>2MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CORTANCYL</medicinalproduct>
        <drugdosagetext>10MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ESIDRIX</medicinalproduct>
        <drugdosagetext>25MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIFFU K</medicinalproduct>
        <drugdosagetext>3UNIT PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059804-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060724</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060711</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-GLAXOSMITHKLINE-B0430770A</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMOCYSTIS JIROVECI PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KIVEXA</medicinalproduct>
        <drugauthorizationnumb>21652</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUSTIVA</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059805-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060724</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060718</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-JPN-A200602679</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>62</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DECREASED APPETITE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSLALIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HALLUCINATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NERVOUS SYSTEM DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VALTREX</medicinalproduct>
        <drugauthorizationnumb>020487</drugauthorizationnumb>
        <drugdosagetext>1000MG THREE TIMES PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HERPES ZOSTER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060713</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060716</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059806-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060724</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060718</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-JPN-A200602687</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>72</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEPRESSED LEVEL OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG TOXICITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMODIALYSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VALTREX</medicinalproduct>
        <drugauthorizationnumb>020487</drugauthorizationnumb>
        <drugdosagetext>1000MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HERPES ZOSTER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060708</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060710</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
        <drugdosagetext>2 PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MUCOSTA</medicinalproduct>
        <drugdosagetext>3 PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
        <drugdosagetext>1 PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERURICAEMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>1 PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANGINA PECTORIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugdosagetext>2 PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RENAL FAILURE CHRONIC</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
        <drugdosagetext>1 PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GASTER</medicinalproduct>
        <drugdosagetext>1 PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTRIC ULCER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TANKARU</medicinalproduct>
        <drugdosagetext>3 PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOXONIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059807-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060724</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060718</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-JPN-A200602721</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>57</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HEPATIC FUNCTION ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATITIS C</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMMUNE RECONSTITUTION SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EPIVIR</medicinalproduct>
        <drugauthorizationnumb>020564</drugauthorizationnumb>
        <drugdosagetext>300MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ACQUIRED IMMUNODEFICIENCY SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040917</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050331</drugenddate>
        <drugtreatmentduration>28</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EPIVIR</medicinalproduct>
        <drugauthorizationnumb>020564</drugauthorizationnumb>
        <drugdosagetext>150MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZERIT</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ACQUIRED IMMUNODEFICIENCY SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041126</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIRACEPT</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ACQUIRED IMMUNODEFICIENCY SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VIRAMUNE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ACQUIRED IMMUNODEFICIENCY SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041011</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041025</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VIRAMUNE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041026</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059808-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060724</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060720</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-JPN-A200602733</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>21</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>COMPLETED SUICIDE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
        <drugauthorizationnumb>020031</drugauthorizationnumb>
        <drugdosagetext>20MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060525</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060529</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SEDIEL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMOBAN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059809-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060724</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060720</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>455246</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>68</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANAPHYLACTIC SHOCK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIOGENIC SHOCK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SHOCK</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARTIST</medicinalproduct>
        <drugauthorizationnumb>20297</drugauthorizationnumb>
        <drugdosagetext>2.5MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SINUS TACHYCARDIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051111</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051111</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ETIZOLAM</medicinalproduct>
        <drugdosagetext>.5MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SINUS TACHYCARDIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051111</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051111</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PILSICAINIDE HYDROCHLORIDE</medicinalproduct>
        <drugdosagetext>100MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051111</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051111</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HEPARIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051111</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051111</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VASOLAN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051111</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051111</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051111</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051111</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059810-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060724</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20020128</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-GLAXOSMITHKLINE-D0025264A</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>42</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>75.7</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FAT REDISTRIBUTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC STEATOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATOSPLENOMEGALY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIPODYSTROPHY ACQUIRED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIPOHYPERTROPHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URTICARIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZIAGEN</medicinalproduct>
        <drugauthorizationnumb>20977</drugauthorizationnumb>
        <drugdosagetext>300MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990715</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051024</drugenddate>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMBIVIR</medicinalproduct>
        <drugauthorizationnumb>020857</drugauthorizationnumb>
        <drugdosagetext>450MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19970411</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051024</drugenddate>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTIPLE MEDICATION</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INDINIVIR SULFATE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19970411</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19990824</drugenddate>
        <drugtreatmentduration>866</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EFAVIRENZ</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990824</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20001221</drugenddate>
        <drugtreatmentduration>486</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TENOFOVIR</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030617</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PEGASYS</medicinalproduct>
        <drugdosagetext>180MCG WEEKLY</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RIBAVIRIN</medicinalproduct>
        <drugdosagetext>800MG UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059811-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060724</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060425</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-GLAXOSMITHKLINE-D0049505A</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>63</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MACULAR OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISION BLURRED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL ACUITY REDUCED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REQUIP</medicinalproduct>
        <drugauthorizationnumb>20658</drugauthorizationnumb>
        <drugdosagetext>.25MG THREE TIMES PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PARKINSON'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031216</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COENZYME Q10</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PARKINSON'S DISEASE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059812-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060724</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060701</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006012023</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>17</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>50</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INTENTIONAL OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NO ADVERSE EFFECT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDE ATTEMPT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAGONIS</medicinalproduct>
        <drugauthorizationnumb>20031</drugauthorizationnumb>
        <drugdosagetext>5TAB SINGLE DOSE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059813-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060724</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060713</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-JNJFOC-20060700186</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>50</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE DRUG OVERDOSE INTENTIONAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDE ATTEMPT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMODIUM</medicinalproduct>
        <drugauthorizationnumb>19487</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DICLOFENAC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUOXETINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059814-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060724</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060710</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20060403304</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</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 TRANSIENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOPAMAX</medicinalproduct>
        <drugauthorizationnumb>20505</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MIGRAINE PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WELLBUTRIN</medicinalproduct>
        <drugindication>DEPRESSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059815-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060724</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060630</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2006DK09998</companynumb>
    <primarysource>
      <reportercountry>DENMARK</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>72</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE ENZYME INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULAR WEAKNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOSITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHABDOMYOLYSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GLEEVEC</medicinalproduct>
        <drugauthorizationnumb>21588</drugauthorizationnumb>
        <drugdosagetext>200 MG/D</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CHRONIC MYELOID LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060522</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugdosagetext>40 MG/D</drugdosagetext>
        <drugindication>HYPERCHOLESTEROLAEMIA</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060628</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059816-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060707</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2005P1000456</companynumb>
    <primarysource>
      <reportercountry>DENMARK</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>83</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>75</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANGINA PECTORIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RETEPLASE (RETEPLASE)</medicinalproduct>
        <drugdosagetext>IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ACUTE MYOCARDIAL INFARCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050831</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050831</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REOPRO</medicinalproduct>
        <drugdosagetext>IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ACUTE MYOCARDIAL INFARCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050831</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETYLSALICYLIC ACID SRT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLOPIDOGREL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARVEDILOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CIPROFLOXACIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059817-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060704</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FABR-11574</companynumb>
    <primarysource>
      <reportercountry>ROMANIA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>45</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>93</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANOREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLUENZA LIKE ILLNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FABRAZYME</medicinalproduct>
        <drugbatchnumb>1369038C</drugbatchnumb>
        <drugdosagetext>105 MG Q2WKS IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>FABRY'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060311</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TELMISARTAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059818-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060704</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006-02700</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>76</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>82</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY DISEASE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KENTERA (WATSON LABORATORIES) (OXYBUTYNIN) TRANSDERMAL PATCH, 3.9MG</medicinalproduct>
        <drugauthorizationnumb>21351</drugauthorizationnumb>
        <drugdosagetext>TRANSDERMAL</drugdosagetext>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>URGE INCONTINENCE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060426</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYMBICORT (BUDESONIDE, FORMOTEROL FUMARATE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETYLSALICYLIC ACID SRT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENALAPRIL MALEATE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059819-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060705</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006EN000129</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>20</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>52</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>APLASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUCOSAL INFLAMMATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCREATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RECTAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ONCASPAR</medicinalproduct>
        <drugdosagetext>2500 IU; X1; IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ACUTE LYMPHOCYTIC LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060424</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060424</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLAGYL</medicinalproduct>
        <drugdosagetext>500 MG</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060422</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060430</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOVIRAX</medicinalproduct>
        <drugdosagetext>380 MG IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060422</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060508</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMIKLIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLAVENTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VANCOCYNE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BACTRIM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLITICAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMBISOME</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPASFON</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOPHREN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NUBAIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059820-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060712</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>EM2006-0340</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>44</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>55</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INFLUENZA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROLEUKIN</medicinalproduct>
        <drugbatchnumb>UA8675B</drugbatchnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060213</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060217</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROLEUKIN</medicinalproduct>
        <drugbatchnumb>UA8675B</drugbatchnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060410</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060414</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROLEUKIN</medicinalproduct>
        <drugbatchnumb>UA8675B</drugbatchnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060612</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060616</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EMTRIVA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VIDEX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SUSTIVA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROZAC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETYLSALICYLIC ACID SRT</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059821-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060712</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>UKP06000178</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>63</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PANCREATITIS ACUTE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACTONEL</medicinalproduct>
        <drugauthorizationnumb>20835</drugauthorizationnumb>
        <drugdosagetext>35 MG, 1/WEEK, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059822-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060724</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060426</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHNU2006DE01788</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DERMATITIS ALLERGIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH PUSTULAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STOMACH DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TESTICULAR NEOPLASM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TESTICULAR OPERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TESTICULAR PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TEGRETOL</medicinalproduct>
        <drugbatchnumb>W0038</drugbatchnumb>
        <drugauthorizationnumb>20234</drugauthorizationnumb>
        <drugdosagetext>UNK, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>EPILEPSY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TEGRETOL</medicinalproduct>
        <drugauthorizationnumb>020234</drugauthorizationnumb>
        <drugdosagetext>1.5-0-1.5  / DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19900101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TEGRETOL</medicinalproduct>
        <drugbatchnumb>W0027</drugbatchnumb>
        <drugauthorizationnumb>020234</drugauthorizationnumb>
        <drugdosagetext>1.5-0-2 / DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PERENTEROL</medicinalproduct>
        <drugtreatmentduration>4320</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LUMINAL</medicinalproduct>
        <drugdosagetext>0.5-0-0.25 / DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RIVOTRIL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059823-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060724</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060620</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-MERCK-0606USA04088</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>63</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>55</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DERMATITIS PSORIASIFORM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COZAAR</medicinalproduct>
        <drugauthorizationnumb>20386</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060329</drugenddate>
        <drugtreatmentduration>119</drugtreatmentduration>
        <drugtreatmentdurationunit></drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19900101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059824-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060724</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060320</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-JNJFOC-20060703747</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>38</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG LEVEL INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MANIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IXPRIM</medicinalproduct>
        <drugauthorizationnumb>21123</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TERALITHE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BIPOLAR I DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACUPAN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NSAIDS</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059825-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060724</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060711</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20060505145</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>16</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PITUITARY TUMOUR BENIGN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERDAL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PSYCHOTIC DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERDAL</medicinalproduct>
        <drugauthorizationnumb>020272</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MAJOR DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GEODON</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PSYCHOTIC DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EFFEXOR</medicinalproduct>
        <drugdosagetext>37.5 MG AND INCREASED UP TO 150 MG</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEXAPRO</medicinalproduct>
        <drugdosagetext>15-20 MG</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEXAPRO</medicinalproduct>
        <drugdosagetext>20-30 MG</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059826-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060724</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060711</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20060702318</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>AGRANULOCYTOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERDAL</medicinalproduct>
        <drugauthorizationnumb>020272</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BIPOLAR I DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WELLBUTRIN XL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COGENTIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAQUENIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059827-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060724</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060711</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20051100117</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>146.97</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIABETES MELLITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIABETIC COMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIABETIC KETOACIDOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FOOD POISONING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCREATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERDAL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERDAL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERDAL</medicinalproduct>
        <drugdosagetext>THREE 2 MG TABLETS AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERDAL</medicinalproduct>
        <drugauthorizationnumb>020272</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEPAKOTE ER</medicinalproduct>
        <drugdosagetext>TWO 500 MG TABLETS AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEPAKOTE ER</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENADRYL</medicinalproduct>
        <drugdosagetext>50 MG IN THE MORNING, 100 MG AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENADRYL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOXYCYCLINE HCL</medicinalproduct>
        <drugdosagetext>ONE EVERY 12 HOURS WITH FOOD</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EMETROL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059828-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060724</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060711</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20030904432</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>102.06</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DELUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIABETIC NEUROPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GLUCOSE URINE PRESENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHOIDAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HALLUCINATION, AUDITORY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HALLUCINATION, VISUAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HOMICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERKERATOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERLIPIDAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTESTINAL POLYP</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RECTAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SCIATICA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEDATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEXUAL DYSFUNCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TARDIVE DYSKINESIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERDAL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERDAL</medicinalproduct>
        <drugdosagetext>BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERDAL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERDAL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERDAL</medicinalproduct>
        <drugdosagetext>1.5 MG IN THE MORNING; 3 MG AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERDAL</medicinalproduct>
        <drugdosagetext>BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BIPOLAR DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERDAL</medicinalproduct>
        <drugauthorizationnumb>020272</drugauthorizationnumb>
        <drugdosagetext>BEDTIME FOR FOUR WEEKS</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOAFFECTIVE DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERIDONE</medicinalproduct>
        <drugindication>BIPOLAR DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERIDONE</medicinalproduct>
        <drugauthorizationnumb>020588</drugauthorizationnumb>
        <drugdosagetext>BEDTIME</drugdosagetext>
        <drugindication>SCHIZOAFFECTIVE DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERDAL CONSTA</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>BIPOLAR DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERDAL CONSTA</medicinalproduct>
        <drugauthorizationnumb>021346</drugauthorizationnumb>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>SCHIZOAFFECTIVE DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HALOPERIDOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LITHIUM CARBONATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WELLBUTRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROZAC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MELLARIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MONOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAZODONE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATIVAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOTREL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRINIVIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>STRATTERA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GEODON</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROLIXIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMANTADINE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZANTAC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RITALIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NOVOLIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLYBURIDE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059829-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060724</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060712</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>HK-JNJFOC-20060600003</companynumb>
    <primarysource>
      <reportercountry>HONG KONG</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PERICARDIAL EFFUSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERDAL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERDAL</medicinalproduct>
        <drugauthorizationnumb>020272</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONAZEPAM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OLANZAPINE</medicinalproduct>
        <drugdosagetext>MORE THAN 10 YEARS</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059830-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060724</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060718</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0607USA04071</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>50</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ALLERGIC GRANULOMATOUS ANGIITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SINGULAIR</medicinalproduct>
        <drugauthorizationnumb>020829</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CORTICOSTEROIDS (UNSPECIFIED)</medicinalproduct>
        <drugadministrationroute>055</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059831-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060724</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060703</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CG-MERCK-0607USA00710</companynumb>
    <primarysource>
      <reportercountry>CONGO</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>7</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>21</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>AGITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANOREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VERTIGO</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>STROMECTOL</medicinalproduct>
        <drugauthorizationnumb>050742</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ONCHOCERCIASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060518</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060518</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059832-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060630</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>227309</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANAPHYLACTIC REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HERCEPTIN</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059833-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060710</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ORYNIA20060023</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>47</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>78.9259</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANGIONEUROTIC OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMPAIRED WORK ABILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERIORBITAL OEDEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugauthorizationnumb>20381</drugauthorizationnumb>
        <drugdosagetext>1000 MG QD PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERCHOLESTEROLAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060501</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COMBIGAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOVAN HCT</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059834-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060724</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060713</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20060702638</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>7</patientonsetage>
      <patientonsetageunit>800</patientonsetageunit>
      <patientsex>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>5059835-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060724</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060719</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006AP03336</companynumb>
    <primarysource>
      <reportercountry>KOREA, REPUBLIC OF</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>25776</patientonsetage>
      <patientonsetageunit>804</patientonsetageunit>
      <patientweight>69</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANGINA UNSTABLE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugauthorizationnumb>021366</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERLIPIDAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060522</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060529</drugenddate>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugauthorizationnumb>021366</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060607</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060607</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMODIPIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050627</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HARNAL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DYSURIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050602</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>THROMBOSIS PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050618</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059836-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060724</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060620</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006CG01088</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>23856</patientonsetage>
      <patientonsetageunit>804</patientonsetageunit>
      <patientweight>65</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>SKIN REACTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IRESSA</medicinalproduct>
        <drugauthorizationnumb>21399</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SQUAMOUS CELL CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060426</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060608</drugenddate>
        <drugtreatmentduration>44</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CISPLATIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>SQUAMOUS CELL CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060503</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060523</drugenddate>
        <drugtreatmentduration>21</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RADIOTHERAPY</medicinalproduct>
        <drugdosagetext>TOTAL DOSE RECEIVED : 36 GRAYS</drugdosagetext>
        <drugindication>SQUAMOUS CELL CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060503</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRACTAZIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059837-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060724</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060526</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006GB00921</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>67</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSED LEVEL OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRY MOUTH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HALLUCINATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HALLUCINATION, AUDITORY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOVENTILATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IRRITABILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOUTH ULCERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL STIFFNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NASAL CONGESTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEGATIVE THOUGHTS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OBSESSIVE THOUGHTS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARYNGOLARYNGEAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHOTOPSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWEATING FEVER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugauthorizationnumb>20639</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060428</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059838-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060724</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060714</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006UW14528</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>44</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>77.3</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLINDNESS TRANSIENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLINDNESS UNILATERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NIGHT SWEATS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RETINAL ARTERY OCCLUSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IRESSA</medicinalproduct>
        <drugbatchnumb>P/4026/8</drugbatchnumb>
        <drugauthorizationnumb>021399</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NEOPLASM MALIGNANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060621</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060630</drugenddate>
        <drugtreatmentduration>10</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMINS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059839-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060724</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060719</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006UW14807</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>80</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG DISPENSING ERROR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WRONG DRUG ADMINISTERED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIPRIVAN</medicinalproduct>
        <drugauthorizationnumb>019627</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROTONIX</medicinalproduct>
        <drugindication>GASTRIC DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059840-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesscongenitalanomali>1</seriousnesscongenitalanomali>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060724</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20000503</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>00USA10610</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>5</patientonsetage>
      <patientonsetageunit>802</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MULTIPLE CONGENITAL ABNORMALITIES</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRENATAL</medicinalproduct>
        <drugadministrationroute>064</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LOTREL</medicinalproduct>
        <drugauthorizationnumb>020364</drugauthorizationnumb>
        <drugadministrationroute>064</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19991001</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059841-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060705</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006BI005842</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>43</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BIPOLAR DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENTAL DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugdosagetext>30 UG QW IM</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980827</drugstartdate>
      </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>5059842-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060705</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006BI007101</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>46</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>UTERINE LEIOMYOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugbatchnumb>P35062</drugbatchnumb>
        <drugdosagetext>30 UG QW IM</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRIMIDONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GABAPENTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059843-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060712</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006086002</companynumb>
    <primarysource>
      <reportercountry>GREECE</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>19</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ALANINE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASPARTATE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MINOXIDIL</medicinalproduct>
        <drugauthorizationnumb>20834</drugauthorizationnumb>
        <drugdosagetext>50 MG/ML TWICE DAILY THEN ONCE DAILY, TOPICAL</drugdosagetext>
        <drugadministrationroute>061</drugadministrationroute>
        <drugindication>ALOPECIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060601</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059844-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060705</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006BI007663</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>63</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BALANCE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISORIENTATION</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>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>5059845-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060710</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006BI006377</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>65</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIABETIC FOOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POOR PERIPHERAL CIRCULATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POST PROCEDURAL COMPLICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POSTOPERATIVE WOUND INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STAPHYLOCOCCAL INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugdosagetext>30 UG QW IM</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990301</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>5059846-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060712</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2005BHI005670</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>53</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>GASTRIC BYPASS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OBESITY</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>20010411</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059847-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060711</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200614510BWH</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>77</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>CEREBRAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISEASE PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENTAL STATUS CHANGES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METASTASES TO CENTRAL NERVOUS SYSTEM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TUMOUR HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SORAFENIB</medicinalproduct>
        <drugauthorizationnumb>21923</drugauthorizationnumb>
        <drugdosagetext>400 MG BID ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>METASTATIC MALIGNANT MELANOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060112</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060620</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TEMADOR (TEMOZOLOMIDE)</medicinalproduct>
        <drugdosagetext>QD</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060119</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060119</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059848-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060703</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200613925BWH</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>85</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ANOREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLISTER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIALYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISEASE PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALIGNANT NEOPLASM PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH GENERALISED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SARCOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STOMATITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXAVAR</medicinalproduct>
        <drugauthorizationnumb>21923</drugauthorizationnumb>
        <drugdosagetext>400 MG BID ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RETROPERITONEAL CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060510</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060522</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059849-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060705</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200613154BWH</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>45</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>72.5755</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHOIDS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTRA-UTERINE DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVELOX</medicinalproduct>
        <drugauthorizationnumb>21085</drugauthorizationnumb>
        <drugdosagetext>400 MG QD ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>EAR INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060309</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060323</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVELOX</medicinalproduct>
        <drugauthorizationnumb>21085</drugauthorizationnumb>
        <drugdosagetext>400 MG QD ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>EAR INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060330</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060405</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CIPRODEX (CIPROFLOXACIN DEXAMETHASONE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLOXIN OTIC (BENZALKONIUM CHLORIDE, OFLOXACIN SODIUM CHLORIDE, SODIUM </medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOTRIMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHYLPREDNISOLONE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059850-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB200606003692</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>41</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>54</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ALANINE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>C-REACTIVE PROTEIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TONSILLITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GEMCITABINE</medicinalproduct>
        <drugauthorizationnumb>20509</drugauthorizationnumb>
        <drugdosagetext>3000 MG, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060522</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PACLITAXEL</medicinalproduct>
        <drugdosagetext>270 MG, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060522</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ONDANSETRON</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RANITIDINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CHLORPHENAMINE (CHLORPHENAMINE)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059851-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060724</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060714</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-JNJFOC-20040600022</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>90</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DURAGESIC-100</medicinalproduct>
        <drugbatchnumb>03JB632</drugbatchnumb>
        <drugauthorizationnumb>19813</drugauthorizationnumb>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>HERNIA PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THYROXINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FYBOGEL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HRT</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059852-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060724</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060714</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IE-JNJFOC-20060703014</companynumb>
    <primarysource>
      <reportercountry>IRELAND</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>80</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BURNS SECOND DEGREE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN REACTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DURAGESIC-50</medicinalproduct>
        <drugauthorizationnumb>019813</drugauthorizationnumb>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059853-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060724</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060712</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20060703511</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIAC ARREST</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DURAGESIC-100</medicinalproduct>
        <drugadministrationroute>062</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DURAGESIC-100</medicinalproduct>
        <drugauthorizationnumb>019813</drugauthorizationnumb>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MARIJUANA</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELEXA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEPAKOTE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059854-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060724</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060713</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>SE-JNJFOC-20060702967</companynumb>
    <primarysource>
      <reportercountry>SWEDEN</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>31</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>BUDD-CHIARI SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRINOVUM</medicinalproduct>
        <drugauthorizationnumb>18985</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONTRACEPTION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059855-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060724</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060711</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-JNJFOC-20051005676</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>OVARIAN NEOPLASM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVARIAN RUPTURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ORTHO M-21</medicinalproduct>
        <drugauthorizationnumb>17919</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041217</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059856-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060724</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060713</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>SE-JNJFOC-20060703141</companynumb>
    <primarysource>
      <reportercountry>SWEDEN</reportercountry>
      <qualification>3</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>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRINOVUM</medicinalproduct>
        <drugauthorizationnumb>18985</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONTRACEPTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XANOR</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMOVANE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CIPRAMIL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059857-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060724</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060710</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20060401324</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>67.81</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ACUTE MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG LEVEL DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG SCREEN POSITIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOXIC ENCEPHALOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTRACARDIAC THROMBUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MITRAL VALVE DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE CONTRACTIONS INVOLUNTARY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ROAD TRAFFIC ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TONIC CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENOUS THROMBOSIS LIMB</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENTRICULAR FIBRILLATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ORTHO EVRA</medicinalproduct>
        <drugauthorizationnumb>21180</drugauthorizationnumb>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>CONTRACEPTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HABITROL</medicinalproduct>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>SMOKING CESSATION THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPROL-XL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVASTATIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERLIPIDAEMIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059858-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060724</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060614</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006AC01119</companynumb>
    <primarysource>
      <reportercountry>NETHERLANDS</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>STOMATITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugauthorizationnumb>021366</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERCHOLESTEROLAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060316</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060406</drugenddate>
        <drugtreatmentduration>22</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THYROX</medicinalproduct>
        <drugindication>HYPOTHYROIDISM</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENALAPRIL MALEATE</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLOPIDOGREL</medicinalproduct>
        <drugindication>ARTERIOSCLEROSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059859-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060724</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006AP03013</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>23913</patientonsetage>
      <patientonsetageunit>804</patientonsetageunit>
      <patientweight>62</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD CREATINE PHOSPHOKINASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC FUNCTION ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOGLOBINURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POST PROCEDURAL COMPLICATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIPRIVAN</medicinalproduct>
        <drugauthorizationnumb>19627</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>INDUCTION OF ANAESTHESIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060622</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060622</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEVOFLURANE</medicinalproduct>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>MAINTENANCE OF ANAESTHESIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060622</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060622</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MEICELIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060622</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060622</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ROPION</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ANALGESIC THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060622</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060622</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ROPIVACAINE</medicinalproduct>
        <drugadministrationroute>008</drugadministrationroute>
        <drugindication>EPIDURAL ANAESTHESIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060622</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060622</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ROPIVACAINE</medicinalproduct>
        <drugadministrationroute>008</drugadministrationroute>
        <drugindication>ANALGESIC THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060622</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060622</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ROPIVACAINE</medicinalproduct>
        <drugadministrationroute>008</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060622</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060624</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ROPIVACAINE</medicinalproduct>
        <drugadministrationroute>008</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060622</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060624</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XYLOCAINE</medicinalproduct>
        <drugadministrationroute>008</drugadministrationroute>
        <drugindication>ANALGESIC THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060622</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060622</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CERCINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PREMEDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060622</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060622</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALTAT</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANAESTHETIC PREMEDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060622</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060622</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MUSCULAX</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>HYPOTONIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060622</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060622</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FENTANEST</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ANALGESIC THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060622</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060622</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FENTANEST</medicinalproduct>
        <drugadministrationroute>008</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060622</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060624</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EPHEDRIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060622</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060622</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATROPINE SULFATE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060622</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060622</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VAGOSTIGMIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060622</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060622</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADALAT</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059860-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060724</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060712</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006AP03255</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>18</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>EXTRASYSTOLES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROCEDURAL COMPLICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENTRICULAR EXTRASYSTOLES</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XYLOCAINE WITH EPINEPHERINE</medicinalproduct>
        <drugauthorizationnumb>6488</drugauthorizationnumb>
        <drugdosagetext>0.25% EPINEPHRINE</drugdosagetext>
        <drugadministrationroute>004</drugadministrationroute>
        <drugindication>INFILTRATION ANAESTHESIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XYLOCAINE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>INDUCTION OF ANAESTHESIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XYLOCAINE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIPRIVAN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>INDUCTION OF ANAESTHESIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FENTANYL CITRATE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>INDUCTION OF ANAESTHESIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FENTANYL CITRATE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MAINTENANCE OF ANAESTHESIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FENTANYL CITRATE</medicinalproduct>
        <drugadministrationroute>055</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FENTANYL CITRATE</medicinalproduct>
        <drugadministrationroute>055</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VECURONIUM BROMIDE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>INDUCTION OF ANAESTHESIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NITROUS OXIDE W/ OXYGEN</medicinalproduct>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>MAINTENANCE OF ANAESTHESIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SEVOFLURANE</medicinalproduct>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>MAINTENANCE OF ANAESTHESIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059861-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060724</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060508</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-SANOFI-SYNTHELABO-A03200602872</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>74.8</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ALANINE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASPARTATE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATITIS B ANTIGEN POSITIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATOCELLULAR DAMAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRANSAMINASES INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>UROXATRAL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>21287</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BENIGN PROSTATIC HYPERPLASIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060504</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMINS</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMITREX</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>MIGRAINE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REGALIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PHERGAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROSCAR</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>BENIGN PROSTATIC HYPERPLASIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TERAZOSIN HCL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>BENIGN PROSTATIC HYPERPLASIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059862-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060724</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060719</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-SANOFI-SYNTHELABO-F03200600164</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>60.8</patientweight>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGE INTRACRANIAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>REFUSAL OF TREATMENT BY RELATIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXALIPLATIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>21492</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER STAGE IIIB</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVAPRO</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN E</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FISH OIL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVASTIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>15 MG/KG, 913 MG EVERY 3 WEEKS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER STAGE IIIB</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060705</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060705</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GEMZAR</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER STAGE IIIB</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059863-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060724</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060622</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHO2006DE10204</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>44</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>66</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANGINA PECTORIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ELECTROCARDIOGRAM ST SEGMENT DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERICARDIAL EFFUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERICARDITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VAL +/- HCTZ VS AMLODIPINE +/- HCTZ</medicinalproduct>
        <drugauthorizationnumb>20818</drugauthorizationnumb>
        <drugdosagetext>LEVEL 1</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060524</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CONTRACEPTIVES UNS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059864-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060724</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060710</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006CG01187</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>0</patientonsetage>
      <patientonsetageunit>804</patientonsetageunit>
      <patientweight>3.3</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BRADYCARDIA NEONATAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONGENITAL HYDRONEPHROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEONATAL RESPIRATORY DEPRESSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TENORMIN</medicinalproduct>
        <drugauthorizationnumb>018240</drugauthorizationnumb>
        <drugadministrationroute>064</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMUREL</medicinalproduct>
        <drugadministrationroute>064</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060314</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SOLUPRED</medicinalproduct>
        <drugadministrationroute>064</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060314</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEORAL</medicinalproduct>
        <drugadministrationroute>064</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060314</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRANDATE</medicinalproduct>
        <drugadministrationroute>064</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060314</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059865-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060724</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060711</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006AP03340</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MYELODYSPLASTIC SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CASODEX</medicinalproduct>
        <drugauthorizationnumb>020498</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROSTATE CANCER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LH-RH AGONIST</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059866-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060724</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060531</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006AP02839</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>22422</patientonsetage>
      <patientonsetageunit>804</patientonsetageunit>
      <patientweight>45</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANOREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EOSINOPHILIC PNEUMONIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARIMIDEX</medicinalproduct>
        <drugauthorizationnumb>020541</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050811</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060524</drugenddate>
        <drugtreatmentduration>287</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARIMIDEX</medicinalproduct>
        <drugauthorizationnumb>020541</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>LUNG NEOPLASM MALIGNANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050811</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060524</drugenddate>
        <drugtreatmentduration>287</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>UFT</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021121</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060601</drugenddate>
        <drugtreatmentduration>1288</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PENTASA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>COLITIS ULCERATIVE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021004</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RADIOTHERAPY</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059867-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060724</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060720</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006UW14872</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>39</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>LEUKOCYTOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugauthorizationnumb>020639</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059868-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060710</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006BI009817</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>63</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE CONGESTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC VALVE 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>20000101</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>5059869-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060710</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006BI009854</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>NEPHROLITHIASIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugdosagetext>IM</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059870-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060710</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006BI009855</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>27</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLUENZA LIKE ILLNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE SCLEROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OPTIC NEURITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SCAR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugdosagetext>30 UG;QW;IM</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059871-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>NL200512000087</companynumb>
    <primarysource>
      <reportercountry>NETHERLANDS</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>68</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>1.8</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>CAMPYLOBACTER INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CULTURE STOOL POSITIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISEASE PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROENTERITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ILEUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METASTASES TO LIVER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GEMCITABINE</medicinalproduct>
        <drugauthorizationnumb>20509</drugauthorizationnumb>
        <drugdosagetext>2400 MG, Q3W, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050812</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051102</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CISPLATIN</medicinalproduct>
        <drugdosagetext>150 MG, Q3W, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050812</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051102</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DICLOFENAC (DICLOFENAC)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACENOCOUMAROL (ACENOCOUMAROL)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOSEC (OMEPRAZOLE)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059872-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060711</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006BI009857</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>52</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>GALLBLADDER PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugbatchnumb>P35080</drugbatchnumb>
        <drugdosagetext>30 UG;QW;IM</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059873-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060711</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006BI009863</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>53</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>JOINT 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>20021001</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>5059874-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060711</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006BI009865</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>67</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HEART RATE 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>20051101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059875-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060711</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006BI009908</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>50</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>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>19990630</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041101</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>20050601</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059876-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060711</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006BI009911</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>63</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugdosagetext>30 UG;QW;IM</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000501</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>5059877-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060630</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006RR-02886</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>40</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>RHABDOMYOLYSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SIMVASTATIN FAMILY (SIMVASTATIN) TABLET</medicinalproduct>
        <drugauthorizationnumb>76285</drugauthorizationnumb>
        <drugdosagetext>80 MG QD ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERCHOLESTEROLAEMIA</drugindication>
        <drugtreatmentduration>183</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059878-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>USA0509107097</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>28</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRE-ECLAMPSIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>60 MG, DAILY (1/D),</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRENATAL VITAMINS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VICODIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMBIEN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059879-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060724</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060613</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-SANOFI-SYNTHELABO-F01200601428</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVASTIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060425</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060425</drugenddate>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CAPECITABINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060328</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060508</drugenddate>
        <drugtreatmentduration>42</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXALIPLATIN</medicinalproduct>
        <drugauthorizationnumb>021492</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLORECTAL CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060425</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060425</drugenddate>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HALDOL</medicinalproduct>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLOMAX</medicinalproduct>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATIVAN</medicinalproduct>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VERAPAMIL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059880-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060724</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060717</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-SANOFI-SYNTHELABO-F01200601665</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>67</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ARTIFICIAL ANUS</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL PERFORATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUOROURACIL</medicinalproduct>
        <drugdosagetext>722MG/BODY=417.3MG/M2 IN BOLUS THEN 1083MG/BODY=626MG/M2 AS CONTINUOUS INFUSION</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLON CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060620</drugstartdate>
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        <drugenddate>20060620</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUOROURACIL</medicinalproduct>
        <drugdosagetext>722MG/BODY=417.3MG/M2 IN BOLUS THEN 1083MG/BODY=626MG/M2 AS CONTINUOUS INFUSION</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060620</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060621</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOXOPROFEN</medicinalproduct>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060704</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGNESIUM OXIDE</medicinalproduct>
        <drugdosagetext>0.9-1.2 G</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONSTIPATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060620</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MINOCYCLINE HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060608</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060704</drugenddate>
        <drugtreatmentduration>27</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIMETICONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>FLATULENCE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060606</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POVIDONE IODINE</medicinalproduct>
        <drugindication>STOMATITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060510</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060620</drugenddate>
        <drugtreatmentduration>42</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONAZEPAM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HICCUPS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060525</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060526</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BUTYRIC ACID BACTERIUM AGENT</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONSTIPATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DAI-KENCHU-TO</medicinalproduct>
        <drugdosagetext>7.5 G - 15.0 G</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ILEUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CALCIUM LEVOFOLINATE</medicinalproduct>
        <drugdosagetext>181MG/BODY=104.6MG/M2 AS INFUSION ON DAYS 1 AND 2</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLON CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060620</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060621</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXALIPLATIN</medicinalproduct>
        <drugauthorizationnumb>021492</drugauthorizationnumb>
        <drugdosagetext>153MG/BODY=88.4MG/M2 IN INFUSION ON DAY 1</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLON CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060620</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060620</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>805</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVASTIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLON CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060620</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060620</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059881-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060724</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060616</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-SANOFI-SYNTHELABO-F01200601474</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>COLORECTAL CANCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERAL PHYSICAL HEALTH DETERIORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALIGNANT NEOPLASM PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SMECTA</medicinalproduct>
        <drugdosagetext>UNK UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050316</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIFFU K</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050727</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLINOMEL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050426</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050801</drugenddate>
        <drugtreatmentduration>98</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TARGOCID</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050721</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050728</drugenddate>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050718</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPASFON</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050718</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050729</drugenddate>
        <drugtreatmentduration>12</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VOGALENE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050718</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOPHREN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050718</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050801</drugenddate>
        <drugtreatmentduration>15</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DI-ANTALVIC</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050526</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TINZAPARIN SODIUM</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050727</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEUCOVORIN CALCIUM</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050727</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050727</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUOROURACIL</medicinalproduct>
        <drugdosagetext>400 MG/M2 AS BOLUS FOLLOWED BY 2400 MG/M2 AS IV INFUSION, Q2W UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050727</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050727</drugenddate>
        <drugtreatmentduration>17</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXALIPLATIN</medicinalproduct>
        <drugauthorizationnumb>021492</drugauthorizationnumb>
        <drugdosagetext>100 MG/M2 Q2W UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLORECTAL CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050727</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050727</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>805</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059882-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060724</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-SANOFI-SYNTHELABO-A04200600664</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>68</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIOVASCULAR DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUS BRADYCARDIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>QUENSYL</medicinalproduct>
        <drugauthorizationnumb>9768</drugauthorizationnumb>
        <drugdosagetext>400 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SYSTEMIC LUPUS ERYTHEMATOSUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040301</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059883-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060724</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060509</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-SANOFI-SYNTHELABO-A01200603715</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ALANINE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASPARTATE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSAESTHESIA PHARYNX</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FACE OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LARYNGEAL OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OBSTRUCTIVE AIRWAYS DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHABDOMYOLYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROAT TIGHTNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DECACORT</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060510</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060512</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEO-MINOPHAGEN C</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060427</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060430</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGENSOL</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060412</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCICOL</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060412</drugenddate>
        <drugtreatmentduration>43</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DECADRON</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060412</drugenddate>
        <drugtreatmentduration>43</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CALCIUM LEVOFOLINATE</medicinalproduct>
        <drugdosagetext>INFUSION ON D1+2</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060412</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060413</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUOROURACIL</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugdosagetext>625MG/BODY=395.6MG/M2 IN BOLUS THEN 950MG/BODY=601.3MG/M2 AS CONTINUOUS INFUSION DAYS 1 AND 2</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060412</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060413</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXALIPLATIN</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021492</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RECTAL CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060412</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060412</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059884-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060724</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060712</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-SANOFI-SYNTHELABO-A01200605539</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>57</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>40</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>POST PROCEDURAL COMPLICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY ARREST</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ROPIVACAINE</medicinalproduct>
        <drugdosagetext>1.5 ML/HR UNK</drugdosagetext>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEPIVACAINE HCL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FENTANYL TRANSDERMAL SYSTEM</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROPOFOL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIDOCAINE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FAMOTIDINE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PENTAGIN</medicinalproduct>
        <drugdosagetext>15 MG</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059885-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060724</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060110</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006AP00149</companynumb>
    <primarysource>
      <reportercountry>RUSSIAN FEDERATION</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>23690</patientonsetage>
      <patientonsetageunit>804</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>MALIGNANT NEOPLASM PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NON-SMALL CELL LUNG CANCER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IRESSA</medicinalproduct>
        <drugauthorizationnumb>21399</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050202</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050315</drugenddate>
        <drugtreatmentduration>42</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRONOLACTONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIGOXIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CONDANONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059886-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US200605005366</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>58</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE SYSTOLIC INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>90 MG, DAILY (1/D),</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCODONE BITARTRATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THIAZIDES</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LAMICTAL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZETIA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLPIDEM TARTRATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATIVAN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059887-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060703</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>06-000588</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>29</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ADRENAL SUPPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ADRENOCORTICAL INSUFFICIENCY ACUTE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TACLONEX</medicinalproduct>
        <drugauthorizationnumb>21852</drugauthorizationnumb>
        <drugdosagetext>TOPICAL</drugdosagetext>
        <drugadministrationroute>061</drugadministrationroute>
        <drugindication>PSORIASIS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060601</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059888-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060627</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US200604002744</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>54</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INADEQUATELY CONTROLLED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugindication>MAJOR DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060206</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060215</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugindication>MAJOR DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060216</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060406</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOFRANIL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059889-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060704</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DK200607000181</companynumb>
    <primarysource>
      <reportercountry>DENMARK</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>53</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ALANINE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASPARTATE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAMMA-GLUTAMYLTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVERDOSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DULOXETINE HYDROCHLORIDE (DULOXETINE HYDROCHLORIDE) CAPSULE</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>180 MG, DAILY (1/D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ORABET (TOLBUTAMIDE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LAMICTAL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REMERON</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059890-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060706</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2005107341</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>29</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>105.6881</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>COMPLETED SUICIDE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL OVERDOSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
        <drugauthorizationnumb>20235</drugauthorizationnumb>
        <drugdosagetext>1200 MG (400 MG, 3 IN 1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BIPOLAR DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030514</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugdosagetext>500 MG (1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KLONOPIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PAMELOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LITHOBID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NAVANE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COGENTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HALDOL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059891-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060703</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ST-2006-008917</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>75</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>74</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>INTERSTITIAL LUNG DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPHOCYTE STIMULATION TEST POSITIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OLMETEC</medicinalproduct>
        <drugauthorizationnumb>21286</drugauthorizationnumb>
        <drugdosagetext>10 MG BID PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060107</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060223</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARTIONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOZYM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059892-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060708</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2005119555</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>78</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>83.9154</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BENIGN PROSTATIC HYPERPLASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD URINE PRESENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POLLAKIURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THERAPEUTIC RESPONSE UNEXPECTED WITH DRUG SUBSTITUTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TINNITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUPRIL</medicinalproduct>
        <drugauthorizationnumb>19885</drugauthorizationnumb>
        <drugdosagetext>20 MG (20 MG, 1 IN 1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>QUINAPRIL HCL</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOPROL-XL</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059893-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060705</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006017888</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>59</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>64.4108</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugauthorizationnumb>21446</drugauthorizationnumb>
        <drugdosagetext>50 MG (50 MG, 1 IN 1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NEURALGIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PERCOCET</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059894-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060630</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP200604003703</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>2</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>AMENORRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PROLACTIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENSTRUAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OBSESSIVE THOUGHTS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PIGMENTATION DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSYCHOTIC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SCHIZOPHRENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
        <drugauthorizationnumb>20592</drugauthorizationnumb>
        <drugdosagetext>10 MG, DAILY (1/D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050601</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
        <drugdosagetext>10 MG, DAILY (1/D), ORAL; SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060405</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060507</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
        <drugdosagetext>10 MG, DAILY (1/D), ORAL; SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060508</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060612</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
        <drugdosagetext>10 MG, DAILY (1/D), ORAL; SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060613</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEPAKENE-R /JPN/ (VALPROATE SODIUM)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DORAL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059895-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060705</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006021530</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>80</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>79</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>AMNESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACTERIAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CULTURE POSITIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD SODIUM DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBRAL ATROPHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMPUTERISED TOMOGRAM ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG NEOPLASM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENTAL STATUS CHANGES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEOPLASM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NORMAL PRESSURE HYDROCEPHALUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERFORMANCE STATUS DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUTENT</medicinalproduct>
        <drugauthorizationnumb>21968</drugauthorizationnumb>
        <drugdosagetext>37.5 MG (37.5 MG, 1 IN 1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RENAL CELL CARCINOMA STAGE UNSPECIFIED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060126</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059896-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060705</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006044084</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>42</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>61.2356</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIAC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EMOTIONAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART TRANSPLANT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHEUMATOID ARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugauthorizationnumb>20998</drugauthorizationnumb>
        <drugdosagetext>400 MG (200 MG, 2 IN 1 D),</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20001001</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059897-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060627</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA200606005702</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>5</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>22.7</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>AGGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CRYING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DARK CIRCLES UNDER EYES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLATULENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IRRITABILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>STRATTERA</medicinalproduct>
        <drugauthorizationnumb>21411</drugauthorizationnumb>
        <drugdosagetext>10 MG</drugdosagetext>
        <drugindication>ATTENTION DEFICIT/HYPERACTIVITY DISORDER</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060612</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RISPERDAL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GABAPENTIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059898-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060630</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR200607000304</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>55</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EVISTA</medicinalproduct>
        <drugauthorizationnumb>20815</drugauthorizationnumb>
        <drugdosagetext>60 MG, DAILY (1/D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059899-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060724</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060719</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-SP-2006-01872</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>URINARY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>THERACYS</medicinalproduct>
        <drugbatchnumb>C2505A</drugbatchnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>BLADDER CANCER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059900-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060724</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060410</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ITWYE544810APR06</companynumb>
    <primarysource>
      <reportercountry>ITALY</reportercountry>
      <qualification>3</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>20050321</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060216</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
        <drugdosagetext>5 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDROL</medicinalproduct>
        <drugdosagetext>8 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACTONEL</medicinalproduct>
        <drugdosagetext>35 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D3</medicinalproduct>
        <drugdosagetext>500 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATORVASTATIN CALCIUM</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051201</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059901-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060724</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060710</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006AP03179</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>58</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CATARACT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHOTOPSIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OMEPRAL</medicinalproduct>
        <drugauthorizationnumb>19810</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059902-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060724</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060714</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006SE03984</companynumb>
    <primarysource>
      <reportercountry>RUSSIAN FEDERATION</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>65</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>68</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CHOLANGITIS SCLEROSING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHOLECYSTITIS CHRONIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCREATIC NEOPLASM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCREATITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ATACAND</medicinalproduct>
        <drugauthorizationnumb>020838</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051215</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060621</drugenddate>
        <drugtreatmentduration>189</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059903-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060724</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060712</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2006JP10463</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>92</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIOVASCULAR INSUFFICIENCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG ADMINISTRATION ERROR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VALSARTAN</medicinalproduct>
        <drugauthorizationnumb>20665</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIGOXIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AROTINOLOL HYDROCHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ISOSORBIDE DINITRATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IFENPRODIL TARTRATE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059904-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060724</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060303</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-NOVOPROD-251312</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>24</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>120</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NOVOSEVEN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>100 UG/KG, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>TRAUMATIC HAEMORRHAGE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060225</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060225</drugenddate>
        <drugtreatmentduration>1440</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EPINEPHRINE</medicinalproduct>
        <drugdosagetext>UNKNOWN</drugdosagetext>
        <drugindication>CARDIAC ARREST</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060225</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060225</drugenddate>
        <drugtreatmentduration>1440</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BLOOD CELLS, PACKED HUMAN</medicinalproduct>
        <drugdosagetext>25 U, SINGLE</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>HAEMORRHAGE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060225</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060225</drugenddate>
        <drugtreatmentduration>1440</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOPHED</medicinalproduct>
        <drugdosagetext>UNKNOWN</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>HYPOTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060225</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060225</drugenddate>
        <drugtreatmentduration>1440</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOPAMINE</medicinalproduct>
        <drugdosagetext>UNKNOWN</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>HYPOTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060225</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060225</drugenddate>
        <drugtreatmentduration>1440</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059905-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US200607000862</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>53</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEAFNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EPILEPSY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL ACUITY REDUCED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMALOG</medicinalproduct>
        <drugauthorizationnumb>20563</drugauthorizationnumb>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INSULIN, ANIMAL (INSULIN, ANIMAL UNKNOWN MANUFACTURER)</medicinalproduct>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19640101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMULIN R</medicinalproduct>
        <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>20000101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DILANTIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059907-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060327</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>VE200607001149</companynumb>
    <primarysource>
      <reportercountry>VENEZUELA</reportercountry>
      <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>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMPLETED SUICIDE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
        <drugauthorizationnumb>20592</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EFFEXOR</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059908-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060630</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US200607000374</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>39</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>COMPLETED SUICIDE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCORRECT DOSE ADMINISTERED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRIAPISM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CIALIS</medicinalproduct>
        <drugauthorizationnumb>21368</drugauthorizationnumb>
        <drugdosagetext>40 MG</drugdosagetext>
        <drugindication>ERECTILE DYSFUNCTION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059909-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050706</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US200607000519</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>13</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ELECTROCARDIOGRAM QT CORRECTED INTERVAL PROLONGED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>STRATTERA</medicinalproduct>
        <drugauthorizationnumb>21411</drugauthorizationnumb>
        <drugdosagetext>25 MG DAILY (1/D)</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059910-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>TW200606005900</companynumb>
    <primarysource>
      <reportercountry>TAIWAN, PROVINCE OF CHINA</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>60</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>EYE PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE SWELLING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EVISTA</medicinalproduct>
        <drugauthorizationnumb>20815</drugauthorizationnumb>
        <drugdosagetext>60 MG DAILY (1/D) ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060621</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARIMIDEX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTIHISTAMINES</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059911-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060701</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US200607000328</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>29</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>95.2</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CARCINOID TUMOUR PULMONARY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SERUM SEROTONIN INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SOMATROPIN (SOMATROPIN)VIAL</medicinalproduct>
        <drugauthorizationnumb>19640</drugauthorizationnumb>
        <drugdosagetext>0.8 MG DAILY (1/D), SUBCUTANEOUS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>HYPOPITUITARISM</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010801</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCORTISONE TAB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANDROGEL (TESTOTESTERONE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOSTINEX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOXYL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059912-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060630</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US200606006288</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL ULCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EVISTA</medicinalproduct>
        <drugauthorizationnumb>20815</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIABETES MEDICATION (METFORMIN HYDROCHLORIDE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BLOOD PRESSURE MEDICATION (ATENOLOL)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059914-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060714</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>008015</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BREAST CANCER FEMALE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MEDROXYPROGESTERONE ACETATE</medicinalproduct>
        <drugauthorizationnumb>40159</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19950701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19981001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19950701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19981001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMPHASE (PREMARIN;CYCRIN 14/14)</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19950701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19981001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROVERA</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19950701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19981001</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059915-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060714</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>008016</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BREAST CANCER FEMALE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MEDROXYPROGESTERONE ACETATE</medicinalproduct>
        <drugauthorizationnumb>40159</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19950101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20011201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19950101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20011201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMPRO</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19950101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20011201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ESTRATEST</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19950101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20011201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROVERA</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19950101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20011201</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059916-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060707</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>S06-GER-02856-01</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>46</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DERMATITIS BULLOUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ESCITALOPRAM OXALATE</medicinalproduct>
        <drugauthorizationnumb>21323</drugauthorizationnumb>
        <drugdosagetext>10 MG QD PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060410</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060602</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATORVASTATIN CALCIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLPIDEM TARTRATE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059917-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060714</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>008017</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BREAST CANCER FEMALE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MEDROXYPROGESTERONE ACETATE</medicinalproduct>
        <drugauthorizationnumb>40159</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19790101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19990401</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19790101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19990401</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMPRO</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19790101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19990401</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROVERA</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19790101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19990401</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059919-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060707</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>S06-GER-02854-01</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>62</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>LIPOMATOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ESCITALOPRAM</medicinalproduct>
        <drugauthorizationnumb>21323</drugauthorizationnumb>
        <drugdosagetext>5 MG QD PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANXIETY DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050524</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060609</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ESCITALOPRAM</medicinalproduct>
        <drugdosagetext>5 MG QD PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANXIETY DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060703</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060705</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BLOPRESS (CANDESARTAN CILEXETIL)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEBIVOLOL HCL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059920-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060706</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>S06-DEN-02851-01</companynumb>
    <primarysource>
      <reportercountry>DENMARK</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>32</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DIABETES MELLITUS INADEQUATE CONTROL</reactionmeddrapt>
      </reaction>
      <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>CITALOPRAM HYDROBROMIDE</medicinalproduct>
        <drugdosagetext>20 MG QD PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ISOPHANE INSULIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059921-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ES200607000254</companynumb>
    <primarysource>
      <reportercountry>SPAIN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>80</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ATRIAL FIBRILLATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BUNDLE BRANCH BLOCK LEFT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRICUSPID VALVE INCOMPETENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugauthorizationnumb>21318</drugauthorizationnumb>
        <drugindication>OSTEOPOROSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FORTEO PEN (FORTEO PEN)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM (CALCIUM)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMERIDE (AMILORIDE HYDROCHLORIDE, HYDROCHLOROTHIAZIDE)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059922-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060630</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PL200607000078</companynumb>
    <primarysource>
      <reportercountry>POLAND</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>60</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMALOG MIX 75/25</medicinalproduct>
        <drugauthorizationnumb>20563</drugauthorizationnumb>
        <drugdosagetext>2/D, SUBCUTANEOUS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>DIABETES MELLITUS NON-INSULIN-DEPENDENT</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059923-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA200606006014</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>71</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEAD INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SCAN ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN LACERATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugauthorizationnumb>21318</drugauthorizationnumb>
        <drugdosagetext>20 UG, DAILY (1/D)</drugdosagetext>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FORTEO PEN (FORTEO PEN)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMITRIPTYLINE (AMITRIPTYLINE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NADOLOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM (CALCIUM)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYLENOL W/ CODEINE NO. 3</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTIVIT (VITAMINS NOS)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCONTIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059924-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060724</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050310</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-ROCHE-398368</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>44</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANGINA PECTORIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC ENZYME INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER TRANSPLANT REJECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLEURAL EFFUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY DEPRESSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VALIUM</medicinalproduct>
        <drugauthorizationnumb>13263</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>SEDATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VALIUM</medicinalproduct>
        <drugauthorizationnumb>013263</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050225</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050225</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZENAPAX</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050217</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050217</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZENAPAX</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050224</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050224</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MYCOPHENOLATE MOFETIL</medicinalproduct>
        <drugauthorizationnumb>050758</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050217</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050222</drugenddate>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MYCOPHENOLATE MOFETIL</medicinalproduct>
        <drugauthorizationnumb>050723</drugauthorizationnumb>
        <drugdosagetext>SWITCH FROM IV TO ORAL - NO DOSE CHANGE.</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050223</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050307</drugenddate>
        <drugtreatmentduration>13</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MYCOPHENOLATE MOFETIL</medicinalproduct>
        <drugauthorizationnumb>050723</drugauthorizationnumb>
        <drugdosagetext>TREATMENT OF REJECTION. 1000MG IN THE MORNING AND 1500MG IN THE EVENING.</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050308</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050308</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MYCOPHENOLATE MOFETIL</medicinalproduct>
        <drugauthorizationnumb>050723</drugauthorizationnumb>
        <drugdosagetext>NEW MAINTENANCE DOSE BECAUSE OF REJECTION.</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050309</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050315</drugenddate>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MYCOPHENOLATE MOFETIL</medicinalproduct>
        <drugauthorizationnumb>050723</drugauthorizationnumb>
        <drugdosagetext>RETURN TOWARDS PER PROTOCOL DOSE.</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050316</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050609</drugenddate>
        <drugtreatmentduration>86</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MYCOPHENOLATE MOFETIL</medicinalproduct>
        <drugauthorizationnumb>050723</drugauthorizationnumb>
        <drugdosagetext>RETURN TOWARDS PROTOCOL DOSE.</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050613</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TACROLIMUS</medicinalproduct>
        <drugauthorizationnumb>050723</drugauthorizationnumb>
        <drugdosagetext>DOSE ADJUSTED TO REACH PREDEFINED TARGET LEVELS.</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050222</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050308</drugenddate>
        <drugtreatmentduration>15</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TACROLIMUS</medicinalproduct>
        <drugauthorizationnumb>050723</drugauthorizationnumb>
        <drugdosagetext>5.5MG DOSE: 2.5MG AND 3MG. NEW MAINTENANCE DOSE BECAUSE OF REJECTION.</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050309</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050321</drugenddate>
        <drugtreatmentduration>13</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TACROLIMUS</medicinalproduct>
        <drugauthorizationnumb>050723</drugauthorizationnumb>
        <drugdosagetext>7MG DOSE: 3MG AND 4MG. DOSE ADJUSTED TO REACH PREDEFINED TARGET LEVELS.</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050322</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHYLPREDNISOLONE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050217</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050217</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHYLPREDNISOLONE</medicinalproduct>
        <drugdosagetext>TREATMENT OF REJECTION.</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050307</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050309</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugdosagetext>TAPER ACCORDING TO LOCAL PROTOCOL.</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050218</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050425</drugenddate>
        <drugtreatmentduration>67</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETYLCYSTEINE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050222</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050306</drugenddate>
        <drugtreatmentduration>13</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NOREPINEPHRINE HCL</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050217</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050219</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTITHROMBIN III</medicinalproduct>
        <drugindication>THROMBOSIS PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050217</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050219</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SULFAMETHOXAZOLE + TRIMETHOPRIM</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050218</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL SUCCINATE</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050222</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NADROPARIN</medicinalproduct>
        <drugindication>THROMBOSIS PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050222</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050315</drugenddate>
        <drugtreatmentduration>22</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUMIN (HUMAN)</medicinalproduct>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050219</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050227</drugenddate>
        <drugtreatmentduration>9</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HEPARIN</medicinalproduct>
        <drugindication>HAEMORRHAGE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050225</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050227</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
        <drugindication>DIURETIC THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050218</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050305</drugenddate>
        <drugtreatmentduration>16</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BROMAZEPAM</medicinalproduct>
        <drugindication>ANXIETY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050224</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050304</drugenddate>
        <drugtreatmentduration>9</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NYSTATIN</medicinalproduct>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050217</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050315</drugenddate>
        <drugtreatmentduration>27</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METAMIZOL</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050222</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050228</drugenddate>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANTOPRAZOL</medicinalproduct>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050217</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050512</drugenddate>
        <drugtreatmentduration>85</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONIDIN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050218</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050226</drugenddate>
        <drugtreatmentduration>9</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SUCRALFAT</medicinalproduct>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050223</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050315</drugenddate>
        <drugtreatmentduration>21</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MUPIROCIN</medicinalproduct>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050217</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050315</drugenddate>
        <drugtreatmentduration>27</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALGANCICLOVIR HCL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050222</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PIRITRAMID</medicinalproduct>
        <drugindication>ANAESTHETIC PREMEDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050217</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050226</drugenddate>
        <drugtreatmentduration>10</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLYCEROLTRINITRAT</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050222</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050222</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOXEPIN HCL</medicinalproduct>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050223</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050315</drugenddate>
        <drugtreatmentduration>21</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCITRIOL</medicinalproduct>
        <drugindication>OSTEOPOROSIS PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050513</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM GLUCONATE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050217</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050218</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CEFOTAXIM</medicinalproduct>
        <drugindication>INFECTION PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050217</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050219</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METRONIDAZOLE</medicinalproduct>
        <drugindication>INFECTION PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050217</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050219</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GANCICLOVIR</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050218</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050222</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROPOFOL</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050217</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050217</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BLOOD, PACKED RED CELLS</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050218</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050219</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FRESH FROZEN PLASMA</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050218</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050218</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050217</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050221</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM CHLORIDE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050217</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050227</drugenddate>
        <drugtreatmentduration>11</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GRANISETRON HCL</medicinalproduct>
        <drugindication>VOMITING</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050221</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050221</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOCLOPRAMID-HCL</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050219</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050221</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>1 CONCOMITANT DRUG</medicinalproduct>
        <drugdosagetext>DRUG REPORTED AS AMBRAXOL.</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050217</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050221</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE/SPIRONOLACTONE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050217</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050220</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAMADOL HCL</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050228</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050228</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>APROTININ</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050217</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050218</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TORSEMIDE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050307</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050307</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALERIAN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050222</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050222</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DICLOFENAC</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050308</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050308</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORMOFUNDIN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050217</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050221</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TPN ELECTROLYTES IN PLASTIC CONTAINER</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050219</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050220</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUMAZENIL</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050225</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050225</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INTESTAMIN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050218</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050219</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059925-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IN200606005947</companynumb>
    <primarysource>
      <reportercountry>INDIA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>65</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BRAIN HYPOXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XIGRIS</medicinalproduct>
        <drugbatchnumb>A128906</drugbatchnumb>
        <drugdosagetext>24 MCG/KG/HR FOR 96 HRS., INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>SEPTIC SHOCK</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060626</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060627</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059926-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060711</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>E2090-00044-SPO-JP</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>4</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>METABOLIC ACIDOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE FRACTURES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOMALACIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL TUBULAR ACIDOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VITAMIN D ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZONISAMIDE</medicinalproduct>
        <drugauthorizationnumb>20789</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>EPILEPSY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VALPROATE SODIUM</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>EPILEPSY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059927-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060707</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>02H-153-0205461-00</companynumb>
    <primarysource>
      <reportercountry>TAIWAN, PROVINCE OF CHINA</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>1</patientonsetage>
      <patientonsetageunit>804</patientonsetageunit>
      <patientweight>3.165</patientweight>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>BRADYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CYANOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEDICATION ERROR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METABOLIC ACIDOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTI-ORGAN FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEONATAL RESPIRATORY ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULSE ABSENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY ACIDOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WRONG DRUG ADMINISTERED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ATRACURIUM BESYLATE</medicinalproduct>
        <drugbatchnumb>76391 DK</drugbatchnumb>
        <drugauthorizationnumb>74633</drugauthorizationnumb>
        <drugdosagetext>10 MG, ONCE, INTRAMUSCULAR</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021129</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20021129</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059928-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060630</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR200607000303</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>55</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EVISTA</medicinalproduct>
        <drugauthorizationnumb>20815</drugauthorizationnumb>
        <drugdosagetext>60 MG, DAILY (1/D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059929-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060707</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>02H-153-0205476-00</companynumb>
    <primarysource>
      <reportercountry>TAIWAN, PROVINCE OF CHINA</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>3.89</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD CREATINE PHOSPHOKINASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRADYCARDIA NEONATAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRAIN OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CYANOSIS NEONATAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEVELOPMENTAL DELAY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTONIA NEONATAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEDICATION ERROR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEONATAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEONATAL RESPIRATORY ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEURODEVELOPMENTAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WRONG DRUG ADMINISTERED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ATRACURIUM BESYLATE</medicinalproduct>
        <drugbatchnumb>76391-DK</drugbatchnumb>
        <drugauthorizationnumb>74633</drugauthorizationnumb>
        <drugdosagetext>10 MG, ONCE, INTRAMUSCULAR</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021129</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20021129</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059930-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060707</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>E2090-00042-SPO-JP</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>24</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CALCULUS URETERIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEPHROLITHIASIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZONISAMIDE</medicinalproduct>
        <drugauthorizationnumb>20789</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CEREBRAL PALSY</drugindication>
        <drugtreatmentduration>10</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZONISAMIDE</medicinalproduct>
        <drugauthorizationnumb>20789</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>EPILEPSY</drugindication>
        <drugtreatmentduration>10</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEPAKENE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059931-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060707</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>02H-153-0205478-00</companynumb>
    <primarysource>
      <reportercountry>TAIWAN, PROVINCE OF CHINA</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD CREATINE PHOSPHOKINASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRADYCARDIA NEONATAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CYANOSIS NEONATAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTONIA NEONATAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEONATAL RESPIRATORY ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEONATAL RESPIRATORY FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WRONG DRUG ADMINISTERED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ATRACURIUM BESYLATE</medicinalproduct>
        <drugbatchnumb>76391 DK</drugbatchnumb>
        <drugauthorizationnumb>74633</drugauthorizationnumb>
        <drugdosagetext>10 MG, ONCE, INTRAMUSCULAR</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021129</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20021129</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059932-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060707</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>02H-153-0205479-00</companynumb>
    <primarysource>
      <reportercountry>TAIWAN, PROVINCE OF CHINA</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>2.835</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD CREATINE PHOSPHOKINASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE IMMEASURABLE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRADYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METABOLIC ACIDOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEONATAL RESPIRATORY ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY ACIDOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WRONG DRUG ADMINISTERED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ATRACURIUM BESYLATE</medicinalproduct>
        <drugbatchnumb>76391 DK</drugbatchnumb>
        <drugauthorizationnumb>74633</drugauthorizationnumb>
        <drugdosagetext>10 MG, ONCE, INTRAMUSCULAR</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021129</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20021129</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059933-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060703</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CH-2006-017580</companynumb>
    <primarysource>
      <reportercountry>SWITZERLAND</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>68</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>COLON CANCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BETASERON</medicinalproduct>
        <drugdosagetext>8 MIU, SUBCUTANEOUS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>SECONDARY PROGRESSIVE MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19971022</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060601</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059934-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060704</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006P1000366</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>44</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>APLASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD ALKALINE PHOSPHATASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAMMA-GLUTAMYLTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCORRECT DOSE ADMINISTERED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUCOSAL INFLAMMATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STOMATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRANSAMINASES INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BUSULFAN (BUSULFAN)</medicinalproduct>
        <drugauthorizationnumb>20954</drugauthorizationnumb>
        <drugdosagetext>208 MG; QD; IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>STEM CELL TRANSPLANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060322</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060326</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALKERAN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059935-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060710</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-2006-015555</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>22</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>60</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ACNE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIPLOPIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EXOPHTHALMOS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYDRIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISION BLURRED</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>20060301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060501</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059936-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060712</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-2006-018727</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>19</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>55</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLD SWEAT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CYANOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FORMICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAIR DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN WRINKLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UNEVALUABLE EVENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YASMIN</medicinalproduct>
        <drugauthorizationnumb>21098</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>POLYCYSTIC OVARIES</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030501</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YASMIN</medicinalproduct>
        <drugauthorizationnumb>21098</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>POLYCYSTIC OVARIES</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060501</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YASMIN</medicinalproduct>
        <drugauthorizationnumb>21098</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>POLYCYSTIC OVARIES</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060703</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060709</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059937-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060713</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>RU-2006-018747</companynumb>
    <primarysource>
      <reportercountry>RUSSIAN FEDERATION</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>43</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEEP VEIN THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIRENA</medicinalproduct>
        <drugauthorizationnumb>21225</drugauthorizationnumb>
        <drugdosagetext>20 UG/DAY, CONT, INTRA-UTERINE</drugdosagetext>
        <drugadministrationroute>015</drugadministrationroute>
        <drugindication>MENORRHAGIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060628</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059938-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060711</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200612941BCC</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </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>ALLERGY TO CHEMICALS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALKA-SELTZER GOLD ANTACID</medicinalproduct>
        <drugdosagetext>2000 MG, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ALLERGY TO CHEMICALS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19870101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NATURES BIOTICS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059940-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060706</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>227162</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>80</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>SQUAMOUS CELL CARCINOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MABTHERA(RITUXIMAB) CONC FOR SOLUTION FOR INFUSION</medicinalproduct>
        <drugdosagetext>1 UNK, 1/WEEK</drugdosagetext>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059941-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060706</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>225993</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>19</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>55</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IDIOPATHIC THROMBOCYTOPENIC PURPURA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MABTHERA(RITUXIMAB) CONC FOR SOLUTION FOR INFUSION</medicinalproduct>
        <drugbatchnumb>B2092</drugbatchnumb>
        <drugdosagetext>375 MG/M2, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>AUTOIMMUNE THROMBOCYTOPENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060524</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060531</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059943-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060706</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>S06-SWI-02852-01</companynumb>
    <primarysource>
      <reportercountry>SWITZERLAND</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>17</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DELIRIUM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EXTRAPYRAMIDAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OXYGEN SATURATION DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CITALOPRAM HYDROBROMIDE</medicinalproduct>
        <drugauthorizationnumb>20822</drugauthorizationnumb>
        <drugdosagetext>40 MG QD PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060612</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NOZINAN (LEVOMEPROMAZINE)</medicinalproduct>
        <drugdosagetext>75 MG QD PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONDUCT DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060608</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060611</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIRTAZAPINE</medicinalproduct>
        <drugdosagetext>15 MG QD PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>TENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060611</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060612</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AKINETON</medicinalproduct>
        <drugdosagetext>4 MG QD PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>EXTRAPYRAMIDAL DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060612</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060612</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059944-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060707</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>226651</companynumb>
    <primarysource>
      <reportercountry>SWITZERLAND</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>25</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XOLAIR</medicinalproduct>
        <drugdosagetext>150 MG, SINGLE, SUBCUTANEOUS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060614</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060614</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DECORTIN (PREDNISONE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AZATHIOPRINE SODIUM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059945-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060724</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060719</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006PK01542</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>20</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>100</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INTENTIONAL OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE DRUG OVERDOSE INTENTIONAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDE ATTEMPT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>QUETIAPINE FUMARATE</medicinalproduct>
        <drugauthorizationnumb>20639</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIPIPERON</medicinalproduct>
        <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>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059946-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060706</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>227165</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>64</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>SQUAMOUS CELL CARCINOMA OF SKIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MABTHERA(RITUXIMAB) CONC FOR SOLUTION FOR INFUSION</medicinalproduct>
        <drugdosagetext>1, 1/WEEK</drugdosagetext>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059947-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060705</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>S06-FRA-02697-01</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>47</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CITALOPRAM HYDROBROMIDE</medicinalproduct>
        <drugauthorizationnumb>20822</drugauthorizationnumb>
        <drugdosagetext>1 UNITS QD PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040115</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SINEMET</medicinalproduct>
        <drugdosagetext>100 MG TID PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050426</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051026</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SINEMET</medicinalproduct>
        <drugdosagetext>400 MG TID PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051027</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060530</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REQUIP</medicinalproduct>
        <drugdosagetext>4 MG TID PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050208</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050425</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REQUIP</medicinalproduct>
        <drugdosagetext>5 MG TID PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050426</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060108</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REQUIP</medicinalproduct>
        <drugdosagetext>5 MG QID PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060109</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060530</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REQUIP</medicinalproduct>
        <drugdosagetext>5 MG TID PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060531</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REQUIP</medicinalproduct>
        <drugdosagetext>2.5 MG BID PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060531</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOLPIDEM TARTRATE</medicinalproduct>
        <drugdosagetext>10 MG QD PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040115</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059948-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060707</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>227221</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>PERICARDITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MABTHERA(RITUXIMAB) CONC FOR SOLUTION FOR INFUSION</medicinalproduct>
        <drugindication>NON-HODGKIN'S LYMPHOMA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059949-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060710</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>227277</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>63</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIOMYOPATHY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MABTHERA(RITUXIMAB) CONC FOR SOLUTION FOR INFUSION</medicinalproduct>
        <drugindication>LYMPHOMA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059950-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060711</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>L06-ESP-02690-01</companynumb>
    <primarysource>
      <reportercountry>SPAIN</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>36</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG TOXICITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEMIPARESIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVERDOSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARBAMAZEPINE</medicinalproduct>
        <drugauthorizationnumb>70231</drugauthorizationnumb>
        <drugdosagetext>600 MG QD</drugdosagetext>
        <drugindication>PARTIAL SEIZURES</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RITONAVIR</medicinalproduct>
        <drugdosagetext>600 MG BID</drugdosagetext>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19971201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SAQUINAVIR</medicinalproduct>
        <drugdosagetext>400 MG BID</drugdosagetext>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19971201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PHENYTOIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LAMIVUDINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIDANOSINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059952-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060714</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006PI000331</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </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>AORTIC CALCIFICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIOMEGALY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EJECTION FRACTION DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GOITRE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTRACARDIAC THROMBUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RETEPLASE (RETEPLASE)</medicinalproduct>
        <drugdosagetext>IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ACUTE MYOCARDIAL INFARCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060425</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060425</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REOPRO</medicinalproduct>
        <drugdosagetext>IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ACUTE MYOCARDIAL INFARCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050425</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TICLOPIDINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RANITIDINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATORVASTATIN CALCIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM CHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NITROGLYCERIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATROPINE SULFATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLOPIDOGREL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMOXICILLIN W/CLAVULANIC ACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METAMIZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LACTOBACILLUS ACIDOPHILUS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059953-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060713</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ESWYE174114JUL06</companynumb>
    <primarysource>
      <reportercountry>SPAIN</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>62</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>LUNG INFILTRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THERAPY NON-RESPONDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RAPAMUNE</medicinalproduct>
        <drugauthorizationnumb>21110</drugauthorizationnumb>
        <drugdosagetext>3 MG 1X PER 1 DAY, ORAL; SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS AGAINST TRANSPLANT REJECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050506</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051003</drugenddate>
        <drugtreatmentduration>151</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RAPAMUNE</medicinalproduct>
        <drugauthorizationnumb>21110</drugauthorizationnumb>
        <drugdosagetext>3 MG 1X PER 1 DAY, ORAL; SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS AGAINST TRANSPLANT REJECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051004</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060317</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RAPAMUNE</medicinalproduct>
        <drugauthorizationnumb>21110</drugauthorizationnumb>
        <drugdosagetext>3 MG 1X PER 1 DAY, ORAL; SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS AGAINST TRANSPLANT REJECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060318</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060501</drugenddate>
        <drugtreatmentduration>165</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROGRAF</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELLCEPT</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059954-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060714</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006P1000325</companynumb>
    <primarysource>
      <reportercountry>ITALY</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>62</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANGINA PECTORIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RETEPLASE              (RETEPLASE)</medicinalproduct>
        <drugbatchnumb>CT001626</drugbatchnumb>
        <drugdosagetext>5 IU;X2;IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ACUTE MYOCARDIAL INFARCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060528</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060528</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REOPRO</medicinalproduct>
        <drugbatchnumb>03330882</drugbatchnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ACUTE MYOCARDIAL INFARCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060528</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060528</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REOPRO</medicinalproduct>
        <drugbatchnumb>03330882</drugbatchnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ACUTE MYOCARDIAL INFARCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060528</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060528</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HEPARIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059955-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060714</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006P1000348</companynumb>
    <primarysource>
      <reportercountry>DENMARK</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>79</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANGINA PECTORIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ATRIAL FIBRILLATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE CONGESTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARPAL TUNNEL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLEURISY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENTRICULAR EXTRASYSTOLES</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RETEPLASE              (RETEPLASE)</medicinalproduct>
        <drugdosagetext>IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ACUTE MYOCARDIAL INFARCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060206</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REOPRO</medicinalproduct>
        <drugdosagetext>IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ACUTE MYOCARDIAL INFARCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060206</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060206</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBYL-ENTEROSOLUBILE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLOPIDOGREL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIGOXIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM CHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ESOMEPRAZOLE MAGNESIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL SUCCINATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOSAMINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IRON</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059956-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060724</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060714</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006AP03321</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>84</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CATARACT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GLAUCOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL DISTURBANCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OMEPRAL</medicinalproduct>
        <drugauthorizationnumb>19810</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059957-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060724</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060714</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006UW14669</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>49</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SELF-INJURIOUS IDEATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugauthorizationnumb>021366</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVANDAMET</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELEXA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HUMULIN 70/30</medicinalproduct>
        <drugdosagetext>30/70</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059958-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060711</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>HQWYE854412JUL06</companynumb>
    <primarysource>
      <reportercountry>MEXICO</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HEART TRANSPLANT REJECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RAPAMUNE</medicinalproduct>
        <drugauthorizationnumb>21083</drugauthorizationnumb>
        <drugdosagetext>DOSE STRENGTH 2 MG; UNSPECIFIED DAILY FREQUENCY, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEART TRANSPLANT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE TAB</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059959-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060704</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>227311</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>METASTASES TO MENINGES</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVASTIN</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059961-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060707</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>227227</companynumb>
    <primarysource>
      <reportercountry>SWITZERLAND</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>50</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>LEUKOENCEPHALOPATHY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MABTHERA</medicinalproduct>
        <drugdosagetext>1 G, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059962-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060706</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>HQWYE404420MAR06</companynumb>
    <primarysource>
      <reportercountry>MEXICO</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>16</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD CREATININE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>KIDNEY TRANSPLANT REJECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TACROLIMUS, CONTROL FOR SIROLIMUS  (TACROLIMUS, CONTROL FOR SIROLIMUS,</medicinalproduct>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS AGAINST TRANSPLANT REJECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031105</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040115</drugenddate>
        <drugtreatmentduration>72</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TACROLIMUS, CONTROL FOR SIROLIMUS  (TACROLIMUS, CONTROL FOR SIROLIMUS,</medicinalproduct>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS AGAINST TRANSPLANT REJECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040116</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040407</drugenddate>
        <drugtreatmentduration>83</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TACROLIMUS, CONTROL FOR SIROLIMUS  (TACROLIMUS, CONTROL FOR SIROLIMUS,</medicinalproduct>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS AGAINST TRANSPLANT REJECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040408</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060329</drugenddate>
        <drugtreatmentduration>721</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MYCOPHENOLATE MOFETIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VERAPAMIL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059964-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060713</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006BI008505</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>46</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>100</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CYTOMEGALOVIRUS INFECTION</reactionmeddrapt>
      </reaction>
      <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>20050601</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059965-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060707</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2005BI018926</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>54</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CHRONIC LYMPHOCYTIC LEUKAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugdosagetext>30 UG;QW;IM</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980101</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>5059966-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060706</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>HQWYE037708JUN06</companynumb>
    <primarysource>
      <reportercountry>ITALY</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>75</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD GASES ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERSTITIAL LUNG DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PO2 ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THYROID DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CORDARONE</medicinalproduct>
        <drugauthorizationnumb>19972</drugauthorizationnumb>
        <drugdosagetext>200 MG TABLET ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARRHYTHMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
        <drugtreatmentduration>274</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059968-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060711</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>14394</companynumb>
    <primarysource>
      <reportercountry>NEW ZEALAND</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL TENDERNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD POTASSIUM INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD SODIUM DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>X-RAY ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARBOPLATIN</medicinalproduct>
        <drugauthorizationnumb>76131</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PACLITAXEL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DMXAA</medicinalproduct>
        <drugdosagetext>3000 MG FREQ UNK IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060215</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060607</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE TAB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE TAB</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059970-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060707</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>HQWYE336621JUN06</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>67</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FACIAL PALSY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RALOXIFENE, CONTROL FOR BAZEDOXIFENE ACETATE (RALOXIFENE, CONTROL FOR </medicinalproduct>
        <drugbatchnumb>2005P1362</drugbatchnumb>
        <drugdosagetext>60 MG 1X PER 1 DAY ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030805</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060619</drugenddate>
        <drugtreatmentduration>1050</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ORPHENADRINE CITRATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIPYRONE (METAMIZOLE SODIUM)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CAFFEINE (CAFFEINE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DICLOFENAC SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALUMINUM HYDROXIDE TAB</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059972-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060707</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHO2004JP15884</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>65</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>55.0213</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CONCOMITANT DISEASE PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CORNEAL ABRASION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MACULOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RETINAL DEGENERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RETINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VITREOUS HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VISUDYNE</medicinalproduct>
        <drugauthorizationnumb>21119</drugauthorizationnumb>
        <drugdosagetext>6 MG/M^2 ONCE IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MACULAR DEGENERATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040917</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040917</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059974-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060705</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHO2006JP04540</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>52.0276</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CEREBRAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VISUDYNE</medicinalproduct>
        <drugauthorizationnumb>21119</drugauthorizationnumb>
        <drugdosagetext>4.6 ML DAILY IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MACULAR DEGENERATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041227</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041227</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059975-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060707</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>HQWYE259310MAY06</companynumb>
    <primarysource>
      <reportercountry>SPAIN</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>52</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>COMPLICATIONS OF TRANSPLANTED KIDNEY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMODIALYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL TUBULAR NECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEROMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY FISTULA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY TRACT INFECTION ENTEROCOCCAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY TRACT INFECTION STAPHYLOCOCCAL</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>20060426</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060520</drugenddate>
        <drugtreatmentduration>25</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059977-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060707</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GXKR2006IT03924</companynumb>
    <primarysource>
      <reportercountry>ITALY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>44</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>49.4</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL DISTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ACHLORHYDRIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD ETHANOL INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CANDIDIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISORIENTATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSARTHRIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERUCTATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE ENZYME INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMOXICILLIN+CLAVULANATE</medicinalproduct>
        <drugauthorizationnumb>65063</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OVERGROWTH BACTERIAL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMOXICILLIN+CLAVULANATE</medicinalproduct>
        <drugauthorizationnumb>65063</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OVERGROWTH BACTERIAL</drugindication>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugdosagetext>20 MG, BID</drugdosagetext>
        <drugindication>GASTROINTESTINAL HYPOMOTILITY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIET (NO INGREDIENTS/SUBSTANCES)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEOSTIGMINE BROMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRIMEBUTINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PAROXETINE HCL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059979-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060710</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GXKR2006BR04017</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AZITHROMYCIN</medicinalproduct>
        <drugauthorizationnumb>65209</drugauthorizationnumb>
        <drugdosagetext>500 MG, QD</drugdosagetext>
        <drugindication>PHARYNGITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060613</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059980-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060711</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GXKR2006BR04028</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RANITIDINE HYDROCHLORIDE</medicinalproduct>
        <drugauthorizationnumb>74467</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTRITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059982-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060704</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>UKP06000170</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>74</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CRYPTOGENIC ORGANISING PNEUMONIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ASACOL</medicinalproduct>
        <drugauthorizationnumb>19651</drugauthorizationnumb>
        <drugdosagetext>800 MG, 2/DAY, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CROHN'S DISEASE</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060501</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059984-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060706</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006JP001906</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ILEUS PARALYTIC</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VESICARE</medicinalproduct>
        <drugauthorizationnumb>21518</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059985-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060724</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-05P-163-0288306-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RITONAVIR SOFT GELATIN CAPSULES</medicinalproduct>
        <drugauthorizationnumb>20945</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030807</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030814</drugenddate>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SAQUINAVIR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030807</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030814</drugenddate>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIDANOSINE</medicinalproduct>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030807</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030814</drugenddate>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TENOFOVIR</medicinalproduct>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030807</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030814</drugenddate>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059986-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060724</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060711</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-US185776</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>LEG AMPUTATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>PSORIASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060501</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059988-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060724</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060329</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0599435A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>51</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABNORMAL DREAMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>APHASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BIPOLAR DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HALLUCINATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MANIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SCHIZOPHRENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SLEEP DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPEECH DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NICODERM CQ</medicinalproduct>
        <drugbatchnumb>0534567</drugbatchnumb>
        <drugauthorizationnumb>20165</drugauthorizationnumb>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>SMOKING CESSATION THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GEODON</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEPAKOTE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TEGRETOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOURO DM (SINUSITIS)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BACTRIM DS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059989-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060706</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006JP001880</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>69</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>60</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VESICARE</medicinalproduct>
        <drugauthorizationnumb>21518</drugauthorizationnumb>
        <drugdosagetext>5 MG, UID/QD, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060613</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060614</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE BESYLATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DASEN                 (SERRAPEPTASE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CHOREITOU             (HERBAL EXTRACT NOS) GRANULE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TINELAC         (SENNOSIDE A+B)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLARITHROMYCIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEPAS                 (ETIZOLAM)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059990-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060724</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060707</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0611396A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>78</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CITRUCEL SUGAR-FREE SUSPENSION ORANGE</medicinalproduct>
        <drugbatchnumb>05M050</drugbatchnumb>
        <drugdosagetext>1TSP IN THE MORNING</drugdosagetext>
        <drugindication>GASTROINTESTINAL DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19910101</drugstartdate>
        <drugtreatmentduration>15</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN E</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM WITH VITAMIN D</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VISION FORMULA</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059991-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060724</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060711</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0611717A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>52</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANEURYSM RUPTURED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTRACRANIAL ANEURYSM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GOODY'S EXTRA STRENGTH HEADACHE POWDER</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugindication>HEADACHE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NO CONCURRENT MEDICATION</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059992-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060724</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060708</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-GLAXOSMITHKLINE-A0611862A</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>43</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NERVOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALLOR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIQUITIN</medicinalproduct>
        <drugbatchnumb>0539462V1R</drugbatchnumb>
        <drugauthorizationnumb>20165</drugauthorizationnumb>
        <drugdosagetext>21MG UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>SMOKING CESSATION THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060708</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PAROXETINE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GINKO BILOBA</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060703</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VERTIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUOXETINA</medicinalproduct>
        <drugdosagetext>1TAB PER DAY</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060703</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLORDIAZEPOXIDO</medicinalproduct>
        <drugdosagetext>1TAB PER DAY</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060705</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059993-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060724</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060717</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0612438A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>76</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CHOKING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ECOTRIN MAXIMUM STRENGTH TABLETS</medicinalproduct>
        <drugbatchnumb>4J18</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HUMALOG</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DYAZIDE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059994-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060724</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060719</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0612752A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>70</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CITRUCEL REGULAR SUSPENSION</medicinalproduct>
        <drugbatchnumb>05M051</drugbatchnumb>
        <drugindication>CONSTIPATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLOMAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORAZEPAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOCUSATE SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOCARBAMOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RISPERIDONE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059995-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060710</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>HQWYE826512JUL06</companynumb>
    <primarysource>
      <reportercountry>MEXICO</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HEART TRANSPLANT REJECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RAPAMUNE</medicinalproduct>
        <drugauthorizationnumb>21110</drugauthorizationnumb>
        <drugdosagetext>4MG, 2MG ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEART TRANSPLANT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE TAB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MYCOPHENOLATE MOFETIL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059997-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060712</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DEWYE128512JUL06</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>30</patientonsetage>
      <patientonsetageunit>802</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ACCIDENTAL DRUG INTAKE BY CHILD</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ACCIDENTAL OVERDOSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VENLAFAXINE HCL</medicinalproduct>
        <drugauthorizationnumb>20699</drugauthorizationnumb>
        <drugdosagetext>1 CAPSULE (OVERDOSE AMOUNT 75 MG)</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060712</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060712</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5059998-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060712</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006JP002175</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>76</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URTICARIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VESICARE</medicinalproduct>
        <drugauthorizationnumb>21518</drugauthorizationnumb>
        <drugdosagetext>5 MG ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTONIC BLADDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060707</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060709</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOXONIN (LOXOPROFEN)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MUCOSTA (REBAMIPIDE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MYONAL (EPERISONE HYDROCHLORIDE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLIVAS (NAFTOPIDIL)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLAVONATE (FLAVOXATE HYDROCHLORIDE)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5060000-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060711</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006BI009835</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>37</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>GOITRE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAPILLARY THYROID 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>20000115</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>20040115</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5060001-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060711</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006JP002145</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>78</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>CEREBRAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VESICARE</medicinalproduct>
        <drugauthorizationnumb>21518</drugauthorizationnumb>
        <drugdosagetext>5 MG ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060619</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIGOXIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPARA-CA (ASPARTATE CALCIUM)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OENALFA (ALFACALCIDOL)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORAZEPAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEPAS (ETIZOLAM)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5060002-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060704</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006JP002049</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>NEOPLASM SKIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROTOPIC</medicinalproduct>
        <drugauthorizationnumb>50777</drugauthorizationnumb>
        <drugdosagetext>TOPICAL</drugdosagetext>
        <drugadministrationroute>061</drugadministrationroute>
        <drugindication>DERMATITIS ATOPIC</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5060004-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060710</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006JP001914</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>55</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>44</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRONCHOPULMONARY ASPERGILLOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSED LEVEL OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIABETES MELLITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPHORIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MELAENA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UPPER GASTROINTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VARICOSE VEIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FUNGUARD(MICAFUNGIN) INJECTION</medicinalproduct>
        <drugauthorizationnumb>21506</drugauthorizationnumb>
        <drugdosagetext>IV DRIP</drugdosagetext>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>BRONCHOPULMONARY ASPERGILLOSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALDACTONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SOLDACTONE (POTASSIUM CANRENOATE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMARYL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GASTER D OROSIDPERSABLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BASEN (VOGLIBOSE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIVACT (AMINO ACIDS NOS)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>URSO (UROSDEOXYCHOLIC ACID)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SELBEX (TEPRENONE)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5060005-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060711</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006JP000812</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>56</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>61</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>BETA 2 MICROGLOBULIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BETA 2 MICROGLOBULIN URINE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BILE DUCT NECROSIS</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 TAMPONADE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CATHETER RELATED COMPLICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMPLICATIONS OF TRANSPLANTED LIVER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSED LEVEL OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIALYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HISTIOCYTOSIS HAEMATOPHAGIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERFORATION BILE DUCT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POST PROCEDURAL BILE LEAK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SERUM FERRITIN INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROGRAF</medicinalproduct>
        <drugauthorizationnumb>50708</drugauthorizationnumb>
        <drugdosagetext>8 MG</drugdosagetext>
        <drugindication>LIVER TRANSPLANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040531</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040708</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROGRAF</medicinalproduct>
        <drugauthorizationnumb>50708</drugauthorizationnumb>
        <drugdosagetext>8 MG</drugdosagetext>
        <drugindication>LIVER TRANSPLANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040709</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040811</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDROL ACETATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SOLU-MEDROL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PENTCILLIN (PIPERACILLIN SODIUM) INJECTION</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUMARIN (FLOMOXEF SODIUM) INJECTION</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUNGUARD (MICAFUNGIN) INJECTION</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EPOGIN (EPOETIN BETA) INJECTION</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HABEKACIN (ARBEKACIN) INJECTION</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CEFTAZIDIME</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARBENIN (BETAMIPRON, PANIPENEM) INJECTION</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DENOSINE (GANCICLOVIR) INJECTION</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BAKTAR (SULFAMETHOXAZOLE, TRIMETHOPRIM) INJECTION</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MINOCYCLINE HCL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5060007-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060710</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006001101</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>52</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALIGNANT NEOPLASM PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METASTATIC BRONCHIAL CARCINOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NORMOCHROMIC NORMOCYTIC ANAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TARCEVA</medicinalproduct>
        <drugauthorizationnumb>21743</drugauthorizationnumb>
        <drugdosagetext>150 MG (QD) ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>METASTATIC BRONCHIAL CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060130</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060430</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLARITHROMYCIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5060009-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>19990820</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>1999-08-0590</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>27</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>70</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHROMATURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CYTOLYTIC HEPATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC FIBROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JAUNDICE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SELF-MEDICATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELESTAMINE TAB</medicinalproduct>
        <drugauthorizationnumb>14215</drugauthorizationnumb>
        <drugdosagetext>3 TAB QD ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>URTICARIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19950802</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19951208</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEXCHLORPHENIRAMINE MALEATE</medicinalproduct>
        <drugdosagetext>3 TABS QD ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>URTICARIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19951201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19951208</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZYRTEC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYPOSTAMINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5060011-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060704</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DEU_2006-0002330</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>47</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INFUSION SITE MASS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MORPHINE SULFATE INJ</medicinalproduct>
        <drugdosagetext>3.5 MG, DAILY, INTRATHECAL</drugdosagetext>
        <drugadministrationroute>037</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugtreatmentduration>488</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BUPIVACAINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5060013-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060705</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200606IM000367</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>57</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>89.8122</patientweight>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BREAST CANCER METASTATIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BREATH SOUNDS ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CYANOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERCAPNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOKALAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IDIOPATHIC PULMONARY FIBROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METASTASES TO LYMPH NODES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OXYGEN SATURATION DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PITTING OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLASMACYTOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROGESTERONE RECEPTOR ASSAY POSITIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RALES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY RATE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPINAL COMPRESSION FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACTIMMUNE</medicinalproduct>
        <drugbatchnumb>403840</drugbatchnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>IDIOPATHIC PULMONARY FIBROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040503</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060619</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACTIMMUNE</medicinalproduct>
        <drugbatchnumb>403840</drugbatchnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>IDIOPATHIC PULMONARY FIBROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20011008</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYGEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GEMFIBROZIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZETIA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEXAPRO</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRILOSEC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENALAPRIL MALEATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PERCOCET</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SOMA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HUMULIN 70/30</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM CHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COLACE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5060014-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060724</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060720</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-BRISTOL-MYERS SQUIBB COMPANY-13450572</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>64</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ERBITUX</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>HEPATIC NEOPLASM MALIGNANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060313</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060516</drugenddate>
        <drugtreatmentduration>64</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXALIPLATIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>HEPATIC NEOPLASM MALIGNANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060314</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060510</drugenddate>
        <drugtreatmentduration>57</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GEMCITABINE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>HEPATIC NEOPLASM MALIGNANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060313</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060509</drugenddate>
        <drugtreatmentduration>57</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROPRANOLOL</medicinalproduct>
        <drugindication>VARICES OESOPHAGEAL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORFLOXACIN</medicinalproduct>
        <drugindication>INFECTION PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TINZAPARIN</medicinalproduct>
        <drugindication>VENOUS THROMBOSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRIMEBUTINE</medicinalproduct>
        <drugindication>ABDOMINAL PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MORPHINE</medicinalproduct>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060515</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5060015-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060712</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>227355</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>44</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DYSPHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUCOSAL INFLAMMATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ERLOTINIB (ERLOTINIB) TABLET</medicinalproduct>
        <drugdosagetext>100 MG, QD, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NEOPLASM MALIGNANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060114</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEVACIZUMAB(BEVACIZUMAB) PWDR + SOLVENT,INFUSION SOLN, 100MG</medicinalproduct>
        <drugdosagetext>10 MG/M2, Q14D, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NEOPLASM MALIGNANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051114</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060109</drugenddate>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CISPLATIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RADIATION (RADIATION THERAPY)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5060016-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060724</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060717</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-13445283</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>65</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ERBITUX</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060707</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060707</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PACLITAXEL</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060707</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060707</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARBOPLATIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060707</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060707</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000301</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CANDESARTAN CILEXETIL</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000301</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000301</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATORVASTATIN CALCIUM</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000301</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCODONE BITARTRATE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000520</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL SULFATE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000501</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5060017-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060724</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060515</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BEWYE628016MAY06</companynumb>
    <primarysource>
      <reportercountry>BELGIUM</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>71</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MYELODYSPLASTIC SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>ANKYLOSING SPONDYLITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060428</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5060018-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060724</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060711</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-US185844</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SENSIPAR</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HYPERPARATHYROIDISM SECONDARY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060502</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060610</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5060019-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060724</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060712</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-AMGEN-KDL186047</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050909</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5060020-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060724</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060710</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FRWYE767922JUN06</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>80</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CELLULITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VEIN PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENOUS INSUFFICIENCY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>ANKYLOSING SPONDYLITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060621</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DAFALGAN</medicinalproduct>
        <drugdosagetext>3-4 G TOTAL DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060421</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5060022-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060711</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>226394</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>49</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEVACIZUMAB (BEVACIZUMAB) PWDR + SOLVENT, INFUSION SOLN, 100MG</medicinalproduct>
        <drugdosagetext>10 MG/KG</drugdosagetext>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060605</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAXOL</medicinalproduct>
        <drugdosagetext>45 MG/M2</drugdosagetext>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060605</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARBOPLATIN</medicinalproduct>
        <drugdosagetext>2 AUC</drugdosagetext>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060605</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RADIOTHERAPY (RADIATION THERAPY)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5060023-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060712</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>227356</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>44</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BONE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMPAIRED HEALING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOUTH ULCERATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ERLOTINIB (ERLOTINIB) TABLET</medicinalproduct>
        <drugdosagetext>100 MG,QD, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NEOPLASM MALIGNANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060114</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEVACIZUMAB(BEVACIZUMAB) PWDR + SOLVENT,INFUSION SOLN, 100MG</medicinalproduct>
        <drugdosagetext>10 MG/M2, Q2W, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NEOPLASM MALIGNANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051114</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060109</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CISPLATIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RADIATION (RADIATION THERAPY)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5060024-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060710</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200611760BCC</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>48</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>81.6475</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL INTAKE REDUCED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALEVE</medicinalproduct>
        <drugauthorizationnumb>20204</drugauthorizationnumb>
        <drugdosagetext>220 MG, QD, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALEVE</medicinalproduct>
        <drugauthorizationnumb>20204</drugauthorizationnumb>
        <drugdosagetext>220 MG, QD, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DYSMENORRHOEA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADVAIR DISKUS 100/50</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL SPIROS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SEASONALE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5060025-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060710</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006AL001720</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>29</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>52.1637</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ACCIDENTAL OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AMNESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LORAZEPAM</medicinalproduct>
        <drugauthorizationnumb>71404</drugauthorizationnumb>
        <drugdosagetext>2 MG;PRN;PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INSOMNIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050308</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050313</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5060026-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060724</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060710</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-STX185884</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE BRUISING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>KNEE ARTHROPLASTY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSORIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSORIATIC ARTHROPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUSITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>D066257</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PSORIATIC ARTHROPATHY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040801</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>D066257</drugbatchnumb>
        <drugindication>PSORIASIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5060027-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060724</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060718</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AUWYE212118JUL06</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MULTIPLE SCLEROSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5060028-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060706</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006-06-1995</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>45</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL DISTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ALOPECIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>APHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEOPLASM PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARYNGITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARYNGOLARYNGEAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SENSATION OF HEAVINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THYROID NEOPLASM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEG-INTRON</medicinalproduct>
        <drugdosagetext>SUBCUTANEOUS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060428</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBETOL</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060428</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN C CHEWABLE TABLETS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5060029-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060707</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006US001341</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>55</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>102</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BRONCHITIS ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CELLULITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THERAPY NON-RESPONDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMEVIVE</medicinalproduct>
        <drugdosagetext>15 MG, WEEKLY, INTRAMUSCULAR</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>PSORIASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040510</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050718</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROTONIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5060031-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060705</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006US001476</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>53</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GUILLAIN-BARRE SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROGRAF</medicinalproduct>
        <drugauthorizationnumb>50708</drugauthorizationnumb>
        <drugindication>RENAL TRANSPLANT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELLCEPT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE TAB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BACTRIM (TRIMETHOPRIM)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALCYTE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRILOSEC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOPRESSOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NOVOLOG</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5060032-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060706</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006US001254</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>49</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLADDER CANCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SQUAMOUS CELL CARCINOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROTOPIC</medicinalproduct>
        <drugauthorizationnumb>50777</drugauthorizationnumb>
        <drugdosagetext>UID/QD, TOPICAL</drugdosagetext>
        <drugadministrationroute>061</drugadministrationroute>
        <drugindication>VITILIGO</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOXYL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTIVITAMINS (ERGOCALCIFEROL, FOLIC ACID, NICOTINAMIDE, PANTHENOL, TH</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5060033-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060705</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>163-21880-06050845</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>63</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>NO ADVERSE EFFECT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugauthorizationnumb>21880</drugauthorizationnumb>
        <drugdosagetext>10 MG, 1 IN 1 D, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MYELODYSPLASTIC SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060502</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5060034-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060705</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>S06-FRA-02693-01</companynumb>
    <primarysource>
      <reportercountry>DENMARK</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>41</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>COMPLETED SUICIDE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJURY ASPHYXIATION</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>20060601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060601</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5060035-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060711</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2005US001469</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>8</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ALPHA HAEMOLYTIC STREPTOCOCCAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACTERAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACTERIAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPH NODE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPHADENITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NON-HODGKIN'S LYMPHOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWELLING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROTOPIC</medicinalproduct>
        <drugauthorizationnumb>50777</drugauthorizationnumb>
        <drugdosagetext>PRN, TOPICAL</drugdosagetext>
        <drugadministrationroute>061</drugadministrationroute>
        <drugindication>ECZEMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5060037-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060703</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>8017270</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>21</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABORTION INDUCED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE BEFORE PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PREGNANCY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KEPPRA</medicinalproduct>
        <drugauthorizationnumb>21035</drugauthorizationnumb>
        <drugdosagetext>1000 MG /D PO</drugdosagetext>
        <drugadministrationroute>047</drugadministrationroute>
        <drugindication>EPILEPSY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5060038-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060704</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>S06-FRA-02604-01</companynumb>
    <primarysource>
      <reportercountry>DENMARK</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>69</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>COMPLETED SUICIDE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJURY ASPHYXIATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARANOIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROPLEX (ESCITALOPRAM)</medicinalproduct>
        <drugauthorizationnumb>21323</drugauthorizationnumb>
        <drugdosagetext>10 MG QD PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANTIDEPRESSANT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060222</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060515</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROPLEX (ESCITALOPRAM)</medicinalproduct>
        <drugauthorizationnumb>21323</drugauthorizationnumb>
        <drugdosagetext>10 MG QD PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CORONARY ARTERY INSUFFICIENCY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060222</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060515</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROPLEX (ESCITALOPRAM)</medicinalproduct>
        <drugauthorizationnumb>21323</drugauthorizationnumb>
        <drugdosagetext>10 MG QD PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PREOPERATIVE CARE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060222</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060515</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GLUCOPHAGE</medicinalproduct>
        <drugdosagetext>1700 MG QD PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060523</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TERCIAN (CYAMEMAZINE)</medicinalproduct>
        <drugdosagetext>0.5 UNITS BID PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060516</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060523</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ATORVASTATIN CALCIUM</medicinalproduct>
        <drugdosagetext>40 MG QD PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060523</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INEXIUM (ESOMEPRAZOLE)</medicinalproduct>
        <drugdosagetext>20 MG QD PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060222</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060523</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RAMIPRIL</medicinalproduct>
        <drugdosagetext>1.25 MG BID PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060523</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>75 MG QD PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060523</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugdosagetext>40 MG QD PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060523</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5060039-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060710</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>TAP2006Q01215</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>39</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD IRON INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOPOROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PORPHYRIA ACUTE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LUPRON</medicinalproduct>
        <drugauthorizationnumb>20011</drugauthorizationnumb>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PANHEMATIN FOR INJECTION (HEMATIN) (INJECTION)</medicinalproduct>
        <drugdosagetext>313 MG EVERY 24 HOURS 5-10 DAYS</drugdosagetext>
        <drugindication>PORPHYRIA ACUTE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19950101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060411</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ESTROGENS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MORPHINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PHENERGAN (PROMETHAZINE HYDROCHLORIDE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHADONE HCL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5060040-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060706</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US017698</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>15</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ACTIVATED PARTIAL THROMBOPLASTIN TIME PROLONGED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ACUTE PRERENAL FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ACUTE RESPIRATORY DISTRESS SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AGITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD FIBRINOGEN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRADYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CAPILLARY LEAK SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC MURMUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COAGULOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DERMATITIS EXFOLIATIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG RASH WITH EOSINOPHILIA AND SYSTEMIC SYMPTOMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERNATIONAL NORMALISED RATIO INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER FUNCTION TEST ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCREATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PETECHIAE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHINORRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN EXFOLIATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWELLING FACE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROVIGIL</medicinalproduct>
        <drugauthorizationnumb>20717</drugauthorizationnumb>
        <drugdosagetext>100 MG QD ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANXIETY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060413</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060416</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROVIGIL</medicinalproduct>
        <drugauthorizationnumb>20717</drugauthorizationnumb>
        <drugdosagetext>100 MG QD ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATTENTION DEFICIT/HYPERACTIVITY DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060413</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060416</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROVIGIL</medicinalproduct>
        <drugdosagetext>200 MG QD ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANXIETY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060417</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060421</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROVIGIL</medicinalproduct>
        <drugdosagetext>200 MG QD ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATTENTION DEFICIT/HYPERACTIVITY DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060417</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060421</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROVIGIL</medicinalproduct>
        <drugdosagetext>300 MG QD ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANXIETY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060422</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060501</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROVIGIL</medicinalproduct>
        <drugdosagetext>300 MG QD ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATTENTION DEFICIT/HYPERACTIVITY DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060422</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060501</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROVIGIL</medicinalproduct>
        <drugdosagetext>400 MG QD ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANXIETY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060502</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060522</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROVIGIL</medicinalproduct>
        <drugdosagetext>400 MG QD ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATTENTION DEFICIT/HYPERACTIVITY DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060502</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060522</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XYPREXA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LUVOX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ABILIFY</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5060041-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060710</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CHPA2006US06770</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>33</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>54.4316</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>GLOSSODYNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NIGHTMARE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWOLLEN TONGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TONGUE ULCERATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NICOTINE</medicinalproduct>
        <drugbatchnumb>3016225</drugbatchnumb>
        <drugauthorizationnumb>20076</drugauthorizationnumb>
        <drugdosagetext>1 PATCH DAILY  DURING DAYTIME TRANSDERMAL</drugdosagetext>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>SMOKING CESSATION THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060630</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060707</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NICOTINE</medicinalproduct>
        <drugbatchnumb>3016225</drugbatchnumb>
        <drugauthorizationnumb>20076</drugauthorizationnumb>
        <drugdosagetext>1 PATCH DAILY  DURING DAYTIME TRANSDERMAL</drugdosagetext>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>SMOKING CESSATION THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060709</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060710</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5060042-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060710</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>S06-IRL-02685-01</companynumb>
    <primarysource>
      <reportercountry>DENMARK</reportercountry>
    </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>LEXAPRO</medicinalproduct>
        <drugauthorizationnumb>21323</drugauthorizationnumb>
        <drugdosagetext>1 TABLET QD PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5060043-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060711</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>T06-SWI-02396-01</companynumb>
    <primarysource>
      <reportercountry>DENMARK</reportercountry>
    </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>ABASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>APATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMPAIRED SELF-CARE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARKINSONISM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ESCITALOPRAM OXALATE</medicinalproduct>
        <drugauthorizationnumb>21323</drugauthorizationnumb>
        <drugdosagetext>10 MG QD PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060326</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060328</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ESCITALOPRAM OXALATE</medicinalproduct>
        <drugdosagetext>5 MG QD PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060320</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060325</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARICEPT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MARCUMAR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALDACTONE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5060044-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060712</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>14400</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>63</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METASTATIC NEOPLASM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUOROURACIL</medicinalproduct>
        <drugauthorizationnumb>8107</drugauthorizationnumb>
        <drugdosagetext>960 MG/M2 PER CYCLE IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RECTAL CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051206</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEUCOVORIN CALCIUM</medicinalproduct>
        <drugdosagetext>400 MG/M2 PER CYCLE IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RECTAL CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051206</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXALIPLATIN</medicinalproduct>
        <drugdosagetext>65 MG/M2 PER CYCLE IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RECTAL CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051206</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVASTIN</medicinalproduct>
        <drugdosagetext>5 MG/KG PER CYCLE IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RECTAL CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051206</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TARCEVA</medicinalproduct>
        <drugdosagetext>100 MG DAILY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RECTAL CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051206</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060315</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ONDANSETRON HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROCHLORPERAZINE EDISYLATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORAZEPAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLINDAMYCIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CEPHALEXIN MONOHYDRATE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5060045-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060714</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200612768BWH</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>61</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ATELECTASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD ALBUMIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD LACTATE DEHYDROGENASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE CONGESTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBRAL ISCHAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSGEUSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERVERTEBRAL DISC DEGENERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JUGULAR VEIN DISTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPHANGIOSIS CARCINOMATOSA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METASTASES TO ABDOMINAL CAVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METASTASES TO LUNG</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERICARDIAL EFFUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLEURAL EFFUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PO2 DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY FIBROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>REFUSAL OF TREATMENT BY PATIENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTHAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOPHLEBITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY RETENTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>YELLOW SKIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXAVAR</medicinalproduct>
        <drugauthorizationnumb>21923</drugauthorizationnumb>
        <drugdosagetext>400 MG BID ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>METASTATIC RENAL CELL CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051017</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060207</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXAVAR</medicinalproduct>
        <drugauthorizationnumb>21923</drugauthorizationnumb>
        <drugdosagetext>400 MG BID ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>METASTATIC RENAL CELL CARCINOMA</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060303</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COLACE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCONTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PERCOCET</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SENNA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MIRAMAX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5060046-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060707</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AR-2006-015875</companynumb>
    <primarysource>
      <reportercountry>ARGENTINA</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>33</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIAC MYXOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BETASERON</medicinalproduct>
        <drugdosagetext>MIU, SUBCUTANEOUS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5060047-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060724</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060717</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-AMGEN-KDL186541</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>AORTIC ANEURYSM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PSORIATIC ARTHROPATHY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010704</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5060048-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060724</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060621</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006UW13203</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>19881</patientonsetage>
      <patientonsetageunit>804</patientonsetageunit>
      <patientweight>56.6</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHABDOMYOLYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugauthorizationnumb>21366</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERLIPIDAEMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugauthorizationnumb>021366</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050823</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060425</drugenddate>
        <drugtreatmentduration>246</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANXIETY MEDICATION</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRILOSEC OTC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugdosagetext>PREVIOUSLY ON LIPITOR BEFORE STARTING CRESTOR</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5060049-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060724</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060710</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-US185964</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HERPES ZOSTER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSORIASIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PSORIASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060515</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5060050-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060609</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>COM # 06-097</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FOOT OPERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
        <drugauthorizationnumb>74644</drugauthorizationnumb>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRIANTERENE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5060051-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060710</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>06-115</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>74</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>STOOL ANALYSIS ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METFORMIN HYDROCHLORIDE</medicinalproduct>
        <drugauthorizationnumb>75967</drugauthorizationnumb>
        <drugdosagetext>ONE 500 MG TABLET DAILY</drugdosagetext>
        <drugindication>DIABETES MELLITUS NON-INSULIN-DEPENDENT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATACAND</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANOXIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLIPZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVOX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THYRICIMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOTROL XL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5060052-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060711</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006-07-0534</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HEPATOTOXICITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TEMODAR</medicinalproduct>
        <drugauthorizationnumb>21029</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GLIOBLASTOMA MULTIFORME</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5060053-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060705</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006-71444</companynumb>
    <primarysource>
      <reportercountry>PUERTO RICO</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>INJURY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENDOSOL EXTRA</medicinalproduct>
        <drugdosagetext>500ML, ONCE, INTRAOCULAR 031</drugdosagetext>
        <drugadministrationroute>031</drugadministrationroute>
        <drugindication>EYE IRRIGATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060201</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5060054-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060707</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200612891BCC</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>55</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>SHOCK</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALEVE</medicinalproduct>
        <drugauthorizationnumb>20204</drugauthorizationnumb>
        <drugdosagetext>440 MG TOTAL DAILY ORAL ; ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BACK PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALEVE</medicinalproduct>
        <drugauthorizationnumb>20204</drugauthorizationnumb>
        <drugdosagetext>440 MG TOTAL DAILY ORAL ; ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5060055-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060709</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200612887BCC</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ATRIAL FIBRILLATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALEVE</medicinalproduct>
        <drugauthorizationnumb>20204</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5060056-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060703</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>227316</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>66</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>76</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANAL ULCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>C-REACTIVE PROTEIN INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVASTIN</medicinalproduct>
        <drugdosagetext>390 MG, Q2W, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RECTAL CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050912</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051102</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IRINOTECAN HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUOROURACIL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5060057-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060710</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200612184BCC</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>58</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>77.1115</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NASOPHARYNGITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVERDOSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALEVE</medicinalproduct>
        <drugauthorizationnumb>20204</drugauthorizationnumb>
        <drugdosagetext>440 MG BID ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRALGIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXTRA STRENGTH BAYER BACK + BODY PAIN</medicinalproduct>
        <drugdosagetext>1000 MG PRN ORAL ; 2000 MG TOTAL DAILY ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BACK PAIN</drugindication>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXTRA STRENGTH BAYER BACK + BODY PAIN</medicinalproduct>
        <drugdosagetext>1000 MG PRN ORAL ; 2000 MG TOTAL DAILY ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCIATICA</drugindication>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXTRA STRENGTH BAYER BACK + BODY PAIN</medicinalproduct>
        <drugdosagetext>1000 MG PRN ORAL ; 2000 MG TOTAL DAILY ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BACK PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060520</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXTRA STRENGTH BAYER BACK + BODY PAIN</medicinalproduct>
        <drugdosagetext>1000 MG PRN ORAL ; 2000 MG TOTAL DAILY ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCIATICA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060520</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LOW DOSE BAYER ASPIRIN (ACETYLSALICYLIC ACID)</medicinalproduct>
        <drugdosagetext>81 MG QD ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALEVE COLD AND SINUS</medicinalproduct>
        <drugdosagetext>440 MG BID ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NASOPHARYNGITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060501</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADVIL COLD AND SINUS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CENTRUM [MINERALS NOS, VITAMINS NOS]</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5060058-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR200606006113</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>83</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugauthorizationnumb>21318</drugauthorizationnumb>
        <drugdosagetext>20 UG, DAILY (1/D), SUBCUTANEOUS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060622</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5060059-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060724</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060503</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-NOVOPROD-253066</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>14</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>76</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NORDITROPIN SIMPLEXX</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>21148</drugauthorizationnumb>
        <drugdosagetext>4.2 MG, UNK</drugdosagetext>
        <drugindication>HYPOPITUITARISM</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCORTISON                      /00028601/</medicinalproduct>
        <drugdosagetext>17.5 MG, QD</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010715</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
        <drugdosagetext>125 UG, QD</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MINIRIN</medicinalproduct>
        <drugdosagetext>.3 MG, QD</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5060061-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060710</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200612762GDS</companynumb>
    <primarysource>
      <reportercountry>COLOMBIA</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>79</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>58</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ARRHYTHMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ATRIOVENTRICULAR BLOCK THIRD DEGREE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDUCTION DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSARTHRIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ELECTROCARDIOGRAM ST SEGMENT ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STUPOR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</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>20060627</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAXIPIME</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLEXANE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CAPTOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIPIRONA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROFENID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BERODUAL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NISTATIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEBRIDAT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METRONIDAZOLE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5060063-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060712</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200610578BFR</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>64</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>45</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>GENERAL PHYSICAL HEALTH DETERIORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALIGNANT NEOPLASM PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL CELL CARCINOMA STAGE UNSPECIFIED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SORAFENIB</medicinalproduct>
        <drugauthorizationnumb>21923</drugauthorizationnumb>
        <drugdosagetext>400 MG, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RENAL CELL CARCINOMA STAGE UNSPECIFIED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060112</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060420</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEXOMIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMOVANE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATHYMIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOPHAGE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FERROUS SULFATE TAB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXERYL [GLYCEROL, PARAFFIN, LIQUID, WHITE SOFT PARAFFIN]</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5060064-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060714</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200610872BVD</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>COMPLETED SUICIDE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDE ATTEMPT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CIPROFLOXACIN</medicinalproduct>
        <drugauthorizationnumb>19847</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5060065-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060712</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200610494BFR</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>49</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>55</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEBRILE NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SORAFENIB</medicinalproduct>
        <drugauthorizationnumb>21923</drugauthorizationnumb>
        <drugdosagetext>400 MG, BID, ORAL; SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RENAL CELL CARCINOMA STAGE UNSPECIFIED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060526</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SORAFENIB</medicinalproduct>
        <drugauthorizationnumb>21923</drugauthorizationnumb>
        <drugdosagetext>400 MG, BID, ORAL; SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RENAL CELL CARCINOMA STAGE UNSPECIFIED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060324</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060421</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SORAFENIB</medicinalproduct>
        <drugauthorizationnumb>21923</drugauthorizationnumb>
        <drugdosagetext>400 MG, BID, ORAL; SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RENAL CELL CARCINOMA STAGE UNSPECIFIED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060421</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060427</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SORAFENIB</medicinalproduct>
        <drugauthorizationnumb>21923</drugauthorizationnumb>
        <drugdosagetext>400 MG, BID, ORAL; SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RENAL CELL CARCINOMA STAGE UNSPECIFIED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060512</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060526</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SORAFENIB</medicinalproduct>
        <drugauthorizationnumb>21923</drugauthorizationnumb>
        <drugdosagetext>400 MG, BID, ORAL; SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RENAL CELL CARCINOMA STAGE UNSPECIFIED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060628</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MONO-TILDIEM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRIATEC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FONZYLANE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CORDIPATCH</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEXOMIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOLIPRANE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASILIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>URBANYL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AUGMENTIN '125'</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRIMPERAN TAB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VOGALIB</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5060067-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnesscongenitalanomali>1</seriousnesscongenitalanomali>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060703</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>S06-FRA-02688-01</companynumb>
    <primarysource>
      <reportercountry>DENMARK</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>35</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART DISEASE CONGENITAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CITALOPRAM HYDROBROMIDE</medicinalproduct>
        <drugauthorizationnumb>20822</drugauthorizationnumb>
        <drugdosagetext>1 UNITS QD PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRANXENE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
        <drugdosagetext>2 TABLET QD</drugdosagetext>
        <drugindication>MIGRAINE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXAZEPAM</medicinalproduct>
        <drugdosagetext>10 MG QD</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5060068-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060705</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>227256</companynumb>
    <primarysource>
      <reportercountry>ISRAEL</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>40</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INFLAMMATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFUSION SITE EXTRAVASATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVASTIN</medicinalproduct>
        <drugdosagetext>540 MG, Q3W, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLON CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051114</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CAPECITABINE (CAPECITABINE)</medicinalproduct>
        <drugdosagetext>3600 MG, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>COLON CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051114</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXALIPLATIN (OXALIPLATIN)</medicinalproduct>
        <drugdosagetext>235 MG, Q3W, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLON CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051114</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5060070-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060707</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006US001243</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>64</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANAPHYLACTIC REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CYANOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ISCHAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEFT VENTRICULAR FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY ARREST</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ADENOSCAN</medicinalproduct>
        <drugauthorizationnumb>20059</drugauthorizationnumb>
        <drugdosagetext>30 MG, IV DRIP</drugdosagetext>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>SCAN MYOCARDIAL PERFUSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060529</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060529</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PIMOBENDAN (PIMOBENDAN)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CIMETIDINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE (FUROSEMIDE SODIUM)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARVEDILOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PERINDOPRIL ERBUMINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENIDIPINE HYDROCHLORIDE (BENIDIPINE HYDROCHLORIDE)</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>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5060071-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060711</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>225873</companynumb>
    <primarysource>
      <reportercountry>SWITZERLAND</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>28</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MENINGITIS CRYPTOCOCCAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RAPTIVA</medicinalproduct>
        <drugdosagetext>1 MG/KG, 1/WEEK, SUBCUTANEOUS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PSORIASIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYCLOSPORINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5060073-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060711</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006JP000079</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>67</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>INTERSTITIAL LUNG DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RED BLOOD CELL SEDIMENTATION RATE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROGRAF</medicinalproduct>
        <drugauthorizationnumb>50708</drugauthorizationnumb>
        <drugdosagetext>3 MG, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060109</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5060074-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060710</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GXKR2006ES03927</companynumb>
    <primarysource>
      <reportercountry>SPAIN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>52</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>SKIN HYPERPIGMENTATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugauthorizationnumb>75757</drugauthorizationnumb>
        <drugdosagetext>20 MG</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVASTATIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5060075-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GXKR2006JP03957</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>85</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PNEUMOMEDIASTINUM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHYLPREDNISOLONE</medicinalproduct>
        <drugauthorizationnumb>40194</drugauthorizationnumb>
        <drugdosagetext>500 MG</drugdosagetext>
        <drugindication>INTERSTITIAL LUNG DISEASE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5060077-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060713</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>227391</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>76</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GRTPA                   (ALTEPLASE)</medicinalproduct>
        <drugdosagetext>INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CEREBROVASCULAR ACCIDENT</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5060078-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GXKR2006JP03956</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>58</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PNEUMOMEDIASTINUM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMOTHORAX</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHYLPREDNISOLONE</medicinalproduct>
        <drugauthorizationnumb>40194</drugauthorizationnumb>
        <drugdosagetext>250 MG</drugdosagetext>
        <drugindication>INTERSTITIAL LUNG DISEASE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5060079-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060706</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>E044-318-3735</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>80</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>78</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>AKINESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGE INTRACRANIAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JUGULAR VEIN THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUBCLAVIAN VEIN THROMBOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DONEPEZIL HCL</medicinalproduct>
        <drugauthorizationnumb>20690</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEMENTIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041116</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041214</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DONEPEZIL HCL</medicinalproduct>
        <drugauthorizationnumb>20690</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEMENTIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041215</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050502</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DONEPEZIL HCL</medicinalproduct>
        <drugdosagetext>DOUBLEBLIND, 1 IN 1 D, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEMENTIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040513</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041115</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CEFIXIM (CEFIXIME)</medicinalproduct>
        <drugdosagetext>400 MG ,ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>LYMPHADENITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050303</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050312</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVODOPA    AND   BENSARAZID (MADOPAR)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVODOPA AND CARBIDOPA    (SINEMET)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENTACAPON        (ENTACAPONE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLOMETHIAZOL       (CLOMETHIAZOLE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>QUETIAPIN    (QUETIAPINE)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5060081-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060712</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>E2020-00169-SPO-JP</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>69</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRADYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ELECTROCARDIOGRAM ST SEGMENT DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCONTINENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINOATRIAL BLOCK</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>20060512</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060516</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>20060517</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060614</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARVEDILOL</medicinalproduct>
        <drugdosagetext>10 MG, 1 IN 1 D, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060614</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BLOPRESS                   (CANDESARTAN CILEXETIL)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CONIEL              (BENIDIPINE HYDROCHLORIDE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ISOSORBIDE MONONITRATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SINLESTAL        (PROBUCOL)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NITRODERM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THEO-DUR</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5060082-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060705</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006JP002087</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>58</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ACUTE GRAFT VERSUS HOST DISEASE IN SKIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CREATININE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBRAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIABETIC COMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRY EYE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FIBRIN D DIMER INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEUKOENCEPHALOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCREATITIS ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STEM CELL TRANSPLANT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROGRAF</medicinalproduct>
        <drugauthorizationnumb>50708</drugauthorizationnumb>
        <drugdosagetext>6 MG</drugdosagetext>
        <drugindication>BONE MARROW TRANSPLANT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHYLPREDNISOLONE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5060084-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060724</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060713</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006UW14733</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>45</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ILL-DEFINED DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARIMIDEX</medicinalproduct>
        <drugauthorizationnumb>020541</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM W/VITAMIN D</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MINERAL SUPPLEMENTATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5060085-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060724</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060713</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-US186207</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CHILLS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH GENERALISED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060626</drugstartdate>
      </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>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOPRESSOR</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5060087-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060711</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>13862</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>33</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ALANINE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASPARTATE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS GENERALISED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugauthorizationnumb>11719</drugauthorizationnumb>
        <drugdosagetext>15 G DAILY IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BONE SARCOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060110</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060110</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugdosagetext>15 G DAILY</drugdosagetext>
        <drugindication>BONE SARCOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060117</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060117</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEOPHAGEN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5060089-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060511</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006ADE/DICLO-008</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>52</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DICLOFENAC RETARD             -RATIOPHARM 100</medicinalproduct>
        <drugauthorizationnumb>74986</drugauthorizationnumb>
        <drugdosagetext>3-5, INJECTIONS</drugdosagetext>
        <drugindication>BACK PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030901</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOSARTAN          AND DIURETICS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL        AND OTHER DIURETICS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIURETICS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5060090-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060705</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>230356K06CAN</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <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>ABORTION SPONTANEOUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ECTOPIC PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VAGINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBIF</medicinalproduct>
        <drugdosagetext>44, 2 IN 1 WEEKS</drugdosagetext>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20011217</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5060091-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060704</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>E3810-00014-SPO-CA</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>33</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>AGITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOOD SWINGS</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>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5060092-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060710</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>RS006060-J</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>89</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>INTERSTITIAL LUNG DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY ARREST</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>REFLUX OESOPHAGITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060423</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060430</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugdosagetext>20 MG, 1 IN 1 D, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>REFLUX OESOPHAGITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060420</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060422</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MAGMITT                (MAGNESIUM OXIDE)</medicinalproduct>
        <drugdosagetext>750 MG, 3 IN 1 D, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONSTIPATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060423</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HALTHROW                  (TAMSULOSIN HYDROCHLORIDE)</medicinalproduct>
        <drugdosagetext>0.2 MG, 1 IN 1 D, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BENIGN PROSTATIC HYPERPLASIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060425</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUMARIN                  (FLOMOXEF SODIUM)</medicinalproduct>
        <drugdosagetext>2 GM, 2 IN 1 D, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>C-REACTIVE PROTEIN INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060420</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060421</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SELBEX (TEPRENONE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADONA                   (CARBAZOCHROME SODIUM SULFONATE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALESION              (EPINASTINE HYDROCHLORIDE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUMARIN (FLOMOXEF SODIUM)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5060093-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060704</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>S06-FRA-02576-01</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>54</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD ALBUMIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CHLORIDE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD SODIUM DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD UREA DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CLONUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HOT FLUSH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPONATRAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCLONUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUROLOGICAL EXAMINATION ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PCO2 DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SALIVARY HYPERSECRETION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPEECH DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROPLEX         (ESCITALOPRAM)</medicinalproduct>
        <drugauthorizationnumb>21323</drugauthorizationnumb>
        <drugdosagetext>1 UNITS QD PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060516</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060516</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BUFLOMEDIL</medicinalproduct>
        <drugdosagetext>300 MG BID PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060516</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANSOPRAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXAZEPAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FORLAX (MACROGOL)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROPOFOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SEDATIF PC</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5060094-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060724</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060531</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-NOVOPROD-253910</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>22</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>57</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVEMIR</medicinalproduct>
        <drugbatchnumb>RP51345</drugbatchnumb>
        <drugauthorizationnumb>21536</drugauthorizationnumb>
        <drugdosagetext>32 IU, QD</drugdosagetext>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NOVORAPID FLEXPEN</medicinalproduct>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5060095-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060706</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>S06-DEN-02855-01</companynumb>
    <primarysource>
      <reportercountry>DENMARK</reportercountry>
      <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>SUDDEN DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ESCITALOPRAM OXALATE</medicinalproduct>
        <drugauthorizationnumb>21323</drugauthorizationnumb>
        <drugdosagetext>15 MG QD PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051129</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ORLISTAT</medicinalproduct>
        <drugdosagetext>140 MG QD PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OVERWEIGHT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050412</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5060096-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060706</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>S06-CAN-02628-01</companynumb>
    <primarysource>
      <reportercountry>DENMARK</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>24</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MULTIPLE DRUG OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDE ATTEMPT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELEXA</medicinalproduct>
        <drugauthorizationnumb>20822</drugauthorizationnumb>
        <drugdosagetext>1600 MG ONCE PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELEXA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugdosagetext>200 MG ONCE</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5060097-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060510</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>STA-AE-06-040</companynumb>
    <primarysource>
      <reportercountry>SPAIN</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>39</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ASCITES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG ERUPTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC ATROPHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC ENCEPHALOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC NECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER TRANSPLANT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PYRAZINAMIDE</medicinalproduct>
        <drugauthorizationnumb>80157</drugauthorizationnumb>
        <drugdosagetext>1800 MG/DAY</drugdosagetext>
        <drugindication>TUBERCULOSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ISONIAZID</medicinalproduct>
        <drugdosagetext>300MG/DAY</drugdosagetext>
        <drugindication>TUBERCULOSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RIFAMPIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>STREPTOMYCIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CIPROFLOXACIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ETHAMBUTOL HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>STREPTOMYCIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAMADOL HCL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5060098-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060714</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2005P1000607</companynumb>
    <primarysource>
      <reportercountry>POLAND</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>71</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>65</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY STENOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENTRICULAR HYPERTROPHY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RETEPLASE              (RETEPLASE)</medicinalproduct>
        <drugdosagetext>IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050930</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050930</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REOPRO</medicinalproduct>
        <drugdosagetext>IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ACUTE MYOCARDIAL INFARCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050930</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRIMETAZIDINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TICLOPIDINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRANDOLAPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NIFUROXAZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LACTOBACILLUS ACIDOPHILUS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PERINDOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RANITIDINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5060099-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060711</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A-CH2006-12580</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>15</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>TRANSAMINASES INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VIRAL INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRACLEER</medicinalproduct>
        <drugauthorizationnumb>21290</drugauthorizationnumb>
        <drugdosagetext>62.5 MG, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020619</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BRONCHOTRETARD              (THEOPHYLLINE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VENTAVIS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIURETICS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5060100-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060724</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060714</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-AVENTIS-200617479GDDC</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CATARACT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAXOTERE</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>020449</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NEOPLASM</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5060101-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060724</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060621</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-AVENTIS-200612244JP</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>62</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>72.8</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>NECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POSTOPERATIVE WOUND COMPLICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SHOCK HAEMORRHAGIC</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAXOTERE</medicinalproduct>
        <drugauthorizationnumb>020449</drugauthorizationnumb>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>NASOPHARYNGEAL CANCER RECURRENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050818</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050818</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAXOTERE</medicinalproduct>
        <drugauthorizationnumb>020449</drugauthorizationnumb>
        <drugadministrationroute>041</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050825</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050825</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BRIPLATIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NASOPHARYNGEAL CANCER RECURRENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050706</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050706</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BRIPLATIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050802</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050802</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUOROURACIL</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NASOPHARYNGEAL CANCER RECURRENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050706</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050710</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUOROURACIL</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050802</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050806</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RADIOTHERAPY</medicinalproduct>
        <drugdosagetext>DOSE: 60 GY/TOTAL</drugdosagetext>
        <drugindication>NASOPHARYNGEAL CANCER RECURRENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050818</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051001</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5060102-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060707</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200612957GDS</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>80</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>75</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HYPOACUSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TINNITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVELOX</medicinalproduct>
        <drugauthorizationnumb>21085</drugauthorizationnumb>
        <drugdosagetext>400 MG, QD,ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INFLUENZA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060608</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060617</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLARITIN-D</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5060103-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060724</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060307</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IT-AVENTIS-200612195GDDC</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>6</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEBRILE NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOLYTIC ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLEBOCORTID</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>80472</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PREMEDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060210</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060210</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VINCRISTINE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOFRAN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORMOSOL</medicinalproduct>
        <drugdosagetext>DOSE: 1000 ML/24 HR</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARBOPLATIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BACTRIM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060209</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060211</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRIMETON</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060210</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060210</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5060104-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060724</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060710</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AVENTIS-200617154GDDC</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>60</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>91</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ABDOMINAL DISTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPHIL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>REFUSAL OF TREATMENT BY PATIENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINE OUTPUT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAXOTERE</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>20449</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060626</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060626</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENOXAPARIN</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060703</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IRINOTECAN</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060626</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060626</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5060105-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060724</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060704</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-AVENTIS-200612070JP</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>71</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>38.6</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CANCER PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERSTITIAL LUNG DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROCTALGIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAXOTERE</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>OVARIAN CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060613</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060613</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GEMZAR</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>OVARIAN CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060606</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060606</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GEMZAR</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060613</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060613</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GEMZAR</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060627</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060627</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANIRAPID</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RENIVACE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060704</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORITREN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CANCER PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060619</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DUROTEP</medicinalproduct>
        <drugindication>CANCER PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051001</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5060106-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060712</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A-CH2006-12523</companynumb>
    <primarysource>
      <reportercountry>BELGIUM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>69</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>44</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>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRACLEER</medicinalproduct>
        <drugauthorizationnumb>21290</drugauthorizationnumb>
        <drugdosagetext>125 MG, BID; ORAL; 62.5 MG, BID; ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050829</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051009</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRACLEER</medicinalproduct>
        <drugauthorizationnumb>21290</drugauthorizationnumb>
        <drugdosagetext>125 MG, BID; ORAL; 62.5 MG, BID; ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051010</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060612</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REMODULIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RYTMONORM              (PROPAFENONE HYDROCHLORIDE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CITALOPRAM HYDROBROMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BUMETANIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KALIUM DURETTES (POTASSIUM CHLORIDE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MOTILIUM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5060107-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060724</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060621</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-AVENTIS-200611919JP</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>BONE MARROW FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISEASE PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUCOSAL INFLAMMATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAXOTERE</medicinalproduct>
        <drugauthorizationnumb>20449</drugauthorizationnumb>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>PHARYNGEAL CANCER STAGE UNSPECIFIED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAXOTERE</medicinalproduct>
        <drugauthorizationnumb>020449</drugauthorizationnumb>
        <drugadministrationroute>041</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CISPLATIN</medicinalproduct>
        <drugindication>PHARYNGEAL CANCER STAGE UNSPECIFIED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUOROURACIL</medicinalproduct>
        <drugindication>PHARYNGEAL CANCER STAGE UNSPECIFIED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RADIOTHERAPY</medicinalproduct>
        <drugindication>PHARYNGEAL CANCER STAGE UNSPECIFIED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CBDCA</medicinalproduct>
        <drugindication>PHARYNGEAL CANCER STAGE UNSPECIFIED</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5060108-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060724</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>19990127</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-BRISTOL-MYERS SQUIBB COMPANY-13445382</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>AXILLARY VEIN THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EMPHYSEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAMMOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HIV ANTIBODY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG INFILTRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG NEOPLASM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VEPESID</medicinalproduct>
        <drugauthorizationnumb>18768</drugauthorizationnumb>
        <drugdosagetext>FOLINIC ACID/FLUOROURACIL/ETOPOSIDE MAR-1995 TO AT LEAST 29-DEC-1999 W/INTERMITTENT IMPLICATIONS.</drugdosagetext>
        <drugindication>GASTRIC CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19981001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19991229</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOLINIC ACID</medicinalproduct>
        <drugdosagetext>FOLINIC ACID/FLUOROURACIL/ETOPOSIDE MAR-1995 TO AT LEAST 29-DEC-1999 W/INTERMITTENT IMPLICATIONS.</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19950301</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUOROURACIL</medicinalproduct>
        <drugdosagetext>FOLINIC ACID/FLUOROURACIL/ETOPOSIDE MAR-1995 TO AT LEAST 29-DEC-1999 W/INTERMITTENT IMPLICATIONS.</drugdosagetext>
        <drugindication>GASTRIC CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19950301</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5060109-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060705</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A-CH2006-12552</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>61</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ASCITES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BREAST CANCER RECURRENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOCALISED OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRANSAMINASES INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRACLEER</medicinalproduct>
        <drugauthorizationnumb>21290</drugauthorizationnumb>
        <drugdosagetext>125 MG, BID; ORAL; 62.5 MG, BID; ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY HYPERTENSION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060601</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRACLEER</medicinalproduct>
        <drugauthorizationnumb>21290</drugauthorizationnumb>
        <drugdosagetext>125 MG, BID; ORAL; 62.5 MG, BID; ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ORAL ANTICOAGULANTS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5060110-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060714</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200612548GDS</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>58</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BRADYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC TAMPONADE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHOLECYSTITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHOLELITHIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSED LEVEL OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISEASE PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION POTENTIATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG LEVEL INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ELECTROMECHANICAL DISSOCIATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPONATRAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHLEBITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESTLESSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SHOCK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIFEDIPINE</medicinalproduct>
        <drugauthorizationnumb>20198</drugauthorizationnumb>
        <drugdosagetext>60 MG, TOTAL DAILY, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051018</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051031</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMLODIPINE BESYLATE</medicinalproduct>
        <drugdosagetext>10 MG, TOTAL DAILY, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051017</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051031</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOXAZOSIN MESYLATE</medicinalproduct>
        <drugdosagetext>8 MG, TOTAL DAILY, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051021</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051031</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DILTIAZEM HYDROCHLORIDE</medicinalproduct>
        <drugdosagetext>36 MG, TOTAL DAILY, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051031</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NICARDIPINE HYDROCHLORIDE</medicinalproduct>
        <drugdosagetext>500 MG, TOTAL DAILY, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051017</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051031</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CALSLOT (MANIDIPINE HYDROCHLORIDE)</medicinalproduct>
        <drugdosagetext>20 MG, TOTAL DAILY, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051021</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051031</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARVEDILOL</medicinalproduct>
        <drugdosagetext>20 MG, TOTAL DAILY, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051018</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051031</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5060111-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060706</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A-JP2006-12569</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>45</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC ENZYME INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER DISORDER</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>20051025</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BERAPROST SODIUM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5060112-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060707</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A-CH2006-12220</companynumb>
    <primarysource>
      <reportercountry>NETHERLANDS</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>73</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>70</patientweight>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LACTIC ACIDOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRACLEER</medicinalproduct>
        <drugauthorizationnumb>21290</drugauthorizationnumb>
        <drugdosagetext>125 MG BID; ORAL, 62.5 MG, BID; ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRACLEER</medicinalproduct>
        <drugauthorizationnumb>21290</drugauthorizationnumb>
        <drugdosagetext>125 MG BID; ORAL, 62.5 MG, BID; ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060407</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METFORMIN               (METFORMIN)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DICLOFENAC             (DICLOFENAC)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5060113-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060711</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A-CH2006-12250</companynumb>
    <primarysource>
      <reportercountry>TURKEY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>48</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>85</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ALANINE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASPARTATE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD BILIRUBIN INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRACLEER</medicinalproduct>
        <drugbatchnumb>BP047A0102</drugbatchnumb>
        <drugauthorizationnumb>21290</drugauthorizationnumb>
        <drugdosagetext>125 MG, BID; ORAL, 62.5 MG, BID; ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051110</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051215</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRACLEER</medicinalproduct>
        <drugbatchnumb>BP047A0102</drugbatchnumb>
        <drugauthorizationnumb>21290</drugauthorizationnumb>
        <drugdosagetext>125 MG, BID; ORAL, 62.5 MG, BID; ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051216</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060116</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRACLEER</medicinalproduct>
        <drugbatchnumb>AP029A0202</drugbatchnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5060114-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR200606004275</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>81</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRY MOUTH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOVEMENT DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPEECH DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugbatchnumb>FF5X22A</drugbatchnumb>
        <drugauthorizationnumb>21318</drugauthorizationnumb>
        <drugdosagetext>20 UG, DAILY (1/D),  SUBCUTANEOUS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060215</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FORTEO PEN (250MCG/ML) (FORTEO PEN 250MCG/ML (3ML)) PEN, DISPOSSABLE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5060115-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060711</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>NLWYE728214JUN06</companynumb>
    <primarysource>
      <reportercountry>NETHERLANDS</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>65</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRAIN COMPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONSCIOUSNESS FLUCTUATING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPHASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EXTENSOR PLANTAR RESPONSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FACIAL PARESIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERAL PHYSICAL HEALTH DETERIORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGIC STROKE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEMIPARESIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EFFEXOR</medicinalproduct>
        <drugauthorizationnumb>20151</drugauthorizationnumb>
        <drugdosagetext>37.5 MG 1X PER 1 DAY</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060508</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REMERON</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PERSANTIN - SLOW RELEASE (DIPYRIDAMOLE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASCAL (ACETYLSALICYLATE CALCIUM)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PERINDOPRIL ERBUMINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5060116-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR200607000088</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>81</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugauthorizationnumb>21318</drugauthorizationnumb>
        <drugdosagetext>20 UG, DAILY (1/D), SUBCUTANEOUS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060221</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060608</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5060117-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060707</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006-145339-NL</companynumb>
    <primarysource>
      <reportercountry>SWITZERLAND</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>17</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DELIRIUM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EXTRAPYRAMIDAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TENSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIRTAZAPINE</medicinalproduct>
        <drugdosagetext>15 MG ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060611</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060612</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CITALOPRAM HYDROBROMIDE</medicinalproduct>
        <drugdosagetext>40 MG ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060612</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CITALOPRAM HYDROBROMIDE</medicinalproduct>
        <drugdosagetext>40 MG ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DISEASE RECURRENCE</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060612</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVOMEPROMAZINE MALEATE</medicinalproduct>
        <drugdosagetext>25 MG ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANTISOCIAL BEHAVIOUR</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060608</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060611</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOMETHIAZOLE EDISILATE</medicinalproduct>
        <drugdosagetext>2 DF ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DELIRIUM</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060613</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060613</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BIPERIDEN HYDROCHLORIDE TAB</medicinalproduct>
        <drugdosagetext>2 MG ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>EXTRAPYRAMIDAL DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060612</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060612</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BIPERIDEN HYDROCHLORIDE TAB</medicinalproduct>
        <drugdosagetext>2 MG ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MOVEMENT DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060612</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060612</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5060118-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060724</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060222</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FRWYE422223FEB06</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>92</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>AORTIC DISSECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugdosagetext>50 MG TOTAL WEEKLY</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>ANKYLOSING SPONDYLITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050603</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060128</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INDOCID</medicinalproduct>
        <drugdosagetext>75 MG TOTAL DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANKYLOSING SPONDYLITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DI-ANTALVIC</medicinalproduct>
        <drugdosagetext>6 CAPSULES TOTAL DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANKYLOSING SPONDYLITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SECTRAL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>APROVEL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5060119-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesscongenitalanomali>1</seriousnesscongenitalanomali>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060710</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006-145361-NL</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
    </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>MIRTAZAPINE</medicinalproduct>
        <drugdosagetext>DF</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>QUETIAPINE FUMARATE</medicinalproduct>
        <drugdosagetext>DF</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5060120-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060712</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006-145368-NL</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MUSCLE TWITCHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALLOR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESTLESSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIRTAZAPINE</medicinalproduct>
        <drugdosagetext>DF</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>QUETIAPINE FUMARATE</medicinalproduct>
        <drugdosagetext>DF</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5060121-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA200607000215</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>92</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugauthorizationnumb>21318</drugauthorizationnumb>
        <drugdosagetext>20 UG, DAILY (1/D), UNK</drugdosagetext>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060110</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060625</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FORTEO PEN (250MCG/ML) 9FORTEO PEN 250MCG/ML (3ML)) PEN, DISPOSABLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYLENOL W/ CODEINE NO. 3</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5060122-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060710</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>THQ2006A00096</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>66</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>0</patientsex>
      <reaction>
        <reactionmeddrapt>ABASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHROPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASPIRATION JOINT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GOUT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PURULENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEUPROLIDE ACETATE</medicinalproduct>
        <drugdosagetext>22.5 MG (22.5 MG, 1 IN 3 M)</drugdosagetext>
        <drugindication>PROSTATE CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051116</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060216</drugenddate>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLEDRONIC ACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CANDESARTAAN CILEXETIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAMADOL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5060123-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060707</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>LTI2006A00164</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>72</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BRONCHITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DELIRIUM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HALLUCINATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY RETENTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OGAST 30 MG (LANSOPRAZOLE) (CAPSULES)</medicinalproduct>
        <drugdosagetext>30 MG (30 MG, 1 IN 1 D)</drugdosagetext>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060411</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LORAZEPAM</medicinalproduct>
        <drugdosagetext>1 MG, 1 IN 1 D)</drugdosagetext>
        <drugindication>ANXIETY</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060411</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALGOTROPYL PROMETHAZINE (MEDISED)</medicinalproduct>
        <drugdosagetext>2 DF (1 DF, 2 IN 1 D)</drugdosagetext>
        <drugindication>BRONCHITIS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060411</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRAZEPAM</medicinalproduct>
        <drugdosagetext>10 MG (10 MG, 1 IN 1 D) ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANXIETY</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060411</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALDALIX (OSYROL-LASIX) (CAPSULES)</medicinalproduct>
        <drugdosagetext>50 MG (50 MG, 1 IN 1 D) ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CARDIAC FAILURE CONGESTIVE</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060411</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugdosagetext>40 MG (20 MG, 2 IN 1 D) ORAL; 10 MG (10 MG, 1 IN 1 D) ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060411</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugdosagetext>40 MG (20 MG, 2 IN 1 D) ORAL; 10 MG (10 MG, 1 IN 1 D) ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060315</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SERETIDE (SERETIDE) (INHALANT)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VENTOLIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5060124-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB200606005921</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>73</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANGINA PECTORIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY BYPASS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMALOG MIX 75/25</medicinalproduct>
        <drugauthorizationnumb>20563</drugauthorizationnumb>
        <drugdosagetext>76 + 56 U, EACH MORNING, UNK - SEE IMAGE</drugdosagetext>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMALOG MIX 75/25</medicinalproduct>
        <drugauthorizationnumb>20563</drugauthorizationnumb>
        <drugdosagetext>76 + 56 U, EACH MORNING, UNK - SEE IMAGE</drugdosagetext>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NITROGLYCERIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5060125-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060706</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>6024125</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>70</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>EOSINOPHILIC PNEUMONIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LODOZ (TABLET) (HYDROCHLOROTHIAZIDE, BISOPROLOL FUMARATE)</medicinalproduct>
        <drugdosagetext>ORAL  FOR A FEW MONTHS</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5060126-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060712</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GBWYE130312JUL06</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>18</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>INTENTIONAL SELF-INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCREATITIS ACUTE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
        <drugauthorizationnumb>18989</drugauthorizationnumb>
        <drugdosagetext>400 MG 7X PER 1 DAY ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5060127-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060630</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR200607000099</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>58</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRY EYE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISION BLURRED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CIALIS</medicinalproduct>
        <drugauthorizationnumb>21368</drugauthorizationnumb>
        <drugdosagetext>0.5 D/F, OTHER, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OFF LABEL USE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060301</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CIALIS</medicinalproduct>
        <drugauthorizationnumb>21368</drugauthorizationnumb>
        <drugdosagetext>0.5 D/F, OTHER, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OFF LABEL USE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060610</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060610</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5060128-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060710</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DEWYE080110JUL06</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>56</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD CREATINE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRANSPLANT REJECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TACROLIMUS, CONTROL FOR SIROLIMUS (TACROLIMUS, CONTROL FOR SIROLIMUS, </medicinalproduct>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS AGAINST TRANSPLANT REJECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050217</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050217</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TACROLIMUS, CONTROL FOR SIROLIMUS (TACROLIMUS, CONTROL FOR SIROLIMUS, </medicinalproduct>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS AGAINST TRANSPLANT REJECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050218</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050218</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TACROLIMUS, CONTROL FOR SIROLIMUS (TACROLIMUS, CONTROL FOR SIROLIMUS, </medicinalproduct>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS AGAINST TRANSPLANT REJECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050219</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050219</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TACROLIMUS, CONTROL FOR SIROLIMUS (TACROLIMUS, CONTROL FOR SIROLIMUS, </medicinalproduct>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS AGAINST TRANSPLANT REJECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050222</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050222</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TACROLIMUS, CONTROL FOR SIROLIMUS (TACROLIMUS, CONTROL FOR SIROLIMUS, </medicinalproduct>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS AGAINST TRANSPLANT REJECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050223</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050223</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TACROLIMUS, CONTROL FOR SIROLIMUS (TACROLIMUS, CONTROL FOR SIROLIMUS, </medicinalproduct>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS AGAINST TRANSPLANT REJECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050224</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050225</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TACROLIMUS, CONTROL FOR SIROLIMUS (TACROLIMUS, CONTROL FOR SIROLIMUS, </medicinalproduct>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS AGAINST TRANSPLANT REJECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050226</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050226</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TACROLIMUS, CONTROL FOR SIROLIMUS (TACROLIMUS, CONTROL FOR SIROLIMUS, </medicinalproduct>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS AGAINST TRANSPLANT REJECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050227</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050301</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TACROLIMUS, CONTROL FOR SIROLIMUS (TACROLIMUS, CONTROL FOR SIROLIMUS, </medicinalproduct>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS AGAINST TRANSPLANT REJECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050302</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050302</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TACROLIMUS, CONTROL FOR SIROLIMUS (TACROLIMUS, CONTROL FOR SIROLIMUS, </medicinalproduct>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS AGAINST TRANSPLANT REJECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050303</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050303</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TACROLIMUS, CONTROL FOR SIROLIMUS (TACROLIMUS, CONTROL FOR SIROLIMUS, </medicinalproduct>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS AGAINST TRANSPLANT REJECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050304</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050304</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TACROLIMUS, CONTROL FOR SIROLIMUS (TACROLIMUS, CONTROL FOR SIROLIMUS, </medicinalproduct>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS AGAINST TRANSPLANT REJECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050305</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050305</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TACROLIMUS, CONTROL FOR SIROLIMUS (TACROLIMUS, CONTROL FOR SIROLIMUS, </medicinalproduct>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS AGAINST TRANSPLANT REJECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050306</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050307</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TACROLIMUS, CONTROL FOR SIROLIMUS (TACROLIMUS, CONTROL FOR SIROLIMUS, </medicinalproduct>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS AGAINST TRANSPLANT REJECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050308</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050308</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TACROLIMUS, CONTROL FOR SIROLIMUS (TACROLIMUS, CONTROL FOR SIROLIMUS, </medicinalproduct>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS AGAINST TRANSPLANT REJECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050309</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050310</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TACROLIMUS, CONTROL FOR SIROLIMUS (TACROLIMUS, CONTROL FOR SIROLIMUS, </medicinalproduct>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS AGAINST TRANSPLANT REJECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050311</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050316</drugenddate>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TACROLIMUS, CONTROL FOR SIROLIMUS (TACROLIMUS, CONTROL FOR SIROLIMUS, </medicinalproduct>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS AGAINST TRANSPLANT REJECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050317</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050320</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TACROLIMUS, CONTROL FOR SIROLIMUS (TACROLIMUS, CONTROL FOR SIROLIMUS, </medicinalproduct>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS AGAINST TRANSPLANT REJECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050321</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050321</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TACROLIMUS, CONTROL FOR SIROLIMUS (TACROLIMUS, CONTROL FOR SIROLIMUS, </medicinalproduct>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS AGAINST TRANSPLANT REJECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050322</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050323</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TACROLIMUS, CONTROL FOR SIROLIMUS (TACROLIMUS, CONTROL FOR SIROLIMUS, </medicinalproduct>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS AGAINST TRANSPLANT REJECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050504</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MYCOPHENOLATE MOFETIL</medicinalproduct>
        <drugdosagetext>1500 MG ORAL; 500 MG ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050217</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050317</drugenddate>
        <drugtreatmentduration>29</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MYCOPHENOLATE MOFETIL</medicinalproduct>
        <drugdosagetext>1500 MG ORAL; 500 MG ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SOLU DACORTIN H (PREDNISOLONE SODIUM SUCCINATE)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5060129-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060707</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>HQWYE840712JUL06</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>51</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYGACIL</medicinalproduct>
        <drugauthorizationnumb>21821</drugauthorizationnumb>
        <drugdosagetext>100 MG LOAD, 50 MG EVERY 12  HOURS INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060614</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUCONAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEOSTIGMINE (NEOSTIGMINE)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5060130-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>RU200606005563</companynumb>
    <primarysource>
      <reportercountry>RUSSIAN FEDERATION</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>51</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>71</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>APPENDIX DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEBRILE NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MASS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERITONITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROCEDURAL COMPLICATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEMETREXED (PEMETREXED UNKNOWN FORMULATION) UNKNOWN</medicinalproduct>
        <drugbatchnumb>9477</drugbatchnumb>
        <drugauthorizationnumb>21462</drugauthorizationnumb>
        <drugdosagetext>930 MG, UNK, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060606</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5060131-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060707</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>HQWYE722710JUL06</companynumb>
    <primarysource>
      <reportercountry>PORTUGAL</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>36</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>KIDNEY TRANSPLANT REJECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RAPAMUNE</medicinalproduct>
        <drugauthorizationnumb>21110</drugauthorizationnumb>
        <drugdosagetext>4 MG 1X PER 1 DAY ORAL; 3 MG 1X PER 1 DAY ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS AGAINST TRANSPLANT REJECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060314</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060703</drugenddate>
        <drugtreatmentduration>112</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RAPAMUNE</medicinalproduct>
        <drugauthorizationnumb>21110</drugauthorizationnumb>
        <drugdosagetext>4 MG 1X PER 1 DAY ORAL; 3 MG 1X PER 1 DAY ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS AGAINST TRANSPLANT REJECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060704</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060711</drugenddate>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MYCOPHENOLATE MOFETIL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5060132-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060712</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>HQWYE037114OCT05</companynumb>
    <primarysource>
      <reportercountry>CROATIA (local name: Hrvatska)</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>80</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ACINETOBACTER INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASPIRATION TRACHEAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CULTURE POSITIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CULTURE POSITIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MONOCYTE PERCENTAGE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTI-ORGAN FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NOSOCOMIAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSEUDOMONAS INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPTIC SHOCK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STAPHYLOCOCCAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TIGECYCLINE (TIGECYCLINE, INJECTION)</medicinalproduct>
        <drugauthorizationnumb>21821</drugauthorizationnumb>
        <drugdosagetext>100 MG LOAD, THEN 50 MG TWICE DAILY INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PNEUMONIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051005</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051011</drugenddate>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIAZEPAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RANITIDINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIGOXIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VERAPAMIL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5060133-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060705</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0430892A</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>EXTRAPYRAMIDAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THERAPEUTIC AGENT TOXICITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LITHIUM SALT (FORMULATION UNKNOWN) (LITHIUM SALT)</medicinalproduct>
        <drugauthorizationnumb>16860</drugauthorizationnumb>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5060134-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>805#1#2006-00004</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>75</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>APNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EJECTION FRACTION DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING COLD</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERMITTENT CLAUDICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUDDEN DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALPROSTADIL</medicinalproduct>
        <drugdosagetext>40 MCG (40 MCG 1 IN 1 DAY(S))</drugdosagetext>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>ARTERIOSCLEROSIS OBLITERANS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060116</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060116</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLETAL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN ASPART(GENETICAL RECOMBINATION)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ISOSRBIDE DINITRATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DISOPYRAMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KALLIDINOGENASE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5060135-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060724</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060716</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20060703768</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>17</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HEPATIC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVERDOSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
        <drugauthorizationnumb>19872</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
        <drugauthorizationnumb>019872</drugauthorizationnumb>
        <drugindication>HEADACHE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5060136-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060707</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>805#9#2006-00083</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INFANTILE APNOEIC ATTACK</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALPROSTADIL</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>HEART DISEASE CONGENITAL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041209</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALPROSTADIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRONOLACTONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM GLUCONATE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5060137-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20051005</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>000#8#2005-00716</companynumb>
    <primarysource>
      <reportercountry>ITALY</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALPROSTADIL</medicinalproduct>
        <drugdosagetext>60 MG (60 MG 1 IN 1 DAY(S))</drugdosagetext>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>SKIN ULCER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPICAL ANTISEPTICS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5060138-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060707</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>006#1#2006-00045</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ARTERIOSPASM CORONARY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EDEX</medicinalproduct>
        <drugadministrationroute>017</drugadministrationroute>
        <drugindication>ERECTILE DYSFUNCTION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5060139-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060711</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>111456ISR</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>6</patientonsetage>
      <patientonsetageunit>802</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE VIA BREAST MILK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FOOD INTOLERANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRANSIENT HYPOGAMMAGLOBULINAEMIA OF INFANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT GAIN POOR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUCONAZOLE</medicinalproduct>
        <drugdosagetext>200 MILLIGRAM</drugdosagetext>
        <drugadministrationroute>063</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041223</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5060140-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060706</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>02100-JPN-06-0244</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>77</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DECREASED APPETITE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSED LEVEL OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARALYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CILOSTAZOL</medicinalproduct>
        <drugdosagetext>200 MG ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CEREBRAL INFARCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060522</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060524</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FAMOTIDINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGNESIUM OXIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRAVASTATIN SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUVOXAMINE MALEATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ETIZOLAM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5060141-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060707</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CAWYE086910JUL06</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>24</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PRIAPISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EFFEXOR XR</medicinalproduct>
        <drugauthorizationnumb>20699</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5060142-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060710</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GBWYE084410JUL06</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>41</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ADVERSE EVENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GEMTUZUMAB OZOGAMICIN (GEMTUZUMAB OGOZAMICIN, INJECTION)</medicinalproduct>
        <drugauthorizationnumb>21174</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUDARABINE (FLUDARABINE, , 0)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYTARABINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEUPOGEN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5060143-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060724</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060516</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-GILEAD-2006-0009594</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>43</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>71</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CONJUNCTIVAL HYPERAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CYTOLOGY ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTHERMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH MACULO-PAPULAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOXIC SKIN ERUPTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EMTRIVA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060225</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060309</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TELZIR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060225</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060309</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RETROVIR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060225</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060309</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVIR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060225</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060309</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5060144-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060724</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060713</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GBWYE178114JUL06</companynumb>
    <primarysource>
      <reportercountry>IRELAND</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>RETINAL DETACHMENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugdosagetext>UNKNOWN</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugdosagetext>UNKNOWN</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5060145-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060724</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060306</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-NOVOPROD-251340</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>71</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>104</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>TRANSIENT ISCHAEMIC ATTACK</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRANDIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>20741</drugauthorizationnumb>
        <drugdosagetext>1 MG, TID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS NON-INSULIN-DEPENDENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
        <drugindication>DIABETES MELLITUS NON-INSULIN-DEPENDENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SOTALOL HCL</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR                                 /NET/</medicinalproduct>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5060146-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060724</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060307</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-NOVOPROD-251415</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>68</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>55</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PLEURISY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYOTHORAX</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NOVOSEVEN</medicinalproduct>
        <drugdosagetext>40 UG/KG, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CEREBRAL HAEMORRHAGE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060220</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060220</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FAMOTIDINE</medicinalproduct>
        <drugdosagetext>40 MG, QD</drugdosagetext>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060221</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
        <drugdosagetext>10 MG, QD</drugdosagetext>
        <drugindication>PLEURAL EFFUSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060227</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENTERONON R</medicinalproduct>
        <drugdosagetext>3 G, QD</drugdosagetext>
        <drugindication>DIARRHOEA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060302</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SOLDEM 1</medicinalproduct>
        <drugdosagetext>960 ML, QD</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060303</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VANCOMYCIN HYDROCHLORIDE</medicinalproduct>
        <drugdosagetext>UNK, QD</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060407</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5060147-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060724</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060711</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FRWYE138313JUL06</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>80</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CHOLECYSTITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYSIPELAS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PELVIC FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN ULCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TELANGIECTASIA</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>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugdosagetext>UNKNOWN</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060501</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugdosagetext>UNKNOWN</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EFFEXOR</medicinalproduct>
        <drugdosagetext>UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugdosagetext>UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CORTANCYL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SKENAN</medicinalproduct>
        <drugdosagetext>20 MG TOTAL DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050901</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5060148-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060724</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060713</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-US186359</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FUNGAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SLEEP APNOEA SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>P074065</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PSORIATIC ARTHROPATHY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5060149-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060724</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060710</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-STX185984</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ARTHROPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JOINT DISLOCATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISION BLURRED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>P068338</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041124</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5060150-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060724</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060524</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GBWYE652124MAY06</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>89</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANAPHYLACTIC SHOCK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANGIONEUROTIC OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSED LEVEL OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWELLING FACE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URTICARIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060207</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060520</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SULFASALAZINE</medicinalproduct>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050221</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
        <drugdosagetext>5MG 6 DAYS A WEEK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CODEINE PHOSPHATE/PARACETAMOL</medicinalproduct>
        <drugdosagetext>AS NEEDED</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CODEINE PHOSPHATE/PARACETAMOL</medicinalproduct>
        <drugdosagetext>AS NEEDED</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ETORICOXIB</medicinalproduct>
        <drugdosagetext>60MG DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COMBIVENT</medicinalproduct>
        <drugdosagetext>4 TIMES A DAY</drugdosagetext>
        <drugindication>COUGH</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SALMETEROL/FLUTICASONE</medicinalproduct>
        <drugdosagetext>2 TIMES A DAY</drugdosagetext>
        <drugindication>COUGH</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5060151-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060724</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060705</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-13434097</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>56</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOKALAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENTAL STATUS CHANGES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUCOSAL INFLAMMATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ERBITUX</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>SQUAMOUS CELL CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060626</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060626</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARBOPLATIN</medicinalproduct>
        <drugdosagetext>INITIAL DOSE: 15MAY06</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>SQUAMOUS CELL CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060626</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060626</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PACLITAXEL</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>SQUAMOUS CELL CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060626</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060626</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RADIATION THERAPY</medicinalproduct>
        <drugdosagetext>DOSAGE FORM = CGY  2100-2700 CGY WEEKS 6-8</drugdosagetext>
        <drugindication>SQUAMOUS CELL CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060630</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060630</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5060152-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060724</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060713</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-BRISTOL-MYERS SQUIBB COMPANY-13441910</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>67</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>50</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD CREATININE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CISPLATIN</medicinalproduct>
        <drugindication>SMALL CELL LUNG CANCER STAGE UNSPECIFIED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060317</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IRINOTECAN HCL</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060317</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLEXANE</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060518</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEBILET</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ISOKET</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060622</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060622</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5060153-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060724</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060411</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-13344130</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>69</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CISPLATIN</medicinalproduct>
        <drugauthorizationnumb>18057</drugauthorizationnumb>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>LUNG NEOPLASM MALIGNANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060321</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060321</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TS-1</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>LUNG NEOPLASM MALIGNANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060321</drugstartdate>
        <drugtreatmentduration>14</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PERCOCET</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DILTIAZEM HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MS CONTIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COMBIVENT</medicinalproduct>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADVAIR DISKUS 100/50</medicinalproduct>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVENOX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CIPROFLOXACIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLAGYL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VANCOMYCIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEUPOGEN</medicinalproduct>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060408</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5060154-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060724</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050321</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-NOVOPROD-243078</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>48</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>99</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NOVOLOG MIX 70/30</medicinalproduct>
        <drugauthorizationnumb>21172</drugauthorizationnumb>
        <drugdosagetext>12 U, QD</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>INSULIN-REQUIRING TYPE II DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050318</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050320</drugenddate>
        <drugtreatmentduration>2880</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NOVOLOG MIX 70/30</medicinalproduct>
        <drugauthorizationnumb>021172</drugauthorizationnumb>
        <drugdosagetext>30 U, QD</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050321</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALTACE</medicinalproduct>
        <drugdosagetext>5 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050316</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
        <drugdosagetext>200 MCQ, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPOTHYROIDISM</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
        <drugdosagetext>40 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BUSPAR</medicinalproduct>
        <drugdosagetext>30 MG, QD</drugdosagetext>
        <drugindication>ANXIETY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZANTAC</medicinalproduct>
        <drugdosagetext>300 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050321</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>162 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050321</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5060155-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060724</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060703</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-AVENTIS-200612058JP</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>38</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>72</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ALOPECIA AREATA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREATMENT NONCOMPLIANCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALLEGRA</medicinalproduct>
        <drugauthorizationnumb>20872</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>URTICARIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060626</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060630</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5060156-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060724</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060504</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2006-BP-05100BP</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>57</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ARRHYTHMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUPRAVENTRICULAR TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
        <drugbatchnumb>508690,5C1207</drugbatchnumb>
        <drugauthorizationnumb>21395</drugauthorizationnumb>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060502</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CATAPRES-TTS-1</medicinalproduct>
        <drugauthorizationnumb>018891</drugauthorizationnumb>
        <drugadministrationroute>061</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NERVE INJURY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM SUPPLEMENT</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>VITAMIN SUPPLEMENTATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL SPIROS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5060157-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060724</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060717</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AR-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2006-BP-08180RA</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>67</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MENINGEAL DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TIPRANAVIR / RITONAVIR CAPSULES, SOFTGELATIN</medicinalproduct>
        <drugdosagetext>TPV/RTV 1000/400 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040921</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5060158-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060724</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060704</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2006-BP-07605NB</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>80</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DYSGEUSIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
        <drugauthorizationnumb>21395</drugauthorizationnumb>
        <drugadministrationroute>055</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5060159-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060724</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060718</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2006-BP-08332NB</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CYTOMEGALOVIRUS VIRAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC FUNCTION ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATITIS C</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIRAMUNE</medicinalproduct>
        <drugauthorizationnumb>020636</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041011</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EPIVIR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040917</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZERIT</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041126</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIRACEPT</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050401</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5060160-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060724</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060718</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2006-BP-08236BR</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>ARRHYTHMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
        <drugbatchnumb>NR</drugbatchnumb>
        <drugauthorizationnumb>21395</drugauthorizationnumb>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050601</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMBIVENT</medicinalproduct>
        <drugbatchnumb>NR</drugbatchnumb>
        <drugauthorizationnumb>020291</drugauthorizationnumb>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050601</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5060161-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060724</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060719</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2006-BP-08353BP</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIAC ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSGEUSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY ARREST</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMBIVENT</medicinalproduct>
        <drugbatchnumb>06008W,665001A</drugbatchnumb>
        <drugauthorizationnumb>020291</drugauthorizationnumb>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19960101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5060162-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060724</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060621</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2006-BP-07175BP</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>28</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>77.27</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CD4 LYMPHOCYTES ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STEVENS-JOHNSON SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIRAMUNE</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>20636</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060517</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060529</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIRAMUNE</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>020636</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060530</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060603</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COMBIVIR</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060517</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060603</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COMBIVIR</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060610</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5060163-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060724</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060718</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2006-BP-08334NB</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>61</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CEREBRAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MICARDIS</medicinalproduct>
        <drugauthorizationnumb>20850</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040723</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050315</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OTHER MEDICATION</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040723</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050315</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5060164-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060724</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060705</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2006-BP-07679NB</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>68.5</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ATRIOVENTRICULAR BLOCK THIRD DEGREE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MICARDIS</medicinalproduct>
        <drugauthorizationnumb>20850</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051003</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051201</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5060165-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060724</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060619</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2006-BP-07215PF</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RECTAL CANCER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>21395</drugauthorizationnumb>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051213</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL</medicinalproduct>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050930</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATIVAN</medicinalproduct>
        <drugindication>RESTLESS LEGS SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051018</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BACTRIM DS</medicinalproduct>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051004</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DURAGESIC-100</medicinalproduct>
        <drugdosagetext>25 MCG/HR</drugdosagetext>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060510</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLEXERIL</medicinalproduct>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
        <drugindication>ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051018</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LYRICA CV</medicinalproduct>
        <drugindication>NEUROPATHY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050330</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NASONEX</medicinalproduct>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051018</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugindication>BLOOD CHOLESTEROL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NIZORAL</medicinalproduct>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050620</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
        <drugindication>NEUROPATHY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060104</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PERCOCET</medicinalproduct>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060519</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRAVACHOL</medicinalproduct>
        <drugindication>BLOOD CHOLESTEROL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051002</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SUSTIVA</medicinalproduct>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051004</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRUVADA</medicinalproduct>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051004</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VICODON ES</medicinalproduct>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060104</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZIAGEN</medicinalproduct>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051004</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugindication>INFLAMMATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060223</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060401</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051007</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060104</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5060166-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060724</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060718</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2006-BP-08231AU</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>81</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MOBIC</medicinalproduct>
        <drugbatchnumb>NR</drugbatchnumb>
        <drugauthorizationnumb>020938</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MICARDIS</medicinalproduct>
        <drugbatchnumb>NR</drugbatchnumb>
        <drugauthorizationnumb>020850</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5060167-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060724</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060627</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2006-BP-07383BP</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>86</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY OCCLUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HALLUCINATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JOB DISSATISFACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NARCOLEPSY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OBSESSIVE-COMPULSIVE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PATHOLOGICAL GAMBLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDE ATTEMPT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIRAPEX</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>020667</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RESTLESS LEGS SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugindication>CARDIAC DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugindication>CARDIAC DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZETIA</medicinalproduct>
        <drugindication>HYPERCHOLESTEROLAEMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>CARDIAC DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMDUR</medicinalproduct>
        <drugindication>CARDIAC DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROZAC</medicinalproduct>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060301</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KLONOPIN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>K-DUR 10</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRIAVIL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5060168-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060724</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060712</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-US186032</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>REFUSAL OF TREATMENT BY PATIENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STOMACH DISCOMFORT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARANESP</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugindication>DIALYSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5060169-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060724</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060712</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-US185994</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>HOSPITALISATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARANESP</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>ANAEMIA OF MALIGNANT DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060621</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060621</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUOROURACIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAXOTERE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEUCOVORIN CALCIUM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5060170-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060707</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A-CH2006-12476</companynumb>
    <primarysource>
      <reportercountry>NETHERLANDS</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>75</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>60</patientweight>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ASPARTATE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUDDEN DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRACLEER</medicinalproduct>
        <drugauthorizationnumb>21290</drugauthorizationnumb>
        <drugdosagetext>62.5 MG, BID, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060501</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOSINOPRIL SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOLBUTAMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOBRADEX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IPRATROPIUM BROMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMIODARONE (AMIODARONE)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5060171-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060707</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A-CH2006-12572</companynumb>
    <primarysource>
      <reportercountry>NETHERLANDS</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>76</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>CARDIAC ARREST</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>20031204</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>PULMONARY HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040105</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060429</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALDACTONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BUMETANIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANTOZOL (PANTOPRAZOLE SODIUM)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE TAB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MOVICOLON (SODIUM CHLORIDE, SODIUM BICARBONATE, POTASSIUM CHLORIDE, MA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACENOCOUMAROL (ACENOCOUMAROL)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMNIC (TAMSULOSIN HYDROCHLORIDE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DURAGESIC-100</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5060172-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060707</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A-CH2006-12570</companynumb>
    <primarysource>
      <reportercountry>NETHERLANDS</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>64</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>SUDDEN DEATH</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>20040701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040801</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>20040801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060610</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SILDENAFIL CITRATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMARIN (COUMARIN)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRAVASTATIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5060173-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060724</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060504</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHNU2006DE01854</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DERMATITIS ALLERGIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH PUSTULAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TESTICULAR NEOPLASM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TESTICULAR OPERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TESTICULAR PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TEGRETOL</medicinalproduct>
        <drugbatchnumb>W0027</drugbatchnumb>
        <drugauthorizationnumb>20234</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TEGRETOL</medicinalproduct>
        <drugbatchnumb>W0035</drugbatchnumb>
        <drugauthorizationnumb>020234</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PERENTEROL</medicinalproduct>
        <drugdosagetext>UNK, UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugtreatmentduration>4320</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5060174-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060706</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DEU-2006-0002335</companynumb>
    <primarysource>
      <reportercountry>AUSTRIA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>58</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>82</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INTERVERTEBRAL DISC PROTRUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULAR WEAKNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NERVE ROOT COMPRESSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXYCODON 10MG/ NALOXON 5MG (NALOXONE HYDROCHLORIDE, OXYCODONE HYDROCHL</medicinalproduct>
        <drugauthorizationnumb>20553</drugauthorizationnumb>
        <drugdosagetext>80 MG, DAILY, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BACK PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060413</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5060175-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060705</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>23100300</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>71</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>BRAIN OEDEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARGATROBAN</medicinalproduct>
        <drugauthorizationnumb>20883</drugauthorizationnumb>
        <drugindication>CEREBRAL INFARCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050629</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050702</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5060176-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060704</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>227314</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>30</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVASTIN</medicinalproduct>
        <drugbatchnumb>C21011404</drugbatchnumb>
        <drugdosagetext>769 MG, Q2W, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLON CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051012</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVASTIN</medicinalproduct>
        <drugbatchnumb>M23007</drugbatchnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVASTIN</medicinalproduct>
        <drugbatchnumb>M48683</drugbatchnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXALIPLATIN (OXALIPLATIN)</medicinalproduct>
        <drugbatchnumb>C21069401</drugbatchnumb>
        <drugdosagetext>185 MG, Q2W, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLON CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051012</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXALIPLATIN (OXALIPLATIN)</medicinalproduct>
        <drugbatchnumb>04218</drugbatchnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUOROURACIL</medicinalproduct>
        <drugbatchnumb>RO92697</drugbatchnumb>
        <drugdosagetext>872 MG, Q2W, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLON CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051012</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEUCOVORIN CALCIUM</medicinalproduct>
        <drugbatchnumb>100100401</drugbatchnumb>
        <drugdosagetext>436 MG, Q2W, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLON CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051012</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IRON (IRON NOS)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTIVITAMIN NOS (MULTIVITAMINS NOS)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RANITIDINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FRAGMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RANITIDINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FRAGMIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5060177-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060714</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006P1000105</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>54</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>60</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY STENOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RETEPLASE (RETEPLASE)</medicinalproduct>
        <drugdosagetext>IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ACUTE MYOCARDIAL INFARCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051112</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REOPRO</medicinalproduct>
        <drugdosagetext>IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ACUTE MYOCARDIAL INFARCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051112</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACEBUTOLOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRANDOLAPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLOPIDOGREL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLOPIDOGREL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5060178-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060706</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>227054</companynumb>
    <primarysource>
      <reportercountry>SPAIN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>63</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MABTHERA(RITUXIMAB) CONC FOR SOLUTION FOR INFUSION</medicinalproduct>
        <drugbatchnumb>B2068</drugbatchnumb>
        <drugdosagetext>637 MG, Q3W, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>B-CELL LYMPHOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051230</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MABTHERA(RITUXIMAB) CONC FOR SOLUTION FOR INFUSION</medicinalproduct>
        <drugbatchnumb>B2023</drugbatchnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOPHOSHPAMIDE (CYCLOPHOSPHAMIDE)</medicinalproduct>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugindication>B-CELL LYMPHOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051230</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOPHOSHPAMIDE (CYCLOPHOSPHAMIDE)</medicinalproduct>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugindication>B-CELL LYMPHOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060327</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOXORUBICIN HCL</medicinalproduct>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugindication>B-CELL LYMPHOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051230</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOXORUBICIN HCL</medicinalproduct>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugindication>B-CELL LYMPHOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060327</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VINCRISTINE</medicinalproduct>
        <drugdosagetext>2 MG, Q3W, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>B-CELL LYMPHOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051230</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISONE TAB</medicinalproduct>
        <drugdosagetext>100 MG, Q3W, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>B-CELL LYMPHOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051230</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHROID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5060179-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060710</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006-07-0402</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>67</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>72</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANOREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBELLAR INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL DISTURBANCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INTRON A</medicinalproduct>
        <drugauthorizationnumb>20903</drugauthorizationnumb>
        <drugdosagetext>6 MIU QD INTRAMUSCULAR</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040430</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040513</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBETOL</medicinalproduct>
        <drugdosagetext>800 MG ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040430</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040513</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POLARAMINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>URSO</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUITRAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIGOSIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DASEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MUCOSOLVAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SELBEX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5060180-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060710</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006-06-0987</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>60</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>46</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>REFLUX OESOPHAGITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TEMOZOLOMIDE CAPSULES</medicinalproduct>
        <drugauthorizationnumb>21029</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GLIOBLASTOMA MULTIFORME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060327</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060613</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RADIATION THERAPY</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KYTRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZONISAMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGNESIUM OXIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BACTRAMIN GRANULES</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5060181-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060707</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006-05-1385</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>24</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>71</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PERIPHERAL SENSORY NEUROPATHY</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>20041201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051101</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>20041201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5060182-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060711</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>E2020-00243-SPO-CH</companynumb>
    <primarysource>
      <reportercountry>SWITZERLAND</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>78</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>DYSKINESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERAL PHYSICAL HEALTH DETERIORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHABDOMYOLYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEROTONIN SYNDROME</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>20060401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060512</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
        <drugdosagetext>50 MG, 1 IN 1 D, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060512</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL SUCCINATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SORBIDILAT (ISOSORBIDE DINITRATE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN TAB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SERETIDE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5060183-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060707</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006-07-0317</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>70</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>52</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ELECTROCARDIOGRAM ST SEGMENT ELEVATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TUBERCULOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEG-INTRON</medicinalproduct>
        <drugdosagetext>80 MCG QW SUBCUTANEOUS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060120</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBETOL</medicinalproduct>
        <drugdosagetext>600 MG ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ISCOTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RIFAMPICIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ESANBUTOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PYRIDOXAL PHOSPHATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAMSULOSIN HCL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5060184-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060706</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>E044-318-3734</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>73</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>80</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CLOSTRIDIUM DIFFICILE COLITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISORIENTATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING COLD</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HALLUCINATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTHERMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOWER RESPIRATORY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DONEPEZIL HCL</medicinalproduct>
        <drugauthorizationnumb>20690</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEMENTIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041220</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050313</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DONEPEZIL HCL</medicinalproduct>
        <drugauthorizationnumb>20690</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEMENTIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050316</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050319</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DONEPEZIL HCL</medicinalproduct>
        <drugdosagetext>DOUBLEBLIND, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEMENTIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040803</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041220</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANSOPRAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRAMIPEXOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CO-CARELODOPA (SINEMET)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5060185-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060630</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB200606006234</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>13</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>35</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>AGGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HOMICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSYCHIATRIC SYMPTOM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>STRATTERA</medicinalproduct>
        <drugauthorizationnumb>21411</drugauthorizationnumb>
        <drugdosagetext>25 MG</drugdosagetext>
        <drugindication>ATTENTION DEFICIT/HYPERACTIVITY DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHYLPHENIDATE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONIDINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5060186-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR200606004095</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>23</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>51</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE ANAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SOMATROPIN (SOMATROPIN) VIAL</medicinalproduct>
        <drugauthorizationnumb>19640</drugauthorizationnumb>
        <drugdosagetext>0.2 MG, DAILY (1/D), SUBCUTANEOUS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>HYPOPITUITARISM</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060522</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060603</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCORTISONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANDROTARDYL (TESTOSTERONE ENANTATE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LAMICTAL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MINIRIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5060187-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060724</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060327</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-ABBOTT-06P-167-0329250-00</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>53</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MEDICAL DEVICE COMPLICATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030117</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMITRIPTYLINE HCL</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN W/ PROPOXYPHENE HCL</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DICLOFENAC</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROVELLA-14</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5060188-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060724</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060627</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ABBOTT-06P-087-0336923-00</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>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CEFZON</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>50739</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060616</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060617</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OSELTAMIVIR</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060616</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060617</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOSFOMYCIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>050</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060616</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060616</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COCARL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060616</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060619</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TIPEPIDINE HIBENZATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060616</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060619</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PARACETA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060617</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060619</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SG GRANULE</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060617</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060619</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TIPEPIDINE HIBENZATE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060616</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060617</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5060189-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060724</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060328</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-06P-163-0329169-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>56.75</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>LUNG CANCER METASTATIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METASTASES TO BONE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METASTASES TO CENTRAL NERVOUS SYSTEM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPINAL COLUMN STENOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FENTANYL TRANSDERMAL SYSTEM</medicinalproduct>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050501</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugdosagetext>5 MG QD AND 10 MG QOD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MORPHINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050501</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IRBESARTAN</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5060190-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060724</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060706</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BE-ABBOTT-06P-013-0337672-00</companynumb>
    <primarysource>
      <reportercountry>BELGIUM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>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>20050714</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEFLUNOMIDE</medicinalproduct>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALENDRONATE SODIUM</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5060191-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060724</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060714</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ABBOTT-06P-087-0338284-00</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>34</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>65</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD CREATINE PHOSPHOKINASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULAR WEAKNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLARITHROMYCIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>050662</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NASOPHARYNGITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060526</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060528</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NASOPHARYNGITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060526</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060527</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOXOPROFEN SODIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NASOPHARYNGITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060526</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060527</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRANEXAMIC ACID</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NASOPHARYNGITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060526</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060527</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5060192-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060724</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060714</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-06P-163-0338061-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>48.578</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>SKIN ULCER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060203</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060301</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5060193-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060724</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060714</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-ABBOTT-06P-167-0338096-00</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>78</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INTESTINAL PERFORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PELVIC FLUID COLLECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040702</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050315</drugenddate>
        <drugtreatmentduration>256</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATORVASTATIN CALCIUM</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOXAZOSIN MESYLATE</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANSOPRAZOLE</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THYROXINE</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>ASPIRIN</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5060194-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060630</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU200607001034</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>90</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RADIUS FRACTURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EVISTA</medicinalproduct>
        <drugauthorizationnumb>20815</drugauthorizationnumb>
        <drugindication>OSTEOPOROSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOSEC (OMEPRAZOLE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALTRATE (CALCIUM CARBONATE)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5060195-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP200606005227</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>82</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ACRODERMATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERALISED ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PURPURA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN ULCER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GEMZAR</medicinalproduct>
        <drugauthorizationnumb>20509</drugauthorizationnumb>
        <drugdosagetext>500 MG, OTHER, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PANCREATIC CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060418</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060517</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5060196-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060630</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB200606006186</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DEEP VEIN THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HERPES ZOSTER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALIMTA</medicinalproduct>
        <drugauthorizationnumb>21462</drugauthorizationnumb>
        <drugindication>MESOTHELIOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CISPLATIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5060197-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060706</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR200607000799</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>64</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>OPTIC ISCHAEMIC NEUROPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RETINAL ARTERY THROMBOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RALOXIFENE HCL</medicinalproduct>
        <drugauthorizationnumb>20815</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060501</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5060198-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ZA200606006217</companynumb>
    <primarysource>
      <reportercountry>SOUTH AFRICA</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>61</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD CREATINE PHOSPHOKINASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRADYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GRAND MAL CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPONATRAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>DAILY (1/D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>STRESS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060602</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>STILNOX /FRA/ (ZOLPIDEM)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TEMAZEPAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CEPHALOSPORINS AND RELATED SUBSTANCES</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5060199-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060718</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR200606005922</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>77</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CHOLANGITIS SUPPURATIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GEMZAR</medicinalproduct>
        <drugauthorizationnumb>20509</drugauthorizationnumb>
        <drugdosagetext>INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ADENOCARCINOMA PANCREAS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060519</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5060200-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060720</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060627</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006087351</companynumb>
    <primarysource>
      <reportercountry>KOREA, REPUBLIC OF</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENTAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PREGNANCY</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>20051207</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051222</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIAZEPAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAZODONE HCL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5060201-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060720</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060704</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006087478</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>72</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>REFUSAL OF TREATMENT BY RELATIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THERAPY NON-RESPONDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
        <drugauthorizationnumb>20235</drugauthorizationnumb>
        <drugdosagetext>200 MG (100 MG, 2 IN 1 D)</drugdosagetext>
        <drugindication>NEURALGIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040801</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugdosagetext>150 MG (75 MG, 2 IN 1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NEURALGIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ANALGESICS (ANALGESICS)</medicinalproduct>
        <drugindication>NEURALGIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TIAGABINE HCL</medicinalproduct>
        <drugdosagetext>5 MG</drugdosagetext>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DRUG, UNSPECIFIED (DRUG, UNSPECIFIED)</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALL OTHER THERAPEUTIC PRODUCTS (ALL OTHER THERAPEUTIC PRODUCTS)</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIPYRONE TAB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOCLOPRAMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ROPIVACAINE (ROPIVACAINE)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5060202-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060720</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060710</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006-05-0380</companynumb>
    <primarysource>
      <reportercountry>BELGIUM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>70</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>CYTOLYTIC HEPATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG TOXICITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSARTHRIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEMIPARESIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATITIS TOXIC</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TEMODAL</medicinalproduct>
        <drugauthorizationnumb>21029</drugauthorizationnumb>
        <drugdosagetext>75 MG/M2 ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GLIOBLASTOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RADIATION THERAPY (LIKE TEMODAR)</medicinalproduct>
        <drugdosagetext>60 GRAYS/1.8 X-RAY THERAPY</drugdosagetext>
        <drugindication>GLIOBLASTOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LACTULOSE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDROL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5060203-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060720</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060713</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>STA-AE-06-MTX-005</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>33</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWELLING FACE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URTICARIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugauthorizationnumb>8085</drugauthorizationnumb>
        <drugdosagetext>10 MG 1XW - PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCLERITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060602</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060602</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5060204-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060720</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060711</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006-07-0073</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>30</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>49</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERIANAL ABSCESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERIRECTAL ABSCESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEG-INTERFERON ALFA-2B REDIPEN</medicinalproduct>
        <drugdosagetext>80 MCG QWK SUBCUTANEOUS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060518</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RIBAVIRIN</medicinalproduct>
        <drugdosagetext>400 MG BID ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060518</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROMORPHONE HCL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5060205-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060721</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060714</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>OSCN-NL-0303S-0081</companynumb>
    <primarysource>
      <reportercountry>DENMARK</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>55</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ALOPECIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AMNESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHROPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CREATININE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSED MOOD</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMODIALYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE ATROPHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANNICULITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SENSORY DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUBCUTANEOUS NODULE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL ACUITY REDUCED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OMNISCAN</medicinalproduct>
        <drugauthorizationnumb>20123</drugauthorizationnumb>
        <drugdosagetext>50 ML, SINGLE DOSE, I.V.</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RENAL CYST</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020108</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020108</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OMNISCAN</medicinalproduct>
        <drugauthorizationnumb>20123</drugauthorizationnumb>
        <drugdosagetext>50 ML, SINGLE DOSE, I.V.</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RENAL TRANSPLANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020108</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020108</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5060206-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060720</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060706</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>MEDI-0004737</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>11</patientonsetage>
      <patientonsetageunit>802</patientonsetageunit>
      <patientsex>0</patientsex>
      <reaction>
        <reactionmeddrapt>BRONCHITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SYNAGIS</medicinalproduct>
        <drugdosagetext>120 MG, INTRAMUSCULAR</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>ANTIVIRAL PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051007</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060131</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5060207-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060724</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060712</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-GILEAD-2006-0009864</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>100</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL TUBULAR DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPSERA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS B</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPOTHYROIDISM</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>URBANYL</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TERCIAN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FRACTAL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENDOTHELON</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5060208-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060724</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060613</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-GILEAD-2006-0009734</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>62</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HEPATITIS C</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOCALCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOARTHRITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIREAD</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SUSTIVA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SUSTIVA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20001001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030701</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EPIVIR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5060209-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060720</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060706</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>MEDI-0004736</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>27</patientonsetage>
      <patientonsetageunit>802</patientonsetageunit>
      <patientsex>0</patientsex>
      <reaction>
        <reactionmeddrapt>DIARRHOEA HAEMORRHAGIC</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SYNAGIS</medicinalproduct>
        <drugdosagetext>150 MG, INTRAMUSCULAR; SEE IMAGE</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>ANTIVIRAL PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051017</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060302</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SYNAGIS</medicinalproduct>
        <drugdosagetext>150 MG, INTRAMUSCULAR; SEE IMAGE</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>ANTIVIRAL PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051017</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SYNAGIS</medicinalproduct>
        <drugdosagetext>150 MG, INTRAMUSCULAR; SEE IMAGE</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>ANTIVIRAL PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051116</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SYNAGIS</medicinalproduct>
        <drugdosagetext>150 MG, INTRAMUSCULAR; SEE IMAGE</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>ANTIVIRAL PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051212</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SYNAGIS</medicinalproduct>
        <drugdosagetext>150 MG, INTRAMUSCULAR; SEE IMAGE</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>ANTIVIRAL PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060102</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SYNAGIS</medicinalproduct>
        <drugdosagetext>150 MG, INTRAMUSCULAR; SEE IMAGE</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>ANTIVIRAL PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060202</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5060210-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060720</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060705</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>MEDI-0004615</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>8</patientonsetage>
      <patientonsetageunit>802</patientonsetageunit>
      <patientweight>8.05</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRONCHIOLITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SYNAGIS</medicinalproduct>
        <drugdosagetext>1 IN 30 D, INTRAMUSCULAR</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>ANTIVIRAL PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051020</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060111</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SYNAGIS</medicinalproduct>
        <drugdosagetext>1 IN 30 D, INTRAMUSCULAR</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>ANTIVIRAL PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060302</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060302</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SYNAGIS</medicinalproduct>
        <drugdosagetext>1 IN 30 D, INTRAMUSCULAR</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>ANTIVIRAL PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051019</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SYNAGIS</medicinalproduct>
        <drugdosagetext>1 IN 30 D, INTRAMUSCULAR</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>ANTIVIRAL PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051116</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SYNAGIS</medicinalproduct>
        <drugdosagetext>1 IN 30 D, INTRAMUSCULAR</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>ANTIVIRAL PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051214</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SYNAGIS</medicinalproduct>
        <drugdosagetext>1 IN 30 D, INTRAMUSCULAR</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>ANTIVIRAL PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060208</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SALBUTAMOL (SALBUTAMOL)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BETAMETHASONE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5060211-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060720</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060706</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>MEDI-0004750</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>4</patientonsetage>
      <patientonsetageunit>802</patientonsetageunit>
      <patientweight>4.53</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BRONCHIOLITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SYNAGIS</medicinalproduct>
        <drugdosagetext>INTRAMUSCULAR</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>ANTIVIRAL PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051117</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5060212-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060720</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060706</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>MEDI-0004747</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>ARTHRITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SYNAGIS</medicinalproduct>
        <drugdosagetext>195 MG, INTRAMUSCULAR</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>ANTIVIRAL PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051006</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060109</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SYNAGIS</medicinalproduct>
        <drugdosagetext>195 MG, INTRAMUSCULAR</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>ANTIVIRAL PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051006</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SYNAGIS</medicinalproduct>
        <drugdosagetext>195 MG, INTRAMUSCULAR</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>ANTIVIRAL PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051104</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SYNAGIS</medicinalproduct>
        <drugdosagetext>195 MG, INTRAMUSCULAR</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>ANTIVIRAL PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051215</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5060213-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060720</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060706</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>MEDI-0004746</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>11</patientonsetage>
      <patientonsetageunit>802</patientonsetageunit>
      <reaction>
        <reactionmeddrapt>BRONCHITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SYNAGIS</medicinalproduct>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>ANTIVIRAL PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050929</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060130</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SYNAGIS</medicinalproduct>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>ANTIVIRAL PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050929</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SYNAGIS</medicinalproduct>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>ANTIVIRAL PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051031</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SYNAGIS</medicinalproduct>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>ANTIVIRAL PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051130</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SYNAGIS</medicinalproduct>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>ANTIVIRAL PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051229</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5060214-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060720</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060706</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>MEDI-0004738</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>6</patientonsetage>
      <patientonsetageunit>802</patientonsetageunit>
      <patientweight>4.14</patientweight>
      <reaction>
        <reactionmeddrapt>BRONCHIOLITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SYNAGIS</medicinalproduct>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>ANTIVIRAL PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051213</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060301</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SYNAGIS</medicinalproduct>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>ANTIVIRAL PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051213</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SYNAGIS</medicinalproduct>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>ANTIVIRAL PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060104</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SYNAGIS</medicinalproduct>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>ANTIVIRAL PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060206</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5060215-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060720</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060707</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>MEDI-0004763</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>14</patientonsetage>
      <patientonsetageunit>802</patientonsetageunit>
      <reaction>
        <reactionmeddrapt>LARYNGITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SYNAGIS</medicinalproduct>
        <drugdosagetext>INTRAMUSCULAR</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>ANTIVIRAL PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051020</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060209</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SYNAGIS</medicinalproduct>
        <drugdosagetext>INTRAMUSCULAR</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>ANTIVIRAL PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051020</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SYNAGIS</medicinalproduct>
        <drugdosagetext>INTRAMUSCULAR</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>ANTIVIRAL PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051115</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SYNAGIS</medicinalproduct>
        <drugdosagetext>INTRAMUSCULAR</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>ANTIVIRAL PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051213</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SYNAGIS</medicinalproduct>
        <drugdosagetext>INTRAMUSCULAR</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>ANTIVIRAL PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060112</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5060216-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060720</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060707</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>MEDI-0004760</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>18</patientonsetage>
      <patientonsetageunit>802</patientonsetageunit>
      <reaction>
        <reactionmeddrapt>RESPIRATORY FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SYNAGIS</medicinalproduct>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugindication>ANTIVIRAL PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051006</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SYNAGIS</medicinalproduct>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugindication>ANTIVIRAL PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051006</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SYNAGIS</medicinalproduct>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugindication>ANTIVIRAL PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051107</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SYNAGIS</medicinalproduct>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugindication>ANTIVIRAL PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051205</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SYNAGIS</medicinalproduct>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugindication>ANTIVIRAL PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060109</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5060217-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060720</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060707</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>MEDI-0004753</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>3</patientonsetage>
      <patientonsetageunit>802</patientonsetageunit>
      <reaction>
        <reactionmeddrapt>BRONCHIOLITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SYNAGIS</medicinalproduct>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>ANTIVIRAL PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060116</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060313</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SYNAGIS</medicinalproduct>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>ANTIVIRAL PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060116</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SYNAGIS</medicinalproduct>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>ANTIVIRAL PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060213</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5060218-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060720</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060707</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>MEDI-0004752</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>16</patientonsetage>
      <patientonsetageunit>802</patientonsetageunit>
      <reaction>
        <reactionmeddrapt>BREATH HOLDING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SYNAGIS</medicinalproduct>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>ANTIVIRAL PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051025</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060214</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SYNAGIS</medicinalproduct>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>ANTIVIRAL PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051025</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SYNAGIS</medicinalproduct>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>ANTIVIRAL PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051122</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SYNAGIS</medicinalproduct>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>ANTIVIRAL PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051202</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SYNAGIS</medicinalproduct>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>ANTIVIRAL PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060117</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5060219-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060720</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060713</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-2006-019067</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL DISTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ACNE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ALOPECIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISTURBANCE IN ATTENTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FURUNCLE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF LIBIDO</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOOD SWINGS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NIGHT SWEATS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVARIAN CYST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SLEEP DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</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>20040101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5060220-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060720</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060714</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PL-2006-013416</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>46</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</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>20050722</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5060221-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060720</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060711</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-2006-016902</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>25</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FACIAL PALSY</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>20060101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060605</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5060222-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060720</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060711</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-2006-016916</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>1</qualification>
    </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>YASMIN</medicinalproduct>
        <drugauthorizationnumb>21098</drugauthorizationnumb>
        <drugdosagetext>1 TAB (S), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5060223-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060720</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060710</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PT-2006-018380</companynumb>
    <primarysource>
      <reportercountry>PORTUGAL</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>71</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>80</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANAPHYLACTIC SHOCK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONTRAST MEDIA REACTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ULTRAVIST 300</medicinalproduct>
        <drugbatchnumb>54517B</drugbatchnumb>
        <drugauthorizationnumb>20220</drugauthorizationnumb>
        <drugdosagetext>150 ML, 1 DOSE, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>SCAN WITH CONTRAST</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060622</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060622</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5060224-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060720</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060711</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IT-2006-018403</companynumb>
    <primarysource>
      <reportercountry>ITALY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>76</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DISSEMINATED INTRAVASCULAR COAGULATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ULTRAVIST 300</medicinalproduct>
        <drugauthorizationnumb>20220</drugauthorizationnumb>
        <drugdosagetext>300 UL, 1 DOSE, IV DRIP</drugdosagetext>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>COMPUTERISED TOMOGRAM ABDOMEN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060615</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060615</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5060225-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060720</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060706</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-2006-013479</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>24</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>IMMUNODEFICIENCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE SCLEROSIS RELAPSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BETASERON</medicinalproduct>
        <drugdosagetext>1 ML, SUBCUTANEOUS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060201</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5060226-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060724</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060703</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CG-MERCK-0607USA00705</companynumb>
    <primarysource>
      <reportercountry>CONGO</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>25</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VERTIGO</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>STROMECTOL</medicinalproduct>
        <drugauthorizationnumb>050742</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060519</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060519</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5060227-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060724</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060711</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ES-MERCK-0607USA04262</companynumb>
    <primarysource>
      <reportercountry>SPAIN</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>77</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERKALAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MODURETIC 5-50</medicinalproduct>
        <drugauthorizationnumb>018201</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ESSENTIAL HYPERTENSION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060315</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRAVASTATIN SODIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>LIPID METABOLISM DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SINTROM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5060228-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060724</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060703</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CG-MERCK-0607USA00536</companynumb>
    <primarysource>
      <reportercountry>CONGO</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>27</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTHERMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENTAL STATUS CHANGES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OCULAR HYPERAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TEMPERATURE INTOLERANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VERTIGO</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>STROMECTOL</medicinalproduct>
        <drugauthorizationnumb>050742</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060527</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060527</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5060229-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060724</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060127</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-MERCK-0601FRA00100</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>74</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG ERUPTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA MULTIFORME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PURPURA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>20560</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050503</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN LYSINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050503</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATORVASTATIN CALCIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050503</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM CARBONATE AND CHOLECALCIFEROL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050503</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VINBURNINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050503</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5060230-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060724</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060703</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CG-MERCK-0607USA00691</companynumb>
    <primarysource>
      <reportercountry>CONGO</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>35</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OCULAR HYPERAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>STROMECTOL</medicinalproduct>
        <drugauthorizationnumb>050742</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060520</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060520</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5060231-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060724</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060228</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0603USA00132</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>83</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HIP FRACTURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>20560</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5060232-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060724</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060703</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CG-MERCK-0607USA00706</companynumb>
    <primarysource>
      <reportercountry>CONGO</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>20</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VERTIGO</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>STROMECTOL</medicinalproduct>
        <drugauthorizationnumb>050742</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060520</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060520</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5060233-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060720</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060707</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-2005-026414</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>33</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ACUTE CORONARY SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIOMYOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENTAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENTAL IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE SCLEROSIS RELAPSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUFFOCATION FEELING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL ACUITY REDUCED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BETASERON</medicinalproduct>
        <drugdosagetext>1 AMP EVERY 2D, SUBCUTANEOUS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RELAPSING-REMITTING MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030107</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5060234-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060720</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060713</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-2005-004331</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>82</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>SCLERODERMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SOTALOL HYDROCHLORIDE</medicinalproduct>
        <drugauthorizationnumb>19865</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5060235-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060720</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060710</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-2006-018872</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>19</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>55</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FORMICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOTOR DYSFUNCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPEECH DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YASMIN</medicinalproduct>
        <drugauthorizationnumb>21098</drugauthorizationnumb>
        <drugdosagetext>1 (TAB(S), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060622</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5060236-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060724</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060703</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CG-MERCK-0607USA00698</companynumb>
    <primarysource>
      <reportercountry>CONGO</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>30</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANOREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VERTIGO</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>STROMECTOL</medicinalproduct>
        <drugauthorizationnumb>050742</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060520</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060520</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5060237-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060724</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050811</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0508USA02131</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>54</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ALLERGIC GRANULOMATOUS ANGIITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRONCHITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CATARACT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MONONEURITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL FIELD DEFECT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SINGULAIR</medicinalproduct>
        <drugauthorizationnumb>20829</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERSENSITIVITY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050601</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SINGULAIR</medicinalproduct>
        <drugauthorizationnumb>020829</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHINITIS ALLERGIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050601</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NASONEX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALAVERT</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NAPROXEN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYANOCOBALAMIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZITHROMAX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5060238-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060724</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20051219</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0604USA03048</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>54</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ALLERGIC GRANULOMATOUS ANGIITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SINGULAIR</medicinalproduct>
        <drugauthorizationnumb>20829</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHINITIS ALLERGIC</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5060239-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060724</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060703</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CG-MERCK-0607USA00703</companynumb>
    <primarysource>
      <reportercountry>CONGO</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>45</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ENCEPHALOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OCULAR HYPERAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY TRACT DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>STROMECTOL</medicinalproduct>
        <drugauthorizationnumb>50742</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060519</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060519</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5060240-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060724</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060703</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CG-MERCK-0607USA00688</companynumb>
    <primarysource>
      <reportercountry>CONGO</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>37</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OCULAR HYPERAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VERTIGO</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>STROMECTOL</medicinalproduct>
        <drugauthorizationnumb>050742</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060522</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060522</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5060241-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060724</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060505</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-MERCK-0605GBR00035</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>71</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>GLOBAL AMNESIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugauthorizationnumb>019766</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERCHOLESTEROLAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020910</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060322</drugenddate>
        <drugtreatmentduration>1290</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GLOBAL AMNESIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050715</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>TRANSIENT ISCHAEMIC ATTACK</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050715</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOTHIEPIN HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050314</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060111</drugenddate>
        <drugtreatmentduration>304</drugtreatmentduration>
        <drugtreatmentdurationunit></drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN AND PROPOXYPHENE HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021015</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060111</drugenddate>
        <drugtreatmentduration>1185</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5060242-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060724</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060703</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CG-MERCK-0607USA00690</companynumb>
    <primarysource>
      <reportercountry>CONGO</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>33</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANOREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OCULAR HYPERAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>STROMECTOL</medicinalproduct>
        <drugauthorizationnumb>050742</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060527</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060527</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5060243-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060724</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060703</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CG-MERCK-0607USA00697</companynumb>
    <primarysource>
      <reportercountry>CONGO</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>37</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OCULAR HYPERAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>STROMECTOL</medicinalproduct>
        <drugauthorizationnumb>050742</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060519</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060519</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5060244-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060724</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060703</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CG-MERCK-0607USA00701</companynumb>
    <primarysource>
      <reportercountry>CONGO</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>60</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>AGITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHILLS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VERTIGO</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>STROMECTOL</medicinalproduct>
        <drugauthorizationnumb>050742</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060520</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060520</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5060245-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060720</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060711</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006-06-0414</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>71</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>57</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>LYMPH NODE TUBERCULOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY TUBERCULOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT 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>20050509</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051011</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>20050509</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060511</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>20051018</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060511</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBETOL</medicinalproduct>
        <drugdosagetext>600 MG ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050509</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060516</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EPADEL (ETHYL ICOSAPENTATE) CAPSULES</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5060246-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060720</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060711</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006-06-0633</companynumb>
    <primarysource>
      <reportercountry>LUXEMBOURG</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>71</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BRONCHITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIABETES MELLITUS INADEQUATE CONTROL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IATROGENIC INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERSTITIAL LUNG DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEG-INTRON</medicinalproduct>
        <drugdosagetext>80 UG QWK SUBCUTANEOUS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050628</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050930</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBETOL</medicinalproduct>
        <drugdosagetext>800 MG  QD ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050628</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050930</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARVEDILOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UTROGESTAN (MICRONIZED ORAL PROGESTERONE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACTONEL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM CARBONATE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5060247-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060720</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060706</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>227163</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>56</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>SQUAMOUS CELL CARCINOMA OF SKIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MABTHERA (RITUXIMAB) CONC FOR SOLUTION FOR INFUSION</medicinalproduct>
        <drugdosagetext>1 1/WEEK</drugdosagetext>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5060248-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060720</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060703</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>226981</companynumb>
    <primarysource>
      <reportercountry>SWITZERLAND</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>31</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MABTHERA (RITUXIMAB) CONC FOR SOLUTION FOR INFUSION</medicinalproduct>
        <drugdosagetext>1000 MG, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BEHCET'S SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060501</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5060249-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060724</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060703</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CG-MERCK-0607USA00700</companynumb>
    <primarysource>
      <reportercountry>CONGO</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>36</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OCULAR HYPERAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>STROMECTOL</medicinalproduct>
        <drugauthorizationnumb>050742</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060527</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060527</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5060250-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060724</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060714</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0607USA02952</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>51</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ADVERSE EVENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD TRIGLYCERIDES INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIABETES MELLITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GOUT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIPODYSTROPHY ACQUIRED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CRIXIVAN</medicinalproduct>
        <drugauthorizationnumb>20685</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMBIVIR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5060251-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060724</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060703</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CG-MERCK-0607USA00689</companynumb>
    <primarysource>
      <reportercountry>CONGO</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>33</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OCULAR HYPERAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>STROMECTOL</medicinalproduct>
        <drugauthorizationnumb>050742</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060520</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060520</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5060252-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060720</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060710</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-2006-019002</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BENIGN BREAST NEOPLASM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEOPLASM PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YASMIN</medicinalproduct>
        <drugauthorizationnumb>21098</drugauthorizationnumb>
        <drugdosagetext>1 TAB(S), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060201</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5060253-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060724</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060717</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-MERCK-0607DEU00164</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PSYCHOTIC DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROSCAR</medicinalproduct>
        <drugauthorizationnumb>020180</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BENIGN PROSTATIC HYPERPLASIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5060254-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060724</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060703</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CG-MERCK-0607USA00702</companynumb>
    <primarysource>
      <reportercountry>CONGO</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>46</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VERTIGO</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>STROMECTOL</medicinalproduct>
        <drugauthorizationnumb>050742</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060527</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060527</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5060255-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060724</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20051021</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0510USA09085</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>74</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOMYELITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BONE DISORDER</drugindication>
        <drugtreatmentduration>52</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PAMIDRONATE DISODIUM</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BONE DISORDER</drugindication>
        <drugtreatmentduration>14</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLEDRONATE DISODIUM</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BONE DISORDER</drugindication>
        <drugtreatmentduration>27</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEUKINE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>BONE DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ESTRADIOL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ROSIGLITAZONE MALEATE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELECOXIB</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ISOTRETINOIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DUTASTERIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEUPROLIDE ACETATE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOXYCYCLINE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATORVASTATIN CALCIUM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EPOETIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ESOMEPRAZOLE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGNESIUM (UNSPECIFIED)</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PEG-INTRON</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>UBIDECARENONE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CAMELLIA SINENSIS</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN E</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LYCOPENE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>[THERAPY UNSPECIFIED]</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SOYBEAN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5060256-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060724</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060703</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CG-MERCK-0607USA00699</companynumb>
    <primarysource>
      <reportercountry>CONGO</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANOREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OCULAR HYPERAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>STROMECTOL</medicinalproduct>
        <drugauthorizationnumb>050742</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060526</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060526</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5060257-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060724</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060703</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CG-MERCK-0607USA00696</companynumb>
    <primarysource>
      <reportercountry>CONGO</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>22</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DEPRESSED LEVEL OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OCULAR HYPERAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VERTIGO</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>STROMECTOL</medicinalproduct>
        <drugauthorizationnumb>050742</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060526</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060526</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5060258-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060724</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060703</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CG-MERCK-0607USA00712</companynumb>
    <primarysource>
      <reportercountry>CONGO</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>21</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NECK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OCULAR HYPERAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>STROMECTOL</medicinalproduct>
        <drugauthorizationnumb>050742</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060520</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060520</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5060259-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060724</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050314</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0503USA02312</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>81</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>84</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EXOSTOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN JAW</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>20560</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20001101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050301</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MIACALCIN</medicinalproduct>
        <drugadministrationroute>055</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EVISTA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ECOTRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLTX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VASOTEC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MOBIC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5060260-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060724</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060703</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CG-MERCK-0607USA00692</companynumb>
    <primarysource>
      <reportercountry>CONGO</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>25</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTHERMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OCULAR HYPERAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VERTIGO</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>STROMECTOL</medicinalproduct>
        <drugauthorizationnumb>050742</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060526</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060526</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5060261-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060724</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060703</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CG-MERCK-0607USA00694</companynumb>
    <primarysource>
      <reportercountry>CONGO</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>17</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OCULAR HYPERAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VERTIGO</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>STROMECTOL</medicinalproduct>
        <drugauthorizationnumb>050742</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060520</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060520</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5060262-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060724</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-MERCK-0606DEU00159</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>81</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>75</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANGINA PECTORIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIOVASCULAR DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHILLS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING COLD</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRUSOPT</medicinalproduct>
        <drugauthorizationnumb>020408</drugauthorizationnumb>
        <drugadministrationroute>047</drugadministrationroute>
        <drugindication>GLAUCOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060529</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060606</drugenddate>
        <drugtreatmentduration>9</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XANTHOPHYLL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GINKGO</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050901</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MINERALS (UNSPECIFIED) AND VITAMINS (UNSPECIFIED)</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5060263-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060720</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060707</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006MP000869</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>81</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>EOSINOPHILIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AGGRASTAT</medicinalproduct>
        <drugauthorizationnumb>20912</drugauthorizationnumb>
        <drugdosagetext>X1;IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MYOCARDIAL ISCHAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060618</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060619</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLOPIDOGREL BISULFATE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5060264-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060720</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060711</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006-01633</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>0</patientsex>
      <reaction>
        <reactionmeddrapt>NO ADVERSE DRUG EFFECT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VELCADE</medicinalproduct>
        <drugauthorizationnumb>21602</drugauthorizationnumb>
        <drugdosagetext>2.50 MG, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5060265-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060720</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060713</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006-00352</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>61</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>52</patientweight>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>DISEASE PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOALBUMINAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MARROW HYPERPLASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE MYELOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLEURAL EFFUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VELCADE</medicinalproduct>
        <drugauthorizationnumb>21602</drugauthorizationnumb>
        <drugdosagetext>1.80 MG/M2, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050526</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050605</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FAMOTIDINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALFAROL (ALFACALCIDOL)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SULFAMETHOXAZOLE + TRIMETHOPRIM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OZEX (TOSUFLOXACIN TOSILATE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIFLUCAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MUCODYNE (CARBOCISTEINE)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5060266-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060720</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060712</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006-06-1222</companynumb>
    <primarysource>
      <reportercountry>BELGIUM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>36</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>AUTOIMMUNE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE SCLEROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NYSTAGMUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POLYNEUROPATHY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEG-INTRON</medicinalproduct>
        <drugdosagetext>100 MCG QWK SUBCUTANEOUS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060327</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060619</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>20060327</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060619</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZANTAC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DYSPEPSIA</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5060267-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060720</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060714</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>T200600087</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>86</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONTRAST MEDIA REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSED LEVEL OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SHOCK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SNEEZING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OPTIRAY 320</medicinalproduct>
        <drugbatchnumb>5111855T</drugbatchnumb>
        <drugauthorizationnumb>19710</drugauthorizationnumb>
        <drugdosagetext>70 ML, SINGLE, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COMPUTERISED TOMOGRAM ABDOMEN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060313</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060313</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5060268-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060720</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060711</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>T200600727</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>64</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCONTINENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SHOCK</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEXABRIX</medicinalproduct>
        <drugauthorizationnumb>18905</drugauthorizationnumb>
        <drugdosagetext>10 ML, SINGLE</drugdosagetext>
        <drugindication>CATHETERISATION CARDIAC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060610</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060610</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5060269-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060724</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060703</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CG-MERCK-0607USA00704</companynumb>
    <primarysource>
      <reportercountry>CONGO</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>45</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANOREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OCULAR HYPERAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>STROMECTOL</medicinalproduct>
        <drugauthorizationnumb>050742</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060521</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060521</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5060270-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060720</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060707</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CERZ-11277</companynumb>
    <primarysource>
      <reportercountry>MEXICO</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>20</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>33</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CEREZYME</medicinalproduct>
        <drugauthorizationnumb>20367</drugauthorizationnumb>
        <drugdosagetext>90 U/KG IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>GAUCHER'S DISEASE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5060271-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060720</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060710</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>227197</companynumb>
    <primarysource>
      <reportercountry>SWITZERLAND</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HERPES ZOSTER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RAPTIVA</medicinalproduct>
        <drugdosagetext>0.142 MG/KG, 1/WEEK, SUBCUTANEOUS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PSORIASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060405</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5060272-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060720</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060713</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006-02910</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>15</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCREATITIS ACUTE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ERYTHROMYCIN</medicinalproduct>
        <drugauthorizationnumb>62087</drugauthorizationnumb>
        <drugdosagetext>5.3 G, SINGLE, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OVERDOSE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5060273-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060720</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060711</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006-02877</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>32</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HEPATIC ENZYME INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRELSTAR DEPOT</medicinalproduct>
        <drugauthorizationnumb>20715</drugauthorizationnumb>
        <drugdosagetext>3 MG, 1 IN 28D, INTRAMUSCULAR</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>INFERTILITY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060408</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060512</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GONAL-F</medicinalproduct>
        <drugdosagetext>150 IU, 1 IN 1 D, SUBCUTANEOUS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>OVARIAN DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060505</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060512</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OVITRELLE (CHORIOGONADOTROPIN ALFA)</medicinalproduct>
        <drugdosagetext>2 DOSAGE FORMS, SUBCUTANEOUS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>OVARIAN DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060514</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060514</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5060274-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060720</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060704</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>227455</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>58</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>VENTRICULAR FLUTTER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HERCEPTIN</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060427</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060519</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EPIRUBICIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYCLOPHOSPHAMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RADIATION (RADIATION THERAPY)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5060275-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060720</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060710</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006BH011761</companynumb>
    <primarysource>
      <reportercountry>NEW ZEALAND</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>5</patientonsetage>
      <patientonsetageunit>802</patientonsetageunit>
      <patientsex>0</patientsex>
      <reaction>
        <reactionmeddrapt>BLISTER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EMOTIONAL DISTRESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFUSION SITE OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN GRAFT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct> 5 % DEXTROSE AND 0.45% SODIUM CHLORIDE INJECTION IN PLASTIC CONTAINER</medicinalproduct>
        <drugauthorizationnumb>16683</drugauthorizationnumb>
        <drugdosagetext>36 ML;EVERY HR;IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>LAPAROSCOPIC SURGERY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SODIUM CHLORIDE</medicinalproduct>
        <drugdosagetext>100 ML;IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>LAPAROSCOPIC SURGERY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MORPHINE</medicinalproduct>
        <drugdosagetext>9 ML;IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>LAPAROSCOPIC SURGERY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5060276-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060720</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060703</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>227499</companynumb>
    <primarysource>
      <reportercountry>NETHERLANDS</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>72</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVASTIN</medicinalproduct>
        <drugdosagetext>590 MG, Q3W, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLORECTAL CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060428</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CAPECITABINE (CAPECITABINE)</medicinalproduct>
        <drugdosagetext>2000 MG, BID, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>COLORECTAL CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060428</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXALIPLATIN (OXALIPLATIN)</medicinalproduct>
        <drugdosagetext>260 MG, Q3W, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLORECTAL CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060428</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROSCAR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DURAGESIC-100</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXAZEPAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCODONE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZINC (ZINC NOS)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5060277-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060720</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060703</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>227502</companynumb>
    <primarysource>
      <reportercountry>HONG KONG</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>41</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD CREATININE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVASTIN</medicinalproduct>
        <drugdosagetext>570 MG, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>HEPATIC NEOPLASM MALIGNANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060516</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060627</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CAPECITABINE (CAPECITABINE)</medicinalproduct>
        <drugdosagetext>1800 MG, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATIC NEOPLASM MALIGNANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060516</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060627</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LAMIVUDINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIROLIMUS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM CHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADEFOVIR DIPIVOXIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NIFEDIPINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PYRIDOXINE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOCLOPRAMIDE HCL (METOCLOPRAMIDE HYDROCHLORIDE)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5060278-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060724</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060703</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CG-MERCK-0607USA00693</companynumb>
    <primarysource>
      <reportercountry>CONGO</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>15</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OCULAR HYPERAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>STROMECTOL</medicinalproduct>
        <drugauthorizationnumb>050742</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060520</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060520</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5060279-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060724</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060703</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CG-MERCK-0607USA00695</companynumb>
    <primarysource>
      <reportercountry>CONGO</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>28</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OCULAR HYPERAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>STROMECTOL</medicinalproduct>
        <drugauthorizationnumb>050742</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060521</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060521</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5060280-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060724</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060714</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-MERCK-0607DEU00122</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>75</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HEPATITIS TOXIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHABDOMYOLYSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VYTORIN</medicinalproduct>
        <drugauthorizationnumb>21687</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERCHOLESTEROLAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060601</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOPIDOGREL BISULFATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CORONARY ARTERY DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060601</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>[THERAPY UNSPECIFIED]</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5060281-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060720</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060704</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>226531</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>52</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>NEPHROTIC SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVASTIN</medicinalproduct>
        <drugindication>GASTROINTESTINAL CARCINOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CHEMOTHERAPY</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5060282-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060720</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060630</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>226310</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>72</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>92</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG TOXICITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SCLERODERMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVASTIN</medicinalproduct>
        <drugdosagetext>750 MG, Q3W, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLORECTAL CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060206</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MITOMYCIN</medicinalproduct>
        <drugindication>COLORECTAL CANCER METASTATIC</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XELODA</medicinalproduct>
        <drugdosagetext>3300 MG, QD, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>COLORECTAL CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060206</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNSPECIFIED MEDICATIONS (GENERIC COMPONENTS)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PERINDOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INDAPAMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRONOLACTONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PAROXETINE (PAROXETINE HYDROCHLORIDE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DESLORATADINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PYROXIN (PYRIDOXINE HYDROCHLORIDE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANADEINE FORTE (ACETAMINOPHEN, CODEINE PHOSPHATE)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5060283-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060720</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060704</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>226474</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>0</patientsex>
      <reaction>
        <reactionmeddrapt>TUMOUR HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVASTIN</medicinalproduct>
        <drugindication>COLON CANCER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5060284-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060724</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060718</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0607USA03926</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>VASCULITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SINGULAIR</medicinalproduct>
        <drugauthorizationnumb>020829</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5060285-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060720</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060705</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>222535</companynumb>
    <primarysource>
      <reportercountry>BELGIUM</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>71</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABSCESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABSCESS BACTERIAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRAIN OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBRAL ASPERGILLOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBRAL TOXOPLASMOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ENCEPHALITIS HERPES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMMUNODEFICIENCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NOCARDIOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMOCYSTIS JIROVECI PNEUMONIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MABTHERA (RITUXIMAB) CONC FOR SOLUTION FOR INFUSION</medicinalproduct>
        <drugdosagetext>500 MG/M2, 1/MONTH, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CHRONIC LYMPHOCYTIC LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051018</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060215</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOPHOSPHAMIDE</medicinalproduct>
        <drugdosagetext>250 MG/M2, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CHRONIC LYMPHOCYTIC LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051019</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUDARABINE</medicinalproduct>
        <drugdosagetext>25 MG/M2, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CHRONIC LYMPHOCYTIC LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051019</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BISOPROLOL FUMARATE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5060286-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060720</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060711</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>225398</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>78</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>75</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG TOXICITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY HYPERTENSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MABTHERA (RITUXIMAB) CONC FOR SOLUTION FOR INFUSION</medicinalproduct>
        <drugdosagetext>375 MG/M2, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MANTLE CELL LYMPHOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060301</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUDARABINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIPARINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5060287-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060720</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060710</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GXKR2006FR03598</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>38</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ELECTROCARDIOGRAM QRS COMPLEX PROLONGED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLATULENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMODIALYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYDRONEPHROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERKALAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OBSTRUCTIVE UROPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SULFADIAZINE</medicinalproduct>
        <drugauthorizationnumb>40091</drugauthorizationnumb>
        <drugdosagetext>4 G/DAY</drugdosagetext>
        <drugindication>TOXOPLASMOSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PYRIMETHAMINE TAB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLINDAMYCIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5060288-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060720</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060705</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2006JP10183</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>54</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BREAST MICROCALCIFICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HERPES ZOSTER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERKERATOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTRADUCTAL PAPILLOMA OF BREAST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NIPPLE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAGET'S DISEASE OF THE BREAST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMOCYSTIS JIROVECI PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN PAPILLOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOSPORINE</medicinalproduct>
        <drugauthorizationnumb>40194</drugauthorizationnumb>
        <drugdosagetext>75 MG/D, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RENAL TRANSPLANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19890101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AZATHIOPRINE</medicinalproduct>
        <drugdosagetext>50 MG/D, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RENAL TRANSPLANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19890101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHYLPREDNISOLONE</medicinalproduct>
        <drugdosagetext>8 MG, Q48H, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RENAL TRANSPLANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19890101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5060289-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060720</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060712</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>430005E06DEU</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>70</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ACUTE MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD LACTATE DEHYDROGENASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ELECTROCARDIOGRAM ST SEGMENT DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENTRICULAR TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NOVANTRONE</medicinalproduct>
        <drugauthorizationnumb>19297</drugauthorizationnumb>
        <drugdosagetext>INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ACUTE MYELOID LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051126</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051128</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GEMTUZUMAB OZOGAMICIN</medicinalproduct>
        <drugdosagetext>12.18 MG, ONCE</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051110</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYTARABINE</medicinalproduct>
        <drugdosagetext>INTRAVENOUS</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051122</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051130</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ETOPOSIDE</medicinalproduct>
        <drugdosagetext>INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051122</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051124</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RAMIPRIL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5060290-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060720</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060711</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>222758</companynumb>
    <primarysource>
      <reportercountry>SWITZERLAND</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>49</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MENINGITIS CRYPTOCOCCAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RAPTIVA</medicinalproduct>
        <drugdosagetext>1 MG/KG, 1/WEEK, SUBCUTANEOUS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PSORIASIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5060291-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060720</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060710</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>227252</companynumb>
    <primarysource>
      <reportercountry>SPAIN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>36</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BRONCHOSPASM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XOLAIR</medicinalproduct>
        <drugdosagetext>300 MG, Q2W</drugdosagetext>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5060292-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060720</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060710</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006-01733</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>45</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ATRIAL THROMBOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VELCADE</medicinalproduct>
        <drugauthorizationnumb>21602</drugauthorizationnumb>
        <drugdosagetext>2.60 MG, INTRAVENOUS; 1.90 MG, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050111</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VELCADE</medicinalproduct>
        <drugauthorizationnumb>21602</drugauthorizationnumb>
        <drugdosagetext>2.60 MG, INTRAVENOUS; 1.90 MG, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THALIDOMIDE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5060293-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060720</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060713</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006-01652</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>68</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>67</patientweight>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>INTERSTITIAL LUNG DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VELCADE</medicinalproduct>
        <drugauthorizationnumb>21602</drugauthorizationnumb>
        <drugindication>MULTIPLE MYELOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MORPHINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOCLOPRAMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCONTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCODONE (OXYCODONE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ONDANSETRON</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CITALOPRAM HYDROBROMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANTOPRAZOLE SODIUM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5060294-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060720</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060706</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2005-00347</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>46</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>114.5</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BEDRIDDEN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISEASE PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYDRONEPHROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPHADENOPATHY MEDIASTINAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METASTASES TO LYMPH NODES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METASTASES TO RETROPERITONEUM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLEURAL EFFUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URETERIC OBSTRUCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VELCADE</medicinalproduct>
        <drugbatchnumb>YB010A3</drugbatchnumb>
        <drugauthorizationnumb>21602</drugauthorizationnumb>
        <drugdosagetext>2.09 MG, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050110</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050210</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5060295-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060720</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>226895</companynumb>
    <primarysource>
      <reportercountry>SPAIN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>56</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>85</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ACUTE CORONARY SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NONSPECIFIC REACTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MABTHERA(RITUXIMAB) CONC FOR SOLUTION FOR INFUSION</medicinalproduct>
        <drugbatchnumb>B??33/B0078</drugbatchnumb>
        <drugdosagetext>500 MG/M2, Q3W, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060327</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060619</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOPHOSPHAMIDE</medicinalproduct>
        <drugbatchnumb>5A508</drugbatchnumb>
        <drugdosagetext>200 MG/M2, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060328</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060619</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUDARABINE</medicinalproduct>
        <drugbatchnumb>5U?2E</drugbatchnumb>
        <drugdosagetext>25 MG/M2, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050328</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060619</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MITOXANTRONE</medicinalproduct>
        <drugbatchnumb>G??3</drugbatchnumb>
        <drugdosagetext>6 MG/M2, Q3W, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060328</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060619</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5060296-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060720</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060712</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>225668</companynumb>
    <primarysource>
      <reportercountry>SPAIN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>66</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>69.5</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FEBRILE NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STAPHYLOCOCCAL INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MABTHERA(RITUXIMAB) CONC FOR SOLUTION FOR INFUSION</medicinalproduct>
        <drugdosagetext>375 MG/M2, Q3W, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NON-HODGKIN'S LYMPHOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050310</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUDARABINE</medicinalproduct>
        <drugdosagetext>25 MG/M2, Q3W, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NON-HODGKIN'S LYMPHOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050209</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOPHOSPHAMIDE</medicinalproduct>
        <drugdosagetext>1000 MG/M2, Q3W, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NON-HODGKIN'S LYMPHOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050209</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SEPTRIN FORTE (SULFAMETHOXAZOLE, TRIMETHOPRIM)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CITALOPRAM HYDROBROMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ORPHOL (ERGOLOID MESYLATES)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5060297-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060720</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060621</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>217743</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>51</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>112.8</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ARTERIAL OCCLUSIVE DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTERIAL THROMBOSIS LIMB</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BETA HAEMOLYTIC STREPTOCOCCAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEEP VEIN THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EXTREMITY NECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERAL PHYSICAL HEALTH DETERIORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC FUNCTION ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATORENAL FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMPAIRED HEALING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JOINT ABSCESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LESION OF SCIATIC NERVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METASTASES TO LUNG</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEOPLASM RECURRENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERONEAL NERVE PALSY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYOTHORAX</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH MACULO-PAPULAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STAPHYLOCOCCAL SEPSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVASTIN</medicinalproduct>
        <drugdosagetext>590 MG, Q2W, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLON CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050429</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050722</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEUCOVORIN CALCIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUOROURACIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IRINOTECAN HCL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5060298-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060720</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060710</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>227207</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>76</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>61</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HYDRONEPHROSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MABTHERA(RITUXIMAB) CONC FOR SOLUTION FOR INFUSION</medicinalproduct>
        <drugindication>NON-HODGKIN'S LYMPHOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20001013</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020418</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5060299-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060707</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CHWYE058307JUL06</companynumb>
    <primarysource>
      <reportercountry>SWITZERLAND</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>32</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANGIONEUROTIC OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TYPE I HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EFFEXOR</medicinalproduct>
        <drugauthorizationnumb>20699</drugauthorizationnumb>
        <drugdosagetext>75 MG 1X PER 1 DAY ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060509</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060509</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUOXETINE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUOXETINE HCL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5060301-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060707</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CAWYE086910JUL06</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>24</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CLOT RETRACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRIAPISM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EFFEXOR XR</medicinalproduct>
        <drugauthorizationnumb>20699</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5060302-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060710</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GBWYE084310JUL06</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>43</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BILIARY SEPSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GEMTUZUMAB OZOGAMICIN (GEMTUZUMAB OZOGAMICIN, INJECTION)</medicinalproduct>
        <drugauthorizationnumb>21174</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5060303-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060714</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>HQWYE350215MAY06</companynumb>
    <primarysource>
      <reportercountry>TURKEY</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>47</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>KIDNEY TRANSPLANT REJECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RAPAMUNE</medicinalproduct>
        <drugauthorizationnumb>21110</drugauthorizationnumb>
        <drugdosagetext>8 MG 1X PER 1 DAY ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS AGAINST TRANSPLANT REJECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051118</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5060304-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060714</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>THQ2006A00440</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>65</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ALANINE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASPARTATE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE MARROW FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CANDIDIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATOSPLENOMEGALY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCYTOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LANSOPRAZOLE</medicinalproduct>
        <drugindication>HELICOBACTER INFECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AZATHIOPRINE SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLARITHROMYCIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METRONIDAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN W/ PROPOXYPHENE HCL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5060305-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060710</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>TCI2006A00758</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>43</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL DISTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASCITES</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEUPROLIDE ACETATE</medicinalproduct>
        <drugdosagetext>3.75 MG (3.75 MG, 1 IN 28 D) SUBCUTANEOUS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>ENDOMETRIOSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051021</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051111</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5060306-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20061208</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20060719</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060710</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>TCI2006A00283</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>60</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL DISTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG ERUPTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FACE OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINE OUTPUT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAKEPRON CAPSULES 30 (LANSOPRAZOLE) (CAPSULE)</medicinalproduct>
        <drugdosagetext>30 MG (30 MG, 1 IN 1 D) PER ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindicat